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,
`
`Vv.
`
`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 U.S.C. § 318(a) and 37 C.F-R. § 42.73
`
`
`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,
`
`Vv.
`
`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 U.S.C. § 318(a) and 37 C.F-R. § 42.73
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`I.
`
`INTRODUCTION
`
`Wehavejurisdiction to decide this inter partes review under
`
`35 U.S.C. § 6(c). This Final Written Decision is issued pursuant to
`
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons discussed herein,
`
`Petitioner has shown by a preponderanceofthe 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 shownby a
`preponderanceof the evidencethe 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 of the Petition, on
`
`August 4, 2015, we instituted an inter partes 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 because the Petition failed to
`
`namethe true patent owneras a real party in interest, where the true patent
`owner was argued to be Carnegie Mellon University. We provided no
`
`authorization to file the motion to terminate because we found no
`
`requirementfor Petitioner to name a patent owner’s real parties-in-interest.
`Paper 13, 2. We further determined that that the filing of mandatory notice
`(Paper5), indicating that Blue Belt Technologies, Inc. is the exclusive
`licensee of the ’411 Patcnt and that Carnegie Mellon University is the owner
`
`of that patent, was sufficientto clarify the record in this proceeding. Paper
`13, 2-3. We determined that Carnegie Mellon University was namedasthe
`
`2
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`patent ownerin this proceedingandis a party to the proceeding suchthatit
`would be bound by any judgmentadverse to Blue Belt Technologies,Inc.
`
`Id. at 4. Therefore, herein, we collectively refer to the Patent Owner and the
`
`Exclusive Licensee as “Patent Owner.”
`
`After institution, Blue Belt Technologies, Inc., filed a Patent Owner
`
`Response (“PO Resp.”), indicating that it was being filed on behalf of the
`paily named as Patent Owner. Paper 11. Petitioner filed a Reply to the
`Patent Owner Response. Paper 23 (“Reply”). Patent Owneralso filed a
`contingent Motion to Amend(Paper12, “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 (Paper 30, “Reply
`
`Mot.”). An oral hearing was held on April 7, 2016, with the transcript of the
`
`hearing included in 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 Patent is involved in the following lawsuit: Mako Surgical
`Corp. v. Blue Belt Technologies, Inc., No. 0:14-cv-61263-MGC(S.D.Fla.).
`
`Pet. 1; Paper5, 2.
`
`C. The ’411 Patent
`
`The °411 Patent relates to an apparatusfor facilitating the
`implantation of an artificial component ofa body joint. Ex. 1001, Abstract.
`The Specification of the °411 Patent describes a system that provides a
`medical practitioner with a tool to precisely determine an optimal size and
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`position of the artificial componentsin a joint to provide the desired range of
`motion of the joint following surgery. Jd. at 4:66—-5:2. The apparatus
`
`includes geometric pre-operative planner 12, which is used to create
`geometric models of the 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 apparatus forfacilitating the implantation of an artificial
`
`componentin one ofa hip joint, a knee joint, a hand and wrist
`joint, an elbow joint, a shoulderjoint, and a foot and anklejoint,
`
`comprising:
`
`a pre-operative geometric planner; and
`
`a pre-operative kinematic biomechanical simulator in
`communication with said pre-operative geometric planner wherein
`said pre-operative geometric planner outputs at least one geometric
`model of the joint and the pre-operative kinematic biomechanical
`simulator outputs a position for implantation of the artificial
`
`component.
`
`Ex. 1001, 13:16—27.
`
`
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`E. Grounds of Unpatentability
`
`Weinstituted an inter partes review of claims 1-17 on the following
`
`grounds (Dec. 11):
`[Claim(s)[Basis[Reference(s)
`
`
`
`
`
`1-15 and 17
`
`
`
`
`
`DiGioia I and DiGoioia I’
`
`
`
`II.
`
`ANALYSIS
`
`A. Principles ofLaw
`
`A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
`
`differences between the claimed subject matter and the prior art are such that
`
`the subject matter, as a whole, would have been obviousat the time the
`invention was made to a person having ordinary 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 obviousness is resolved on the basis of underlying
`factual determinations including: (1) the scope and contentofthe priorart;
`
`(2) any differences between the claimed subject matter and the 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
`teachings directed to the specific subject matter of the challenged claim,for
`
`1 A.M. DiGioiaet al., “HipNav: Pre-operative Planning and Intra-operative
`Navigational Guidance for Acetabular Implant Placementin Total Hip
`Replacement Surgery,” 2nd CAOS Symposium (1996) (Ex. 1005)
`(“DiGioia IP’).
