Trials@uspto.gov
`571-272-7822
`
`Paper 59
`Date: July 8, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ALPHATEC HOLDINGS, INC., and ALPHATECSPINE,INC.,
`Petitioner,
`
`Vv.
`
`NUVASIVE, INC.,
`Patent Owner.
`
`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.
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`Denying Patent Owner’s Motion to Exclude
`35 U.S.C. § 318(a)
`
`
`571-272-7822
`
`Paper 59
`Date: July 8, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ALPHATEC HOLDINGS, INC., and ALPHATECSPINE,INC.,
`Petitioner,
`
`Vv.
`
`NUVASIVE, INC.,
`Patent Owner.
`
`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.
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`Denying Patent Owner’s Motion to Exclude
`35 U.S.C. § 318(a)
`
`
`
`IPR2019-00361
`Patent 8,187,334 B2
`
`I.
`
`INTRODUCTION
`
`Wehavejurisdiction under 35 U.S.C. § 6. This Final Written
`
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`
`A. Background and Summary
`
`Alphatec Holdings, Inc., and Alphatec Spine,Inc., (collectively,
`
`“Petitioner’’) filed a Petition (Paper 2, “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). Pursuant to 35 U.S.C. § 314, we
`
`instituted an inter partes review of the ’334 patent. Paper 19 (“Dec. to
`
`Inst.’”’). In particular, we instituted review of claims 6—9 and 18 onall
`
`presented challenges. Dec. to Inst. 2, 24, 25, 26, 29, 30, 38, 41, 43.
`
`After institution, Patent Ownerfiled a Response (Paper 28, “PO
`
`Resp.”), to which Petitioner filed a Reply (Paper 35, “Pet. Reply”). Patent
`
`Ownerthereafter filed a Sur-Reply (Paper 41, “PO Sur-reply”). Patent
`
`Owneralso filed a Motion to Exclude (Paper 39, “Mot.”), and Petitioner
`
`filed an Opposition to Patent Owner’s Motion to Exclude (Paper 45,
`
`“Opp.’’), to which Patent Ownerfiled a Reply (Paper 49, “Mot. Reply”). In
`
`an Order (Paper 38), we authorized Patent Ownerto file a Supplemental Sur-
`
`reply, which wasfiled (Paper 42) and Petitioner to file a Supplemental Sur-
`
`sur-reply, which wasalso filed (Paper 43). An oral hearing in this
`
`proceeding washeld on April 3, 2020; a transcript of the hearing is included
`
`in the record (Paper 56, “Tr.”). See also Exs. 1066, 2062 (parties’ transcript
`
`errata sheets).
`
`For the reasons that follow, we determine that Petitioner has shown by
`
`a preponderanceofthe evidence that claims 6-9, but not claim 18, of the
`
`
`
`
`
`IPR2019-00361
`Patent 8,187,334 B2
`
`°334 patent are unpatentable. We also deny Patent Owner’s Motion to
`
`Exclude.
`
`B. Real Parties in Interest
`
`Petitioner states that “Alphatec Holdings, Inc. and Alphatec Spine,
`
`Inc. are the real-parties-in-interest for purposes of this proceeding.” Pet. 75.
`
`“In accordance with 37 C.F.R. § 42.8(b)(1), Patent Owneridentifies
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`NuVasive,Inc. as the real party-in-interest.” Paper 4, 2.
`
`C. Related Matters
`
`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.) and Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case No.
`
`3:12-cv-002738-CAB-MDD(S.D. Cal.). Pet. 75; Paper 4, 2. The parties
`
`also indicate that the °334 patent is the subject of IPR2019-00546. Paper4,
`
`2; Paper6, 2.
`
`Patent Owner additionally notes that the ’334 patent was previously
`
`challenged in IPR2013-00507 and IPR2013-00508. Paper 4, 2 (citing Jn 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
`
`(Ex. 1004) that sole independent claim 1 of the ’334 patent and eighteen
`
`dependent claims (2—5, 10, 11, 14, 15, and 19-28) are invalid”). A related
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`patent, U.S. Patent No. 8,361,156 B2, is challenged in IPR2019-00362.
