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
`
`
`
`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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`

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`TABLE OF CONTENTS
`
`I. 
`
`II. 
`III. 
`
`IV. 
`
`V. 
`
`VI. 
`
`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) ................................ 5 
`“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) ................................................................. 5 
`“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) .................................. 6 
`“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) .......... 6 
`“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) ............................................ 8 
`SUMMARY OF THE `997 PATENT ............................................................................ 8 
`A. Brief Description ....................................................................................................... 8 
`B. Summary of the Prosecution History of the `997 Patent ....................................... 9 
`THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE CLAIM OF THE
``997 PATENT IS UNPATENTABLE ......................................................................... 10 
`[GROUND 1] – Obviousness under §103 by Jacobson in view of Leu, McAfee,
`and Michelson ‘247 ................................................................................................. 17 
`
`5. 
`
`6. 
`
`i
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`

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`VII. 
`
`IX. 
`
`X. 
`
`VIII. 
`
`[GROUND 2] – Obviousness under §103 by Jacobson in view of Leu, McAfee,
`Michelson ‘247, and Frey ........................................................................................ 24 
`[GROUND 3] – Obviousness under §103 by Jacobson in view of Leu and
`Brantigan .................................................................................................................. 26 
`[GROUND 4] – Obviousness under §103 by Jacobson in view of Leu,
`Brantigan, and Frey ................................................................................................. 33 
`[GROUND 5] – Obviousness under §103 by Jacobson in view of Leu and
`Michelson ‘247 ......................................................................................................... 34 
`[GROUND 6] – Obviousness under §103 by Jacobson in view of Leu, Michelson
`‘247, and Frey .......................................................................................................... 42 
`[GROUND 7] – Obviousness under §103 by Michelson ‘661 in view of McAfee
`and Lynn................................................................................................................... 43 
`[GROUND 8] – Obviousness under §103 by Michelson ‘661 in view of Lynn ... 51 
`XIII. 
`XIV.  CONCLUSION .......................................................................................................... 60 
`
`
`XI. 
`
`XII. 
`
`ii
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`

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`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”)
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`U.S. Pat. No. 5,015,247 to Michelson (“Michelson ‘247”)
`
`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”)
`
`U.S. Pat. No. 8,343,224 to Lynn et al. (“Lynn”)
`
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`NUVASIVE 1001
`
`NUVASIVE 1002
`
`NUVASIVE 1003
`
`NUVASIVE 1004
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`NUVASIVE 1005
`
`NUVASIVE 1006
`
`NUVASIVE 1007
`
`NUVASIVE 1008
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`NUVASIVE 1009
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`NUVASIVE 1010
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`NUVASIVE 1011
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`
`
`iii
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`

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`NuVasive, Inc. (“Petitioner”) petitions for Inter Partes Review (“IPR”) under 35
`
`U.S.C. §§ 311–319 and 37 C.F.R. § 42 of claims 9-30 of U.S. Patent No. 8,251,997. Below,
`
`NuVasive demonstrates there is a reasonable likelihood of prevailing in its challenge of at
`
`least one of claims 9-30 identified in this petition as being unpatentable.
`
`I. MANDATORY NOTICES UNDER 37 C.F.R § 42.8
`A.
`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`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 pending prosecution con-
`
`cerning the `997 patent, and is aware of a Certificate of Correction. Petitioner is a named
`
`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.
`
`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-
`
`1
`
`

`

`tioner consents to service by email at APSI@fr.com (ref.: Docket No. 13958-0112IP2).
`
`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
`
`C.F.R. § 42.15(a), and authorizes payment of any additional fees 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 the `997 patent is eligible for IPR and Petitioner is not barred or
`
`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).
`
`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
`
`that the claims be found unpatentable. An explanation of how claims 9-30 are unpatentable
`
`is provided below in the claim charts, including where each element can be found in the pri-
`
`or art publications and the relevance of the prior art references. Additional explanation and
`
`support is in the Declaration of Dr. McAfee, M.D., M.B.A. (NUVASIVE 1001).
`
`Ground
`
``997 Patent
`Claims
`Ground 1 9 and 16
`
`Ground 2 10-15
`
`Ground 3 17 and 23
`
`Ground 4 18-22
`
`Ground 5 24 and 30
`
`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,
`Michelson ‘247, and Frey
`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-
`
`2
`
`

