Trials@uspto.gov
`571-272-7822
`
`Paper 19
`Entered: July 9, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ALPHATEC HOLDINGS,INC. and ALPHATECSPINE,INC.,
`Petitioner,
`
`V.
`
`NUVASIVE,INC.,
`Patent Owner.
`
`Case IPR2019-00361
`Patent 8,187,334 B2
`
`Before DENISE M. POTHIER, HYUN J. JUNG,and
`SHEILA F. McSHANE,Administrative Patent Judges.
`
`JUNG, Administrative Patent Judge.
`
`DECISION TO INSTITUTE
`35 US.C. § 314
`
`

`

`IPR2019-00361
`Patent 8,187,334 B2
`
`I.
`
`INTRODUCTION
`
`Alphatec Holdings, Inc. and Alphatec Spine, Inc. (collectively,
`
`“Petitioner’’) filed a Petition (Paper2, “Pet.”’”) requesting institution of an
`
`inter partes review of claims 6—9 and 18 of U.S. Patent No. 8,187,334 B2
`
`(Ex. 1001, “the °334 patent”). NuVasive Inc. (“Patent Owner’)filed a
`
`Preliminary Response (Paper 12, “Prelim. Resp.”). Under 35 U.S.C. § 314,
`
`an inter partes review maynotbeinstituted “unless .. . 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 and Preliminary Response and for
`
`the reasons explained below, we determinethat Petitioner has shownthat
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`there is a reasonablelikelihood that it would prevail with respect to at least
`
`one of the challenged claims. In particular, we institute an inter partes
`
`review of all challenged claims on all presented challenges, and thus,
`
`institute an inter partes review of claims 6-9 and 18 of the °334 patent.
`
`Yl.
`
`BACKGROUND
`
`A. Related Proceedings
`The parties indicate that the ’334 patent has been asserted in
`
`NuVasive, Inc. v. Alphatec Holdings, Inc., Case No. 3:18-cv-00347-CAB-
`MDD(S.D.Cal.). Pet. 75; Paper 4, 2. The parties also indicate that the °334
`patent is the subject of Case IPR2019-00546. Paper 4, 2; Paper 6, 2.
`
`Patent Owneradditionally notes that the ’334 patent was previously
`challenged in Cases IPR2013-00507 and IPR2013-00508. Paper4, 2 (citing
`In re NuVasive, Inc., 841 F.3d 966 (Fed. Cir. 2016)); see also Pet. 1 (stating
`that “the Federal Circuit affirmed the Board’s finding in IPR2013-00507
`
`

`

`IPR2019-00361
`Patent 8,187,334 B2
`
`(Ex. 1004) that sole independentclaim 1 of the ’334 patent and eighteen
`
`dependent claims (2-5, 10, 11, 14, 15, and 19-28)are invalid”). The parties
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`also state that a related patent is challenged in Case IPR2019-00362.
`
`Pet. 75; Paper4, 2.
`
`B. The ’334 Patent (Ex. 1001)
`The 334 patent issued May 29, 2012, from an application filed April
`
`4, 2011, which is a continuation of an application filed on March 29, 2005,
`
`and claimspriority to a provisional application filed on March 29, 2004.
`
`Ex. 1001, [22], [45], [60], [63], 1:7-13.
`
`The *334 patent particularly relates to “a system and methodfor spinal
`
`fusion comprising a spinal fusion implant of non-bone construction.. . to
`
`introducethe spinal fusion implant into any of a variety of spinal target
`
`sites.” Jd. at 1:18-21. Figure 2 of the ’334 patent is reproduced below.
`
`12
`
`FIG. 2
`
`*
`
`10
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`

