Paper 17
`Date: September 23, 2013
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`Trials@uspto.gov
`571-272-7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_____________
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`____________
`
`Case IPR2013-00206
`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
`
`
`
`

`

`IPR2013-00206
`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 9-30 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 9-30.
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`Accordingly, we authorize institution of an inter partes review of claims 9-30 of
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`the ’997 patent.
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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
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`
`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
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`

`

`IPR2013-00206
`Patent 8,251,997 B2
`
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`also filed a petition seeking inter partes review of claims 1-8 of the ’997 patent
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`
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`(IPR2013-00208).
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`
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`B.
`
`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
`
`Of the challenged claims, claims 9, 17 and 24 are independent claims. Each
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`of the dependent claims 10-16 depend either directly or indirectly from claim 9.
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`Each of the dependent claims 18-23 depend either directly or indirectly from claim
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`17. Each of the dependent claims 25-30 depend either directly or indirectly from
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`claim 24. Claim 9 is exemplary of the claimed subject matter of the ’997 patent,
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`and is reproduced as follows:
`
`
`
`
`A method comprising:
`9.
`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
`
`3
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`

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`IPR2013-00206
`Patent 8,251,997 B2
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`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 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 a single elongated portion removably attached to
`said distal end of said third surgical instrument over the disc space,
`said single elongated portion having a length, a thickness, and a width,
`the length of said single elongated portion being greater than the
`width and the thickness of said single elongated portion, the width of
`said single elongated portion being greater than the thickness of said
`single elongated portion, said single elongated portion being tapered
`to facilitate entry between the vertebral bodies of the two adjacent
`vertebrae;
`inserting said single elongated portion into the disc space with
`the width of said single elongated portion being oriented along a
`height of the disc space; and
`inserting, from the position anterior to the transverse processes
`of the two adjacent vertebrae and along said path, an interbody
`intraspinal implant through said third surgical instrument into a
`
`4
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`

`

`
`
`IPR2013-00206
`Patent 8,251,997 B2
`
`
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`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.
`
`
`
`D.
`
`The Prior Art
`
`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 5,569,290 (McAfee)
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`
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`Oct. 29, 1996
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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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`
`
`Ex. 1004
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`Ex. 1006
`
`Ex. 1007
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`Ex. 1008
`
`Ex. 1009
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`Ex. 1010
`
`Ex. 1011
`
`
`Hansjörg F. Leu and Adam Schreiber; “Percutaneous Fusion of the Lumbar
`Spine: A Promising Technique,” 6(3) Spine: State of the Art Reviews
`593 , (September 1992) (“Leu”) (Ex 1005.)
`
`
`
`E.
`
`The Alleged Grounds of Unpatentability
`
`Petitioner asserts the following grounds of unpatentability:
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`5
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`IPR2013-00206
`Patent 8,251,997 B2
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`Reference(s)
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`Basis
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`Claims challenged
`
`§103
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`§103
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`§ 103
`
`Jacobson, Leu, McAfee, and
`Michelson ’247
`Jacobson, Leu, McAfee,
`Michelson ’247, and Frey
`Jacobson, Leu, and Brantigan §103
`Jacobson, Leu, Brantigan, and
`§103
`Frey
`Jacobson, Leu, and Michelson
`’247
`Jacobson, Leu, Michelson
`’247, and Frey
`Michelson ’661, McAfee, and
`Lynn
`Michelson ’661 and Lynn
`
`
`§ 103
`
`§ 103
`
`§ 103
`
`9 and 16
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`10-15
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`17 and 23
`18-22
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`24 and 30
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`25-29
`
`9-16
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`17-30
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`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).
`
`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 his
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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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`6
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`IPR2013-00206
`Patent 8,251,997 B2
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`York Prods., Inc. v. Cent. Tractor Farm & Family Ctr., 99 F.3d 1568, 1572 (Fed.
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`
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`Cir. 1996). When an inventor acts as a lexicographer, the definition must be set
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`forth with reasonable clarity, deliberateness, and precision. Ranishaw PLC v.
