`
`Trials@uspto.gov Paper No. 35
`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 IPR2013-00396
`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
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`
`I. INTRODUCTION
`A. Background
`Petitioner, NuVasive Inc. (“NuVasive”), filed a Corrected Petition
`requesting inter partes review of claims 7–12 (“the challenged claims”) of
`U.S. Patent No. 8,444,696 B2 (“the ’696 patent”). Paper 5 (“Pet.”). Patent
`Owner, Warsaw Orthopedic, Inc. (“Warsaw”), did not file a Patent Owner
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`IPR2013-00396
`Patent 8,444,696 B2
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`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 7-12 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 11
`(“Institution Decision”; “Dec. Inst.”).
`Patent Owner filed a Response (Paper 23, “PO Resp.”), but did not
`file a motion to amend. Petitioner subsequently filed a Reply. Paper 24
`(“Reply”). An oral hearing was held on July 31, 2014. The transcript of the
`hearing has been entered into the record. Paper 34.
`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 7–12 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-
`00395, involves claims 1–6 of the patent. Petitioner indicates further that
`Patent Owner has asked the 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. 1102, 1:20–23.
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`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.” 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 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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`IPR22013-003996
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`Patennt 8,444,6996 B2
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`is reproducced below
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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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`9:18–19.
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`In additionn,
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`first termiinal part ddefining aa first
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`the implant . . . inncludes a
`bearing
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`surface aadapted to bear agaainst an eendplate off the
`vertebra
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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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`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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`terminal ppart definees a third bbearing suurface
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`to bear aggainst the
`adapted
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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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`Patennt 8,444,6996 B2
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`The ’6966 patent also disclosees an emboodiment wiith ratchetiing. Figuree
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`the patent is reproduuced beloww:
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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 the Figurre, the ratchhetings aree oriented
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`in thhe directionn of inserti
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`on end, 2220, allowinng for one-wway insertiion of the
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`impllant, and boone engagiing end, 2552, preventts the impllant from bbacking ouut
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`oncee implantedd. Id. at 8:40–49.
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`The ’6966 patent teaaches furthher that whhen a posteerior lumbaar
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`interrbody fusioon is perforrmed, it is not possibble to replaace the remmoved
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`disc with a single, laarge implanant. Id. at 22:35–38. IIn such
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`portiions of the
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`cases, a “moduular implannt[ ]” may bbe used. IdId. at 2:40––42. The mmodular
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`impllants are ass long as thhe length oof the disc mmaterial thhat is remo
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`space fromm the
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`are nnarrower, aand thus, c
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`an be “intrroduced intto the disc
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`posteerior aspecct to either side of thee dural sac
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`aligned sidde to side
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`withhin the discc space so tthat a numbber of themm each havving a lenggth
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`conssistent withh the depthh of the discc removedd in that areea would inn
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`combbination haave a widthh equal to the width oof the discc material rremoved.”
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`Id. aat 2:42–50.
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`IPR2013-00396
`Patent 8,444,696 B2
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`According to the ’696 patent, because the disc spaces in the lumbar
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`spine are generally lordotic, the modular implants would be taller at the
`insertion end than at 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.
`D. Illustrative Claim
`Petitioner challenges claims 7–12 of the ’696 patent. Claims 7 and 10
`are independent claims. Claim 7 is illustrative, 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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`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
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`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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`a 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
`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,
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`IPR2013-00396
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`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.
`E. Instituted Challenge
`References
`Claims
`Basis
`§ 103(a) Steffee,1 Michelson ’037,2 and Kim3
`7–12
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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
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`1 Steffee (“Steffee”), US 5,443,514, issued August 22, 1995 (Ex. 1108).
`2 Michelson (“Michelson ’037”), WO 90/00037, published January 11, 1990
`(Ex. 1109).
`3 Kim (“Kim”), US 5,645,596, issued July 8, 1997 (Ex. 1110).
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`Patent 8,444,696 B2
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`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 need only construe the following claim terms.
`1. “opening”
`Independent claims 7 and 10 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. Petitioner responds that “[t]here is
`no language in claims [7] and [10] that would require the claimed “opening”
`to be oriented in a specific direction (e.g., vertically oriented from the lower
`to upper surface).” Reply 2.
`Independent claim 7 requires that the implant have a first side and an
`opposite second side, wherein “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.”
