Trials@uspto.gov
`571-272-7822
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` Paper 9
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`Entered: 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 IPR2013-00506
`Patent 8,361,156
`____________
`
`Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C. SIU,
`Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC., IPR2019-00362, Ex. 1031, 1 of 21
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`

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`Case IPR2013-00506
`Patent 8,361,156
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`I.
`
`BACKGROUND
`
`Medtronic, Inc. (“Medtronic”) filed a petition (“Pet.”) requesting an inter partes
`
`review of claims 1–14, 19, 20, and 23–27 of U.S. Patent No. 8,361,156 (Ex. 1115),
`
`“the ’156 patent”) on August 14, 2013. Paper 1. Patent Owner, NuVasive, Inc.
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`(“NuVasive”), filed a preliminary response on November 25, 2013. Paper 8. We
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`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 Medtronic has
`
`established a reasonable likelihood that it would prevail with respect to claims
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`1–14, 19, 20, and 23–27 of the ’156 patent. Accordingly, we grant the Petition,
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`and institute an inter partes review of claims 1–14, 19, 20, and 23–27 of the ’156
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`patent.
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`
`
`A. Related Proceedings
`
`Medtronic indicates that it has filed concurrently another petition for an inter
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`partes review of the ’156 patent. Pet. 2. Medtronic indicates further that it is a
`
`named counterclaim-defendant in the litigation titled Warsaw Orthopedic, Inc. v.
`
`
`
`2
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`NuVasive Inc., Case No: 3:12-cv-02738-CAB-MDD (S.D. Cal.), which also
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`involves the ’156 patent. Pet. 1.
`
`
`
`B. The ’156 Patent (Ex. 1115)
`
`The ’156 patent is drawn to a spinal implant, and methods of spinal fusion
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`using the implant. ’156 patent, col. 1, ll. 20–24. A spinal fusion procedure
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`generally involves removing some or all of a diseased spinal disc, and inserting an
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`intervertebral implant into the disc space. Id. at col. 1, ll. 30–33. 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. Id. at col. 5, ll. 29–
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`35. As taught by the ’156 patent, the implant is made from a material “having
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`suitable radiolucent characteristics,” such as PEEK (poly-ether-ether-ketone). Id.
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`at col.5, ll. 10-15.
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`
`
`C. Representative Claim
`
`Medtronic challenges claims 1–14, 19, 20, and 23–27 of the ’156 patent.
`
`Claims 1 is the only independent claim, and reads as follows:
`
`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 generally
`opposite from the first sidewall, wherein said distal wall, proximal wall, first
`sidewall, and second sidewall comprise a radiolucent material;
`
`
`
`
`3
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`wherein said implant has a longitudinal length extending from a
`proximal end of said proximal wall to a distal end of said distal wall, said
`implant has a maximum lateral width extending from said first sidewall to
`said second sidewall along a medial plane that is generally perpendicular to
`said longitudinal length, and said longitudinal length is 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
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`at least first and second radiopaque markers oriented generally
`parallel to a height of the implant, wherein said first radiopaque marker
`extends into said first sidewall at a position proximate to said medial plane,
`and said second radiopaque marker extends into said second sidewall at a
`position proximate to said medial plane.
`
`D. Prior Art Relied Upon
`
`Medtronic relies upon the following prior art references:
`
`Michelson (“Michelson”), US 5,860,973, issued January 19, 1999
`(Ex. 1105).
`
`Frey et al. (“Frey”), U.S. Patent Appl. Pub. No. 2002/0165550 A1,
`published November 7, 2002 (Ex. 1103).
`
`Baccelli et al. (“Baccelli”), U.S. Patent Appl. Pub. No. 2003/0028249 A1,
`published February 6, 2003 (Ex. 1104).
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`Synthes Vertebral Spacer–PR Brochure, Synthes Spine 2002 (“SVS”; Ex.
`1106).
