Trials@uspto.gov Paper No. 47
`571.272.7822 Filed: February 11, 2015
`
`
`
`
`
`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 B2
`___________________
`
`Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C. SIU,
`Administrative Patent Judges.
`
`
`GREEN, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`I. INTRODUCTION
`A. Background
`Petitioner, Medtronic, Inc. (“Medtronic”), filed a Petition requesting
`inter partes review of claims 1–14, 19, 20, and 23–27 (“the challenged
`claims”) of U.S. Patent No. 8,361,156 B2 (“the ’156 patent”). Paper 1
`(“Pet.”). Patent Owner, NuVasive, Inc. (“NuVasive”), filed a Patent Owner
`
`
`571.272.7822 Filed: February 11, 2015
`
`
`
`
`
`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 B2
`___________________
`
`Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C. SIU,
`Administrative Patent Judges.
`
`
`GREEN, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`I. INTRODUCTION
`A. Background
`Petitioner, Medtronic, Inc. (“Medtronic”), filed a Petition requesting
`inter partes review of claims 1–14, 19, 20, and 23–27 (“the challenged
`claims”) of U.S. Patent No. 8,361,156 B2 (“the ’156 patent”). Paper 1
`(“Pet.”). Patent Owner, NuVasive, Inc. (“NuVasive”), filed a Patent Owner
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`Preliminary Response. Paper 8. We determined that the information
`presented in the Petition and the Preliminary response demonstrated that
`there was a reasonable likelihood that Petitioner would prevail in
`challenging claims 1–14, 19, 20, and 23–27 as unpatentable under 35 U.S.C.
`§ 103(a). Pursuant to 35 U.S.C. § 314, the Board instituted trial on February
`13, 2014 , as to the challenged claims of the ’156 patent. Paper 9
`(“Institution Decision”; “Dec. Inst.”).
`Patent Owner filed a Response (Paper 21, “PO Resp.”), but did not
`file a motion to amend. Petitioner subsequently filed a Reply. Paper 28
`(“Reply”). An oral hearing was held on November 18, 2014. The transcript
`of the hearing has been entered into the record. Paper 46. Patent Owner
`also filed a Corrected Motion for Observation on certain cross-examination
`testimony of Petitioner’s declarant, Richard A. Hynes, M.D. (Paper 38,
`“Hynes Obs.”) and a Corrected Motion for Observation on certain cross-
`examination testimony of Petitioner’s declarant, Loic Josse (Paper 39, “Josse
`Obs.”). Petitioner filed a Response to each of Patent Owner’s Motions for
`Observation (Paper 44, “Hynes Obs. Resp.”; Paper 43, “Josse Obs. Resp.”).
`We have 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.
`Based on the record before us, we conclude that Petitioner has demonstrated
`by a preponderance of the evidence that claims 1–14, 19, 20, and 23–27 of
`the ’156 patent are unpatentable.
`B. Related Proceedings
`Medtronic filed concurrently another petition for an inter partes
`review of the ’156 patent, IPR2013-00504, in which we declined to institute
`inter partes review. IPR2013-00504, Paper 8. Petitioner subsequently filed
`
`2
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`another petition for an inter partes review, IPR2014-00487, in which we
`also declined to institute inter partes review. IPR2014-00487, Paper 8.
`Medtronic indicates further that it is a named counterclaim-defendant
`in the district court action titled Warsaw Orthopedic, Inc. v. NuVasive Inc.,
`Case No: 3:12-cv-02738-CAB-MDD (S.D. Cal.), which also involves the
`’156 patent. Pet. 1.
`
`C. The ’156 Patent (Ex. 1115)
`The ’156 patent issued on January 29, 2013, with Matthew Curran and
`Mark Peterson as the listed co-inventors. The ’156 patent is drawn to a
`spinal implant, and methods of spinal fusion using the implant. Ex. 1115,
`1:20–24. 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 1:30–33. 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, depending on the size of the implant. Id.
`at 5:29–35. 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 5:10–15.
