Trials@uspto.gov
`571-272-7822
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`Paper 9
`Entered: February 26, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`SMITH & NEPHEW, INC.
`Petitioner
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`v.
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`BONUTTI SKELETAL INNOVATIONS, LLC
`Patent Owner
`____________
`
`Case IPR2013-00605
`Patent 7,749,229 B1
`____________
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`
`Before WILLIAM V. SAINDON, MICHAEL R. ZECHER, and
`RICHARD E. RICE, Administrative Patent Judges.
`
`RICE, Administrative Patent Judge.
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`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`
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`S&N EXHIBIT 1027
`S&N v. BSI
`IPR2013-00629
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`571-272-7822
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`Paper 9
`Entered: February 26, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SMITH & NEPHEW, INC.
`Petitioner
`
`v.
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`BONUTTI SKELETAL INNOVATIONS, LLC
`Patent Owner
`____________
`
`Case IPR2013-00605
`Patent 7,749,229 B1
`____________
`
`
`Before WILLIAM V. SAINDON, MICHAEL R. ZECHER, and
`RICHARD E. RICE, Administrative Patent Judges.
`
`RICE, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
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`
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`S&N EXHIBIT 1027
`S&N v. BSI
`IPR2013-00629
`
`
`
`Case IPR2013-00605
`Patent 7,749,229 B1
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`
`I.
`INTRODUCTION
`Smith & Nephew, Inc. (“Petitioner”) filed a petition (Paper 3, “Pet.”)
`requesting an inter partes review of claim 23 of U.S. Patent No. 7,749,229 B1
`(Ex. 1001, “the ’229 Patent”). The owner of the ’229 Patent, Bonutti Skeletal
`Innovations LLC (“Patent Owner”), 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 35 U.S.C.
`§ 314(a), which provides as follows:
`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.
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`We determine that the information presented in the petition establishes that
`there is a reasonable likelihood that Petitioner would prevail in its challenge of
`claim 23 of the ’229 Patent as unpatentable. Accordingly, pursuant to 35 U.S.C.
`§ 314, we institute an inter partes review for claim 23 of the ’229 Patent.
`
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`A. Related Proceeding
`The ’229 Patent is involved in co-pending litigation styled Bonutti Skeletal
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`Innovations LLC v. Smith & Nephew, Inc., D. Del. Case No. 12-1111-GMS.
`Pet. 1.
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`B. The ’229 Patent
`The ’229 Patent, titled “Total Knee Arthroplasty Through Shortened
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`Incision,” issued on July 6, 2010, based on U.S. Patent Application Serial
`No. 11/170,969, filed on June 30, 2005. The ’229 Patent is a continuation of U.S.
`Patent Application Serial No. 10/191,751 (“the ’751 Application”), filed on July 8,
`2002. The ’751 Application is a continuation-in-part of U.S. Patent Application
`Serial No. 09/976,396, filed Oct. 11, 2001, and a continuation-in-part of U.S.
`Patent Application Serial No. 09/941,185 (“the ’185 Application”), filed Aug. 28,
`2001. The ’751 Application is also a continuation-in-part of a number of earlier-
`filed applications that are not relevant to our decision.
`The ’229 Patent uses the term “total knee arthroplasty” in claim 23 and the
`abstract. Claim 23 recites “[a] method of performing total knee arthroplasty
`through a primary incision having a length of less than thirteen (13)
`centimeters . . . .” (Emphasis added).
`The abstract of the ’229 Patent states that “[a] method is provided for
`performing total knee arthroplasty.” Ex. 1001, Abstr. 1 (emphasis added). The
`abstract states that the method includes “making a primary incision,” “cutting
`medial and lateral condyles of the femur of the leg,” “moving a femoral component
`of a total knee implant through the primary incision,” and “positioning the femoral
`component with respect to the . . . femoral cut surface.” Id. at Abstr. 2-8. The
`abstract also states that “[t]he primary incision has a length of less than thirteen
`(13) centimeters.” Id. at Abstr. 8-9.
