Case 3:18-cv-00347-CAB-MDD Document 307-9 Filed 02/16/21 PageID.29796 Page 1 of 78
`
`EXHIBIT 8
`
`TO THE DECLARATION OF BRIAN J.
`NISBET IN SUPPORT OF DEFENDANTS’
`OPPOSITION TO NUVASIVE’S MOTION
`FOR PARTIAL SUMMARY JUDGMENT
`AND MOTION TO EXCLUDE
`
`

`

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`Case: 20-2245 Document: 17 Page: 1 Filed: 02/08/2021
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`
`
`Nos. 2020-2245, -2269, -2246, -2247
`United States Court of Appeals
`for the Federal Circuit
`____________________
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE, INC.,
`Appellants
`
`
`v.
`
`NUVASIVE, INC,
`Cross-Appellant
`____________________
`
`Appeals from the United States Patent and Trademark Office
`Patent Trial and Appeal Board, IPR2019-00361, -00362, -00546
`____________________
`
`APPELLANTS’ PRINCIPAL BRIEF
`____________________
`
`
`
`BRIAN J. NISBET
`Winston & Strawn LLP
`35 West Wacker Drive
`Chicago, IL 60601
`(312) 558-5700
`bnisbet@winston.com
`
`EIMERIC REIG-PLESSIS
`Winston & Strawn LLP
`101 California Street
`San Francisco, CA 94111
`(415) 591-1000
`ereigplessis@winston.com
`
`NIMALKA WICKRAMASEKERA
`DAVID P. DALKE
`Winston & Strawn LLP
`333 South Grand Avenue
`38th Floor
`Los Angeles, CA 90071
`(213) 615-1700
`nwickramasekera@winston.com
`ddalke@winston.com
`
`Counsel for Appellants
`Alphatec Holdings, Inc.
`and Alphatec Spine, Inc.
`
`
`
`
`
`
`
`EXHIBIT 8 - PAGE 145
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`

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`CERTIFICATE OF INTEREST
`
`Counsel for Appellants certify that the following information is accurate and
`
`complete to the best of counsel’s knowledge:
`
`1. Represented Entities.
`Fed. Cir. R. 47.4(a)(1).
`
`2. Real Party
`in Interest.
`Fed. Cir. R. 47.4(a)(2).
`
`3. Parent Corporations
`and Stockholders.
`Fed. Cir. R. 47.4(a)(3).
`
`Provide the full names of
`all entities represented by
`undersigned counsel in
`this case.
`
`Provide the full names of
`all real parties in interest
`for the entities. Do not
`list the real parties if they
`are the same as the
`entities.
`
`Provide the full names of
`all parent corporations for
`the entities and all
`publicly held companies
`that own 10% or more
`stock in the entities.
`
`Alphatec Holdings, Inc.
`
`None/Not Applicable
`
`None/Not Applicable
`
`Alphatec Spine, Inc.
`
`None/Not Applicable
`
`Alphatec Holdings, Inc.
`
`
`4. Legal Representatives. List all law firms, partners, and associates that (a)
`appeared for the entities in the originating court or agency or (b) are
`expected to appear in this court for the entities. Do not include those who
`have already entered an appearance in this court. Fed. Cir. R. 47.4(a)(4).
`
`
`
`Winston & Strawn LLP: Jovial Wong
`
`
`5. Related Cases. Provide the case titles and numbers of any case known to be
`pending in this court or any other court or agency that will directly affect or
`be directly affected by this court’s decision in the pending appeal. Do not
`include the originating case number(s) for this case. Fed. Cir. R. 47.4(a)(5).
`See also Fed. Cir. R. 47.5(b).
`
`
`
`NuVasive, Inc. v. Alphatec Holdings, Inc.,
`No. 3:18-cv-00347-CAB-MDD (S.D. Cal.)
`
`
`6. Organizational Victims and Bankruptcy Cases. Provide any information
`required under Fed. R. App. P. 26.1(b) (organizational victims in criminal
`
`i
`
`EXHIBIT 8 - PAGE 146
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`

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`cases) and 26.1(c) (bankruptcy case debtors and trustees). Fed. Cir. R.
`47.4(a)(6).
