Paper 35
`
`
`Trials@uspto.gov
`Tel: 571–272–7822 Entered: May 18, 2015
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ZIMMER HOLDINGS, INC.
`and ZIMMER, INC.,
`Petitioner,
`
`v.
`
`BONUTTI SKELETAL INNOVATIONS LLC,
`Patent Owner.
`____________
`
`Case IPR2014-00321
`Patent 7,806,896 B1
`
`
`Before WILLIAM V. SAINDON, MICHAEL R. ZECHER, and
`RICHARD E. RICE, Administrative Patent Judges.
`
`SAINDON, Administrative Patent Judge.
`
`
`
`DECISION
`Final Written Decision
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
`Trials@uspto.gov
`Tel: 571–272–7822 Entered: May 18, 2015
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ZIMMER HOLDINGS, INC.
`and ZIMMER, INC.,
`Petitioner,
`
`v.
`
`BONUTTI SKELETAL INNOVATIONS LLC,
`Patent Owner.
`____________
`
`Case IPR2014-00321
`Patent 7,806,896 B1
`
`
`Before WILLIAM V. SAINDON, MICHAEL R. ZECHER, and
`RICHARD E. RICE, Administrative Patent Judges.
`
`SAINDON, Administrative Patent Judge.
`
`
`
`DECISION
`Final Written Decision
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`IPR2014-00321
`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) and 37 C.F.R. § 42.73.
`With respect to the grounds asserted in this trial, we have considered
`the papers submitted by the parties and the evidence cited therein. For the
`reasons discussed below, we determine that claim 42, the only remaining
`challenged claim of U.S. Patent No. 7,806,896 B1 (Ex. 1001, “the ’896
`patent”), is unpatentable.
`
`A. Procedural History
`
`Zimmer Holdings, Inc. and Zimmer, Inc. (“Petitioner”) filed a
`corrected Petition requesting an inter partes review of claims 40–47 of the
`’896 patent. Paper 7 (“Pet.”). Petitioner included a Declaration of
`Dr. Arthur G. Erdman, Ph.D. Ex. 1002. Bonutti Skeletal Innovations, LLC
`(“Patent Owner”) elected not to file a Preliminary Response to the Petition.
`Paper 12.
`In our Decision Instituting Inter Partes Review, we granted review as
`to some of the challenged claims, namely, claims 40–42 and 44–47, but not
`claim 43. Paper 13 (“Dec. Inst.”). Patent Owner filed a Response to the
`Petition (Paper 28, “PO Resp.”). Patent Owner also filed notices indicating
`that it disclaimed claims 40, 41, and 44–47, leaving only claim 42 remaining
`of the challenged claims. Papers 15, 27; Exs. 2001, 2002. Petitioner then
`filed a Reply to the Response (Paper 31, “Pet. Reply”).
`
`B. Related Matters
`
`Petitioner states that the ’896 patent is involved in a co-pending
`district court proceeding titled Bonutti Skeletal Innovations LLC v. Zimmer,
`
` 2
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`IPR2014-00321
`Patent 7,806,896 B1
`
`Inc., 1:12-cv-01107-GMS (D. Del.). Paper 19, 1. The ’896 patent also is
`discussed in a Final Written Decision determining claim 1 of the ’896 patent
`to be unpatentable. Smith & Nephew, Inc. v. Bonutti Skeletal Innovations
`LLC, Case IPR2013-00629, slip op. at 35 (PTAB Feb. 18, 2015) (Paper 31).1
`
`C. The ’861 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, [54], [45], [21], [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].
`Claim 42 is the sole remaining claim challenged, and depends from
`independent claim 40. Independent claim 40 is directed to a method for
`performing joint replacement surgery. An alignment guide is custom
`fabricated for the patient based on patient imaging information. Ex. 1001,
`116:18–24. A cutting guide is referenced to the alignment guide, and using
`the cutting guide, a cut is made. Id. at 116:25–31. Claim 42 specifies how
`the “referencing” step is performed. Id. at 116:34–37.
`
`D. Challenged Claim
`
`Claim 42, which depends from claim 40, is the sole remaining
`challenged claim. Claims 40 and 42 of the ’896 patent are reproduced
`below:
`
`
`1 Wright Medical Group, Inc. v. Bonutti Skeletal Innovations LLC, Case
`IPR2014-00354, was joined to IPR2013-00629.
`
` 3
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`IPR2014-00321
`Patent 7,806,896 B1
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`40. A method of replacing at least a portion of a joint
`in a patient, the method comprising the steps of:
`obtaining an alignment guide positionable on a
`bone using references derived independently of
`an
`intramedullary
`device, wherein
`the
`alignment guide is custom fabricated for the
`patient based on patient imaging information;
`positioning the alignment guide in relation to the
`surface of an unresected bone of the joint;
`referencing a cutting guide with respect to the
`alignment guide; and
`cutting the unresected bone of the joint for the first
`time, by moving a cutting tool along a guide
`surface of the cutting guide.
