Trials@uspto.gov
`571-272-7822
`
`Paper 6
`Date Entered: August 4, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MAKO SURGICAL CORP.,
`Petitioner,
`
`V.
`
`BLUE BELT TECHNOLOGIES, INC.,
`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.
`
`DECISION
`Institution of Inter Partes Review
`37 CFR. § 42.108
`
`I. INTRODUCTION
`
`Petitioner, Mako Surgical Corporation,filed a Petition requesting an
`
`inter partes review of claims 1-17 of U.S. Patent No. 6,205,411 B1 (Ex.
`
`1001, “the °411 Patent”). Paper 2 (“Pet.”). Patent Owner, Blue Belt
`
`Technologies, Inc., did not file a Preliminary Response. We have
`
`
`571-272-7822
`
`Paper 6
`Date Entered: August 4, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MAKO SURGICAL CORP.,
`Petitioner,
`
`V.
`
`BLUE BELT TECHNOLOGIES, INC.,
`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.
`
`DECISION
`Institution of Inter Partes Review
`37 CFR. § 42.108
`
`I. INTRODUCTION
`
`Petitioner, Mako Surgical Corporation,filed a Petition requesting an
`
`inter partes review of claims 1-17 of U.S. Patent No. 6,205,411 B1 (Ex.
`
`1001, “the °411 Patent”). Paper 2 (“Pet.”). Patent Owner, Blue Belt
`
`Technologies, Inc., did not file a Preliminary Response. We have
`
`
`
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`Patent 6,205,411 Bl
`
`jurisdiction under 35 U.S.C. § 314, which provides that an inter partes
`
`review may notbeinstituted “unless... the information presented in the
`petition .
`.
`. showsthat there is a reasonable likelihoodthat the petitioner
`
`would prevail with respect to at least 1 of the claims challenged in the
`
`.
`petition.”
`For the reasonsthat follow, we institute an inter partes review of
`
`claims 1—17 of the ’411 Patent.
`
`A. Related Proceeding
`
`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.
`|
`
`B. The ’411 Patent
`
`The 411 Patent relates to an apparatus for facilitating the
`implantation ofan artificial componentofa bodyjoint. Ex. 1001, Abstract.
`The Specification of the ’411 patent describes a system that provides a
`
`medical practitioner with a tool to precisely determine an optimally size and
`
`position ofthe artificial components in a joint to provide the desired range of
`
`motion ofthe joint following surgery. Jd. at 4:66—5:2. The apparatus
`
`includes geometric pre-operative planner12, that is used to create geometric
`models of the joint and the components to be implanted based on geometric
`data received fromaskeletal structure data source 13, and is interfaced with
`
`pre-operative kinematic biomechanical simulator 14, that simulates
`
`movementofthe joint using the geometric models for use in determining
`
`
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`IPR2015-00630
`Patent 6,205,411 Bl
`
`implant positions, including angular orientations, for the components. Jd. at
`
`5:63-6:5.
`
`C.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 ofanartificial
`
`componentin oneofa hip joint, a knee joint, a hand and wrist
`
`joint, an elbow joint, a shoulder joint, and a foot and anklejoint,
`
`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 outputsat least one geometric
`modelof the joint and the pre-operative kinematic biomechanical
`
`simulator outputs a position for implantation of the artificial
`component.
`|
`
`Ex. 1001, 13:16-27.
`
`D. Asserted Grounds of Unpatentability
`
`Petitioner asserts that claims 1-17 are unpatentable based on the
`following grounds’:
`
`' Petitioner alleges that claims 1-17 are obvious over DiGioiaII and other
`references, Pet. 29; a review ofthe actual discussion of the grounds, Pet. 28—
`46, however, reveals that Petitioner is not alleging obviousnessof claims1,
`2, and 4-8 over DiGioiaII, only anticipation.
`3
`
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`
`Reference(s);Claim(s)__|Basis___|Challenged
`
`
`DiGioia I [§103(a)[|1-15and17
`
`
`DiGioia I and DiGioia II°
`DiGioia II
`DiGioia II and O’ Toole’
`
`DiGioia II and Taylor §ioxa)|oD
`|13and14
`DiGioia II, O’Toole, and Taylor
`13 and 14
`
`
`DiGioia II, Chao*, and O’ Toole
`
`
`
`
`
`If. ANALYSIS
`
`A. Claim Interpretation
`|
`In an inter partes review, claim terms in an unexpired patent are given
`
`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 see also In re
`
`Cuozzo Speed Techs., LLC, No. 2014-1301, 2015 WL 4097949, *7-8 (Fed.
`
`Cir. July 8, 2015) (“Congress implicitly approved the broadest reasonable
`
`? AM.DiGioiaet al., “HipNav: Pre-operative Planning andIntra-operative
`Navigational Guidance for Acetabular Implant Placement in Total Hip
`Replacement Surgery,” 2nd CAOS Symposium, 1996 (Ex. 1005)
`.
