IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`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.: 108136.00021
`
`
`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. Real Party-in-Interest Under 37 C.F.R. § 42.8(b)(1)
`
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`
`1
`
`1
`
`1
`
`Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) 2
`
`C.
`
`D.
`
`Service Information
`
`II.
`
`PAYMENT OF FEES – 37 C.F.R. § 42.103
`
`III. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`
`2
`
`2
`
`2
`
`2
`
`4
`
`4
`
`5
`
`5
`
`6
`
`B. Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
`
`2
`
`C. 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
`
`7.
`
`Oriented Generally Parallel to a Height of the Implant 7
`
`IV. SUMMARY OF THE ‘156 PATENT
`
`A. Overview of the ‘156 Patent
`
`7
`
`7
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`B.
`
`C.
`
`Summary of the Prosecution History of the ‘156 Patent
`
`Legal Standard for Obviousness
`
`V.
`
`THE CHALLENGED CLAIMS ARE UNPATENTABLE
`
`9
`
`12
`
`13
`
`A. Ground 1 – Claims 1-8, 10-14, 19, 20 and 23-27 Are Obvious
`Under § 103 over Frey in View of Baccelli
`13
`
`B. Ground 2 – Claims 1-8, 10-14, 19, 20, and 23-27 Are Obvious
`Under § 103 over Frey in view of Baccelli and in further view
`of Messerli
`36
`
`C. Ground 3 – Claims 1-14, 19, 20, and 23-27 Are Obvious Under
`§ 103 over Frey in view of Baccelli and in further view of
`Michelson
`
`38
`
`D. Ground 4 – Claims 1-8, 10-14, 19, 20, and 23-27 Are Obvious
`Under § 103 over Frey in view of Baccelli and in further view
`of Moret
`43
`
`E. Ground 5 – Claims 1-8, 10-14, 19, 20, and 23-27 Are Obvious
`Under § 103 over Baccelli in view of Frey
`45
`
`VI. CONCLUSION
`
`
`
`
`
`60
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`EXHIBITS
`
`MSD 1001 – Declaration of Richard Hynes, M.D. Regarding U.S. Patent No.
`8,187,334
`
`MSD 1002 – Declaration of Steven D. DeRidder Regarding U.S. Patent
`Application Publication No. 2002/0165550
`
`MSD 1003 – U.S. Patent Application Publication No. 2002/0165550
`
`MSD 1004 – U.S. Patent Application Publication No. 2003/0028249
`
`MSD 1005 – U.S. Patent No. 5,860,973
`
`MSD 1006 – U.S. Patent Application Publication No. 2003/0100950
`
`MSD 1007 – U.S. Patent Application Publication No. 2003/0139813
`
`MSD 1008 – Prosecution History of U.S. Patent No. 8,187,334
`
`MSD 1009 – Prosecution History of U.S. Patent No. 7,918,891
`
`MSD 1010 – 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 1011 – Curriculum Vitae of Richard Hynes, M.D.
`
`MSD 1012 – 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 1013 – 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 1-14, 19, 20, and 23-27
`
`of U.S. Patent No. 8,361,156 (the “‘156 patent”) (Exhibit MSD 1013). 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 two
`
`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
`
`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 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 1-8, 10-14, 19,
`20, and 23-27
`
`Ground 2 1-8, 10-14, 19,
`20, and 23-27
`
`Ground 3 1-14, 19, 20,
`and 23-27
`
`Ground 4 1-8, 10-14, 19,
`20, and 23-27
`
`Ground 5 1-8, 10-14, 19,
`20, and 23-27
`
`Basis for Rejection
`
`Obvious under § 103 by U.S. Patent Appl. Pub. No.
`2002/0165550 to Frey (“Frey”) (Exhibit MSD 1003)
`in view of U.S. Patent Appl. Pub. No. 2003/0028249
`to Baccelli (“Baccelli”) (Exhibit MSD 1004)
`Obvious under § 103 by Frey in view of Baccelli and
`in further view of U.S. Patent Appl. Pub. No.
`2003/0139813 to Messerli (“Messerli”) (Exhibit
`MSD 1007)
`Obvious under § 103 by Frey in view of Baccelli and
`further in view of U.S. Patent No. 5,860,973 to
`Michelson (“Michelson”) (MSD 1005)
`Obvious under § 103 by Frey in view of Baccelli
`and further in view of U.S. Patent Appl. Pub. No.
`2003/0100950 to Moret (“Moret”) (Exhibit MSD
`1006)
`Obvious under § 103 by Baccelli in view of Frey
`
`
`
`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.
`
`Messerli qualifies as prior art under 35 U.S.C. § 102(a) because it was published
`
`on July 24, 2003. Michelson qualifies as prior art under at least 35 U.S.C. § 102(b)
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`because it issued more than one year prior to March 29, 2004. Moret qualifies as
`
`prior art under 35 U.S.C. § 102(a) because it was published on May 29, 2003.
