IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
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`
`
`In re Patent of: Curran et al.
`
`U.S. Patent No.: 8,361,156
`Issue Date:
`January 29, 2013
`Appl. Ser. No.: 13/441,092
`Filing Date: April 6, 2012
`Title:
`SYSTEMS AND METHODS FOR SPINAL FUSION
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Attorney Docket No.: 108136.00029
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF UNITED STATES
`PATENT NO. 8,361,156 PURSUANT TO 35 U.S.C. §§ 311-319, 37 C.F.R. § 42
`
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`TABLE OF CONTENTS
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`I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`A.
`
`B.
`
`C.
`
`D.
`
`Real Party-in-Interest Under 37 C.F.R. § 42.8(b)(1)
`
`Related Matters Under 37 C.F.R. § 42.8(b)(2)
`
`Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`
`Service Information
`
`II.
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`PAYMENT OF FEES – 37 C.F.R. § 42.103
`
`III. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
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`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`
`1
`
`1
`
`1
`
`2
`
`2
`
`2
`
`2
`
`2
`
`B.
`
`C.
`
`Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested 2
`
`Claim Construction under 37 C.F.R. §§ 42.104(b)(3)
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Distal Wall / Proximal Wall
`
`Releasably Mate
`
`Extend Generally Perpendicular to Said Longitudinal
`Length
`
`Elongate Body
`
`Generally Rectangular and Generally Oblong in Shape 6
`
`A Lateral Width of the Distal End of Said Distal Wall/A
`Lateral Width of Said Proximal End of Said Proximal Wall
`
`7
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`4
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`4
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`5
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`5
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`6
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`7.
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`Oriented Generally Parallel to a Height of the Implant 7
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`IV. SUMMARY OF THE ‘156 PATENT
`
`A. Overview of the ‘156 Patent
`
`B.
`
`Summary of the Prosecution History of the ‘156 Patent
`
`7
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`7
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`9
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`
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`C.
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`Legal Standard for Obviousness
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`V.
`
`THE CHALLENGED CLAIMS ARE UNPATENTABLE
`
`12
`
`13
`
`A. Ground 1 – Claims 1-14, 19, 20, and 23-27 Are Obvious Under §
`103 over the SVS-PR in view of Frey, Baccelli and/or Michelson
`or Telamon
`13
`
`B. Ground 2 – Claims 1-14, 19, 20, and 23-27 Are Obvious Under §
`103 over Telamon in view of Frey, Baccelli and/or Michelson or
`SVS-PR
`37
`
`60
`
`
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`VI. CONCLUSION
`
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`EXHIBITS
`
`MSD 1101 - Declaration of Richard Hynes, M.D. Regarding U.S. Patent No.
`8,361,156
`
`MSD 1102 – Declaration of Mary Phelps Regarding Telamon Verte-Stack PEEK
`Vertebral Body Spacer
`
`MSD 1103 – U.S. Patent Application Publication No. 2002/0165550
`
`MSD 1104 – U.S. Patent Application Publication No. 2003/0028249
`
`MSD 1105 – U.S. Patent No. 5,860,973
`
`MSD 1106 - Synthes Vertebral Spacer-PR Brochure
`
`MSD 1107 - Telamon Verte-Stack PEEK Vertebral Body Spacer Brochure
`
`MSD 1108 – Telamon Implantation Guide
`
`MSD 1109 – Prosecution History of U.S. Patent No. 8,187,334
`
`MSD 1110 – Prosecution History of U.S. Patent No. 7,918,891
`
`MSD 1111 - First Amended Complaint, filed on October 6, 2008, and Judgment
`Following Jury Verdict, entered on September 29, 2011, in Warsaw
`Orthopedics, Inc. v, NuVasive, Inc., Case No. 3:08-CV-01512,
`Southern District of California
`
`MSD 1112 – Curriculum Vitae of Richard Hynes, M.D.
`
`MSD 1113 – S.H. Zhou et al., Geometrical Dimensions of the Lower Lumbar
`Vertebrae – Analysis of Data from Digitised CT Images, 9 EUR SPINE
`J 242, 244 (2000)
`
`MSD 1114 – U.S. Patent No. 6,241,770
`
`MSD 1115 – U.S. Patent No. 8,361,156
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`Medtronic, Inc. (“Petitioner”) petitions for Inter Partes Review (“IPR”)
`
`under 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42 of claims 1-8, 10-14, 19, 20, and
`
`23-27 of U.S. Patent No. 8,361,156 (the “‘156 patent”). As set forth below,
`
`Petitioner demonstrates there is a reasonable likelihood of prevailing in its
`
`challenge of at least one of claims 1-14, 19, 20, and 23-27 identified in this petition
`
`as being unpatentable.
