GIBSON DUNN
`
`.
`
`Gibson, Dunn & Crutcher LLP
`
`1050 Connecticut Avenue, N.W.
`Washington, DC 20036-5306
`Tel 202.955.8500
`www.gibsondunn.com
`
`Brian M. Buroker
`Direct: +1 202.955.8541
`Fax: +1 202.530.4200
`BBuroker@gibsondunn.com
`
`September 30, 2016
`
`VIA UPS
`
`Director of the United States Patent and Trademark Office
`c/o Office of the General Counsel
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Re:
`
`Notice of Appeal in IPR2015-00630
`
`To the Director and the Office of General Counsel:
`
`Attachedplease find the notice ofappeal
`
`in IPR2015-00630.
`
`tto the U.S. Court ofAppeals for the Federal Circuit
`
`Sincerely,
`
`/Brian M. Buroker/
`Brian M. Buroker
`Reg. No. 39,125
`Attorneyfor Exclusive Licensee Blue Belt Technologies, Inc.
`BMB/bmb
`
`ed
`con
`Sin
`3
`ote See
`Oo
`ry
`m S
`= Z oe
`ze
`Bork
`as
`W on oo
`~ wa!
`Sor
`
`LN LEilny 2 }
`
`JUAIOHayy
`
`Beijing » Brussels « Century City > Datlas - Denver + Dubai + Frankfurt - Hong Kong » London Los Angeles+Munich
`New York+Orange County - Palo Alto - Paris - San Francisco + S30 Paulo + Singapore + Washington,D.C.
`
`
`
`.
`
`Gibson, Dunn & Crutcher LLP
`
`1050 Connecticut Avenue, N.W.
`Washington, DC 20036-5306
`Tel 202.955.8500
`www.gibsondunn.com
`
`Brian M. Buroker
`Direct: +1 202.955.8541
`Fax: +1 202.530.4200
`BBuroker@gibsondunn.com
`
`September 30, 2016
`
`VIA UPS
`
`Director of the United States Patent and Trademark Office
`c/o Office of the General Counsel
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Re:
`
`Notice of Appeal in IPR2015-00630
`
`To the Director and the Office of General Counsel:
`
`Attachedplease find the notice ofappeal
`
`in IPR2015-00630.
`
`tto the U.S. Court ofAppeals for the Federal Circuit
`
`Sincerely,
`
`/Brian M. Buroker/
`Brian M. Buroker
`Reg. No. 39,125
`Attorneyfor Exclusive Licensee Blue Belt Technologies, Inc.
`BMB/bmb
`
`ed
`con
`Sin
`3
`ote See
`Oo
`ry
`m S
`= Z oe
`ze
`Bork
`as
`W on oo
`~ wa!
`Sor
`
`LN LEilny 2 }
`
`JUAIOHayy
`
`Beijing » Brussels « Century City > Datlas - Denver + Dubai + Frankfurt - Hong Kong » London Los Angeles+Munich
`New York+Orange County - Palo Alto - Paris - San Francisco + S30 Paulo + Singapore + Washington,D.C.
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MAKO SURGICAL CORP.,
`Petitioner
`
`V.
`
`BLUE BELT TECHNOLOGIES,INC. and
`CARNEGIE MELLON UNIVERSITY,
`Exclusive Licensee and Patent Owner.
`
`IPR2015-00630
`U.S. Patent No. 6,205,411 Bl
`
`NOTICE OF APPEAL
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`,
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`ms
`;
`2
`= me
`39
`ao Ix
`rd
`Qa M tm
`Gow 8 BS
`Bee Cy
`2O a oo
`SOR B St
`= SE CT
`—t
`Dp os
`ates
`
`ma So
`
`
`
`Pursuant to 35 U.S.C. §§ 141 and 142 and 37 C.F.R. § 90.2(a), Patent Owner
`
`Camegie Mellon University and Exclusive Licensee Blue Belt Technologies, Inc.
`
`hereby provide notice that they appeal to the United States Court of Appeals for
`the Federal Circuit from the Final Written Decision of the Patent Trial and Appeal
`
`Board (“Board”) entered August 1, 2016 (Paper 42), and from all underlying
`
`findings, orders, decisions, rulings, and opinions,including, without limitation, the
`
`institution decision entered August 4, 2015 (Paper 6)(the “Institution Decision”)
`
`and the Order on the Conduct of the Proceeding entered December 17, 2015 (Paper
`
`13).