`The term “total knee arthroplasty” does not appear in the specification other
`than the claims. Rather, the specification uses, interchangeably, the terms “total
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`knee joint replacement,” “total knee replacement,” and “full knee replacement” (all
`being hereinafter referred to as “total knee replacement”). See, e.g., id. at 1:47, 58;
`11:22-28; 37:14-15.
`The specification describes a method for performing total knee replacement
`through an incision of less than 13 centimeters. See, e.g., id. at 14:54-61; 18:40-
`44; 26:26-34; 30:26-28; 49:2-19, 44-57;105:47-55. As described, the method
`requires cutting and shaping both the femoral and tibial sides of the knee joint, and
`installing an implant comprising femoral and tibial components. See, e.g., id. at
`30:26-28; 31:48‒32:37. Total knee replacement may, or may not, involve work on
`the patella. See id. at 29:59−30:7.
`The specification describes making a cut across anterior portions of the
`lateral and medial condyles of the femur, such that the anterior portion of the
`lateral and medial epicondyles are cut away and flat anterior cut surface 182 is
`disposed on distal end portion 124 of femur 126. See id. at 20:21-23; 22:4-7;
`figs. 13, 14, & 15.
`After making the anterior cut, distal resection guide 186 is positioned on flat
`anterior cut surface 182 (see, e.g., id. at 23:8-9; figs 16 & 17), and distal femoral
`cut is made by moving saw blade 170 along guide surface 202 of the resection
`guide (see, e.g., id. at 23:57-59; figs. 17 & 18). “When the distal femoral cut is
`completed, a flat distal end surface 209 extends across the distal end of the femur
`126,” and “[t]he trochlear groove of the femur extends through the distal end
`surface 209.” Id. at 24:34-35, 41-42; figs. 17 & 18.
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`FFigures 17 aand 18 of tthe ’229 Paatent is repproduced bbelow:
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`Figuures 17 andd 18 depict
`the manneer
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`in whhich the disstal femur
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`cut is madde.
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`TThe methodd of total kknee replacement desccribed in thhe specificcation,
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`thereforre, involves cutting aand shapingg the two ccondyles off the femurr and the ddistal
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`end porrtion of the femur. Seee, e.g., id. at 20:18-225; 24:34-442; figs. 133 & 17; seee
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`also id. at 75:45-446 (explainning that, inn contrast wwith total kknee replaccement,
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`“[w]henn a partial kknee replaccement is tto be madee, only onee of the twoo condyless . . .
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`is cut”).. The methhod of totaal knee repllacement ddescribed iin the speciification allso
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`involves cutting and shapingg the proximal end poortion of thhe tibia. SeSee, e.g., idd. at
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`27:19-330; fig. 21. After the femoral annd tibial cuuts have beeen made,
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`and any wwork
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`ounted on on the ppatella has been perfoormed, a tibbial compoonent is mo
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`the proximmal
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`end portion of the tibia, and a femoral component is mounted on the distal end
`portion of the femur. See, e.g., id. at 30:26-28; 31:48‒32:37; 96:39-52.
`
`
`C. Claim 23
`Claim 23 is the only claim challenged in this proceeding, and it is
`reproduced below:
`
`23. A method of performing tota1 knee arthroplasty through
`a primary incision having a length of less than thirteen (13)
`centimeters, comprising the steps of:
`making a primary incision of less than thirteen (13) centimeters
`near the knee joint of a leg of a patient, and carrying out the further
`steps, through the primary incision, of
`cutting medial and lateral condyles, and the trochlear groove of
`the femur of the leg to create at least one femoral cut surface;
`moving a single femoral component of a total knee implant
`operative to replace the entire articulating surfaces of the medial and
`lateral condyles and the trochlear groove, through the primary
`incision; and
`positioning the femoral component with respect to the at least
`one femoral cut surface.