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`4
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`Patent 8,361,156
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`Medtronic Sofamor Danek, Telamon, Verte-Stack PEEK Vertebral Body
`spacer (Ex. 1107); and Telamon, Posterior Impacted Fusion Devices, 2003
`(Ex. 1108) (collectively, “Telamon”).
`
`The Asserted Grounds of Unpatentability
`
`Medtronic challenges the patentability of the claims of the ’156 patent on the
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`following grounds. Pet. 14, 37–38.
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`
`
`
`
`
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`
`
`Reference(s)
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`SVS and Baccelli
`
`SVS, Baccelli, and Frey or
`Michelson
`SVS, Baccelli, and
`Michelson
`SVS and Baccelli with or
`without Frey
`SVS and Baccelli, with or
`without Frey or Michelson
`SVS, Baccelli, and
`Telamon or Frey
`Telamon and Baccelli
`
`Telamon and Baccelli,
`with or without Frey
`Telamon, Baccelli, and
`Frey or Michelson
`Telamon, Baccelli, Frey,
`and Michelson or SVS
`Telamon, Baccelli, and
`Michelson
`
`
`
`Basis
`
`§ 103
`
`§ 103
`
`§ 103
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`§ 103
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`§ 103
`
`§103
`
`§103
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`§103
`
`§103
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`§103
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`§103
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`5
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`Claims challenged
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`1–4, 7, 8, 11, 12,
`14, 19, 20, 23, 24,
`and 26
`5–8
`
`9
`
`10 and 27
`
`13
`
`25
`
`1, 2, 4, 7, 10–14,
`19, 20, and 23–27
`3
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`5–7
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`8
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`9
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`II. ANALYSIS
`
`A.
`
`Claim Interpretation
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`In an inter partes review, claim terms in an unexpired patent are given their
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`broadest reasonable construction in light of the specification of the patent in which
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`they appear. 37 C.F.R. § 42.100(b). Under the broadest reasonable construction
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`standard, claim terms are given their ordinary and customary meaning in view of
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`the specification as would be understood by one of ordinary skill in the art at the
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`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
`
`specification with reasonable clarity, deliberateness, and precision. In re Paulsen,
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`30 F.3d 1475, 1480 (Fed. Cir. 1994). For purposes of this decision, we interpret
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`the claim language consistently with its plain and ordinary meaning, when read in
`
`view of the Specification.
`
`
`
`
`
`B. Medtronic’s Petition Does not meet the Requirements of
`37 C.F.R. § 42.22
`
`NuVasive argues1 that Medtronic fails to state “the precise relief requested”
`
`pursuant to 37 C.F.R. § 42.22. Prelim. Resp. 9-10. According to NuVasive,
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`Medtronic included multiple combinations of references in its listed grounds of
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`unpatentability. Id. (citing Pet. 3). NuVasive does not demonstrate persuasively,
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`however, that merely including multiple combinations of references is
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`insufficiently precise for purposes of determining the specific proposed ground of
`
`
`1 NuVasive argues further that Medtronic has failed to demonstrate how the
`proposed grounds are not redundant over the other challenges presented in the
`instant Petition, or over the challenge presented in IPR2013-00506. Prelim. Resp.
`10-14. The use of redundancy to decline to institute inter partes review as to
`certain challenges, however, is within the Board’s discretion, and is not a basis for
`contesting a challenge asserted by a petitioner.
`
`
`
`6
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`unpatentability. We note that Medtronic states with sufficient specificity the
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`references involved in each proposed ground of unpatentability and provides claim
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`charts that describe, with sufficient precision, the portion of the reference relied
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`upon for each claim limitation. See e.g., Pet. 13-60.
`
`
`
`
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`C.
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`Public Availability of the SVS and Telamon References
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`NuVasive argues that neither the SVS reference, nor the Telamon reference,
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`is a prior art publication. Prelim. Resp. 14. According to NuVasive, Medtronic
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`has not shown that the SVS and Telamon references “had been ‘disseminated or
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`otherwise made available to the extent that persons interested and ordinarily skilled
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`in the subject matter or art, exercising reasonable diligence, can locate it.’” Id.
