Trademark Trial and Appeal Board Electronic Filing System. https://estta.uspto.gov
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`ESTTA Tracking number:
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`ESTTA1171236
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`Filing date:
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`11/09/2021
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
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`Proceeding
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`92058781
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`Party
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`Correspondence
`Address
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`Plaintiff
`C5 Medical Werks, LLC
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`DIANA RUTOWSKI
`ORRICK HERRINGTON & SUTCLIFFE LLP
`1000 MARSH ROAD
`MENLO PARK, CA 94025-1015
`UNITED STATES
`Primary Email: ipprosecution@orrick.com
`Secondary Email(s): drutowski@orrick.com, djustice@orrick.com,
`pvogl@orrick.com, bwright@orrick.com
`650-614-7400
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`Submission
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`Filer's Name
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`Filer's email
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`Signature
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`Date
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`Brief on Merits for Plaintiff
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`Diana Rutowski
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`drutowski@orrick.com, ipprosecution@orrick.com, mweddington@orrick.com
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`/Diana Rutowski/
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`11/09/2021
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`Attachments
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`C5 Opening Trial Brief -Public.pdf(1405749 bytes )
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`

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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
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`CANCELLATION NO.: 92058781 (Parent)
`CANCELLATION NO.: 92058796
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`C5 Medical Werks, LLC,
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`Petitioner,
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`v.
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`CeramTec GmbH,
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`Respondent.
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`PETITIONER C5 MEDICAL WERKS, LLC’S TRIAL BRIEF
`PUBLIC VERSION
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`TABLE OF CONTENTS
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`I.
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`INTRODUCTION ................................................................................................................ 5
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`II. STATEMENT OF THE ISSUES ......................................................................................... 9
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`III. DESCRIPTION OF THE RECORD ................................................................................ 10
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` REGISTRATIONS AND FILE HISTORIES FOR THE SUBJECT REGISTRATIONS ......................... 10
` PETITIONER C5’S EVIDENCE .............................................................................................. 10
` RESPONDENT CERAMTEC’S EVIDENCE .............................................................................. 12
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`IV. STATEMENT OF FACTS ................................................................................................. 13
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` PARTY AND INDUSTRY OVERVIEW ..................................................................................... 13
` CERAMTEC’S ‘816 PATENT CLAIMS THE USE OF CHROMIUM IN ZTA CERAMICS .............. 15
` CERAMTEC AND THIRD-PARTY LITERATURE ESTABLISH THAT CHROMIUM IMPARTS
`NUMEROUS FUNCTIONAL BENEFITS TO ZTA CERAMICS FOR HIP IMPLANT COMPONENTS ........ 16
` FOR DECADES, CERAMTEC REPRESENTED TO THE INDUSTRY AND GOVERNMENT AGENCIES
`THAT CHROMIUM CONFERS FUNCTIONAL BENEFITS AND RESULTS IN A PINK MATERIAL ......... 19
` UPON THE EXPIRATION OF THE ‘816 PATENT, CERAMTEC MADE MATERIAL
`MISREPRESENTATIONS TO THE USPTO IN AN EFFORT TO SECURE TRADEMARK RIGHTS .......... 24
` C5 ATTEMPTED TO ENTER THE ORTHOPEDIC MARKET AND WAS FRUSTRATED BY
`CERAMTEC’S CLAIMED TRADEMARK MONOPOLY..................................................................... 26
` CERAMTEC’S NEW LITIGATION DRIVEN POSITION LACKS CREDIBILITY ........................... 28
` DESPITE CERAMTEC’S “NEW SCIENCE,” CERAMTEC CONTINUED ITS REPRESENTATIONS IN
`SCIENTIFIC AND PROMOTIONAL MATERIALS AS WELL AS REGULATORY FILINGS. .................... 32
` C5’S DEVELOPMENT AND TESTING CONFIRMS PINK’S FUNCTIONALITY ............................ 35
` WHEN PRESENTED WITH ALL THE EVIDENCE DURING AN ELEVEN DAY TRIAL, A FEDERAL
`JUDGE FOUND CERAMTEC’S PINK COLOR FUNCTIONAL AND UNPROTECTABLE ........................ 36
` SURVEY EVIDENCE AND CERAMTEC’S OWN MARKETING CONFIRM THAT THE COLOR PINK
`FUNCTIONS AS AN INDICATOR OF MATERIAL, NOT SOURCE ...................................................... 38
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`V. ARGUMENT ....................................................................................................................... 39
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` STANDING IS UNDISPUTED ................................................................................................. 39
` THE COLOR PINK IS FUNCTIONAL IN ZTA CERAMICS ....................................................... 39
` HAVING ENJOYED THE BENEFITS OF ITS 20-YEAR MONOPOLY, CERAMTEC IS NOW
`ESTOPPED FROM DENYING FUNCTIONALITY .............................................................................. 50
` CERAMTEC OBTAINED THE ’095 AND ’096 REGISTRATIONS THROUGH FRAUD ................. 51
` CERAMTEC’S UNCLEAN HANDS DEFENSE FAILS LEGALLY AND FACTUALLY ................... 53
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`VI. CONCLUSION ................................................................................................................... 54
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`Cases
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`TABLE OF AUTHORITIES
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`Page(s)
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`Alcohol Monitoring Sys., Inc. v. ActSoft, Inc.,
`2011 WL 5075619 (D. Colo. Oct. 25, 2011), aff’d, 499 F. App’x 974 (Fed.
