Trials@uspto.gov
`571-272-7822
`
`
` Paper 18
` Entered: July 9, 2019
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.,
`Petitioner,
`
`v.
`
`NUVASIVE, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00362
`Patent 8,361,156 B2
`____________
`
`
`Before DENISE M. POTHIER, HYUN J. JUNG, and
`SHEILA F. McSHANE, Administrative Patent Judges.
`
`POTHIER, Administrative Patent Judge.
`
`
`
`DECISION TO INSTITUTE
`35 U.S.C. § 314
`
`
`
`
`
`
`
`571-272-7822
`
`
` Paper 18
` Entered: July 9, 2019
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.,
`Petitioner,
`
`v.
`
`NUVASIVE, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00362
`Patent 8,361,156 B2
`____________
`
`
`Before DENISE M. POTHIER, HYUN J. JUNG, and
`SHEILA F. McSHANE, Administrative Patent Judges.
`
`POTHIER, Administrative Patent Judge.
`
`
`
`DECISION TO INSTITUTE
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`
`I.
`
`INTRODUCTION
`
`Alphatec Holdings, Inc. and Alphatec Spine, Inc. (collectively,
`
`“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting institution of an
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`inter partes review of claims 1–3, 5, 9, 10, 12–21, 23, 24, and 27 of
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`U.S. Patent No. 8,361,156 B2 (Ex. 1001, “the ’156 patent”). NuVasive Inc.
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`(“Patent Owner”) filed a Preliminary Response (Paper 11, “Prelim. Resp.”).
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`Under 35 U.S.C. § 314, an inter partes review may not be instituted “unless .
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`. . there is a reasonable likelihood that the petitioner would prevail with
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`respect to at least 1 of the claims challenged in the petition.”
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`Upon consideration of the Petition and Preliminary Response and for
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`the reasons explained below, we determine that Petitioner has shown that
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`there is a reasonable likelihood that it would prevail with respect to at least
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`one of the challenged claims. We institute an inter partes review of all
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`challenged claims on all presented challenges and, thus, institute an inter
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`partes review of claims 1–3, 5, 9, 10, 12–21, 23, 24, and 27 of the ’156
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`patent.
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`
`
`II.
`
`BACKGROUND
`
`A. Related Proceedings
`
`The parties indicate that the ’156 patent has been asserted in
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`NuVasive, Inc. v. Alphatec Holdings, Inc., Case No. 3:18-cv-00347-CAB-
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`MDD (S.D. Cal.) and Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case No.
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`3:12-cv-002738-CAB-MDD (S.D. Cal.). Pet. 76–77; Paper 4, 2. Petitioner
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`indicates the latter litigation was settled on July 27, 2016. Pet. 77.
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`The parties additionally note that the ’156 patent was previously
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`challenged in Cases IPR2013-00504, IPR2013-00506, and IPR2014-00487.
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`IPR2019-00362
`Patent 8,361,156 B2
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`Pet. 16, 21; Paper 4, 2 (citing In re NuVasive, Inc., 842 F.3d 1376 (Fed. Cir.
`
`2016)).
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`The parties also state that a related patent, U.S. Patent 8,187,334, is
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`challenged in Cases IPR2019-00361 and IPR2019-00546. Pet. 77; Paper 4,
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`2 (further citing Cases IPR2013-00507 and IPR2013-00508 and In re
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`NuVasive, Inc., 841 F.3d 966 (Fed. Cir. 2016)); Paper 7, 2.
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`B. The ’156 Patent (Ex. 1001)
`
`The ’156 patent issued January 29, 2013, from an application filed
`
`April 6, 2012, which is a continuation of an application filed on April 5,
`
`2012, which is a continuation of an application filed on April 4, 2011, which
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`is a continuation of an application filed on March 29, 2005, and claims
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`priority to a provisional application filed on March 29, 2004. Ex. 1001,
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`(22), (60), (63), 1:6–15.
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`The ’156 patent relates to “a system and method for spinal fusion
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`comprising a spinal fusion implant of non-bone construction . . . to introduce
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`the spinal fusion implant into any of a variety of spinal target sites.” Id. at
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`1:21–25. Figure 2 of the ’156 patent is reproduced below.
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`IPR2019-00362
`Patent 8,361,156 B2
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`The above Figure 2 shows a perspective view of a lumbar fusion implant.