`
`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), Patent Owner and Exclusive
`
`the Board’s
`Licenseestate that the issues for appealinclude, butare not limited to:
`determination that claims 1-17 of U.S. Patent No. 6,205,411 B1 have been shown
`
`by a preponderance of the evidence to be unpatentable; the Board’s construction
`
`andinterpretation of those claims; the Board’s denial of the contingent Motion to
`
`Amend; the Board’sallocation of the burdens of persuasion and/or production with
`
`respect to the contingent Motion to Amend;the Board’s interpretation of 35 U.S.C.
`
`§ 312(a)(2); the Board’s consideration of the expert testimony, priorart, and other
`
`evidence in the record; the Board’s determinationsin the Institution Decision; and
`the Board’s factual
`findings, conclusions of law, or | other determinations
`
`supportingor relating to the above issues.
`
`
`
`Pursuant to 35 U.S.C. § 142 and 37 CFR. § 90.2(a), this Notice is being
`
`filed with the Director of the United States Patent and Trademark Office.
`
`Simultaneous with this submission, a copy of this Notice is being filed with the
`
`Patent Trial and Appeal Board.
`
`In addition, a copy of this Notice, along with the
`
`required docketing fees, is being filed with the Clerk’s Office for the United States
`Court ofAppeals for the Federal Circuit.
`|
`
`DATED: September 30, 2016
`
`By: /Brian M. Buroker/
`
`Respectfully submitted,
`
`Brian M. Buroker (Reg. No. 39,125)
`GIBSON, DUNN & CRUTCHER LLP
`1050 Connecticut Avenue, N.W.
`Washington, DC 20036-5306
`Telephone: 202.955.8500
`Facsimile: 202.467.0539
`bburoker@gibsondunn.com
`
`Attorneyfor Exclusive Licensee Blue Belt
`Technologies, Inc.
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that,
`
`in addition to being filed electronically
`
`through the Patent Trial and Appeal Board’s End to End system (PTAB E2E),the
`
`foregoing Notice of Appeal was filed by Express Mail on September 30, 2016,
`
`with the Director of the United States Patent and Trademark Office, at the
`
`following address:
`
`Director of the United States Patent and Trademark Office
`c/o Office of the General Counsel
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`The undersigned certifies that a copy of the foregoing Notice of Appeal, .
`
`along with the required docket fee, was filed on September 30, 2016, with the
`
`Clerk’s Office of the United States Court of Appeals for the Federal Circuit
`
`through the Court’s CM/ECF filing system.
`
`The undersignedcertifies service pursuant to 37 C.F.R. § 42.6(e) of a copy
`
`of this Notice of Appeal by electronic mail on September 30, 2016, on the counsel
`
`of record for Petitioner Mako Surgical Corp:
`
`MathewI. Kreeger, mkreeger@mofo.com
`Walter Wu, wwu@mofo.com
`
`DATED: September 30, 2016
`
`/Brian M. Buroker/
`By:
`Brian M. Buroker (Reg. No. 39,125)
`Attorneyfor Exclusive Licensee Blue Belt
`Technologies, Inc.
`
`
`
`Trials@uspto.gov
`571-272-7822
`
`Paper 42
`Date Entered: August 1, 2016
`
`- UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MAKO SURGICAL CORP.,
`Petitioner,
`
`V.
`
`BLUE BELT TECHNOLOGIES,INC. and
`CARNEGIE MELLON UNIVERSITY
`Exclusive Licensee and Patent Owner.
`
`Case IPR2015-00630
`Patent 6,205,411 Bl
`
`Before SALLY C. MEDLEY, KEVIN F. TURNER,and
`WILLIAM M.FINK,Administrative Patent Judges.
`
`TURNER,Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`- Inter Partes Review
`35 US.C. § 318(a) and 37 CFR. § 42.73
`
`
`
`IPR2015-00630
`Patent 6,205,411 Bl
`
`I.
`
`INTRODUCTION
`
`Wehavejurisdiction to decide this interpartes review under
`35 U.S.C. § 6(c). This Final Written Decisionis issued pursuantto
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons discussed herein,
`Petitioner has shown by a preponderanceof the evidence that claims 1-17 of
`U.S. Patent No. 6,205,411 B1 (Ex. 1001, “the °411 Patent”) are
`
`unpatentable. Additionally, Patent Owner has not shown by a
`preponderanceofthe evidence the patentability of its proposed substitute
`
`claims.
`
`A. Procedural History
`
`Petitioner, Mako Surgical Corporation, filed a Petition requesting an
`inter partes review of claims 1-17 of the ’411 Patent. Paper 2 (“Pet.”). No
`Preliminary Response wasfiled. Upon consideration ofthe Petition, on
`August 4, 2015, weinstituted an interpartes review of claims 1-17,
`pursuant to 35 U.S.C. § 314. Paper 6 (“Dec.”).
