Trials@uspto.gov
`571-272-7822
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`Paper 16
`Date: September 23, 2013
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`____________
`
`Case IPR2013-00208
`Patent 8,251,997 B2
`____________
`
`
`Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C. SIU,
`Administrative Patent Judges.
`
`SIU, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`
`
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`

`

`IPR2013-00208
`Patent 8,251,997 B2
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`
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`I.
`
`BACKGROUND
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`
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`
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`NuVasive, Inc. (“Petitioner”) requests inter partes review of claims 1-8 of
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`U.S. Patent No. 8,251,997 (Ex. 1002, “the ’997 Patent”) pursuant to 35 U.S.C.
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`§§ 311 et seq.1 Warsaw Orthopedic, Inc. (“Patent Owner”) filed a preliminary
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`response (“Prelim. Resp.”) on June 25, 2013. Paper No. 11. We have jurisdiction
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`under 35 U.S.C. § 314. The standard for instituting inter partes review is set forth
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`in 35 U.S.C. § 314 (a) which provides:
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`THRESHOLD -- The Director may not authorize an inter partes review
`to be instituted unless the Director determines that the information
`presented in the petition filed under section 311 and any response
`filed under section 313 shows that there is a reasonable likelihood that
`the petitioner would prevail with respect to at least 1 of the claims
`challenged in the petition.
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`
`
`We determine based on the record that there is a reasonable likelihood that
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`Petitioner would prevail in showing unpatentability of all challenged claims 1-8.
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`Accordingly, we authorize institution of an inter partes review of claims 1-8 of the
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`’997 patent.
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`
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`A.
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`Related Proceedings
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`Petitioner indicated that the ’997 patent is involved in co-pending litigation
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`captioned Warsaw Orthopedic, Inc. et al. v. NuVasive, Inc. (originally filed in N.D.
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`Ind. as Case No. 3:12-cv-00438-JD-CAN on Aug. 17, 2012 and transferred to S.D.
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`Cal. on Nov. 8, 2012 as Case No. 3:12-cv-02738-CAB (MDD)). Pet. 1. Petitioner
`
`
`1 We cite to Petitioner’s Corrected Petition for Inter Partes Review of United States
`Patent No. 8,251,997, filed April 3, 2013. Paper No. 5.
`
`2
`
`
`

`

`IPR2013-00208
`Patent 8,251,997 B2
`
`
`also filed a petition seeking inter partes review of claims 9-30 of the ’997 patent
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`
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`(IPR2013-00206).
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`
`
`
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`B.
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`The ’997 Patent (Ex. 1002)
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`The ’997 patent describes methods and instrumentation for performing
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`surgery on the spine along its lateral aspect. Ex. 1002, 3:34-36; Figs. 1 and 2. A
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`guide pin 30 is inserted from the lateral approach to the spine and functions as a
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`guide post for a distractor 100. The distractor 100 is placed over the guide pin and
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`inserted into the disc space to distract the vertebrae. Ex. 1002, 8:52-53; 9:12-14;
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`10:10-12; Figs. 2-5. An extended outer sleeve 140 is placed over the distractor and
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`inserted into the disc space. Ex. 1002, 10:22-25; Fig. 12. A spinal implant I is
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`introduced through the extended outer sleeve and installed across the disc space.
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`Ex. 1002, 15:64-65; 16:24-26; Figs. 19, 22, 23, 30, and 30A.
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`
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`C.
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`Exemplary Claim
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`Of the challenged claims, claim 1 is an independent claim and each of
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`dependent claims 2-8 depend either directly or indirectly from claim 1. Claim 1 is
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`exemplary of the claimed subject matter of the ’977 patent and is reproduced as
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`follows:
`
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`1. A method comprising:
`making an incision in skin of a patient's body to gain access to a disc
`space between two adjacent vertebrae located within a portion of one of a
`human thoracic or lumbar spine, said portion of one of the human thoracic or
`lumbar spine defined by the two adjacent vertebrae having an anterior aspect
`and a posterior aspect being divided by a first plane through transverse
`processes of the two adjacent vertebrae, the disc space having a depth
`measured from an anterior aspect to a posterior aspect of the disc space, each
`
`3
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`

