`
`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.
`________________
`
`Case No. IPR2019-00361
`United States Patent No. 8,187,334
`________________
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 8,187,334
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313–1450
`Submitted Electronically via the Patent Review Processing System
`
`
`
`
`
`
`

`

`TABLE OF CONTENTS
`
`
`Page
`I.
`INTRODUCTION ........................................................................................... 1
`PETITIONER’S STANDING ......................................................................... 7
`II.
`III. THE ’334 PATENT ......................................................................................... 7
`IV. THE PRIOR ART ............................................................................................ 8
`A.
`Frey ........................................................................................................ 8
`B. Michelson .............................................................................................. 9
`C.
`Berry .................................................................................................... 12
`D.
`Brantigan ............................................................................................. 14
`E.
`Baccelli ................................................................................................ 15
`PROSECUTION HISTORY ......................................................................... 16
`V.
`VI. PREVIOUS CHALLENGES ........................................................................ 17
`VII.
`IDENTIFICATION OF CHALLENGES ...................................................... 21
`VIII. PATENT OWNER USED BRANTIGAN AND BERRY IN ITS PRIOR
`CHALLENGES ............................................................................................. 22
`IX. GROUNDS FOR TRIAL ARE NOT CUMULATIVE ................................ 25
`X.
`CLAIM CONSTRUCTION UNDER 37 C.F.R. §§ 42.100(b),
`42.104(b)(3) ................................................................................................... 26
`XI. DETAILED EXPLANATION UNDER 37 C.F.R. § 42.104(b) ................... 27
`A.
`The Grounds for Trial Are Based on Prior Art Patents and Printed
`Publications ......................................................................................... 27
`1.
`Frey is a prior art printed publication ....................................... 27
`2. Michelson is a prior art patent. ................................................. 27
`3.
`Berry is a prior art printed publication. ..................................... 27
`4.
`Brantigan is a prior art patent. ................................................... 28
`5.
`Baccelli is a prior art printed publication. ................................. 28
`Level of Ordinary Skill in the Art ....................................................... 28
`B.
`C. Ground 1: Claims 6–9 and 18 are rendered obvious by Frey in
`view of Michelson and Berry. ............................................................. 29
`1. Motivation to Combine Frey and Michelson and Berry ........... 29
`2.
`Claim 1 ...................................................................................... 32
`3.
`Claim 6 ...................................................................................... 33
`4.
`Claim 7 ...................................................................................... 35
`5.
`Claim 8 ...................................................................................... 36
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`ii
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`Claim 9 ...................................................................................... 38
`6.
`Claim 18 .................................................................................... 40
`7.
`D. Ground 2: Claims 6–9 and 18 are rendered obvious by Brantigan
`in view of Baccelli, Berry, and Michelson .......................................... 43
`1. Motivation to Combine Brantigan with Baccelli, Berry, and
`Michelson .................................................................................. 43
`Claim 1 ...................................................................................... 48
`2.
`Claim 6 ...................................................................................... 70
`3.
`Claim 7 ...................................................................................... 71
`4.
`Claim 8 ...................................................................................... 72
`5.
`Claim 9 ...................................................................................... 73
`6.
`Claim 18 .................................................................................... 73
`7.
`XII. THERE ARE NO SECONDARY CONSIDERATIONS OF
`NONOBVIOUSNESS ................................................................................... 74
`XIII. MANDATORY NOTICES – 37 C.F.R. § 42.8 ............................................. 75
`A.
`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) .......................... 75
`B.
`Related Matters Under 37 C.F.R. § 42.8(b)(2) ................................... 75
`C.
`Lead and Backup Counsel Under 37 C.F.R. § 42.8(b)(3) ................... 76
`D.
`Service Information Under 37 C.F.R. § 42.8(b)(4) ............................. 76
`XIV. PAYMENT OF FEES – 37 C.F.R. § 42.103 ................................................. 76
`XV. CONCLUSION .............................................................................................. 76
`
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`iii
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`