`Blue Belt Technologies, Inc., the named Patent Owner, sought
`
`authorization to file a motion to terminate becausethe Petition failed to
`
`namethe true patent ownerasa real party in interest, wherethe true patent
`owner wasargued to be Carnegie Mellon University. We provided no
`
`authorization to file the motion to terminate because we found no
`
`requirement for Petitioner to name a patent owner’s real parties-in-interest.
`Paper 13, 2. Wefurther determinedthat thatthe filing of mandatory notice
`(Paper 5), indicating that Blue Belt Technologies, Inc. is the exclusive
`licensee of the °411 Patent and that Carnegie Mellon University is the owner
`
`of that patent, was sufficient to clarify the record in this proceeding. Paper
`13, 2-3. We determined that Carnegie Mellon University was namedas the
`
`2
`
`
`
`IPR2015-00630
`Patent 6,205,411 Bl
`
`patent ownerin this proceeding andis a party to the proceeding such thatit
`would be bound by any judgment adverse to Blue Belt Technologies,Inc.
`Id. at 4. Therefore, herein, wecollectively refer to the Patent Ownerand the
`
`Exclusive Licensee as “Patent Owner.”
`
`Afterinstitution, Blue Belt Technologies, Inc., filed a Patent Owner
`Response (“PO Resp.”), indicating that it was being filed on behalf of the
`party named as Patent Owner. Paper 11. Petitioner filed a Reply to the
`Patent Owner Response. Paper 23 (“Reply”). Patent Owneralsofiled a
`contingent Motion to Amend (Paper 12, “Mot.”), to which Petitioner filed an
`Opposition to Patent Owner’s Motion to Amend (Paper 25, “Opp. Mot.”),
`and Patent Ownerfiled a Reply to Petitioner’s Opposition (Paper30, “Reply
`Mot.”). An oral hearing was held on April 7, 2016, with the transcriptof the
`hearing includedin the record. Paper 41 (“Tr.”).
`Patent Ownerfiled a Motion to Exclude (Paper 33; “PO Mot. to
`Exclude”) certain portions of Exhibit 2006. Petitioner filed an Opposition to
`the Motion to Exclude (Paper 34; “Pet. Exclude Opp.”), and Patent Owner
`filed a Reply (Paper 38; “PO Exclude Reply”).
`B. Related Proceedings
`The °411 Patentis involved in the following lawsuit: Mako Surgical
`Corp. v. Blue Belt Technologies, Inc., No. 0:14-cv-61263-MGC (S.D.Fla.).
`
`Pet. 1; Paper 5, 2.
`
`C. The ’411 Patent
`
`The ’411 Patent relates to an apparatus for facilitating the
`implantation of an artificial componentof a body joint. Ex. 1001, Abstract.
`The Specification of the *411 Patent describes a system that providesa
`medicalpractitioner with a toolto precisely determine an optimal size and
`
`3
`
`
`
`IPR2015-00630
`Patent 6,205,411 Bl
`
`position ofthe artificial components in a joint to provide the desired range of
`motionofthe joint following surgery. Jd. at 4:66-5:2. The apparatus
`includes geometric pre-operative planner 12, which is used to create
`geometric models ofthe joint and the components to be implanted based on
`geometric data received from skeletal structure data source 13. The
`geometric pre-operative planneris interfaced with pre-operative kinematic
`biomechanical simulator 14 that simulates movementofthe joint using the
`geometric models for use in determining implant positions, including
`angular orientations, for the components. Jd. at 5:63—6:5.
`
`D.Illustrative Claim
`
`Claims 1, 10, and 17 are independent claims. Claims 2-9 directly or
`indirectly depend from claim 1, and claims 11-16 directly depend from
`independent claim 10. Claim 1 is reproduced below.
`1. An apparatusforfacilitating the implantation ofanartificial
`componentin oneofa hip joint, a knee joint, a hand and wrist
`joint, an elbowjoint, a shoulderjoint, and a foot and ankle joint,
`
`comprising:
`
`a pre-operative geometric planner; and
`a pre-operative kinematic biomechanical simulatorin
`communication with said pre-operative geometric planner wherein
`said pre-operative geometric planner outputs at least one geometric
`modelofthe joint and the pre-operative kinematic biomechanical
`simulator outputs a position for implantation ofthe artificial
`
`component.