`

`Ground
`
``997 Patent
`Claims
`
`Ground 6 25-29
`
`Ground 7 9-16
`
`Basis for Rejection
`
`chelson ‘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
`
`
`
`Ground 8 17-30
`
`Jacobson, Leu, Brantigan, Frey, and Michelson ’247 are prior art under 35 U.S.C. §
`
`102(b), having been published more than a year before the earliest claimed priority of Feb.
`
`27, 1995. McAfee is prior art under at least 35 U.S.C. § 102(e), having been filed in Janu-
`
`ary 1995. Michelson ‘661 is prior art under 35 U.S.C. § 102(b) and Lynn under at least 35
`
`U.S.C. § 102(e) to the extent the claims of the ‘997 patent are not entitled to the earliest
`
`claimed priority date (as described in Grounds 7-8). Some of these references (Jacobson,
`
`Leu, Brantigan, Michelson ‘247, and Michelson ‘661) were cited in an IDS, but none were
`
`addressed during prosecution.
`
`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). Thus, the words of
`
`the claim are given their plain meaning unless that meaning is inconsistent with the specifi-
`
`3
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`

`

`cation. In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989).1 Petitioner submits that, for pur-
`
`poses of this proceeding, all claim terms except those specifically addressed below should
`
`be given their plain meaning. Petitioner contends that some or all of the claim limitations
`
`addressed below render the ‘997 patent claims 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). As a result, the Peti-
`
`tioner suggests, for the sake of rational analysis only, that the broadest reasonable con-
`
`struction to be applied in this proceeding for these limitations is at least as broad as what
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`Patent Owner is believed to be asserting in the pending litigation.
`
`1. “a single elongated portion removably attached to said distal end of said
`third surgical instrument” (claim 9)
`This phrase is interpreted to include a removable ring with at least one (and not nec-
`
`essarily only one) elongated portion, such as the removable anchor ring structure 1104
`
`(FIG. 35) that removably attaches to the outer tubular member 1102. See NUVASIVE 1001
`
`at ¶ 16. Throughout the ‘997 patent, this removable anchor ring structure 1104 is the only
`
`structure that is “removably attached” to any type of instrument (tubular member 1102) that
`
`might be considered a third surgical instrument. Because the ‘997 patent discloses only
`
`methods for using the detachable ring structure 1104 in which the third surgical instrument
`
`
`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
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`

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`(tubular member 1102) is entirely removed from the patient before the spinal implant is in-
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`serted (and, thus, no implant can be inserted through the tubular member 1102 as required
`
`by the claims), such inconsistencies give rise to issues under 35 U.S.C. § 112 that are not
`
`addressed in this Petition. NUVASIVE 1002 at 21:39-22:35; FIG. 35.
`
`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” in this phrase is interpreted to include circumstances in which
`
`the single elongated portion (e.g., ring 1104 in FIG. 35) is transiently moved through a loca-
`
`tion where the single elongated portion is disposed over the disc space prior to penetrating
`
`into the disc space. Although transiently moving through a location is normally understood
`
`as being different from the plain meaning of “positioning” (e.g., NUVASIVE 1002 at 22:3-7),
`
`Patent Owner’s allegations of infringement require this unconventional meaning. Such in-
`
`consistencies give rise to issues under 35 U.S.C. § 112 not addressed herein.
`
`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-
`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” in this phrase is interpreted to include circumstances in which
`
`the two elongated portions (e.g., prongs 149 and 150 in FIGS. 7 and 7A) are transiently
`
`moved through a location where the two elongated portions are disposed over the respec-
`
`tive vertebrae prior to penetrating into the vertebrae. Although this is different from the plain
`
`meaning of “positioning” (e.g., NUVASIVE 1002 at 12:37-44), Patent Owner’s allegations of
`
`5
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`