`Independent claim 10 has the same limitation. The remaining two sides of
`the implant are then defined by the claims as becoming the upper and lower
`bearing surfaces. The claims, thus, define the first and second sides as being
`the horizontal sides after the implant is placed and rotated 90 degrees. The
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`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. “ratchetings”
`Independent claims 7 and 10 require “ratchetings on each of said
`upper and lower bearing surfaces . . . 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.” An embodiment of the ratchetings can be seen in Figure 9 of the
`’696 patent, reproduced above in Section I(C).
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`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. 17 (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.
`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).
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`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) 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.
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`2. Obviousness under 35 U.S.C. § 103(a) of claims 7–12 over
`the Combination of Steffee, Michelson ’037, and Kim
`Petitioner contends that the combination of Steffee, Michelson ’037,
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`and Kim renders obvious independent claims 7 and 10, as well as dependent
`claims 8, 9, 11, and 12. Pet. 14–19. Petitioner sets forth a claim chart
`demonstrating where each element of the claims is taught by the reference
`(Id. at 47–60), and relies, initially, on the Declaration of Dr. John W.
`Brantigan (Ex. 1101). Patent Owner disagrees with Petitioner’s assertions
`(PO Resp. 23–46), 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. Steffee (Ex. 1108)
`Steffee is drawn to a spinal implant, as well as methods of using the
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`implant, to fuse adjacent vertebrae of the spine together. Ex. 1108, 1:5–7.
`In order to place the implant, at least a portion of the spinal disc is removed
`from between the adjacent vertebrae. Id. at 1:32–35. The implant is inserted
`between the adjacent vertebra, “with the first and second substantially
`parallel side surfaces facing the adjacent vertebrae.” Id. at 1:35–38. The
`implant is then rotated ninety degrees so that the upper and lower surfaces
`can engage the adjacent vertebrae. Id. at 1:38–42.
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`Figure 22 of Steffeee is reproduuced beloww:
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`Figure 22, above, shhows a perrspective viiew of an eembodimeent of the
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`. Id. at 1:555–56. Impplant 10, aas shown inn the
`of Steffeespinaal implant
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`figurre, has “paarallel side surfaces 20 and 22.”” Id. at 2:332–33. Thee implant
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`also has upper surface 244, and loweer surface 226, that enngage the a
`djacent
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`verteebrae, and plurality oof triangulaar-shaped tteeth 36 fo
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`r engagingg the
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`verteebrae. Id. at 2:33–344, 44–47. SSpecifically
`y, Steffee
`teaches:
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`Thhe surface
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`40 of the ttooth 36 exxtends at aan acute anngle x
`at an
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`to the pllane 48. TThe surfacce 42 of thhe tooth 366 extends
`y are
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`acute anngle y to thhe plane 488. Preferabbly, the anggles x and
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`equal annd have a vvalue of 455° so that ssurfaces 400 and 42 exxtend
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`perpendiicular to eeach otherr. Therefoore, the teeeth 36 aree not
`from
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`preferenntial. The
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`teeth 36 pprevent thee spinal immplant 10
`16 as
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`toward thee anterior
`moving
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`portion off the spinaal column
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`much ass they prevvent the sppinal impllant from mmoving tooward
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`the posteerior portioon of the sppinal colummn 16.
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`Id. aat 2:54–63.
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`The implant also has a plurality of openings 56 and 58 that extend
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`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. 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.
`b. Michelson ’037 (Ex. 1109)
`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, 1:2–4.4 The implant allows for bone fusion across the intervertebral
`space, and may contain a plurality of cells or openings of 1-3 mm, into
`which fusion promoting materials may be placed, allowing a bony bond
`between the adjacent vertebrae to each other, as well as to the implant. Id. at
`8:10–21.
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`4 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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`Figure 1 of Michellson ’037 iis reproducced below:
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`wall, 22, of thee implant, iis slightly convex, annd has deprressed porttion 24 thaat
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`Figure 1
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`, above, iss a top righht perspectiive view off the implaant of
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`7. Id. at 100:13–14. AAs seen in
`Michhelson ’03
`the above
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` Figure, thhe front
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`has ccentral threeaded openning 26 thaat can receiive the enggaging endd of a
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`driviing membeer. Id. at 11:38–40. AAs seen allso in the FFigure, the
`recessed
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`portiion intersects the sidees of the immplant thatt face the vvertebrae dduring the
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`inserrtion step, such that rrestriction members oof the inserrter tool acct as a stopp
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`whenn they abut the vertebbrae, thus ppreventingg over inserrtion of thee implant.
