`
`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. IPR2019-00362
`United States Patent No. 8,361,156
`________________
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 8,361,156
`
`
`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
`
`
`
`
`
`
`

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`TABLE OF CONTENTS
`
`
`Page
`
`
`INTRODUCTION ....................................................................................... 1
`I.
`PETITIONER’S STANDING ..................................................................... 5
`II.
`III. THE ’156 PATENT ..................................................................................... 5
`IV. THE PRIOR ART ........................................................................................ 8
`A.
`Brantigan ........................................................................................... 8
`B.
`Baccelli .............................................................................................. 9
`C.
`Berry ................................................................................................ 10
`D. Michelson ’973 ................................................................................ 11
`PROSECUTION HISTORY ..................................................................... 14
`V.
`VI. PREVIOUS CHALLENGES .................................................................... 16
`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) ............... 26
`A.
`The Grounds for Trial Are Based on Prior Art Patents and Printed
`Publications ..................................................................................... 26
`1.
`Brantigan is a prior art patent. ............................................... 26
`2.
`Baccelli is a prior art printed publication. ............................. 27
`3.
`Berry is a prior art printed publication. ................................. 27
`4. Michelson ’973 is a prior art patent. ..................................... 28
`Level of Ordinary Skill in the Art ................................................... 28
`B.
`C. Ground 1: Claims 1-3, 5, 9–10, 12-21, 23–24, and 27 are rendered
`obvious by Brantigan in view of Baccelli and Berry ...................... 28
`1. Motivation to Combine Brantigan with Baccelli and Berry . 28
`2.
`Claim 1 .................................................................................. 33
`3.
`Claim 2 .................................................................................. 52
`4.
`Claim 3 .................................................................................. 53
`5.
`Claim 5 .................................................................................. 54
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`ii
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`Claim 9 .................................................................................. 56
`6.
`Claim 10 ................................................................................ 57
`7.
`Claim 12 ................................................................................ 57
`8.
`Claim 13 ................................................................................ 58
`9.
`10. Claim 14 ................................................................................ 59
`11. Claim 15 ................................................................................ 60
`12. Claim 16 ................................................................................ 61
`13. Claim 17 ................................................................................ 61
`14. Claim 18 ................................................................................ 62
`15. Claim 19 ................................................................................ 63
`16. Claim 20 ................................................................................ 63
`17. Claim 21 ................................................................................ 64
`18. Claim 23 ................................................................................ 66
`19. Claim 24 ................................................................................ 67
`20. Claim 27 ................................................................................ 68
`D. Ground 2: Claim 9 is rendered obvious by Brantigan, Baccelli,
`Berry, and Michelson ’973. ............................................................. 69
`1. Motivation to combine Brantigan, Berry, Baccelli, and
`Michelson ’973. .................................................................... 69
`Claim 9 .................................................................................. 70
`2.
`XII. THERE ARE NO SECONDARY CONSIDERATIONS OF
`NONOBVIOUSNESS ............................................................................... 75
`XIII. MANDATORY NOTICES – 37 C.F.R. § 42.8 ......................................... 76
`A.
`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) ...................... 76
`B.
`Related Matters Under 37 C.F.R. § 42.8(b)(2) ............................... 76
`C.
`Lead and Backup Counsel Under 37 C.F.R. § 42.8(b)(3) ............... 77
`D.
`Service Information Under 37 C.F.R. § 42.8(b)(4) ......................... 77
`XIV. PAYMENT OF FEES – 37 C.F.R. § 42.103 ............................................. 77
`XV. CONCLUSION .......................................................................................... 77
`
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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
`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
`35 U.S.C. § 282(b) ................................................................................................... 18
`
`
`
`
`iv
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`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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`
`
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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
`
`TABLE OF EXHIBITS
`
`
`PETITIONER’S EXHIBIT LIST
`Brief Description
`U.S. Patent No. 8,361,156 to Curran et al. (“’156 patent”)
`Declaration of Charles L. Branch, Jr., M.D.
`Curriculum Vitae of Charles L. Branch, Jr., M.D.
`IPR2013-00506, Final Written Decision, Paper No. 47 (“IPR506
`FWD”)
`In re: NuVasive, Inc., No. 2015-1670, Opinion, (Fed. Cir. Dec. 7,
`2016) (“IPR2013-00506 CAFC Opinion”)
`IPR2013-00506, Judgment Granting Joint Motion to Terminate
`after Remand from the Court of Appeals for the Federal Circuit,
`Paper No. 57
`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”)
`
`
`vi
`
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`
`
`
`

`

`Exhibit No.