`4 A.M. DiGioiaet 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”).
`
`
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`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 itself would 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 the prior art of
`
`record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001);
`
`Inre GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich,
`
`579 F.2d 86, 91 (CCPA 1978).
`
`B. Claim Interpretation
`
`In aninter partes review, we construc claim terms in an unexpired
`patent according to their broadest reasonable construction in light of the
`specification of the 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
`reasonable interpretation standard in enacting the AIA.”), aff'd sub nom.
`Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 2131, 2144-46 (2016).
`Consistent with the broadest reasonable interpretation, claim terms are
`presumed to havetheir ordinary and customary meaning as understood by a
`person of ordinary skill in the art in the context of the entire patent
`disclosure. Translogic, 504 F.3d at 1257. Also, we must be careful notto
`read a particular embodiment appearingin the written description into the
`claim if the claim language is broader than the embodiment. See In re Van
`Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (“[L]imitationsare not to be
`
`read into the claims from the specification.”). However, an inventor may
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`provide a meaningfor 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 purposesoftheinstitution decision, we determined that 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
`
`termsin 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, whohasbeenretained as an expert witness by Petitioner for the
`
`instant proceeding. Ex. 1004.
`
`i. DiGioia I, Petitioner’s Contentions
`
`DiGioia I describes a system and methods to determine optimal
`implant placement during hip replacementsurgery through the useof pre-
`operative planning, a range of motion simulator, and intra-operative
`navigational tracking and guidance. Ex. 1005, Abstract. The pre-operative
`planner allows the surgeon to manually specify the position of the acetabular
`component within the pelvis based upon pre-operative CT images. Id. at 2.
`
`7
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`Fig. 3 of DiGioia I, reproduced below,illustrates connections between the
`
`pre-operative planner and a range of motion simulator.
`
`Pre-operative
`Planner
`
`Simulator
`
`Range of Motion
`
`Intra-operative
`Tracking &
`Guidance
`
`Figure 3 HipNav system overview
`
`Fig. 3 of DiGioia I provides a system overview.
`The pre-operative CT scan is used to determine the patient’s specific
`
`bone geometry and different orthogonal viewsare presented to the surgeon.
`Id. at 3. 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 knowthe positions of
`the pelvis and acetabulum atall times, and optical tracking through a camera
`tracks the positions of special light emitting diodes, which may be 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 I discloses that feedback from
`the simulator can aid the surgeon in determining optimal implant 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
`
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`optimal position, and output that position to the pre-operative planner. Jd. at
`
`15 (citing Ex. 1004 4 38).
`Additionally, claim 17 requires the system to determine an implant
`position based on a predetermined range of motion andthe calculated range
`of motion. Petitioner points out that DiGioia I discloses the calculation of a
`range of motion andstates that the surgeon may choose to modify a selected
`position to achieve optimal implant positioning. Pet. 15. Petitioner alleges
`that it would have been obviousto considerthe 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 { 38).
`Petitioner also asserts that dependent claims 2—9 and 11-15 are also
`
`obvious over DiGioiaI. Pet. 15-20. Claims 2 and 15 recite that the system
`
`also includes an intra-operative navigational module in communication with
`the pre-operative kinematic biomechanical simulator. Petitioner urges that
`DiGioia I’s disclosure of an “inter-operative guidance system,” which uses
`“pre-operative information,” to provide “navigational feedback to the
`surgeon” as meeting these limitations. Pet. 15-16, Ex. 1005, 5-6.
`Additionally, claims 6 and7recite that the geometric planner outputs
`a geometric model of the component and/oran implantposition based on
`that model. Petitioner urges that DiGioia I discloses that “{t]he range of
`motion simulator estimates femoral range of motion based upon the implant
`placement parameters providedby the pre-operative planner” andthatit
`would have been obviousto a personofskill in the art to utilize the
`
`simulator feedback to modify the position ofan implant, rerun the
`
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`simulation to determine optimal position, and outputthat position to the pre-
`operative planner. Pet. 16-17 (quoting Ex. 1005, 2); Ex. 1004 q 38.
`With respect to claims 11 and 12, those claimsrecite that the system
`also includes at least one display monitoror at 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,” andit “allows the surgeon to manually
`specify the position of the acetabular componentwithin the pelvis.” Pet. 19
`
`(quoting Ex. 1005, 2-3).
