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.
`
`NUVASIVE, 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 U.S.C. § 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 February 13, 2014, the Board instituted an inter partes
`review of claims 1–5, 10, 11, and 14–28 (Paper 7) (“Dec. on Inst.”).
`
`

`
`IPR2013-00507
`Patent 8,187,334 B2
`
`
`
`
`
`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
`
`
`

`
`IPR2013-00507
`Patent 8,187,334 B2
`
`
`and is made from a radiolucent material, such as PEEK (poly-ether-ether-
`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.
`
`
`
`
`Illustrative Claim
`B.
`Claim 1 is illustrative of the claimed subject matter of the ’334 patent,
`and is reproduced 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, 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
`
`
`

`
`
`
`IPR2013-00507
`Patent 8,187,334 B2
`
`
`
`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.
`
`
`
`
`Instituted Challenge
`C.
`This inter partes review involves the following ground of
`unpatentability:
`Reference(s)
`Frey1 and Michelson2
`
`Basis
`
`§103
`
`
`
`Claims challenged
`
`1–5, 10, 11, 14, 15, and
`18–28
`
`D. Claim Interpretation
`The parties appear to agree on the interpretation of claim terms of 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 A1, filed Nov. 7, 2001 (Ex. 1103).
`2 Michelson, US 5,860,973, issued Jan. 19, 1999 (Ex. 1105).
`4
`
`
`

`
`IPR2013-00507
`Patent 8,187,334 B2
`
`
`
`
`
`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 longitudinal length (that is greater than 40 mm) is “at least
`two and a half times greater than the maximum lateral width.” Claims 2–5,
`10, 11, and 14–28 depend from claim 1.
`Petitioner argues that “Frey provides that the length of the implant is
`‘sufficient to span the disc space’” and discloses “using the disclosed
`implant in lateral . . . approaches to the disc space.” Pet. 53, 54 (citing Ex.
`1003 ¶ 0130). Petitioner also argues that Michelson discloses “a spinal
`fusion implant – that is used in a lateral . . . fashion . . . that has a
`longitudinal length greater than 40 mm.” Pet. 56 (citing Michelson 10:41–
`46). Hence, Petitioner argues that it would have been obvious to one of
`ordinary skill in the art, given Frey’s laterally inserted spinal implant, to
`have provided that the laterally inserted spinal implant measures greater than
`40 mm in length, as disclosed by Michelson.
`Patent Owner argues that it would not have been obvious to combine
`the teachings of Frey and Michelson to achieve an implant with a length
`greater than 40 mm as disclosed by Michelson because “the proposed
`modification would render the resulting implant inoperable for Frey’s
`intended purpose.” PO Resp. 27 (citing Ex. 2020 ¶¶ 108, 109). Patent
`Owner further characterizes the “intended purpose” of Frey to be “to provide
`
`
`II. ANALYSIS
`Frey and Michelson
`
`A.
`
`5
`
`
`

`
`
`
`IPR2013-00507
`Patent 8,187,334 B2
`
`
`the capability for posterolateral TLIF procedure.” PO Resp. 30. However,
`Frey discloses “spinal surgery from a unilateral posterior approach, a lateral
`approach, an oblique approach, and through laparoscopic or endoscopic
`instruments from any of a variety of angles or approaches to the spine.” Ex.
`1003 ¶ 184. Given that Frey discloses spinal surgery performed “from any
`of a variety of angles or approaches,” and not just from the posterolateral
`approach, we are not persuaded by Patent Owner that the “intended purpose”
`of Frey is to perform spinal surgery from a posterolateral approach,
`specifically.
`Rather, Frey discloses that “spinal discs may be displaced or
`damaged” and “may result in nerve damage, pain, numbness, muscle
`weakness, and even paralysis.” Ex. 1003 ¶ 3. According to Frey, these
`issues are addressed by “surgical correction of a collapsed disc space” by
`“discectomy . . . often followed by restoration of normal disc space height
`and bony fusion of the adjacent vertebrae to maintain the disc space height.”
`Id. Hence, the “intended purpose” of the implant of Frey, as explicitly
`disclosed by Frey, is to correct surgically a collapsed disc space, to restore
`normal disc space height, and to provide bony fusion of the adjacent
`vertebrae. We disagree with Patent Owner that incorporating Michelson,
`which discloses an implant that “engage[s] more of the adjacent vertebrae,”
`(Ex. 1105, 3:49–50) would have rendered the resulting implant inoperable
`for Frey’s intended purpose of surgically correcting a collapsed disc space or
`providing bony fusion of the adjacent vertebrae.
`Even if the “intended purpose” of Frey is to practice a “TLIF
`procedure,” as Patent Owner contends, we are not persuaded by Patent
`Owner’s argument that an implant measuring greater than 40 mm in length
`
`6
`
`
`

