IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of: Michelson
`U.S. Patent No.: 8,251,997 Attorney Docket No.: 13958-0112IP1
`Issue Date:
`August 28, 2012
`Appl. Serial No.: 13/306,583
`Filing Date:
`November 29, 2011
`Title:
`METHOD FOR INSERTING AN ARTIFICIAL IMPLANT BETWEEN TWO
`ADJACENT VERTEBRAE ALONG A CORONAL PLANE
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`CORRECTED PETITION FOR INTER PARTES REVIEW OF UNITED STATES PATENT
`NO. 8,251,997 PURSUANT TO 35 U.S.C. §§ 311–319, 37 C.F.R. § 42
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 1 of 65
`
`

`

`TABLE OF CONTENTS
`
`I. 
`
`II. 
`III. 
`
`IV. 
`
`V. 
`
`VI. 
`
`VII. 
`
`VIII. 
`
`IX. 
`
`X. 
`
`XI. 
`
`2. 
`
`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) .............................................. 4 
`1. 
`“said distal end of said third surgical instrument is proximate a lateral aspect of the
`vertebral bodies” (claim 1) .................................................................................... 5 
`“the length of said implant being sized to occupy substantially the full transverse
`width of the vertebral bodies of the two adjacent vertebrae, the length of said
`implant being greater than the depth of the disc space” (claim 1) ........................ 5 
`SUMMARY OF THE `997 PATENT ............................................................................ 7 
`A. Brief Description ....................................................................................................... 7 
`B. Summary of the Prosecution History of the `997 Patent ....................................... 8 
`THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE CLAIM OF THE
``997 PATENT IS UNPATENTABLE ........................................................................... 9 
`[GROUND 1] – Obviousness under §103 by Jacobson in view of Leu and
`Brantigan .................................................................................................................. 14 
`[GROUND 2] – Obviousness under §103 by Jacobson in view of Leu,
`Brantigan, and Frey ................................................................................................. 21 
`[GROUND 3] – Obviousness under §103 by Jacobson in view of Leu and
`Michelson ‘247 ......................................................................................................... 23 
`[GROUND 4] – Obviousness under §103 by Jacobson in view of Leu, Michelson
`‘247, and Alacreu ..................................................................................................... 30 
`[GROUND 5] – Obviousness under §103 by Baulot in view of Rosenthal and
`Kambin ..................................................................................................................... 32 
`[GROUND 6] – Obviousness under §103 by Baulot, Rosenthal, Kambin, and
`Frey ........................................................................................................................... 39 
`
`i
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 2 of 65
`
`

`

`XII. 
`
`XIII. 
`
`[GROUND 7] – Obviousness under §103 by Michelson PCT in view of Jacobson
`and Brantigan .......................................................................................................... 41 
`[GROUND 8] – Obviousness under §103 by Michelson PCT in view of
`Jacobson, Brantigan, and Alacreu ........................................................................ 48 
`[GROUND 9] – Obviousness under §103 by Michelson ‘661 in view of Lynn ... 50 
`XIV. 
`XV.  CONCLUSION .......................................................................................................... 58 
`
`
`ii
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 3 of 65
`
`

