throbber
Trials@uspto.gov
`Tel: 571–272–7822
`
`
`
`
`
`Paper 31
`Entered: February 18, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`SMITH & NEPHEW, INC.,
`WRIGHT MEDICIAL GROUP, INC., and
`WRIGHT MEDICAL TECHNOLOGY, INC.,
`Petitioners,
`
`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.
`
`
`
`
`
`FINAL WRITTEN DECISION
` 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`

`

`IPR2013-00629
`Patent 7,806,896 B1
`
`I. INTRODUCTION
`
`We have jurisdiction under 35 U.S.C. § 6(c). This Final Written
`
`Decision is entered pursuant to 35 U.S.C. § 318(a).
`
`With respect to the asserted grounds in this trial, we have considered
`
`the positions set forth by Petitioners and Patent Owner in the Petition, Patent
`
`Owner’s Response, Petitioners’ Reply, and the evidence cited therein. For
`
`the reasons discussed below, we determine that Petitioners have shown, by a
`
`preponderance of the evidence, that claim 1 of the ’896 patent is
`
`unpatentable.
`
`A. Procedural History
`
`Smith & Nephew, Inc., filed a Petition requesting an inter partes
`
`review (Paper 3, “Pet.”) of claims 1 and 13 of U.S. Patent No. 7,806,896 B1
`
`(Ex. 1001, “the ’896 patent”). Pet. 2. Smith & Nephew included a
`
`Declaration of Dr. Jay Mabrey, M.D. (Ex. 1002). In our Decision to
`
`Institute Inter Partes Review (Paper 10, “Inst. Dec.”), we instituted a trial
`
`only as to claim 1 of the ’896 patent on four grounds. Inst. Dec. 27.
`
`In another proceeding, Wright Medical Group, Inc. and Wright
`
`Medical Technology, Inc., filed a Petition requesting an inter partes review
`
`of claims 1 and 40 of the ’896 patent, which we granted. IPR2014-00354,
`
`Paper 10. Subsequently, Bonutti Skeletal Innovations LLC (“Patent
`
`Owner”) filed a notice disclaiming claim 40 of the ’896 patent. IPR2014-
`
`00354, Paper 12.
`
`On June 30, 2014, we issued a decision granting the parties’ joint
`
`motion for joinder of Case IPR2013-00629 with Case IPR2014-00354.
`
`IPR2013-00629, Paper 18; IPR2014-00354, Paper 14.
`
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`IPR2013-00629
`Patent 7,806,896 B1
`
`Patent Owner filed a Response addressing the asserted grounds (Paper
`
`17, “PO Resp.”) with a Declaration of Dr. Scott D. Schoifet, M.D.
`
`(Ex. 2004). Smith & Nephew, Wright Medical Group, and Wright Medical
`
`Technology (collectively, “Petitioners”) then filed a Reply to Patent
`
`Owner’s Response (Paper 22, “Pet. Reply”) with a Reply Declaration of Dr.
`
`Mabrey (Ex. 1023).
`
`An oral hearing was held on October 27, 2014, with all parties
`
`present. Paper 30 (“Tr.”).
`
`No motions are outstanding.
`
`B. Related Proceedings
`
`Patent Owner identifies that an inter partes review has been instituted
`
`against the ’896 patent in Zimmer Holdings, Inc. v. Bonutti Skeletal
`
`Innovations LLC, IPR2014-00321 (PTAB June 2, 2014) (Paper 13) (trial
`
`instituted on claims 40–42 and 44–47 of the ’896 patent). Paper 9.