`Cir. 2013) .................................................................................................................................50
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`Am. Vitamin Prods. Inc. v. Dowbrands Inc.,
`22 U.S.P.Q.2d 1313, 1992 WL 88051 (T.T.A.B. 1992) ..........................................................53
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`AS Holdings, Inc. v. H & C Milcor, Inc., f/k/a Aquatico of Texas, Inc.,
`107 U.S.P.Q.2d 1829 (T.T.A.B. 2013) ....................................................................................47
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`Binney & Smith Inc. v. Magic Marker Indus. Inc.,
`222 U.S.P.Q. 1003 (T.T.A.B. 1984) (non-precedential) ..........................................................39
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`In re Becton, Dickinson, and Co., 675 F.3d 1368, 102 U.S.P.Q.2d 1372 (Fed. Cir.
`2012) ............................................................................................................................40, 41, 43
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`In re Bose Corp.,
`772 F.2d 866, 227 U.S.P.Q. 1 (Fed. Cir. 1985) .......................................................................47
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`In re Bose Corp.,
`580 F. 3d 1240, 91 U.S.P.Q.2d 1928 (Fed. Cir. 2009) ............................................................51
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`Chutter, Inc. v. Great Mgmt. Grp., LLC,
`21 U.S.P.Q.2d 1001, 2021 WL 4494251 (T.T.A.B. 2021) ......................................................51
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`Disc Golf Ass’n Inc. v. Champion Discs, Inc.,
`158 F.3d 1002 (9th Cir. 1998) .................................................................................................51
`
`In re E.R. Shaw,
`No. 85797528, 16 TTABVUE (T.T.A.B. Sept. 29, 2015) (non-precedential) ..................44, 48
`
`Ezaki Glico Kabushiki Kaisha v. Lotte Int'l Am. Corp.,
`986 F.3d 250, 2021 U.S.P.Q.2d 102 (3d Cir. 2021), as amended (Mar. 10,
`2021) ........................................................................................................................................44
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`In re Honeywell, Inc.,
`532 F.2d 180, 189 U.S.P.Q. 343 (CCPA 1976) .......................................................................47
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`Inwood Labs., Inc. v. Ives Labs, Inc.,
`456 U.S. 844, 214 U.S.P.Q. 1 (1982).......................................................................................39
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`Kellogg v. Nat’l Biscuit Co.,
`305 U.S. 111 (1938) .................................................................................................................42
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`
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`Loglan Inst., Inc. v. Logical Language Group, Inc.,
`962 F.2d 1038, 22 U.S.P.Q. 1531 (Fed. Cir. 1992) .................................................................53
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`In re Morton-Norwich Prods., Inc.,
`671 F.2d 1332, 213 U.S.P.Q. 9 (CCPA 1982) .........................................................................40
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`Phoenix Trading, Inc. v. Loops, LLC,
`No. 92051757, 25 TTABVUE (T.T.A.B. November 15, 2012) (non-
`precedential) .......................................................................................................................42, 47
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`Poly-Am., L.P. v. Ill. Tool Works Inc.,
`124 U.S.P.Q.2d 1508, 2017 WL 4287891 (T.T.A.B. 2017) ..............................................42, 47
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`Qualitex Co. v. Jacobson Prods. Co., Inc.,
`514 U.S. 159, 34 U.S.P.Q.2d 1161 (1995)...............................................................................39
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`Singer Mfg. v. June Mfg.,
`163 U.S. 169 (1896) .................................................................................................................42
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`Specialized Seating, Inc. v. Greenwich Industries, L.P.,
`472 F. Supp. 2d 999 (N.D. Ill. 2007) .......................................................................................53
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`TrafFix Devices, Inc. v. Mktg. Displays, Inc.,
`532 U.S. 23, 58 U.S.P.Q.2d 1001 ..........................................................................40, 41, 42, 45
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`Valu Eng’g, Inc. v. Rexnord Corp.,
`278 F.3d 1268, 61 U.S.P.Q.2d 1422 (Fed. Cir. 2002) .............................................................47
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`Other Authorities
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`37 CFR § 2.122(b) .........................................................................................................................10
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`I.