`
`Pet. 75; Paper 4, 2; Paper6, 2.
`
`D. The ’334 Patent (Ex. 1001)
`
`The ’334 patent issued May 29, 2012, from an application filed April
`
`4, 2011, whichis a continuation of an application filed on March 29, 2005,
`
`and claimspriority to a provisional application filed on March 29, 2004.
`
`Ex. 1001, codes (22), (45), (60), (63), 1:7—13.
`
`
`
`
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`IPR2019-00361
`Patent 8,187,334 B2
`
`The *334 patent particularly relates to “a system and methodfor spinal
`
`fusion comprising a spinal fusion implant of non-boneconstruction. . . to
`
`introduce the 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. iG. 2
`
`Figure 2 showsa perspective view of a lumbar fusion implant. Jd. at 3:36.
`
`The spinal fusion implantis introduced into the disc spacevia a lateral
`
`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,
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`proximalside 22, and distal side 16. Jd. at 6:6-9, Figs. 2-3. Spinal fusion
`
`
`
`IPR2019-00361
`Patent 8,187,334 B2
`
`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
`
`features, such as ridges 6 and pairs of spike elements 7-9, designed to
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`increase friction between spinal fusion implant 10 and adjacent contacting
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`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.
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`/d. 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. Jd. at
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`6:57-59, Figs. 2-3. “[F]Jusion apertures 2 function primarily as an avenue
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`for bony fusion between adjacent vertebrae.” Jd. at 6:59-61.
`
`E.
`
`Illustrative Claims
`
`The *334 patent has 28 claims. In IPR2013-00507, claim 18 was
`
`found to be “patentable,” and claims 1-5, 10, 11, 14, 15, and 19-28 were
`
`cancelled. Ex. 1001, 34. Petitioner challenges claims 6—9 and 18, all of
`
`which ultimately depend from cancelled claim 1. Claims1, 6, and 18 are
`
`reproduced below.
`
`A spinal fusion implant of non-bone construction
`1.
`positionable within an interbody space betweenafirst vertebra
`and a second vertebra, said implant comprising:
`an upper surface including anti-migration elements to
`contact said first vertebra whensaid implantis positioned within
`the interbody space, a lower surface including anti-migration
`elements to contact said second vertebra whensaid 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;
`
`
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`IPR2019-00361
`Patent 8,187,334 B2
`
`wherein said implanthas 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 maximum lateral width;
`at leasta first fusion aperture extending through said upper
`surface and lowersurface and configured to permit bone growth
`between the first vertebra and the second vertebra when said
`implantis 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 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; whereina first of the at
`least three radiopaque markersis at least partially positioned in
`said distal wall, a second of 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.
`
`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.
`maximum lateral width of said implant is approximately 18 mm.
`
`Ex. 1001, 12:32—13:4, 13:17-19, 14:11-13.
`
`F. Asserted Prior Art and Proffered Testimonial Evidence
`
`Petitioner identifies the following referencesas priorart in the
`
`asserted grounds of unpatentability:
`
`
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`IPR2019-00361
`Patent 8,187,334 B2
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`(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) James L. Berry et 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, 29-74. Patent Owner
`
`proffers a Declaration of Jim A. Youssef, M.D. (Ex. 2055), Declaration of
`
`Carl R. McMillin, Ph.D. (Ex. 2057), and Declaration of Matthew Link
`
`(Ex. 2059). Deposition transcripts for Dr. Branch (Ex. 2022), Dr. Youssef
`
`(Ex. 1050), Dr. McMillin (Ex. 1051), and Mr. Link (Ex. 1052) werefiled.
`
`
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`IPR2019-00361
`Patent 8,187,334 B2
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`G. Asserted Grounds
`
`Petitioner asserts that claims 6-9 and 18 would have been
`
`unpatentable on the following grounds:
`
`Claims Challenged
`6-9, 18
`6-9, 18
`
`.
`
`35 U.S.C. §!