`(“DiGioia I’).
`> A.M.DiGioiaetal., “An Integrated Approach to Medical Robotics and
`Computer Assisted Surgery in Orthopaedics,” PRoc. 1ST INT’L SYMPOSIUM
`ON MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY,pp. 106-111,
`1995 (Ex. 1006) (“DiGioia IT”).
`*R.V. O’Toole et al., “Towards More Capable and Less Invasive Robotic
`Surgery in Orthopaedics,” COMPUTERVISION, VIRTUAL REALITY AND
`ROBOTICS IN MEDICINE LECTURE NOTES IN COMPUTER SCIENCE, Vol. 905,
`pp. 123-130, 1995 (Ex. 1008) (“O’ Toole”).
`> Taylor, et al., “An Image-Directed Robotic System for Precise
`Orthopaedic Surgery,” IEEE TRANSACTIONS ON ROBOTICS AND
`AUTOMATION,Vol. 10, No. 3, June 1994 (Ex. 1009) (“Taylor”).
`° E.Y.S. Chaoet al., “Simulation and Animation of Musculoskeletal Joint
`System,” TRANSACTIONS OF THE ASME,Vol. 115, pp. 562-568, Nov. 1993
`(Ex. 1007) (“Chao”).
`
`4
`
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`interpretation standard in enacting the AIA,” and “the standard wasproperly
`adopted by PTOregulation.”’). Underthe broadest reasonable construction
`standard, claim terms are given their ordinary and customary meaning, as
`
`would be understood by oneof ordinary skill in the art in the context of the
`
`entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed.
`
`Cir. 2007).
`
`Petitioner proposes no specific constructions for any claim terms.
`
`Therefore, for the purposesofthis decision, and on this record, we determine
`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
`
`whichare in controversy need to be construed, and only to the extent
`
`necessary to resolve the controversy).
`
`B. 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 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 on the basis of underlying
`
`factual determinations including: (1) the scope and contentofthe priorart;
`
`(2) any differences between the claimed subject matter and thepriorart;
`(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 obviousnessanalysis “need not seek out precise
`
`teachings directed to the specific subject matter of the challenged claim,for
`
`5
`
`
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`
`a court can take accountof the inferences and creative steps that a person of
`
`ordinary skill in the art would employ.” KSR, 550 U.S. at 418; see
`
`Translogic, 504 F.3d at 1259. A primafacie case of obviousnessis
`
`established whenthepriorart itself would appear to have suggested the
`
`claimed subject matter to a person of ordinary skill in the art. Jn 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).
`
`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. Jd. Petitioner also relies upon a Declaration of Robert D.
`Howe, who has been retainedas an expert witness by Petitioner for the
`
`instant proceeding. Ex. 1004.
`
`DiGioia I describes a system and methodsto determine optimal
`
`implant placement during hip replacement surgery throughthe use ofpre-
`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
`
`component within the pelvis based upon pre-operative CT images. Jd. at 2.
`
`Fig. 3 of DiGioia I, reproduced below,illustrates connections between the
`
`pre-operative planner and a range of motion simulator.
`
`6
`
`
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`
`Pre-operative
`Planner
`
`Simulator
`
`Range of Motion
`
`Intra-operative
`Tracking &
`Guidance
`
`Figure 3 HipNav system overview
`
`Fig. 3 of DiGioia I provides an 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. 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 the positions of
`the pelvis and acetabulum atall 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. Pet. 14—15..
`Specifically, DiGioia I discloses that feedback from the simulator can aid the
`surgeon in determining optimal implant placement, and Petitioneralleges
`
`that it would have been obviousto utilize the feedback to modify the
`position of an implant, re-run the simulation to determine optimalposition,
`and output that position to the pre-operative planner. /d. at 15, citing Ex.
`
`
`
`IPR2015-00630
`Patent 6,205,411 B1
`
`1004 38. At this juncture of the proceeding, we are persuaded by the
`
`Petition that such a modification would have been obvious.
`
`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 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. /d. at 15, citing Ex. 1004 4 38. We are persuaded by the
`Petition such a modification would have been obvious. Weare further
`
`persuaded,at this juncture of the proceeding, that Petitioner has established a
`reasonablelikelihood that Petitioner would prevail in its challenge to
`
`independentclaims 1, 10, and 17.
`
`Petitioneralso asserts that dependent claims 2—9 and 11—15 are also
`obvious over DiGioia I. Pet. 15-20. We have reviewed the Petition and the
`contentions made, and are persuaded, at this juncture of the proceeding,that
`Petitioner has established a reasonable likelihood that Petitioner would
`
`prevail in its challenge to dependent claims 2—9 and 11-15.
