`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of: Michelson
`U.S. Patent No.: 8,251,997 Attorney Docket No.: 13958-0112IP2
`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
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`I. 
`
`II. 
`III. 
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`IV. 
`
`V. 
`
`VI. 
`
`TABLE OF CONTENTS
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`2. 
`
`3. 
`
`4. 
`
`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 ................................................................................................... 1 
`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 
`1. 
`“a single elongated portion removably attached to said distal end of said third
`surgical instrument” (claim 9) ................................................................................ 4 
`“positioning a single elongated portion removably attached to said distal end of
`said third surgical instrument over the disc space” (claim 9) ................................ 4 
`“positioning said third surgical instrument such that at least part of one of said at
`least two elongated portions is over one of the two adjacent vertebrae and at
`least part of another of said at least two elongated portions is over the other of
`the two adjacent vertebrae” (claim 17) ................................................................. 4 
`“positioning said third surgical instrument such that the midpoint of the width of
`said first elongated portion is over the disc space and said second elongated
`portion is over one of the two adjacent vertebrae and said third elongated portion
`is over the other of the two adjacent vertebrae” (claim 24) .................................. 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” (claims 9 and 17) .......... 5 
`“the length of said implant being sized to occupy 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 24) ............................................ 6 
`SUMMARY OF THE `997 PATENT ............................................................................ 7 
`A. Brief Description ....................................................................................................... 7 
`B. Summary of the Prosecution History of the `997 Patent ....................................... 7 
`THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE CLAIM OF THE
``997 PATENT IS UNPATENTABLE ........................................................................... 8 
`[GROUND 1] – Claims 9 and 16 are obvious under §103 over Jacobson in view
`of Leu, McAfee, and Michelson ‘247 ...................................................................... 13 
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`5. 
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`6. 
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`i
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`VII. 
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`IX. 
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`X. 
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`XI. 
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`XII. 
`
`VIII. 
`
`[GROUND 2] – Claims 10-15 are obvious under §103 over Jacobson in view of
`Leu, McAfee, Michelson ‘247, and Frey ................................................................. 21 
`[GROUND 3] – Claims 17 and 23 are obvious under §103 over Jacobson in view
`of Leu and Brantigan .............................................................................................. 22 
`[GROUND 4] – Claims 18-22 are obvious under §103 over Jacobson in view of
`Leu, Brantigan, and Frey ........................................................................................ 30 
`[GROUND 5] – Claims 24 and 30 are obvious under §103 over Jacobson in view
`of Leu and Michelson ‘247 ...................................................................................... 31 
`[GROUND 6] – Claims 25-29 are obvious under §103 over Jacobson in view of
`Leu, Michelson ‘247, and Frey ............................................................................... 40 
`[GROUND 7] – Claims 9-16 are obvious under §103 over Michelson ‘661 in view
`of McAfee and Lynn ................................................................................................ 41 
`[GROUND 8] – Claims 17-30 are obvious under §103 over Michelson ‘661 in
`view of Lynn ............................................................................................................. 50 
`XIV.  CONCLUSION .......................................................................................................... 60 
`
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`XIII. 
`
`ii
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`NUVASIVE 1001
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`NUVASIVE 1002
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`NUVASIVE 1003
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`NUVASIVE 1004
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`NUVASIVE 1005
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`NUVASIVE 1006
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`NUVASIVE 1007
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`NUVASIVE 1008
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`NUVASIVE 1009
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`NUVASIVE 1010
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`NUVASIVE 1011
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`EXHIBITS
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`Declaration of Dr. McAfee, M.D., M.B.A.
`
`U.S. Patent No. 8,251,997 to Michelson (“‘997 patent”)
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`Select Prosecution History of the ‘997 patent
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`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”)
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`U.S. Pat. No. 4,917,704 to Frey et al. (“Frey”)
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`U.S. Pat. No. 5,015,247 to Michelson (“Michelson ‘247”)
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`U.S. Pat. No. 5,569,290 to McAfee (“McAfee”)
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`U.S. Pat. No. 5,772,661 to Michelson (“Michelson ‘661”)
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`U.S. Pat. No. 8,343,224 to Lynn et al. (“Lynn”)
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`iii
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`NuVasive, Inc. (“Petitioner”) petitions for Inter Partes Review (“IPR”) under 35
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`U.S.C. §§ 311–319 and 37 C.F.R. § 42 of claims 9-30 of U.S. Patent No. 8,251,997. Below,
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`NuVasive demonstrates there is a reasonable likelihood of prevailing (“RLP”) in its chal-
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`lenge of at least one of claims 9-30 identified in this petition as being unpatentable.
