Trials@uspto.gov
`571-272-7822
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`Paper 10
`Entered: February 28, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SMITH & NEPHEW, INC.
`Petitioner
`
`v.
`
`BONUTTI SKELETAL INNOVATIONS LLC
`Patent Owner
`____________
`
`Case IPR2013-00629
`Patent 7,806,896 B1
`
`
`
`Before WILLIAM V. SAINDON, MICHAEL R. ZECHER, and
`RICHARD E. RICE, Administrative Patent Judges.
`
`SAINDON, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`571-272-7822
`
`
`
`
`
`
`
`Paper 10
`Entered: February 28, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SMITH & NEPHEW, INC.
`Petitioner
`
`v.
`
`BONUTTI SKELETAL INNOVATIONS LLC
`Patent Owner
`____________
`
`Case IPR2013-00629
`Patent 7,806,896 B1
`
`
`
`Before WILLIAM V. SAINDON, MICHAEL R. ZECHER, and
`RICHARD E. RICE, Administrative Patent Judges.
`
`SAINDON, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`Case IPR2013-00629
`Patent 7,806,896 B1
`
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`I. INTRODUCTION
`
`Smith & Nephew, Inc., filed a Petition (Paper 3, “Pet.”) to institute an
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`inter partes review of claims 1 and 13 of U.S. Patent No. 7,806,896 B1
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`(Exhibit 1001, the “’896 patent”) pursuant to 35 U.S.C. § 311 et seq. Patent
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`Owner, Bonutti Skeletal Innovations LLC, did not file a preliminary
`
`response. We have jurisdiction under 35 U.S.C. § 314.
`
`The standard for instituting an inter partes review is set forth in
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`35 U.S.C. § 314(a):
`
`THRESHOLD – The Director may not authorize an inter partes
`review to be instituted unless the Director determines that the
`information presented in the petition filed under section 311
`and any response filed under section 313 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.
`
`Upon consideration of the Petition, we determine that the information
`
`presented in the Petition establishes that there is a reasonable likelihood that
`
`Petitioner would prevail with respect to claim 1 of the ’896 patent.
`
`Accordingly, pursuant to 35 U.S.C. § 314, we authorize an inter partes
`
`review to be instituted only as to claim 1 of the ’896 patent.
`
`A. Related Proceedings
`
`
`
`Petitioner states that the ’896 patent is involved in co-pending
`
`litigation, styled Bonutti Skeletal Innovations LLC v. Smith & Nephew, Inc.,
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`Civil Action No. 12-1111-GMS (D. Del.). Pet. 1. Petitioner states that the
`
`pending lawsuit includes certain other patents and that the Petitioner has
`
`filed concurrently other petitions for inter partes review challenging the
`
`validity of those patents. Id. Since the filing of those petitions, several have
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`terminated; Smith & Nephew, Inc. v. Bonutti Skeletal Innovations LLC,
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`IPR2013-00605, challenging U.S. Patent No. 7,749,229, remains pending.
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`Patent 7,806,896 B1
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`B. Background
`
`The human knee joint is formed by the lower (distal) end of the femur
`
`(thighbone) and the upper (proximal) end of the tibia (shinbone), with the
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`patella (kneecap) covering the joint. Ex. 1002 ¶ 25. The distal end of the
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`femur includes two rounded protrusions called condyles; the groove between
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`them is known as the femoral groove, patellar groove, or trochlear groove.
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`Id. The condyles glide on a piece of cartilage on top of the tibia to form the
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`main load-bearing interface of the knee joint. Id. ¶¶ 23, 25.
`
`In general, knee replacement surgery involves removal of one or more
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`portions of the knee’s bones and replacing them with artificial analogues.
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`The process typically follows this procedure: exposing the knee by making
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`an incision through the skin (id. ¶ 29), inserting one or more cutting guides
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`(id. ¶¶ 32-35), resurfacing one or more bones (id.), and attaching the
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`replacement portions (id. ¶ 36, noting the replacement also is called an
`
`implant). See also Pet. 9-13.
