Trials@uspto.gov Paper 42
`571-272-7822
`
`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 B1
`____________
`
`
`
`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
`
`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 B1
`____________
`
`
`
`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
`We have jurisdiction 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 preponderance of 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
`preponderance of the 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 was filed. 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
`name the true patent owner as 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
`requirement for Petitioner to name a patent owner’s real parties-in-interest.
`Paper 13, 2. We further determined that that the 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 named as the
`
`2
`
`
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`patent owner in this proceeding and is a party to the proceeding such that it
`would be bound by any judgment adverse 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
`party named as Patent Owner. Paper 11. Petitioner filed a Reply to the
`Patent Owner Response. Paper 23 (“Reply”). Patent Owner also filed 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 Owner filed 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 Owner filed 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; Paper 5, 2.
`
`C. The ’411 Patent
`The ’411 Patent relates to an apparatus for facilitating the
`implantation of an artificial component of a 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
`
`3
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`
`position of the artificial components in a joint to provide the desired range of
`motion of the joint following surgery. Id. 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 planner is interfaced with pre-operative kinematic
`biomechanical simulator 14 that simulates movement of the joint using the
`geometric models for use in determining implant positions, including
`angular orientations, for the components. Id. 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 for facilitating the implantation of an artificial
`component in one of a hip joint, a knee joint, a hand and wrist
`joint, an elbow joint, a shoulder joint, and a foot and ankle joint,
`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.
`
`
`4
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`
`
`
`E. Grounds of Unpatentability
`We instituted an inter partes review of claims 1–17 on the following
`grounds (Dec. 11):
`Claim(s)
`1–15 and 17
`16
`
`
`Basis
`§ 103(a)
`§ 103(a)
`
`Reference(s)
`DiGioia I1
`DiGioia I and DiGoioia II2
`
`II. ANALYSIS
`A. Principles of Law
`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 obvious at 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 content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
`(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. 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 A.M. 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 II”).
`
`5
`
`
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`a court can take account of the 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 prima facie case
`of obviousness is established when the prior art itself would appear to have
`suggested the claimed subject matter to a person of ordinary skill in the art.
`In re Rinehart, 531 F.2d 1048, 1051 (CCPA 1976).
`The level 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);
`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 inter partes review, we construe 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 have their 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 not to
`read a particular embodiment appearing in 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]imitations are not to be
`read into the claims from the specification.”). However, an inventor may
`
`6
`
`
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`provide a meaning for a term that is 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 purposes of the institution decision, we determined that no
`claim term needs express interpretation. 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 Owner nor Petitioner 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
`DiGioia I. Pet. 10–28. To support its contentions, Petitioner provides
`detailed explanations as to how DiGioia I meets or renders obvious each
`claim limitation. Id. Petitioner also relies upon a Declaration of Robert D.
`Howe, who has been retained 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 replacement surgery through the use of 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
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`Fig. 3 of DiGioia I, reproduced below, illustrates connections between the
`pre-operative planner and a range of motion simulator.
`
`
`
`
`
`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 views are 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. Id.
`During the surgery, the system permits the surgeon to know the positions of
`the pelvis and acetabulum at all 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. Id. at 4–5.
`Petitioner acknowledges that 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 obvious to utilize the feedback
`to modify the position of an implant, re-run the simulation to determine
`
`8
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`
`optimal position, and output that position to the pre-operative planner. Id. 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 implant positioning. Pet. 15. Petitioner alleges
`that it would have been obvious to 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. Id. at 15 (citing Ex. 1004 ¶ 38).
`Petitioner also asserts that 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 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 and 7 recite that the geometric planner outputs
`a geometric model of the component and/or an implant position 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 provided by the pre-operative planner” and that it
`would have been obvious to a person of skill in the art to utilize the
`simulator feedback to modify the position of an implant, rerun the
`
`9
`
`
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`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 claims recite that the system
`also includes at least one display monitor or 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 views of the pelvis,” and it “allows the surgeon to manually
`specify the position of the acetabular component within the pelvis.” Pet. 19
`(quoting Ex. 1005, 2–3).