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`(citing In re Wyer, 655 F.2d 221, 226 (CCPA 1981)).
`
`In particular, regarding the SVS reference, NuVasive argues that Medtronic
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`states that the SVS reference was publicly available as of May 2002 (see e.g., Pet.
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`3–4), but that Petitioner’s declarant states that the SVS reference was publicly
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`available as of a different date, namely June 2002 (see, e.g., Hynes Decl. ¶52).
`
`Prelim. Resp. 15. In that regard, we note that both May 2002 and June 2002
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`predate the presumed priority date of the ’156 patent of March 29, 2004.
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`NuVasive does not explain sufficiently how the SVS reference being publicly
`
`available in either May or June of 2002 demonstrates that the SVS reference was
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`not publicly available prior to the presumed priority date of the ’156 patent.
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`Regarding the Telamon reference, NuVasive argues that the Telamon
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`reference is “limited only to Medtronic’s customers and employees” and is thus
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`“not ‘publicly posted’ for access by ordinary members of the public seeking a
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`copy.” Prelim. Resp. 16 (citations omitted). Medtronic’s declarant states that the
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`Telamon reference was “published and publicly available at least as early as
`
`
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`August of 2003” (Phelps Declaration, Ex. 1102 ¶ 3) and provides a memorandum
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`announcing the release of the “Telamon Verte-Stack PEEK Vertebral Body
`
`Spacer” including an apparent date of August 2003. Ex. 1102, Appendix B.
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`Nevertheless, NuVasive asserts that the Telamon reference was only
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`available “at a password-protected website” that was “limited only to Medtronic’s
`
`customers and employees.” Prelim. Resp. 16. NuVasive further asserts that
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`“access [of the website containing the Telamon reference] without authorization is
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`a violation of state and federal law,” and that, with respect to the memorandum
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`(Ex. 1102, Appendix B), only “Medtronic employees receive copies of Telamon
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`materials.” Prelim. Resp. 16-17 (citations omitted).
`
`Although Medtronic’s evidence pertaining to the public availability of the
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`Telamon reference is somewhat general, Medtronic has provided evidence to a
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`degree that is sufficient at this stage of the proceeding to demonstrate a reasonable
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`likelihood that Medtronic will prevail.
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`
`
`D. Overview of the Prior Art relied upon by Medtronic
`
`i.
`
`SVS (Ex. 1106)
`
`SVS discloses a vertebral spacer (or spinal implant) made of a radiolucent
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`polymer that allows fusion to occur through the implant. In one embodiment, the
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`implant measures 22 mm depth by 8 mm width and includes two radiopaque
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`marker pins. Ex. 1106, pp. 1-2.
`
`
`
`ii. Telamon (Ex. 1107)
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`Telamon discloses a radiolucent spinal implant measuring 22-26 mm length
`
`by 10 mm width. Ex. 1107, p. 2. The implant further includes radiographic
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`markers. Id.
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`
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`
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`iii. Baccelli (Ex. 1104)
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`Baccelli discloses an intervertebral implant. Ex. 1104 ¶ 0001. The implant
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`has a front wall (id. at ¶ 0036, Fig. 8 – element 4b) that contains an orifice (id. at ¶
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`0039, Fig. 8, element 18) into which a threaded endpiece is connected for placing
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`the implant into position between vertebrae. Id. at ¶¶ 0044–0045.
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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 used
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`to identify the position and/or the presence of the implant when X-rays are taken.
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`Id. The radiopaque markers may be positioned within the anterior (i.e., proximal)
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`wall and/or the posterior (i.e., distal) wall of the implant. Id. at Figs. 1–4, 8, 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, 9. The spikes may be made of a radiopaque material (i.e., a
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`material that is opaque to X-rays). Id. at ¶ 0051.
`
`
`
`iv. Michelson (Ex. 1105)
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`Michelson discloses a translateral spinal fusion implant. Ex. 1105, 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
`
`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. col.7, ll. 28-30.
`
`
`
`
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`E.