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`D. References Relied Upon
`Petitioner relies upon the following references:
` Ex. 1003
`Lacey ’483 US 4,502,483
` Mar. 5, 1985
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` (filed Mar. 9, 1983)
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`Engh ’209
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`Dow Corning Wright, Lacey Condylar Total Knee System Surgical
`Procedure (hereinafter “the Lacey Guide”) (Ex. 1004).
`
` Ex. 1005
` US 6,482,209 B1 Nov. 19, 2002
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` (filed June 14, 2001)
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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
`(“the Scorpio Guide”) (Ex. 1006).
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`Smith & Nephew, Profix Total Knee System Primary Procedure (“the Profix
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`Guide”) (Ex. 1020).
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`E. The Alleged Grounds of Unpatentability
`Petitioner challenges claim 23 of the ’229 Patent based on the alleged
`grounds of unpatentability set forth in the table below:
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`Reference(s)
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`Basis
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`§ 102
`Lacey ’483
`§ 103
`Lacey ’483
`§ 102
`Lacey Guide
`§ 103
`Lacey Guide
`Lacey ’483 and the Lacey Guide § 103
`Lacey ’483 and the Scorpio
`§ 103
`Guide
`Engh ’209
`Engh ’209 and Profix Guide
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`§ 103
`§ 103
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`Challenged
`Claim
`23
`23
`23
`23
`23
`23
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`23
`23
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`II. ANALYSIS
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are interpreted
`according to their broadest reasonable construction in light of the specification of
`the patent in which they appear. 37 C.F.R. § 42.100(b); Office Patent Trial
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`Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012). Applying this
`standard, we construe the following claim terms or phrases recited in claim 23.
`1. performing total knee arthroplasty through a primary incision
`having a length of less than thirteen (13) inches
`The preamble of claim 23 recites, “[a] method of performing tota1 knee
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`arthroplasty through a primary incision having a length of less than thirteen (13)
`centimeters.” Petitioner does not state explicitly that the preamble of the ’229
`Patent is entitled to patentable weight and, therefore, constitutes a claim limitation.
`However, Petitioner treats the preamble as a claim limitation when it argues that
`“Engh ’209 discloses a method of ‘performing total knee arthroplasty through a
`primary incision having a length of less than thirteen (13) centimeters,’ as recited
`in the preamble . . . .” Pet. 48-49 (referencing Ex. 1005, 8:53-59, fig. 2; Ex. 1002
`¶ 70).
`“In general, a preamble limits the invention if it recites essential structure or
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`steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.”
`Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir.
`2002) (quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305
`(Fed. Cir. 1999)). “[C]lear reliance on the preamble during prosecution to
`distinguish the claimed invention from the prior art transforms the preamble into a
`claim limitation because such reliance indicates use of the preamble to define, in
`part, the claimed invention.” Id. at 808-09 (citing Bristol-Myers Squibb Co. v. Ben
`Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed.Cir.2001)). Here, the preamble
`clearly was relied on during prosecution to distinguish the prior art. See Ex. 1011
`(Resp. to Office Action filed May 8, 2008), at 7) (“Caspari [U.S. Patent No.
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`5,395,376] does not address the problem of performing a total knee replacement
`through a reduced size incision.”).
`Accordingly, we construe the preamble of claim 23 as a claim limitation that
`requires performing total knee arthroplasty through a primary incision having a
`length of less than 13 centimeters.
`2. total knee arthroplasty
`Petitioner contends that the term “total knee arthroplasty” should be
`construed as “resurfacing the medial and lateral femoral condyle and the associated
`tibial plateau.” Pet. 8 (citing Ex. 1001, 96:39-47). The portion of the specification
`upon which Petitioner relies states as follows:
`In general, prior art knee prostheses for partially or totally replacing a
`knee joint include a femoral component for attachment to the distal
`end of the femur and a tibial component for attachment to the
`proximal end of the tibia. The tibial component typically includes a
`base or tray that is implanted in the tibia and an insert or meniscal
`plate placed on the face of the tray for articulating with the condyles
`of the femoral component. The tray often includes a keel or stem that
`inserts in the tibia to provide stability.
