Paper
`Filed on behalf of: BONUTTI SKELETAL INNOVATIONS LLC
` Date: May 30, 2014
`
`
`
`By: Cary Kappel, Lead Counsel
`
`William Gehris, Backup Counsel
`
`Davidson, Davidson & Kappel, LLC
`
`485 Seventh Avenue
`
` New York, NY 10018
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`Telephone (212) 736-1257
`
`
`
`(212) 736-2015
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`Facsimile (212) 736-2427
`
`E-mail:
`ckappel@ddkpatent.com
`
`
`
`wgehris@ddkpatent.com
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SMITH & NEPHEW, INC.
`
`Petitioner,
`
`
`
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`v.
`
`
`
`BONUTTI SKELETAL INNOVATIONS LLC
`
`Patent Owner
`
`
`
`
`
`Case: IPR2013-00629
`
`Patent 7,806,896
`_______________
`PATENT OWNER’S RESPONSE
`PURSUANT TO 37 C.F.R. § 42.120
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`TABLE OF CONTENTS
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` Case IPR2013-00629
`
`Patent 7,806,896
`
`
`
`The '896 patent…………………………………………………..…………..1
`
`
`
`I.
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`II. The Priority Date of Claim 1 of the '896 patent…………………..…………9
`
`III. The Prior Art of the Instituted Grounds………….………………..……….10
`
`A. Stulberg………………………………………………………….…..11
`
`B. Delp……………………………………… .…………………..…….13
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`C. Turner…….………………………… …………………………..…..16
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`D.
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`Scorpio…….……………………………… ………………………..17
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`IV. Petitioner Has Not Established that Claim 1 is Unpatentable Under
`35 U.S.C. §103 as Obvious Over Stulberg in view of Turner or
`Scorpio…………………………………………………………....………..21
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`
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`
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`A. Stulberg In view of Turner…………………………………..….………24
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`
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`1.
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`Stulberg and Turner are Not Combinable……………. .……..24
`
`Even if Combined, Stulberg and Turner Would Not
`2.
`Create the Claimed Invention……….……………….…….…30
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`Stulberg in view of Scorpio……………………………………........32
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`1.
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`2.
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`Stulberg and Scorpio are Not Combinable……………...……32
`
`
`Even if Combined Stulberg and Scorpio Would Not
`Create the Claimed Invention………………….………..……35
`
`B.
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`V. Petitioner Has Not Established that Claim 1 is Unpatentable Under
`35 U.S.C. §103 as Obvious Over Delp in view of Turner or
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`i
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`Scorpio………………………………………………………………......…45
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`A. Delp in view of Turner………………………………………….…..47
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`1. Delp and Turner are Not Combinable……………………......48
`2.
`Even if Combined Delp and Turner Would Not Create the
`Claimed Invention………………………...………………....51
` B. Delp in view of Scorpio……………………………………………..53
`
`1. Delp and Scorpio are Not Combinable……………………….53
`
`2.
`Even if Combined Delp and Scorpio Would Not Create the
`
`
`Claimed Invention……………………………………….…...54
`VI. Conclusion………………………………………….……………………..….59
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` TABLE OF AUTHORITIES
`
`Case IPR2013-00629
`Patent 7,806,896
`
`Cases
`
`In re Abbott Diabetes Care, Inc., 696 F.3d 1142 (Fed. Cir. 2012) ....................... 39, 40
`Ex parte Datacard Corp., Appeal 2009-013947, 2010 Pat. App. LEXIS 15588 (Pat.
`App. 2010)…. .................................................................................................... 44, 52
`Ex parte Frede, Appeal 2010-008757, 2012 Pat. App. LEXIS 4492 (Pat. App.
`2012) ...................................................................................................... 31, 45, 52, 58
`Ex parte Habashi et al , Appeal 2011-008847, 2013 Pat. App. LEXIS 8057 (Pat.
`App. 2013) ............................................................................................................... 43
`In re:HOEG et al, Appeal 2011-011778, 2014 Pat. App. LEXIS 1132 (Pat. App.
`2014) ............................................................................................................ 23, 29, 47
`Ex Parte Kodas, et al, Appeal 2008-3302, 2008 Pat. App. LEXIS 8431 (Pat. App.
`2008) ........................................................................................................................ 26
`Ex parte LIN et al, Appeal 2011-009169, 2014 Pat. App. LEXIS 951 (Pat. App.