`
`The ’896 patent is involved in several district court actions: Bonutti
`
`Skeletal Innovations LLC v. Smith & Nephew, Inc., Civil Action No. 12-
`
`1111-GMS (D. Del.); Bonutti Skeletal Innovations LLC v. Zimmer Holdings
`
`Inc., Civil Action No. 1:2012-cv-01107 (D. Del.); Bonutti Skeletal
`
`Innovations LLC v. Wright Medical Group Inc., Civil Action No. 1:2012-cv-
`
`01110 (D. Del. 2012); Bonutti Skeletal Innovations LLC v. ConforMIS Inc.,
`
`Civil Action No. 1:2012-cv-01109 (D. Del.); Biomet Inc v. Bonutti Skeletal
`
`Innovations LLC, Civil Action No. 3:2013-cv-00176 (N.D. Ind.); and
`
`Bonutti Skeletal Innovations v. DePuy Mitek, Inc., Civil Action No. 1:2012-
`
`cv-11667 (D. Mass). Pet. 1; Paper 8, 2.
`
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`IPR2013-00629
`Patent 7,806,896 B1
`
`C. Technical 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
`
`patella (kneecap) covering the joint. Ex. 1002 ¶ 25. The distal end of the
`
`femur includes two rounded protrusions called condyles; the groove between
`
`them is known as the femoral groove, patellar groove, or trochlear groove.
`
`Id. The condyles glide on a piece of cartilage on top of the tibia to form the
`
`main load-bearing interface of the knee joint. Id. ¶¶ 23, 25.
`
`In general, knee replacement surgery involves removal of one or more
`
`portions of the knee’s bones and replacing them with artificial analogues.
`
`The process typically follows this procedure: exposing the knee by making
`
`an incision through the skin (id. ¶ 29), inserting one or more cutting guides
`
`(id. ¶¶ 32–35), resurfacing one or more bones (id.), and attaching the
`
`replacement portions (id. ¶ 36, noting the replacement also is called an
`
`implant). See also Pet. 9–13 (discussing knee replacement surgery).
`
`“Accurate alignment of knee implants is essential for the success of
`
`total knee replacement.” Ex. 1003, 49 (emphasis removed). Mechanical
`
`alignment guides typically are used “to assure that cutting guides were
`
`properly aligned with the leg when placed on the bone.” Ex. 1002 ¶ 34; see
`
`also Ex. 1001, 17:16–18 (disclosing that intramedullary instrumentation is
`
`used to cut a femur). These mechanical device guides often come in the
`
`form of a rod that is secured to the patient. Installation of the rod can be
`
`either intramedullary, wherein the rod is inserted into the medullary canal
`
`(bone marrow cavity) of the tibia, or extramedullary, wherein the rod is
`
`attached to the patient’s leg. Ex. 1002 ¶ 34; Ex. 1001, 17:16–18 (“either . . .
`
`can be utilized”). Figures 10 and 11 of Stulberg (Ex. 1005) depict
`
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`IPR2013-00629
`Patent 7,806,896 B1
`
`intramedullary and extramedullary rods, respectively, and are reproduced
`
`below:
`
`
`
`Figure 10 depicts a cutting guide secured to a patient using an
`
`intramedullary rod inserted into the medullary canal of the tibia. Ex. 1002
`
`¶ 34. Figure 11 depicts a cutting guide secured to a patient using an
`
`extramedullary rod strapped to the patient’s ankle. Id.
`
`D. The ’896 Patent
`
`The ’896 patent, titled “KNEE ARTHROPLASTY METHOD,”
`
`issued October 5, 2010 from U.S. Patent Application No. 10/722,102, filed
`
`November 25, 2003. Ex. 1001 at [54], [45], [21], and [22]. The ’896 patent
`
`is a continuation of U.S. Patent Application No. 10/191,751, filed July 8,
`
`2002, now U.S. Patent No. 7,104,996, and is a continuation-in-part of a
`
`number of earlier-filed applications. Id. at [63].
`
`The ’896 patent discusses methods for performing knee replacement
`
`surgery. Particularly, the ’896 patent discusses alignment systems that do
`
`not use intramedullary and/or extramedullary rods. Such alternative
`
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`IPR2013-00629
`Patent 7,806,896 B1
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`alignment systems are described as including percutaneous mounting
`
`(exterior mounting, through the skin), and the use of computer imaging
`
`devices. Ex. 1001, 38:9–12 (percutaneous mount), 36:55–62, 72:7 et seq.