`

`infringement require this unconventional meaning. Such inconsistencies give rise to issues
`
`under 35 U.S.C. § 112 not addressed herein.
`
`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” in this phrase is interpreted to include circumstances in which
`
`the first, second, and third elongated portions (e.g., extension member 148 and prongs 149,
`
`150 in FIGS. 7 and 7A) are transiently moved through a location where the first, second,
`
`and third elongated portions are disposed over the designated portions of the spine prior to
`
`penetrating into those designated portions. This is different from the plain meaning of “posi-
`
`tioning” (e.g., NUVASIVE 1002 at 12:37-44), Patent Owner’s allegations of infringement re-
`
`quire this unconventional meaning. Such inconsistencies give rise to issues under 35 U.S.C.
`
`§ 112 not addressed herein.
`
`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)
`This “implant length” limitation of claims 9 and 17 includes within its scope lengths of
`
`implants that, when positioned in a patient, occupy less than the full transverse width of the
`
`two adjacent vertebral bodies, but greater than the depth of the disc space. This broadest
`
`reasonable construction is supported by the ‘997 specification, which does not provide writ-
`
`ten description support for implants that span the entire transverse width, but only discloses
`
`6
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`

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`implants that are shorter than that. See, e.g., NUVASIVE1002, FIGS. 19, 23, 30A, 30;
`
`NUVASIVE1001, ¶¶ 18-19. In addition, for typical vertebrae the full transverse width of the
`
`two vertebrae adjacent a disc space is greater than the depth of the disc space. See, e.g.,
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`NUVASIVE1002, FIGS. 30, 30A, 32 & 33; NUVASIVE1001, Exhibit C.
`
`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-
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`ample implant sizes, and no example measurements comparing the size of an implant with
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`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
`
`transverse width is exaggerated), thus rendering FIG. 30 entirely unhelpful in quantifying
`
`what “substantially” means in claim 1. Moreover, the view being shown in FIG. 30 – as de-
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`fined in FIG. 29 – is a view looking upward toward the smaller L3 vertebra above the disc
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`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, to the extent the “length occupying substantially the full transverse width” claim limi-
`
`tation is read narrowly to distinguish prior art implants in existence before the priority appli-
`
`7
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`

`

`cation filing in 1995, then the ‘997 claims are not supported by the original 1995 priority
`
`document disclosure, 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
`
`of implants that, when positioned in a patient, occupy less than the full transverse width of
`
`the two adjacent vertebral bodies, but greater than the depth of the disc space. This broad-
`
`est reasonable construction is supported by the ‘997 specification, which does not provide
`
`written description support for implants that span the entire transverse width, but only dis-
`
`closes implants that are shorter than that. See, e.g., NUVASIVE1002, FIGS. 19, 23, 30A,
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`30; NUVASIVE1001, ¶ 18-19. Clearly, the length limitation of claim 24 (which does not in-
`
`clude the modifier “substantially”) is not supported by the ‘997 specification, thus rendering
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`claims 24-30 invalid under 35 U.S.C. § 112, but this is not the proper forum to address such
`
`issues. In addition, as will be discussed below (Ground 8), claims 24-30 must be afforded a
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`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
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`spinal fusion procedure] on the spine along its lateral aspect (side) and generally by a lat-
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`eral or anterolateral surgical approach.” NUVASIVE1002, col. 3:34-37; NUVASIVE1001 ¶
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`10 (providing illustration of lateral and anterolateral approaches). The use of a lateral ap-
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`8
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`

`

`proach to the spine for performing a spinal fusion procedure pre-dated the ‘997 patent’s
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`claimed 1995 priority, having been disclosed at least as early as a 1982 paper by Dr. Crock
`
`and also in a patent by Dr. Robert Jacobson filed in 1982. NUVASIVE1001 ¶ 11. Patent
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`Owner itself recognized that a lateral approach to the spine was known prior to February 27,
`
`1995. Indeed, the priority application (issued as U.S. 5,772,661) acknowledged that fact
`
`(see ‘661 patent, col. 1:43-44), and shortly after invalidity contentions against the ‘661 pa-
`
`tent 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). Patent Owner thus separately pursued the continuation application
`
`that became the ‘997 patent, and in it, presented claims that recite a specific set of tools and
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`fusion implant features that were well known in the prior art before 1995, as will be dis-
`
`cussed 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
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`9
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`

