Case: 15-1670 Document: 19 Page: 1 Filed: 07/23/2015
`
`No. 2015-1670
`
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`NUVASIVE, INC.,
`
`Appellant,
`
`v.
`
`MEDTRONIC, INC.,
`
`Appellee.
`
`Appeal from the United States Patent and Trademark Office,
`Patent Trial and Appeal Board in No. IPR2013-00506
`
`CORRECTED NUVASIVE’S OPENING BRIEF
`
`Michael T. Rosato
`Andrew S. Brown
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`(206) 883-2500
`
`Richard L. Torczon
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street, NW
`Washington, DC 20006
`202-973-8800
`
`July 23, 2015
`
`Paul D. Tripodi, II
`Grace J. Pak
`WILSON SONSINI GOODRICH & ROSATI
`633 West 5th Street, Suite 1550
`Los Angeles, CA 90071
`(323) 210-2900
`
`Counsel for Appellant NuVasive, Inc.
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC., IPR2019-00362, Ex. 1039, p. 1 of 107
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`

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`Case: 15-1670 Document: 19 Page: 2 Filed: 07/23/2015
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`U.S. Patent No. 8,361,156, Claim 1 (A54)
`
`construction
`fusion implant of non-bone
`1. A spinal
`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
`medial plane, and said second radiopaque marker extends into said
`second sidewall at a position proximate to said medial plane.
`
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`Case: 15-1670 Document: 19 Page: 3 Filed: 07/23/2015
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`CERTIFICATE OF INTEREST
`
`Counsel for NuVasive, Inc. certifies the following:
`
`1.
`
`2.
`
`The full name of every party represented by me is: NuVasive, Inc.
`
`The name of the real party in interest (if the party named in the
`
`caption is not the real party in interest) represented by me is: N/A.
`
`3.
`
`All parent corporations and any publicly held companies that own 10
`
`percent or more of the stock of the party or amicus curiae represented by me are:
`
`N/A.
`
`4.
`
`The names of all law firms and the partners and associates that have
`
`appeared for the party in the lower trial court or agency or are expected to appear
`
`for the party in this Court are:
`
`Michael T. Rosato, Paul D. Tripodi, II, Richard L. Torczon, Andrew S.
`Brown, and Grace J. Pak of Wilson Sonsini Goodrich & Rosati.
`
`Stephen R. Schaefer, Stuart Nelson, and Michael A. Amon of Fish &
`Richardson.
`
`July 23, 2015
`
`/s/ Michael T. Rosato
`Michael T. Rosato
`Counsel for Appellant NuVasive, Inc.
`
`i
`
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`Case: 15-1670 Document: 19 Page: 4 Filed: 07/23/2015
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`TABLE OF CONTENTS
`
`Certificate of Interest ................................................................................................. i
`
`Table of Contents...................................................................................................... ii
`
`Table of Authorities ................................................................................................. iv
`
`Related Cases .......................................................................................................... vii
`
`Jurisdiction .................................................................................................................1
`
`Issues on Appeal ........................................................................................................1
`
`Statement of the Case.................................................................................................2
`
`I.
`
`II.
`
`’156 Patent.............................................................................................2
`
`Alleged Prior Art...................................................................................8
`
`A.
`
`B.
`
`C.
`
`D.
`
`SVS-PR Brochure .......................................................................8
`
`Telamon Brochure.......................................................................9
`
`Telamon Implantation Guide....................................................10
`
`Baccelli......................................................................................11
`
`III.
`
`Inter Partes Review.............................................................................12
`
`Summary of Argument ............................................................................................19
`
`Argument..................................................................................................................21
`
`I.
`
`II.
`
`III.
`
`Standards of Review............................................................................21
`
`The Board Erred in Concluding that the SVS-PR Brochure and
`Telamon References Are Printed Publication Prior Art......................22
`
`The Board Erred in Concluding It Would Have Been Obvious to
`Include Radiopaque Markers Proximate to the Medial Plane.............26
`
`ii
`
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`Case: 15-1670 Document: 19 Page: 5 Filed: 07/23/2015
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`A.
`
`B.
`
`C.
`
`D.