`
`103
`
`
`
`
`References/Basis
`Frey, Michelson, Berr
`Brantigan, Baccelli, Berry,
`.
`Michelson
`
`
`
`
`Pet. 21-22, 29-74.
`
`A. Patent Owner’s Motion to Exclude
`
`Il. ANALYSIS
`
`Patent Owner movesto exclude Exhibits 1041, 1042, 1053-1056,
`
`1059-1062, 1064, and 1065. Mot. 1. Patent Ownerindicates that objections
`
`to these exhibits, except for Exhibit 1064, were previously filed. Jd. (citing
`
`Papers 24, 36). Patent Owner, as the “movingparty,” “has the burden of
`
`proofto establish thatit is entitled to the requestedrelief.” 37 C.F.R.
`
`§ 42.20(c).
`
`1. Exhibits 1041 and 1042
`
`Exhibits 1041 and 1042 are declarations by Richard Hynes, M.D. filed
`
`in IPR2013-00507 and IPR2013-00508, respectively. Patent Owner argues
`
`that these exhibits should be excludedas irrelevant under Rules 401 and 402
`
`of Federal Rules of Evidence (“FRE”). Mot.2.
`
`' The relevant sections of the Leahy-Smith America Invents Act (“AIA”),
`Pub. L. No. 112-29, 125 Stat. 284 (Sept. 16, 2011), took effect on March 16,
`2013. Because the application from which the °334 patent issued was a
`continuation of an application filed before that date and claims the benefit of
`a filing date of provisional application also filed before that date, our
`citations to Title 35 are to its pre-AIA version. See Ex. 1001, codes (60),
`(63), 1:7-12.
`
`
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`IPR2019-00361
`Patent 8,187,334 B2
`
`Patent Ownercontendsthat“Petitioner relies on these exhibits solely
`
`to support the assertion that it is presenting a materially different theory
`
`compared to what waspresented in these earlier proceedings.” Jd. at 1
`
`(citing Pet. 25-26). Patent Owneragrees that a different theory has been
`
`presented and arguesthat the agreement“should be considereda stipulated
`
`fact,” so that Exhibits 1041 and 1042 should be excluded.
`
`/d. at 2.
`
`Petitioner responds that Exhibits 1041 and 1042 demonstrate that
`
`claim 18 is unpatentable based on a combination of references not
`
`previously presented in IPR2013-00507 and IPR2013-00508 and are
`
`relevant to § 325(d) issues. Opp. 1. Patent Ownerreplies that Petitioner’s
`
`assertions undermineits collateral estoppel arguments andstates that “[t]o
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`the extent the materially different nature of Petitioner’s Petition and the prior
`
`IPRs is deemed an admission offact, these exhibits should be excluded.”
`
`Mot. Reply 1.
`
`Patent Owner’s basis for moving to exclude Exhibits 1041 and 1042is
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`that they support Petitioner’s contention, and Patent Owneragrees with that
`
`contention. The mere fact that an exhibit supports the parties’ agreement
`
`does not demonstrate a reason to excludeit from the record.
`
`Accordingly, we deny Patent Owner’s Motion to Exclude with respect
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`to Exhibits 1041 and 1042.
`
`2. Exhibits 1053 and 1054
`
`Exhibit 1053 is U.S. Patent No. 6,241,770 B1 to Michelson, issued
`
`June 5, 2001, and Exhibit 1054 is an article titled “Minimally Invasive
`
`Anterior Retroperitoneal Approach to the Lumbar Spine”by Paul C.
`
`McAfeeet al., from pages 1476-1484 of volume 23, number 13 of Spine,
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`published in 1998. Patent Ownerargues that these exhibits should be
`
`
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`IPR2019-00361
`Patent 8,187,334 B2
`
`excluded under Rules 401-403asirrelevant to a ground of review,likely to
`
`cause confusion, and prejudicial. Mot. 2-4.
