CeramTec GMBH v. CoorsTek Bioceramics LLC

Case: 23-1502 Document: 1-1 Page: 1 Filed: 02/13/2023 (1 of 113)
UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT
717 MADISON PLACE, N.W.
WASHINGTON, D.C. 20439
PETER R. MARKSTEINER CLERK’S OFFICE

CLERK OF COURT 202-275-8000
February 13, 2023
NOTICE OF DOCKETING
Federal Circuit Docket No.: 2023-1502
Federal Circuit Short Caption: CeramTec GmbH v. CoorsTek Bioceramics LLC
Date of Docketing: February 13, 2023
Originating Tribunal: United States Patent and Trademark Office
Originating Case No.: 92058781, 92058796
Appellant: CeramTec GmbH
A petition for review has been filed and assigned the above Federal Circuit case
number. The court's official caption is included as an attachment to this notice. Unless
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/s/ Peter R. Marksteiner

Peter R. Marksteiner
Clerk of Court
By: C. Harper, Deputy Clerk

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cc: United States Patent and Trademark Office

Official Caption
CERAMTEC GMBH,
Appellant
v.
COORSTEK BIOCERAMICS LLC, fka C5 Medical Werks, LLC,

Appellee
Short Caption
CeramTec GmbH v. CoorsTek Bioceramics LLC

FORM 5. Petition for Review or Notice of Appeal of an Order or Decision of an Form 5

Agency, Board, Commission, Office, Bureau July 2020
UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT
CeramTec GmbH
, Petitioner or Appellant,
v.
CoorsTek Bioceramics
LLC f/k/a C5 Medical
Werks, LLC , Respondent or Appellee.
PETITION FOR REVIEW

Notice is hereby given that the following party/parties* CeramTec GmbH
hereby petition(s)/appeal(s) the court for review of the order of the Trademark Trial &
Appeal Board entered on 12/6/22 . The order or decision was received
on 12/6/22 .
Date: 2/3/23 Signature: /s/ Anna Kurian Shaw
Name: Anna Kurian Shaw
Address: 555 13th St. N.W.

Washington, D.C. 20004
Phone Number: 202-637-5600
Email Address: [email protected]
*See Fed. R. App. P. 15(a)(2) for permissible ways of identifying petitioners.

CERTIFICATE OF SERVICE
I HEREBY CERTIFY that on this day, a copy of the foregoing document was served via
electronic mail to the following attorneys of record. Fed. R. App. P. 25(c)(2).
[email protected],
[email protected],
[email protected]
[email protected]
Dated: February 3, 2023

/s/Anna Kurian Shaw
Anna Kurian Shaw
HOGAN LOVELLS US LLP
555 13th St., N.W.
Washington, D.C. 20004
Email: [email protected]
EXHIBIT A
This Opinion is Not a

Precedent of the TTAB
Hearing Date: February 22, 2022 Mailed: December 6, 2022
UNITED STATES PATENT AND TRADEMARK OFFICE

_____
Trademark Trial and Appeal Board

_____
CoorsTek Bioceramics LLC

f/k/a C5 Medical Werks, LLC
v.
CeramTec GmbH
_____
Cancellation Nos. 92058781 and 92058796
_____
Diana Rutowski, Peter D. Vogl and Briggs M. Wright

of Orrick, Herrington & Sutcliffe LLP
for CoorsTek Bioceramics LLC f/k/a C5 Medical Werks, LLC.
Anna Kurian Shaw, Katherine Bastian Phillips, Lauren Cury, Ryan Stephenson and
Brendan Quinn of Hogan Lovells US L.L.P.
for CeramTec GmbH.
_____
Before Goodman, Lynch and Hudis,

Administrative Trademark Judges.
Opinion by Hudis, Administrative Trademark Judge:
I. Background
This pair of cancellation proceedings is another chapter in the parties’ eight-year
odyssey to decide whether the color pink as applied to a composition for hip joint
implant parts is functional. CeramTec GmbH (“Respondent”) is the owner of record
of two registrations on the Supplemental Register for the following marks and goods:
Appln. No.
Appln Filing Date
Reg. No.
Mark Mark Description Reg. Date Goods
The color(s) pink is/are 85521237 Hip joint implants

claimed as a feature of the filed Jan. 20, 2012 and their parts
mark. The mark consists of made of artificial
the color pink applied to the 4319095 materials, namely,
goods. The configuration of a issued Apr. 9, 2013 hip joint balls, in
hip joint ball is shown in International
dotted lines in the drawing. First use and first use Class 10
The matter shown in in commerce alleged:
broken lines indicates Mar. 16, 2000
placement of the mark on
the goods and neither the
matter shown in broken
lines nor the configuration
of the goods are claimed as
a feature of the mark.
(emphasis added).
The color(s) pink is/are 85521240 Hip joint implants

claimed as a feature of the filed Jan. 20, 2012 and their parts
mark. The mark consists of made of artificial
the color pink applied to the 4319096 materials, namely,
entire surface of the goods. issued Apr. 9, 2013 acetabular shell,
The matter shown in acetabular fossa,
broken lines indicates First use and first use in International
placement of the mark on in commerce alleged: Class 10
the goods and neither the Mar. 16, 2000
matter shown in the
broken lines nor the
configuration of the goods
is claimed as a feature of
the mark. (emphasis added).
To be clear, in neither registration does Respondent claim protection for the
configuration of the goods. The sole claim for protection in each registration is for the
color pink only.1
1Because of the size of the reproductions of the registration drawings above, the broken lines
are difficult to discern. According to convention for color marks, in the drawings, the entire
configurations appear in broken lines, “inform[ing] the viewer where and how color is used
on the product…, while at the same time making it clear that the shape of the product … is
not claimed as part of the mark.” TRADEMARK MANUAL OF EXAMINING PROCEDURE (TMEP)
§ 1202.05(d)(i) (2022).
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In each Petition for Cancellation, both filed on March 3, 2014,2 C5 Medical Werks,
LLC, which by change of name is now known as CoorsTek Bioceramics LLC
(“Petitioner”), seeks cancellation of Respondent’s registrations under Trademark Act
Section 23(c), 15 U.S.C. § 1091(c), on the grounds that the color pink, as applied to
the goods identified in the registrations, is functional; and that Respondent
committed fraud on the U.S. Patent and Trademark Office (“USPTO”) in obtaining
the registrations. The Board has updated the case caption to identify CoorsTek
Bioceramics LLC as the petitioner and party-plaintiff.
In its Orders of May 8 and May 10, 2014, the Board suspended both proceedings,3
pending the resolution of a then-pending civil action between the parties in the U.S.
District Court for the District Court of Colorado (the “Colorado Litigation”). We
address the Colorado Litigation below, following the Summary of proceedings.
On February 4, 2016 in Cancellation No. 92058796, Respondent moved without
Petitioner’s consent to amend the date of first use claimed in Registration No.
4319096 from March 16, 2000 to March 20, 2001.4 Because, in its response, Petitioner
2 Cancellation Nos. 92058781 and 92058796; each petition for cancellation is located at
1 TTABVUE. References to the pleadings, the evidence of record and the parties’ briefs refer
to the Board’s TTABVUE docket system. Coming before the designation TTABVUE is the
docket entry number; and coming after this designation are the page and paragraph
references, if applicable.
3Board Order of May 8, 2014 in Cancellation No. 92058781, 8 TTABVUE; Board Order of
May 10, 2014 in Cancellation No. 92058796, 8 TTABVUE.
4 12 TTABVUE in Cancellation No. 92058796.
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did not provide its unequivocal consent to the amendment,5 Respondent’s motion was
deferred until final disposition.6
In its Order issued February 14, 2017, the Board consolidated the two cancellation
proceedings, with Cancellation No. 92058781 being designated the parent case.7
Unless otherwise stated, from this point forward our citations to the evidentiary
record and the parties’ briefs shall be to the parent proceeding.
Following a final determination of the Colorado Litigation, on June 29, 2020 the
Board resumed the cancellation proceedings.8 In its Answers filed separately in each
of these proceedings, Respondent denied the salient allegations of the Petitions for
Cancellation and asserted the affirmative defense of unclean hands.9
The consolidated cases are fully briefed. The parties participated in an oral
hearing on February 22, 2022.10
II. Summary
Petitioner bears the burden of proving its Trademark Act Section 23(c)
functionality claim by a preponderance of the evidence. See Poly-America, L.P. v. Ill.
5 14 TTABVUE in Cancellation No. 92058796.

6 Board Order of June 21, 2016 in Cancellation No. 92058796, 15 TTABVUE.
7Board Order February 14, 2017 in Cancellation No. 92058781, 16 TTABVUE; and in
Cancellation No. 92058796, 20 TTABVUE.
8 Board Order of January 29, 2020, 26 TTABVUE.
9 Answer in in Cancellation No. 92058781, 28 TTABVUE; Answer in Cancellation No.
92058796, 22 TTABVUE.
10The day before the hearing, Respondent moved to strike unspecified visual aids submitted
by Petitioner, and to prevent these visual aids from being used at the hearing. See
166 TTABVUE. No such visual aids were presented at the hearing, nor did we rely on them
in this decision. Respondent’s motion, therefore, is denied as moot.
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Tool Works Inc., 124 USPQ2d 1508, 1520 (TTAB 2017) (“We conclude, based on the
preponderance of the evidence, that Respondent’s registered configurations are
functional.”). Having considered the evidentiary record, the parties’ arguments and
applicable authorities, as explained below, we find that Petitioner has carried this
burden, and grant the cancellation sought in each proceeding.
Because we find Respondent’s marks to be functional, we need not reach
Petitioner’s additional claim regarding Respondent’s alleged fraud upon the USPTO.
Fuji Medical Instr. Mfg. Co., Ltd. v. Am. Crocodile Int’l Grp., Inc., 2021 USPQ2d 831,
at *38 n. 69 (TTAB 2021) (citing Multisorb Techs., Inc. v. Pactiv Corp., 109 USPQ2d
1170, 1171 (TTAB 2013) (“[T]he Board ... generally use[s] its discretion to decide only
those claims necessary to enter judgment and dispose of the case. ... More specifically,
the Board’s determination of registrability does not require, in every instance,
decision on every pleaded claim.”)).
As explained in further detail below, we also find Respondent’s affirmative defense
of unclean hands inapplicable to these proceedings. Finally, we deny as moot
Respondent’s motion filed in Cancellation No. 92058796 to amend the claimed date
of first use in Registration No. 4319096.
III. The Colorado Litigation
Simultaneous with its filing of these cancellation proceedings, Petitioner initiated
the Colorado Litigation, through which Petitioner sought cancellation of
Respondent’s trademark registrations now before us, and a declaratory judgment
that it did not infringe the mark in either registration. Respondent (a German
company) moved to dismiss Petitioner’s lawsuit on the ground that the Colorado
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district court lacked personal jurisdiction over it. C5 Med. Werks, LLC v. CeramTec
GmbH, 112 USPQ2d 1857, 1858-59 (D. Colo. 2014) (“CeramTec I”). Finding that it
had jurisdiction, the district court denied Respondent’s motion. Id., 112 USPQ2d at
1861.
Two years later, the parties proceeded to a bench trial, extending from August
through October 2016. In April 2017, the district court issued its opinion (with a final
judgment to follow) that Respondent’s registered trademarks for the composition of
its pink-colored ceramic hip implant components were functional and thus
unenforceable, noted that Respondent’s trademark registrations would be cancelled,
and granted Petitioner judgment in its favor as to Respondent’s counterclaims for
trademark infringement and unfair competition under federal and Colorado state
law. C5 Med. Werks, LLC v. CeramTec GmbH, 249 F. Supp. 3d 1210, 1212 and 1223
(D. Colo. 2017) (“CeramTec II”).
On appeal, the U.S. Court of Appeals for the Tenth Circuit held that the Colorado
district court did not possess personal jurisdiction over Respondent, C5 Med. Werks,
LLC v. CeramTec GmbH, 937 F.3d 1319, 2019 USPQ2d 339846, at *1 (10th Cir. 2019)
(“CeramTec III”), thus reversing the district court’s denial of Respondent’s motion to
dismiss for lack of personal jurisdiction, and remanded the case to the district court
with instructions that the case be dismissed. Id., 2019 USPQ2d 339846, at *5. The
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district court entered its amended final judgment, dismissing the case without
prejudice for lack of personal jurisdiction, on November 12, 2019.11
As noted, these consolidated proceedings resumed on June 29, 2020, at which time
the parties submitted their stipulated protective order and stipulation regarding
discovery.12 The Board approved and entered these stipulations into the record by its
Order dated August 25, 2020.13
IV. The Evidentiary Record
The record includes the pleadings and, by operation of Trademark Rule 2.122(b),
37 C.F.R. § 2.122(b), the files of Respondent’s involved registrations. In addition, the
parties stipulated to or otherwise introduced the following evidence:
A. The Parties’ Stipulations
The parties entered into numerous stipulations regarding the evidence obtained
during the Colorado Litigation and these proceedings, which they filed during the
parties’ testimony periods before the Board.14 Thus, the parties stipulated to the
11The District Court Amended Final Judgment was submitted as an attachment to

Respondent’s Notice to Board of Disposition of Civil Action on December 10, 2019. 24
TTABVUE 5.
12 Board Order resuming proceedings, 26 TTABVUE; stipulated protective order,
30 TTABVUE; stipulation regarding discovery 31 TTABVUE.
13 Board Order approving stipulations, 32 TTABVUE.
14 See Stipulation Regarding Discovery (31 TTABVUE, June 29, 2020). The parties’
stipulation of 31 TTABVUE was approved and entered into the record on August 25, 2020.
32 TTABVUE. Stipulation for Presentation of Certain Trial Testimony and Exhibits (67
TTABVUE, July 1, 2021). Stipulation for Admission of Federal Court Evidence via Notice of
Reliance and for Filing of Confidential Material (68 TTABVUE, April 21, 2021). The parties’
stipulations of 67 and 68 TTABVUE were approved and entered into the record on July 12,
2021. 69 TTABVUE. Trial Testimony and Exhibits (132 TTABVUE, August 18, 2021). The
parties’ stipulation of 132 TTABVUE was approved and entered into the record on September
7, 2021. 142 TTABVUE.
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introduction under Notices of Reliance of many materials not otherwise admissible
when submitted in this form.15
B. Petitioner’s Evidence
• Petitioner’s First Notice of Reliance (“PNOR1”) on e-mail correspondence

(many with attachments) exchanged among Respondent’s personnel
(41 TTABVUE).
• Petitioner’s Second Notice of Reliance (“PNOR2”) on excerpts of trial and
deposition testimony from the Colorado Litigation (42 TTABVUE).
• Petitioner’s Third Notice of Reliance (“PNOR3”) on U.S. patents issued and
patent applications filed in the name of Respondent or its predecessors,
portions of patent file histories and Respondent’s correspondence with the
federal Food and Drug Administration (“FDA”) (43 TTABVUE).
• Petitioner’s Fourth Notice of Reliance (“PNOR4”) on Respondent’s internal
correspondence and memoranda, Respondent’s external e-mail
correspondence; results of Petitioner’s product analyses, technical articles, a
data sheet featuring Respondent’s product, and reports Respondent filed with
the FDA (44 TTABVUE).
• Petitioner’s Fifth Notice of Reliance (“PNOR5”) on promotional materials
featuring Respondent’s product; Respondent’s external and internal e-mail
correspondence (some with attachments); technical articles; Petitioner’s
survey and expert witness report from the Colorado Litigation by Sara Parikh,
On April 21, 2021, Respondent filed the parties’ joint stipulation regarding the admission of
certain trial testimony and trial exhibits in Cancellation No. 92058796, the child proceeding.
25 TTABVUE in Cancellation No. 92058796. Inasmuch as these proceedings were
consolidated in 2017, 16 TTABVUE, the stipulation should have been filed in the parent
proceeding only. For purposes of efficiency, the then-assigned Interlocutory Attorney noted
the April 21, 2021 stipulation and placed a copy in the parent proceeding. 68 TTABVUE.
15 Submission of non-conforming materials under Notices of Reliance is normally
impermissible under the Board's Rules of Practice. However, the parties stipulated to this
method of introduction here. See Target Brands Inc. v. Hughes, 85 USPQ2d 1676, 1678 (TTAB
2007) (parties stipulated to the entire record in the case including business records, public
records, government documents, marketing materials, Internet materials, and numerous
factual matters); Blackhorse v. Pro-Football Inc., 111 USPQ2d 1080, 1084-85 (TTAB 2014)
(parties stipulated that the record of a prior proceeding may be submitted into evidence under
notice of reliance, reserving the right to object based on relevance), aff’d, 112 F. Supp. 3d 439,
115 USPQ2d 1524 (E.D. Va. 2015), vacated and remanded, 709 F. App’x 183 (4th Cir. 2018)
(mem.); See generally TRADEMARK TRIAL AND APPEAL BOARD MANUAL OF PROCEDURE
(TBMP) § 705 (2022) (noting the various ways of stipulating to evidence not otherwise
admissible pursuant to the Board’s Rules of Practice).
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Ph.D. (“Parikh Lit. Rpt.”), Respondent’s admissions’ responses from the

Colorado Litigation; declaration of D. Burkhardt in support of Respondent’s
motion to dismiss the Colorado Litigation (“Burkhardt Decl.”) and trade show
agenda and sponsor list (45 TTABVUE).
• Petitioner’s Sixth Notice of Reliance (“PNOR6”) on technical articles and
third-party submissions to the FDA (46 TTABVUE).
• The testimony declaration and report of Petitioner’s survey expert, Sara
Parikh, Ph.D. (“Parikh Decl.” and “Parikh Rpt.”) (47 TTABVUE).
• The testimony declaration and initial report of Petitioner’s materials expert,
William M. Carty, Ph.D. (“Carty Decl.” and “Carty Rpt.”) (48 TTABVUE
(confidential); 60 TTABVUE (public/redacted)).
• Petitioner’s Seventh Notice of Reliance (“PNOR7”) on European Union and
U.S. patents issued and patent applications filed in the name of Respondent or
its related companies and the Colorado district court’s opinion in CeramTec II
(49 TTABVUE).
• Petitioner’s Eighth Notice of Reliance (“PNOR8”) on technical articles;
promotional materials featuring Respondent’s product and an article on
Master Files by the FDA (50 TTABVUE).
• Petitioner’s Ninth Notice of Reliance (“PNOR9”) on technical articles
(51 TTABVUE).
• Petitioner’s Tenth Notice of Reliance (“PNOR10”) on technical articles
(52 TTABVUE).
• Petitioner’s Eleventh Notice of Reliance (“PNOR11”) on technical articles
(53 TTABVUE).
• Petitioner’s Twelfth Notice of Reliance (“PNOR12”) on Respondent’s internal
e-mail correspondence (some with attachments), Respondent’s marketing
materials, Respondent’s correspondence with the FDA, Petitioner’s evidentiary
submissions pursuant to Fed. R. Evid. 1006 of presentations by Respondent,
Petitioner’s business plan, excerpts from the discovery deposition of Grant
Shopoff, Respondent’s Commercial Director for the Americas (“Shopoff Depo.”)
and Respondent’s admissions’ responses and interrogatory answers from this
proceeding (54 TTABVUE (confidential); 61 TTABVUE (public/redacted)).
• The testimony declaration and rebuttal report of Petitioner’s statistics expert,
Arnold Barnett, Ph.D. (“Barnett Decl.” and “Barnett Rebuttal Rpt.”)
(55 TTABVUE (confidential); 56 TTABVUE (public/redacted)).
• The testimony declaration of Lucian Strong, Petitioner’s Commercial Vice
President of the Americas (“Strong Decl.”) (57 TTABVUE).
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• The testimony declaration of Jonathan D. Haftel, Petitioner’s Plant Manager

(“Haftel Decl.”) with exhibits (58 TTABVUE (confidential); 59 TTABVUE
(public/redacted)).
C. Respondent’s Evidence16
• Respondent’s First Notice of Reliance (“RNOR1”) on excerpts of trial testimony

from the Colorado litigation, Respondent’s internal memoranda, a U.S. patent
issued in the name of Respondent’s predecessor, a Standard issued by the
International Organization for Standardization (“ISO”) and technical articles
(70 TTABVUE).17
• Respondent’s Second Notice of Reliance (“RNOR2”) on Petitioner’s engineering
report, Petitioner’s marketing materials, Respondent’s external e-mail
correspondence, technical articles and a U.S. patent (with its file history)
issued in the name of Respondent’s related company (71 TTABVUE).
• Respondent’s Third Notice of Reliance (“RNOR3”) on the file history for a U.S.
patent issued in the name of Respondent’s predecessor, portions of the initial
expert report of Petitioner’s materials expert in the Colorado Litigation, G.
Fischman, Ph.D., a Standard issued by the ISO, Respondent’s internal e-mail
correspondence (with English translation), Petitioner’s internal e-mail
correspondence (many with attachments), U.S. patents issued and patent
applications filed in the name of Respondent or its predecessors, portions of a
patent file history, and one of Petitioner’s trial exhibits (a timeline) from the
Colorado Litigation (72 TTABVUE).
• Respondent’s Fourth Notice of Reliance (“RNOR4”) on Petitioner’s internal and
external e-mail correspondence (many with attachments), Petitioner’s
engineering report, Petitioner’s marketing materials and Petitioner’s business
plan (73 TTABVUE).
• Respondent’s Fifth Notice of Reliance (“RNOR5”) on the technical file for one
of Petitioner’s products, and Petitioner’s internal e-mail correspondence (one
with an attachment) (74 TTABVUE).
• Respondent’s Sixth Notice of Reliance (“RNOR6”) on Petitioner’s internal and
external e-mail correspondence (some with attachments), a technical article,
16Pursuant to a Notice Respondent filed at 125 TTABVUE, Respondent withdrew its

Eighteenth through Twenty-Third and Twenty-Fifth Notices of Reliance, at 88-94 and
96 TTABVUE.
17 Respondent filed a Corrected First Notice of Reliance at 122 TTABVUE, in which portions
of the trial testimony transcript of Respondent’s FDA expert, Mark Kramer, were omitted.
Since Mr. Kramer’s trial testimony was never expressly withdrawn, and we find portions of
it helpful, we have considered it.
- 10 -
Respondent’s internal memorandum (entirely in German), Respondent’s

marketing material and an experimental data spreadsheet (75 TTABVUE).
• Respondent’s Seventh and Eighth Notices of Reliance (“RNOR7” and
“RNOR8”) on Respondent’s experimental data records (76 and 77 TTABVUE).
• Respondent’s Ninth Notice of Reliance (“RNOR9”) on Respondent’s
experimental data records, Petitioner’s external and internal e-mail
correspondence, technical articles, experimental data spreadsheets and
records, exhibits to the report of Mark Kramer, Respondent’s FDA expert
witness, from the Colorado Litigation, photos of Respondent’s product
development archives, Respondent’s lab testing notes, a color swatch and a
color board (78 TTABVUE).
• Respondent’s Tenth and Eleventh Notices of Reliance (“RNOR10” and
“RNOR11”) on photos of experimental sample discs (79 and 80 TTABVUE).
• Respondent’s Twelfth Notice of Reliance (“RNOR12”) on a U.S. patent issued
in the name of Respondent’s predecessor, Petitioner’s external e-mail
correspondence (some with attachments), Petitioner’s technical file
distribution log, and demonstrative exhibits used by Respondent’s witnesses
during the trial in the Colorado Litigation (81 TTABVUE).18
• Respondent’s Thirteenth Notice of Reliance (“RNOR13”) on portions of the
transcript and certain exhibits from the discovery deposition of Jonathan
Haftel (“Haftel Discov. Depo.”) (82 TTABVUE (confidential); 129 TTABVUE
(public/redacted)).
• Respondent’s Fourteenth Notice of Reliance (“RNOR14”) on Petitioner’s
interrogatory answers and responses to Respondent’s production requests
(83 TTABVUE).
• The testimony declaration and report of Respondent’s survey expert, Robert
Klein (“Klein Decl.” and “Klein Rpt.”) (84 TTABVUE).
• The testimony declaration of Grant Shopoff, Respondent’s Commercial
Director for the Americas (“Shopoff Decl.”) (85 TTABVUE).
• Respondent’s Fifteenth Notice of Reliance (“RNOR15”) on Petitioner’s
admissions responses and interrogatory answers (86 TTABVUE (confidential);
130 TTABVUE (public/redacted)).
• Respondent’s Sixteenth Notice of Reliance (“RNOR16”) on Petitioner’s
marketing materials and social media postings (87 TTABVUE).
18 Respondent filed a Corrected Twelfth Notice of Reliance at 124 TTABVUE, in which the
demonstrative exhibits used by Respondent’s witnesses during the trial in the Colorado
litigation were omitted and expressly withdrawn.
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• Respondent’s Twenty-Fourth Notice of Reliance (“RNOR24”) on a technical

article (95 TTABVUE).
• Respondent’s Twenty-Sixth Notice of Reliance (“RNOR26”) on portions of the
transcript and certain exhibits from the discovery deposition of Lucian Strong,
Petitioner’s Commercial Vice-President, Americas (“Strong Discov. Depo.”)
• The testimony declaration of Dr. Allessandro Alan Porporati, an employee in
Respondent’s Oxide Department (“Porporati Decl.”) with exhibits
• Respondent’s Twenty-Seventh Notice of Reliance (“RNOR27”) on excerpts of
trial testimony from the Colorado Litigation, list of meetings/trainings
attended and photos of Respondent’s trade show materials (100 TTABVUE).
• The testimony declaration of Dr. Meinhard Kuntz, the former Manager of
Respondent’s Oxide Development and presently the Dean of and professor at
Heilbronn University in Germany (“Kuntz Decl.”) with exhibits
• The testimony declaration, litigation expert report, litigation rebuttal expert
report, TTAB expert report and TTAB rebuttal expert report of Respondent’s
statistics expert, Joseph B. Kadane, Ph.D. (“Kadane Decl.”, “Kadane Lit. Rpt.”,
“Kadane Lit. Rebuttal Rpt.”, “Kadane TTAB Rpt.” and “Kadane TTAB Rebuttal
Rpt.”) with exhibits (103 TTABVUE (confidential); 104 TTABVUE
(public/redacted)).
• The testimony declaration, litigation expert report, litigation rebuttal expert
report, TTAB expert report and TTAB rebuttal expert report of Respondent’s
materials expert, Dr. John J. Mecholsky, Jr. (“Mecholsky Decl.”, “Mecholsky
Lit. Rpt.”, “Mecholsky Lit. Rebuttal Rpt.”, “Mecholsky TTAB Rpt.” and
“Mecholsky TTAB Rebuttal Rpt.”) with exhibits (106-112 TTABVUE
(confidential); 105 TTABVUE (public/redacted)).
• The testimony declaration of Florence Petkow, Respondent’s Director of
Marketing and Communications (“Petkow Decl.”) with exhibits
(113 TTABVUE (confidential); public/redacted (114-120 TTABVUE).
• Respondent’s Twenty-Eighth Notice of Reliance (“PNOR28”) on excerpts of
discovery deposition testimony from the Colorado Litigation (121 TTABVUE).
• Respondent’s Twenty-Ninth Notice of Reliance (“RNOR29”) on Petitioner’s
internal and external e-mail correspondence (some with attachments),
Petitioner’s correspondence and reports exchanged with the FDA and
Petitioner’s marketing materials (123 TTABVUE).
• The transcript from the testimony deposition of Angel Abeyta, Petitioner’s
Market Development Manager in its Medical Division (“Abeyta Testim. Depo.”)
with exhibits (133 TTABVUE (confidential)).
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• The transcript from the testimony deposition of Megan Maguire, Petitioner’s

