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`EXHIBIT 3
`(PART 4)
`
`TO THE DECLARATION OF
`BRIAN J. NISBET IN SUPPORT OF
`DEFENDANTS’ MOTION FOR
`SUMMARY JUDGMENT
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`
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`

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`Case 3:18-cv-00347-CAB-MDD Document 304-12 Filed 01/26/21 PageID.28604 Page 2 of
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`Trials@uspto.gov
`571-272-7822
`
`Paper 7
`Date: February 13, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC.
`Petitioner
`
`v.
`
`NUV ASIVE, INC.
`Patent Owner
`
`Case No. IPR2013-00508
`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
`
`ATEC_LLIF000051761
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`EXHIBIT 3 - PAGE 734
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`Patent No. 8,187,334 B2
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`I.
`
`BACKGROUND
`
`A.
`
`Background
`
`Medtronic, Inc. ("Petitioner") filed a petition requesting an inter partes
`
`review of claims 1-5, 10, 11, and 14-28 ofU.S. Patent No. 8,187,334 B2 ("the '334
`patent," Ex. 1115) pursuant to 35 U.S.C. §§ 311-319. Paper I ("Pet."). NuVasive,
`Inc. ("Patent Owner") filed a preliminary response ("Pr~lim. Resp."). Paper 6. We
`
`have jurisdiction under 35 U.S.C. § 314. The standard for instituting an inter
`partes review is set forth in 35 U.S.C. § 314 (a) which provides:
`
`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 I of the claims
`·
`challenged in the petition.
`
`We determine based on the record that Petitioner has shown, under 35
`U.S.C. § 314(a), that there is a reasonable likelihood that it wou_ld prevail with
`
`respect to at least one of the challenged claims.
`
`Petitioner relies on the following prior art:
`
`US 2002/0165550 Al (Frey)
`
`Nov. 7, 2002
`
`US 2003/0028249 Al(Baccelli)
`
`Feb.6,2003
`
`Ex. 1103
`
`Ex. 1104
`
`US 5,860,973 (Michelson)
`Synthes Vertebral Spacer - PR Brochure, Synthes Spine 2002 ("SVS"; Ex.
`1106).
`
`Jan. 19, 1999
`
`Ex. 1005
`
`Medtronic Sofamor Daneek, Telamon, Verte-Stack PEEK Vertebral Body
`spacer (Ex. 1107); and Telamon, Posterior Impacted Fusion Devices, 2003 (Ex.
`1108) ( collectively, "Telamon").
`
`2
`
`ATEC_LLIF000051762
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`EXHIBIT 3 - PAGE 735
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`Petitioner contends that the challenged claims are unpatentable under
`
`35 U.S.C § 103(a) based on the following specific grounds (Pet. 3):
`
`"Clainis c~?ll¢n g~d \
`
`~-
`
`,,,
`
`···· q.;i: . • ". ,·.•·-"
`
`.... ,.· >
`
`,'
`
`'
`
`'
`
`SVS and Frey, Baccelli,
`and/or Michelson or Telamon
`Telamon and Frey, Baccelli,
`and/or Michelson or SVS
`
`§ 103
`
`§ 103
`
`1-5, 10, 11, and 14-28
`
`1-5, 10, 11, and 14-28
`
`B.
`
`The '334 patent
`
`The '334 patent describes a spinal fusion system, including a spinal fusion
`
`implant and an insertion instrument. Ex. 1115, col.5, 11. 6-9. 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, and is made from a
`radio lucent material, such as PEEK (poly-ether-ether-ketone). Id. at col.5, 11. 10-
`
`15 and 29-33. In one embodiment, the spinal fusion implant has a width ranging
`
`between 9 and 1_8 mm and a length ranging between 25 and 44 mm. Id. at col.5, 11.
`
`17-19.
`
`Claim 1 of the '334 patent is reproduced below:
`
`A spinal fusion implant of non-bone construction
`1.
`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;
`
`3
`
`ATEC_LLIF000051763
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`EXHIBIT 3 - PAGE 736
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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 the Petitioner, the '334 patent is presently the subject of co(cid:173)
`
`pending district court litigation, Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`
`originally filed in the Northern District oflndiana, Case No. 3: 12-cv-00438-JD(cid:173)
`
`CAN on August 17, 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 petition seeking inter partes review of the '334 patent (IPR2013-
`
`00507) and two additional petitions seeking inter partes review of related U.S.
`
`Patent No. 8,361,156 B2 (IPR2013-00504 and IPR2013-00506).
