`
`Trials@uspto.gov Paper No. 36
`571.272.7822 Filed: December 17, 2014
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`NUVASIVE, INC.,
`Petitioner,
`v.
`WARSAW ORTHOPEDIC, INC.,
`Patent Owner.
`____________________
`
`Case IPR2013-00395
`Patent 8,444,696 B2
`___________________
`
`Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C. SIU,
`Administrative Patent Judges.
`
`
`GREEN, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`I. INTRODUCTION
`A. Background
`Petitioner, NuVasive Inc. (“NuVasive”), filed a Corrected Petition
`requesting inter partes review of claims 1–6 (“the challenged claims”) of
`U.S. Patent No. 8,444,696 B2 (“the ’696 patent”). Paper 7 (“Pet.”). Patent
`Owner, Warsaw Orthopedic, Inc. (“Warsaw”), did not file a Patent Owner
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`IPR2013-00395
`Patent 8,444,696 B2
`
`Preliminary Response. We determined that the information presented in the
`Petition demonstrated that there was a reasonable likelihood that Petitioner
`would prevail in challenging claims 1-6 as unpatentable under 35 U.S.C.
`§ 103(a). Pursuant to 35 U.S.C. § 314, the Board instituted trial on
`December 20, 2013, as to the challenged claims of the ’696 patent. Paper 12
`(“Institution Decision”; “Dec. Inst.”).
`Patent Owner filed a Response (Paper 24, “PO Resp.”), but did not
`file a motion to amend. Petitioner subsequently filed a Reply. Paper 25
`(“Reply”). An oral hearing was held on July 31, 2014. The transcript of the
`hearing has been entered into the record. Paper 35.
`We have jurisdiction under 35 U.S.C. § 6(c). This final written
`decision is issued pursuant to 35 U.S.C. § 318(a). Based on the record
`before us, we conclude that Petitioner has demonstrated by a preponderance
`of the evidence that claims 1–6 of the ’696 patent are unpatentable.
`B. Related Proceedings
`Petitioner filed concurrently with the instant Petition another petition
`for an inter partes review of the ’696 patent. That proceeding, IPR2013-
`00396, involves claims 7–12 of the patent. Petitioner indicates further that
`Patent Owner has asked the district court for permission to add the ’696
`patent to the case Warsaw Orthopedic, Inc. v. NuVasive Inc., Case No. 3:12-
`cv-02738-CAB (S.D. Cal.). Pet. 1.
`C. The ’696 Patent
`The ’696 patent issued on May 21, 2013, with Gary Karlin Michelson
`as the listed inventor. The ’696 patent is drawn to an interbody spinal fusion
`implant that is “configured to restore and maintain two adjacent vertebrae of
`the spine in correct anatomical angular relationship.” Ex. 1002, 1:20–23.
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`2
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`IPR2013-00395
`Patent 8,444,696 B2
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`As taught by the ’696 patent, the cervical and lumbar areas of the
`human spine are lordotic in a healthy state, that is, they are “curved convex
`forward.” Id. at 1:25–27. In degenerative conditions of the spine, the
`lordosis may be lost. Id. at 1:27–28. Surgical treatment of such
`degenerative conditions often involves spinal fusion, where adjacent
`vertebrae are joined together through an area of shared bone. Id. at 1:36-40.
`The ’696 patent discloses spinal implants that are sized to fit within
`the disc space that is created when the disc material between two adjacent
`vertebrae is removed, and that conform “wholly or in part to the disc space
`created.” Id. at 1:61–64. The implants have upper and lower surfaces that
`form a support structure for the adjacent vertebrae, and, in a preferred
`embodiment, the upper and lower surfaces “are disposed in a converging
`angular relationship to each other such that the implants of the present
`invention have an overall ‘wedged-shape’ in an elevational side view.” Id.
`at 1:67–2:4.
`As taught by the ’696 patent, the various faces of the implant may be
`curved to allow the implant “to conform to the shape of the vertebral
`surfaces adjacent to the area of the disc removal.” Id. at 2:23–25. That is,
`“the upper and/or lower surfaces may be convex, and/or the front and/or rear
`surfaces may be convex.” Id. at 2:26–27. The ’696 patent teaches further
`that the “upper and lower surfaces conforming to the contours of the
`vertebral endplates, which contours include but are not limited to being
`relatively flat or convex.” Id. at 2:52–55. The surfaces of the implants may
`have openings, which may or may not pass all the way through the implant,
`but that connect through a central chamber. Id. at 2:27–31. The opening
`may be of random size, shape, and/or distribution. Id. at 2:31–32.
