`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`Attorney Docket No.: 108136.00033
`
`
`
`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
`
`
`
`
`
`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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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC., IPR2019-00362, Ex. 1042, p. 1 of 65
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`TABLE OF CONTENTS
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`I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
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`A. Real Party-in-Interest Under 37 C.F.R. § 42.8(b)(1)
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`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
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`C.
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`Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
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`D.
`
`Service Information
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`II.
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`PAYMENT OF FEES – 37 C.F.R. § 42.103
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`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)
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`B. Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
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`C. Claim Construction under 37 C.F.R. §§ 42.104(b)(3)
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`1
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`1
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`1
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`3
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`3
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`3
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`3
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`3
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`4
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`5
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`5
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`6
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`6
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`7
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`7
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`1.
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`2.
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`3.
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`4.
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`5.
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`6.
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`Distal Wall / Proximal Wall
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`Releasably Mate
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`Extend Generally Perpendicular to Said Longitudinal
`Length
`
`Elongate Body
`
`Generally Rectangular and Generally Oblong in Shape
`
`A Lateral Width of the Distal End of Said Distal Wall/A
`Lateral Width of Said Proximal End of Said Proximal Wall 8
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`7.
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`Oriented Generally Parallel to a Height of the Implant
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`IV. SUMMARY OF THE ‘156 PATENT
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`A. Overview of the ‘156 Patent
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`8
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`8
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`8
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`B.
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`Summary of the Prosecution History of the ‘156 Patent
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`10
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`C.
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`Legal Standard for Obviousness
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`V.
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`THE CHALLENGED CLAIMS ARE UNPATENTABLE
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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
`
`12
`
`13
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`13
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`B. Ground 2 – Claims 1-8, 10-14, 19, 20, and 23-27 Are Obvious
`Under § 103 over Frey in view of Baccelli and Messerli
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`37
`
`C. Ground 3 – Claims 1-14, 19, 20, and 23-27 Are Obvious Under
`§ 103 over Frey in view of Baccelli and 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 Moret
`
`43
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`E. Ground 5 – Claims 1-8, 10-14, 19, 20, and 23-27 Are Obvious
`Under § 103 over Baccelli in view of Frey and/or Michelson
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`VI. CONCLUSION
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`
`
`
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`45
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`60
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`EXHIBITS
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`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
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`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. 8,361,156
`
`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
`
`MSD 1014 – Gray, H., Gray’s Anatomy 489 (Peter L. Williams et al. eds., 37th ed.
`1989)
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC., IPR2019-00362, Ex. 1042, p. 4 of 65
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`Medtronic, Inc. (“Petitioner”) petitions for Inter Partes Review (“IPR”)
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`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). This
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`Petition presents new arguments and provides new evidence to cure any noted
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`deficiencies in Petitioner’s previously filed petition for IPR, now styled Medtronic,
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`Inc. v. NuVasive, Inc., Case No. IPR2013-00504 (LMG) (the “‘504 IPR”). In light
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`of this newly offered information, as set forth below, Petitioner demonstrates there
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`is a reasonable likelihood of prevailing in its challenge of at least one of claims 1-
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`14, 19, 20, and 23-27 identified in this petition as being unpatentable.
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`I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
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`A. Real Party-in-Interest Under 37 C.F.R. § 42.8(b)(1)
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`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.
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`3:12-cv-00438-JD-CAN on August 17, 2012, and transferred to the Southern
`
`
`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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`District of California on November 8, 2012, as case No. 3:12-cv-02738-CAB-
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`MDD. The ‘156 patent was added by counterclaim filed on March 7, 2013.