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`I. MANDATORY NOTICES UNDER 37 C.F.R § 42.8
`A.
`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`NuVasive, Inc. is the real party-in-interest for the instant petition.
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`
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`Related Matters Under 37 C.F.R. § 42.8(b)(2)
`B.
`Petitioner is not aware of any reexamination certificates or pending prosecution con-
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`cerning the `997 patent, and is aware of a Certificate of Correction. Petitioner is a named
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`defendant in litigation concerning the ‘997 patent, Warsaw Orthopedic, Inc. et al. v. NuVa-
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`sive, Inc. (originally filed in N.D. Ind. as Case No. 3:12-cv-00438-JD-CAN on Aug. 17, 2012,
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`and transferred to S.D. Cal. on Nov. 8, 2012, as Case No. 3:12-cv-02738-CAB (MDD)). The
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`‘997 patent was added by amended complaint filed Aug. 28, 2012, served on Petitioner that
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`same day. Petitioner is concurrently filing an IPR petition for claims 1-8 of the ‘997 patent.
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`Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`C.
`LEAD COUNSEL
`BACK-UP COUNSEL
`Michael T. Hawkins, Reg. No. 57,867
`Stephen R. Schaefer, Reg. No. 37,927
`3200 RBC Plaza
`3200 RBC Plaza
`60 South Sixth Street
`60 South Sixth Street
`Minneapolis, MN 55402
`Minneapolis, MN 55402
`D.
`Service Information
`Please address all correspondence and service to both counsel listed above. Peti-
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`1
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`tioner consents to service by email at APSI@fr.com (ref.: Docket No. 13958-0112IP2).
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`II. PAYMENT OF FEES – 37 C.F.R. § 42.103
`Petitioner authorizes the PTO to charge Dep. Account 06-1050 for the fee set in 37
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`C.F.R. § 42.15(a), and authorizes payment of any additional fees to this Deposit Account.
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`III. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`A.
`Grounds for Standing Under 37 C.F.R. § 42.104(a)
`Petitioner certifies the `997 patent is eligible for IPR and Petitioner is not barred or
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`estopped from requesting IPR. This petition is being filed within one year of service of a
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`complaint against Petitioner in district court litigation (as discussed above).
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`Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
`B.
`Petitioner requests IPR of claims 9-30 on the grounds set forth below, and requests
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`that the claims be found unpatentable. In support, Petitioner provides discussion and claim
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`charts below and a supporting Declaration of Dr. McAfee, M.D., M.B.A. (NUVASIVE 1001).
`
``997 Claims
`Ground
`Ground 1 9 and 16
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`Ground 2 10-15
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`Ground 3 17 and 23
`Ground 4 18-22
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`Ground 5 24 and 30
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`Ground 6 25-29
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`Ground 7 9-16
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`Ground 8 17-30
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`Basis for Rejection
`Obvious under § 103 by Jacobson in view of Leu, McAfee, and
`Michelson ‘247
`Obvious under § 103 by Jacobson in view of Leu, McAfee, Mi-
`chelson ‘247, and Frey
`Obvious under § 103 by Jacobson in view of Leu and Brantigan
`Obvious under § 103 by Jacobson in view of Leu, Brantigan,
`and Frey
`Obvious under § 103 by Jacobson in view of Leu and Michel-
`son ‘247
`Obvious under § 103 by Jacobson in view of Leu, Mi-chelson
`‘247, and Frey
`Obvious under § 103 by Michelson ‘661 in view of McAfee and
`Lynn
`Obvious under § 103 by Michelson ‘661 in view of Lynn
`
`2
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`Assuming the earliest claimed priority of 2/27/95 (Grounds 1-6), Jacobson, Leu, Brantigan,
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`Frey, and Michelson ’247 are prior art under § 102(b), and McAfee is prior art under at least
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`§ 102(e). Under Grounds 7-8 applying a later priority date (no earlier than Nov. 29, 2011),
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`Michelson ‘661 and McAfee are prior art under § 102(b) and Lynn is prior art under at least
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`§ 102(e). Petitioner submits it is permissible for such grounds to be considered in this IPR.