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`Id. at 3:36. The spinal fusion implant is introduced into a lumbar disc space
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`through a lateral, a posterior, an anterior, an antero-lateral, or a postero-
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`lateral approach to the spine. Id. at 5:29–35. The implant is made from a
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`radiolucent material, such as poly-ether-ether-ketone (PEEK). Id. at
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`5:10–15.
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`Common attributes of the various embodiments of spinal fusion
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`implant 10 includes top surface 31, bottom surface 33, lateral sides 14,
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`proximal side 22, and distal side 16. Id. at 6:6–9, Figs. 2–3. By way of
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`example, spinal fusion implant 10 may have “a width ranging between 9 and
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`18 mm, a height ranging between 8 and 16 mm, and a length ranging
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`between 25 and 45 mm.” Id. at 5:15–19.
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`Spinal fusion implant 10 also preferably includes anti-migration
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`features, such as ridges 6 and spike elements 7–9, designed to increase
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`friction between spinal fusion implant 10 and adjacent contacting surfaces of
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`vertebral bodies. Id. at 6:21–32, Figs. 2–3. Spike elements 7–9 are
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`preferably made from materials having radiopaque characteristics. Id. at
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`6:35–38.
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`Spinal fusion implant 10 has fusion apertures 2, separated by medial
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`support 50, extending through top surface 31 and bottom surface 33. Id. at
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`6:57–59, Figs. 2–3. “[F]usion apertures 2 function primarily as an avenue
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`for bony fusion between adjacent vertebrae.” Id. at 6:59–61.
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`C. Illustrative Claim
`
`The ’156 patent has 27 claims. Ex. 1001, 12:32–14:43. Petitioner
`
`challenges claims 1–3, 5, 9, 10, 12–21, 23, 24, and 27. Claim 1 is the only
`
`independent claim and is reproduced below.
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`
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`4
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`IPR2019-00362
`Patent 8,361,156 B2
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`
`implant of non-bone construction
`1. A spinal fusion
`positionable within an interbody space between a first vertebra
`and a second vertebra, said implant comprising:
`an upper surface including anti-migration elements to
`contact said first vertebra when said implant is positioned within
`the interbody space, a lower surface including anti-migration
`elements to contact said second vertebra when said implant is
`positioned within the interbody space, a distal wall, a proximal
`wall, a first sidewall, and a second sidewall generally opposite
`from the first sidewall, wherein said distal wall, proximal wall,
`first sidewall, and second sidewall comprise a radiolucent
`material;
`wherein said implant has a longitudinal length extending
`from a proximal end of said proximal wall to a distal end of said
`distal wall, said implant has a maximum lateral width extending
`from said first sidewall to said second sidewall along a medial
`plane that is generally perpendicular to said longitudinal length,
`and said longitudinal length is greater than said maximum lateral
`width;
`at least a first fusion aperture extending through said upper
`surface and lower surface and configured to permit bone growth
`between the first vertebra and the second vertebra when said
`implant is positioned within the interbody space, said first fusion
`aperture having: a longitudinal aperture length extending
`generally parallel to the longitudinal length of said implant, and
`a lateral aperture width extending between said first sidewall to
`said second sidewall, wherein the longitudinal aperture length is
`greater than the lateral aperture width; and
`at least first and second radiopaque markers oriented
`generally parallel to a height of the implant, wherein said first
`radiopaque marker extends into said first sidewall at a position
`proximate to said medial plane, and said second radiopaque
`marker extends into said second sidewall at a position proximate
`to said medial plane.
`
`Ex. 1001, 12:32–67 (emphases added).
`
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`D. Evidence Relied Upon
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`Petitioner identifies the following references as prior art in the
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`asserted grounds of unpatentability:
`
`(1) U.S. Patent No. 5,192,327, issued March 9, 1993 (Ex. 1007,
`
`“Brantigan”);
`
`(2) U.S. Patent No. 5,860,973, issued January 19, 1999 (Ex. 1032,
`
`“Michelson”);
`
`(3) U.S. Patent Application Publication No. US 2003/0028249 A1,
`
`published February 6, 2003 (Ex. 1008, “Baccelli”); and
`
`(4) James L. Berry et al., A Morphometric Study of Human Lumbar
`
`and Selected Thoracic Vertebrae, 12 SPINE 362–67 (1987) (Ex.
`
`1022, “Berry”).
`
`In support of its challenges, Petitioner provides a Declaration of
`
`Charles L. Branch, Jr., M.D. (Ex. 1002). See Pet. 21–22, 26–28.
