`571-272-7822
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`Paper 7
`Date: February 13, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MEDTRONIC, INC.
`Petitioner
`
`v.
`
`NUVASIVE, INC.
`Patent Owner
`____________
`
`Case IPR2013-00507
`U.S. Patent No. 8,187,334 B2
`____________
`
`
`Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C. SIU,
`Administrative Patent Judges.
`
`SIU, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`
`
`
`
`
`
`
`
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`Case No. IPR2013-00507
`Patent No. 8,187,334 B2
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`I.
`
`BACKGROUND
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`
`
`
`
`A.
`
`Background
`
`Medtronic, Inc. (“Petitioner”) filed a petition requesting an inter partes
`
`review of claims 1-5, 10, 11, and 14-28 of U.S. Patent No. 8,187,334 B2 (“the ’334
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`patent,” Ex. 1013) pursuant to 35 U.S.C. §§ 311-319. Paper 1 (“Pet.”). NuVasive,
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`Inc. (“Patent Owner”) filed a preliminary response (“Prelim. Resp.”). Paper 6. We
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`have jurisdiction under 35 U.S.C. § 314. The standard for instituting an inter
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`partes review is set forth in 35 U.S.C. § 314(a), which provides:
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`THRESHOLD – The Director may not authorize an inter partes review to
`be instituted unless the Director determines that the information
`presented in the petition filed under section 311 and any response
`filed under section 313 shows that there is a reasonable likelihood that
`the petitioner would prevail with respect to at least 1 of the claims
`challenged in the petition.
`
`
`
`We determine based on the record that Petitioner has shown, under 35
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`U.S.C. § 314(a), that there is a reasonable likelihood that it would prevail with
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`respect to at least one of the challenged claims.
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`
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`Petitioner relies on the following prior art:
`
`US 2002/0165550 A1 (Frey)
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`
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`Nov. 7, 2002
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`US 2003/0028249 A1 (Baccelli)
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`Feb. 6, 2003
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`US 5,860,973 (Michelson)
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`
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`Jan. 19, 1999
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`US 2003/0100950 A1 (Moret)
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`May 29, 2003
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`US 2003/0139813 A1 (Messerli)
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`Jul. 24, 2003
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`
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`
`
`
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`
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`
`
`Ex. 1003
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`Ex. 1004
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`Ex. 1005
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`Ex. 1006
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`Ex. 1007
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`
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`Petitioner contends that the challenged claims are unpatentable under
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`35 U.S.C § 103(a) based on the following specific grounds (Pet. 3):
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`2
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`Case No. IPR2013-00507
`Patent No. 8,187,334 B2
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`
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`Reference(s)
`
`Frey
`Frey and Baccelli
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`Frey and Messerli
`Frey and Michelson
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`Frey and Moret
`
`
`Basis
`
`§ 102(b)
`§ 103(a)
`
`§ 103(a)
`§ 103(a)
`
`§ 103(a)
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`
`
`Claims challenged
`
`1-3, 10, 14, 15, and 19-28
`1-5, 10, 11, 14-17, and 19-
`28
`1-3, 10, 14, 15, and 19-28
`1-5, 10, 11, 14, 15, and 18-
`28
`1-3, 10, 14, 15, and 19-28
`
`B.
`
`The ’334 patent
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`The ’334 patent describes a spinal fusion system, including a spinal fusion
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`implant and an insertion instrument. Ex. 1013, col. 5, ll. 6-9. The spinal fusion
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`implant is introduced into the disc space via a lateral approach to the spine or via a
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`posterior, anterior, antero-lateral, or postero-lateral approach, and is made from a
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`radiolucent material, such as PEEK (poly-ether-ether-ketone). Id. at col. 5, ll. 10-
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`15 and 29-33. In one embodiment, the spinal fusion implant has a width ranging
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`between 9 and 18 mm and a length ranging between 25 and 44 mm. Id. at col. 5,
`
`ll. 17-19.