`
`(computer imaging). Claim 1 specifies that the position of the cutting guide
`
`is determined “using references derived independently from an
`
`intramedullary device,” and that the cutting guide is secured to the bone
`
`“free of an extramedullary or intramedullary alignment rod.” Id. at 112:63–
`
`64, 113:1–2.
`
`The ’896 patent also highlights the importance of smaller incisions,
`
`“[t]he benefits of [which] include improved cosmetic results, improved
`
`rehab, less dissection of muscle and soft tissue, and preservation of the
`
`quadriceps mechanism.” Id. at 15:15–18. In order to have smaller incisions,
`
`smaller instruments must be used. Id. at 17:48–59. Claim 1 specifies that
`
`the “replacement portion [of the knee] ha[s] a transverse dimension that is
`
`larger than a transverse dimension of the [cutting] guide surface.” Id. at
`
`113:8–10.
`
`E. The Challenged Claim
`
`Claim 1 is the only remaining claim challenged.
`
`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
`
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`IPR2013-00629
`Patent 7,806,896 B1
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`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.
`
`F. The Instituted Grounds
`
`The following grounds asserted by Petitioners were instituted in this
`
`proceeding (Inst. Dec. 27):
`
`References
`
`Basis Claim
`
`Challenged
`
`Delp1 and either Turner2 or Scorpio3
`
`Stulberg4 and either Turner or Scorpio
`
`§ 103 1
`
`§ 103 1
`
`
`1 Scott L. Delp, et al., Computer Assisted Knee Replacement, 354 CLINICAL
`ORTHOPAEDICS AND RELATED RESEARCH 49–56 (1998) (“Delp Article”)
`(Ex. 1003).
`2 Roderick H. Turner, et al., Geometric and Anametric Total Knee
`Replacement, in TOTAL KNEE REPLACEMENT 171–93 (A.A. Savastano, M.D.
`ed. 1980) (“Turner”) (Ex. 1008).
`3 Stryker Howmedica Osteonics, Scorpio Single Axis Total Knee System –
`Passport Total A.R. Total Knee Instruments – Passport A.R. Surgical
`Technique (May 2000) (“Scorpio”) (Ex. 1009).
`4 S. David Stulberg, et al., Computer-Assisted Total Knee Replacement
`Arthroplasty,” 10(1) OPERATIVE TECHNIQUES IN ORTHOPAEDICS 25–39 (Jan.
`2000) (“Stulberg”) (Ex. 1005).
`
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`IPR2013-00629
`Patent 7,806,896 B1
`
`II. ANALYSIS
`
`A. Claim Construction
`
`We interpret the claims of an unexpired patent using the broadest
`
`reasonable interpretation in light of the specification of the patent. 37 C.F.R.
`
`§ 42.100(b). 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). Further, “the specification and prosecution history only compel
`
`departure from the plain meaning in two instances: lexicography and
`
`disavowal.” GE Lighting Solutions, LLC v. Agilight, Inc., 750 F.3d 1304,
`
`1309 (Fed. Cir. 2014) (citing Thorner v. Sony Computer Entm’t Am. LLC,
`
`669 F.3d 1362, 1365 (Fed. Cir. 2012)). The standards for lexicography and
`
`disavowal are exacting, and require clear intent to define or narrow a term.
`
`Thorner, 669 F.3d at 1365–66. Any special definition for a claim term must
`
`be set forth with reasonable clarity, deliberateness, and precision. In re
`
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`In our Decision to Institute, we adopted Petitioners’ proposed
`
`constructions. Inst. Dec. 9.5 Neither party argues that these terms, or any
`
`other terms, require further construction. Accordingly, we maintain the
`
`following constructions:
`
`
`5 We refer only to the Decision to Institute and Petition filed in IPR2013-
`00629 in this Decision. The Decision to Institute and Petition filed in
`IPR2014-00354 are similar to those in IPR2013-00629, such that we need
`not refer to those.