`

`NUVASIVE1001
`
`NUVASIVE1002
`
`NUVASIVE1003
`
`NUVASIVE1004
`
`NUVASIVE1005
`
`NUVASIVE1006
`
`NUVASIVE1007
`
`NUVASIVE1008
`
`NUVASIVE1009
`
`NUVASIVE1010
`
`NUVASIVE1011
`
`NUVASIVE1012
`
`NUVASIVE1013
`
`NUVASIVE1014
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`EXHIBITS
`
`Declaration of Dr. McAfee, M.D., M.B.A.
`
`U.S. Patent No. 8,251,997 to Michelson (“‘997 Patent”)
`
`Select Prosecution History of the ‘997 patent
`
`U.S. Pat. No. 4,545,374 to Jacobson (“Jacobson”)
`
`Leu et al., Percutaneous Fusion of the Lumbar Spine, Spine
`Vol. 6, No. 3, pp. 593-604 (September 1992) (“Leu”)
`
`U.S. Pat. No. 5,192,327 to Brantigan (“Brantigan”)
`
`U.S. Pat. No. 4,917,704 to Frey et al. (“Frey”)
`
`U.S. Pat. No. 5,015,247 to Michelson (“Michelson ‘247”)
`
`European Pub. No. EP 0567424A1 to Alacreu (“Alacreu”)
`
`Baulot et al., Adjuvant Anterior Spinal Fusion Via Thorascopy,
`Lyon Chirurgical Vol. 90, No. 5, pp. 347-51 (1994) (“Baulot”)
`
`English Translation of Baulot and Certificate of Translation
`
`Rosenthal et al., Removal of a Protruded Thoracic Disc Using
`Microsurgical Endoscopy, Spine Vol. 19, No. 9, pp. 1087-91
`(1994) (“Rosenthal”)
`
`U.S. Pat. No. 4,573,448 to Kambin (“Kambin”)
`
`WO 94/28824 to Michelson (“Michelson PCT”)
`
`iii
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 4 of 65
`
`

`

`NUVASIVE1015
`
`NUVASIVE1016
`
`
`
`
`
`U.S. Pat. No. 5,772,661 to Michelson (“Michelson ‘661”)
`
`U.S. Pat. No. 8,343,224 to Lynn et al. (“Lynn”)
`
`
`
`
`
`iv
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 5 of 65
`
`

`

`NuVasive, Inc. (“Petitioner”) petitions for Inter Partes Review (“IPR”) under 35 U.S.C.
`
`§§ 311–319 and 37 C.F.R. § 42 of claims 1-8 of U.S. Patent No. 8,251,997 (the `997 pa-
`
`tent). A second petition is being filed concurrently challenging claims 9-30. Below, NuVa-
`
`sive demonstrates there is a reasonable likelihood of prevailing (“RLP”) in its challenge of at
`
`least one claim identified as unpatentable in this petition.
`
`I. 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 the instant petition.
`
`
`
`Related Matters Under 37 C.F.R. § 42.8(b)(2)
`B.
`Petitioner is not aware of any reexamination certificates or any pending prosecution
`
`concerning the `997 patent. Petitioner is aware of a Certificate of Correction for the `997
`
`patent. Also, Petitioner is a named defendant in a litigation concerning the ‘997 patent,
`
`styled Warsaw Orthopedic, Inc. et al. v. NuVasive, Inc. (originally filed in N.D. Indiana as
`
`Case No. 3:12-cv-00438-JD-CAN, on Aug. 17, 2012, and then transferred to S.D. Cal. on
`
`November 8, 2012, as Case No. 3:12-cv-02738-CAB (MDD)). The ‘997 patent was added
`
`to the litigation by way of a first amended complaint filed Aug. 28, 2012, and served on Peti-
`
`tioner that same day. Petitioner is concurrently filing an IPR petition for claims 1-8 of the
`
`‘997 patent.
`
`Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`C.
`Petitioner provides the following designation of counsel.
`
`
`
`1
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 6 of 65
`
`