`1020
`1021
`1022
`
`1023
`
`1024
`
`1025
`1026
`1027
`1028
`1029
`
`1030
`
`1031
`1032
`1033
`1034
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`1040
`1041
`
`PETITIONER’S EXHIBIT LIST
`Brief Description
`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”)
`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)
`IPR2013-00506 Decision to Institute, Paper No. 9
`U.S. Patent No. 5,860,973 to Michelson (“Michelson ’973”)
`IPR2013-00504, Decision Denying Institution, Paper No. 8
`IPR2013-00506, 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
`NuVasive Inc. v. Medtronic, Inc., No. 2015-1670, Corrected
`NuVasive’s Opening Brief, Docket No. 19 (Fed. Cir. July 23, 2015)
`U.S. Patent Application No. 2002/0165550 to Frey et al.
`IPR2013-00504, Petition, Paper No. 3
`
`
`
`
`vii
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`
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`
`

`

`Exhibit No.
`1042
`1043
`1044
`1045
`1046
`
`1047
`
`PETITIONER’S EXHIBIT LIST
`Brief Description
`IPR2014-00487, Petition, Paper No. 1
`IPR2013-00506, Patent Owner Response, Paper No. 21
`IPR2014-00487, Decision Denying Institution, Paper No. 8
`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
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`

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`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 1–3, 5, 9–10, 12–21, 23–24, and 27 of U.S. Patent 8,361,156 (the “’156
`
`patent”). As shown herein, Petitioner is reasonably likely to prove these challenged
`
`claims unpatentable. Accordingly, Petitioner requests that the Board institute trial
`
`and cancel all challenged claims.
`
`I.
`
`INTRODUCTION
`
`Spinal fusion procedures for treating, for example, chronic back or neck pain,
`
`generally involve removing some or all of the diseased or damaged intervertebral
`
`disc and inserting one or more intervertebral implants into the disc space. Ex. 1001,
`
`1:27–37. The ’156 patent is directed to generic spinal fusion implants of non-bone
`
`construction that purportedly “overcome” the drawbacks of the prior art in that it is
`
`not supply limited (as with allograft [cadaver bone]) and does not require harvesting
`
`bone from the patient (as with autograft).” Ex. 1001, 2:2–6. Beyond being made of
`
`non-bone construction, the ’156 patent identifies no additional benefits over the prior
`
`art. Id., 1:16–3:24. Nor does the ’156 patent discuss the numerous prior art implants
`
`of non-bone construction known well before the earliest claimed filing date of the
`
`’156 patent.
`
`The ’156 patent instead describes and claims features that were found in prior
`
`art non-bone implants well before March 2004. There was nothing new in the ’156
`
`
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`patent. For example, the ’156 patent claims a spinal fusion implant having four walls
`
`(a distal wall, a proximal wall, and two side walls), upper and lower surfaces
`
`including anti-migration elements to contact the vertebrae when the implant is
`
`positioned in the intervertebral space, at least one fusion aperture extending between
`
`the upper and lower surfaces that allows a boney bridge to form through the spinal
`
`fusion implant, and a length that is greater than a maximum lateral width of the
`
`implant along its midpoint. Ex. 1001, 12:31–67. Exemplary shapes and sizes of the
`
`claimed implant are illustrated in Figures 18, 20, and 22.
`
`
`The ’156 patent further indicates that “when the spike elements are provided
`
`having radiodense characteristics and the implant is manufactured from a radiolucent
`
`material (such as, by way of example only, PEEK and/or PEKK), the spike elements
`
`will be readily observable under X-ray or fluoroscopy such that a surgeon may track
`
`the progress of the implant during implantation and/or the placement of the implant
`
`after implantation.” Id., 3:4–10.
`
`The ’156 patent claims only what was old and obvious. U.S. Patent 5,192,327
`
`to Brantigan (“Brantigan”) (Ex. 1007) issued in March 1993 and, like the ’156
`
`
`
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`2
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`

`

`patent, discloses spinal fusion implants “preferably made of radiolucent material
`
`such as carbon fiber reinforced polymers known commercially as ‘Peek’,
`
`(polyetherether ketone) or ‘Ultrapek’ (polyether ketone, ether ketone, ketone).” Ex.