`
`
`42. The method of claim 40, wherein referencing the
`cutting guide includes positioning a pin into the
`bone to secure the cutting guide to the bone and
`wherein the pin position is determined by the
`alignment guide.
`Ex. 1001, 116:18–31, 34–37.
`
`E. Asserted Grounds and Prior Art
`
`The sole remaining ground in this proceeding is whether claim 42 is
`obvious in view of Radermacher ’1572 and the Radermacher Article.3
`
`
`2 WO 93/25157, published Dec. 23, 1993 (Ex. 1003).
`3 Klaus Radermacher et al., Computer-Integrated Orthopaedic Surgery:
`Connection of Planning and Execution in Surgical Intervention, in
`Computer-Integrated Surgery (Russell H. Taylor et al. eds., 1996)
`(“Radermacher Article”) (Ex. 1004).
`
` 4
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`IPR2014-00321
`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); In re Cuozzo Speed Techs., LLC, 778 F.3d 1271, 1281–82 (Fed.
`Cir. 2015). Under the broadest reasonable interpretation standard, claim
`terms are given their ordinary and customary meaning, as would be
`understood by one of ordinary skill in the art, in the context of the entire
`disclosure. In re Translogic Tech. Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). Any special definition for a claim term must be set forth with
`reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d
`1475, 1480 (Fed. Cir. 1994).
`Claim 40 includes a step of “positioning” an alignment guide “in
`relation to the surface of an unresected bone.” Ex. 1001, 116:25–26. The
`claim also includes a step of “referencing” a cutting guide with respect to the
`alignment guide. Id. at 116:27–28. Claim 42 further defines the
`“referencing” step, specifying that the step “includes positioning a pin into
`the bone to secure the cutting guide to the bone,” wherein the pin position is
`“determined by the alignment guide.” Id. at 116:34–37. A dispositive issue
`in this proceeding turns on the proper construction of these limitations.
`Petitioner argues that the above limitations read on a procedure
`wherein an alignment guide is secured to the bone using pins and then a
`cutting guide is secured to the alignment guide, the pins thus securing the
`cutting guide to the bone via the alignment guide. See Pet. Reply 3–5.
`Patent Owner argues that the above limitations do not read on such a
`procedure, and that these limitations require that the cutting guide is secured
`
` 5
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`IPR2014-00321
`Patent 7,806,896 B1
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`directly on the bone by pins. See PO Resp. 8–18. Petitioner replies that the
`claims simply recite that the “referencing . . . includes positioning a pin” and
`does not preclude the pin being used to secure the alignment guide, which, in
`turn, secures the cutting guide. See Pet. Reply 5–6.
`In construing these limitations, we first turn to the specification. We
`are unable, however, to locate any description of a “referencing” step
`involving a cutting guide.4 With respect to how a cutting guide is attached
`to the femur, the ’896 patent describes, in one embodiment, both the
`alignment guide and the resection (cutting) guide as “connected with the
`femur” and “mounted on the . . . femur” even though only the alignment
`guide is directly connected to the femur. Ex. 1001, 19:44–50, 20:10–13.
`This arrangement is depicted in Figures 10 and 11, reproduced below.
`
`
`
`
`4 The “referencing” step was not found in an original claim. It first appeared
`in new claim 58 in an amendment received June 25, 2009—that amendment
`did not discuss the new claim or the new limitation and simply stated “[n]o
`new matter has been added.” Ex. 3001, 14 (Response to Office Action,
`received June 25, 2009). The Examiner subsequently indicated that claim 58
`was allowable, without explanation or analysis. Ex. 3002, 4 (Final
`Rejection, mailed Sept. 22, 2009).
`
` 6
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`IPR2014-00321
`Patent 7,806,896 B1
`
`
`Figures 10 and 11 of the ’896 patent depict alignment guide 134
`secured to femur 126 via intramedullary rod 132.5 Ex. 1001, 19:44–49,
`20:10–17, 23:18–20. Cutting guide 138 is secured to alignment guide 134
`via two pins (unlabeled). See id. at 17:39–41.
`Patent Owner argues that when the claims state “securing a cutting
`guide to the bone,” they mean securing the cutting guide directly to the bone.
`See, e.g., PO Resp. 9. In view of the above disclosures of the ’896 patent,
`however, we are persuaded that a person of ordinary skill in the art reading
`the ’896 patent would have understood that a cutting guide is secured to a
`bone even if it is secured indirectly by way of an alignment guide.