`

`LEAD COUNSEL
`Stephen R. Schaefer, Reg. No. 37,927
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`D.
`Service Information
`Please address all correspondence and service to both counsel listed in Section I(C)
`
`BACK-UP COUNSEL
`Michael T. Hawkins, Reg. No. 57,867
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`
`of this Petition, at the addresses identified in that Section. Petitioner also consents to elec-
`
`tronic service by email at APSI@fr.com (referencing Attorney Docket No. 13958-0112IP1).
`
`II. PAYMENT OF FEES – 37 C.F.R. § 42.103
`Petitioner authorizes the Patent and Trademark Office to charge Deposit Account
`
`No. 06-1050 for the fee set in 37 C.F.R. § 42.15(a) for this Petition and further authorizes
`
`payment of any additional fees to be charged to this Deposit Account.
`
`III. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`A.
`Grounds for Standing Under 37 C.F.R. § 42.104(a)
`Petitioner certifies that the `997 patent is eligible for IPR and that Petitioner is not
`
`barred or estopped from requesting IPR. The present petition is being filed within one year
`
`of service of the original complaint against Petitioner in the district court litigation, which was
`
`filed on Aug. 17, 2012 (the complaint naming the ‘997 patent was served on Aug. 28, 2012).
`
`Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
`B.
`Petitioner requests IPR of claims 1-8 of the `997 patent on the grounds set forth in
`
`the table below and requests that each of the claims be found unpatentable. An explanation
`
`of how claims 1-8 are unpatentable under the statutory grounds identified below, including
`
`2
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 7 of 65
`
`

`

`the identification of where each element can be found in the prior art patents or publications
`
`and the relevance of the prior art references, is provided in the form of detailed claim charts.
`
`Additional explanation and support for each ground of rejection is set forth in the Declaration
`
`of Dr. McAfee, M.D. (NUVASIVE1001).
`
`Ground
`
``997 Patent
`Claims
`Ground 1 1 and 8
`
`Ground 2 2-7
`
`Ground 3 1 and 8
`
`Ground 4 2-7
`
`Ground 5 1 and 8
`
`Ground 6 2-7
`
`Ground 7 1 and 8
`
`Ground 8 2-7
`
`Basis for Rejection
`
`Obvious under § 103 by Jacobson in view of Leu and Bran-
`tigan
`Obvious under § 103 by Jacobson in view of Leu, Branti-
`gan, and Frey
`Obvious under § 103 by Jacobson in view of Leu and Mi-
`chelson ‘247
`Obvious under § 103 by Jacobson in view of Leu, Michel-
`son ‘247, and Alacreu
`Obvious under § 103 by Baulot in view of Rosenthal and
`Kambin
`Obvious under § 103 by Baulot in view of Rosenthal,
`Kambin, and Frey
`Obvious under § 103 by Michelson PCT in view of Jacob-
`son and Brantigan
`Obvious under § 103 by Michelson PCT in view of Jacob-
`son, Brantigan, and Alacreu
`Obvious under § 103 by Michelson ‘661 in view of Lynn
`
`
`
`Ground 9 1-8
`
`Assuming the earliest claimed priority of 2/27/95 (Grounds 1-8), Jacobson, Leu,
`
`Brantigan, Michelson ‘247, Frey, Alacreu, and Kambin each qualify as prior art under at
`
`least 35 U.S.C. § 102(b), Baulot and Rosenthal qualify as prior art under at least 35 U.S.C.
`
`§ 102(a) or (b) because they were published in 1994, and Michelson PCT qualifies as prior
`
`art under at least 35 U.S.C. § 102(a) because it was published in December 1994. Under
`
`Ground 9 applying a later priority date (no earlier than Nov. 29, 2011), Michelson ‘661 is pri-
`
`3
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 8 of 65
`
`

`

`or art under 35 U.S.C. § 102(b) and Lynn is prior art under at least 35 U.S.C. § 102(e). Peti-
`
`tioner submits it is permissible for such grounds to be considered in this IPR. See In re NTP,
`
`654 F.3d 1268 (Fed. Cir. 2011) (permissible to determine in reexam if claim are entitled to
`
`claimed priority, and if not, to apply intervening art). Some of the references (Jacobson, Leu,
`
`Brantigan, Michelson ‘247, Michelson PCT, Rosenthal, Kambin and Michelson ‘661) were
`
`cited in an IDS shortly before allowance, but none of these prior art references was consid-
`
`ered in an Office Action or addressed in Applicant’s remarks during the prosecution of the
`
``997 patent.
`
`Claim Construction under 37 C.F.R. §§ 42.104(b)(3)
`C.
`A claim subject to IPR is given its “broadest reasonable construction in light of the
`
`specification of the patent in which it appears.” 37 C.F.R. § 42.100(b). This means that the
`
`words of the claim are given their plain meaning unless that meaning is inconsistent with the
`
`specification. In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989).1 Petitioner submits that, for
`
`purposes of this IPR, all claim terms should be given their plain meaning, and provides two
`
`specific constructions below to the extent that these interpretations may be considered dif-
`
`ferent from a plain meaning.
`
`
`1 Because the standards of claim interpretation applied in litigation differ from PTO proceed-
`
`ings, any interpretation of claim terms in this IPR is not binding upon Petitioner in any litiga-
`
`tion related to the `997 patent. See In re Zletz, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
`
`4
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 9 of 65
`
`