`
`There Is No Articulated Reasoning with Rational Underpinning
`to Support the Legal Conclusion of Obviousness.....................27
`
`The Board Explicitly Relied On Impermissible Hindsight.......28
`
`The Board Improperly Disregarded NuVasive’s Evidence of
`Nonobviousness Based on Baccelli ..........................................31
`
`The Board Improperly Placed a Burden of Proving
`Nonobviousness on NuVasive..................................................37
`
`Conclusion ...............................................................................................................38
`
`Certificate of Service
`
`Certificate of Compliance
`
`Addendum
`
`iii
`
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`Case: 15-1670 Document: 19 Page: 6 Filed: 07/23/2015
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Page
`
`3M v. Chemque, Inc.,
`303 F.3d 1294 (Fed. Cir. 2002) ...............................................................24, 26
`Bruckelmyer v. Ground Heaters, Inc.,
`445 F.3d 1374 (Fed. Cir. 2006) .....................................................................23
`Carella v. Starlight Archery,
`804 F.2d 135 (Fed. Cir. 1986) ................................................................ 25, 26
`Cooper Cameron Corp. v. Kvaerner Oilfield Prods.,
`291 F.3d 1317 (Fed. Cir. 2002) ...............................................................21, 22
`Cordis Corp. v. Boston Scientific Corp.,
`561 F.3d 1319 (Fed. Cir. 2009) ...............................................................23, 24
`Eurand, Inc. v. Mylan Pharms., Inc.,
`676 F.3d 1063 (Fed. Cir. 2012) .....................................................................37
`Flo Healthcare Solutions, LLC v. Kappos,
`697 F.3d 1367 (Fed. Cir. 2012) .....................................................................22
`Graham v. John Deere Co.,
`383 U.S. 1 (1966)...........................................................................................31
`In re Bayer,
`568 F.2d 1357 (C.C.P.A. 1978).....................................................................23
`In re Cronyn,
`890 F.2d 1158 (Fed. Cir. 1989) .....................................................................24
`In re Gartside,
`2013 F.3d 1305 (Fed. Cir. 2000) ...................................................................21
`In re Hall,
`781 F.2d 897 (Fed. Cir. 1986) .................................................................23, 24
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) .................................................................26, 28
`In re Wyer,
`665 F.2d 221(C.C.P.A. 1981)........................................................................23
`
`iv
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`InTouch Techs., Inc. v. VGo Comm’ns, Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) .....................................................................28
`Kennametal, Inc. v. Ingersoll Cutting Tool Co.,
`780 F.3d 1376 (Fed. Cir. 2015) .....................................................................22
`Koito Mfg. Co. v. Turn-Key-Tech, LLC,
`381 F.3d 1142 (Fed. Cir. 2004) .........................................................24, 25, 28
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007)...........................................................................26, 28, 36
`Microsoft Corp. v. Proxyconn, Inc.,
`Nos. 2014-1542, -1543 (Fed. Cir. June 16, 2015).........................................21
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) .....................................................................35
`Northern Telecom Inc. v. Datapoint Corp.,
`908 F.2d 931 (Fed. Cir. 1990) .......................................................................25
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008) .....................................................................22
`On-Line Careline, Inc. v. Am. Online, Inc.,
`229 F.3d 1080 (Fed. Cir. 2000) .....................................................................21
`SRI Int’l, Inc. v. Internet Sec. Sys., Inc.,
`511 F.3d 1186 (Fed. Cir. 2008) ...............................................................21, 23
`Versata Dev. Grp. v. SAP Am., Inc.,
`No. 2014-1194 (Fed. Cir. July 9, 2015) ........................................................22
`W. L. Gore & Assoc. v. Garlock, Inc.,
`721 F.2d 1540 (Fed. Cir. 1983) .....................................................................31
`Warsaw Orthopedic Inc. v. NuVasive Inc.,
`No. 3:12-cv-02738-CAB-MDD (S.D. Cal.) ................................................. vii
`STATUTES
`28 U.S.C. § 1295(a)(4)(A) .........................................................................................1
`35 U.S.C. § 102..................................................................................................21, 23
`35 U.S.C. §§ 141(c) and 142......................................................................................1
`35 U.S.C. § 311(b) .............................................................................................22, 23
`
`v
`
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`Case: 15-1670 Document: 19 Page: 8 Filed: 07/23/2015
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`35 U.S.C. § 316(e) .............................................................................................21, 37
`RULES
`37 C.F.R. §§ 42.123, 42.120....................................................................................15
`
`vi
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`RELATED CASES
`
`This is an appeal by NuVasive, Inc. from an inter partes review (“IPR”) of
`
`U.S. Patent No. 8,361,156 (“the ’156 patent”) before the United States Patent and
`
`Trademark Office, Patent Trial and Appeal Board (“the Board”) with Medtronic,
`
`Inc. as Petitioner and NuVasive as Patent Owner. No prior appeal from this IPR
`
`was previously before this Court or any other court.
