Tria1s@uspto.goV
`571-272-7822
`
`Paper 13
`Entered: June 2, 2014
`
`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
`
`Institution of Inter Partes Review
`
`37 C.F.R. § 42.108
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 1
`
`
`571-272-7822
`
`Paper 13
`Entered: June 2, 2014
`
`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
`
`Institution of Inter Partes Review
`
`37 C.F.R. § 42.108
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 1
`
`
`
`Case IPR2014-00321
`
`Patent 7,806,896 B1
`
`1. INTRODUCTION
`
`Petitioner filed a corrected petition (Paper 7, “Pet.”) requesting an
`
`inter partes review of claims 40-47 of U.S. Patent No. 7,806,896 B1
`
`(Ex. 1001, “the ’896 patent”) pursuant to 35 U.S.C. § 311-319. 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. § 3l4(a):
`
`THRESHOLD — The Director may not authorize an inter partes
`review to be instituted unless the Director determines that the
`
`information presented in the petition filed under section 311
`and any response filed under section 313 shows that there is a
`reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition.
`
`Upon consideration of the petition, we determine that the information
`
`presented in the petition establishes that there is a reasonable likelihood that
`
`Petitioner would prevail with respect to claims 40-42 and 44-47, but not
`
`claim 43, of the ’896 patent. Accordingly, pursuant to 35 U.S.C. § 314, we
`
`authorize an inter partes review to be instituted only as to claims 40-42 and
`
`44-47 of the ’896 patent.
`
`A. Related Proceedings
`
`Petitioner states that the ’896 patent is involved in co-pending district
`
`court proceeding Bonutti Skeletal Innovations LLC v. Zimmer, Inc., 1:12-cv-
`
`01107-GMS (D. Del.). Pet. 1. Petitioner also states the ’896 patent is
`
`involved in Smith & Nephew, Inc. v. Bonutti Skeletal Innovations LLC,
`
`IPR2013-00629 (“Smith & Nephew IPR”). Id. We note that a trial was
`
`commenced in the Smith & Nephew IPR on February 28, 2014 (Paper 10),
`
`and also note that another petition, Wright Medical Group, Inc. v. Bonutti
`
`Skeletal Innovations LLC, IPR2014-00354, was filed against the ’896 patent.
`
`2
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 2
`
`
`
`Case lPR2014-00321
`
`Patent 7,806,896 B1
`
`B. The ’896 Patent (Ex. I001)
`
`The ’896 patent, titled “KNEE ARTHROPLASTY METHOD,”
`
`issued October 5, 2010 from U.S. Patent Application No. 10/722,102, filed
`
`November 25, 2003. Ex. 1001 at [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. Ex. 1001 at [63].
`
`Claim 40 is the sole independent claim challenged, and 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. Claims 41-47
`
`dependent directly or indirectly from independent claim 40.
`
`D. Illustrative Claim
`
`Independent claim 40 is the only independent claim challenged and is
`
`reproduced below.
`
`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.
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 3
`
`
`
`Case IPR2014-00321
`
`Patent 7,806,896 B1
`
`Id. at 116:18-31.
`
`E. The Assertea’ Prior Art
`
`Petitioner relies on the following prior art:
`
`Reference
`Androphy
`Raderrnacher ’157 WO 93/25157 Dec. 23, 1993
`
`Insall
`
`US 6,068,658 May 30, 2000
`
`Issued/Published Exhibit
`
`
`
`22
`
`1006
`
`1003
`
`Klaus Raderrnacher et al., Computer—Integratea’ Orthopaedic Surgery.‘
`
`Connection ofPlanning and Execution in Surgical Intervention, in
`
`Computer—Integrated Surgery (Russell H. Taylor et al. eds., 1996)
`
`(“Raderrnacher Article”) (Ex. 1004).
`
`Zimmer Holdings, Inc. and Zimmer, Inc., casey total knee, (1976)
`
`(“Casey”) (Ex. 1007).
`
`Zimmer Holdings, Inc. and Zimmer, Inc., NexGen® Complete Knee
`
`Solution, (1996) (“NexGen”) (Ex. 1008).