`TABLE OF AUTHORITIES
`
`
` Page(s)
`
`Cases
`Becton Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper No. 8, 17-18 (P.T.A.B Dec. 15, 2017) .......................... 18
`C & D Zodiac, Inc. v. B/E Aerospace, Inc.,
`IPR2017-01276, Paper No. 41, 12-13 (P.T.A.B. Sept. 28, 2018) ...................... 24
`Interactive Gift Exp., Inc. v. Compuserve Inc.,
`256 F.3d 1323 (Fed. Cir. 2001) .......................................................................... 24
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 31
`Noah Sys., Inc. v. Intuit Inc.,
`675 F.3d 1302 (Fed. Cir. 2012) .......................................................................... 19
`In re: NuVasive, Inc.,
`842 F.3d 1376 ............................................................................................... 12, 15
`NuVasive, Inc. v. Alphatec Holdings, Inc. et al.,
`Case No. 3:18-cv-00347-CAB-MDD (S.D.Cal.) ............................................... 62
`Warsaw Orthopedic, Inc. et al. v. NuVasive, Inc.,
`Case No. 3:12-cv-002738-CAB-MDD (S.D.Cal.) ....................................... 24, 63
`Williamson v. Citrix Online,
`LLC, 792 F.3d. 1339 (Fed. Cir. 2015) (en banc) .......................................... 19, 20
`Statutes
`35 U.S.C. § 102(a) ............................................................................................. 21, 22
`35 U.S.C. § 102(b) ................................................................................................... 21
`35 U.S.C. § 102(e) ................................................................................................... 21
`35 U.S.C. § 103(a) ............................................................................................. 11, 17
`35 U.S.C. § 112 ........................................................................................................ 19
`
`
`
`
`iv
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`35 U.S.C. § 282(b) ................................................................................................... 18
`35 U.S.C. §§ 311–319 ................................................................................................ 1
`Other Authorities
`37 C.F.R. § 42 ............................................................................................................ 1
`37 C.F.R. § 42.8 ....................................................................................................... 62
`37 C.F.R. § 42.8(b)(1) .............................................................................................. 62
`37 C.F.R. § 42.8(b)(2) .............................................................................................. 62
`37 C.F.R. § 42.8(b)(3) .............................................................................................. 63
`37 C.F.R. § 42.8(b)(4) .............................................................................................. 63
`37 C.F.R. § 42.100(b) .............................................................................................. 18
`37 C.F.R. § 42.103 ................................................................................................... 64
`37 C.F.R. § 42.104(B) .............................................................................................. 20
`37 C.F.R. § 42.104(b)(3) .......................................................................................... 18
`83 Fed. Reg. 51340, 51343 (Oct. 11, 2018) ............................................................. 19
`
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`v
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`
`
`Exhibit No.
`1001
`1002
`1003
`1004
`
`1005
`1006
`1007
`1008
`1009
`1010
`1011
`1012
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`1021
`
`TABLE OF EXHIBITS
`
`PETITIONER’S EXHIBIT LIST
`Brief Description
`U.S. Patent No. 8,187,334 to Curran et al. (“’334 patent”)
`Declaration of Charles L. Branch, Jr., M.D.
`Curriculum Vitae of Charles L. Branch, Jr., M.D.
`IPR2013-00507, Final Written Decision, Paper No. 43 (“IPR507
`FWD”)
`In re: NuVasive, Inc., No. 2015-1670, Opinion, (Fed. Cir. Dec. 7,
`2016) (“IPR2013-00507, IPR2013-00508 CAFC Opinion”)
`RESERVED
`U.S. Patent No. 5,192,327 to Brantigan (“Brantigan”)
`U.S. Patent App. Pub. No. 2003/0028249 to Baccelli et al.
`(“Baccelli”)
`Synthes Vertebral Spacer-PR Brochure (“SVS-PR”)
`Telamon Verte-Stack PEEK Vertebral Body Spacer Brochure
`(“Telamon Brochure”)
`Telamon Implantation Guide (“Telamon Guide”)
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 2013-1576, -1577,
`Joint Appendix, Docket No. 52-1 (Fed. Cir. June 16, 2014)
`Prosecution History of the ’156 patent, U.S. App. No. 13/441,092
`IPR2013-00208, Corrected Petition for Inter Partes Review of
`United States Patent No. 8,251,997, Paper No. 5 (“IPR208
`Petition”)
`IPR2013-00206, Corrected Petition for Inter Partes Review of U.S.
`Patent No. 8,251,997, Paper No. 5 (“IPR206 Petition”)
`IPR2013-00206, Petitioner’s Reply to Patent Owner’s Response,
`Paper No. 43, (“IPR206 Reply”)
`IPR2013-00206, Final Written Decision, Paper No. 65 (“IPR206
`FWD”)
`IPR2013-00208, Final Written Decision, Paper No. 62 (“IPR208
`FWD”)
`In re: Warsaw Orthopedic, Inc., Nos. 2015-1050, 2015-1058 (Fed.
`Cir. Aug. 9, 2016) (“IPR208 CAFC opinion”)
`Prosecution History of U.S. Patent No. 7,918,891, U.S. App. No.
`11/093,409
`U.S. Patent No. 8,251,997 to Michelson (“Michelson ’997”)
`
`
`
`
`vi
`
`
`
`
`
`