`
`Claim 1 of the ’334 patent is reproduced below:
`
`1. A spinal fusion implant of non-bone construction
`positionable within an interbody space between a first vertebra and a
`second vertebra, said implant comprising:
`an upper surface including anti-migration elements to contact
`said first vertebra when said implant is positioned within the interbody
`space, a lower surface including anti-migration elements to contact
`said second vertebra when said implant is positioned within the
`interbody space, a distal wall, a proximal wall, a first sidewall and a
`second sidewall, said distal wall, proximal wall, first sidewall, and
`second sidewall comprising a radiolucent material;
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`3
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`Case No. IPR2013-00507
`Patent No. 8,187,334 B2
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`wherein said implant has a longitudinal length greater than 40
`mm extending from a proximal end of said proximal wall to a distal
`end of said distal wall;
`wherein a central region of said implant includes portions of the
`first and second sidewalls positioned generally centrally between the
`proximal wall and the distal wall, at least a portion of the central
`region defining a maximum lateral width of said implant extending
`from said first sidewall to said second sidewall, wherein said
`longitudinal length is at least two and halftimes greater than said
`maximum lateral width;
`at least a first fusion aperture extending through said upper
`surface and lower surface and configured to permit bone growth
`between the first vertebra and the second vertebra when said implant
`is positioned within the interbody space, said first fusion aperture
`having: a longitudinal aperture length extending generally parallel to
`the longitudinal length of said implant, and a lateral aperture width
`extending between said first sidewall to said second sidewall, wherein
`the longitudinal aperture length is greater than the lateral aperture
`width; and
`at least three radiopaque markers; wherein a first of the at least
`three radiopaque markers is at least partially positioned in said distal
`wall, a second of said at least three radiopaque markers is at least
`partially positioned in said proximal wall, and a third of said at least
`three radiopaque markers is at least partially positioned in said central
`region.
`
`According to Petitioner, the ’334 patent is the subject of co-pending district
`
`court litigation, Warsaw Orthopedic, Inc. v. NuVasive, Inc., originally filed in the
`
`Northern District of Indiana, Case No. 3:12-cv-00438-JD-CAN, on August 17,
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`2012, and transferred to the Southern District of California on November 8, 2012,
`
`as Case No. 3:12-cv-02738-CAB-MDD. See Pet. 1. Petitioner has filed a second
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`petition seeking inter partes review of the ’334 patent (IPR2013-00508) and two
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`additional petitions seeking inter partes review of related U.S. Patent No.
`
`8,361,156 B2 (IPR2013-00504 and IPR2013-00506).
`
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`4
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`Case No. IPR2013-00507
`Patent No. 8,187,334 B2
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`
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`
`
`
`
`C.
`
`Claim Interpretation
`
`Consistent with the statute and the legislative history of the Leahy-Smith
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`America Invents Act, Pub. L. No. 112-29, 125 Stat. 284, 329 (2011) (“AIA”), the
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`Patent Trial and Appeal Board (“Board”) interprets claim terms by applying the
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`broadest reasonable construction in the context of the Specification in which the
`
`claims reside. 37 C.F.R. § 42.100(b); see Office Patent Trial Practice Guide, 77
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`Fed. Reg. 48,756, 48,766 (Aug. 14, 2012.)
`
`Under the broadest reasonable interpretation standard, claim terms 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.,
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`504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definition for a claim term
`
`must be set forth in the specification with reasonable clarity, deliberateness, and
`
`precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). In this regard,
`
`however, we are careful not to read a particular embodiment appearing in the
`
`written description into the claim if the claim language is broader than the
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`embodiment. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).
`
`Petitioner provides a construction for each of “distal wall / proximal wall”
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`(claim 1), “releasably mate” (claim 3), “longitudinal length” (claim 11), “extend
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`generally perpendicular to said longitudinal length” (claim 11), “elongate body”
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`(claims 14 and 17), “generally rectangular and generally oblong in shape” (claim
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`23), “lateral width of the distal end of said distal wall / a lateral width of said
`
`proximal end of said proximal wall” (claim 24), and “oriented generally parallel to
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`a height of the implant” (claim 17 recites an elongate body oriented generally
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`perpendicular to said longitudinal length and entirely through a height of said
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`5
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`Patent No. 8,187,334 B2
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`proximal wall). Pet. 4-7. Patent Owner does not provide a construction for any of
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`
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`these terms.
