IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of: Michelson
`U.S. Patent No.: 8,444,696 Attorney Docket No.: 13958-0113IP2
`Issue Date:
`May 21, 2013
`Appl. Serial No.: 13/235,998
`Filing Date:
`September 19, 2011
`Title: ANATOMIC SPINAL IMPLANT HAVING ANATOMIC BEARING SURFACES
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`PETITION FOR INTER PARTES REVIEW OF UNITED STATES PATENT NO. 8,444,696
`PURSUANT TO 35 U.S.C. §§ 311–319, 37 C.F.R. § 42
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`

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`TABLE OF CONTENTS
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`MANDATORY NOTICES UNDER 37 C.F.R § 42.8 .................................................... 1 
`A.  Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) ........................................... 1 
`B.  Related Matters Under 37 C.F.R. § 42.8(b)(2) .................................................... 1 
`C.  Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) ................................ 1 
`D.  Service Information ............................................................................................. 2 
`PAYMENT OF FEES – 37 C.F.R. § 42.103 ................................................................ 2 
`REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104 .......................................... 2 
`A.  Grounds for Standing Under 37 C.F.R. § 42.104(a) .......................................... 2 
`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) ........................................ 3 
`SUMMARY OF THE `696 PATENT ............................................................................ 4 
`A.  Brief Description .................................................................................................. 4 
`B.  Summary of the Original Prosecution and Inter Partes Reexamination
`of the Related U.S. Patent No. 8,021,430 ........................................................... 5 
`C.  Summary of the Original Prosecution on the ‘696 Patent (Serial No.
`13/225,998) ............................................................................................................ 6 
`THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE CLAIM
`OF THE `696 PATENT IS UNPATENTABLE ............................................................. 8 
`[GROUND 1 CLAIM CHARTS] – Obviousness of Claims 7-8 and 10-11
`under §103 by Tropiano in view of Michelson ‘247 and Brantigan ‘035 ............ 15 
`[GROUND 2 CLAIM CHARTS] – Obviousness of Claims 9 and 12 under
`§103 by Tropiano in view of Michelson ‘247, Brantigan ‘035, and Beckers ...... 29 
`[GROUND 3 CLAIM CHARTS] – Obviousness of Claims 7-12 under §103
`by Beckers in view of Michelson ‘247 and Brantigan ‘035 .................................. 30 
`[GROUND 4 CLAIM CHARTS] – Obviousness of Claims 7-12 under §103
`by Steffee in view of Michelson ‘037 and Kim ...................................................... 45 
`CONCLUSION .......................................................................................................... 60 
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`I. 
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`II. 
`III. 
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`IV. 
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`V. 
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`VI. 
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`VII. 
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`VIII. 
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`IX. 
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`X. 
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`i
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`

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`EXHIBITS
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`Declaration of Dr. John W. Brantigan, M.D.
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`U.S. Patent No. 8,444,696 to Michelson (“the ‘696 patent”)
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`Select Prosecution History of the ‘696 patent (Serial No.
`13/235,998)
`U.S. Pat. No. 5,607,424 to Tropiano (“Tropiano”)
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`U.S. Pat. No. 5,015,247 to Michelson (“Michelson ‘247”)
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`PCT Pub. No. WO89/009035 to Brantigan (“Brantigan ‘035”)
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`PCT Pub. No. WO95/008306 to Beckers and certified English
`translation thereof (“Beckers”)
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`U.S. Pat. No. 5,443,514 to Steffee (“Steffee”)
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`PCT Pub. No. 90/00037 to Michelson (“Michelson ‘037”)
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`U.S. Patent No. 5,645,596 to Kim et al. (“Kim”)
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`Select prosecution history of inter partes reexamination pro-
`ceedings on U.S. Patent No. 8,021,430 (Control No.
`95/002,380)
`Plaintiffs’ Disclosure of Asserted Claims and Infringement Con-
`tentions re U.S. Patent No. 8,444,696, from Warsaw Orthope-
`dic, Inc. et al. v. NuVasive, S.D. Cal., Case No. 3:12-cv-02738-
`CAB (MDD)
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`NUVASIVE1101
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`NUVASIVE1102
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`NUVASIVE1103
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`NUVASIVE1104
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`NUVASIVE1105
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`NUVASIVE1106
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`NUVASIVE1107
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`NUVASIVE1108
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`NUVASIVE1109
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`NUVASIVE1110
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`NUVASIVE1111
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`NUVASIVE1112
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`ii
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`