`

`Exhibit No.
`1022
`
`1023
`
`1024
`
`1025
`1026
`1027
`1028
`1029
`
`1030
`
`1031
`1032
`1033
`1034
`1035
`
`1036
`
`1037
`
`1038
`1039
`1040
`1041
`
`1042
`
`PETITIONER’S EXHIBIT LIST
`Brief Description
`Berry et al. “A Morphometric Study of Human Lumbar and
`Selected Thoracic Vertebrae,” 12 SPINE, 362–367 (1987) (“Berry”)
`Prosecution History of U.S. Patent No. 8,187,334, U.S. App. No.
`13/079,645
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 3:08-cv-1512
`CAB-MDD, NuVasive Inc.’s Memorandum of Points and
`Authorities in Support of its Renewed Motion for Judgment as a
`Matter of Law or a New Trial, Docket No. 407-1 (S.D. Cal. Oct. 27,
`2011) (“Warsaw JMOL”)
`Prosecution History of U.S. Patent No. 8,246,686, U.S. App. No.
`13/440,062
`U.S. Provisional Patent App. No. 60/557,536, filed March 29, 2004
`RESERVED
`U.S. Patent No. 5,127,912 to Ray et al.
`U.S. Patent No. 5,514,180 to Heggeness et al.
`Amonoo-Kuofi, “Age-Related Variation in the Horizontal and
`Vertical Diameters of the Pedicles of the Lumbar Spine,” 186 J.
`ANAT., 321–328 (1995)
`IPR2013-00508, Final Written Decision, Paper No. 48 (“IPR508
`FWD”)
`U.S. Patent No. 5,860,973 to Michelson (“Michelson”)
`IPR2013-00507, Petition, Paper No. 1
`IPR2013-00508, Petition, Paper No. 1
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 2013-1576, -1577,
`NuVasive’s Opening Brief, Docket No. 33 (Fed. Cir. Feb. 3, 2014)
`Panjabi et al., “Complexity of the Thoracic Spine Pedicle
`Anatomy,” 6 EUR. SPINE J., 19–24 (1997)
`Kopperdahl et al., “Yield Strain Behavior of Trabecular Bone,” 31
`J. BIOMECHANICS, 601–608 (1998)
`IPR2013-00208, Declaration of Dr. Paul McAfee, M.D., M.B.A.,
`Paper No. 1001
`
`RESERVED
`U.S. Patent Application No. 2002/0165550 to Frey et al.
`IPR2013-00507, Declaration of Richard Hynes, M.D. Regarding
`U.S. Patent No. 8,187,334, Paper No. 1001
`IPR2013-00508, Declaration of Richard Hynes, M.D. Regarding
`U.S. Patent No. 8,187,334, Paper No. 1101
`
`
`
`
`vii
`
`
`
`
`
`