`
`Challenges based SVS (Ex. 1106)
`
`Medtronic contends that claims 1–4, 7, 8, 11, 12, 14, 19, 20, 23, 24, and 26
`
`are rendered obvious under 35 U.S.C. § 103 by the combination of SVS and
`
`Baccelli. See, e.g., Pet. 14–27.
`
`
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`9
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`Medtronic relies on SVS for its disclosure of a spinal fusion implant having
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`most of the features of the spinal implant of claim 1. Id. at 14-15. The implant of
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`SVS has radiopaque markers in its distal and proximal wall. Id. at 15. Medtronic
`
`asserts that Baccelli also teaches the use of radiopaque markers, wherein the “at
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`least first and second radiopaque markers . . . extend into a first sidewall and a
`
`second sidewall at positions proximate to a medial plane of the implant.” Id.
`
`
`
`Medtronic contends that it would have been obvious to the ordinary artisan
`
`at the time of invention to include the radiopaque markers of Baccelli in the
`
`implant of SVS in order to provide additional information regarding the location
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`and/or orientation of the implant, both during surgery and after implantation. Id.
`
`(citing Hynes Decl. ¶ 67). Medtronic contends further that such a combination is
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`“nothing more than an application of known prior art elements to improve a similar
`
`device in the same way.” Pet. 15.
`
`
`
`In its Preliminary Response, NuVasive only presents arguments as to the
`
`merits of the challenge as to claims 12 and 13. Claims 12 and 13 both depend
`
`from claim 1. Claim 12 recites that the “upper and lower surfaces are generally
`
`parallel to one another,” while claim 13 recites that the “upper and lower surfaces
`
`are generally angled relative to one another.” NuVasive asserts that that “the upper
`
`and lower surfaces of . . . the [SVS implant] are not generally parallel to one
`
`another.” Prelim. Resp. 32. NuVasive argues further that Medtronic cannot
`
`contend as to claim 12 that the upper and lower surfaces of the SVS implant “are
`
`generally parallel to each other,” but then contend separately with respect to claim
`
`13 that the upper and lower surfaces “generally angle [relative] to one another.”
`
`Prelim. Resp. 31 (citing Pet. 31-32).
`
`Medtronic contends that the upper and lower surfaces of the implant
`
`disclosed by SVS are generally parallel. Pet. 31. The upper and lower surfaces of
`
`
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`the implant of SVS are convex shaped and are not strictly parallel to each other
`
`given the curved shapes of the surfaces. Nevertheless, we agree with Medtronic
`
`that one of ordinary skill in the 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 curved upper and lower surfaces are oriented in
`
`approximately the same direction. NuVasive does not provide sufficient evidence
`
`demonstrating that the upper and lower surfaces of the implant of SVS are not
`
`oriented in approximately the same direction, and are, therefore, not “generally
`
`parallel to one another.”
`
`As discussed above, the upper and lower surfaces of the implant of SVS are
`
`curvilinear. The upper and lower surfaces of the implant of SVS thus contain
`
`portions that generally angle relative to one another (e.g., at various curved
`
`portions of the surfaces). NuVasive does not provide sufficient evidence
`
`demonstrating that the upper and lower surfaces of the SVS implant are not
`
`“generally angled relative to one another,” as recited in claim 13.
`
`Thus, an upper surface that is generally parallel in at least some aspects to a
`
`lower surface meets the claim 12 limitation. Moreover, an upper and lower surface
`
`that are generally angled relative to one another in at least some aspect meets the
`
`claim 13 limitation. We, therefore, disagree with NuVasive that Medtronic’s
`
`reliance on a single embodiment showing both generally parallel and generally
`
`angled surfaces is improper.
`
`
`
`We have considered the arguments and evidence presented by Medtronic
`
`and NuVasive, and we are persuaded that Medtronic has demonstrated a
`
`reasonable likelihood that independent claim 1 is rendered obvious by the
`
`combination of SVS and Baccelli. We have considered the arguments and
`
`evidence presented by Medtronic and NuVasive, moreover, as to the obviousness
`
`
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`of dependent claims 2–4, 7, 8, 11, 12, 14, 19, 20, 23, 24, and 26, and are persuaded
`
`that Medtronic has demonstrated a reasonable likelihood that it will prevail as to
`
`those claims as well.