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`3
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`IPR22013-003995
`
`
`Patennt 8,444,6996 B2
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`
`
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`is reproducced below
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`:
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`
`
`Figure 14 of the ’6696 patent
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`Figure 1
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`4, above, iis a left sidde elevationnal view oof a lordoticc interbodyy
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`spinaal fusion immplant. Idd. at 5:11–112. The immplant showwn in Figuure 14 has
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`inserrtion end 3320 and traailing end 3330. Id. at
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`
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`9:18–19.
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`In additionn,
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`
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`first termiinal part ddefining aa first
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`the implant . . . inncludes a
`bearing
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`
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`
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`surface aadapted to bear agaainst an eendplate off the
`vertebra
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`
`
`
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`ted to rface adaptbearing sure second bae V1, and aan opposit
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`bear agaainst an enndplate of
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`
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`nt . . . The implanthe vertebbrae V2. T
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`also inclludes a seccond termiinal part oopposite thhe first termminal
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`part. Thhe second
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`
`
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`terminal ppart definees a third bbearing suurface
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`to bear aggainst the
`adapted
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`
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`and a endplate oof the verteebrae V1 a
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`fourth bbearing surrface adaptted to beaar against tthe endplaate of
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`the verteebrae V2.
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`Id. aat 9:20–29.
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`4
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`IPR22013-003995
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`Patennt 8,444,6996 B2
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`The ’6966 patent also disclosees an emboodiment wiith ratchetiing. Figuree
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` of
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`
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`the patent is reproduuced beloww:
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` 9
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`usion dy spinal futic interbodof a lordotonal view oide elevatioFiguure 9 is a si
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`impllant. Id. att 4:63:67. As seen inn Figure 9,
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`the ratchettings are ooriented in
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`the ddirection off the inserttion end, 220, allowinng for one
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`-way inserrtion of thee
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`impllant, and thhe bone enggaging endd, 252, prevvents the i
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`mplant froom backingg
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`out oonce implaanted. Id. aat 8:40-49..
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`D. Illusttrative Claim
`1–6 of the
`
`
`Petitioneer challengges claims
`
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`e ’696 patennt. Claimss 1 and 4
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`
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`Claim 1 iss illustrativve, and readds as followws:
`
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`are independennt claims.
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`
`. A spinal fusion immplant for
`1
`insertion
`
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`between aa first verttebra and
`a
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`
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`second vvertebra addjacent thee first verteebra, the ffirst vertebbra having
`a
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`generallyy verticallyy extendinng first periipheral waall and a firrst endplatte
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`
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`and the second vvertebra hhaving a
`generally
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`verticallyy extendinng
`a second
`endplate,
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`second pperipheral
`wall and
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`wherein tthe implannt
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`comprises:
`
`
`
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`defining aa trailing
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`a
`first termminal part
`
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`face, a fiirst bearinng
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`
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`suurface adappted to bear against
`a portion
`of the fir
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`st endplatee,
`
`
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`surface addapted to bbear againsst
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`
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`annd an oppoosite seconnd bearing
`a
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`portion off the seco
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`nd endplaate, said tr