`
`“Accurate alignment of knee implants is essential for the success of
`
`total knee replacement.” Ex. 1003, p. 49 (emphasis removed). Mechanical
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`alignment guides typically are used “to assure that cutting guides were
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`properly aligned with the leg when placed on the bone.” Ex. 1002 ¶ 34; see
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`also Ex. 1001, 17:16-18. These mechanical device guides often come in the
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`form of a rod that is secured to the patient. Installation of the rod can be
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`either intramedullary, wherein the rod is inserted into the medullary canal
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`(bone marrow cavity) of the tibia, or extramedullary, wherein the rod is
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`attached to the patient’s leg. Ex. 1002 ¶ 34; Ex. 1001, 17:16-18 (“either . . .
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`can be utilized”). Figures 10 and 11 of Stulberg (Exhibit 1005) depict
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`Patent 7,806,896 B1
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`intramedullary and extramedullary rods, respectively, and are reproduced
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`below:
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`Figure 10 depicts a cutting guide secured to a patient using an
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`intramedullary rod inserted into the medullary canal of the tibia. Ex. 1002
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`¶ 34. Figure 11 depicts a cutting guide secured to a patient using an
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`
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`extramedullary rod strapped to the patient’s ankle. Id.
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`C. The ’896 Patent (Ex. 1001)
`
`The ’896 patent, titled “KNEE ARTHROPLASTY METHOD,”
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`issued October 5, 2010 from U.S. Patent Application No. 10/722,102, filed
`
`November 25, 2003. The ’896 patent is a continuation of U.S. Patent
`
`Application No. 10/191,751, filed July 8, 2002, now U.S. Patent No.
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`7,104,996, and is a continuation-in-part of a number of earlier-filed
`
`applications.
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`Patent 7,806,896 B1
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`The ’896 patent claims methods for performing knee replacement
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`surgery.1 The ’896 patent discusses alignment systems that do not use
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`intramedullary and/or extramedullary rods. Such alternative alignment
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`systems are described as including percutaneous mounting (exterior
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`mounting, through the skin), and the use of computer imaging devices.
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`Ex. 1001, 38:9-12 (percutaneous mount), 36:55-62, 72:7 et seq. (computer
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`imaging). Claim 1 specifies that the position of the cutting guide is
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`determined “using references derived independently from an intramedullary
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`device,” and that the cutting guide is secured to the bone “free of an
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`extramedullary or intramedullary alignment rod.” Claim 13 specifies that
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`the cutting guide is “positionable . . . using references derived independently
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`from an intramedullary device.”
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`The ’896 patent also highlights the importance of smaller incisions,
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`“[t]he benefits of [which] include improved cosmetic results, improved
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`rehab, less dissection of muscle and soft tissue, and preservation of the
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`quadriceps mechanism.” Id. at 15:15-18. In order to have smaller incisions,
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`smaller instruments must be used. Id. at 17:48-59. Claims 1 and 13 both
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`specify that the “replacement portion [of the knee] ha[s] a transverse
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`dimension that is larger than a transverse dimension of the [cutting] guide
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`surface.”
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`Lastly, the ’896 patent considers the use of disposable cutting blocks
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`that “could easily be modified for new or updated instrumentation or for
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`customized instrumentation.” Id. at 108:19-21. Claim 13 recites steps of
`
`
`1 Claim 1: “[a] method of replacing at least a portion of a patient’s knee.”
`Claim 13: “[a] method of replacing at least a portion of a joint . . . attaching
`a replacement portion of the knee.”
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`“obtaining a customized cutting guide fabricated for the patient based on
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`preoperative information” and “disposing of the cutting guide.”
`
`D. Exemplary Claims
`
`Claims 1 and 13 are the only claims challenged. Pet. 2. Both are
`
`independent and are reproduced below.