`In addition, we are not persuaded that “positioning a pin . . . to secure
`the cutting guide” requires that, immediately after positioning the pin, the
`cutting guide is secure. Instead, the claim simply requires that positioning a
`pin secures the cutting guide; it does not say when this occurs. Thus, an
`action of placing a pin into a bone to secure an alignment guide also serves
`to secure a cutting guide to the bone once the cutting guide is attached to the
`bone via the alignment guide. Accordingly, we are not persuaded that the
`broadest reasonable interpretation of the “referencing” step, as further
`defined in claim 42, requires that the cutting guide is secured directly to the
`bone, that the claimed pins secure only the cutting guide to the bone, or that
`
`
`5 We recognize that claim 40 is directed to a custom alignment guide
`positionable using references derived independently of an intramedullary
`device, and that Figures 10 and 11 depict an intramedullary device. We
`refer to the embodiments depicted in Figures 10 and 11, however, because,
`aside from the custom guide aspect, the examples and description of those
`figures are informative as to remainder of the claimed steps.
`
` 7
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`IPR2014-00321
`Patent 7,806,896 B1
`
`the cutting guide is secured to the bone immediately upon positioning the
`pins.
`
`B. Radermacher ’157 and the Radermacher Article
`
`Radermacher ’157 discloses an individual template obtained by
`imaging a patient’s bone structure and forming a surface of the template to
`correspond to the bone structure. Ex. 1003, 10.6 Tool guides can be
`mounted thereon. Id. at 11. The individual template can be used to perform
`different types of surgeries, such as knee surgery. Id. at 30, Figs. 13a–13d.
`
`The Radermacher Article discusses an individual template in
`additional detail. For example, the individual template can be used as a way
`to position and orient reusable cutting guides and tools relative to the
`patient’s anatomy. Ex. 1004, 455–56.7 The individual template also may be
`affixed to the bone using pins or screws. Id.
`
`C. Petitioner’s Asserted Ground
`
`Petitioner asserts that the subject matter of claim 42, which depends
`from claim 40, is obvious in view of Radermacher ’157 and the
`Radermacher Article. Pet. 27–31, 32–34. Regarding the “obtaining an
`alignment guide” limitation, Petitioner alleges that both references disclose
`
`
`6 All references to page numbers in Radermacher ’157 are to the page
`numbers originally in the reference (top center), not the page numbers added
`by Petitioner (bottom right, preceded by “Ex. 1003”).
`7 All references to page numbers in the Radermacher Article are to the page
`numbers originally in the reference (bottom right or bottom left), not the
`page numbers added by Petitioner (bottom right, preceded by “Ex. 1004”).
`
`
` 8
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`IPR2014-00321
`Patent 7,806,896 B1
`
`an individual template customized to a particular person’s anatomy using,
`for example, tomography. Pet. 29–30 (citing Ex. 1002 ¶¶ 87–88; Ex. 1003,
`10–12; Ex. 1004, 454–455).
`Regarding the “positioning the alignment guide” limitation, Petitioner
`alleges that Radermacher ’157 discloses that the individual template is
`placed onto the exposed surface of the bone. Pet. 30 (citing Ex. 1003, 11,
`30, Figs. 13a, 13c; Ex. 1002 ¶ 90).
`Regarding the “referencing a cutting guide” limitation, Petitioner
`alleges that Radermacher ’157 discloses that the individual templates include
`attachment points for “standardized tool guides” or a “drill sleeve.” Pet. 30–
`31 (citing Ex. 1003, 11, 30, Figs. 13a, 13c; Ex. 1002 ¶¶ 64, 88). Petitioner
`further alleges that the Radermacher Article discloses that the individual
`template (alignment guide) is secured to the bone with pins. Pet. 33–34
`(citing Ex. 1004, 454–455; Ex. 1002 ¶ 88).
`Regarding the “cutting the unresected bone” limitation, Petitioner
`alleges that Radermacher ’157 discloses cutting an unresected bone. Pet. 31
`(citing Ex. 1003, 30, Figs. 13a, 13c; Ex. 1002 ¶¶ 65, 90).
`Petitioner alleges that it would have been obvious to combine the
`teachings of Radermacher ’157 and the Radermacher Article because they
`are both written by the same author and are directed to the same individual-
`template technology. Pet. 27–28 (citing Ex. 1002 ¶¶ 46–72, 86–91, 94, 95).
`Petitioner also alleges that it would have been obvious that these references
`“inherently or expressly teach the use of the individual templates . . . as
`guides for determining the positions of pins used to secure standard cutting
`guides to the bone.” Pet. 32 (citing Ex. 1002 ¶ 92).