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`INTRODUCTION
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`Petitioner C5 Medical Werks, LLC (“C5”) requests cancellation of Respondent
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`CeramTec Gmbh’s (“CeramTec”) U.S. Registration Nos. 4,319,095 (the “’095 Registration”)
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`and 4,319,096 (the “’096 Registration”) on the grounds of functionality and fraud. Regarding
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`functionality, (1) the color pink is a natural byproduct of the chemical compound chromium
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`oxide (also known as “chromia” and hereinafter referred to as “chromium”), and (2) CeramTec
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`adds chromium to its products for functional purposes as demonstrated in its now-expired patent
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`covering the composition, marketing materials, regulatory submissions, and scientific literature.
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`Regarding fraud, CeramTec failed to disclose this information in response to the Examiner’s
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`questions during prosecution of
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`the
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`registrations,
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`intentionally making material
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`misrepresentations to the U.S. Patent and Trademark Office (“USPTO”).
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`CeramTec markets a ceramic hip implant product under the name Biolox Delta, holding a
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`virtual monopoly acquired through now-expired patent rights on ceramic material used in hip
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`replacements. During the manufacturing process, CeramTec adds chromium to the ceramic
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`composite making up its Biolox Delta products. The overwhelming evidence in the record
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`shows that it does so for a functional purpose, including to increase the hardness of the
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`composite. Once added, chromium (which makes rubies red) causes the ceramic composite to
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`turn pink—as a natural, inevitable chemical reaction. Biolox Delta products are pink because
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`they have chromium, and they have chromium because it improves desirable performance
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`characteristics. The functional purpose of chromium in CeramTec’s products is beyond any
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`reasonable dispute. The record is replete with CeramTec representations to governmental
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`agencies and the industry, made over decades and consistent with scientific literature, that it adds
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`chromium to its hip implant products for improved performance. CeramTec did not choose pink
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`as an arbitrary color for brand identification; pink resulted from functional considerations.
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`Through a predecessor entity, CeramTec obtained U.S. Patent 5,830,816 (the “’816
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`Patent”) which identified chromium as a key functional component. CeramTec admits that its
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`pink zirconia-toughened alumina (“ZTA”) Biolox Delta material practices one or more claims of
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`the ’816 Patent, all of which require the addition of chromium. That patent solves the problem
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`of decreased material properties and performance in prior alumina ceramic materials (such as
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`CeramTec’s Biolox Forte hip implant components) through “a specific molar ratio” of zirconium
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`dioxide (also known as “zirconia,” which is tough, but not hard) with chromium (which increases
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`hardness).1 Indeed, it was critical in obtaining the patent that CeramTec’s predecessor overcome
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`an office action by arguing that chromium made “it possible for the first time to achieve hardness
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`values such as have not previously been achieved at such zirconium dioxide contents.”
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`For years, CeramTec’s ’816 Patent blocked competitors from using chromium in their
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`products in the ratio claimed in the patent. That patent monopoly was key to CeramTec’s market
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`dominance. Within the range taught by the ’816 Patent, and at the levels included in its Biolox
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`Delta material, chromium also naturally renders the material pink. Throughout the entire time it
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`enjoyed the protection of the ’816 Patent, CeramTec knew pink was a natural, incidental
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`byproduct of a functional component, not an arbitrary color chosen for brand purposes. It was
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`only after the ’816 Patent expired—and CeramTec lost its patent monopoly over the use of
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`chromium as a hardening agent—that CeramTec sought trademark protection for the color pink
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`as an alternative strategy to prevent competitors from supplying competing pink material.