`
`As to claims 10 and 27, Medtronic provides reasons as to why the ordinary
`
`artisan would have combined SVS and Baccelli to arrive at the limitations of those
`
`claims. Pet. 29-30, 37. Upon consideration of the evidence and arguments
`
`provided by Medtronic, we are persuaded that Medtronic has demonstrated a
`
`reasonable likelihood that claims 10 and 27 are rendered obvious by the
`
`combination of SVS and Baccelli. Moreover, we conclude that the teachings of
`
`Frey are redundant to the teachings of SVS and Baccelli, and thus only institute
`
`over the combination of SVS and Baccelli.
`
`Similarly, as to claim 13, as discussed above with respect to claim 12,
`
`Medtronic provides reasons as to why the ordinary artisan would have combined
`
`SVS and Baccelli to arrive at the limitations of that claim. Pet. 31–32. We thus
`
`conclude that the teachings of Frey and Michelson are redundant to the teachings
`
`of SVS and Baccelli, and thus only institute over the combination of SVS and
`
`Baccelli.
`
`Accordingly, we institute inter partes review of claims 1–4, 7, 8, 10–14, 19,
`
`20, 23, 24, 26, and 27 for obviousness over SVS and Baccelli.
`
`
`
`Medtronic further cites Frey or Michelson to meet the limitations of
`
`dependent claims 5 and 6 (Pet. 22–25) and provides a detailed claim chart showing
`
`where the additional limitations may be found. Id. at 25–27.
`
`
`
`In its Preliminary Response, NuVasive specifically argues the challenge of
`
`claim 5. Prelim. Resp. 18–30. Claim 5 depends from claim 1, and specifies that
`
`the “longitudinal length is greater than 40 mm.”
`
`
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`12
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`According to Medtronic, “Michelson discloses a spinal fusion implant that
`
`may have a longitudinal length greater than 40 mm.” Pet. 22. (citation omitted).
`
`NuVasive argues that it would not have been obvious to one of ordinary skill in the
`
`art to have combined the teachings of Michelson with that of SVS because such a
`
`combination would have rendered the SVS implant “inoperable for its intended
`
`purpose” and “would . . . require a ‘change in the basic principle under which the
`
`[SVS implant] construction was designed to operate.’” Prelim. Resp. 18 (citation
`
`omitted).
`
`In particular, NuVasive argues that the “proposed modification to [the SVS
`
`implant] would reconstruct the posterior insertion implant so that its leading end
`
`would penetrate through the annulus on the anterior aspect of the disc and
`
`dangerously protrude from the anterior of the spine.” Prelim. Resp. 27. We note
`
`that specific dimensions of the body of the vertebrae or disc space are not provided
`
`by the SVS brochure. The measurement of the disc space or vertebral body in SVS
`
`is not known. It is, therefore, not known, without additional evidence, if the
`
`distance from the posterior to anterior edges of the disc space in SVS is less than,
`
`equal to, or greater than 40 mm. NuVasive does not provide evidence sufficient to
`
`show that using an implant that is greater than 40 mm in length would, in fact,
`
`“penetrate through the annulus on the anterior aspect of the disc,” the distance
`
`between the point of insertion of the implant and the anterior aspect of the disc
`
`being unknown in SVS.
`
`Even assuming that the distance between the point of insertion of the
`
`implant and the anterior aspect of the disc was disclosed by SVS as being less than
`
`40 mm, NuVasive provides insufficient evidence to demonstrate that, with respect
`
`to the level of skill in the art, maneuvering the implant to prevent damage to the
`
`annulus on the anterior aspect of the disc would have been challenging uniquely or
`
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`13
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`difficult for one of ordinary skill in the art. See Leapfrog Enters., Inc. v. Fisher-
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`Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR Int’l Co. v. Teleflex,
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`Inc., 550 U.S. 398, 418 (2007)). Indeed, Michelson discloses an implant with a
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`length that is greater than 40 mm and does not disclose that inserting such an
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`implant results in damage to the annulus on the anterior aspect of the disc. Ex.