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`On August 14, 2013, Petitioner filed two Petitions for Inter Partes Review
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`requesting review of claims 1-14, 19, 20, and 23-27 of the ‘156 patent, now styled
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`Medtronic, Inc. v. NuVasive, Inc., Case No. IPR2013-00504 (LMG) (“‘504 IPR”)
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`and Medtronic, Inc. v. NuVasive, Inc., Case No. IPR2013-00506 (LMG) (“‘506
`
`IPR”). The Patent Trial and Appeal Board (“PTAB”) instituted the ‘506 IPR for
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`all of the requested claims. The ‘504 IPR, which contained similar grounds to
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`those included in the present Petition, was denied by the PTAB. In its decision to
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`deny institution of the ‘504 IPR, the PTAB noted that “Medtronic does not explain
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`how the maximum lateral width of the [Frey] implant is along a medial plane that
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`is generally perpendicular to the longitudinal length as required by independent
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`claim 1 [of the ‘156 patent].” Petitioner submits this Petition to provide such
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`explanation. Additionally, Petitioner adds new arguments and evidence as to the
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`length disclosure of U.S. Patent Appl. Pub. No. 2002/0165550 to Frey (“Frey”).
`
`While Petitioner is mindful of 35 U.S.C. § 325(d), the denial of the ‘504
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`Petition has no bearing on this Petition because instead of containing “the same or
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`substantially the same . . . argument previously presented to the Office,” it is
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`responding to a noted deficiency with new argument and new evidence supporting
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`these new arguments to further explain how these previously propounded prior art
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`references render claims 1-14, 19, 20, and 23-27 of the ‘156 patent invalid.
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`Additionally, the grounds presented in this Petition are not redundant to those in
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`the granted ‘506 IPR because those grounds are based on different prior art
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`references and different arguments. Further, the Petition is being filed within the
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`one year time period and the Petitioner has no other avenue to challenge these
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`claims because the rules prohibit new argument in a request for rehearing.
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`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 and service to both counsel listed above.
`
`Petitioner consents to service by email at ipdocket@foxrothschild.com
`
`(referencing Attorney Docket No. 108136.00033).
`
`II. PAYMENT OF FEES – 37 C.F.R. § 42.103
`
`Petitioner authorizes the PTO to charge Deposit Account No. 50-1943 for
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`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)
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`Petitioner certifies the ‘156 patent is eligible for IPR and Petitioner is not
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`barred or estopped from requesting IPR. This petition is filed within one year of
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`service of a counterclaim against Petitioner in district court litigation in which the
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`‘156 patent was asserted.
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`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
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`found unpatentable. A detailed explanation of the statutory grounds for the
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`unpatentability of each claim is provided in the form of claim charts. Additional
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`evidence supporting each ground is provided for in the Declarations of Richard A.
`
`Hynes, M.D. and Steven D. DeRidder, and the appendices attached thereto.
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`Ground Claims
`1
`1-8, 10-14, 19,
`20, and 23-27
`
`2
`
`3
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`4
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`5
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`1-8, 10-14, 19,
`20, and 23-27
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`1-14, 19, 20,
`and 23-27
`
`1-8, 10-14, 19,
`20, and 23-27
`
`1-8, 10-14, 19,
`20, and 23-27
`
`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”) (Exhibit 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 and/or
`Michelson
`
`
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`Frey, Baccelli, and Michelson each qualify as prior art under at least 35
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`U.S.C. § 102(b) because they were published more than one year prior to March
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`29, 2004. Messerli qualifies as prior art under 35 U.S.C. § 102(a) because it was
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`published on July 24, 2003. 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
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`a rejection during prosecution of the ‘156 patent.
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`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
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`understood by their plain and ordinary meanings except where construed in the
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`specification. The broadest reasonable construction is the broadest reasonable
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`interpretation of the claim language. See In re Yamamoto, 740 F.2d 1569, 1572
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`(Fed. Cir. 2004). Consistent with this standard, a proposed interpretation for
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`certain claim terms is provided below.
