`
`Entered: February 13, 2014
`
`
`
`
`
`
`
`
`
`
`
`Trials@uspto.gov
`571-272-7822
`
`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
`
`
`
`
`
`
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`
`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.
`
`(“NuVasive”), filed a preliminary response on November 25, 2013. Paper 8. We
`
`have jurisdiction under 35 U.S.C. §§ 6(b) and 314.
`
` The standard for instituting an inter partes review is set forth in 35 U.S.C.
`
`§ 314(a), which states:
`
`THRESHOLD. – The Director may not authorize an inter partes review
`to be instituted unless the Director determines that the information
`presented in the petition filed under section 311 and any response
`filed under section 313 shows that there is a reasonable likelihood that
`the petitioner would prevail with respect to at least 1 of the claims
`challenged in the petition.
`
`Inter partes review is instituted only if the petition supporting the ground
`
`demonstrates “that there is a reasonable likelihood that at least one of the claims
`
`challenged in the petition is unpatentable.” 37 C.F.R. § 42.108(c).
`
`
`
`Upon consideration of the Petition, we conclude that Medtronic has
`
`established a reasonable likelihood that it would prevail with respect to claims
`
`1–14, 19, 20, and 23–27 of the ’156 patent. Accordingly, we grant the Petition,
`
`and institute an inter partes review of claims 1–14, 19, 20, and 23–27 of the ’156
`
`patent.
`
`
`
`A. Related Proceedings
`
`Medtronic indicates that it has filed concurrently another petition for an inter
`
`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
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`NuVasive Inc., Case No: 3:12-cv-02738-CAB-MDD (S.D. Cal.), which also
`
`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
`
`using the implant. ’156 patent, col. 1, ll. 20–24. A spinal fusion procedure
`
`generally involves removing some or all of a diseased spinal disc, and inserting an
`
`intervertebral implant into the disc space. Id. at col. 1, ll. 30–33. The spinal fusion
`
`implant is introduced into the disc space via a lateral approach to the spine, or via a
`
`posterior, anterior, antero-lateral, or postero-lateral approach. Id. at col. 5, ll. 29–
`
`35. As taught by the ’156 patent, the implant is made from a material “having
`
`suitable radiolucent characteristics,” such as PEEK (poly-ether-ether-ketone). Id.
`
`at col.5, ll. 10-15.
`
`
`
`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
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`
`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
`
`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).
`
`Synthes Vertebral Spacer–PR Brochure, Synthes Spine 2002 (“SVS”; Ex.
`1106).
`
`
`4
`
`
`
`
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`
`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
`
`following grounds. Pet. 14, 37–38.
`
`Claims challenged
`
`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
`
`5–7
`
`8
`
`9
`
`Reference(s)
`
`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
`
`§ 103
`
`§ 103
`
`§103
`
`§103
`
`§103
`
`§103
`
`§103
`
`§103
`
`5
`
`
`
`
`
`
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`
`II. ANALYSIS
`
`A.
`
`Claim Interpretation
`
`In an inter partes review, claim terms in an unexpired patent are given their
`
`broadest reasonable construction in light of the specification of the patent in which
`
`they appear. 37 C.F.R. § 42.100(b). Under the broadest reasonable construction
`
`standard, claim terms are given their ordinary and customary meaning in view of
`
`the specification as would be understood by one of ordinary skill in the art at the
`
`time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`
`2007). Any special definition for a claim term must be set forth in the
`
`specification with reasonable clarity, deliberateness, and precision. In re Paulsen,
`
`30 F.3d 1475, 1480 (Fed. Cir. 1994). For purposes of this decision, we interpret
`
`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,
`
`Medtronic included multiple combinations of references in its listed grounds of
`
`unpatentability. Id. (citing Pet. 3). NuVasive does not demonstrate persuasively,
`
`however, that merely including multiple combinations of references is
`
`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
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`unpatentability. We note that Medtronic states with sufficient specificity the
`
`references involved in each proposed ground of unpatentability and provides claim
`
`charts that describe, with sufficient precision, the portion of the reference relied
`
`upon for each claim limitation. See e.g., Pet. 13-60.