`2014) ............................................................................................................ 24, 29, 47
`Ex parte McKiernan et al, Appeal 2011-012188, 2012 Pat. App. LEXIS 5598, *9-
`11 (Pat. App. 2012) .................................................................................................. 39
`Ex parte Vanscoyok, Appeal 2011-011717, 2013 Pat. App. LEXIS 7627 (Pat. App.
`2013) ........................................................................................................................ 43
`Grain Processing Corp. v. American-Maize Prods. Co., 840 F.2d 902, 907 (Fed.
`Cir. 1988) ........................................................................................................... 27, 51
`In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986) .................................................. 28
`KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 417 (2007) .......................... 23,24,26,47
`In re NTP, Inc., 654 F.3d 1279 (Fed. Cir. 2011) ...................................... 27, 44, 51, 56
`
`iii
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`Orthopedic Equip Co. v. United States ................................................................. 27, 51
`In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2011) .............................. 39
`Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003)........................................ 43
`Versata Development Group, Inc., v. Sap America, Inc., Appeal No. 2014-1194 .... 40
`W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed.
`Cir. 1983) ............................................................................................................ 44,52
`
`
`
`Statutes/Regulatations
`
`35 U.S.C. § 103 ..................................................................................................... 21, 45
`35 U.S.C. § 316(a)(8) .................................................................................................... 2
`35 U.S.C. § 316(e) ........................................................................................................ 2
`37 C.F.R. § 42.120 ........................................................................................................ 2
`
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`Case: IPR2013-00629
`Patent 7,806,896
`Pursuant to 35 U.S.C. § 316(a)(8) and 37 C.F.R. § 42.120, Patent Owner
`
`
`
`
`
`Bonutti Skeletal Innovations, LLC ("Bonutti") responds to the Petition filed by
`
`Smith & Nephew, Inc. ("Smith & Nephew") concerning claim 1 of U.S. Patent No.
`
`7,806,896 ("the '896 patent") (Paper 3), with respect to Grounds A(1) and A(3) of
`
`the Petition, the only grounds on which the Board instituted inter partes review:
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`A(1) “Delp Article in View of Any One of Turner or Scorpio” (Petition, pp. 27-37);
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`and A(3) “Stulberg in View of Any One of Turner or Scorpio” (Id., pp. 42-47). (See
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`Institution Decision, Paper 10, page 27).
`
`Petitioner bears "the burden of proving a proposition of unpatentability by a
`
`preponderance of the evidence." 35 U.S.C. § 316(e). For the reasons set forth
`
`herein, Petitioner has failed to meet its burden to show by a preponderance of the
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`evidence that claim 1 is unpatentable as obvious over the Delp Article in view of
`
`either Turner or Scorpio, or that claim 1 is unpatentable as obvious over Stulberg in
`
`view of either Turner or Scorpio.
`
`I.
`
`The '896 patent
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`Claim 1 of the '896 patent recites:
`
`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;
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`1
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`Case: IPR2013-00629
`Patent 7,806,896
`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.
`
`Accordingly, as recited in claim 1, the cutting guide is passed through the
`
`incision and onto the surface of a distal end portion of an unresected femur, the
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`cutting guide has a guide surface and is secured to the bone free of an
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`extramedullary or intramedullary alignment rod. At least an initial cut is formed in
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`the femur by moving a cutting tool along the guide surface. A replacement portion
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`of the knee is attached to the cut surface, and that replacement portion has “a
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`transverse dimension that is larger than a transverse dimension of the guide
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`surface.”
`
`The '896 patent describes a number of inventive surgical devices and surgical
`
`methods. In particular, the '896 patent describes the use of reduced size cutting
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`guides in knee replacement surgery. ('896 patent, col. 3, ll. 15-30, col. 17, ll. 47-60,
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`cols. 69-71, cols. 103-104). The '896 patent explains that the “benefits of having a
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`Patent 7,806,896
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`smaller incision include improved cosmetic results, improved rehab, less dissection
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`
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`of muscle and soft tissue, and preservation of the quadriceps mechanism.” (Id., col.
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`15, ll. 15-18). By using reduced size cutting guides, “the size of the incision … can
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`be reduced”, and “reducing the size of the incision … reduces damage to body tissue
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`of the patient.” (Id., col. 18, ll. 36-38).