`
`In particular, Patent Owner contendsthat “Petitioner cites these
`
`exhibits in support of a prima facie case of obviousnessraised forthe first
`
`time in Petitioner’s Reply” andto fill a gap identified in the Patent Owner
`
`Response. Jd. at 3-4 (citing Pet. 4-5, 30, 45, 47-48; PO Resp. 19-20, 55;
`
`Pet. Reply 10). Petitioner responds that Exhibits 1053 and 1054 are proper
`
`rebuttal evidence. Opp. 1-2. Petitioner also identifies which of Patent
`
`Owner’s arguments that the exhibits rebut and how they respondto those
`
`arguments.
`
`/d. at 2-5 (citing PO Resp. 9, 13, 62; Pet. Reply 2-4, 10, 15—
`
`16). Patent Ownerreplies that “Petitioner does not contest that it could have
`
`presented them with the Petition” and “concedesthat it is improperin reply
`
`to rely on a new rationale to combinethe prior art references.” Mot.
`Reply 1-2. Patent Ownerreiterates its argument that Exhibits 1053 and
`1054 support a new rationale for combining the references. Jd. at 2—3 (citing
`Pet. 4-5, 30, 47-58; Opp. 3-4). Patent Owneralso argues that these exhibits
`
`fail to support the theory presented in the Petition.
`
`/d. at 4 (citing Pet. 45;
`
`Opp. 3-4).
`
`The parties dispute whether Exhibits 1053 and 1054 support rebuttal
`
`arguments or are new arguments. Patent Owner’s arguments are not
`properly the subject of a motion to exclude based on inadmissibility, but
`rather should have beenfiled as a motionto strike because they seek to
`
`exclude belatedly presented evidence that Patent Owner contends exceeds
`
`the proper scope of reply. In any event, because the dispute has been
`presented (see Papers 38, 42, 43), and the exhibits at issue support a possible
`
`rebuttal argument, we deny Patent Owner’s Motion to Exclude with respect
`
`to Exhibits 1053 and 1054.
`
`10
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`IPR2019-00361
`Patent 8,187,334 B2
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`3. Exhibits 1055 and 1056
`
`Exhibit 1055 is an article titled ““A Carbon Fiber Implant to Aid
`
`Interbody Lumbar Fusion” by John W.Brantigan, M.D. and Arthur D.
`
`Steffee, M.D., from pages 2106-2117 of volume 18, number 14 of Spine,
`
`published in 1993, Exhibit 1056 is an excerpt from a transcript in related
`
`litigation. The excerpt contains Dr. Brantigan’s direct testimony regarding
`
`implants. See Ex. 1056, 2-9. Patent Ownerargues that Exhibit 1055 should
`
`be excluded under Rules 401-403 of FRE because it is cited in Petitioner’s
`
`Reply with no substantive discussion and no explanationofits significance
`
`and Exhibit 1056 should be excluded under Rules 106 and 401-403 ofthe
`
`FRE becauseit is “more likely to cause confusion and unreasonable
`
`prejudice than add probative value.” Mot. 5. More specifically, Patent
`
`Ownerarguesthat Exhibit 1056 is an incomplete document from another
`
`proceeding, omits other information that should be considered, and is
`irrelevantto this proceeding. Id. at 5-6. Patent Owneralso arguesthat,
`
`because Exhibit 1056 is an excerpt, it is confusing andfails to provide
`
`context. Id. at 6.
`
`Petitioner responds that Exhibits 1055 and 1056 were offered to rebut
`
`Dr. Youssef’s testimony. Opp. 5—6. Petitioner argues that the exhibits are,
`
`thus, relevant and their relevance outweighsanyrisk of confusion.
`
`/d. at 6.
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`Petitioner also contends that Patent Ownerrelied on Exhibit 1055 in
`
`previouslitigation and relies on exhibits from the samelitigation to support
`
`arguments in this proceeding. Jd. (citing Ex. 2029; Ex. 2030; Ex. 2060, 27—
`
`29, 51).