`
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`IPR2013-00629
`Patent 7,806,896 B1
`
`Term
`
`Adopted Construction
`
`“cutting guide”
`
`“guide that has a guide surface”
`
`“guide surface”
`
`“a surface that guides a cutting instrument”
`
`
`
`
`
`The term “a transverse dimension of the guide surface” appears in
`
`claim 1. Ex. 1001, 113:8–9. This term was not construed in our Decision to
`
`Institute, and neither party offers a construction of the term. We construe
`
`the term for this Decision, however, because an issue now requires us to
`
`consider what is “a transverse dimension of the guide surface.”
`
`
`
`The ’896 patent does not define the term “transverse dimension” as it
`
`relates to the guide surface. The ’896 patent discusses the term “transverse
`
`dimension” as it relates to a cutting guide making an anterior resection, but it
`
`does not speak to the guide surface. Ex. 1001, 17:48–59. The guide surface
`
`of the cutting guide discussed in this passage is shown in Figure 13 to have a
`
`roughly trapezoidal planar shape. Figures 11 and 13 of the ’896 patent are
`
`reproduced below:
`
`
`
`Figure 11 of the ’896 patent depicts a view of cutting guide 138 along the
`
`femoral axis. Guide surface 178 is described as a slot on cutting guide 138.
`
`Id. at 21:44–45 (“anterior resection guide 138 has a slot which forms the
`
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`IPR2013-00629
`Patent 7,806,896 B1
`guide surface 178”).6 Figure 13 depicts a top-down cross section of cutting
`
`guide 138 along a plane of guide surface 178. As can be seen in Figure 13,
`
`guide surface 178 is a roughly trapezoidal planar shape, and the width of
`
`guide surface 178 where saw blade 170 enters cutting guide 138 (“physician
`
`side”) is narrower than the portion of guide surface 178 where saw blade 170
`
`leaves cutting guide 138 (“bone side”).7 Likewise, Figure 13 shows the
`
`coaxial dimension of guide surface 178 (i.e., the dimension in a direction
`
`coaxial to the femoral axis) is smaller on the side closer to the midline of the
`
`femur than on the medial side due to a triangular portion of the cutting
`
`guide.
`
`Patent Owner recognizes that Figure 13 of the ’896 patent depicts the
`
`width of guide surface 178 on the physician side to be smaller than the width
`
`of guide surface 178 on the bone side. See PO Resp. 39–40. Patent Owner
`
`argues, however, that the ’896 patent equates the width of guide surface 178
`
`(and thus, presumably, “a transverse dimension of the guide surface”) to be
`
`the width of cutting guide 138. Specifically, Patent Owner argues, “the
`
`specification describes the cutting guide of Figures 11 and 13 as having a
`
`single guide surface 178 extending across the entire cutting guide 138
`
`notwithstanding the fact that the slot extends across only a part of the handle
`
`side of the cutting guide 138 ('896 patent, Col. 20, ll. 15-46).” PO Resp. 39.
`
`Patent Owner does not explain, however, how the cited passage supports its
`
`
`6 The terms “guide surface” and “cutting guide” are not used in the
`specification of the ’896 patent at these passages to describe items 138 and
`178, but we identify the structures in the same manner as Patent Owner.
`PO Resp. 39.
`7 The width of the cutting guide corresponds to a “transverse dimension”
`because it is “in a direction perpendicular to the longitudinal central axis of
`the femur.” Ex. 1001, 17:58–59; Tr. 13:5–8, 25:114.
`
`
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`IPR2013-00629
`Patent 7,806,896 B1
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`position. Upon reviewing this passage, we find it discusses guide surface
`
`178 and cutting guide 134 in relation to the bone, but never to each other.
`
`Accordingly, we discern no portion of this passage that is a clear intent to
`
`limit “a transverse dimension of the guide surface” to mean the transverse
`
`dimension of the cutting guide. See Thorner, 669 F.3d at 1365–66.