`

`IPR2019-00361
`Patent 8,187,334 B2
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`Figure 2 showsa perspective view of a lumbar fusion implant. Jd. at
`
`3:36. The spinal fusion implantis introduced into the disc space viaa lateral
`
`approachto the spineorvia a posterior, anterior, antero-lateral, or postero-
`
`lateral approach, and is made from a radiolucent material, such as PEEK
`
`(poly-ether-ether-ketone). Jd. at 5:10-15, 5:29-33.
`
`Commonattributes of the various embodimentsof spinal fusion
`
`implant 10 includes top surface 31, bottom surface 33, lateral sides 14,
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`proximalside 22, and distal side 16. Jd. at 6:6—9, Figs. 2-3. Spinal fusion
`implant 10 may have “a width ranging between 9 and 18 mm,a height
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`ranging between 8 and 16 mm,and a length ranging between 25 and 45
`
`mm.” Jd. at 5:15-19.
`
`Spinal fusion implant 10 also preferably includes anti-migration
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`features, such as ridges 6 and pairs of spike elements 7—9, designed to
`
`increase friction between spinal fusion implant 10 and adjacent contacting
`
`surfaces of vertebral bodies. Jd. at 6:21-32, Figs. 2-3. Spike elements 7-9
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`are preferably made from materials having radiopaque characteristics. Id. at
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`6:35-38.
`
`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.” Jd. at 6:59-61.
`
`C. Illustrative Claim
`
`The °334 patent has 28 claims andits claim 18 was found patentable
`
`and claims 1—5, 10, 11, 14, 15, and 19-28 were cancelled in IPR2013-
`00507. Ex. 1001, 34. Petitioner challenges claims 6-9 and 18,all of which
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`

`

`IPR2019-00361
`Patent 8,187,334 B2
`
`ultimately depend from cancelled claim 1. Claims 1, 6, and 18 are
`
`reproduced below.
`
`A spinal fusion implant of non-bone construction
`1.
`positionable within an interbody space betweena first vertebra
`and a secondvertebra, said implant comprising:
`an upper surface including anti-migration elements to
`contact said first vertebra when said implantis positioned within
`the interbody space, a lower surface including anti-migration
`elements to contact said second vertebra when said implantis
`positioned within the interbody space, a distal wall, a proximal
`wall, a first sidewall and a second sidewall, said distal wall,
`proximal wall, first sidewall, and second sidewall comprising a
`radiolucent material;
`wherein said implant has a longitudinal length greater
`than 40 mm extending from a proximalend ofsaid proximal wall
`to a distal end of said distal wall;
`wherein a central region of said implant includes portions
`of the first and second sidewalls positioned generally centrally
`between the proximal wall and the distal wall, at least a portion
`of the central region defining a maximum lateral width of said
`implant extending from said first sidewall
`to said second
`sidewall, wherein said longitudinal length is at least two and half
`times greater than said maximumlateral 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 whensaid
`implant is positioned within the interbody space,saidfirst fusion
`aperture having: a longitudinal aperture length extending
`generally parallelto the longitudinal length ofsaid 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 three radiopaque markers; wherein a first of the at
`least three radiopaque markersis at least partially positioned in
`said distal wall, a secondof said at least three radiopaque markers
`is at least partially positioned in said proximal wall, and a third
`of said at least three radiopaque markers is at least partially
`positioned in said central region.
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`

`

`IPR2019-00361
`Patent 8,187,334 B2
`
`further
`fusion implant of claim 1,
`The spinal
`6.
`comprising a medial support extending between the first and
`second sidewalls.
`
`The spinal fusion implant of claim 1, wherein said
`18.
`maximumlateral width of said implant is approximately 18 mm.
`
`Ex. 1001, 12:32—13:4 (emphases added), 13:17—19, 14:11—-13.
`
`D. Evidence Relied Upon
`Petitioner identifies the following referencesas prior art in the
`
`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 2002/0165550 Al,
`
`published November 7, 2002 (Ex. 1040, “Frey”);
`
`(4) U.S. Patent Application Publication No. US 2003/0028249 Al,
`
`published February 6, 2003 (Ex. 1008, “Baccelli”); and
`
`(5) JamesL. Berryet al., A Morphometric Study ofHuman Lumbar
`
`and Selected Thoracic Vertebrae, 12 Spine 362-367 (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, 27-28.
`
`E. Asserted Grounds
`
`Petitioner challenges, under 35 U.S.C. § 103, claims 6~9 and 18 as
`
`unpatentable over (1) Frey, Michelson, and Berry; and (2) Brantigan,
`
`Baccelli, Berry, and Michelson. Pet. 21-22, 29-74.
`
`