`
`I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`A. Real Party-in-Interest Under 37 C.F.R. § 42.8(b)(1)
`
`Petitioner is the real party-in-interest for the instant petition.1
`
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`
`Petitioner is not aware of any reexamination certificates or pending
`
`prosecution concerning the ‘156 patent. Petitioner is a named counterclaim-
`
`defendant in litigation concerning the ‘156 patent, Warsaw Orthopedic, Inc. et al.
`
`v. NuVasive, Inc., originally filed in the Northern District of Indiana as Case No.
`
`3:12-cv-00438-JD-CAN on August 17, 2012, and transferred to the Southern
`
`District of California on November 8, 2012, as case No. 3:12-cv-02738-CAB-
`
`MDD. The ‘156 patent was added by counterclaim filed on March 7, 2013.
`
`
`1 Other parties that have an interest in the instant petition include Petitioner’s co-
`counterclaim defendants in Case No. 3:12-cv-00438-JD-CAN; including:
`Medtronic Sofamor Danek U.S.A., Inc. and Medtronic Sofamor Danek
`Deggendorf, GmbH.
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`Petitioner is concurrently filing an IPR petition for the ‘156 patent on five
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`additional grounds not presented herein.
`
`C. Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`
`LEAD COUNSEL
`Jeff E. Schwartz, Reg. No. 39,019
`1030 15th Street, NW
`Washington, DC 20005
`
`
`D. Service Information
`
`BACK-UP COUNSEL
`Seth A. Kramer, Reg. No. 67,813
`2000 Market Street, 20th Floor
`Philadelphia, PA 19103
`
`Please address all correspondence to both counsel listed above. Petitioner
`
`consents to service by email at ipdocket@foxrothschild.com (referencing Attorney
`
`Docket No. 108136.00021).
`
`II.
`
`PAYMENT OF FEES – 37 C.F.R. § 42.103
`
`Petitioner authorizes the Patent and Trademark Office to charge Deposit
`
`Account No. 50-1943 for any fees due as a result of the filing of the present
`
`petition.
`
`III. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`
`Petitioner certifies the ‘156 patent is eligible for IPR and Petitioner is not
`
`barred or estopped from requesting IPR. This petition is filed within one year of
`
`service of a counterclaim against Petitioner in district court litigation in which the
`
`‘156 patent was asserted.
`
`B. Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
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`Petitioner requests IPR of claims 1-14, 19, 20, and 23-27 of the ‘156 patent
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`on the grounds set forth in the table below and requests that each of the claims be
`
`found unpatentable. A detailed explanation of the statutory grounds for the
`
`unpatentability of each claim is provided in the form of claim charts. Additional
`
`evidence supporting for each ground is provided for in the Declaration of Richard
`
`A. Hynes, M.D., and the appendices attached thereto.
`
`Ground
`
`‘156 Patent
`Claims
`Ground 1 1-14, 19, 20,
`and 23-27
`
`Ground 2 1-14, 19, 20,
`and 23-27
`
`Basis for Rejection
`
`Obvious under § 103(a) by Synthes Vertebral
`Spacer–PR (“SVS-PR”) (Exhibit MSD 1106) and in
`view of U.S. Patent Appl. Pub. No. 2002/0165550 to
`Frey (“Frey”) (Exhibit MSD 1103), U.S. Patent
`Appl. Pub. No. 2003/0028249 to Baccelli
`(“Baccelli”) (Exhibit MSD 1104), and/or U.S. Patent
`No. 5,860,973 to Michelson (“Michelson”) (Exhibit
`MSD 1105) or Telamon Verte-Stack PEEK Vertebral
`Body Spacer Brochure (“Telamon Brochure”)
`(Exhibit MSD 1107) and Implantation Guide
`(“Telamon Guide”) (Exhibit MSD 1108)
`(collectively, “Telamon”)2
`Obvious Under § 103 over Telamon in view of Frey,
`Baccelli and/or Michelson or SVS-PR
`
`
`
`Frey and Baccelli each qualify as prior art under at least 35 U.S.C. § 102(b)
`
`because they were published more than one year prior to March 29, 2004.