`
`Patent Ownerreplies that Petitioner “improperly attempt[s] to back-
`
`fill arguments regarding Exhibit 1055” and the arguments are “belated and
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`non-responsive.” Mot. Reply 5. Patent Owneralso replies that “Petitioner
`
`1]
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`IPR2019-00361
`Patent 8,187,334 B2
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`approved of NuVasive’s filing of EX2060 as a complete version of the
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`transcript Petitioner filed as EX1056,” which Patent Owner arguesis
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`incomplete, and that Petitioner “‘fails to establish the admissibility ofits
`
`exhibits.” Jd. (citing Mot. 5-8; Opp. 6).
`
`Petitioner cites Exhibits 1055 and 1056 in its Reply in support ofits
`
`argumentthat Dr. Youssef was unaware of Patent Owner’s reliance on
`
`Brantigan. Pet. Reply 4-5. Some of Patent Owner’s arguments are again
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`not properly the subject of a motion to exclude based on inadmissibility
`
`because they seek to exclude belatedly presented evidence that Patent Owner
`
`contends exceeds the proper scope of reply. In any event, we do not agree
`
`with Patent Ownerthat the explanation ofits significance is insufficient or
`
`that these exhibits are irrelevant. The exhibits at issue are properly
`
`presented as rebuttal evidenceto aid in determining what weight we should
`
`afford Dr. Youssef’s testimony in this proceeding. These exhibits inform us
`
`about Dr. Youssef’s knowledge about a reference asserted in this proceeding
`
`which,in turn with all other record evidence, may or may notaffect the
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`credence we give to Dr. Youssef’s opinion of the asserted reference.
`
`Accordingly, Patent Ownerhas notsatisfied its burden to show that
`
`Exhibits 1055 and 1056 should be excluded, and thus, we deny Patent
`
`Owner’s Motion to Exclude with respect to Exhibits 1055 and 1056.
`
`4. Exhibits 1059 and 1064
`
`Exhibit 1059 is an excerpt from a transcript of the deposition of Dr.
`
`Youssefin related litigation, and Exhibit 1064 is open payments data for Dr.
`
`Youssef. Patent Ownerarguesthat these exhibits should be excluded under
`
`Rules 106 and 401-403 becausethey are “more likely to cause confusion
`
`and unreasonable prejudice than add probative value.”” Mot. 5.
`
`12
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`IPR2019-00361
`Patent 8,187,334 B2
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`In particular, Patent Owner argues that Exhibit 1059 is an incomplete
`
`document from another proceedings, omits other information that should be
`
`considered, andis irrelevant to this proceeding. Jd. at 5-6. According to
`
`Patent Owner, Exhibits 1059 and 1064 support that Dr. Youssef has been
`
`compensated for consulting services provided to Patent Owner beyondthis
`
`proceeding andthe partial record is confusing, provides minimal context,
`
`and likely to cause undueprejudice. Jd. at 6, 8; see also id. at 6-7 (arguing
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`that Dr. Branch has also provided consulting services). Petitioner responds
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`that they were offered ‘“‘to demonstrate the bias associated with Dr.
`
`Youssef’s opinions.” Opp. 7-8. Petitioner also describes Dr. Branch’s
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`consulting arrangement with Medtronic and other companies. Jd. at 8.
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`Patent Ownerreplies that “Petitioner’s use of [Exhibit 1064]is
`
`misleading and incomplete because Dr. Branchtestified during his
`
`deposition in the district court case that he was paid several million dollars
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`as a consultant for Medtronic and that this range of compensation reflected
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`fair market value” and that “Petitioner does not contest the authenticity or
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`veracity of Dr. Branch’s testimony.” Mot. Reply 5 (citing Mot. 6-7;
`
`Opp. 8). Patent Owner does not provide a reply specific to Exhibit 1059.
`
`See id.
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`Dr. Youssef’s testimony (Ex. 1059) and open paymentsdata
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`(Ex. 1064) would aid in determining bias, if any, that may have affected his
`
`opinion in this proceeding. Because these exhibits aid in determining what
`
`weight we should give to his testimony, we deny Patent Owner’s Motion to
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`Exclude with respect to Exhibits 1059 and 1064.
