Trials@uspto.gov
`571-272-7822
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` Paper 11
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`Entered: December 20, 2013
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`NUVASIVE, INC.
`Petitioner
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`v.
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`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`____________
`
`Case IPR2013-00396
`Patent 8,444,696
`____________
`
`Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C. SIU,
`Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
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`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`

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`Case IPR2013-00396
`Patent 8,444,696
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`
`I.
`
`BACKGROUND
`NuVasive, Inc. (“NuVasive”) filed a corrected petition (“Pet.”) requesting an
`inter partes review of claims 7–12 of U.S. Patent No. 8,444,696 (Ex. 1102, the
`“’696 patent”) on July 9, 2013. Paper 5. Patent Owner, Warsaw Orthopedic, Inc.
`(“Warsaw”), did not file a preliminary response. We have jurisdiction under 35
`U.S.C. §§ 6(b) and 314.
` The standard for instituting an inter partes review is set forth in 35 U.S.C.
`§ 314(a), which states:
`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.
`
`Inter partes review is instituted only if the petition supporting the ground
`demonstrates “that there is a reasonable likelihood that at least one of the claims
`challenged in the petition is unpatentable.” 37 C.F.R. § 42.108(c).
`
`Upon consideration of the petition, we conclude that NuVasive has
`established a reasonable likelihood that it would prevail with respect to claims 7–
`12 of the ’696 patent. Accordingly, we grant the petition, and institute an inter
`partes review of claims 7–12 of the ’696 patent.
`
`
`A. Related Proceedings
`NuVasive indicates that it has concurrently filed another petition for an inter
`partes review of the ’696 patent. Pet. 1. NuVasive indicates further that Warsaw
`has asked the court for permission to add the ’696 patent to the litigation styled
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`Case IPR2013-00396
`Patent 8,444,696
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`Warsaw Orthopedic, Inc. v. NuVasive Inc., Case No: 3:12-cv-02738-CAB (S.D.
`Cal.). Id.
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`B. The ’696 Patent (Ex. 1102)
`The ’696 patent is drawn to an interbody spinal fusion implant, which is
`“configured to restore and maintain two adjacent vertebrae of the spine in correct
`anatomical angular relationship.” Ex. 1102, 1:20–23. The spinal implants are
`sized to fit within the disc space that is created when the disc material between two
`adjacent vertebrae is removed, and 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 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.” 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.
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`Case IPPR2013-00396
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`Patent 88,444,696
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`FFigure 14 oof the ’696 patent is r
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`eproducedd below:
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`TThe implannt shown inn Figure 144 has inserttion end 3220 and trai
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`ling end 3330.
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`ot
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`pa
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`Id. at 9:20–29.
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`TThe ’696 paatent teachhes further, that whenn a posterioor lumbar iinterbody
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`fusion is performeed, it is nott possible tto replace tthe removeed portionss of the dissc
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`with a ssingle, largge implant. Id. at 2:355–38. In ssuch cases,, a “modulaar implant””
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`may be used. Id. at 2:40–422. The moddular implaants are ass long as thhe length of
`f the
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`disc maaterial that is removedd, but are nnarrower, aand thus, ccan be “intrroduced innto
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`4
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`Figuure 14, above, is a lefft side elevvational vieew of a lorddotic interbbody spinaal
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`fuusion implaant. Id. at
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`5:11–12.
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`Id. at 9:18–19. Inn addition,
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`thhe implantt 300 incluudes a firstt terminal
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`part definning a firstt bearing
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`suurface adappted to beaar against aan endplatte of the veertebrae V11, and an
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`opposite seccond beariing surfacee adapted too bear agaainst an enddplate of
`terminal
`a second
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` includes t 300 also he implanthhe vertebraae V2. Th
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`second terrminal partt defines
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`part oppositte the firstt terminal ppart. The
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`third beaaring surfaace adaptedd to bear
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`against thhe endplatee of the
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`ainst the to bear agae adapted tng surfaceourth bearivertebrae VV1 and a fo
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`ndplate of f the vertebbrae V2.