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`1 A glossary of technical concepts is included as part of the testimony of C5’s expert Dr. William
`M. Carty. 48 TTABVUE, Ex. 1 at ¶ 33.
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`CeramTec did so even while it pursued further patents touting the functional benefits of
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`chromium.
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`The parties have previously litigated the questions now before the Board. From 2014 to
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`2017 the parties litigated in federal district court in Colorado in a declaratory judgment action
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`filed by C5 seeking cancellation of CeramTec’s trademark registrations at issue here and a
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`declaration that the color pink is functional in ZTA ceramic hip implant components (the
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`“District Court Action”). During this litigation, indeed just weeks before responding to C5’s
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`interrogatory regarding functionality, CeramTec first published a White Paper with purported
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`“new science” allegedly showing that chromium has no effect on the properties or performance
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`of its Biolox Delta product. It is this “new science” on which CeramTec’s case rests, both here
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`and before the district court.
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`The District Court Action resulted in a 2017 bench trial in which the court had before it
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`virtually the same evidence and record on functionality now before the Board. In a 20-page
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`decision, the district court found that the color pink in CeramTec’s Biolox Delta products is
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`functional, a natural byproduct of a functional component (chromium), and therefore ineligible
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`for trade dress protection. The judgment, however, was overturned on appeal, solely on the
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`ground that the district court lacked personal jurisdiction over CeramTec. The Tenth Circuit did
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`not address the merits of the dispute or the district court’s findings. Even though the district
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`court’s findings and conclusions of law are not binding on the Board, they are highly instructive.
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`Among other things, the district court held (49 TTABVUE, Ex. 10):
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` CeramTec added chromium to its products to increase hardness.
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` The color pink occurs naturally as a result of the chromium, making it functional.
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` CeramTec repeatedly represented to government agencies that it added chromium for
`functional reasons, not to generate a brand identifier.
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` CeramTec’s litigation-inspired position—the “new science” that chromium has no
`hardening benefit—is not credible and contradicted by years of CeramTec’s own
`research.
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` Under Supreme Court precedent, the identification of chromium in the ’816 Patent as a
`critical component of the invention is strong evidence chromium is functional,
`foreclosing trade dress protection for the resulting pink color.
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`Even aside from the science, the color pink is functional for a second reason. Survey
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`evidence in the record establishes that pink functions as an indicator of material to orthopedic
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`surgeons and not as an indicator of source. Much like a generic word tells you what a product is,
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`pink functions to tell surgeons that the hip implant is the latest generation of ceramic material
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`with chromium—not that it is any particular brand.
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`CeramTec’s registrations should also be canceled because CeramTec committed fraud on
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`the USPTO in procuring them. During prosecution, the Trademark Examiner expressly asked
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`CeramTec whether “the identified color is a natural by-product of the manufacturing process for
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`the goods.” In response, CeramTec represented that “[t]he sole purpose of the use of pink on
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`Applicant’s products is as a source-identifier.” This was a material misrepresentation designed
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`to deceive the USPTO. CeramTec failed to disclose that its products have a pink color because
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`pink is a natural byproduct of the use of chromium and CeramTec adds chromium during “the
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`manufacturing process” to achieve greater hardness. Further, CeramTec failed to disclose the
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`existence of the ’816 Patent or that chromium was claimed in the patent as a key functional
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`component added to increase hardness. Additionally, CeramTec failed to disclose C5 as a
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`competitor that also manufactured pink material in response to a specific request from the
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`Examiner, even though CeramTec had known for years that C5 had developed a pink material.
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`Finally, CeramTec’s unclean hands affirmative defense is meritless. As a matter of law,
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`an unclean hands defense is not available where there is a strong public interest in canceling
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`invalid registrations and clearing the Register for fair competition without fear of infringement.
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`Because of that strong public interest, the Board has not allowed cancellation proceedings to be
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`derailed by unclean hands allegations against petitioners. Moreover, C5’s attempts to engage in
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`fair competition by developing and marketing a competitive white material cannot rise to the
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`level of unclean hands.