`
`Case Nos. 15-1672 (lead), -1673, -1674, and -1712 are consolidated appeals
`
`from IPRs of U.S. Patent No. 8,187,334 (“the ’334 patent”). The ’334 patent is in
`
`the same patent family as the ’156 patent, and the two patents share largely the
`
`same specification. The consolidated appeal has been identified by the Court as a
`
`companion case to this appeal.
`
`The ’156 patent has been asserted by NuVasive against Medtronic in
`
`Warsaw Orthopedic Inc. v. NuVasive Inc., No. 3:12-cv-02738-CAB-MDD (S.D.
`
`Cal.). The claims and counterclaims in that case related to the ’156 patent are
`
`currently stayed pending the IPR that is the subject of this appeal.
`
`vii
`
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`Case: 15-1670 Document: 19 Page: 10 Filed: 07/23/2015
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`JURISDICTION
`
`The Board issued its Final Written Decision on February 11, 2015. A1.
`
`NuVasive filed a timely notice of appeal on April 15, 2015 under 35 U.S.C.
`
`§§ 141(c) and 142. This Court has jurisdiction under 28 U.S.C. § 1295(a)(4)(A).
`
`ISSUES ON APPEAL
`
`Whether the Board’s ruling that the challenged claims are obvious should be
`
`reversed where:
`
`1.
`
`The Board erred in concluding that the asserted primary references
`
`qualify as printed publication prior art in the absence of substantial evidence to
`
`support the conclusion because there was no evidence of public accessibility; and
`
`2.
`
`The Board further erred in concluding that it would have been obvious
`
`to modify the primary references to include radiopaque markers proximate to the
`
`medical plane:
`
`a. Without articulating any reason to combine with a rational
`
`underpinning,
`
`b. Relying on impermissible hindsight reasoning,
`
`c. Improperly disregarding evidence of nonobviousness based solely
`
`on a misreading of a prior art reference, and
`
`d. Placing the burden of proof on the patent owner.
`
`1
`
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`STATEMENT OF THE CASE
`
`This appeal is from an inter partes review of the ’156 patent owned by
`
`NuVasive. NuVasive appeals the Board’s ruling that claims 1-14, 19, 20, and 23-
`
`27 (“the challenged claims”) of the ’156 patent are unpatentable as obvious in view
`
`of the prior art.
`
`I.
`
`’156 Patent
`
`The claims of the ’156 patent are directed to a spinal fusion implant that is
`
`particularly suited for insertion into an intervertebral disc space using a lateral,
`
`trans-psoas approach. The psoas is a nerve-rich muscle running along the side of
`
`the lumbar portion of the spine. A trans-psoas surgical approach was uncommon,
`
`and even considered dangerous, prior to the invention of the ’156 patent, so
`
`generally implants designed for a lateral, trans-psoas approach did not exist. A4885
`
`¶ 48. In 2003, NuVasive pioneered the surgical procedure that made the lateral,
`
`trans-psoas approach safe—which NuVasive calls eXtreme Lateral Interbody
`
`Fusion, or XLIF—and also owns patents directed to other aspects of the procedure.
`
`As depicted below, the human spine comprises a series of stacked vertebrae
`
`separated by intervertebral discs. A4875-76 ¶ 28.
`
`2
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`The left image shows a view of the spine from the back, while the right
`
`image shows a view of the spine from the side. Spinal fusion surgery is most
`
`commonly performed to correct chronic back pain caused by diseased or damaged
`
`intervertebral discs. A49, 1:28-30; A4877 ¶ 33. At a most basic level, spinal fusion
`
`surgery involves removing some or all of a diseased or damaged disc and inserting
`
`a spinal implant in the resulting disc space. A49, 1:31-33. The inserted implant
`
`restores the height between adjacent vertebral bodies and is designed to induce
`
`bone growth between the vertebrae. Id. at 1:33-37; A4877 ¶ 31.