Senior Marketing Communications Manager (“Maguire Testim. Depo.”) with
exhibits (134 TTABVUE (confidential)).
• The transcript from the testimony deposition of Nicole Stavish, Petitioner’s
Strategic Marketing Manager for the Americas (“Stavish Testim. Depo.”) with
exhibits (135 TTABVUE (confidential)).
• The transcript from the cross-examination testimony deposition of Jonathan
Haftel (“Haftel CX Testim. Depo.”) with exhibits (146-147 TTABVUE
(confidential)).
• The transcript from the cross-examination testimony deposition of Arnold I.
Barnett, Ph.D. (“Barnett CX Testim. Depo.”) with exhibits (148 TTABVUE
(confidential)).
• The transcript from the cross-examination testimony deposition of William M.
Carty, Ph.D. (“Carty CX Testim. Depo.”) with exhibits (149-151 TTABVUE
(confidential)).
• The transcript from the cross-examination testimony deposition of Sara
Parikh, Ph.D. (“Parikh CX Testim. Depo.”) with exhibits (149-152 TTABVUE
(confidential)).
D. Petitioner’s Rebuttal Evidence
• Petitioner’s Thirteenth Notice of Reliance (“PNOR13”) on excerpts of the

discovery depositions of Petitioner’s former Scientific Consultants who are now
Petitioner’s Commercial Managers, Rebecca Echols (“Echols Discov. Depo.”),
with exhibits; (“McCormick Discov. Depo.”); and Blake Miller (“Miller Discov.
Depo.”) (136 TTABVUE (confidential); 154 TTABVUE (public/redacted).
• The rebuttal testimony declaration of Jonathan D. Haftel (“Haftel Rebuttal
Decl.”) with exhibits (137 TTABVUE (confidential); 138 TTABVUE
(public/redacted)).
• The rebuttal testimony declaration and rebuttal report of Petitioner’s statistics
expert, Arnold Barnett, Ph.D. (“Barnett Rebuttal Decl.” and “Barnett Rebuttal
Rpt.”) (139 TTABVUE (confidential); 140 TTABVUE (public/redacted)).19
• The rebuttal testimony declaration and rebuttal report of Petitioner’s
materials expert, William M. Carty, Ph.D. (“Carty Rebuttal Decl.” and “Carty
Rebuttal Rpt.”) (141 TTABVUE (confidential); 153 TTABVUE
(public/redacted)).
19The confidential and public versions of Dr. Barnett’s Rebuttal Report also were filed at
55-56 TTABVUE.
- 13 -
• The transcript from the cross-examination testimony deposition of

Respondent’s survey expert, Robert Klein (“Klein CX Testim. Depo.”) with
exhibits (143 TTABVUE).
Respondent’s statistics expert, Joseph B. Kadane, Ph.D. (“Kadane CX Testim.
Depo.”) with exhibits (144 TTABVUE (confidential); 156 TTABVUE
(public/redacted)).
Respondent’s materials expert, Dr. John J. Mecholsky, Jr. (“Mecholsky CX
Testim. Depo.”) with exhibits (145 TTABVUE (confidential); 155 TTABVUE
(public/redacted)).
V. Evidentiary Issues
Before proceeding to the merits of the cancellation proceedings, we address a
number of evidentiary matters.
A. Applicability of the District Court’s Decision in CeramTec II
To begin, in an Appendix to its Brief,20 Respondent “objects to any reliance on or
consideration” in these cancellation proceedings of the “now-vacated decision in the
District of Colorado [action] … between the Parties” (that is, the district court’s
decision in CeramTec II). As a retort to Respondent’s objection, Petitioner essentially
argues that (i) Respondent did not object to the manner in which Petitioner
introduced the Colorado district court’s decision into evidence in these proceedings,
and (ii) none of the evidence introduced in these proceedings which came into being
subsequent to the CeramTec II trial would have persuaded the Colorado district court
to rule any differently.21 Respondent’s objection is sustained.
20 Respondent’s Brief, 160 TTABVUE 55.

21 Petitioner’s Reply Brief, 162 TTABVUE 27.
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The vacated decision has been set aside and has no effect. We therefore cite the
Colorado district court’s opinion solely for procedural context and to explain the
sources of the evidence the parties submitted from the Colorado Litigation. We do not
rely on it for any of the findings of fact, conclusions of law or the holdings of the
district court in CeramTec II. The Board’s rulings in these proceedings are based upon
our own review of the evidence and application of pertinent law.
B. Problems with Large Portions of

the Evidentiary Record Labeled as Confidential
The parties over-designated as confidential large portions of the record. Only the
particular exhibits, declaration passages or deposition transcript pages that truly
disclosed confidential information should have been filed under seal pursuant to a
protective order. Made in Nature, LLC v. Pharmavite LLC, 2022 USPQ2d 557, at *12
(TTAB 2022).
If a party over-designates material as confidential, the Board will not be bound by
the party’s designation, and will treat as confidential only testimony and evidence
that is truly confidential and commercially sensitive trade secrets. See Trademark
Rule 2.116(g), 37 C.F.R. § 2.116(g) (“The Board may treat as not confidential that
material which cannot reasonably be considered confidential, notwithstanding a
designation as such by a party.”). In this decision, in instances where Petitioner or
Respondent improperly designated material as confidential, we disregard the
designation.22 See AT&T Mobility LLC v. Thomann, 2020 USPQ2d 53785 , at *12
22Our treatment here of the parties’ confidentiality over-designations should not come as a
surprise. In the Board’s August 25, 2020 order approving and entering the parties’ Stipulated
- 15 -
(TTAB 2020) (parties reminded to limit confidential designation to truly confidential
or commercially sensitive materials).
C. Needless Duplication of Evidence
We credit the parties for having entered into the numerous stipulations discussed
above regarding the entry and admissibility of evidence. However, less helpfully, the
parties also elected to file duplicative evidence by different methods of introduction;
for example, once (sometimes twice or even thrice) by Notice(s) of Reliance and again
by way of exhibit(s) to testimony declarations or testimony deposition transcripts. See
Made in Nature, 2022 USPQ2d 557, at *12 (criticizing the parties for this practice).
The parties further paid little attention to Trademark Rules 2.120(k)(7) and 2.122(a),
37 C.F.R. §§ 2.120(k)(7) and 2.122(a), which provide that when evidence has been
made of record by one party, it may be referred to by any party for any purpose
permitted by the Federal Rules of Evidence.
Whether the parties are unfamiliar with the Board’s Rules of Practice or simply
disregarded them, the Board’s evaluation of the evidentiary record required
reviewing some of the same testimony, technical articles, patents, promotional
materials and other exhibits numerous times (or at least spending the time to
determine whether they were duplicates, if not actually reviewing them in toto). The
Board views with disfavor the practice of introducing cumulative evidence at
trial. See Calypso Tech. Inc. v. Calypso Cap. Mgmt. LP, 100 USPQ2d 1213,
Protective Order, 32 TTABVUE, they were warned of the potential consequences of

over-designating as confidential materials filed with the Board.
- 16 -
1218 (TTAB 2011). Suffice it to say, testimony and evidence does not become more
probative if introduced multiple times.
D. Irrelevant Evidence
Moreover, noticeable portions of the evidentiary record were not pertinent to the
functionality claim or unclean hands defense, such that the Board was forced to spend
needless time sifting through an inappropriately large record in search of germane
proofs. See, e.g., RxD Media, LLC v. IP Appln. Dev. LLC, 125 USPQ2d 1801,
1803 (TTAB 2018), aff’d, 377 F. Supp. 3d 588 (E.D. Va. 2019), aff’d, 986 F.3d
361, 2021 USPQ2d 81 (4th Cir. 2021) (“Simply put, the parties introduced into the
record thousands of pages of testimony and other evidence without regard to what
they needed to prove, apparently in the hope that in wading through it, we might find
something probative. This is not productive. ‘Judges are not like pigs, hunting for
truffles buried in ... [the record].’”) (quoting U.S. v. Dunkel, 927 F.2d 955, 956 (7th
Cir. 1991).
E. Submission of Entire Discovery Deposition Transcripts
Accompanying submission of the trial testimony of witnesses Messrs. Klein and
Haftel, as well as Drs. Kadane, Mecholsky, Barnett and Carty, were the entirety of
the transcripts from each of their discovery depositions. These filings were in
derogation of Trademark Rules 2.120(k) and 2.122(g), 37 C.F.R. §§ 2.120(k) and
2.122(g).
Of all these witnesses, only Mr. Haftel was a person designated by Petitioner to
testify pursuant to Fed. R. Civ. P. 30(b)(6) at the time his discovery deposition was
taken; all the others were expert witnesses. We first discuss the introduction of Mr.
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Haftel’s discovery deposition transcript in its entirety as an exhibit to his testimony
cross-examination.
Notably, well prior to the submission of Mr. Haftel’s testimony deposition
transcript and exhibits, Respondent already had introduced by way of Notice of
Reliance those portions of Mr. Haftel’s discovery deposition transcript and select
exhibits on which Respondent wished to rely, together with a statement of the
relevance of those transcript portions and exhibits to the issues in the proceeding
pursuant to Trademark Rule 2.122(g).23
Thus, refiling the entirety of Mr. Haftel’s discovery deposition transcript again as
an exhibit to his testimony deposition transcript 24 was not only unnecessarily
duplicative, it skirted the requirements of Trademark Rule 2.122(g). We have
considered only those portions of Mr. Haftel’s discovery deposition transcript that
were included with Respondent’s applicable Notice of Reliance, or read or used as
part of his testimony on cross-examination.
The entire discovery deposition transcripts of third-party expert witnesses, such
as Mr. Klein and Drs. Kadane, Mecholsky, Barnett and Carty, should not have been
offered in evidence except by stipulation of the parties or by order of the Board on
motion under the specific circumstances noted in Trademark Rule 2.120(k)(2). The
Rule requires that the party seeking to rely on a discovery deposition of a third-party
witness for purposes of trial make an affirmative showing at the time of the proffer
23 Haftel Discov. Depo., RNOR13, 82 TTABVUE 2-202 (confidential), 129 TTABVUE 2-199
(redacted/non-confidential).
24 Haftel CX Testim. Depo., 146 TTABVUE 129-537.
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of such evidence that circumstances exist that justify acceptance of the evidence,
unless the party is invoking “exceptional circumstances,” in which case the motion
must be filed promptly after the party learns of the circumstances. Vans, Inc. v.
Branded, LLC, 2022 USPQ2d 742, at *7 (TTAB 2022) (citing numerous cases). No
such stipulations or motions were filed with respect to these trial witnesses.
As mentioned, Trademark Rule 2.120(k)(6) permits the reading or use of the
transcripts from the discovery depositions of Mr. Klein and Drs. Kadane, Mecholsky,
Barnett and Carty as part of their cross-examination trial testimony. However, use
of these witnesses’ discovery deposition transcripts to impeach or otherwise clarify
their trial testimony does not automatically make the entire discovery deposition
transcripts of record. Vans, 2022 USPQ2d 742, at *8. Therefore, only to the extent
that portions of these expert witnesses’ discovery deposition transcripts were read or
used as part of their cross-examination testimony do we consider these witnesses’
discovery deposition transcripts. Otherwise, we decline to consider these witnesses’
discovery deposition transcripts in their entirety.
F. The Parties’ Citations to the Record
Finally, rather than using full TTABVUE citations with the docket entry and
electronic page numbers, as recommended, see TBMP § 801.03 and Turdin v.
Trilobite, Ltd., 109 USPQ2d 1473, 1477 n.6 (TTAB 2014), the parties used their own
numbering systems. For exhibits, the parties used the TTABVUE docket number but
then cited to exhibits by their assigned exhibit numbers (without specifying the
TTABVUE page numbers). For testimony submitted by deposition transcripts, the
parties used the page and line numbers provided by the court reporters rather than
- 19 -
the TTABVUE citations with the docket entry and electronic page numbers. For
testimony submitted by declarations, the parties used the numbers assigned to each
paragraph, but neglected to provide the TTABVUE electronic page numbers at which
the text of each of these numbered paragraphs could be found.
Especially with the voluminous record compiled by the parties, this citation
practice made it extremely cumbersome to locate the evidence and provide
evidentiary references for use in this opinion. In turn, this lengthened the time for
review of the record, drafting of the decision and ultimately for issuance of this
opinion. See Made in Nature, 2022 USPQ2d 557, at *14-15 (criticizing this practice,
and encouraging parties in future cases to cite properly to the evidentiary record).
VI. The Parties
Respondent, CeramTec GmbH, is a limited liability company organized under the
laws of Germany and headquartered in Germany. Since 1974, Respondent has
manufactured ceramic prosthetic implant components for hip, knee and shoulder
joint replacements. Respondent sells these products to medical device companies that
incorporate those components into their own prosthetic devices. Those medical device
companies subsequently sell such devices to their customers such as, for example,
hospitals.25
Petitioner was formed in 2005, under its original name C5 Medical Werks, LLC,
to become a new entrant to the medical-implant component supply business, initially
focusing primarily on hip replacement implant components – recognizing at the
25 Burkhardt Decl., 45 TTABVUE 250, ¶ 2; Petkow Decl., 114 TTABVUE 4, ¶¶ 7-9.
- 20 -
outset that Respondent would be its principal major competitor.26 The original
company has since undergone a number of re-organizations and name changes;27 and
today is known as CoorsTek Bioceramics, LLC, a limited liability company of
Delaware whose manufacturing facility is located in Grand Junction, Colorado.28
VII. Technical Terminology
Our resolution of these proceedings will involve the use of numerous scientific and
other technical terms. For the benefit of the reader, we have culled from the record
and present here the definitions of these terms. Throughout this opinion, for brevity,
we include in any citations to technical articles only the principal author(s) and year
of publication (unless no author is provided, in which case we recite the article title).
We have omitted formal citations to article titles and the publications in which the
articles appeared. However, we have included cites to the TTABVUE record, and
there the reader can find the formal citations to the article titles.
• A ceramic is a compound of a metal and nonmetal element. Nonmetal

elements in ceramics can include, among other things, oxygen, nitrogen, and
carbides. Oxide ceramics include oxygen as the nonmetal element. These
oxide ceramics have special properties, and require specialized techniques to
properly produce.29
• Ion: An atom or molecule that has lost or gained one or more electrons,
resulting in a net positive or negative charge. The net charge, positive or
negative, is written with a superscript representing the net charge and
whether it is positive or negative. A chromium ion that has given up three
26 Brad Coors Colorado litigation trial testimony (“Brad Coors Lit. Testim.”), PNOR2,
42 TTABVUE 129-134; Petitioner’s business plan; PNOR12, 54 TTABVUE 475-78, 480, 483,
492-93, 504.
27Jonathan Coors Colorado litigation trial testimony (“Jonathan Coors Lit. Testim.”),
PNOR2, 42 TTABVUE 145-46.
28 Strong Decl., 57 TTABVUE 2, ¶¶ 3-4; Haftel Decl., 59 TTABVUE 2-3, ¶¶ 4-7.
29 Kuntz Decl., 101 TTABVUE 4, ¶ 10.
- 21 -
electrons (and is thus positively charged), for instance, would be represented

as Cr3+.30
• Microstructure: The structure of a material, including a ceramic material, at
a microlevel. The microstructure of ceramic materials is composed of small
crystals known as “grains.”31
• Lattice: The arrangement of atoms in a crystal structure at the
microstructural level.32
• Aluminum/Aluminum Oxide/Alumina: Aluminum (Al) is the elemental
metal on the periodic table of elements. Aluminum Oxide (Al2O3) or Alumina
is the oxide of Aluminum. Chemical names that end with an “a” denote the
oxide form.33
• Chromium/Chromium Oxide/Chromia: Chromium (Cr) is the elemental
metal on the periodic table of elements. Chromium Oxide (Cr2O3 or presented
in its common ionic form Cr3+) or Chromia is the oxide of chromium.34
• Zirconium/Zirconium Dioxide/Zirconia: Zirconium (Zr) is the elemental
metal on the periodic table of elements. Zirconium dioxide (ZrO2) or Zirconia is
the oxide of Zirconium.35
• Yttrium/Yttrium Oxide/Yttria: Yttrium (Y) is the elemental metal on the
periodic table of elements. Yttrium oxide (Y2O3) or Yttria is the oxide of
Yttrium.36
• Zirconia Toughened Alumina (“ZTA”): A composite material composed of
Alumina and Zirconia. It also may include other additives including, but not
limited to, chromium.37 Alumina ceramics are well known to be hard and
biocompatible. Zirconia, when added to alumina, toughens the material. When
strontium aluminate platelets are added to the material, it contributes to
30 Carty Rpt., 60 TTABVUE 15, ¶ 33; Mecholsky Lit. Rpt., 105 TTABVUE 51, ¶ 78.
31Carty Rpt., 60 TTABVUE 15, 21-23, ¶¶ 33, 48, 50, 52; Mecholsky Lit. Rpt., 105 TTABVUE
40, ¶ 59.
32Carty Rpt., 60 TTABVUE 15, ¶ 33; Mecholsky Lit. Rpt. (confidential), 106 TTABVUE 108,
¶ 170.
37 Carty Rpt., 60 TTABVUE 16-17, ¶¶ 33, 36; Mecholsky TTAB Rpt. 105 TTABVUE 197, ¶ 14.
- 22 -
higher toughness as well.38 ZTA ceramics exhibit superior strength and

toughness compared to conventional alumina and zirconia.39
• Doping: The addition of a small amount of a material to a composite to alter
the composite’s properties.40
• Sintering: The process of compacting and forming a solid mass of material
through exposure to heat and pressure without liquefying the material.
Sintering is a common method for manufacturing ceramic materials such as
orthopedic ceramics.41
• In vivo: Within the body.42
• Hydrothermal ageing: Degradation of material when exposed to
temperature and moisture, which increases with increased temperature and
humidity, for example when in vivo for extended periods of time.43
• Autoclaving: Exposure to elevated temperatures and steam pressures to
mimic long-term exposure to heated, humid conditions such as those
experienced in vivo. Autoclaving previously has been used as a re-sterilization
method for orthopedic ceramics, and is an accepted method for accelerated
ageing of ZTA material.44
• Hardness: The resistance of a material to permanent deformation (such as
surface impression) after force is applied to the surface from a standardized
harder material.45

39 Kurtz et al. (2014), PNOR9, Exh. 5, 51 TTABVUE 105-115 at 107.
40 Carty Rpt., 60 TTABVUE 14, ¶ 33; Mecholsky Lit. Rpt., 105 TTABVUE 85-86, ¶ 135.
41Carty Rpt., 60 TTABVUE 15, 18-19, 22, ¶¶ 33, 41-42, 50; Mecholsky Lit. Rpt., 105
TTABVUE 58, ¶ 92.
42Carty Rpt., 60 TTABVUE 15, 64, ¶¶ 33, 140; Mecholsky Lit. Rpt. (confidential), 106
TTABVUE 42, ¶ 65.
43Carty Rpt., 60 TTABVUE 15, ¶ 33; Mecholsky Lit. Rpt. (confidential), 106 TTABVUE 68,
¶ 105.
44Carty Rpt., 60 TTABVUE 14, 19-20, ¶¶ 33, 45-47; Mecholsky Lit. Rpt. (confidential), 106
TTABVUE 76, ¶ 105.
45Carty Rpt., 60 TTABVUE 15, 26, ¶¶ 33, 60; Mecholsky Lit. Rpt., 105 TTABVUE 26, ¶ 34;
DePuy Synthes brochure (2013), PNOR5, 45 TTABVUE 83; (Green (1998), PNOR9, 51
TTABVUE 163-171 at 166.
- 23 -
• Fracture toughness: The resistance of a material to crack propagation (i.e.,

the spreading of a crack through the material).46
• Strength: The ability of a material to withstand a force without cracking or
failing. Flexural strength is the ability of a material to withstand bending
without cracking or failing. Burst strength is the ability of a material to
withstand an exertion of force without bursting.47
• Wear resistance/Stability: The ability of a material to withstand loss,
erosion or displacement of material over time in response to an application of
force caused by environmental factors, such as temperature or contact with
other material (such as friction between moving surfaces).48
• Debris: Particles of different material and size shed from the surface of the
various parts of an implant due to wear.49
• Osteolysis: Bone resorption due to biological response to debris that can
compromise the bone around a medical implant device and lead to loosening of
the prosthesis.50
• Mechanical property: Physical property that a material exhibits upon the
application of force. Mechanical properties include such functional
characteristics as hardness, fracture toughness, flexural strength and wear
resistance.51
• Biocompatibility: A material’s interaction and compatibility with the human
body.52
• Phase Stabilization: For purposes of these proceedings, the tetragonal and

monoclinic phases refer to the stages during which the physical properties
of Zirconia may be affected during the heating and cooling of the sintering
process. Phase stabilization refers to the proper balance that must be
maintained between the tetragonal and monoclinic phases of the Zirconia. The
46Carty Rpt., 60 TTABVUE 15. 24-25, 85, ¶¶ 33, 56, 178; ; Mecholsky Lit. Rpt. 105 TTABVUE
23-24, ¶ 28; DePuy Synthes brochure (2013), PNOR5, 45 TTABVUE 83; (Green (1998),
PNOR9, 51 TTABVUE 163-171 at 170.
47Carty Rpt., 60 TTABVUE 15, 22-23, ¶¶ 33, 50, 53; Mecholsky Lit. Rpt. 105 TTABVUE
24-25, ¶¶ 30-31; DePuy Synthes brochure (2013), PNOR5, 45 TTABVUE 83.
48 Carty Rpt., 60 TTABVUE 16, 28-29, 66-67, ¶¶ 33, 65, 67, 146; Mecholsky Lit. Rpt. 105
TTABVUE 42, ¶¶ 66; DePuy Synthes brochure (2013), PNOR5, 45 TTABVUE 83; Zagra et
al. (2018), PNOR8, Exh. 15, 50 TTABVUE 348-354 at 350.
49 Zagra et al. (2018), PNOR8, Exh. 15, 50 TTABVUE 348-354 at 350.
50 Zagra et al. (2018), PNOR8, Exh. 15, 50 TTABVUE 348-354 at 350.
51 Carty Rpt., 60 TTABVUE 15, 22, ¶ 33, 50; Mecholsky Lit. Rpt. 105 TTABVUE 22, ¶ 25.
52 Mecholsky Lit. Rpt. 105 TTABVUE 43, ¶ 68.
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phase stability of the Zirconia portion of the ZTA compound in turn affects the
toughness and wear performance of the material.53
VIII. Trial by Implied Consent
Generally, plaintiffs in proceedings before the Board may not rely on unpleaded
matters, and the Board will not consider them. See P.A.B. Produits et Appareils de
Beaute v. Satinine Societa In Nome Collettivo di S.A. e.M. Usellini, 570 F.2d 328, 196
USPQ 801, 804 (CCPA 1978); UVeritech, Inc. v. Amax Lighting, Inc., 115 USPQ2d
1242, 1244 (TTAB 2015). As an exception to this general rule, the Board will consider
matters that have been tried by express or implied consent of the parties. Fed. R. Civ.
P. 15(b)(2); NT-MDT LLC v. Kozodaeva, 2021 USPQ2d 433, at *14-15 (TTAB 2021).
Matters will be found as having been tried by implied consent when, even if not
expressly raised in the pleadings, the parties introduce evidence regarding the unpled
matters without objection and discuss the issues relating thereto in their briefs.
Conolty v. Conolty O’Connor NYC LLC, 111 USPQ2d 1302, 1305 (TTAB 2014).
In its Petitions for Cancellation, Petitioner asserts that the color pink as applied
to the chemical composition of ceramic hip implant components is functional because,
when chromium oxide is added to the composition, it naturally appears in that color.
Moreover, Petitioner alleges, chromium oxide (chromia) is added for the hardening
effect it provides.54 However, the parties did not limit their functionality evidence and
53Porporati Decl., 99 TTABVUE 6, ¶¶ 15-16; Chevalier/Gremillard (2009), PNOR10, 52