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`See In re NTP, 654 F.3d 1268 (Fed. Cir. 2011) (permissible to determine in reexam if claims
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`entitled to claimed priority, and if not, to apply intervening art). Jacobson, Leu, Brantigan,
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`Michelson ‘247, and Michelson ‘661 are cited but were not addressed during prosecution.
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`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
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`specification of the patent in which it appears.” 37 C.F.R. § 42.100(b).1 Petitioner submits,
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`for purposes of this IPR only, all claim terms are to be given their plain meaning in view of
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`the ‘997 specification, except the limitations specifically discussed below. Also, Petitioner
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`suggests, for the sake of rational analysis only, that the broadest reasonable construction
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`be at least as broad as what Patent Owner is asserting in the pending litigation. Petitioner
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`1 Because the standards of claim interpretation applied in litigation differ from PTO proceed-
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`ings, any interpretation of claim terms in this IPR is not binding upon Petitioner in any litiga-
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`tion related to the `997 patent. See In re Zletz, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
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`3
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`further contends that claims 9-30 are invalid under 35 U.S.C. § 112, but IPR is not the prop-
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`er forum to address such invalidity. 37 C.F.R. § 42.104(b)(2).
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`1. “a single elongated portion removably attached to said distal end of said
`third surgical instrument” (claim 9)
`This phrase is interpreted to encompass the only disclosed embodiment in FIG. 35 of
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`a structure removably attached to something that may be considered to be the claimed
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`“third instrument,” namely, the removable anchor ring structure 1104 (FIG. 35) having multi-
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`ple elongated portions. See NUVASIVE 1001 at ¶ 16. Notably, because the ‘997 patent
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`(21:39-22:35) discloses that the tubular member 1102 is removed from the ring 1104 before
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`insertion of an implant (and thus no implant is advanced through the tube 1102 as required
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`by claim 9), claims 9-16 are invalid under 35 U.S.C. § 112, although that defect cannot be
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`addressed in this Petition.
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`2. “positioning a single elongated portion removably attached to said distal
`end of said third surgical instrument over the disc space” (claim 9)
`The term “positioning” is interpreted to include circumstances in which the single
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`elongated portion (e.g., the elongated portion from ring 1104, FIG. 35) is transiently moved
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`through a location “over the disc space” before reaching a position within the disc space.
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`Although this interpretation is different from a plain meaning of “positioning” (e.g., NUVA-
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`SIVE 1002 at 22:3-7), Patent Owner’s allegations of infringement require such an interpreta-
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`tion and give rise to defects under 35 U.S.C. § 112 not addressed in this IPR.
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`3. “positioning said third surgical instrument such that at least part of one of
`said at least two elongated portions is over one of the two adjacent verte-
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`4
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`brae and at least part of another of said at least two elongated portions is
`over the other of the two adjacent vertebrae” (claim 17)
`The term “positioning” is interpreted to include circumstances in which the two elon-
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`gated portions (e.g., prongs 149 and 150 in FIGS. 7 & 7A) are transiently moved through a
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`location “over the vertebrae” prior to reaching a position of being lodged in the vertebrae.
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`Although this interpretation is different from a plain meaning of “positioning” (e.g., NUVA-
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`SIVE 1002 at 12:37-44), Patent Owner’s allegations of infringement require such an inter-
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`pretation and give rise to defects under 35 U.S.C. § 112 not addressed in this IPR.