`
`Ex. 1001, 13:16—27.
`
`
`
`IPR2015-00630
`Patent 6,205,411 Bl
`
`Y
`
`
`
`E. Grounds of Unpatentability
`' Weinstituted an interpartes review of claims 1-17on the following
`grounds (Dec. 11):
`
`
`
`‘Claim(s) . -| Basis: “=|Reference(s). -| |.
`
`
`1-15 and 17
`[g103(a)|DiGioia Cd
`§ 103(a
`DiGioia I and DiGoioia II’
`
`
`
`
`
`
`
`Il.
`
`ANALYSIS
`
`A. Principles ofLaw
`A patentclaim is unpatentable under 35 U.S.C. § 103(a) if the
`differences between the claimed subject matter andthe priorart are suchthat
`the subject matter, as a whole, would have been obviousat the time the
`invention was madeto a person havingordinary skill in the art to which said
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousnessis resolved onthe basis ofunderlying
`factual determinations including: (1) the scope and content of the priorart; .
`(2) any differences between the claimed subject matter andthe priorart;
`(3) the level of ordinary skill in the art; and (4) objective evidence of
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966).
`In that regard, an obviousness analysis “need not seek out precise
`teachingsdirected to the specific subject matter of the challenged claim, for
`
`1 A.M. DiGioia et al., “HipNav: Pre-operative Planning and Intra-operative
`Navigational Guidance for Acetabular Implant Placement in Total Hip
`., Replacement Surgery,” 2nd CAOS Symposium (1996) (Ex. 1005)
`(“DiGioia I”).
`.
`2 AM. DiGioia et al., “An Integrated Approach to Medical Robotics and
`Computer Assisted Surgery in Orthopaedics,” PRoc. 1ST INT’L SYMPOSIUM
`ON MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY 106-111 (1995)
`(Ex. 1006) (“DiGioia IT”).
`
`5
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1 |
`
`a court can take accountofthe inferences and creative steps that a person of
`ordinary skill in the art would employ.” KSR, 550 U.S. at 418; see In re
`Translogic, Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007). A primafacie case
`of obviousnessis established whenthepriorart itselfwould appear to have
`suggested the claimed subject matter to a person of ordinary skill in theart.
`
`In re Rinehart, 531 F.2d 1048, 1051 (CCPA 1976).
`
`Thelevel of ordinary skill in the art is reflected by thepriorart of
`
`record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001);
`
`In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich,
`
`579 F.2d 86, 91 (CCPA 1978).
`
`B. Claim Interpretation
`In an interpartes review, we construe claim terms in an unexpired
`patent accordingto their broadest reasonable construction in light ofthe
`specification ofthe patent in which they appear. 37 C.F.R. § 42.100(b); see
`also In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1277-78 (Fed. Cir.
`
`2015) (“We conclude that Congress implicitly approved the broadest
`reasonableinterpretation standard in enacting the AIA.”), aff'd sub nom.
`Cuozzo Speed Techs. LLC v. Lee, 136 8. Ct. 2131, 214446 (2016).
`
`Consistent with the broadest reasonable interpretation, claim termsare
`
`presumedto havetheir ordinary and customary meaning as understood by a
`person ofordinary skill in the art in the context ofthe entire patent
`disclosure. Translogic, 504 F.3d at 1257. Also, we must be careful not to
`read a particular embodimentappearingin the written descriptioninto the
`claim if the claim languageis broader than the embodiment. See Jn re Van
`
`Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (“[L]imitations are not to be
`
`read into the claims from the specification.”). However, an inventor may
`
`6
`
`
`
`IPR2015-00630
`Patent 6,205,411 Bl
`
`provide a meaning for a term thatis different from its ordinary meaning by
`defining the term in the specification with reasonable clarity, deliberateness,
`and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`Petitioner proposed no specific constructions for any claim terms.
`
`Therefore, for the purposesofthe institution decision, we determinedthat no
`
`claim term needs expressinterpretation. See Vivid Techs., Inc. v. Am. Sci. &
`Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only those terms which are
`in controversy need to be construed, and only to the extent necessary to
`
`resolve the controversy).
`
`Neither Patent OwnernorPetitioner asserts any specific claim
`
`constructions in their responsive papers. See PO Resp.; Reply. As such, no
`
`terms in this proceeding will receive express interpretation.
`
`C. Obviousness of Claims. 1—15 and 17 over DiGioia I
`
`Petitioner contends that claims 1-15 and 17 are obvious over
`DiGioiaI. Pet. 10-28. To support its contentions, Petitioner provides
`detailed explanations as to how DiGioia I meets or renders obvious each
`claim limitation. Jd. Petitioner also relies upon a Declaration of Robert D.
