Trials@uspto.gov
`571-272-7822
`
` Paper 8
`
`Entered: February 13, 2014
`
`
`
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`
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`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MEDTRONIC, INC.
`Petitioner
`
`
`
`
`
`
`
`
`v.
`
`NUVASIVE, INC.
`Patent Owner
`____________
`
`Case IPR2013-00504
`Patent 8,361,156
`____________
`
`Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C. SIU,
`Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`571-272-7822
`
` Paper 8
`
`Entered: February 13, 2014
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MEDTRONIC, INC.
`Petitioner
`
`
`
`
`
`
`
`
`v.
`
`NUVASIVE, INC.
`Patent Owner
`____________
`
`Case IPR2013-00504
`Patent 8,361,156
`____________
`
`Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C. SIU,
`Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`Case IPR2013-00504
`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.
`1013, “the ’156 patent”) on August 14, 2013. Paper 3. Patent Owner, NuVasive,
`Inc. (“NuVasive”), filed a preliminary response on November 25, 2013. Paper 7.
`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 not
`established a reasonable likelihood that it would prevail with respect to any of the
`challenged claims of the ’156 patent. Accordingly, we deny the Petition, and
`decline to institute inter partes review.
`
`
`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
`
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`Case IPR2013-00504
`Patent 8,361,156
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`NuVasive Inc., Case No: 3:12-cv-02738-CAB-MDD (S.D. Cal.), which also
`involves the ’156 patent. Pet. at 1.
`
`
`B. The ’156 Patent (Ex. 1013)
`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.
`Claim 1 is the only independent claim, and reads as follows (emphasis added):
`1. A spinal fusion implant of non-bone construction positionable within
`an interbody space between a first vertebra and a second vertebra, said
`implant comprising:
`
`
`an upper surface including anti-migration elements to contact
`said first vertebra when said implant is positioned within the interbody
`space, a lower surface including anti-migration elements to contact
`said second vertebra when said implant is positioned within the
`interbody space, a distal wall, a proximal wall, a first sidewall, and a
`second sidewall generally opposite from the first sidewall, wherein
`said distal wall, proximal wall, first sidewall, and second sidewall
`comprise a radiolucent material;
`
`
`
`
`3
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`Case IPR2013-00504
`Patent 8,361,156
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`wherein said implant has a longitudinal length extending from a
`proximal end of said proximal wall to a distal end of said distal wall,
`said implant has a maximum lateral width extending from said first
`sidewall to said second sidewall along a medial plane that is
`generally perpendicular to said longitudinal length, and said
`longitudinal length is greater than said maximum lateral width;
`
`at least a first fusion aperture extending through said upper
`surface and lower surface and configured to permit bone growth
`between the first vertebra and the second vertebra when said implant
`is positioned within the interbody space, said first fusion aperture
`having: a longitudinal aperture length extending generally parallel to
`the longitudinal length of said implant, and a lateral aperture width
`extending between said first sidewall to said second sidewall, wherein
`the longitudinal aperture length is greater than the lateral aperture
`width; and
`
`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. 1005).
`
`Frey et al. (“Frey”), US Patent Appl. Pub. No. 2002/0165550 A1,
`published November 7, 2002 (Ex. 1003).
`
`Baccelli et al. (“Baccelli”), US Patent Appl. Pub. No. 2003/0028249
`A1, published February 6, 2003 (Ex. 1004).
`
`Messerli et al. (“Messerli”), US Patent Appl. Pub. No. 2003/0139813
`A1, published July 24, 2003 (Ex. 1007).
`
`
`4
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`Case IPR2013-00504
`Patent 8,361,156
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`Moret, US Patent Appl. Pub. No. 2003/0100950 A1, published May
`29, 2003(Ex. 1006).
`
`
`
`E. The Asserted Grounds of Unpatentability
`Medtronic challenges the patentability of claims of the ’156 patent on the
`following grounds. Pet. 3.