`

`IPR2013-00208
`Patent 8,251,997 B2
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`
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`of the two adjacent vertebrae having a vertebral body having a transverse
`width perpendicular to the depth of the disc space, said incision being
`proximate an intersection of the skin and a path having an axis lying in a
`coronal plane passing through a lateral aspect and a medial aspect of the two
`adjacent vertebrae and anterior to the transverse processes;
`advancing a first surgical instrument having a length into the body of
`the patient through said incision until proximate the disc space along said
`path and anterior to the transverse processes;
`advancing a second surgical instrument into the body of the patient
`through said incision and over at least a portion of the length of said first
`surgical instrument, said second surgical instrument having a distal end and
`an opposite proximal end and a length therebetween, said second surgical
`instrument having a passageway configured to receive a portion of the length
`of said first surgical instrument therein;
`advancing a third surgical instrument into the body of the patient
`through said incision and over at least a portion of the length of said second
`surgical instrument, said third surgical instrument having a distal end for
`insertion over said second surgical instrument and an opposite proximal end;
`positioning said third surgical instrument such that said distal end of
`said third surgical instrument is proximate a lateral aspect of the vertebral
`bodies of the two adjacent vertebrae; and
`inserting, from the position anterior to the transverse processes of the
`two adjacent vertebrae and along said path, a non-bone interbody intraspinal
`implant through said third surgical instrument into a laterally facing opening
`in said portion of one of the human thoracic or lumbar spine, said implant
`having an insertion end for insertion first into the laterally facing opening
`and a trailing end and a length therebetween, the length of said implant
`being sized to occupy substantially the full transverse width of the vertebral
`bodies of the two adjacent vertebrae, the length of said implant being greater
`than the depth of the disc space, said implant having opposed surfaces
`oriented toward each of the vertebral bodies of the two adjacent vertebrae
`when inserted therebetween, said opposed surfaces having bone engaging
`projections configured to engage the vertebral bodies of the two adjacent
`vertebrae, said implant having a maximum height between said bone
`engaging projections of said opposed surfaces and perpendicular to the
`length of said implant, the length of said implant being greater than the
`maximum height of said implant.
`
`
`
`4
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`

`

`IPR2013-00208
`Patent 8,251,997 B2
`
`
`
`The Prior Art
`
`D.
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`
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`Petitioner relies on the following prior art:
`
`US 4,545,374 (Jacobson)
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`US 5,192,327 (Brantigan)
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`US 4,917,704 (Frey)
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`
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`Oct. 8, 1985
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`March 9, 1993
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`April 17, 1990
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`US 5,015,247 (Michelson ’247)
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`May 14, 1991
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`US 4,573,448 (Kambin)
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`
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`March 4, 1986
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`US 5,772,661 (Michelson ’661)
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`June 30, 1998
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`US 8,343,224 B2 (Lynn)
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`
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`Jan. 1, 2013
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`WO 94/28824 (Michelson PCT)
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`Dec. 22, 1994
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`EP 0567424 A1 (Alacreu)
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`Oct. 27, 1993
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`
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`Ex. 1004
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`Ex. 1006
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`Ex. 1007
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`Ex. 1008
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`Ex. 1013
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`Ex. 1015
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`Ex. 1016
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`Ex. 1014
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`Ex. 1009
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`E. Baulot, P. Trouilloud, A. Bernard, and P. Grammont, “Adjuvant Anterior
`Spinal Fusion Via Thoracoscopy. Technical Note Concerning a Case,” Lyon
`Chir., 90/S/ 1994 (“Baulot”) (Ex. 1011)
`
`Daniel Rosenthal, Raul Rosenthal, and Anna de Simone, “Removal of a
`Protruded Thoracic Disc Using Microsurgical Endoscopy,” 19(9) Spine,
`1087 (1994) (“Rosenthal”) (Ex. 1012)
`
`Hansjorg F. Leu and Adam Schreiber; “Percutaneous Fusion of the Lumbar
`Spine: A Promising Technique,” 6(3) Spine: State of the Art Reviews,
`(September 1992) (“Leu”) (Ex 1005.)
`
`
`
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`E.
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`The Alleged Grounds of Unpatentability
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`Petitioner asserts the following grounds of unpatentability:
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`
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`Reference(s)
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`Basis
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`Claims challenged
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`Jacobson, Leu, and Brantigan §103
`Jacobson, Leu, and Michelson
`§103
`’247
`
`1 and 8
`1 and 8
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`5
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`