`
`Michelson qualifies as prior art under at least 35 U.S.C. § 102(b) because it issued
`
`
`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.
`Alternatively, because they do in fact disclose the same implant, it would have
`been obvious to combine their disclosures. See Hynes Decl., at 54.
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`more than one year prior to March 29, 2004. The SVS-PR, as shown in a printed
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`and publicly available brochure as of May 2002, qualifies as prior art at least under
`
`35 U.S.C. § 102(b). The Telamon Brochure and the Telamon Guide, printed and
`
`publicly available brochures as of 2003, qualify as prior art at least under 35
`
`U.S.C. § 102(a). See Declaration of Mary Phelps Regarding Telamon Verte-Stack
`
`PEEK Vertebral Body Spacer (Exhibit MSD 1102). None of these references were
`
`cited in a rejection during prosecution of the ‘156 patent.
`
`C. Claim Construction under 37 C.F.R. §§ 42.104(b)(3)
`
`In an IPR, the claim terms are given their “broadest reasonable construction
`
`in light of the specification.” 37 C.F.R. § 42.100(b). The claims terms are
`
`understood by their plain and ordinary meanings except where construed in the
`
`specification. The broadest reasonable construction is the broadest reasonable
`
`interpretation of the claim language. See In re Yamamoto, 740 F.2d 1569, 1572
`
`(Fed. Cir. 2004). Consistent with this standard, a proposed interpretation for
`
`certain claim terms is provided below.
`
`1. Distal Wall / Proximal Wall
`
`Under the broadest reasonable construction, the
`
`distal wall is the side or end of the implant that generally enters the patient first, i.e.
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`the leading end wall, opposite the proximal or trailing end wall. The proximal wall
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`is the side or end of the implant that enters patient last; opposite of the distal wall.
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`Further, as discussed in detail in Section IV.B., infra, the PTO has previously taken
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`the position that the apertures (1044) shown in the prior art
`
`spinal fusion implant figures reproduced above are located
`
`on the proximal wall of the implant. The Applicant
`
`implicitly acquiesced to the USPTO on its interpretation. Therefore, the broadest
`
`reasonable construction of the terms “distal wall” and “proximal wall” include the
`
`regions, for example, of the Frey implant disclosed above where apertures 1044
`
`and 1048 are located.
`
`2. Releasably Mate
`
`Under the broadest reasonable construction, the term “releasably mate” as
`
`used in the ‘156 patent should be construed as “an impermanent stabilized
`
`connection.” In the ‘156 patent, this term is used to describe the connecting
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`relationship between the implant and insertion tool. See ‘156 patent, at 8:26-33
`
`(“In order to secure the spinal fusion implant 10 onto the threaded connector 24 of
`
`the inserter instrument 20, the clinician employs the thumbwheel 34 to rotate the
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`inserter shaft 44 and threaded connector 24. The rotation of the threaded connector
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`24 will releasably engage the receiving aperture of the spinal fusion implant 10 and
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`stabilize the insertion instrument 20 relative to the spinal fusion implant 10.”).
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`3. Extend Generally Perpendicular to Said Longitudinal Length
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`Under the broadest reasonable construction, this term is construed as
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`extending approximately in a direction that crosses a plane along the general
`
`direction of the longitudinal length of the implant at generally or roughly a right
`
`angle. The “longitudinal length” in its broadest reasonable interpretation, is the
`
`dimension measured from end to end of the implant, or from insertion/leading end
`
`to trailing end. For example, Webster’s Third New International Dictionary of the
`
`English Language Unabridged (2002) at page 1293, defines “length” to mean “the
`
`extent from end to end.” Similarly, The New Shorter Oxford English Dictionary
`
`(1993) at page 1565 defines “length” as “the linear extend of anything as measured
`
`from end to end.” See Manual of Patent Examining Procedure, Section 2111.01
`
`(“Under a broadest reasonable interpretation, words of the claim must be given
`
`their plain meaning, unless such meaning is inconsistent with the specification. . . .
`
`Ordinary, simple English words whose meaning is clear and unquestionable,
`
`absent any indication that their use in a particular context changes their meaning,
`
`are construed to mean exactly what they say.”).
`
`4. Elongate Body
`
`Under the broadest reasonable construction, an “elongate body” is construed
`
`as a body longer than it is wide. See id.