`
`C.
`
`Public Availability of the SVS and Telamon References
`
`NuVasive argues that neither the SVS reference, nor the Telamon reference,
`
`
`
`is a prior art publication. Prelim. Resp. 14. According to NuVasive, Medtronic
`
`has not shown that the SVS and Telamon references “had been ‘disseminated or
`
`otherwise made available to the extent that persons interested and ordinarily skilled
`
`in the subject matter or art, exercising reasonable diligence, can locate it.’” Id.
`
`(citing In re Wyer, 655 F.2d 221, 226 (CCPA 1981)).
`
`In particular, regarding the SVS reference, NuVasive argues that Medtronic
`
`states that the SVS reference was publicly available as of May 2002 (see e.g., Pet.
`
`3–4), but that Petitioner’s declarant states that the SVS reference was publicly
`
`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
`
`predate the presumed priority date of the ’156 patent of March 29, 2004.
`
`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
`
`not publicly available prior to the presumed priority date of the ’156 patent.
`
`Regarding the Telamon reference, NuVasive argues that the Telamon
`
`reference is “limited only to Medtronic’s customers and employees” and is thus
`
`“not ‘publicly posted’ for access by ordinary members of the public seeking a
`
`copy.” Prelim. Resp. 16 (citations omitted). Medtronic’s declarant states that the
`
`Telamon reference was “published and publicly available at least as early as
`
`
`
`7
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`August of 2003” (Phelps Declaration, Ex. 1102 ¶ 3) and provides a memorandum
`
`announcing the release of the “Telamon Verte-Stack PEEK Vertebral Body
`
`Spacer” including an apparent date of August 2003. Ex. 1102, Appendix B.
`
`Nevertheless, NuVasive asserts that the Telamon reference was only
`
`available “at a password-protected website” that was “limited only to Medtronic’s
`
`customers and employees.” Prelim. Resp. 16. NuVasive further asserts that
`
`“access [of the website containing the Telamon reference] without authorization is
`
`a violation of state and federal law,” and that, with respect to the memorandum
`
`(Ex. 1102, Appendix B), only “Medtronic employees receive copies of Telamon
`
`materials.” Prelim. Resp. 16-17 (citations omitted).
`
`Although Medtronic’s evidence pertaining to the public availability of the
`
`Telamon reference is somewhat general, Medtronic has provided evidence to a
`
`degree that is sufficient at this stage of the proceeding to demonstrate a reasonable
`
`likelihood that Medtronic will prevail.
`
`
`
`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
`
`polymer that allows fusion to occur through the implant. In one embodiment, the
`
`implant measures 22 mm depth by 8 mm width and includes two radiopaque
`
`marker pins. Ex. 1106, pp. 1-2.
`
`
`
`ii. Telamon (Ex. 1107)
`
`Telamon discloses a radiolucent spinal implant measuring 22-26 mm length
`
`by 10 mm width. Ex. 1107, p. 2. The implant further includes radiographic
`
`markers. Id.
`
`
`
`
`
`8
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`
`iii. Baccelli (Ex. 1104)
`
`Baccelli discloses an intervertebral implant. Ex. 1104 ¶ 0001. The implant
`
`has a front wall (id. at ¶ 0036, Fig. 8 – element 4b) that contains an orifice (id. at ¶
`
`0039, Fig. 8, element 18) into which a threaded endpiece is connected for placing
`
`the implant into position between vertebrae. Id. at ¶¶ 0044–0045.
`
`The implant is made of a material that is transparent to X-rays, such as
`
`PEEK. Id. at ¶ 0050. One or more markers that are opaque to X-rays may be used
`
`to identify the position and/or the presence of the implant when X-rays are taken.
`
`Id. The radiopaque markers may be positioned within the anterior (i.e., proximal)
`
`wall and/or the posterior (i.e., distal) wall of the implant. Id. at Figs. 1–4, 8, 9.