`

`IPR2013-00208
`Patent 8,251,997 B2
`
`Baulot, Rosenthal, and
`Kambin
`Michelson PCT, Jacobson,
`and Brantigan
`Michelson ’661 and Lynn
`Jacobson, Leu, Brantigan, and
`Frey
`Jacobson, Leu, Michelson
`’247, and Alacreu
`Baulot, Rosenthal, Kambin,
`and Frey
`Michelson PCT, Jacobson,
`Brantigan, and Alacreu
`
`
`
`
`§103
`
`§103
`
`§ 103
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
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`
`
`
`
`1 and 8
`
`1 and 8
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`1 and 8
`2-7
`
`2-7
`
`2-7
`
`2-7
`
`
`F.
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`Claim Interpretation
`
`Consistent with the statute and the legislative history of the Leahy-Smith
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`America Invents Act, Pub. L. 112-29, 125 Stat. 284, 329 (2011) (“AIA”), the
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`Board interprets claim terms by applying the broadest reasonable construction in
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`the context of the specification in which the claims reside. 37 C.F.R. § 42.100(b);
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`see Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14,
`
`2012).
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`We give claim terms their ordinary and customary meaning as would be
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`understood by one of ordinary skill in the art in the context of the entire patent
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`disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en
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`banc). That ordinary and customary meaning applies unless the inventor, as their
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`own lexicographer, has set forth a special meaning for a term in the specification.
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`Multiform Desicants, Inc., v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998);
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`York Prods., Inc. v. Cent. Tractor Farm & Family Ctr., 99 F.3d 1568, 1572 (Fed.
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`Cir. 1996). When an inventor acts as a lexicographer, the definition must be set
`
`6
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`

`

`IPR2013-00208
`Patent 8,251,997 B2
`
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`forth with reasonable clarity, deliberateness, and precision. Ranishaw PLC v.
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`
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`Marposs Societa’ per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998).
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`In assessing the merit of Petitioner’s and Patent Owner’s arguments, we
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`have construed the following claim limitations in light of the specification of the
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`’997 patent.
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`1.
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`“distal end of said third surgical instrument is proximate a lateral
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`aspect of the vertebral bodies”
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`Independent claim 1 requires positioning a third surgical instrument such
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`that the distal end of the third surgical instrument is proximate a lateral aspect of
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`the vertebral bodies of the two adjacent vertebrae. Petitioner contends that the
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`“lateral aspect of the vertebral bodies” encompasses both the lateral aspect of the
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`vertebral bodies on the side of the skin incision and the lateral aspect of the
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`vertebral bodies on the side opposite that of the skin incision. Pet. 5. Claim 1 does
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`not require a specific lateral aspect of the vertebral bodies. Accordingly, we adopt
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`Petitioner’s proposed construction for “lateral aspect of the vertebral bodies” to
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`include either the lateral aspect of the vertebral bodies on the side of the skin
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`incision or the lateral aspect of the vertebral bodies on the opposite side of the skin
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`incision.
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`
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`2.
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`“the length of said implant being sized to occupy substantially the full
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`transverse width of the vertebral bodies of the two adjacent vertebrae”
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`Independent claim 1 requires that the length of the implant is sized to occupy
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`substantially the full transverse width of the vertebral bodies. Petitioner contends
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`that the length of the implant as recited in claim 1 encompasses a length that is less
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`than the full transverse width of the vertebral bodies. Claim 1 recites a length
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`sized to occupy substantially the full transverse width of the vertebral bodies but
`
`7
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`