`
`None/Not Applicable
`
`
`
`
`
`
`February 8, 2021
`
`
`
`
`/s/ Nimalka Wickramasekera
`NIMALKA WICKRAMASEKERA
`Lead Counsel for Appellants
`
`ii
`
`EXHIBIT 8 - PAGE 147
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`

`

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`
`
`TABLE OF CONTENTS
`
`B.
`
`Page
`TABLE OF AUTHORITIES ..................................................................................... v
`GLOSSARY OF ABBREVIATIONS ..................................................................... ix
`STATEMENT OF RELATED CASES ..................................................................... x
`INTRODUCTION ..................................................................................................... 1
`JURISDICTIONAL STATEMENT .......................................................................... 5
`STATEMENT OF ISSUES ....................................................................................... 5
`STATEMENT OF THE CASE .................................................................................. 6
`A.
`The challenged ’334 and ’156 patents .................................................. 6
`1.
`The issued specification .............................................................. 6
`2.
`The challenged claims ................................................................. 8
`Prior-art references .............................................................................. 10
`1.
`Frey ........................................................................................... 10
`2. Michelson .................................................................................. 11
`3.
`Berry .......................................................................................... 13
`4.
`Brantigan ................................................................................... 14
`5.
`Baccelli ...................................................................................... 15
`This Court’s previous decisions .......................................................... 16
`1.
`NuVasive I (’334 patent) ........................................................... 16
`2.
`NuVasive II (’156 patent) .......................................................... 18
`Proceedings below before the Board ................................................... 19
`1.
`IPR2019-00361 (’334 patent claims 6-9, 18) ........................... 19
`
`C.
`
`D.
`
`
`
`iii
`
`EXHIBIT 8 - PAGE 148
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`

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`
`TABLE OF CONTENTS (continued)
`
`
`Page
`
`
`2.
`IPR2019-00362 (’156 patent) ................................................... 24
`IPR2019-00546 (’334 patent claim 16) .................................... 29
`3.
`SUMMARY OF ARGUMENT ............................................................................... 32
`STANDARD OF REVIEW ..................................................................................... 35
`ARGUMENT ........................................................................................................... 36
`I.
`The decision upholding claim 18 of the ’334 patent should be reversed. ..... 36
`A.
`Based on this Court’s decision in NuVasive I, NuVasive is
`collaterally estopped from disputing Frey and Michelson render
`elements of claim 1 of the ’334 patent obvious. ................................. 37
`In holding the prior art did not disclose the long-and-narrow
`implant of claim 1, the Board contradicted its own analysis on
`collateral estoppel and this Court’s binding decision. ........................ 39
`The Board’s inconsistent approach to collateral estoppel between
`different dependent claims is arbitrary and capricious. ...................... 41
`To the extent the Board addressed claim 18’s additional
`limitation at all, its decision lacks any reasoned basis. ....................... 42
`The decision upholding the ’156 patent should be reversed. ........................ 45
`A.
`The Board legally erred in construing “longitudinal length.” ............. 46
`B.
`The Board legally erred in requiring both Brantigan and Baccelli
`to meet the claimed dimensional limitation. ....................................... 54
`The Board legally erred by requiring an explicit motivation to
`combine and refusing to consider common knowledge. ..................... 56
`III. The decision upholding claim 16 of the ’334 patent should be reversed. ..... 61
`CONCLUSION ........................................................................................................ 66
`
`D.
`
`B.
`
`C.
`
`II.
`
`C.