TTABVUE 7-8.
54Petition for Cancellation, 1 TTABVUE 4, 6, 10-11, ¶¶ 7-8, 15, 28-32 in Cancellation No.
92058781; Petition for Cancellation, 1 TTABVUE 4, 6, 10-11, ¶¶ 7-8, 15, 28-32 in Cancellation
No. 92058796.
- 25 -
arguments solely to the hardening effects of chromia. Both parties also presented
evidence and arguments regarding chromia’s contributions (or not) to other
mechanical properties, such as the fracture toughness, flexural/burst strength,
wear/aging resistance and phase stabilization properties of ZTA.55 We therefore deem
the pleadings amended to conform to the evidence and arguments of the parties
pursuant to Fed. R. Civ. P. 15(b).
IX. How the Parties’ Products are Used within a Hip Replacement
System
We reproduce here the drawings of the color pink as applied to Respondent’s
goods, as depicted in Respondent’s registrations:
Registration No. 4319095 Registration No. 4319096

hip joint ball acetabular shell or fossa
As used within a hip replacement system, the products appear and function as
shown below:
55Petitioner’s factual materials and expert opinions summarized in Carty Decl. and Carty
Rpt., 48/60 TTABVUE, Carty Rebuttal Decl. and Carty Rebuttal Rpt., 141/153 TTABVUE;
Respondent’s factual materials and expert opinions summarized in Mecholsky Decl.,
Mecholsky Lit. Rpt., Mecholsky Lit. Rebuttal Rpt., Mecholsky TTAB Rpt. and Mecholsky
TTAB Rebuttal Rpt., 105/106-116 TTABVUE. See respective arguments made in Petitioner’s
Brief, 157/158 TTABVUE 17-20; and Respondent’s Brief, 159/160 TTABVUE 11-16.
- 26 -
56 57
58 59
As can be seen from the above diagrams, a hip joint “ball” is also referred to as a
“head”; an acetabular shell or fossa is also referred to as a “cup” or a “liner,” depending
upon the overall construction of the total hip replacement system.
Stating the obvious, the implantation of a hip replacement system into the human
body involves major surgery to provide a patient with a substitute for a significantly
56 Stavish Testim. Depo., Exh. 6, 135 TTABVUE 258.

57 Pektow Decl., Exh. 17, 116 TTABVUE 46.
58Abeyta Testim. Depo., Exh. 133 TTABVUE 213. “THR” is the acronym for Total Hip
Replacement system.
59 Pektow Decl., Exh 17, 118 TTABVUE 41.
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deteriorating skeletal joint. This is not the type of surgery a patient would want to
repeat. Thus, it is undesirable that any part of the replacement system would fail,
degrade or cause an adverse bodily reaction in vivo.
The parties agree the development of materials that are highly resistant to impact
fracturing and long-term wear has historically been a major challenge in the
development of hip implant components. Metal heads and polyethylene inserts have
been used, but these systems have created polyethylene wear debris causing
osteolysis (bone decay) in patients. Ceramic implant components began replacing
metal implants because they produced less polyethylene wear debris, thus reducing
osteolysis. However, while ceramics have some favorable characteristics, they also
have limited impact resistance and a greater risk of fracturing.60 At one time, hip
replacement systems outfitted with a poorly functioning femoral head implant
component (the subject of unacceptably high fracture rates) were subject to a major
product recall.61 Therefore, the processing and manufacture of ceramic femoral heads
and acetabular cups with the most efficacious chemical combination, resulting in the
optimal mechanical properties, is critically important.
60Petition for Cancellation, 1 TTABVUE 4, ¶¶ 4-5 in Cancellation No. 92058781; Answer, 28

TTABVUE 2, ¶¶ 4-5 in Cancellation No. 92058781; Petition for Cancellation, 1 TTABVUE 4,
¶¶ 4-5 in Cancellation No. 92058796; Answer, 22 TTABVUE 3, ¶¶ 4-5 in Cancellation No.
92058796.
61Mecholsky Lit. Rpt., Ex. 3 - Major Recalls of Organ Replacement Devices, Saint Gobain
Desmarquest Hip Implant Recall (2007) Exh. 3, 106 TTABVUE 217-223.
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X. The Parties’ Ceramic Hip Plant Product Offerings
A. Respondent’s Ceramic Hip Implant Components
Respondent began offering ceramic femoral heads and acetabular cups as hip
implant components using an alumina chemical composition sold under the name
BIOLOX in 1974. The first generation introduced in 1974 was made of highly-pure
alumina and was manufactured using a pressureless sintering process. The second
generation of the BIOLOX composition was introduced in 1985, containing fewer
impurities and featuring a decreased grain size. The third generation chemical
composition was introduced under the name BIOLOX forte in 1995, featuring an even
smaller grain that was manufactured using hot isostatic pressing (or “H.I.P.”). The
fourth generation chemical composition was introduced under the name BIOLOX
delta in 2003, which is a zirconia-toughened alumina (“ZTA”) composite (and which
includes chromia that makes the compound pink).62
Today, in the United States, Respondent offers ceramic ball head and liner hip
implant components made from the BIOLOX forte and BIOLOX delta chemical
compositions. The BIOLOX forte composition features pure alumina ceramic, and
the BIOLOX delta composition features a ZTA ceramic chemical combination.
Respondent asserts that the BIOLOX delta composition has superior material
properties – particularly the fracture rate and wear rates – compared to BIOLOX
62Petkow Decl., 114 TTABVUE 4, ¶¶ 7-8, Exh. 1, 27-28; see also Clark et al. (2007) describing
the history of the development of ceramics used for hip replacement system components,
PNOR4, 44 TTABVUE 645-655 at 645-646.
- 29 -
forte, but Respondent claims the BIOLOX forte composition has a higher hardness
value.63
Whereas BIOLOX forte has an ivory, beige or cream color, BIOLOX delta is
decidedly pink:64
BIOLOX forte BIOLOX delta
We find, and the parties do not dispute, that the chemical composition of BIOLOX
delta hip joint implant components are pink in color because of the presence of
chromia as a material constituent.65 BIOLOX delta is a ZTA composite ceramic with
three main components: alumina, zirconia and strontium aluminate (SrAl12O19)
platelets. Each of these three components contains other ingredients. Specifically, the
alumina portion of the BIOLOX delta composition contains chromia. This chromia is
dissolved into the alumina portion of BIOLOX delta material. Similarly, yttria is
dissolved into the zirconia portion of the BIOLOX delta material.66
The production of the BIOLOX delta composition begins with four raw fine
powder materials: alumina, zirconia, yttrium chromite (YCrO3), and strontium
63 Petkow Decl., 114 TTABVUE 4, ¶ 9.

64 Petkow Decl., 114 TTABVUE 5, ¶ 10; images from Parikh Rpt., 47 TTABVUE 32-33.
65 Kuntz Decl., 101 TTABVUE 5, ¶ 14; Petkow Decl., 114 TTABVUE 5, ¶ 10.
66Kuntz Decl., 101 TTABVUE 5-6, ¶¶ 13-15; Dobbs (2010), PNOR4, 44 TTABVUE 785-820
at 787.
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zirconate (SrZrO3). After quality control, Respondent’s ceramics manufacturing
process comprises milling, binder addition, spray drying, powder pressing, green
shaping, sintering in a furnace at high temperatures and hard machining. During
manufacturing, Respondent uses a technique called “pressure-assisted sintering,” or
hot isostatic pressing, towards the end of the sintering process to further densify the
material and control the grain size of the material. Changes to any of these processes
can affect the final properties and performance of the material.67 As discussed in
greater detail below, the parties dispute the contribution of chromia (which turns the
product pink), versus the addition of yttrium, better sintering techniques, and control
of grain size as contributing to the material performance of the composition.
Today, BIOLOX delta accounts for the vast majority of Respondent’s hip implant
components sales. This is because, as Respondent claims, components made with the
BIOLOX delta compound have a superior mechanical performance and lower fracture
rates than components made with the BIOLOX forte compound, although both
products meet and exceed the international standards for hip implant components.68
Petitioner continually opines that Respondent has maintained a dominant (90-95%
67 Kuntz Decl., 101 TTABVUE 6, ¶¶ 16-17.

68Petkow Decl., 113/114 TTABVUE 5 ¶¶ 10-11. See ISO Standard 6474-2, Implants for
Surgery – Ceramic Materials (2012), DNOR1 70 TTABVUE 709-726. This ISO Standard sets
out prescribed chemical composition and mechanical performance requirements for ZTA
material. Mark Kramer Colorado litigation trial testimony (“Kramer Lit. Testim.”), DNOR1,
70 TTABVUE 639-44.
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or greater) share of the ceramic hip implant component market.69 Respondent has not
shown or alleged to the contrary.
B. Petitioner’s Ceramic Hip Implant Components
Petitioner has developed two ZTA ceramic materials for hip implants:
(1) CeraSurf-p, a material that contains chromium oxide, which renders it pink, and
(2) CeraSurf-w, a white-colored material that does not contain chromium oxide. The
primary difference between the two materials is the presence of chromium oxide in
CeraSurf-p. The two products have different technical characteristics.70 Petitioner’s
pink CeraSurf-p ceramic femoral head and acetabular cup appear as follows:
71
Almost all of Petitioner’s customers buy CeraSurf-p instead of CeraSurf-w,
because (says Petitioner) CeraSurf-p contains chromium oxide (which Petitioner
contends the marketplace understands to improve the performance-related
properties of the material), while CeraSurf-w does not. Petitioner claims the market
69Strong Decl., 57 TTABVUE 4, ¶ 9; Abeyta Testim. Depo., Exh. 3, 133 TTABVUE 148, 152;
Respondent’s Business Plan, PNOR12, Exh. 12, 54 TTABVUE 478; e-mail exchange between
Nield and Wanadoo/Biotechni (April 2015), DNOR6, Exh. 6, 75 TTABVUE 37-41 at 38;
Petitioner’s Brief, 157/158 TTABVUE 7.
70 Haftel Decl., 59 TTABVUE 5, ¶ 12.
71Image from CoorsTek Bioceramics Overview (2018), Stavish Testim. Depo., Exh. 7, 135
TTABVUE 284.
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demands the current state-of-the-art material, which is a ceramic material that
contains chromium oxide. It is Petitioner’s understanding that, because of
Respondent’s education of the market, when surgeons see a pink hip ball, they
recognize it as the state-of-the-art ceramic material.72
At least as of the close of testimony periods before the Board, Petitioner had not
developed any specific marketing materials for its white product, CeraSurf-w,73 and
Petitioner had only one significant customer interested in purchasing CeraSurf-w for
use as part of its hip replacement implant system.74
C. Customers and Potential Customers for the Parties’ Products
The customers and potential customers for the parties’ ceramic hip implant
components are original equipment manufacturers (“OEMs”) – such as Zimmer
Biomet, Smith & Nephew, DePuy Synthes and Stryker – that in turn produce total
hip replacement implant systems supplied to hospitals, buying associations or
surgeons.75
The parties compete in a highly demanding industry, operating under a complex
regulatory system requiring assurances that their products comply with applicable
requirements imposed by the U.S. Food and Drug Administration (“FDA”) for implant
grade materials. The OEM customers comprise major medical device companies that
72 Strong Decl. 57 TTABVUE 5, ¶ 14.

73 Strong Discov. Depo., RNOP26, 97/131 TTABVUE 99.
74 Haftel Decl., 58/59 TTABVUE 6, ¶ 16.
75Shopoff Decl., 85 TTABVUE 3, ¶¶ 5-6; Petkow Decl., 114 TTABVUE 5, ¶¶ 12-13; Strong
Decl. 57 TTABVUE 3, 6, ¶¶ 7, 19; Haftel Decl., 58/59 TTABVUE 6, ¶ 16.
- 33 -
are experts in the medical device field and have high standards for their suppliers.76
They have deep technical knowledge of orthopedic implant products, complete their
own internal product and material testing, perform their own clinical testing while
working closely with surgeons and other healthcare professionals, and are
responsible for obtaining regulatory approval for devices incorporating the parties’
components.77
XI. Respondent’s Relevant Patents and Patent Application
On November 3, 1998, a related company to Respondent78 was issued U.S. Patent
No. 5830816 (the “’816 Patent”), Burger et al., for a chemical composition to be used
in the manufacture of cutting tools, titled “Sintered Molding,”79 the same chemical
composition presently used in Respondent’s BIOLOX delta hip implant components.
The ’816 patent expired on January 21, 2013.80 As we discuss below, it is after this
76 Strong Decl. 57 TTABVUE 3, ¶ 7.

77 Haftel Decl., 59 TTABVUE 5-6, ¶ 14.
78A concise description of Respondent and its related or predecessor companies may be found
at Dobbs (2010), PNOR4, 44 TTABVUE 785-820 at 787.
79’816 Patent, PNOR3, Exh. 1, 43 TTABVUE 5-18; Petition for Cancellation, 1 TTABVUE
4-5, ¶ 9 in Cancellation No. 92058781; Answer, 28 TTABVUE 4, ¶ 9 in Cancellation No.
92058781; Petition for Cancellation, 1 TTABVUE 5, ¶ 9 in Cancellation No. 92058796;
Answer, 22 TTABVUE 4, ¶ 9 in Cancellation No. 92058796.
80 Under 35 U.S.C. § 154(a)(2), a U.S. patent has “a term beginning on the date on which the
patent issues and ending 20 years from the date on which the application for the patent was
filed in the United States or, if the application contains a specific reference to an earlier filed
application or applications under [35 U.S.C. §] 120 …, from the date on which the earliest
such application was filed.” Pursuant to 35 U.S.C. § 120, “[a]n application for patent for an
invention …, which names an inventor or joint inventor in the previously filed application
shall have the same effect, as to such invention, as though filed on the date of the prior
application, if filed before the patenting or abandonment of or termination of proceedings on
the first application or on an application similarly entitled to the benefit of the filing date of
the first application and if it contains or is amended to contain a specific reference to the
earlier filed application.” Here, the filing date of the earliest application from which, through
- 34 -
date that Respondent began to change its position regarding the contribution of
chromia (which turns the compound pink) to the material properties of the
composition.
In any event, the Abstract of the ’816 patent, in part, states: “[z]irconium dioxide
containing 2 to 40 vol. % of stabilizing oxides is embedded in the matrix material of a
sintered molding consisting of an aluminum oxide/chromium oxide mixed crystal.”
(emphasis added). Independent Claim 3 of the ’816 Patent recites (emphasis added):
3. A sintered molding comprising:

a1) 60 to 98 vol.-% of a matrix material, the latter consisting of
a2) 67.1 to 99.2 vol.-% of an aluminum oxide/chromium oxide mixed
crystal
a3) 0.8 to 32.9 vol.-% of a mixed crystal of the formula SrA112-x,CrxO19,
x corresponding to a value of 0.0007 to 0.045,
b) 2 to 40 vol.-% of zirconium dioxide incorporated into the matrix
material, which
c) contains as stabilizing oxides more than 10 to 15 mol.-% of one or more
of the oxides of cerium, praseodymium and terbium and/or 0.2 to 3.5
mol.-% of yttrium oxide, with respect to the mixture of zirconium dioxide
and stabilizing oxides,
d) the added amount of the stabilizing oxides being chosen such that the
zirconium dioxide is present predominantly in the tetragonal
modification, and
e) the molar ratio between the zirconium dioxide containing the
stabilizing oxide and the chromium oxide amounting to 1,000:1 to
20:1,
t) the portions of the components making up 100 vol.-% of the sintered
molding, and
continuations, the ’816 issued was January 21, 1993. ’816 Patent, PNOR3, Exh. 1, 43
TTABVUE 13, col. 1, lines 3-8. Twenty years from that date is January 21, 2013.
- 35 -
g) the zirconium dioxide has a grain size not exceeding 2 μm. (emphasis
added).81
Respondent concedes that BIOLOX delta chemical combination practices one or
more of the inventions described and claimed in the ’816 patent.82 However, nowhere
in the ’816 patent is the color pink mentioned. The disclosures and discussion within
the ’816 patent, in relevant part, provide (emphasis added):
The problem still exists of improving the known materials and to make
available sintered moldings which have a high strength level and in
which good toughness is combined with great hardness. The invention
is aimed at making available a sintered molding which will satisfy these
requirements, and due to its range of properties will have greater
resistance to wear, so that the sintered molding will be suitable as a
cutting tool, especially as a cutting insert, and quite especially as a
cutting insert for the machining of cast-iron and steel materials, while
an additional objective is seen in proposing a sintered molding which
can be used as a cutting insert for interrupted cutting.83
It has now been found that the solution of the problem in question
requires a sintered molding with an entirely special composition. In
addition to the transformation toughening, which is achieved by
embedding in a ceramic matrix a zirconium dioxide containing
stabilizing oxides, the invention, in accordance with a first embodiment,
provides as the matrix a mixed crystal of aluminum oxide/chromium
oxide. Furthermore, the invention provides that the zirconium dioxide
embedded in the matrix, and the chromium oxide forming the mixed
crystal with the aluminum oxide, are in a specific molar ratio to one
another. This measure makes it possible for the first time to achieve
hardness values such as have not previously been achieved at such
zirconium dioxide contents, even at the relatively high zirconium dioxide
contents which may be necessary to obtain an especially good
toughness. On the other hand, at low zirconium dioxide contents,
81 ’816 Patent, PNOR3, Exh. 1, 43 TTABVUE 17, col. 9, lines 59-67; col. 10, lines 21-37.
82Respondent’s Admission Response No. 28 from the Colorado litigation, PNOR5, 45
TTABVUE 239; Kuntz Colorado litigation trial testimony (“Kuntz Lit. Testim.”), PNOR2, 42
TTABVUE 195-97.
83 ’816 Patent, PNOR3, Exh. 1, 43 TTABVUE 14, col. 3, lines 39-50.
- 36 -
relatively low chromium oxide contents can be present, thereby

counteracting the embrittlement of the material.84
The statement that the zirconium dioxide and chromium oxide
containing the stabilizing oxides are to be present in a specific molar
ratio necessarily also implies specific ratios for the rest of the
components, because for example as the zirconium dioxide content
decreases, the contents of the stabilizing oxides also decrease with
respect to the sintered moldings, while on the other hand the content of
the aluminum oxide increases. With respect to the aluminum oxide
in the sintered molding, the chromium oxide is present in a
weight ratio of 0.004 to 6.57% by weight, but it must not be
overlooked that chromium oxide and the zirconium dioxide containing
the stabilizing oxides are in the stated molar ratio. …85
The term, “mixed crystal,” used in the claims and description, … means
a solid solution of chromium oxide in aluminum oxide and in
strontium aluminate.86
The sintered molding in accordance with the invention is made by
pressureless sintering or hot pressing a mixture of aluminum
oxide/zirconium dioxide/chromium oxide and stabilizing oxides or a
mixture of these components is used …87
Applications of the sintered molding preferably lie in its use as a cutting
tool for cutting paper, textiles and films, but especially preferred is the
use of the sintered molding as a cutting insert for the machining of cast
iron or of steel materials, especially interrupted cutting.88
During the prosecution of the underlying application to the ’816 patent, in order
to overcome a prior art reference to patentability raised by the patent examiner,
Respondent’s patent counsel at the time, in an Office action response, stated
(emphasis added):
The invention of the present application is not suggested by [the prior

art reference]. The solution of the object according to the present
84 ’816 Patent, PNOR3, Exh. 1, 43 TTABVUE 4, col. 3, lines 51-67 through col. 4, lines 1-2.
- 37 -
invention requires a sintered body with an entirely unique composition.

For this purpose, inter alia, a very specific molar ratio of the
zirconium dioxide deposited in the matrix and the chromium
oxide which together with the aluminum oxide forms the mixed
crystal is required. Only in this way has it for the first time been
possible to obtain hardness values, even at higher zirconium dioxide
contents, which have heretofore not been achievable with corresponding
zirconium dioxide contents. On the other hand, relatively low chromium
oxide contents can be present at low zirconium dioxide contents,
whereby a brittleness of the sintered body can be suppressed.
[The prior art reference] does not teach or suggest any of these
advantages.89 (emphasis added)
Respondent’s materials expert, Dr. John Mecholsky, concedes that “[t]he ’816
Patent … covers a broad range of chromium, including amounts so low that they
would be almost undetectable … [f]or example, having .004 wt % chromium (with
respect to alumina) … [and, o]n the high end, … at least 6 wt % chromium, and
possibly higher. The ’816 Patent also discloses a very broad range of ratios between
the zirconia and chromia, from as low as 20:1 to as much as 1,000:1.”90
That the ’816 patent, on its face, is directed to a sintered molding of a particular
composition for use as a cutting tool is of no moment. Respondent’s internal and sales
presentation documents (some of which mention the color pink as being caused by the
addition of chromia) disclose that even though the material developed under the
name DC25, now produced and sold under the name BIOLOX delta, was conceived in
Respondent’s industrial division and initially manufactured for cutting tools, it has
since been optimized for medical use – specifically for prosthetic hip joint
89Patent Appln. Ser. No. 08/674,458, Office Action Response dated April 15, 1997, PNOR3,
Exh. 7, 43 TTABVUE 404.
90Mecholsky Lit. Rpt., 105 TTABVUE 174, ¶¶ 301-02; see also Kuntz Decl., 101 TTABVUE
12, ¶ 36 (“The [’816 P]atent claims a wide range of chromium content.”).
- 38 -
components.91 The Gottwik memorandum identified in the footnote below explicitly
identifies ZTA formulations including chromium oxide as contributing to desired
mechanical properties such as hardness, toughness and strength.
Respondent has sought or obtained additional patent protection for compositions
claiming the beneficial effects of chromia, the chemical that turns the compound pink.
On September 17, 2002, a related company to Respondent was issued U.S. Patent No.
6452957 (the “’957 Patent”), Burger et al., “Sintered Shaped Body Reinforced with
Platelets.”92 The ’957 patent expired on November 2, 2018.93 Chromium oxide is noted
as a constituent element in nearly all of the claims of this patent.94
The disclosures and discussion within the ’957 patent, in relevant part, provide
(emphasis added):
The subject-matter of the present invention is a sintered shaped body

consisting of a matrix material that contains an aluminum
oxide/chromium oxide mixed crystal and which is in situ reinforced
with platelets.95
[T]he invention provides that the matrix contains a mixed crystal of
aluminum oxide/chromium oxide. Furthermore, the invention
provides that the zirconium dioxide, incorporated in the matrix, and the
chromium oxide, forming the mixed crystal together with the
91Questions and Answers for Respondent’s Meeting Discussion (May 2013), PNOR1, 41
TTABVUE 49; Respondent’s internal memorandum authored by Lukas Gottwik, (Translated
Version, August 2, 2011), PNOR4, Exh. 3, 44 TTABVUE 38-44; CeramTec Sales
Questionnaire and FAQs (March 2, 2012), PNOR5, Exh. 5, 45 TTABVUE 91-144 at 95;
CeramTec/DePuy Sales Training (August 2013), PNOR12, Exh. 1, 61 TTABVUE 6-105 at 18;
Kuntz Lit. Testim., RNOR1, 70 TTABVUE 388-96.
92 ’957 Patent, PNOR6, Exh. 6, 43 TTABVUE 215-222.
93The filing date of the earliest application from which the ’816 patent issued was the Patent
Cooperation Treaty (PCT) application filed on November 2, 1998. ’957 Patent, PNOR3, Exh.
6, 43 TTABVUE 216.
94 ’957 Patent, PNOR3, Exh. 6, 43 TTABVUE 221, cols. 9-10.
- 39 -
aluminum oxide, are in a specific molar ratio with respect to each other.
This measure makes it possible for particular hardness values to be
attained even in the case of comparatively high proportions of
zirconium dioxide that may be required in order to obtain a particularly
good level of fracture toughness. On the other hand, in the case of
low proportions of zirconium dioxide there may even be a comparatively
small chromium-oxide content, inhibiting embrittlement of the
material.96
In accordance with the invention, the matrix material contains an
aluminum oxide/chromium oxide mixed crystal and a further mixed
crystal in accordance with one of the general formulae … One effect
that increases the toughness results from the zirconium dioxide that
is incorporated in the mixed-crystal matrix, whilst the chromium
addition counteracts any drop in the hardness values when the
proportion of zirconium dioxide rises.97
On January 19, 2016, Respondent was issued U.S. Patent No. 9237955 (the “’955
Patent”), Niess et al., “Intervertebral Disc Endoprosthesis.” 98 Chromium oxide is
noted as a constituent element in one of the dependent claims of this patent.99 The
disclosures and discussion within the ’955 patent, in relevant part, provide (emphasis
added):
The object on which the invention is based is to improve an

intervertebral disc endoprosthesis …. [T]he sliding bodies should have
extreme hardness, so that no abrasion occurs over the entire period of
service.100
[T]the invention provides that the zirconium dioxide, incorporated in the
matrix, and the chromium oxide, forming the mixed crystal together
with the aluminum oxide, are in a specific molar ratio with respect to
each other. This measure makes it possible for the first time for
hardness values to be attained, even with comparatively high
proportions of zirconium dioxide that may be required in order to obtain