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`NuVasive, Inc. (“Petitioner”) petitions for Inter Partes Review (“IPR”) under 35 U.S.C.
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`§§ 311–319 of claims 7-12 of the `696 patent, and below demonstrates there is a reasona-
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`ble likelihood of prevailing (“RLP”) in its validity challenge against at least one claim.
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`I.
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`
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`MANDATORY NOTICES UNDER 37 C.F.R § 42.8
`A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`NuVasive, Inc. is the real party-in-interest for this Petition.
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`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`Petitioner is not aware of any reexamination certificate for the ‘696 patent; there is a
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`certificate of correction. Petitioner is concurrently filing another IPR petition for claims 1-6 of
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`the ‘696 patent. A parent patent (US 8,021,430) is engaged in inter partes reexamination in
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`which all claims stand rejected in a Right of Appeal Notice. See NUVASIVE1110. The Pa-
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`tent Owner has asked the Court for permission to add the ‘696 patent in an ongoing patent
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`lawsuit against the Petitioner (Warsaw Orthopedic, Inc. et al. v. NuVasive, Inc., S.D. Cal.,
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`Case No. 3:12-cv-02738-CAB (MDD)), but the Patent Owner’s request remains pending and
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`the ‘696 patent has not yet been added to the lawsuit.
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`C. Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`Petitioner provides the following designation of counsel.
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`LEAD COUNSEL
`Stephen R. Schaefer, Reg. No. 37,927
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 612-337-2508 / Fax: 612-288-9696
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`BACK-UP COUNSEL
`Michael T. Hawkins, Reg. No. 57,867
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 612-337-2569 / Fax: 612-288-9696
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`1
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`

`

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`D. Service Information
`Please address all correspondence and service to the address of both counsel listed
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`above. Petitioner also consents to electronic service by email at APSI@fr.com (referencing
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`No. 13958-0113IP2 and cc’ing schaefer@fr.com and hawkins@fr.com).
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`II.
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`PAYMENT OF FEES – 37 C.F.R. § 42.103
`Petitioner authorizes the Patent and Trademark Office to charge Deposit Account
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`No. 06-1050 for the petition fee set in 37 C.F.R. § 42.15(a) and for any other required fees.
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`III.
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`REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`Petitioner certifies that the `696 patent is eligible for IPR and that Petitioner is not
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`barred or estopped from requesting IPR.
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`B. Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
`Petitioner requests IPR of claims 7-12 of the `696 patent on the grounds listed in the
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`table below. In support, this Petition includes claim charts for each of these grounds and a
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`supporting evidentiary declaration of Dr. John W. Brantigan, M.D. (NUVASIVE1001).
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`Ground
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`1
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`2
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`3
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`4
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``696
`Claims
`7-8 and
`Obvious under § 103 by Tropiano in view of Michelson ‘247 and
`10-11
`Brantigan ‘035
`9 and 12 Obvious under § 103 by Tropiano in view of Michelson ‘247, Branti-
`gan ‘035, and Beckers
`Obvious under § 103 by Beckers in view of Michelson ‘247 and
`Brantigan ‘035
`Obvious under § 103 by Steffee in view of Michelson ‘037 and Kim
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`7-12
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`7-12
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`Basis for Rejection
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`2
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`