`

`IPR2013-00208
`Patent 8,251,997 B2
`
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`does not recite a length sized to occupy only the full transverse width of the
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`
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`vertebral bodies (and no less). Claim 9 merely requires that the length occupies
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`“substantially” the full transverse width as opposed to requiring the length to
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`occupy the full transverse width. We, therefore, agree that one of skill in the art
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`would have understood the length to occupy something less than the full transverse
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`width. One of skill in the art would have understood also that, if the length
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`occupies “substantially” the full transverse width, the length may occupy the full
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`transverse width but also may occupy only a length that is less than the full
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`transverse width of the vertebral bodies by an insubstantial amount.
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`
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`3.
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`“the length of said implant being greater than the depth of the disc
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`space”
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`Independent claim 1 requires that the length of the implant is greater than the
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`depth of the disc space, the depth of the disc space being measured from the
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`anterior aspect to the posterior aspect of the disc space. Petitioner contends with
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`extrinsic evidence2 that claim 1 requires that the length of the implant is greater
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`than the depth of the disc space because “for typical vertebrae the full transverse
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`width of the two vertebrae adjacent a disc space is greater than the depth of the
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`disc space.” Pet. 6, citing Ex. 1002, Figs. 30, 30A, 32, 33 and Ex. 1001, Exhibit C.
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`Claim 1 recites that the length of the implant is greater than the depth of the disc
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`space. Accordingly, consistent with the plain meaning of the claim, we adopt
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`Petitioner’s proposed construction for the length of the implant to be greater than
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`the depth of the disc space.
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`
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`
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`2 Declaration of Dr. Paul McAfee. Ex. 1001.
`8
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`

`

`IPR2013-00208
`Patent 8,251,997 B2
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`
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`II. ANALYSIS
`
`
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`A. Grounds Based at least in part on Jacobson, Leu, and one of Michelson ’247
`or Brantigan
`
`Petitioner contends that independent claims 1 and 8 are unpatentable under
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`35 U.S.C. § 103(a) over Jacobson, Leu, and Michelson ’247 and dependent claims
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`2-7 are unpatentable under 35 U.S.C. § 103(a) over Jacobson, Leu, and one of the
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`combination of Michelson ’247 and Alacreu or the combination of Brantigan and
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`Frey. Based on our review of the record before us, we determine that there is a
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`reasonable likelihood that Petitioner will prevail with respect to (1) claims 1 and 8
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`on the ground that these claims are unpatentable over the combination of Jacobson,
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`Leu, and one of Michelson ’247 or Brantigan and (2) claims 2-7 on the ground that
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`these claims are unpatentable over the combination of Jacobson, Leu, and one of
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`the combination of Michelson ’247 and Alacreu or the combination of Brantigan
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`and Frey.
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`Claims 1 and 8
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`Jacobson describes accessing a disc space between two adjacent vertebrae
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`by advancing laterally a needle and speculum into the disc space to create a body
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`channel through which a cannula is introduced. Ex. 1004, 5:1-3, 28-31, 49-51;
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`6:3-5; 8:53-55, 68; 9:13-14; Figs. 1-6, 9-11. The cannula “acts as a conduit for
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`insertion of surgical instruments through its lumen or bore” to perform “surgical
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`procedures in the spinal column . . . such as disk realignment, fusion, or any other
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`surgical or diagnostic procedure.” Ex. 1004, 6:5-7, 11-13. Petitioner explains with
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`extrinsic evidence that a “fusion” procedure “necessarily includes the insertion of
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`an implant into the disc space.” Pet. 27; Ex. 1001, ¶¶ 27, 31. Patent Owner does
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`not refute Petitioner’s contention.
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`9
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`

