Patent No. 6,205,411
`Petition For Inter Partes Review
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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
`
`Patent No. 6,205,411
`Issue Date: March 20, 2001
`Title: COMPUTER-ASSISTED SURGERY PLANNER AND
`INTRA-OPERATIVE GUIDANCE SYSTEM
`______________________
`
`Case IPR: Unassigned
`______________________
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,205,411
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`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. §§ 42.1-.80, 42.100-.123
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`sf-3468564
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`Petition For Inter Partes Review
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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
`
`Patent No. 6,205,411
`Issue Date: March 20, 2001
`Title: COMPUTER-ASSISTED SURGERY PLANNER AND
`INTRA-OPERATIVE GUIDANCE SYSTEM
`______________________
`
`Case IPR: Unassigned
`______________________
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,205,411
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`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. §§ 42.1-.80, 42.100-.123
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`Inter Partes Review of USPN 6,205,411
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`TABLE OF CONTENTS
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`Page
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`NOTICES AND STATEMENTS ................................................................... 1
`I.
`INTRODUCTION .......................................................................................... 2
`II.
`III. THE ’411 PATENT ........................................................................................ 4
`A.
`Background and Summary of Patent .................................................... 4
`B.
`Prosecution History and Priority .......................................................... 7
`IV. DETAILED EXPLANATION OF GROUNDS FOR INVALIDITY ........... 9
`A. DiGioia. .............................................................................................. 10
`B. DiGioia II. .......................................................................................... 28
`CONCLUSION ............................................................................................. 47
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`V.
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`Inter Partes Review of USPN 6,205,411
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`Exhibit List for Inter Partes Review of U.S. Patent No. 6,205,411
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`Exhibit Description
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`Exhibit #
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`U.S. Patent No. 6,205,411 (“the ’411 patent”)
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`Prosecution History of U.S. Patent No. 6,205,411
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`Prosecution History of U.S. Patent No. 5,880,976
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`Declaration of Robert D. Howe
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`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 (“DiGioia”)
`
`Anthony M. DiGioia III 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 (“DiGioia II”)
`
`E.Y.S. Chao et al., “Simulation and Animation of Musculoskeletal
`Joint System,” Transactactions of the ASME, Vol. 115, pp. 562-
`568, Nov. 1993 (“Chao”)
`
`R.V. O’Toole III 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 (“O’Toole”)
`
`Russell H. Taylor et al., An Image-Directed Robotic System for
`Precise Orthopaedic Surgery, IEEE Transactions on Robotics and
`Automation, Vol. 10, No. 3, June 1994 (“Taylor”)
`
`
`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`Inter Partes Review of USPN 6,205,411
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`Petitioner Mako Surgical Corp. (“Petitioner”) respectfully petitions for inter
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`partes review of claims 1-17 (the “Challenged Claims”) of U.S. Patent
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`No. 6,205,411 (“the ’411 patent”) (Ex. 1001) in accordance with 35 U.S.C. §§ 311-
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`319 and 37 C.F.R. § 42.100 et seq.
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`I.
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`NOTICES AND STATEMENTS
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`Pursuant to 37 C.F.R. § 42.8(b)(1), Petitioner identifies Mako Surgical Corp.
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`and Stryker Corporation as the real parties-in-interest. Pursuant to 37 C.F.R.
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`§ 42.8(b)(2), Petitioner discloses as a related matter Mako Surgical Corp. v. Blue
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`Belt Technologies, Inc., No. 0:14-cv-61263-MGC (S.D. Fla.) (the “Concurrent
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`Litigation”). Blue Belt Technologies, Inc. (“Patent Owner”) served Petitioner with
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`counterclaims asserting infringement of the ’411 patent on September 2, 2014.