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`Assuming entitlement to the earliest claimed priority, June 7, 1995, Beckers is prior art un-
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`der at least §102(a), and Tropiano, Steffee and Kim qualify under at least §102(e); all other
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`references above were published more than a year before the earliest priority and thus qual-
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`ify under §102(b). Tropiano, Michelson ‘247, Beckers, Steffee, and Kim were of record in
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`the original prosecution; Brantigan ‘035 and Michelson ‘037 were not. Although Patent
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`Owner submitted, in an IDS after allowance, invalidity claim charts prepared by Petitioner
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`(NUVASIVE1111), those claim chart grounds were significantly different from the grounds in
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`this Petition and were not considered in light of the pertinent evidence submitted in this IPR.
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`C. Claim Construction under 37 C.F.R. §§ 42.104(b)(3)
`Petitioner submits that, for purposes of this IPR, all claim terms should be given their
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`plain meaning under the proper broadest reasonable construction standard, and provides
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`the following specific constructions for terms where the plain meaning may not be not entire-
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`ly clear. First, for purposes of this IPR, the phrase “substantially flat” in relation to the
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`“first side” and the “second side” of the implant (claims 7 and 10) is interpreted to include
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`sides that are either planar or outwardly bowed. See NUVASIVE1101 at ¶13. While the
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`‘696 patent discloses only implants with planar sides (see FIGS. 1-32), Patent Owner’s in-
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`fringement allegations against Petitioner’s implants with outwardly bowed sides, as well as
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`the non-quantified “substantially” modifier used in the claim, forces this construction. See
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`NUVASIVE1112 at Ex. A, pp. 6-8; NUVASIVE1101 at ¶ 13. Second, the phrase “upper
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`and lower bearing surfaces … being convex along the entire length of said upper and
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`3
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`

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`lower bearing surfaces” (claims 1 and 4) does not require that the claimed convexity be
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`present along the entire length of the implant (or in other words, from the implant’s “trailing
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`face” to its “insertion face”), although that configuration also is within the scope of the
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`claims. Instead, the claimed convexity, as recited, need only be “along the entire length of
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`said upper and lower bearing surfaces.” Indeed, both independent claims 7 and 10 de-
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`fine “a length” for the “upper and lower bearing surfaces” (see claim 7, col. 15:51-53), and
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`separately define a different “length” for the overall implant that is “between said trailing
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`face and … said insertion face” (see claim 7, col. 15: 24-25). In addition, claims 1 and 4
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`recite four more “bearing surfaces” – first, second, third and fourth bearing surfaces (also
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`labeled in FIGS. 13-14) – that are on the end-parts of the implant, namely, on the “first ter-
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`minal part” and the “second terminal part.” As such, the claimed “upper and lower bearing
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`surfaces” may include only the bearing surface portions that are entirely between the first
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`and second terminal parts (i.e., including only the region between the two vertical lines in
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`FIGS. 13-14).
`
`IV.
`
`SUMMARY OF THE `696 PATENT
`A. Brief Description
`Spinal fusion implants like those described in the ‘696 patent were invented in the
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`early 1980’s. See NUVASIVE1101 at ¶¶ 6-7. Claims 7-12, the subject of this IPR, describe
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`a spinal implant that is “adapted to be inserted . . . and then rotated ninety degrees into an
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`upright position.” The “insert-and-rotate” technique was well known before the ‘696 patent,
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`4
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`

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`as evidenced by Tropiano, Beckers, and Steffee. See also NUVASIVE1101 at ¶ 11.
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`The two independent claims 7 and 10 at issue here have cobbled-together features
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`not found in any one embodiment of the ‘696 patent. For example, claims 7 and 10 define
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`upper and lower bearing surfaces that are “convex” (outwardly bowing), a feature present
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`only in FIGS. 13-17. Other recited features are absent from FIGS. 13-17, and only present
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`in implants with upper/lower bearing surfaces that are flat. For example, the claimed inser-
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`tion tool engagement mechanism (i.e., the claimed “recessed portion”/“threaded opening”) is
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`only in the implants of FIGS. 18-29, and the claimed “ratchetings” are only in the implant of
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`FIGS. 8-12. Patent Owner’s picking and choosing features from different embodiments of
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`the ‘696 patent and cobbling them together in a single claim indeed highlights the “design
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`option well within the skill of the art” nature of the features included in the claims.
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`B. Summary of the Original Prosecution and Inter Partes Reexamination of the
`Related U.S. Patent No. 8,021,430
`The relevant prosecution history begins with the immediate parent, the ‘430 patent,
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`which attempted to broadly claim an implant design with “convex” upper and lower bearing
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`surfaces, as shown in FIG. 14. The original examiner allowed the ’430 claims over the cited
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`art in a first action that gave no reasons for allowance, and was subject only to an obvious-
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`ness-type double patenting rejection over an earlier family member. On Aug. 17, 2012, Pa-
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`tent Owner filed a lawsuit against Petitioner, alleging infringement of the ‘430 patent by Peti-
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`tioner’s implants that had been on the market five years before the ‘430 patent issued.
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`In response, Petitioner sought inter partes reexamination of the ‘430 patent, and, on
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`5
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`

