`Trials@uspto.gov
`571-272-7822
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`Date Entered: August 4, 2015
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`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 B1
`____________
`
`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 C.F.R. § 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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`jurisdiction under 35 U.S.C. § 314, which provides that an inter partes
`review may not be instituted “unless . . . the information presented in the
`petition . . . shows that there is a reasonable likelihood that the petitioner
`would prevail with respect to at least 1 of the claims challenged in the
`petition.”
`For the reasons that 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 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 optimally size and
`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, that is used to create geometric
`models of the joint and the components to be implanted based on geometric
`data received from a skeletal structure data source 13, and is interfaced with
`pre-operative kinematic biomechanical simulator 14, that simulates
`movement of the joint using the geometric models for use in determining
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`implant positions, including angular orientations, for the components. Id. at
`5:63–6:5.
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`
`
`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 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.
`
`
`D. Asserted Grounds of Unpatentability
`Petitioner asserts that claims 1–17 are unpatentable based on the
`following grounds1:
`
`
`1 Petitioner alleges that claims 1-17 are obvious over DiGioia II and other
`references, Pet. 29; a review of the actual discussion of the grounds, Pet. 28–
`46, however, reveals that Petitioner is not alleging obviousness of claims 1,
`2, and 4–8 over DiGioia II, only anticipation.
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`Reference(s)
`DiGioia I2
`DiGioia I and DiGioia II3
`DiGioia II
`DiGioia II and O’Toole4
`DiGioia II and Taylor5
`DiGioia II, O’Toole, and Taylor
`DiGioia II, Chao6, and O’Toole
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`
`
`Basis
`§ 103(a)
`§ 103(a)
`§ 102(b)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`§ 103(a)
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`
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`Challenged Claim(s)
`1–15 and 17
`16
`1, 2, and 4–8
`3, 10–12, 15, and 16
`9
`13 and 14
`17
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`II. 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
`
`2 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”).
`3 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, pp. 106–111,
`1995 (Ex. 1006) (“DiGioia II”).
`4 R.V. O’Toole et al., “Towards More Capable and Less Invasive Robotic
`Surgery in Orthopaedics,” COMPUTER VISION, VIRTUAL REALITY AND
`ROBOTICS IN MEDICINE LECTURE NOTES IN COMPUTER SCIENCE, Vol. 905,
`pp. 123–130, 1995 (Ex. 1008) (“O’Toole”).
`5 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”).
`6 E.Y.S. Chao et al., “Simulation and Animation of Musculoskeletal Joint
`System,” TRANSACTIONS OF THE ASME, Vol. 115, pp. 562–568, Nov. 1993
`(Ex. 1007) (“Chao”).
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`interpretation standard in enacting the AIA,” and “the standard was properly
`adopted by PTO regulation.”). Under the broadest reasonable construction
`standard, claim terms are given their ordinary and customary meaning, as
`would be understood by one of 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 purposes of this 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
`which are in controversy need to be construed, and only to the extent
`necessary to resolve the controversy).
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`B. 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
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`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
`Translogic, 504 F.3d at 1259. 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).
`
`
`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.
`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.
`Fig. 3 of DiGioia I, reproduced below, illustrates connections between the
`pre-operative planner and a range of motion simulator.
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`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 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. 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 optimal position,
`and output that position to the pre-operative planner. Id. at 15, citing Ex.
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`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 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. We are persuaded by the
`Petition such a modification would have been obvious. We are further
`persuaded, at this juncture of the proceeding, that Petitioner has established a
`reasonable likelihood that Petitioner would prevail in its challenge to
`independent claims 1, 10, and 17.
`Petitioner also 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.
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`As another 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
`¶ 38.
`
`Additionally, 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. The present record supports
`the contention 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, Ex. 1005, 2–3. We concur that this
`would require the use of a display monitor and a controller.
`For all of the above reasons, we are persuaded, at this juncture of the
`proceeding, that Petitioner has established a reasonable likelihood that
`Petitioner would prevail in its challenge to claims 1–15 and 17 as obvious
`over DiGioia I.
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`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.
`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.
`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 prevail in its challenge to claim 16 on this ground.
`
`E. Remaining Grounds Challenging the Claims of the ’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
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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). As a
`result, and in determining whether to institute an inter partes review of a
`patent, the Board, in its discretion, may “deny some or all grounds for
`unpatentability for some or all of the challenged claims.” 37 C.F.R. §
`42.108(b).
`We exercise our discretion and decline to institute review based on
`any of the other asserted grounds advanced by Petitioner that are not
`identified below as being part of the trial. 37 C.F.R. § 42.108(a).
`
`
`III. CONCLUSION
`For the foregoing reasons, we determine that the information
`presented establishes a reasonable likelihood that Petitioner would prevail in
`showing that claims 1–17 of the ’411 Patent are unpatentable. At this stage
`of the proceeding, the Board has not made a final determination with respect
`to the patentability of the challenged claims.
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`IV. ORDER
`For the foregoing reasons, it is
`ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
`review is hereby instituted for the following grounds of unpatentability:
`Claim(s)
`Basis
`Reference(s)
`1–15 and 17
`§ 103(a)
`DiGioia I
`16
`§ 103(a)
`DiGioia I and DiGoioia II
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`FURTHER ORDERED that no other ground of unpatentability
`asserted in the Petition is authorized for this inter partes review; and
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and
`37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; the trial
`will commence on the entry date of this decision.
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`PETITIONER:
`Matthew I. Kreeger
`Walter Wu
`Morrison & Foerster LLP
`wwu@mofo.com
`mkreeger@mofo.com
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`
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`PATENT OWNER:
`Brian Buroker
`Stuart Rosenberg
`Gibson, Dunn & Crutcher LLP
`bburoker@gibsondunn.com
`srosenberg@gibsondunn.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