`
`Prior to NuVasive’s development of the XLIF procedure, almost all spinal
`
`fusion surgeries used either an anterior or posterior approach to the spine. A4885
`
`¶ 48. That is, they involved inserting a spinal implant through the front or back of
`
`3
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`the patient, respectively. In contrast, a lateral approach to the spine involves
`
`inserting a spinal implant through the side of the patient. More particularly, a trans-
`
`psoas approach is a lateral approach that goes directly through the psoas muscle,
`
`which runs along the side of the lumbar (lower) portion of the spine and contains
`
`large bundles of motor nerve roots that exit the spinal cord to innervate the muscles
`
`of the legs and lower extremities. A4873-74 ¶26; A4885 ¶ 49. Historically,
`
`surgeons avoided using such an approach for fear of damaging these large motor
`
`nerve roots while penetrating the psoas muscle. Id.
`
`The spinal fusion implants claimed in the ’156 patent are designed for
`
`insertion using such a lateral trans-psoas approach based, in part, on the placement
`
`of radiopaque markers in specific positions that a surgeon can use to determine
`
`whether the implant is correctly placed in the disc space. A51, 5:29-31.
`
`Proximal and distal refer to nearer to and away from, respectively, the point
`
`of attachment of the surgical instrument used for insertion, so that the medial plane
`
`runs parallel to and equidistant from the proximal wall and the distal wall, as
`
`shown in this annotated Figure 1 of the ’156 patent.
`
`4
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`Surgical instrument
`
`Point of attachment
`
`Proximal wall
`Medial plane
`Distal wall
`
`Claim 1, from which all of the challenged claims depend, requires, among
`
`other things, that the implant have two markers that are radiopaque (in other words,
`
`visible during the use of radiation such as X-rays) placed proximate to the
`
`implant’s medial plane, as depicted in the annotated Figure 2 of the ’156 patent
`
`below. The rest of the implant is radiolucent (in other words, translucent or
`
`invisible during the use of radiation such as X-rays). The radiopaque markers are
`
`specifically placed to allow a surgeon to use imaging techniques to ensure that the
`
`implant is properly positioned in the disc space, both during and after implantation.
`
`A4884-85 ¶¶ 46-47. The location of the markers in the medial plane enables
`
`surgeons to properly visualize both the orientation and location of laterally-inserted
`
`implants. Id.
`
`5
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`Radiopaque
`marker
`
`Medial Plane
`
`Radiopaque
`marker
`
`This is in contrast to prior art implants designed for implantation through
`
`either an anterior or posterior approach, which if they provided radiopaque markers,
`
`typically placed the markers in the proximal and distal walls, rather than in the
`
`middle of the implant. A4910 ¶ 95.
`
`Accordingly, claim 1 of the ’156 patent reads:
`
`construction
`fusion implant of non-bone
`1. A spinal
`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
`
`6
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`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
`medial plane, and said second radiopaque marker extends into said
`second sidewall at a position proximate to said medial plane. A54
`(emphasis added).
`
`7
`
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`II.
`
`Alleged Prior Art
`
`There are four references Medtronic has asserted as prior art that are relevant
`
`to the issues in this appeal. No reference disclosed an implant with radiopaque
`
`markers positioned in the middle of an elongated implant, as all the disclosed
`
`implants were designed for posterior or anterior insertion.
`
`A.
`
`SVS-PR Brochure
`
`The Synthes Vertebral Spacer-PR brochure (“SVS-PR brochure”) is a sales
`
`brochure for a spinal fusion implant designed to be inserted using a posterior
`
`approach. A769-70. Accordingly, the brochure shows two radiopaque markers
`
`(which appear below as darker circles), one in each of the proximal and distal walls
`
`of the implant. Id. The SVS-PR brochure does not disclose any radiopaque markers
`
`near the middle or medial plane of the implant. Id.
`
`The SVS-PR brochure bears a 2002 copyright date on its face. A770.
`
`Medtronic has variously asserted that the SVS-PR brochure was “printed and
`
`8
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`Case: 15-1670 Document: 19 Page: 18 Filed: 07/23/2015
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`publicly available” as of either May or June 2002. A73; A578 ¶ 52. The brochure
`
`is also stamped “FOR REFERENCE ONLY.” A769. There is not, however, any
`
`evidence of record to indicate whether, when, and to what extent the SVS-PR
`
`brochure was accessible to the public.
`
`B.