`
`1007, 3:9–12. Also like the ’156 patent, Brantigan discloses a spinal fusion implant
`
`having a distal wall, a proximal wall, and two side walls, upper and lower surfaces
`
`including anti-migration elements, at least one fusion aperture extending between
`
`the upper and lower surfaces, and a length that is greater than a maximum lateral
`
`width of the implant along its midpoint. One of Brantigan’s embodiments is:
`
`Ex. 1007, Fig. 6.
`
`
`
`Although Brantigan does not mention using radiopaque markers, the use of
`
`such markers had become commonplace by March 2004. For example, U.S. Patent
`
`App. Pub. No. 2003/0028249 to Baccelli et al. (“Baccelli”) (Ex. 1008), published in
`
`February 2003, teaches an implant 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
`
`
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`3
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`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 along
`
`the medial plane that bisects the length of the implant from distal to proximal end.
`
`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:
`
`Ex. 1008, Fig. 2.
`
`
`
`The Patent Office allowed the challenged claims of the ’156 patent because
`
`the examiner did not believe that the prior art disclosed or rendered obvious “a spinal
`
`fusion implant with a longitudinal length that is greater than the maximum width and
`
`with two radiopaque markers parallel to an implant height, in the sidewalls of the
`
`implant.” Ex. 1013, 193; infra § V. Baccelli, however, was never cited to or
`
`otherwise considered by the examiner, nor was the combination of Brantigan in view
`
`of Baccelli. That combination—along with other prior art in this petition—renders
`
`the challenged claims unpatentable.
`
`
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`4
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`Petitioner therefore requests the Board institute inter partes review and cancel
`
`claims 1–3, 5, 9–10, 12–21, 23–24, and 27 of the ’156 patent.
`
`II.
`
`PETITIONER’S STANDING
`
`Petitioner certifies that (1) the ’156 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 ’156 patent was first asserted in a complaint
`
`served on Petitioner on February 16, 2018.
`
`III. THE ’156 PATENT
`
`The ’156 patent describes “a spinal fusion implant of non-bone construction”
`
`that can be positioned in the interbody space between a first and second vertebrae.
`
`Ex. 1001, Abst., 12:33–34. One embodiment of the claimed spinal fusion implant
`
`is illustrated below:
`
`Ex. 1001, Fig. 2 (annotated).
`
`At times, Patent Owner has suggested that the ’156 patent is narrower than
`
`
`
`the claims. Ex. 1039, 13. The ’156 patent refers to “a lateral (trans-psoas) approach
`
`5
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`to the spine,” but adds that “posterior, anterior, antero-lateral, and postero-lateral”
`
`approaches may be used “without departing from the scope of the present invention
`
`(depending upon the sizing of the implant 10).” Ex. 1001, 5:29–35. The claimed
`
`implant may also “be provided in any number of suitable shapes and sizes depending
`
`upon the particular surgical procedure or need” and “may be dimensioned for use in
`
`the cervical and/or lumbar spine without departing from the scope of the present
`
`invention.” Id., 2:12–17, 12:21–26 (also suitable for thoracic spine). Nothing in the
`
`claims limits them to a lateral implant.
`
`The ’156 patent provides exemplary sizes following common knowledge of
`
`spinal anatomy: for lumbar use the implant is larger, having “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,” and for cervical use it is smaller, having “a width about 11
`
`mm, a height ranging between 5 and 12 mm, and a length about 14 mm.” Id., 2:17–
`
`25. The implant sizes and shapes discussed in the ’156 patent are no revelation.
`
`These dimensions were widely-reported nearly two decades earlier by Berry et al. A
`
`Morphometric Study of Human Lumbar and Selected Thoracic Vertebrae, 12 SPINE,
`
`362–367 (1987) (“Berry”), an often-cited study of “selected human vertebrae
`
`undertaken” for the purpose of “provid[ing] data for implant design.” Ex. 1022,
`
`Abst., 364.