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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.
`
`1.
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`“a single elongated portion removably attached to said distal end of
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`said third surgical instrument” (claim 9)
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`Independent claim 9 requires an elongated portion removably attached to the
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`distal end of the third surgical instrument. Petitioner contends, citing to the
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`Declaration of Dr. Paul McAfee, that the elongated portion includes a removable
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`ring structure. Pet. 4; Ex. 1001, ¶ 16. Claim 9 does not limit the shape or structure
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`of the elongated portion, but does require the elongated portion to be attached
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`removably to the third surgical instrument. Petitioner arrives at its construction by
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`importing features from an embodiment described in the ’997 patent, but has failed
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`to explain sufficiently why we should import such features into the claims.
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`Therefore, we adopt a construction of the term “single elongated portion
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`removably attached to said distal end of said third surgical instrument” to include a
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`structure of unspecified shape that is attached removably to the distal end of the
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`third surgical instrument.
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`2.
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`“positioning a single elongated portion removably attached to said
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`distal end of said third surgical instrument over the disc space” (claim 9) and
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`“positioning said third surgical instrument such that at least part of one of said at
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`least two elongated portions is over one of the two adjacent vertebrae and at least
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`7
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`IPR2013-00206
`Patent 8,251,997 B2
`
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`part of another of said at least two elongated portions is over the other of the two
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`
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`adjacent vertebrae.” (Claim 17)
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`Petitioner contends that “positioning” the elongated portion over the disc
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`space has been construed to include “transiently” moving the elongated portion
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`over the disc space. (Pet. 5-6.) The claim does not require a specific length of
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`time that either the single elongated portion or the third surgical instrument is
`
`positioned or located over the respective locations recited in claim 9 or claim 17.
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`We, therefore, agree that the term “positioning” with respect to claims 9 and 17
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`includes locating the elongated portion or third surgical instrument at the recited
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`locations for any length of time. As such we adopt Petitioner’s construction of the
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`term “positioning” the single elongated portion over the disc space and
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`“positioning” the third surgical instrument to include moving the elongated portion
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`or moving the third surgical instrument such that the elongated portion or third
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`surgical instrument is located over the recited locations and/or orientations for any
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`length of time, including transiently.
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`
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`3.
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`“positioning said third surgical instrument such that the midpoint of
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`the width of said first elongated portion is over the disc space and said second
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`elongated portion is over one of the two adjacent vertebrae and said third
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`elongated portion is over the other of the two adjacent vertebrae.” (Claim 24)
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`As described above, Petitioner contends that “positioning” the third surgical
`
`instrument includes “transiently” moving the third surgical instrument. (Pet. 6.)
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`Claim 24 does not recite a specific length of time that the third surgical instrument
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`must be positioned in the recited orientation. Therefore, we construe the term
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`“positioning” to include locating the instrument at a position for any length of
`
`time. We also construe any length of time to include “transiently” because one of
`
`8
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`IPR2013-00206
`Patent 8,251,997 B2
`
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`ordinary skill in the art would have understood that an event that exists transiently
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`
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`exists for some length of time, albeit a possibly short period of time. Hence, we
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`adopt Petitioner’s construction of the term “positioning” the third surgical
`
`instrument to include moving the third surgical instrument such that the midpoint
`
`of the width of said first elongated portion is over the disc space and said second
`
`elongated portion is over one of the two adjacent vertebrae and said third elongated
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`portion is over the other of the two adjacent vertebrae for any length of time.
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`4.