97 ’957 Patent, PNOR3, Exh. 6, 43 TTABVUE 219, col. 5, lines 13-15, 41-46.
98 ’955 Patent, PNOR7, Exh. 8, 49 TTABVUE 46-55.
- 40 -
particularly good fracture toughness, that have not been attainable

hitherto with corresponding proportions of zirconium dioxide. On the
other hand, with low proportions of zirconium dioxide there may even
be a relatively small chromium-oxide content, which counteracts
embrittlement of the material.101
[T]he chromium addition can counteract any drop in the hardness
values due to the proportion of zirconium dioxide.102
An effect that increases the toughness results from the zirconium
dioxide that is incorporated in the mixed crystal matrix, whilst the
chromium addition counteracts any drop in the hardness values when
the proportion of zirconium dioxide rises.103
On February 14, 2012, Respondent’s then-Manager of Oxide Development in its
Development Department, Meinhard Kuntz,104 with others, filed U.S. Patent
Application No. 2012/0142237 (the “’237 Application”), Kuntz et al., “Sintered
Moulded.”105 The Abstract of the ’237 Application describes “[a] sintered molded body
consisting of a material that contains aluminum oxide with chromium doping,
zirconium oxide with Y-stabilization and strontium aluminates with variable Cr-
doping, which is particularly suitable for medial [sic] application.”106 (emphasis
added). Chromium oxide is noted as a constituent element in all of the published
claims of this application.107
101’955 Patent, PNOR7, Exh. 8, 49 TTABVUE 50, col. 2, lines 51-63; see also 49 TTABVUE
52, col. 6, lines 35-44.
104 Kuntz Decl., 101 TTABVUE 3-4, ¶¶ 4, 8-9.
105 ’237 Application, PNOR7, Exh. 7, 49 TTABVUE 42-45.
106 ’237 Application, PNOR7, Exh. 7, 49 TTABVUE 3.
107’237 Application, PNOR7, Exh. 7, 49 TTABVUE 44, second column, to 45, first and second
columns.
- 41 -
The disclosures and discussion within the ’237 Application, in relevant part,
provide:
The object of the invention is to provide a sintered moulding made of a

ceramic material which combines optimum properties such as
hardness, elasticity and thermal conductivity and is particularly
suitable for medical technology applications.108
The material composition disclosed in the ‘237 Application includes “aluminum oxide
with chromium doping” and “strontium aluminate (with variable Cr doping).”
(emphasis added).109
XII. Technical Literature Regarding the Advantages of Chromia in

Chemical Compounds for Industrial and Medical Applications
The parties made of record a wealth of technical literature about the benefits of
chromia to the mechanical properties of ceramics compounds comprising or including
alumina, particularly hardness, strength and wear resistance, spanning about 54
years,110 some of which was authored by current or former employees of Respondent
(for example, Burger, Kuntz and Porporati). We summarize below pertinent portions
from these scientific articles (emphasis added throughout):
• [T]he enhancement of alumina’s hardness, strength, wear resistance,

and other mechanical properties by chromia in solid solution is generally
accepted …. This note describes the variation of the microhardness of
108 ’237 Application, PNOR7, Exh. 7, 49 TTABVUE 44, first column, paragraph 0002.
109 ’237 Application, PNOR7, Exh. 7, 49 TTABVUE 44, first column, table immediately
following paragraph 0003.
110Petitioner and Respondent submitted many of the same technical articles as evidence. Due
to the order in which the parties’ evidence was presented, if Petitioner made of record a
technical article first, we do not recite where the identical article submitted by Respondent
appears elsewhere in the record. Further, neither party objected that any of these articles
are hearsay or otherwise are inadmissible. We set out below the article excerpts not for their
truth, but for what they show on their face at the time of publication, as stated by
knowledgeable persons in the scientific community.
- 42 -
alumina with increasing chromia content in dense, fine-grained solid

solutions. [Bradt (1966), PNOR6, Exh. 12, 46 TTABVUE 315-317 at 316].
• A positive influence of Cr2O3 was observed for the … grindability of all
samples. … [T]he abrasion resistance of alumina ceramics increases with
increased additions of chromium oxide. … [T]here is a lack of correlation
between the abrasion resistance of alumina ceramics and the porosity increase
at all firing temperatures, when Cr2O3 is added. This increase of hardening
and abrasion resistance of hot-pressed Al2O3 with increased Cr2O3
additions has been reported by Bradt and an increase of the crater wear
resistance of vacuum-pressure-sintered alumina cutting tools alloyed with
chromium oxide was observed by Ghate et al. This study indicates a
disadvantageous effect of Cr2O3 on the sintering of alpha-alumina in the
presence of a liquid phase. The effect of chromium oxide is so significant as
to decrease the sintered density of the alumina ceramics. This is correlated
with the influence of Cr2O3 in increasing the dihedral angle. As a result, the
distinct deterioration of the mechanical properties of alumina ceramics is
observed. [Tomaszewksi (1982), PNOR10, Exh. 15, 52 TTABVUE 176-181 at
181. The conclusions in this article appear to be an outlier compared to the
other published scientific studies reported herein].
• The only positive role of Cr2O3 on sintered Al2O3 was the improved
grindability, and this was only at a low level of addition (≤ 0.34 mole% Cr2O3).
The Cr2O3 addition, however, improved densification and hardness when
Al2O3 with a little MgO as a grain growth inhibitor was hot-pressed in
hydrogen and in vacuum. In the latter, the Cr2O3 exhibited significantly
greater wear resistance than the non-alloyed cutting tools. [Cho et al. (1990),
PNOR10, Exh. 14, 52 TTABVUE 166-175 at 172].
• High hardness and fracture toughness can be achieved by forming solid
solutions. of Al2-xCrxO3, and SrAl12-xCrxO19. In the system
Al2O3-Cr2O3-SrO-ZrO2-Y2O3 the fracture toughness reaches 10 MPa√m and
in the system Al2O3-Cr2O3-SrO-ZrO2-CeO2 15 MPa√m. Due to the excellent
hardness, fracture toughness and mechanical strength of 800 MPa,
these platelet- and zirconia toughened (ZPTA-) materials have great potential
for future applications. … Chrome oxide forms a solid solution together with
aluminum oxide. The hardness can be increased by incorporating Cr atoms
into the Al2O3‐grid. … [I]t could be proven that an increase in hardness in
substance system Al2O3‐Cr2O3‐ZrO2‐Y2O3 can be realized with rather low
additions of chrome oxide. … However, a significant embrittlement
occurred due to the chrome oxide alloying of the matrix. … [Burger (1997),
English transl.), PNOR11, Exh. 11, 53 TTABVUE 119-123 at 119, 122].
• The formation of SrAl12O19 platelets in the structure can be achieved with a
suitable process with the addition of e.g., SrO to the Al2O3-ZrO2-(:Y2O3) matrix.
In addition to the suitable process, the ratio of SrO : Al2O3 is also important.
In such ceramic materials, a significant increase in toughness can be achieved.
- 43 -
However, due to the formation of platelets, a significant decrease in

hardness can be found in such ceramics. This has an adverse effect on the
wear resistance. On a material basis, small amounts of chromium oxide
can be added to counteract this effect. Apart from the formation of a Al2O3-
Cr2O3 solid solution, the solid solution SrAl12-xCrxO19 is also formed. This solid
solution exhibits a significantly increased hardness compared to the
chrome-free ternary phase. ... The in-situ platelet reinforcement through
the deposit of ternary hexagonal aluminates into an alumina matrix or an
alumina-zirconia-matrix leads to a significant increase of the mechanical
properties. Through the additional formation of solid solutions, due to the
addition of chrome oxide, the hardness may also be kept at a very high
level. [Burger (1998, English transl.), PNOR11, Exh. 12, 53 TTABVUE 128-
133 at 129, 131].
• Reference is made to the five-material system Al2O3-Cr2O3-SrO-ZrO2-Y2O3 for
the production of DC25, hereinafter described. … [I]t can be seen that even at
high zirconium oxide concentrations, high hardness is maintained and facture
toughness increases steadily, compared to ZTA materials. … The DC25
material is based on an aluminum oxide matrix. “Yttrium-coated” zirconium
oxide is dispersed at a concentration of 25 wt% in this matrix. 0.8 wt% SrO and
0.3 wt% Cr2O3 are added as additional components. … With this material, it
was possible to exceed the excellent mechanical properties of Y-TZP materials
for the first time and at the same time, to achieve the high hardness of
aluminum oxide materials. [Burger (2000), English transl.), PNOR11, Exh. 9,
53 TTABVUE 90-104 at 97-98].
• The effects of Cr2O3 addition on the microstructural evolution and the
mechanical properties of Al2O3 were investigated. … The fracture toughness
and the flaw tolerance of Al2O3 were improved remarkably by the addition of
small amounts (~2 mol % ) of Cr2O3. Crack bridging by the large platelike
grains was the main cause for the improvements. The hardness and the
elastic modulus also increased, however, the fracture strength decreased
by the Cr2O3 additions. [Riu et al. (2000), PNOR11, Exh. 1, 53 TTABVUE 6-13
at 7].
• Already in 1977 a composite material, based on an alumina matrix and therein
homogeneously dispersed metastable tetragonal zirconia particles, was
developed (ZTA). ... From literature, it is well known that alumina and
chromia form a solid solution. Experimental investigation has shown that by
addition of chromia the hardness is increased significantly. … [H]igh
hardness is retained even at high zirconia concentrations by adding small
amounts of chromia. … Wear tests … with rings and discs made of Biolox
delta have shown extremely low wear rate. [Burger and Richter (2001),
PNOR4, Exh. 7, 44 TTABVUE 174-179 at 176-77].
• [T]he hardness [of the ZTA matrix] is recaptured by alloying the material
with chromium oxide which creates a solid solution with the basic alumina
- 44 -
matrix. The distribution of chromium inside the alumina atomic lattice

activates a colorizing effect similar to natural ruby. … Matrix hardening
[is achieved] … by creating a solid solution with chromium oxide. … The …
addition of chromium oxide as a solid solution in the alumina matrix as a
means of compensating for the drop in hardness caused by the addition of
the lower hardness zirconia particles throughout the microstructure. [Kuntz
(2006), PNOR6, Exh. 2, 46 TTABVUE 14-19 at 16].
• Additionally to the reinforcing components, there are also stabilizing elements
doped to the material. Chromium is added which is soluble in the alumina
matrix and increases the hardness of the composite. The minor amount of
chromium is the reason for the pink color of the material …. [Kuntz (2008),
• In order to further reinforce the [BIOLOX delta] components, stabilising
elements are also doped to the material. Chromium is added, which is soluble
in the alumina matrix and increases the hardness of the composite. The
small amount of chromium is the reason for the pink colour of the material.
[Pandorf and Kuntz (2009), PNOR6, Exh. 4, 46 TTABVUE 37-41 at 39].
• Additionally to the reinforcing components, there are also stabilizing elements
doped to the material. Chromium is added which is soluble in the alumina
matrix. and increases the hardness of the composite. The minor amount of
chromium [1.4-2.0% by weight according to Table 2] is the reason for the pink
color of the material. [Kuntz et al. (2009), PNOR6, Exh. 8, 46 TTABVUE 259-
282 at 264].
• A new alumina-zirconia matrix composite (AMC: Al2O3 = 80.5%, ZrO2= 18
vol%) was introduced in 2000 as a high-strength implant material with
virtually double the fatigue resistance of alumina ... The improvement came
from small and well-dispersed zirconia (24%; grains < 0.3 μm) constrained by
the alumina matrix. The chromium and strontium (1%) platelet distributions
(aspect ratio 3–6) combined with the zirconia allowed for suppression of
crack initiation, growth and deflection while the alumina matrix
contributed overall hardness. This new bioceramic is known as Biolox-delta
(CeramTec Inc., Plochingen, Germany). [Clark et al. (2009), PNOR11, 53
TTABVUE 105-113 at 106].
• BIOLOX delta is an alumina based composite ceramic. … Additionally to the
reinforcing components, there are also stabilizing elements doped to the
material. Chromium is added which is soluble in the alumina matrix and
increases the hardness of the composite. The minor amount of chromium is
the reason for the pink color of the material …. [Kuntz (2010), PNOR4, Exh.
10, 44 TTABVUE 612-637 at 618].
• [T]he newest generation of ceramics (named Biolox Delta) … incorporate
zirconia into the alumina matrix. … Chromium oxide (0.5%) has been added
to improve the hardness and wear characteristics, and strontium crystals
- 45 -
(0.5%) to enhance toughness and diffuse crack energy. The final AMC [alumina
matrix composite] material consists of roughly 75% aluminum oxide, 25%
zirconia, and less than l % chromium oxide and strontium oxide. [Cai and
Yan (2010), PNOR5, Exh. 6, 45 TTABVUE 145-152 at 149].
• [A]lumina/zirconia composites represent the newest generation of ceramic
materials and the most promising candidates for replacing metallic bearing
parts in arthroplastic applications. … Cr3+ addition to the composite structure
could … affect … an ability of the alumina phase [during processing], thus
ultimately leading to a different rate in polymorphic transformation in the
zirconia phase. Results collected by [other authors] on the phase stability at
room temperature of tetragonal zirconia added with Cr2O3 dopant indeed
support this suggestion. According to the findings of those researchers, the
observed stabilization … resulted from a strong interaction between Cr2O3 and
the ZrO2 surface, which prevented the diffusion of oxygen from the atmosphere
into the ZrO2 lattice. … [T]his paper … suggests a role of Cr2O3 dopant on
thermal stability and, thus, the possibility of tailoring environmental
performance through a suitable doping not only of the ZrO2 phase but also of
the Al2O3 matrix phase. [Pezzotti, Porporati, et al. (2010), PNOR6, Exh. 1, 46
TTABVUE 5-13 at 6, 12].
• Some alumina-zirconia composites are already implanted or developed by
companies (Biolox delta by Ceramtec being an improved version of these
composites, with SrO and Cr2O3 additions and alumina grains with platelet-
like morphology). As expected, they show significant improvement in
ageing resistance …, and excellent crack resistance. [Douillard et al.
• Additionally to the reinforcing components, there are also stabilising elements
doped to the material. Chromium is added, which is soluble in the alumina
matrix and which increases the hardness of the composite. The minor
amount of chromium is the reason for the mauve colour of the material.
[Masson and Kuntz (2013), PNOR6, Exh. 5, 46 TTABVUE 42-51 at 45].
• Chromia (Cr2O3) is one the many additives potentially able to improve the
physical properties of alumina. … The addition of Cr2O3 … increases the
hardness, tensile strength and thermal shock resistance of alumina (Riu
et al., 2000). When a small amount of Cr2O3 (~ 2 mol %) is added, the grains
become larger and bimodal in size distribution. At the same time, the fracture
toughness and flaw tolerance of alumina are also improved. The hardness
as well as elastic modulus is increased. However, fracture strength
decreases with the addition of Cr2O3 (Riu et al., 2000). … The effects of Cr2O3
addition on the mechanical properties and microstructurc of ZTA were
investigated. When a small amount of Cr2O3 (~0.6 wt %) was added, the grains
becomes larger and acquired a platelike shape. As a result, fracture
toughness was improved remarkably by the small addition of Cr2O3 (~0.6
wt %). [Azhar et al. (2013), PNOR11, Exh. 2, 53 TTABVUE 14-21 at 16, 20].
- 46 -
• Th[e] fourth generation of composite ceramics of alumina matrix (BIOLOX

Delta, CeramTec GmbH, Germany) is composed of 82% of alumina and 17%
zirconia. Improved oxidation resistance, hardness and wear were
achieved adding a 0.5% of chromium oxide …. [Gabarro et al. (2014), PNOR8,
Exh. 6, 50 TTTABVUE 47-59 at 49].
• Chromium oxide is another additive used in Biolox Delta to increase the
hardness and wear characteristics … [T]he addition of chromia is reported
to lead to an increase in toughness with no change in hardness for ZTA
composites with different zirconia and alumina contents. … Chromium oxide
added to the alumina phase is also shown to slow down the hydrothermal
degradation in the zirconia … The addition of chromia further enhances
[the] … protective effect [of zirconia from undergoing phase
transformation]. [Kurtz et al. (2014), PNOR9, Exh. 5, 51 TTABVUE 105-115
at 111.
• Biolox Delta, a commercialized product by CeramTec AG, is a ZTA but also
contains small quantities of SrO and Cr203. These additives react with
alumina and form plate-like alumina grains that produce extra toughening
mechanisms through crack deflection and crack bridging ... In addition to
enhancing toughness, the addition of chromium oxide in alumina matrix
enhances the hardness, the tensile strength and resistance to
corrosion and thermal shock … In addition to the positive role of Cr in the
enhancement of wear resistance, this dopant also helps maintain the
stability of zirconia, under a hydrothermal environment. As Cr dopant
changes the oxygen vacan[c]y concentration it prohibits or delays moisture
transfer to zirconia. As a result, oxygen vacancy annihilation and thereby
polymorphic phase transformation in a hydrothermal environment is
postponed. … The enhancement of density and mechanical properties
(fracture toughness/Vickers hardness) are achievable by incorporation of a
specific amount of Cr203 and SrCO3. [Bostanchi (2017), PNOR8, Exh. 8, 50
TTABVUE 75-149 at 98, 100, 259, 272].
• BIOLOX delta, an example of a fourth-generation ceramic, has even higher
grain uniformity and smaller grain size than previous generations. Alumina
still makes up a significant portion of the material, but [z]irconium oxide
crystals have been added in small amounts to help increase toughness. …
[C]hromium oxide is added to the composite to help increase the hardness
that was lost by the addition of zirconium. [Gamble et al. (2017), PNOR, Exh.
5, 53 TTABVUE 37-44 at 38].
• Nowadays the most commonly used ceramic is the alumina matrix composite
(AMC) (Biolox Delta; CeramTec AG, Plochingen, Germany). AMC, introduced
in the early 2000s, is the fourth generation of Biolox Ceramics, composed of
82% alumina and 17% zirconia, with the addition of chromium oxide (0.5%)
to enhance hardness and strontium crystals (0.5%) to diffuse crack energy.
[Zagra et al. (2018), PNOR8, Exh. 15, 50 TTABVUE 348-354 at 352].
- 47 -
• The Biolox delta ceramic was developed to address some of the drawbacks of
the third-generation alumina designs using nano-sized yttria-stabilized
zirconia particles (17%), which are dispersed in the alumina matrix (81.6%)
along with strontium (1%) in the form of a platelet to inhibit crack propagation,
providing more strength. The addition of zirconia greatly increases the fracture
toughness; and the addition of chromium oxide recaptures the hardness of
the basic alumina matrix. [Chang et al. (2018), Exh. 3, 53 TTABVUE 22-29 at
26].
• [T]he fourth and most recent edition of the ceramic (CeramTec, BIOLOX delta)
femoral head has been optimized with zirconia, strontium oxide, and
chromium oxide to diffuse crack energy, limit crack propagation, and
improve hardness. This has shown to further reduce the incidence of
ceramic head fractures …. [Robinson, et al. (2019), PNOR8, Exh. 14, 50
TTABVUE 341-347 at 343].
• Fourth-generation ceramics are called alumina matrix composites (AMC) and
marketed as BIOLOX Delta (CeramTec GmbH, Plochigen; Germany). They
have higher grain uniformity, smaller grain size, and contain about 82%
alumina and 17% zirconia which is incorporated as tetragonal, nano-sized
yttrium-stabilized particles and this improves the composite’s mechanical
properties by preventing initiation and propagation of cracks. Chromium
oxide is added to increase hardness while addition of small quantity
strontium oxide forms platelets which deflect subcritical cracks, further adding
to the toughness. [Tapasvi, et al. (2019), PNOR10, Exh. 4, 52 TTABVUE 60-67
at 61].
• The effect of Cr2O3 addition in different volume ratios (0.5, 1, 5 vol %) on
microstructure and mechanical properties of Al2O3 were examined to assess as
an alternative to the pure Al2O3 for ceramic armour applications. … 0.5 vol%
Cr2O3 addition increased the flexural strength 44% by the grain boundary
modification of the larger size of the Cr3+ ions. A 6% and 13% hardness
increase was achieved because of the combined effect of increasing relative
density and solid solution formation with 0.5 vol% and 1 vol% Cr2O3
additions, respectively. Even though the fracture toughness values remained
unchanged for all the compositions, the crack propagation behavior turned
from mostly intergranular to a mixture of intergranular and transgranular
with the Cr2O3 addition by the localized compressive stresses that induce the
strengthening of the grain boundary. [Yildiz et al. (2019), PNOR10, Exh. 5, 52
TTABVUE 68-76 at 75].
• [T]he fourth and most recent edition of the ceramic (CeramTec, BIOLOX delta)
femoral head has been optimized with zirconia, strontium oxide, and chromium
oxide to diffuse crack energy, limit crack propagation, and improve hardness.
This has shown to further reduce the incidence of ceramic head fractures.
[Rankin et al. (2019), PNOR11, 53 TTABVUE 30-36 at 32].
- 48 -
• [A] fourth generation of CoC [ceramic on ceramic] bearings … incorporates

yttria-stabilized tetragonal zirconia (Y-TZP) into alumina matrix. This new
generation is marketed as Biolox Delta ceramic bearings and was introduced
by CeramTec AG (Plochingen, Germany) in 2004 ... The aim of this composite
is to reduce both the risk of fracture and wear rate, as well as to obtain
excellent scratch resistance together with low coefficient of friction ... This new
ceramic consists of 82% alumina, 17% zirconia, and 0.5% chromium oxide to
improve hardness and wear characteristics …. [Fernández-Fairén et al.
• BIOLOX delta represents the latest advancement in alumina ceramic
technology due to the addition of zirconium oxide which provides the basic
hardness and wear resistance, and strontium oxide and chromium oxide
which provide the improved mechanical properties. Compared with pure
aluminum oxide, ceramic BIOLOX delta offers higher mechanical
properties including higher fracture toughness …. [Davis et al. (2020),
XIII. Respondent’s Submissions to the U.S. Food and Drug Administration