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`5. Exhibits 1060, 1061, and 1065
`
`Exhibits 1060, 1061, and 1065 are, respectively, an excerpt of
`
`Petitioner’s Reply to Patent Owner’s Response in IPR2013-00206, an
`
`13
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`IPR2019-00361
`Patent 8,187,334 B2
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`excerpt of an expert report regarding damagesin related litigation, and a
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`declaration by Mr. Link in support of a motion for preliminary injunctionin
`
`related litigation. Patent Owner argues that these exhibits should be
`
`excluded under Rules 106 and 401-403 of the FRE because they are “more
`
`likely to cause confusion and unreasonable prejudice than add probative
`
`value.” Mot. 5. As discussed below, Patent Owneralso argues that Exhibit
`
`1060 should be excluded under Rules 401 and 402 for other reasons. Seeid.
`
`at 8.
`
`In particular, Patent Owner argues that Exhibits 1060, 1061, and 1065
`
`are incomplete documents from other proceedings, omit other information
`
`that should be considered, andareirrelevant to this proceeding. Id. at S—6.
`
`Patent Owneralso argues that, because these exhibits are excerpts, they are
`
`confusing and fail to provide context.
`/d. at 6. For Exhibits 1061 and 1065,
`Petitioner responds that they “were offered to rebut Patent Owner’s evidence
`
`of secondary indicia of non-obviousness.” Opp. 7. For Exhibit 1060,
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`Petitioner does not provide a response. See id. at 7-8 (arguments underthe
`
`heading “Exhibits 1059-1061, 1064, and 1065”). Patent Owner doesnot
`
`provide a reply specific to these exhibits. See Mot. Reply 5.
`
`Because wedo not rely on Exhibit 1060 for our analysis, we deny as
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`moot Patent Owner’s Motion to Exclude with respect to Exhibit 1060. Also,
`
`for the reasons discussed below, we consider Exhibits 1061 and 1065 to be
`
`proper rebuttal evidence to Patent Owner’s asserted objective indicia for
`nonobviousnessand, thus, we deny Patent Owner’s Motion to Exclude with
`
`respect to Exhibits 1061 and 1065.
`
`6. Exhibits 1060 and 1062
`
`Exhibits 1060 is an excerpt of Petitioner’s Reply to Patent Owner’s
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`Response in IPR2013-00206, and Exhibit 1062 is an order regarding a
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`IPR2019-00361
`Patent 8,187,334 B2
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`motion to dismissin a related litigation. Patent Owner argues that these
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`exhibits should be excluded under Rules 401 and 402. Mot. 8. Patent
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`Ownercontendsthat the exhibits were filed with Petitioner’s Reply but were
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`not cited and are, thus, not relevant to the proceeding. Jd. Petitioner does
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`not respondto these arguments. See generally Opp.
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`Because we do notrely on Exhibits 1060 and 1062 in our analysis, we
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`deny as moot Patent Owner’s Motion to Exclude with respect to Exhibits
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`1060 and 1062.
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`B. Legal Standards
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`In an inter partes review, Petitioner bears the burden of proving
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`unpatentability of the challenged claims, and the burden of persuasion never
`shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail in its challenges,
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`Petitioner must prove unpatentability by a preponderanceof the evidence.
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`35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
`
`A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
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`between the subject matter sought to be patented and the prior art are such
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`that the subject matter as a whole would have been obviousat the time the
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`invention was madeto a person having ordinary skill in the art to which said
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`subject matter pertains. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406
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`(2007). The question of obviousnessis resolved on the basis of underlying
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`factual determinations including: (1) the scope and content ofthe priorart;
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`(2) any differences between the claimed subject matter and the priorart; (3)
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`the level of ordinary skill in the art; and (4) objective evidence of
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`nonobviousness. See Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966).