`
`1. A method of replacing at least a portion of a patient’s knee,
`the method comprising the steps of:
`making an incision in a knee portion of a leg of the patient;
`determining a position of a cutting guide using references
`derived independently from an intramedullary device;
`positioning a cutting guide using the determined position,
`passing the cutting guide through the incision and on a
`surface of a distal end portion of an unresected femur,
`the cutting guide secured to the bone free of an
`extramedullary or intramedullary alignment rod;
`moving a cutting tool through the incision into engagement
`with a guide surface on the cutting guide; and
`forming at least an initial cut on the femur by moving the
`cutting tool along the guide surface;
`attaching a replacement portion of the knee to the cut
`surface, the replacement portion having a transverse
`dimension that is larger than a transverse dimension of
`the guide surface.
`
`
`Ex. 1001, 112:60-113:10.
`
`13. A method of replacing at least a portion of a joint in a
`patient, the method comprising the steps of:
`obtaining a customized cutting guide fabricated for the
`patient based on preoperative information, the cutting
`guide positionable in a pre-determined position on a
`bone of the joint using references derived independently
`from an intramedullary device;
`making an incision adjacent to the joint in the patient;
`positioning the cutting guide in the pre-determined position
`by passing the cutting guide through the incision and on
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`a surface of an end portion of an unresected bone of the
`joint;
`moving a cutting tool through the incision into engagement
`with a guide surface on the positioned cutting guide;
`cutting the unresected bone of the joint for the first time, by
`moving the cutting tool along the guide surface;
`attaching a replacement portion of the knee to the cut
`surface, the replacement portion having a transverse
`dimension that is larger than a transverse dimension of
`the guide surface; and
`disposing of the cutting guide, as it is no longer safely
`usable the bone for which it was custom fabricated
`having been cut and therefore changed.
`
`
`Id. at 113:64-114:21.
`
`E. The Prior Art
`
`Petitioner relies on the following prior art:
`
`Reference
`
`Number
`
`Published
`
`Exhibit
`
`Feb. 16, 1999
`US 5,871,018
`Delp ’018
`Radermacher ’157 WO 93/25157 Dec. 23, 1993
`
`
`1004
`1007
`
`Scott L. Delp, et al., “Computer Assisted Knee Replacement,”
`354 Clinical Orthopaedics and Related Research (1998) (“Delp Article”)
`(Ex. 1003).
`
`S. David Stulberg, et al., “Computer-Assisted Total Knee
`Replacement Arthroplasty,” 10(1) Operative Techniques in Orthopaedics
`(Jan. 2000) (“Stulberg”) (Ex. 1005).
`
`Klaus Radermacher, et al., “Computer Assisted Orthopaedic Surgery
`With Image Based Individual Templates,” 354 Clinical Orthopaedics and
`Related Research (1998) (“Radermacher Article”) (Ex. 1006).
`
`Roderick H. Turner, et al., “Geometric and Anametric Total Knee
`Replacement,” in Total Knee Replacement (A.A. Savastano, M.D. ed. 1980)
`(“Turner”) (Ex. 1008).
`
`
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`Patent 7,806,896 B1
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`Stryker Howmedica Osteonics, Scorpio Single Axis Total Knee System
`– Passport Total A.R. Total Knee Instruments – Passport A.R. Surgical
`Technique (May 2000)2 (“Scorpio”) (Ex. 1009).
`
`F. The Asserted Grounds
`
`Reference(s)
`
`Delp Article and either Turner or Scorpio
`Delp ’018 and either Turner or Scorpio
`Stulberg and either Turner or Scorpio
`Radermacher ’157
`Radermacher Article and either Turner or Scorpio
`
`
`Basis Claims
`Challenged
`§103 1
`§103 1
`§103 1
`§102 13
`§103 13
`
`II. ANALYSIS
`
`A. Claim Construction
`
`As a step in our analysis for determining whether to institute a trial,
`
`we determine the meaning of the claims. Consistent with the statute and
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`legislative history of the Leahy-Smith America Invents Act (“AIA”), Pub. L.
`
`No. 112-29, 125 Stat. 284, 329 (2011), claims of unexpired patents are
`
`construed by applying the broadest reasonable interpretation, in light of the
`
`specification. 37 C.F.R. § 42.100(b); see also Office Patent Trial Practice
`
`Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012). Under the broadest
`
`reasonable interpretation 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). Any special definition for a claim term
`
`
`2 Petitioner asserts this reference is prior art under 35 U.S.C. § 102(b).