(“FDA”)
As explained, in its filings with the FDA, Respondent states that the presence of
chromium oxide causes the pink color of the chemical composite.
The FDA is a large agency, organized into centers. For example, there are centers
for medical devices, drugs, biologics, veterinary medicines, foods and cosmetics, and
tobacco products. The Device Center primarily reviews and approves or clears new
medical devices prior to their coming to the market.111
The categories of medical devices for which the Device Center has oversight
responsibility cut across multiple medical disciplines from orthopedics to
cardiovascular and more. The FDA categorizes these devices into classes. The amount
of regulatory control applied to a particular class of device is a function of its relative
111Kramer Colorado litigation trial testimony (“Kramer Lit. Testim.”) on FDA practices,
RNOR1, 70 TTABVUE 611-12. Petitioner did not introduce any testimony of its own expert
on FDA practices.
- 49 -
risk and novelty or the extent of information known about the product. Class 1
includes simple devices, some of which do not even require FDA clearance prior to
marketing. Class 3 devices carry the highest risk, such as heart valves and
pacemakers. Class 2 devices fall in the middle. Orthopedic hip implants are
categorized into either Class 2 or Class 3. How a medical device is classified depends
on a variety of factors, including the type of surfaces that are articulating or moving
against each other. For example, an orthopedic device having a femoral head that is
ceramic articulating against a polyethylene acetabular component is a Class 2 device.
If the device has two ceramic components articulating against each other, it is a Class
3 device.112
If a company wants to sell a new orthopedic device, the documentation it needs to
file with the FDA depends on the class in which the device is categorized. If it is a
Class 2 device, for example a ceramic component articulating against a polyethylene
component, then the company would file a Premarket Notification, commonly
referred to as a 510k, from the section of the law where it originated. The premise of
a 510k is to demonstrate that one’s device is “substantially equivalent” to a “predicate
device.” For one device to be substantially equivalent to another, the two devices must
have the same intended use. A new device does not need to be identical to a predicate
device in order to be substantially equivalent to that predicate device. A predicate
device typically is a legally marketed product. The predicate device most often is itself
found substantially equivalent to an earlier legally marketed device through the 510k
112 Kramer Lit. Testim., RNOR1, 70 TTABVUE 612-13.
- 50 -
process, and shown to be in the same generic category as the new device. If a company
is unsuccessful in convincing the FDA that its Class 2 device is substantially
equivalent to a predicate device, then it would be considered a Class 3 device and
have to undergo the process for Premarket Approval (or “PMA”) used for Class 3
devices.113
The FDA found hip-implant systems incorporating components made from the
BIOLOX delta composition to be substantially equivalent to hip-implant systems
integrating a different ceramic component on at least four separate occasions. The
very first 510k for a device incorporating BIOLOX delta components was such an
example because there was no prior BIOLOX delta. Yet the FDA still found the
devices with and without BIOLOX delta components substantially equivalent
because they had the same technological characteristics. That is, BIOLOX delta was
(and is), a ZTA-type material and the predicate devices contained components made
from alumina and zirconia. Even though there was a change to the material
composition, the FDA cleared the medical device incorporating a component made
from the BIOLOX delta composition for marketing and sale in the U.S.114
Component parts for medical devices are not subject to being cleared through the
510k clearance process. The FDA reviews or clears and approves finished medical
devices, not pieces and parts. So unless for some reason a component is presented as
a finished medical device in its own right, it would be approved only in the context of

- 51 -
a larger system. A medical device component could be a material, software within a
device, an assembly, but not a finished device in its own right.115
For some medical devices, the component manufacturer might have information
in its possession that is helpful to its customer, the final medical device manufacturer
needing to submit a 510k or PMA application to the FDA. In such a case, a method
has been set up for a component manufacturer, if it wishes to maintain confidentiality
over some of its information, to provide that information directly to the FDA. The
form for providing confidential information directly to the FDA is called a “master
file.” A master file permits a third party, such as a component supplier, to provide
information directly to the FDA, confidentially, but the finished-device manufacturer
would not have direct access to it. However, the finished-device manufacturer could
tell the FDA it knows this master file exists, and provide a letter from the master file
owner permitting the FDA to access it on the finished-device manufacturer’s behalf.
Component suppliers are not required to submit master files to the FDA; it is a
voluntary process.116
Petitioner made of record Respondent’s master files (or their amendments)
submitted to the FDA in 2004, 2008, 2012, 2013 and 2015, in which Respondent

116Kramer Lit. Testim., RNOR1, 70 TTABVUE 625-26; see also, U.S. FDA “Introduction to
Master Files for Devices (MAFs),” PNOR8, Exh. 4, 50 TTABVUE 37-40 at 38 (“To help
preserve the trade secrets of the ancillary medical device industry and at the same time
facilitate the sound scientific evaluation of medical devices, FDA established the device
master file system. In addition, a master file may be considered when several applications
may be submitted for different products which may use a common material or process, etc.
….”).
- 52 -
stated that chromium oxide had been added to BIOLOX delta ceramic matrix to
increase the hardness of the ceramic, explaining in some, but not all, instances that
the addition of chromia is the cause of the pink color of the material (emphasis added):
The selected Alumina Matrix Composite [BIOLOX delta] makes use of

three different principles in order to achieve its excellent properties.
These are: [1] [t]ran[s]formation toughening resulting from the addition
of the small Zirconia particles homogeneously dispersed in the Alumina
Matrix, [2] [platelet reinforcement resulting from the in situ formation
of elongated oxide crystals, [3] [c]omposite hardening by the addition
of chromium oxide. … The final mechanism is the addition of
chromium oxide as a solid solution in the Alumina Matrix composite
as a means of compensating for the drop in hardness caused by
the addition of the lower hardness zirconia particles throughout the
microstructure. (2004).117
***
[A]n [a]lumina matrix composite of approximately 82% by volume
[a]lumina with roughly 17% by volume of zirconia, chromium oxide
and other oxides presented the ideal base for … [improved] material
[when compared to BIOLOX forte]. … Additionally to the reinforcing
components, there are also stabilizing elements doped to the material.
Chromium is added which is soluble in the alumina matrix and
increases the hardness of the composite. The minor amount of
chromium is the reason for the pink color of the material. … (2008).118
***
The intention of this submission is to assure that our future customers’
filings for their hip replacement products incorporating BIOLOX delta
or BIOLOX forte ceramic ball heads will refer to accurate and recent
data with respect to CeramTec’s manufacturing processes and quality
systems data. … Description of BIOLOX delta[:] … BIOLOX delta is an
alumina based composite ceramic. Approximately 80 vol.-% of the
matrix consist[s] of fine grained high purity alumina which is very
similar to the well[-]known material BIOLOX forte. … Additionally to
the reinforcing components, there are also stabilizing elements doped to
Respondent’s updated information on Alumina Matrix Composite, BIOLOX delta, into

117
Master File No. 197 for Respondent’s ceramic ball heads (April 17, 2004), PNOR3, Exh. 2, 43
TTABVUE 19-59 at 24-25; Exh. 5, 43 TTABVUE 173-193 at 178-79.
118Respondent’s BIOLOX forte and BIOLOX delta ceramic cups and inserts (October 1,
2008), PNOR3, Exh. 3, 43 TTABVUE 60-107 at 62-63, 86.
- 53 -
the material. Chromium is added which is soluble in the alumina

matrix and increases the hardness of the composite. The minor amount
of chromium is the reason for the pink color of the material. …
(2012).119
***
BIOLOX delta Alumina Ceramic is an alumina based composite ceramic
that was created based on the proven attributes of the BIOLOX forte
Alumina Ceramic. The goal of the development of the BIOLOX delta
material was to preserve the desirable properties of the BIOLOX forte –
as an excellent bioceramic with more than 30 years clinical experience
– while increasing the strength and toughness. … This goal was
accomplished by integrating reinforcing components (tetragonal
zirconia particles and platelet shaped crystals of the composition
strontium aluminate) and by adding stabilizing elements (Yttrium and
Chromium) into the BIOLOX delta material. … Chromium oxide is
added as a solid solution to increase hardness and compensate for the
decrease in hardness caused by the addition of the lower hardness
zirconia particles in the microstructure. The minor amount of Cr is the
reason for the pink color of the composite. … The resulting BIOLOX
delta material further develops nearly the hardness of Alumina while
offering a major improvement in strength and toughness. (2013).120
***
BIOLOX delta is the tradename of a Composite Material based on high
purity alumina matrix with zirconia reinforcement (ZTA). … BIOLOX
delta Alumina Ceramic is an alumina based composite ceramic that was
created based on the proven attributes of the BIOLOX forte Alumina
Ceramic. The goal of the development of the BIOLOX delta material was
to preserve the desirable properties of the BIOLOX forte – as an
excellent bioceramic with more than 30 years clinical experience – while
increasing the strength and toughness. … This goal was accomplished
by integrating reinforcing components (tetragonal zirconia particles
and platelet shaped crystals of the composition strontium aluminate)
and by adding stabilizing elements (Yttrium and Chromium) into the
BIOLOX delta material. …Chromium oxide is added as a solid
solution to increase hardness and compensate for the decrease in
hardness caused by the addition of the lower hardness zirconia
particles in the microstructure. The minor amount of Cr is the reason
119 Respondent’s Master File 197, Amendment 11, BIOLOX forte, [a]nd BIOLOX delta
ceramic ball heads (October 11, 2012), PNOR3, Exh. 4, 43 TTABVUE 197-172 at 109, 134.
120Respondent’s Master File 746, Amendment 20, BIOLOX delta ceramic liners (June 25,
2013), PNOR12, Exh. 6, 61 TTABVUE 343-428 at 377, 379.
- 54 -
for the pink color of the composite. … The resulting BIOLOX delta
material further develops nearly the hardness of Alumina while
offering a major improvement in strength and toughness. (2015).121
Respondent did not retract the statements made in its master files regarding the
contributions of chromia to the desired mechanical properties of the BIOLOX delta
composition until 2015 and 2016 in correspondence and enclosures filed with the
FDA. This was after Petitioner filed its district court action and these cancellation
proceedings against Respondent.
Specifically, in its letters to the FDA dated August 26, 2015 and April 25, 2016, 122
Respondent cited to an October 22, 2014 article written by Dr. Meinhard Kuntz
entitled “The Effect of Chromia Content on Hardness of Zirconia Platelet Toughened
Alumina Composites” (the so-called “White Paper” discussed in detail below). In its
correspondence, Respondent reported Dr. Kuntz’s conclusions to the FDA that the
chromia in the BIOLOX delta ceramic material did not contribute to the hardness of
the material. Respondent’s correspondence sought to amend historical statements
previously made in its Device Master Files, quoted above, that chromium increases
hardness in the BIOLOX delta ceramic material, which Respondent said were at odds
with its most recent research to be found in the Kuntz article.
Respondent’s Master File 746, BIOLOX delta ceramic liners (Update March 15, 2015),
121
PNOR4, Exh. 5, 44 TTABVUE 50-156 at 77-78, 80.

122Petkow Decl., 114 TTABVUE 12, ¶ 41 and 120 TTABVUE 15-20, Exh. 19; Stroetgen
Colorado litigation trial testimony (“Stroetgen Lit. Testim.”), PNOR28, 128 TTABVUE 41-46.
- 55 -
XIV. Product Advertising by Respondent and its OEM Customers

Regarding the Benefits of the BIOLOX delta chemical composition
used in Hip Implant Components
Respondent and its customers (OEM medical device manufacturers) have for
many years engaged in product advertising, extolling the benefits of chromia within
the BIOLOX delta ZTA ceramic composite:
• BIOLOX delta is a new alumina matrix composite, which makes use of the
following principles: [1] Transformation toughening resulting from the
addition of small homogeneously dispersed oxide particles in the alumina
matrix, [2] Platelet reinforcement resulting from the formation of larger oxide
crystals. [3] Composite hardening resulting from the addition of chromium
oxide. BIOLOX delta is composed of aluminum oxide (approximately 75%),
zirconium oxide, chromium oxide and other oxides. [BIOLOX delta, A new
ceramic in Orthopaedics, CeramTec (undated), PNOR5, Exh. 1, 45 TTABVUE
5-13 at 8].
• BIOLOX delta is an aluminum oxide matrix composite ceramic consisting of
approx. 82% alumina (Al203), 17% zirconia (ZrO2) and other trace elements
(percent by volume). The pink color is due to the chromium oxide (Cr2O3).
… Alumina provides the material’s hardness and wear resistance, while
zirconia, together with other additives, provides improved mechanical
properties. These properties are achieved, among other things, by means of
the high strength, the high density of the material and the very small grain
size of the alumina matrix. [Ceramic-on-Ceramic – Scientific Information,
BIOLOX delta Ceramic, Zimmer website (undated), PNOR8, Exh. 10, 50
TTABVUE 301-03 at 302].
• The alumina material provides BIOLOX delta with high hardness, excellent
biocompatibility and hydrothermal stability. Yttria-stabilized zirconia
particles (Y-TZP) are finely dispersed throughout the alumina matrix,
increasing mechanical strength and fracture toughness over pure alumina. In
zirconia-toughened alumina (ZTA) materials, some of the original hardness of
the alumina material is lost. The addition of chromium oxide restores the
desired material hardness to the matrix. [BIOLOX delta ceramic femoral
heads material rationale, DePuy Synthes (2003), RNOR5, Exh. 7, 45
TTABVUE 153-65 at 157].
• BIOLOX delta is an aluminum oxide matrix composite ceramic consisting of
approx. 75% alumina (Al2O3), 24% zirconia (ZrO2) and other trace elements.
The pink color is due to the chromium oxide (Cr2O3) that improves the
hardness of the composite material. [BIOLOX delta ceramic femoral head
data sheet, Zimmer (2008), PNOR4, Exh. 8, 44 TTABVUE 180-84 at 182].
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• Alumina Matrix Ceramic Composite, chromium oxide compensates the

hardness difference. [Ceramic Market and Main Trends Worldwide:
Technical Evolution of Ceramics in Orthopaedics, CeramTec (2008), PNOR5,
Exh. 9, 45 TTABVUE 201-228 at 208].
• Vadin Implants uses the newest ceramic material which is an alumina matrix
composite, labeled BIOLOX Delta. BIOLOX delta is a zirconia-toughened,
platelet-reinforced alumina ceramic (ZPTA), designed to incorporate the wear
properties and stability of alumina with vastly improved material strength and
toughness. BIOLOX delta contains approximately 74% alumina and 25%
zirconia. Additives of chromium dioxide and strontium oxide enhance the
performance of the material. [Vadin Implants (website) (© 2008-2020),
PNOR8, Exh. 9, 50 TTABVUE 298-300 at 299-300].
• Biolox delta is an alumina composite matrix comprised of 74% alumina, 25%
zirconia and 1 % additives such as strontium and chromium to enhance the
performance of the material. As we will see later, this matrix improves wear
characteristics and fracture toughness which are critical factors for hard
bearings. … BIOLOX delta is a nanocomposite, of 82% Alumina and 17%
Zirconia nanoparticles with traces of Strontium Aluminate platelet crystals for
crack shielding and Chromium Oxide for stabilization. … The last
components of the Biolox delta matrix are mixed oxides …. The mixed oxides
consist of chromium oxide which helps to achieve the desired hardness.
Strontium oxide prevents micro cracks in the material from advancing by
dissipating crack energy. These two oxides further increase the materials
strength and fracture toughness. 453 [BIOLOX delta Education Guide
(DePuy) (September 2009), PNOR12, Exh. 11, 61 TTABVUE 438-67 at 446-47,
453]
• BIOLOX delta: Alumina Matrix Composite, Chromium Oxide, Phase
Stabilization, Hardness; Questions before my presentation or during the
coffee breaks: Why Biolox delta has a pink color? Answer: Cr3+ [Advanced
metrology of bioceramics: an independent overview on BIOLOX delta,
Sponsored by CeramTec (December 2011), PNOR1, Exh. 1, 41 TTABVUE 5-36
at 14]
• Biolox delta: 82 Vol.% aluminum oxide, 17 Vol.% zirconium oxide (zirconia
oxide) and less than 1 Vol.% strontium aluminate platelets and chromium
oxide [for] hardness. … Why is Biolox delta pink colored? A: The added
chromium oxide gives the pink color after sintering. Chromium oxide is
added to increase the hardness of Biolox delta. [CeramTec Sales
Questionnaire and FAQs (March 2, 2012), PNOR5, Exh. 5, 45 TTABVUE 91-
144 at 99, 101].
• BIOLOX delta composition (AMC) Alumina Matrix Composite: Chromium
oxide (Cr2O3) [added] to balance hardness reduction introduced by the
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Y-TZP [Yttria Stabilized Zirconia]; CeramTec/DePuy Sales Training (August

2013), PNOR12, Exh. 1, 61 TTABVUE 6-105 at 31].
• BIOLOX delta (AMC) Chemical Composition: Chromium Oxide (0.5 vol %),
phase stabilization, hardness; Chromium makes it pink. It is from ruby
[CeramTec/Biomet Training (March 2013), PNOR12, Exh. 2, 61 TTABVUE
106-84 at 123].
• BIOLOX Delta [i]s composed of approximately 75% aluminum oxide, which
provides the basic hardness and wear resistance. and approximately 25%
zirconia. which together with other additives (mixed oxide platelets like
chromium oxide) provide the improved mechanical properties.
Compared with pure aluminum oxide, ceramic BIOLOX Delta offers higher
mechanical properties including higher fracture toughness. R3○ acetabular
system, design rationale, Smith & Nephew (2013), PNOR8, 50 TTABVUE
317-37 at 324].
Respondent readily concedes that “in certain older advertising and marketing for
BIOLOX delta,” it “stated that the product was pink because of the presence of
chromium in the BIOLOX delta material and in some instances also stated that the
chromium increased the hardness of the product,” and “included this statement
originally in some of [its] … materials in order to provide … customers with the full
information about the BIOLOX delta material and to explain why the components
were pink.”123 Prior to late 2014 (as noted in the numerous examples above), the
statement that chromium increased the hardness of the BIOLOX delta compound
appeared in Respondent’s marketing materials, such as presentations to OEM
customers, Respondent’s website, brochures, as well as on Respondent’s customers’
websites and materials – going (by Respondent’s own account) as far back as 2001.124
Since at least as early as 2012, Respondent in fact was actively giving presentations
123 Petkow Decl., 114 TTABVUE 8-9, ¶¶ 26, 31.

124 Petkow Decl., 114 TTABVUE 9, ¶ 30; see also Exh. 14, 115 TTABVUE 225-38 at 228, 231.
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and telling customers that chromium oxide contributed to hardness,125 and as late as
2019 Respondent was still sending articles to its customers referencing the fact that
chromium oxide increases the hardness of the BIOLOX delta ceramic.126
All of the above statements made by Respondent or its OEM customers in
scientific literature, filings with the FDA, and advertising and marketing activities,
regarding the contribution of chromia to the mechanical properties of the BIOLOX
delta composition, render suspect Respondent’s current assertions that (1) “it was not
[Respondent]’s understanding that this increase to the hardness of the material [from
chromia, when added to alumina] was of significant importance to the performance
of the material” and that (2) Respondent “did not believe chromia materially impacted
the quality of BIOLOX [d]elta or was essential to the use or purpose of BIOLOX
[d]elta.”127
As an attempted counter-balance to the above-quoted advertising literature and
above-noted marketing activities, Respondent states it was the first to offer pink
ceramic hip implant components, and points to its advertising and marketing efforts
around the color pink, from 2009 through 2021, evincing its evolving strategy to build
an entire brand around the color pink.128 Respondent also states that, once one of its
scientists (Dr. Meinhard Kuntz) in late 2014 (after the petitions for cancellation were
125 Echols Discov. Depo., PNOR13, 154 TTABVUE 13, 23-25, Exh. 1.
Echols Colorado litigation trial testimony (“Echols Lit. Testim.”), PNOR2, 42 TTABVUE
126
167-69; Echols Discov. Depo., PNOR13, 154 TTABVUE 31-41, 52-117, Exhs. 1, 3-6.
128 Petkow Decl., 114 TTABVUE 6-8, ¶¶ 14-15, 17, 19-22, 24 and 115 TTABVUE 138-74, Exh.
8.
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filed) investigated and reported that chromia did not contribute to the hardness of
the BIOLOX delta ceramic, Respondent formulated a plan to contact all customers
and inform them of this new information and ask them to correct their websites and
marketing materials accordingly.129
XV. Reported Experimental Data
The parties submitted a wealth of experimental data and reports, and suggested
implications to be drawn from them, regarding whether the addition of chromia to
the ZTA compound (resulting in the pink color of the ceramic) contributes to the
mechanical performance of the compound. Unsurprisingly, for each set of
experimental data and report submitted by the proponent (by way of experts or
employees), its adversary criticizes the experimental methodology, data collection
procedures or stated conclusions.
A. The Kuntz White Paper (2014)
Dr. Meinhard Kuntz joined Respondent’s Oxide Ceramics Department in 2005,
which he later managed until his departure from the company in 2017.130 Based on
other experimental activities conducted by his work colleagues in 2006, 2008 and
2009, Dr. Kuntz began to suspect that chromium possibly may not be contributing to
Petkow Decl., 114 TTABVUE 9-11, ¶¶ 29, 33-39 and 115 TTABVUE 175-79, 206-250, 116
129
TTABVUE 2-46, 117 TTABVUE 2-30, 118 TTABVUE 2-59, 119 TTABVUE 2-51, 120
TTABVUE 2-13, Exhs. 9, 12-17, 113 TTABVUE 23-47, Exh. 18.
130 Kuntz Decl., 101 TTABVUE 4, ¶¶ 8-9; Kuntz Lit. Testim., RNOR1, 70 TTABVUE 373-74.
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the desirable mechanical properties of BIOLOX delta notwithstanding Respondent’s
ongoing marketing statements that it did so.131
In order to confirm his suspicions, Dr. Kuntz conducted an experiment testing the
effect of chromium on the material properties of BIOLOX delta. Dr. Kuntz published
the results of his findings in a so-called “White Paper” in October 2014.132 In his White
Paper, Dr. Kuntz concluded:
The acceptable range of chromia content for BIOLOX delta is between

0.31 – 0.37% [by weight]. … [My test] results demonstrate that the
existence or non-existence of chromia in a ZTA material that is
otherwise identical to BIOLOX delta has no influence on the hardness
of the material, at least in the range of the amount of chromia
investigated here ([0.0%, 0.14%, 0.32% and] 0.5% by weight). ... [T]he
statistically substantiated test results discussed herein demonstrate
that the chromia content of BIOLOX delta does not measurably
influence the hardness.133
At the trial in the Colorado Litigation, Petitioner’s materials expert, Dr.
Fischman, criticized the experiment and results of Dr. Kuntz’s white paper in several
respects: (1) Dr. Kuntz’s experiment was not reproducible because the oxide
information was not provided, (2) the alumina levels were not held constant in the
different vats of materials Dr. Kuntz compared, and (3) Dr. Kuntz’s study lacked a
control.134 Even Respondent’s materials expert at the Colorado Trial, Dr. Mecholsky,
Kuntz Decl., 102 TTABVUE 14-17; ¶¶ 42-50; Kuntz Lit. Testim., RNOR1, 70 TTABVUE
131
413-429.
Kuntz Decl., 101 TTABVUE 20-21; ¶¶ 56-57; Kuntz Lit. Testim., RNOR1, 70 TTABVUE
132
450-57.
133 Kuntz White Paper, Kuntz Decl., Exh. 7, 101 TTABVUE 77-81 at 78, 81.
134Dr. Gary Fischman Colorado litigation trial testimony (“Fischman Lit. Testim.”), DNOR1,
70 TTABVUE 284-86, 291-92.
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had his own criticisms of Dr. Kuntz’s white paper: (1) it wasn’t peer-reviewed, and
(2) it contained insufficient references to and consideration of prior experimental
literature in this area.135 Dr. Kuntz himself recognized some of the shortcomings of
the White paper when he testified at the Colorado trial that (1) it was not peer-
reviewed by persons outside of Respondent, (2) it was important to Respondent that
the White Paper be sent out as quickly as possible, so the paper was not scientific
journal quality, and (3) Dr. Kuntz did not show in the White Paper the complete
experimental techniques he employed.136
In his initial report for these proceedings, Petitioner’s materials expert, Dr.
William Carty, discusses his similar criticisms of Dr. Kuntz’s White Paper, and
included others, namely: (1) lack of peer review, (2) the samples Dr. Kuntz used for
the White Paper were processed differently than the equivalent medical grade
product intended for implantation, (3) the paper does not fully disclose the
chemistries of the samples tested, making the study as published impossible to
reproduce, (4) the underlying worksheet memorializing the data from Dr. Kuntz’s
study contains numerous errors, again making a reproduction of the study underlying
the White Paper impossible, (5) Dr. Kuntz’s study does not attempt to optimize the
mechanical properties of the material for purposes of implantation in the body, (6) the
White Paper does not evaluate any mechanical properties of the samples other than
hardness, and (7) the White Paper does not disclose the sintering conditions of the
Dr. John Mecholsky Colorado litigation trial testimony (“Mecholsky Lit. Testim.”),
135
PNOR2, 42 TTABVUE 230-31.

136 Kuntz Lit. Testim., PNOR1, 41 TTABVUE 221-25.
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samples tested, which can have significant impact on the properties of the
composite.137 In his rebuttal report for these proceedings, Dr. Mecholsky dismisses
Dr. Carty’s criticisms at every turn, either as irrelevant or because of additional
factors outside of the White Paper’s scope (that is, the mechanical properties other
than hardness).138
B. The Kuntz and Krüger Paper (2018)
As we noted earlier, the trial in the Colorado Litigation ended in late 2016, the
district court’s decision issued in 2017, and the Tenth Circuit’s decision reversing the
district court on jurisdictional grounds issued in 2019. In between these events, Dr.
Kuntz and his colleague, Dr. Reinhard Krüger, performed experiments on different
material properties of the same samples Dr. Kuntz used for his 2014 White Paper.139
In 2018, Drs. Kuntz and Krüger published their paper in a scientific journal (which
was anonymously peer-reviewed) discussing the results of their findings.140 In their
paper, Drs. Kuntz and Krüger concluded:
[U]p to an amount of 0.5 wt% [the amounts tested here were 0.00, 0.14,
0.32 (prepared with a compound YCr03 oxide), 0.33 (prepared with
separate Y203 and Cr203 oxides) and 0.5 wt%], there is no effect of
chromia to the mechanical performance (hardness, toughness, stiffness,
scratch performance) or manufacturing process [of ZTA compositions
and alumina similar or equivalent to the commercial materials BIOLOX
delta and BIOLOX forte]. It was further investigated how variation of
grain size and final density influence the material properties of ZTA and
137 Carty Rpt., 60 TTABVUE 74-76, ¶ 159.