`

`IPR2019-00361
`Patent 8,187,334 B2
`
`II.
`
`35 U.S.C. § 325(d)
`
`Patent Ownerrequests denial of institution under 35 U.S.C. § 325(d)
`
`because Petitioner incorrectly argues that its presented groundsare not
`
`cumulative. Prelim. Resp. 15 (citing Pet. 25-26), 23. Patent Owner
`provides a summaryofthe prosecutionhistory of the application that issued
`
`as the °334 patent, its parent application, and a related application. Jd. at 12-
`
`15.
`
`Patent Owneralso providesits analysis of the factors identified in
`
`Becton, Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-01586,
`
`slip op. at 16-18 (PTAB Dec. 15, 2017) (Paper 8) (informative). Jd. at 15—
`
`23. Patent Owner’s analysis is based on,inter alia, the alleged extensive
`
`consideration of Brantigan, Berry, and Michelson; the cumulative nature of
`
`Brantigan, Baccelli, and Frey; the overlap of Petitioner’s radiopaque marker
`
`configuration arguments with arguments considered during prosecution;
`
`Petitioner’s failure to identify Examinererror; and Petitioner’s failure to
`
`provide new evidenceto warrant reconsideration. Seeid.
`
`The bases for Patent Owner’s arguments relate to radiopaque markers.
`
`See Prelim. Resp. 16 (arguing that “the Patent Office considered multiple
`
`references discussing the use of radiopaque markers on radiolucentspinal
`
`implants” and that “Baccelli and Frey ’550 are cumulative to Kuntz, Garcia,
`
`Villiers because noneof these references discloses the claimed marker
`
`configuration for the claimed implant’), 19 (arguing “[nJeither [Brantigan
`
`nor Michelson ’973] provides any reason to adopt a marker configuration
`
`from either Baccelli or Frey ’550 for the type of implant claimed in the
`
`challenged claims”). The portions of prosecution histories from related
`
`applications and the application that issued as the ’334 patent upon which
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`

`

`IPR2019-00361
`Patent 8,187,334 B2
`
`Patent Ownerreliesalso relate to radiopaque markers. See id. at 19-20
`
`(citing Ex. 1020, 97, 108-110, 224-226, 230, 245, 247-250, 271, 273-275;
`Ex. 1023, 212-213, 215-216, 219, 222, 226), 21 (citing Ex. 1025, 104, 112),
`
`22 (citing Ex. 1023, 212-213). The challenged dependentclaims, however,
`relate to a medial support, a second fusion aperture, or a maximumlateral
`width. See Ex. 1001, 13:17-29, 14:11-13. The record does not indicate that
`
`the same or substantially the same arguments for the medial support and
`second fusion aperture were presented previously to the Office. And claim
`18 was previously challenged, but it recites a maximum lateral width, which
`is not related to the radiopaque markers issues that Patent Owner argues.
`Regardingthe asserted failure to identify Examinererror, the previous
`proceeding IPR2013-00507 cancelled claim 1, thereby determiningthat the
`claim should not have been allowedto issue and indicating an error in
`
`evaluating the prior art. As for the argument that new evidencehasnot been
`submitted to warrant reconsideration, Petitioner’s evidencein this
`
`proceedingis directed to the recited medial support, second fusion aperture,
`and maximumlateral width, not the radiopaque marker limitation of
`
`cancelled claim 1. Petitioner’s evidence, and its argumentsarising
`
`therefrom, have not been previously consideredfor, at least, challenged
`
`claims 6-9.
`
`For the above reasons, the particular circumstancesof this case do not
`
`indicate that we should exercise our discretion under 35 U.S.C. § 325(d) to
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`deny instituting review ofall presently challenged claims.
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`