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`1105, col. 10, ll. 41-46. Hence, Michelson demonstrates that it would have been
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`obvious to one of ordinary skill in the art to have inserted an implant measuring at
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`least 40 mm in length without damage to the annulus on the anterior aspect of the
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`disc.
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`Medtronic relies on Frey and Michelson for similar teachings; we thus find
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`the use of both references redundant, and only institute over the combination of
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`SVS, Baccelli, and Michelson. Medtronic also relies on Michelson to meet the
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`additional limitations of dependent claim 9, and provides reasons as to why the
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`ordinary artisan would have combined Michelson with SVS and Baccelli. Pet. 27–
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`29. Upon consideration of the evidence and arguments provided by Medtronic, we
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`are persuaded that Medtronic has demonstrated a reasonable likelihood that
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`dependent claims 5, 6, and 9 are rendered obvious by the combination of SVS,
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`Baccelli, and Michelson. Accordingly, we institute inter partes review of claims 5,
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`6, and 9 for obviousness over SVS, Baccelli, and Michelson.
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`Medtronic additionally relies on Telamon or Frey to meet the limitation of
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`dependent claim 25, and provides reasons as to why the ordinary artisan would
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`have combined the teachings of the references to arrive at the claimed limitations.
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`Pet. 34–36. The teachings of Frey relied upon by Medtronic are redundant to those
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`of Baccelli. As we are persuaded that Medtronic has demonstrated a reasonable
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`likelihood that claim 25 is rendered obvious by the combination of SVS, Baccelli,
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`and Telamon, we institute inter partes review of that claim only over that
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`combination.
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`F.
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`Challenges based on Telamon (Ex. 1107 and Ex. 1108).
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`Medtronic contends that claims 1, 2, 4, 7, 10–14, 19, 20, and 23–27 are
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`rendered obvious under 35 U.S.C. § 103 by the combination of Telamon and
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`Baccelli. See, e.g., Pet. 37–60.
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`Medtronic relies on Telamon for its disclosure of a spinal fusion implant
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`having most of the features of the spinal implant of claim 1. Id. at 38. The implant
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`of Telamon has radiopaque markers in its distal and proximal wall. Id. Medtronic
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`asserts that Baccelli also teaches the use of radiopaque markers, wherein the “at
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`least first and second radiopaque markers . . . extend into a first sidewall and a
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`second sidewall at positions proximate to a medial plane of the implant.” Id. at 39.
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`Medtronic contends that it would have been obvious to the ordinary artisan
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`at the time of invention to include the radiopaque markers of Baccelli in the
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`implant of Telamon in order to provide additional information regarding the
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`location and/or orientation of the implant, both during surgery and after
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`implantation. Id. (citing Hynes Decl. ¶ 67). Medtronic contends further that such
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`a combination is “nothing more than an application of known prior art elements to
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`improve a similar device in a same way.” Pet. 39.
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`In its Preliminary Response, NuVasive only presents arguments as to the
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`merits of the challenge as to claims 12 and 13. Prelim. Resp. 30–32. As noted
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`above in the analysis of the obviousness challenge based on SVS, claims 12 and 13
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`both depend from claim 1. Claim 12 recites that the “upper and lower surfaces are
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`generally parallel to one another,” while claim 13 recites that the “upper and lower
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`surfaces are generally angled relative to one another.” NuVasive asserts that that
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`“the upper and lower surfaces of . . . the [Telamon implant] are not generally
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`parallel to one another.” Prelim. Resp. 32. NuVasive argues further that
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`Medtronic cannot contend as to claim 12 that the upper and lower surfaces of the
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`Telamon implant “are generally parallel to each other,” but then contend separately
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`with respect to claim 13 that the upper and lower surfaces “generally angle
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`[relative] to one another.” Prelim. Resp. 31 (citing Pet. 31-32).