`
`Petitioner’s proposed constructions for the above-mentioned claim terms
`
`appear to take into account the plain meaning of the terms and their usage in the
`
`specification. We, therefore, adopt Petitioner’s proposed constructions for the
`
`above-mentioned claim terms for purposes of this decision.
`
`
`
`
`
`II. ANALYSIS
`
`A.
`
`Cited References
`
`
`
`a. Overview of Frey
`
`
`Frey discloses a spinal implant that “has a length sufficient to span the disc
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`space from the distal portion . . . to the proximal portion.” Ex. 1003 ¶ [0130]. The
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`implant has grooves to increase frictional resistance between adjacent vertebrae
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`(id. at ¶ [0153]) and may be inserted “from a postero-lateral or uni-lateral approach
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`into the disc space” or can be inserted via “other approaches to the disc space, such
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`as lateral, anterior or antero-lateral approaches.” Id. at ¶ [0150].
`
`
`
`b. Overview of Baccelli
`
`
`Baccelli discloses an intervertebral implant. Ex. 1004 ¶ [0001]. The
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`implant has a front wall (id. at ¶ [0036], Fig. 8 – element 4b) that contains an
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`orifice (id. at ¶ [0039], Fig. 8 – element 18) into which a threaded endpiece is
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`connected for placing the implant into position between vertebrae. Id. at ¶¶ [0044]
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`– [0045].
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`The implant is made of a material that is transparent to X-rays, such as
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`PEEK. Id. at ¶ [0050]. One or more markers that are opaque to X-rays may be
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`6
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`used to identify the position and/or the presence of the implant when X-rays are
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`
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`taken. Id. The radiopaque (i.e., a material that is opaque to X-rays) markers may
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`be positioned within the anterior (i.e., proximal) wall and/or the posterior (i.e.,
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`distal) wall of the implant. Id. at Figs. 1-4, 8, and 9.
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`The implant may further include spikes positioned symmetrically about the
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`sagittal midplane and extending in the frontal midplane in a vertical axis. Id. at ¶
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`[0041], Figs. 1-5, 8, and 9. The spikes may be made of a radiopaque material. Id.
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`at ¶ [0051].
`
`
`
`c. Overview of Michelson
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`Michelson discloses a translateral spinal fusion implant. Ex. 1005, col.5, ll.
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`44-45. In one embodiment, the implant has “a length in the range of 32 mm to 50
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`mm, with 42 mm being the preferred length.” Id. at col.10, ll. 46-47. The implant
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`may also have “a maximum diameter in the range of 14-26 mm, with the preferred
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`diameter being 20 mm.” Id. at col. 7, ll. 28-30.
`
`
`d. Overview of Messerli
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`
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`Messerli discloses a spinal implant that “range[s] from about 26 to about 32
`
`mm in length, and [has] a width from about 9 to 11 mm.” Ex. 1007 ¶ [0055].
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`
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`
`
`e. Overview of Moret
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`Moret discloses an intervertebral implant that contains a marker of high
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`density metal that permits the implant to be “observed and assessed during the
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`operation by means of an image intensifier.” Ex. 1006 ¶ [0026].
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`7
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`Anticipation by Frey
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`B.
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`
`
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`Petitioner asserts that claims 1-3, 10, 14, 15, and 19-28 are anticipated by
`
`Frey. Pet. 3. Claim 1 recites that the implant has a longitudinal length greater than
`
`40 mm. Petitioner argues that Frey discloses an implant that is “sufficient to span
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`the disc space.” Pet. 20 (citing Ex. 1003 ¶ 0130). Petitioner also argues that the
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`average width of the body of a vertebrae is greater than 40 mm at L3, L4, and L5.
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`Pet. 20 (citing S. H. Zhou, et al., Geometrical Dimensions of the Lower Lumbar
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`Vertebrae – Analysis of Data from Digitised CT Images, 9 EUR SPINE J. 242-248
`
`(2000), “Zhou,” Ex. 1012).