`
`E. Asserted Grounds
`
`Petitioner challenges the patentability of claims 1–3, 5, 9, 10, 12–21,
`
`23, 24, and 27 of the ’156 patent on the following grounds:
`
`Statutory Basis
`
`Reference(s)
`
`§ 103
`
`§ 103
`
`Brantigan, Baccelli, and Berry
`
`Brantigan, Baccelli, Berry, and
`Michelson
`
`Claim(s)
`
`Challenged
`
`1–3, 5, 9, 10,
`12–21, 23, 24, 27
`
`9
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`
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`Pet. 21–22, 28–75.
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`III.
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`35 U.S.C. § 325(d)
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`Patent Owner requests denial of institution under 35 U.S.C. § 325(d)
`
`because the Office has previously considered the same or substantially the
`
`same prior art or arguments (Prelim. Resp. 10) and Petitioner incorrectly
`
`argues that its presented grounds are not cumulative to references applied
`
`during prosecution of the ’156 patent (id. at 15–16 (citing Pet. 25–26)). See
`
`id. at 10–20. Patent Owner provides a summary of the prosecution histories
`
`of the application that issued as the ’156 patent and its parent applications.
`
`Id. at 10–14.
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`Patent Owner also provides its analysis of the factors identified in
`
`Becton, Dickinson and Co. v. B. Braun Melsungen AG, Case
`
`IPR2017-01586, slip op. at 16–18 (PTAB Dec. 15, 2017) (Paper 8)
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`(informative) (“Becton, Dickinson”). Patent Owner’s analysis focuses on,
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`inter alia, the extensive consideration of Brantigan, Berry and Michelson
`
`during prosecution of the ’156 patent and other related patents; the
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`cumulative nature of Brantigan and Baccelli; the overlap of Petitioner’s
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`radiopaque marker configuration with arguments considered during
`
`prosecution; Petitioner’s failure to identify Examiner error; and Petitioner’s
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`failure to provide new evidence to warrant reconsideration. See Prelim.
`
`Resp. 10–20.
`
`Although Brantigan, Michelson, and Berry were cited during
`
`prosecution of the ’156 patent on an extensive information disclosure
`
`statement (see Ex. 1013, 207–217; see Ex. 1001, 2–3), there is no evidence
`
`in the record that Baccelli was considered. Ex. 1001, 1–3; Pet. 16 (stating
`
`“[t]he [E]xaminer never had Baccelli”). As such, any arguments previously
`
`made, including during prosecution of the ’156 patent, differ from the
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`arguments presented by Petitioner at least as far as Baccelli is concerned.
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`Also, as Petitioner and Patent Owner indicate, no substantive rejection was
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`presented during the prosecution of the ’156 patent or the other noted related
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`applications, such as U.S. Application Nos. 13/079,645 and 13/440,062.1
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`Pet. 16 (citing Ex. 1013, 191–194; Ex. 1023, 206–214; Ex. 1025, 106–110);
`
`see Prelim. Resp. 10–14, 19 (stating that Brantigan, Michelson, and Berry
`
`were “considered” by the Examiner and indicating the claims of the ’156
`
`patent were not rejected based on prior art). Moreover, during prosecution
`
`of the ’156 patent, the Examiner did not discuss Brantigan, Michelson, or
`
`Berry but rather discussed the “prior art” generally when addressing the
`
`reasons for allowance. Ex. 1013, 193. Thus, the first and third Becton,
`
`Dickinson factors (see Prelim. Resp. 15, 19) disfavor denying institution.
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`Also, the fourth and fifth Becton, Dickinson factors (see id. at 19–20) weigh
`
`neither for nor against institution. Specifically, given that there were no
`
`arguments presented during examination and the Examiner did not consider
`
`Baccelli, Petitioner could not have pointed out the Examiner’s error in
`
`evaluating the asserted prior art.
`
`Patent Owner’s arguments under Becton, Dickinson’s second and
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`sixth factors relate to radiopaque markers. See Prelim. Resp. 15–16 (arguing
`
`that “the [E]xaminer considered at least three references discussing the use
`
`of radiopaque markers on radiolucent spinal implants” and that “Brantigan
`
`and Baccelli are cumulative to the references . . . because they too do not
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`disclose the claimed marker configuration for the claimed implant”),
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`20. Patent Owner directs our attention to portions of prosecution histories
`
`
`1 These applications matured into U.S. Patent Nos. 8,187,334 and 8,246,686
`respectively.