`

`IPR2019-00361
`Patent 8,187,334 B2
`
`IV.
`
`35US.C. § 314(a)
`
`Patent Owneralso urges us to exercise our discretion under 35 U.S.C.
`
`§ 314 to deny institution. Prelim. Resp. 23-37. Patent Owner asserts that
`
`instituting review “would not be an efficient use of Board resources because
`
`the Petition contradicts, without justification, prior findings of the Board that
`
`were affirmed by the Federal Circuit and fails to address major defects in its
`case despite having strategic advantage from reviewing NuVasive’s briefing
`
`in prior IPRs.” /d. at 23.
`Patent Ownerarguesthat, in IPR2013-00507 and IPR2013-00508,the
`
`Board determined that Frey did not disclose inherently an implant longer
`
`than 40 mm andthat Michelson doesnot disclose an implant with a length
`
`greater than 40 mm anda width of 18 mm,as required by claim 18. Id. at
`23—26 (citing Ex. 1023, 104, 105, 115-117, 124, 129-157; Ex. 1033, ii;
`
`Ex. 1034, ii). Patent Owneralso notes that the Board concludedthat one of
`
`ordinary skill in the art would not have expanded Michelson to 26 mm. Id.
`at 26 (citing Ex. 1023, 117). Patent Owner summarizes the Federal Circuit’s
`
`determinations and notes that the Federal Circuit affirmed the Board’s
`
`conclusion that Michelson does not disclose the length and width required
`
`by claim 18. Jd. at 26-27 (citing Ex. 1023, 1-4, 16-19, 21).
`
`Patent Owneralso asserts its application of the factors identified in
`
`General Plastic Industries Co. v. Canon Kabushiki Kaisha, Case IPR2016-
`
`01357 (PTAB Sept. 6, 2017) (Paper 19) (precedential) to the facts of this
`
`case and contendsthat the factors favor denying the petition.
`
`/d. at 28-37.
`
`Patent Ownerarguesthat, although Petitioner has not previously filed a
`
`petition challenging the ’334 patent, discretion under § 314 is not limited to
`
`the samepetitionerfiling multiple petitions.
`
`/d. at 28. Patent Owner points
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`

`IPR2019-00361
`Patent 8,187,334 B2
`
`to (1) the recent departure of Petitioner’s employees from Patent Owner’s
`company, (2) substantially the same challenge being brought against claim
`18, (3) the references having been previously asserted orcited in
`prosecution,(4) Petitioner having reviewed the previous Board decisions
`and filings, (5) no justification being given for the delay in filing, and (6) no
`
`reasons being given to revisit unpersuasive arguments. See id. at 29-37.
`
`As noted by Patent Owner, the present Petition challenges claim 18,
`
`which wasat issue in IPR2013-00507 and IPR2013-00508,and challenges
`
`claims 6-9, which were not previously challenged. See Prelim. Resp. 24.
`
`Weacknowledgethat, including the instant case, the Board has been
`
`presented thus far with multiple challenges to the 334 patent. Although we
`understand the purposeof § 314(a) regarding repeated challenges, we also
`
`recognize the purposeofthe availability of inter partes review to parties
`
`accused ofinfringement. Patent Owner’s complaint about the multiple inter
`
`partes review petitionsfiled against the ?334 patent is not persuasive when
`the respective filings appearto be a direct result of its ownlitigation activity.
`
`See supra Section II.A. The discretion to deny petitions is for the panelto
`
`exercise undercertain conditions, but not in every situation where a Patent
`
`Owner complains of repeated challenges againstits patent.
`
`Notably, our precedent indicates the application of the General Plastic
`
`factors is not limited solely to instances when multiple petitions are filed by
`
`the samepetitioner but considers any relationship between different
`
`petitioners. Valve Corp. v. Elec. Scripting Prods., Inc., Case
`
`IPR2019-00062, -00063, -00084,slip op. at 9 (PTAB Apr. 2, 2019) (Paper
`
`11) (precedential). Here, potentially relevant to factors 1 and 3 of the
`
`General Plastic factors, Patent Owner argues that some of Petitioner’s
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`