`Ex. 1001, 96:39-47. Petitioner also states that the ’229 Patent sometimes refers to
`“total knee arthroplasty” as “total knee replacement.” Pet. 8.
`We agree with Petitioner that the terms “total knee arthroplasty” and “total
`knee replacement” are used interchangeably in the ’229 Patent, because the
`abstract describes “total knee arthroplasty” in a manner that is consistent with the
`description of “total knee replacement” in the specification. See section I. B supra.
`We note that interpreting “total knee arthroplasty” to mean “total knee
`replacement” is consistent with the ordinary meaning of “arthroplasty” as “plastic
`surgery of a joint: the operative formation or restoration of a joint.” WEBSTER’S
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`THIRD NEW INTERNATIONAL DICTIONARY OF THE ENGLISH LANGUAGE UNABRIDGED
`123 (1971). Further, we credit the testimony of Plaintiff’s expert, Dr. Mabrey, on
`this point. See Ex. 1002 (Mabrey Decl.), ¶ 14 (“The challenged claim of the [’229
`Patent] relates to a method for knee surgery, specifically total knee arthroplasty
`(‘TKA’) or, sometimes, total knee replacement.”).
`We do not agree, however, that “total knee replacement,” as used in the ’229
`Patent, means “resurfacing” the medial and lateral femoral condyles and the
`associated tibial plateau, as Petitioner contends. See Pet. 8. In particular, the
`proposed claim construction is overly broad, because it encompasses any form of
`“resurfacing,” including, for example, “biological resurfacing.” The specification
`indicates clearly that biological resurfacing is only an aspect of, and is distinct
`from, total knee replacement. See, e.g., Ex. 1001, 4:43-47.
`We construe “total knee arthroplasty,” consistent with the specification of
`the ’229 Patent, to mean a surgical procedure that involves cutting and shaping the
`two condyles of the femur, the distal end portion of the femur, and the proximal
`end portion of the tibia, and installing a knee implant having femoral and tibial
`components. See, e.g., id. at 30:26-28; 31:48‒32:37; 75:45-46; 96:39-47.
`3. a single femoral component
`Claim 23 recites the step of “moving a single femoral component of a total
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`knee implant operative to replace the entire articulating surfaces of the medial and
`lateral condyles and the trochlear groove, through the primary incision.”
`(Emphasis added).
`
`Petitioner argues implicitly that the italicized portion of the claim language
`quoted above requires the entire femoral side of the total knee implant to be in the
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`form of a single piece, as opposed to an assembly of separate portions. Pet. 50, 52-
`53. Petitioner relies on this implicit claim construction to argue that a person of
`ordinary skill in the art predictably would have substituted “a single femoral
`component” for “the separate femoral components,” as taught by Engh ’209. Id.
`Petitioner also argues that “Engh ’209 recognizes that in ‘traditional total knee
`replacements, the femoral component is generally a unitary piece and the tibial
`component is a unitary piece.’” Id. at 49 (quoting Ex. 1005, 5:14-16, Ex. 1002
`¶ 73) (emphasis added).
`We agree that “a single femoral component” refers to a single piece or
`portion of the femoral component of a total knee implant. However, contrary to
`Petitioner’s argument, nothing in the claim language requires the entire femoral
`side of a total knee implant to consist of just a single piece or unitary body. See
`Pet. 50, 52-53. Further, Petitioner’s implicit construction would be inconsistent
`with the specification of the ’229 Patent, which teaches the benefit of using an
`assembly of separate portions, or a plurality of femoral components, to form the
`femoral side of a total knee plant. See, e.g., Ex. 1001 49:2-5 (“In order to enable
`surgery . . . to be conducted through an incision 114 of relatively small size, the
`implant may advantageously be formed in two or more portions.”); id. at 49:44-46
`(“In the embodiment of the invention illustrated in FIG. 40, the femoral component
`290 of an implant is formed as two separate portions 572 and 574.”); id. at 99:17-
`19 (“In order to facilitate insertion of femoral component 1224 through a
`minimally invasive lateral or medial incision, femoral component 1224 can be
`made modular.”); figs. 40 & 87.