`
`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. the leading end wall,
`
`opposite the proximal or trailing end wall. The
`
`proximal wall is the side or end of the implant that
`
`enters patient last; opposite of the distal wall. Further,
`
`as discussed in detail in Section IV.B., infra, the PTO has previously taken the
`
`position that the apertures (1044) shown in the prior art spinal fusion implant
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`figures reproduced at right are located on the proximal
`
`wall of the implant. The Applicant implicitly acquiesced
`
`to the PTO 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
`
`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
`
`inserter shaft 44 and threaded connector 24. The rotation of the threaded connector
`
`24 will releasably engage the receiving aperture of the spinal fusion implant 10 and
`
`stabilize the insertion instrument 20 relative to the spinal fusion implant 10.”).
`
`3. Extend Generally Perpendicular to Said Longitudinal Length
`
`Under the broadest reasonable construction, this term is construed as
`
`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
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`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.
`
`5. Generally Rectangular and Generally Oblong in Shape
`
`Under the broadest reasonable construction, the
`
`term “generally rectangular and generally oblong in
`
`shape is construed as a shape having portions roughly
`
`approximating sides and being elongated in at least
`
`one dimension. In support of such construction, as discussed in further detail in
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`
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`Section IV.B., infra, the PTO 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.
`
`IV. SUMMARY OF THE ‘156 PATENT
`
`A. Overview of the ‘156 Patent
`
`The application that issued as the ‘156 patent was filed on April 6, 2012, and
`
`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
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`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
`
`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. 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 radiopaque markers oriented generally parallel to height of the implant,
`
`with at least one in the first sidewall, and one in the second sidewall. The ‘156
`
`patent describes the implant as being manufactured from a radiolucent material so
`
`that the markers “will be readily observable under X-ray or fluoroscopy such that a
`
`surgeon may track the progress of the implant 110 during implantation and/or the
`
`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
`
`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
`
`1008 and MSD 1009.
`
`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
`
`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,
`
`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
`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
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`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.
`
`
`
`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.
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`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 1009, at 1010. The
`
`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 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
`
`and distal sides and between the top and bottom surfaces of the implant thereby
`
`separating the fusion apertures of the implant to avoid the rejections based on the
`
`Frey ‘570 patent. See Exhibit MSD 1009, at 1029-30.
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`During prosecution of the ‘156 patent, the claims were amended in
`
`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
`
`content of the prior art drive the obviousness analysis. KSR Int’l Co. v. Teleflex,
`
`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 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,
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`and motivation” or by overemphasis on published articles and explicit content of
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`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.
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`If “a patent ‘simply arranges old elements with each performing the function
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`it had been known to perform’ and yields no more than one would expect from
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`such an arrangement, the combination is obvious.” Id. at 1740. When “design
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`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
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`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
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`function.” Id.
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`V. THE CHALLENGED CLAIMS ARE UNPATENTABLE
`The challenged claims recite spinal fusion implants with features that were
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`well known prior to the earliest possible priority date of the ‘156 patent. See e.g.,
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`Declaration of Richard Hynes, M.D. Regarding U.S. Patent No. 8,361,156
`
`(hereinafter, the “Hynes Decl.”), attached hereto as Exhibit MSD 1001, at ¶ 57. As
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`detailed in claim charts below, prior art reference both anticipate and, alternatively,
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`render obvious the challenged claims of the ‘156 patent.
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`A. Ground 1 – Claims 1-8, 10-14, 19, 20 and 23-27 Are Obvious
`Under § 103 over Frey in View of Baccelli
`
`As shown in the claim chart below, claims 1-8, 10-14, 19, 20, and 23-27 of
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`the ‘156 patent are obvious under 35 U.S.C. § 103 over Frey in view of Baccelli.
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`Both Frey and Baccelli are artificial intervertebral implants used for spinal fusion
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`procedures. Baccelli offers alternative locations and orientations for its
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`radiographic markers to supplement the teachings of Frey, but otherwise a person
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`of skill would be motivated to look to the teachings of Baccelli for information
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`pertaining to such markers and also to various means for interfacing a tool with an
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`implant to be inserted.