`
`4
`
`ATEC_LLIF000051764
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`EXHIBIT 3 - PAGE 737
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`C.
`
`Claim Interpretation
`
`Consistent with the statute and the legislative history of the Leahy-Smith
`
`America Invents Act, Pub. L. No. 112-29, 125 Stat. 284, 329(2011) ("AIA"), the
`
`Board interprets claim terms by applying the broadest reasonable construction in
`
`the context of the Specification in which the claims reside. 37 C.F.R. § 42.IO0(b);
`
`see Office Patent Trial Practice Guide, 77 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.,
`
`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
`
`embodiment. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).
`
`Petitioner provides a construction for each of "distal wall / proximal wall"
`
`( claim 1 ), "releasably mate" ( claim 3 ), "longitudinal length" ( claim 1 ), "extend
`
`generally perpendicular to said longitudinal length" ( claim 11 ), "elongate body"
`
`( claims 14 and 17), "generally rectangular and generally oblong in shape" ( claim
`
`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 a height of the implant" ( claim 17 recites an elongate body oriented generally
`
`perpendicular to said longitudinal length and entirely through a height of said
`
`5
`
`A TEC _LLI F0000S 1765
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`EXHIBIT 3 - PAGE 738
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`proximal wall). Pet. 4-7. Patent Owner does not provide a construction for any of
`
`these terms.
`Petitioner's proposed construction for the above-mentioned claim terms
`appears to take into account the plain meaning of the terms and their usage in the
`specification. We, therefore, adopt Petitioner's proposed construction for the
`
`above-mentioned claim terms for purposes of this decision.
`
`II. ANALYSIS
`
`A.
`
`Cited References
`
`a. Overview of SVS
`
`SVS discloses a vertebral spacer ( or spinal implant) made of a radio lucent
`polymer that allows fusion to occur through the implant. In one embodiment, the
`implant measures 22 mm depth x 8 mm width and includes two radiopaque marker
`
`pins. Ex. 1106, pp. 1-2.
`
`b. Overview of Baccelli
`
`Baccelli discloses an intervertebral implant. Ex. 1104 il [0001]. The
`implant has a front wall (id. at if [0036], Fig. 8 - element 4b) that contains an
`orifice (id. at if [0039], Fig. 8 - element 18) into which a threaded endpiece is
`connected for placing the implant into position between vertebrae. Id. at ilil [0044]
`- [0045].
`
`The implant is made of a material that is transparent to X-rays, such as
`PEEK. Id. at ,r [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 (i.e., a material that is opaque to X-rays) markers may
`
`. 6
`
`\
`
`ATEC_LLIF000051766
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`EXHIBIT 3 - PAGE 739
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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.
`
`1[0041], Figs. 1-5, 8, and 9. The spikes may be made ofa radiopaque material. Id.
`
`at 1 [0051].
`
`c. Overview of Michelson
`
`Michelson discloses a translateral spinal fusion implant. Ex. 1105 col.5, 11.
`
`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.IO, 11. 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, 11. 28-30.
`
`d. Overview ofTelamon
`
`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.
`
`B.
`
`Obviousness over Baccelli, Michelson, and any one of SVS or
`Telamon
`
`Petitioner asserts that claims 1-5, 10, 11, and 14-28 are obvious under 35
`
`U.S.C. § 103(a) over Baccelli, Michelson, and any one of SVS or Telamon. Pet. 3.
`
`In support of these asserted grounds of unpatentability, Petitioner provides
`
`explanations as to how each claim limitation is disclosed or suggested by Baccelli,
`
`Michelson, and any one of SVS or Telamon and, based on the current record,
`
`7
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`A TEC _LLI F0000S 1767
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`EXHIBIT 3 - PAGE 740
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`articulates sufficient reasoning with a rational underpinning to justify support for
`
`the conclusion of obviousness. See Pet. 14-60. Upon consideration of Petitioner's
`
`analysis and supporting evidence, and taking into account Patent Owner's
`
`preliminary response, we determine that Petitioner's contentions have merit. On
`
`this record, we conclude that Petitioner has demonstrated that there is a reasonable
`
`likelihood that it would prevail with respect to obviousness of claims 1-5, 10, 11,
`
`and 14-28 over Baccelli, Michelson, and any one of SVS or Telamon.