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`CeramTec has used its improperly obtained trademark registrations to threaten and
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`intimidate competitors from offering implants containing chromium, even though CeramTec’s
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`patent is long-expired. Once the ’816 Patent expired, CeramTec’s monopoly ended. The public
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`interest is served by allowing others in the industry to offer their customers and patients the
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`technological and market benefits of using known materials containing chromium in ceramic hip
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`implants. The inevitable and natural color of such materials is pink. CeramTec should not be
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`permitted to use invalid and fraudulently obtained trademark registrations to prevent the use of a
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`technology now in the public domain. C5 respectfully requests that the subject registrations
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`therefore be cancelled.
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`II.
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`STATEMENT OF THE ISSUES
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`1. Whether CeramTec’s the ’095 Registration and ’096 Registration should be cancelled
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`because they convey exclusive rights to a feature that is a functional and, therefore,
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`cannot serve as a trademark.
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`2. Whether the ’095 and ’096 Registrations should be cancelled because they were
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`obtained through fraud on the USPTO.
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`3. Whether C5’s claims for cancellation are barred by the doctrine of unclean hands.
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`III. DESCRIPTION OF THE RECORD
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` Registrations and File Histories for the Subject Registrations
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`The files of the subject registrations—the ’095 and ’096 Registrations—are automatically
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`a part of the record of this proceeding. 37 CFR § 2.122(b).
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` Petitioner C5’s Evidence
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`1. C5’s Notices of Reliance
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`C5’s First through Sixth Notices of Reliance were filed on May 18, 2021, its Seventh
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`through Twelfth Notices of Reliance were filed on May 19, 2021, and its Thirteenth Notice of
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`Reliance (Rebuttal) was filed on September 2, 2021.
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`TTABVUE
`Docket Number
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`Description
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`Citation Format
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`Petitioner C5 Medical Werks, LLC’s First
`Notice of Reliance (Exhibits 1-10 attached)
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`41 TTABVUE, Ex. __
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`Petitioner C5 Medical Werks, LLC’s Second
`Notice of Reliance (Exhibits 1-15 attached)
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`42 TTABVUE, Ex. __
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`Petitioner C5 Medical Werks, LLC’s Third
`Notice of Reliance (Exhibits 1-11 attached)
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`43 TTABVUE, Ex. __
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`Petitioner C5 Medical Werks, LLC’s Fourth
`Notice of Reliance (Exhibits 1-10 attached)
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`44 TTABVUE, Ex. __
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`Petitioner C5 Medical Werks, LLC’s Fifth
`Notice of Reliance (Exhibits 1-15 attached)
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`45 TTABVUE, Ex. __
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`Petitioner C5 Medical Werks, LLC’s Sixth
`Notice of Reliance (Exhibits 1-12 attached)
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`46 TTABVUE, Ex. __
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`Petitioner C5 Medical Werks, LLC’s Seventh
`Notice of Reliance (Exhibits 1-10 attached)
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`49 TTABVUE, Ex. __
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`Petitioner C5 Medical Werks, LLC’s Eighth
`Notice of Reliance (Exhibits 1-15 attached)
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`50 TTABVUE, Ex. __
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`41
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`42
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`43
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`44
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`45
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`46
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`49
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`50
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`TTABVUE
`Docket Number
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`Description
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`Citation Format
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`51
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`52
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`53
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`54
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`136
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`Petitioner C5 Medical Werks, LLC’s Ninth
`Notice of Reliance (Exhibits 1-16 attached)
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`51 TTABVUE, Ex. __
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`Petitioner C5 Medical Werks, LLC’s Tenth
`Notice of Reliance (Exhibits 1-15 attached)
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`52 TTABVUE, Ex. __
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`Petitioner C5 Medical Werks, LLC’s Eleventh
`Notice of Reliance (Exhibits 1-12 attached)
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`53 TTABVUE, Ex. __
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`Petitioner C5 Medical Werks, LLC’s Twelfth
`Notice of Reliance (Exhibits 1-16 attached)
`(Public Version at 61 TTABVUE)
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`54 TTABVUE, Ex. __
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`Petitioner C5 Medical Werks, LLC’s Thirteenth