`
`Telamon Brochure
`
`The Telamon Verte-Stack PEEK Vertebral Body Spacer brochure
`
`(“Telamon brochure”) is a sales brochure for a Medtronic spinal fusion implant
`
`designed to be inserted using a posterior approach. A771-72. The Telamon
`
`brochure discloses radiopaque (“radiographic”) markers, but does not specifically
`
`disclose the location of those markers in the implant. Id. As a posteriorly inserted
`
`implant, however, the commercial embodiment of the implant in the Telamon
`
`brochure would have had radiopaque markers on the proximal and distal walls of
`
`the implant. A4905-06 ¶ 86; A4910 ¶ 95.
`
`The Telamon brochure bears a 2003 copyright date on its face. A771.
`
`Medtronic has asserted that the Telamon brochure was “printed and publicly
`
`available” as of 2003. A73. An August
`
`2003 memorandum, which Medtronic
`
`submitted with a supporting affidavit,
`
`indicates that the Telamon brochure was to
`
`be distributed only to certain Medtronic
`
`9
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`employees, that is, “U.S. Distributors, Area Managers, U.S. Sales Associates,
`
`GDS’s, AVP’s, Interbody/Ortho Technologies, Steve Foster, and Pete Wehrly.”
`
`A673. The memorandum also indicates that information about the implant
`
`disclosed in the Telamon brochure would be available through the website
`
`myspinetools.com, which is “a protected and restricted site for Medtronic
`
`customers and employees only.” Id.; http://myspinetools.com (last visited June 29,
`
`2015). Again, however, there is not any evidence of record to indicate whether,
`
`when, and to what extent the Telamon brochure was accessible to the public.
`
`C.
`
`Telamon Implantation Guide
`
`The Telamon Posterior Impacted Fusion Devices guide (“Telamon guide”) is
`
`a guide that describes a procedure for implanting the Telamon spinal fusion
`
`implant using a posterior approach. A773-82. The Telamon guide does not disclose
`
`radiopaque markers. Id. As a posteriorly inserted implant, however, the implant
`
`described in the Telamon guide had radiopaque markers on the proximal and distal
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`walls of the implant. A4905-06 ¶ 86; A4910 ¶ 95.
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`As with the Telamon brochure, the Telamon guide bears a 2003 copyright
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`date on its face. A782. Medtronic has asserted that the Telamon brochure was
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`“printed and publicly available” as of 2003. A73. Again, however, there is not any
`
`evidence of record to indicate whether, when, and to what extent the Telamon
`
`guide was accessible to the public.
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`Case: 15-1670 Document: 19 Page: 20 Filed: 07/23/2015
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`D.
`
`Baccelli
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`U.S. Patent Application Publication No. 2003/0028249 to Baccelli
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`(“Baccelli”) is entitled “Intervertebral Implant with Toothed Faces.” A744-51.
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`Baccelli discloses an implant designed to be inserted in the cervical spine, likely
`
`from an anterior approach. A4906 ¶ 87. As shown below, Baccelli discloses spikes
`
`(labeled 24) located in the middle of the implant that can “dig[] into the vertebral
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`plate and further increase[] the quality of the anchoring.” A748; A749 ¶¶ 20-21;
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`A750 ¶ 41.
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`Spike
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`Marker/Duct
`
`Distal wall
`
`Spike
`
`Insertion
`tool
`
`Marker/
`Duct
`
`Proximal wall
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`In contrast to the anchoring spikes 24, Baccelli discloses radiopaque markers
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`(labeled 47) placed at a different location in the implant. A750 ¶ 50. Baccelli
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`discloses that “there are two markers 47 and they are constituted by wires in
`
`rectilinear ducts parallel to the axis 6 and formed in the wall of the cage.” Id. One
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`duct is located on the proximal wall and the other duct is located on the distal wall.
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`Id. Finally, Baccelli discloses that, besides “wires in rectilinear ducts,” markers 47
`
`can include spikes that “can be inserted and fixed rigidly in the ducts,” referring to
`
`the aforementioned ducts in the proximal and distal walls containing radiopaque
`
`markers.A751 ¶ 51. Baccelli further discloses that those spikes “can be made of a
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`material that is opaque to X-rays.” Id. Nowhere does Baccelli teach markers other
`
`than those located on the proximal and distal walls, nor does Baccelli teach that the
`
`spikes not associated with markers 47 be made radiopaque. Various features of the
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`Baccelli implant are depicted in the annotated figure above.