`
`Precise relief
`
`Patent Owner argues that Petitioner fails to state "the precise relief
`
`requested," pursuant to 37 C.F.R. § 42.22, because, according to Patent Owner,
`
`multiple combinations ofreferences areincluded in each of Petitioner's listed
`
`grounds of unpatentability. See, e.g., Prelim. Resp. 9-10. Patent Owner does not
`
`demonstrate persuasively, however, that merely including multiple combinations
`
`of references within one listed ground of unpatentability is insufficiently precise
`
`for purposes of determining the specific proposed ground ofunpatentability. We
`
`note that Petitioner states with sufficient specificity the references involved in the
`
`proposed ground of unpatentability and provides claim charts that describe, with
`
`sufficient precision, the relied upon reference for each claim limitation. See e.g.,
`
`Pet. 19-60.
`
`Public availability o(References (SVS and Telamon)
`
`Patent Owner argues that neither the SYS reference nor the Telamon
`
`reference is a prior art publication because, according to Patent Owner, Petitioner
`
`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
`
`8
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`A TEC _LLI F0000S 1768
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`EXHIBIT 3 - PAGE 741
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`in the subject matter or art, exercising reasonable diligence, can locate it'." Prelim.
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`Resp. 14, citing In re Wyer, 655 F.2d 211,226 (CCPA 1981).
`
`In particular, regarding the SVS reference, Patent Owner argues that
`
`Petitioner states that the SVS reference was publicly available as of May 2002 (see
`
`e.g., Pet. 3-4) but that Petitioner's declarant (Dr. Richard Hynes, Hynes
`
`Declaration, Ex. 1101) states that the SVS reference was publicly available as of a
`
`different date, namely June 2002. Prelim. Resp. 15, citing Hynes Declaration, ,r52.
`
`We note that both May 2002 and June 2002 predate the presumed priority date of
`
`the '334 patent of March 29, 2004. Patent Owner 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 '334 patent.
`
`Regarding the Telamon reference, Patent Owner argues that the Telamon
`
`reference is "limited only to Medtronic's customers and employees" and "not
`
`'publicly posted' for access by ordinary members of the public seeking a copy."
`
`Prelim. Resp. 16 (citations omitted). Petitioner's declarant states that the Telamon
`
`reference was "published and publicly available at least as early as August of
`
`2003" (Phelps Declaration, Ex. 1102, ,r 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.
`
`Patent Owner asserts that the Telamon reference was only available "at a
`
`password-protected website" that was "limited only to Medtronic's customers and
`
`employees," in which "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 Telamqn materials." Prelim. Resp. 16-17 ( citations omitted).
`
`9
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`A TEC _LLI F0000S 1769
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`EXHIBIT 3 - PAGE 742
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`At this preliminary phase of the proceedings, although Petitioner's evidence
`
`pertaining to the public availability of the Telamon reference is somewhat general,
`
`Petitioner has provided evidence to a degree that is sufficient, at least, to
`
`demonstrate a reasonable likelihood that Petitioner will prevail.
`
`SVS or Telamon in combination with 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." Ex. 1115, col.12, IL 44-46. As Petitioner explains, "Michelson
`
`provide[ s] that a spinal fusion implant may have a longitudinal length that is
`
`greater than 40 mm." Pet. 20 ( citation omitted). Patent Owner 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 or Telamon because, according to Patent
`
`Owner, such a combination would have rendered "the primary reference ...
`
`'inoperable for its intended purpose"' and "would require 'a change in the basic
`
`principle under which the [SVS or Telamon implant] construction was designed to
`
`operate."' Prelim. Resp. 25, 29 ( citation omitted).
`
`In particular, Patent Owner argues that the "proposed modification to [the
`
`SVS or Telamon 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.
`
`Specific dimensions of the body of the vertebrae, or disc space, in either the SVS
`
`or the Telamon reference are not provided. The measurement of the disc space, or
`
`vertebral body, in Telamon, for example, is not known and 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, for
`
`ATEC_LLIF000051770
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`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, "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, 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 to the annulus on the anterior aspect of the disc 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'/ 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 riot disclose that inserting such an implant results in damage
`
`to the annulus on the anterior aspect of the disc. 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.
`
`With respect to SYS, Patent Owner provides similar arguments that inserting
`
`an implant measuring greater than 40 mm in length via the posterior aspect of the
`
`vertebrae results in rupture of the annulus on the anterior aspect of the disc. See
`
`e.g., Prelim. Resp. 27-28. We note that SYS discloses a spinal implant but does
`
`not disclose that the spinal implant is inserted via a posterior approach. Patent
`
`Owner does not demonstrate sufficiently that SVS discloses any particular
`
`approach to inserting the spinal implant, much less that the implant must be
`
`inserted via the posterior aspect of the vertebrae.