`
`iv
`
`EXHIBIT 8 - PAGE 149
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`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Allergan, Inc. v. Apotex Inc.,
`754 F.3d 952 (Fed. Cir. 2014) ............................................................................ 66
`Alza Corp. v. Mylan Labs., Inc.,
`464 F.3d 1286 (Fed. Cir. 2006) .......................................................................... 57
`Arendi S.A.R.L. v. Apple Inc.,
`832 F.3d 1355 (Fed. Cir. 2016) .................................................................... 59, 61
`Arista Networks, Inc. v. Cisco Sys., Inc.,
`726 F. App’x 787 (Fed. Cir. 2018) ..................................................................... 45
`B/E Aerospace, Inc. v. C&D Zodiac, Inc.,
`962 F.3d 1373 (Fed. Cir. 2020) .......................................................................... 58
`Banner Eng’g Corp. v. Tri-Tronics Co.,
`29 U.S.P.Q.2d 1389 (Fed. Cir. 1993) ........................................................... 54, 55
`BASF Corp. v. Enthone, Inc.,
`749 F. App’x 978 (Fed. Cir. 2018) ............................................................... 42, 45
`Bicon, Inc. v. Straumann Co.,
`441 F.3d 945 (Fed. Cir. 2006) ............................................................................ 50
`Celgene Corp. v. Peter,
`931 F.3d 1342 (Fed. Cir. 2019) .......................................................................... 64
`
`DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick
`Co.,
`464 F.3d 1356 (Fed. Cir. 2006) ........................................................ 34, 56, 57, 58
`Emerson Elec. Co. v. SIPCO, LLC,
`745 F. App’x 369 (Fed. Cir. 2018) ............................................................... 42, 45
`Exxon Chem. Patents, Inc. v. Lubrizol Corp.,
`64 F.3d 1553 (Fed. Cir. 1995) ............................................................................ 50
`
`
`
`v
`
`EXHIBIT 8 - PAGE 150
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`

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`
`
`TABLE OF AUTHORITIES (continued)
`
`
`Page(s)
`
`
`
`In re Freeman,
`30 F.3d 1459 (Fed. Cir. 1994) ...................................................................... 37, 38
`In re Fulton,
`391 F.3d 1195 (Fed. Cir. 2004) .......................................................................... 64
`Google Inc. v. Intellectual Ventures II LLC,
`701 F. App’x 946 (Fed. Cir. 2017) ..................................................................... 45
`In re Gurley,
`27 F.3d 551 (Fed. Cir. 1994) .......................................................................... 4, 65
`Idemitsu Kosan Co. v. SFC Co.,
`870 F.3d 1376 (Fed. Cir. 2017) .......................................................................... 65
`Koninklijke Philips N.V. v. Google LLC,
`948 F.3d 1330 (Fed. Cir. 2020) .................................................................... 57, 58
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ................................................................................ 57, 61, 62
`MaxLinear, Inc. v. CF CRESPE LLC,
`880 F.3d 1373 (Fed. Cir. 2018) .......................................................... 1, 37, 39, 40
`Medichem, S.A. v. Rolabo, S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) .......................................................................... 65
`In re Merck & Co., Inc.,
`800 F.2d 1091 (Fed. Cir. 1986) .......................................................................... 55
`Merck & Co. v. Biocraft Labs., Inc.,
`874 F.2d 804 (Fed. Cir. 1989) ............................................................................ 55
`Merck Sharp & Dohme Corp. v. Wyeth LLC,
`792 F. App’x 813 (Fed. Cir. 2019) ............................................................... 33, 45
`Motorola, Inc. v. Interdigital Tech. Corp.,
`121 F.3d 1461 (Fed. Cir. 1997) .................................................................... 57, 58
`
`vi
`
`EXHIBIT 8 - PAGE 151
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`

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`Case: 20-2245 Document: 17 Page: 8 Filed: 02/08/2021
`
`
`TABLE OF AUTHORITIES (continued)
`
`
`Page(s)
`
`
`
`In re Mouttet,
`686 F.3d 1322 (Fed. Cir. 2012) .......................................................................... 47
`Nestle USA, Inc. v. Steuben Foods, Inc.,
`884 F.3d 1350 (Fed. Cir. 2018) .......................................................................... 40
`In re NuVasive, Inc.,
`841 F.3d 966 (Fed. Cir. 2016) (“NuVasive I”) ............................................passim
`In re NuVasive, Inc.,
`842 F.3d 1376 (Fed. Cir. 2016) (“NuVasive II”) .........................................passim
`Ohio Willow Wood Co. v. Alps S., LLC,
`735 F.3d 1333 (Fed. Cir. 2013) .............................................................. 36, 39, 40
`Outdry Techs. Corp. v. Geox S.p.A.,