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`4. “positioning said third surgical instrument such that the midpoint of the
`width of said first elongated portion is over the disc space and said second
`elongated portion is over one of the two adjacent vertebrae and said third
`elongated portion is over the other of the two adjacent vertebrae” (claim 24)
`The term “positioning” is interpreted to include circumstances in which the first, se-
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`cond, and third elongated portions (e.g., extension member 148 and prongs 149, 150 in
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`FIGS. 7 & 7A) are transiently moved through a location wherein designated portions of the
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`structure are “over” designated portions of the spine before reaching a position of being
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`lodged in the spine. Although this interpretation is different from a plain meaning of “posi-
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`tioning” (e.g., NUVASIVE 1002 at 12:37-44), Patent Owner’s allegations of infringement re-
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`quire such an interpretation and give rise to defects under 35 U.S.C. § 112 not addressed in
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`this IPR.
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`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” (claims
`9 and 17)
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`5
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`This “implant length” limitation of claims 9 and 17 includes within its scope lengths of
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`implants that, when positioned in a patient, occupy less than the full transverse width of the
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`two adjacent vertebral bodies, but greater than the depth of the disc space. This broadest
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`reasonable construction is supported by the ‘997 specification, which discloses only im-
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`plants that are shorter than the full transverse width. See, e.g., NUVASIVE 1002, FIGS. 19,
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`23, 30A, 30; NUVASIVE 1001, ¶¶ 17-20. Notably, the ‘997 specification provides no guid-
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`ance on what the modifier “substantially” means – e.g., no disclosure of example implant
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`sizes and no example measurements comparing the size of an implant with the size of the
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`full transverse width of the two adjacent vertebrae. Petitioner contends these defects ren-
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`der claims 9-23 invalid under 35 U.S.C. § 112, but this is not the proper forum to address
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`such invalidity. 37 C.F.R. § 42.104(b)(2). In addition, to the extent the “length” claim limita-
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`tion is read narrowly to distinguish implants that predate the 2/27/95 filing date, then the nar-
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`rowly-construed ‘997 claims would not be supported by the 2/27/95 priority document dis-
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`closure, and must be afforded a later priority date in determining validity.
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`“the length of said implant being sized to occupy the full transverse width
`6.
`of the vertebral bodies of the two adjacent vertebrae, the length of said im-
`plant being greater than the depth of the disc space” (claim 24)
`This “implant “length” limitation is also interpreted to include within its scope lengths
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`of implants that, when positioned in a patient, occupy less than the full transverse width of
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`the two adjacent vertebral bodies (which, as discussed above, are all that the ‘997 patent
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`discloses), but greater than the depth of the disc space. Given there is no modifier of “sub-
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`6
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`stantially” in claim 24, it is absolutely clear that claims 24-30 are invalid under 35 U.S.C. §
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`112, but that defect cannot be raised in this IPR. Also, this new matter in claims 24-30 re-
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`quires that claims 24-30 be afforded a later priority date (see Ground 8).
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`IV. SUMMARY OF THE `997 PATENT
`A.
`Brief Description
`The `997 patent discloses “performing surgery on the spine along its lateral aspect
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`(side) and generally by a lateral or anterolateral surgical approach.” NUVASIVE1002, col.
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`3:34-37; NUVASIVE1001 ¶ 10 (illustrating lateral and anterolateral approaches). A lateral
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`approach pre-dated the 2/27/1995 claimed priority date, having been disclosed in a 1982
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`paper by Dr. Crock and in a patent by Dr. Jacobson filed in 1982. NUVASIVE1001 ¶ 11.
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`Patent Owner itself recognized that; indeed, shortly after Petitioner NuVasive had served
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`invalidity contentions in litigation against U.S. 5,772,661 (in 2009), Patent Owner tried to
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`narrow the invalid claims of the ‘661 patent in reissue, but that attempt failed. See App. Se-
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`rial No. 12/655,178 (expressly abandoned after the narrowed ‘661 patent claims were finally
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`rejected). As such, the ‘997 claims are not directed to a broadly claimed lateral approach
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`like the originally issued ‘661 patent. Rather, the ‘997 claims recite many details of the spe-
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`cific tools and fusion implant, but like the lateral approach all these features were also well
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`known before 1995.
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`Summary of the Prosecution History of the `997 Patent
`B.
`The application that became the ‘997 patent was filed on Nov. 29, 2011, claiming
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`priority, via intervening applications, to a 1995 application that had become the ‘661 patent.