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`1. Distal Wall / Proximal Wall
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`Under the broadest reasonable construction, the distal wall is the side or end
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`of the implant that generally enters the patient first, i.e. the leading end wall,
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`opposite the proximal or trailing end wall. The proximal
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`wall is the side or end of the implant that enters patient
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`last; opposite of the distal wall. Further, as discussed in
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`detail in Section IV.B., infra, the PTO has previously taken the position that the
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`apertures (1044) shown in the prior art spinal fusion implant figures reproduced at
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`right are located on the proximal wall of the implant. The Applicant implicitly
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`acquiesced to the PTO on its interpretation. Therefore, the
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`broadest reasonable construction of the terms “distal wall”
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`and “proximal wall” include the regions, for example, of
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`the Frey implant disclosed above where apertures 1044 and 1048 are located.
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`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
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`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
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`(“In order to secure the spinal fusion implant 10 onto the threaded connector 24 of
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`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.”).
`
`3. Extend Generally Perpendicular to Said Longitudinal Length
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`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
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`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
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`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
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`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. . . .
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`Ordinary, simple English words whose meaning is clear and unquestionable,
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`absent any indication that their use in a particular context changes their meaning,
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`are construed to mean exactly what they say.”).
`
`4. Elongate Body
`
`Under the broadest reasonable construction, an “elongate body” is construed
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`as a body longer than it is wide. See id.
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`5. Generally Rectangular and Generally Oblong in Shape
`
`Under the broadest reasonable construction, the
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`term “generally rectangular and generally oblong in
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`shape is construed as a shape having portions roughly
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`approximating sides and being elongated in at least
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`one dimension. In support of such construction, as discussed in further detail in
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`Section IV.B., infra, the PTO has previously taken the position that the fusion
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`apertures (1018a, 1018b) shown in the Frey prior art spinal fusion implant figure
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`reproduced above are generally rectangular and elongated in at least one direction.
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`6. A Lateral Width of the Distal End of Said Distal Wall/A
`Lateral Width of Said Proximal End of Said Proximal Wall
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`Under the broadest reasonable construction, these terms are construed as
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`being a width of the most distal end of the distal wall extending in a direction from
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`the first side wall to the second sidewall and a width of the most proximal end of
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`the proximal wall extending in a direction from the first side wall to the second
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`sidewall. See MPEP, Section 2111.01.
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`7. Oriented Generally Parallel to a Height of the Implant
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`Under the broadest reasonable construction, this term is construed as being
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`oriented generally or roughly along the Y-axis (up and down) or oriented generally
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`or roughly in a direction running from the top to the bottom. See id.
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`IV. SUMMARY OF THE ‘156 PATENT
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`A. Overview of the ‘156 Patent
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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, filed on April 5, 2012, which is a
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`continuation of U.S. Patent No. 8,187,334, filed on April 4, 2011, which is a
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`continuation of 7,918,891 (the “‘891 patent”), filed on March 29, 2005, which
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`claims the benefit U.S. Prov. Appl. Ser. No. 60/557,536, filed on March 29, 2004.
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`The ‘156 patent is directed to a spinal fusion implant of non-bone
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`construction that is positionable in the interbody space between first and second
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`vertebrae. See, e.g., ‘156 patent, 1:66 to 2:2. As described and claimed, the
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`implant of the ‘156 patent has a distal wall, a proximal wall, and two sidewalls,
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`with the walls being at least partly constructed from a radiolucent material. The
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`length of the implant extending from the proximal wall to the distal wall is greater
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`than the maximum width of the implant, as defined by greatest distance between
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`the two sidewalls along a medial plane of the implant. The upper and lower
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`surfaces of the implant contain anti-migration elements that come in contact with
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`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
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`implant. The claimed implant also contains at least two radiopaque markers
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`oriented generally parallel to height of the implant, with at least one in the first
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`sidewall, and one in the second sidewall. The ‘156 patent describes the implant as
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`being manufactured from a radiolucent material so that the markers “will be
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`readily observable under X-ray or fluoroscopy such that a surgeon may track the
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`progress of the implant 110 during implantation and/or the placement of the
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`implant 110 after implantation.” ‘156 patent, 10:2-9. The ‘156 patent does not
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`discuss whether or how the size, shape, location, or orientation of the markers is
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`critical to, or otherwise may affect the ability of the surgeon to track the progress
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`or placement of the implant.
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`B.