`

`I” filing (prioritized examination). Before Patent Owner had filed an information disclosure
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`statement (IDS), the Examiner, in a first Action mailed Jan. 19, 2012, allowed the sole pend-
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`ing claim over the art, and entered only a Section 112 rejection. In response, the Patent
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`Owner canceled the sole claim, and inserted thirty new claims (the claims in the issued ‘997
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`patent). NUVASIVE1003 at pp. 25-36 and 54-63. Also, in that the new claims recited a
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`path of approach “lying in a coronal plane”—a phrase not used in the ‘997 specification—
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`Patent Owner included an explanation of this phrase, with a figure illustrating it. NUVA-
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`SIVE1003 at pp. 25-36 and 54-63. The Patent Owner also, for the first time, filed its IDS
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`with hundreds of references. Sixteen days later, the examiner allowed the 30 new claims.
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`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
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`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
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`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 below, prior art references show independent claims 9, 17 and 24, and
`
`their dependents, are merely a combination of “prior art elements according to known meth-
`
`10
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`

`

`ods 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). As such, there ex-
`
`ists a reasonable likelihood that at least one of the challenged claims is unpatentable.
`
`RLP for Claims 9-16
`
`Claim 9 of the `997 patent is directed to a method that starts with an incision in the
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`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 ver-
`
`tebrae”). Claim 9 also recites three “advancing” steps, namely, advancing a first instrument
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`(e.g., guide pin 30 in FIG. 1), a second instrument (e.g., distractor 100 in FIG. 2) over the
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`first, and a third instrument (e.g., outer tube 1102 in FIG. 35) over the second. Claim 9 de-
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`scribes that a single elongate portion (detachable anchor ring 1104 in FIG. 35) is removably
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`attached to the third instrument (outer tube 1102). Further, claim 9 recites a step of insert-
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`ing a “non-bone interbody intraspinal implant” (e.g., threaded implant “I” in FIG. 19) through
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`the third surgical instrument.
`
`First regarding Grounds 1-2, Jacobson alone discloses nearly all features recited in
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`claim 9, except for the use of sequential dilators over Jacobson’s guide needle (in lieu of
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`Jacobson’s speculum 10), an anchor tip that is “removably attached” to the outer tube, and
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`the traditional structure of a fusion implant. For example, in comparison to the ‘997 patent,
`
`Jacobson 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.
`
`11
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`