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`7
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`The examiner – in a first action mailed before submission of any IDS – allowed sole pending
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`claim 1, subject to a Section 112 rejection. In response, Patent Owner (i) canceled claim 1
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`and replaced it with 30 new claims (the issued ‘997 claims), (ii) explained the new terms re-
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`citing a path of approach “lying in a coronal plane” used in the claims but not in the ‘997
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`specification, and (iii) filed an IDS with the numerous references listed on the ‘997 patent’s
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`front page. NUVASIVE1003 at pp. 25-36 and 54-63. The examiner then allowed the
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`claims. NUVASIVE1003 at pp. 22-24. Nowhere of record is there any reason given for al-
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`lowance, nor any explanation as to why the rejection in the ‘661 patent reissue proceeding
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`(based in part on Jacobson) did not apply.
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`V. THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE CLAIM OF THE
``997 PATENT IS UNPATENTABLE
`There exists a reasonable likelihood of prevailing in the challenge that at least one of
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`claims 9-30 is unpatentable under Grounds 1-8, as discussed below and in the claim charts.
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`RLP for Claims 9-16 (Grounds 1-2 and 7)
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`Under Grounds 1-2, the primary reference Jacobson discloses a direct lateral ap-
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`proach to the spine, and an access system with three instruments, the first being a guide
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`needle or wire 8 and the third being a tubular working cannula 12 through which the proce-
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`dure is performed. NUVASIVE 1004 at FIGS. 3 and 8; 2:23-33; 2:40-43; 6:13. Jacobson
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`discloses all limitations of claim 9 except (i) a “sequential dilation” technique of the third in-
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`strument being advanced “over” the second (as opposed to being advanced within the se-
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`cond), (ii) a single elongated portion that is “removaby attached” to the third instrument, and
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`8
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`(iii) the conventional structure and positioning of a fusion implant.
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`Modifying Jacobson to include these features would have been obvious to a person
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`of skill in the art at the time of the alleged invention of the ‘997 patent. First, regarding se-
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`quential dilation of the third instrument vis-à-vis the second, Jacobson’s speculum 10 and
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`working cannula 12 achieves the same effect, namely, a widening of the initial access path
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`(created by the guide wire or needle 8) to accommodate the working cannula 12. Id. at
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`5:48-54; FIGS. 4-5. By the early 1990s as illustrated by Leu, it was well known for surgeons
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`to employ sequential dilation to widen an initial spinal access path in order to accommodate
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`a working cannula. NUVASIVE 1001 at ¶ 23-24; NUVASIVE 1005 at p. 594; p. 596. Thus,
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`as described in the claim chart, modifying Jacobson to use the known technique of sequen-
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`tial dilation, as taught by Leu, would have been an obvious design change to one of skill in
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`the art at the time. NUVASIVE 1001 at ¶ 25-26. Second, regarding the removably attacha-
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`ble single elongated portion (and referring to the claim interpretation above and the ‘997 pa-
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`tent’s sole embodiment of a removable ring 1104 with multiple spine engagement exten-
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`sions, as shown in FIG. 35), McAfee teaches the use of a removably attachable ring 20 with
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`multiple spine engaging extensions (teeth) wherein the ring is removably attachable to the
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`distal end of the working cannula 12; as such, in McAfee each tooth of ring 20 is a “single
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`elongated portion” that is removably attached to the access cannula 12. NUVASIVE 1009 at
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`3:37-41; FIGS. 2 and 5; 5:63-67. Thus, as described in the claim chart, modifying Jacobson
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`and Leu to use the known technique of a removable distal ring with teeth, as taught by
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`9
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`McAfee, would have been obvious to one of skill in the art at the time. NUVASIVE 1001 at ¶
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`27. Third, regarding the claimed implant structure and positioning, Jacobson discloses a
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`“fusion” procedure (at 6:13), and thus impliedly the use of an implant (NUVASIVE 1001 at ¶
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`28), but does not disclose the specifically claimed implant sizing and positioning (namely, a
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`length that, when positioned, occupies “substantially the full transverse width” of the two ad-
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`jacent vertebrae). But by 1995, numerous designs and sizes of such implants had become
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`known in which the length of the implant extended longitudinally across nearly the full disc
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`space along the direction of insertion. NUVASIVE 1001 at ¶ 28. One example is Michelson
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`‘247, which discloses the same threaded cylindrical “cage” design as the implant of the ‘997
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`patent. NUVASIVE 1008 at FIG. 5. The relevance of the implant shown in the ‘247 patent to
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`the ‘997 patent is further shown by the fact that Michelson ‘661 (again, the priority case for
`
`the ‘997 patent) claims priority back to the 1988 application that became Michelson ‘247. Of
`
`course, the ‘997 patent had to cut off the priority chain at 1995, because going back further
`
`would have left the ‘997 patent with no remaining patent term. In any event, as described in
`
`the claim chart, selecting an implant size (as suggested by Michelson ‘247) and laterally in-
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`serting it in the patient (as taught by Jacobson), would have been obvious to one of skill in
`
`the art at the time. NUVASIVE 1001 at ¶ 28-29.