`Pet. 4. The reference indicates a copyright date of “2000” and “REV 05/00”
`on the back cover page. The Scorpio Single Axis Total Knee System is
`mentioned by name in the ’629 patent as a “known anterior resection guide”
`that is “commercially available.” Ex. 1001, 18:27-31.
`
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`must be set forth with reasonable clarity, deliberateness, and precision. In re
`
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`Petitioner proposes constructions for three terms. Pet. 5-6.
`
`Term
`
`“cutting guide”
`“guide surface”
`“customized cutting
`guide”
`
`
`Found in
`Claims
`1, 13
`1, 13
`13
`
`Petitioner’s Proposed Construction
`
`“guide that has a guide surface”
`“a surface that guides a cutting instrument”
`“a cutting guide modified for a specific
`patient”
`
`
`
`These proposed constructions are consistent with the way these terms
`
`are used in the ’896 patent’s written description and represent their plain and
`
`ordinary meaning. See Pet. 5-6 (citing Ex. 1001, 24:57-59 (“cuts are made
`
`by moving the saw blade 170 or other cutting tool along the guide surfaces
`
`on the femoral cutting guide”); Exs. 1010, 1011, 1012 (providing dictionary
`
`definitions for “customize,” a term not described in the specification of the
`
`’896 patent, outside of the claims)).
`
`We adopt Petitioner’s proposed constructions for purposes of this
`
`decision, and see no utility in further explanation at this time. Likewise, for
`
`purposes of this decision, all other terms are given their ordinary and
`
`customary meaning, as would be understood by one of ordinary skill in the
`
`art upon reviewing the specification, and need not be construed explicitly at
`
`this time.
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`B. Asserted Grounds of Unpatentability
`
`Petitioner asserts five grounds of unpatentability; three addressing
`
`claim 1 only and two addressing claim 13 only. We discuss the ground
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`addressing claim 1 and relying on Stulberg first.
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`1. Stulberg and either Turner or Scorpio
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`Petitioner asserts that the subject matter of claim 1 is obvious in view
`
`of Stulberg in combination with either Turner or Scorpio. Pet. 43-47. We
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`first describe some features of these references before turning to the
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`proposed grounds of unpatentability.
`
`Stulberg (Ex. 1005)
`
`Stulberg teaches that successful knee replacement surgery is driven by
`
`proper alignment of the replacements. Ex. 1005, p. 25. To that end,
`
`Stulberg discusses and contrasts computer-assisted total knee replacement
`
`arthroplasty with conventional, mechanically-assisted arthroplasty. Id.
`
`Stulberg states that the computer-assisted method “improve[s] the accuracy
`
`of the surgical technique.” Id. In the computer-assisted method, the surgeon
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`uses the computer to align a cutting block over the bone, and then secures
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`the cutting block using a wire. Id. at 30, fig. 16. The cuts are made and the
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`replacement is fitted and tested. Id. at 32.
`
`Stulberg contrasts the mechanical and computer-assisted techniques
`
`with respect to femoral cuts in further detail. Stulberg states that the
`
`mechanical technique uses an intramedullary rod; the rod is depicted in
`
`figure 15, reproduced below:
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`Figure 15 of Stulberg depicts an intramedullary rod (ghosted), introduced
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`into the femoral medullary canal to secure the distal femoral cutting block.
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`Id. at 35.
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`To contrast the mechanical technique, Stulberg presents figure 16B,
`
`showing the cutting block used in the computer-assisted technique,
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`reproduced below:
`
`Figure 16B of Stulberg depicts the distal femoral cutting block placed in the
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`sagittal (front-rear) plane during the computer-assisted technique. Id. at 35.
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`Figure 16B does not depict, nor does the accompanying text describe, an
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`intramedullary or extramedullary rod, however, Figure 16B depicts the use
`
`of rigid bodies attached to the femur and the cutting block, which are tracked
`
`by a computer. Id. at 30. The cutting block is secured by threaded wire to
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`the femur. Id.