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`Lead Counsel
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`Back-Up Counsel
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`Matthew I. Kreeger
`Registration No. 56,398
`Morrison & Foerster LLP
`425 Market Street
`San Francisco, CA 94105
`mkreeger@mofo.com
`Telephone: (415) 268-7000
`Facsimile: (415) 268-7522
`
`Pursuant to 37 C.F.R. § 42.8(b)(4), service information for lead and back-up
`
`Walter Wu
`Registration No. 50,816
`Morrison & Foerster LLP
`755 Page Mill Road
`Palo Alto, CA 94306
`wwu@mofo.com
`Telephone: (650) 813-5600
`Facsimile: (650) 494-0792
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`counsel is provided above. Pursuant to 37 C.F.R. § 42.104(a), Petitioner certifies
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`that the ’411 patent is available for inter partes review and that the Petitioner is not
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`barred or estopped from requesting an inter partes review challenging the patent
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`claims on the grounds identified in this Petition.
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`II.
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`INTRODUCTION
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`Inter Partes Review of USPN 6,205,411
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`The ’411 patent was filed on November 12, 1998. It has three independent
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`claims and 14 dependent claims, all directed to methods and systems for planning
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`and guiding implantation of an artificial component into a joint (hip, knee, hand
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`and wrist, elbow, shoulder, or foot and ankle). The same systems and methods,
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`however, were described in detail by several of the named inventors in articles
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`published at least as early as 1996 and 1995, both well over a year before the ’411
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`patent was filed. As a result, the’411 patent claims are unpatentable.
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`The ’411 patent is a continuation-in-part of an application filed February 21,
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`1997, which issued as U.S. Patent No. 5,880,976 (“the ’976 patent”). The
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`independent claims of the ’411 patent, however, specifically recite implantation in
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`“a hip joint, a knee joint, a hand and wrist joint, an elbow joint, a shoulder joint,
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`[or] a foot and ankle joint.” Other than the hip joint, this is new matter with no
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`support in the parent application, as the parent merely disclosed a “joint” and only
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`specifically discussed a hip joint. This new matter is included in each claim that
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`remains in the ’411 patent. All of the claims are therefore entitled only to their
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`actual filing date of November 12, 1998.
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`The Examiner’s views on priority are unclear from the prosecution history.
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`In an April 5, 2000, office action, the Examiner stated that because the scope of the
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`’976 patent was open-ended, it covered “joint” generally as recited in the ’976
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`patent and also the specific joints recited in the ’411 patent claims. (Ex. 1002 at
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`265.) On the next page of the same office action, the Examiner incorrectly and
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`more broadly stated that the ’976 patent actually disclosed and claimed “[a]n
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`apparatus for facilitating the implantation of an artificial component in one of a hip
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`joint, a knee joint, a hand and wrist joint, an elbow joint, a shoulder joint, and a
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`foot and ankle joint.” (Id. at 266.) In the September 21, 2000, Notice of
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`Allowance, however, the Examiner pointed to the same specific language as the
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`patentable improvement provided by the ’411 patent over the ’976 patent:
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`The instant application is directed to a nonobvious
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`improvement over the invention described in U.S. Patent
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`No. 5,880,976 . . . . The improvement comprises an
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`apparatus for facilitating the implantation of an artificial
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`component in one of a hip joint, a knee joint, a hand and
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`wrist joint, an elbow joint, a shoulder joint, and a foot
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`and ankle joint. This patentable distinction is included in
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`each of the independent claims 1, 10, and 29. (Id. at 287-
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`88.)
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`The Examiner’s September 21, 2000, view is partially correct: the specific
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`list of joints is indeed a distinction between the ’411 patent and its parent. The
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`distinction is not, however, patentable. The purported invention was thoroughly
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`described years earlier, both in an article published at least as early as 1996, two
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`years before the continuation-in-part filing date, which is the earliest priority date
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`to which the ’411 patent is entitled; and in an article published at least as early as
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`1995, which is 1-2 years before even the filing date of the ’976 parent application.
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`This Petition for inter partes review shows how DiGioia (Ex. 1005), an
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`article published at least as early as 1996, and DiGioia II (Ex. 1006), an article
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`published at least as early as 1995, anticipate or render obvious each of the
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`Challenged Claims of the ’411 patent. Indeed, these references disclose nearly all
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`of the ’411 claimed methods and systems, with only a few minor differences that
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`would have been obvious in view of other art. Part III of this Petition summarizes
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`the ’411 patent, its prosecution history, and priority, and Part IV sets forth the
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`detailed grounds for invalidity of the ’411 patent’s challenged independent and
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`dependent claims in view of DiGioia, DiGioia II plus Chao, and other prior art.