138 Mecholsky TTAB Rebuttal Rpt., 105 TTABVUE 437-440, ¶¶ 94-97, 99-101.
140Kuntz Decl., 101 TTABVUE 22, 134-44, ¶ 60, Exh. 9. Respondent also made the
Kuntz/Krüger article of record at RNOR24, Exh. 1, 95 TTABVUE 5-15. We cite herein to the
version of the article submitted under Respondent’s Twenty-Fourth Notice of Reliance.
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alumina. There is a measurable effect on hardness but a negligible effect

on fracture toughness. The scratch performance seems to be closely
linked to the toughness as can be seen from the comparison of ZTA and
alumina. There is a certain probability that formerly misleading results
about the correlation of hardness and chromia content arise from
secondary effects (grain size, density) and measurement uncertainty of
inappropriately chosen [hardness testing] load levels.141
As he did with Dr. Kuntz’s 2014 White Paper, Dr. Carty had a number of criticisms
of the 2018 Kuntz/Krüger paper: (1) the actual chemistry of the test specimens was
not provided, so it is impossible to duplicate or reproduce the test results, (2) the
specific sintering conditions for the samples in order to isolate potential effects of
grain growth on mechanical properties are not disclosed, (3) the levels of raw
materials and the densities of chromium used to prepare the samples for testing were
not given, i.e., the batch information, or recipe, used to create the test specimens were
not provided, (4) the Kuntz/Krüger paper does not consider the impact of the variation
of chromium on a ceramic hip implant component system that is optimized for
performance in vivo, (5) in their paper, Dr. Kuntz and Dr. Krüger claim their research
and conclusions are consistent with the Bradt (1966) article,142 when Dr. Carty
believes they are not, and (6) the data in Dr. Kuntz and Dr. Krüger’s 2018 paper is
also insufficient to rebut the well-established literature143 that chromium has an
impact on hardness.144 Once again in his rebuttal report, Dr. Mecholsky dismisses
Dr. Carty’s criticisms point-by-point, either as immaterial to the results Dr. Kuntz
141 Kuntz/Krüger article, RNOR24, Exh. 1, 95 TTABVUE 5-15 at 14.

142 See discussion of the Bradt (1966) article in Section X above.
143 See discussion and summary of the technical literature in Section X above.
144 Carty Rpt., 60 TTABVUE 75-77, ¶¶ 161-67.
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and Dr. Krüger obtained or because Dr. Carty did not conduct these experiments
himself using Dr. Carty’s desired methodology.145 However, when pressed on
cross-examination, Dr. Mecholsky did admit to many of the above-noted shortcomings
of the Kuntz/Krüger paper146 – although on re-direct he suggested methods to address
those shortcomings147 – and that the data used for the Kuntz White Paper and
Kuntz/Krüger paper indeed were the same.148
Of particular import in adjudicating witness credibility, Dr. Mecholsky was chosen
as an anonymous, independent peer reviewer for the Kuntz/Krüger paper,149 yet he
did not reveal to the publication in which the article appeared that he was a testifying
expert on Respondent’s behalf. This presented Dr. Mecholsky with a clear conflict of
interest, on which he remained silent despite the publication’s policies he should
disclose his interest in the matter.150 When asked about his apparent conflict of
interest during cross-examination, Dr. Mecholsky conceded that he did not bring the
pertinent facts to the publication’s attention, because he thought the parties’
litigation was over and that his participation in the litigation was not relevant.151 Dr.
Mecholsky also noted there was another designated anonymous reviewer for the
145 Mecholsky TTAB Rebuttal Rpt., 105 TTABVUE 440-442, ¶¶ 102-107.

146 Mecholsky CX Testim. Depo., 155 TTABVUE 17-22, 40-44.
147 Mecholsky CX Testim. Depo., 155 TTABVUE 31-36.
148 Mecholsky CX Testim. Depo., 155 TTABVUE 16.
149 Mecholsky TTAB Rpt., 105 TTABVUE 201 at n.3.
150 Carty Rebuttal Rpt., 153 TTABVUE 18-22, ¶¶ 39-44, 48.
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Kuntz/Krüger paper, Jerome Chevalier, but later when pressed, Dr. Mecholsky could
not say for sure whether Dr. Chevalier was actually another reviewer of the paper.152
C. Dr. Mecholsky’s Testing and Analysis (2016)
Part of Dr. Mecholsky’s report in the Colorado Litigation included his own analysis
of ceramic test samples he requested and received from Respondent. 153
Unfortunately, a very sizeable portion of this part of Dr. Mecholsky’s report has been
filed under seal in these proceedings. We therefore can only discuss Dr. Mecholsky’s
analysis and conclusions in general terms.
Similar to the experiments supporting the Kuntz White Paper and the Kuntz/
Krüger paper, Dr. Mecholsky conducted hardness testing on ZTA ceramic compounds
containing < 0.01, 0.15, 0.33 and 0.5 %-vol. chromium oxide, discussing the make-up
of the samples and his testing procedures in detail.154 Based upon this data, as
confirmed with Respondent’s statistics expert Dr. Kadane, Dr. Mecholsky concludes
that “the hardness values are the same for all compositions” and “that chromium did
not impact the hardness of these ZTA samples.”155 Except in a passing footnote,156 Dr.
Carty appears not to have critiqued Dr. Mecholsky’s testing and analysis of the
ceramic samples he obtained from Respondent.

153Mecholsky Lit. Rpt. 105 TTABVUE 89-102, ¶¶ 144-65 (public/redacted); 106 TTABVUE
89-102, ¶¶ 144-65.
154Mecholsky Lit. Rpt. 106 TTABVUE 89-102, ¶¶ 145-160, 162-65. All of this discussion has
been redacted from the public version of the Mecholsky Lit. Rpt.
155 Mecholsky Lit. Rpt. 105 TTABVUE 96, ¶ 161; 106 TTABVUE 96, ¶ 161.
156 Carty Rpt., 60 TTABVUE 83 at n.123.
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D. Testing and Analysis Conducted in Connection with German

Litigation between the Parties (2018)
In addition to the Colorado Litigation and these proceedings, Petitioner and
Respondent were engaged in trademark litigation in Germany (the “German
Litigation”). Respondent also was engaged in trademark litigation in Germany with
Metoxit, another supplier of ZTA ceramic hip implant components based in
Switzerland. As a part of those litigations, the Stuttgart Regional Court directed the
Federal German Institute for Materials Research and Testing (Bundesanstalt Für
Materialforschung und-prüfung, hereinafter the “German Federal Institute” or
“BAM”) to examine whether chromium had any effect, other than color, on the
material properties of certain ceramic hip implant components. The German Federal
Institute is a senior scientific and technical federal institute with responsibility to the
German Federal Ministry for Economic Affairs and Energy. In the German
Litigation, BAM was commissioned as an independent, scientific fact-finder. Dr.
Torsten Rabe, the leader of the German Federal Institute’s department of Technical
Ceramics, conducted BAM’s testing and drafted these reports.157 As the only BAM
report for the German Litigation (translated into English) made of record in these
proceedings was the one for the litigation between Petitioner and Respondent (and
not between Respondent and Metoxit), that is the only report we discuss here. Since
the BAM report in its entirety was filed as confidential, we discuss it only in general
terms.
157 Mecholsky TTAB Rpt., 105 TTABVUE 210, ¶ 44.
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In the German Litigation, Dr. Rabe obtained ceramic specimens from both
Petitioner and Respondent containing 0, 0.1, 0.3 and 0.5 % chromium oxide content
by weight percent.158 Otherwise, the material variations of the specimens provided
by both companies were produced with identical production parameters, with BAM
requiring that these parameters for the test specimens correspond to the respective
standard manufacturing conditions for ZTA materials at both companies as much as
possible.159 The BAM report notes there were no significant differences in the Al2O3
(alumina), ZrO2 (zirconia), HfO2 (hafnia), Y2O3 (yttria) and SrO (strontia) content
between the specimens provided by the parties, except the strontia content of the
samples free from chromium oxide was somewhat higher in the samples provided by
Petitioner.160
BAM tested the parties’ specimens for color, hardness and wear resistance. The
German Federal Institute concluded that, with the addition of chromium oxide to a
ZTA ceramic in quantities up to 0.5 Ma.-% wt., the pink color intensity increases as
the chromium oxide content increases, but there was no increase in the hardness or
wear resistance of either company’s ZTA ceramic test specimens.161
Petitioner’s materials expert, Dr. Carty, criticizes BAM’s testing methodology and
conclusions as follows: (1) the hardness levels start high and remain high with the
addition of chromium oxide throughout Respondent’s samples in the BAM study, and
158 BAM Report, Haftel CX Testim. Depo., Exh. 11, 147 TTABVUE 4 at 13-14.
159 BAM Report, Haftel CX Testim. Depo., Exh. 11, 147 TTABVUE 4 at 15.
160 BAM Report, Haftel CX Testim. Depo., Exh. 11, 147 TTABVUE 4 at 24-25.
161 BAM Report, Haftel CX Testim. Depo., Exh. 11, 147 TTABVUE 4 at 7-8, 48, 56, 63.
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this high baseline hardness serves to mask any contribution of chromium oxide; (2)
the BAM report does not state that the tested samples were subject to autoclaving
before testing; (3) the BAM report does not provide the precise sintering conditions of
the samples; (4) the BAM report does not seek to determine the role of chromium in
a ZTA system optimized for performance in the body over long periods of time;
(5) contrary to the conclusions of the BAM report, the wear data of Petitioner’s tested
samples shows a significant improvement in wear resistance with the addition of
chromium; and (6) BAM’s experimental procedure does not mirror the environmental
conditions under which it has been demonstrated that chromium improves the in vivo
wear performance of ZTAs.162
Dr. Mecholsky’s replies to Dr. Carty’s criticisms of the BAM report were all filed
as confidential, so here we only discuss them in general terms. Dr. Mecholsky’s
rebuttals to Dr. Carty may be summarized as follows: (1) as noted by Dr. Carty,
chromia’s contribution, if any, to the tested ZTA specimens is undetectable through
measurement techniques, and thus could not result in a sufficient difference in
material properties to represent a functional difference in the material; (2) Dr. Carty
does not explain what he means by “an optimized system” or how such discussion is
relevant to the question presented (whether chromium affects any property of a ZTA
ceramic material); (3) Dr. Carty cites to no experimental data on the relevant
materials to establish that chromia at a level within the range tested, and not any
162 Carty Rpt., 60 TTABVUE 89-90, ¶¶ 184-185, 187.
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other factor, contributes to any material property of a ZTA ceramic; (4) Dr. Mecholsky
questions Dr. Carty’s conclusion regarding the improvement in wear resistance with
the addition of chromia to Petitioner’s samples, because Dr. Carty does not appear to
have conducted any statistical analysis of the BAM data; and (5) Dr. Carty’s
criticisms that BAM did not perform its examinations using in vivo testing or
autoclaving is not supported by any such testing Dr. Carty performed himself, and no
such testing appears to exist anywhere else.163
E. Research Conducted by Dr. Porporati
As noted above in our review of the technical literature, Dr. Alessandro Alan
Porporati was co-author of a paper with Dr. Giuseppe Pezzotti suggesting a role of
Cr2O3 (chromium oxide) dopant on thermal stability and, thus, the possibility of
tailoring environmental performance through a suitable doping not only of the ZrO2
(zirconia) phase but also of the Al2O3 (alumina) matrix phase.164 At trial in the
Colorado Litigation, Dr. Porporati testified about his theories that chromium might
be impacting phase stabilization of the ZTA material, which in turn would mean it
had an effect on fracture toughness or aging resistance of the material.165 Dr.
Porporati’s experiments first indicated to him that chromium oxide might improve
163 Mecholsky TTAB Rebuttal Rpt., 112 TTABVUE 820-23, ¶¶ 114-21.

164 Pezzotti, Porporati, et al. (2010), PNOR6, Exh. 1, 46 TTABVUE 5-13 at 6, 12.
Porporati Colorado Litigation trial testimony (“Porporati Lit. Testim.”), RNOR1, 70
165
TTABVUE 496-97.
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phase stabilization, then that it might negatively affect phase stabilization, then that
chromium oxide had no effect on phase stabilization at all.166
Dr. Porporati also testified at the Colorado trial regarding his hardness testing on
Respondent’s materials with and without chromium oxide. When reporting his
inconclusive results to Respondent (some results indicating that chromia was
contributing to hardness, others not), Respondent pointed to a number of possible
mistakes in Dr. Porporati’s measurements.167 Another topic of Dr. Porporati’s trial
testimony concerned his experiments on the effect of yttria on zirconia stabilization,
and in turn its positive effect on fracture toughness and aging resistance in
Respondent’s ZTA material.168
Dr. Porporati also submitted a testimony declaration in these proceedings.169 In
his declaration, Dr. Porporati seeks to distance himself from the paper he co-wrote
with Dr. Pezzotti, stating “Prof. Pezzotti’s observations when comparing chromia and
chromia-free material were due to the fact that the yttria contents in the chromia and
chromia-free material varied, and were not due to the chromia content in the
material.”170 Dr. Porporati’s present position is that “small changes in yttria content
have a significant effect on the toughness, zirconia phase stabilization, and
potentially the wear performance of a ZTA ceramic material …. By contrast, my
166 Porporati Lit. Testim., RNOR1, 70 TTABVUE 498-500, 519.

167 Porporati Lit. Testim., RNOR1, 70 TTABVUE 520-27, 530-51.
168 Porporati Lit. Testim., RNOR1, 70 TTABVUE 506-10.
169 Porporati Decl., 98 (confidential)/99 (public, redacted) TTABVUE.
170 Porporati Decl., 99 TTABVUE 3, ¶ 3.
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research does not establish that changes in chromia content between 0 and 0.33 wt
% have any impact on the material properties or wear performance of a ZTA ceramic
….”171
We reviewed Dr. Porporati’s internal research report submitted to Respondent,172
his current employer.173 What Dr. Porporati reports in his declaration as “changes in
yttria content” having an “effect on … toughness, zirconia phase stabilization, and
potentially … wear performance” of the ZTA material is in fact the addition of yttrium
chromite (YCrO3), a chemical combination of yttrium and chromia, not the addition
of yttrium by itself, albeit increasing the overall yttria content while keeping chromia
content relatively constant.174 In addition to this observation from our own reading
of the evidence, Petitioner responds that “[e]ven assuming … Dr. Porporati’s
experiments demonstrate that yttria can have an impact on zirconia phase stability
in ZTA ceramic materials, this does not establish that chromium oxide does not also
impact zirconia phase stability.” (emphasis original).175
F. Analysis of Certain Mechanical Properties of Petitioner’s

Ceramic Materials at Certain Intervals and over the Passage of
Time
In 2020, Jonathan Haftel, Petitioner’s Plant Manager,176 analyzed data from
internal hardness testing Petitioner conducted on its CeraSurf-p and CeraSurf-w

172 Porporati Decl., 99 TTABVUE 10, 56-76, ¶ 28, Exh. 3.
174 Porporati Decl., Exh. 3, 99 TTABVUE 56-76 at 56-58.
175 Haftel Rebuttal Decl., 138 TTABVUE 3, ¶ 6.
176 Haftel Decl., 59 TTABVUE 2, ¶ 4.
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materials between 2010 and 2020. Petitioner’s tests show that CeraSurf-w — which
does not contain chromium oxide — is not as hard as CeraSurf-p — which does
contain chromium oxide (0.33 wt%).177 Also in 2020, Petitioner conducted and
analyzed strength testing on its CeraSurf-p and CeraSurf-w materials in addition to
hardness. Petitioner’s test data showed significantly higher flexural strength values
for CeraSurf-p than for CeraSurf-w.178 In 2021, Petitioner conducted further testing
and analysis, again to demonstrate that its CeraSurf-p material has greater hardness
and greater flexural strength than its CeraSurf-w material from that year.179
Dr. Mecholsky’s critique of Petitioner’s analysis of and conclusions from its
CeraSurf-p and CeraSurf-w testing data was filed in this proceeding as entirely
confidential.180 We therefore discuss Dr. Mecholsky’s numerous criticisms in general
177 Haftel Decl., 59 TTABVUE 7-9, ¶¶ 18-23; and Exhs. 2-4, 58 TTABVUE 35-64
(confidential).
178 Haftel Decl., 59 TTABVUE 9-10, ¶¶ 26-26; and Exh. 5, 58 TTABVUE 65-67.
179Haftel Rebuttal Decl. 138 TTABVUE 2-3, ¶¶ 4-5; and Exhs. 1-2, 137 TTABVUE 5-48
(confidential).
180 The critique from Dr. Joseph Kadane (Respondent’s statistics expert) of Petitioner’s
CeraSurf-p and CeraSurf-w testing data mirrors that of Dr. Mecholsky, except from a
statistical analysis point of view. Kaden Rpt. 103 TTABVUE 21-31, ¶¶ 26-43. Dr. Kadane’s
critique too was filed in this proceeding as entirely confidential. Like Dr. Mecholsky, Dr.
Kadane opines that, over time, the hardness of Petitioner’s pink samples increased. This
increase, Dr. Kadane says, was not related to chromium oxide concentration because, over
time, all of the pink samples had the same amount of chromium oxide by percentage of
weight. To determine whether the inclusion of chromium oxide increases the hardness of a
sample, says Dr. Kadane, it is necessary to compare samples from the identical time periods.
According to Dr. Kadane, Petitioner’s data from 2013-2016 was unreliable for the reasons
explained by Dr. Mecholsky. Thus, the only reliable test data Petitioner provided, from 2010,
shows at best weak evidence that the 2010 pink samples were harder than the 2010 white
samples. Petitioner’s statistics expert, Dr. Arnold Barnett, opines that Dr. Kadane’s remedy
of excluding the vast majority of Petitioner’s pink measurements between 2010 and 2020 is
far more extreme than warranted. Dr. Barnett’s analyses that compare pink measurements
with a far larger data set from the disputed time periods generates statistically-significant
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terms. In the Colorado Litigation, Dr. Mecholsky investigated the hardness testing
performed by Petitioner and concluded that Petitioner’s hardness testing failed to
show that chromium oxide had any impact on the hardness of Petitioner’s material.181
Among other things, Dr. Mecholsky concluded that:
• Even assuming that there is some hardness difference between Petitioner’s

Cerasurf-w and Cerasurf-p materials, it is an inconsequential difference that
would not have any impact on the performance of Petitioner’s white and pink
ZTA materials when used in hip implant components.182
• The hardness of Petitioner’s pink material increased over time. If Petitioner’s
pink material went from the same hardness as its white material to slightly
harder over a number of years, without any change in chromium content, then
chromium must not be responsible for any hardness improvement in the pink
material. If chromium was causing the pink material to be harder, it would
have been harder in 2010, and would not have gotten harder between 2010 and
2016, without any chromium increase. Thus, something else must be
responsible for the hardness increase. The potential causes of this apparent
change in hardness include one or more of: measurement inconsistencies;
differences in processing over time; improvements in the hardness
measurement technique and procedure; differences in the number of samples
tested (far more pink than white); and improper, and/or inconsistent,
measurement techniques.183
• In 2011, Petitioner opened a new facility, and powder production was
performed at this new facility sometime after that date. This new facility
helped solve contamination and processing issues that Petitioner was
experiencing with its material. Thus, the processing and manufacture of
Petitioner’s ZTA materials went through significant change between 2010 and
2012.184
evidence that chromium oxide increases the hardness of Petitioner’s ZTA samples. Kadane
Rpt., 56 TTABVUE 15-24, ¶¶ 23-38.
181 Mecholsky TTAB Rpt., 112 TTABVUE 59, ¶ 98.
182 Mecholsky Lit. Rpt., 106 TTABVUE 128, 137, 151-52, ¶¶ 204, 225, 227, 246 and 249.
Mecholsky Lit. Rpt., 106 TTABVUE 128, 133-34, 136, 137-150, ¶¶ 205, 216, 223, 226, 228-
183
241 and 243.

184Mecholsky Lit. Rpt., 106 TTABVUE 129, 135, 150, ¶¶ 207, 219, 221 and 245; See also
Steven Hughes Colorado Litigation trial testimony (“Hughes Lit. Testim.”), RNOR1, 70
TTABVUE 71-74 and Frank Anderson Colorado Litigation trial testimony (“Anderson Lit.
Testim.”), RNOR1, 70 TTABVUE 246-248.
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• Dr. Mecholsky noted several irregularities calling into question the hardness
measurements and the ultimate conclusions reached by Petitioner. Any
hardness differences Petitioner found was due to one or more of the following
deficiencies or discrepancies: differences in the number of samples tested (far
more pink than white), differences in the timing and testing and powder
preparation from which the samples were made, differences in testing methods
over time, differences in material processing.185
Mr. Haftel appears to agree with Dr. Mecholsky’s conclusion that Petitioner has
gotten better at making ceramic samples over time including “getting better
repeatability out of the preparation process.” Mr. Haftel also notes that Petitioner
has seen improvements to both its pink and white material over time, but that “there
[are] not a lot of data points” with regard to any potential improvement in the white
material. Mr. Haftel notes that Petitioner produces pink material on a regular basis,
but, with the exception of two batches made in 2020, does not regularly produce white
material.186
As Dr. Mecholsky noted during the Colorado Litigation, Petitioner’s hardness
testing was performed at different times, on samples created during different time
periods, and using different techniques. An analysis of Petitioner’s pre-2016 hardness
testing showed that four different testing methods were used.187 The measurement
variance in Petitioner’s testing of its white samples alone appears to be atypically
185 Mecholsky Lit. Rpt., 106 TTABVUE 130-135, ¶¶ 210-215 and 218.
186Mecholsky TTAB Rpt., 112 TTABVUE 60, ¶ 99; Haftel Discov. Depo., RNOR13,
129 TTABVUE 75-77; Haftel CX Testim. Depo., 146 TTABVUE 42-44.
187Mecholsky TTAB Rpt., 112 TTABVUE 60, ¶ 101; Mecholsky Lit. Rpt., 106 TTABVUE 131,
¶ 213; Haftel CX Testim. Depo., 146 TTABVUE 42-44.
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high, having a wide range of potential testing values, making it less likely to
accurately represent the properties of the material.188
According to Dr. Mecholsky, there are many potential explanations for
measurement variance that have nothing to do with chromium content in a material,
including differences in: testing machinery, testing methodology, testing machine
calibration, electronic measuring equipment calibration, the skill of the technicians
performing the tests and taking the measurements, the performance of visual versus
automatic measurements; material variability, such as surface finish, and processing
methods.189
Even if Petitioner’s pink material is, on average, harder than its white material,
as Petitioner’s average of hardness measurements suggests, Dr. Mecholsky opines
such difference is slight, having no functional effect on the quality of the ceramic
material produced. The ceramics used to make hip implant components are very hard,
and small changes in hardness (on the order of the changes that Petitioner is arguing
exist in these proceedings) do not impact the performance or function of the material
used to produce the hip implant components.190
Dr. Mecholsky also says his criticisms discussed above of Petitioner’s hardness
testing apply to its fracture toughness testing measurements of its pink and white
materials as well. Dr. Mecholsky notes Mr. Haftel’s belief that a further “scientific
188 Mecholsky TTAB Rpt., 112 TTABVUE 60-61, ¶ 102.