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`5. Generally Rectangular and Generally Oblong in Shape
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`Under the broadest reasonable construction, the term “generally rectangular
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`and generally oblong in shape is construed as a
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`shape having portions roughly approximating sides
`
`and being elongated in at least one dimension. In
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`support of such construction, as discussed in further detail in Section IV.B., infra,
`
`the USPTO has previously taken the position that the fusion apertures (1018a,
`
`1018b) shown in the Frey prior art spinal fusion implant figure reproduced above
`
`are generally rectangular and elongated in at least one direction.
`
`6. A Lateral Width of the Distal End of Said Distal Wall/A
`Lateral Width of Said Proximal End of Said Proximal Wall
`
`Under the broadest reasonable construction, these terms are construed as
`
`being a width of the most distal end of the distal wall extending in a direction from
`
`the first side wall to the second sidewall and a width of the most proximal end of
`
`the proximal wall extending in a direction from the first side wall to the second
`
`sidewall. See MPEP, Section 2111.01.
`
`7. Oriented Generally Parallel to a Height of the Implant
`
`Under the broadest reasonable construction, this term is construed as being
`
`oriented generally or roughly along the Y-axis (up and down) or oriented generally
`
`or roughly in a direction running from the top to the bottom. See id.
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`IV. SUMMARY OF THE ‘156 PATENT
`
`A. Overview of the ‘156 Patent
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`
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`The application that issued as the ‘156 patent was filed on April 6, 2012, and
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`is a continuation of U.S. Patent No. 8,246,686, April 5, 2012, which is a
`
`continuation of U.S. Patent No. 8,187,334, filed on April 4, 2011, which is a
`
`continuation of 7,918,891 (the “‘891 patent”), filed on March 29, 2005, which
`
`claims the benefit U.S. Provisional Application Ser. No. 60/557,536, filed on
`
`March 29, 2004.
`
`The ‘156 patent is directed to a spinal fusion implant of non-bone
`
`construction that is positionable in the interbody space between first and second
`
`vertebrae. See, e.g., ‘156 patent, 1:66 to 2:2. As
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`described and claimed, the implant of the ‘156 patent
`
`has a distal wall, a proximal wall, and two sidewalls, with the walls being at least
`
`partly constructed from a radiolucent material. The length of the implant
`
`extending from the proximal wall to the distal wall is greater than the maximum
`
`width of the implant, as defined by greatest distance between the two sidewalls.
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`The upper and lower surfaces of the implant contain anti-migration elements that
`
`come in contact with the first and second vertebrae. At least one fusion aperture
`
`that is longer than it is wide and extends from the top surface to the bottom surface
`
`is included in the implant. The claimed implant also contains at least two
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`radiopaque markers oriented generally parallel to the height of the implant, with at
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`least one in the first sidewall, and one in the second sidewall. The ‘156 patent
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`describes the implant as being manufactured from a radiolucent material so that the
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`markers “will be readily observable under X-ray or fluoroscopy such that a
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`surgeon may track the progress of the implant 110 during implantation and/or the
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`placement of the implant 110 after implantation.” ‘156 patent, 10:2-9. The ‘156
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`patent does not discuss whether or how the size, shape, location, or orientation of
`
`the markers is critical to, or otherwise may affect the ability of the surgeon to track
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`the progress or placement of the implant.
`
`B. Summary of the Prosecution History of the ‘156 Patent
`
`The prosecution histories of the ‘156 patent, and of its parent patent, the
`
`“‘891 patent”, as obtained from PAIR, are submitted herewith as Exhibits MSD
`
`1109 and MSD 1110.