`
`Likewise, we discern no portion of this passage that is a clear intent to limit
`
`“a transverse dimension of the guide surface” to be any particular transverse
`
`dimension of the guide surface. See id.
`
`Because the ’896 patent does not limit which particular transverse
`
`dimension of the guide surface one must measure to determine “a transverse
`
`dimension of the guide surface,” and the guide surface has at least two
`
`apparent transverse dimensions to measure (physician- and bone-side edges),
`
`we determine that the broadest reasonable interpretation of “a transverse
`
`dimension of the guide surface” is any measure of a transverse dimension of
`
`the guide surface. See Ex. 1002 ¶ 70 (Dr. Mabrey demarcates the extent of
`
`the transverse dimension of the guide surface as measured at the physician-
`
`side edge of the guide surface)
`
`Having construed the claim terms or phrases that are necessary to
`
`resolve the issues raised by the parties, we now turn to the asserted grounds.
`
`B. The Stulberg-Scorpio Ground
`
`
`
`We first discuss the prior art used in Petitioners’ ground. Then we
`
`discuss the ground itself, the issues raised in Patent Owner’s arguments, and,
`
`finally, we present our analysis.
`
`
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`IPR2013-00629
`Patent 7,806,896 B1
`
`1. Stulberg
`
`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.
`
`Stulberg teaches that successful knee replacement surgery is driven by
`
`proper alignment of the replacements. Ex. 1005, 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
`
`uses the computer to align a cutting block over the bone, and then secures
`
`the cutting block using a wire. Id. at 30, Fig. 16. A cutting guide is
`
`attached, then the cuts are made and the replacement is fitted and tested. Id.
`
`at 32, Fig. 17.
`
`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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`IPR2013-00629
`Patent 7,806,896 B1
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`Figure 15 of Stulberg depicts an intramedullary rod (ghosted), introduced
`
`into the femoral medullary canal to secure the distal femoral cutting block.
`
`Id. at 35.
`
`To contrast the mechanical technique, Stulberg presents Figure 16B,
`
`showing the cutting block used in the computer-assisted technique,
`
`reproduced below:
`
`Figure 16B of Stulberg depicts the distal femoral cutting block placed in the
`
`sagittal (front-rear) plane during the computer-assisted technique. Id. at 35.
`
`Figure 16B does not depict, nor does the accompanying text describe, an
`
`intramedullary or extramedullary rod; however, Figure 16B depicts the use
`
`of rigid bodies attached to the femur and the cutting block, which are tracked
`
`
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`IPR2013-00629
`Patent 7,806,896 B1
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`by a computer. Id. at 30. The cutting block is secured by threaded wire to
`
`the femur. Id.
`
`2. Scorpio
`
`The Scorpio reference provides instructions for surgeons installing the
`
`“Scorpio® Total Knee” replacement (Ex. 1009, 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 resection
`
`(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.
`
`Figure 15 of Scorpio depicts an anterior resection guide having two laterally
`
`spaced cutting guide slots, the guide seated atop a femoral alignment guide
`
`
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`IPR2013-00629
`Patent 7,806,896 B1
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`attached to the distal end of the femur. See also id. at Fig. 17 (depicting a
`
`saw inserted into one cutting guide slot).
`
`3. Petitioners’ Proposed Combination
`
`Petitioners assert 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; see also Inst. Dec. 14–19 (determining Petitioner Smith &
`
`Nephew had established a reasonable likelihood of showing the subject
`
`matter of claim 1 obvious on this ground). Petitioners assert that each of the
`
`two resection guide slots in Scorpio is a guide surface, and they are each
`
`smaller than the replacement portion. Pet. 33–34, 45–46. Petitioners further
`
`assert that a person of ordinary skill in the art would “follow the teachings of
`
`Stulberg that computer-assisted surgery can overcome the deficiencies of
`
`standard mechanical measuring techniques,” specifically the mechanical
`
`instrument in Scorpio. Id. at 45–46; see also Pet. Reply 11 (“A person of
`
`ordinary skill therefore would have been motivated to reduce trauma by
`
`eliminating mechanical alignment, as taught in . . . Stulberg, combined with
`
`smaller guide surfaces, as shown in . . . Scorpio.”); Ex. 1023 ¶ 43.