`Howe, whohasbeen retained as an expert witness by Petitioner for the
`instant proceeding. Ex. 1004.
`|
`i. DiGioial, Petitioner *s Contentions
`DiGioia I describes a system and methodsto determine optimal
`implant placement during hip replacement surgery throughthe useofpre-
`operative planning, a range of motion simulator, and intra-operative
`navigational tracking and guidance. Ex. 1005, Abstract. The pre-operative
`plannerallows the surgeon to manually specify the position of the acetabular
`componentwithin the pelvis based upon pre-operative CT images. Id. at 2.
`
`7
`
`
`
`1PR2015-00630
`Patent 6,205,411 BI
`Fig. 3 ofDiGioia I, reproduced below,illustrates connections between the
`pre-operative planner and a range of motion simulator.
`
`‘
`
`Pre-operative
`Planner
`
`Simulator
`
`Range ofMotion
`
`Intra-operative
`Tracking &
`Guidance
`
`Figure 3 HipNav system overview
`. Fig: 3 of DiGioia I provides a system overview.
`The pre-operativeCT scan is used to determine the patient’s specific
`bone geometry and different orthogonal viewsare presented to the surgeon.
`Id. at3. The range of motion simulator performs a kinematic analysis which
`
`_
`
`determines an “envelope”for the safe range of motions of the implant. Jd.
`During the surgery, the system permits the surgeon to know thepositions of
`the pelvis and acetabulum at all times, and optical tracking through a camera
`tracks the positions of special light emitting diodes, which maybe attached
`to bones, tools, or other pieces of operating equipment. Jd. at 4—5.
`Petitioner acknowledgesthat specific elements of independent claims
`
`1, 10, and 17 are not explicitly disclosed in DiGioia I, but are minor, obvious
`variations. Pet. 14-15. Specifically, DiGioia J discloses that feedback from
`the simulator can aid the surgeon in determining optimalimplant placement, |
`and Petitioner alleges that it would have been obviousto utilize the feedback
`to modify the position of an implant, re-run the simulation to determine.
`
`8
`
`
`
`IPR2015-00630
`Patent 6,205,411 Bl
`optimal position, and output that position to the pre-operative planner. Jd. at
`15 (citing Ex. 1004 { 38).
`Additionally, claim 17 requires the system to determine an implant.
`position based on a predetermined range of motion and the calculated range
`of motion. Petitioner points out that DiGioia I discloses the calculation of a
`range of motion and states that the surgeon may choose to modify a selected
`position to achieve optimal implantpositioning. Pet. 15. Petitioner alleges
`that it would have been obviousto consider the specific patient’s functional
`
`needs and the range of motion needed to perform those functional needs,
`which could be predetermined, to help in determining optimal implant
`positioning. Jd. at 15 (citing Ex. 1004 4 38).
`Petitioneralso assertsthat dependent claims 2—9 and 11—15 are also
`obvious over DiGioia I. Pet. 15-20. Claims 2 and 15 recite that the system
`
`- also includesan intra-operative navigational module in communication with
`the pre-operative kinematic biomechanicalsimulator. Petitioner urges that
`DiGioiaI’s disclosure of an “inter-operative guidance system,” which uses
`“pre-operative information,” to provide “navigational feedbackto the
`surgeon” as meetingtheselimitations. Pet. 15-16, Ex. 1005, 5-6.
`Additionally, claims 6 and 7 recite that the geometric planner outputs
`a geometric modelofthe component and/or an implantposition based on
`that model. Petitioner urges that DiGioia J discloses that “[t]he range of
`
`motion simulator estimates femoral range of motion based upon the implant
`placement parameters provided by the pre-operative planner”andthatit
`would have been obviousto a personofskill in the art to utilize the
`
`simulator feedback to modify the position of an implant, rerun the
`
`
`
`IPR2015-00630
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`
`simulation to determine optimal position, and output that position to the pre-
`operative planner. Pet. 16-17 (quoting Ex. 1005, 2); Ex. 1004 ¢ 38.
`With respect to claims 11 and 12, those claimsrecite that the system
`also includesat least one display monitororat least one controller, in
`communication with the system. Petitioner urges that DiGioia I discloses
`that “the surgeon can position cross sections of the acetabular implant upon
`orthogonal viewsofthe pelvis,” and it “allows the surgeon to manually
`specify the position of the acetabular componentwithinthepelvis.” Pet. 19
`(quoting Ex. 1005, 2-3).