`

`1. “said distal end of said third surgical instrument is proximate a lateral as-
`pect of the vertebral bodies” (claim 1)
`The broadest reasonable construction of “said distal end of said third surgical in-
`
`strument is proximate a lateral aspect of the vertebral bodies” includes one of either the
`
`nearside lateral aspect (closer to the skin incision) or the opposite aspect (positioned oppo-
`
`site from the skin incision). The opposite lateral aspect is included because it is within the
`
`plain meaning of the claim language (“a lateral aspect”, without limitation as to any specific
`
`lateral aspect) and because it is the only embodiment supported in the ‘997 patent specifi-
`
`cation, as shown by the distal end 146 (FIG. 6) being positioned next to the opposite lateral
`
`aspect (FIG. 7). To the extent that the nearside lateral aspect does not fall within the plain
`
`meaning (and is not described or enabled by the ‘997 patent specification), the nearside lat-
`
`eral aspect is also included in the interpretation in light of what Petitioner believes Patent
`
`Owner’s infringement allegations may be. Namely, the Patent Owner may assert that the
`
`claimed distal end being positioned next to the nearside lateral aspect also falls within the
`
`claims, which is not supported by the ‘997 specification. Petitioner contends that this un-
`
`supported breadth in claiming renders claims 1-8 invalid under 35 U.S.C. § 112, but this is
`
`not the proper forum to address such invalidity. 37 C.F.R. § 42.104(b)(2).
`
`2. “the length of said implant being sized to occupy substantially the full
`transverse width of the vertebral bodies of the two adjacent vertebrae, the
`length of said implant being greater than the depth of the disc space”
`(claim 1)
`The broadest reasonable construction of “the length of said implant being sized to
`
`5
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 10 of 65
`
`

`

`occupy substantially the full transverse width of the vertebral bodies of the two adjacent ver-
`
`tebrae, the length of said implant being greater than depth of the disc space” recited in claim
`
`1 includes within its scope lengths of implants that, when positioned in a patient, occupy
`
`less than the full transverse width of the patient’s two adjacent vertebral bodies, but greater
`
`than the depth of the patient’s disc space. This broadest reasonable construction is sup-
`
`ported by the ‘997 specification, which discloses only implants that are shorter than the full
`
`transverse width. See, e.g., NUVASIVE1002, FIGS. 19, 23, 30A, 30; NUVASIVE1001, ¶¶
`
`17-20. Notably, the ‘997 specification provides no guidance on what the modifier “substan-
`
`tially” in claim 1 means. For example, the ‘997 specification provides no disclosure of ex-
`
`ample implant sizes, and no example measurements comparing the size of an implant with
`
`the size of the full transverse width of the two adjacent vertebrae. Instead, the ‘997 specifi-
`
`cation only provides figures that are not drawn to scale and thus have limited value in what
`
`they teach. For example, FIG. 30, upon which Patent Owner has relied most heavily in ar-
`
`guing that the ‘997 specification discloses a long implant, is not anatomically accurate (its
`
`length is exaggerated), thus rendering FIG. 30 entirely unhelpful in quantifying what “sub-
`
`stantially” means in claim 1. Moreover, the view being shown in FIG. 30 – as defined in
`
`FIG. 29 – is a view looking upward toward the smaller L3 vertebra above the disc space D,
`
`not a view of the larger L4 vertebra below. Accordingly, Petitioner contends these defects in
`
`claim 1 render claims 1-8 invalid under 35 U.S.C. § 112, but this is not the proper forum to
`
`address such invalidity. 37 C.F.R. § 42.104(b)(2). In addition, as will be discussed below,
`
`6
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 11 of 65
`
`