`
`The implant may further include spikes positioned symmetrically about the
`
`sagittal midplane and extending in the frontal midplane in a vertical axis. Id. at ¶
`
`0041, Figs. 1–5, 8, 9. The spikes may be made of a radiopaque material (i.e., a
`
`material that is opaque to X-rays). Id. at ¶ 0051.
`
`
`
`iv. Michelson (Ex. 1105)
`
`Michelson discloses a translateral spinal fusion implant. Ex. 1105, col.5, ll.
`
`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
`
`may also have “a maximum diameter in the range of 14-26 mm, with the preferred
`
`diameter being 20 mm.” Id. col.7, ll. 28-30.
`
`
`
`
`
`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.
`
`
`
`9
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`
`
`Medtronic relies on SVS for its disclosure of a spinal fusion implant having
`
`most of the features of the spinal implant of claim 1. Id. at 14-15. The implant of
`
`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
`
`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
`
`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
`
`“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
`
`
`
`10
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`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
`
`
`
`11
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`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.”
`
`
`
`12
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`
`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
`
`
`
`13
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`difficult for one of ordinary skill in the art. 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 damage to the annulus on the anterior aspect of the disc. Ex.
`
`1105, col. 10, ll. 41-46. Hence, Michelson demonstrates that it would have been
`
`obvious to one of ordinary skill in the art to have inserted an implant measuring at
`
`least 40 mm in length without damage to the annulus on the anterior aspect of the
`
`disc.
`
`Medtronic relies on Frey and Michelson for similar teachings; we thus find
`
`the use of both references redundant, and only institute over the combination of
`
`SVS, Baccelli, and Michelson. Medtronic also relies on Michelson to meet the
`
`additional limitations of dependent claim 9, and provides reasons as to why the
`
`ordinary artisan would have combined Michelson with SVS and Baccelli. Pet. 27–
`
`29. Upon consideration of the evidence and arguments provided by Medtronic, we
`
`are persuaded that Medtronic has demonstrated a reasonable likelihood that
`
`dependent claims 5, 6, and 9 are rendered obvious by the combination of SVS,
`
`Baccelli, and Michelson. Accordingly, we institute inter partes review of claims 5,
`
`6, and 9 for obviousness over SVS, Baccelli, and Michelson.
`
`
`
`Medtronic additionally relies on Telamon or Frey to meet the limitation of
`
`dependent claim 25, and provides reasons as to why the ordinary artisan would
`
`have combined the teachings of the references to arrive at the claimed limitations.
`
`Pet. 34–36. The teachings of Frey relied upon by Medtronic are redundant to those
`
`of Baccelli. As we are persuaded that Medtronic has demonstrated a reasonable
`
`likelihood that claim 25 is rendered obvious by the combination of SVS, Baccelli,
`
`
`
`14
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`and Telamon, we institute inter partes review of that claim only over that
`
`combination.
`
`F.
`
`Challenges based on Telamon (Ex. 1107 and Ex. 1108).
`
`Medtronic contends that claims 1, 2, 4, 7, 10–14, 19, 20, and 23–27 are
`
`
`
`
`
`rendered obvious under 35 U.S.C. § 103 by the combination of Telamon and
`
`Baccelli. See, e.g., Pet. 37–60.
`
`
`
`Medtronic relies on Telamon for its disclosure of a spinal fusion implant
`
`having most of the features of the spinal implant of claim 1. Id. at 38. The implant
`
`of Telamon has radiopaque markers in its distal and proximal wall. Id. Medtronic
`
`asserts that Baccelli also teaches the use of radiopaque markers, wherein the “at
`
`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. at 39.
`
`
`
`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 Telamon in order to provide additional information regarding the
`
`location 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 “nothing more than an application of known prior art elements to
`
`improve a similar device in a same way.” Pet. 39.