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`Summary of the Prosecution History of the ‘156 Patent
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`The prosecution histories of the ‘156 patent, and of its parent patent, the
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`“‘891 patent”, as obtained from PAIR, are submitted herewith as Exhibits MSD
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`1008 and MSD 1009.
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`The parent ‘891 patent, like the continued ‘156 patent, has claims directed to
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`a spinal fusion implant of non-bone construction. The ‘891 patent issued from
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`U.S. Pat. Appl. Ser. No. 11/093,409 (the “‘409 application”), which was filed with
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`two independent claims (Claims 1 and 14) and twenty-four dependent claims
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`(Claims 2-13 and 15-26). During prosecution of the ‘409 application, Applicants
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`amended the claims to recite limitations that are similar to the limitations currently
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`found in the ‘156 patent. For example, Claim 1 was amended to include the
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`limitation that “the length is so dimensioned as to extend between lateral aspects of
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`said interbody space and is at least two and a half times greater than said width;”
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`Claim 5 was amended to recite that the “first and second fusion apertures are one
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`of generally rectangular and oblong in shape;” and new Claims 31-33 were added
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`and were directed to a threaded receiving aperture “at least partial defined along
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`said proximal side” of the implant. See MSD 1009, at 996-998.
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`In an Office Action dated August 27, 2009, the PTO rejected these claims.
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`In support of these rejections, the PTO cited U.S. Patent No. 6,830,570 to Frey (the
`
`“‘570 patent”) as disclosing, inter alia, first and second fusion apertures (1018a,
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`1018b) that are “generally rectangular and oblong in shape.” Id. at 1010. The PTO
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`also cited the ‘570 patent as disclosing a threaded receiving element (1044) on the
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`proximal side of the implant that engages with an insertion instrument. See id.
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`With respect to the limitation regarding the proportional relationship
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`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
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`invention was made to have the length be at least two and a half times greater than
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`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
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`Boesch, 617 F.2d 272 (CCPA 1980)).
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` The Applicants did not argue past these rejections, but instead amended the
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`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 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.
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC., IPR2019-00362, Ex. 1042, p. 15 of 65
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`
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`C. Legal Standard for Obviousness
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`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
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`combination of familiar elements according to known methods is likely to be
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`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,
`
`and motivation” or by overemphasis on published articles and explicit content of
`
`issued patents. Id. Courts should apply common sense, recognizing that “familiar
`
`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
`
`like pieces of a puzzle.” Id. at 1742.
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`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
`
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC., IPR2019-00362, Ex. 1042, p. 16 of 65
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`
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`
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`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
`
`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 MSD 1001, at ¶ 59. As
`
`detailed in claim charts below, prior art references render obvious the challenged
`
`claims of the ‘156 patent.
`
`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
`
`the ‘156 patent are obvious under 35 U.S.C. § 103 over Frey in view of Baccelli.
`
`Both Frey and Baccelli are artificial intervertebral implants used for spinal fusion
`
`procedures. Baccelli offers alternative locations and orientations for its
`
`radiographic markers to supplement the teachings of Frey, but otherwise a person
`
`of skill would be motivated to look to the teachings of Baccelli for information
`
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC., IPR2019-00362, Ex. 1042, p. 17 of 65
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`
`
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`pertaining to such markers and also to various means for interfacing a tool with an
`
`implant to be inserted.
`
`With respect to Claim 1, Frey, 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. The implant is described for use in various “approaches to
`
`the disc space, such as lateral, anterior or antero-lateral approaches” for insertion
`
`of implant 1400 as well as “for insertion from a postero-lateral or uni-lateral
`
`approach into [a] disc space . . . .” Frey, at ¶ [0150]. The curvatures of the
`
`opposing sidewalls are generally the same so the maximum lateral width of the
`
`implant, as measured from sidewall to sidewall in a direction perpendicular to that
`
`of the longitudinal length of the implant, is located at least at and near the exact
`
`center of the middle portion, including a medial plane of the implant, as well as
`
`along the other areas of the middle portion where the opposing sidewalls maintain
`
`generally the same curve. See Hynes Decl., at ¶ 38; Declaration of Steven D.