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`Nov. 29, 2012, the Central Reexamination Unit (“CRU”) rejected all claims on seven sepa-
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`rate and independent grounds, including four anticipation grounds based on prior art that
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`was of record in the original prosecution and thus presumably considered by the original
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`examiner. The Patent Owner responded on Feb. 19, 2013, abandoning its defense of the
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`“convex” claims, and submitting narrowing amendments to include well-known implant fea-
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`tures described in the prior art Michelson ‘037. The CRU issued an action closing prosecu-
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`tion (“ACP”) and right of appeal notice (“RAN”) rejecting the amended claims (and indeed all
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`pending claims) as obvious over the “convex” implant prior art, in view of Michelson ‘037.
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`C. Summary of the Original Prosecution on the ‘696 Patent
`(Serial No. 13/225,998)
`It was “déjà vu all over again” in the ‘696 patent’s prosecution. Initially in the ‘696
`
`prosecution, the Patent Owner advanced claims that, like the ‘430 patent, were directed to a
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`“convex” implant design. On Dec. 7, 2012 (eight days after the CRU rejected the ‘430 “con-
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`vex” claims), the ‘696 patent’s examiner (the same examiner from the ‘430 patent’s original
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`prosecution) allowed the claims in a first action that was strikingly similar to the first action in
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`the ‘430 patent prosecution; he allowed the claims giving no reasons for allowance, subject
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`only to an obviousness-type double patenting obviousness rejection based on the ‘430 pa-
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`tent and another family member. Notably, the examiner at that time gave no indication he
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`knew about the CRU’s recent rejection of all of the ‘430 patent in the reexamination.
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`On Feb. 25, 2013, six days after the Patent Owner’s extensive amendments in the
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`‘430 reexamination abandoning any defense of the original ‘430 “convex” claims, the Patent
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`6
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`

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`Owner in the ‘696 prosecution amended the previously allowed claim 1 (which became is-
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`sued claim 1), canceled claims 2-20, added new claims 21-38 (which became issued claims
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`2-19), and made further specification amendments. The claim amendments to the ‘696
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`claims kept the “convex” implant design, and, just as the Patent Owner had done in the ‘430
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`reexamination amendment, added various implant features that were all well known in the
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`art (including in Michelson ‘037). At the same time, the Patent Owner filed a terminal dis-
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`claimer to overcome the obviousness-type double patenting rejection over the ‘430 claims,
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`and submitted an IDS that provided copies of two papers from the ‘430 reexamination.
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`Thereafter, on March 27, 2013, the examiner allowed the ‘696 claims as amended
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`(again providing no reasons for allowance), accepted the terminal disclaimer, and noted his
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`consideration of the IDS that had included the ‘430 reexamination materials. Shortly there-
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`after (Apr. 5, 2013), the Patent Owner submitted another IDS, providing a copy of invalidity
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`claim charts for the allowed ‘696 claims that the Petitioner had recently prepared. On Apr.
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`19, 2013, the examiner made an entry that the IDS had been considered, although made no
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`substantive comment on these materials. On the next business day, the Patent Owner paid
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`the issue fee. After that, on Apr. 30, 2013, the examiner made a brief comment on the rec-
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`ord, stating, in effect, that the invalidity claim charts from the ‘430 patent reexamination
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`were considered but not enough to pull this case from issue. Although the examiner made
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`general reference to Patent Owner’s Feb. 25, 2013 claim amendments, he again provided
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`no substantive reasons for allowance, and nothing in the record indicates what claim limita-
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`7
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`