`
`it. Patent Owner’s Contentions
`
`a) Prior Art Status ofDiGioia I
`Patent Ownerargues that DiGioia I is not priorart 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 who hadbeenrecently involved in the day-to-day operations
`developing the HipNav system,”but the contributions of the authors not
`listed as inventors are not reflected in claims 1-17 ofthe 411 Patent. Jd, at
`19-20 (citing Ex. 2002 Jf 11, 13-17). Additionally, Patent Owner argues
`that there is an inventor notlisted as an author because “by the time DiGioia
`
`I was published, Dr. Kanade had assumedan advisory role,” but that his
`original contributions supported the claims of the instant patent. Jd. at 20-
`21 (citing Ex. 2002
`15; Ex. 2006, 52:10-53:19, 86:7-10).
`
`10
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`In response, Petitioner contends that Dr. Jaramaz’s declaration lacks
`
`foundation andis not reliable. Reply 11-17. Petitioner points out that Dr.
`
`Jaramaz does not know whodecided to omit Dr. Kanadeas an author of
`DiGioia I and “in describing Mr. Kischell’s role in the article, Dr. Jaramaz
`was simply providing his opinion about what might have happened, rather
`than whatdid in fact happen.” 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. 1013) and argues that the testimony evidences that Mr.
`
`Kischell’s contributions were important to the project’s success and were not
`
`insubstantial. Jd. at 13-14. As such, Petitioner contends that the inventive
`
`entities are different, such that DiGioiaI is prior art to the °411 claims under
`
`35 U.S.C. § 102(a).
`
`We mustreview the totality of circumstances in determining if a
`
`sufficient showing has been made that DiGioia I is not the work of the
`inventors of the °411 Patent. See Katz, 687 F.2d at 45 5-56. Although we
`acknowledgethe points raised by Dr. Jaramaz, we are persuadedthathis
`testimony provides more opinion than facts. The testimony of Mr. Kischell
`makesclear that he provided substantial and important portions to 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 Patent is correct. As such, we are not persuadedthat the
`inventive entity of the ’411 Patent is the same as the authorship of DiGioiaI,’
`or that DiGioia I represents only the work of the inventors of the °411
`Patent. Accordingly, we determine that DiGioia I qualifies as prior art under
`
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`35 U.S.C. § 102(a). In any event, we also consider whether DiGioia I is
`
`prior art under 35 U.S.C. § 102(b) as Petitioner asserts.
`Patent Ownerarguesthat the claims of the ’411 Patent are entitled to
`
`the benefit of the filing date of U.S. Patent No. 5,880,976 (“the 976
`
`Patent”), thus negating the application of DiGioia I under 35 U.S.C. §
`102(b). PO Resp. 21-22. Patent Ownercontinuesthatthe filing date of the
`°976 Patent was February 21, 1997, and thefirst public disclosure of
`
`DiGioia I was February 22, 1996, where the application that matured into
`
`the °411 Patent was a continuation-in-part of the application that matured
`
`into the °976 Patent. Jd. Patent Owneralso argues that to support the instant
`
`claims, there is no need of a verbatim list ofjoints, such as those found in
`
`the preambles of the independentclaims, and that the joint disclosedin the
`976 Patentis “representative of a class of surgeries.” Jd. at 22-25 (citing
`
`Ex. 2003 ff 32-38). Petitioner contends that there is no support for other
`
`joints in 976 disclosure and that a general disclosure of a genus cannot
`provide written description support for the species. Reply 4-8. We agree
`
`with Petitioner that Patent Owneris not entitled to the benefit of the °976
`
`Patent because 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 wasin possession of the 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
`
`quotationsandcitations omitted). Additionally, the disclosure of a broad
`genus doesnot necessarily provide written description support for a
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`particular subgenusor 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 of the
`
`976 Patent does not explicitly recite the myriad ofjoints recited in the
`
`claims of the ’411 Patent, which are only found in the disclosure of the °411
`
`Patent; Patent Owner does not argue otherwise. PO Resp. 22-23; Reply 5.
`
`Evenif the total hip replacement surgery,disclosed in the ’976 Patent, is
`representative of a class of surgeries, that would not necessarily provide
`written description support for specific surgeries in that class. Even
`assuming “one of ordinary skill in the art would have been able to apply the
`techniques described in the ’976 Patent to surgeries involving a knee joint, 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 {| 37)),
`such an observation goesto the obviousness of those other surgeries and not
`
`their disclosures.