`

`to the extent the “length occupying substantially the full transverse width” claim limitation is
`
`read narrowly to distinguish prior art implants (using the 2/27/95 priority date), then the ‘997
`
`claims are not supported by 2/27/95 priority document disclosure, and must be afforded a
`
`later priority date in determining validity.
`
`IV. SUMMARY OF THE `997 PATENT
`A.
`Brief Description
`The `997 patent discloses a method and instruments for “performing surgery [i.e., a
`
`spinal fusion procedure] on the spine along its lateral aspect (side) and generally by a lat-
`
`eral or anterolateral surgical approach.” NUVASIVE1002, col. 3:34-37; NUVASIVE1001 ¶
`
`10 (providing illustration of lateral and anterolateral approaches). The use of a direct or far
`
`lateral approach to the spine for performing a spinal fusion procedure pre-dated the ‘997
`
`patent’s claimed 1995 priority by a long shot, having been disclosed at least as early as a
`
`1982 paper by Dr. Henry Crock of Australia and also in a patent by Dr. Robert Jacobson
`
`that was filed in 1982. NUVASIVE1001 ¶ 11. Patent Owner itself recognized that a lateral
`
`approach to the spine was known prior to February 27, 1995. Indeed, the priority applica-
`
`tion (issued as U.S. 5,772,661) acknowledged that fact (see ‘661 patent, col. 1:43-44).
`
`Moreover, shortly after invalidity contentions against the ‘661 patent based on Jacobson
`
`prior art were presented by NuVasive in litigation in 2009, Patent Owner sought to narrow
`
`the claims of the ‘661 patent in reissue, but that attempt failed. See App. Serial No.
`
`12/655,178 (expressly abandoned after narrowed ‘661 patent claims were finally rejected).
`
`7
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 12 of 65
`
`

`

`In the face of this, Patent Owner separately pursued the continuation application that be-
`
`came the ‘997 patent, and in it presented claims that recited a specific set of tools and fu-
`
`sion implant, but like the lateral approach all these features were also well known in the pri-
`
`or art before 1995, as will be discussed in more detail below.
`
`Summary of the Prosecution History of the `997 Patent
`B.
`The ‘997 patent claims priority, via two intervening applications, back to a 1995 ap-
`
`plication that issued as U.S. 5,772,661 (NUVASIVE1015). The ‘661 patent claims a lateral
`
`method for spinal fusion, and as discussed above, Patent Owner failed in its attempt to nar-
`
`row its claim scope to an allowable form through a reissue proceeding, and expressly aban-
`
`doned it. The application that became the ‘997 patent was filed on Nov. 29, 2011 – while the
`
`‘661 reissue proceeding was pending, and after a final rejection in the reissue – as a “Track
`
`I” filing (prioritized examination). Before Patent Owner had filed an information disclosure
`
`statement (IDS), the Examiner, in a first Action mailed Jan. 19, 2012, allowed the sole pend-
`
`ing claim over the art, and entered only a Section 112 rejection. In response, the Patent
`
`Owner canceled the sole claim, and inserted thirty new claims (the claims in the issued ‘997
`
`patent). NUVASIVE1003 at pp. 25-36 and 54-63. Also, in that the new claims recited a
`
`path of approach “lying in a coronal plane”—a phrase not used in the ‘997 specification—
`
`Patent Owner included an explanation of this phrase, with a figure illustrating it. NUVA-
`
`SIVE1003 at pp. 25-36 and 54-63. The Patent Owner also, for the first time, filed its IDS
`
`with hundreds of references. Sixteen days later, the Examiner allowed the 30 new claims.
`
`8
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 13 of 65
`
`

