Trials@uspto.gov
`571-272-7822
`
`Paper 58
`Date: July 8, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ALPHATEC HOLDINGS, INC., and ALPHATEC SPINE, INC.,
`Petitioner,
`v.
`NUVASIVE, INC.,
`Patent Owner.
`
`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.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claim Unpatentable
`Denying Patent Owner’s Motion to Exclude
`35 U.S.C. § 318(a)
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 58
`Date: July 8, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ALPHATEC HOLDINGS, INC., and ALPHATEC SPINE, INC.,
`Petitioner,
`v.
`NUVASIVE, INC.,
`Patent Owner.
`
`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.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claim Unpatentable
`Denying Patent Owner’s Motion to Exclude
`35 U.S.C. § 318(a)
`
`
`
`
`
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`INTRODUCTION
`I.
`We have jurisdiction 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 claim 16 of U.S. Patent No. 8,187,334 B2 (Ex. 1001,
`“the ’334 patent”). NuVasive Inc. (“Patent Owner”) filed a Preliminary
`Response. Paper 10. Pursuant to 35 U.S.C. § 314, we instituted an inter
`partes review of the ’334 patent. Paper 17 (“Dec. to Inst.”). In particular,
`we instituted review of claim 16 on all presented challenges. Dec. to Inst. 2,
`26, 33, 35.
`After institution, Patent Owner filed a Response (Paper 27, “PO
`Resp.”), to which Petitioner filed a Reply (Paper 35, “Pet. Reply”). Patent
`Owner thereafter filed a Sur-Reply (Paper 41, “PO Sur-reply”).
`Patent Owner also 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 Owner filed a Reply (Paper 49, “Mot. Reply”).
`In an Order (Paper 38), we authorized Patent Owner to file a Supplemental
`Sur-Reply, which was filed (Paper 42) and Petitioner to file a Supplemental
`Sur-Sur-Reply, which was also filed (Paper 43). An oral hearing in this
`proceeding was held on April 3, 2020; a transcript of the hearing is included
`in the record (Paper 55, “Tr.”). See also Exs. 1066, 2062 (parties’ errata
`sheets for the transcript).
`For the reasons that follow, we determine that Petitioner has not
`shown by a preponderance of the evidence that claim 16 of the ’334 patent is
`unpatentable. We also deny Patent Owner’s Motion to Exclude.
`
`2
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`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. 70.
`“In accordance with 37 C.F.R. § 42.8(b)(1), Patent Owner identifies
`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. 70; Paper 4, 2. The parties
`also indicate that the ’334 patent is the subject of IPR2019-00361. Pet. 70;
`Paper 4, 2.
`Patent Owner additionally notes that the ’334 patent was previously
`challenged in Cases IPR2013-00507 and IPR2013-00508. Paper 4, 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
`(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
`patent, U.S. Patent No. 8,361,156 B2, is challenged in IPR2019-00362.
`Pet. 70; Paper 4, 2.
`D. 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 claims priority to a provisional application filed on March 29, 2004.
`Ex. 1001, codes (22), (45), (60), (63), 1:7–13.
`The ’334 patent particularly relates to “a system and method for spinal
`fusion comprising a spinal fusion implant of non-bone construction . . . to
`
`3
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`introduce the spinal fusion implant into any of a variety of spinal target
`sites.” Id. at 1:18–21. Figure 2 of the ’334 patent is reproduced below.
`
`
`
`Figure 2 shows a perspective view of a lumbar fusion implant. Id. at 3:36.
`The spinal fusion implant is introduced into the disc space via a lateral
`approach to 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). Id. at 5:10–15, 5:29–33.
`Common attributes of the various embodiments of spinal fusion
`implant 10 includes top surface 31, bottom surface 33, lateral sides 14,
`proximal side 22, and distal side 16. Id. 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, and a length ranging between 25 and 45
`mm.” Id. at 5:15–19.
`
`4
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`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. Id. at 6:21–32, Figs. 2–3. Spike elements 7–9
`are preferably made from materials having radiopaque characteristics. Id. 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. Id. at
`6:57–59, Figs. 2–3. “[F]usion apertures 2 function primarily as an avenue
`for bony fusion between adjacent vertebrae.” Id. at 6:59–61.