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`Case IPR2013-00396
`Patent 8,444,696
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`the disc space from the posterior aspect to either side of the dural sac, and then
`aligned side to side within the disc space so that a number of them each having a
`length consistent with the depth of the disc removed in that area would in
`combination have a width equal to the width of the disc material removed.” Id. at
`2:42–50.
`
`According to the ’696 patent, the disc spaces in the lumbar spine are
`generally lordotic, and thus the modular implants would be taller at the insertion
`end than the trailing end. Id. at 2:55–58. As the insertion of such implants may be
`problematic, the implant may incorporate a mechanism that engages an insertion
`instrument at its trailing end, such as a box and threaded opening, which allows the
`modular implant to be rotated ninety degrees to its fully upright position after
`insertion. Id. at 2:59–62, 3:7-26.
`
`
`C. Representative Claims
`NuVasive challenges claims 7–12 of the ’696 patent. Claims 7 and 10 are
`independent claims. Claim 7 is representative, and reads as follows:
`7.
`A lordotic spinal fusion implant for insertion between a first vertebra
`and a second vertebra adjacent the first vertebra, the first vertebra
`having a generally vertically extending first peripheral wall and a first
`endplate and the second vertebra having a generally vertically
`extending second peripheral wall and a second endplate, wherein the
`implant comprises:
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`a first terminal part defining a trailing face, a first bearing
`surface adapted to bear against a portion of the first endplate,
`and an opposite second bearing surface adapted to bear against
`a portion of the second endplate, said trailing face extending
`between said first bearing surface and second bearing surface;
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` second terminal part opposite said first terminal part, said
`second terminal part having an insertion face extending
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` a
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`5
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`Patent 8,444,696
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` a
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`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;
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` 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, said
`implant being adapted to be inserted between the first vertebra
`and the second vertebra with said first side and said second side
`of said implant being oriented toward the first endplate and the
`second endplate, respectively, and then rotated ninety degrees
`into an upright position, said trailing face having a recessed
`portion intersecting each of said first and second sides and
`being configured to receive an insertion instrument for inserting
`said implant between the first vertebra and the second vertebra;
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`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;
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`upper and lower bearing each surfaces 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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`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, said upper and lower bearing surfaces being
`disposed in a converging angular relationship toward each other
`such that said implant appears wedge-shaped from a side view,
`the converging angular relationship of said upper and lower
`bearing surfaces maintaining the first vertebra and the second
`vertebra adjacent to said upper and lower bearing surfaces in an
`angular relationship to maintain the desired lordosis between
`the first vertebra and the second vertebra;
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`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
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`said implant being adapted to hold bone fusion promoting
`materials.
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`D. Prior Art Relied Upon
`NuVasive relies upon the following prior art references:
`Kim et al. (“Kim”), US 5,645,596, issued July 8, 1997 (Ex. 1110).
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`Michelson (“Michelson ’247”), US 5,015,247, issued May 14, 1991
`(Ex. 1105).
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`Steffee (“Steffee”), US 5,443,514, issued August 22, 1995 (Ex. 1108).
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`Tropiano (“Tropiano”), US 5,607,424,
`(Ex. 1104).
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`Brantigan (“Brantigan ’035”), WO 89/09035, published October 5,
`1989 (Ex. 1106).
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`issued March 4, 1997
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`7
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`Case IPR2013-00396
`Patent 8,444,696
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`Beckers et al. (“Beckers”), WO 95/08306, published March 30, 1995
`(Ex. 1107).
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`Michelson (“Michelson ’037”), WO 90/00037, published January 11,
`1990 (Ex. 1109).
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`E. The Asserted Grounds of Unpatentability
`NuVasive challenges the patentability of claims of the ’696 patent on the
`following grounds. Pet. 2–3.