`The ’156 patent teaches further that the implant “may be provided in
`any number of suitable shapes and sizes depending on the particular surgical
`procedure or need,” and that it “may be dimensioned for use in the cervical
`and/or lumbar spine.” Id. at 2:12–16. Thus, before a spinal fusion
`procedure is performed, “the clinician must first designate the appropriate
`implant size.” Id. at 11:10–12.
`
`
`3
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`
`D. Illustrative Claim
`Petitioner challenges claims 1–14, 19, 20, and 23–27 of the ’156
`patent. Claims 1, 5, and 9 read 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;
`
`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
`
`4
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`
`
`5.
`
`
`9.
`
`medial plane, and said second radiopaque marker extends into said
`second sidewall at a position proximate to said medial plane.
`
`The spinal fusion implant of claim 1, further including at least one
`receiving aperture position at said proximal wall wherein said
`longitudinal length is greater than 40 mm.
`
`The spinal fusion implant of claim 1, wherein said maximum lateral
`width of said implant is approximately 18 mm.
`
`E. Instituted Challenges
`References
`Claims
`Basis
`1–4, 7, 8, 10–14, 19, 20,
`§ 103(a) SVS1 and Baccelli2
`23, 24, 26, and 27
`5, 6, and 9
`
`§ 103(a) SVS, Baccelli, and Michelson3
`
`25
`1–4, 7, 10–14, 19, 20, and
`23–27
`5, 6, 8, and 9
`
`
`
`§ 103(a) SVS, Baccelli, and Telamon4
`
`§ 103(a) Telamon and Baccelli
`
`§ 103(a) Telamon, Baccelli, and Michelson
`
`II. ANALYSIS
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are
`interpreted according to their broadest reasonable construction in light of the
`
`1 Synthes Vertebral Spacer – PR Brochure, Synthes Spine 2002 (“SVS”,
`Ex. 1106).
`2 Baccelli, US 2003/0028249 A1, filed February 6, 2003 (Ex. 1104).
`3 Michelson, US 5,860,973, issued January 19, 1999 (Ex. 1105).
`4 Medtronic Sofamor Danek, Telamon, Verte-Stack PEEK Vertebral Body
`Spacer, ©2003 Medtronic Sofamor Danek USA, Inc (Ex. 1107); and
`Telamon, Posterior Impacted Devices, ©2003 Medtronic Sofamor Danek
`USA, Inc. (Ex. 1108) (collectively, “Telamon”).
`
`5
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766
`(Aug. 14, 2012). Claim terms also are given their ordinary and customary
`meaning, as would be understood by one of ordinary skill in the art in the
`context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249,
`1257 (Fed. Cir. 2007). If an inventor acts as his or her own lexicographer,
`the definition must be set forth in the specification with reasonable clarity,
`deliberateness, and precision. Renishaw PLC v. Marposs Societa’ per
`Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998).
`In the Institution Decision, we “interpret[ed] the claim language
`consistently with its plain and ordinary meaning, when read in view of the
`Specification.” See, e.g., Dec. Inst. 6. The parties appear to agree on the
`interpretation of the claim terms, and we see no reason to depart from our
`interpretation in the Institution Decision.
`B. Patentability
`1. Principles of Law
`To prevail on its challenges to the patentability of claims, Petitioner
`must prove unpatentability by a preponderance of the evidence. 35 U.S.C.
`§ 316(e); 37 C.F.R. § 42.1(d).
`A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
`between the subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations including: (1) the scope and content of the prior art;
`
`6
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`(2) any differences between the claimed subject matter and the prior art;
`(3) the level of ordinary skill in the art; and (4) objective evidence of
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`The level of ordinary skill in the art usually is evidenced by the references
`themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.
`2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich,
`579 F.2d 86, 91 (CCPA 1978).