`
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`6
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`The ’156 patent says the claimed implants may have “any number of
`
`additional features for promoting fusion.” Ex. 1001, 2:26–28. These include:
`
` “apertures extending between the upper and lower vertebral bodies
`
`which allow a boney bridge to form through the spinal fusion implant,”
`
`id., 2:28–30;
`
` “anti-migration features to prevent spinal fusion implant from
`
`migrating or moving from the disc space after implantation,” (e.g.,
`
`“angled teeth formed along the upper and/or lower surfaces of the spinal
`
`fusion implant and/or spike elements disposed partially within and
`
`partially outside the upper and/or lower surfaces of the spinal fusion
`
`implant”), id., 2:41–48; and
`
` “any number of features for enhancing the visualization of the implant
`
`during and/or after implantation into a spinal target site,” such as,
`
`“spike elements used for anti-migration, which may be manufactured
`
`from any of a variety of suitable materials, including but not limited to
`
`a metal, ceramic, and/or polymer material, preferably having
`
`radiopaque characteristics.” Id., 2:54–3:62.
`
`While the ’156 patent acknowledges that autologous and allograft bone grafts
`
`were “widely used for intervertebral implant[s] for lumbar fusion,” (id., 1:38–39), it
`
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`7
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`does not acknowledge any of the dozens of non-bone spinal fusion implants known
`
`to those of skill in the art. Some art teaching such implants are discussed below.
`
`IV. THE PRIOR ART
`
`A. Brantigan
`Brantigan (Ex. 1007) issued in March 1993. Patent Owner is no stranger to
`
`Brantigan, having relied on it to successfully invalidate claims in a different patent
`
`discussing spinal implants. See Ex. 1017, 36; Ex. 1018, 35; Ex. 1019, 9–10.
`
`Brantigan discloses spinal fusion implants for insertion between adjacent
`
`vertebrae composed of “rigid biologically acceptable and inactive material,
`
`preferably a radiolucent plastics material.” Ex. 1007, 4:3–4. Brantigan’s implant is
`
`“suitable for anterior, posterior or lateral placement in any area of the spine requiring
`
`replacement of disc or vertebral body.” Id., 2:56–59. It is “generally shaped and
`
`sized to conform with the disc space between adjoining vertebrae in a vertebral
`
`column.” Id., 4:5–8; see also id., Figs. 10–11, 13–14, Abst., 1:18–23, 1:54–56;
`
`1:68–2:4, 2:19–22, 7:29–34.
`
`Patent Owner has made numerous admissions about Brantigan’s teachings.
`
`Patent Owner concedes that Brantigan “describes an implant that is ‘shaped to
`
`conform with the general outline perimeter of the vertebrae,’ is ‘dimensionally
`
`similar to normal vertebral bodies,’ has ‘dimensions in the same ratio as normal
`
`vertebral bodies,’ and is ‘sized to match the height of an average disc.’” Ex. 1035,
`
`
`
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`8
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`49. Patent Owner also admits Brantigan’s implant would have “a length
`
`substantially greater than the depth of the vertebrae” and “a height for contacting
`
`each of the two adjacent vertebrae.” Id. A person having ordinary skill in the art
`
`(“POSA”), therefore, would have understood Brantigan to teach a longitudinal
`
`length greater than the maximum lateral width of the implant, including a length
`
`greater than 40 mm and a width of approximately 18 mm. Ex. 1002, ¶¶ 165-175,
`
`202, 209-211.
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`B. Baccelli
`Baccelli (Ex. 1008) was filed in April 2002 and published in February 2003.
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`Baccelli discloses a spinal fusion implant that “can be made of a material that is
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`transparent to X-rays,” like PEEK. Ex. 1008, [0050]. Baccelli’s implant includes a
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`distal wall, a proximal wall, and two sidewalls (id., [0033]–[0034]), in addition to
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`upper and lower surfaces that contain anti-migration elements in the form of teeth
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`that “limit[] the ability of the cage to move forwards from its position” after “the
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`cage is put into place between the vertebrae from behind” (id., [0045]). Additionally,
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`Baccelli’s “implant has a central hole extending from one of the main faces to the
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`other [e.g., from the top to the bottom surface]” (id., [0012]) that can “receive the
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`[bone] graft that facilitates vertebral bone integration” (id., [0013]).
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`Baccelli explains that the spinal fusion implant “can have one or more markers
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`47 included therein . . . to identify the position and/or the presence of the implant
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`when X-rays are taken during or after the operation.” Id., [0050], Figs. 1–5, 8, 9. In
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`addition to markers, Baccelli also describes how “spikes 24 can be inserted and fixed
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`rigidly in the ducts formed in the cage. They too can be made of a material that is
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`opaque to X-rays.” Id., [0051]. The four radiopaque markers (24, 47) of Baccelli
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`located in the proximal (4b), distal (4a), and side (16, 4) walls are illustrated below:
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`Ex. 1008, Figs. 1–2 (annotated); see also Figs. 3–5, 8, 9.