`Notice of Reliance (Exhibits 1-9 attached)
`(Public Version at 154 TTABVUE)
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`136 TTABVUE, Ex. __
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`2. C5’s Trial Testimony
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`During its opening and rebuttal testimony periods, C5 presented evidence by and
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`through the declarations of five witnesses and cross-examined three CeramTec witnesses. C5’s
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`trial witnesses and cross examination of CeramTec witnesses, and the exhibits offered during
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`their testimony, are as follows:
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`TTABVUE
`Docket Number
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`Description
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`Citation Format
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`Opening Testimony of C5’s Survey Expert Sara
`Parikh, Ph.D. (Exhibits 1-2 attached)
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`47 TTABVUE, Ex. __
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`Opening Testimony of C5’s Technical Expert
`William M. Carty, Ph.D. (Exhibit 1 attached)
`(Public Version at 60 TTABVUE)
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`48 TTABVUE, Ex. __
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`Opening Testimony of C5’s Statistics Expert
`Arnold Barnett, Ph.D. (Exhibit 1 attached)
`(Public Version at 56 TTABVUE)
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`55 TTABVUE, Ex. __
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`48
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`55
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`TTABVUE
`Docket Number
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`Description
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`Citation Format
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`57
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`58
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`137
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`139
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`141
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`144
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`143
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`145
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`Opening Testimony of C5 Representative
`Lucian Strong
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`57 TTABVUE at __
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`Opening Testimony of C5 Representative
`Jonathan D. Haftel (Exhibits 1-5 attached)
`(Public Version at 59 TTABVUE)
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`58 TTABVUE, Ex. __
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`Rebuttal Testimony of C5 Representative
`Jonathan D. Haftel (Exhibits 1-2 attached)
`(Public Version at 138 TTABVUE)
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`137 TTABVUE, Ex. __
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`Rebuttal Testimony of C5’s Statistics Expert
`Arnold Barnett, Ph.D. (Exhibits 1-2 attached)
`(Public Version at 140 TTABVUE)
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`139 TTABVUE, Ex. __
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`Rebuttal Testimony of C5’s Technical Expert
`William M. Carty, Ph.D. (Exhibits 1-2 attached)
`(Public Version at 153 TTABVUE)
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`141 TTABVUE, Ex. __
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`Cross Examination of CeramTec’s Statistics
`Expert Dr. Joseph Kadane (Exhibit 1 attached)
`(Public Version at 156 TTABVUE)
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`144 TTABVUE, Ex. __
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`Cross Examination of CeramTec’s Survey
`Expert Robert Klein (Exhibits 1-6 attached)
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`143 TTABVUE, Ex. __
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`Cross Examination of CeramTec’s Technical
`Expert Dr. John Jay Mecholsky Jr. (Exhibits 1-
`5 attached) (Public Version at 155 TTABVUE)
`
`145 TTABVUE, Ex. __
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` Respondent CeramTec’s Evidence
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`1. CeramTec’s Notices of Reliance
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`Respondent CeramTec filed twenty-nine Notices of Reliance. It withdrew and submitted
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`corrected versions for its First (122 TTABVUE) and Twelfth (124 TTABVUE) Notices of
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`Reliance and withdrew entirely its Seventeenth through Twenty-Third (88-94 TTABVUE) and
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`Twenty-Fifth (96 TTABVUE) Notices of Reliance. 125 TTABVUE.
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`2. CeramTec’s Trial Testimony
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`During its testimony period, Respondent CeramTec presented evidence by and through
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`the testimony by declaration of seven witnesses: CeramTec’s survey expert Mr. Robert Klein
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`(84 TTABVUE), CeramTec’s sales representative Mr. Grant Shopoff (85 TTABVUE),
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`CeramTec’s scientist and representative Dr. Alessandro Porporati (98 TTABVUE), CeramTec’s
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`former scientist and representative Dr. Meinhard Kuntz (102 TTABVUE), CeramTec’s statistics
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`expert Dr. Joseph Kadane (103 TTABVUE), CeramTec’s technical expert Dr. John Jay
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`Mecholsky (105-112 TTABVUE), and CeramTec marketing representative Ms. Florence Petkow
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`(113-120 TTABVUE). CeramTec also presented evidence by oral examination and/or cross
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`examination of six C5 witnesses, C5’s sales representative Mr. Angel Abeyta (133 TTABVUE),
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`C5’s marketing representative Ms. Megan Maguire (134 TTABVUE), C5’s marketing
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`representative Ms. Nicole Stavish (135 TTABVUE), C5’s survey expert Dr. Sara Parikh (152
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`TTABVUE), C5’s technical expert Dr. William M. Carty (149-151 TTABVUE), C5’s statistics
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`expert Dr. Arnold Barnett (148 TTABVUE), and C5 scientist and representative Mr. Jonathan D.