`
`
`
`IPR2013-00507
`Patent 8,187,334 B2
`
`
`would be inoperable in a “TLIF procedure.” As Petitioner explains, U.S.
`Patent No. 7,815,682 (the ’682 patent) demonstrates that when performing
`“Transforaminal lumbar interbody fusion (TLIF) procedures,” one of
`ordinary skill in the art may employ a spinal implant with “a length ranging
`between 20 and 45 mm.” Pet. Resp. 6 (citing, Ex. 1028, 1:37–38; 4:45).
`The ’682 patent does not disclose that the use of a spinal implant measuring
`up to 45 mm in length would render the “TLIF procedure” inoperable.
`Patent Owner argues that “it would still not be obvious to enlarge the
`boomerang implant of Frey to exceed 40 mm because such boomerang
`implants are sized and shaped to sit within a portion of the intra-annulus
`region of the disc space inside the annulus” and that a spinal implant
`measuring greater than 40 mm in length presumably would extend beyond
`the “intra-annulus region of the disc space inside the annulus.” PO Resp. 32
`(citing Ex. 2020 ¶¶ 98, 100, 108). However, even if Patent Owner is correct
`that the implant of Frey is a “boomerang” implant, Patent Owner provides
`insufficient evidence that a boomerang implant must fit within the “intra-
`annulus region of the disc space” or that even if an implant is restricted to
`the “intra-annulus region of the disc space,” that such an implant could not
`measure greater than 40 mm in length.
`Patent Owner’s declarant (Dr. Hansen A. Yuan) testifies that, “[i]n my
`experience, [boomerang] implants, like those described in Frey, are
`generally positioned within a portion of the intra-annulus region within the
`disc annulus.” Ex. 2020 ¶ 98. Even if positioned and restricted to being
`completely within the intra-annulus region was a requirement of implants
`“like those described in Frey,” as Dr. Yuan testifies (Ex. 2020 ¶ 98), neither
`Patent Owner nor Dr. Yuan demonstrates that an implant measuring greater
`
`7
`
`
`

`
`
`
`IPR2013-00507
`Patent 8,187,334 B2
`
`
`than 40 mm in length must extend beyond the intra-annulus region (i.e.,
`would not fit within the intra-annulus region). In any event, Dr. Yuan
`merely testifies that “[i]n my experience, [boomerang] implants, like those
`described in Frey, are generally positioned within a portion of the intra-
`annulus region within the disc annulus.” Ex. 2020 ¶ 98. Even if implants
`similar to those disclosed by Frey “generally” are positioned within a certain
`region, Dr. Yuan does not assert or demonstrate persuasively that such
`implants are required to be so positioned. We are not persuaded by Patent
`Owner’s argument.
`Dr. Yuan further testifies that he “see[s] no description in Frey as to
`how one of skill in the art would insert the Frey device using a ‘lateral
`approach’.” Ex. 2020 ¶ 100. However, as Petitioner explains, Michelson
`discloses “an implant inserted laterally.” Pet. 54. We are not persuaded by
`Patent Owner’s argument.
`Patent Owner argues that “[i]f it were obvious . . . to size such
`boomerang implants to exceed 40 mm . . . Medtronic would offer such
`implants. It does not.” PO Resp. 35. We are not persuaded by Patent
`Owner’s argument because “the test [for obviousness] is what the combined
`teachings of those references would have suggested to those of ordinary skill
`in the art.” In re Keller, 642 F.2d 413, 425 (CCPA 1981). As such, we do
`not see the relevance of whether Medtronic offers a particular type of
`implant for sale or not.
`Patent Owner also argues that the combination of Frey and Michelson
`fails to disclose or suggest “longitudinal length is at least two and half times
`greater than said maximum lateral width” and that “if one were to modify
`Frey according to the dimensions of Michelson, the resulting implant would
`
`8
`
`
`