`ii. Patent Owner’s Contentions
`a) Prior Art Status of DiGioia I
`Patent Owner argues that DiGioia I is not prior 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. Id. at 19–27 (citing In 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 Owner argues that the authorship of DiGioia I listed
`“everyone who had been recently 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 of the ’411 Patent. Id. at
`19–20 (citing Ex. 2002 ¶¶ 11, 13–17). Additionally, Patent Owner argues
`that there is an inventor not listed as an author because “by the time DiGioia
`I was published, Dr. Kanade had assumed an advisory role,” but that his
`original contributions supported the claims of the instant patent. Id. at 20–
`21 (citing Ex. 2002 ¶ 15; Ex. 2006, 52:10–53:19, 86:7–10).
`
`10
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`
`
`
`In response, Petitioner contends that Dr. Jaramaz’s declaration lacks
`foundation and is not reliable. Reply 11–17. Petitioner points out that Dr.
`Jaramaz does not know who decided to omit Dr. Kanade as 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 what did in fact happen.” Id. 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. Id. 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 must review 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 455–56. Although we
`acknowledge the points raised by Dr. Jaramaz, we are persuaded that his
`testimony provides more opinion than facts. The testimony of Mr. Kischell
`makes clear 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 named as an inventor of the
`invention claimed in the ’411 Patent; we assume that the inventorship listed
`on the ’411 Patent is correct. As such, we are not persuaded that the
`inventive entity of the ’411 Patent is the same as the authorship of DiGioia I,
`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
`
`11
`
`
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`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 Owner argues that 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 Owner continues that the filing date of the
`’976 Patent was February 21, 1997, and the first 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. Id. Patent Owner also argues that to support the instant
`claims, there is no need of a verbatim list of joints, such as those found in
`the preambles of the independent claims, and that the joint disclosed in the
`’976 Patent is “representative of a class of surgeries.” Id. at 22–25 (citing
`Ex. 2003 ¶¶ 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 Owner is 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 was in 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
`quotations and citations omitted). Additionally, the disclosure of a broad
`genus does not necessarily provide written description support for a
`
`12
`
`
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`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 of the
`’976 Patent does not explicitly recite the myriad of joints 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.
`Even if 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 goes to 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 Owner has 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 been predictable from
`the example of hip surgery disclosed in the ’976 Patent. Even Dr. Cleary
`recognizes that each joint has a different geometry. Ex. 2003 ¶ 27. Based
`on the record presented, we do not give substantial weight to Dr. Cleary’s
`testimony that one of ordinary skill in the art would have recognized that
`
`13
`
`
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`Patent Owner had possession of the genus claimed in the ’411 patent from
`the species of the hip joint described in the ’976 Patent.
`Patent Owner also alleges that the Examiner disagreed with the
`proposition that there was no support for new claims in the continuation. PO
`Resp. 26–27. Patent Owner points to the Examiner’s language in the April
`5, 2000, Office Action stating that “[a]n apparatus for facilitating the
`implantation of an artificial component in one of a hip joint, a knee joint[,] a
`hand and wrist joint, 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 shows that the specific joints claimed were
`adequately disclosed in the earlier specification for written description
`purposes. As such, 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 of claims 1-15 and 17 over DiGioia I
`Patent Owner also argues that Petitioner has not demonstrated that
`DiGioia I, or DiGioia I in view of DiGioia II, 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 underpinning is provided by Petitioner. Id. at 28–31.
`Patent Owner continues 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. Id. at 29–30. Additionally,
`
`14
`
`
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`Patent Owner argues that the second part of Petitioner’s rationale to modify
`DiGioia I, based on the arrows illustrated in Fig. 3 of DiGioia I, is faulty
`because the arrows signify participation by the surgeon, and not bidirectional
`communication independent of the surgeon. Id. 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 for the
`system to “accurately place the implant in the predetermined optimal
`position.” Ex. 1005, 2. Although DiGioia I does not explicitly detail re-
`running the simulation, we are persuaded that such a repetition would have
`been understood as an obvious part of optimizing the placement.