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`Petitioner has established a reasonable likelihood that it will prevail on at least one
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`claim of the ’411 Patent, if not all of them. Accordingly, Petitioner respectfully
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`requests a Decision to institute inter partes review.
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`III. THE ’411 PATENT
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`A.
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`Background and Summary of Patent
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`The ’411 patent is directed to systems and methods for facilitating
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`implantation of an artificial component in a hip joint, knee joint, hand and wrist
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`joint, elbow joint, shoulder joint, or foot and ankle joint. The apparatus and related
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`method consist of essentially two pieces: a pre-operative geometric planner and a
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`pre-operative kinematic biomechanical simulator that communicates with the
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`geometric planner.
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`The ’411 specification describes as background several challenges and
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`concerns related to hip arthroplasty, which is a procedure to restore the function of
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`a joint by resurfacing, remodeling, or complete replacement. Dislocation of the
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`implanted component was known to be a major problem, but could be lessened
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`with certain implantation angles. (Ex. 1001 at 1:37-55.) Variations in individual
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`anatomies were also known to cause complications, as there is no single optimal
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`component design and orientation. (Id. at 2:56-61.) According to the ’411
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`specification, most prior operation planning methods for hip joint surgery used
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`acetate templates and a single anterior-posterior x-ray, providing only a two-
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`dimensional image of the pelvis. (Id. at 3:10-18.) The ’411 specification states
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`that prior intra-operative positioning devices assumed that the pelvis and trunk
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`were aligned in a known orientation and did not take into account individual
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`anatomies. (Id. at 3:19-32.) Several other prior solutions assumed that a correct
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`and precise implant position would be provided, and therefore did not solve the
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`issue of determining or confirming a high-quality implant position. (Id. at 4:28-
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`41.)
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`The ’411 applicants proposed to address these problems by combining a pre-
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`operative geometric planner and a kinematic biomechanical simulator. (Ex. 1001
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`at 4:59-65.) The geometric planner creates geometric models of both the target
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`joint and the artificial components to be implanted. (Id. at 5:63-67.) The simulator
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`simulates movement of the joint to assist in determining implant positions,
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`including angular orientation. (Id. at 6:1-5.) In some embodiments, the positions
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`and geometric models are used with intra-operative navigational software to guide
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`the surgeon. (Id. at 6:45-48.) In others, all three pieces—the planner, the
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`simulator, and the navigational software—are implemented using a computer
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`system with a display monitor. (Id. at 6:8-12.) The computer system could include
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`a tracking device so relative locations of objects can be tracked and displayed
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`during the operation. (Id. at 6:21-26.)
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`The ’411 patent has three independent claims and 14 dependent claims.
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`Independent claim 1 specifies the joints into which an artificial component will be
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`implanted and claims a pre-operative geometric planner and a pre-operative
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`kinematic biomechanical simulator in communication with the geometric planner.
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`Independent claim 10 claims a computer system with the components set out in
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`claim 1, and adds a tracking device in communication with the system.
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`Independent claim 17 is directed to a method of facilitating implantation of an
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`artificial component into one of the specified joints, comprising the steps of:
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`creating a bone model; creating a component model; simulating movement of the
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`joint with the implant; calculating a range of motion; determining an implant
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`position based on a predetermined range of motion and the calculated range of
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`motion; identifying the implant position in the bone model; aligning the bone
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`model with the actual bone and placing the implant based on tracking data; and
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`tracking the implant and bone to maintain alignment.
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`B.
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`Prosecution History and Priority
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`The ’411 patent was filed on November 12, 1998. It is a continuation-in-
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`part of application 08/803,993 (“the ’993 application”), which was filed on
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`February 21, 1997, and issued as the ’976 patent. (Ex. 1003.) All three
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`independent claims in the ’411 patent recite implantation in “a knee joint, a hand
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`and wrist joint, an elbow joint, a shoulder joint, [or] a foot and ankle joint.”
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`(Ex. 1001 at Abstract.) This specific list is in the preamble of each independent
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`claim, and provides antecedent basis for “the joint” in the claim language of each.