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`With respect to Claim 1, Frey (a representative embodiment of Frey implant,
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`Fig. 59, is reproduced below), which was not cited during prosecution of the ‘156
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`patent, discloses a spinal fusion implant having a distal wall, a proximal wall, and
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`two sidewalls, with the walls being at least partly constructed from a radiolucent
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`material. The implant is described for use in various
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`“approaches to the disc space, such as lateral, anterior
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`or antero-lateral approaches” for insertion of implant
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`1400 as well as “for insertion from a poster-lateral or uni-lateral approach into [a]
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`disc space . . . .” Frey, at ¶ [0150]. Additionally, the Frey implant’s longitudinal
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`length is greater than its maximum lateral width. See Hynes Decl., at ¶ 61;
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`Declaration of Steven D. DeRidder Regarding U.S. Patent Application Publication
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`No. 2002/0165550 (“DeRidder Decl.”) (attached hereto as Exhibit MSD 1002), at
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`¶ 7 (noting that Figures 47, 55, 59, 63, 64, and 66 are drawn to scale). The upper
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`and lower surfaces of the Frey implant also contain anti-migration elements that
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`come in contact with the first and second vertebrae. Additionally, the Frey implant
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`contains at least one fusion aperture that extends from the top surface to the bottom
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`surface. Frey discloses that the fusion aperture has a longitudinal length that is
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`greater than the lateral width of the fusion aperture (and would be obvious in view
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`of the teachings of Frey). See Hynes Decl., at ¶ 61
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`Frey also discloses the use of radiopaque markers in its distal and proximal
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`walls and at least one of its sidewalls for radiographic imaging. As in the ‘156
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`patent, Frey teaches the use of such markers for radiographic imaging to determine
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`the location of the implant after insertion into the patient. See Frey, at ¶ [0156]
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`(“A number of radiographic markers 1438 can also be provided in implant 1400 to
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`facilitate X-ray assessment of the locating and positioning of implant 1400 in the
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`patient's body.”).
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`Baccelli, likewise, discloses the use of radiopaque markers with a spinal
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`fusion implant. Baccelli specifically discloses the use of at least first and second
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`radiopaque markers that extend into a first sidewall and a second sidewall at
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`positions proximate to a medial plane of the implant. Like the ‘156 patent,
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`Baccelli explicitly teaches the use of such markers to assist a surgeon in tracking
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`the progress and placement of the implant during and after surgery. See Baccelli,
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`at ¶¶ [0050]-[0051] (“[T]he cage can have one or more markers 47 included therein
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`and serving, because they are opaque to X-rays, to identify the position and/or the
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`presence of the implant when X-rays are taken during or after the operation. . . .
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`The spikes 24 . . . too can be made of a material that is opaque to X-rays.”).
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`Accordingly, it would have been obvious one of ordinary skill in the art at the time
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`of invention to combine the teachings of Baccelli with those of Frey to provide
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`additional information regarding the orientation or location of an implant during
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`surgery and after implantation. Frey and Baccelli are from the same field of
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`artificial implants used in spinal fusion by insertion in the intervertebral disc space
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`and having a space provided in the implant to fill with bone growth promoting
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`substances to enhance the fusion, and both references expressly teach the use of
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`radiographic markers to track the placement of such implants within the patient.
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`See Hynes Decl., at ¶ 62. Thus, a spinal implant incorporating the teachings of
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`these references represents nothing more than an obvious combination of known
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`mechanical elements arranged in a conventional manner in response to a known
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`design incentive to achieve predictable results. See KSR, 550 U.S. at 418.
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`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
`
`Frey discloses a spinal fusion implant of non-bone
`construction positionable within an interbody space between
`a first vertebra and a second vertebra. See, e.g., Frey, at ¶
`[0150] (“Implant 1400 is an interbody fusion device or cage
`that can be packed with bone growth material or other known
`substance and inserted into disc space D1 to promote bony
`fusion between adjacent vertebrae V1 and V2.”); ¶ [0181]
`(“The implants described herein can be made from any
`biocompatible material, including synthetic . . ..”).
`
`Frey provides that the spinal fusion implant has an upper
`surface and a lower surface, both of which contain anti-
`migration elements that contact the first and second vertebra,
`respectively. See Frey, at ¶ [0153] (“Upper bearing surface
`1410 can further be provided with a number of first grooves
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`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]:
`
`
`
`1414 a along anterior wall 1404 and second grooves 1414 b
`along leading and trailing end walls 1406, 1408. Lower
`bearing surface 1412 can be provided with a number of
`grooves 1416 a along anterior wall 1404 and second grooves
`1416 b along leading and trailing end walls 1406, 1408.
`Grooves 1414 a, 1414 b and 1416 a, 1416 b increase
`frictional resistance between the adjacent vertebral endplate
`and the bearing surfaces 1410, 1412 to resist posterior and
`anterior migration of implant 1400 in the disc space.”).
` Upper Surface
`
` Anti-Migration
` Elements
`
`
` Lower Surface
`Frey discloses that the spinal fusion implant has a distal wall
`(leading end wall 1406), a proximal wall (trailing end wall
`1408), a first sidewall (posterior wall 1402) and a second
`sidewall (anterior wall 1404). See ¶ [0151] (“Implant 1400
`includes a body having a leading end portion 1450, a trailing
`end portion 1452, and a middle portion 1454 therebetween.
`A concave posterior wall 1402 and an opposite convex
`anterior wall 1404 extend along middle portion 1454, and
`also along at least part of the corresponding side of leading
`end portion 1450 and trailing end portion 1452. Implant 1400
`further includes an arcuate leading end wall 1406 extending
`along leading end portion 1450 between posterior wall 1402
`and anterior wall 1404. Implant 1400 also includes an
`arcuate trailing end wall 1408 extending along trailing end
`portion 1452 between posterior wall 1402 and anterior wall
`1404.”).
` Second Sidewall
`
`