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`8
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`Patent 8,361,156 B2
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`from related applications and the application that issued as the ’156 patent
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`concerning radiopaque markers. See id. at 16–18 (citing Ex. 1013, 190–193,
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`196, 201; Ex. 1020, 97, 108–110, 224–226, 230, 245, 247–250, 271–275;
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`Ex. 1023, 212–213, 215–216, 219, 222, 226; Ex. 1025, 104, 112, 114;
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`Ex. 2005, 7:56–60; Ex. 2007 ¶¶ 60, 74, 76, 90, Figs. 7–8; Ex. 2008 ¶ 19;
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`Pet. 15–16). But, as explained in more detail below in addressing the
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`proposed grounds, Baccelli at least raises issues relating to radiopaque
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`marker arrangements on an implant which differ from the previously
`
`considered prior art. As such, there is a material difference between the
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`asserted art in this Petition and previously considered art. Compare, e.g.,
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`Ex. 1008 ¶¶ 41, 50, 51, Figs. 1–2, 8 (Baccelli), with e.g., Ex. 1001, 1–4; see
`
`Ex. 1013, 190–193 (the prosecution history of the ’156 patent). At this
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`stage, we disagree that Baccelli is cumulative to references considered
`
`during prosecution of the ’156 patent. Moreover, the challenged claims do
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`not recite a lateral, lumbar implant as discussed by Patent Owner (see
`
`Prelim. Resp. 16). See Ex. 1001, 12:32–67. As a result, the second and
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`sixth Becton, Dickinson factors disfavor denying institution.
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`When considering all the factors for and against institution, the
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`particular circumstances of this case do not indicate that we should exercise
`
`our discretion under 35 U.S.C. § 325(d) to deny institution.
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`
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`IV.
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`35 U.S.C. § 314(a)
`
`Patent Owner also urges us to exercise our discretion under 35 U.S.C.
`
`§ 314 to deny institution. Prelim. Resp. 21–34. Patent Owner asserts that
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`this is the fourth inter partes review (“IPR”) petition challenging the ’156
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`patent and instituting review
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`IPR2019-00362
`Patent 8,361,156 B2
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`would not be an efficient use of Board resources because the
`Petition contradicts, without adequate justification, prior
`findings of the Board that were affirmed by the Federal Circuit
`and because the Petition fails to address major defects in its
`case despite having improperly obtained strategic advantage by
`reviewing NuVasive’s briefing in prior IPRs challenging this
`very same patent using many of the same references.
`
`Id. at 21. Cases IPR2013-00504 and IPR2013-00487, filed by Medtronic,
`
`Inc., were not instituted. See Prelim. Resp. 21; Ex. 1033; Ex. 1044. Case
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`IPR2013-00506, also filed by Medtronic, Inc., was instituted. Ex. 1031. In
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`the latter case, Case IPR2013-00506, the challenged claims were held to be
`
`unpatentable by the Board, but on appeal, the Federal Circuit vacated the
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`Board’s final written decision and remanded for further consideration. The
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`case was then settled before a decision on remand issued. See Prelim. Resp.
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`21–23; Pet. 16–21.
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`Patent Owner also applies the factors identified in General Plastic
`
`Industrial Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357 (PTAB
`
`Sept. 6, 2017) (Paper 19) (precedential) to the facts of this case and contends
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`that the factors favor denying the Petition. Prelim. Resp. 27–34. Patent
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`Owner asserts although Petitioner has not previously filed a petition
`
`challenging the ’156 patent, discretion under § 314 is not limited to the same
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`petitioner filing multiple petitions. Id. at 28. Patent Owner argues that
`
`(1) Petitioner’s employees recently departed from NuVasive, Patent Owner,
`
`(2) claims 1–14, 19, 20, and 23–27 of the ’156 patent were previously
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`challenged in three prior petitions (IPR2013-00504, IPR2013-00506, and
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`10
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`IPR2019-00362
`Patent 8,361,156 B2
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`IPR2014-004872), (3) many of the issues and arguments in this Petition are
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`the same as the prior petitions, (4) the references were previously asserted or
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`cited in the prosecution of the ’156 patent, and (5) no justification has been
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`given for the delay in filing the instant Petition years after the prior IPRs
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`were instituted. See id. at 27–34.