`
`As Patent Owner explains, however, Petitioner does not demonstrate
`
`sufficiently that Frey discloses an implant that has a longitudinal length greater
`
`than 40 mm, as required by claim 1, either expressly or inherently. In addition,
`
`even assuming that Zhou discloses average widths of vertebrae as being greater
`
`than 40 mm, as Petitioner contends, Petitioner has not demonstrated persuasively
`
`that the width of a disc space of Frey is also greater than 40 mm. In other words,
`
`Petitioner does not show adequately that Zhou discloses that disc spaces (as
`
`opposed to vertebral bodies) are larger than 40 mm. Nor does Petitioner provide
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`sufficient evidence to show that the implant of Frey spans the entire dimension of a
`
`disc space that measures greater than 40 mm in length. Indeed, Frey appears to
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`disclose that the implant does not span the entire width of the vertebral body and
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`does not disclose the measurement of the portion(s) of the body of the vertebrae
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`that the implant does not span (much less the length of the portion of the vertebra
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`body that the implant does span). See e.g., Ex. 1003, Fig. 47.
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`8
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`C. Obviousness over Frey and any one of Baccelli, Messerli, or Moret
`
`
`
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`Petitioner asserts that claims 1-3, 10, 14, 15, and 19-28 are obvious over
`
`Frey and any one of Messerli or Moret, and that claims 1-5, 10, 11, 14-17, and 19-
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`28 are obvious over Frey and Baccelli. Pet. 3. Petitioner does not demonstrate that
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`any of Baccelli, Messerli, or Moret make up for the deficiency noted above with
`
`respect to Frey by disclosing an implant that has a longitudinal length greater than
`
`40 mm, as required by claim 1.
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`
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`D. Obviousness over Frey and Michelson
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`
`
`Petitioner asserts that claims 1-5, 10, 11, 14, 15, and 18-28 are obvious over
`
`Frey and Michelson. Pet. 3. In support of this asserted ground of unpatentability,
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`Petitioner provides explanations as to how each claim limitation is disclosed or
`
`suggested by Frey and Michelson and, based on the current record, articulates
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`sufficient reasoning with a rational underpinning to justify support for the
`
`conclusion of obviousness. See Pet. 52-58. Upon consideration of Petitioner’s
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`analysis and supporting evidence, and taking into account Patent Owner’s
`
`preliminary response, we determine that Petitioner’s contentions have merit. On
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`this record, we conclude that Petitioner has demonstrated that there is a reasonable
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`likelihood that it would prevail with respect to obviousness of claims 1-5, 10, 11,
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`14, 15, and 18-28 over Frey and Michelson.
`
`Claim 1 recites that the implant “has a longitudinal length greater than 40
`
`mm extending from a proximal end of said proximal wall to a distal end of said
`
`distal wall.” As Petitioner explains, “Michelson discloses a spinal fusion
`
`implant . . . that has a longitudinal length greater than 40 mm.” Pet. 56. Patent
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`Owner argues that it would not have been obvious to one of ordinary skill in the art
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`9
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`to have combined the teachings of Michelson with that of Frey because, according
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`
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`to Patent Owner, such a combination would have rendered the Frey implant
`
`“inoperable for its intended purpose” and “would require ‘a change in the basic
`
`principle under which the [Frey] construction was designed to operate.’” Prelim.
`
`Resp. 14, 17 (citations omitted).
`
`In particular, Patent Owner argues that “modifying Frey’s implant . . . to be
`
`greater than 40 mm [as disclosed by Michelson] would fully eliminate Frey’s most
`
`preferred insertion path, thereby rendering it inoperable for Frey’s intended
`
`purpose.” Prelim. Resp. 15. Patent Owner contends that such a modification
`
`“would reconstruct [Frey’s] implant so that its leading end would impinge upon the
`
`anterior wall of the disc annulus well before the trailing end reaches the disc space,
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`thereby requiring unsafe damage/impingement upon the transverse process, the
`
`superior articular process, the spinal canal, and other portions of the spine.”
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`Prelim. Resp. 15-16.