`859 F.3d 1364 (Fed. Cir. 2017) .......................................................................... 58
`PAR Pharm., Inc. v. TWI Pharm., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) .................................................................... 35, 65
`Polygroup Ltd. MCO v. Willis Elec. Co.,
`758 F. App’x 943 (Fed. Cir. 2019) ..................................................................... 54
`Ruiz v. A.B. Chance Co.,
`357 F.3d 1270 (Fed. Cir. 2004) .......................................................................... 56
`SIBIA Neurosciences, Inc. v. Cadus Pharm. Corp.,
`225 F.3d 1349 (Fed. Cir. 2000) .......................................................................... 55
`Soverain Software LLC v. Victoria’s Secret Direct Brand Mgmt., LLC,
`778 F.3d 1311 (Fed. Cir. 2015) .......................................................................... 35
`Uber Techs., Inc. v. X One, Inc.,
`957 F.3d 1334 (Fed. Cir. 2020) ........................................................ 35, 55, 63, 64
`Vicor Corp. v. SynQor, Inc.,
`869 F.3d 1309 (Fed. Cir. 2017) .............................................................. 33, 41, 42
`
`vii
`
`EXHIBIT 8 - PAGE 152
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`

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`
`TABLE OF AUTHORITIES (continued)
`
`
`Page(s)
`
`
`
`In re Warsaw Orthopedic, Inc.,
`832 F.3d 1327 (Fed. Cir. 2016) .......................................................................... 53
`Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc.,
`853 F.3d 1272 (Fed. Cir. 2017) .......................................................................... 36
`Statutes
`28 U.S.C. §1295(a)(4)(A) .......................................................................................... 5
`35 U.S.C. §§142, 319 ................................................................................................. 5
`35 U.S.C. §§311-319.................................................................................................. 5
`Other Authorities
`37 C.F.R. §90.3(a)(1) ................................................................................................. 5
`
`
`viii
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` 2 0 - 2 2 4 5
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`
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` D o c u m e n t
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`:
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` 1 7
`
`
`
`
`
`C a s e :
`
`
`
`Berry
`
`GLOSSARY OF ABBREVIATIONS
`U.S. Patent No. 8,361,156 (Appx7490-7519)
`’156 patent
`U.S. Patent No. 8,187,334 (Appx1253-1286)
`’334 patent
`Appellants Alphatec Holdings, Inc. and Alphatec Spine, Inc.
`Alphatec
`anterior-to-posterior
`A-P
`Board (or PTAB) Patent Trial and Appeal Board
`Baccelli
`U.S. Patent Application Publication No. US 2003/0028249 A1
`(Appx1488-1495)
`James L. Berry et al., A Morphometric Study of Human Lumbar
`and Selected Thoracic Vertebrae, 12 Spine 362-67 (1987)
`(Appx3498-3503)
`U.S. Patent No. 5,192,327 (Appx1478-1487)
`U.S. Patent Application Publication No. US 2002/0165550 A1
`(Appx4662-4731)
`inter partes review
`U.S. Patent No. 5,860,973 (Appx4308-4324)
`Cross-Appellant NuVasive, Inc.
`poly-ether-ether-ketone
`person having ordinary skill in the art
`U.S. Patent and Trademark Office
`NuVasive’s expert declarant, Jim A. Youssef, M.D.
`
`
`
`Brantigan
`Frey
`
`IPR
`Michelson
`NuVasive
`PEEK
`PHOSITA
`PTO
`Youssef
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ix
`
`EXHIBIT 8 - PAGE 154
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`STATEMENT OF RELATED CASES
`Pursuant to Circuit Rule 47.5, Appellants state as follows:
`
`(a) No previous appeal has been taken in this action.
`
`(b) The patents at issue in these consolidated appeals are currently being
`
`asserted and litigated by the parties in NuVasive, Inc. v. Alphatec Holdings, Inc.,
`
`No. 3:18-cv-00347-CAB-MDD (S.D. Cal.).
`
`As discussed further below, both patents at issue in these appeals were pre-
`
`viously subject to inter partes review proceedings that were appealed to this Court
`
`in In re NuVasive, Inc., 841 F.3d 966 (Fed. Cir. 2016) (“NuVasive I”) and In re
`
`NuVasive, Inc., 842 F.3d 1376 (Fed. Cir. 2016) (“NuVasive II”).
`
`x
`
`EXHIBIT 8 - PAGE 155
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`INTRODUCTION
`This appeal arises from three inter partes reviews involving NuVasive’s
`
`’334 and ’156 patents—two related patents this Court has previously considered
`
`that claim conventional spinal-fusion implants. The only purported differences be-
`
`tween the claims and the prior art are the implants’ width and their precise ar-
`
`rangement of radiopaque markers—well-known features that help surgeons locate
`
`implants on X-rays. The Board found these trivial differences patentable only by
`
`committing legal errors in all three proceedings.