`
`The parent ‘891 patent, like the continued ‘156 patent, has claims directed to
`
`a spinal fusion implant of non-bone construction. The ‘891 patent issued from
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`U.S. Patent Appl. Ser. No. 11/093,409 (the “‘409 application”), which was filed
`
`with two independent claims (i.e., Claims 1 and 14) and twenty-four dependent
`
`claims (i.e., Claims 2-13 and 15-26). During prosecution of the ‘409 application,
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`Applicants amended Claim 1 to recite as follows:
`
`Claim 1 [A]: A spinal fusion system implant positionable within an interbody
`space between a first vertebral endplate and a second vertebral endplate, said
`interbody space being at least partially defined by a posterior aspect, and [sic]
`anterior aspect, and opposing lateral aspects, said implant comprising:
`[B]: an interbody spinal fusion implant, including at least in part a top surface
`including a plurality of ridges to engage said for contacting a first vertebral
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`endplate when said implant is positioned within the interbody space, a bottom
`surface including a plurality of ridges to engage said for contacting a second
`vertebral endplate when said implant is positioned within the interbody space, at
`least one fusion aperture extending between the top surface and the bottom surface
`to allow bony fusion between the first vertebral end plate and the second vertebral
`endplate, a distal side, a proximal side, having a pair of receiving apertures
`separated by a distance and situated within the boundaries of the proximal side for
`engaging an insertion instrument, and two lateral sides; and a first side wall
`defining an anterior side when said implant is positioned within the interbody
`space, and a second side wall defining a posterior side when said implant is
`positioned within the interbody space;
`[C]: wherein said implant has a length extending from said proximal side to said
`distal side, a width extending from said first side wall to said second side wall, and
`a height extending from said top surface to said bottom surface;
`[D]: wherein said length is so dimensioned as to extend between lateral aspects of
`said interbody space and is at least two and a half times greater than said width;
`[E]: wherein said width is greater than said height;
`[F]: said implant further including first and second fusion apertures that each
`extend between the top and bottom surfaces and permit bone growth between the
`first vertebral endplate and the second vertebral endplate when said implant is
`positioned within the interbody space, said first and second fusion apertures being
`adjacent to one another and separated by a medial support;
`[G]: said implant further including at least one radiopaque marker situated between
`said top and bottom surfaces.
`
`an insertion instrument, including a generally elongated tubular member
`having a distal opening and a proximal opening, a generally elongated shaft
`member having a distal end and a proximal end and being generally dimensioned
`to be inserted through the elongated tubular member such that the distal end
`extends beyond the distal opening and the proximal end extends beyond the
`proximal opening, and the distal end including an implant engagement feature; and
`
`a securing mechanism for releasably securing the engagement feature in one
`or more receiving apertures of the implant.
`
`
`
`Applicants also amended Claim 5 to recite:
`
`Claim 5: The spinal fusion system implant of Claim 1, wherein the implant further
`includes anti migration features to increase friction between the implant and
`vertebral endplate minimizing unwanted movement said first and second fusion
`apertures are one of generally rectangular and oblong in shape.
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`Additionally, Applicants added Claim 31-33, which recited:
`
`Claim 31: The Spinal [sic] fusion implant of claim 1, further including at least one
`receiving aperture at least partially defined along said proximal side.
`Claim 32: The spinal fusion implant of claim 31, wherein said receiving element is
`engageable with an insertion instrument.
`Claim 33: The spinal fusion implant of claim 32, wherein said receiving element
`comprises a threaded aperture.
`
`In an Office Action dated August 27, 2009, the PTO rejected these claims.
`
`In support of these rejections, the PTO cited U.S. Patent No. 6,830,570 to Frey (the
`
`“‘570 patent”) as disclosing first and second fusion apertures (1018a, 1018b) that
`
`are “generally rectangular and oblong in shape.” Exhibit MSD 1110, at 1010. The
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`PTO also cited the ‘570 patent as disclosing a threaded receiving element (1044)
`
`on the proximal side of the implant that is engageable with an insertion instrument.
`
`See id.
`
`With respect to the limitation regarding the proportional relationship
`
`between the length and the width of the implant, the PTO explained that “[i]t
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`would have been obvious to one having ordinary skill in the art at the time of
`
`invention was made to have the length be at least two and a half times greater than
`
`the width, since it has been held that discovering an optimum value of a result
`
`effective variable involves only routine skill in the art.” See id. (citing In re
`
`Boesch, 617 F.2d 272 (CCPA 1980)).
`
` The Applicants did not argue past these rejections, but instead amended the
`
`claims to add the element of a medial support extending parallel to the proximal
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`and distal sides and between the top and bottom surfaces of the implant thereby
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`separating the fusion apertures of the implant, to avoid the rejections based on the
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`Frey ‘570 patent. See MSD 1110, at 1029-30.
`
`During prosecution of the ‘156 patent, the claims were amended in
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`preliminary amendments, but were never rejected by the PTO.