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`Reference(s)
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`Tropiano, Michelson ’247,
`and Brantigan ’035
`Tropiano, Michelson ’247,
`Brantigan ’035, and
`Beckers
`Beckers, Michelson ’247,
`and Brantigan ’035
`Steffee, Michelson ’037,
`and Kim
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`Basis
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`§ 103
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`§ 103
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`§ 103
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`§ 103
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`Claims challenged
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`7, 8, 10, and 11
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`9 and 12
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`7-12
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`7-12
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`II. ANALYSIS
`A.
`Claim Interpretation
`In an inter partes review, claim terms in an unexpired patent are given their
`broadest reasonable construction in light of the specification of the patent in which
`they appear. 37 C.F.R. § 42.100(b). Under the broadest reasonable interpretation
`standard, claim terms are given their ordinary and customary meaning in view of
`the specification as would be understood by one of ordinary skill in the art at the
`time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). Any special definition for a claim term must be set forth in the
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`Case IPR2013-00396
`Patent 8,444,696
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`specification with reasonable clarity, deliberateness, and precision. In re Paulson,
`30 F.3d 1475, 1480 (Fed. Cir. 1994).
`Independent claims 7 and 10 recite (emphasis added) “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.” The claims also require (emphasis added) “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.”
`NuVasive contends that the broadest reasonable interpretation of the term
`“‘substantially flat’ in relation to the ‘first side’ and the ‘second side’ of the
`implant . . . is interpreted to include sides that are either planar or outwardly
`bowed.” Pet. 3 (emphasis removed). NuVasive acknowledges that the examples
`provided in the Specification of the ’696 patent all have flat sides, but that the use
`of the modifier “substantially” allows this construction. Id.
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`Claims 7 and 10 require only that portions of the first and second side are
`substantially flat, and do not define how much of the side is substantially flat. In
`addition, the substantially flat portions intersect a second plane that is
`perpendicular to a first plane, and are symmetrical about the first plane. Thus,
`what appears to be required by the claim is that there is some substantially flat
`portion on each of the first and second sides, and that they are symmetrical about
`the first plane and intersect the second plane. Thus, we agree with NuVasive that
`the claim language encompasses sides that are outwardly bowed, with the proviso
`that there is some small portion on each side that is “substantially planar.”
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`NuVasive contends further that the claim limitation of “upper
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`and lower bearing surfaces having portions . . . being convex along the entire
`length of said upper and lower bearing surfaces” does not require that the
`convexity is along the entire length of the implant. Pet. 4 (emphasis removed).
`Rather, NuVasive contends, the convexity “need only be ‘along the entire length of
`said upper and lower bearing surfaces,’” including the gearing surface portions that
`is between the two vertical lines shown in Figure 14. Id. (emphasis removed).
`
`As demonstrated by the embodiment shown in Figure 14, reproduced above,
`there may be more that a single bearing surface. The claim language only requires
`that those bearing surfaces be convex. Thus, we agree with NuVasive that the
`claim language does not require that convexity to be along the entire length of the
`implant.
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`We note that in its Patent Owner Response, Warsaw has the opportunity to
`inform the Board as to its construction of the claim limitations, and how those
`claim limitations are supported in the Specification of the ’696 patent. If Warsaw
`declines to exercise that opportunity, it will leave the Board recourse only to the
`intrinsic record, as well as NuVasive’s proposed construction of the claim
`limitations.
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`Obviousness over Steffee (Ex. 1108), Michelson ’037 (Ex. 1109), and
`B.
`Kim (Ex. 1110).
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`NuVasive contends that claims 7-12 are rendered obvious under 35 U.S.C.
`§ 103 by the combination of Steffee, Michelson ’037, and Kim. See, e.g., Pet.
`16-21.
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`Steffee is drawn to a spinal implant, as well as methods of using the implant
`to fuse adjacent vertebrae of the spine together. Ex. 1108, 1:5–7. In order to place
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`Patent 88,444,696
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`lant, at leaast a portionn of the sppinal disc iss removed
`the imp
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`from betwween the
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`adjacennt vertebraee. Id. at 1:332-35. Thhe implant iis inserted
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`between tthe adjacennt
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`vertebraa, “with thee first and second subbstantially parallel siide surfacees facing thhe
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`adjacennt vertebraee.” Id. at 1:35-38. Thhe implantt is then rootated ninetty degrees
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`Id. at 1:388-42.