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`IPR2013-00208
`Patent 8,251,997 B2
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`
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`Leu describes percutaneous fusion of the lumbar spine by introducing
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`
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`laterally multiple cannulas “of increasing diameter [that] are stepwise overslipped,
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`one upon the other” to “permit the necessary approach to the intervertebral space.”
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`Ex. 1005, p. 596. Leu also discloses the use of an “interbody graft” containing
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`“porous apatites” and “bone-inducing protein.” Ex. 1005, p. 603.
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`Michelson ’247 discloses an “artificial fusion implant to be placed into the
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`intervertebral space.” Ex. 1008, 1:5-6. As indicated by Petitioner, the artificial
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`fusion implant of Michelson ’247 is introduced from the posterior aspect of the
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`vertebrae and occupies substantially the full dimension of the vertebral bodies in
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`the direction of insertion of the artificial fusion implant (Ex. 1008, 8:37-39; Figs. 3,
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`4, 4d, and 5.)
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`Brantigan discloses “vertebral prosthetic implant devices suitable for . . .
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`lateral placement in any area of the spine.” Ex. 1006, 2:56-58. The Petitioner
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`explains that Brantigan discloses inserting into the intervertebral space an implant
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`that is “generally oval shaped to conform with the general outline perimeter of the
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`vertebrae” and “generally conforming in shape and size with opposing hard end
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`plates of vertebrae on which it is to be seated.” Pet. 19, citing Ex. 1006, 2:2-4,
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`8:57-59.
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`Petitioner has shown how the prior art describes (1) gaining “access to a disc
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`space between two adjacent vertebrae . . . through a lateral aspect” by “advancing a
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`first surgical instrument,” (2) “a second surgical instrument . . . over at least a
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`portion of the . . . first surgical instrument,” (3) “advancing a third surgical
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`instrument . . . over at least a portion of the length of said second surgical
`
`instrument,” and (4) “inserting . . . [an] implant through said third surgical
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`instrument into a laterally facing opening” created by the third surgical instrument.
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`As described above, Jacobson discloses advancing a needle, a speculum, and a
`
`10
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`