`
`DeRidder Regarding U.S. Patent Application Publication No. 2002/0165550
`
`(“DeRidder Decl.”) (attached hereto as Exhibit MSD 1002), at ¶ 10.
`
`To the extent that Frey does not explicitly teach that the lateral width is
`
`largest in the precise center of the implant, a person of ordinary skill in the art
`
`would find it obvious to provide approximately the same width along the middle
`
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC., IPR2019-00362, Ex. 1042, p. 18 of 65
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`
`
`
`
`portion of the implant for ease of manufacture and to allow for easy insertion of the
`
`device during implantation. See Hynes Decl., at ¶ 38. Additionally, it would have
`
`been obvious to include the maximum lateral width in the middle portion of the
`
`implant to better fill the disc space, thus providing optimal load support capacity.
`
`See Frey, at ¶ [0149] (“The shape and location of the bars, struts and walls
`
`positions the load bearing members at the strong bony surfaces of the vertebral
`
`endplates to provide maximum load support capacity and avoid implant subsidence
`
`into the vertebral endplates.”); Hynes Decl., at ¶ 38; DeRidder Decl., at ¶ 11.
`
`Under either scenario, because the middle portion of the implant encompasses a
`
`medial plane of the implant – i.e., a plane at or towards the middle of the implant –
`
`the maximum lateral width is necessarily found along this medial plane. Frey
`
`further discloses that its implant’s longitudinal length is greater than the maximum
`
`lateral width along the medial plane. See Hynes Decl., at ¶¶ 38 and 63; DeRidder
`
`Decl., at ¶¶ 7-9 (noting that Figs. 47, 55, 59, 63, 64 and 66 are drawn to scale).
`
`The upper and lower surfaces of the Frey implant contain anti-migration
`
`elements that come in contact with the first and second vertebrae. Additionally,
`
`the Frey implant discloses and makes obvious the inclusion of at least one fusion
`
`aperture that extends from the top surface to the bottom surface and has a
`
`longitudinal length that is greater than its lateral width. See Hynes Decl., at ¶ 63.
`
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC., IPR2019-00362, Ex. 1042, p. 19 of 65
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`
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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
`
`patent, Frey teaches the use of such markers for radiographic imaging to determine
`
`the location of the implant after insertion into the patient. See Frey, at ¶ [0156]
`
`(“A number of radiographic markers 1438 can also be provided in implant 1400 to
`
`facilitate X-ray assessment of the locating and positioning of implant 1400 in the
`
`patient's body.”).
`
`Baccelli, likewise, discloses the use of radiopaque markers with a spinal
`
`fusion implant. 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. Like the ‘156 patent,
`
`Baccelli explicitly teaches the use of such markers to assist a surgeon in tracking
`
`the progress and placement of the 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 when X-rays are taken during or after the operation. . . .
`
`The spikes 24 . . . too can be made of a material that is opaque to X-rays.”).
`
`Accordingly, it would have been obvious one of ordinary skill in the art at the time
`
`of invention to combine the teachings of Baccelli with those of Frey to provide
`
`additional information regarding the orientation or location of an implant during
`
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC., IPR2019-00362, Ex. 1042, p. 20 of 65
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`
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`surgery and after implantation. Frey and Baccelli are from the same field of
`
`artificial implants used in spinal fusion by insertion in the intervertebral disc space
`
`and having a space provided in the implant to fill with bone growth promoting
`
`substances to enhance the fusion, and both references expressly teach the use of
`
`radiographic markers to track the placement of such implants within the patient.
`
`See Hynes Decl., at ¶ 64. Thus, a spinal implant incorporating the teachings of
`
`these references represents nothing more than an obvious combination of known
`
`mechanical elements arranged in a conventional manner in response to a known
`
`design incentive to achieve predictable results. See KSR, 550 U.S. at 418.
`
`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
`
`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, incl
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