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`Turner (Ex. 1008)
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`
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`The Turner reference describes the state of the knee replacement art as
`
`of 1980. Ex. 1008, inside cover.3 Of importance to the discussion in this
`
`decision, Turner discloses a femoral cutting guide. Id. at fig. 8. “The
`
`femoral cutting guide is inserted in the midline, deep to the suprapatellar
`
`pouch.” Id. at 181.4 Figures 8 and 9 of Turner are reproduced below.
`
`
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`
`
`Figure 8 of Turner depicts a femoral cutting guide that fits in the midline of
`
`the femur, such that its width is much smaller than the width of the resected
`
`bone. Figure 9 depicts the resulting appearance of the femur after the cut.
`
`
`3 This Exhibit begins with two unnumbered pages, which we refer to as the
`cover and inside cover.
`4 The suprapatellar pouch extends between the quadriceps tendon and the
`front of the femur, and is an extension of the synovial sac that encloses and
`lubricates the knee joint.
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`The portions of the femur that are cut are later covered by the prosthesis.
`
`See, e.g., id., fig. 20. Accordingly, the transverse dimension of the
`
`prosthesis will be larger than the transverse dimension of the cutting guide
`
`shown in figure 8. See also Pet. 33.
`
`Scorpio (Ex. 1009)
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`
`
`The Scorpio reference provides instructions for surgeons installing the
`
`“Scorpio® Total Knee” replacement (Ex. 1009, p. 2) using the “Passport
`
`A/R” surgical technique and tools (id. at 1). See also id. at 48-49 (providing
`
`various product limitations and warnings). Of importance to the discussion
`
`in this decision, Scorpio discloses an anterior (frontal) femoral cutting guide.
`
`Id. at 9. After installing a femoral alignment guide onto the distal end of the
`
`femur (see id. at 4-8), the anterior resection guide is inserted on top of the
`
`femoral alignment guide (id. at 9-11). Figure 15 of Scorpio, which is
`
`reproduced below with annotations added, depicts the anterior resection
`
`guide placed on the femoral alignment guide.
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`Figure 15 of Scorpio depicts an anterior resection guide having two laterally
`
`spaced cutting guide slots, the guide seated atop a femoral alignment guide
`
`attached to the distal end of the femur. See also id. at fig. 17 (depicting a
`
`saw inserted into one cutting guide slot).
`
`The Stulberg-Turner and Stulberg-Scorpio Combinations
`
`In the Petition, Petitioner asserts that Stulberg teaches every limitation
`
`of claim 1 except for the limitation, “the replacement portion having a
`
`transverse dimension that is larger than a transverse dimension of the guide
`
`surface.” Pet. 43-47. Petitioner asserts that Turner and Scorpio each
`
`disclose this feature. Id.
`
`Petitioner asserts that the width of the cutting guide shown in Turner,
`
`figure 8, is substantially smaller than the implant. Pet. 33 (citing Ex. 1008,
`
`figs. 3, 8, pp. 177, 181; Ex. 1002 ¶ 69).
`
`Petitioner also asserts that the width of the cutting guide shown in
`
`Scorpio, figure 15 (i.e., one of the slots), is smaller than the implant. Pet. 33
`
`(citing Ex. 1009, pp. 2, 9, fig. 15; Ex. 1002 ¶ 70).
`
`Petitioner asserts that it would have been obvious to use “the cutting
`
`guides and implants disclosed in Turner or Scorpio” along with the
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`“computer-assisted system disclosed in Stulberg.” Pet. 45. Petitioner’s
`
`reason for such a combination is to “overcome the deficiencies of standard
`
`mechanical measuring techniques.” Pet. 45-46. Petitioner points to a
`
`declaration of Dr. Jay D. Mabrey, who declares that the proposed
`
`combination is “no more than the predictable use of prior art technology
`
`according to its established function to achieve a predictable result.”
`
`Ex. 1002 ¶ 92.
