`571-272-7822
`
`Paper 17
`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 IPR2019-00546
`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
`
`
`
`IPR2019-00546
`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 claim 16 of U.S. Patent No. 8,187,334 B2 (Ex. 1001,
`
`“the °334 patent”). NuVasiveInc. (“Patent Owner”) filed a Preliminary
`
`Response (Paper 10, “Prelim. Resp.”). Under 35 U.S.C. § 314, an inter
`
`partes review may notbeinstituted “unless .
`
`.
`
`. there is a reasonable
`
`likelihood that the petitioner would prevail with respect to at least 1 of the
`
`claims challengedin the petition.”
`
`Upon consideration of the Petition and Preliminary Response and for
`
`the reasons explained below, we determine that Petitioner has shownthat
`
`there is a reasonable likelihood that it would prevail with respect to the only
`
`challenged claim, claim 16. Thus, weinstitute an inter partes review of
`
`claim 16 of the ’334 patent onall presented challenges.
`
`Il.
`
`BACKGROUND
`
`A. Related Proceedings
`
`The parties indicate that the 334 patent has beenasserted in
`
`NuVasive, Inc. v. Alphatec Holdings, Inc., Case No. 3:18-cv-00347-CAB-
`
`MDD(S.D.Cal.). Pet. 70; Paper 4, 2. The parties also indicate that the °334
`
`patentis the subject of Case IPR2019-00361. Pet. 70; Paper 4,2.
`
`Patent Owneradditionally notes that the °334 patent was previously
`
`challenged in Cases IPR2013-00507 and IPR2013-00508. Paper4, 2 (citing
`
`Inre 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
`
`(Ex. 1004) that sole independent claim 1 of the ’334 patent and eighteen
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`dependent claims (2—5, 10, 11, 14, 15, and 19-28) are invalid”). The parties
`
`also state that a related patent is challenged in Case IPR2019-00362. Pet.
`
`70; 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 methodforspinal
`
`fusion comprising a spinal fusion implant of non-bone construction .
`.
`. to
`introducethe spinal fusion implantinto any of a variety ofspinal target
`
`sites.” Id. at 1:18-21. Figure 2 of the ’334 patent is reproduced below. FIG. 2
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`Figure 2 showsa perspective view of a lumbar fusion implant. Jd. at
`
`3:36. The spinal fusion implant is introduced into the disc space viaalateral
`
`approachto the spine or via 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 embodiments of spinal fusion
`
`implant 10 includes top surface 31, bottom surface 33, lateral sides 14,
`
`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
`ranging between 8 and 16 mm,anda length ranging between 25 and 45
`
`mm.” Jd. at 5:15-19.
`
`Spinal fusion implant 10 also preferably includes anti-migration
`
`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.
`
`/d. at 6:21—32, Figs. 2-3. Spike elements 7—9
`
`are preferably made from materials having radiopaque characteristics. Jd. at
`
`6:35-38.
`
`Spinal fusion implant 10 has fusion apertures 2 separated by medial
`support 50, extending through top surface 31 and bottom surface 33. Jd. at
`6:57—-59, Figs. 2-3. “[FJusion apertures 2 function primarily as an avenue
`
`for bony fusion between adjacent vertebrae.” Jd. at 6:59-61.
`
`C. Sole Challenged 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 claim 16, which depends from
`
`cancelled claim 1. Claims 1 and 16 are reproduced below.
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`A spinal fusion implant of non-bone construction
`l.
`positionable within an interbody space betweena 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, said distal wall,
`proximalwall, first sidewall, and second sidewall comprising a
`radiolucent material;
`wherein said implant has a longitudinal length greater than
`40 mm extending from a proximal end of said 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 maximum lateral width;
`at least a first fusion aperture extending throughsaid 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, saidfirstfusion
`aperture having: a longitudinal aperture length extending
`generally parallel to the longitudinal length ofsaid implant, and
`a lateral aperture width extending betweensaid 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 secondofsaid 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.
`
`further
`fusion implant of claim 1,
`The spinal
`16.
`comprising a fourth radiopaque marker situated within said
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`implant, said fourth radiopaque markerpositionedin said central
`region at a position spaced apart from said third radiopaque
`marker.
`
`Ex. 1001, 12:32—13:4 (emphases added), 13:51—14:3.