`
`11
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`ATEC_LLIF000051771
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`Claims 21 and 22
`
`With respect to claim 21, Patent Owner argues that "the upper and lower
`
`surfaces of each of the [SVS and Telamon implants] are not generally parallel to
`
`one another." Prelim. Resp. 32. Claim 21 recites that the "upper and lower
`
`surfaces are generally parallel to one another." In particular, Patent Owner argues
`
`that Petitioner argues that the upper and lower surfaces of the SVS 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 "generally
`
`angle [relative] to one another." Prelim. Resp. 31, citing Pet. 3 5.
`
`Petitioner indicates that the upper and lower surfaces of the implant
`
`disclosed by SVS are generally parallel. The upper and lower surfaces of the
`
`implant of SVS are convex shaped and are not strictly parallel to each other given
`
`the curved shapes of the surfaces. We agree with Petitioner, _however, 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. Patent Owner 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. Therefore, the upper and lower surfaces of the implant of SVS contain
`
`portions that generally angle relative to one another ( e.g., at various curved
`
`portions of the surfaces). We are not persuaded that the upper and lower surfaces
`
`12
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`of the SVS implant are not "generally angled relative to one another," as recited in
`
`claim 22.
`
`Thus, an upper surface that is generally parallel in at least sqme 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 embodiment showing both generally parallel and
`
`generally angled surfaces is improper.
`
`C.
`
`Other asserted grounds of unpatentability
`
`Petitioner alleges additional grounds of unpatentability of claims 1-5, 10, 11,
`
`and 14-28 based on alternative combinations of SVS, Telamon, Frey, Baccelli, and
`
`Michelson. These additional (alternate) grounds are redundant to the grounds
`
`based on Baccelli, Michelson and any one of SVS or Telamon, on which we have
`
`instituted a trial, as explained above with ~~spect to these claims. We do not
`
`authorize inter partes review on those additional redundant grounds. See 37
`
`C.F.R. § 42.108.
`
`III. CONCLUSION
`
`We institute an inter partes review of claims 1-5, 10, 11, and 14-28 under 35
`
`U.S.C. § 103(a) as obvious over Baccelli, Michelson, and any one of SVS or
`
`Telamon.
`
`IV. ORDER
`
`For the reasons given, it is
`
`13
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`A TEC _LLI F0000S 1773
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`EXHIBIT 3 - PAGE 746
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`Patent No. 8,187,334 B2
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`ORDERED that pursuant to 35 U.S.C. § 314(a), inter partes review of the
`
`'334 patent is hereby instituted commencing on the entry date of this Order, and
`
`pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is hereby given of the
`
`institution of a trial.
`
`FURTHER ORDERED that the trial is limited to the grounds and claims
`
`identified above in the ·conclusion. No other grounds are authorized as to these
`
`claims.
`
`FURTHER ORDERED that an initial conference call with the Board is
`
`scheduled for Thursday, February 27, 2014 at 3PM. The parties are directed to the
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,765-66 (Aug. 14,
`
`2012), for guidance in preparing for the initial conference call, and should be
`
`prepared to discuss any proposed changes to the Scheduling Order entered
`
`herewith and any motions the parties anticipate filing during the trial.
`
`PETITIONER:
`
`JeffE. Schwartz
`Seth A. Kramer
`Fox Rothschild LLP
`jeschwartz@foxrothschild.com
`skramer@foxrothschiJd.com
`
`PATENTO\VNER:
`
`Stephen R. Schaefer
`Michael T. Hawkins
`Fish & Richardson P.C.
`Schaefer@fr.com
`Hawkins@fr.com
`IPR13958-0l l7IP2@fr.com
`
`14
`
`A TEC _LLI F0000S 177 4
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`EXHIBIT 3 - PAGE 747
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`

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`Case 3:18-cv-00347-CAB-MDD Document 304-12 Filed 01/26/21 PageID.28618 Page 16 of
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`Paper 43
`Trials@uspto.gov
`Date: February 11, 2015 .
`571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC.,
`Petitioner,
`
`V.
`
`NUV ASIVE, INC.,
`Patent Owner.
`
`Case IPR2013-00507
`Patent 8,187,334 B2
`
`Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C. SIU,
`Administrative Patent Judges.