`
`F. The Assertea’ Grounds
`
`Raderrnacher ’ 157 and Raderrnacher Article
`
`§§ 102/103
`
`Challenged
`40, 41, 44, 45
`
`Raderrnacher ’ 157, Raderrnacher Article,
`and NexGen
`
`§§ 102/ 103
`
`42
`
`and NexGen
`
`Androphy and/or Casey
`
`Raderrnacher ’157, Raderrnacher Article,
`Raderrnacher ’157, Raderrnacher Article,
`Raderrnacher ’157, Raderrnacher Article,
`
`and Insall
`
`II. ANALYSIS
`
`A. Claim Construction
`
`As a step in our analysis for determining whether to institute a trial,
`
`we determine the meaning of the claims. Consistent with the statute and
`
`4
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 4
`
`
`
`Case IPR2014-00321
`
`Patent 7,806,896 B1
`
`legislative history of the Leahy-Smith America Invents Act (“AIA”), Pub. L.
`
`No. 112-29, 125 Stat. 284, 329 (2011), claims of unexpired patents are
`
`construed by applying the broadest reasonable interpretation in light of the
`
`specification. 37 C.F.R. § 42.100(b); see also Office Patent Trial Practice
`
`Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012). Under the broadest
`
`reasonable interpretation standard, claim terms are given their ordinary and
`
`customary meaning, as would be understood by one of ordinary skill in the
`
`art in the context of the entire disclosure. In re Translogic Tech. Inc., 504
`
`F.3d 1249, 1257 (Fed. Cir. 2007). Any special definition for a claim term
`
`must be set forth with reasonable clarity, deliberateness, and precision. In re
`
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`Regarding claim construction, Petitioner points out that “alignment
`
`guide” and “cutting guide,” as claimed, recite two distinct elements. Pet. 26-
`
`27. We agree. The specification of the ’896 patent shows, for example,
`
`extramedullary alignment guide 504 upon which tibial resection (cutting)
`
`guide 500 is placed. Ex. 1001, 44:21-30, figs. 37, 38.
`
`B. Asserted Grounds of Unpatentability
`
`1. Radermacher ’157(Ex. 1003) and
`
`the Radermacher Article (Ex. 1004)
`
`Petitioner asserts that the subject matter of claims 40, 41, 44, and 45
`
`would have been obvious in view of Radermacher ’ 157 and the
`
`Radermacher Article. 1 Pet. 27-32.
`
`1 While Petitioner presents the ground as one based on anticipation or
`obviousness, the ground includes two references and a discussion regarding
`their combination. We treat the ground presented as one directed to
`obviousness,
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 5
`
`
`
`Case IPR2014-00321
`
`Patent 7,806,896 B1
`
`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, 10.2 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 the 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, 456.3
`
`The subject matter of challenged claim 40 is directed to a method of
`
`performing joint surgery using a custom fabricated alignment guide. Ex.
`
`1001, 116: 1 8-24. Petitioner asserts that Radermacher ’ 157 discloses an
`
`alignment guide (individual template) custom fabricated based on patient
`
`imaging. Pet. 28-30 (citing Ex. 1003, 10-12). Petitioner asserts that
`
`Radermacher ’ 157 discloses referencing a cutting guide (drill sleeve) using
`
`the alignment guide, and further points to the Radermacher Article as
`
`disclosing how cutting guides are fixed to the custom fabricated alignment
`
`guides. Pet. 29-30 (citing Ex. 1003, 10-12; Ex. 1004, 454-455). Petitioner
`
`asserts that it would have been obvious to consult the Radermacher Article
`
`for additional teachings and details because it has the same author and is
`
`directed to the same individual template technology. Pet. 28.
`
`2 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”).
`3 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”).
`
`6
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 6
`
`
`
`Case IPR2014-00321
`
`Patent 7,806,896 B1
`
`Challenged claim 41 depends from claim 40 and specifies that the
`
`particular type of surgery is total knee replacement surgery. Ex. 1001,
`
`11:32-33. Petitioner asserts that Radermacher ’ 157 discloses its customized
`
`individual template as being applicable to total knee replacement surgery.
`
`Pet. 31 (citing Ex. 1003, 30, figs. 13a-13d, depicting an individual template
`
`used to perform knee replacement). Claim 44 specifies that the joint can be
`
`a knee. Ex. 1001, 116:40-42. Petitioner asserts Radermacher ’157 discloses
`
`the joint is a knee. Pet. 31 (citing Ex. 1003, 30, figs 13a-13d). Claim 45
`
`specifies that a portion of the articulating surface of the joint is replaced.
`
`Ex. 1001 , 116:43-45. Petitioner asserts Radermacher ’157 discloses
`
`replacing at least a portion of the condyles of the femur (i.e., of the knee
`
`joint). Pet. 31-32 (citing Ex. 1003, 30, figs. 13a-13d, depicting a resected
`
`femur).