`

`Exhibit No.
`1043
`1044
`1045
`1046
`
`1047
`
`PETITIONER’S EXHIBIT LIST
`Brief Description
`RESERVED
`RESERVED
`RESERVED
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 2013-1576, 2013-
`1577, Opinion, Docket No. 77 (Fed. Cir. March 2, 2015)
`IPR2013-00208, Petitioner’s Reply to Patent Owner’s Response,
`Paper No. 40
`
`
`viii
`
`
`
`
`
`
`
`
`
`
`

`

`Alphatec Holdings, Inc. and Alphatec Spine, Inc. (collectively “Petitioner”)
`
`petition for Inter Partes Review under 35 U.S.C. §§ 311–319 and 37 C.F.R., Part 42
`
`of claims 6–9, and 18 of U.S. Patent 8,187,334 (the “’334 patent”). In February
`
`2018, the Director cancelled claims 1–5, 10, 11, 14, 15, and 19–28 under 35 U.S.C.
`
`§ 318(b). Ex. 1001, Inter Partes Review Certificate; see also, Ex. 1004, at 13, Ex.
`
`1005, at 17. As shown herein, Petitioner is reasonably likely to prove the challenged
`
`claims unpatentable. Accordingly, Petitioner requests that the Board institute trial
`
`and cancel all challenged claims.
`
`I.
`
`INTRODUCTION
`
`The claims of the ’334 patent are drawn to a radiolucent spinal fusion implant
`
`with three radiopaque markers that “has a longitudinal length greater than 40 mm”
`
`that is also “at least two and a half times greater than the maximum lateral width.”
`
`Ex. 1001, cl. 1; Ex. 1004, 5.
`
`In 2016, 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. Ex. 1005, 17. In doing so, the
`
`Federal Circuit agreed that the combination of U.S. Patent App. Pub. 2002/0165550
`
`A1 to Frey et al. (“Frey”) (Ex. 1040) in view of U.S. Patent 5,860,973 to Michelson
`
`(“Michelson”) (Ex. 1032) disclosed a “long-and-narrow” radiolucent spinal fusion
`
`implant of non-bone construction with at least three radiopaque markers. Ex. 1005,
`
`
`
`
`

`

`14–16. Two of Frey’s alternative embodiments—one illustrating three radiopaque
`
`markers—are shown below:
`
`
`
`Ex. 1040, Figs. 55, 59 (annotated).
`
`With respect to the dimensional limitations of claim 1, the Federal Circuit
`
`affirmed the Board’s finding that Michelson disclosed “longer-than-wide” implants.
`
`Ex. 1005, 14–16. Specifically, the Federal Circuit noted that Michelson “expressly
`
`states that the preferred length of embodiment 900 was 42 mm and the preferred
`
`width was 26 mm,” and “that ‘spinal fusion implant 1000 is similar to the spinal
`
`fusion implant 900, but has a narrower width such that more than one spinal fusion
`
`implant 1000 may be combined in a modular fashion for insertion within the disc
`
`space.’” Id., 14–15. The Michelson long-and-narrow implant is illustrated in
`
`Figures 18–19 of that patent:
`
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`2
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`
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`Ex. 1032, 10:50–55, Figs. 18–19. Regarding Figure 19 of Michelson, the Federal
`
`Circuit noted that “its point is to show more than one” implant lined up in the disc
`
`space. Ex. 1005, 15. Thus, the Federal Circuit affirmed the Board’s finding that
`
`claims 1–5, 10, 11, 14, 15, and 19–28 of the ’334 patent are unpatentable based on
`
`“substantial, and anything but speculative, evidence.” Id.
`
`Presently challenged claims 6–9 are not patentably distinct from the claims
`
`the Board and Federal Circuit deemed invalid. These claims—which were not
`
`challenged in any prior proceeding regarding the ’334 patent—are drawn to the
`
`spinal fusion implant of invalid claim 1 that additionally has a medial support in the
`
`central region of the implant separating a first and second fusion aperture. Ex. 1001,
`
`cl. 6–9. These limitations are expressly disclosed in Frey, as illustrated in annotated
`
`Figure 55 above. Ex. 1040, Fig. 55.
`
`Presently challenged claim 18 is drawn to the invalid spinal fusion implant of
`
`claim 1, which requires a longitudinal length of greater than 40 mm that is also two
`
`and a half times greater than the maximum lateral width, but further requires the
`
`maximum lateral width to be “approximately 18 mm.” Ex. 1001, cl. 18. In IPR2013-
`
`
`
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`3
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`