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`Consistent with the specification of the ’229 Patent, the broadest reasonable
`construction of “a single femoral component of a total knee implant operative to
`replace the entire articulating surfaces of the medial and lateral condyles and the
`trochlear groove” is a single piece or portion of the femoral component of a total
`knee implant that functions to replace the entire articulating surfaces of the medial
`and lateral condyles and the trochlear groove.
`6. Other Terms
`All other terms recited in claim 23 are given their ordinary and customary
`meaning, as would be understood by one with ordinary skill in the art, and need not
`be construed explicitly at this time.
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`B. Alleged Grounds of Unpatentability
`As noted above, Petitioner alleges that claim 23 is unpatentable over
`(1) Lacey ’483; (2) the Lacey Guide; (3) Lacey ’483 and Lacey Guide; (4) Lacey
`’483 and the Scorpio Guide; (5) Engh ’209; and (6) Engh ’209 and the Profix
`Guide. In light of the arguments and supporting evidence submitted with the
`petition, Petitioner has established a reasonable likelihood that it would prevail in
`its challenge of claim 23 as unpatentable for the reasons explained below.
`1. Grounds of unpatentability based on the Lacey Guide
`Petitioner alleges that the Lacey Guide “was submitted to the PTO prior to
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`1985[,] and is identified as a reference cited in issued patents 4,567,886;
`4,979,957; 4,979,957 [sic]; and 4,474,177.” Pet. 3 n. 3. The earliest of these
`patents, U.S. Patent No. 4,474,177, issued on October 2, 1984. At this stage of the
`proceeding, we will treat the Lacey Guide as prior art to the ’229 Patent under
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`35 U.S.C. § 102(b).
`Petitioner alleges, inter alia, that the Lacey Guide “makes obvious” the
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`limitations of claim 23. Pet. 42-43. In support of its position, Petitioner relies on
`the declaration of its expert, Dr. Mabrey. See id. at 40-43; Ex. 1002, ¶¶ 61-64.
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`Dr. Mabrey testifies that the Lacey Guide “discloses a method of
`‘performing total knee arthroplasty through a primary incision having a length of
`less than thirteen (13) centimeters,’ as recited in the preamble.” Ex. 1002, ¶ 61.
`Dr. Mabrey further testifies that the Lacey Guide “describes and illustrates the
`surgical procedure for a ‘Lacey condylar total knee surgical procedure,’” in which
`“[a]n anterior 5-6 inch [i.e., 12.7 – 15.2 centimeter] midline incision is made with
`the knee flexed to 90 degrees.” Ex. 1002, ¶ 47 (quoting Ex. 1004, p. 2).
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`The Lacey Guide discloses cutting and shaping the two condyles of the
`femur (Ex. 1004, p. 8), the distal end portion of the femur (id.), and the proximal
`end portion of the tibia (id. at 9), and installing a knee implant having femoral and
`tibial components (id. at 11). For purposes of this decision, based on the evidence
`discussed in detail below, we are persuaded that the Lacey Guide discloses
`performing all of the steps of the Lacey condylar total knee surgical procedure
`through a primary incision having a length of less than 13 centimeters.
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`Dr. Mabrey also testifies that the Lacey Guide discloses the steps of
`(a) “making a primary incision of less than thirteen (13) centimeters near the knee
`joint of a leg of a patient, and carrying out the further steps, through the primary
`incision,” and (b) “cutting medial and lateral condyles, and the trochlear groove of
`the femur of the leg to create at least one femoral cut surface,” as recited in claim
`23. Ex. 1002, ¶¶ 61, 62.
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`are reprroduced beelow:
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`FFigures (A)) and (B), aas set forthh in paragraaph 47 of tthe Mabry
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`declarationn,
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`Dr. Mabbrey pointss to Figuree (B) as eviidence thatt the Laceyy Guide “ddescribes annd
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`FFigures (AA) and (B) aare figuress reproduceed from
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`thhe Lacey GGuide. Figuure (A) illuustrates thee anterior
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`mmidline inccision (Ex.. 1004, p. 22), and Figgure (B)
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`illlustrates thhe cut surfaaces of thee femur (idd. at p. 8).