`
`D. Evidence Relied Upon
`
`Petitioner identifies the following referencesas priorart 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 November7, 2002 (Ex. 1040,“Frey”’);
`
`(4) U.S. Patent Application Publication No. US 2003/0028249 Al,
`
`published February 6, 2003 (Ex. 1008, “Baccelli”); and
`
`(5)James L. Berry et al., A Morphometric Study ofHuman Lumbar
`
`and Selected Thoracic Vertebrae, 12 Spine 362-367 (1987)
`
`(Ex. 1022, “Berry”).
`
`In support ofits challenges, Petitioner provides a Declaration of
`
`Charles L. Branch, Jr., M.D. (Ex. 1002).
`
`E. Asserted Grounds
`
`Petitioner challenges, under 35 U.S.C. § 103, claim 16 as unpatentable
`
`over (1) Frey, Michelson, and Baccelli; and (2) Brantigan, Baccelli, Berry,
`
`and Michelson. Pet. 22, 29-69.
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`TH.
`
`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. 10, 28. Patent Owner provides a summaryofthe
`
`prosecution history of the application that issued as the ’334 patent, its
`
`parent application, and a related application.
`
`/d. at 11-15.
`
`Patent Owneralso provides a summary ofpreviouspetitions
`
`challenging the ’334 patent and argues that the present Petition “gives an
`
`incomplete and misleading picture of the prior proceedings.” Jd. at 15-16.
`
`Patent Owner contendsthat the Board previously rejected arguments
`
`regarding the dimensions of an implant.
`
`/d. at 16-19 (citing Ex. 1023, 104—
`
`105, 115-117, 124, 136, 137, 153). Patent Owneralso discusses the Federal
`
`Circuit’s treatment of previous Board findings.
`
`/d. at 19-20 (citing Ex.
`
`1023, 3-4, 16-19, 21).
`
`Patent Ownerprovidesits 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 20-28.
`
`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 evidence to warrant reconsideration. See id.
`
`Patent Owner’s argumentsrelate to radiopaque markers. See Prelim.
`
`Resp. 21 (arguing that “the Patent Office considered multiple references
`
`discussing the use of radiopaque markers on radiolucent spinal implants”
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`and that “[e]ach of Brantigan, Baccelli, and Frey ’550 is cumulative to
`
`Kuntz, Garcia, and Villiers because none of these references discloses the
`
`claimed marker configuration for the claimed implant’), 24 (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 that Patent Ownerdirects ourattention to also relate to radiopaque
`
`markers. See id. at 24-25 (citing Ex. 1020, 97, 108-110, 224-226,230,
`
`245, 247-250, 271, 273-275; Ex. 1023, 212-213, 215-216, 219, 222, 226),
`
`26 (citing Ex. 1025, 104, 112), 27 (citing Ex. 1023, 212-213).
`
`As acknowledged by Patent Owner, Petitioner challenges claim 16
`
`based on a combination of references not previously presented to the Office.
`
`See Prelim. Resp. 15 (indicating that claim 16 was challenged “as obvious
`
`over Frey ’550 and Baccelli” and “as obvious over SVS-PR (Ex. 1009)
`and/or Telamon Brochure (Ex. 1010) and Guide (Ex. 1011), each in view of
`
`Frey ’550, Baccelli, and/or Michelson”), 20 (stating that “Frey ’550 and
`
`Baccelli were not cited during prosecution but were presented to the Office
`
`in the prior IPRs”). Even if Brantigan, Baccelli, and Frey are cumulative,
`
`Petitioner presents a combination ofreferences that has not been considered
`
`previously. See id. at 21 (arguing that “[e]ach of Brantigan, Baccelli, and
`
`Frey 7550 is cumulative to Kuntz, Garcia, and Villiers ...”). The
`
`circumstancesofthis case do not indicate that the same or substantially the
`
`same arguments were presented previously to the Office.
`
`Regarding the asserted failure to identify Examinererror, the previous
`
`proceeding IPR2013-00507 cancelled claim 1, thereby determining that the
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`claim should not have been allowed to issue and indicating an error in
`
`evaluating the prior art. As for the argument that new evidence has not been
`
`submitted to warrant reconsideration, Petitioner’s evidencein this
`
`proceeding is directed to the fourth radiopaque markerof claim 16, not the
`
`radiopaque markerlimitation of cancelled claim 1.
`
`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
`
`deny institution.