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`Id. aat 12:38–133:3.
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`c. Kiim (Ex. 11110)
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`Kim is ddrawn to ann implant tthat may bee used “as
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`a substitutte for one
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` or mmore interveertebral dissks that haave been reesected in aa resection
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`operation.” Ex. 1110, 1:7–10. According to Kim, the “contact surface of
`the vertebra body with the intervertebral disk is macroscopically a concave
`surface.” Id. at 2:31–33. The vertebrae prosthesis is, thus, provided with a
`convex surface that corresponds to the concave surface of the vertebra,
`allowing for multiple advantages, such as ease of insertion, increase in
`stability, etc. Id. at 2:33–41.
`d. Analysis
`Petitioner 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.
`Petitioner 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.
`
`Specifically, according to Petitioner, 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. Petitioner 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 Petitioner, combining
`Steffee, Michelson ’037, and Kim to arrive at the implant claimed by the
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`’696 patent, is “merely [the] use of known technique[s] to improve similar
`devices in the same way.” Id. at 21 (citing KSR, 550 U.S. at 417).
`
`Moreover, Petitioner contends that, to the extent that Steffee does not
`disclose a vertical opening, that configuration is disclosed by Michelson
`’037, whose opening serves the same purpose as the opening of Steffee, that
`is, “to promote bone ingrowth between the implant and the adjacent
`vertebrae.” Reply 5 (quoting Ex. 1109, 13).
`
`Patent Owner contends that Steffee does not teach or suggest
`ratchetings, as suggested by Petitioner. PO Resp. 24–30. In particular,
`Patent Owner contends that the teeth of Steffee are not preferential—that is,
`they resist movement equally in the anterior and posterior directions. Id. at
`25 (citing Ex. 1108, 2:59–63). The ratchetings used on the implant of the
`challenged claims, however, allow for forward direction during insertion,
`but prevent the implant from backing out after insertion. Id. (citing Ex.
`1102, 8:42–47). Thus, Patent Owner contends, the teeth of Steffee do not
`correspond to the claimed ratchetings. Id. at 26.
`
`Patent Owner notes that Petitioner relies on the teaching of Steffee
`that the orientation of the teeth is achieved by selecting the surface angle ‘x’
`and ‘y,’ wherein ‘x’ and ‘y’ are limited to acute angles. Id. at 27 (citing Pet.
`54, 59). Patent Owner contends that, according to Petitioner, “so long as the
`angles are acute, the angles x and y can vary with respect to one another
`within a selected range, and that the angles x and y could be selected that
`result in teeth 36 that are ratchetings.” Id. Patent Owner asserts that reading
`of Steffee is incorrect, as the portions of Steffee relied upon must be read in
`association with the remainder of the disclosure of Steffee, which indicates
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`that the teeth are configured to prevent movement in two directions. Id. at
`27–28.
`Moreover, Patent Owner argues that the ordinary artisan would not
`have modified the teeth of Steffee, which prevent movement in two
`directions, to ratchetings, which allow forward movement during insertion,
`but prevent backward movement. Id. at 29. Specifically, Patent Owner
`argues that the spacer implants of Steffee are inserted linearly between
`adjacent vertebrae, and then rotated 90 degrees. Id. The teeth are not
`oriented towards the adjacent vertebrae during insertion, but only contact the
`vertebrae after insertion and rotation. Id. Thus, Patent Owner contends,
`there would be no reason to modify the teeth of Steffee to ratchetings, which
`allow forward movement and prevent backward movement. Id. at 30 (citing
`Ex. 2005 ¶ 73; Ex. 2009, 124:21–125:11).
`
`Petitioner responds that embodiments with one-way ratchetings were
`contemplated by Steffee. Reply 2–3 (citing Ex. 1101 ¶ 52; Ex. 1117, 42–47,
`50; Ex. 1116 ¶¶ 26–27). Petitioner asserts further that using unequal angles
`for ‘x’ and ‘y’ for the teeth of Steffee would not hinder the stated purpose of
`the teeth of Steffee—preventing movement of the spinal implant. Id. at 3
`(citing Ex. 1108, 2:60–63). According to Petitioner, “[a]lthough angling the
`teeth in a particular direction would afford slightly easier mobility in one
`direction over another during insertion/manipulation by the surgeon using an
`inserter tool, the implant would still resist movement in both forward and
`backward directions (just like any traditional ratchetings that bite into the
`bone after reaching the final position) after implantation.” Id.