`.
`ii. Patent Owner’s Contentions
`
`a) Prior Art Status ofDiGioia I
`Patent Ownerargues that DiGioiaI is notprior art to the °411 claims
`under 35 U.S.C. § 102(a). PO Resp. 18-27. First, Patent Owner contends
`that DiGioia I is not a publication “by others,” despite differences in named
`authorship and inventorship. Jd. at 19-27(citing Jn re Katz, 687 F.2d 450,
`455 (Fed. Cir. 1982)). Relying on testimony of Dr. Branislav Jaramaz (Ex.
`2002), listed both as an inventor on the °411 Patent and as an author on
`DiGioia I, Patent Ownerarguesthat the authorship of DiGioiaI listed
`“everyone whohad beenrecently involved in the day-to-day operations
`developing the HipNav system,” but the contributionsof the authors not
`listed as inventors are notreflected in claims 1-17 of the ’411] Patent. Jd.at
`
`19-20(citing Ex. 2002 {§ 11, 13-17). Additionally, Patent Owner argues
`that there is an inventor notlisted as an author because “by the time DiGioia
`
`I waspublished, Dr. Kanade had assumedan advisory role,” but that his
`original contributions supported the claimsof the instant patent. Jd. at 20-
`21 (citing Ex. 2002 4 15; Ex. 2006, 52:10-53:19, 86:7-10).
`
`10
`
`
`
`IPR2015-00630
`Patent 6,205,411 BI
`__ Inresponse, Petitioner contends that Dr. Jaramaz’s declaration lacks
`foundation andis not reliable. Reply 11-17. Petitioner points outthat Dr.
`Jaramaz does notknowwho decided to omit Dr. Kanade as an author of
`DiGioia I and “in describing Mr. Kischell’s rolein thearticle, Dr. Jaramaz
`was simply providing his opinion about what might have happened, rather
`than whatdid in facthappen.” Jd. at 11-13 (citing Ex. 1011, 25:14-26:5,
`26:6-29:18, 27:14-18, 47:9-19). Petitioner also provides a declaration of
`Mr. Kischell (Ex. 101 3) and arguesthat the testimony evidences that Mr.
`Kischell’s contributions were importantto the project’s success and were not
`insubstantial. Jd. at 13-14. As such, Petitioner contends that the inventive
`
`|
`
`|
`
`entities are different, such that DiGioia I is prior art to the ’411 claims under
`35 U.S.C. § 102(a).
`|
`We mustreview the totalityof circumstances in determining ifa
`sufficient showing has been made that DiGioiaI is not the work ofthe ©
`inventorsof the *4ll Patent. See Katz, 687 F.2d ‘at 455-56. Although we
`acknowledgethe points raised by Dr. Jaramaz, we are persuadedthat his
`testimony provides more opinion than facts. The testimony ofMr. Kischell
`makes clear that he provided substantial and importantportionsto the
`overall disclosure of DiGioia I. However, it is not our role to determine
`
`_
`
`whether Mr. Kischell should have been namedas an inventorof the
`invention claimed in the °411 Patent; we assumethat the inventorship listed
`on the °411 Patentis correct. As such, we are not persuaded that the
`inventiveentity ofthe 7411 Patentis the same asthe authorship ofDiGioia I,
`,or that DiGioia I represents only the work ofthe inventors ofthe °411
`Patent. Accordingly, we determinethat DiGioiaI qualifies as prior art under
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`35 U.S.C: § 102(a). In any event, we also consider whether DiGioiaI is
`. priorart under 35 U.S.C. § 102(b) as Petitioner asserts.
`Patent Owner argues that the claims ofthe ’411 Patent are entitled to
`the benefit ofthe filing date ofU.S. Patent No. 5,880,976 (“the ’976
`Patent”), thus negating theapplication of DiGioia I under35 U.S.C.§.
`102(b). PO Resp. 21-22. Patent Owner continues that the filing date of the
`°976 Patent was February 21, 1997, and the first publicdisclosure of
`DiGioia I was February 22, 1996, where the application that matured into
`the ’411 Patent was a continuation-in-part ofthe application that matured
`into the °976 Patent. Jd. Patent Owneralso arguesthat to support the instant
`claims, there is no need ofa verbatim list ofjoints, such as those found in
`the preambles ofthe independentclaims, and that thejoint disclosed in the
`°976 Patentis “representative ofa class of surgeries.” Jd. at 22-25 (citing
`Ex. 2003 §§ 32-38). Petitioner contends that there is no support for other
`joints in *976 disclosure andthat a general disclosure of a genus cannot
`provide written description support for the species. Reply 4-8. Weagree
`with Petitioner that Patent Owneris not entitled to the benefit of the 976
`Patentbecause the °976 Patent does not provide written description support
`for the claimed subject matter in the ’411 Patent.