`For example, claims 2 and 15 recite that the system also includes an
`intra-operative navigational module in communication with the pre-
`
`operative kinematic biomechanical simulator. The present record supports
`the contention that DiGioia I’s disclosure of an “inter-operative guidance
`
`system,” which uses “pre-operative information,” to provide “navigational
`
`
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`feedback to the surgeon”as meeting these limitations. Pet. 15-16, Ex. 1005,
`
`5-6.
`
`Asanother example, 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. The present record supports the contention 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 simulation to determine optimal position, and output
`that position to the pre-operative planner. Pet. 16-17, Ex. 1005, 2, Ex. 1004
`q 38.
`
`|
`
`Additionally, 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. The present record supports
`
`the contention 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
`
`-component within the pelvis.” Pet. 19, Ex. 1005, 2-3. We concurthatthis
`would require the use of a display monitor and a controller.
`Forall ofthe above reasons, we are persuaded,at this juncture ofthe
`proceeding, that Petitioner has established a reasonable likelihood that
`
`Petitioner would prevail in its challenge to claims 1-15 and 17 as obvious
`
`over DiGioiaI.
`
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`D. Obviousness ofClaim 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 theprior
`
`art meets each claim limitation of claim 16. Jd. Petitioner also relies upon
`
`the Declaration of Robert D. Howe for support. Ex. 1004.
`
`Claim 16 dependsdirectly from claim 10 andspecifies that the system
`further comprises a robotic device in communication with the computer
`system and a surgical tool connectedto the robotic device.
`
`DiGioia II discloses an approach to improvedsurgical 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. Jd. 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 sameproblems, in the same approximate timeframe. Pet. 20.
`We have reviewed the proposed ground of obviousness over DiGioia I
`and DiGioia II against claim 16, and we are persuaded,at this juncture of the
`
`proceeding, that Petitioner has established a reasonable likelihood that
`Petitioner would prevailin its challenge to claim 16 on this ground.
`
`E. Remaining Grounds Challenging the Claims ofthe ’411 Patent
`
`Pursuant to 35 U.S.C. § 316(b), the rules for inter partes. proceedings
`
`were promulgated to take into account the “regulation on the economy,the
`
`integrity of the patent system, the efficient administration of the Office, and
`
`10
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`IPR2015-00630
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`the ability of the Office to timely complete proceedings.” The promulgated
`rules provide that they are to “be construed to secure the just, speedy, and
`inexpensive resolution of every proceeding.” 37 C.F.R. § 42.1(b). Asa
`
`result, and in determining whetherto institute an inter partes review of a
`
`patent, the Board,in its discretion, may “deny someorall grounds for
`
`unpatentability for someorall of the challenged claims.” 37 C.F.R. §
`
`42.108(b).
`
`Weexercise ourdiscretion and decline to institute review based on
`
`any of the other asserted grounds advanced by Petitionerthat are not
`identified below as beingpart ofthe trial. 37 C.F.R. § 42.108(a).
`
`III. CONCLUSION
`
`For the foregoing reasons, we determinethat the information
`
`presented establishes a reasonable likelihood that Petitioner would prevailin
`showing that claims 1-17 of the ’411 Patent are unpatentable. Atthis stage
`of the proceeding, the Board has not madea final determination with respect
`
`to the patentability of the challenged claims.
`
`IV. ORDER
`
`For the foregoing reasons,it is
`
`ORDEREDthatpursuant to 35 U.S.C. § 314(a), an inter partes
`
`review is hereby instituted for the following grounds of unpatentability:
`
`
`
`
`
`
`[Claim(s)———S——s«d[Basis—s|Reference(s)
`
`
`1-15 and17___
`
`
`
`
`DiGioia I and DiGoioia II
`
`11
`
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`
`FURTHER ORDEREDthatno other ground of unpatentability
`
`asserted in the Petition is authorized for this inter partes review; and
`
`FURTHER ORDEREDthat pursuant to 35 U.S.C. § 314(c) and
`
`37 C.F.R. § 42.4, notice is hereby given ofthe institution of a trial; the trial
`will commenceontheentry date ofthis decision.
`
`12
`
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`
`PETITIONER:
`
`Matthew I. Kreeger
`Walter Wu
`Morrison & Foerster LLP
`wwu@mofo.com
`mkreeger@mofo.com
`
`PATENT OWNER:
`
`Brian Buroker —
`Stuart Rosenberg
`Gibson, Dunn & Crutcher LLP
`bburoker@gibsondunn.com
`srosenber
`ibsondunn.com
`
`.
`Greg Stark
`Schwegman, Lundberg & Woessner
`gstark@slwip.com
`
`Patrick J. McElhinny
`Mark. G. Knedeisen
`K&L Gates LLP
`patrick.mcelhinny@klgates.com
`mark.knedeisen@klgates.com
`
`13
`
`
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