`
`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. IPR2019-00546
`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
`INTRODUCTION ........................................................................................... 1
`I.
`PETITIONER’S STANDING ......................................................................... 6
`II.
`III. THE ’334 PATENT ......................................................................................... 6
`IV. THE PRIOR ART ............................................................................................ 8
`A.
`Frey ........................................................................................................ 8
`B.
`Brantigan ............................................................................................. 10
`C. Michelson ............................................................................................ 11
`D.
`Berry .................................................................................................... 14
`E.
`Baccelli ................................................................................................ 15
`PROSECUTION HISTORY ......................................................................... 17
`V.
`VI. PREVIOUS CHALLENGES ........................................................................ 18
`VII.
`IDENTIFICATION OF CHALLENGES ...................................................... 22
`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. ................................................... 27
`2. Michelson is a prior art patent. ................................................. 27
`3.
`Berry is a prior art printed publication. ..................................... 27
`4.
`Baccelli is a prior art printed publication. ................................. 28
`5.
`Frey is a prior art printed publication ....................................... 28
`Level of Ordinary Skill in the Art ....................................................... 28
`B.
`C. Ground 1: Claim 16 is Rendered Obvious by Frey in View of
`Michelson and Baccelli. ...................................................................... 29
`1. Motivation to Combine Frey and Michelson with Baccelli ..... 29
`2.
`Claim 1 ...................................................................................... 31
`3.
`Claim 16 .................................................................................... 32
`
`i
`
`

`

`D. Ground 2: Claim 16 is Rendered Obvious by Brantigan in View of
`Baccelli, Berry, and Michelson ........................................................... 38
`1. Motivation to Combine Brantigan with Baccelli, Berry, and
`Michelson .................................................................................. 38
`Claim 1 ...................................................................................... 42
`2.
`Claim 16 .................................................................................... 63
`3.
`XII. THERE ARE NO SECONDARY CONSIDERATIONS OF
`NONOBVIOUSNESS ................................................................................... 69
`XIII. MANDATORY NOTICES – 37 C.F.R. § 42.8 ............................................. 70
`A.
`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) .......................... 70
`B.
`Related Matters Under 37 C.F.R. § 42.8(b)(2) ................................... 70
`C.
`Lead and Backup Counsel Under 37 C.F.R. § 42.8(b)(3) ................... 71
`D.
`Service Information Under 37 C.F.R. § 42.8(b)(4) ............................. 71
`XIV. PAYMENT OF FEES – 37 C.F.R. § 42.103 ................................................. 71
`XV. CONCLUSION .............................................................................................. 71
`
`
`
`
`
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Cardpool, Inc. v. Plastic Jungle, Inc.,
`817 F.3d 1316 (Fed. Cir. 2016) .......................................................................... 25
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 31
`MaxLInear, Inc. v. CF CRESPE LLC,
`880 F.3d 1373 (Fed. Cir. 2018) .......................................................................... 31
`NuVasive, Inc. v. Alphatec Holdings, Inc. et al.,
`Case No. 3:18-cv-00347-CAB-MDD (S.D. Cal.) .............................................. 70
`The Ohio Willow Wood Co. v. Alps South, LLC,
`735 F.3d 1333 (Fed. Cir. 2013) .......................................................................... 32
`Trustees in Bankr. of N. Am. Rubber Thread Co. v. United States,
`593 F.3d 1346 (Fed. Cir. 2010) .......................................................................... 25
`Warsaw Orthopedic, Inc. et al. v. NuVasive, Inc.,
`Case No. 3:12-cv-002738-CAB-MDD (S.D. Cal.) ............................................ 70
`Statutes
`35 U.S.C. § 102(a) ................................................................................................... 28
`35 U.S.C. § 102(b) ............................................................................................. 27, 28
`35 U.S.C. § 103(a) ....................................................................................... 18, 19, 22
`35 U.S.C. § 282(b) ................................................................................................... 26
`35 U.S.C. §§ 311–319 ................................................................................................ 1
`35 U.S.C. § 318(b) ..................................................................................................... 1
`Other Authorities
`37 C.F.R. § 42 ............................................................................................................ 1
`
`iii
`
`

`

`37 C.F.R. § 42.8 ....................................................................................................... 70
`37 C.F.R. § 42.8 ....................................................................................................... 70
`37 C.F.R. § 42.8(b)(1) .............................................................................................. 70
`37 C.F.R. § 42.8(b)(1) .............................................................................................. 70
`37 C.F.R. § 42.8(b)(2) .............................................................................................. 70
`37 C.F.R. § 42.8(b)(2) .............................................................................................. 70
`37 C.F.R. § 42.8(b)(3) .............................................................................................. 71
`37 C.F.R. § 42.8(b)(3) .............................................................................................. 71
`37 C.F.R. § 42.8(b)(4) .............................................................................................. 71
`37 C.F.R. § 42.8(b)(4) .............................................................................................. 71
`37 C.F.R. § 42.73(d)(3)(i) ........................................................................................ 31
`37 C.F.R. § 42.73(d)(3)(i) ........................................................................................ 31
`37 C.F.R. § 42.100(b) .............................................................................................. 26
`37 C.F.R. § 42.100(b) .............................................................................................. 26
`37 C.F.R. § 42.103 ................................................................................................... 71
`37 C.F.R. § 42.103 ................................................................................................... 71
`37 C.F.R. § 42.104(b) .............................................................................................. 26
`37 C.F.R. § 42.104(b) .............................................................................................. 26
`37 C.F.R. § 42.104(b)(3) .......................................................................................... 26
`37 C.F.R. § 42.104(b)(3) .......................................................................................... 26
`83 Fed. Reg. 51340, 51343 (Oct. 11, 2018) ............................................................. 26
`83 Fed. Reg. 51340, 51343 (Oct. 11, 2018) ............................................................. 26
`
`
`
`iv
`
`iV
`
`