`
`
`
`IPR2013-00507
`Patent 8,187,334 B2
`
`
`have a length between 32-50 mm and a width between 24-32 mm.” PO
`Resp. 38, 39 (citing Ex. 1013, claim 1; Ex. 1005, 10:41–46). Patent Owner
`further argues that “Michelson discloses no implant that is both long (over
`40 mm) and narrow (length at least 2.5 times width).” PO Resp. 41.
`However, Michelson expressly discloses an implant “with 42 mm being the
`preferred length” and a width that “approximates the depth of the vertebrae,”
`that measures “in the range of 24 mm to 32 mm,” with “the preferred width
`being 26 mm.” Ex. 1005, 10:40–41, 44–47. In other words, Michelson
`discloses that an implant with a preferred width of 26 mm (or between 24
`mm and 32 mm) would approximate the depth of the vertebrae. In one
`embodiment of Michelson, one implant “has a narrower width such that
`more than one spinal fusion implant . . . may be combined . . . for insertion
`within the disc space.” Ex. 1005, 10:52–54. For example, if the total width
`of at least two spinal fusion implants measures 26 mm (i.e., the depth of the
`vertebrae), then each implant would measure 26 mm/2 implants = 13 mm,
`which, when multiplied by a factor of 2.5, would be less than the length of
`the implant (e.g., preferably 42 mm).
`Thus, it would have been obvious to one of ordinary skill in the art to
`have provided an implant with a length of greater than 40 mm (e.g., 42 mm)
`and at least 2.5 times the width, as recited in claim 1.
`Claim 18 depends from claim 1 and further recites that the maximum
`lateral width of the implant is approximately 18 mm. Petitioner argues that
`Michelson discloses an implant that “would have a . . . maximum lateral
`width in the range of 14 to 26 mm.” Pet. 57 (citing Ex. 1005, 7:26–30).
`Patent Owner, however, points out that, “Michelson discloses no implant
`that is longer than 40 mm and has a width of 18mm.” PO Resp. 42 (citing
`
`9
`
`
`

`
`
`
`IPR2013-00507
`Patent 8,187,334 B2
`
`
`Ex. 2020 ¶¶ 94, 110–112). Instead, even if the cited implant of Michelson
`has a maximum width of 18 mm, as argued by Petitioner, Michelson
`discloses that the implant measures 12-30 mm in length, which is less than
`40 mm, in contrast to the requirement of claim 18 of an implant length that
`is greater than 40 mm. Nor does Petitioner articulate reasoning, with some
`rational underpinning, to support the conclusion that it would have been
`obvious to one of ordinary skill in the art to have modified Michelson’s
`implant to have a length greater than 40 mm and a maximum width of 18
`mm.
`
`Petitioner also asserts Michelson incorporates by reference U.S.
`Patent No. 5,772,661 (Ex. 1046, “Michelson ’661”) and U.S. Patent No.
`5,484,437 (Ex. 1048, “Michelson ’437”) and argues that “Michelson
`’661”discloses an implant with a maximum width of 18 mm. See Pet. 57–
`58. Michelson ’661 discloses an implant with a width “in the range of 10
`mm to 30 mm.” Ex. 1046, 10:31. Even if Michelson ’661 discloses an
`implant with a maximum width of 18 mm (as within the range of 10 mm to
`30 mm), Michelson ’661 discloses that the length of the implant is “less than
`the known transverse width W (side to side) of the vertebrae T7 and T8.”
`Ex. 1046, 10:21–23. Petitioner does not assert, or demonstrate sufficiently,
`that the “known transverse width W (side to side) of the vertebrae T7 and
`T8” (corresponding to the length of the implant) is greater than 40 mm, as
`required by claim 18. Nor does Petitioner articulate reasoning, with some
`rational underpinning, to support the conclusion that it would have been
`obvious to one of ordinary skill in the art to have modified the cited implant
`to have a length greater than 40 mm.
`
`10
`
`
`