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`illustrattes that the medial annd lateral coondyles annd the trochhlear groovve of the
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`mplant.” IId. ¶ 62 (coomparing FFig. (B) wi
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`femur aare cut to acccommodaate a new i
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`Ex. 10001, fig. 22).
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` DDr. Mabreyy testifies tthat the Laacey Guidee also disclloses the stteps of
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`(c) “mooving a singgle femoraal componeent of a totaal knee immplant operrative to
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`replace the entire articulating surfaces of the meddial and latteral condyyles and thhe
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`trochleaar groove, tthrough thhe primary incision” aand (d) “poositioning tthe femoraal
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`componnent with reespect to thhe at least one femorral cut surfface,” as reecited in
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`claim 233. Id. ¶ 633. Dr. Mabbrey opiness that “[o]nne skilled iin the art wwould
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`femur thhrough thee incision ddescribed ppreviously..” Id.
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`understaand from the disclosuure that thee implant iis placed onn the distaal end of thhe
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`Patent 77,749,229 BB1
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`AA figure froom Dr. Maabrey’s decclaration (inn ¶ 47) is rreproducedd below:
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`This figure, wwhich is repproduced frfrom the Laacey Guidee
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`(EEx. 1004, pp. 11) withh annotatioons by Dr. MMabrey,
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`depicts a singlee femoral ccomponent
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`We are persuadedd that the feemoral commponent deepicted in tthe figure aabove, wh
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`m 23 for ““a
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`duced fromm the Laceey Guide, ssatisfies thee requiremment of clai
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`single fefemoral commponent o
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`f a total knnee implannt operativee to replacee the entiree
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`articulatting surfacces of the mmedial andd lateral conndyles andd the trochllear groovee.”
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`FFor the foreegoing reassons, Petitiioner has eestablishedd a reasonabble likelihoood
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`that it wwould prevail in its chhallenge off claim 23
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`as unpatenntable overr the Laceyy
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`Guide.
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`2. GGrounds off unpatentaability baseed in part
`on Lacey
`’483
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`1983, andd is
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`PPetitioner aasserts that Lacey ’4883 has a filiing date off March 9,
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`3. Petitionner allegess,
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`prior artt to the ’2229 Patent uunder 35 UU.S.C. § 1022(b). Pet.
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`inter aliia, that claim 23 is unnpatentablee as obviouus over: (11) Lacey ’4483;
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`Case IPR2013-00605
`Patent 7,749,229 B1
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`(2) Lacey ’483 and the Lacey Guide; and (3) Lacey ’483 and the Scorpio Guide.
`Pet. 44-48. Our analysis below focuses on Petitioner’s alleged ground of
`unpatentability based on obviousness over Lacey ’483 and the Lacey Guide.
`Lacey ’483 discloses a method and apparatus for shaping the distal surface
`of a femur to receive a distal femoral prosthesis. Ex. 1003, 2:21-22. First, “[a]n
`anterior 5″ to 6″ (127 mm to 152 mm) midline incision is made with the knee
`flexed to 90 degrees.” Id. at 7:54-58. If a total knee replacement is being
`performed, Lacey ’483 discloses cutting and shaping the proximal end portion of
`the tibia before cutting and shaping the distal end portion of the femur. Id. at 7:65‒
`8:1. Lacey ’483 states: “If a proximal tibial prosthesis is to also be implanted as in
`total knee implant surgery, the proximal tibial surface may preferably . . . be
`shaped to receive that proximal tibial prosthesis in the manner typically employed
`for such a prosthesis.” Id. (emphasis added). Lacey ’483 further discloses that
`“[t]he tibial surface should be prepared such that the tibial prosthesis will properly
`align and cooperate with the distal femoral prosthesis which is attached to the
`distal femoral surface being shaped in accordance with the method of the present
`invention.” Id. at 8:1-6 (emphasis added). After the proximal tibial surface has
`been shaped, the distal femur is shaped. Id. at 8:7-9:62; figs. 13-17.