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`tions in the allowed claims were different from the prior art. The ‘696 issued thereafter.
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`V.
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`THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE CLAIM OF THE
``696 PATENT IS UNPATENTABLE
`As detailed below and in the following claim charts, three different obviousness
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`grounds (1, 3 and 4) show that independent claims 7 and 10 are unpatentable, and merely a
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`combination of “prior art elements according to known methods to yield predictable results”
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`and/or the “[u]se of known technique[s] to improve similar devices . . . in the same way.”
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`MPEP § 2143(A) and (C). These three obviousness grounds are not cumulative, but in-
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`stead all rely upon different primary references that individually disclose unique benefits to
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`the patient, the practitioner, or both. Here, there is a reasonable likelihood that at least one
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`claim of the ‘696 patent is unpatentable.
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`Referring to Ground 1 (charted below), Tropiano discloses an implant having “an ar-
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`cuate structure that will stabilize the adjacent vertebrae” and that has openings to “contain a
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`large amount of bone graft.” NUVASIVE1104 at 2:22-42; 3:45-50; FIGS. 1-3. Tropiano dis-
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`closes nearly all of the implant structures recited in claims 7 and 10, including the claimed
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`“first terminal part,” “second terminal part,” “first side and an opposite second side” with “in-
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`sert” and “rotate” capability, the “opening . . . for the growth of bone,” and “upper and lower
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`bearing surfaces” with the required “converging angular relationship [wedge shape]”:
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`8
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`

`

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`Id. at FIGS. 1-3; see also cols. 3-4; NUVASIVE1101 at ¶¶ 16-19 & 22-25.
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`
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`To the extent Tropiano does not describe the claimed features of (i) a “trailing face
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`having a recessed portion intersecting each of said first and second sides,” or (ii) “ratchet-
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`ings on each of said upper and lower bearing surfaces,” such traditional structures were
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`widely known in similar spinal implants. For example, regarding the “recessed portion,” Mi-
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`chelson ‘247 describes a similar spinal fusion implant and plainly teaches the well-known
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`option for equipping spinal fusion implants with a recessed portion in the trailing face so as
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`to mate with an inserter tool:
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`NUVASIVE1105 at FIG. 4; col. 8:52 to col. 9:3; 10:15-17. As described in the charts below,
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`a skilled artisan would have been prompted to modify Tropiano’s spinal fusion implant to
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`include this ordinary design option taught by Michelson ‘247 so as to achieve the known
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`9
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`

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`advantages (described below) associated with such mating
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`structures. NUVASIVE1104 at FIG. 3 (modified at right to in-
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`clude a traditional option suggested by Michelson ‘247); see al-
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`so NUVASIVE1101 at ¶¶ 20-21.
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`Regarding the “ratchetings,” Brantigan ‘035 also describes a similar spinal fusion im-
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`plant and illustrates the well-known option for
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`equipping spinal fusion implants with “ratchet-
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`ings” on the upper and lower bearing surfac-
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`es. NUVASIVE1106 at FIGS. 18-19 (FIG. 18
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`shown at right); pp. 19-21. As described in
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`the charts below, a person of ordinary skill in the art would have been prompted to modify
`
`the combination of Tropiano and Michelson ‘247 to include this conventional design option
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`taught by Brantigan ‘035 so as to achieve the known advantages (expressly detailed below)
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`associated with such ratchetings:
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`NUVASIVE1104 at FIG. 3 (modified above to include traditional options suggested by Mi-
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`chelson ‘247 and Brantigan ‘035); see also NUVASIVE1101 at ¶¶ 26-27. As such, there is
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`10
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`