`
`The '896 patent explains:
`
`Although any one of many known surgical procedures may be
`undertaken through the limited incision, down sized instrumentation for
`use in the making of cuts in a femur and/or tibia may be moved through
`or part way through the incision. The down sized instrumentation may
`be smaller than implants to be positioned in the knee portion of the
`patient. . . .
`
`It is contemplated that the down sized instrumentation may have cutting
`tool guide surfaces of reduced length. The length of the cutting tool
`guide surfaces may be less than the length of a cut to be made on a
`bone. A cut on a bone in the patient may be completed using previously
`cut surfaces as a guide for the cutting tool.
`
` Col. 3, ll. 15-30 (emphasis added).
`
`The '896 patent contrasts its reduced size cutting guides from conventional
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`cutting guides such as the Scorpio cutting guides of Exhibit 1009:
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`The distance between opposite ends of the known . . . anterior resection
`guide are greater than the transverse dimensions of the femoral and
`tibial implants. This known anterior resection guide and femoral
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`Patent 7,806,896
`alignment guide are commercially available from Howmedica Osteonics
`of 359 Veterans Boulevard, Rutherford, N.J. under the designation
`"Scorpio" (trademark) Single Axis Total Knee System.
`(Col. 18, ll. 18-31).
`
`The reduced size cutting guides of the '896 patent include: femoral and tibial
`
`cutting guides secured with intramedullary alignment rods (col. 17, ll. 15-17, Figs. 9-
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`13), femoral and tibial cutting guides secured with extramedullary alignment rods
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`(Figs. 37-38, col. 17, ll. 15-17, col. 44, ll. 20-36); and femoral cutting guides which
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`are secured to the bone free of an extramedullary or intramedullary alignment rod
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`(Figs. 53, 54, cols. 69-71, Figs. 94, 95, cols. 103-105).1 The latter cutting guides are
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`the subject of claim 1 of the '896 patent.
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`The '896 patent also discusses the “guide surface” of the aforementioned
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`cutting guides. (Col. 20, ll. 15-21 (Figs. 9-13), col. 45, ll. 46-48 (Fig. 38), col. 69, ll.
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`6-34 (Fig. 53), col. 70, ll. 27-63 (Fig. 54), col. 104, ll. 37-38, col. 105, ll. 13-27 (Fig.
`
`94)).
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`1 Although he chose not to mention it in his Declaration, Petitioner’s expert Dr.
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`Mabrey agrees that the cutting guides of Figures 53 and 54 are secured “free of an
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`extramedullary or intramedullary alignment rod”, and that the cutting guide of Figure
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`94 can be. (Exhibit 2003, Mabrey Transcript, p. 33, ll. 11-17 (Fig. 53); p. 33, l. 25 to
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`p. 34, l. 7 (Fig. 54), and p. 35, ll. 20-23 (Fig. 94), hereinafter “Mabrey Tr.,
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`page:line”).
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`Patent 7,806,896
`The '896 patent explains that the guide surface extends only part way across
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`the femur (or tibia in the case of Figs. 37-38). (Col. 20, ll. 18-19 (Fig. 13), col. 45, ll.
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`45-62 (Fig. 38), col. 69, ll. 47-49 (Fig. 53), col. 71, ll. 9-12, 22-25, 45-48 (Fig. 54),
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`col. 105, ll. 17-19 (Fig. 94)).
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`The '896 patent explains that an initial cut can be made with the guide surface,
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`and then the remainder of the cut can be made using the initial cut as a guide. (Col.
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`20, l. 52 - col. 21, line 9 (Fig. 13), col. 45, ll. 57-67 (Fig. 38), col. 69, ll. 51-63 (Fig.
`
`53), col. 71, ll. 12-16, 22-29, 45-49 (Fig. 54), col. 105, ll. 19-22 (Fig. 94), col. 110,
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`ll. 45-50).
`
`The use of shorter cutting surfaces allows for reduced incision sizes (Id., col.
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`17, ll. 47-50) and, accordingly “improved cosmetic results, improved rehab, less
`
`dissection of muscle and soft tissue, and preservation of the quadriceps mechanism.”
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`(Id., col. 15, ll. 15-18, see also col. 18, ll. 34-38, col. 19, ll. 36-42, col. 21, ll. 28-30).
`
`With reference to the cutting guide of Figures 10-13 which is secured with an
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`intramedullary alignment rod, the '896 patent describes guide surface 178:
`
`('896 patent, col. 20, ll. 15-46).