`Prior art references must be “considered together with the knowledge
`of one of ordinary skill in the pertinent art.” In re Paulsen, 30 F.3d 1475,
`1480 (Fed. Cir. 1994) (quoting In re Samour, 571 F.2d 559, 562 (CCPA
`1978)). Moreover, “it is proper to take into account not only specific
`teachings of the reference but also the inferences which one skilled in the art
`would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d
`825, 826 (CCPA 1968). That is because an obviousness analysis “need not
`seek out precise teachings directed to the specific subject matter of the
`challenged claim, for a court can take account of the inferences and creative
`steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S.
`at 418; see In re Translogic Tech., Inc., 504 F.3d. 1249, 1259 (Fed. Cir.
`2007).
`
`2. Obviousness of Claim 1 under 35 U.S.C. § 103(a) Over One
`of SVS or Telamin, Combined with Baccelli
`Petitioner contends that the combination of one of SVS or Telamon
`
`with Baccelli renders obvious independent claim 1. Pet. 14–16; 38–39.
`Petitioner sets forth claim charts demonstrating where each element of the
`claim is taught by the reference (Id. at 16–18; 39–42), and relies, initially, on
`the Declaration of Dr. Hynes (Ex. 1101). Patent Owner disagrees with
`Petitioner’s assertions (PO Resp. 32–47), and relies on the Declaration of
`
`7
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`Dr. Hansen A. Yuan (Ex. 2020) as evidence that the asserted combination
`does not render obvious the challenged claims.
`a. 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, 1–2.
`
`
`b. 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.
`c. Baccelli (Ex. 1104)
`Baccelli discloses an intervertebral implant. Ex. 1104 ¶ 1. The
`
`implant has a front wall (id. ¶ 6, Fig. 8 – element 4b) that contains an orifice
`(id. ¶ 39, Fig. 8, element 18) into which a threaded endpiece is connected for
`placing the implant into position between vertebrae. Id. ¶¶ 44–45.
`The implant is made of a material that is transparent to X-rays, such as
`PEEK. Id. ¶ 50. 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
`
`8
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`vertical axis. Id. ¶ 41, 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. ¶ 51.
`d. Analysis
`Petitioner asserts that SVS and Telamon disclose almost all the
`limitations of independent claim 1. Pet. 14–15, 38. The SVS and Telamon
`implants have radiopaque markers in their distal and proximal walls. Id at
`15, 38. Petitioner 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 15, 39.
`
`According to Petitioner, it would have been obvious to the ordinary
`artisan at the time of invention to include the radiopaque markers of Baccelli
`in the implants of SVS or Telamon in order to provide additional
`information regarding the location and/or orientation of the implant, both
`during surgery and after implantation. Id. at 15, 39 (citing Ex. 1101 ¶ 68).
`Petitioner 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.” Id. at 15, 39.
`
`Patent Owner contends that neither Telamon nor SVS disclose an
`interbody fusion implant “with radiopaque markers in the medial plane.”
`PO Resp. 33. Patent Owner contends further that the implant designed by
`Dr. Hynes, the Saber implant, does not include radiopaque markers in the
`medial plane. Id. (citing Ex. 2011; Ex. 2020 ¶ 95). Rather, the markers are
`only at the proximal and distal ends. Id. at 33–34. Thus, Patent Owner
`contends, “it is plainly apparent that the implant designers for each of
`Medtronic, Synthes, and DePuy Spine all considered radiopaque markers to
`
`9
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`be inappropriate or at least unnecessary in the medial plane for PLIF
`[posterior lumbar interbody fusion] implants.” Id. at 34 (citing Ex. 2020
`¶¶ 45, 98–99, and 102). We are not persuaded by Patent Owner’s argument,
`because the question is whether it would have been obvious to one of
`ordinary skill in the art to combine the cited references, and not whether any
`specific implants on the market contain a radiopaque marker in a central
`region.
`
`Patent Owner contends further that none of the references relied upon
`by Petitioner provide a reason to add a pair of radiopaque markers to the
`medial plane of a PLIF implant, such as those of Telamon and SVS. Id. at
`36 (citing Ex. 2020 ¶¶ 89, 98, 99). Patent Owner argues that the reason
`articulated by Petitioner’s expert, Dr. Hynes, of providing additional
`information “is simply a vague explanation with no rational underpinning.”