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`a reasonable likelihood that independent claims 7 and 10 of the `696 patent are unpatenta-
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`ble based upon Tropiano in view of Michelson ‘247 and Brantigan ‘035.
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`Referring to Ground 3 (charted below), Beckers also discloses nearly all limitations
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`of independent claims 7 and 10. For example, Beckers discloses “an implant for the inter-
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`vertebral space,” which is intended to be “filled with bone graft material 24.” See NUVA-
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`SIVE1107 at pp. 2 and 10-11; FIG. 8. Becker’s implant 6 provides the claimed “first terminal
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`part,” “second terminal part,” “first side and an opposite second side,” “opening . . . to permit
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`for the growth of bone,” and “upper and lower bearing surfaces”:
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`Id. at FIGS. 7-8; NUVASIVE1101 at ¶¶ 31-33 & 36-38.
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`
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`To the extent Beckers does not expressly describe the claimed features of (i) the
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`trailing face having “a recessed portion intersecting each of said first and second sides,” or
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`(ii) the “ratchetings” (even though Beckers arguably discloses “ratchetings”), such traditional
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`structures were widely known in conventional spinal implants. Again, as discussed above,
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`these features are taught by Michelson ‘247 and Brantigan ‘035. As described in the charts
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`11
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`

`

`below, a skilled artisan would have been prompted to modify the combination of Beckers to
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`include the conventional design options taught by Michelson ‘247 (“recessed portion” for in-
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`serter tool) and Brantigan ‘035 (“ratchetings”) so as to achieve the known advantages (de-
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`tailed below) associated with such structures:
`
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`NUVASIVE1107 at FIG. 8 (modified above to include traditional options suggested by Mi-
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`chelson ‘247 and Brantigan); see also NUVASIVE1101 at ¶¶ 34-35 & 39-40. As such, there
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`is a reasonable likelihood that claims 7 and 10 of the ‘696 patent are unpatentable based
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`upon Beckers in view of Michelson ‘247 and Brantigan ‘035.
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`Referring to Ground 4 (charted below), Steffee also discloses or suggests nearly all
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`limitations of independent claims 7 and 10. For example, Steffee’s “insert-and-rotate” im-
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`plant provides the claimed “first terminal part,” “second terminal part,” “first side and an op-
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`posite second side,” “opening . . . to permit for the growth of bone,” “upper and lower bear-
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`ing surfaces . . . disposed in a converging angular relationship,” and “ratchetings”:
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`12
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`

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`
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`See NUVASIVE1108 at FIG. 2; NUVASIVE1101 at ¶¶ 41-44 & 47.
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`To the extent Steffee does not expressly describe the claimed features of (i) the
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`“trailing face having a recessed portion intersecting each of said first and second sides,” or
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`(ii) the upper and lower bearing surfaces being “convex,” such traditional structures were
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`widely known in the prior art. For example, Michelson ‘037 describes a similar spinal fusion
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`implant and teaches the traditional design choice for equipping the implant with a “recessed
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`portion” 24 in the trailing face so as to mate with an
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`inserter tool. NUVASIVE1109 at p. 11; FIGS. 1
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`and 5 (at right, also showing the traditional option
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`for bone growth openings through the bearings
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`surfaces).
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`As described in the charts below, a person of ordinary skill in the art would have
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`been prompted to modify the combination of Steffee to include this conventional design op-
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`tions taught by Michelson ‘037 (“recessed portion” for inserter tool) so as to achieve the
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`known advantages (expressly detailed below) associated with such structures. NUVA-
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`13
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`

`

`SIVE1101 at ¶¶ 45-46. Here, a skilled artisan would recognize that Michelson ‘037 sug-
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`gests the recessed portion intersects the particular sides that face toward the vertebrae dur-
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`ing the insertion step, so the resulting combination of Steffee in view of Michelson ‘037
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`would likewise provide such an orientation for the recessed portion (also suggested by the
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`orientation of Steffee’s inserter tool). NUVA-
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`SIVE1101 at ¶ 46; NUVASIVE1108 at FIG. 2
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`(modified at right to show the recessed por-
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`tion/ hole suggested by Michelson ‘037).
`
`Regarding the claim “convex” upper and lower bearing surfaces, the prior art in-
`
`cludes numerous teachings that it was a common design option for bearing surfaces to be
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`“convex” as claimed. See NUVASIVE1101 at ¶ 10. For example, Kim discloses the known
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`configuration in which the upper and lower bearings surfaces are “convex” so as to corre-
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`spond with the “concave contact surfaces” of the vertebrae. NUVASIVE1110 at 2:28-37;
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`5:61; FIGS. 4 and 2 (below).
`
`
`A skilled artisan would have been prompted to modify Steffee’s implant 10 to provide a con-
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`vex curvature along the length of the upper and lower bearing surfaces (suggested by Kim)
`
`for the specific advantages described by Kim (detailed below) and known in the prior art:
`
`14
`
`