`E. Sole Challenged Claim
`The ’334 patent has 28 claims, 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.
`1. A spinal fusion implant of non-bone construction
`positionable within an interbody space between a first vertebra
`and a second vertebra, said implant comprising:
`an upper surface including anti-migration elements to
`contact said first vertebra when said implant is positioned within
`the interbody space, a lower surface including anti-migration
`elements to contact said second vertebra when said implant is
`positioned within the interbody space, a distal wall, a proximal
`wall, a first sidewall and a second sidewall, 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 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
`
`5
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`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 through said upper
`surface and lower surface and configured to permit bone growth
`between the first vertebra and the second vertebra when said
`implant is positioned within the interbody space, said first fusion
`aperture having: a longitudinal aperture length extending
`generally parallel to the longitudinal length of said implant, and
`a lateral aperture width extending between said first sidewall to
`said second sidewall, wherein the longitudinal aperture length is
`greater than the lateral aperture width; and
`at least three radiopaque markers; wherein a first of the at
`least three radiopaque markers is 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.
`
`16. The spinal fusion implant of claim 1, further
`comprising a fourth radiopaque marker situated within said
`implant, said fourth radiopaque marker positioned in said central
`region at a position spaced apart from said third radiopaque
`marker.
`
`Ex. 1001, 12:32–13:4, 13:51–14:3.
`F. Asserted Prior Art and Proffered Testimonial Evidence
`Petitioner identifies the following references as 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”);
`
`6
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`(3) U.S. Patent Application Publication No. US 2002/0165550 A1,
`published November 7, 2002 (Ex. 1040, “Frey”);
`(4) U.S. Patent Application Publication No. US 2003/0028249 A1,
`published February 6, 2003 (Ex. 1008, “Baccelli”); and
`(5) James L. Berry et al., A Morphometric Study of Human 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. 22, 26–70. Patent Owner
`proffers a Declaration of Jim A. Youssef, M.D. (Ex. 2055), Declaration of
`Carl R. McMillan, Ph.D. (Ex. 2057), and Declaration of Matthew Link
`(Ex. 2059). Deposition transcripts for Dr. Branch (Ex. 2022), Dr. Youssef
`(Ex. 1050), Dr. McMillan (Ex. 1051), and Mr. Link (Ex. 1052) were filed.
`G. Asserted Grounds
`Petitioner asserts that claim 16 would have been unpatentable on the
`following grounds:
`Claim Challenged
`16
`16
`
`References/Basis
`Frey, Michelson, Baccelli
`Brantigan, Baccelli, Berry,
`Michelson
`
`35 U.S.C. §1
`103
`103
`
`Pet. 22, 26–70.
`
`
`
`1 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.
`
`7
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`
`II. ANALYSIS
`A. Patent Owner’s Motion to Exclude
`Patent Owner moves to exclude Exhibits 1041, 1042, 1053–1056,
`1059–1062, 1064, and 1065. Mot. 1, 5–8 (discussing Ex. 1064 along with
`other exhibits). Patent Owner indicates that objections to these exhibits
`were previously filed. Id. at 1 (citing Papers 23, 36). Patent Owner, as the
`“moving party,” “has the burden of proof to establish that it is entitled to the
`requested relief.” 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 excluded as irrelevant under Rules 401 and 402
`of Federal Rules of Evidence (“FRE”). Mot. 2.
`Patent Owner contends that “Petitioner relies on these exhibits solely
`to support the assertion that it is presenting a materially different theory
`compared to what was presented in these earlier proceedings.” Id. at 1
`(citing Pet. 25–26). Patent Owner agrees that a different theory has been
`presented and argues that the agreement “should be considered a stipulated
`fact,” so that Exhibits 1041 and 1042 should be excluded. Id. 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 Owner replies that Petitioner’s
`assertions undermines its collateral estoppel arguments and states that “[t]o
`the extent the materially different nature of Petitioner’s current Petition and
`the prior IPRs is deemed an admission of fact, these exhibits should be
`excluded.” Mot. Reply 1.