`Id. at 37 (citing Ex. 1101 ¶ 68). In particular, Patent Owner contends that
`Dr. Hynes “does not provide a rational explanation for what ‘additional
`information’ and certainly does not cite any evidence that what he proposes
`was ‘common sense’ in 2004 or ever.” Id. at 37–38. Patent Owner argues
`that any information provided by adding markers to the medial plane would
`be at best redundant, or at worst, a possible source of confusion. Id. at 38.
`Dr. Hynes, Patent Owner contends, engaged in impermissible hindsight to
`combine Bacelli with SVS and Telamon to arrive at an implant having
`radiopaque markers at the medial plane. Id. at 38–40.
`
`Patent Owner contends that the ordinary artisan would not have added
`markers to the medial plane “because doing so would add no meaningful
`‘additional information’ beyond that already provided by the existing
`markers and would increase the likelihood of causing confusion.” Id. at 49
`
`10
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`(citing Ex. 2020 ¶¶ 98–99). Patent Owner cites their expert, Dr. Yuan, in
`arguing that the “conventional and proper position for radiopaque markers in
`PLIF implants is at the proximal and distal ends,” as they allow the surgeon
`to determine the location and orientation of the PLIF implant in PLIF
`implantation procedures. Id. at 40–41 (citing Ex. 2020 ¶¶ 45, 98, 99). Thus,
`having markers as the proximal and distal walls provides all the information
`necessary for both during and after the surgery. Id. at 42.
`
`Moreover, according to Patent Owner, Petitioner’s expert, Dr. Hynes,
`testified that markers in the wrong place may actually create confusion. Id.
`at 43 (citing Ex. 2013, 163:23–164:25). “Every excess marker increases the
`risk of confusing one marker for another,” and, thus, “designers are very
`purposeful about the number and location of markers added to fusion
`implants.” Id. at 44 (citing Ex. 2020, ¶¶ 45–46, 98, 99).
`
`We do not find Patent Owner’s arguments persuasive. As Petitioner
`notes (Reply 11), Baccelli teaches the use of radiopaque markers in the
`central regions of an implant. See Ex. 1104 ¶¶ 41, 51; Figs. 1–5, 8, 9. We
`also agree with Petitioner that the addition of markers along the medial plan
`would not confuse a surgeon of ordinary skill in the art, and “vastly
`underestimates the ordinary skill of surgeons in this field.” Reply 11 (citing
`Ex. 1104, FIG. 2; Ex. 1129).
`
`In that regard, we credit the testimony of Patent Owner’s Declarant,
`Dr. Yuan, that one of ordinary skill in the art would have understood that an
`implant that “includes two radiopaque markers in the central region [would
`provide] . . . better align[ment of] the implant” and “also allows a surgeon to
`see in an anterior-to-posterior x-ray view whether the implant is askew and
`the degree to which the implant is askew.” Ex. 2020 ¶ 60. Given the
`
`11
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`relative level of skill in the art, we agree with Dr. Yuan that the use of
`markers to improve x-ray visualization of the alignment of implants, for
`example, would have been well within the purview of one of ordinary skill
`in the art at the time of the invention.
`We note that Dr. Yuan testified that one “complication with using
`markers . . . is that the implant can have too many of them” (Ex. 2020 ¶ 45),
`and testified also that the use of a radiopaque marker in the central region of
`an implant “could cause problems, including confusing the surgeon” (Ex.
`2020 ¶ 98). Dr. Yuan, however, provides insufficient evidence in support of
`this contention. For example, Dr. Yuan does not provide persuasive
`evidence supporting the contention that problems would arise in the use of a
`radiopaque marker in the central region of an implant, the nature and extent
`of any potential problems, or how any such problems would confuse a
`surgeon of ordinary skill in the art and to what extent. Indeed, as previously
`discussed, Baccelli discloses radiopaque markers in the central region of an
`implant, and does not disclose that one of ordinary skill in the art is confused
`by such an arrangement.