`
`Ground 7 applies a priority date of Mar. 20, 2012 or Nov. 29, 2011 at the earliest,
`
`given two items of new matter added in claim 9, as discussed in Section XII below. As such,
`
`claims 9-16 are not patentable as obvious over Michelson ‘661 in view of McAfee and Lynn.
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. - IPR2019-00362, Ex. 1015, p. 14 of 65
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`RLP for Claims 17-23 (Grounds 3-4 and 8)
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`Under Grounds 3-4, Jacobson (again, the primary reference, and discussed above)
`
`discloses all limitations of claim 17 except (i) a “sequential dilation” technique of the third
`
`instrument being advanced “over” the second (as opposed to being advanced within the se-
`
`cond), and (ii) the conventional structure and positioning of a fusion implant. NUVASIVE
`
`1001 at ¶ 23-24, 31. Modifying Jacobson to include these features would have been obvi-
`
`ous to a person of skill in the art at the time of the alleged invention of the ‘997 patent. First,
`
`modifying Jacobson to use the known technique of sequential dilation, as taught by Leu,
`
`would have been an obvious design change to one of skill in the art at the time. NUVASIVE
`
`1001 at ¶ 25-26. Second, using the Brantigan implant in the Jacobson fusion procedure,
`
`and selecting an implant size and positioning it in the patient as required by the claim, would
`
`have been obvious to one of skill in the art at the time. NUVASIVE 1001 at ¶ 28, 32-33.
`
`Ground 8 applies a priority date of Nov. 29, 2011 at the earliest, given new matter
`
`added in claim 17, as discussed in Section XIII below. As such, claims 17-23 are not pa-
`
`tentable as obvious over Michelson ‘661 in view Lynn.
`
`RLP for Claims 24-30 (Grounds 5-6 and 8)
`
`Under Grounds 5-6, Jacobson (again, the primary reference, and discussed above)
`
`discloses all limitations of claim 24 except (i) a “sequential dilation” technique of the third
`
`instrument being advanced “over” the second (as opposed to being advanced within the se-
`
`cond), (ii) the specific dimensions of the first, second and third elongated portions of the
`
`11
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`third instrument, and (ii) the conventional structure and positioning of a fusion implant.
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`NUVASIVE 1001 at ¶ 23-24, 31. Modifying Jacobson to include these features would have
`
`been obvious to a person of skill in the art at the time of the alleged invention of the ‘997
`
`patent. First, modifying Jacobson to use the known technique of sequential dilation, as
`
`taught by Leu, would have been an obvious design change to one of skill in the art at the
`
`time. NUVASIVE 1001 at ¶ 25-26. Second, regarding the “first, second, and third elongated
`
`portions” of the third surgical instrument, Jacobson also suggests using anchor elements at
`
`the distal end of the working cannula (NUVASIVE 1004 at 10:1-6), but does not expressly
`
`illustrate the claimed dimensions of those anchor elements. Such conventional anchor ele-
`
`ments, however, commonly included the structural features of the claimed first, second, and
`
`third elongated portions. For example, Michelson ‘247 shows a similar anchoring tip with
`
`sharp tines in which the length of each anchoring tooth is greater than the width and thick-
`
`ness. NUVASIVE 1008 at FIGS. 1-3. As discussed in the claim charts, modifying the Jacob-
`
`son access cannula to incorporate the specifically claimed elongated portion dimensions, as
`
`taught by Michelson ‘247, would have been an obvious design change to one of skill in the
`
`art at the time. NUVASIVE 1001 at ¶ 35-36. Third, using the Michelson ‘247 implant in the
`
`Jacobson fusion procedure, and selecting an implant size and positioning it in the patient as
`
`required by the claim, would have been obvious to one of skill in the art at the time. NUVA-
`
`SIVE 1001 at ¶ 28-29, 36.