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`Discussion of the Stulberg-Turner and Stulberg-Scorpio Combinations
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`Based on the information provided in the Petition, Petitioner has
`
`shown a reasonable likelihood of prevailing in showing claim 1 to be
`
`unpatentable over Stulberg in combination with either Turner or Scorpio.
`
`As we discussed above, Stulberg describes a method of replacing at
`
`least a portion of a patient’s knee, including the steps of making an incision,
`
`positioning a cutting guide, and using the cutting guide to guide a cutting
`
`tool to form a cut. See Ex. 1005, fig. 2 (depicting the incision), fig. 16B
`
`(depicting a cutting guide on a femur), fig. 19B (depicting cuts), fig. 20A
`
`(depicting a trial implant); see also Ex. 1002 ¶¶ 29-41 (describing a typical
`
`knee replacement surgery); Pet. 43-47.
`
`Reviewing Petitioner’s citations and supporting analysis, discussed
`
`above, we address three limitations recited in claim 1 in further detail below.
`
`
`
`“determining a position [without] an intramedullary device” (claim 1)
`
`Stulberg describes a method of positioning a cutting guide using a
`
`computer. Ex. 1005, p. 30 (“The surgeon can then track on the monitor the
`
`position of the cutting block relative to the distal femur”). This computer-
`
`assisted technique is contrasted with the mechanical technique, in which
`
`positioning requires placing the cutting guide onto an intramedullary rod.
`
`Id. (“Mechanical technique[:] . . . The distal femoral cutting block device is
`
`placed onto the rod.”); see also id. at Abstract. (pointing out the superiority
`
`of computer-assisted procedures over the mechanically-assisted procedure);
`
`Ex. 1002 ¶ 87 (declaring that an intramedullary rod is not used in the
`
`computer-assisted technique). Further, the main purpose of the
`
`intramedullary device is to position the cutting guide (Ex. 1002 ¶ 34), a
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`function that would be redundant in view of more precise computer
`
`positioning. Based on these considerations, Petitioner’s assertion (Pet. 44)
`
`that Stulberg’s computer-assisted technique does not use an intramedullary
`
`rod to determine the position of the cutting guide is reasonable.
`
`
`
`“the cutting guide secured to the bone free of an extramedullary or
`intramedullary alignment rod”(claim 1)
`
`In the computer-assisted technique of Stulberg, the cutting guide is
`
`secured to the femur using wire. Ex. 1005, p. 30. In contrast, in the
`
`mechanical technique, the cutting guide is secured to the femur with pins.
`
`Id.; see also Ex. 1002 ¶ 88 (declaring that one of ordinary skill in the art
`
`would understand that no rod is used in Stulberg because wire is used
`
`instead). Further, the cutting guide used in the mechanical technique is
`
`depicted as attached to the rod of the intramedullary device (Ex. 1005, fig.
`
`15), whereas no corresponding intramedullary rod is depicted in the
`
`analogous figure for the computer-assisted technique (id., fig. 16).
`
`Accordingly, Petitioner’s assertion that Stulberg’s technique secures the
`
`cutting guide to the bone free of an extramedullary or intramedullary
`
`alignment rod (Pet. 44) is reasonable.
`
`
`
`“the replacement portion having a transverse dimension that is larger than
`a transverse dimension of the guide surface”(claim 1)
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`Turner
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`The femoral cutting guide in Turner is sized to fit in the groove
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`between the condyles of the femur, which, in turn, are to be covered by the
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`replacement. Ex. 1008, 181, 177. Thus, the relative size of the guide
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`relative to the bone depicted in figure 8 sufficiently represents their true
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`Patent 7,806,896 B1
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`spatial relationship to support a finding that the guide in Turner is smaller in
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`a transverse dimension than the replacement. As such, based on this record,
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`Petitioner has made a threshold showing that Turner describes the relative
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`size relationship of the replacement portion and the guide surface as
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`claimed.