`

`IPR2013-00208
`Patent 8,251,997 B2
`
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`cannula to access a disc space laterally, while Leu discloses that one of ordinary
`
`
`
`skill in the art would have known to introduce multiple cannulas that are “stepwise
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`overslipped” (or each cannula advanced over at least a portion of the length of the
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`previously introduced cannula) to “permit the necessary approach to the
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`intervertebral space.” Petitioner also articulates reasoning with rational
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`underpinning to justify support for the conclusion of obviousness over the
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`combination of Jacobson and Leu. Pet. 16-17.
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`Petitioner also has shown how the prior art describes inserting an intraspinal
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`implant through the third surgical instrument into a laterally facing opening of the
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`spine. As indicated by Petitioner and described above, Jacobson discloses a
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`laterally introduced cannula through which a spinal fusion procedure is performed.
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`Petitioner explains that an intraspinal implant is inserted necessarily in a spinal
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`fusion procedure, which Patent Owner does not contest. Leu also discloses a
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`spinal fusion procedure that includes the use of an “interbody graft.” Ex. 1005, p.
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`603.
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`Further, Petitioner has explained that it would have been obvious to one of
`
`ordinary skill in the art, given the combination of Jacobson, Leu, and one of
`
`Michelson ’247 or Brantigan, to have inserted into an intervertebral space an
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`implant that occupies substantially the full transverse width of the vertebral bodies
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`and that has a length that is greater than the depth of the disc space. As described,
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`Jacobson discloses accessing laterally an intervertebral disc space to perform a
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`spinal fusion procedure (and inserting an implant), while Leu confirms that one of
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`ordinary skill in the art would have inserted an implant during the performance of a
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`spinal fusion procedure.
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`As Petitioner explains with extrinsic evidence, Michelson ’247 further
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`suggests that an implant “should extend longitudinally across the full disc space
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`11
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`IPR2013-00208
`Patent 8,251,997 B2
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`along the direction of insertion.” Pet. 28; Ex. 1001, ¶ 31. Hence, one of ordinary
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`
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`skill in the art, based on Jacobson, would have accessed the intervertebral space
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`laterally for inserting an implant and further would have utilized an implant of a
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`length that occupied substantially the dimension of the intervertebral space in the
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`direction of insertion based on Michelson ’247. The implant is inserted from the
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`lateral direction (as disclosed by Jacobson), and, therefore, the implant would have
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`had a length that occupies substantially the transverse width, and would have been
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`longer than the depth of the vertebral bodies. Petitioner further articulates
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`reasoning with rational underpinning to justify support for the conclusion of
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`obviousness. Pet. 24-28.
`
`Patent Owner argues that “NuVasive raised these identical issues . . . in the
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`parties’ two prior trials regarding the ’973 patent” which, according to Patent
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`Owner, “precludes NuVasive from relitigating its rejected interpretation.” Prelim.
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`Resp. 22, 31. Patent Owner does not indicate, however, that the identical issues
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`were addressed in a trial regarding the ’997 patent, the patent at issue, or that the
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`disputed claims of the ’997 patent are identical to the disputed claims in the ’973
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`patent. In fact, the claims of the ’973 patent that were litigated previously do not
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`appear to be identical to the currently disputed claims in the ’997 patent. The
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`claims at issue are not identical, and, therefore, it cannot be confirmed at this stage
`
`of the proceeding, based on the preliminary record before us, that the issue litigated
`
`in the ’973 patent was, in fact, identical to the present issue regarding the ’997
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`patent.
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`Patent Owner argues that Michelson ’247 discloses a posterior implant but
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`does not disclose a lateral implant. Prelim Resp. 44. As Petitioner points out,
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`however, Jacobson discloses “a lateral approach path to the spine.” Thus, even
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`assuming that Michelson ’247 fails to disclose a “lateral implant,” Patent Owner
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`12
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`IPR2013-00208
`Patent 8,251,997 B2
`
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`has not demonstrated that the combination of Jacobson, Leu, and Michelson ’247
`
`
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`fails to disclose or suggest lateral access of a disc space.
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`Patent Owner also argues that Michelson ’247 “teaches away from the
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`claims of the ’997 patent” (Prelim. Resp. 45) because, according to Patent Owner,
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`Michelson ’247 utilizes two implants placed side-by-side, rather than by using a
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`single implant. Prelim. Resp. 47. “A reference may be said to teach away when a
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`person of ordinary skill, upon [examining] the reference, would be discouraged
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`from following the path set out in the reference, or would be led in a direction
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`divergent from the path that was taken by the applicant.” Para-Ordnance Mfg.,
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`Inc. v. SGS Importers Int’l, Inc. 73 F.3d 1085, 1090 (Fed. Cir. 1995) (quoting In re
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`Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994)). As Petitioner indicates, Michelson