`
`Petitioners reason this would improve the accuracy of Scorpio (Pet. Reply
`
`8), and is “the predictable use of prior art technology according to its
`
`established function to achieve a predictable result” (Pet. at 46 (citing
`
`Ex. 1002 ¶ 92)).
`
`4. Issues
`
`Patent Owner makes two principal arguments. First, Patent Owner
`
`argues that the two slots of Scorpio are actually part of the same guide
`
`
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`IPR2013-00629
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`surface, such that their combined width is greater than the replacement
`
`portion. PO Resp. 20, 35–40. Second, Patent Owner argues that there is no
`
`reason to combine the references. Id. at 32–35, 40–45. We address each
`
`argument in turn.
`
`5. Scorpio’s Guide Surface
`
`Patent Owner does not dispute Petitioners’ assertion that Figure 15 of
`
`Scorpio depicts two slots within which a cutting blade may enter. Patent
`
`Owner disputes that those two slots should be considered two separate guide
`
`surfaces, and argues that Scorpio only discloses one guide surface.
`
`PO Resp. 20, 35–40. In support of this position, Patent Owner offers
`
`evidence, outside of the Scorpio reference itself, that the cutting guide of the
`
`product described in the Scorpio reference allegedly has a small passage that
`
`connects the left and right slots, such that they are both part of the same
`
`guide surface. Ex. 2004 ¶ 59. Patent Owner’s declarant, Dr. Schoifet,
`
`testifies that he is in possession of such a Scorpio-branded resection guide.
`
`Id.
`
`Patent Owner offers the following schematics showing the small
`
`passage of Dr. Schoifet’s Scorpio-branded guide:
`
`PO Resp. 20. Reproduced above on the left is a perspective drawing of a
`
`Scorpio-branded resection guide, allegedly depicting the slots of Scorpio
`
`from the bone side of the guide. Reproduced above on the right is a top-
`
`
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`Patent 7,806,896 B1
`
`down cross-section drawing of the Scorpio-branded anterior resection guide
`
`as sectioned along line 2 (at the slots) of the drawing on the left. This
`
`drawing reveals a triangular portion between the two slots of the guide.
`
`Patent Owner’s position is that the apex of the triangle is truncated, such that
`
`there is a small passage that joins the two slots, making them both part of the
`
`same guide surface. PO Reply 20, 35–40.8
`
`
`
`Petitioners respond that the proper inquiry is what the Scorpio
`
`reference discloses, not any given Scorpio-branded product. Pet. Reply 5.
`
`We agree. See, e.g., In re Boe, 355 F.2d 961, 965 (CCPA 1966) (cited in In
`
`re Inland Steel Co., 265 F.3d 1354 (Fed. Cir. 2001) (holding that a reference
`
`must be evaluated for all that it teaches one of ordinary skill in the art)).9
`
`Notably, Petitioners do not rely on a theory of inherency in their Petition.
`
`See Pet. 43–47; Tr. 11:7–12 (“we don’t rely on inherency at all for
`
`Scorpio”). Further, we find that Patent Owner has not met a threshold
`
`showing that the features of the Scorpio-branded product (see, e.g., Ex.
`
`2007) are inherent to the Scorpio reference, or would have been understood
`
`by one of ordinary skill in the art to be disclosed by the Scorpio reference.
`
`Patent Owner merely offers the testimony of Dr. Schoifet that the particular
`
`Scorpio-branded guide having the small passage is a “Scorpio Anterior
`
`Resection Guide that [he] used in 2003.” Ex. 2004 ¶ 59. There is a three-
`
`year timespan between the publishing date of Scorpio reference (2000) and
`
`
`8 Although Patent Owner does not discuss how big this passage is,
`Petitioners’ expert, Dr. Mabrey, measures it to be about 1 mm wide by 0.5
`mm deep. Ex. 1023 ¶ 14.