`
`IV.
`
`35US.C. § 314(a)
`
`Patent Owneralso urges us to exercise our discretion under 35 U.S.C.
`
`§ 314 to deny institution because institution would not be an efficient use of
`
`Board resources. Prelim. Resp. 10, 39. In addition to the summary of
`
`prosecution histories of the application that issued as the °334 patent and
`
`related applications, Patent Owner provides a summary ofpreviouspetitions
`
`challenging the ’334 patent and argues that the present Petition “gives an
`
`incomplete and misleading picture of the prior proceedings.” Jd. at 15-16.
`
`Patent Owner contendsthat the Board previously rejected arguments
`
`regarding the dimensionsof an implant. Jd. at 16-19 (citing Ex. 1023, 104—
`
`105, 115-117, 124, 136, 137, 153). Patent Owneralso discusses the Federal
`
`Circuit’s treatment of previous Board findings. Jd. at 19-20 (citing Ex.
`
`1023, 3-4, 16-19, 21).
`In addition, Patent Ownerasserts 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. Jd.
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`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 same petitionerfiling multiple petitions. Jd. at 29. Patent
`
`Ownerpoints to the recent departure of Petitioner’s employees from Patent
`
`Owner’s company, substantially the same challenge being brought against
`
`claim 18, the references having been previously asserted or cited in
`
`prosecution, Petitioner having reviewed the previous Board decisions and
`
`filings, no justification being given for the delay in filing, and no reasons
`
`being given to revisit unpersuasive arguments. See id. at 30-39.
`
`As noted by Patent Owner, the present Petition challenges claim 16,
`
`which wasalso at issue in IPR2013-00507 and IPR2013-00508. See Prelim.
`
`Resp. 15-16. We acknowledgethat, including the instant case, the Board
`
`has been presented thus far with multiple challenges to the °334 patent.
`
`Although we understand the purpose of § 314(a) regarding repeated
`
`challenges, we also recognize the purposeofthe availability of inter partes
`
`review to parties accused of infringement. Patent Owner’s complaint about
`
`the multiple inter partes review petitions filed against the ’334 patent is not
`
`persuasive whenthe respective filings appear to be a direct result of its own
`
`litigation activity. See supra Section IJ.A. The discretion to deny petitions
`
`is for the panel to exercise under certain 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
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`IPR2019-00062, -00063, -00084, slip op. at 9 (PTAB Apr. 2, 2019) (Paper
`
`11) (precedential). Here, relevant to potentially factors 1 and 3 of the
`
`General Plastic factors, Patent Owner argues that some of Petitioner’s
`
`employees were previously employeesof “NuVasive” (Prelim. Resp. 30-
`
`31), which is the Patent Ownerof the ’334 patent. The former employees
`
`were not previously a petitioner for another petition directed to the same
`
`claims of the same patent. Patent Owneralsofails to direct us to sufficient
`
`evidence indicating that present Petitioner’s companies havea relationship
`
`with any previous petitioners, or that the noted former employees have such
`
`arelationship. See id. at 30-31. Thus, factors 1 and 3 weigh against
`
`exercising our discretion to denyinstitution.
`
`Also, for the remaining factors, as discussed above and acknowledged
`
`by Patent Owner, claim 16 has not yet been challenged by Petitioner’s
`
`proposed combination of references. See id. at 15 (indicating that claim 16
`
`was challenged “as obvious over Frey ’550 and Baccelli” and “as obvious
`
`over SVS-PR (Ex. 1009) and/or Telamon Brochure (Ex. 1010) and Guide
`(Ex. 1011), each in view of Frey ’550, Baccelli, and/or Michelson”), 20
`
`(stating that “Frey °550 and Baccelli were not cited during prosecution but
`
`were presented to the Office in the prior IPRs”). Petitioner challenges claim
`
`16 based on a proposed combination of references that has not been
`
`considered in prosecution or in previous proceedings and, thus, does not
`amountto an inefficient use of Board resources.
`
`Thus,for the foregoing reasons, we do not exercise our discretion
`
`under 35 U.S.C. § 314(a) to deny institution.
`
`ll
`
`
`
`IPR2019-00546
`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 usedin federal district court.