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`It is noteworthy that guide surface 178 is shown as extending substantially
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`Patent 7,806,896
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`across the entire cutting guide 138 (Fig. 13) notwithstanding the fact that the slot
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`
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`extends across only about two-thirds of the front face of the cutting guide 138 (Fig.
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`11). The guide surface 178 narrows in thickness as it extends from top to bottom of
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`Figure 13 (or right to left from the perspective of Fig. 11), but remains continuous on
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`the bone-side2 of the guide. (Mabrey Tr., 82: 2-21, Exhibit 2002, Declaration of
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`Scott D. Schoifet, M.D. (Schoifet Decl.), par. 33).
`
`With regard to the cutting guide 500 of Figure 37-38 which is secured with an
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`extramedullary alignment rod, the '896 patent describes guide surface 530 at column
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`45, line 45 to column 46, line 20:
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`
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`With regard to the cutting guide 750 of Figure 53, which is “secured to the
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`bone free of an extramedullary or intramedullary alignment rod” as claimed, the
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`'896 patent describes guide surfaces 762, 764, 770 and 780:
`
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`2 From the perspective of Figure 13, the bone side is the left side of the guide 138.
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`Patent 7,806,896
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`('896 patent, col. 69, ll. 1-50). As shown in Figure 53, and a corresponding cross-
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`sectional sketch, femoral cutting guide 750 is positioned on the on the distal end of
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`the femur 126 and is secured to the femur 126 by pins 784, 786. (Id., col. 69, ll. 35-
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`41). No intramedullary or extramedullary alignment rod is used. The “guide
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`surfaces 762 for the guide slot 752 are skewed at an acute angle of forty-five degrees
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`to a major side surface 766 of the femoral cutting guide 750;” “the guide surfaces
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`764 are skewed at an angle of forty-five degrees to the major side surface”; and
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`“[t]he guide surfaces 762 extend perpendicular to the guide surfaces 764.” (Id., col.
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`69, ll. 6-12) (emphasis added). The anterior guide surface 770 “extends across the
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`femoral cutting guide 750 between the lateral end portion 774 and a medial end
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`portion 776” and “extends perpendicular to the major side surface 766 of the
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`femoral cutting guide 750.”(Id., col. 69, ll. 20-24) (emphasis added). Similarly, the
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`posterior guide surface 780 “extends perpendicular to the major side surface 766.”
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`(Id., col. 69, ll. 30-31) (emphasis added). Accordingly, as with the guide surface 178
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`of Figure 13, the guide surfaces of Figure 53 extend to the bone side of the cutting
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`guide.
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`Case: IPR2013-00629
`Patent 7,806,896
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`With regard to the cutting guide 800 of Figure 54, which is “secured to the
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`bone free of an extramedullary or intramedullary alignment rod” as claimed, the
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`'896 patent describes guide surfaces 806, 812, 816, 820, 824:
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`(Col. 70, ll. 19-62). Figure 54 is in fact discussed in this regard in the prosecution
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`history (Exhibit 1014, p. 13). As shown in Figure 54, femoral cutting guide 800 is
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`positioned on a lateral surface 802 of the femur 126 and secured to the femur 126 by
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`pins 830, 832. ('896 patent, col. 70, ll. 64-67). No intramedullary or extramedullary
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`alignment rod is used. The “distal guide surface 806 is disposed in a plane which
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`extends perpendicular to a longitudinal central axis of the femur 126 and extends
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`through the lateral and medial condyles;” and “[t]he distal guide surface 806 extends
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`perpendicular to a major side surface 808 of the femoral cutting guide 800.” (Id., col.
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`70, ll. 28-32) (emphasis added). Guide surfaces 812, 816, 820, and 824 also extend
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`perpendicular to the major side surface 808, and extend between the opposite major
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`sides of the cutting guide 800. (Id., col. 70, ll. 38-41, 49-53, 57-62). Accordingly, as
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`with the guide surfaces of Figures 13 and 53, the guide surfaces of Figure 54 extend
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`to the bone side of the cutting guide.
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`Patent 7,806,896
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`Cutting guide 1372 shown in Figures 94 and 95 includes a base 1376 and
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`cutting guide surface 1374:
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`Cutting guide 1372 can be secured to the bone free of an extramedullary or
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`intramedullary alignment rod” as claimed. (Id., col. 104, ll. 49-51 (“If desired, the
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`base 1376 could be pinned directly to the femur in a manner analogous to the cutting
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`guide 800 (FIG. 54)”). Further, “the guide surface 1374 can be made so that the size
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`of the guided portion of the cuts can be adjusted depending upon the size of the bone
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`and the implant that is to be used;” and “the guide surface 1374 can be made to have
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`a length less than the extent of the cut to be formed on the distal end portion of the
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`femur.” (Id., col. 105, ll. 13-19). The cutting guide 1372 can be “positioned on the
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`femur using a computer navigation system.” (Id., col. 104, ll. 53-54).