`
`
`
`In its Preliminary Response, NuVasive only presents arguments as to the
`
`merits of the challenge as to claims 12 and 13. Prelim. Resp. 30–32. As noted
`
`above in the analysis of the obviousness challenge based on SVS, 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
`
`
`
`15
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`“the upper and lower surfaces of . . . the [Telamon 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
`
`Telamon 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).
`
`The upper and lower surfaces of the implant of Telamon are curvilinear. Ex.
`
`1107, 2. That is, the upper and lower surfaces of the implant of Telamon are
`
`convex shaped, and are not strictly parallel to each other given the curved shapes
`
`of the surfaces. Nevertheless, we agree with Medtronic on this record 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.
`
`
`
`The upper and lower surfaces of the implant of Telamon also 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 Telamon 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.
`
`
`
`16
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`
`
`We have considered the arguments and evidence presented by Medtronic,
`
`and we are persuaded that Medtronic has demonstrated a reasonable likelihood that
`
`independent claim 1 is rendered obvious by the combination of Telamon and
`
`Baccelli. We have considered Medtronic’s arguments and evidence, moreover, as
`
`to the obviousness of dependent claims 2, 4, 7, 10–14, 19, 20, and 23–27, and are
`
`persuaded that Medtronic has demonstrated a reasonable likelihood that it will
`
`prevail as to those claims as well.
`
`As to claim 3, Medtronic provides reasons why the ordinary artisan would
`
`have combined Telamon and Baccelli to arrive at the limitations of that claim. Pet.
`
`42-45. Upon consideration of the evidence and arguments provided by Medtronic,
`
`we are persuaded that Medtronic has demonstrated a reasonable likelihood that
`
`claim 3 is rendered obvious by the combination of Telamon and Baccelli.
`
`Accordingly, we institute inter partes review of claim 3 for obviousness over
`
`Telamon and Baccelli. Moreover, we conclude that the teachings of Frey are
`
`redundant to the teachings of Telamon and Baccelli, and thus only institute over
`
`the combination of Telamon and Baccelli.
`
`Accordingly, we institute inter partes review of claims 1–4, 7, 10–14, 19,
`
`20, and 23–27 for obviousness over Telamon and Baccelli.
`
`
`
`Medtronic further cites Frey or Michelson to meet the limitations of
`
`dependent claims 5 and 6, (Pet. 45–49), and provides a detailed claim chart
`
`pointing out where the additional limitations may be found. Id. at 49–51.
`
`
`
`In its Preliminary Response, NuVasive specifically argues the challenge of
`
`claim 5 for the same reasons set forth above with respect to the challenge based on
`
`SVS. Prelim. Resp. 18–30. Specifically, NuVasive argues that the “proposed
`
`modification to [the Telamon implant] would reconstruct the posterior insertion
`
`implant so that its leading end would penetrate through the annulus on the anterior
`
`
`
`17
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`aspect of the disc and dangerously protrude from the anterior of the spine.”
`
`Prelim. Resp. 27. Similarly to SVS, Telamon does not provide the specific
`
`dimensions of the body of the vertebrae or disc. The measurement of the disc
`
`space or vertebral body in Telamon 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 Telamon 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 Telamon.
`
`Even assuming that the distance between the point of insertion of the
`
`implant and the anterior aspect of the disc was disclosed by Telamon 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 difficult for one of ordinary skill in the art. See Leapfrog Enters., 485
`
`F.3d at 1157. 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 damage
`
`to the annulus on the anterior aspect of the disc. Ex. 1105, col. 10, ll. 41-46.
`
`Hence, Michelson demonstrates that it would have been obvious to one of ordinary
`
`skill in the art to have inserted an implant measuring at least 40 mm in length
`
`without damage to the annulus on the anterior aspect of the disc.
`
`In the challenge of claims 5 and 6, Medtronic relies on Frey and Michelson
`
`for similar teachings. We find the use of both references redundant, and only
`
`institute over the combination of Telamon, Baccelli, and Michelson. Medtronic
`
`also relies on Michelson to meet the additional limitations of dependent claims 8
`
`
`
`18
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`and 9, and provides reasons as to why the ordin