`
`We determine that Steffee discloses teeth that would be encompassed
`by the ratchetings of challenged independent claims 7 and 10. In particular,
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`while we agree that the preferred embodiment of Steffee is one in which the
`angles ‘x’ and ‘y’ are equal, having a value of 45°, a reference is not limited
`to its preferred embodiment, but is available for all that it discloses and
`suggests to the ordinary artisan. In re Applied Mat’ls, Inc., 692 F.3d 1289,
`1298 (Fed. Cir. 2012); see also Merck & Co. Inc. v. Biocraft Labs., Inc., 874
`F.2d 804, 807 (Fed. Cir. 1989) (“[I]n a section 103 inquiry, ‘the fact that a
`specific [embodiment] is taught to be preferred is not controlling, since all
`disclosures of the prior art, including unpreferred embodiments, must be
`considered.’”). Steffee teaches that the angles ‘x’ and ‘y’ are limited to
`acute angles, and further states that, in a preferred embodiment, the angles
`‘x’ and ‘y’ are equal. As explained by Dr. Brantigan, the selection of angles
`‘x’ and a ‘y’ that are not equal “would, by nature, afford preferential
`movement of the implant in one direction over the opposite direction.” Ex.
`1116 ¶ 26. Thus, while the use of teeth in which the angles ‘x’ and ‘y’ are
`equal is preferred by Steffee, the disclosure of Steffee is not so limited.
`
`In addition, Patent Owner acknowledges that ratchetings were known
`in the art at the time of Steffee. In particular, Patent Owner argues that
`Steffee cites Brantigan ’757 (Ex. 2003), which discloses nubs, or
`ratchetings. PO Resp. 31. Steffee, Patent Owner asserts, does not adopt the
`nubs of Brantigan ’757, which “reinforces that one of ordinary skill would
`not have modified the teeth 36 to be ratchetings.” Id. We disagree.
`Steffee’s use of ‘x’ and ‘y’ to define the angles, and Steffee’s statement that,
`in a preferred embodiment, angles ‘x’ and ‘y’ are equal, demonstrate that
`Steffee was not excluding the nubs of Brantigan ’757, which would provide
`preferential movement in one direction. See, e.g., Ex. 2003, Figs. 7, 8
`(showing angled nubs), 6:40–50 (describing the angled nubs).
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`Patent Owner contends further that the recitation of an opening in
`
`challenged independent claims 7 and 10 “makes it clear that the implants of
`independent claims 7 and 10 are spinal fusion implants.” PO Resp. 32.
`Steffee is not drawn to a spinal fusion implant, but to a spacer implant or
`interbody support. Id. at 32–33. That is, Patent Owner asserts, “the spacer
`implants 10 of Steffee are used in a spinal fusion process, but are not
`themselves spinal fusion implants.” Id. at 33. After the spacer implants of
`Steffee are positioned, the space between the implants is packed with bone
`graft material to promote fusion. Id. (citing Ex. 1108, 4:57–59). Once the
`implants of Steffee are positioned, Patent Owner notes that the openings of
`Steffee are oriented horizontally, away from the adjacent vertebrae, allowing
`for blood flow and bone growth from one side of the implant to the other, Id.
`at 34 (citing Ex. 1108, 2:65–67). Thus, Patent Owner contends, “fusion
`between the adjacent vertebrae 12 and 14 occurs via the bone graft bone, not
`growth of bone into and through the openings 56 and 58.” Id. Thus, Patent
`Owner contends, the implants of Steffee do not meet the limitation of “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,” as required by challenged
`independent claims 7 and 10. Id. at 35 (citing Ex. 2005 ¶ 79).
`
`Petitioner responds that Steffee specifically teaches that the disclosed
`invention relates “to a spinal implant, and to a method of using the spinal
`implant to fuse together adjacent vertebrae of a spinal column.” Reply 5
`(quoting Ex. 1108, 1:5–7). Moreover, Steffee teaches that the horizontal
`openings allo