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`See Highmark, Inc. v. Allcare Health Mgmt. Sys., 687 F.3d 1300, 1311 (Fed. Cir.
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`2012) (preamble limiting where “limitations in the body of the claim rely upon and
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`derive antecedent basis from the preamble”) (quotations and citation omitted),
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`rev’d on other grounds, 134 S. Ct. 1744 (2014).
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`The specific joints set out in the preamble constitute subject matter not
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`found in the ’993 application or ’976 patent, as that application and patent
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`disclosed “joint” generally with “hip” as the only specific example. (See, e.g., Ex.
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`1003 at 21, 1:17-33 (discussing hip replacement operations).) Adding specificity
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`to narrow claims after an earlier, broader disclosure constitutes new matter, and the
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`’411 patent claims are therefore not supported by the disclosure of the ’993
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`application. MPEP § 2163.05 Part II (“The introduction of claim changes which
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`involve narrowing the claims by introducing elements or limitations which are not
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`supported by the as-filed disclosure” constitutes new matter.). As a result, the ’411
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`patent is only entitled to its own filing date for all claims—not the filing date of the
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`’993 application. See Cordance Corp. v. Amazon.com, Inc., 658 F.3d 1330, 1333-
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`35 (Fed. Cir. 2011) (continuation-in-part claims not entitled to parent filing date
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`where parent lacks written description support for CIP claims).
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`The Examiner issued a single non-final rejection on April 5, 2000, on the
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`grounds that 1) the claims were invalid due to non-statutory double patenting over
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`claims of the ’976 patent; 2) the claims (particularly claims 1 and 10) were directed
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`to non-statutory subject matter under 35 U.S.C. § 101, because they were “devoid
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`of any limitation to a practical application” (Ex. 1002 at 269); and 3) the claims
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`were invalid due to statutory double patenting over claims that were exact
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`duplicates of claims of the ’976 patent.
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`To resolve the double patenting rejections, Patent Owner canceled the claims
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`that were exact duplicates of claims of the ’976 patent and submitted a terminal
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`disclaimer for the remaining claims. To resolve the Section 101 rejection, Patent
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`Owner amended claims 1 and 10 to claim that the “pre-operative geometric planner
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`outputs at least one geometric model of the joint and the pre-operative kinematic
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`biomechanical simulator outputs a position for implantation of the artificial
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`component.” (Ex. 1002 at 282.) Notably, this language specifies “the joint” and
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`thus relies on the new matter language in the preamble for antecedent basis.
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`The Patent Office issued a notice of allowance on September 21, 2000, and
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`the ’411 patent issued on March 20, 2001.
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`IV. DETAILED EXPLANATION OF GROUNDS FOR INVALIDITY
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`Pursuant to 37 C.F.R. §§ 42.22(a)(1) and 42.104(b), Petitioner respectfully
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`requests the cancellation of claims 1-17 of the ’411 patent as they are unpatentable
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`for the reasons set forth in this Petition. Specifically, Petitioner shows below that
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`all of the claims of the ’411 patent are anticipated or rendered obvious by the ’411
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`inventors’ own disclosures well over a year before the ’411 patent was filed. As
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`demonstrated in Part IV.B, DiGioia is an article published at least as early as 1996
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`that teaches nearly all of the elements of the claimed systems and methods, with
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`only minor variations that would have been obvious to one of skill in the art.
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`DiGioia II is an article published even earlier that teaches, in combination with
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`another article by the same authors, the claimed systems and methods as well.
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`In each of the following sections, Petitioner sets forth the specific art and
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`statutory grounds on which the challenge is based in a table at the beginning of the
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`section. 37 C.F.R. §§ 42.22(a)(2) and 42.104(b)(2). Petitioner then presents a
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`discussion of how the claims are unpatentable under the statutory grounds raised.
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`37 C.F.R. § 42.104(b)(4). Finally, Petitioner sets forth a claim chart that specifies
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`where each element of each of the Challenged Claims is met by the prior art for
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`ease of reference. Id. The showing in these sections establishes more than a
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`reasonable likelihood of prevailing as to each ground of invalidity.