189Mecholsky TTAB Rpt., 112 TTABVUE 61, ¶ 103; Mecholsky Lit. Rpt., 106 TTABVUE
133-34, ¶ 215.
Mecholsky TTAB Rpt., 112 TTABVUE 61-62, ¶ 104; Mecholsky Lit. Rpt., 106 TTABVUE
190
151, ¶¶ 246-47.
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endeavor” would be required to draw any conclusion that Petitioner’s pink material
is tougher than its white material.191
Dr. Carty reviewed Petitioner’s comparative hardness and flexural strength test
results of Petitioner’s pink CeraSurf-p product and its white CeraSurf-w product. In
Dr. Carty’s opinion, Petitioner’s data confirms that chromium oxide affects the
material’s hardness. Specifically, Petitioner’s hardness testing data shows
significantly higher values in hardness for CeraSurf-p over CeraSurf-w. Additionally
Petitioner’s flexural strength test data shows significantly higher values in flexural
strength in CeraSurf-p as compared to CeraSurf-w.192
Responding to Dr. Mecholsky’s criticisms of Petitioner’s testing data, Dr. Carty
says that even though there is scatter (outliers in the measurement observations) in
the data, hardness measurably increases with the addition of chromium oxide, even
at the low levels observed in Petitioner’s chromium-doped ZTA.193 Dr. Carty was not
surprised that the hardness properties of Petitioner’s pink ZTA material changed
over time, because this was also true with respect to Respondent’s pink ZTA material
based on Respondent’s data Dr. Carty analyzed.194 Finally, Dr. Carty points out that
191Mecholsky TTAB Rpt., 112 TTABVUE 62, ¶ 105; Haftel CX Testim. Depo., 146 TTABVUE
50-52.
192Carty Rpt. 48 TTABVUE 61-64, ¶¶ 134-39 (confidential); 60 TTABVUE 62-65, ¶¶ 134-39
(charts redacted).
193 Carty Rebuttal Rpt., 153 TTABVUE 26, ¶ 65.
194 Carty Rebuttal Rpt., 141 TTABVUE 27, ¶ 66 (confidential).
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the documents on which Dr. Mecholsky relied in criticizing Petitioner’s fracture
toughness data were actually measurements of flexural strength.195
As to the additional testing data that Petitioner provided for its ZTA ceramic
products for 2021, it appears that the backup documentation on Mr. Haftel’s
summary chart (in his rebuttal declaration) was not provided for Petitioner’s white,
CeraSurf-w product; only for Petitioner’s pink, CeraSurf-p product.196 This renders
Mr. Haftel’s summary chart suspect as it purports to include testing data for both
products.
Respondent’s experts, Drs. Mecholsky and Kadane, as well as the
cross-examination of Jonathan Haftel, raised sufficient concerns about Petitioner’s
processing and testing methods, data collection, reporting and conclusions reached
over the relevant time period to cast doubt on the probative value of this evidence.
We further find wanting the efforts of Petitioner’s experts, Drs. Carty and Barnett,
to explain away Respondent’s critique of Petitioner’s testing data.
G. Petitioner’s Survey Evidence
Petitioner’s expert, Dr. Sara Parikh, prepared and conducted a survey of
orthopaedic surgeons to establish that the primary significance of the color pink used
in the context of hip implant components is to tell orthopaedic surgeons from what
type of material the hip implant component is made. Ninety percent of respondents
in Dr. Parkih’s survey considered the color pink used in the context of hip implant
195 Carty Rebuttal Rpt., 153 TTABVUE 228-29, ¶ 67.

196 Haftel CX Testim. Depo., 146 TTABVUE 77-81, 554-556 Exh. 6 at ¶¶ 4-5.
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components to be an indicator of the material composition of the component, and 85%
consider it to indicate that the material is ceramic.197 Dr. Parikh’s test stimulus was
a BIOLOX delta (pink) hip joint ball or head; the control stimulus was a BIOLOX
forte (ivory) hip joint ball or head.198 Dr. Parikh’s understanding of “primary
significance” refers to the general meaning of something, for example when someone
encounters something what it tells them, brings to mind or connotes.199
Respondent’s survey expert, Robert Klein, opines that neither the methodology
nor the primary question employed by Dr. Parikh tests for or measures functionality.
Dr. Parikh conceded during her cross-examination that her survey did not test for
functionality.200 Instead, Dr. Parikh’s survey purports to measure the “primary
significance” of the color pink for a femoral ball hip implant component. The “primary
significance” of a trademark, however (says Mr. Klein), commonly relates to the issue
of whether a mark is generic; it is not the proper methodological inquiry for
measuring any alleged functionality of a mark.201 That is, the key question of Dr.
Parikh’s survey: “What, if anything, does the color tell you about the hip implant
component in the photograph? Please be specific,” in no way inquires as to whether
the color pink is essential to the use or purpose of a hip implant component (the
197 Parikh Decl., 47 TTABVUE 2, ¶ 3; Parikh Rpt., 47 TTABVUE 4-40 at 19-20.

198 Parikh Rpt., 47 TTABVUE at 32-33.
199 Parikh CX Testim., 152 TTABVUE 24-25.
Parikh CX Testim., 152 TTABVUE 18-22. In fact, Dr. Parikh conceded that she had never
200
worked on a functionality survey before. 152 TTABVUE 22-24.

201 Klein Decl., 84 TTABVUE 6, ¶ 16.
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considerations used to determine whether trade dress is functional based on
utilitarian concerns).202 Mr. Klein’s other criticisms of Dr. Parikh’s survey include:
• The question presented to the respondents was leading;203 and

• The near identical answers and their virtually identical distribution in Dr.
Parikh’s test and control cells when comparing material responses contradicts
Dr. Parikh’s conclusion that the primary significance of the color pink, used in
this context, is to tell orthopedic surgeons from what type of material the hip
implant component is made.204
Other problems with Dr. Parikh’s survey methodology were elicited from her
during cross-examination, namely:
• The survey universe was too broad, in that it included both users and
prospective users of metal and ceramic hip implant components. That is, they
could use any type of material as implant components in the surgeries that
they perform, and they would still qualify for Dr. Parikh’s survey. Even an
orthopedic surgeon who had never used a ceramic hip implant component
before, or an orthopedic surgeon who would never consider using a ceramic hip
implant component were considered part of the survey universe.205
• Dr. Parikh did not screen for respondents who were familiar with ceramic hip
implant components in particular. Dr. Parikh did not know whether it was
possible that respondents in her survey may never have used ceramic hip
implant components before in their surgeries.206
• In reporting her results, Dr. Parikh did not “net out” (subtract) the ivory
(control) survey results from the pink (test) survey results. This is important,
because one of the conclusions Parikh drew when she looked at the results in
the test group and in the control group was that the results were similar in
several respects; if not virtually identical.207
202 Klein Decl., 84 TTABVUE 6-7, ¶ 17.

Klein Decl., 84 TTABVUE 7, ¶ 19. Dr. Parikh agreed on cross-examination that questions
203
which are suggestive or leading in nature are an inappropriate Parikh CX Testim., 152
TTABVUE 31-34).
204 Klein Decl., 84 TTABVUE 8, ¶¶ 20-21.
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Respondent’s critique raised significant concerns – with which we agree –
regarding Dr. Parikh’s survey methodology (namely, a leading question, insufficient
accounting for control group results, an overly broad survey universe and insufficient
screening of survey respondents). These concerns alone cast significant doubt on the
probative value of Petitioner’s survey evidence.
Our greater problem with Petitioner’s survey is that it asked the wrong question.
Inquiring about the primary significance to orthopaedic surgeons of the color pink in
connection with a hip implant component in no way seeks to resolve the issue involved
in this case: whether pink as applied to a ceramic implant component is functional
from a utilitarian perspective. On cross-examination, Dr. Parikh testified that her
survey did not test for functionality. For this reason alone, we give Petitioner’s survey
evidence no probative weight.
XVI. Entitlement to a Statutory Cause of Action
A plaintiff’s entitlement to invoke a statutory cause of action for opposition or
cancellation is a necessary element in every inter partes case. Corcamore, LLC v.
SFM, LLC, 978 F.3d 1298, 2020 USPQ2d 11277, at *6-7 (Fed. Cir. 2020), cert. denied,
141 S. Ct. 2671 (2021). To establish entitlement to a statutory cause of action under
Trademark Act Section 14, 15 U.S.C., § 1064, a plaintiff must demonstrate “an
interest falling within the zone of interests protected by the statute and … proximate
causation.” Corcamore, 2020 USPQ2d 11277, at *4 (citing Lexmark Int’l, Inc. v. Static
Control Components, Inc., 572 U.S. 118, 109 USPQ2d 2061, 2067-70 (2014)).208 Stated
Our decisions have previously analyzed the requirements of Trademark Act Sections 13
208
and 14, 15 U.S.C. §§ 1063-64, under the rubric of “standing.” We now refer to this inquiry as
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another way, a plaintiff is entitled to bring a statutory cause of action by
demonstrating a real interest in the proceeding and a reasonable belief of damage
from the registration. Australian Therapeutic Supplies Pty. Ltd. v. Naked TM, LLC,
965 F.3d 1370, 2020 USPQ2d 10837, at *3 (Fed. Cir. 2020), cert. denied, 142 S. Ct. 82
(2021); see also Empresa Cubana Del Tabaco v. Gen. Cigar Co., 753 F.3d 1270, 111
USPQ2d 1058, 1062 (Fed. Cir. 2014).
There is “no meaningful, substantive difference between the analytical
frameworks expressed in Lexmark and Empresa Cubana.” Corcamore, 2020 USPQ2d
11277 at *4. Thus, “a party that demonstrates a real interest in canceling a
trademark under [Trademark Act Section 14, 15 U.S.C.] § 1064 has demonstrated an
interest falling within the zone of interests protected by § 1064. Similarly, a party
that demonstrates a reasonable belief of damage by the registration of a trademark
demonstrates proximate causation within the context of § 1064.” See Corcamore, 2020
USPQ2d 11277 at *7.
When Petitioner first sought to enter the ceramic hip replacement component
market as a competitor to Respondent, Petitioner was aware of Respondent’s
then-extant patent rights covering ceramics containing chromium oxide. In
developing its first ceramic component products, Petitioner waited to introduce its
entitlement to a statutory cause of action. Despite the change in nomenclature, our prior
decisions and those of the Federal Circuit interpreting Trademark Act Sections 13 and 14
remain applicable. Spanishtown Enters., Inc. v. Transcend Res., Inc., 2020 USPQ2d 11388,
at *2 (TTAB 2020).
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products until Respondent’s ’816 patent had expired in 2013.209 Upon introduction of
Petitioner’s pink ceramic component products, Respondent caused them to be seized
at a Paris trade show. This event was the first time Petitioner became aware that
Respondent claimed trademark rights in the color pink for the compound used to
make ceramic hip implant components.210 Following the seizure, Respondent sent
Petitioner a cease-and-desist letter, dated November 20, 2013, reading in part as
follows:
At [a trade show] … that took place in Paris [in] … November 2013,

[Respondent] … learn[ed] about [Petitioner’s] pink coloured hip joint
balls. As you know, [Respondent] … immediately requested … an
authorization to have an infringement seizure conducted by a court
bailiff during the [trade show] … which was granted …. We initiated
these measures because [Respondent] considers this use of the colour
pink in connection with hip joint balls as an infringement of its
trademark rights and … unfair competition.
As you know as being a direct competitor, [Respondent] … is [a] ..
manufacturer of technical ceramics, specializing in the development,
manufacture and distribution of … products made of ceramics ….
[Respondent] … has been producing ceramic components for the
manufacturer of hip implants for more than 30 years.
In 2004, [Respondent] … launched a new product line of hip joint balls
and hip shells as well as other hip and knee joint components named
BIOLOX-delta[,] … distinguished by the unusual and unique colouring
in pink ….
***
[Respondent] has applied for various trademarks worldwide illustrating
its pink coloured hip joint balls. Several registration proceedings are
already completed …. In other countries, the applications are at least
already published ….
***
Jonathan Haftel Colorado Litigation trial testimony (“Haftel Lit. Testim.”), PNOR2, 42
209
TTABVUE 103-104; Haftel Decl., 59 TTABVUE 4-5, ¶¶ 9-11.

210 Hughes Lit. Testim., PNOR2, 42 TTABVUE 85-88.
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The … colouring of [Petitioner’s] … implant components … infringes

[Respondent’s] … trademark rights and violates unfair competition law.
[Petitioner’s pink] colour [on its products] …constitutes a likelihood of
confusion. The relevant public of implant manufacturers, orthopaedists
and surgeons will … assume that [Respondent] … is the manufacturer
or cooperates with [Petitioner].
***
[Respondent] will not tolerate this infringement of its rights and is
willing to commence legal action in each and every country in
which it is necessary to stop the use of the colour pink.211
(emphasis added).
As discussed earlier, nearly simultaneous with its filing of these cancellation
proceedings, Petitioner filed an action for a declaratory judgment of non-infringement
and for cancellation of Respondent’s trademark registrations in Colorado federal
court. Respondent counterclaimed for infringement and unfair competition with
respect to its asserted trademark rights in the color pink.
Based on the foregoing, Petitioner has demonstrated that its interest in
cancellation of Respondent’s registrations falls within the zone of interests protected
by the statute, and Petitioner has a reasonable belief that damage is proximately
caused by continued registration of Respondent’s asserted marks. See Tanners’
Council of Am., Inc. v. Gary Indus., Inc., 440 F.2d 1404, 169 USPQ 608, 609 (CCPA
1971) (“It seems clear enough that registration of the mark as applied for could
weaken the sales positions of appellants’ members and hence reduce the income of
appellant. We think this last factor is alone sufficient to bring appellant within the
category of ‘any person who believes he would be damaged’ by the registration.”);
211 Respondent’s cease-and-desist letter, PNOR5, Exh. 12, 45 TTABVUE 272-93.
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McGowen Precision Barrels, LLC v. Proof Research, Inc., 2021 USPQ2d 559, at *17-
17 (TTAB 2021) (entitlement to a statutory cause of action found where Respondent
filed complaint in federal court against Petitioner as the defendant, alleging that gun
barrels being manufactured and sold by Petitioner’s sister company infringed
Respondent’s registered trademark rights); Ipco Corp. v. Blessings Corp., 5 USPQ2d
1974, 1977 (TTAB 1988) (Opposer’s “use of the word [CONFIDENCE] on its
brochures, its right to continue such use, and the cease and desist letter sent by
applicant, evidence a sufficient interest by opposer to demonstrate its [entitlement to
a cause of action].”). Petitioner has thus established its entitlement to petition for
cancellation of Respondent’s registrations.
XVII. Functionality: Applicable Law and Analysis
Generally, for matter claimed as trade dress to be capable of protection as a
“mark,” it must be distinctive and not functional. Two Pesos, Inc. v. Taco Cabana,
Inc., 505 U.S. 763, 23 USPQ2d 1081, 1084 (1992). These also are requisites when the
claimed “mark” is a particular color applied to the entirety of a product. Qualitex Co.
v. Jacobson Prods. Co., 514 U.S. 159, 34 USPQ2d 1161, 1163-64 (1995) (green-gold as
applied to dry cleaning press pads); Brunswick Corp. v. British Seagull Ltd., 35 F.2d
1527, 32 USPQ2d 1120, 1121-22 and 1125 (Fed. Cir. 1994), cert. denied, 514 U.S. 1050
(1995) (black as applied to outboard boat motors). Petitioner has not pled that the
color pink as applied to Respondent’s hip implant components lacks distinctiveness,
and the parties have not argued that question in their briefs. The sole issue to be
decided in these proceedings pertaining to Respondent’s trademark rights is
functionality.
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The Trademark Act does not exist to reward manufacturers for their innovations.
“It is the province of patent law, not trademark law, to encourage invention by
granting inventors a monopoly over new product designs or functions for a limited
time …, after which competitors are free to use the innovation.” Qualitex, 34 USPQ2d
at 1163. “[T]rademark … law can[not] properly make an ‘end run’ around the strict
requirements of utility patent law by giving equivalent rights to exclude.” J. Thomas
McCarthy, MCCARTHY ON TRADEMARKS AND UNFAIR COMPETITION § 7:64 (5th ed.,
Sept. 2022 update). Thus, a product feature that is functional “is incapable of
registration on either the Principal or Supplemental Register.” AS Holdings, Inc. v.
H & C Milcor, Inc., 107 U.S.P.Q.2d 1829, 1837 (TTAB 2013). Accordingly, Trademark
Act Section 2(e)(5), 15 U.S.C. § 1052(e)(5), prohibits registration of “a mark which ...
comprises any matter that, as a whole, is functional.”
There are two types of functionality recognized by controlling case law. One
formulation states that “a product feature is functional if it is essential to the use or
purpose of the article or if it affects the cost or quality of the article.” Inwood Labs.,
Inc. v. Ives Labs., Inc., 456 U.S. 844, 214 USPQ 1, 4 n.10 (1982). This we refer to as
“utilitarian functionality.” The other theory of functionality posits “that, if a design’s
‘aesthetic value’ lies in its ability to ‘confe[r] a significant benefit that cannot
practically be duplicated by the use of alternative designs,’ then the design is
‘functional.’ … The ‘ultimate test of aesthetic functionality,’ … [under this theory], ‘is
whether the recognition of trademark rights would significantly hinder competition.’”
Qualitex, 34 USPQ2d at 1165 (citing RESTATEMENT (THIRD) OF UNFAIR
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COMPETITION § 17, Comment c, pp. 175-176 (1993)). This we refer to as “aesthetic
functionality.” It is clear from our reading of the pleadings, evidence and briefing in
this case that Petitioner’s functionality claim under Trademark Act Section 2(e)(5) is
based on functionality based on utilitarian considerations and not aesthetic
functionality. Neither Petitioner nor Respondent argue otherwise.
The Court of Customs and Patent Appeals, in In re Morton-Norwich Prods., Inc.,
671 F.2d 1332, 213 USPQ 9, 15-16 (CCPA 1982), suggested four factors to consider
when evaluating utilitarian functionality:
(1) the existence of a utility patent that discloses the utilitarian

advantages of the registered subject matter;
(2) advertising by the registrant that touts the utilitarian advantages of

the subject matter;
(3) facts pertaining to the availability of alternative designs; and
(4) facts pertaining to whether the subject matter results from a

comparatively simple or inexpensive method of manufacture.
See also, In re Change Wind Corp., 123 USPQ2d 1453, 1456 (TTAB 2017)
(“Morton-Norwich identifies four nonexclusive categories of evidence which may be
helpful in determining whether a particular design is functional[.]”).
However, the U.S. Supreme Court has stated that if functionality is established
under the Inwood test (essential to the use or purpose of the article or affecting the
cost or quality of the article), a full analysis of all types of Morton-Norwich evidence
is not necessary. TrafFix Devices, Inc. v. Mktg. Displays, Inc., 532 U.S. 23, 58 USPQ2d
1001, 1006-07 (2001) (“Where the design is functional under the Inwood formulation
there is no need to proceed further to consider if there is a competitive necessity for
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the feature. … There [also] is no need, furthermore, to engage … in speculation about
other design possibilities, … which might serve the same purpose. ... Other designs
need not be attempted.”).
The U.S. Court of Appeals for the Federal Circuit later had occasion to comment
on the Supreme Court’s observations in TrafFix:
We do not understand the Supreme Court’s decision in TrafFix to have

altered the Morton-Norwich analysis. … [T]he Morton-Norwich factors
aid in the determination of whether a particular feature is functional,
… [one] factor focus[ing] on the availability of “other
alternatives.” (citation omitted). … Nothing in TrafFix suggests that
consideration of alternative designs is not properly part of the overall
mix, and we do not read the Court’s observations in TrafFix as
rendering the availability of alternative designs irrelevant. Rather …,
once a product feature is found functional based on other considerations
[such as if it “affects the cost or quality of the device,”] there is no need
to consider the availability of alternative designs, because the feature
cannot be given trade dress protection merely because there are
alternative designs available. But that does not mean that the
availability of alternative designs cannot be a legitimate source of
evidence to determine whether a feature is functional in the first place.
Valu Eng’g, Inc. v. Rexnord Corp., 278 F.3d 1268, 61 USPQ2d 1422, 1427 (Fed. Cir.
2002).
Functionality is a question of fact and depends on the totality of the evidence in
each particular case. Valu Eng’g, 61 USPQ2d at 1424. Petitioner bases its
functionality claim on an application of the Morton-Norwich factors, and Respondent
equally argues the non-application of those factors to its trademark rights.212 We
consider the Morton-Norwich factors to the extent raised in the arguments and based
on the evidence made of record. All four Morton-Norwich factors need not be
212 Petitioner’s Brief, 158 TTABVUE 41-51; Respondent’s Brief, 160 TTABVUE 40-49.
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considered or proven in every case, nor do all four factors have to weigh in favor of
functionality to support a functionality refusal. Poly-America, 124 USPQ2d at 1514.
However, for the sake of completeness, we will address each Morton-Norwich factor
below.
A. Respondent’s Utility Patents and Patent Application
As the Supreme Court said long ago, “there passe[s] to the public upon the
expiration of [a] patent … the right to make the article as it was made during the
patent period .…” Kellogg Co. v. Nat’l Biscuit Co., 305 U.S. 111, 39 USPQ 296, 299
(1938). That is because “[s]haring in the goodwill of an article unprotected by patent
or trade-mark is the exercise of a right possessed by all – and in the free exercise of
which the consuming public is deeply interested.” Id. at 301. The public policy as
stated in Kellogg has been brought into the modern age by the Supreme Court’s
functionality case law; particularly when expired patent rights are involved.
Whether one can assert trademark rights following the expiration of its utility
patent is not newly trodden ground in trademark law. For example, in TrafFix, the
plaintiff, Marketing Displays, Inc. (“MDI”) was the holder of two utility patents for a
two-spring mechanism (the “dual-spring design”) to keep outdoor signs upright
despite adverse wind conditions. After the patents expired, a competitor, TrafFix
Devices, Inc. (“TrafFix”), sold sign stands with a visible spring mechanism that looked
like MDI’s. MDI brought suit against TrafFix for, inter alia, trade dress infringement
based on the copied dual-spring design. TrafFix, 58 USPQ2d at 1003-04. The district
court granted summary judgment to TrafFix, in part on the basis that MDI’s asserted
dual-spring design was functional. Id. at 1004. The court of appeals reversed,
- 89 -
suggesting that the district court committed legal error in its functionality ruling on
the dual-spring design. Id.
Considering the legal significance of an expired utility patent on a trade dress
claim, the Supreme Court stated:
A prior patent, we conclude, has vital significance in resolving the trade

dress claim. A utility patent is strong evidence that the features
therein claimed are functional. If trade dress protection is sought
for those features the strong evidence of functionality based on the
previous patent adds great weight to the statutory presumption
that features are deemed functional until proved otherwise by
the party seeking trade dress protection. Where the expired patent
claimed the features in question, one who seeks to establish trade dress
protection must carry the heavy burden of showing that the
feature is not functional, for instance by showing that it is merely an
ornamental, incidental, or arbitrary aspect of the device. … Th[is] rule
… bars [a] … trade dress claim [when the plaintiff] … cannot[] carry the
burden of overcoming the strong evidentiary inference of functionality
based on the disclosure of the [invention] … in the claims of the expired
patents.
Id. at 1005 (emphasis added).
Our inquiry whether a utility patent renders asserted trade dress functional is
not limited to our examination of the patent’s claims:
The inquiry into whether such features, asserted to be trade dress, are
functional by reason of their inclusion in the claims of an expired utility
patent could be aided by going beyond the claims and examining
the patent and its prosecution history to see if the feature in
question is shown as a useful part of the invention.
Id. at 1005 (emphasis added); see also, Kohler Co. v. Honda Giken Kogyo K.K.,
125 USPQ2d 1468, 1478 (TTAB 2017) (Our “analysis requires us to do what we must
do in considering Applicant’s issued United States patents to determine whether the
claims and disclosures in the patent show the utilitarian advantages of the design
- 90 -
sought to be registered as a trademark.”) (citing In re Becton, Dickinson and
Co., 675 F.3d 1368, 102 USPQ2d 1372, 1377 (Fed. Cir. 2012)). The Supreme Court, in
fact, did just that in TrafFix by looking not only at the claims of MDI’s expired patents
but also their specifications and “statements made in the patent applications and in
the course of procuring the patents demonstrat[ing] the functionality of the design.”
TrafFix, 58 USPQ2d at 1006.
The exception to the general rule expressed in TrafFix is stated as follows:
In a case where a manufacturer seeks to protect arbitrary,

incidental, or ornamental aspects of features of a product found in
the patent claims, such as arbitrary curves in the legs or an ornamental
pattern painted on the springs, a different result might
obtain. There the manufacturer could perhaps prove that those aspects
do not serve a purpose within the terms of the utility patent.
Id. at 1007 (emphasis added).
We start with the parties’ agreement that the addition of chromia to a ZTA
ceramic causes the material to become pink. In further support of its argument that
practicing the ’816 patent renders Respondent’s pink trade dress functional,
Petitioner directs us to (1) Respondent’s admitted practicing of the claimed invention
in its BIOLOX delta product, with each patent claim including the presence of
chromium oxide, (2) statements made in the patent’s specification regarding the
benefits of chromia to the mechanical properties of the material, and (3) assertions
made by Respondent’s patent counsel during prosecution regarding the addition of
chromia in a specified ratio to the other chemical additives (alumina and zirconia) in
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order to overcome prior art;213 all of which we set out in detail above. Looking at this
evidence collectively, the claims, specification and prosecution history of the ’816
patent disclose the functional benefits of chromia with respect to the toughness,
hardness, stability and suppression of brittleness of the ZTA ceramic.
Petitioner also directs us to Respondent’s ’955 and ’970 patents, the disclosures of
which discuss the benefits of chromia to toughness and hardness; as well as
Respondent’s ’237 application that discusses the benefits of Cr-doping to make the
material particularly suitable for medical applications.214
Respondent asserts that the expired ’816 patent does not, by the evidentiary
presumptions outlined in TrafFix, render its trade dress functional because pink is
not claimed in the patent.215 However, Respondent readily concedes that a pink
ceramic results from the implementation of the patent.216 Nonetheless, Respondent
argues that the patent claims a range of chromium that could naturally produce a
broader range of pinkish hues (“almost white, red, or purple”).217 However, “[t]he fact
that the patent[] may encompass a wide variety of [design variations] means only
that the patent[] [is] broad in scope, not that [Respondent’s] particular [registered]
213 Petitioner’s Brief, 158 TTABVUE 16-17.