`
`8
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`Patent Owner’s basis for moving to exclude Exhibits 1041 and 1042 is
`that they support Petitioner’s contention, and Patent Owner agrees with that
`contention. The mere fact that an exhibit supports the parties’ agreement
`does not demonstrate a reason to exclude it from the record.
`Accordingly, we deny Patent Owner’s Motion to Exclude with respect
`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.
`McAfee et al., from pages 1476–1484 of volume 23, number 13 of Spine,
`published in 1998. Patent Owner argues that these exhibits should be
`excluded under Rules 401–403 as irrelevant to a ground of review, likely to
`cause confusion, and prejudicial. Mot. 2–5.
`In particular, Patent Owner contends that “Petitioner cites these
`exhibits in support of a prima facie case of obviousness raised for the first
`time in Petitioner’s Reply” and to fill a gap identified in the Patent Owner
`Response. Id. at 2–4 (citing Pet. 4–5, 30, 45, 47–48; PO Resp. 20–23; Pet.
`Reply 10). Petitioner responds that Exhibits 1053 and 1054 are proper
`rebuttal evidence. Opp. 2. Petitioner also identifies which of Patent
`Owner’s arguments that the exhibits rebut and how they respond to those
`arguments. Id. at 2–4 (citing PO Resp. 9, 30; Pet. Reply 2–4, 10, 15–16).
`Patent Owner replies that “Petitioner does not contest that it could have
`presented them with the Petition” and “concedes that it is improper in reply
`to rely on a new rationale to combine the prior art references.” Mot.
`Reply 2. Patent Owner reiterates its arguments that Exhibits 1053 and 1054
`support a new rationale for combining the references. Id. at 2–4 (citing
`
`9
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`Pet. 4–5, 31–32, 41–42; Opp. 3–4). Patent Owner also argues that these
`exhibits fail to support the theory presented in the Petition. Id. at 4 (citing
`Pet. 30; 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 been filed as a motion to 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 proper
`rebuttal argument, we deny Patent Owner’s Motion to Exclude with respect
`to Exhibits 1053 and 1054.
`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. Patent Owner argues that Exhibit 1055 should be
`excluded under Rules 401–403 because it is cited in Petitioner’s Reply with
`no substantive discussion and no explanation of its significance. Mot. 5.
`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 Owner argues that Exhibit 1056 should be excluded
`under Rules 106 and 401–403 because it is “more likely to cause confusion
`and unreasonable prejudice than add probative value.” Mot. 5. Specifically,
`Patent Owner argues that Exhibit 1056 is an incomplete document from
`another proceeding, omits other information that should be considered, and
`is irrelevant to this proceeding. Id. at 5–6. Patent Owner also argues that,
`
`10
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`because Exhibit 1056 is an excerpt, it is confusing and fails to provide
`context. Id. at 6.
`Petitioner responds that Exhibits 1055 and 1056 were offered to rebut
`Dr. Youssef’s testimony. Opp. 6. Petitioner argues that the exhibits are,
`thus, relevant and their relevance outweighs any risk of confusion. Id.
`Petitioner also contends that Patent Owner relied on Exhibit 1055 in
`previous litigation and relies on exhibits from the same litigation to support
`arguments in this proceeding. Id. (citing Ex. 2029; Ex. 2030; Ex. 2060, 27–
`29, 51).
`Patent Owner replies that Petitioner “improperly attempt[s] to back-
`fill arguments regarding Exhibit 1055” and the arguments are “belated and
`non-responsive.” Mot. Reply 5 (citing Opp. 6). Patent Owner also replies
`that “Petitioner approved of NuVasive’s filing of EX2060 as a complete
`version of the transcript Petitioner filed as EX1056” and “fails to establish
`the admissibility of its exhibits.” Id. (citing Mot. 5–8; Opp. 6).
`Petitioner cites Exhibits 1055 and 1056 in its Reply in support of its
`argument that Dr. Youssef was unaware of Patent Owner’s reliance on
`Brantigan. Pet. Reply 4–5. Some of Patent Owner’s arguments are again
`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 Owner that the explanation of its significance is insufficient or
`that these exhibits are irrelevant. The exhibits at issue are properly
`presented as rebuttal evidence to aid in determining what weight we should
`afford to 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 not
`
`11
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`affect the credence we give to Dr. Youssef’s opinion of the asserted
`reference.