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`00507, the prior petitioner relied on embodiments for the mid-thoracic region of the
`
`spine (vertebral bodies T7 and T8) to show that Michelson disclosed a width of
`
`approximately 18 mm. Ex. 1004, 9–11. The Board rejected this argument,
`
`indicating that the prior petitioner “d[id] not assert, or demonstrate sufficiently, that
`
`the ‘known transverse width W (side to side) of the vertebrae T7 and T8’
`
`(corresponding to the length of the implant) is greater than 40 mm, as required by
`
`claim 18.” Id., 10. The Board, however, did not consider—because the prior
`
`petitioner did not raise—that claim 18 would have been obvious in view of
`
`Michelson’s disclosure of spinal fusion implants having “a narrower width such that
`
`more than one spinal fusion implant 1000 may be combined in a modular fashion”
`
`to “approximate[] the depth of the vertebra.” Ex. 1032, 10:36–40, 10:48–59, Figs.
`
`18–19. Although this teaching was raised in IPR2013-00507 for claim 1, it was
`
`never raised in the same or any other proceeding for claim 18 of the ’334 patent. Ex.
`
`1033; Ex. 1034 (IPR2013-00508). Accordingly, the Board did not consider
`
`Michelson’s disclosure of a long-and-narrow modular implant that renders claim 18
`
`obvious. See In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380-81 (Fed. Cir.
`
`2016) (The Board may not “raise, address, and decide unpatentability theories never
`
`presented by the petitioner and not supported by the record evidence.”)
`
`Michelson’s disclosure of a long-and-narrow modular implant coupled with
`
`the known depth of the human vertebra in the lumbar region—as widely reported by
`
`
`
`
`4
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`

`

`Berry et al., A Morphometric Study of Human Lumbar and Selected Thoracic
`
`Vertebrae, 12 Spine, 362–367 (1987) (Ex. 1022, “Berry”), for the purpose of
`
`“provid[ing] data for implant design”—would have motivated a person of ordinary
`
`skill in the art (“POSA”) to create the long-and-narrow implant of Frey in a modular
`
`fashion as taught by Michelson to have a width of 18 mm, which is half the known
`
`depth of the lumbar vertebra from front to back as taught by Berry. Ex. 1022, Abst.,
`
`364, Table 1.
`
`In addition to Frey, other long-and-narrow radiolucent implants were known
`
`in the art prior to the critical date. For example, U.S. Patent 5,192,327 to Brantigan
`
`(“Brantigan”) (Ex. 1007) issued in March 1993 and, like the ’334 patent, discloses a
`
`long-and-narrow, radiolucent, spinal fusion implant. Ex. 1007, 3:9–12.
`
`Id., Fig. 6.
`
`
`
`Although Brantigan does not mention using radiopaque markers, using such
`
`markers in radiolucent implants was commonplace before March 2004 as disclosed
`
`in, for example, U.S. Patent App. Pub. No. 2003/0028249 to Baccelli et al.
`
`(“Baccelli”) (Ex. 1008). Baccelli published in February 2003 and teaches an implant
`
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`5
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`that “can be made of a material that is transparent to X-rays, e.g. out of poly-ether-
`
`ether-ketone (PEEK). In which case, the cage can have one or more markers 47
`
`included therein and serving, because they are opaque to X-rays, to identify the
`
`position and/or the presence of the implant when X-rays are taken during or after the
`
`operation.” Ex. 1008, [0050]. Baccelli’s radiopaque markers may be positioned
`
`within any of the implant’s four walls, including the central region between the
`
`proximal and distal walls of the implant. Id., [0050]–[0051], Figs. 1–4, 8, 9. The
`
`radiolucent Baccelli implant with radiopaque markers (denoted “47”) and
`
`radiopaque spikes (denoted “24”) is illustrated in Figure 2 of Baccelli:
`
`Id., Fig. 2.
`
`
`
`Neither Frey nor Baccelli were cited to or considered by the examiner during
`
`prosecution of the ’334 patent. Ex. 1023. And the combinations cited herein were
`
`never raised or considered during prosecution or in any prior proceeding for the
`
`presently challenged claims. Id.; Ex. 1033; Ex. 1034. These combinations render
`
`the challenged claims unpatentable.
`
`
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`
`6
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`