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`The grounds for invalidity set forth below are supported by the declaration
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`of Robert Howe, who provides testimony regarding the prior art and the
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`understanding of one of ordinary skill in the art. Robert Howe’s declaration is
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`attached as Exhibit 1004. Petitioner notes that during inter partes review a claim is
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`given the “broadest reasonable construction in light of the specification.” See 37
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`C.F.R. § 42.100(b). Petitioner submits, for the purposes of this inter partes review
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`only, that claim terms are presumed to take on their broadest reasonable ordinary
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`and customary meaning to a person of ordinary skill in the art in light of the
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`specification of the ’411 patent. Petitioner reserves the right to advocate a different
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`claim construction in district court or any other forum.
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`A. DiGioia.
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`Ground 1 is based on DiGioia (Ex. 1005) and is addressed below.
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`Ground 35 U.S.C. §
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`Claims
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`References
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`1
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`103
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`1-17
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`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
`(“DiGioia”) (Ex. 1005), in view of
`“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
`(“DiGioia II”) (Ex. 1006) and
`knowledge of person of ordinary
`skill.
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`DiGioia is an article published at least as early as 1996. (See Ex. 1002 at 96
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`(Patent Owner admitting in IDS that DiGioia has a 1996 publication date).) As
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`discussed above, the earliest priority date for claims 1-17 of the ’411 patent can be
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`no earlier than November 12, 1998, two years later. Thus, DiGioia qualifies as
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`prior art under § 102(b).
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`DiGioia describes a system and methods to determine optimal implant
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`placement during hip replacement surgery through the use of pre-operative
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`planning, a range of motion simulator, and intra-operative navigational tracking
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`and guidance. As it explains, a common problem causing complications after hip
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`replacement surgery is poor positioning of the implant. The DiGioia system,
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`called HipNav, allowed the surgeon to specify a component position, after which
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`the range of motion simulator would estimate femoral range of motion based on
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`parameters provided by the pre-operative planner. The feedback from the
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`simulator allowed the surgeon to determine patient-specific optimal implant
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`placement. The intra-operative tracking and guidance helped place the implant in
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`that optimal position, regardless of the position of the patient on the operating
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`table.
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`DiGioia is clearly relevant to the patentability of the claims of the ’411
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`patent, as it describes in detail the systems and methods claimed in the ’411 patent
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`over a year before the ’411 patent was filed. Like the system disclosed in the
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`’411’s independent system claims 1 and 10, DiGioia discloses:
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`(1) a computer system for facilitating implantation of an artificial
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`component in one of the specified joint types (Ex. 1005 at 1 (HipNav “allows a
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`surgeon to determine optimal patient specific acetabular implant placement and
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`accurately achieve the desired acetabular implant placement during surgery”)) with
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`(2) a pre-operative geometric planner (id. at 2 (“[P]re-operative planner
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`allows the surgeon to manually specify the position of the acetabular component
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`within the pelvis based upon pre-operative CT images,” and is therefore
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`geometric)) and
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`(3) a pre-operative kinematic biomechanical simulator in
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`communication with the geometric planner (id. at Fig. 3 (depicting range of
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`motion simulator with arrows illustrating communication between simulator and
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`planner)), where
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`(4) the geometric planner outputs a geometric model of the joint (id. at 2
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`(simulator receives from pre-operative planner implant placement parameters,
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`which are necessarily based upon and described relative to geometric model of
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`joint)), and
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`(5) a tracking device communicating with the computer system (id. at 4
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`(intra-operative system includes Optotrak optical tracking camera capable of
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`tracking special LEDs)).