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`ailing facee extendinng
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`
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`beetween said first beaaring surfaace and seccond beariing surfacee,
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`5
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`IPR2013-00395
`Patent 8,444,696 B2
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`said trailing face having a recessed portion and a threaded
`opening configured to receive an insertion instrument for
`inserting said implant between the first vertebra and the second
`vertebra;
`
` a
`
` a
`
` second terminal part opposite said first terminal part, said
`second terminal part having an insertion face extending
`between a third bearing surface and a fourth bearing surface,
`said implant having a longitudinal axis extending through said
`trailing face of said first terminal part and said insertion face of
`said second terminal part, and having a cross section in a first
`plane extending through said first bearing surface and said
`second bearing surface, and along the longitudinal axis, said
`implant having a length between said trailing face of said first
`terminal part and said insertion face of said second terminal part
`and parallel to the longitudinal axis, said implant having a
`width and a height each perpendicular to the length of said
`implant, the width of said implant being greater than the height
`of said implant;
`
` first side and an opposite second side, said first side and said
`second side extending from said first terminal part to said
`second terminal part, portions of said first side and said second
`side being substantially flat, said substantially flat portions
`intersecting a second plane that is perpendicular to the first
`plane and extends through said insertion face and said trailing
`face, wherein said substantially flat portions of said first side
`and said second side are symmetrical about the first plane;
`
`an opening between said trailing face and said insertion face
`and between said first and second sides to permit for the growth
`of bone through said implant from the first vertebra to the
`second vertebra;
`
`upper and lower bearing surfaces each having a length
`measured parallel to the longitudinal axis of said implant, said
`upper and lower bearing surfaces having portions proximate
`each of said first and second sides and being convex along the
`entire length of said upper and lower bearing surfaces relative
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`IPR2013-00395
`Patent 8,444,696 B2
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`to the second plane and in a direction parallel to the
`longitudinal axis, said trailing face having a height less than and
`measured parallel to a maximum height measured between said
`upper and lower bearing surfaces proximate one of said first
`and second sides;
`
`ratchetings on each of said upper and lower bearing surfaces
`adapted to engage the first vertebra and the second vertebra,
`respectively, each of said ratchetings having a ridge oriented in
`a direction generally parallel to the width of said implant, said
`ratchetings on each of said upper and lower bearing surfaces
`facing one direction; and
`
`said implant being adapted to hold bone fusion promoting
`materials.
`
`
`
`
`
`E. Instituted Challenges
`References
`Claims
`Basis
`§ 103(a) Senter1 and Brantigan ’0352
`1, 3, 4, and 6
`§ 103(a) Senter, Brantigan ’035, and
`Brantigan ’3273
`§ 103(a) Michelson ’037,4 Wagner,5 and
`Brantigan ’035
`
`2 and 5
`
`1–6
`
`
`1 Senter (“Senter”), WO 93/01771, published February 4, 1993 (Ex. 1007).
`2 Brantigan (“Brantigan ’035”), WO 89/09035, published October 5, 1989
`(Ex. 1005).
`3 Brantigan (“Brantigan ’327”), US 5,192,327, issued March 9, 1993
`(Ex. 1006).
`4 Michelson (“Michelson ’037”), WO 90/00037, published January 11, 1990
`(Ex. 1008).
`5 Wagner (“Wagner”), US 5,306,309, issued April 26, 1994 (Ex. 1009).
`
`7
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`IPR2013-00395
`Patent 8,444,696 B2
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`II. ANALYSIS
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are
`interpreted according to their broadest reasonable construction in light of the
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766
`(Aug. 14, 2012). Claim terms also are given their ordinary and customary
`meaning, as would be understood by one of ordinary skill in the art in the
`context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249,
`1257 (Fed. Cir. 2007). If an inventor acts as his or her own lexicographer,
`the definition must be set forth in the specification with reasonable clarity,
`deliberateness, and precision. Renishaw PLC v. Marposs Societa’ per
`Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998). For purposes of this decision,
`we only need to construe the following claim terms.
`1. “opening”
`Independent claims 1 and 4 each require “an opening between said
`trailing face and said insertion face and between said first and second sides
`to permit for the growth of bone through said implant from the first vertebra
`to the second vertebra.” Patent Owner argues that “opening” “requires a
`hole that necessarily extends through the spinal fusion implant from
`proximate the top thereof to proximate the bottom thereof in the space
`between the trailing face, the insertion face, and the first and second sides of
`the spinal fusion implant.” PO Resp. 15–16. Petitioner responds that Patent
`Owner’s interpretation is overly narrow. Reply 1.
`Independent claim 1 requires that the implant have a first side and a
`second, opposite side, with the remaining two sides of the implant defined
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`IPR2013-00395
`Patent 8,444,696 B2
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`by the claims as having the upper and lower bearing surfaces. The claims,
`thus, define the first and second sides as being the horizontal sides. The
`claim then requires that the opening be “between said trailing face and said
`insertion face and between said first and second sides to permit for the
`growth of bone through said implant from the first vertebra to the second
`vertebra.”
`Thus, we construe “opening,” consistent with the language of the
`claims, as a hole that extends from the upper bearing surface to the lower
`bearing surface that is of sufficient size to permit growth of bone
`therethrough.