`“To satisfy the written description requirement, the applicant must
`_ convey with reasonable clarity to those skilled in the art that, as of the filing
`date sought, he or she was in possession ofthe invention, and demonstrate
`that by disclosure in the specification of the patent.” Centocor Ortho
`Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011) (internal
`quotations and citations omitted). Additionally, the disclosure ofa broad
`genus does notnecessarily provide written description support for a
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`particular subgenus or species claimed. Novozymes A/S v. DuPont Nutrition
`Biosciences APS, 723 F.3d 1336, 1344 (Fed. Cir. 2013), cert. denied, 134 S.
`
`Ct. 1501 (2014).
`In the instant case, we agree with Petitioner that the disclosure ofthe
`’976 Patent doesnot explicitly recite the myriad ofjoints recited in the
`claims of the ’411 Patent, which are only foundin the disclosure of the °411
`
`Patent; Patent Owner does not argue otherwise. PO Resp. 22-23; Reply 5.
`Even if the total hip replacement surgery, disclosed in the ’976 Patent,is
`representative ofa class of surgeries, that would not necessarily provide
`written description support for specific surgeries in that class. Even
`assuming “oneofordinary skill in the art would have beenable to apply the
`techniques described in the 976 Patent to surgeries involving a kneejoint, a
`hand and wrist joint, an elbow joint, a shoulder joint, or a foot and ankle
`joint without undue experimentation” (PO Resp. 25 (citing Ex. 2004 4 37)),
`such an observation goes to the obviousness of those other surgeries andnot
`
`their disclosures.
`
`In any event, even considering the arguments on the merits andthat
`Petitioner has the burden of persuasion, Patent Ownerhas not provided
`sufficient evidence that the hip replacement surgery is representative as to
`the claimedjoints that are claimed in the °411 patent. Dr. Cleary’s
`testimony is conclusory because he does not explain sufficiently whyall of
`the joints being claimedin the ’411 patent would have been predictable from
`the example ofhip surgery disclosed in the 976 Patent. Even Dr. Cleary
`recognizesthat each joint has a different geometry. Ex. 2003 427. Based
`on the record presented, we do not give substantial weight to Dr. Cleary’s
`testimonythat one of ordinary skill in the art would have recognized that
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`.
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`Patent Owner had possession of the genus claimed in the 411 patent from
`the species ofthe hip joint described in the ’976 Patent.
`‘Patent Owneralso alleges that the Examiner disagreed with the
`proposition that there was no support for new claimsin the continuation. PO
`Resp. 26-27. Patent Ownerpoints to the Examiner’s language in the April
`5, 2000, Office Action stating that “[a]n apparatusfor facilitating the
`implantation ofan artificial componentin oneofa hip joint, a knee joint[,] a
`hand and wrist joint, an elbow joint, a shoulderjoint, and a foot and ankle
`joint, comprising,”as recited in claim 1 of the 411 Patent, was “fully
`disclosed in patent no[.] 5,880,976.” PO Resp. 26 (quoting Ex. 1002, 265).
`However,as Petitioner points out, the presence of the obviousness-type
`double patenting rejection does not demonstrate support for the recited
`joints. Nothing in this rejection showsthat the specific joints claimed were
`adequately disclosed in the earlier specification for written description
`purposes. Assuch, we remain persuaded that DiGioia I is prior art to the
`411 Patent claims under 35 U.S.C. § 102(a) or (b).
`
`b) Obviousness ofclaims 1-15 and 17 over DiGioia I
`Patent Owneralso arguesthat Petitioner has not demonstrated that
`DiGioiaI, or DiGioia I in view of DiGioiaII, renders claims 1-17 obvious.
`PO Resp. 28. Patent Owner argues that DiGioia I does not disclose
`outputting a position for implantation, as providedin claims 1 and 10,
`becausenorationale underpinningis provided by Petitioner. Jd. at 28-31.
`Patent Ownercontinuesthat the first part of Petitioner’s rationale to modify
`DiGioia I is conclusory, and Petitioner does not provide any reason why
`such a modification, i.e., to utilize feedback to re-run the simulation and
`output that position, would have been obvious. Jd. at 29-30. Additionally,
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`Patent Ownerarguesthat the secondpart of Petitioner’s rationale to modify
`DiGioia I, based onthe arrowsillustrated in Fig. 3 of DiGioiaI, is faulty
`because the arrowssignify participation by the surgeon, and not bidirectional
`communication independent of the surgeon. Jd. at 29-33.