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`Patent 77,749,229 BB1
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`FFigure 17 oof Lacey ’4483 is reprooduced bellow:
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`Figure 177 depicts thhe shaped ffemoral suurface.
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`As illusstrated in FFigure 17, LLacey ’4833 discloses
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`condylees, and the trochlear ggroove of tthe femur oof the leg tto create att least one
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`femorall cut surfacce,” as reciited in claimm 23. See
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`Pet. 30-311 (citing Exx. 1003, 9::56-
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`61; Fig.. 17); Ex. 11002, ¶ 56..
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`83 disclosees “performming total
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`WWe are perssuaded tha
`knee
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`less than thhirteen (133)
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`arthropllasty throuugh a primaary incisionn having a
`length of
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`centimeeters,” as reecited in thhe preamblle of claim m 23. Pet. 337, 39, 44 nn. 9 (citingg Ex.
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`1003, 2:20-38; 7:226-34, 56-558; figs. 133-15); see EEx. 1002 ((Mabrey DDecl.),
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`¶¶ 55, 559. We aree also persuuaded that Lacey ’4883 disclose
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`medial andd
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`femur of thhe leg to crreate at leaast
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`lateral ccondyles, aand the trocchlear grooove of the
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`one femmoral cut suurface.” Seee Pet. 37--38 (citing
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`Ex. 1003,
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`fig. 17 Exx. 1002, ¶ 556).
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`loses the liimitations
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`AAs discusseed above, thhe Lacey GGuide disc
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`of “movinng a
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`single fefemoral commponent o
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`f a total knnee implannt operativee to replacee the entiree
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`articulatting surfacces of the mmedial andd lateral conndyles andd the trochllear groovee,
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`throughh the primaary incisionn” and “positioning thhe femorall componennt with resspect
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`to the at least one femoral cut surface,” as recited in claim 23. Petitioner contends
`that the Lacey Guide remedies any deficiencies in Lacey ’483 with respect to these
`limitations. Pet. 44, 47-48.
`Petitioner argues that a person of ordinary skill in the art would have been
`motivated to combine the teachings of Lacey ’483 with the known femoral
`prosthesis taught by the Lacey Guide, because the combination would have been
`“no more than the predictable application of a known technique—implanting a
`femoral prosthesis—with known prostheses to yield the predictable outcome of a
`successful TKA [total knee arthroplasty] performed through a small incision.” Id.
`at 46 (citing Ex. 1002, ¶ 68). Petitioner’s reasoning is persuasive, and we note that
`Lacey ’483 teaches that “[d]istal femoral prostheses are well known to those
`skilled in the art,” and that:
`[i]t is well within the ability of those skilled in the art to construct
`guide instruments in accordance with the . . . description [set forth in
`the specification of Lacey ’483] which meet the specific design
`requirements to produce a shaped distal femoral surface for a
`particular distal femoral prosthesis.
`Ex. 1003, 7:26-34. For purposes of this decision, therefore, we are persuaded that
`Petitioner has provided an articulated reason with a rational underpinning that
`explains why a person of ordinary skill would have had reason to combine the
`teachings of Lacey ’483 and the Lacey Guide.
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`For the foregoing reasons, Petitioner has established a reasonable likelihood
`that it would prevail in its challenge of claim 23 as unpatentable over Lacey ’483
`and the Lacey Guide.
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`3. Grounds of unpatentability based in part on Engh ’209
`Petitioner asserts that Engh ’209 has a filing date of June 14, 2001, and is
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`prior art to the ’229 Patent under 35 U.S.C. § 102(e). Pet. 3.