`2. “upper and lower bearing surfaces”
`Independent claims 1 and 4 require “upper and lower bearing surfaces
`
`each having a length measured parallel to the longitudinal axis of said
`implant, said upper and lower bearing surfaces having portions proximate
`each of said first and second sides and being convex along the entire length
`of said upper and lower bearing surfaces relative to the second plane and in a
`direction parallel to the longitudinal axis.” Patent Owner contends that, in
`view of the disclosure of the ’696 patent, the upper and lower bearing
`surfaces should be construed as “upper and lower surfaces for bearing
`against the anatomic endplates of the adjacent vertebrae.” PO Resp. 17. In
`particular, Patent Owner contends that the “upper and lower bearing
`surfaces” should be construed as having “a length measured parallel to the
`longitudinal axis of the spinal fusion implant, have portions proximate each
`of the first and second sides, and are convexly curved along the entire length
`thereof relative to the second plane in a direction parallel to the longitudinal
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`IPR2013-00395
`Patent 8,444,696 B2
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`axis, the convex curvatures conforming to the anatomic endplates of the
`adjacent vertebrae along the entire length thereof.” Id.
`As demonstrated by the embodiment shown in Figure 14, reproduced
`above, however, there may be more than a single bearing surface. The claim
`language only requires that those bearing surfaces be convex. We agree,
`therefore, with Petitioner that the claim language does not require that the
`convexity be along the entire length of the implant. Moreover, independent
`claims 1 and 4 only require that the “upper and lower bearing surfaces . . .
`being convex along the entire length of said upper and lower bearing
`surfaces.” There is nothing in the claim language that requires that the
`convexity conform to the anatomic endplates of the adjacent vertebrae. The
`Specification does not provide a definition of convexity as conforming to the
`anatomic endplates of the adjacent vertebrae with reasonable clarity,
`deliberateness, and precision. We decline, therefore, to construe the
`convexity of the bearing surfaces as requiring that the convexity conform to
`the anatomic endplates of the adjacent vertebrae.
`Thus, we construe “upper and lower bearing surfaces” as requiring
`that the bearing surface itself must be convex along the entire length of the
`bearing surface, but as the implant may have more than one upper bearing
`surface, as well as more than one lower bearing surface, the convexity need
`not be along the entire length of the implant. Moreover, the convexity need
`not conform to the anatomic endplates of the adjacent vertebrae.
`3. “ratchetings”
`Independent claims 1 and 4 require “ratchetings on each of said upper
`and lower bearing surfaces adapted to engage the first vertebra and the
`second vertebra, respectively, each of said ratchetings having a ridge
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`IPR2013-00395
`Patent 8,444,696 B2
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`oriented in a direction generally parallel to the width of said implant, said
`ratchetings on each of said upper and lower bearing surfaces facing one
`direction.” An embodiment of the ratchetings can be seen in Figure 9 of the
`’696 patent, reproduced above in Section I(C).
`
`Patent Owner argues that ratchetings should be construed as “facets
`that are angled to afford forward movement of the spinal fusion implant in
`one direction and facets that are angled to prevent the spinal fusion implant
`from backing out in the opposite direction.” PO Resp. 18 (citing Ex. 2005 ¶
`38). Petitioner does not present an alternate construction. We determine
`that Patent Owner’s construction is consistent with the Specification and the
`language of the claim itself, and, thus, we adopt that construction. We note,
`however, that the claim does not require any specific directionality of the
`ratchets, such as, allowing for easier movement in the direction of insertion.
`B. Patentability
`1. Principles of Law
`To prevail on its challenges to the patentability of claims, Petitioner
`must prove unpatentability by a preponderance of the evidence. 35 U.S.C.
`§ 316(e); 37 C.F.R. § 42.1(d).
`A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
`between the subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art; (3)
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`the level of ordinary skill in the art; and (4) objective evidence of
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`The level of ordinary skill in the art usually is evidenced by the references
`themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.
`2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich,
`579 F.2d 86, 91 (CCPA 1978).
`Prior art references must be “considered together with the knowledge
`of one of ordinary skill in the pertinent art.” In re Paulsen, 30 F.3d 1475,
`1480 (Fed. Cir. 1994) (quoting In re Samour, 571 F.2d 559, 562 (CCPA
`1978)). Moreover, “it is proper to take into account not only specific
`teachings of the reference, but also the inferences which one skilled in the
`art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d
`825, 826 (CCPA 1968). That is because an obviousness analysis “need not
`seek out precise teachings directed to the specific subject matter of the
`challenged claim, for a court can take account of the inferences and creative
`steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S.