`
`SIU, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 USC.§ 318(a) and 37 C.F.R. § 42.73
`
`I. BACKGROUND
`Medtronic, Inc. ("Petitioner") filed a Petition (Paper 1) ("Pet.")
`seeking inter partes review of claims 1-5, 10, 11, and 14-28 of U.S. Patent
`No. 8,187,334 B2 (Ex. 1013, "the '334 patent") pursuant to 35 U.S.C.
`§§ 311~319. On Febr,uary 13, 2014, the Board instituted an inter partes
`review of claims 1-5, 10, 11, and 14-28 (Paper 7) ("Dec. on Inst.").
`
`ATEC_LLIF000051775
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`EXHIBIT 3 - PAGE 748
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`Subsequent to institution, Nuvasive, Inc. ("Patent Owner") filed a
`Patent Owner Response (Paper 17) ("PO Resp."), and Petitioner filed a
`Reply (Paper 24) ("Pet. Reply"). Patent Owner also filed a Motion to
`Exclude Evidence. Paper 34. Petitioner filed an Opposition to Patent
`Owner's Motion to Exclude (Paper 37) ("Opp."), and Patent Owner filed a
`Reply (Paper 41) ("PO Reply"). An Oral Hearing was conducted on
`November 18, 2014, pursuant to Requests for Oral Argument filed by
`Petitioner (Paper 28) and Patent Owner (Paper 29). Patent Owner also filed
`a Motion for Observation on certain cross-examination testimony of
`Petitioner's declarant, Richard A. Hynes, M.D. (Paper 35, "Hynes Obs.")
`and a Motion for Observation on certain cross-examination testimony of
`·, Petitioner's declarant, Loic Josse (Paper 34, "Josse Obs."). Petitioner filed a
`Response to each of Patent Owner's Motions for Observation (Paper 39,
`"Hynes Obs. Resp."; Paper 40, "Josse Obs. Resp.").
`The Board has jurisdiction under 35 U.S.C. § 6(c). This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`For the reasons that follow, we determine that Petitioner has shown by a
`preponderance of the evidence that claims 1-5, 10, 11, 14~17, and 19-28 of
`the '334 patent are unpatentable, but has not shown by a preponderance of
`the evidence that claim 18 of the '334 patent is unpatentable.
`
`The '334 Patent
`A.
`The '334 patent describes a spinal fusion system, including a spinal
`fusion implant and an insertion instrument. Ex. 1013, 5:6-9. 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,
`
`2
`
`ATEC_LLIF000051776
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`EXHIBIT 3 - PAGE 749
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`and is made from a radiolucent material, such as PEEK (poly-ether-ether(cid:173)
`ketone). Id. at 5:10-15, 5:29-33. In one embodiment, the spinal fusion
`implant has a width ranging between 9 and 18 mm and a length ranging
`
`between 25 and 44 mm. Id. at 5: 17-19.
`
`B.
`
`Illustrative Claim
`
`Claim 1 is illustrative of the claimed subject matter of the '334 patent,
`
`and is reproduced as follows:
`A spinal fusion implant of non-bone construction
`1.
`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;
`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
`
`3
`
`A TEC _LLI F0000S 1777
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`EXHIBIT 3 - PAGE 750
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`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.
`
`C.
`
`Instituted Challenge
`
`This inter partes review involves the following ground of
`
`unpatentabi lity:
`
`Claim Interpretation
`D.
`The parties appear to agree on the interpretation of claim terms o~ the
`'334 patent. Having considered whether the construction set forth in the
`Decision to Institute should be changed in light of evidence introduced
`during trial, we are not persuaded any modification is necessary. Therefore,
`we maintain the constructions set forth in the Decision to Institute and
`determine that no other express constructions are necessary. See Dec. on
`
`Inst. 4-5.
`
`1 Frey, US 2002/0165550 Al, filed Nov. 7, 2001 (Ex. 1103).
`2 Michelson, US 5,860,973, issued Jan. 19, 1999 (Ex. 1105).
`4
`
`ATEC_LLIF000051778
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`EXHIBIT 3 - PAGE 751
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`II. ANALYSIS
`
`A.
`
`Frey and Michelson
`
`We conclude that Petitioner has shown by a preponderance of the
`evidence that all of the limitations of claims 1-5, 10, 11, 14, 15, and 19-28.
`are taught or suggested by the combination of Frey and Michelson. Pet. 52-
`56. Claim 1 recites an implant that "has a longitudinal length greater than 40
`mm" and that the longitudin