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`Haftel (146-147 TTABVUE).
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`IV.
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`STATEMENT OF FACTS
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` Party and Industry Overview
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`1.
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`Petitioner C5, which became CoorsTek Medical, LLC and is now known as
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`CoorsTek Bioceramics, LLC,2 was founded in 2005 to apply CoorsTek, Inc.’s 90 years of
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`ceramics experience to the orthopedic market, including hip implants. 57 TTABVUE ¶¶ 3-6; 42
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`TTABVUE, Ex. 6 at 153:3-17, 149:19-151:25; Ex. 3 at 213:9-15; 54 TTABVUE, Ex. 12.
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`2.
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`Registrant CeramTec is a German company who developed a dominant position
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`2 Petitioner is referred to as “C5” or “Petitioner.”
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`in the ceramic hip implant market in the United States during the pendency of the now expired
`
`
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`
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`’816 Patent, which teaches use of chromium to improve the properties of ceramics and covers its
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`pink ZTA Biolox Delta material. 43 TTABVUE, Ex. 1; Exs. 6-7; Exs. 9-10; 57 TTABVUE ¶ 9;
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`58 TTABVUE ¶¶ 9-10.
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`3.
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`CeramTec and C5 each sell material and manufacture components to the
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`specifications of its customers, which are Original Equipment Manufacturers (“OEMs”), for
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`incorporation as one component into their hip implant systems. 57 TTABVUE ¶¶ 3-5; 58
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`TTABVUE ¶ 6.
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`4.
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`Hip implant systems are sold by OEM sales representatives and distributors to
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`hospitals for use by orthopedic surgeons in hip replacement procedures. 57 TTABVUE ¶ 19.
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`5.
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`ZTA ceramic materials constitute an advancement of the previous generation
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`alumina materials, such as CeramTec’s Biolox Forte alumina material, which suffered from
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`certain biocompatibility and wear resistance issues that were solved by the advent of ZTA. 48
`
`TTABVUE, Ex. 1 at ¶¶ 34-36.
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`6.
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`The prior generation Biolox Forte alumina material is not a ZTA, does not contain
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`chromium, and is off-white in color. 54 TTABVUE, Ex. 1 (Part 1 of 2) at 23 of 98.
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`7.
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`CeramTec introduced its pink ZTA material, Biolox Delta, as a new generation of
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`ceramic material. 45 TTABVUE, Ex. 1; 48 TTABVUE, Ex. 1 at ¶ 37.
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`8.
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`Biolox Delta is pink because of the presence of chromium. The color pink is a
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`natural, inevitable byproduct of the presence of chromium. 46 TTABVUE, Ex. 8 at 5 of 23; 43
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`TTABVUE, Ex. 4 at 26 of 64.
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`9.
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`When added to ZTA, chromium compensates for the loss of hardness caused by
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`the presence of zirconia. 42 TTABVUE, Ex. 3 at 218:9-219:2; 46 TTABVUE, Exs. 2-5.
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`10.
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`C5 has developed and offers two ZTA ceramic materials: CeraSurf®-p (which has
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`chromium oxide and is pink) and CeraSurf®-w (which lacks chromium oxide and is white). 57
`
`TTABVUE ¶ 14; 58 TTABVUE ¶ 12.
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`11.
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`Test data confirms that CeraSurf®-p performs better than CeraSurf®-w along
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`several performance attributes, due to the presence of chromium in CeraSurf®-p. 58 TTABVUE
`
`¶¶ 18-23, 25-26 and Exs. 2 and 5.
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` CeramTec’s ‘816 Patent Claims the Use of Chromium in ZTA Ceramics
`
`12.
`
`CeramTec’s predecessor in interest, an entity named Cerasiv GmbH Innovatives
`
`Keramik Engineering, obtained the ’816 Patent on November 3, 1998. 43 TTABVUE, Ex. 1.
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`The ’816 Patent expired in 2013. CeramTec admits that its Biolox Delta product practices the
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`’816 Patent, which includes the presence of chromium in each claim. 45 TTABVUE, Ex. 11 at 4
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`(RFA 28); 42 TTABVUE, Ex. 12 at 1020:11-18.