`at 418; see In re Translogic Tech., Inc., 504 F.3d. at 1259.
`2. Secondary Considerations
`Patent Owner contends that Dr. Michelson is a prolific inventor, and
`his “spinal implants are the preferred implants of choice for many surgeons
`performing spinal fusion surgeries.” PO Resp. 24. According to Patent
`Owner:
`
`The widespread adoption of Dr. Michelson’s spinal
`fusion implants is evidenced by the commercial success thereof.
`In particular, sales of spinal fusion implants by Medtronic (e.g.,
`CLYDESDALE® Spinal System (Ex. 2011)) that are covered
`by independent claims 1 and 4 have totaled more than $80
`million from inception to present and $15 million in fiscal year
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`2013 alone. (Ex. 2010) Warsaw submits that the commercial
`success of the spinal fusion implants covered by independent
`claims 1 and 4 support a finding of nonobviousness.
`Id. Patent Owner contends further that Petitioner’s expert, Dr. Brantigan,
`“agrees that there has been significant adoption of spinal fusion implants that
`appear to fall within the scope of the ’696 patent.” Id. (citing Ex. 2009.
`172:15–173:2).
`Before we can determine that the obviousness determinations above
`render the challenged claims unpatentable, we must consider the evidence of
`obviousness anew in light of any evidence of secondary considerations of
`nonobviousness presented by Patent Owner. See Graham, 383 U.S. at 17-18
`(“Such secondary considerations as commercial success, long felt but
`unsolved needs, failure of others, etc., might be utilized to give light to the
`circumstances surrounding the origin of the subject matter sought to be
`patented. As indicia of obviousness or nonobviousness, these inquiries may
`have relevancy.”); Transocean Offshore Deepwater Drilling, Inc. v. Maersk
`Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012) (“This objective
`evidence must be ‘considered as part of all the evidence, not just when the
`decision maker remains in doubt after reviewing the art.’”) (quoting
`Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538-39 (Fed. Cir. 1983)).
`“Evidence of commercial success, or other secondary considerations,
`is only significant if there is a nexus between the claimed invention and the
`commercial success.” Ormco Corp. v. Align Tech. Inc., 463 F.3d 1299,
`1311-12 (Fed. Cir. 2006). “For objective evidence to be accorded
`substantial weight, its proponent must establish a nexus between the
`evidence and the merits of the claimed invention.” In re GPAC Inc., 57 F.3d
`1573, 1580 (Fed. Cir. 1995). In order to establish a proper nexus, the patent
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`owner must offer proof that the sales were a direct result of the unique
`characteristics of the claimed invention—as opposed to other economic and
`commercial factors unrelated to the quality of the patented subject matter.
`See Microsoft v. Proxyconn, Inc., IPR2012-00026, slip op. at 4 (PTAB Mar.
`8, 2013) (Paper 32).
`
`Patent Owner, however, has not attempted to establish a nexus
`between the claims of the ’696 and the CLYDESDALE® Spinal System.
`Thus, Patent Owner’s arguments and evidence as to commercial success are
`entitled to little or no weight.
`3. Obviousness under 35 U.S.C. § 103(a) of claims 1, 3,
`4, and 6 over the Combination of Senter and Brantigan ’035
`Petitioner contends that the combination of Senter and Brantigan ’035
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`would have rendered obvious independent claims 1 and 4, as well as
`dependent claims 3 and 6. Pet. 14–19. Petitioner sets forth a claim chart
`demonstrating where each element of the claims is taught by the
`combination (Pet. 34–47), and relies, initially, on the Declaration of Dr. John
`W. Brantigan (Ex. 1001). Patent Owner disagrees with Petitioner’s
`assertions (PO Resp. 25–46), and relies on the Declaration of Dr. Charles L.
`Branch, Jr. (Ex. 2005) as evidence that the asserted combination does not
`render obvious the challenged claims.
`a. Senter (Ex. 1007)
`Senter is drawn to an implant that is placed between two vertebrae to
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`fuse the vertebrae together. Ex. 1007, 1:4–7.6 The posterior ledge of the
`implant is tapered inward preferably to permit the implant to be inserted
`between the vertebrae during a surgical procedure. Id. at 5:34–37. Senter
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`6 Page numbers refer to the numbers at the top of each page rather than those
`on the bottom.