`
`Frey does not disclose specific dimensions of the body of the vertebrae or
`
`disc space. Therefore, the measurement of the disc space or vertebral body in Frey
`
`is not known and, therefore, without additional evidence it is not known whether
`
`the distance from the posterior to anterior edges of the disc space in Frey is less
`
`than, equal to, or greater than 40 mm, for example. Patent Owner does not provide
`
`evidence sufficient to show that using an implant that is greater than 40 mm in
`
`length would, in fact, result in “unsafe damage/impingement upon the transverse
`
`process, the superior articular process, the spinal canal, and other portions of the
`
`spine,” the distance between the point of insertion of the implant and the anterior
`
`aspect of the disc not being disclosed in Frey.
`
`Even assuming that the distance between the point of insertion of the
`
`implant and the anterior aspect of the disc space was disclosed by Frey as being
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`10
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`less than 40 mm, Patent Owner provides insufficient evidence to demonstrate that,
`
`
`
`with respect to the level of ordinary skill in the art, maneuvering the implant to
`
`prevent damage or impingement to the transverse process, superior articular
`
`process, spinal canal or other portions of the spine would have been uniquely
`
`challenging or difficult. See Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d
`
`1157, 1162 (Fed. Cir. 2007) (citing KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398,
`
`418 (2007)). Indeed, Michelson discloses an implant with a length that is greater
`
`than 40 mm and does not disclose that inserting such an implant results in the
`
`alleged damage or impingement. Hence, Michelson demonstrates that it would
`
`have been obvious to one of ordinary skill in the art to have inserted an implant
`
`measuring greater than 40 mm in length without unsafe damage or impingement
`
`upon the transverse process, the superior articular process, the spinal canal, or
`
`other portions of the spine.
`
`Patent Owner argues that Michelson discloses inserting an implant into an
`
`intervertebral space laterally, but that Frey discloses inserting an implant into an
`
`intervertebral space posteriorly, and that inserting the implant of Frey into an
`
`intervertebral space laterally (instead of posteriorly) would produce a “result [that]
`
`is entirely contrary to Frey’s principle purpose of providing a solution for a
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`‘posterior lateral approach to the disc space . . .’.” Prelim. Resp. 18. However, as
`
`noted previously, Frey explicitly discloses inserting an implant into an
`
`intervertebral space using “other approaches . . . such as lateral . . . .” Ex. 1003,
`
`¶ [0150]. Patent Owner does not explain adequately how an approach of inserting
`
`an implant that is explicitly disclosed by Frey is contrary to the intended purpose
`
`(or principle of operation) of Frey.
`
`Even assuming that it would have been impossible for one of ordinary skill
`
`in the art to have inserted an implant measuring greater than 40 mm in length into
`
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`an intervertebral space via a posterior approach without resultant damage or
`
`
`
`impingement, as Patent Owner contends, Frey alternatively discloses inserting an
`
`implant into an intervertebral space via a lateral approach, the same orientation of
`
`insertion of an implant described by Michelson. Patent Owner appears to agree
`
`that one of ordinary skill in the art would have understood that it was obvious to
`
`insert safely a spinal implant with a length greater than 40 mm using a lateral
`
`approach. Hence, contrary to Patent Owner’s contention, Frey would not be
`
`rendered “inoperable” even under Patent Owner’s hypothesized scenario because
`
`Frey could still be “operable” to insert the spinal implant measuring greater than 40
`
`mm in length via a lateral approach (an approach explicitly disclosed by both Frey
`
`and Michelson).
`
`With respect to claim 21, Petitioner explains that the upper and lower
`
`surfaces of the implant disclosed by Frey are generally parallel. Pet. 29 (citing Ex.
`
`Frey, Fig. 62). Patent Owner argues that “the upper and lower surfaces of Frey’s
`
`implant . . . are not generally parallel.” Prelim. Resp. 20. Claim 21, which
`
`depends from claim 1, recites that the “upper and lower surfaces are generally
`
`parallel to one another.” Patent Owner argues that Petitioner asserts that the upper
`
`and lower surfaces of the Frey implant “are generally parallel to [each other]” but
`
`also argues separately, with respect to claim 22 which depends from claim 1, that
`
`the upper and lower surfaces are “generally angled relative to one another.”
`
`Prelim. Resp. 19-21.