`
`Changes to 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 change applies
`
`to petitions filed on or after November13, 2018, so the revised claim
`
`construction standard applies this proceeding. Jd.; see Pet. 26 (stating that
`
`the “Board applies ‘the standard used in federal courts ...°”
`
`(quoting 83
`
`Fed. Reg. at 51343)); Paper 3, 1 (according filing date of January 10, 2019
`
`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 maximum lateral width of the implant.”
`
`Prelim. Resp. 8-9 (citing also Ex. 2009, 424 (dictionary definition for
`
`“longitudinal”)). Patent Owner also contends that claim 1 defines
`
`“longitudinal aperture length” to mean “a dimensionof the aperture that runs
`
`lengthwise andis greater than the lateral aperture width that extends between
`
`the first sidewall and the second sidewall.” Jd. at 9. We interpret
`
`“longitudinal length” and “longitudinal aperture length” consistent with the
`
`claim language, and further express interpretation is not required for
`
`purposesof this Decision.
`
`For the purposes of determining whether Petitioner demonstrates a
`
`reasonable likelihood of prevailing in its challenges, we determine that no
`
`12
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`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
`
`using interbody spinal fusion implants” or “would have a mechanicalor
`
`biomechanical engineering degree with at least two years’ experience
`
`working in developing implant devices and associated instruments with
`
`significant access to orthopedic surgeons or neurosurgeons.” Pet. 28
`
`(quoting Ex. 1002 § 18). Patent Owner does not yet proposea level of
`
`ordinary skill.’
`
`Wepreliminarily adopt Petitioner’s unchallenged, asserted level of
`
`ordinary skill solely to determine whetherthere is a reasonable likelihood
`
`that Petitioner would prevail with respect to challenged claim 16.
`
`C. Challenge Based on Frey, Michelson, and Baccelli
`
`1. Frey (Ex. 1040)
`
`Frey relates to “implants insertable in the spinal disc space,” and
`
`specifically relates to “implants, methods and instruments for use in a
`
`' Wenotethat, in the related IPR2019-00362 which addresses a continuation
`of the °334 patent and similar prior art, Patent Owner does not contest
`Petitioner’s proposed level of ordinary skill.
`
`13
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`posterior lateral approachto the disc space, including a transforaminal
`
`approach.” Ex. 1040 § 2. Figure 55 of Frey is reproduced below.
`5
`"000
`A
`
`1046
`
`1004
`
`Fig. 55
`Figure 55 is a plan view of an implant. Jd. {| 66, 67. “Implant 1000
`
`is an interbody fusion device or cage that can be packed with bone growth
`
`material or other knownsubstance andinserted into disc space D1 to
`
`promote bony fusion between vertebrae V1 and V2.” Jd. J 140. It hasa
`
`“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
`disc space.” Jd. J 141, 143. Implant 1000 has “upper openings 1018a and
`
`1018b separated by an upperstrut 1019.” Jd. 7 144. “Implant 1000 can be
`
`made from titanium, surgical grade stainless steel, or other bio-compatible
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`material using fabricating techniques knownin theart,” such as PEEK. Id.
`
`qq 149, 181.
`
`A dual lobe implant such as implant 1000, “is placed in the disc space
`
`D1 andhasa length sufficient to span the disc space from the distal portion
`
`37 to the proximal portion 41.” Jd. ¢ 130.
`
`Figure 63 of Frey is reproduced below.
`
`1454
`
`1434
`
`1400
`
`1404 J 1452
`
`
`
`
` 1402 4448
`Fig. 63
`
`Figure 63 is a plan view of another embodiment of an implant. Jd.
`
`q§ 71, 75. “Implant 1400 is an interbody fusion device or cage that can be
`
`packed with bone growth material or other knownsubstance and inserted
`
`into disc space D1 to promote bony fusion between adjacent vertebrae V1
`
`and V2.” Id. 4150. “Implant 1400 includes a body having a leading end
`
`portion 1450, a trailing end portion 1452, and a middle portion 1454
`
`therebetween.” Jd. 4 151.
`
`“Tn order to provide avenues for bone growth through implant 1400,
`
`... leading end portion 1450 includes first chamber 1418 andtrailing end
`
`15
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`portion 1452 includes second chamber 1420.” Jd. 9 154. “Middle portion
`
`1454 includes a middle chamber 1422.” Id.