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`13.
`
`The ’816 Patent solves the problem of decreased material properties in prior
`
`alumina ceramics by combining zirconium dioxide (tough but not hard) with chromium
`
`(increases hardness). 43 TTABVUE, Ex. 1 at 3:39-42, 3:58-66, 4:40-45; 42 TTABVUE, Ex. 12
`
`at 1098:12-1100:10, 1158:14-17. The’816 Patent specification explains that the chromium was
`
`added to the composite to increase hardness, making, it possible for the first time to achieve a
`
`certain level of hardness values in zirconium dioxide, even at the high zirconium dioxide levels
`
`necessary to achieve toughness.
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`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 . . . . It has now been found that the solution of
`the problem in question requires a sintered molding with an entirely special
`composition . . . . [T]he 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
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`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.
`
`43 TTABVUE, Ex. 1 at 3:39-42; 3:51-66 (emphasis added)
`
`14.
`
`The two independent claims of the ’816 Patent each include “a specific molar
`
`ratio” of zirconium dioxide to chromium. 43 TTABVUE, Ex. 1 at claims 1 and 3; 48
`
`TTABVUE, Ex. 1 at ¶¶ 86-89. This was vital to overcome an office action and convince the
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`USPTO to issue the ’816 Patent over the prior art. 43 TTABVUE, Ex. 7 at 213-20 of 270
`
`(C5_0002084-91); 58 TTABVUE ¶¶ 9-10. As the applicant’s response to the office action made
`
`clear, inclusion of chromium served a specific functional purpose essential to the invention:
`
`The invention of the present application is not suggested by Ekstrom. The
`solution of the object according to the present 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 . . . is required. Only in this way has it for the first time been possible to
`obtain hardness values, even at higher zirconium dioxide contents . . . .
`
`43 TTABVUE, Ex. 7 at 216 of 270 (emphasis added)
`
`15.
`
`In addition to the ’816 Patent, CeramTec has sought and obtained numerous
`
`utility patents that claim and disclose the inclusion of chromium in ZTA ceramics as a functional
`
`component of the composition. See 141 TTABVUE, Ex. 1 at Section VI. See also 43
`
`TTABVUE, Ex. 1 at 12 (claims 1 and 3); Ex. 6 (U.S. Patent 9,237,955), claims 1-4 and at 4:37-
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`56, 5:12-51, 7:14-27; Ex. 9 (U.S. Patent 8,932,970) at claims 1, 20; Ex. 10 (U.S. Patent Publ. No.
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`2012/0142237) at claim 8; 49 TTABVUE, Exs. 1-9.
`
` CeramTec and Third-Party Literature Establish that Chromium Imparts
`Numerous Functional Benefits to ZTA Ceramics for Hip Implant Components
`
`16.
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`The composition of a ceramic dictates the color as well as the attributes of the
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`material and adding a component to make a ceramic (such as to make it a different color)
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`necessarily affects the material composition, which can have performance, regulatory, and public
`
`health implications. See, e.g., 43 TTABVUE, Ex. 4 at 26 of 64; 46 TTABVUE, Ex. 2 at 2; Ex. 4
`
`at 2; Ex. 5 at 3; 42 TTABVUE, Ex. 3 at 219:3-11; Ex. 12 at 1040:11-1041:24, 1127:3-4; Ex. 5 at
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`392:12-393:3.
`
`17.
`
`The importance of chromium as a hardening agent in ZTA ceramic material has
`
`been widely documented by third-party scientific publications. 48 TTABVUE, Ex. 1 at ¶¶ 94-
`
`157; 43 TTABVUE, Ex. 8; 45 TTABVUE, Ex. 3; 44 TTABVUE, Ex. 2; 46 TTABVUE, Exs. 1-
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`5; Exs. 8-10; Ex. 12; 42 TTABVUE, Ex. 3 at 219:3-11, 234:23-235:3; 43 TTABVUE, Ex. 1 at
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`3:51-66; 51 TTABVUE; 52 TTABVUE; 58 TTABVUE ¶ 18.
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`18.
`
`Such improvements have also been extensively catalogued in academic papers by
`
`CeramTec scientists, including Dr. Meinhard Kuntz and Dr. Alessandro Porpo