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`We have considered the parties’ respective arguments and decline to
`
`exercise our discretion under § 314(a) to deny the present Petition. Our
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`precedent indicates that application of the General Plastic factors is not
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`limited solely to instances when multiple petitions are filed by the same
`
`petitioner, and that relationships between different petitioners are to be
`
`considered in weighing the factors. Valve Corp. v. Elec. Scripting Prods.,
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`Inc., Case IPR2019-00062, -00063, -00084, slip op. at 9 (PTAB Apr. 2,
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`2019) (Paper 11) (precedential). Potentially relevant to factors 1 and 3 of
`
`the General Plastic factors, Patent Owner argues here that “the lack of
`
`identity between prior and current petitioners” weighs against institution.
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`Prelim. Resp. 29. Additionally, Patent Owner asserts the employees of the
`
`instant Petitioner are recently departed employees of “NuVasive” (id.),
`
`which is Patent Owner’s company. Patent Owner, however, does not
`
`identify the nature of any relationship of these former employees with
`
`previous petitioners (e.g., Medtronic, Inc.) or provide any support for such a
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`relationship. See Prelim. Resp. 29 (citing Ex. 2003, 1–5; Ex. 2018). Thus,
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`General Plastic factors 1 and 3 weigh against exercising our discretion to
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`deny institution.
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`2 Petitioner asserts Medtronic filed this petition “to remedy deficiencies in
`IPR2013-00504.” Pet. 21.
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`Additionally, with respect to the remaining General Plastic factors,
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`we acknowledge that the Board has considered challenges to the ’156 patent,
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`and the Board has previously addressed one of those challenges, IPR2013-
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`00506, in a final written decision. See Ex. 1004. Although we understand
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`the purpose of § 314(a) regarding repeated challenges, we also recognize the
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`purpose of the availability of inter partes review to parties accused of
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`infringement. Patent Owner’s complaint about the multiple inter partes
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`review petitions filed against the ’156 patent is not persuasive as the
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`respective filings appear to be a direct result of its litigation activity. See
`
`supra Section II.A. Moreover, claims 15–18 of the ’156 patent challenged
`
`in this Petition have not been previously challenged in the noted IPRs.
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`Prelim. Resp. 27 (stating the prior petitions challenged claims 1–14, 19, 20,
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`and 23–27 of the ’156 patent).
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`On balance, we determine it is not appropriate to exercise our
`
`discretion under 35 U.S.C. § 314(a) to deny institution in this case.
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`
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`V.
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`CHALLENGES UNDER 35 U.S.C. § 103
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`A. Claim Construction
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`On October 11, 2018, the Office revised its rules to harmonize the
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`Board’s claim construction standard with that used in federal district court.
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`Changes to the Claim Construction Standard for Interpreting Claims in Trial
`
`Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51340
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`(Oct. 11, 2018) (to be codified at 37 C.F.R. pt. 42). This rule change applies
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`to petitions filed on or after November 13, 2018. Thus, the revised claim
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`construction standard applies this proceeding. Id.; see Pet. 26 (stating that
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`the “Board applies ‘the standard used in federal courts . . . ’” (quoting 83
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`Fed. Reg. at 51343)); Paper 5, 1 (according filing date of December 13, 2018
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`to the Petition).
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`Petitioner states that “no express construction is needed to resolve the
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`issues in this Petition.” Pet. 26.
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`According to Patent Owner, claim 1 defines “longitudinal length” to
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`mean “‘a dimension of the implant that extends lengthwise and is greater
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`than the maximum lateral width of the implant.’” Prelim. Resp. 8 (citing Ex.
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`2009, 424 (a dictionary definition for “longitudinal”)). At this stage of the
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`proceeding, no express construction is required for this term other than that
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`required under the express language of claim 1, which is: “a longitudinal
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`length” “extend[s] from a proximal end of said proximal wall to a distal end
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`of said distal wall” where “said longitudinal length is greater than said
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`maximum lateral width.” Ex. 1001, 12:45–47, 50–51.
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`Patent Owner additionally proposes interpreting “medial plane.”
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`Prelim. Resp. 8–9. Patent Owner proposes “a medial plane” to mean “a
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`plane that intersects the implant approximately at the midpoint of the
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`longitudinal length” with Patent Owner providing support from the language
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`of claim 1, a dictionary definition, a prior Board determination regarding
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`“medial plane,” and Petitioner’s proposed interpretation in related litigation.