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`’247 suggests that an implant “should extend longitudinally across the full disc
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`space along the direction of insertion.” Pet. 28. Patent Owner does not show
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`sufficiently how the suggestion of Michelson ’247 regarding extending an implant
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`longitudinally across the full disc space along the direction of insertion would
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`discourage a person of ordinary skill from extending an implant longitudinally
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`across the full disc space along the direction of insertion when the implant is
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`introduced from a lateral aspect.
`
`As Petitioner also explains with supporting evidence,3 Brantigan discloses
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`an implant inserted laterally into an intervertebral disc space, the implant being
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`“shaped to conform with the general outline perimeter of the vertebrae.” Pet. 19.
`
`
`3 Petitioner cites Declaration of Dr. Paul McAfee, which explains that one of
`ordinary skill in the art “would recognize that Brantigan’s Figure 10 shows
`implants 53 and 54 that have been inserted laterally into the disc space” and that “a
`person of ordinary skill in the art would have been prompted . . . to employ an
`implant structure . . . so that the implant extends longitudinally across nearly the
`full disc space.” Ex. 1001, ¶ 28, 29.
`
`13
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`IPR2013-00208
`Patent 8,251,997 B2
`
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`Given that the implant conforms to the perimeter of the vertebrae, one of ordinary
`
`
`
`skill in the art would have understood the implant to occupy substantially the
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`transverse width of the vertebral body because the outline perimeter of the
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`vertebrae includes the transverse edges of the vertebral body with which the
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`implant conforms. Petitioner also articulates reasoning with rational underpinning
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`to justify support for the conclusion of obviousness over the combination of
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`Jacobson, Leu, and Brantigan. Pet. 19-20.
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`Claim 8 recites that the implant is provided with fusion promoting
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`substances. Petitioner explains that Leu discloses “autologous bone marrow” and
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`“bone-inducing proteins.” Pet. 30. Petitioner indicates that the “autologous bone
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`marrow” or “bone-inducing proteins” constitute fusion promoting substances as
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`recited in claim 8 and Patent Owner does not contest Petitioner’s contention.
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`Petitioner has shown a reasonable likelihood that it will prevail with respect to
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`claim 8 on the ground that claim 8 is unpatentable over the combination of
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`Jacobson, Leu, and one of Michelson ’247 or Brantigan.
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`Claims 2-7
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`Claim 2 depends from claim 1 and recites engaging a spinal fixation device
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`to the adjacent vertebrae after inserting the implant.
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`Petitioner explains that Alacreu discloses attaching a spinal fixation plate
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`laterally “to the next above and the next below vertebras, contributing to
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`stabilization by preventing . . . movements.” Pet. 30, citing Ex. 1009, 2:6-11, 3:34-
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`39, Fig. 11. Petitioner has shown that there is a reasonable likelihood that it will
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`prevail on the ground that Alacreu discloses the recited features of claim 2. In
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`addition, Petitioner articulates reasoning with rational underpinning to justify
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`support for the conclusion of obviousness over the combination of Jacobson, Leu,
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`
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`Michelson ’247, and Alacreu. Pet. 30-31.
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`Petitioner explains that Frey discloses a spinal fixation plate that is engaged
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`to a vertebrae. Pet. 21, citing Ex. 1007, Fig. 5. Petitioner has shown that there is a
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`reasonable likelihood that it will prevail on the ground that claim 2 is unpatentable
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`over the combination of Jacobson, Leu, Brantigan, and Frey. In addition Petitioner
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`articulates reasoning with rational underpinning to justify support for the
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`conclusion of obviousness over the combination of Jacobson, Leu, Brantigan, and
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`Frey.
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`Claim 3 depends from claim 2 and recites that the spinal fixation device has
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`a plate configured to cover a portion of the trailing end of the implant.
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`Petitioner explains that Alacreu discloses a spinal fixation plate that covers a
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`portion of the trailing end of the implant. Pet. 30; Ex. 1009, Fig. 11. Petitioner has
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`shown that there is a reasonable likelihood that it will prevail on the ground that
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`claim 3 is unpatentable over the combination of Jacobson, Leu, Michelson ’247,
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`and Alacreu..
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`Petitioner explains that Frey discloses a spinal fixation plate that covers at
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`least a portion of the trailing end of the implant. Pet. 22, citing Ex. 1007, 3:16-17,
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`Fig. 5. Petitioner has shown that there is a reasonable likelihood that it will prevail
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`on the ground that claim 3 is unpatentable over the combination of Jacobson, Leu,
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`Brantigan, and Frey.
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`Claim 4 depends from claim 1 and recites engaging a plate with the adjacent
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`vertebrae to prevent unwanted excursion of said implant from the spine.
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`As Petitioner explains, Alacreu discloses a plate that is engaged with
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`vertebrae. Pet. 30; Ex. 1009, Fig. 11. Petitioner has shown that there is a
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`reasonable likelihood that it will prevail on the ground that claim 4 is unpatentable
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`
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`over the combination of Jacobson, Leu, Michelson ’247, and Alacreu.