`
`
`Reference(s)
`
`Frey and Baccelli
`
`Frey, Baccelli, and
`Messerli
`Frey, Baccelli, and
`Michelson
`Frey, Baccelli, and Moret
`
`Baccelli and Frey
`
`Basis
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`
`
`II. ANALYSIS
`
`Claims challenged
`
`1–8, 10–14, 19, 20,
`and 23–27
`1–8, 10–14, 19, 20,
`and 23–27
`1–14, 19, 20, and
`23–27
`1–8, 10–14, 19, 20,
`and 23–27
`1–8, 10–14, 19, 20,
`and 23–27
`
`A.
`Claim Construction
`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
`
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`Case IPR2013-00504
`Patent 8,361,156
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`the claim language consistently with its plain and ordinary meaning, when read in
`view of the Specification.
`
`
`
`
`B.
`Obviousness Challenges.
`Claim 1 requires (emphasis added):
`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.
`
`All of the challenges asserted by Medtronic in this proceeding rely on Frey
`
`(Ex. 1003) to teach the above limitation. Frey is drawn to implants that may be
`inserted into the spinal disc space, as well as techniques for insertion of the implant
`using a posterior lateral approach. Ex. 1003, ¶¶ [0002] and [0006].
`
`According to Medtronic:
`Frey provides that the implant has a longitudinal length that extends
`from the proximal wall to the distal wall and a maximum lateral width
`extending from the first side wall to the second sidewall. As shown in
`Figure 63 of Frey, the longitudinal length is perpendicular to, and
`greater than, the maximum lateral width.
`
`
`Pet. 18; see id. at 37, 38, 43, and 48.
`
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`6
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`Case IPR2013-00504
`Patent 8,361,156
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`Medtronic (Pet. 18) provides the following annotated reproduction of Figure
`
`63 of Frey:
`
`
`Figure 63 of Frey shows an elevational view of an implant of Frey.
`Ex. 1003 ¶¶ 0071, 0075.
`
`As asserted by NuVasive, however, Medtronic does not address the
`
`limitation that the “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,” as required by claim 1. Prelim. Resp. 9-
`10. That is, while Medtronic identifies the longitudinal length, as well as the
`maximum lateral width, Medtronic does not specify how the maximum lateral
`width extends between the two sidewalls along the medial plane of the implant.
`
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`7
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`Case IPR2013-00504
`Patent 8,361,156
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`Moreover, Medtronic provides the following annotated reproduction of
`Figure 59 of Frey (Pet. 20):
`
`
`Figure 59 is a perspective view of an implant taught by Frey.
`Ex. 1003 ¶ 0071.
`
`As can be seen from annotated Figure 59, Medtronic recognizes that the
`
`medial plane of the implant would be a plane that intersects the implant
`approximately at the midpoint of the longitudinal length. The maximal lateral
`width, as shown in annotated Figure 63, is not at the midpoint of the longitudinal
`length, but is closer to one end of the implant than the other. Stated differently,
`Medtronic does not explain how the maximum lateral width of the implant is along
`a medial plane that is generally perpendicular to the longitudinal length, as
`required by independent claim 1.
`
`Thus, Medtronic has not demonstrated a reasonable likelihood that it will
`prevail on any of its challenges.
`
`
`III. CONCLUSION
`For the foregoing reasons, we determine that Medtronic has not
`demonstrated a reasonable likelihood that it will prevail on its challenges of claims
`1–14, 19, 20, and 23–27 of the ’156 patent. We, therefore, do not institute an inter
`partes review on any of the asserted grounds as to any of the challenged claims.
`
`
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`8
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`Case IPR2013-00504
`Patent 8,361,156
`
`
`IV. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied as to all challenged claims of the ’156
`patent.
`
`PETITIONER:
`
`Jeff E. Schwartz
`Seth A. Kramer
`Fox Rothschild LLP
`jeschwartz@foxrothschild.com
`skramer@foxrothschild.com
`
`PATENT OWNER:
`
`Stephen R. Schaefer
`Michael T. Hawkins
`Fish & Richardson P.C.
`Schaefer@fr.com
`Hawkins@fr.com
`IPR13958-0117IP1@fr.com
`
`
`
`
`9
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`
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