`

`
`NUVASIVE1108 at FIG. 2 (modified in view of Michelson ‘037 (described above) and fur-
`
`thermore to show the convexity of the upper and lower bearing surfaces as suggested by
`
`Kim); see also NUVASIVE1101 at ¶¶ 49-50. As such, there is a reasonable likelihood that
`
`independent claims 7 and 10 of the ‘696 patent are unpatentable based upon Steffee in
`
`view of Michelson ‘037 and Kim.
`
`VI.
`
`[GROUND 1 CLAIM CHARTS] – Obviousness of Claims 7-8 and 10-11 under
`§103 by Tropiano in view of Michelson ‘247 and Brantigan ‘035
`U.S. Pat. 8,444,696
`Tropiano in view of Michelson ‘247 and Brantigan ‘035
`Tropiano discloses a lordotic spinal fusion implant for insertion
`7. A lordotic spinal fusion
`between first and second vertebrae as recited in the preamble.
`implant for insertion be-
`For example, Tropiano discloses an implant design to provide
`tween a first vertebra and
`“fusion between adjacent vertebrae” that is “open enough to
`a second vertebra adja-
`contain a large amount of bone graft.” NUVASIVE1104 at col.
`cent the first vertebra, the
`2:32-38; cols. 3-4; Abstract.
`first vertebra having a
`generally vertically ex-
`tending first peripheral
`wall and a first end plate
`and the second vertebra
`having a generally verti-
`cally extending second
`peripheral wall and a se-
`cond endplate, wherein
`the implant comprises:
`
`
`Id. at FIG. 5 (modified to show the implant of FIG. 2). See also
`
`15
`
`

`

`generally NUVASIVE1101 at ¶¶ 16-27.
`Tropiano discloses the claimed first terminal part.
`
`Id. at FIG. 2
`
`
`
`Tropiano discloses the claimed second terminal part.
`
`Id. at FIG. 2.
`Tropiano’s implant provides these claimed features, including
`the longitudinal axis, first plane, second plane, length, width,
`and height.
`
`
`
`a first terminal part defin-
`ing a trailing face, a first
`bearing surface adapted
`to bear against a portion
`of the first end plate, and
`an opposite second bear-
`ing surface adapted to
`bear against a portion of
`the second end plate, said
`trailing face extending be-
`tween said first bearing
`surface and second bear-
`ing surface;
`a second terminal part
`opposite said first terminal
`part, said second terminal
`part having an insertion
`face extending between a
`third bearing surface and
`a fourth bearing surface,
`
`said implant having a lon-
`gitudinal axis extending
`through said trailing face
`of said first terminal part
`and said insertion face of
`said second terminal part,
`and having a cross sec-
`tion in a first plane ex-
`tending through said first
`bearing surface and said
`second bearing surface,
`and along the longitudinal
`
`16
`
`