`
`As to Patent Owner’s argument that Petitioner’s Declarant, Dr.
`Hynes), testified that it would not have been obvious to one of ordinary skill
`in the art to have incorporated a radiopaque marker in the central region of
`an implant because doing so may cause confusion, Dr. Hynes merely
`testifies that using “the wrong marker” in “the wrong place” may “create[]
`confusion sometimes.” Ex. 2013, 164:11, 12–13. As already noted,
`however, Baccelli discloses the use of such a marker in the central region of
`an implant, thus suggesting to one of ordinary skill in the art that such a
`
`12
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`marker would not have been “wrong” and that the central region would not
`have been a “wrong place” for such a marker.
`Hence, we are not persuaded by Patent Owner’s contention that the
`addition of pair of radiopaque markers to the medial region of an implant
`would not add any meaningful information and would cause confusion.
`
`Patent Owner contends further that neither Telamon nor SVS disclose
`an interbody fusion implant with elongate metal fixation spikes, such as
`those taught by Baccelli, and that the Saber implant designed by Dr. Hynes
`also did not incorporate such spikes. PO Resp. 34. According to Patent
`Owner, such spikes “would hinder or interfere with the intended PLIF usage
`of those implants.” Id. That is, Patent Owner argues, as the Medtronic,
`Synthese, and DePuy Spine did not incorporate such spikes, it is “plainly
`apparent” that the designers “considered such metal fixation spikes to be
`inappropriate for the PLIF implant.” Id. at 35. Thus, Patent Owner argues,
`the ordinary artisan would not have included the metal spikes of Baccelli on
`the implants of SVS or Telamon. Id. at 46.
`
`Petitioner responds that the disclosure of Baccelli was not relied upon
`for the disclosure of spikes, but for locating radiopaque markers along the
`medial plane. Reply 12. We agree with Petitioner that the ordinary artisan
`would understand from the disclosure of Baccelli that radiopaque markers
`could be also located at the medial plane of the implant. “The test for
`obviousness is not whether the features of a secondary reference may be
`bodily incorporated into the structure of the primary reference; nor is it that
`the claimed invention must be expressly suggested in any one or all of the
`references. Rather, the test is what the combined teachings of the references
`
`13
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`would have suggested to those of ordinary skill in the art.” In re Keller, 642
`F.2d 413, 425 (CCPA 1981) (citations omitted).
`3. Obviousness of Claims 5 and 9 under 35 U.S.C. § 103(a)
`Over One of SVS or Telamin, Combined with Baccelli and
`Michelson
`a. Michelson
`The disclosures of SVS, Telamon, and Baccelli are discussed above as
`to the challenge of claim 1. Michelson discloses a translateral spinal fusion
`implant. Ex. 1105, 5:44-45. 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 10:46-47. The implant may also have “a maximum diameter in the
`range of 14-26 mm, with the preferred diameter being 20 mm.” Id. at 7:28-
`30.
`
`b. Claims 5 and 9
`Petitioner contends that the combination of SVS or Telamon with
`Baccelli and Michelson renders obvious claims 5 and 9. Pet. 21–24, 27–29,
`45–49, 52–53. Petitioner sets forth a claim chart demonstrating where each
`element of the claims is taught by the reference (id. at 25–26, 29, 49–50, 53),
`and relies, initially, on the Declaration of Dr. Hynes (Ex. 1101). Patent
`Owner disagrees with Petitioner’s assertions (PO Resp. 47–59), and relies on
`the Declaration of Dr. Yuan. (Ex. 2020) as evidence that the asserted
`combination does not render obvious the challenged claims.