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`Asdiscussed below,the parties’ disputes are related to each of the
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`above-listed underlying factual determinations. After reviewing the
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`IPR2019-00361
`Patent 8,187,334 B2
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`complete record and for the reasons below, we conclude that Petitioner has
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`shown bya preponderanceof the evidence that claims 6—9 would have been
`
`unpatentable over Frey, Michelson, and Berry. Petitioner, however, does not
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`show by a preponderanceof the evidence that claim 18 would have been
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`unpatentable.
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`C. Level of Ordinary Skill in the Art
`
`Petitioner asserts that one of ordinary skill in the art ““would have a
`
`medical degree with twoor 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. 28-29
`
`(quoting Ex. 1002 4 18). In our Decisionto Institute, we preliminarily
`
`adopted Petitioner’s unopposed proposal. Dec. to Inst. 15.
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`Patent Ownerrespondsthat Petitioner “fails to view the art through
`
`the knowledge ofa [person of ordinary skill in the art] at the time” because,
`
`as an example, the person of ordinary skill in the art “would not be familiar
`
`with developmentsin the art that came after the relevant time, such as
`
`XLIF.”? PO Resp. 9. However, Patent Owner does not dispute Petitioner’s
`
`asserted qualifications for one of ordinary skill in the art and applies those
`
`qualifications. See Tr. 27:19-28:9. Patent Owner’s declarants also state that
`
`2 Mr. Link indicates that XLIF is an abbreviation for “eXtreme Lateral
`Interbody Fusion.” Ex. 2059 93. Patent Owner also describes XLIF is an
`“XLIF productline, including CoRoent® XL implants” and “a minimally
`invasive surgical approach to spinal fusion surgery that .
`.
`. accesses the disc
`space from the lateral aspect of the patient.” PO Resp. 66 (citing Ex. 2059
`{{ 4-8).
`
`
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`IPR2019-00361
`Patent 8,187,334 B2
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`they applied Petitioner’s asserted level of ordinary skill. See Ex. 2055
`
`q] 28-29; Ex. 2057 ¥ 14.
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`In determining the level of ordinary skill in the art, various factors
`
`maybe considered,including the “type of problems encounteredin theart;
`
`prior art solutions to those problems; rapidity with which innovationsare
`
`made; sophistication of the technology; and educationallevel of active
`
`workersin the field.” Jn re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)
`
`(citation and internal quotation marks omitted).
`
`Based onthe full record before us, we see no reason to disturb our
`
`preliminary finding regarding the level of ordinary skill in the art. Patent
`
`Ownerdoes not expressly provide its own definition of a level of ordinary
`
`skill in the art. See PO Resp. 9. Patent Owneralso applies Petitioner’s
`
`asserted qualifications for one of ordinary skill in the art. See Tr. 27:19-
`
`28:9; Ex. 2055 J] 28-29; Ex. 2057 ¢ 14.
`
`Accordingly, we maintain and reaffirm that one of ordinary skill in the
`
`art ‘““would have a medical degree with two or three years’ experience
`999
`
`performing procedures using interbody spinal fusion implants’”
`
`or “‘would
`
`have a mechanical or 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.’” Dec. to Inst. 14-15 (citing Pet. 28-29; Ex. 1002 4 18).
`
`This level of skill in the art is consistent with the disclosure of the °334
`
`patent and the prior art of record. Also, our analysis below does not hinge
`
`on whetheroneof ordinary skill in the art would have been familiar with
`
`XLIF technology or developmentsin the art that comeafter the relevant
`
`time.
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`IPR2019-00361
`Patent 8,187,334 B2
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`Dr. Branch,Petitioner’s expert, has completed residencies and a
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`fellowship in neurosurgery departments between 1985-1987, has taught
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`spinal surgery since 1987, focusing his practice and research onspinal
`
`diseases and injuries (e.g., minimally invasive lumbar interbody fusion
`
`techniques), and has obtained various patents related to spinal surgery,
`
`spinal implants, and spinal surgical instrumentation. Ex. 1002 4 5-13;
`
`Ex. 1003. Dr. Branch’s qualifications are sufficient as a person ofskill in
`
`the art for purposesof this proceeding.