`9 In other words, if it can be shown that a reference would have led a person
`of ordinary skill in the art to believe a product had feature X, then that
`reference teaches feature X even if it can be shown, by other evidence in a
`different reference, that the product in fact had feature X′.
`
`
`
`
`17
`
`

`

`IPR2013-00629
`Patent 7,806,896 B1
`
`Dr. Schoifet’s use of a Scorpio-branded product (2003). Further, Patent
`
`Owner does not offer when Dr. Schoifet obtained the Scorpio-branded
`
`product, or when it was made. Lastly, a trademark identifies the source of
`
`goods, rather than the good itself, such that the mere circumstance that the
`
`prior art reference and the product share the “Scorpio” trade name is
`
`insufficient to conclude they are the same. In view of these factors, Patent
`
`Owner has not made a sufficient showing that the Scorpio-branded product
`
`Dr. Schoifet discusses is the same thing as, or understood to be included in,
`
`the Scorpio reference.
`
`Accordingly, we look to determine what a person of ordinary skill in
`
`the art, reviewing the Scorpio reference, would have understood regarding
`
`the extent and quantity of guide surfaces. As we stated above, Petitioners
`
`assert that Scorpio’s two slots are two small guide surfaces. Patent Owner
`
`argues, essentially, that the two slots of Scorpio are part of the same
`
`“continuous guide surface.” PO Resp. 19–21, 36–39. Patent Owner, relying
`
`on the testimony of Dr. Schoifet, argues that, if the two slots of Scorpio were
`
`not connected on the bone side of the guide, “the cutting guide could not
`
`make the anterior skim cut” and that Scorpio guide would be “inoperable for
`
`making the cut described.” Id. at 36–39 (citing Ex. 2004 ¶ 77). Patent
`
`Owner’s argument here is misplaced. The issue is not whether the slots are
`
`connected in some location, but rather whether a transverse dimension of a
`
`guide surface is smaller than a replacement portion. Boe, 355 F.2d at 965.
`
`As to this inquiry, the evidence before us supports Petitioners’ position.
`
`Petitioners rely on the testimony of Dr. Mabrey, who testifies that one
`
`of ordinary skill in the art, upon reviewing Figure 15 of Scorpio, would
`
`consider it to show two slots, each offering a guide surface for a different
`
`
`
`18
`
`
`
`

`

`IPR2013-00629
`Patent 7,806,896 B1
`
`cut, i.e., the surgeon would have to remove the cutting blade from a first slot
`
`on the device before cutting using the other slot. Ex. 1023 ¶¶ 10–13, 20; see
`
`also id. ¶¶ 12–13, 20 (offering expert opinion and evidence that one slot is
`
`intended to be used for the left knee, one for the right). Thus, the slots are
`
`two different guide surfaces for two different cutting motions. Whether
`
`these guide surfaces are connected at some unseen portion (as Patent Owner
`
`alleges) is not relevant for purposes of claim 1 of the ’896 patent because,
`
`looking at Figure 15 of Scorpio, we can ascertain the transverse dimension
`
`of the physician-side opening of that slot, which is a transverse dimension of
`
`that guide surface. According to Dr. Mabrey, this transverse dimension is
`
`less than a transverse dimension of a replacement portion. Ex. 1002 ¶ 70;
`
`Ex. 1023 ¶¶ 10–11. Patent Owner does not convince us otherwise. We,
`
`therefore, credit the testimony of Dr. Mabrey that this transverse dimension
`
`of the right guide surface of Scorpio in Figure 15 is less than a transverse
`
`dimension of a replacement portion.