`
`C. Legal Standard for Obviousness
`
`A claim is obvious, and therefore invalid, under 35 U.S.C. § 103(a) if, at the
`
`time the invention was made, “the combined teachings of the prior art, taken as a
`
`whole, would have rendered the claimed invention obvious to one of ordinary skill
`
`in the art.” In re Napier, 55 F. 3d 610, 613 (Fed. Cir. 1995). The scope and
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`content of the prior art drive the obviousness analysis. KSR Int’l Co. v. Teleflex,
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`Inc., 550 U.S. 398, 406, 127 S. Ct. 1727, 1734, 167 L. Ed. 2d 705 (2007). “The
`
`combination of familiar elements according to known methods is likely to be
`
`obvious when it does no more than yield predictable results.” KSR, 127 S. Ct. at
`
`1739. There is no requirement to find precise teachings directed to specific
`
`subject matter of a claim; common sense, inferences, and creative steps that a
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`person of ordinary skill in the art would employ should be considered. Id. at 1741.
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`Obviousness is not confined to a formalistic conception of “teaching, suggestion,
`
`and motivation” or by overemphasis on published articles and explicit content of
`
`issued patents. Id. Courts should apply common sense, recognizing that “familiar
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`items may have obvious uses beyond their primary purposes, and in many cases a
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`person of ordinary skill will be able to fit the teachings of multiple patents together
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`like pieces of a puzzle.” Id. at 1742.
`
`If “a patent ‘simply arranges old elements with each performing the function
`
`it had been known to perform’ and yields no more than one would expect from
`
`such an arrangement, the combination is obvious.” Id. at 1740. When “design
`
`incentives and other market forces . . . prompt variations of [an existing device] . . .
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`[and] a person of ordinary skill can implement a predictable variation, § 103 likely
`
`bars its patentability.” Id. In short, “a court must ask whether the improvement is
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`more than a predictable use of prior art elements according to their established
`
`function.” Id.
`
`V. THE CHALLENGED CLAIMS ARE UNPATENTABLE
`The challenged claims recite spinal fusion implants with features that were
`
`well known prior to the earliest possible priority date of the ‘156 patent. See e.g.,
`
`Declaration of Richard Hynes, M.D. Regarding U.S. Patent No. 8,361,156
`
`(hereinafter, the “Hynes Decl.”), attached hereto as Exhibit 1101, at ¶ 57. As
`
`detailed in claim charts below, prior art reference both anticipate and, alternatively,
`
`render obvious the challenged claims of the ‘156 patent.
`
`A. Ground 1 – Claims 1-14, 19, 20, and 23-27 Are Obvious Under §
`103 over the SVS-PR in view of Frey, Baccelli and/or Michelson
`or Telamon
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`As shown in the claim chart below, claims 1-14, 19, 20, and 23-27 of the
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`‘156 patent are obvious under 35 U.S.C. § 103 over the Synthes Vertebral Spacer-
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`PR Brochure (“SVS-PR”) in view of Frey, Baccelli, and/or Michelson or Telamon.
`
`The specific combinations for each claim are as follows:
`
`Claim
`1-4, 7, 8, 11, 12, 14,
`19, 20, 23, 24, and 26
`5-8
`
`9
`10, 27
`13
`
`25
`
`Combination of References
`SVS-PR and Baccelli
`
`SVS-PR, Baccelli, and Frey; or SVS-PR, Baccelli, and
`Michelson
`SVS-PR, Baccelli, and Michelson
`SVS-PR and Baccelli, or SVS-PR, Baccelli, and Frey
`SVS-PR and Baccelli; SVS-PR, Baccelli, and Frey; or
`SVS-PR, Baccelli, and Michelson
`SVS-PR, Baccelli, and Telamon; or SVS-PR, Baccelli,
`and Frey
`
`With respect to Claim 1, the SVS-PR Brochure (a representative
`
`embodiment of the SVS-PR, is reproduced below), which was not cited during
`
`prosecution of the ‘156 patent, discloses a spinal fusion implant
`
`having a distal wall, a proximal wall, and two sidewalls, with
`
`the walls being at least partly constructed from a radiolucent
`
`material. Additionally, the SVS-PR has a longitudinal length
`
`that is greater than its maximum lateral width. The upper and lower surfaces of the
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`SVS-PR also contain anti-migration elements that come in contact with first and
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`second vertebrae. Additionally, the SVS-PR contains at least one fusion aperture
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`that extends from the top surface to the bottom surface. The fusion aperture of the
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`SVS-PR has a longitudinal length that is greater than its lateral width.