`
`Having reviewed Petitioner’s assertions and the cited portions of the
`
`record, we are persuaded that Petitioner has demonstrated a reasonable
`
`likelihood of prevailing on its contention that the subject matter of claims
`
`40, 41, 44, and 45 would have been obvious in view of Radermacher ’ 157
`
`and the Radermacher Article.
`
`
`
`2. Radermacher ’ 157
`
`the Radermacher Article and
`
`optionally NexGen (Ex. 1008 )
`
`Claim 42 depends from claim 40 and adds a step of positioning a pin
`
`into the bone to secure the cutting guide to the bone. Ex. 1001, 116:34-37.
`
`Petitioner asserts that the Radermacher disclosures “inherently or expressly
`
`teach .
`
`.
`
`. positions of pins used to secure standard cutting guides to the
`
`bone,” and relies on the declaration of Dr. Erdman (Ex. 1002), who, in turn,
`
`points to pages 454-455 of the Radermacher Article. Pet. 32 (citing Ex.
`
`7
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 7
`
`
`
`Case IPR2014-00321
`
`Patent 7,806,896 B1
`
`1002 1] 92). Reviewing this portion of the Radermacher Article, we find the
`
`individual template is described as having “reference points (bores) for the
`
`fixation of reusable standard tool guides [to the individual template],” and
`
`“[o]ptional fixation of the template on bone by small pins or screws.” Ex.
`
`1004, 455. Accordingly, pins are inserted into the bone to secure the
`
`alignment guide (individual template) to the bone, which, in turn, secures the
`
`cutting guide (tool guide, secured to the alignment guide) to the bone.
`
`Petitioner’s assertions with respect to claim 42 persuade us that it has a
`
`reasonable likelihood of prevailing on its contention that the subject matter
`
`of claim 42 would have been obvious in view of Radermacher ’ 157 and the
`
`Radermacher Article.
`
`Petitioner also asserts that NexGen discloses a step of positioning a
`
`pin in a bone to secure a cutting guide. Pet. 32-33. However, Petitioner
`
`proposes to incorporate this feature into the disclosures of Radermacher ’ 157
`
`and the Radermacher Article for the sole reason that each “relate to total
`
`knee replacement instruments.” Id. at 32. At best, Petitioner indicates that
`
`these prior art references are analogous art. However, merely pointing out
`
`that a reference is analogous art does not amount to providing an articulated
`
`reason with a rationale underpinning to support a conclusion of obviousness.
`
`As such, we determine that Petitioner has not provided sufficient rationale to
`
`support its asserted ground on the basis of Radermacher ’157, the
`
`Radermacher Article, and NexGen. Accordingly, we do not institute an inter
`
`partes review of claim 42 based on obviousness over Radermacher ’157, the
`
`Radermacher Article, and NexGen. See 37 C.F.R. § 42.108(a).
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 8
`
`
`
`Case 1PR2014-00321
`
`Patent 7,806,896 B1
`
`
`
`the Radermacher Article and either
`
`3. Radermacher ’ 157
`
`Androphy §Ex. 1005) or Casey (Ex. 1007)
`
`With respect to claim 43, Petitioner asserts that it would have been
`
`obvious to include teachings from Androphy or Casey into the disclosures of
`
`the individual templates in Radermacher ’ 157 and the Radermacher Article
`
`because these references “all relate to total knee replacement instruments.”
`
`Pet. 34. As above, arguing that references are analogous art is insufficient,
`
`by itself, to show it would have been obvious to combine the teachings of
`
`those references in a particular manner to arrive at the claimed invention.
`
`As such, we determine that Petitioner has not demonstrated a reasonable
`
`likelihood of prevailing in its contention that the subject matter of claim 43
`
`would have been obvious in view of Radermacher ’ 157, the Radermacher
`
`Article, and either Androphy or Casey.
`
`
`
`4. Radermacher ’ 157
`
`the Radermacher Article and
`
`Insall §Ex. 1006)
`
`Claim 46 depends from claim 45 and specifies that the replacement is
`
`made of a particular material. Ex. 1001, 116:46-51. Petitioner asserts that it
`
`would have been implicit or obvious from the disclosures of Radermacher
`
`’157 and the Radermacher Article to use metal because “it was common
`
`knowledge at the time of the invention that femoral implants could be
`
`formed from metal.” Pet. 36. In support of this assertion, Petitioner cites to
`
`Insall, which, in turn, discloses a meniscal component made of metal and
`
`plastic. See Pet. 38 (citing Ex. 1006, 4:63).