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`Id. at 8–9 (citing Ex. 2009, 5; Ex. 1033,3 5, 8; Ex. 2010, 21, 23 respectively).
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`At this stage of the proceeding, we construe this term in accordance with the
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`express language of claim 1 which recites that the medial plane “is [a plane]
`
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`3 Patent Owner appears to err in citing to Exhibit 1041 when referring to
`“the Board’s non-institution decision in IPR2013-00504.” Prelim. Resp. 9.
`Exhibit 1033 is the “Decision Denying Institution for Inter Partes Review”
`for IPR2013-00504.
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`generally perpendicular to said longitudinal length.” Ex. 1001, 12:49–50.
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`Further, the plain and ordinary meaning of the term “medial” includes
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`“being or occurring in the middle” and “extending toward the middle,
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`especially: lying or extending toward the median axis of the body.”4 Thus,
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`in the context of claim 1, the “medial plane” is located approximately at the
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`midpoint of the longitudinal length. See Ex. 1033, 8; see Ex. 2010, 215; see
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`Prelim. Resp. 9 (citing Ex. 1033; Ex. 2010).
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`Patent Owner further proposes interpreting the phrase “position
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`proximate to said medial plane” in claim 1. Prelim. Resp. 10; Ex. 1001,
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`12:65, 67. Patent Owner proposes “proximate” to mean “near” with support
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`from a dictionary definition, and the phrase “position proximate to said
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`medial plane” to mean a “position near the medial plane.” Prelim. Resp. 10;
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`Ex. 2009, 6. At this stage of the proceeding, the express language of claim 1
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`and the dictionary definition support Patent Owner’s proposed interpretation
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`of “proximate” to mean “near.” Further express interpretation is not
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`required for purposes of this Decision.
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`For purposes of determining whether Petitioner demonstrates a
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`reasonable likelihood of prevailing in its challenges, we determine that no
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`other express interpretation is required for any claim term. Vivid Techs., Inc.
`
`v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (construing
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`explicitly only those claim terms in controversy and only to the extent
`
`necessary to resolve the controversy); see also Nidec Motor Corp. v.
`
`
`4 Medial, The Merriam-Webster Online Dictionary, available at
`https://www.merriam-webster.com/dictionary/medial (defs. 2a and 2b) (last
`visited June 15, 2019).
`5 NuVasive, Inc. v. Alphatec Holdings, Inc., Case No. 3:18-cv-00347-CAB-
`MDD (S.D. Cal.), App’x B1, Joint Claim Construction Worksheet.
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`14
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`IPR2019-00362
`Patent 8,361,156 B2
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`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
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`(applying Vivid Techs. in the context of an inter partes review).
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`B. Level of Ordinary Skill in the Art
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`Petitioner asserts that one of ordinary skill in the art “‘would have a
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`medical degree with two to three years’ experience performing procedures
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`using interbody spinal fusion implants’” or “‘would have a mechanical or
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`biomechanical engineering degree with at least two years’ experience
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`working in developing implant devices and associated instruments with
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`significant access to orthopedic surgeons or neurosurgeons.’” Pet. 28
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`(quoting Ex. 1002 ¶ 18). Patent Owner does not assert a different skill level
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`than Petitioner. Prelim. Resp. 3 n.1.
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`We preliminarily adopt Petitioner’s unchallenged, asserted level of
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`ordinary skill solely to determine whether there is a reasonable likelihood
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`that Petitioner would prevail with respect to at least one of the claims
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`challenged in the Petition.
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`C. Challenge Based on Brantigan, Baccelli, and Berry (Ground 1)
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`1. Brantigan (Ex. 1007)
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`Brantigan “relates to inert rigid vertebral prosthetic devices and
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`methods for implanting the devices between adjacent vertebrae.” Ex. 1007,
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`1:7–9. Brantigan specifically “deals with ring-like prosthetic plugs or discs
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`used singly or stacked together between vertebrae to form support [struts] in
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`the spinal column and having rigid surfaces facilitating anchoring and
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`providing valleys for bone ingrowth from adjoining vertebrae.” Id. at
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`1:14–18.