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`During prosecution of the ’229 Patent, the Examiner found that the claimed
`subject matter was first disclosed in the ’185 Application (the great grandparent of
`the application from which the ’229 Patent issued), which was filed on August 28,
`2001. Ex. 1013 (Office Action mailed May 15, 2008), p. 2. For the purpose of
`antedating Engh ’209, therefore, the inventor submitted an Affidavit of Prior
`Invention Pursuant To 37 C.F.R. § 1.131, which stated that “[t]he date I conceived
`of my invention and conveyed same to my registered representative, as evidenced
`by ‘Exhibit B’, was prior to June 14, 2001.” Ex. 1015, p. 2. Exhibit B to the
`affidavit is simply a one-page printout of the “Properties” dialog box
`corresponding to the document that Petitioner filed on August 28, 2001, as the
`’185 Application. Id. at 1-2; Ex. 1017. The “Properties” dialog box does not
`constitute sufficient and credible evidence that Petitioner was in possession of the
`subject matter of the ’185 Application prior to its filing date (August 28, 2001),
`much less prior to June 14, 2001. Ex. 1017. On this record, the affidavit is
`insufficient to antedate Engh ’209, because nothing in the affidavit, including
`Exhibit B thereto, corroborates the inventor’s testimony that he conceived of the
`invention of the ’229 Patent prior to June 14, 2001. See Pet. 27-28; see also
`Mahukar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed. Cir. 1996) (An inventor’s
`testimony, standing alone, is insufficient to prove conception, as some form of
`corroboration is required.).
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`Petitioner asserts that claim 23 is unpatentable as obvious over Engh ’209.
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`Pet. 48-52. Petitioner asserts, alternatively, that claim 23 is unpatentable as
`obvious over Engh ’209 and the Profix Guide. Id. at 52-58. Our analysis below
`focuses on Petitioner’s alleged ground of unpatentability based on obviousness
`over Engh ’209.
`Engh ’209 discloses that, typically, surgeons perform total knee replacement
`through a primary incision having a length of less than 13 centimeters. Engh ’209
`states that “[t]he incision 40 must be large enough to expose the entire knee joint
`articular surfaces with the patella subluxed or dislocated” and that, “[a]dditionally,
`the incision must accommodate insertion of components that fully cover the end of
`the femur, the top of the tibia and the undersurface of the patella.” Ex. 1005, 8:57-
`62. More particularly, as to the size of the incision, Engh ’209 states that “the
`conventional midline incision 40 for a total knee replacement surgery . . .
`[t]ypically . . . is roughly 8 to 15 centimeters in length.” Id. at 8:53-57, fig. 2.
`As such, we are persuaded that Engh ’209 discloses: “performing total knee
`arthroplasty through a primary incision having a length of less than thirteen (13)
`centimeters” and, further, “making a primary incision of less than thirteen (13)
`centimeters near the knee joint of a leg of a patient, and carrying out the further
`steps, through the primary incision,” as recited in claim 23 of the ’229 Patent.
`Pet. 48-49.
`We are also persuaded, on the present record, that that Engh ’209 discloses
`“cutting medial and lateral condyles, and the trochlear groove of the femur of the
`leg to create at least one femoral cut surface,” as required by claim 23. Id. at 49.
`As Petitioner points out, “Engh ’209 recognizes that ‘[t]ypically, a total knee joint
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`replacement involves replacing the articular surfaces of the lateral femoral condyle
`12, the medial femoral condyle 14, the medial tibial condyle 30 and the lateral
`tibial condyle 32.’” Id. (citing Ex. 1005, 8:43-46; Ex. 1002, ¶ 71). In addition,
`Engh ’209 discloses sculpting the distal end of the femur to form flat anterior and
`posterior surfaces, a flat end surface normal to the anterior and posterior surfaces,
`and angled flat surfaces joining these surfaces (Ex. 1005, 2:2-7), and sculpting the
`proximal end of the tibia to form a generally upwardly-facing bearing surface that
`articulates with the condylar surfaces of the femoral prosthesis (id. at 2:8-13).
`We are persuaded that Engh ’209 also discloses “moving a single femoral
`component of a total knee implant operative to replace the entire articulating
`surfaces of the medial and lateral condyles and the trochlear groove, thro
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