`
`III.
`
`Inter Partes Review
`
`Medtronic filed a Petition requesting IPR of claims 1-14, 19-20, and 23-27
`
`of the ’156 patent alleging that the challenged claims were invalid as obvious over
`
`various interrelated combinations of the references. A72. NuVasive filed a
`
`Preliminary Response. A140-78. The Board instituted IPR of all challenged claims
`
`on the five grounds listed below. A197-98.
`
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`Alleged Prior Art
`Claims
`1-4, 7, 8, 10-14, 19, 20, 23, 24, 26, and 27 SVS-PR and Baccelli
`5, 6, and 9
`SVS-PR, Baccelli, and Michelson
`25
`SVS-PR, Baccelli, and Telamon
`Telamon1 and Baccelli
`1-4, 7, 10-14, 19, 20, and 23-27
`5, 6, 8, and 9
`Telamon, Baccelli, and Michelson
`
`1
`2
`3
`4
`5
`
`For each instituted ground, Medtronic relied on either the SVS-PR or
`
`Telamon references for most elements. Medtronic further argued that one of
`
`ordinary skill in the art would have been motivated to modify the implants
`
`disclosed in the SVS-PR and Telamon references in light of the Baccelli reference
`
`to provide radiopaque markers proximate to the medial plane of the implant. See,
`
`e.g., A84; A108. Medtronic argued that it would have been obvious to do so,
`
`because such markers would provide “additional information” regarding the
`
`orientation or location of an implant during surgery and after implantation. Id. In
`
`so doing, Medtronic cited to the declaration of its expert, Dr. Hynes, which states
`
`in relevant part:
`
`it is my opinion that, prior to the earliest effective filing of the ’156
`patent, a person of ordinary skill in the art would have considered it to
`
`1 Both Medtronic and the Board referred to the Telamon brochure and the
`Telamon guide collectively as “Telamon” and generally treated the references as a
`single commercial embodiment, rather than as distinct printed publications. See,
`e.g., A183 n.2 (“The Telamon Brochure and the Telamon Guide both describe the
`same implant. As such, Petitioner is treating their combined disclosure as a single
`publication.”).
`
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`be common sense and to yield predictable results to modify the spinal
`fusion implant described in the SVS-PR Brochure or in the Telamon
`Brochure and Telamon Guide to include the radiopaque markers as
`described in Baccelli to provide additional information regarding the
`orientation or location of an implant during surgery and after
`implantation. A591 ¶ 68 (emphasis added).
`
`Medtronic provided no other evidence or analysis as to why a person of
`
`ordinary skill in the art would make such a modification. Neither Medtronic’s
`
`Petition nor Dr. Hynes’ declaration explained why one of ordinary skill in the art
`
`would add markers at all, let alone add markers specifically to the medial plane of
`
`the Telamon or SVS-PR implant as opposed to any other location. In addition,
`
`neither Medtronic’s Petition nor Dr. Hynes’ declaration explained what additional
`
`information medial plane markers would provide beyond the information already
`
`provided by the other markers on the Telamon or SVS-PR implants.
`
`In its Preliminary Response, NuVasive argued that the SVS-PR brochure,
`
`the Telamon brochure, and the Telamon guide did not qualify as prior art printed
`
`publications because Medtronic failed to prove that the references were accessible
`
`to the public. A159-63. With respect to the SVS-PR brochure, NuVasive pointed
`
`out that Medtronic provided no objective evidence that the brochure was accessible
`
`by the public, instead relying on conclusory statements that the reference was
`
`“publicly available.” A160. If anything, the “FOR REFERENCE ONLY” stamp on
`
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`the face of the SVS-PR brochure suggests that it was not intended for public
`
`dissemination. A769. As to the Telamon references, NuVasive pointed out that
`
`Medtronic provided no evidence of public availability other than the memorandum,
`
`which in actual fact only indicated distribution to Medtronic employees and further
`
`indicated that access to Telamon materials was restricted by a password-protected
`
`website. A161-62. Nonetheless, the Board instituted IPR, finding that “Medtronic
`
`has provided evidence to a degree that is sufficient at this stage of the proceeding
`
`to demonstrate a reasonable likelihood that Medtronic will prevail.” A186.
`
`Following institution,