`

`IPR2019-00361
`Patent 8,187,334 B2
`
`employees were previously employees of “NuVasive”(Prelim. Resp. 29,
`
`31-32), which is the Patent Ownerofthe ’334 patent. The former
`
`employees were not previously a petitioner for another petition directed to
`
`the same claims of the same patent. Patent Owneralso fails to direct us to
`
`sufficient evidence indicating that present Petitioner’s companies have a
`
`relationship with any previouspetitioners, or that the noted former
`employees have such a relationship. See id. at 29,31-32. Thus, factors 1
`and 3 weigh against exercising our discretion to deny institution.
`
`Additionally, for the remaining factors, we are not persuaded for
`
`claims 6—9 that Petitioner’s potential review of papers in IPR2013-00507
`
`and IPR2013-00508 amountsto a petitioner receiving the benefit of a
`
`preliminary responseor decisiononinstitution before filing a second
`
`petition challenging the same patent, which were the circumstances
`
`addressed by the General Plastic factors. Given that claims 6—9 were not
`
`challenged in the previous proceedings, the additional use of Board
`
`resources to consider claim 18 in this proceeding along with the
`
`consideration of claims 6—9 does not amountto an inefficient use of Board
`
`resources. See also Guidance on the Impact of SAS on AIATrial
`
`Proceedings (Apr. 26, 2018), https://www.uspto.gov/patents-application-
`
`process/patent-trial-and-appeal-board/trials/guidance-impact-sas-aia-trial
`(explaining that “the PTAB will institute as to all claims or none” and“if the
`
`PTAB institutesatrial, the PTAB will institute on all challenges raised in
`
`the petition’’).
`
`Thus, for the foregoing reasons, we do not exercise our discretion
`
`under 35 U.S.C. § 314(a) to denyinstitution.
`
`1]
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`

`

`IPR2019-00361
`Patent 8,187,334 B2
`
`V.
`
`CHALLENGES UNDER35 U.S.C. § 103
`
`A. Claim Construction
`
`On October 11, 2018, the Office revised its rules to harmonize the
`
`Board’s claim construction standard with that used in federal district court.
`
`Changesto the Claim Construction Standard for Interpreting Claims in Trial
`Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51340
`(Oct. 11, 2018) (to be codified at 37 C.F.R. pt. 42). This rule changeapplies
`to petitions filed on or after November 13, 2018, so the revised claim
`construction standard applies to this proceeding. Id.; see Pet. 26 (stating that
`
`the “Board applies ‘the standard used in federal courts... ””
`Fed. Reg. at 51343)); Paper 5, 1 (according filing date of December 21, 2018
`
`(quoting 83
`
`to the Petition).
`
`Petitioner states that “no express construction is needed to resolve the
`
`issues in this Petition.” Pet. 26. According to Patent Owner, claim 1 defines
`
`“longitudinal length” to mean “a dimension of the implant that extends
`lengthwise andis greater than the maximumlateral width of the implant.”
`Prelim. Resp. 9 (citing also Ex. 2009, 424 (dictionary definition for
`“Jongitudinal”)). Patent Owneralso contends that claim 1 defines
`“longitudinal aperture length” to mean “a dimension of the aperture that runs
`lengthwise and is greater than the lateral aperture width that extends between
`
`the first sidewall and the second sidewall.” Jd.
`
`Weagree with Patent Ownerthat claim 1 recites limitations regarding
`
`“longitudinal length” and “longitudinal aperture length.” See Ex. 1001,
`
`12:4446, 12:59-61. Atthis stage of the proceeding, analyzing whether
`
`Petitioner demonstrates a reasonablelikelihood of prevailing with respect to
`
`at least one of the challenged claims only requires determining if the
`
`12
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`