`
`“A first strut 1424 is located between first chamber 1418 andthird
`
`chamber 1422 and extends between posterior wall 1402 and anterior wall
`
`1404,” and a “second strut 1426 is located between second chamber 1420
`
`and third chamber 1422 and extends between posterior wall 1402 and
`
`anterior wall 1404.” Id.
`
`2. Michelson (Ex. 1032)
`
`Michelson relates “particularly to spinal fusion implants for insertion
`
`from the side of a patient (translateral) across the transverse width of the
`
`spine and between two adjacent vertebrae.” Ex. 1032, 1:16—-19; see alsoid.
`
`at 3:3-5 (describing translateral approach). Figures 18 and 19 of Michelson
`
`are reproduced below.
`
`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 fashion in the disc space between two adjacent vertebrae
`
`along the transverse width of the vertebrae.” Jd. at 5:31-39. Michelson
`
`16
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`states that the “transverse width of a vertebra is measured from onelateral
`
`aspect of the spine to the opposite lateral aspect” and that the “depth ofa
`
`vertebra is measured from the anterior aspect to the posterior aspect of the
`
`spine.” Jd. at 3:7-10.
`
`Michelson’s implant “is dimensionedto fit within the disc space
`
`created by the removal of disc material between two adjacent vertebrae,”
`
`“thas 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
`
`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 by a
`
`single procedure into 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 combined in a modular fashion for
`
`insertion within the disc space D between the adjacent vertebrae.” Jd. at
`
`10:50-55. Spinal implant 1000is an alternative embodimentof a preferred
`embodimentthat has “a width in the range of 24 mm to 32 mm,with the
`
`preferred width being 26 mm; and a length in the range of 32 mm to 50 mm,
`
`with 42 mm beingthe preferred length.” Jd. at 10:42-48, Fig. 17.
`
`Michelson also claims an implant “having a length that is greater than one
`
`half the transverse width of the vertebrae, said length being substantially
`
`greater than the depth of the vertebrae.” Jd. at 11:21-26.
`
`3. Baccelli (Ex. 1008)
`
`.
`
`Baccelli “relates to intervertebral implant.” Ex. 1008 91. Figures 1
`
`and 2 of Baccelli are reproduced below.
`
`17
`
`
`
`IPR2019-00546
`
`Patent 8,187,334 B2
`
`Figures 1 and 2 show perspective and plan views of an implant.
`
`/d.
`
`q 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,
`
`superior main face 8, and inferior main face 10 opposite face 8. Id. J¥ 33-
`
`35. Wall 4 defines hole 7 that extends between faces 8, 10. Id. JJ 34, 35.
`
`Faces 8 and 10 have a toothed profile forming teeth 12. Jd. § 36-37. The
`
`18
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`cage has spikes 24 on faces 8, 10. Jd.
`
`41, Figs. 3-5. Fitting tool 40 puts
`
`the cage into place. Id. [¥ 44-45, Fig. 9.
`
`“The cage can be made ofa material that is transparent to X-rays” and
`
`“can have one or more markers 47 included therein and serving, because
`
`they are opaque to X-rays, to identify the position and/or presence of the
`
`implant when X-rays are taken during orafter the operation.” Jd. 450. “The
`
`spikes 24 can be inserted and fixed rigidly in the ducts formedin the cage.”
`
`Id. 51. “They too can be madeof a material that is opaque to X-rays.” Id.
`
`4. Claim ]
`
`For claim 1, from which claim 16 depends, Petitioner states that “the
`
`Board determinedthatall limitations of claim 1 ‘are taught or suggested by
`
`the combination of Frey and Michelson’” and that the “Federal Circuit
`
`affirmed the Board’s decision.” Pet. 31 (citing Ex. 1001; Ex. 1004, 5, 13;
`
`Ex. 1005, 17); see also id. at 29 (stating that “[a]s the Board and the Federal
`
`Circuit have previously concluded, a [person of ordinary skill in theart]
`
`would have been motivated to combine Frey and Michelson”) (citing
`
`Ex. 1002 {¥ 142-143, 147-149; Ex. 1005, 14-17). 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[]elson as those references have been definitively established as
`
`rendering claim 1, amongothers, unpatentable.” Jd. at 31-32.
`
`The Preliminary Response presents arguments that are based on
`
`limitations of claim 1 that are incorporated in claim 16, whichis asserted to
`
`be unpatentable over Frey, Michelson, and Baccelli. Prelim. Resp. 39-44.