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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, the length of
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`said implant being greater than the depth of the disc space.” (Claim 9)
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`Petitioner contends that the length of the implant encompasses a length that
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`is less than the full transverse width of the vertebral bodies. Pet. 6-7. Claim 9, for
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`example, recites a length sized to occupy substantially the full transverse width of
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`the vertebral bodies, but does not recite a length sized to occupy only the full
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`transverse width of the vertebral bodies (and no less). Claim 9 merely requires that
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`the length occupies “substantially” the full transverse width as opposed to
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`requiring the length to occupy the full transverse width. We, therefore, agree that
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`one of ordinary skill in the art would have understood the length to occupy
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`something less than the full transverse width. One of ordinary skill in the art
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`would have understood also that if the length occupies “substantially” the full
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`transverse width, the length may occupy the full transverse width but also may
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`occupy only a length that is less than the full transverse width of the vertebral
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`bodies by an insubstantial amount. Also, Petitioner’s construction of the length of
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`the implant conforms to the recited limitations, i.e., being greater than the depth of
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`the disc space. We, therefore, adopt Petitioner’s proposed construction for the
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`length of the implant to be greater than the depth of the disc space. Pet. 8.
`
`9
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`IPR2013-00206
`Patent 8,251,997 B2
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`II. ANALYSIS
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`A. Grounds Based at least in part on Jacobson, Leu, and Brantigan
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`Petitioner contends that independent claims 17 and 23 are unpatentable
`
`under 35 U.S.C. § 103(a) over Jacobson, Leu, and Brantigan and dependent claims
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`18-22 are unpatentable under 35 U.S.C. § 103(a) over Jacobson, Leu, and
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`Brantigan and Frey. Based on our review of the record before us, we determine
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`that there is a reasonable likelihood that Petitioner will prevail with respect to (1)
`
`claims 17 and 23 on the ground that these claims are unpatentable over the
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`combination of Jacobson, Leu, and Brantigan, and (2) claims 18-22 on the ground
`
`that these claims are unpatentable over the combination of Jacobson, Leu,
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`Brantigan, and Frey.
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`Claims 17 and 23
`
`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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`8:53-55, 68; 6:3-5; 9:13-14; Figs. 1-6, 9-11. The cannula includes an “anchor
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`means” that is “advanced into the disc capsule.” Ex. 1004, 7:4-6; Figs. 5-6. This
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`further includes, for example, “pieces of wire” or “sharp tines.” Ex. 1004, 7:5,
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`10:2. The cannula “acts as a conduit for insertion of surgical instruments through
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`its lumen or bore” to perform “surgical procedures in the spinal column . . . such as
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`disk realignment, fusion, or any other surgical or diagnostic procedure.” Ex. 1004,
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`6:5-7, 11-13. Petitioner explains that a “fusion” procedure “necessarily includes
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`the insertion of an implant into the disc space.” Pet. 18. The Patent Owner does
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`not refute Petitioner’s contention.
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`10
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`IPR2013-00206
`Patent 8,251,997 B2
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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 proteins.” Ex. 1005, p. 603.
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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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`states 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.” Pet. 28, citing Ex. 1006, 2:2-4, 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
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`instrument,” (4) “inserting . . . [an] implant through said third surgical instrument
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`into a laterally facing opening” created by the third surgical instrument, and (5) the
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`third surgical instrument having elongated portions for insertion having a length
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`greater than its width and thickness.
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`As described above, Jacobson discloses advancing a needle, a speculum, and
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`a cannula, including an anchor means (or “elongated portion”) that is advanced
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`into a disc capsule to access a disc space laterally, while Leu discloses that one of
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`ordinary skill in the art would have known to introduce multiple cannulas that are
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`“stepwise overslipped” (or each cannula advanced over at least a portion of the
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`length of the previously introduced cannula) to “permit the necessary approach to
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`IPR2013-00206
`Patent 8,251,997 B2
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`the intervertebral space.” Petitioner also articulates reasoning with rational
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`
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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. 27-28.
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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 states that an intraspinal implant is inserted necessarily in a spinal fusion
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`procedure, which Patent Owner does not contest. Leu also discloses a spinal
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`fusion procedure that includes the use of an “interbody graft.”
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`Further, Petitioner has explained that it would have been obvious to one of
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`ordinary skill in the art, given the combination of Jacobson, Leu, and Brantigan, to
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`have inserted into an intervertebral space an implant that occupies substantially the
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`full transverse width of the vertebral bodies and that has a length that is greater
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`than the depth of the disc space. As described, Jacobson discloses accessing
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`laterally an intervertebral disc space to perform a spinal fusion procedure (and
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`inserting an implant), while Leu confirms that one of ordinary skill in the art would
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`have inserted an implant during the performance of a spinal fusion procedure.