`
`In any event, even considering the arguments on the merits and that
`Petitioner has the burden of persuasion, Patent Ownerhas not provided
`sufficient evidence that the hip replacement surgery is representative as to
`
`the claimed joints that are claimed in the ’411 patent. Dr. Cleary’s
`testimony is conclusory because he does not explain sufficiently why all of
`the joints being claimed in the ’411 patent would have beenpredictable from
`the example of hip surgery disclosed in the 976 Patent. Even Dr. Cleary
`recognizesthat eachjoint has a different geometry. Ex. 2003 27. Based
`on the record presented, we do not give substantial weight to Dr. Cleary’s
`testimony that oneofordinary skill in the art would have recognized that
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`Patent Ownerhad possession of the genus claimed in the ’411 patent from
`
`the species of the hip joint described in the ’976 Patent.
`Patent Owneralsoalleges 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 apparatus for facilitating the
`
`implantation of an artificial componentin one ofa hip joint, a kneejoint[,] a
`hand and wristjoint, an elbow joint, a shoulder joint, 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. As such, we remain persuaded that DiGioiaI 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
`
`DiGioia I, 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 provided in claims 1 and 10,
`because no rationale underpinningis provided by Petitioner. Jd. at 28-31.
`Patent Ownercontinues that 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
`DiGioiaI, based on the arrowsillustrated in Fig. 3 of DiGioiaI, is faulty
`
`because the arrowssignify participation by the surgeon, and notbidirectional
`
`communication independent of the surgeon. Jd. at 29-33.
`In responding to Patent Owner, Petitioner points to portions of the
`Petition where DiGioia I discloses that “feedback from the simulator can aid
`
`the surgeon in 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 forthe
`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 of a
`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 back andforth. 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. Jaramazthat, without his personal knowledge of
`
`15
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`
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`the system of DiGioiaI, a person reading the 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 weare persuadedthat one of ordinary skill in the art
`
`would haveinterpreted Fig. 3 as Petitioner suggests. See Pet. 15.
`
`Additionally, although Patent Owner argues that Fig. 3 need not connote
`
`bidirectional communication independentof the surgeon, such specificity is
`
`not necessary. Claim 10, for example, merely details that the simulatoris
`
`“in communication with” the planner, and any independencefrom 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 superior to 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 Petitionerthat
`the article (Ex. 2001) authored by 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 of ordinary skill in the art would have had a reasonable
`expectation that the system of DiGioia I could be modified to utilize
`feedback to determine and output an optimal position. PO Resp. 34-35. To
`that point, Patent Ownernotes that DiGioia I provides no algorithm or
`mathematical formula that would allow oneof ordinary skill in theart to
`
`relate the 3-D implant location to the estimated femoral range of motion. Jd.
`
`16
`
`
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`However, weare not persuadedthat 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
`
`of receiving that model. Jd. at 35-37 (citing Ex. 2003 {J 50-51). Petitioner
`
`asserts that Patent Owner’s characterization amounts to an obviousvariation,
`
`and doesnot distinguish the claims from the disclosure of DiGioiaI. Reply
`23. We agree with Petitioner that Patent Owner has acknowledgedthat the
`geometric model wasan input to both the preoperative planner and the range
`of motion simulator (PO Resp. 36 (citing Ex. 2002 10)), such that
`
`receiving the at least one geometric model of the joint from the pre-operative
`geometric planner would have been an obviousvariation.
`Patent Owneralso argues that Petitioner has provided no teaching or
`
`suggestion that a person of ordinary skill in the art would have sought to use
`a 3D model, per claim 17, instead of 2D cross sections, as disclosed in
`DiGioia I. PO Resp. 37-38. Petitioner responds that the three orthogonal
`views, provided in DiGioia I, would have been understoodto represent a 3D
`model. Reply 23-25. We agree with Petitioner that a 3D model can be
`represented by two-dimensional views of that model, and that one of
`ordinary skill in the art viewing Fig. 4 of DiGioia I would have interpreted
`the positioning of the implant across three orthogonal viewsofthe pelvis as
`
`representing a three dimensional model.
`
`17
`
`
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`Forall of the above reasons, and based on the record before us,
`
`Petitioner has shownsufficiently, by a preponderance of the evidence,that
`
`DiGioia I renders the subject matter of claims 1-15 and 17 obvious.