`
`IPR2013-00507
`Patent 8,187,334 B2
`
`
`
`
`Petitioner also cites U.S. Patent No. 5,484,437 (Ex. 1048, “Michelson
`’437”) as disclosing an implant with a maximum width of 18 mm. See Pet.
`57–58. Even if Michelson ’437 discloses an implant with a maximum width
`of 18 mm, Petitioner does not assert, or demonstrate sufficiently, that
`Michelson ’437 also discloses that the implant with a maximum width of 18
`mm measures greater than 40 mm in length, as required by claim 18. Nor
`does Petitioner articulate reasoning, with some rational underpinning, to
`support the conclusion that it would have been obvious to one of ordinary
`skill in the art to have modified the cited implant to have a length greater
`than 40 mm.
`
`
`B.
`
` Secondary Considerations
`
`
`Patent Owner argues “the evidence of commercial success here and its
`nexus to the claimed invention is sufficient to overcome [the proposed
`ground of unpatentability]” and that “the detailed testimony establishes a
`nexus between NuVasive’s CoRoent XL implants and the invention of the
`‘’334 patent . . . proves the commercial success of the product.” PO Resp.
`44.
`
`We recognize that evidence of secondary considerations must always
`be considered en route to the determination of obviousness, but its existence
`alone does not control the conclusion of obviousness. Richardson-Vicks v.
`Upjohn Co., 122 F.3d 1476, 1483 (Fed. Cir. 1997). The weight given to
`evidence of secondary considerations is dependent upon whether there is a
`nexus between the merits of the claimed invention and the evidence offered.
`Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1539 (Fed. Cir. 1983).
`
`11
`
`
`

`
`
`
`IPR2013-00507
`Patent 8,187,334 B2
`
`
`
`Even assuming that NuVasive’s CoRoent XL implant experienced
`“commercial success,” as Patent Owner asserts, Patent Owner has not
`demonstrated sufficiently that there is a nexus between the merits of the
`claimed invention and the evidence offered. For example, Patent Owner
`argues that NuVasive “pioneered the market for lateral, trans-psoas
`interbody fusion surgeries,” (PO Resp. 44) but fails to demonstrate
`sufficiently that any of the disputed claims recite “lateral, trans-psoas
`interbody fusion surgeries.” We are not persuaded by Patent Owner’s
`arguments.
`
`
`C. Motion to Exclude
`
`
`In its Motion to Exclude, Patent Owner seeks to exclude the
`Declaration of Loic Josse (Ex. 1116, “Josse Declaration”). We did not rely
`on the Josse Declaration in this decision. Therefore, Patent Owner’s motion
`to exclude is dismissed as moot.
`
`
`D. Motion for Observation
`
`
`Patent Owner’s observations are directed to the cross-examination
`testimony of Richard A. Hynes, M.D. (Ex. 35), who was cross-examined
`after Petitioner filed its Reply. We have considered Patent Owner’s
`observations and Petitioner’s responses in rendering our decision, and have
`accorded the testimony the appropriate weight as explained above. See Obs.
`1–10.
`Patent Owner also submits observations to the cross-examination
`testimony of Loic Josse (Ex. 34). As previously discussed, we did not rely
`
`12
`
`
`

`
`IPR2013-00507
`Patent 8,187,334 B2
`
`
`
`on the Josse Declaration in this decision. Therefore, we have not considered
`Patent Owner’s observations directed to the cross-examination testimony of
`Loic Josse.
`
`
`ORDER
`Petitioner has demonstrated, by a preponderance of the evidence, that
`claims 1–5, 10, 11, 14–17, and 19–28 are unpatentable over Frey and
`Michelson under 35 U.S.C. § 103(a). Petitioner has not demonstrated, by a
`preponderance of the evidence, that claim 18 is unpatentable over Frey and
`Michelson under 35 U.S.C. § 103(a).
`In consideration of the foregoing, it is hereby:
`ORDERED that claims 1–5, 10, 11, 14–17, and 19–28 of the ’334
`
`patent have been shown to be unpatentable;
`FURTHER ORDERED that Patent Owner’s Motion to Exclude is
`dismissed.
`This is a final decision. Parties to the proceeding seeking judicial
`review of the decision must comply with the notice and service requirements
`of 37 C.F.R. § 90.2.
`
`
`
`
`13
`
`
`
`
`

`
`
`
`
`
`14
`
`
`IPR2013-00507
`Patent 8,187,334 B2
`
`PETITIONER:
`
`Jeff E. Schwartz
`Seth A. Kramer
`FOX ROTHSCHILD LLP
`jeschwartz@foxrothschild.com
`skramer@foxrothschild.com
`
`
`
`PATENT OWNER:
`
`Stephen R. Schaefer
`Michael T. Hawkins
`Stuart Nelson
`FISH AND RICHARDSON PC
`schaefer@fr.com
`hawkins@fr.com
`IPR13958-0117IP1@fr.com