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`Scorpio
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`Regarding Scorpio, close inspection of figure 15 of Scorpio
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`(reproduced above) reveals that either one of the guides is narrower than the
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`distal end of the femur to be replaced, and, thus, would be smaller than the
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`replacement of that portion of the femur. See also Ex. 1002 ¶ 70 (“the
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`implant is approximately the width of the thighbone”). It is well established
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`that patent drawings are typically not to scale, however, and that written
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`support for the proportional relationship is generally necessary to support
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`such findings. See, e.g., Hockerson-Halberstadt, Inc. v. Avia Group Int'l,
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`Inc. 222 F.3d 951, 956 (Fed. Cir. 2000) (“it is well established that patent
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`drawings do not define the precise proportions of the elements and may not
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`be relied on to show particular sizes if the specification is completely silent
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`on the issue”) but see In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972)
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`(notwithstanding the general rule, “things patent drawings show clearly are
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`[not] to be disregarded.”). While Scorpio is not a patent, the rationale
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`behind the Hockerson-Halberstadt and Mraz holdings is instructive with
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`respect to drawings in non-patent literature such as Scorpio. To that end, we
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`determine whether it is reasonable to rely on the particular size relationship
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`depicted in figure 15 of Scorpio.
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`Petitioner does not offer an explanation, and merely cites to Dr.
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`Mabrey’s declaration, which, in turn, offer no more explanation than the
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`Petition. Pet. 33; Ex. 1002 ¶¶ 69-70. We do not find any explicit discussion
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`as to the precision of the drawings in Scorpio. Reviewing these drawings,
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`however, we find detail, precision, and consistency of the objects depicted.
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`See Mraz, 455 F.2d at 1072 (“things patent drawings show clearly are [not]
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`to be disregarded”). Further, the purpose of Scorpio is to instruct surgeons
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`on how to perform a surgical technique. Thus, it would seem particularly
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`important that the relative sizes of the objects depicted in the drawings
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`would be to scale, because out-of-proportion objects would not be as
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`instructive in showing proper technique and alignment, reducing the
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`usefulness of this document.
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`
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`Furthermore, to the extent the precision of the drawings in Scorpio
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`may not be relied on, Petitioner asserts that it would have been obvious to
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`one with ordinary skill in the art to narrow the slots, because reducing the
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`length of the guide surface “was a known solution for reducing trauma.”
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`Pet. 34 (citing Ex. 1002 ¶ 70 (“modifying the length of a guide surface is a
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`matter of routine practice”)); Ex. 1004, 22:45-50 (“smaller jigs” allow “a
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`smaller incision to be made,” which “will result in a less invasive
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`procedure”)). In view of the above, on this record, Petitioner has made a
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`threshold showing that Scorpio describes the relative size relationship of the
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`replacement portion and the guide surface as claimed.
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`Reason for Combination
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`
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`Petitioner offers an articulated reason with a rational underpinning to
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`combine the teachings of Stulberg with either Turner or Scorpio. According
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`to Petitioner, the combination “overcome[s] the deficiencies of standard
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`mechanical measuring techniques,” such as those of Turner and Scorpio, by
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`utilizing the computer-assisted system of Stulberg. Pet. 45-46. As
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`explained above, Stulberg explains that computer-assisted surgical
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`techniques “improve[] the accuracy of the surgical technique.” Ex. 1005,
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`p. 25. This improved technique “uses currently available mechanical total
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`knee instruments.” Id. at 33; see also Pet. 46. Accordingly, the proposed
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`combination appears to be nothing more than using a known technique to
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`improve a similar device in the same way. KSR Int’l Co. v. Teleflex, Inc.,
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`550 U.S. 398, 417 (2007).
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`In view of the above, Petitioner has shown a reasonable likelihood
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`that it would prevail in showing that claim 1 is obvious in view of the
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`combined teachings of Stulberg with either Turner or Scorpio.
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`2. Delp Article and either Turner or Scorpio
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`Petitioner asserts that the subject matter of claim 1 is unpatentable in
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`view of the Delp Article and either Turner or Scorpio. Pet. 27-37. We first
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`turn to the Delp Article’s disclosure, then to the proposed ground of
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`unpatentability.