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`As Petitioner explains, Brantigan discloses an implant inserted laterally into
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`an intervertebral disc space, the implant being “shaped to conform with the general
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`outline perimeter of the vertebrae.” Pet. 28. Given that the implant conforms with
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`the perimeter of the vertebrae, one of ordinary skill in the art would have
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`understood the implant to occupy substantially the transverse width of the vertebral
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`body, because the outline perimeter of the vertebrae includes the transverse edges
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`of the vertebral body with which the implant conforms. Petitioner also articulates
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`12
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`IPR2013-00206
`Patent 8,251,997 B2
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`reasoning with rational underpinning to justify support for the conclusion of
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`obviousness over the combination of Jacobson, Leu, and Brantigan. Pet. 27-28.
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`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 claims currently in dispute in the ’997 patent. The
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`claims at issue are not identical. Therefore, it cannot be confirmed at this stage of
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`the proceeding, based on the preliminary record before us, that the issue litigated in
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`the ’973 patent was, in fact, identical to the present issue regarding the ’997 patent.
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`Patent Owner also argues that “Brantigan’327 does not have a length [of the
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`implant] being sized to occupy substantially the full transverse width of the
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`vertebrae.” Prelim. Resp. 35. However, the Petitioner has explained, with
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`supporting evidence,2 that a person of ordinary skill in the art would have
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`understood the implant of Brantigan ’327 to conform with the outline perimeter of
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`the vertebrae. Patent Owner has not demonstrated otherwise.
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`Claim 23 recites that the implant is provided with fusion-promoting
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`substances. Petitioner shows how Leu discloses “autologous bone marrow” and
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`“bone-inducing proteins.” Pet. 30. Petitioner explains that “autologous bone
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`2 Petitioner cites Declaration of Dr. Paul McAfee, which explains that one of
`ordinary skill in the art “would have recognized from the suggestion in Michelson
`’247 that the size of the threaded cage implant 50 should be selected to extend
`longitudinally across the full disc space in the axial direction of insertion (lateral
`insertion in this resulting method).” Ex. 1001, ¶ 29.
`
`13
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`IPR2013-00206
`Patent 8,251,997 B2
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`marrow” or “bone-inducing proteins” constitutes fusion-promoting substances, as
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`
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`recited in claim 23, 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
`
`claim 23 on the ground that claim 23 is unpatentable over the combination of
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`Jacobson, Leu, and Brantigan.
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`Claims 18-22
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`Claim 18 depends from claim 17 and recites engaging a spinal fixation
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`device to the adjacent vertebrae after inserting the implant.
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`Petitioner explains that Frey discloses a spinal fixation plate that is engaged
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`to a vertebrae. Pet. 30, citing Ex. 1007, Fig. 5. In addition, Petitioner articulates
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`reasoning with rational underpinning to justify support for the conclusion of
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`obviousness over the combination of Jacobson, Leu, Brantigan, and Frey.
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`Petitioner has shown that there is a reasonable likelihood that it will prevail with
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`respect to claim 18 on the ground that claim 18 is unpatentable over the
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`combination of Jacobson, Leu, Brantigan , and Frey.
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`Claim 19 depends from claim 18 and recites that the spinal fixation device
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`has a plate configured to cover a portion of the trailing end of the implant.
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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. 31, 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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`with respect to claim 19 on the ground that claim 19 is unpatentable over the
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`combination of Jacobson, Leu, Brantigan, and Frey.
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`Claim 20 depends from claim 17 and recites that the step of “engaging a
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`plate” with the adjacent vertebrae to prevent unwanted excursion of said implant
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`from the spine.
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`Petitioner explains that Frey discloses engaging a plate with adjacent
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`vertebrae as recited in claim 4. Pet. 31, 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 20 is unpatentable over the combination of Jacobson, Leu, Brantigan, and
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`Frey.