`
`IPR2019-00361 involves claims 6-9 and 18 of the ’334 patent. These claims
`
`depend from claim 1—the sole independent claim—which this Court invalidated in
`
`NuVasive I, 841 F.3d 966. Among other elements, claim 1 required an implant that
`
`is “long and narrow”—shorthand for “a longitudinal length greater than 40 mm”
`
`and “at least two and [a] half times greater than [its] maximum lateral width.” Id.
`
`at 968. In holding claim 1 obvious, this Court found the prior art “disclosed an
`
`implant having both the length and width characteristics at issue.” Id. at 973.
`
`Because the challenged claims here depend from claim 1, which this Court
`
`“held to be unpatentable,” the holding that long-and-narrow implants were known
`
`is “binding in this proceeding, as a matter of collateral estoppel.” MaxLinear, Inc.
`
`v. CF CRESPE LLC, 880 F.3d 1373, 1374-76 (Fed. Cir. 2018). Thus, as the Board
`
`acknowledged, NuVasive is “precluded from relitigating … the limitations of
`
`
`
`
`
`
`
`
`
`
`
`
`
` 1
`
`EXHIBIT 8 - PAGE 156
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`claim 1, … including for purposes of determining the patentability of dependent
`
`claims.” Appx27. For claims 6-9, the Board applied collateral estoppel consistent-
`
`ly with that holding, addressing only the “additionally recited limitations” of these
`
`dependent claims and finding each one obvious. Appx28, Appx34-45.
`
`The Board, however, deviated from its own holding for claim 18. Instead of
`
`analyzing this claim’s “additionally recited limitation”—“wherein said maximum
`
`lateral width of said implant is approximately 18 mm” (Appx45)—the Board ana-
`
`lyzed the “long and narrow” limitation of claim 1. Appx63. Worse, in relitigating
`
`the issue on which it held collateral estoppel applies, the Board held the exact op-
`
`posite of this Court’s holding in NuVasive I—concluding the same prior art “does
`
`not support Petitioner’s proposed modification to make [an] implant long and nar-
`
`row.” Appx62-63. Because the Board failed to properly apply collateral estoppel,
`
`it did not assess whether claim 18’s additional limitation requiring a width of “ap-
`
`proximately 18 mm” would have been obvious. These and other errors require re-
`
`versal, or at least vacatur. Infra 36-45.
`
`IPR2019-00362 involves 19 claims of the ’156 patent, with claim 1 as the
`
`sole independent claim. This Court vacated a decision invalidating these claims on
`
`procedural grounds in NuVasive II, without reaching the merits of patentability.
`
`842 F.3d at 1385. Alphatec challenges these claims over a new prior-art combina-
`
`tion that neither the Board nor this Court previously considered.
`
`2
`
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`The Board found these claims nonobvious based on a single limitation in
`
`claim 1 requiring “first and second radiopaque markers” at either “sidewall” of the
`
`implant “proximate to [the] medial plane” (Appx118), which the claims define as
`
`the dimension “perpendicular to [the] longitudinal length” (Appx7518). Alphatec
`
`cited a prior-art implant with first and second radiopaque markers in the middle of
`
`each sidewall—the only question was whether they lie along the “medial plane.”
`
`The Board held they do not, based on claim construction. Appx128-130 &
`
`n.23. It construed “longitudinal length” as “an object’s longer dimension” “greater
`
`than [its] maximum lateral width.” Appx100. Based on that construction, the
`
`Board decided “the longitudinal length of [the prior-art] implant ‘is measured
`
`sidewall to sidewall,’” such that the markers lie across its length instead of the
`
`“medial plane.” Appx123. That construction, however, contradicts the claims’
`
`plain language, which defines “longitudinal length [as] extending from … [the im-
`
`plant’s] proximal wall to … [its] distal wall.” Appx7518. Moreover, the claims
`
`define the distance from the “first sidewall to [the] second sidewall” as the “maxi-
`
`mum lateral width”—not the length. Id. Under the claims’ plain language, there is
`
`no dispute the prior-art implant’s length extends insertion-to-trailing-end from its
`
`proximal to distal wall, with each “sidewall” marker “proximate to [the] medial
`
`plane”—exactly as the claims require. Appx129.