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`II. The Priority Date of Claim 1 of the '896 patent
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`
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`Petitioner alleges that claim 1 is entitled to an effective filing date of
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`November 25, 2003. Patent Owner disagrees and contends that claim 1 of the '896
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`Patent 7,806,896
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`patent is entitled to an effective filing date of August 28, 2001, the earliest date
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`
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`which contained the disclosure of Figures 53 and 54 discussed above. 3
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`However, as noted by the Petitioner, all of the prior art asserted in this
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`proceeding has a publication date earlier than August 28, 2000.
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`III. The Prior Art of the Instituted Grounds
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`Although the Petition includes seven documents alleged as prior art patents
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`and printed publications (Petition, pp. 2-3), this proceeding was instituted solely with
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`regard to claim 1 and solely on the basis of four publications: 1) S. David Stulberg,
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`et al., “Computer-Assisted Total Knee Replacement Arthroplasty,” (Jan. 2000)
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`(“Stulberg” (Exhibit 1005)); 2) Scott L. Delp, et al., “Computer Assisted Knee
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`Replacement,” (1998) (“Delp ” (Exhibit 1003)); 3) Roderick H. Turner et al.,
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`“Geometric and Anametric Total Knee Replacement,” (1980) (“Turner” (Exhibit
`
`3 The '896 patent was filed as U.S.S.N. 10/722,102 on November 25, 2003 (“102
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`application”) and is: (i) a 35 U.S.C. §120 continuation of U.S.S.N. 10/191,751, filed
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`on July 8, 2002 (which has the same specification and drawings as the '102
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`application); (ii) a 35 U.S.C. §120 continuation-in-part of U.S.S.N. 09/976,396, filed
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`on October 11, 2001 (which includes Figs. 1-66 of the '896 patent, and the
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`corresponding description thereof); and (iii) a continuation-in-part of U.S.S.N.
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`09/941,185, filed on August 28, 2001 (which includes Figs. 1-58 of the '896 patent,
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`and the corresponding description thereof).
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`Patent 7,806,896
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`1008)); and 4) Stryker Howmedica Osteonics, “Scorpio Single Axis Total Knee
`
`
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`System: Passport A.R. Surgical Technique” (“Scorpio” (Exhibit 1009)).
`
`A.
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`Stulberg
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`
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`Stulberg is an article purportedly published in January 2000 that is directed to
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`computer-assisted total knee replacement. Stulberg reports that “alignment errors of
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`greater than 3° are associated with more rapid failure and less satisfactory results . . .
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`.” (Stulberg, p. 25). Stulberg further reports that while “[m]echanical alignment
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`guides have improved . . . accuracy” (id.), they are still unsatisfactory in that they
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`have “fundamental limitations that limit their ultimate accuracy.” (Id.).
`
`Stulberg notes that the computer assisted techniques it describes use
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`“conventional incision and exposure.” (Id. p. 27). Stulberg does not indicate that a
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`smaller incision size is necessary, and does not in any way indicate that the size of
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`the alignment guides or cutting guides is of interest. Nothing in Stulberg suggests
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`that the size of conventional mechanical alignment guides or cutting guides is
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`problematic. Indeed, Stulberg does not object to extramedullary or intramedullary
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`alignment guides per se, but rather is concerned with more accurate placement of the
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`cutting and alignment guides. Thus, for example, in its computer-assisted tibial
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`procedure, an extramedullary alignment guide is used (Fig. 12), and the computer
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`technique is used to more finely tune the position of the cutting guide. (Id., p. 29,
`
`final two pars.).
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`Patent 7,806,896
`As shown in Figures 16B and 17, the guide surface of the cutting guide is
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`larger than the replacement component. In particular, it can be seen that the guide
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`surface extends beyond the femur. Thus, the replacement component (Fig. 20)
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`clearly has a transverse dimension that is smaller than the transverse dimension of
`
`the guide surface. (Schoifet Decl., par. 40). There is no indication whatsoever that
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`this is disadvantageous and in fact no indication anywhere in Stulberg that the
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`relative sizes of the guide surface and the replacement portion are of interest. Rather,
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`Stulberg is concerned with accurate placement of the cutting guides so that a more
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`precise cut can be made:
`
`The reliability of techniques for total knee replacement (TKR) is still
`limited by the relative inaccuracy of instrumentation. (Id. at p. 25
`(Abst.))