214 Petitioner’s Brief, 158 TTABVUE 17.
215Respondent’s Brief, 160 TTABVUE 41. Respondent’s corollaries to this argument are that
“[o]ne can practice the patent’s claims without yielding a pink product, and … one can
produce a pink-colored hip implant component without practicing the patent.” Respondent’s
Brief, 160 TTABVUE 41. These arguments at best are the product of circular reasoning; at
worst a red herring.
- 92 -
design is not functional.” McGowen Precision Barrels, 2021 USPQ2d 559, at *75.
Respondent’s further statement that “the color pink is not a natural byproduct of
practicing [its] … patent”218 is thus a non sequitur. In any event, we need not, and do
not, constrict our inquiry to the ’816 patent claims. As noted above, the patent’s
specification and prosecution history provide additional evidence regarding the
contribution of chromia to the inventions claimed therein.
Respondent further contends that the so-called “central advance” of the ’816
patent is not directed to the improvement of the composition for hip implant
components, but rather for cutting tools.219 This argument fails for two reasons. First,
Respondent derives its “not the central advance” theory from a passing comment in
TrafFix, 58 USPQ2d at 1005 (“the central advance claimed in the expired utility
patents … is the dual-spring design”). This passing comment comprises neither a
holding of nor arguably even dicta from TrafFix. Second, as noted numerous times in
the record, even though the ZTA chemical combination developed, produced and now
sold under the name BIOLOX delta originally was conceived for cutting tools, it has
since been optimized for medical use – specifically for prosthetic hip joint components
– with ZTA formulations including chromium oxide as contributing to the desired
mechanical properties of hardness, toughness and strength.
We thus find that the expired ’816 patent, as supported by the statements made
in the ’955 and ’970 patents and the ’237 application combined with Respondent’s

219 Respondent’s Brief, 160 TTABVUE 43-44.
- 93 -
admissions that the addition of chromia renders the ZTA ceramic pink, is strong
evidence that the color pink for ceramic hip implant components is functional. We
further find that the color pink is not merely an ornamental, incidental, or arbitrary
aspect of what is disclosed in the patent, but rather the natural byproduct of
practicing the patent. See McGowen Precision Barrels, 2021 USPQ2d 559, at *81
(“[T]he appearance of the barrel [resulting from practicing expired patent] is dictated
by its function”).
B. Respondent’s Advertising and Other Public Statements Touting

Utilitarian Advantages
“If a seller advertises the utilitarian advantages of a particular feature of its
product, this constitutes strong evidence of functionality.” Kohler, 125 USPQ2d 1468,
1502 (TTAB 2017) (quoting Kistner Concrete Prods., Inc. v. Contech Arch Techs., Inc.,
97 USPQ2d 1912, 1924 (TTAB 2011)). In the context of the evidence made of record,
we examine the promotional literature and other public statements made by
Respondent, as well as statements made on Respondent’s behalf (or with its apparent
permission and consent).
As noted, Respondent’s hip implant components comprised of its BIOLOX delta
pink ceramic material were introduced in 2003. Since at least that time until 2013,
the record discloses that Respondent and its OEM customers made promotional
literature available to the public extolling the benefits of chromia to the mechanical
properties and performance of its compound used to make ceramic hip implant
components; particularly hardness but other mechanical properties as well. Some of
this literature also mentions that chromia is responsible for the pink color of the
- 94 -
material. As late as 2019, Respondent was still sending articles to its customers
referencing the fact that chromium oxide increases the hardness of the BIOLOX delta
ceramic compound.
The record also includes technical literature dated from 1966 to 2020, expressing
the benefits of chromia to the mechanical properties of compound ceramics
comprising or including alumina; particularly hardness, strength and wear
resistance. A good number of these articles excerpted above were written or co-
written by Respondent’s current or former employees – such as Drs. Burger, Kuntz
and Porporati. Some of these articles also mention that chromia is responsible for the
pink color of the material.
The evidence further contains references to Respondent’s master files submitted
to the FDA in 2004, 2008, 2012 and 2013, stating that chromia contributes to the
hardness of its ceramic hip components, once again mentioning that chromia is
responsible for the pink color of the material. Respondent did not alter or revise these
statements made in its FDA filings until 2015.
Collectively, the above statements regarding the contribution of chromia to the
mechanical properties of BIOLOX delta made by Respondent or its OEM customers
in scientific literature, filings with the FDA, and advertising and marketing
activities, served to educate the relevant market for an extended period of time that
hip replacement components made from ceramic compositions including chromia
(thus turning the compound pink) were superior in mechanical performance.
- 95 -
In the context of Respondent’s current litigation position that chromia does not
contribute to the mechanical properties or performance of ceramic hip implant
components, contrary to what Respondent has publicly stated over an extended
period of time, Respondent’s internal correspondence made of record in these
proceedings is probative:
• Challenges - new Branding + Advertising Campaign: In former times

were [sic] our market share was low a higher price of our technology was not a
big problem. … This have [sic] changed dramatically - WW increasing demands
for Ceramics … BIOLOX is going in the direction of “Commodity “ … Increasing
price pressure for our customers in their hospital price negotiations …
BIOLOX Patents expired … Risk that cheaper Generika [sic] Ceramic from our
competition will enter the market … Establishment of the color pink in
conjunction with the branding BIOLOX inside [2012-2013].220
• Strategy Project: Pink Trademark Protection: Our pink color is closely
connected with our Biolox Delta product in the market and thus greatly helps
with Biolox Delta branding. … Now we have verifiable information that our
competitors are preparing to enter the market with a ceramic in the color pink.
For this reason, we are currently engaged in activities designed to obtain
trademark protection for the color pink in connection with orthopedic implants
[2013].221
• The Coorstec [sic] guys are not just “ceramic bloody starters”, in my eyes their
current strategy will become very very dangerous for us and this very very
soon. … This is conjunction with our pricing strategy were we [sic] blaming all
of our customers and destroying long term relationships - this is poison for us.
… The feedback we got so far from customers is absolut[e]ly negativ[e] – all of
them are looking for alternatives. Nobody is understanding and also not
accepting our current approach. It’s coming at the wrong time [2014].222
Review 2012 and BIOLOX Brand: New Slogan, New advertising Campaign Message 2013,
220
PNOR1, Exh. 9, 41 TTABVUE 201-274 at 233.

Internal memorandum from Dieter Burkhardt, October 17, 2013, PNOR1, Exh. 8, 41
221
TTABVUE 197-200 at 199 (English translation).

222Email from Dieter Burkhardt, November 27, 2014, PNOR1, Exh. 6, 41 TTABVUE 145-151
at 147.
- 96 -
The impression we are left with is that Respondent sought trademark protection
to stave off competition after the expiration of its patent protection. We find
Respondent’s extended and continual advertising and other public statements (made
at least until the institution of these proceedings), highlighting the utilitarian
advantages of chromia in its ceramic product mix and that adding chromia turns the
product pink, constitute strong evidence of functionality.
C. Facts Pertaining to the Availability of Alternative Designs
Although above we found that pink is a natural byproduct of the manufacturing
process for Respondent’s BIOLOX delta chemical composition, we examine the
Morton-Norwich “alternative designs (or colors) factor” to determine if it weighs
against a finding of functionality. To consider this question, we begin with the
understanding that there are only a few companies that make these ceramic hip
implant components because of the technical challenges involved; there are only a
few companies that have the proper technology.223
Respondent provided evidence that, in addition to Respondent’s components,
OEM customers purchase other manufacturers’ ceramic components – produced and
sold in different colors – and integrate them into their own total hip replacement
systems, which are then sold to hospitals or buying associations. Respondent cites
the following examples: a Swiss company called Metoxit AG offers blue and
peach-colored ceramic hip implant components; a Japanese company called Kyocera
offers a blue ceramic hip implant component; a Swiss company called Mathys AG
223 Haftel Lit. Testim., RNOR1, 70 TTABVUE 147-48.
- 97 -
manufactures and sells a white ceramic hip implant component; and Smith &
Nephew offers a black ceramic-coated hip implant component.224
A problem we have with these examples is that, except for Kyocera,225 Respondent
has not provided evidence that the competitors’ products are equivalent in desired
ceramic mechanical properties to those of Respondent. See Valu Eng’g, 61 USPQ2d
at 1427 (discussing that the law of functionality considers in part “[t]he existence of
actual or potential alternative designs that work equally well [which] strongly
suggests that the particular design used by plaintiff is not needed by competitors to
effectively compete on the merits.” (emphasis added)) (citing J. Thomas McCarthy, 1
MCCARTHY ON TRADEMARKS AND UNFAIR COMPETITION, § 7:75, 7-180-1 (4th ed. 2001)).
In view of the dearth of probative evidence, we find the presence or absence of
alternative “designs” (colors) to be a neutral factor regarding our ultimate
determination whether the color pink for the products of interest is functional.
D. Whether the Subject Matter Results from a Comparatively Simple

or Inexpensive Method of Manufacture
Petitioner is not aware of any difference in the overall cost for manufacturing its
pink and white products, whether in manufacturing or raw material. They are pretty
similar to make and manufacture.226 Respondent, on the other hand, believes that
because the raw material yttrium chromite is much more expensive than if
224 Petkow Decl., 114 TTABVUE 5, ¶ 13, 115 TTABVUE 104-131, Exhs. 2-5.
225 As to the competitive equivalence of Kyocera’s product, see, e.g., Dieter Burkhardt
Colorado Litigation Testimony (“Burkhardt Lit. Testim.”), PNOR2, 42 TTABVUE 9-14;
Kuntz Lit. Testim., PNOR2, 42 TTABVUE 198-99 and DNOR1, 70 TTABVUE 423; Haftel
Lit. Testim., DNOR1, 70 TTABVUE 146-47; Kuntz Decl., 101 TTABVUE 17, ¶ 47.
226 Hughes Lit. Testim., RNOR1, 70 TTABVUE 113.
- 98 -
Respondent were to use yttrium oxide, chromia does impact the cost of its product.
That is, using chromia makes Respondent’s product more expensive to produce.227 In
either event, in view of this testimony, we find that adding chromia to a ZTA ceramic
does not make the product simpler or less expensive to make. We therefore find this
Morton-Norwich factor to be neutral.
E. Other Considerations
1. Respondent’s Testing Data
Respondent spent a great deal of time and effort to support its argument that
“recent” reported experimental data should convince us that chromia has little to no
impact on the desired mechanical properties of a ZTA ceramic. The experimental data
to which we refer comprises the Kuntz 2014 White Paper, the Mecholsky 2016
litigation findings, the Kuntz/Krüger 2018 paper and the BAM 2018 findings from
the German Litigation. As detailed above, Dr. Carty extensively criticized this
research, and we find his criticisms persuasive.228 Our additional concerns with this
research over and above what Dr. Carty testified to are of a different ilk.
Specifically, the theme running through most of the experimental research offered
in Respondent’s favor is that the addition of chromia to a ZTA ceramic up to 0.5% by
weight has no influence on the hardness, toughness, stiffness or mechanical
227 Kuntz Lit. Testim. RNOR1, 70 TTABVUE 475-77.
228We are additionally troubled that the Kuntz 2014 White Paper and the Kuntz/Krüger 2018
paper appear to have been written to justify Respondent’s litigation positions that are
contrary to its public statements regarding chromia made for over a decade prior. We also
noted above our concern that the Kuntz/Krüger 2018 paper was peer reviewed by
Respondent’s litigation expert, Dr. Mecholsky, who failed to disclose his conflict of interest to
the publisher.
- 99 -
performance of the composite material. Kuntz and Krüger suggest other reasons for
improvements in the material, such as grain size and final density. Dr. Porporati’s
research suggests that changes in yttria content have an effect on toughness, zirconia
phase stabilization, and potentially wear performance of the ZTA material (although
the product actually tested was yttrium chromite (YCrO3), a chemical combination of
yttrium and chromia, not the addition of yttrium by itself, albeit increasing the
overall yttria content while keeping chromia content relatively constant).
The problem with Respondent’s research is that it goes only so far, and not far
enough in its scope – to address the full range of chromia content encompassed by the
’816 patent. For one, suggesting other reasons for improvements in the material does
not perforce exclude the contributions of chromia as well based upon the technical
literature made of record. Further, we recall here the disclosures in the ’816 patent
that the addition of chromium oxide in a weight ratio of 0.004 to 6.57% by
weight contributes to hardness and toughness, and can serve to counteract the
embrittlement of the material. When the ’816 patent expired, its claimed and
disclosed inventions were dedicated to the public. Kellogg, 39 USPQ at 299.
In 2008, Respondent produced hundreds of specimens of varied material
properties as part of an internal research project. The picture below shows
Respondent’s so-called “color board,” containing some of the samples Respondent
created along with composition information for the samples:229
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As can be observed, the materials vary in color. The first three materials on the top
left comprise a combination of alumina and chromia with no zirconia. At much higher
chromia concentrations than the 0.33 wt % of BIOLOX delta, the material becomes
dark red. In between the lightest shades (practically white) and the dark red are
multiple gradations of pink, growing progressively darker. The materials colored blue
and green were simply test samples as a proof of concept that Respondent could
develop material in several different colors.230
What this evidence shows is that chromia can be added to the ceramic composite
in greater concentrations by weight percent than the 0%-0.5% wt. levels
tested. It is certainly possible that, based on the historical literature made of record
and reviewed by both parties’ materials experts, 231 greater concentrations of chromia

231 Summarizing his prior testimony and reports, Respondent’s materials expert, Dr.
Mecholsky, suggests that we should dispense with this body of experimental research (the
“older” literature from 1967 to 2013) as being of limited (if any) use in these proceedings
because: (i) the compositions of ceramics addressed by the literature are either not reported
or are different than the products at issue in these proceedings; (ii) the concentrations of
chromium are different than the range of concentrations relevant to these proceedings; and
(iii) other variables that affect material properties, such as grain size and density of the tested
ceramic, are not reported. Mecholsky TTAB Rebuttal Rpt., 105 TTABVUE 393-94, ¶ 8.
Petitioner’s materials expert, Dr. Carty, notes that even the composition of BIOLOX delta
did not remain constant during its development. However, with the exception of two testing
samples, all of Respondent’s samples contained chromia. Once an optimal chromia level was
- 101 -
by weight than those Respondent tested do contribute to the desired mechanical
properties of the ceramic material and still come within the coverage of the now-
expired ’816 patent. However, we do not know this because the research was not done
and brought to our attention.
Thus, due to a lack of proof, we do not know whether adding levels of chromia in
excess of 0.5% (by %-wt.) to the ZTA ceramic would contribute to the mechanical
properties of the material, yet the material would still turn out pink – as shown in
Respondent’s trademark registrations.
2. Petitioner’s Testing Data and Survey Evidence
Petitioner also spent a great deal of time and effort to support its argument that,
over time, its pink ZTA ceramic containing chromia, CeraSurf-p, exhibited greater
hardness and strength than its white ZTA ceramic not containing chromia,
CeraSurf-w. As we extensively discussed above, Respondent’s experts, Drs.
Mecholsky and Kadane, as well as the cross-examination of Jonathan Haftel, raised
sufficient doubts about Petitioner’s processing and testing methods, data collection,
reporting and conclusions reached over the relevant time period to cast doubt on the
established, that level was kept constant. In any event, Respondent’s developmental timeline
for the BIOLOX delta composition showed that hardness clearly increased linearly with
chromium content. Accordingly, different compositions (including those in the so-called
“older” literature) are relevant to the ultimate issue of whether chromia contributes to the
hardness of a ZTA ceramic compound. Accordingly, Dr. Mecholsky’s suggestion that
measured properties in prior literature should not be considered, because they are not the
same composition as BIOLOX delta, is unsupportable given the developmental timeline for
the development of the BIOLOX delta compound. Carty Rebuttal Rpt. (confidential), 141
TTABVUE 11-13 ¶¶ 15-18. We decline Dr. Mecholsky’s invitation to cast aside the findings
made and conclusions from the historical experimental research, published over an extended
period of time in peer-reviewed articles by experts in the field.
- 102 -
probative value of this evidence. We further find wanting the efforts of Petitioner’s
experts, Drs. Carty and Barnett, to explain away Respondent’s critique of Petitioner’s
testing data.
Petitioner’s survey conducted by Dr. Parikh, to establish that the primary
significance of the color pink used in the context of hip implant components, was
heavily criticized by Respondent’s survey expert. Further problems with Dr. Parikh’s
survey were uncovered during her cross-examination. As we discussed above, these
survey methodology defects alone cast significant doubt on the probative value of
Petitioner’s survey evidence.
As we also noted above, our greater problem with Petitioner’s survey is that it
asked the wrong question. Petitioner’s survey in no way sought to determine whether
pink as applied to the compound of a ceramic implant component is functional based
on utilitarian considerations. We thus give Petitioner’s survey evidence no probative
weight.
XVIII. Conclusion: Functionality
Respondent’s expired ’816 patent, as well the other patent properties in
Respondent’s portfolio discussed above, disclose the utilitarian advantages of Cr3+-
doped ZTA ceramic hip replacement component materials, which as a natural
byproduct turns the chemical compound pink – and that is the color shown in
Respondent’s Trademark Registration Nos. 4319095 and 4319096. The advertising
and public statements made by Respondent and OEM customers on Respondent’s
behalf – for an extended period of time – touted the utilitarian advantages of chromia
to Respondent’s ZTA ceramic compounds; some statements made in conjunction with

- 103 -
the comment that the addition of chromia turns the material pink. Respondent did
not withdraw these noted advertising and other public statements until the parties
were in litigation and its registrations were being challenged.
Facts pertaining to the availability of alternative “designs” (colors) comprise a
neutral factor here, due to the dearth of relevant evidence. In view of the parties’
testimony that the use of chromia either does not affect the cost of a ZTA ceramic or
makes the product more expensive, whether the addition of chromia (turning the
product pink) results from a comparatively simple or inexpensive method of
manufacture is also a neutral factor.
The parties’ product testing data, and the survey evidence offered by Petitioner,
does not change our findings with respect to the Morton-Norwich factors. In sum, we
find that the color pink (caused by the addition of chromia) of the compound used to
make ceramic hip implant components, as shown in Respondent’s trademark
registrations, is functional based on utilitarian considerations.
XIX. Respondent’s Unclean Hands Defense
In its Answers to both Petitions for Cancellation, Respondent alleges that
“Petitioner is precluded from petitioning to cancel [Respondent’s] … U.S. Registration
Number[s] 4,319,095 [and] 4,319,096 by the affirmative defense of unclean hands.”232
Generally, unclean hands is an available defense in cancellation proceedings before
the Board. Trademark Act Section 19, 15 U.S.C. § 1069 (“In all inter partes
232Answer in in Cancellation No. 92058781, 28 TTABVUE 8-12, ¶¶ 37-52; Answer in

Cancellation No. 92058796, 22 TTABVUE 8-12, ¶¶ 37-52.
- 104 -
proceedings equitable principles … where applicable, may be considered and
applied.”); Trademark Rule 2.114(b)(2), 37 C.F.R. § 2.114(b)(2) (“An answer may
contain any defense, including the affirmative defense[] of unclean hands, …, or any
other matter constituting an avoidance or affirmative defense.”).
However, we may properly exercise our discretion, when there is a strong public
policy interest in removing a category of marks from the Register, to find the defense
unavailable against certain claims for cancellation. See Loglan Inst., Inc. v. Logical
Language Grp., Inc., 962 F.2d 1038, 22 USPQ2d 1531, 1534 (Fed. Cir. 1992) (“The
Board did not err in declining to apply the [unclean hands] defense[], as the public
interest in a cancellation proceeding to rid the register of a generic mark transcends
[this defense].”); Maids to Order of Ohio, Inc. v. Maid-to-Order, Inc., 78 USPQ2d 1899,
1904 (TTAB 2006) (“[S]ince … the affirmative defense of unclean hands … is …
unavailable against a claim of fraud …, we have given it no consideration.”); Am.
Vitamin Prods. Inc. v. DowBrands Inc., 22 USPQ2d 1313, 1314 (TTAB 1992) (“Where
the ground for cancellation is abandonment, equitable defenses such as … unclean
hands, are not available in light of the overriding public interest in removing
abandoned registrations from the register.”).
We exercise our discretion now, and thus hold that the unclean hands defense is
unavailable in Board functionality proceedings in view of the prevailing public
interest in removing registrations of functional marks from the register. See ERBE
Elektromedizin GmbH v. Canady Tech. LLC, 629 F.3d 1278, 97 USQP2d 1048, 1057
(Fed. Cir. 2010) (“the ‘functionality doctrine stems from the public interest in
- 105 -
enhancing competition’ and avoiding improper hindrance of competition in the
marketplace”) (citation omitted).
XX. Culmination of Findings and Rulings
In sum, we find that the color pink for the identified goods in Respondent’s
Trademark Registration Nos. 4319095 and 4319096 is functional and therefore
unregistrable. In view of our determination of Petitioner’s functionality claim, we do
not reach Petitioner’s alternative claim that Respondent’s Registration Nos. 4319095
and 4319096 were procured through fraud. We further find Respondent’s unclean
hands defense inapplicable to these proceedings (including as against Petitioner’s
fraud claim that we did not reach). Finally, we deny as moot Respondent’s motion
filed in Cancellation No. 92058796 to amend the date of first use claimed in
Registration No. 4319096.
Decision:
The Petitions to Cancel Trademark Registration Nos. 4319095 and 4319096 are
granted. The registrations will be canceled in due course.
- 106 -

CeramTec GMBH v. CoorsTek Bioceramics LLC - Notice of Appeal

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Case: 23-1502 Document: 1-1 Page: 1 Filed: 02/13/2023 (1 of 113)

UNITED STATES COURT OF APPEALS

PETER R. MARKSTEINER CLERK’S OFFICE

February 13, 2023

Federal Circuit Docket No.: 2023-1502

Federal Circuit Short Caption: CeramTec GmbH v. CoorsTek Bioceramics LLC

Date of Docketing: February 13, 2023

Originating Tribunal: United States Patent and Trademark Office

Originating Case No.: 92058781, 92058796

Appellant: CeramTec GmbH

The following filings are due within 14 days of this notice:

• Entry of Appearance or Notice of Unrepresented Person. (Fed. Cir. R. 47.3.)

• Statement Concerning Discrimination in MSPB or arbitrator cases. (Fed. Cir. R.

FILING DOCUMENTS: Each counsel representing a party must be a member of the

CONTACT INFORMATION: Electronic filers, or unrepresented parties registered to

/s/ Peter R. Marksteiner

By: C. Harper, Deputy Clerk

cc: United States Patent and Trademark Office

COORSTEK BIOCERAMICS LLC, fka C5 Medical Werks, LLC,

FORM 5. Petition for Review or Notice of Appeal of an Order or Decision of an Form 5

UNITED STATES COURT OF APPEALS

PETITION FOR REVIEW

Date: 2/3/23 Signature: /s/ Anna Kurian Shaw

Name: Anna Kurian Shaw

Address: 555 13th St. N.W.

Phone Number: 202-637-5600

Email Address: [email protected]

*See Fed. R. App. P. 15(a)(2) for permissible ways of identifying petitioners.

electronic mail to the following attorneys of record. Fed. R. App. P. 25(c)(2).

Dated: February 3, 2023

This Opinion is Not a

Hearing Date: February 22, 2022 Mailed: December 6, 2022

UNITED STATES PATENT AND TRADEMARK OFFICE

Trademark Trial and Appeal Board

CoorsTek Bioceramics LLC

Cancellation Nos. 92058781 and 92058796

Diana Rutowski, Peter D. Vogl and Briggs M. Wright

Before Goodman, Lynch and Hudis,

Opinion by Hudis, Administrative Trademark Judge:

This pair of cancellation proceedings is another chapter in the parties’ eight-year

implant parts is functional. CeramTec GmbH (“Respondent”) is the owner of record

Cancellation Nos. 92058781 and 92058796

The color(s) pink is/are 85521237 Hip joint implants

The color(s) pink is/are 85521240 Hip joint implants

To be clear, in neither registration does Respondent claim protection for the

color pink only.1

Cancellation Nos. 92058781 and 92058796

LLC, which by change of name is now known as CoorsTek Bioceramics LLC

(“Petitioner”), seeks cancellation of Respondent’s registrations under Trademark Act

the goods identified in the registrations, is functional; and that Respondent

Bioceramics LLC as the petitioner and party-plaintiff.

address the Colorado Litigation below, following the Summary of proceedings.

On February 4, 2016 in Cancellation No. 92058796, Respondent moved without

Cancellation Nos. 92058781 and 92058796

deferred until final disposition.6

record and the parties’ briefs shall be to the parent proceeding.

Cancellation and asserted the affirmative defense of unclean hands.9

hearing on February 22, 2022.10