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`The upper and lower surfaces of the implant of Telamon are curvilinear. Ex.
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`1107, 2. That is, the upper and lower surfaces of the implant of Telamon are
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`convex shaped, and are not strictly parallel to each other given the curved shapes
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`of the surfaces. Nevertheless, we agree with Medtronic on this record that one of
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`ordinary skill in the art would have understood that the upper and lower surfaces
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`are “generally” parallel to each other at least because the general overall relative
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`positions of the curved upper and lower surfaces are oriented in approximately the
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`same direction.
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`The upper and lower surfaces of the implant of Telamon also contain
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`portions that generally angle relative to one another (e.g., at various curved
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`portions of the surfaces). NuVasive does not provide sufficient evidence
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`demonstrating that the upper and lower surfaces of the Telamon implant are not
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`“generally angled relative to one another,” as recited in claim 13.
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`Thus, an upper surface that is generally parallel in at least some aspects to a
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`lower surface meets the claim 12 limitation. Moreover, an upper and lower surface
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`that are generally angled relative to one another in at least some aspect meets the
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`claim 13 limitation. We, therefore, disagree with NuVasive that Medtronic’s
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`reliance on a single embodiment showing both generally parallel and generally
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`angled surfaces is improper.
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`We have considered the arguments and evidence presented by Medtronic,
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`and we are persuaded that Medtronic has demonstrated a reasonable likelihood that
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`independent claim 1 is rendered obvious by the combination of Telamon and
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`Baccelli. We have considered Medtronic’s arguments and evidence, moreover, as
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`to the obviousness of dependent claims 2, 4, 7, 10–14, 19, 20, and 23–27, and are
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`persuaded that Medtronic has demonstrated a reasonable likelihood that it will
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`prevail as to those claims as well.
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`As to claim 3, Medtronic provides reasons why the ordinary artisan would
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`have combined Telamon and Baccelli to arrive at the limitations of that claim. Pet.
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`42-45. Upon consideration of the evidence and arguments provided by Medtronic,
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`we are persuaded that Medtronic has demonstrated a reasonable likelihood that
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`claim 3 is rendered obvious by the combination of Telamon and Baccelli.
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`Accordingly, we institute inter partes review of claim 3 for obviousness over
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`Telamon and Baccelli. Moreover, we conclude that the teachings of Frey are
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`redundant to the teachings of Telamon and Baccelli, and thus only institute over
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`the combination of Telamon and Baccelli.
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`Accordingly, we institute inter partes review of claims 1–4, 7, 10–14, 19,
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`20, and 23–27 for obviousness over Telamon and Baccelli.
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`Medtronic further cites Frey or Michelson to meet the limitations of
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`dependent claims 5 and 6, (Pet. 45–49), and provides a detailed claim chart
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`pointing out where the additional limitations may be found. Id. at 49–51.
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`In its Preliminary Response, NuVasive specifically argues the challenge of
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`claim 5 for the same reasons set forth above with respect to the challenge based on
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`SVS. Prelim. Resp. 18–30. Specifically, NuVasive argues that the “proposed
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`modification to [the Telamon implant] would reconstruct the posterior insertion
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`implant so that its leading end would penetrate through the annulus on the anterior
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`aspect of the disc and dangerously protrude from the anterior of the spine.”
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`Prelim. Resp. 27. Similarly to SVS, Telamon does not provide the specific
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`dimensions of the body of the vertebrae or disc. The measurement of the disc
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`space or vertebral body in Telamon is not known. It is, therefore, not known,
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`without additional evidence, if the distance from the posterior to anterior edges of
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`the disc space in Telamon is less than, equal to, or greater than 40 mm. NuVasive
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`does not provide evidence sufficient to show that using an implant that is greater
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`than 40 mm in length would, in fact, “penetrate through the annulus on the anterior
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`aspect of the disc,” the distance between the point of insertion of the implant and
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`the anterior aspect of the disc being unknown in Telamon.
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`Even