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`that the upper andd lower surfaces can eengage thee adjacent vvertebrae.
`Steffee is
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`FFigure 2 of
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`reproduced below:
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`ment of the n embodimview of anerspective vshows a peFigure 2, above, s
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`spinal impplant
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`of Steffeee. Id. at 1:555–56.
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`Immplant 10,, as shown in the figuure, has “paarallel sidee surfaces 220 and 22.
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`Id. at 2:32–33. Thhe implant also has uupper surfaace 24, andd lower surrface 26, thhat
`engage
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`the adjacennt vertebraae, and pluurality of trriangular-shhaped teethh 36 for
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`engaginng the verteebrae. Id. at 2:33–344, 44–47. TThe teeth pprevent thee implant frfrom
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`movingg toward the anterior pportion of the spinal
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`column, aas well as ppreventing
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`implantt from movving towardd the posteerior portioon of the sppinal colummn. Id. at
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`Patent 8,444,696
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`2:59–63. The implant may be implanted using any instrument or tool that firmly
`holds the implant, and also allows the implant to be rotated into position. Id. at
`3:24-26.
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`The implant also has plurality of openings 56 and 58 that extend between the
`side surfaces to allow for blood flow, as well as bone growth from one side of the
`implant to the other. Id. at 2:64–67.
`Michelson ’037 is drawn to an implant to be placed into the space between
`two vertebrae after a damaged spinal disc has been removed. Ex. 1109, 1:2–4.1
`The implant allows for bone fusion across the intervertebral space, and may
`contain cells or openings into which fusion promoting materials may be placed. Id.
`at 8:10–21.
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`1 Page numbers refer to the numbers at the top of each page rather than those on
`the bottom.
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`Case IPPR2013-00396
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`FFigure 1 of Michelsonn ’037 is reeproduced
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`Patent 88,444,696
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`below:
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`of the impplant of Miichelson ’0037.
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`Figuree 1, above, is a top rigght perspecctive view
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`Id. aat 10:13–144.
`is slightly , 22, of thee implant, i
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`AAs seen in tthe above ffigure, the front wall
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`convex,, and has ddepressed pportion 24 tthat has ceentral threaaded openinng 26 that
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`receive the engagiing end of a driving mmember. IId. 11:38–440. As seeen also in th
`he
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`figure, tthe recesseed portion iintersects tthe sides o
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`f the implaant that facce the
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`vertebraae during the insertioon step, succh that resttriction meembers of tthe inserterr
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`tool act as a stop wwhen they abut the veertebrae, thhus prevennting over iinsertion oof
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`lant. Id. att 12:38–133:3.
`the imp
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`KKim is drawwn to an immplant that
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`may be ussed “as a suubstitute fofor one or mmore
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`interverrtebral diskks that that have beenn resected iin a resectiion operatiion.” Ex.
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`1110, 1:7–10. Acccording too Kim, the “contact suurface of thhe vertebraa body witth
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`the interrvertebral disk is maccroscopicaally a concaave surfacee.” Id. at 22:31-33. TThe
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`vertebrae prosthesis is, thus, provided with a convex surface that corresponds the
`concave surface of the vertebra, allowing for multiple advantages, such as ease of
`insertion, increase in stability, etc. Id. at 2:33–41.
`
`NuVasive asserts that Steffee discloses almost all the limitations of
`independent claims 7 and 10, Pet. 17–18, and provides a detailed claim chart
`demonstrating where each of the limitations may be found, id. at 47–60. NuVasive
`notes, however, that Steffee may “not expressly describe the claimed features of (i)
`the ‘trailing face having a recessed portion intersecting each of said first and
`second sides’ of the trailing face, or (ii) the upper and lower bearing portions being
`‘convex.’” Id. at 18. NuVasive asserts, however, that those features were widely
`known and conventionally used in spinal implants, as evidenced by Michelson
`’037 and Kim. Id. at 18–21.