`
`The SVS-PR also discloses the use of radiopaque markers in its distal and
`
`proximal walls. Baccelli likewise teaches the use of such markers in a spinal
`
`fusion implant, to assist a surgeon in tracking the progress and placement of the
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`implant during and after surgery. See Baccelli, at ¶¶ [0050]-[0051] (“. . . [T]he
`
`cage can have one or more markers 47 included therein and serving, because they
`
`are opaque to X-rays, to identify the position and/or the presence of the implant
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`when X-rays are taken during or after the operation. . . . The spikes 24 . . . too can
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`be made of a material that is opaque to X-rays.”). Baccelli specifically discloses
`
`the use of at least first and second radiopaque markers that extend into a first
`
`sidewall and a second sidewall at positions proximate to a medial plane of the
`
`implant. It would have been obvious to one of ordinary skill in the art at the time
`
`of invention to modify the SVS-PR implant to provide radiographic markers in the
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`first and second sidewalls thereof as taught by Baccelli, to provide additional
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`information regarding the orientation or location of an implant during surgery and
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`after implantation. See Hynes Decl., at ¶ 67. Modifying the SVS-PR implant
`
`based on teachings of Baccelli represents nothing more than an application of
`
`known prior art elements to improve a similar device in the same way.
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`Furthermore, the SVS-PR modified in accordance with the teachings of Baccelli is
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`merely a combination of prior art elements according to known methods to yield
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`predictable results. See id. Accordingly, such modification of the SVS-PR implant
`
`would have involved nothing more than the exercise of ordinary skill and common
`
`sense to apply an identified, predictable solution to a known design need. See id.
`
`Claim 1 [A]: A spinal
`fusion implant of non-
`bone construction
`positionable within an
`interbody space between
`a first vertebra and a
`second vertebra, said
`implant comprising:
`Claim 1 [B]: 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,
`Claim 1 [C]: a distal
`wall, a proximal wall, a
`first sidewall and a
`second sidewall
`generally opposite from
`the first sidewall,
`
`Claim 1 [D]: wherein
`said distal wall,
`
`The SVS-PR describes a spinal fusion implant
`constructed from a biocompatible radiolucent polymer,
`which is intended for implantation between first and
`second vertebral endplates.
`
`The upper and lower surfaces of the SVS-PR have anti-
`migration elements to contact the first and second
`vertebrae. SVS-PR Brochure, at 1 (“Saw-tooth pattern
`on superior and inferior surfaces of implant is designed
`to provide secure engagement with adjacent vertebral
`bodies.”).
`
`
`
`Anti-
`Migration
`Elements
`
`The SVS-PR has a distal wall, a proximal wall, a first
`sidewall and a second sidewall generally opposite from
`the first sidewall. See SVS-PR Brochure, at 1.
`
`Second
`Distal Wall
`Sidewall
`
`Proximal
`First
`Sidewall Wall
`The SVS-PR is constructed from a “[b]iocompatible
`radiolucent polymer [that] allows clear assessment of
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`bony fusion.” SVS-PR Brochure, at 1.
`
`The SVS-PR Brochure provides that the SVS-PR has a
`longitudinal length that is two and half times greather
`than the maximum
`lateral width. See
`SVS-PR Brochure,
`at 1 (disclosing that
`implant has an
`axial footprint of
`22 mm by 8 mm).
`
`The SVS-PR includes a “single axial canal [that]
`receives autograft to allow fusion to occur through the
`implant.” As shown in the
`figure below, this first
`fusion aperture extends
`through the upper surface
`to the lower surface. See
`SVS-PR Brochure, at 1.
`
` First Fusion Aperture
`
`The first fusion aperture of the SVS-PR has a
`longitudinal length greater than its lateral width. See
`SVS-PR Brochure, at 1.
`
`
`
`
`
`
`
`proximal wall, first
`sidewall, and second
`sidewall comprise a
`radiolucent material;
`Claim 1 [E]: 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;
`Claim 1 [F]: 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,
`Claim 1 [G]: said first
`fusion aperture having:
`a longitudinal aperture
`length extending
`generally parallel to the
`longitudinal length of
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`Longitudinal Length
`of Fusion Aperture
`
`
`
`Lateral Width of
`Fusion Aperture
`
`Baccelli discloses a spinal fusion implant having at least
`first and second radiopaque markers (spikes 24) that
`extend into a first sidewall and a second sidewall at
`positions proximate to a medial plane of the implant.
`See Baccelli, at ¶ [0041] (“The ca