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`Petitioner also explains that Frey discloses engaging a plate with an adjacent
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`vertebrae as recited in claim 4. Pet. 21, citing Ex. 1007, 3:16-17. Petitioner has
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`shown that there is a reasonable likelihood that it will prevail on the ground that
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`claim 4 is unpatentable over the combination of Jacobson, Leu, Brantigan, and
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`Frey.
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`Claim 5 depends from claim 4 and recites that the step of ‘engaging the
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`plate’ includes attaching a portion of the plate to each of the adjacent vertebrae
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`with a fastening member.
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`Petitioner explains that Alacreu discloses a plate with a portion that is
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`attached to a vertebral body and another portion that is attached to an adjacent
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`vertebral body. Pet. 30. The plate is attached to the vertebral bodies with screws
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`(or a fastening member.) Ex. 1009, fig. 11. Petitioner has shown that there is a
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`reasonable likelihood that it will prevail on the ground that claim 5 is unpatentable
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`over the combination of Jacobson, Leu, Michelson ’247, and Alacreu.
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`Petitioner also explains that Frey discloses attaching a portion of the plate to
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`each of the adjacent vertebrae with a fastening member. Pet. 22-23. Frey discloses
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`a plate with portions attached to each of adjacent vertebrae. Ex. 1007, Fig. 5. The
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`plate is attached to the vertebrae via bone screws or “fastening members.” Ex.
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`1007, 3:20. Petitioner has shown that there is a reasonable likelihood that it will
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`prevail on the ground that claim 5 is unpatentable over the combination of
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`Jacobson, Leu, Brantigan, and Frey.
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`Claim 6 depends from claim 4 and recites that the step of ‘engaging the
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`plate’ includes engaging a screw with said plate after inserting of said implant into
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`the laterally facing opening.
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`Petitioner explains that Alacreu discloses a plate that includes a screw
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`
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`engaged with the plate. Pet. 30; Ex. 1009, Fig. 11. Petitioner has shown that there
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`is a reasonable likelihood that it will prevail on the ground that claim 6 is
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`unpatentable over the combination of Jacobson, Leu, Michelson ’247, and Alacreu.
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`Petitioner also explains that Frey discloses engaging a screw with the plate.
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`Pet. 22-23. Frey discloses a plate attached to the vertebrae via bone screws. Ex.
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`1007, 3:30. Petitioner has shown that there is a reasonable likelihood that it will
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`prevail on the ground that claim 6 is unpatentable over the combination of
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`Jacobson, Leu, Brantigan, and Frey.
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`Claim 7 depends from claim 1 and recites coupling a spinal fixation device
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`to the implant and engaging the spinal fixation device to the adjacent vertebrae.
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`Petitioner explains that Alacreu discloses a fixation device that is engaged
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`(via a screw) to an implant within an intervertebral disc space and also fixed (via
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`another screw) to an adjacent vertebrae (adjacent to the disc space containing the
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`implant.) Pet. 30-31; Ex. 1009, Fig. 11. Petitioner has shown that there is a
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`reasonable likelihood that it will prevail on the ground that claim 7 is unpatentable
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`over the combination of Jacobson, Leu, Michelson ’247, and Alacreu.
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`Petitioner also explains that Frey discloses that a plate that “is integrally
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`formed with the implant.” Pet. 22. Frey also discloses the spinal fixation device,
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`or plate engaged with an adjacent vertebrae. Ex. 1007, Fig. 5. Petitioner has
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`shown that there is a reasonable likelihood that it will prevail on the ground that
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`claim 7 is unpatentable over the combination of Jacobson, Leu, Brantigan, and
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`Frey.
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`We are persuaded by the analysis set forth in the petition and accompanying
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`declaration that there is a reasonable likelihood that Petitioner will prevail on its
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`contention that (1) claims 1 and 8 are unpatentable over Jacobson, Leu, and one of
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`Michelson ’247 or Brantigan and (2) claims 2-7 is unpatentable over Jacobson,
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`Leu, and one of the combination of Michelson ’247 and Alacreu or the
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`combination of Brantigan and Frey.
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`
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`B. Other Grounds based at least in part on Baulot, Rosenthal, Kambin,
`Michelson ’661, Michelson PCT, or Lynn
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`
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`Petitioner alleges additional grounds of unpatentability based on (1) the
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`combination of Baulot, Rosenthal, and Kambin; (2) the combination of Baulot,
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`Rosenthal, Kambin, and Frey; (3) the combination of Michelson PCT, Jacobson,
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`and Brantigan, (4) the combination of Michelson PCT, Jacobson, Brantigan, and
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`Alacreu; (5) the combination of Michelson ’661 and Lynn. Those additional
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`grounds are redundant in light of the grounds on the basis of which we institute
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`review.
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`
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`CONCLUSION
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`We conclude that Petitioner has demonstrated a reasonable likelihood of
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`prevailing on the challenge of claims 1 and 8 under 35