`
`3
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`Beyond claim construction—which alone is dispositive—the Board made
`
`other legal errors. It required two references to teach the same limitation, required
`
`an explicit motivation to combine, and discounted common knowledge. Each error
`
`independently requires reversal or vacatur. Infra 45-61.
`
`IPR2019-00546 involves claim 16 of the ’334 patent. Like claim 18 above,
`
`it depends from claim 1, which NuVasive I invalidated. Unlike for claim 18, the
`
`Board correctly applied collateral estoppel, limiting its analysis to claim 16’s addi-
`
`tional limitation requiring “a fourth radiopaque marker.” Appx180. The Board did
`
`not dispute the prior art disclosed the use of four markers, which provides more in-
`
`formation than three markers. Appx179-181, Appx185-186. Yet the Board held a
`
`fourth marker nonobvious because it was not “necessary” to a specific embodiment
`
`in the prior art and renders a specific X-ray position “ambiguous”—ignoring that
`
`neither the prior art nor the claim are limited to any specific embodiment or X-ray
`
`position. Appx187-188. “A known or obvious composition does not become pa-
`
`tentable simply because it has been described as somewhat inferior to some other
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`product for the same use.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Re-
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`gardless of whether four markers were preferred, claim 16 recites “no discovery
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`beyond what was known.” Id.; infra 61-66.
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`All three decisions should be reversed or at least vacated.
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`4
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`JURISDICTIONAL STATEMENT
`These consolidated appeals arise from inter partes reviews under 35 U.S.C.
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`§§311-319. The Board entered final written decisions on July 8, 2020. Appx1-
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`217. Alphatec appealed on September 8, 2020. Appx1160-1165, Appx7484-7489,
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`Appx8656-8661; 35 U.S.C. §§142, 319; 37 C.F.R. §90.3(a)(1). This Court has ju-
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`risdiction under 28 U.S.C. §1295(a)(4)(A).
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`STATEMENT OF ISSUES
`I. Whether the Board legally erred in upholding claim 18 of the ’334 pa-
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`tent, where the Board’s sole basis was a limitation in independent claim 1, which
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`this Court invalidated as obvious over the same prior art in a decision the Board
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`acknowledged has preclusive effect.
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`II. Whether the Board legally erred in upholding the ’156 patent, where
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`the Board (A) construed “longitudinal length” contrary to the claims’ express defi-
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`nition; (B) discounted a prior-art reference because it did not meet a limitation sat-
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`isfied by another reference; and (C) required an explicit motivation to combine—
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`without considering common knowledge.
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`III. Whether the Board legally erred in upholding claim 16 of the ’334 pa-
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`tent, where the only limitation added by this dependent claim was known, but the
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`Board found it nonobvious because it allegedly was not the best option for a spe-
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`cific prior-art embodiment and a specific use to which the claim is not limited.
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`5
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`EXHIBIT 8 - PAGE 160
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`STATEMENT OF THE CASE
`Alphatec appeals three final written decisions:
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`• IPR2019-00361—The Board held claims 6-9 of the ’334 patent un-
`patentable over Frey, Michelson, and Berry, but upheld claim 18 over the
`same references. Appx81.
`• IPR2019-00362—The Board upheld 19 claims of the ’156 patent over
`Brantigan, Baccelli, and Berry. Appx155.
`• IPR2019-00546—The Board upheld claim 16 of the ’334 patent over
`Frey, Michelson, and Baccelli. Appx216.
`In each proceeding, the Board addressed additional prior-art combinations, but
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`they are not at issue in this appeal.
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`A. The challenged ’334 and ’156 patents
`1.
`The issued specification
`The ’334 and ’156 patents are related and share a specification. Appx1253-
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`1286; Appx7490-7519. The patents are titled “System and Methods for Spinal Fu-
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`sion” and claim priority to a provisional application filed in March 2004.
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`Appx1253. They relate to “a system and method for spinal fusion comprising a
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`spinal fusion implant of non-bone construction … to introduce the spinal fusion
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`implant into any of a variety of spinal target sites.” Appx1276(1:18-21).
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`The implants are made of radiolucent material and have four walls, shown
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`below—a “distal wall” (the implant’s leading end during spinal insertion), a “prox-
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`imal wall” (the trailing end), and two “sidewalls”:
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`6
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`EXHIBIT 8 - PAGE 161
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`pox
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`first side wall
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`anti-migration elements
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`second side wall
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`longitudinal length
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`maximum lateral width ,.