`
`D. Obviousness ofClaim 16 over DiGioia I and DiGioia Ll
`Petitioner contends that claim 16 is unpatentable under 35 U.S.C.
`
`§ 103(a) as obvious over DiGioia I and DiGioia II. Pet. 20, 26. To support
`
`its contentions, Petitioner provides detailed explanations as to how the prior
`art meets each claim limitation of claim 16. Jd. Petitioner also relies upon
`the Declaration of Robert D. Howe for support. Ex. 1004. Patent Owner
`
`disputes this ground on the same basis as Patent Owner disputes the ground
`
`uver DiGivia I above.
`
`Claim 16 dependsdirectly from claim 10 and specifies that the system
`
`further comprises a robotic device in communication with the computer
`
`system anda surgical tool connected to the robotic device.
`DiGioia II discloses an approach to improvedsurgical techniques
`
`incorporating pre-operative planning with biomechanical analysis and
`computeror robot-assisted surgery. Ex. 1006, 107-108. Fig. 1 of DiGioia II
`illustrates a robotic arm with a surgical tool. /d. Petitioner relies on these
`
`disclosures, and concludesthat it would have been obvious to modify the
`system in DiGioia I to incorporate the robotic arm with the surgicaltool of
`DiGioia II because they describe similar systems by the same authors,
`
`addressing the same problems, in the same approximate timeframe. Pet. 20.
`Patent Ownerdoesnot separately contest this ground against claim
`
`16, relying on the arguments discussed above with respectto the first
`obviousness ground. As we do notfind those arguments persuasive, we are
`persuadedthatone ofordinary skill in the art would have combined
`
`18
`
`
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`DiGioia I and DiGioia II as described with respect to 16, and we determine
`
`that Petitioner has shown, by a preponderanceof the evidence, that claim 16
`
`is obvious over DiGioia I and DiGioia II.
`
`E. Patent Owner’s Motion to Exclude
`Patent Owner movesto exclude certain portions of Dr. Howe’s
`redirect testimony (Exhibit 2006), alleging that this redirect testimony seeks
`
`to introduce concepts that could have been in the Petition or his original
`
`declaration. PO Mot. to Exclude, 1. Although not specified by page and
`
`line numbers in the Motion, we presume that Patent Owner seeks to exclude
`
`the specific questions asked on redirect and the answers to those questions
`
`(Ex. 2006, 86:21-91:3). Id. at 4.
`
`In rendering the Final Written Decision, we do not rely on those
`
`portions of Howe’s testimony that Patent Ownerseeks to exclude.
`
`Accordingly, we dismiss Patent Owner’s Motion to Exclude as moot.
`
`III. MOTION TO AMEND
`
`Patent Ownerrequests, should we find claims 1-17 to be
`
`unpatentable, cancellation of claims 1-17, and entry of substitute claims 18—
`
`34. Mot. 1-17 (citing, e.g., Exs. 1001, 2002, 2003, 2004, 2007, 2008).
`Petitioner opposes the request (Opp. Mot. 1-24), and Patent Ownerreplies
`
`(Reply Mot. 1-11).
`
`A. Procedural Burdens
`
`Patent Ownerhas the burden of proving patentability of a proposed
`
`substitute claim. See Nike, Inc. v. Adidas AG, 812 F.3d 1326, 1334 (Fed.
`
`Cir. 2015) (“the Board permissibly interpreted [37 C.F.R. § 42.20(c)] as
`imposing the burden of proving patentability of a proposed substitute claim
`
`19
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`on the movant: the patent owner.”). Accordingly, at a minimum,Patent
`
`Ownerhas the burden of showingthat (1) the substitute claims overcomeall
`
`the grounds under which independent claims 1-17 were determinedto be
`unpatentable, namely, 35 U.S.C. § 103 and (2)its request meetsall the
`procedural requirements concerning motions to amendset forth, for
`example, in our rules, Idle Free Systems, Inc. v Bergstrom, Inc., Case
`IPR2012-00027 (PTAB June 11, 2013) (Paper 26) (informative), and
`MasterImage 3D, Inc. v. RealD Inc., Case IPR2015-00040 (PTAB July 15,
`
`2015) (Paper 42) (precedential).
`
`B.
`
`Nature ofSubstitute Claims
`
`Patent Ownerasserts substitute claims 18—34 in its Motion to Amend,
`
`wi
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