`

`IPR2019-00361
`Patent 8,187,334 B2
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`asserted references teach or suggest “a longitudinal length .
`
`.
`
`. extending
`
`from a proximal end ofsaid proximal wall to a distal end of said distal wall”
`and “a longitudinal aperture length extending generally parallel to the
`
`longitudinal length of said implant,”as recited by claim 1. Jd. Further
`express interpretation is not required for purposes of this Decision.
`Patent Owneradditionally proposesinterpreting “medial support”to
`
`mean “a supporting wall that intersects the sidewalls of the implant
`approximately at the midpointof its longitudinal length” with support from
`the Specification, a dictionary definition, a prior Board determination
`regarding “medial plane,” and a joint proposed interpretation of “medial
`plane”in relatedlitigation. Jd. at 10-11 (citing Pet. 75; Ex. 1001, 6:57—59,
`Figs. 2-5; Ex. 1013, 130-133; Ex. 2009, 446; Ex. 2010, 21, 23).
`Claims6, 7, and 9, respectively, require “a medial support extending
`
`betweenthe first and second sidewalls,” “said medial support is positioned
`
`along said central region,” and a medial support separatingfirst and second
`
`fusion apertures. Ex. 1001, 13:17—21, 13:27-29. Patent Ownerpoints to a
`portion ofthe Specification that states that the “spinal fusion implant 10 has
`two large fusion apertures 2, separated by a medial support 50, extending in
`
`a vertical fashion through the top surface 31 and bottom surface 33.” Id. at
`
`6:57-59. Patent Owneralso points to Figures 2-5, which show one
`
`embodiment, but the ’334 patent is not limited to what is shownin those
`
`figures. See id. at 3:32—56, 12:12-20. At this stage of the proceeding, the
`express language of the claims and the relied-upon portions ofthe
`
`Specification do not indicate that interpreting “medial support” requiresit to
`be “at the midpointof its longitudinal length,” as proposed by Patent Owner.
`
`13
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`IPR2019-00361
`Patent 8,187,334 B2
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`At this stage, the dictionary definition and prior Board determination
`
`regarding “medial plane” also do not support persuasively Patent Owner’s
`
`proposedinterpretation of “medial support.” Patent Owneralso points to the
`
`joint proposedinterpretationsin relatedlitigation, but those interpretations
`
`relate to patents that are not at issue in this proceeding.
`
`Thus, we analyze whetherthe asserted references teach or suggest “a
`medial support extending between the first and second sidewalls,”
`“positioned along said central region,” and separating first and second fusion
`apertures, as required by challenged claims 6, 7, and 9, to determine whether
`
`Petitioner demonstrates a reasonable likelihood of prevailing with respect to
`
`at least one of the challenged claims. After the record has been developed,
`
`we mayrevisit whether “medial support” needs to be interpreted expressly.
`
`For the reasons above and for the purposes of determining whether
`
`Petitioner demonstrates a reasonable likelihood of prevailingin its
`
`challenges, we determine that no 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 explicitly only those claim terms in controversy
`
`and only to the extent necessary to resolve the controversy); see also Nidec
`
`Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017
`
`(Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter partes
`
`review).
`
`B. Level of Ordinary Skill in the Art
`
`Petitioner asserts that one of ordinary skill in the art “‘would have a
`
`medical degree with two or three years’ experience performing procedures
`999
`
`using interbody spinal fusion implants’”
`
`or “““would have a mechanical or
`
`biomechanical engineering degree with at least two years’ experience
`
`14
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`