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`Brantigan provides a “biologically acceptable, but inert rigid annular
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`prosthesis units [that] are provided to support and fuse with adjacent
`
`
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`15
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`IPR2019-00362
`Patent 8,361,156 B2
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`vertebrae in both the cervical, thoracic spine and lumbar portions of a human
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`vertebral column.” Id. at 1:64–68. “The rings are bottomed on the opposing
`
`end faces of adjoining vertebrae, are preferably oval shaped with medial-
`
`lateral and anterior-posterior dimensions in the same ratio as normal
`
`vertebral bodies . . . .” Id. at 1:18–21. They “are generally oval shaped to
`
`conform with the general outline perimeter of the vertebrae.” Id. at 2:2–4.
`
`Figure 1 of Brantigan is reproduced below.
`
`
`
`Figure 1 shows a perspective view of a full oval prosthetic device. Id.
`
`at 3:21–22. Oval ring plug 11 has opposed sides 11a, ends 11b, top and
`
`bottom surfaces 11c, and central upstanding aperture 11d.6 Id. at 4:5–10.
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`Top and bottom surfaces 11c have ridges 12 for engaging adjacent vertebrae.
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`Id. at 4:15–16, 5:22–26; see also id. at 6:5–16 (describing stack of plugs 11
`
`between vertebrae). One of side walls 11a has an internally threaded hole
`
`
`6 The ’156 patent also describes element “11d” as a central aperture and a
`hollow interior. Id. at 4:50, 6:37, Figs. 1–2, 11 (showing reference numeral
`11).
`
`
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`16
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`IPR2019-00362
`Patent 8,361,156 B2
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`13 for receiving a mounting tool, and interiors of side walls 11a have
`
`grooves 14 for mounting rectangular connecting bar 15. Id. at 4:20–27.
`
`Figs. 1, 3, 4. In one embodiment, bar 15 separates central aperture 11d into
`
`two chambers that can be “packed with bone graft material to expedite the
`
`fusion of the prosthesis device in the spinal column.” Id. at 4:50–53, Figs. 1,
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`3; see also id. at 2:15–18 (describing placement of bone graft material).
`
`“The individual plugs or the stack of plugs can be introduced
`
`anteriorly, laterally or posteriorly depending upon conditions . . . .” Id. at
`
`5:30–32; see also id. at 2:34–38 (describing implants of varying height
`
`achieved by stacks of rings of varying height), 2:55–66 (describing
`
`placement and insertion), 6:61–7:6 (describing insertion of plugs 11).
`
`Brantigan further discusses the devices “are also provided in partial
`
`(preferably hemi-oval) annular shape to accommodate those surgical
`
`procedures where only a portion of the vertebrae . . . is damaged,” and
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`“[t]wo such hemi-oval rings can be used in the posterior lumbar area in side-
`
`by-side relation.” Id. at 2:2–8, 3:24–25, Fig. 2.
`
`“The implants are preferably made of radiolucent material such as
`
`carbon fiber reinforced polymers known commercially as ‘Peek’,
`
`(polyetherether ketone) . . . .” Id. at 3:9–11. Figure 6 of Brantigan is
`
`reproduced below.
`
`
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`17
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`Patent 8,361,156 B2
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`
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`Figure 6 shows a perspective view of a modified device with an
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`integral cross bar. Id. at 3:36–37, Fig. 6. Modified device 30 is plug 31 with
`
`the same shape as plug 11 but has reinforcing bar 32 integral with side walls
`
`31a. Integral internal partition 327 bisects hollow interior 238 (not shown)
`
`forming “side-by-side apertures through the plug adapted to receive bone
`
`graft material.” Id. at 5:37–43, Fig. 6.
`
`2. Baccelli (Ex. 1008)
`
`Baccelli “relates to intervertebral implant.” Ex. 1008 ¶ 1. Figures 1
`
`and 2 of Baccelli are reproduced below.
`
`
`7 Brantigan describes element “32” as an internal cross bar, a reinforcing
`bar, and internal partition. Id. at 3:36–37, 5:37–43, Fig. 6.
`8 Brantigan previously describes element “23” as a receiving recess. Id. at
`5:1–2, 5:32–33.
`
`
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`18
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`
`
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`Figures 1 and 2 show perspective and plan views of an implant. Id.
`
`¶ 29. Implant 2 is made up of a cage having wall 4 with first portion 4a that
`
`is horseshoe shaped and joined to second portion 4b that is cylindrical,
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`superior main face 8, and inferior main face 10 opposite face 8. Id.
`
`¶¶ 33–35. Wall 4 defines hole 7 that extends between faces 8, 10. Id.