`
`In view of this, we are
`
`persuaded by Petitioner’s assertion, and determine Petitioner has
`
`demonstrated a reasonable likelihood of prevailing in its contention that the
`
`subject matter of claim 46 would have been obvious in view of Radermacher
`
`9
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 9
`
`
`
`Case IPR2014-00321
`
`Patent 7,806,896 B1
`
`’157, the Radermacher Article, and Insall.
`
`Claim 47 depends from claim 40 and specifies that the joint has a
`
`plurality of articulating surface compartments, and at least a portion of the
`
`articulating surface is not replaced in all articulating surface compartments.
`
`Ex. 1001, 116:52-55. Petitioner asserts that the Radermacher references and
`
`Insall disclose replacing the articulating surface of the condyles, but not the
`
`articulating surface of the patella. Pet. 37. Thus, Petitioner concludes that it
`
`would have been obvious to a person of ordinary skill in the art to not
`
`replace all articulating surface components. Id. at 37-38 (citing Ex. 1002 111]
`
`97, 98). Accordingly, we determine that Petitioner has demonstrated a
`
`reasonable likelihood of prevailing in its contention that the subject matter of
`
`claim 47 would have been obvious in view of Radermacher ’ 157, the
`
`Radermacher Article, and Insall.
`
`
`
`5. Radermacher ’ 157
`
`the Radermacher Article and
`
`NexGen
`
`Petitioner asserts claims 40 and 42 are unpatentable over these
`
`references. Pet. 39-40. We are not persuaded Petitioner has demonstrated a
`
`reasonable likelihood of prevailing on this ground because Petitioner, in the
`
`manner we discussed above, has not provided an articulated reason with a
`
`rational underpinning in support of the proposed combination. See Pet. 39-
`
`40 (“Since [the three references] all relate to total knee arthroplasty, it would
`
`have been obvious to .
`
`.
`
`. .”).
`
`C. Conclusions
`
`We conclude that Petitioner has demonstrated a reasonable likelihood
`
`of prevailing on its assertion that claims 40-42 and 44-47 of the ’896 patent
`
`are unpatentable.
`
`10
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 10
`
`
`
`Case IPR2014-00321
`
`Patent 7,806,896 B1
`
`We conclude that Petitioner has not demonstrated a reasonable
`
`likelihood of prevailing on its assertion that claim 43 of the ’896 patent is
`
`unpatentable.
`
`At this stage of the proceeding, we have not made a final
`
`determination on the patentability of any claim.
`
`III. ORDER
`
`In consideration of the foregoing, it is hereby:
`
`ORDERED that we authorize an interpartes review of claims 40-42
`
`and 44-47, but do not authorize an interpartes review as to claim 43;
`
`FURTHER ORDERED that that this proceeding is authorized as to
`
`the following grounds presented in the petition:
`
`A. Claims 40-42, 44, and 45 under 35 U.S.C. § 103 as obvious in
`
`view of Radermacher ’ 157 and the Radermacher Article.
`
`B. Claims 46 and 47 under 35 U.S.C. § 103 as obvious in view of
`
`Radermacher ’ 157, the Radermacher Article, and Insall.
`
`FURTHER ORDERED that no other grounds set forth in the petition
`
`are authorized;
`
`FURTHER ORDERED that this decision is to be considered as
`
`entered simultaneously with the decision to institute in IPR2014-00354; and
`
`FURTHER ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter
`
`partes review of the ’896 patent is instituted, commencing on the entry date
`
`of this Decision, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4,
`
`notice is given of the institution of a trial.
`
`11
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 11
`
`
`
`Case IPR20l4-00321
`
`Patent 7,806,896 B1
`
`PETITIONER:
`
`Walter Linder
`
`Daniel Lechleiter
`
`FAEGRE BAKER DANIELS LLP
`
`Walter.Linder@Fae greBD.c0m
`Daniel.Lechleiter@FaegreBD.c0m
`patentd0cketing@fae grebd.c0m
`
`PATENT OWNER:
`
`Cary Kappel
`William Gehris
`
`DAVIDSON, DAVIDSON & KAPPEL, LLC
`ckaQ_pel@ddkpatent.c0m
`wgehris@ddkpatent.c0m
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1009 — 12
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