`In responding to Patent Owner,Petitioner points to portionsof the
`Petition where DiGioia I discloses that “feedback from the simulator can aid
`_the surgeonin determining optimal implant placement.” Reply 17 (citing
`| Pet. 14-15; Ex. 1005, 2). We agree with Petitioner that portions of DiGioia
`I ‘suggest this feedback process, as well as the system allowing for the
`system to “accurately place the implant in the predetermined optimal
`position.” Ex. 1005, 2. Although DiGioiaI doesnot explicitly detail re-
`running the simulation, we are persuaded that such a repetition would have
`been understood as an obviouspart of optimizing the placement.
`Petitioner also notes that a modification can be madein a
`semiautonomoussystem that allows for surgeon input,i.e., that the output of
`a position for implantation does not negate surgeon involvementin
`placement. Reply 19-20. Weagree that Petitioner’s modification of
`DiGioia I does not require the formation of an autonomoussystem, without
`surgeon control. The independent claims merely require the outputting ofa
`position for implantation, not a singular position that disallows surgical
`
`input.
`
`With respect to the interpretation of DiGioia I’s Fig. 3, Petitioner
`notes that Patent Owner’s own declarants acknowledged that the units
`disclosed in DiGioia I pass information backand forth. Jd. at 18-19 (citing |
`Ex. 1010, 31:6-32:7; Ex. 1011 at 37:10-24, 41:1-4.). As well, Petitioner
`points to testimony of Dr. Jaramaz that, withouthis personal knowledge of
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`the system of DiGioiaI, a person readingthe article would not believe that
`the communication between the pre-operative planner and the range of
`motion simulator was narrowly limited. Reply 19 (citing Ex. 1011, 43:24—
`44:17). We agree and we are persuadedthat one ofordinary skill in the art
`would haveinterpreted Fig. 3 as Petitioner suggests. See Pet. 15.
`Additionally, although Patent Owner arguesthat Fig. 3 need not connote
`bidirectional communication independentofthe surgeon, such specificity is
`not necessary. Claim 10, for example, merely details that the simulatoris
`“in communication with”the planner, and any independence from the
`surgeon, as discussed above,is a matter of supposition by Patent Owner.
`Patent Owneralso arguesthat Petitioner’s declarant contradicts
`himself such that he professes that computers are superiorto humansin
`processing quantitative data, but has also explained that a strength of
`humansis that they exercise good judgment and a weakness of computersis
`that they have poor judgment. PO Resp. 33-34(citing Ex. 2006, 66:9-13;
`Ex. 2001, 212-213). We do not agree. Rather, we agree with Petitioner that
`the article (Ex. 2001) authoredby Petitioner’s declarant, Dr. Howe, also
`addresses semiautonomouscapabilities and is not necessarily contradictory
`of Dr. Howe’s declaration. Reply 21 (citing Ex. 2006 at 66:14—72:4).
`Patent Owneralso argues that Petitioner has failed to provide
`evidence that one ofordinary skill in the art would have had a reasonable
`expectation that the system of DiGioia I could be modifiedto utilize
`feedback to determine and output an optimal position. PO Resp. 34-35. To
`that point, Patent Ownernotes that DiGioiaI provides no algorithm or
`mathematical formula that would allow oneofordinary skill in the art to
`relate the 3-D implantlocation to the estimated femoral range of motion. Id.
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`However, weare not persuaded that Petitioner need provide an algorithm or
`mathematical formula to.show obviousness. As discussed above, we are
`persuadedthat Petitioner has sufficiently demonstrated how the system of
`DiGioia I could be modified to supply the claimed position for implantation.
`Patent Owneralso argues that DiGioia I’s pre-operative planner
`doesn’t necessarily output the geometric model and that there are other ways
`ofreceiving that model. Id.at 35-37 (citing Ex. 2003 ff 50-51). Petitioner
`asserts that Patent Owner’s characterization amounts to an obviousvariation,
`and does not distinguish the claims from the disclosure of DiGioia I. Reply
`23. Weagree with Petitioner that Patent Owner has acknowledgedthat the
`geometric model wasan input to both the preoperativeplanner and the range
`of motion simulator (PO Resp.36 (citing Ex. 2002 4 10)), such that
`receiving the at least one geometric model ofthejoint from the pr
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