`

`Petitioner therefore requests the Board institute inter partes review and cancel
`
`claims 6–9 and 18 of the ’334 patent.
`
`II.
`
`PETITIONER’S STANDING
`
`Petitioner certifies that (1) the ’334 patent is available for IPR, (2) none of the
`
`parties constituting Petitioner are the Patent Owner, and (3) it is not barred or
`
`estopped from requesting IPR. The ’334 patent was first asserted in a complaint
`
`served on Petitioner on February 16, 2018.
`
`III. THE ’334 PATENT
`
`The ’334 patent describes a spinal fusion system, including a spinal fusion
`
`implant and an insertion instrument. Ex. 1001, 5:6–9. 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-etherketone). Id. at 5:10–15, 5:29–33.
`
`
`
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`7
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`Id., Fig. 2 (annotated).
`
`In one embodiment, the spinal fusion implant has a width ranging between 9
`
`and 18 mm and a length ranging between 25 and 45 mm. Id. at 5:17–19. The implant
`
`sizes and shapes discussed in the ’334 patent are no revelation. These implant sizes
`
`were described decades earlier in Frey, Michelson, Brantigan, and Berry.
`
`IV. THE PRIOR ART
`
`A. Frey
`Frey (Ex. 1040) published in November 2002. Frey discloses a spinal fusion
`
`implant that can be made from radiolucent material known as PEEK. Ex. 1040, ¶
`
`[0181]. Frey’s implants include a distal wall, a proximal wall, and two sidewalls
`
`spanned by a medial support in the central region. Id., ¶ [0151].
`
`Ex. 1040, Figs. 55, 59 (annotated).
`
`
`
`
`8
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`