`

`
`
`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”)
`
`v
`
`

`

`Exhibit No.
`1022
`
`1023
`
`1024
`
`1025
`1026
`1027
`1028
`1029
`
`1030
`
`1031
`1032
`1033
`1034
`1035
`
`1036
`
`1037
`1038
`1039
`1040
`1041
`
`1042
`1043
`
`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
`
`RESERVED
`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)
`RESERVED
`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
`RESERVED
`
`vi
`
`

`

`Exhibit No.
`1044
`1045
`1046
`
`1047
`1048
`
`PETITIONER’S EXHIBIT LIST
`Brief Description
`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
`IPR2013-00507, Decision to Institute, Paper No. 7
`
`
`
`
`vii
`
`

`

`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 claim 16 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 claim
`
`unpatentable. Accordingly, Petitioner requests that the Board institute trial and
`
`cancel the challenged claim.
`
`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,
`
`1
`
`

`

`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:
`
`2
`
`

`

`
`
`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 claim 16 is not patentably distinct from the claims the
`
`Board and Federal Circuit deemed invalid based on the combination of Frey and
`
`Michelson. This claim is drawn to the spinal fusion implant of invalid claim 1 that
`
`additionally has a fourth radiopaque marker positioned in the central region of the
`
`implant at a position spaced apart from the third radiopaque marker. Ex. 1001, cl.
`
`16. This limitation is expressly disclosed in Baccelli, as described below.
`
`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. Further,
`
`Brantigan describes implants for use in the lumbar spine (Ex. 1007, 1:65–68). The
`
`3
`
`

`

`Brantigan implants are “generally shaped and sized to conform with the disc space
`
`between adjoining vertebrae in a vertebral column” (id., 4:5–8, 2:2–4), “with medial-
`
`lateral and anterior-posterior dimensions in the same ratio as normal vertebral
`
`bodies” (id., 1:20–21).
`
`Id., Fig. 6.
`
`
`
`The medial-lateral dimensions (i.e., longitudinal length) of the Brantigan
`
`spinal fusion implant and normal vertebral bodies—as widely reported by 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”—was greater than 40 mm for the lumbar region. Ex. 1022, Abst.,
`
`364, Table 1 (describing the mean longitudinal length of the L1 vertebra as 45.2 mm
`
`and the mean longitudinal length of the L5 vertebra as 53.4 mm).
`
`Michelson’s disclosure of a long-and-narrow modular implant coupled with
`
`the known depth of the human vertebrae in the lumbar region—as reported by
`
`Berry—would have motivated a person of ordinary skill in the art (“POSA”) to
`
`create the long-and-narrow implant of Brantigan in a modular fashion as taught by
`
`4
`
`

`

`Michelson to have a width of approximately 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. The resulting implant would have a longitudinal length at least two and a
`
`half times greater than its maximum lateral width. See infra § XI.D.f.
`
`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
`
`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:
`
`5
`
`

`

`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 claim. Id.; Ex. 1033; Ex. 1034. These combinations render the
`
`challenged claim unpatentable.
`
`Petitioner requests the Board institute inter partes review and cancel claim 16
`
`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 an amended
`
`complaint served on Petitioner on September 13, 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
`
`6
`
`

`

`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., 5:10–15, 5:29–33.
`
`
`
`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., 5:17–19. In another
`
`embodiment, the spinal fusion implant includes four pairs of radiopaque markers—
`
`described as “spike elements” in the specification: one at least partially positioned
`
`in the distal wall, a second at least partially positioned in the proximal wall, a third
`
`at least partially positioned in the central region, and a fourth positioned in the central
`
`region at a position spaced apart from the third marker. Id., cl. 1, 16, 6:27-38; see
`
`also Fig. 2. The implant sizes and shapes discussed in the ’334 patent are no
`
`revelation. These implant sizes were described decades earlier in Frey, Michelson,
`
`7
`
`

`

`Brantigan, and Berry. Similarly, the inclusion of four radiopaque markers was also
`
`unremarkable because Baccelli previously disclosed a spinal fusion implant having
`
`four radiopaque markers positioned in the same locations within the implant as
`
`claimed in the ’334 patent.
`
`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
`
`

`

`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 a number of radiopaque markers, and in one example, the
`
`radiopaque markers are located in the proximal wall, the distal wall, and the central
`
`region of the implant. Id., ¶ [0156], Figs. 59–62 (radiopaque markers denoted
`
`“1438”).
`
`9
`
`

`

`B. 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 composed of “rigid biologically
`
`acceptable and inactive material, preferably a radiolucent plastics material” for
`
`insertion between adjacent vertebrae. 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 conceded 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,
`
`49. Patent Owner also admitted that Brantigan discloses “a length substantially
`
`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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`10
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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, ¶ 171.
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`C. Michelson
`Michelson (Ex. 1032) issued in January 1999. Michelson 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 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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`11
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`Id., Fig. 4.
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`
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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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`12
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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
`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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`
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`13
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`

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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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`
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`Id., 10:50–55, Figs. 18–19.
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`D. 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
`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.
`
`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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`14
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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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`
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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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`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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`

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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. The two markers positioned in
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`the central region are spaced apart from each other. Id.
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`
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`16
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`V.
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`PROSECUTION HISTORY
`
`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 material and Kuntz disclosed a radiopaque marker. Ex.
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`1020, 245–253. However, because Kuntz did not specify where to place the
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`radiopaque marker, the examiner