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`C. Berry
`Berry was published in the Journal “Spine” in 1987. (Ex. 1022.) The study
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`discussed in Berry 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
`spinal instrumentation. The authors’ interest in spinal
`implants and fixation devices resulted in a need for more
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`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 and
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`inferior surfaces of the vertebral body, as well as at the midpoint between them) from
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`240 different vertebrae. Id., 362–363, Fig. 1; Ex. 1002, ¶¶ 102, 169-172.
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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. Michelson ’973
`U.S. Patent 5,860,973 to Michelson (“Michelson ’973”) (Ex. 1032) was filed
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`in October 1996 and issued in January 1999. Michelson ’973 describes a spinal
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`fusion implant “dimensioned to fit within the disc space created by removal of the
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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 ’973 refers to such a laterally-
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`inserted implant as a “translateral spinal fusion implant.” Id., 3:1–7. A cross-
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`sectional view of a cylindrical embodiment of Michelson ’973 is:
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`Id., Fig. 4.
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`Michelson ’973 explains, “[t]he dimensions of the translateral spinal fusion
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`implant of the present invention permits a single implant to be inserted by a single
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`procedure into the spine and to engage more of the adjacent vertebrae. As a result,
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`the translateral spinal fusion implant of the present invention has more surface area
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`of contact and thus permits greater stability so as to withstand torque.” Id., 3:47–53.
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`Additionally, Michelson ’973 teaches that translateral implants “are safer to use than
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`implants inserted from the front or back as the aorta and vena cava lie anterior to the
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`spine and the dural sac and nerves posteriorly, all of which structures are simply
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`avoided in the lateral approach.” Id., 3:56–60.
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`To maximize safety of the lateral approach to the spine, Michelson ’973
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`discloses a minimally invasive method of insertion: “the translateral spinal fusion
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`implant of the present invention may be inserted into the disc space through a hollow
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`tube which is engaged to the lateral aspect of the spine through a lateral, anterior, or
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`anterolateral incision making the procedure safe and simple.” Id., 3:61–65.
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`As an alternative to the cylindrical embodiment, Michelson ’973 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
`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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`Additionally, as illustrated below, Michelson ’973 teaches that such implants
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`may have a “narrower width such that more than one spinal fusion implant 1000 may
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`be combined in a modular fashion for insertion within the disc space.”
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`Id., 10:50–55, Figs. 18–19.
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`V.
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`PROSECUTION HISTORY
`Through a series of continuations, the ’156 claims priority to Provisional App.
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`No. 60/557,536 (the “Provisional”), filed March 29, 2004. The sole independent
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`claim requires a spinal fusion implant having a “longitudinal length [that] is greater
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`than said maximum lateral width.” Ex. 1001, 12:45–51. This feature is absent from
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`the Provisional. The Provisional disclosed only the following dimensions: for
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`lumbar, “a length ranging between 9 and 18 mm, a height ranging between 8 and 16
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`mm, and a width ranging between 25 and 45 mm,” and for cervical, “a length about
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`11 mm, a height ranging between 5 and 12 mm, and a width about 14 mm.” Ex.
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`1026, 4:18–5:2, 11:12–14, 20:11–14. While dependent claims 5–8 and 9 of the ’156
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`patent require a length of 40 mm and a maximum width of approximately 18 mm,
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`these measurements are not disclosed in the Provisional.
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`Finally, to the extent Patent Owner contends that the ’156 patent is limited to
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`spinal implants for “a lateral (trans-psoas) approach to the spine” (Ex. 1001, 5:29–
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`35, 11:58–63)—and it is not—this disclosure is also not in the Provisional.
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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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`In that application, Patent Owner added new matter. Ex. 1020, 1234 [4:16–21] (new
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`lengths), 1241 [11:15–18] (new lengths), 1242 [12:2–5] (new “lateral (trans-
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`psoas)”), 1249 [19:7–9] (new lengths), 1254–55 [24:20–25:16] (new lengths, new
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`“lateral (trans-psoas),” and new “enhanced visualization features of the implants”),
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`Figures 18–23 (newly added).
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`During prosecution of the ’891 patent, the examiner rejected the claims as
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`obvious over Michelson ’973 in view of U.S. Patent 6,1