`

`NUVASIVE1003 at pp. 22-24.
`
`The examiner provided no reasons for allowance, and nothing in the record indicates
`
`what the examiner or the Patent Owner deemed to be the most pertinent prior art, how the
`
`allowed claims were different from the prior art, or why the rejection in the ‘661 patent reis-
`
`sue proceeding (based in part on Jacobson) did not apply. The Patent Owner then filed a
`
`request for continued examination (RCE) to expunge some of the cited documents that
`
`were subject to a Court protective order, and after that was done, the examiner again al-
`
`lowed the claims without reasons for allowance. NUVASIVE1003 at pp. 1-3.
`
`V. THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE CLAIM OF THE
``997 PATENT IS UNPATENTABLE
`As detailed in the claim charts below, prior art references, some which were cited in
`
`an IDS but never mentioned in any Office Action or Remarks during prosecution, plainly
`
`demonstrate the limitations of method claim 1 and its dependent claims. These references
`
`show that the `997 patent claims are merely a combination of “prior art elements according
`
`to known methods to yield predictable results” and/or the “[u]se of known technique[s] to
`
`improve similar devices (methods, or products) in the same way.” MPEP § 2143(A, C). For
`
`this reason, there exists a reasonable likelihood that at least one claim of the ‘997 patent is
`
`unpatentable.
`
`Immediately below, select features of Jacobson are mapped to elements of claim 1
`
`to preview the correspondence of the prior art to the claim elements which is set forth in
`
`greater detail within the claim charts that follow, thus demonstrating the existence of a rea-
`
`9
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 14 of 65
`
`

`

`sonable likelihood of prevailing in this challenge for at least claim 1. Claim 1 of the `997 pa-
`
`tent is directed to a surgical method that includes making an incision near the lateral side of
`
`a patient (“proximate an intersection of the skin and a path having an axis lying in a coronal
`
`plane passing through a lateral aspect and a medial aspect of the two adjacent vertebrae”).
`
`Claim 1 also recites, in part, three “advancing” steps, namely, advancing a first instrument
`
`(e.g., guide pin 30 in FIG. 1), advancing a second instrument (e.g., distractor 100 in FIG. 2)
`
`over at least a portion of the length of the first instrument, and advancing a third instrument
`
`(e.g., outer sleeve 140 in FIG. 7) over at least a portion of the length of the second instru-
`
`ment. NUVASIVE1002 at claim 1. Further, claim 1 recites, in part, the step of inserting a
`
`“non-bone interbody intraspinal implant” (e.g., threaded implant “I” in FIG. 19) through the
`
`third surgical instrument.
`
`Referring to Grounds 1 and 3, Jacobson alone discloses nearly all features recited in
`
`claim 1, except for the use of “sequential dilators” over Jacobson’s guide needle (in lieu of
`
`Jacobson’s speculum 10) and the traditional structure of a fusion implant. For example, Ja-
`
`cobson discloses virtually the same method of use for the guide needle or wire 8 (first in-
`
`strument), the working cannula 12 (third instrument), and the direct lateral access path.
`
`NUVASIVE1004 at FIGS. 3 and 8; col. 2:23-33; col. 2:40-43; col. 6:13 (describing a “fusion”
`
`procedure through the direct lateral working cannula). Jacobson discloses that a speculum
`
`10 (not sequential dilators) may be advanced over the initial guide needle or wire 8 so as to
`
`widen the surgical access path for subsequent insertion of the final working cannula 11. Id.
`
`10
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 15 of 65
`
`