`

`Frey’s implants have “a length sufficient to span the disc space from the distal
`
`portion . . . to the proximal portion” (id., ¶ [0130], Fig. 47), and “may be utilized or
`
`modified for use in a variety of surgical applications including, but not limited to,
`
`spinal surgery from a unilateral posterior approach, a lateral approach, an oblique
`
`approach, and through laparoscopic or endoscopic instruments from any of a variety
`
`of angles or approaches to the spine” (id., ¶ [0184]). Frey explicitly “contemplate[s]
`
`that disc space D1 can be accessed and prepared…using any other known techniques
`
`and instruments and other approaches to the disc space, such as lateral, anterior or
`
`antero-lateral approaches, for insertion of implant 1400.” Id., ¶ [0150], [0140]
`
`(equivalent statement for implant 1000).
`
`Frey’s implants have grooves to increase frictional resistance between
`
`adjacent vertebrae (id., ¶ [0153]), in addition to first and second fusion apertures
`
`extending from the top surface to the bottom surface (id., ¶ [0154]) configured to
`
`hold “[a]ny suitable osteogenetic material” to facilitate bone growth (id., ¶ [0182]).
`
`Frey’s implants include at least three radiopaque markers, located in the proximal
`
`wall, the distal wall, and the central region of the implant. Id., ¶ [0156], Figs. 59–
`
`62 (radiopaque markers denoted “1438”).
`
`B. Michelson
`Michelson (Ex. 1032) issued in January 1999. Michelson describes a spinal
`
`fusion implant “dimensioned to fit within the disc space created by removal of the
`
`
`
`
`9
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`disc material between two adjacent vertebrae.” Ex. 1032, 3:35–36. The “implant is
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`inserted from the translateral approach to the spine and has a length that is
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`substantially greater than the depth of the vertebrae and a width that approximates
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`the depth of the vertebrae.” Id., 3:37–40. Michelson refers to the laterally-inserted
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`implant as a “translateral spinal fusion implant.” Id., 3:1–7. A cross-sectional view
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`of a cylindrical embodiment of Michelson is:
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`Id., Fig. 4.
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`Michelson explains, “[t]he dimensions of the translateral spinal fusion implant
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`of the present invention permits a single implant to be inserted by a single procedure
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`into the spine and to engage more of the adjacent vertebrae. As a result, the
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`translateral spinal fusion implant of the present invention has more surface area of
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`contact and thus permits greater stability so as to withstand torque.” Id., 3:47–53.
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`Additionally, translateral implants “are safer to use than implants inserted from the
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`front or back as the aorta and vena cava lie anterior to the spine and the dural sac
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`and nerves posteriorly, all of which structures are simply avoided in the lateral
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`approach.” Id., 3:56–60.
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`To maximize safety, Michelson discloses minimally invasive methods of
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`lateral insertion: “the translateral spinal fusion implant of the present invention may
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`be inserted into the disc space through a hollow tube which is engaged to the lateral
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`aspect of the spine through a lateral, anterior, or anterolateral incision making the
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`procedure safe and simple.” Id., 3:61–65.
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`As an alternative to the cylindrical embodiment, Michelson discloses an
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`embodiment that “does not require the removal of any portion of bone from the
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`adjacent vertebrae as the spinal fusion implant 900 fits within the natural disc space
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`between the adjacent vertebrae.” Id., 10:6–16. As illustrated below, such a
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`spinal fusion implant 900 comprises a rectangular block
`901 having a top surface 902 and a bottom surface 904 for
`engaging the adjacent vertebrae and may be flat or may
`conform at least in part. The top and bottom surfaces 902
`and 904 may comprise any of the surface roughenings
`described herein for engaging the bone of the adjacent
`vertebrae to promote firm stability. The spinal fusion
`implant 900 may be solid or hollow at least in part and
`have a plurality of openings 906 to allow bone ingrowth.
`The openings 906 may be present on all surfaces of the
`implant 900 and may either pass through the entire implant
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`900, or may be closed bottom wells for holding fusion
`promoting materials.
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`Id., 10:19–31, Figs. 16–17.
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`Michelson further teaches that such implants may have a “narrower width
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`such that more than one spinal fusion implant 1000 may be combined in a modular
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`fashion for insertion within the disc space.”
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`Id., 10:50–55, Figs. 18–19.
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`C. Berry
`Berry (Ex. 1022) was published in the journal “Spine” in 1987. Berry’s study
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`was “undertaken to provide data for implant design.” Id., 362.
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`[A]ccurate anatomic descriptions of vertebral shape are
`necessary for the development of implantable devices and
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`spinal instrumentation. The authors’ interest in spinal
`implants and fixation devices resulted in a need for more
`detailed morphologic and anthropometric data on the
`vertebrae than could be found in the existing literature.
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`Id.
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`Berry measured “major body diameter” (vertebral transverse width) and
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`“minor body diameter” (vertebral depth) at three different points (the superior, i.e.,
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`upper, and inferior, i.e., lower, surfaces of the vertebral body, as well as at the
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`midpoint between them) from 240 different vertebrae. Id., 362–363, Fig. 1; Ex.