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`Patennt 8,444,6996 B2
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`teachhes furtherr that the “ssurface of
`rably ge is preferthe intermmediate ridg
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`same reasson.” Id.at 5:37–6:2.
`, the
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`smoooth for the
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`As taughtt by Senter
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`ridge can bbe bowed
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`“anteerior platfoorm and/orr the posterrior ledge aand/or the
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`outwwardly slighhtly to mattch the shaape of the ccontacted vvertebrae mmore
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`precisely.” Id. at 6:13–1
`6.
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`Figure 44 of Senter is reproduuced beloww:
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` Id. at 8:6––9. Implannt 50, as shhown in Fiigure 4, haas
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`Figure 44, above, shhows a perrspective viiew of an eembodimeent of the
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`of Senter. spinaal implant
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`” Id. at
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`four sides, andd “a pair of f spaced-appart, oppos
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`ed parallell bases 92.”
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`10:2–4. The immplant inclludes patteern of serraations 66, wwhich mayy be small
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`teethh, continuoous small riidges, bummps, or equuivalent struuctures. Idd. at 11:12
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`ebrae to
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`17. The serratiions “interrlock with tthe cancelllous bone oof the vert
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`inhibbit dislocattion (moveement) of immplant 50
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`relative too the vertebbrae after
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`impllantation.” Id. at 11:
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`17–20.
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`Senter teaches:
`Dislocation (movement) of any spinal implant is a
`serious concern, and the present implant 50 is designed to avoid
`such movement. Dislocation of the implant 50 posteriorly
`toward the foramen 38 is of particular concern, because such
`dislocation could result in the implant 50 impinging against the
`spinal cord. The combination of the ridge 68, the serrations 66,
`and the slightly wedge-shaped configuration of the implant 50
`all aid in avoiding dislocation of the implant 50, and
`particularly in avoiding dislocation in the direction of the spinal
`cord.
`Id. at 11:33–12:7.
`
`The implant of Senter is implanted surgically by grinding a groove
`into the superior and inferior vertebrae. Id. at 15:35–37. The groove is
`positioned so as to provide a flush placement of the implant, such that close
`contact between the ridge of the implant and the groove ground into the
`vertebrae is achieved. Id. at 16:3-10. As taught by Senter, typically, the
`spine is distended to ease insertion of the implant. Id. at 16:20–22.
`b. Brantigan ’035 (1005)
`Brantigan ’035 is drawn to an implant, in the form of inert plugs, to be
`placed in prepared sites between opposed faces of adjacent vertebrae. Ex.
`1005, 1:3–8.7 The plugs may have barbs to bite into the vertebrae, as well as
`slots for carrying bone graft material. Id. at 1:16–17.
`The plugs are mounted endwise on a tool to facilitate insertion. Id. at
`1:12–13. Specifically, the plugs may have at one end an internally threaded
`axial hole, and wings or slots radiating from the hole. Id. at 5:13–16. An
`insertion tool then may be threaded into the hole and surrounded by a sleeve
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`7 Page numbers refer to the numbers at the top of each page rather than those
`on the bottom.
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`IPR2013-00395
`Patent 8,444,696 B2
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`that is fitted into the wings or slots. Id. at 5:16–18. Brantigan ’035 teaches
`the use of “[b]ristle or prong surfaces,” which may be shaped to facilitate
`insertion and resist retraction. Id. at 6:13–15. The implant also may have
`horizontal or vertical slots that are packed with bone graft material. Id. at
`7:10–15.
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`c. Analysis
`Petitioner asserts that Senter discloses almost all the limitations of
`independent claims 1 and 4, Pet. 14, and provides a detailed claim chart
`demonstrating where each of the limitations may be found, id. at 34–47.
`Petitioner notes, however, that Senter may “not disclose (i) ‘a recessed
`portion and a threaded opening’ of the trailing face, (ii) ‘an opening’ for the
`growth bone, or (iii) the ‘ratchetings.’” Id. at 14. Petitioner asserts that
`those features were known widely and used conventionally in spinal
`implants, as evidenced by Brantigan ’035. Id.