`

`at col. 5:48-54; FIGS. 4-5. By the early 1990s, however, surgeons commonly employed the
`
`obvious choice of using one or more sequential dilators (rather than Jacobson’s speculum
`
`10) over the initial guide needle to widen the surgical access path for thereafter introducing
`
`the final working cannula (Leu provides an example of this general prior art practice).
`
`NUVASIVE1005 at p. 594; p. 596. As described in greater detail in the claim charts below,
`
`a person of ordinary skill in the art would have been prompted (especially by the early
`
`1990s) to replace Jacobson’s speculum with sequential dilators (as suggested by Leu) so
`
`as to widen the surgical access path from the initial guide needle in a manner that reduces
`
`the trauma to the intervening tissue. Furthermore, and referring to Ground 1, prior art refer-
`
`ences such as Brantigan show that when a non-bone fusion implant is inserted laterally (in
`
`accordance with Jacobson’s method), the implant should include the basic structural ele-
`
`ments recited in claim 1 and the implant length should be sized to reach the “perimeter of
`
`the vertebrae.” NUVASIVE1006 at col. 2:2-4; col. 2:64-66; FIG. 10. For the reasons de-
`
`scribed below, there is a reasonable likelihood that claim 1 of the `997 patent is unpatenta-
`
`ble based upon Jacobson in view of Leu and Brantigan.
`
`Referring to Ground 3, as an alternative to Brantigan, Michelson ‘247 discloses a
`
`threaded cage implant similar to the ‘997 patent, and furthermore suggests to a skilled arti-
`
`san that the threaded cage implant 50 should extend longitudinally across the full disc
`
`space in the axial direction of insertion. NUVASIVE1008 at FIG. 5. Thus, for substantially
`
`the same reasons described above (and in Ground 3 below), there is a reasonable likeli-
`
`11
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 16 of 65
`
`

`

`hood that claim 1 of the `997 patent is unpatentable based upon the obvious combination of
`
`Jacobson in view of Leu and Michelson ‘247.
`
`Referring to Ground 5, claim 1 also recites that the surgical method can also be used
`
`in the “thoracic” spine (not just the “lumbar” spine), and prior art references also disclose
`
`this. Indeed, Applicant originally acknowledged that, by the time the priority application had
`
`been filed on February 27, 1995, surgeons had begun performing procedures in the thoracic
`
`region using a lateral approach, although Patent Owner delete that admission from the
`
`specification when the ‘997 application was filed. NUVASIVE1015, 1:43-45; compare
`
`NUVASIVE1002, 1:38-39. The Baulot reference discloses a surgical method for accessing
`
`a targeted thoracic disc space, and furthermore discloses nearly all elements of method
`
`claim 1, except for a direct lateral path (to the extent claim 1 is interpreted to require such a
`
`direct lateral path) for the working cannula/third surgical instrument and the use of a guide
`
`wire/dilator to define the path for the working cannula/third surgical instrument. As de-
`
`scribed in the chart below (Ground 5), Rosenthal discloses a lateral approach to the spine
`
`and collectively, the Rosenthal and Kambin references show that the claim features missing
`
`from Baulot were commonly used in similar spinal access procedures. NUVASIVE1012 at
`
`FIGS. 1 and 3; p. 1087 (Rosenthal suggesting that the access path to the thoracic disc
`
`space can be directly lateral with instruments inserted along the “middle axillary line”);
`
`NUVASIVE1013 at col. 4:33-44 (Kambin suggesting the use of a guide wire and cannulated
`
`trocar/dilator to define the insertion path for the larger working cannula); FIGS. 3, 4, and 6.
`
`12
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 17 of 65
`
`