`
` 9
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`IPR2014-00321
`Patent 7,806,896 B1
`
`
`D. Patent Owner’s Arguments
`
`Patent Owner’s chief argument is that none of Radermacher ’157 (PO
`
`Resp. 8–10), the Radermacher Article (id. at 10–11), and their respective
`combination (id. at 12–18) teach that “referencing the cutting guide includes
`positioning a pin into the bone to secure the cutting guide to the bone and
`wherein the pin position is determined by the alignment guide.” Patent
`Owner also argues that neither reference inherently teaches such a limitation.
`Id. at 18–20.
`
`E. Analysis
`
`Petitioner has shown that the Radermacher Article describes an
`
`individual template (alignment guide) that is secured to the bone using pins.
`Ex. 1004, 455 (“Optional fixation of the template on bone by small pins or
`screws can be useful”). Further, Petitioner has shown that the Radermacher
`Article describes the individual template having reference points for the
`attachment of standard tool guides (cutting guides). Id. (“Alternatively, we
`have to define reference points (bores) for the fixation of reusable standard
`tool guides.”). Based on these showings, we are persuaded that the
`Radermacher Article discloses that “pin position is determined by the
`alignment guide” because the pins are used to secure the individual template
`(alignment guide) and, thus, the pin position is determined by whatever bore
`is provided by the alignment guide for those pins. Further, we are persuaded
`that the Radermacher Article discloses “referencing a cutting guide with
`respect to the alignment guide” because the standard tool guide (cutting
`guide) is mounted to the individual template (alignment guide) in the proper
`position by using the provided reference points.
`
`
`10
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`IPR2014-00321
`Patent 7,806,896 B1
`
`
`Where Petitioner and Patent Owner disagree is whether the act of
`securing Radermacher’s individual template to the bone using pins, and then
`securing the standard tool guide to the individual template, satisfies the
`limitation in claim 42 of “wherein referencing the cutting guide includes
`positioning a pin into the bone to secure the cutting guide to the bone and
`wherein the pin position is determined by the alignment guide.” Consistent
`with our analysis of this limitation in our claim construction section, we are
`persuaded that “positioning a pin into the bone to secure the cutting guide to
`the bone” is satisfied by the actions of first positioning a pin into the bone to
`secure the alignment guide, and then securing the cutting guide to the
`alignment guide. That is, the action of positioning the pin into the bone to
`secure the alignment guide to the bone also serves to secure the cutting guide
`to the bone once the cutting guide is secured to the alignment guide.
`We are not persuaded by Patent Owner’s arguments that such
`positioning is not part of any “referencing” step, because referencing the
`cutting guide to the alignment guide relies on the alignment guide being
`properly positioned, such that anything that serves to align the alignment
`guide also serves to align the cutting guide. Further, claim 42 states that the
`referencing step includes positioning a pin; the claim does not state that the
`entire referencing step consists solely of positioning a pin. Nor does the
`claim require positioning a pin into a cutting guide to secure the cutting
`guide to the bone. Lastly, as we discussed in the claim construction section,
`Petitioner’s reading of the claim on the prior art is commensurate with the
`specification, which considers a cutting guide to be “mounted” or
`“connected” to a femur, terms synonymous with “secure,” even when there
`is no direct contact between the bone and cutting guide.
`
`11
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`IPR2014-00321
`Patent 7,806,896 B1
`
`
`In view of the above, we are persuaded that Petitioner has shown, by a
`preponderance of the evidence, that the combined disclosure of
`Radermacher ’157 and the Radermacher Article teach all the limitations of
`claim 42 in the manner required by the claim.
`
`III. RESULTS OF THE PROCEEDING
`
`Patent Owner has disclaimed claims 40, 41, and 44–47 of the ’896
`patent. Papers 15, 27; Exs. 2001, 2002.
`Petitioner has shown by a preponderance of the evidence that the
`subject matter of claim 42 of the ’896 patent would have been obvious to a
`person of ordinary skill in the art at the time of the invention in view of
`Radermacher ’157 and the Radermacher Article. See supra Section II(A–E).
`
`IV. ORDER
`
`In view of the foregoing, it is hereby:
`
`ORDERED that claim 42 of U.S. Patent No. 7,806,896 B1 is
`unpatentable; and
`
`FURTHER ORDERED that, because this is a final written decision,
`the parties to the proceeding seeking judicial review of the decision must
`comply with the notice and service requirements of 37 C.F.R. § 90.2.
`
`
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`12
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`IPR2014-00321
`Patent 7,806,896 B1
`
`PETITIONER:
`Naveen Modi
`Joseph Palys
`Paul Hastings LLP
`naveenmodi@paulhastings.com
`josephpalys@paulhastings.com
`
`PATENT OWNER:
`Cary Kappel
`William Gehris
`Davidson, Davidson & Kappel, LLC
`ckappel@ddkpatent.com
`wgehris@ddkpatent.com
`
`
`
`13
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`
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