`

`NUVASIVE 1004 at FIGS. 3 and 8; 2:23-33; 2:40-43; 6:13 (describing a “fusion” procedure
`
`through the direct lateral working cannula). Jacobson discloses that a speculum 10 (not se-
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`quential dilators) may be advanced over the initial guide needle or wire 8 so as to widen the
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`surgical access path for subsequent insertion of the final working cannula 11. Id. at 5:48-
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`54; FIGS. 4-5. By the early 1990s, however, surgeons commonly employed the obvious
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`choice of using one or more sequential dilators (rather than Jacobson’s speculum 10) over
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`the initial guide needle to widen the surgical access path for thereafter introducing the final
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`working cannula (Leu provides an example of this general prior art practice). NUVASIVE
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`1005 at p. 594; p. 596. As described in greater detail in the claim charts below (in which
`
`claim language is set forth in bold font), 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.
`
`Regarding the claimed “single elongate portion” that is removably attached to the
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`third surgical instrument (refer to the anchor ring 1104 that is removably attached to the
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`outer tube 1102 in FIG. 35), Jacobson also suggests using anchor elements at the distal
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`end of the working cannula (NUVASIVE 1004 at 10:1-6), but does not expressly disclose
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`that the anchor elements should be “removably attached” to the working cannula. As de-
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`scribed in greater detail in the claim charts below, it was traditionally known in the prior art
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`that such anchor elements can be removably attached to a distal end of a cannula. For ex-
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`12
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`ample, McAfee plainly teaches the conventional configuration in which a ring bearing the
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`anchoring teeth is removably attached to the end of the working cannula. NUVASIVE 1009
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`at 3:37-41; FIGS. 2 and 5 (reproduced below, showing that the length and width of each an-
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`choring tooth is greater than the thickness); 5:63-67. Here, a person of ordinary skill in the
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`art would have been prompted to include McAfee’s removably attached anchoring tip on the
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`end of Jacobson’s working cannula for the reasons described in the claim chart below.
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`Regarding the claimed implant structure, Jacobson suggests a “fusion” procedure,
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`but does not specify the structure of the implant to be used. NUVASIVE 1004 at 6:13. A
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`number of prior art references, such as Michelson ‘247, explicitly show that a threaded spi-
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`nal implant should extend longitudinally across nearly the full disc space in the axial direc-
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`tion of insertion. NUVASIVE 1008 at FIG. 5; NUVASIVE 1001 at ¶ 28-29. Thus, when such
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`a fusion implant is inserted laterally (in accordance with Jacobson’s method), the threaded
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`implant would extend longitudinally across nearly the full disc space in the axial direction of
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`insertion for the multiple reasons described in in the claim chart below. NUVASIVE 1001 at
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`¶ 28-29. As described herein, there is a reasonable likelihood that claim 9 is unpatentable
`
`based upon Jacobson in view of Leu, McAfee, and Michelson ‘247.
`
`Also, as described below under Ground 7, claims 9-16 are not entitled to the earliest
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`claimed priority of Feb. 25, 1995. Thus, there is a reasonable likelihood that claims 9-16 are
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`unpatentable based upon the obvious combination of Michelson ‘661 in view of McAfee and
`
`Lynn (wherein Michelson ‘661, McAfee and Lynn are prior art under § 102(b) or § 102(e)
`
`13
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`(for Lynn) for Ground 7).
`
`RLP for Claims 17-23
`
`Regarding Grounds 3-4, Jacobson discloses nearly all features recited in claim 17,
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`except for the use of sequential dilators over Jacobson’s guide needle (in lieu of Jacobson’s
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`speculum 10), and the traditional structure of a fusion implant. Similar to the ‘997 patent,
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`Jacobson discloses virtually the same method of use for the guide needle or wire 8 (first in-
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`strument), the working cannula 12 (third instrument), and the direct lateral access path.
`
`NUVASIVE 1004 at FIGS. 3 and 8; 2:23-33; 2:40-43; 6:13. As described above (and as de-
`
`scribed 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.
`
`Regarding the claimed implant structure, Jacobson suggests a “fusion” procedure
`
`but does not specify the structure of the implant to be used. NUVASIVE 1004 at 6:13. A
`
`number of prior art references, such as Brantigan, show that when a traditional fusion im-
`
`plant is inserted laterally (in accordance with Jacobson’s method), the implant should in-
`
`clude the basic structural elements recited in claim 17 and the implant length should be
`
`sized to reach the “perimeter of the vertebrae.” NUVASIVE 1006 at 2:2-4; 2:64-66; FIG. 10.
`
`For the reasons described below (Ground 3), there is a reasonable likelihood that claim 17
`
`of the `997 patent is unpatentable based upon Jacobson in view of Leu and Brantigan.
`
`14
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`Also, as described below under Ground 8, claims 17-23 are not entitled to the earli-
`
`est claimed priority of Feb. 25, 1995. Thus, there is a reasonable likelihood that claim 17 of
`
`the `997 patent is unpatentable based upon the obvious combination of Michelson ‘661 in
`
`view of Lynn (wherein Michelson ‘661 and Lynn are prior art under § 102(b) or § 102(e) (for
`
`Lynn) for Ground 8).
`
`RLP for Claims 24-30
`
`Regarding Grounds 5-6, Jacobson discloses nearly all features recited in claim 24,
`
`except for the use of sequential dilators over Jacobson’s guide needle (in lieu of Jacobson’s
`
`speculum 10), the three elongated portions at the distal end of the working tube, and the
`
`traditional structure of a fusion implant. Again, Jacobson discloses the virtually the same
`
`method of use for the guide needle or wire 8 (first instrument), the working cannula 12 (third
`
`instrument), and the direct lateral access path. NUVASIVE 1004 at FIGS. 3 and 8; 2: 23-33;
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`2: 40-43; 6:13. As previously described above (and as described in greater detail in the
`
`claim charts below), a person of ordinary skill in the art would have been prompted (espe-
`
`cially by the early 1990s) to replace Jacobson’s speculum with sequential dilators (as sug-
`
`gested 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.
`
`Regarding the “first, second, and third elongated portions” of the third surgical in-
`
`strument (the outer tube), Jacobson also suggests using anchor elements are at the distal
`
`end of the working cannula (NUVASIVE 1004 at 10:1-6), but does not expressly illustrate
`
`15
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`the dimensions of those anchor elements. Such conventional anchor elements, however,
`
`commonly included the structural features of the claimed first, second, and third elongated
`
`portion