`
`On this record, we are not persuaded that the upper and lower surfaces are
`
`oriented relative to one another in such a way that one of ordinary skill in the art
`
`would have considered the surfaces not to be “generally” parallel to one another, as
`
`recited in claim 21, and “generally” angled relative to one another, as recited in
`
`claim 22. For example, we agree with Petitioner that one of ordinary skill in the
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`12
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`art would have understood that the upper and lower surfaces are “generally”
`
`
`
`parallel to each other at least because the general overall relative positions of the
`
`upper and lower surfaces are oriented in approximately the same direction in at
`
`least one aspect.
`
`Patent Owner points out that the upper and lower surfaces of the implant of
`
`Frey, when considered from the rear aspect of the implant, appears to be generally
`
`parallel to each other but that the upper and lower surfaces of the implant of Frey,
`
`when considered from the side aspect of the implant appears to be generally angled
`
`relative to each other. Prelim. Resp. 19-21. Patent Owner does not demonstrate
`
`sufficiently that claim 21 requires the upper and lower surfaces of the implant to be
`
`generally parallel in all aspects.
`
`Claim 21 recites that the upper and lower surfaces of the implant are
`
`“generally” parallel to each other and does not require that the upper and lower
`
`surfaces of the implant are strictly parallel to each other in every aspect. Similarly,
`
`claim 22 recites that the upper and lower surfaces of the implant are “generally”
`
`angled relative to one another and does not require that the upper and lower
`
`surfaces of the implant are angled relative to each other in every aspect. Indeed,
`
`both claims 21 and 22 recite that the upper and lower surfaces are “generally”
`
`oriented relative to one another in a particular manner. Thus, an upper surface that
`
`is generally parallel in at least some aspects to a lower surface meets the claim 21
`
`limitation. Moreover, an upper and lower surface that are generally angled relative
`
`to one another in at least some aspect meets the claim 22 limitation. Thus, we
`
`disagree with Patent Owner’s argument that Petitioner’s reliance on a single
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`embodiment showing both generally parallel and generally angled surfaces is
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`improper.
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`13
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`III. CONCLUSION
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`
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`
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`For the foregoing reasons, we determine that the information presented in
`
`the Petition establishes that there is a reasonable likelihood that Petitioner would
`
`prevail with respect to claims 1-5, 10, 11, 14, 15, and 18-28 under 35 U.S.C.
`
`§ 103(a) as obvious over Frey and Michelson.
`
`The information presented in the petition does not, however, establish that
`
`there is a reasonable likelihood that Petitioner would prevail with respect to claims
`
`1-3, 10, 14, 15, and 19-28 under 35 U.S.C. § 102(b) as anticipated by Frey; claims
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`1-5, 10, 11, 14-17, and 19-28 under 35 U.S.C. § 103(a) as obvious over Frey and
`
`Baccelli; and claims 1-3, 10, 14, 15, and 19-28 under 35 U.S.C. § 103(a) as
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`obvious over Frey and any one of Messerli or Moret.
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`IV. ORDER
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`For the reasons given, it is
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`ORDERED that the petition is granted as to claims 1-5, 10, 11, 14, 15, and
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`18-28 under 35 U.S.C. § 103(a) as obvious over Frey and Michelson.
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`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter partes
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`review of the ’334 patent is hereby instituted commencing on the entry date of this
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`Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is hereby
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`given of the institution of a trial.
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`FURTHER ORDERED that an initial conference call with the Board is
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`scheduled for Thursday, February 27, 2014 at 3PM. The parties are directed to the
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`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,765-66 (Aug. 14,
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`2012), for guidance in preparing for the initial conference call, and should be
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`14
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`Case No. IPR2013-00507
`Patent No. 8,187,334 B2
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`prepared to discuss any proposed changes to the Scheduling Order entered
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`herewith and any motions the parties anticipate filing during the trial.
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`PETITIONER:
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`Jeff E. Schwartz
`Seth A. Kramer
`Fox Rothschild LLP
`jeschwartz@foxrothschild.com
`skramer@foxrothschild.com
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`PATENT OWNER:
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`Stephen R. Schaefer
`Michael T. Hawkins
`Fish & Richardson P.C.
`Schaefer@fr.com
`Hawkins@fr.com
`IPR13958-0117IP1@fr.com
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`15
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