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`Specifically, according to NuVasive, the ordinary artisan would have
`included a recessed portion and threaded opening that engages an insertion tool, as
`taught by Michelson ’037, in order to provide a convenient process to insert and
`remove the insertion tool “while maintaining the established orientation of the
`implant.” Id. at 19. NuVasive also asserts that the ordinary artisan would have
`convexly bowed the upper and lower bearing surfaces outward, as taught by Kim,
`in order conform to the contours of the vertebral endplates. Id. at 20–21.
`According to Nuvasive, combining Steffee, Michelson ’037, and Kim to arrive at
`the implant claimed by the ’696 patent, is “merely [the] use of known technique[s]
`to improve similar devices in the same way.” Id. at 21 (citing KSR Int’l Co. v.
`Teleflex Inc., 550 U.S. 398, 417 (2007)).
`
`We have considered the arguments and evidence presented by NuVasive,
`and we are persuaded that NuVasive has demonstrated a reasonable likelihood that
`independent claims 7 and 10 are rendered obvious by the combination of Steffee,
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`Michelson ’037, and Kim. We have considered NuVasive’s arguments and
`evidence, moreover, as to the obviousness of dependent claims 8, 9, 11, and 12,
`and are persuaded also that NuVasive has demonstrated a reasonable likelihood
`that it will prevail as to those claims as well. Accordingly, we institute inter partes
`review of claims 7-12 for obviousness over Steffee, Michelson ’037, and Kim.
`
`Other Challenges
`Upon review of the other challenges asserted by NuVasive against claims 7–
`12, we conclude that they are redundant in light of the grounds on the basis of
`which we institute review.2
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`III. CONCLUSION
`For the foregoing reasons, we determine that NuVasive has demonstrated a
`reasonable likelihood that it will prevail on its challenges of claims 7–12 of the
`’696 patent.
`At this stage of the proceeding, the Board has not made a final determination as
`to the patentability of any challenged claim.
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`2 We acknowledge Petitioner’s statement the “three sets of obviousness grounds for
`claims 7-12 are not cumulative, but instead all rely upon different primary
`references that individually disclose unique benefits to the patient, the practitioner,
`or both, address the dependent claims in different ways, and have different critical
`dates.” Pet. 8. Except for stating that the references may have different critical
`dates, Petitioner does not provide further explanation why the grounds are not
`redundant. In addition, the references relied upon in the grounds upon which inter
`partes review was instituted appear to have the earliest critical dates.
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`15
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`Case IPR2013-00396
`Patent 8,444,696
`
`
`IV. ORDER
`It is
`ORDERED that the petition is granted as to claims 7–12 with respect to the
`following grounds:
`Claims 7–12 as obvious under 35 U.S.C. § 103 by the combination of
`Steffee, Michelson ’037, and Kim;
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter partes
`review of the ʼ696 patent is hereby instituted commencing on the entry date of this
`Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is hereby
`given of the institution of a trial;
`FURTHER ORDERED that all other grounds presented in NuVasive’s
`petition are denied, and no ground other than those specifically granted above is
`authorized for the inter partes review as to claims 7–12; and
`FURTHER ORDERED that an initial conference call with the Board is
`scheduled for 2:00 PM Eastern Time January 16, 2014. The parties are directed to
`the Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48765-66 (Aug. 14,
`2012) for guidance in preparing for the initial conference call, and should be
`prepared to discuss any proposed changes to the Scheduling Order entered
`herewith and any motions the parties anticipate filing during the trial.
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`Case IPR2013-00396
`Patent 8,444,696
`
`
`Petitioner:
`
`Stephen Schaefer
`Michael Hawkins
`FISH & RICHARDSON P.C.
`schaefer@fr.com
`hawkins@fr.com
`
`Patent Owner:
`
`Thomas Martin
`Wesley Meinerding
`MARTIN & FERRARO, LLP
`tmartin@martinferraro.com
`wmeinerding@martinferraro.com
`
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`17
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