`along a medial plane
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`distal wall
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`lower surface
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`Ill
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`
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`Appx6953; Appx1257(Fig. 2).
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`As the Board explained, “Figure 2 shows a perspective view of a lumbar fu-
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`sion implant,” “introduced into the disc space via a lateral approach to the spine or
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`via a posterior, anterior, antero-lateral, or postero-lateral approach, and is made
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`from a radiolucent material, such as PEEK (poly-ether-ether-ketone).” Appx4 (cit-
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`ing Appx1277(3:36), Appx1278(5:10-15, 5:29-33)). It “includes anti-migration
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`features, such as ridges 6 and spike elements 7-9.”
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` Appx87 (citing
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`Appx1278(6:21-32), Appx1257-1258(Figs. 2-3)). The issued specification (but not
`
`the provisional application to which the patents claim priority) states the anti-
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`migration spike elements are “observable under X-ray or fluoroscopy[,] such that a
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`surgeon may track the progress of the implant 10 during implantation and/or the
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`placement of the implant 10 after implantation.” Appx1278(6:53-56).
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`7
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`EXHIBIT 8 - PAGE 162
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`As this Court noted, “[t]he implant shares many features with prior-art im-
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`plants.” NuVasive I, 841 F.3d at 968. The specification’s main basis for distin-
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`guishing prior art is the implants’ “non-bone composition.” Appx1276(1:66-2:11).
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`Prior-art implants were allegedly made from “bone grafts,” which had “draw-
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`backs” the claimed invention “overcomes.” Id. (1:37-2:2). In this proceeding,
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`however, there is no dispute non-bone implants—including PEEK implants with
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`radiopaque markers—were known. Rather, NuVasive’s only bases for distinguish-
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`ing the prior art are the implant’s dimensions and arrangement of radiopaque
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`markers. Notably, the specification does not identify these features as novel. On
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`the contrary, it emphasizes the “implant of the present invention may be provided
`
`in any number of suitable shapes and sizes depending upon the particular surgical
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`procedure or need,” “dimensioned for use in the cervical and/or lumbar spine with-
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`out departing from the scope of the present invention,” and “provided with any
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`number of features for enhancing the visualization of the implant during and/or af-
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`ter implantation into a spinal target site [i.e., radiopaque markers],” with “any of a
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`variety of suitable shapes.” Appx1276(2:12-17, 2:53-66).
`
`2.
`The challenged claims
`The ’334 and ’156 patents each have one independent claim. Appx1281-
`
`1282; Appx7518-7519.
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`8
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`EXHIBIT 8 - PAGE 163
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`As discussed below, independent claim 1 of the ’334 patent was invalidated
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`by this Court. Among other limitations, it required an implant that is long and nar-
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`row—“a longitudinal length greater than 40 mm” and “at least two and half times
`
`greater than [the] maximum lateral width.” Appx1281. The claim also required
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`“at least three radiopaque markers.” Id. Claims 18 and 16 at issue in this appeal
`
`depend from claim 1 and each add one limitation. Appx1282. Claim 18 requires
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`the “maximum lateral width of said implant is approximately 18 mm.” Id. Claim
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`16 requires “a fourth radiopaque marker situated within said implant, said fourth
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`radiopaque marker positioned in said central region at a position spaced apart from
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`said third radiopaque marker.” Id.
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`Claim 1 of the ’156 patent has two relevant limitations. First, it requires an
`
`implant with “a longitudinal length extending from a proximal end of said proxi-
`
`mal wall to a distal end of said distal wall, said implant has a maximum lateral
`
`width extending from said first sidewall to said second sidewall along a medial
`
`plane that is generally perpendicular to said longitudinal length, and said longitu-
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`dinal length is greater than said maximum lateral width”—i.e., “the claimed im-
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`plant dimensional features.” Appx7518; Appx107.
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`Second, it requires “first and second radiopaque markers oriented generally
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`parallel to a height of the implant, wherein said first radiopaque marker extends in-
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`to said first sidewall at a position proximate to said medial plane, and said second
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`9
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`EXHIBIT 8 - PAGE 164
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`radiopaque marker extends into said second sidewall at a position proximate to
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`said medial plane”—i.e., “the claimed marker limitation.” Appx7518; Appx118