`
`Dr. Youssef, Patent Owner’s expert, is an orthopedic surgeon,has
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`been a practicing spine surgeon for over two decades, including treating
`
`spinal injuries and performing spine surgery, is a memberorfellow of
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`various organizations related to surgery, orthopedics, and the spine, has
`
`written articles related to the spine, treatments, and surgery, and is a named
`
`inventor on patents related to spine implants and fixations systems.
`
`Ex. 2055 Jf 1-12. Dr. McMillin, another of Patent Owner’s experts, has a
`
`B.S. in mechanical engineering and Ph.D. in Macromolecular Science, has
`
`experience in the field of biomedical engineering beginning in 1974,
`
`including designing orthopedic products for the spine, and has served on
`
`various committees or advisory boards in the biomedicalindustry. Ex. 2057
`
`q{ 1-7; Ex. 2058. Both, Dr. Youssef’s and Dr. McMillin’s qualifications are
`
`sufficient as persons ofskill in the art for purposes of this proceeding.
`
`D. Claim Construction
`
`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.
`
`Changesto the Claim Construction Standard for Interpreting Claimsin Trial
`
`Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51340
`
`(Oct. 11, 2018) (amending 37 C.F.R. § 42.100(b) effective November13,
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`18
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`IPR2019-00361
`Patent 8,187,334 B2
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`2018) (now codified at 37 C.F.R. § 42.100(b) (2019)). This rule change
`
`applies to petitions filed on or after November 13, 2018, so the revised claim
`
`construction standard applies to this proceeding. /d.; see Pet. 26 (stating that
`
`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 21, 2018
`
`to the Petition).
`
`Petitioner states that “no express construction is needed to resolve the
`
`issues in this Petition.” Pet. 26. In our Decision to Institute, we determined
`
`that “[a]t this stage of the proceeding, analyzing whether Petitioner
`
`demonstrates a reasonable likelihood of prevailing with respectto at least
`
`one of the challenged claims only requires determining if the 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 extending generally parallel to the longitudinal length
`
`of said implant,’ as recited by claim 1” and that “[fJurther express
`
`interpretation is not required.” Dec. to Inst. 12-13.
`
`Patent Ownerproposesinterpretations for “longitudinal length,”
`
`“longitudinal aperture length,” and “medial support,” to which the parties
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`provide reply arguments. PO Resp. 4—9; Pet. Reply 5—6; PO Sur-reply 15-
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`17. For the reasons discussed below, our analysis does not depend on a
`
`particular interpretation for “longitudinal length,” “longitudinal aperture
`
`length,” and “medial support.”
`
`Accordingly, we do not need to provide express claim interpretations
`
`for any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean
`
`Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we
`
`need only construe terms ‘that are in controversy, and only to the extent
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`IPR2019-00361
`Patent 8,187,334 B2
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`necessary to resolve the controversy’”) (citing Vivid Techs., Inc. v. Am. Sci.
`
`& Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
`
`E. Ground Based on Frey, Michelson, and Berry
`
`1. The Limitations of Claim 1 Incorporated into Claims 6—9 and 18
`
`a) Petitioner’s Assertions
`
`Petitioner states that “the Board determinedthatall limitations of
`
`claim 1 ‘are taught or suggested by the combination of Frey and Michelson”
`
`and the “Federal Circuit affirmed the Board’s decision.” Pet. 32 (citing
`
`Ex. 1004, 5, 13; Ex. 1005, 17°). Petitioner argues that “Patent Owneris
`
`therefore estopped from arguing that claim 1 renders any dependentclaim
`
`patentable over Frey and Michaelsonas those references have been
`
`definitively established as rendering claim 1, among others, unpatentable.”
`
`Id.
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`b) Patent Owner’s Response
`
`Patent Owner respondsthat Petitioner appears to rely on common law
`
`collateral estoppel to argue that Patent Owneris estopped from arguing
`
`claim 1 renders a dependent claim patentable. PO Resp. 21.
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`Patent Ownerarguesthat “Petitioner has failed to satisfy its burden of
`
`showing the required elements of collateral estoppel are satisfied here and
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`effectivel
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