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`Delp Article (Ex. 1003)
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`
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`The Delp Article discusses the limitations of mechanical alignment
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`guides, such as intramedullary and extramedullary devices, and proposes
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`three computer-based systems to improve the success of knee replacement
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`surgeries. Ex. 1003, p. 49. The first system utilizes computer-integrated
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`instruments to “augment[] mechanical instruments through the addition of
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`measurement probes that can be used to locate joint centers, track surgical
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`tools, and align prosthetic components.” Id. at 50-51. In this system, a
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`computer “displays the position of the cutting block relative to the desired
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`position.” Id. at 51. The cutting block (jig) is secured and the cuts are
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`made. Id. According to the Delp Article, this method “eliminates the need
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`for intramedullary and extramedullary alignment guides.” Id. at 55. The
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`second system in the Delp Article includes the use of computer imaging to
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`determine a preoperative plan that guides the placement of the components.
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`Id. at 50. The third system uses a robotic device to perform the cutting
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`operations. Id.
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`The Delp Article-Turner and Delp Article-Scorpio Combinations
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`
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`Petitioner asserts that the Delp Article teaches every limitation of
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`claim 1. Pet. 27-37. Petitioner asserts that Turner and Scorpio additionally
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`disclose the “transverse dimension” limitation. Pet. 32-33.
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`Petitioner asserts that the width of the cutting guide shown in Turner
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`at figure 8 is substantially smaller than the implant. Pet. 33 (citing Ex. 1008,
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`figs. 3, 8, pp. 177, 181; Ex. 1002 ¶ 69).
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`Petitioner also asserts that the width of the cutting guide shown in
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`Scorpio at figure 15 (i.e., one of the slots) is smaller than the implant.
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`Pet. 33 (citing Ex. 1009, pp. 2, 9, fig. 15; Ex. 1002 ¶ 70).
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`Petitioner determines that it would have been obvious to one of
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`ordinary skill in the art to use “the cutting guides and implants disclosed in
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`Turner or Scorpio” along with the “systems described in the Delp Article.”
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`Pet. 34. One reason for doing this, according to Petitioner, is because
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`“[u]sing ‘measurement probes’ . . . disclosed in the Delp Article to improve
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`the accuracy of mechanical instruments from Turner or Scorpio would have
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`been no more than the predictable use of prior art elements according to their
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`established functions.” Pet. 35; see also Ex. 1002 ¶ 72; Ex. 1003, p. 50 (the
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`purpose of the computer-integrated instruments are to “augment[]
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`mechanical instruments”). Petitioner also relies on the opinion of
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`Dr. Mabrey that the proposed combination is “no more than the predictable
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`use of prior art elements according to their established functions” requiring
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`no more than “routine skill.” Pet. 35 (citing Ex. 1002 ¶ 72).
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`Discussion of the Delp Article-Turner and Delp Article-Scorpio
`Combinations
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`Based on the information provided in the Petition, Petitioner has
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`shown a reasonable likelihood of prevailing in showing claim 1 to be
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`unpatentable over the Delp Article and either Turner or Scorpio. As we
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`explained above, the Delp Article describes a method of replacing at least a
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`portion of a patient’s knee. Based on our review of the Delp Article, we
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`agree with Petitioner that the Delp Article teaches the steps of making an
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`incision, positioning a cutting guide, and using the cutting guide to guide a
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`cutting tool to form a cut. See Ex. 1003, p. 51 (“Once a jig is oriented
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`properly it is secured . . . and the cuts are made with a standard oscillating
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`saw,” “Knee implants were installed in seven cadavers to test this system”);
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`see also Ex. 1002 ¶¶ 60-67; Pet. 27-32. In addition, the Delp Article
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`explicitly discloses eliminating intramedullary and extramedullary alignment
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`devices. Ex. 1003, p. 55.
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`We are not persuaded by Petitioner’s assertion that the Delp Article
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`discloses the limitation regarding the transverse dimension of the
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`replacement portion being larger than the transverse length of the cutting
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`guid
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