`

`axis, said implant having
`a length between said
`trailing face of said first
`terminal part and said in-
`sertion face of said se-
`cond terminal part and
`parallel to the longitudinal
`axis, said implant having
`a width and a height each
`perpendicular to the
`length of said implant;
`a first side and an oppo-
`site second side, said first
`side and said second side
`extending from said first
`terminal part to said se-
`cond terminal part, por-
`tions of said first side and
`said second side being
`substantially flat, said
`substantially flat portions
`intersecting a second
`plane that is perpendicu-
`lar to the first plane and
`extends through said in-
`sertion face and said trail-
`ing face, wherein said
`substantially flat portions
`of said first side and said
`second side are symmet-
`rical about the first plane,
`said implant being
`adapted to be inserted
`between the first vertebra
`and the second vertebra
`with said first side and
`said second side of said
`implant being oriented
`toward the first end plate
`and the second end plate,
`
`Id. at FIGS. 2-3 (illustrating the implant 10 having the claimed
`length, width, and height limitations).
`
`Under the broadest reasonable interpretation standard for
`“substantially flat,” Tropiano’s sides 12 and 14 each include
`substantially flat portions (examples shown below in FIG. 3)
`that intersect a second plane (illustrated above in depiction of
`Tropiano’s FIG. 2) and that are symmetrical about the first
`plane.
`
`Id. at FIG. 3; see also FIG. 1.
`
`According to the broadest reasonable interpretation of “adapted
`to,” Tropiano discloses an implant structure (implant 10) that is
`capable of being inserted with the first side and the second side
`of the implant being oriented toward the first and second end
`plates, and then rotated ninety degrees into an upright position.
`See MPEP §§ 2114. For example, Tropiano’s implant 10 has
`the same structural features as the insert-and-rotate embodi-
`ments in the ‘696 patents in that the width of the implant 10 is
`substantially less than the height of the implant 10 (as shown
`
`17
`
`

`

`respectively, and then ro-
`tated ninety degrees into
`an upright position,
`
`by FIGS. 2-3) and that the implant 10 is configured to be ori-
`ented in a final upright position in the disc space (as shown in
`FIG. 4). Thus, as illustrated below, Tropiano’s implant provides
`the claimed structure and furthermore has the capability to be
`inserted with the first and second sides being oriented toward
`the first and second end plates, and then rotated ninety de-
`grees into final upright position
`
`said trailing face having a
`recessed portion inter-
`secting each of said first
`and second sides and be-
`ing configured to receive
`an insertion instrument for
`inserting said implant be-
`tween the first vertebra
`and the second vertebra;
`
`
`NUVASIVE1104 at FIG. 5 (modified to shown the view of the
`implant from FIG. 3 (at left) and the view of the implant 10 from
`FIG. 2 (at right)).
`To the extent that Tropiano does not expressly disclose the
`trailing face having a recessed portion “intersecting each of
`said first and second sides and being configured to receive an
`insertion instrument for inserting said implant between the first
`vertebra and the second vertebra,” such a configuration was
`traditionally employed in prior art spinal implants, as evidenced
`by the Michelson ‘247 reference. Michelson ‘247 discusses a
`spinal implant 50 as shown in FIGS. 4 and 4A-D that includes a
`driver engaging element 70 comprising “a raised rectangular
`portion 63 and a central threaded opening 65, for engaging the
`driver apparatus, shown in FIG. 4c and FIG. 4d.” NUVA-
`SIVE1105 at 8:52-61.
`
`
`
`18
`
`

`

`Id. at FIG. 4. A person of ordi-
`nary skill in the art would have
`been prompted to modify Tropi-
`ano’s implant so that the implant
`includes recessed portions along
`the trailing face of the implant
`(example illustrated at right) so
`that the insertion and removal
`tool “locks onto the implant” and
`allows for greater mechanical advantage during manipulation
`and installation of the implant. Id. at 9:1-3 & 10:15-17. Addi-
`tionally, a skilled artisan would have been prompted to modify
`Tropiano’s implant so that the implant includes recessed por-
`tions along the trailing face of the implant (in addition to Tropi-
`ano’s threaded opening 39) so that a surgeon could readily en-
`gage/disengage a threaded tool into the central threaded open-
`ing 39 while maintaining the orientation of the implant (with the
`portion of the inserter tool that mates with the recessed por-
`tions). See NUVASIVE1101 at ¶¶ 20-21. Finally, a skilled arti-
`san would have been prompted to modify Tropiano’s implant to
`include recessed portions in the trailing face because to do so
`would be merely “[u]se of known technique to improve similar
`devices . . . in the same way.” MPEP § 2143(C).
`Tropiano discloses these claim features. For example, Tropi-
`ano discloses that “[p]artitions or struts 24 and 26 divide the
`cage 10 into three compartments; namely, 40, 42 and 44.”
`NUVASIVE11014 at 3:39-40. Stated another way, the surfaces
`are formed with large openings so that maximum bone graft
`material can be received and placed in contact with graft mate-
`ria