`IPR2019-00361
`Patent 8,187,334 B2
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`working in developing implant devices andassociated instruments with
`significant access to orthopedic surgeons or neurosurgeons.” Pet. 28-29
`(quoting Ex. 1002 4 18). Patent Owner does not yet proposealevel of
`
`ordinary skill.!
`Wepreliminarily adopt Petitioner’s unchallenged, asserted level of
`
`ordinary skill solely to determine whether there is a reasonable likelihood
`
`that Petitioner would prevail with respect to at least 1 of the claims
`
`challengedin the Petition.
`
`C. Challenge Based on Frey, Michelson, and Berry
`
`1. Frey (Ex. 1040)
`Frey relates to “implants insertable in the spinal disc space,” and
`specifically relates to “implants, methods and instrumentsfor use in a
`
`posteriorlateral approachto the disc space, including a transforaminal
`approach.” Ex. 1040 J 2. Figure 55 of Frey is reproduced below.
`
`
`
`' We note that, in the related IPR2019-00362 which addresses a continuation
`of the ’334 patent and similar prior art, Patent Owner doesnotassert a
`different skill level than Petitioner.
`
`15
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`IPR2019-00361
`Patent 8,187,334 B2
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`Figure 55 is a plan view of an implant. Jd. J] 66, 67. “Implant 1000
`
`is an interbody fusion device or cage that can be packed with bone growth
`
`material or other known substance andinserted into disc space D1 to
`
`promote bony fusion between vertebrae V1 and V2.” Jd. § 140. It has a
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`“boomerang or banana shape.” Id.
`
`Implant 1000 also “includes a concave posterior wall 1002 and an
`
`opposite convex anterior wall 1004,” “an arcuate leading end wall 1006 and
`
`an arcuate trailing end wall 1008”that “connect posterior wall 1002 and
`
`anterior wall 1004,” and grooves 1014, 1016 that “engage the vertebral
`
`endplates to resist posterior and anterior migration of implant 1000 in the
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`disc space.” Id. §§ 141, 143. Implant 1000 has “upper openings 101 8a and
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`10185 separated by an upperstrut 1019.” Jd. | 144. “Implant 1000 can be
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`made from titanium, surgical gradestainless steel, or other bio-compatible
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`material using fabricating techniques knownin the art,” such as PEEK. Jd.
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`q7 149, 181.
`A dual lobe implant such as implant 1000,“is placed in the disc space
`D1 and has a length sufficient to span the disc space from the distal portion
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`37 to the proximal portion 41.” Jd. J 130.
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`Figure 63 of Frey is reproduced below.
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`1454
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`1434
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`1400
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`1404 J 1452
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`
`1444
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`1402
`44g
`Fig. 63
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`«AT AD
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`16
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`Patent 8,187,334 B2
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`Figure 63 is a plan view of another embodimentof an implant. Id.
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`q{ 71, 75. “Implant 1400 is an interbody fusion device or cage that can be
`packed with bone growth material or other known substanceandinserted
`into disc space D1 to promote bony fusion between adjacent vertebrae V1
`and V2.” Id. J 150. “Implant 1400 includes a body having a leading end
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`portion 1450,a trailing end portion 1452, and a middle portion 1454
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`therebetween.” Jd. { 151.
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`“In order to provide avenues for bone growth through implant 1400,
`... leading end portion 1450 includes first chamber 1418 and trailing end
`portion 1452 includes second chamber 1420.” Id. 4 154. “Middle portion
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`1454 includes a middle chamber 1422.” Id.
`
`“A first strut 1424 is located between first chamber 1418 andthird
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`chamber 1422 and extends between posterior wall 1402 and anterior wall
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`1404,” and a “secondstrut 1426 is located between second chamber 1420
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`and third chamber 1422 and extends between posterior wall 1402 and
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`anterior wall 1404.” Id.
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`2. Michelson (Ex. 1032)
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`Michelsonrelates “particularly to spinal fusion implants for insertion
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`from the side ofa patient (translateral) across the transverse width of the
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`spine and between two adjacent vertebrae.” Ex. 1032, 1:16-19;see also id.
`at 3:3-5 (describing translateral approach). Figures 18 and 19 of Michelson
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`are reproduced below.
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`17
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`Patent 8,187,334 B2
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`
`
`Figure 18 is a perspective side view of a spinal fusion implant, and
`Figure 19 is a perspective lateral anterior view of a segmentofthe spinal
`column with the implants shownin Figure 18 “inserted from thelateral
`aspect in a modular fashionin the disc space between two adjacent vertebrae
`along the transverse width of the vertebrae.” Jd. at 5:31-39. Michelson
`
`states that the “transverse width of a vertebra is measured from onelateral
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`aspect ofthe spine to the opposite lateral aspect” andthat the “depth of a
`vertebra is measured from the anterior aspect to the posterior aspect of the
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`spine.” Id. at 3:7—-10.
`
`Michelson’s implant“is dimensionedto fit within the disc space
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`created by the removal of disc material between two adjacent vertebrae,”
`“has a length that is substantially greater than the depth of the vertebrae and
`a width that approximates the depth of the vertebrae,” “has more surface
`area of contact and thus permits greater stability,” and “may be inserted into