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`1002, ¶ 101.
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`Id., Fig. 1 (excerpted). Berry identified the means and standard deviations associated
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`with dimensions of human vertebrae in the thoracic and lumbar spine. Id., Table 1.
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`D. Brantigan
`Brantigan (Ex. 1007) issued in March 1993. Patent Owner is no stranger to
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`Brantigan, having relied on it to successfully invalidate claims in a different patent
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`discussing spinal implants. See Ex. 1017, 36; Ex. 1018, 35; Ex. 1019, 9–10.
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`Brantigan discloses spinal fusion implants composed of “rigid biologically
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`acceptable and inactive material, preferably a radiolucent plastics material” for
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`insertion between adjacent vertebrae. Ex. 1007, 4:3–4. Brantigan’s implant is
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`“suitable for anterior, posterior or lateral placement in any area of the spine requiring
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`replacement of disc or vertebral body.” Id., 2:56–59. It is “generally shaped and
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`sized to conform with the disc space between adjoining vertebrae in a vertebral
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`column.” Id., 4:5–8; see also id., Figs. 10–11, 13–14, Abst., 1:18–23, 1:54–56;
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`1:68–2:4, 2:19–22, 7:29–34.
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`Patent Owner has made numerous admissions about Brantigan’s teachings.
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`Patent Owner conceded that Brantigan “describes an implant that is ‘shaped to
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`conform with the general outline perimeter of the vertebrae,’ is ‘dimensionally
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`similar to normal vertebral bodies,’ has ‘dimensions in the same ratio as normal
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`vertebral bodies,’ and is ‘sized to match the height of an average disc.’” Ex. 1035,
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`49. Patent Owner also admitted that Brantigan discloses “a length substantially
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`greater than the depth of the vertebrae” and “a height for contacting each of the two
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`adjacent vertebrae.” Id.
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`Brantigan discloses the same modularity concept Michelson describes. In
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`particular, Brantigan discloses implants that are “preferably hemi-oval” in a partial-
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`annular “shape to accommodate those surgical procedures where only a portion of
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`the vertebrae or disc is damaged.” Ex. 1007, 2:4–7. According to Brantigan, “[t]wo
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`such hemi-oval rings can be used in the posterior lumbar area in side-by-side
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`relation.” Id., 2:7–11. Thus, Brantigan teaches narrowing the width of the implant
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`in the direction of insertion in the same way Michelson teaches. See, e.g., Ex. 1032,
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`10:50–55.
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`A POSA, therefore, would have understood Brantigan to teach a longitudinal
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`length greater than 40 mm and a width of approximately 18 mm. Ex. 1002, ¶197.
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`E. Baccelli
`Baccelli (Ex. 1008) published in February 2003. Baccelli discloses a spinal
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`fusion implant “made of a material that is transparent to X-rays,” like PEEK. Ex.
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`1008, [0050]. Baccelli discloses a distal wall, a proximal wall, and two sidewalls
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`(id., [0033]–[0034]), in addition to upper and lower surfaces that contain anti-
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`migration elements in the form of teeth that “limit[] the ability of the cage to move
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`forwards from its position” after “the cage is put into place between the vertebrae
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`from behind” (id., [0045]). Additionally, Baccelli’s “implant has a central hole
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`extending from one of the main faces to the other [e.g., from the top to the bottom
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`15
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`surface]” (id., [0012]) that can “receive the [bone] graft that facilitates vertebral bone
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`integration” (id., [0013]).
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`Baccelli’s spinal fusion implant “can have one or more markers 47 included
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`therein . . . to identify the position and/or the presence of the implant when X-rays
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`are taken during or after the operation.” Id., [0050], Figs. 1–5, 8, 9. Baccelli also
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`describes how “spikes 24 can be inserted and fixed rigidly in the ducts formed in the
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`cage. They too can be made of a material that is opaque to X-rays.” Id., [0051].
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`The four radiopaque markers (24, 47) of Baccelli located in the proximal wall (4b),
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`distal wall (4a), and central region of the side (16, 4) walls are illustrated below:
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`Id., Figs. 1–2 (annotated); see also Figs. 3–5, 8, 9.
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`V.
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`PROSECUTION HISTORY
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`On March 29, 2005, Patent Owner filed U.S. Patent App. No. 11/093,409,
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`which issued as parent U.S. Patent 7,918,891 (the “’891 patent”). Ex. 1001, 1:6–15.
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`During prosecution of that patent, the examiner rejected the claims as obvious over
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`Michelson in view of U.S. Patent 6,159,211 to Boriani et al. (“Boriani”) and U.S.
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`Patent 4,349,921 to Kuntz (“Kuntz”), finding that Boriani and Kuntz disclosed
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`radiolucent spinal implant mater