`

`Thus, for the reasons described in Ground 5 below, there is a reasonable likelihood that
`
`claim 1 of the `997 patent is unpatentable based upon the obvious combination of Baulot in
`
`view of Rosenthal and Kambin.
`
`Furthermore, as described in Ground 7 below, the inventor’s own prior art publication
`
`(Michelson PCT) discloses nearly all features recited in claim 1, except for the location of
`
`the incision/insertion path to the spine, the use of an initial guide pin before the second in-
`
`strument/distractor, and the relative length of the implant. For example, Michelson PCT dis-
`
`closes virtually the same method of use for the distractor 100 (second instrument), outer
`
`sleeve 140 (third instrument), and implant structure “I”. NUVASIVE1014 at FIGS. 1, 7A, and
`
`16. Even though Michelson PCT does not expressly describe the claimed incision loca-
`
`tion/insertion path and the claimed first-instrument/guide pin, such surgical steps were wide-
`
`ly known long before 1995. For example, Jacobson discloses a lateral approach to the
`
`lumbar spine that includes an initial guide needle or wire inserted along a coronal plane path
`
`to serve as a guide for a second instrument. NUVASIVE1004 at FIG. 3; col. 5:38-44. As
`
`described in greater detail in the claim charts below (Ground 7), a person of ordinary skill in
`
`the art would have been prompted to modify the surgical method of Michelson PCT so as to
`
`employ Jacobson’s lateral approach path and initial guide wire so as to avoid “major back
`
`support muscles” that “would otherwise have to be cut or retracted,” and for the additional
`
`reasons described below. Id. at col. 2:31-33. Furthermore, prior art references such as
`
`Brantigan show that when Michelson PCT’s implant is inserted laterally (as described
`
`13
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 18 of 65
`
`

`

`above), the length of the implant should be sized to reach the “perimeter of the vertebrae.”
`
`NUVASIVE1006 at col. 2:2-4; col. 2:64-66; FIG. 10. Accordingly, there is a reasonable like-
`
`lihood that claim 1 of the `997 patent is unpatentable based upon Michelson PCT in view of
`
`Jacobson and Brantigan.
`
`Finally, for reasons described below (Ground 9), at least claims 1-8 of the ‘997 pa-
`
`tent are not entitled to the alleged priority date (Feb. 25, 1995). As such, there is a reason-
`
`able likelihood that claim 1 of the `997 patent is unpatentable based upon the obvious com-
`
`bination of Michelson ‘661 in view of Lynn (wherein Michelson ‘661 is deemed a § 102(b)
`
`publication and Lynn a § 102(e) publication).
`
`These obvious combinations, alone or in combination with various secondary refer-
`
`ences, provide all elements of claims 1-8, thus raising a reasonable likelihood of prevailing
`
`(RLP) with respect to at least one of the claims challenged in this Petition.
`
`VI. [GROUND 1] – Obviousness under §103 by Jacobson in view of Leu and Brantigan
`As shown in the claim chart below, limitations recited by claims 1 and 8 of the `997
`
`patent are obvious under §103 based upon Jacobson in view of Leu and Brantigan.
`
`1. A method comprising:
`making an incision in skin
`of a patient's body to gain
`access to a disc space
`between two adjacent ver-
`tebrae located within a
`portion of one of a human
`thoracic or lumbar spine,
`said portion of one of the
`human thoracic or lumbar
`
` Jacobson discloses a surgical method of accessing a spinal
`disc space that, much like the ‘997 patent, includes a lateral
`approach path to the spine. For example, Jacobson expressly
`describes a “lateral” approach for accessing a disc space be-
`tween two adjacent vertebrae via a working cannula for pur-
`poses of performing a discectomy and, optionally, a vertebral
`fusion procedure. NUVASIVE1004 at FIGS. 3 and 8; col. 2:23-
`33; col. 2:40-43; col. 6:13 (describing a “fusion” procedure
`which would include an interbody implant in the disc space to
`achieve fusion).
`
`14
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1014, p. 19 of 65
`
`

`

`spine defined by the two
`adjacent vertebrae having
`an anterior aspect and a
`posterior aspect being
`divided by a first plane
`through transverse pro-
`cesses of the two adja-
`cent vertebrae, the disc
`space having a depth
`measured from an anteri-
`or aspect to a posterior
`aspect of the disc space,
`each of