`
`19
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`Weaddress those arguments here for clarity instead of below with
`
`arguments related to claim 16.
`
`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. 39-41. Patent Ownerarguesthat Petitioner’s
`
`reliance on the cancellation of claim 1 does not relieve Petitioner from
`“demonstrating that each challenged claim as a whole would have been
`obvious.” Jd. at 40. Patent Owneralso arguesthatit is not attempting to
`
`“obtain” any claim and thus, not barred by 37 C.F.R. § 42.73(d)(3)(i). Jd. at
`
`40-41 (citing Pet. 31).
`
`We agree with Petitionerat this stage, that Patent Owneris estopped
`
`from arguing that limitations of claim 1 render the challenged dependent
`
`claim patentable over Frey and Michelson becauseof the determination in
`
`IPR2013-00507 thatthose references rendered claim 1 obvious. See Pet. 32.
`
`Patent Ownerfully participated in the prior proceeding, andthe prior
`
`proceeding reached a final written decision that determined that claim 1 was
`
`shownto be unpatentable over Frey and Michelson. Thatfinal written
`
`decision was appealed, and the determination that claim 1 is unpatentable
`
`over Frey and Michelson wasaffirmed. An “Inter Partes Review
`
`Certificate” that cancelled claim 1 wasissued, thus indicating that further
`
`judicial review was not sought. Ex. 1001, 33-34.
`
`If Patent Ownerintendsto reassert this argument duringtrial, Patent
`
`Ownershould explain whyit is not estopped from arguing that the
`
`limitations of claim 1 incorporated into challenged claim 16 demonstrate
`
`patentability over Frey, Michelson, and Baccelli, when those same
`
`limitations were determined to be unpatentable over Frey and Michelson.
`
`20
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`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 1 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 argue with particularity the
`
`limitations of claim 1, even to the extent they are included in challenged
`
`|
`claim 16 by virtue of dependency.
`Turning to Patent Owner’s arguments based on limitations in
`
`cancelled claim 1, claim 1| recites, inter alia, “said first fusion aperture
`
`having: a longitudinal aperture length extending generally parallel to the
`
`longitudinal length of said implant .
`
`.
`
`. wherein the longitudinal aperture
`
`length is greater than the lateral aperture width.” Ex. 1001, 12:59-64.
`
`Patent Owner respondsthat Petitionerfails to establish that Frey’s implant
`
`has apertures with “a longitudinal aperture length extending generally
`
`parallel to the longitudinal length of said implant”that is “greater than the
`
`lateral aperture width” betweenfirst and second sidewalls. Prelim. Resp. 41.
`
`Patent Owneralso contendsthat Petitioner’s asserted longitudinal
`
`lengths are not parallel to each otheror to the longitudinal length of the
`
`implant. Jd. at 42-43 (citing Pet. 7; Ex. 2019, 33-40) (reproducing
`
`Petitioner’s annotated Ex. 1040, Figs. 55, 63). Patent Owner arguesthat
`
`Frey teaches axis Cl extending longitudinally through the implant’s center
`
`and the asserted fusion aperturesare not parallel to the axis. Id. at 43
`
`(quoting Ex. 1040
`
`159) (providing annotated Ex. 1040, Figs. 55, 63).
`
`21
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`Patent Owneralso argues that Petitioner does not provide a rationale for
`
`modifying Frey’s implant to have such dimensionallimitations. Jd. at 43-—
`
`44.
`
`Asdiscussed above, we agree with Petitioner that Patent Owneris
`
`estopped from arguing that Frey and Michelson would not have rendered
`
`obvious claim 1 because claim 1 was shown to be unpatentable in a prior
`
`proceeding. See Pet. 32. Also, as indicated above, if Patent Ownerintends
`
`to reassert this argument duringtrial, Patent Owner should explain whyit is
`
`not estopped from arguinglimitations of claim 1, evenif it is in the context
`
`of arguing for dependent claim 16.
`
`Moreover, even if we were to consider Patent Owner’s arguments
`
`regarding “longitudinal aperture length,” claim 1 does not require that the
`
`fusion aperture have a longitudinal aperture length alongits longest
`
`dimension. Claim 1 only requires “a longitudinal aperture length extending
`
`generally parallel to the longitudinal length of said implant.”
`
`5. Claim 16
`
`Claim 16 depends from claim 1 andrecites “a fourth radiopaque
`
`