`Accordingly, Patent Owner has not satisfied 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.
`Youssef in related litigation, and Exhibit 1064 is open payments data for Dr.
`Youssef. Patent Owner argues that these exhibits should be excluded under
`Rules 106 and 401–403 because they are “more likely to cause confusion
`and unreasonable prejudice than add probative value.” Mot. 5.
`In particular, Patent Owner argues that Exhibit 1059 is an incomplete
`document from another proceedings, omits other information that should be
`considered, and is irrelevant to this proceeding. Id. 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 beyond this
`proceeding and the partial record is confusing, provides minimal context,
`and likely to cause undue prejudice. Id. at 6, 8; see also id. at 6–7 (arguing
`that Dr. Branch has also provided consulting services). Petitioner responds
`that they were offered “to demonstrate the bias associated with Dr.
`Youssef’s opinions.” Opp. 7–8. Petitioner also describes Dr. Branch’s
`consulting arrangement with Medtronic and other companies. Id. at 8.
`Patent Owner replies that “Petitioner’s use of [Exhibit 1064] is
`misleading and incomplete because Dr. Branch testified during his
`deposition in the district court case that he was paid several million dollars
`as a consultant for Medtronic and that this range of compensation reflected
`fair market value” and that “Petitioner does not contest the authenticity or
`
`12
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`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.
`Dr. Youssef’s testimony (Ex. 1059) and open payments data
`(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
`Exclude with respect to Exhibits 1059 and 1064.
`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
`excerpt of an expert report regarding damages in related litigation, and a
`declaration by Mr. Link in support of a motion for preliminary injunction in
`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 Owner also argues that Exhibit
`1060 should be excluded under Rules 401 and 402 for other reasons. See id.
`at 8.
`
`In particular, Patent Owner argues that Exhibits 1060, 1061, and 1065
`are incomplete documents from other proceedings, omits other information
`that should be considered, and are irrelevant to this proceeding. Id. at 5–6.
`Patent Owner also argues that, because these exhibits are excerpts, they are
`confusing and fail to provide context. Id. 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,
`Petitioner does not provide a response. See id. at 7–8 (arguments under the
`
`13
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`heading “Exhibits 1059–1061, 1064–1065”). Patent Owner does not provide
`a reply specific to these exhibits. See Mot. Reply 5.
`Because we do not rely on Exhibit 1060, we deny as moot Patent
`Owner’s Motion to Exclude with respect to Exhibit 1060. For the reasons
`discussed below, we do not reach Patent Owner’s asserted objective indicia
`for nonobviousness and do not consider evidence thereof. Therefore, we
`deny as moot 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
`Response in IPR2013-00206, and Exhibit 1062 is an order regarding a
`motion to dismiss counts in related litigation. Patent Owner argues that
`these exhibits should be excluded under Rules 401 and 402. Mot. 8. Patent
`Owner contends that the exhibits were filed with Petitioner’s Reply but were
`not cited and are, thus, not relevant to the proceeding. Id. Petitioner does
`not respond to these arguments. See generally Opp.
`Because we do not rely on Exhibits 1060 and 1062 in our analysis, we
`deny as moot Patent Owner’s Motion to Exclude with respect to Exhibits
`1060 and 1062.
`B. Legal Standards
`In an inter partes review, Petitioner bears the burden of proving
`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,
`Petitioner must prove unpatentability by a preponderance of the evidence.
`35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
`
`14
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
`between the subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art; (3)
`the level of ordinary skill in the art; and (4) objective evidence of
`nonobviousness. See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`As discussed below, the parties’ disputes are related to each of the
`above-listed underlying factual determinations. After reviewing the
`complete record, we conclude that Petitioner has not shown by a
`preponderance of the evidence that one of ordinary skill in the art would
`have combined the asserted references in the manner asserted by Petitioner.
`C. 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 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.” Pet. 28
`(quoting Ex. 1002 ¶ 18). In our Decision to Institute, we preliminarily
`adopted Petitioner’s unopposed proposal. Dec. to Inst. 13.