`
`Specifically, as to the limitation of claim 5 that the longitudinal length
`is greater than 40 mm, Petitioner relies on Michelson for its disclosure of a
`spinal fusion implant that may have a longitudinal length greater than 40
`mm. Pet. 22, 47. According to Petitioner, it would have been obvious to the
`ordinary artisan to include a longitudinal length greater than 40 mm to the
`
`14
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`SVS or Telamon implant, as the implant would span the disc space and
`provide for more stable support. Id. at 22, 47 (Ex. 1101 ¶ 81). Petitioner
`contends that increasing the length of the SVS or Telamon implant would
`involve nothing more than routine optimization, requiring only the “exercise
`of ordinary skill and common sense to apply an identified, predictable
`solution to a known design need.” Id. at 24, 49.
`
`Claim 9 adds the limitation that the maximum lateral width of the
`implant is approximately 18 mm. Petitioner relies on Michelson’s teaching
`of an implant having a width in the range of 14 to 26 mm, as disclosing an
`embodiment of a lumbar spinal fusion implant having a width of 18 mm. Id.
`at 27,52 . According to Petitioner, the ordinary artisan would have modified
`the implant of SVS or Telamon to have a maximum width of approximately
`18 mm, as Michelson teaches that a greater surface area of contact of the
`implant with the adjacent vertebra allows for greater stability. Id. at 27–28,
`52 (citing Ex. 1105, 7:11–20).
`
`Patent Owner contends that the SVS and Telamon “disclose PLIF
`implants designed with the intended purpose of use in PLIF procedures.”
`PO resp. 47 (citing Ex. 2020, ¶¶ 79, 80, 84, 85). Although Petitioner relies
`on Michelson to meet the limitation of the implant being lengthened to
`exceed 40 mm in length, Patent Owner asserts that “Michelson discloses
`length in excess of 40 mm only for laterally inserted implants.” Id.
`Petitioner asserts that modifying the implant of either SVS or Telamon to be
`greater than 40 mm would eliminate SVS and Telamon’s “specifically
`intended insertion path and usage,” making the SVS and Telamon implants
`inoperable for their intended use in PLIF procedures. Id. at 51 (citing Ex.
`2020 ¶¶ 105, 106). That is, Patent Owner argues, the increased length would
`
`15
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`make the implant of SVS and Telamon unsafe for a posterior insertion path.
`Id. at 51–55. Patent Owner asserts that Petitioner’s approach that “require[s]
`a wholesale abandonment of the primary reference’s intended PLIF purpose
`so as to achieve an entirely different use and operation.” Id. at 53. Patent
`Owner contends that “[t]he fact that Dr. Hynes proposes modifying the SVS-
`PR and Telamon implants in a way that would cause them to be unsafe in
`PLIF procedures is evidence that Dr. Hynes is simply reading the claim
`language and then improperly inventing combinations using the benefit of
`hindsight.” Id. at 56.
`
`Petitioner responds that the claims are drawn to an apparatus, that is, a
`spinal implant, and are not method claims. Reply 1. Moreover, Petitioner
`notes that the Specification of the ’156 patent states that the implants may be
`introduced through a variety of approaches. Id. (citing Ex. 1115, 5:31–34).
`Petitioner asserts further that Patent Owner’s expert, Dr. Yuan, testifies that
`he had inserted implants suitable for a PLIF or ALIF approach using a lateral
`or oblique approach. Id. (citing Ex. 2020 ¶ 51).
`
`Petitioner responds further that both Dr. Hynes and Dr. Yuan
`acknowledge that “a longer implant increases stability and provides more
`structural support to the adjacent vertebrae.” Reply 4 (citing Ex. 1157 ¶¶ 7,
`24; Ex. 2020 ¶ 41). Moreover, Petitioner argues, longer implants have been
`inserted using a posterior approach, and Dr. Yuan in fact “admitted that the
`disc space can accommodate such implants, much like the ones he himself
`inserted.” Id. at 5 (citing Ex. 1173, 62, 121–122, 245). Dr. Yuan also
`testified that the Telamon implant, “as a vertebral body spacer, could be put
`in laterally, at an angle, or anteriorly,” and that the SVS implant “could be
`inserted laterally, at an angle, or anteriorally.” Id. at 7 (citing Ex. 1173, 62,
`
`16
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`121–122). Dr. Yuan testified also that “an implant over 40 mm could be
`inserted posterior laterally (at an angle) from the back and fit in the disc
`space.” Id. at 10 (citing Ex. 1173, 233–234). According to Petitioner, Dr.