`
`Ground 8 applies a priority date of Nov. 29, 2011 at the earliest, given new matter
`
`12
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. - IPR2019-00362, Ex. 1015, p. 16 of 65
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`added in claim 24, as discussed in Section XIII below. As such, claims 24-30 are not pa-
`
`tentable as obvious over Michelson ‘661 in view Lynn.
`
`VI. [GROUND 1] – Claims 9 and 16 are obvious under §103 over Jacobson in view of
`Leu, McAfee, and Michelson ‘247
` Jacobson discloses a surgical method of accessing a spinal disc
`9. A method com-
`space that, much like the ‘997 patent, includes a lateral approach
`prising:
`path to the spine. For example, Jacobson expressly describes a
` making an inci-
`“lateral” approach for accessing a disc space between two adjacent
`sion in skin of a pa-
`vertebrae via a working cannula for purposes of performing a discec-
`tient's body to gain
`tomy and, optionally, a vertebral fusion procedure. NUVASIVE 1004
`access to a disc
`at FIGS. 3 and 8; 2:23-33; 2:40-43; 6:13 (describing a “fusion” pro-
`space between two
`cedure which would include an interbody implant in the disc space to
`adjacent vertebrae
`achieve fusion).
`located within a por-
` Similar to many prior art lateral spinal surgeries that accessed the
`tion of one of a hu-
`spine through an outer tubular cannula, Jacobson discloses the
`man thoracic or
`claimed step of making a laterally-located incision to gain access to
`lumbar spine, said
`a disc space between two adjacent vertebrae located within a por-
`portion of one of the
`tion of the lumbar spine. For example, Jacobson discloses the later-
`human thoracic or
`ally-located incision point in at least two instances. First, Jacobson
`lumbar spine defined
`teaches that the laterally-located incision point is formed when the
`by the two adjacent
`initial guide member 8 (needle or 3-mm wire) penetrates the skin.
`vertebrae having an
`Id. at FIG. 3; 5:28-31; 5:42-45 (describing a guide wire having a di-
`anterior aspect and
`ameter of nearly “3-mm,” which would require formation of small skin
`a posterior aspect
`incision); NUVASIVE 1001 at ¶ 24. Second, Jacobson also discloses
`being divided by a
`that the laterally-located incision point is further incised to “an ap-
`first plane through
`proximately one centimeter long skin incision.” Id. at 5:45-46.
`transverse process-
`
`es of the two adja-
`cent vertebrae, the
`disc space having a
`depth measured
`from an anterior as-
`pect to a posterior
`aspect of the disc
`space, each of the
`two adjacent verte-
`brae having a verte-
`bral body having a
`
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`transverse width
`perpendicular to the
`depth of the disc
`space, said incision
`being proximate an
`intersection of the
`skin and a path hav-
`ing an axis lying in a
`coronal plane pass-
`ing through a lateral
`aspect and a medial
`aspect of the two
`adjacent vertebrae
`and anterior to the
`transverse process-
`es;
`advancing a first
`surgical instrument
`having a length into
`the body of the pa-
`tient through said
`incision until proxi-
`mate the disc space
`along said path and
`anterior to the trans-
`verse processes;
`
`advancing a second
`surgical instrument
`into the body of the
`patient through said
`incision and over at
`least a portion of the
`length of said first
`surgical instrument,
`said second surgical
`instrument having a
`distal end and an
`opposite proximal
`
` Jacobson teaches that, during the lateral surgical approach to the
`spine, a first surgical instrument (e.g., Jacobson’s guide needle or
`wire 8) is advanced into the body of the patient through said incision
`until pro