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`Similarly, like the method disclosed in the ’411’s independent method claim
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`17, DiGioia discloses a computerized method:
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`(1) for facilitating implantation of an artificial implant in one of the
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`specified joint types (Ex. 1005 at 1), comprising
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`(2) creating a three-dimensional bone model (id. at 5-6, Fig. 8 (system
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`uses pelvic surface model constructed from CT data using techniques discussed in
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`three-dimensional modeling article)),
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`(3) creating a three-dimensional component model (id. at Fig. 4
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`(depicting positioning of implant component across three orthogonal views of
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`pelvis)),
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`(4) simulating movement of the joint with the artificial implant in a test
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`position (id. at 2 (discussing range of motion simulator)),
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`(5) calculating a range of motion (id. at 3-4 (simulator performs kinematic
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`analysis to determine envelope of safe range of motion)),
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`(6) identifying the implant position in the bone model (id. at 3 (surgeon
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`can position cross sections of implant upon orthogonal view of pelvis)),
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`(7) aligning the bone model with the bone based on tracking data (id. at
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`5 (disclosing registration process to align position of patient to pre-operative
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`plan)), and
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`(8) tracking the implant and bone to maintain alignment and determine
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`the position of the implant relative to the bone (id. at 5-7 (discussing tracking of
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`implant and bone and use of navigational feedback)).
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`The few claim elements that are not explicitly disclosed by DiGioia are
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`minor, obvious variations. For example, claim 1 requires the pre-operative
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`kinematic biomechanical simulator to output a position for implantation of the
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`artificial component. The DiGioia system discloses that feedback from the
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`simulator can aid the surgeon in determining optimal implant placement.
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`(Ex. 1005 at 2.) It would have been obvious to utilize the feedback to modify the
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`position of an implant, re-run the simulation to determine optimal position, and
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`output that position to the pre-operative planner. (Ex. 1004 ¶ 38.) This is also
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`suggested by DiGioia Figure 3, which depicts bi-directional communication
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`between the pre-operative planner and the range of motion simulator. (Id.)
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`Similarly, claim 17 requires the system to determine an implant position based on a
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`predetermined range of motion and the calculated range of motion. DiGioia
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`discloses calculation of a range of motion and states the surgeon may choose to
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`modify a selected position to achieve optimal implant positioning. (Ex. 1005 at 3.)
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`It would have been obvious to consider the specific patient’s functional needs and
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`the range of motion needed to perform those functional needs, which could be
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`predetermined, to help in determining optimal implant positioning. (Ex. 1004
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`¶ 41.)
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`DiGioia also matches the ’411 patent’s dependent claims:
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`• Claims 2 and 15 add an intra-operative navigational module in
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`communication with the pre-operative kinematic biomechanical
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`simulator. DiGioia illustrates that the system also includes an “Intra-
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`operative Tracking & Guidance” component. DiGioia indicates that
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`this component includes an “intra-operative guidance system” which
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`includes “registration of pre-operative information . . . to the position
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`of the patient. (Ex. 1005 at 5.) Once anatomical location is
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`determined “via registration, navigational feedback can be provided to
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`the surgeon on a television monitor, as seen in Figure 9.” (Id. at 6.)
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`• Claim 3 requires a tracking device in communication with said intra-
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`operative navigational module. DiGioia discloses that the intra-
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`operative system includes “an ‘Optotrak’ optical tracking camera . . .
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`which is capable of tracking the position of special light emitting
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`diodes . . . to allow highly reliably tracking.” (Ex. 1005 at 4.) “In
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`order to determine the location of the pelvis and the acetabular
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`implant during surgery, Optotrak targets are attached to several
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`conventional surgical tools, as seen in Figure 7.” (Id.) DiGioia
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`indicates that “[o]nce the location of the pelvis is determined . . .
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`navigational feedback can be provided to the surgeon.” (Id. at 6.)
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`Thus, because the navigation module relies upon the tracking device,
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`the navigation module is in communication with the tracking device.
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`• Claim 4 requires the pre-operative geometric planner to be responsive
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`to a skeletal data source. DiGioia states that the “first step in using
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`the HipNav system is the pre-operative CT scan which is used to
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`determine the patient’s specific bony geometry. The CT images are
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`used in the pre-operative planner which allows the surgeon to
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`determine appropriate implant size and placement.” (Ex. 1005 at 3.)
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`Therefore, the data source inherently is a skeletal data source.
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`• Claim 5 adds that the skeletal data source includes geometric data.
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`DiGioia states that “the pre-operative CT scan . . . is used to determine
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`the patient’s specific bony geometry” (Ex. 1005 at 3) and therefore the
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`skeletal data source inherently includes geometric data.