`Petitioner also notes that a modification can be made in a
`semiautonomous system that allows for surgeon input, i.e., that the output of
`a position for implantation does not negate surgeon involvement in
`placement. Reply 19–20. We agree that Petitioner’s modification of
`DiGioia I does not require the formation of an autonomous system, 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 and forth. Id. 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, without his personal knowledge of
`
`15
`
`
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`the system of DiGioia I, 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 we are persuaded that one of ordinary skill in the art
`would have interpreted Fig. 3 as Petitioner suggests. See Pet. 15.
`Additionally, although Patent Owner argues that Fig. 3 need not connote
`bidirectional communication independent of the surgeon, such specificity is
`not necessary. Claim 10, for example, merely details that the simulator is
`“in communication with” the planner, and any independence from the
`surgeon, as discussed above, is a matter of supposition by Patent Owner.
`Patent Owner also argues that Petitioner’s declarant contradicts
`himself such that he professes that computers are superior to humans in
`processing quantitative data, but has also explained that a strength of
`humans is that they exercise good judgment and a weakness of computers is
`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) authored by Petitioner’s declarant, Dr. Howe, also
`addresses semiautonomous capabilities and is not necessarily contradictory
`of Dr. Howe’s declaration. Reply 21 (citing Ex. 2006 at 66:14–72:4).
`Patent Owner also 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 Owner notes that DiGioia I provides no algorithm or
`mathematical formula that would allow one of ordinary skill in the art to
`relate the 3-D implant location to the estimated femoral range of motion. Id.
`
`16
`
`
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`However, we are not persuaded that Petitioner need provide an algorithm or
`mathematical formula to show obviousness. As discussed above, we are
`persuaded that Petitioner has sufficiently demonstrated how the system of
`DiGioia I could be modified to supply the claimed position for implantation.
`Patent Owner also 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. Id. at 35–37 (citing Ex. 2003 ¶¶ 50–51). Petitioner
`asserts that Patent Owner’s characterization amounts to an obvious variation,
`and does not distinguish the claims from the disclosure of DiGioia I. Reply
`23. We agree with Petitioner that Patent Owner has acknowledged that the
`geometric model was an 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 obvious variation.
`Patent Owner also 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 understood to 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 views of the pelvis as
`representing a three dimensional model.
`
`17
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`
`
`
`For all of the above reasons, and based on the record before us,
`Petitioner has shown sufficiently, by a preponderance of the evidence, that
`DiGioia I renders the subject matter of claims 1–15 and 17 obvious.
`D. Obviousness of Claim 16 over DiGioia I and DiGioia II
`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. Id. 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
`over DiGioia I above.
`Claim 16 depends directly from claim 10 and specifies that the system
`further comprises a robotic device in communication with the computer
`system and a surgical tool connected to the robotic device.
`DiGioia II discloses an approach to improved surgical techniques
`incorporating pre-operative planning with biomechanical analysis and
`computer or robot-assisted surgery. Ex. 1006, 107–108. Fig. 1 of DiGioia II
`illustrates a robotic arm with a surgical tool. Id. Petitioner relies on these
`disclosures, and concludes that it would have been obvious to modify the
`system in DiGioia I to incorporate the robotic arm with the surgical tool of
`DiGioia II because they describe similar systems by the same authors,
`addressing the same problems, in the same approximate timeframe. Pet. 20.
`Patent Owner does not separately contest this ground against claim
`16, relying on the arguments discussed above with respect to the first
`obviousness ground. As we do not find those arguments persuasive, we are
`persuaded that one of ordinary skill in the art would have combined
`
`18
`
`
`
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`
`DiGioia I and DiGioia II as described with respect to 16, and we determine
`that Petitioner has shown, by a preponderance of the evidence, that claim 16
`is obvious over DiGioia I and DiGioia II.
`E. Patent Owner’s Motion to Exclude
`Patent Owner moves to 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 Owner seeks to exclude.
`Accordingly, we dismiss Patent Owner’s Motion to Exclude as moot.
`
`
`III. MOTION TO AMEND
`Patent Owner requests, 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 Owner replies
`(Reply M
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