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`Specifically, according to Petitioner, the ordinary artisan would have
`included a recessed portion and threaded opening, as taught by Brantigan
`’035, in order to provide a convenient process to insert and remove the
`insertion instrument without disturbing the mounting. Id. at 15. Petitioner
`also asserts that the ordinary artisan also would have incorporated at least
`one opening into the implant, and Brantigan ’035 teaches that the opening
`may be filled with strips of bone implant, which then may grow into the
`bone tissue of the adjacent vertebrae. Id. Similarly, Petitioner also argues
`that the ordinary artisan would have included ratchetings on the upper and
`lower bearing surfaces, as Brantigan ’035 discloses that such ratchetings
`inhibit dislocation of the implant once it has been placed. Id. at 16.
`According to Petitioner, combining Senter and Brantigan to arrive at the
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`implant claimed by the ’696 patent is “merely [the] use of known
`technique[s] to improve similar devices in the same way.” Id. at 17 (citing
`KSR, 550 U.S. at 417).
`
`Patent Owner contends that Senter does not teach or suggest the
`limitation of claims 1 and 4 that the upper and lower bearing surfaces are
`convex. PO Resp. 26. According to Patent Owner, Petitioner relies on
`features 68 and 68a of Senter as the upper and lower bearing surfaces of
`independent claims 1 and 4. Id. at 29. Senter teaches cutting away portions
`of the endplates of the superior and inferior vertebrae, 22a and 22b, and,
`therefore, Patent Owner contends that “the intermediate ridges 68, 68a do
`not conform to the anatomic endplates of the superior and inferior vertebrae
`22a and 22b, but instead, conform to the grooves 80.” Id.
`As construed above (see Section II(A)(2), above), the convexity of the
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`upper and lower bearing surfaces need not extend along the entire length of
`the implant, and also need not conform to the anatomic endplates of the
`adjacent vertebrae. It is irrelevant, therefore, that the convex surfaces of
`Senter conform to grooves cut into the endplates of the superior and inferior
`vertebrae, rather than to the anatomic endplates of the superior and inferior
`vertebrae. As Senter teaches upper and lower bearing surfaces that are
`convex, it meets that limitation of challenged independent claims 1 and 4.
`
`Patent Owner argues further that that the ordinary artisan would not
`have modified Senter to include ratchetings. PO Resp. 30. Patent Owner
`contends that Senter is concerned about movement of the spinal disk implant
`towards the spinal cord, and is configured to prevent forward movement of
`the implant. Id. at 33–34 (citing Ex. 1007, 11:35–12:2). The nubs of
`Brantigan ’035, Patent Owner argues, accommodate movement in the
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`direction of insertion, and prevent movement in the opposite direction. Id. at
`33 (citing Ex. 1005, 20:30–21:3). According to Patent Owner, because the
`nubs of Brantigan ’035 would afford forward movement of the implant,
`Senter teaches away from their use by its use of an implant that is configured
`to prevent forward movement. Id. at 34.
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`Petitioner responds that “[d]uring implantation the vertebrae are
`distracted (i.e., spread apart) to allow for insertion of the implant.” Reply 4
`(citing Ex. 1017 ¶¶ 7, 18; Ex. 1018, 69–70). Although the ratchets may
`accommodate movement in one direction during insertion, once implanted,
`the ratchets would resist both forward and backward movement, as well as
`side-to-side movement, due to the ratchets digging into the surrounding
`vertebrae. Id. (citing Ex. 1017 ¶¶ 4–9). Petitioner asserts further that the
`ratchets do not propel movement of the implant in any direction. Id. (citing
`Ex. 1017 ¶ 5). Thus, Petitioner contends that Senter does not teach away
`from the combination with Brantigan ’035.
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`We credit the Declaration of Dr. Brantigan that the two adjacent
`vertebrae may be distracted upon insertion of the implant. Ex. 1017 ¶¶ 7, 1;
`see also ex. 1007, 16:20–22 (noting that the spine is distended typically to
`ease insertion of the implant). In fact, Patent Owner’s expert, Dr. Branch,
`agreed that if serrations were put on the convex surfaces of the device of
`Senter, and the vertebral bodies were distracted sufficiently, the ratchets
`would not contact the vertebral bodies upon insertion. Ex. 1018, 69–70.
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`Moreover, as taught by Brantigan ’035, the sharp apexes of the nubs
`bite into the vertebrae bone, and, thus, once the implant is in the proper
`position, it will not shift from that position. Ex. 1005, 21:1–5. We, thus,
`credit Dr. Brantigan’s testimony that the ratchetings would not propel an
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`implant forward,