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`Claim 21 depends from claim 20 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 Frey discloses attaching a portion of the plate to each
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`of the adjacent vertebrae with a fastening member. Pet. 31. Frey discloses a plate
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`with portions attached to each of adjacent vertebrae. Ex. 1007, Fig. 5. The plate is
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`attached to the vertebrae via bone screws or “fastening members.” Ex. 1007, 3:20.
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`Petitioner has shown that there is a reasonable likelihood that it will prevail on the
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`ground that claim 21is unpatentable over the combination of Jacobson, Leu,
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`Brantigan, and Frey.
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`Claim 22 depends from claim 20 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 also explains that Frey discloses engaging a screw with the plate.
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`Pet. 31. Frey discloses a plate attached to the vertebrae via bone screws. Ex. 1007,
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`3:30. Petitioner has shown that there is a reasonable likelihood that it will prevail
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`on the ground that claim 22 is unpatentable over the combination of Jacobson, Leu,
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`Brantigan, and 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 17 and 23 are unpatentable over Jacobson, Leu, and
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`Brantigan and (2) claims 18-22 is unpatentable over Jacobson, Leu, Brantigan, and
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`Frey.
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`B. Grounds Based at least in part on Jacobson, Leu, and Michelson ’247
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`Petitioner contends that independent claims 24 and 30 are unpatentable
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`under 35 U.S.C. § 103(a) over Jacobson, Leu, and Michelson ’247, and dependent
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`claims 25-29 are unpatentable under 35 U.S.C. § 103(a) over Jacobson, Leu,
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`Michelson ’247, and Frey. Based on our review of the record before us, we
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`determine that there is a reasonable likelihood that Petitioner will prevail with
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`respect to (1) claims 24 and 30 on the ground that these claims are unpatentable
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`over the combination of Jacobson, Leu, Michelson ’247, and (2) claims 25-29 on
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`the ground that these claims are unpatentable over the combination of Jacobson,
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`Leu, Michelson ’247, and Frey.
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`Claims 24 and 30
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`As discussed above, Petitioner has shown how the prior art describes
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`accessing a disc space, advancing a first surgical instrument, advancing a second
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`surgical instrument over a portion of the first surgical instrument, advancing a third
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`surgical instrument over a portion of the second surgical instrument, the third
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`surgical instrument including an elongated portion with a length greater than its
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`width and thickness, and inserting an implant through the third surgical instrument,
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`as recited in claim 24.
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`Claim 24 recites the third surgical instrument having a first, second and third
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`elongated portion for insertion into the patient. Petitioner explains how Jacobson
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`discloses the third surgical instrument (i.e., a cannula) having “anchor wires” or
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`“sharp tines.” Pet. 35-36. Petitioner also explains how Michelson ’247 discloses a
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`known “anchoring tip with sharp tines,” including a first, second, and third
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`elongated portion for insertion into the patient. Pet. 35, 36, citing Ex. 1008, Fig. 1,
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`9:22-25. Petitioner also 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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`and Michelson ’247. Pet. 36. Petitioner has shown a reasonable likelihood that it
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`will prevail with respect to the third surgical instrument having a first, second and
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`third elongated portion for insertion into the patient.
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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.
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`3, 4, 4d, and 5.
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`Further, Petitioner has shown a reasonable likelihood that it will prevail with
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`respect to the issue of whether it would have been obvious to one of ordinary skill
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`in the art, given the combination of Jacobson, Leu, and Michelson ’247 to have
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`inserted into an intervertebral space an implant that occupies substantially the full
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`transverse width of the vertebral bodies, and that has a length that is greater than
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`the depth of the disc space. As described, Jacobson discloses accessing laterally an
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`intervertebral disc space to perform a spinal fusion procedure (and inserting an
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`implant), while Leu confirms that one of ordinary skill in the art would have
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`inserted an implant during the performance of a 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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`along the direction of insertion.” Pet. 38, citing Ex. 1001, ¶ 35. Hence, one of
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`ordinary skill in the art, based on Jacobson, would have accessed the intervertebral
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`space laterally to insert an implant, and would have further 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 fu