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`• Claim 6 requires the geometric planner to output at least one
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`geometric model of the component. DiGioia states that the “pre-
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`operative planner allows the surgeon to manually specify the position
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`of the acetabular component within the pelvis . . . [and then] [t]he
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`range of motion simulator estimates femoral range of motion based
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`upon the implant placement parameters provided by the pre-operative
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`planner.” (Ex. 1005 at 2.) Thus, the pre-operative planner outputs a
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`geometric model of the component to the range-of-motion simulator.
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`• Claim 7 requires the pre-operative kinematic biomechanical simulator
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`to be responsive to the geometric model and output an implant
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`position. As noted under claim 6, “[t]he range of motion simulator
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`estimates femoral range of motion based upon the implant placement
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`parameters provided by the pre-operative planner” (Ex. 1005 at 2) and
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`therefore is responsive to said geometric model. As discussed under
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`claim 1, it would have been obvious to a person of skill in the art to
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`utilize the simulator feedback to modify the position of an implant, re-
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`run the simulation to determine optimal position, and output that
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`position to the pre-operative planner. (Ex. 1004 ¶ 38.)
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`• Claim 8 requires the implant position to include an angular orientation
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`of the component. DiGioia notes that using navigational feedback
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`provided to the surgeon, “[o]nce aligned, the implant is in the pre-
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`operatively planned position and orientation.” (Ex. 1005 at 6.) Thus,
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`pre-operative planning involves determining both the position and
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`orientation of the implant location.
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`• Claim 9 adds that the tracking device must be selected from the group
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`consisting of an acoustic tracking system, shape based recognition
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`tracking system, video-based tracking system, mechanical tracking
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`system, electromagnetic tracking system and radio frequency tracking
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`system, and claim 13 requires that the tracking device include at least
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`one camera. DiGioia discloses an Optotrak camera-based tracking
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`system. (Ex. 1005 at 4.) Even if this was not considered a video-
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`based tracking system, video-based tracking systems were widely
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`used and known to those of skill in the art in the mid-1990s, and it
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`would have been obvious to combine video-based capability with the
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`DiGioia system or substitute a video-based tracking system for the
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`Optotrak camera system. (See Ex. 1004 ¶ 39.)
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`• Claim 11 adds a display monitor in communication with the computer
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`system of claim 10. DiGioia states that using “the planner, the
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`surgeon can position cross sections of the acetabular implant upon
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`orthogonal views of the pelvis, as seen in Figure 4.” (Ex. 1005 at 3.)
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`This user interface of the pre-operative planner is a display monitor in
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`communication with the computer of the pre-operative planner.
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`• Claim 12 adds a controller in communication with the computer
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`system. DiGioia states that the “pre-operative planner allows the
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`surgeon to manually specify the position of the acetabular component
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`within the pelvis.” (Ex. 1005 at 2.) A controller, such as a mouse,
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`joystick or keyboard, or voice-activated control, would necessarily
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`have been provided to allow the surgeon to manually specify the
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`implant position.
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`• Claim 14 adds that the tracking device includes at least one target.
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`DiGioia states that “[i]n order to determine the location of the pelvis
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`and the acetabular implant during surgery, Optotrak targets are
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`attached to several conventional surgical tools, as seen in Figure 7.
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`The pelvis is tracked by attaching a target to the pelvic portion of a
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`Harris leg length caliper . . . . The acetabular implant is tracked by
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`attaching a second target to the handle of an HGP II acetabular cup
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`holder and positioner . . . . A third Optotrak target is required by the
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`HipNav system to determine operating room coordinates . . . .” (Ex.
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`1005 at 4-5.)
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`• Claim 16 adds the requirement of a robotic device and surgical tool.
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`Several of the same authors, including DiGioia himself, previously
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`published “An Integrated Approach to Medical Robotics and
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`Computer Assisted Surgery in Orthopaedics,” Proc. 1st Int’l
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`Symposium on Medical Robotics and Computer Assisted Surgery, pp.
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`106-111, 1995 (“DiGioia II”) (Ex. 1006). DiGioia II discloses an
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`approach to improved surgical techniques incorporating pre-operative
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`planning with biomechanical analysis and computer or robot-assisted
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`surgery. (Ex. 1006 at 3.) It depicts a c
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