`
`Further, even if we were to consider the Scorpio-branded guide as
`
`evidence of what a person of ordinary skill in the art would have understood
`
`reading the Scorpio reference, and we were limited to considering “a
`
`transverse dimension of the guide surface” to mean the longest transverse
`
`dimension of the guide surface, arguendo, we would still be persuaded that
`
`Scorpio disclose the claimed features. First, Dr. Mabrey’s testimony that the
`
`two slots define two different guide surfaces because they are used in two
`
`different cutting motions is persuasive, even if the slots in Scorpio’s Figure
`
`
`
`19
`
`
`
`

`

`IPR2013-00629
`Patent 7,806,896 B1
`15 were to overlap.10 In other words, a person of ordinary skill in the art
`
`would consider them different guide surfaces because of the way they are
`
`used, and a small overlap would not change that use. Second, we are not
`
`persuaded that this incredibly tiny passage even is used as a cutting guide.
`
`Dr. Schoifet testifies that the small passage is necessary to sufficiently angle
`
`a cutting blade (Ex. 2004 ¶ 78), but Dr. Mabrey’s performance of a complete
`
`resection using only one slot and not using the small passage refutes Dr.
`
`Schoifet’s testimony on this matter (Ex. 1023 ¶¶ 15–16, 19–21). Dr.
`
`Schoifet offers no other explanation as to why the small passage is necessary
`
`for resection. See also Ex. 1031, 127:7–148:9 (during over 30 minutes of
`
`questioning on this topic, Dr. Schoifet did not answer why he believed the
`
`Scorpio device would be inoperable without the small passage). Thus, even
`
`if we were to consider the Scorpio-branded guide in the manner Patent
`
`Owner proposes, Petitioners have established persuasively that the bone
`
`sides of both slots define two separate guide surfaces, either of which would
`
`be smaller than a transverse dimension of a replacement portion. See
`
`Ex. 2007 (noting the physician-side and bone-side transverse dimensions of
`
`the guide surfaces are essentially the same)
`
`In view of the above, we determine that Petitioners have shown, by a
`
`preponderance of the evidence, that Scorpio describes a guide surface having
`
`
`10 The overlap would be extremely small. Dr. Mabrey testifies that the small
`passage in the Scorpio-branded product is about 1 mm wide by 0.5 mm
`deep. Ex. 1023 ¶ 14. This would make the passage the size of about half a
`pinhead on an object a little larger than a person’s knee. See Ex. 1005, Fig.
`15 (depicting the cutting guide extending past both sides of a femur);
`Scorpio Demonstration Photos, Ex. 1030, 40 (depicting the cutting guide
`installed on a cadaver, extending past both sides of the knee).
`
`
`
`20
`
`
`
`

`

`IPR2013-00629
`Patent 7,806,896 B1
`
`a transverse dimension less than a transverse dimension of a replacement
`
`portion.
`
`6. Reason to Combine Stulberg and Scorpio
`
`
`
`Petitioners assert that a person of ordinary skill in the art would
`
`“follow the teachings of Stulberg that computer-assisted surgery can
`
`overcome the deficiencies of standard mechanical measuring techniques,”
`
`such as the mechanical instrument in Scorpio. Pet. at 45–46. Patent Owner
`
`makes several arguments: there is “no apparent reason [to] abandon the
`
`cutting guide of Stulberg” (PO Resp. 32); “if . . . Scorpio is to be used, it
`
`would need to be mounted with an intramedullary alignment rod” (id. at 33,
`
`35); “Stulberg provides a distal femoral cutting guide [but] Scorpio . . . is an
`
`anterior resection guide” (id. at 34). Each of these arguments is
`
`unpersuasive because they presume bodily incorporation and do not speak to
`
`the combination proposed by Petitioners in the Petition.
`
`
`
`First, Petitioners show that the prior art establishes that one of
`
`ordinary skill in the art reviewing Stulberg had a reason to look to the use of
`
`computer assistance with respect to other cutting guides. Pet. 34–35 (citing
`
`Ex. 1002 ¶¶ 70–7

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