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`¶¶ 34–35. Faces 8 and 10 have a toothed profile forming teeth 12. Id.
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`¶¶ 36–37. The cage has spikes 24 on faces 8, 10. Id. ¶ 41, Figs. 3–5. Fitting
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`tool 40 puts the cage into place between two vertebrae. Id. ¶¶ 44–45, Fig. 9.
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`“The cage can be made of a material that is transparent to X-rays” and
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`“can have one or more markers 47 included therein and serving, because
`
`they are opaque to X-rays, to identify the position and/or the presence of the
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`implant when X-rays are taken during or after the operation.” Id. ¶ 50. “The
`
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`19
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`IPR2019-00362
`Patent 8,361,156 B2
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`spikes 24 can be inserted and fixed rigidly in the ducts formed in the cage”
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`and “can be made of a material that is opaque to X-rays.” Id. ¶ 51.
`
`3. Berry (Ex. 1022)
`
`Berry presents “results of a morphometric study of selected human
`
`vertebrae undertaken to provide data for implant design.” Ex. 1022, 362
`
`(emphasis omitted). Berry states that “[a]ccurate anatomic descriptions of
`
`vertebral shape are necessary for the development of implantable devices
`
`and spinal instrumentation” and that the “current study was undertaken due
`
`to a lack of information needed for design projects involving instrumentation
`
`for the lumbar and thoracic vertebrae.” Id. “[V]irtually the entire geometry
`
`of the vertebrae was quantified by recording a total of 27 measurements per
`
`vertebra.” Id. “The means and standard deviations of the dimensional data
`
`for all 240 vertebrae are presented in Table 1.” Id. at 363; see also id. at 364
`
`(presenting Table 1).
`
`4. Claims 1, 5, 10, 12–21, 23, 24, and 27
`
`Petitioner argues that Brantigan teaches or suggests most of the
`
`limitations of claim 1. Pet. 8–9, 28–48 (citing Ex. 1002 ¶¶ 30, 122–126,
`
`129–135, 137–138, 142–152, 154–155, 158, 160–163, 165–183, 185, 187,
`
`189, 191–193, 202, 209–211, 241, 257; Ex. 1004, 13; Ex. 1007, Abstract,
`
`1:7–12, 1:14–15, 1:18–29, 1:41–47, 1:54–56, 1:64–24, 2:15–23, 2:34–38,
`
`2:56–62, 3:9–12, 4:3–10, 4:15–18, 4:20–22, 4:50–53, 5:22–26, 5:30–43,
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`5:59–66, 6:5–16, 6:61–7:6, 7:29–34, Figs. 1, 6, 8, 10, 11, 13, 14; Ex. 1014,
`
`24–25; Ex. 1015, 32–33; Ex. 1019, 5–9, Ex. 1035, 49). Petitioner relies on
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`Berry to reflect the knowledge of a skilled artisan concerning implants,
`
`including to teach (1) the average, known length and width of human
`
`vertebrae before March 2004 and (2) one skilled in the art would have
`
`
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`20
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`recognized that accurate descriptions of vertebral shape would have been
`
`necessary to develop implantable devices. Id. at 10–11, 29–30 n.7 (citing
`
`Ex. 1002 ¶¶ 102, 123, 169–172; Ex. 1022, 362–364, Table 1), 45–46 (citing
`
`Ex. 1002 ¶¶ 169, 174–175; Ex. 1022, 362–363, Fig. 1, Table 1). Petitioner
`
`also relies on Baccelli for teaching or suggesting the limitations related to
`
`radiopaque markers. Id. at 9–10, 30–33 (citing Ex. 1002 ¶¶ 122–126, 257;
`
`Ex. 1004, 13; Ex. 1008 ¶¶ 12–13, 33–34, 45, 50–51, Figs. 1–5, 8, 9), 49–52
`
`(citing Ex. 1002 ¶¶ 189, 191–193; Ex. 1008 ¶¶ 36, 41, 44, 50–51, Figs. 1–5,
`
`8, 9).
`
`Petitioner contends that an ordinary artisan would have been
`
`motivated to combine Brantigan with Baccelli and Berry. Id. at 28. More
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`specifically, Petitioner alleges that one skilled in the art would have known
`
`the average length and width of vertebrae based on Berry’s teachings and
`
`would have turned to Berry when developing Brantigan’s implant. Id. at
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`29–30 (citing Ex. 1022, 362–364). Additionally, Petiti
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