`Patent Owner responds that Petitioner “fails to view the art through
`the knowledge of a [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
`
`15
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`with developments in the art that came after the relevant time, such as
`XLIF.” 2 PO Resp. 9 (citing Ex. 2055 ¶¶ 28–29). 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.
`In determining the level of ordinary skill in the art, various factors
`may be considered, including the “type of problems encountered in the art;
`prior art solutions to those problems; rapidity with which innovations are
`made; sophistication of the technology; and educational level of active
`workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)
`(citation and internal quotation marks omitted).
`Based on the full record before us, we see no reason to disturb our
`preliminary finding regarding the level of ordinary skill in the art. Patent
`Owner does not expressly provide its own definition of a level of ordinary
`skill in the art. See PO Resp. 9. Patent Owner also applies Petitioner’s
`asserted qualifications for one of ordinary skill in the art. See Tr. 27:19–
`28:9. Accordingly, we maintain and reaffirm 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 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. 13 (citing Pet. 28; Ex. 1002 ¶ 18). This level
`
`2 Mr. Link indicates that XLIF is an abbreviation for “eXtreme Lateral
`Interbody Fusion.” Ex. 2059 ¶ 3. Patent Owner also describes XLIF is an
`“XLIF product line, 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).
`
`16
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`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 whether one
`of ordinary skill in the art would have been familiar with XLIF technology
`or developments in the art that come after the relevant time.
`Dr. Branch, Petitioner’s expert, has completed residencies and a
`fellowship in neurosurgery departments between 1985–1987, has taught
`spinal surgery since 1987, focusing his practice and research on spinal
`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 ¶¶ 5–13;
`Ex. 1003. Dr. Branch’s qualifications are sufficient as a person of skill in
`the art for purposes of this proceeding.
`Dr. Youssef, Patent Owner’s expert, is an orthopedic surgeon, has
`been a practicing spine surgeon for over two decades, including treating
`spinal injuries and performing spine surgery, is a member or fellow of
`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 ¶¶ 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 biomedical industry. Ex. 2057
`¶¶ 1–7; Ex. 2058. Both, Dr. Branch’s and Dr. McMillin’s qualifications are
`sufficient as persons of skill in the art for purposes of this proceeding.
`
`17
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`D. 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.
`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) (amending 37 C.F.R. § 42.100(b) effective November 13,
`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. Id.; 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. In our Decision to Institute, we stated that
`“[w]e interpret ‘longitudinal length’ and ‘longitudinal aperture length’
`consistent with the claim language, and further express interpretation is not
`required for purposes of this Decision.” Dec. to Inst. 12. We also
`determined that no express interpretation of any claim term was required at
`that stage of the proceeding. Id. at 12–13.
`Patent Owner proposes interpretations for “longitudinal length,”
`“longitudinal aperture length,” and “central region.” PO Resp. 4–8. For the
`reasons discussed below, a preponderance of the evidence does not persuade
`us that one of ordinary skill in the art would have made Petitioner’s
`proposed combination of Frey, Michelson, and Baccelli or Brantigan,
`Baccelli, Berry, and Michelson. Our determination does not depend on a
`particular interpretation for “longitudinal length,” “longitudinal aperture
`length,” and “central region.”
`
`18
`
`
`
`IPR2019-00546
`Patent 8,187,334 B2
`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
`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 Baccelli
`Petitioner argues that Frey and Michelson were previously determined
`to teach or suggest all the limitations of claim 1 and that Baccelli teaches or
`suggests the further limitations recited by dependent claim 16. Pet. 31, 32–
`38. Petitioner also argues that one of ordinary skill in the art would have
`been motivated to combine Frey as modified by Michelson with the further
`teachings of Baccelli. Id. at 29, 38.
`Patent Owner responds the asserted references do not teach all the
`limitations of claims 1 and 16, Petitioner fails to provide a motivation to
`combine the references, and Petitioner fails to show collateral estoppel
`should be applied to the limitations of claim 1 incorporated in claim 16 by
`dependency. PO Resp. 19–25, 27–31, 34–55. Patent Owner also presents
`objective indicia of non-obviousness. Id. at 55–59.
`For the reasons below, Petitioner does not persuade us by a
`prepon
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