`
`The goal of the total knee instrumentation procedure is to achieve cuts
`that are perpendicular to the mechanical axes of the femur and the tibia.
`The longevity of total knee arthroplasty is closely related to its
`intraoperative positioning. The computer-assisted procedure offers an
`effective and novel positioning method that improves the accuracy of
`the surgical technique of the TKR. (Id.).
`
`Incorrect positioning or orientation of implants and improper alignment
`of the limb can lead to accelerated implant wear and loosening and
`suboptimal functional performance. A number of studies have suggested
`that alignment errors of greater than 3° are associated with more rapid
`failure and less satisfactory functional results of total knee
`
`
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`12
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`arthroplasties. (Id. at p. 25)
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`Case: IPR2013-00629
`Patent 7,806,896
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`Computer-based alignment systems have been developed to address the
`problems inherent in mechanical total knee instrumentation. (Id.)
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` B. Delp
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`Like Stulberg, Delp is directed to computer assisted knee replacement, and is
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`concerned with the accuracy of mechanical alignment systems: “[a]lthough
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`mechanical alignment guides have been designed to improve alignment accuracy,
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`there are several fundamental limitations of this technology that will inhibit
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`additional improvements.” (Delp, p. 49, left col.).
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`Like Stulberg, Delp does not express any concern for the size of conventional
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`incisions, or the size of conventional alignment devices or cutting guides. (Schoifet
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`Decl., pars. 42, 62, 88). Rather, it is the accuracy of the alignment and cutting guides
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`that is of concern. (Id., p. 49, left col. to p. 50, left col.).
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`Delp discusses three distinct technologies: (i) computer integrated instruments,
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`(id., pp. 50-51); (ii) image guided knee replacement, (id., pp. 51-53); and (iii) robot
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`assisted knee replacement, (id., pp. 53-54).
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`computer integrated instruments - This technique uses an optical localizer to
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`determine the mechanical axes of the femur and tibia, and then uses a computer
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`workstation to display the position of the cutting block relative to its desired
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`position. Once the cutting block is “oriented properly it is secured in position and the
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`Patent 7,806,896
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`cuts are made with a standard oscillating saw.” (Id., p. 51, left col.). As reported at
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`
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`page 55, this technique uses “standard cutting guides.” (emphasis added).
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`Accordingly, although Delp does not specifically discuss how the cutting guide is
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`secured, it follows that since a “standard cutting guide” is used, it is to be secured in
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`the standard way.
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`image guided knee replacement – In this technique, three dimensional
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`computer models of the patient’s femur and tibia are constructed using computer
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`tomographic data. (Id., p. 51, last par.). An intraoperative system is used to
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`“determine the position and orientation of the patient’s femur and tibia and to guide
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`the surgeon in the placement of the cutting jigs.” (Id., p. 52, last two pars.).
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`According to Delp, the intraoperative system includes a graphics workstation, a
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`coordinate measurement probe, and “a set of cutting blocks that have been modified
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`to attach to the measurement probe.” (Id.). There is no suggestion that the cutting
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`blocks/cutting jigs are in any other way different than standard cutting blocks/jigs.
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`There is no indication that they are not secured to the femur/tibia in a conventional
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`manner.
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`Robot assisted knee replacement- Three robot assisted techniques are
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`described: Kienzle et al - In this technique, a robotic procedure is used to more
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`accurately “drill the alignment holes for conventional cutting blocks for femoral and
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`tibial implants.” (Id., p. 54, 1st par.); Fadda et al- In this technique, “a sophisticated
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`Patent 7,806,896
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`pre-operative planning system [is linked] to a standard industrial robot to allow
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`placement of cutting blocks and machining of the bones.” (Id., p. 54, 2nd par.); and
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`Davies et al.- In this technique, an active constraint robot (ACROBOT) is used to cut
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`the femur without the use of cutting guides. (Id., p. 54 (“virtual cutting block”)).