`Hynes agrees, and has done such surgeries. Id. (citing Ex. 1157 ¶ 5).
`
`After considering the parties respective positions and evidence, we do
`not find Patent Owner’s contentions persuasive SVS discloses that “[t]he
`Vertebral Spacer is a vertebral body replacement device intended for use in
`the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or
`unstable vertebral body due to tumor or trauma (i.e., fracture).” Ex. 1106, 1.
`Hence, the “intended purpose” of the implant of SVS is to replace
`components within vertebrae. Telamon discloses a process of inserting an
`implant into an intervertebral space to achieve “decompression of the neural
`elements” and “satisfactory immobilization of the grafted interspace.” Ex.
`1108, 9. Hence, the “intended purpose” of the implant of Telamon is to
`achieve immobilization of the grafted interspace (and/or decompression of
`neural elements). We disagree with Patent Owner that Michelson, which
`discloses an implant that “engage[s] more of the adjacent vertebrae,” and,
`thus, “permits greater stability” (Ex. 1105, 3:49–51) would have “fully
`eliminated” the purpose of the SVS or Telamon implants of replacing
`collapsed, damaged, or unstable intervertebral components or immobilizing
`the interspace. Instead, the intended purpose of Michelson (a spinal fusion
`implant) appears to be the same as the intended purpose of either of SVS or
`Telamon, i.e., to achieve immobilization of the grafted interspace.
`
`As to the argument that inserting a longer implant, such as an implant
`that is approximately 40 mm in length, posteriorly, would have been
`dangerous, Petitioner submits evidence supporting the contention that the
`
`17
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`insertion of implants measuring over 40 mm in length via a posterior
`approach is practiced safely in the art and, therefore, we are not persuaded
`by Patent Owner (PO Resp. 53–54) that “no responsible surgeon” would
`insert an implant measuring greater than 40 mm in length posteriorly. For
`example, Petitioner explains that Tohmeh (US Patent No. 8,623,088 B1 (Ex.
`1131)) discloses a spinal implant measuring up to 45 mm in length uses a
`“posterior approach.” Reply 5 (citing Ex. 1131, 4:3, 5:32–35). Tohmeh
`does not disclose that such a practice would be “extremely dangerous to the
`patient, risking paralysis or death” (PO resp. 53). In addition, as Petitioner
`explains, Dr. Yuan testified that a spinal implant measuring greater than 40
`mm in length would fit within the circumference of the intervertebral space.
`Reply 5 (citing Ex. 1173, 244–245).
`
`Moreover, even assuming to be true Patent Owner’s contention that a
`responsible surgeon would not insert a 41 mm implant in the PLIF approach,
`we are not persuaded by Patent Owner’s argument because one of ordinary
`skill in the art, based on Michelson, would have inserted the “41 mm
`implant” laterally, not posteriorly. Patent Owner presents no evidence that
`maneuvering the implant to prevent damage to the annulus on the anterior
`aspect of the disc would have been uniquely challenging or 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, 10:41–46. Hence, Michelson demonstrates that it would have
`been obvious to one of ordinary skill in the art to have inserted an implant
`
`18
`
`
`
`IPR2013-00506
`Patent 8,361,156 B2
`
`measuring at least 40 mm in length without damage to the annulus on the
`anterior aspect of the disc.
`
`As to claim 9, Patent Owner contends again that the intended purpose
`of the SVS and Telamon implants is PLIF implantation, whereas Michelson
`teaches a width of 18mm only for laterally inserted implants. PO Resp. 57.
`According to Patent Owner. “[w]ideni
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