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`the disc space through a hollow tube.” Jd. at 3:35—40, 3:51-52. 3:61-63.
`The dimensionsof the implant “permit[] a single implant to be inserted bya
`single procedureinto the spine.” Jd. at 3:46—50.
`Spinal implant 1000 “has a narrower width such that more than one
`spinal fusion implant 1000 may be combinedin a modularfashion for
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`18
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`insertion within the disc space D between the adjacent vertebrae.” Jd. at
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`10:50-55. Spinal implant 1000 is an alternative embodimentof a preferred
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`embodimentthat has “a width in the range of 24 mm to 32 mm,with the
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`preferred width being 26 mm; anda length in the range of 32 mm to 50 mm,
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`with 42 mm beingthe preferred length.” Jd. at 10:42-48, Fig. 17.
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`Michelson also claims an implant “having a length that is greater than one
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`half the transverse width of the vertebrae, said length being substantially
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`greater than the depth of the vertebrae.” Jd. at 11:21-26.
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`3. Berry (Ex. 1022)
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`Berry presents “results of a morphometric study of selected human
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`vertebrae undertaken to provide data for implant design.” Ex. 1022, 362.
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`Berry states that “[a]ccurate anatomic descriptions of vertebral shape are
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`necessary for the development of implantable devices and spinal
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`instrumentation”andthat the “current study was undertaken due to a lack of
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`information needed fordesign projects involving instrumentation for the
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`lumbarand thoracic vertebrae.” Jd.
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`“With present and future applications in mind, virtually the entire
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`geometry of the vertebrae was quantified by recordinga total of 27
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`measurementsper vertebra.” Jd. “The means and standard deviations of the
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`dimensional data for all 240 vertebrae are presented in Table 1.” Jd. at 363;
`
`see also id. at 364 (presenting Table 1).
`
`4. Claim 1
`
`The challenged claims, claims 6—9 and 18, depend from cancelled
`
`claim 1. Ex. 1001, 13:17-29, 14:11-13. Petitioner states that “the Board
`
`determinedthatall limitations of claim 1 ‘are taught or suggested by the
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`combination of Frey and Michelson’” and that the “Federal Circuit affirmed
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`the Board’s decision.” Pet. 32 (citing Ex. 1001; Ex. 1004, 5, 13; Ex. 1005,
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`17). Petitioner, thus, contends that “Patent Owneris precluded from taking
`any ‘action inconsistent with the adverse judgment,’ including obtaining any
`claims that are ‘not patentably distinct from a finally refused or canceled
`
`claim’” and “estopped from arguing that claim 1 renders any dependent
`
`claim patentable over Frey and Mich[]Jelson as those references have been
`definitively established as rendering claim 1, amongothers, unpatentable.”
`
`Id.
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`The Preliminary Responsepresents argumentsthat are based on
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`limitations of claim 1 that are incorporated in the dependent claims asserted
`
`to be unpatentable over Frey, Michelson, and Berry. Prelim. Resp. 37-40.
`Weaddress those arguments here for clarity instead of below with
`|
`argumentsrelated to the subject matter of claims 6—9 and 18.
`
`Patent Ownerrespondsthat Petitioner fails to map adequately the
`
`prior art to the elements of claim 1, thereby violating 37 C.F.R.
`§ 42.104(b)(4). Prelim. Resp. 37-38. Patent Ownerarguesthat Petitioner’s
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`reliance on the cancellation of claim 1 does notrelieve Petitioner from
`
`- “demonstrating that each challenged claim as a whole would have been
`
`obvious, including the elements incorporated from claim 1.” Jd. at 38.
`
`Weagree with Petitioner at this stage that Patent Owneris estopped
`
`from arguing that limitations of claim 1 render the challenged dependent
`
`claims patentable over Frey and Michelson because of the determination in
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`IPR2013-00507 that those references rendered claim 1 obvious. See Pet. 32.
`
`Patent Ownerfully participated in the prior proceeding, and the prior
`
`proceeding reacheda final written decision that determined that claim 1 was
`shownto be unpatentable over Frey and Michelson. Thatfinal written
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`decision was appealed, and the determination that claim 1 is unpatentable
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`over Frey and Michelson wasaffirmed. An “Inter Partes Review
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`Certificate” that cancelled claim 1 was issued, thus indicating that further
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`judicial review was not sought. Ex. 1001, 33-34.
`
`If Patent Ownerintendsto reassert this argument duringtrial, Patent
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`Ownershould explain whyit is not estopped from arguing that the .
`
`limitations of claim 1 incorporated into challenged claims 6-9 and 18
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`demonstrate patentability over Frey, Michelson, and Berry, when those same
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`limitations were determined to be unpatentable over Frey and Michelson.
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`Moreover, we do not understand Petitioner to be challenging claim 1,
`
`and thereby implicating the requirements of 37 C.F.R. § 42.104(b)(4),
`because claim 1 was cancelled by IPR2013-00507. Petitioner has submitted
`
`evidence from IPR2013-00507 that supports the determination that claim 1
`
`was unpatentable over Frey and Michelson. In view of the circumstances of
`this case where the patentability of claim | has been fully decided with no
`further judicial review possible, and the evidence from the previous case has
`been filed, we discern no need for Petitioner to