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`The computer integrated technique, the image guided technique and the first
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`two robot assisted techniques use standard cutting blocks, presumably secured in
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`their standard way, and the last uses no cutting block at all. However, in each
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`technique, Delp is concerned with the accuracy of the placement of the cuts, not the
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`size of the cutting surfaces:
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`• “Accurate alignment of knee implants is essential for the success of
`total knee replacement. Although mechanical alignment guides have
`been designed to improve alignment accuracy, there are several
`fundamental limitations of this technology that will inhibit additional
`improvements. Various computer assisted techniques have been
`developed to examine the potential to install knee implants more
`accurately and consistently than can be done with mechanical
`guides.” (Id., p. 49, Abst.) (emphasis added).
`• “Even a small (2.5 mm) anteroposterior displacement of the femoral
`component has been shown to alter knee range of motion (ROM) as
`much as 20°.” (Id., p. 50).
`• “Even when using state of the art intramedullary alignment systems,
`surgeons find that it is difficult to install knee implants within 2° to
`3° varus or valgus alignment.” (Id.).
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`C. Turner
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`Case: IPR2013-00629
`Patent 7,806,896
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` Turner is an article published in 1980, 18 years prior to Delp, and 20 years
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`prior to Stulberg. Turner is directed to geometric and anametric total knee
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`replacement (“TKR”) techniques. The cutting guide that is relied upon by the
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`Petitioner (Fig. 8) is employed in the geometric technique. The geometric TKR was a
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`primitive design that had been abandoned as a failure by 1990, long before Delp or
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`Stulberg. (Schoifet Decl., pars. 48, 65). In particular, it was found that while the
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`theory of the geometric TKR was that “(4) although stability in flexion [as the knee
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`flexes] may be sacrificed somewhat with spherical surfaces, the requirements for
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`stability in flexion are no nearly as significant functionally as are the requirements
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`for stability at or near full extension,” (Turner, p. 174), the opposite was in fact true
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`because flexion instability is one of the primary causes of total knee pain and failure,
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`not extension instability. (Schoifet Decl., pars. 48, 67). By 1988, it the geometric
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`TKR was known to have a 10 year survivability of only 69%. (Id., pars. 48, 68).
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`In the technique described in Turner, the femoral cutting guide is mounted
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`with an extramedullary alignment rod, as illustrated in Figure 8:
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`A person of ordinary skill in the art at the time of the invention would
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`Patent 7,806,896
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`recognize the above figure as an extramedullary alignment rod that terminates with a
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`
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`cutting guide. (Mabrey Tr. 72:6-11; Schoifet Decl., pars. 50, 66). A person of
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`ordinary skill in the art at the time of the invention would also recognize that this
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`cutting guide, whose extramedullary alignment is achieved by inserting “[t]he
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`femoral cutting guide … in the midline, deep to the suprapatellar pouch,” and which
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`is thereafter used to cut the femur “with a power or hand saw parallel with the guide
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`that is approximately 30 degrees to the long axis of the femur,” would provide a far
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`more imprecise cut than the techniques criticized in Delp and Stulberg. (Schoifet
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`Decl., pars. 50, 66, 70). At the time of the invention, a person of ordinary skill in the
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`art would not have considered using the femoral cutting guide of Figure 8 in a knee
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`replacement surgery. (Schoifet Decl., pars. 50, 65).
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`There is no discussion of limiting incision sizes in Turner, and no indication
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`that the relative size of the cutting surface of the cutting guide and the replacement
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`component is of any interest.
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`D.
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`Scorpio
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`Scorpio was considered by the United States Patent and Trademark Office
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`during prosecution of the '896 patent, and moreover, the Scorpio system was
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`discussed in the specification of the '896 patent. In particular, the '896 patent
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`describes the following:
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`Case: IPR2013-00629
`Patent 7,806,896
`The distance between opposite ends of the known femoral alignment
`guide and the distance between opposite ends of the known anterior
`resection guide are greater than the transverse dimensions of
`the femoral and tibial implants 286, 290 and 294 (FIG. 29). This known
`anterior resection guide and femoral alignment guide are commercially
`available from Howmedica Osteonics of 359 Veterans Boulevard,
`Rutherford, N.J. under the designation "Scorpio" (trademark) Single
`Axis Total Knee System.
`Col. 8, ll. 18-31
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`In Scorpio, the initial femoral cut is made using the anterior resection guide
`shown below:
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`The anterior resection guide is mounted to the femur with an intramedullary
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`alignment rod, as clearly shown in Figure 9