Paper No. ____
`Filed: April 17, 2019
`
`
`Filed on behalf of: NuVasive, Inc.
`By: Michael T. Rosato (mrosato@wsgr.com)
`
`Paul D. Tripodi II (ptripodi@wsgr.com)
`
`Jad A. Mills (jmills@wsgr.com)
`
`Sonja R. Gerrard (sgerrard@wsgr.com)
`
`Wilson Sonsini Goodrich & Rosati
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.
`Petitioners,
`
`v.
`
`NUVASIVE, INC.,
`Patent Owner.
`_____________________________
`
`Case No. IPR2019-00362
`Patent No. 8,361,156
`_____________________________
`
`
`PATENT OWNER PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.107
`
`

`

`Table of Contents
`
`I. 
`
`II. 
`
`Page
`Introduction ...................................................................................................... 1 
`A. 
`The Challenged Patent .......................................................................... 3 
`B. 
`Claim Construction ............................................................................... 7 
`The Board Should Deny the Petition under 35 U.S.C. § 325(d) ................... 10 
`A. 
`The Prosecution History ...................................................................... 10 
`B. 
`The Becton, Dickinson Factors ............................................................ 14 
`III.  The Board Should Deny the Petition Under 35 U.S.C. § 314 ....................... 21 
`A. 
`Prior Petitions Challenging ’156 Patent .............................................. 21 
`B. 
`IPRs of Related U.S. Patent No. 8,187,334 ........................................ 24 
`C. 
`The General Plastic Factors ................................................................ 27 
`IV.  Both Grounds Fail For All Claims Because They Are Based On a
`Misreading of Baccelli. .................................................................................. 34 
`A. 
`Petitioners’ challenges fail because Baccelli does not disclose
`the claimed radiopaque marker configuration ..................................... 34 
`Petitioners’ challenges fail to establish motivation to employ
`Baccelli’s marker configuration on a lateral, lumbar implant. ........... 39 
`Petitioners’ challenges fail to establish that employing
`Baccelli’s marker configuration on Brantigan would satisfy the
`claimed marker configuration. ............................................................ 41 
`Petitioners’ challenges fail to establish motivation to modify
`Baccelli’s marker configuration such that it would satisfy the
`claimed marker configuration. ............................................................ 43 
`Both grounds fail for claims 2, 3, and 22. ........................................... 47 
`E. 
`Petitioners’ Challenges to Claim 9 Fail ......................................................... 48 
`
`V. 
`
`B. 
`
`C. 
`
`D. 
`
`-i-
`
`

`

`C. 
`
`A. 
`B. 
`
`The Ground 1 Challenge to Claim 9 Fails .......................................... 48 
`Ground 2 fails for lack of motivation to modify Brantigan’s
`maximum lateral width to be 18 mm .................................................. 50 
`Ground 2 fails to explain how cutting Brantigan’s implant in
`half longitudinally would result in a modular member satisfying
`the claim requirements. ....................................................................... 55 
`VI.  Petitioners’ Judicial Estoppel Arguments Fail .............................................. 58 
`VIII.  Conclusion ..................................................................................................... 62 
`IX.  Appendix – List of Exhibits ........................................................................... 64
`
`-ii-
`
`

`

`I.
`
`INTRODUCTION
`The Petition should be denied because it fails to establish a reasonable
`
`likelihood of proving the challenged claims are unpatentable. This is the fourth
`
`petition to challenge the same claims. Petitioners enjoyed years of hindsight
`
`(including decades as NuVasive employees) and used prior Board decisions,
`
`NuVasive’s briefing, and the Federal Circuit’s decision as a roadmap for drafting
`
`their Petition. Despite this advantage, the present Petition suffers from the same
`
`fatal errors that previously led the Federal Circuit to vacate the prior Board
`
`decision finding the same challenged claims unpatentable. In re NuVasive, Inc.,
`
`842 F.3d 1376, 1383-85 (Fed. Cir. 2016). The Board should exercise its discretion
`
`to deny institution instead of rehash the same hindsight-driven arguments that the
`
`Federal Circuit already rejected.
`
`Even if considered on the merits, Petitioners’ Grounds both fail. Petitioners’
`
`argument that “[t]here was nothing new in the ’156 patent” (Pet. at 1-2) is
`
`contradicted by the content of the Petition, which does not even assert the claims
`
`are anticipated (they are not). Moreover, none of the references identified by
`
`Petitioner discloses first and second radiopaque markers located respectively in the
`
`first and second sidewalls of the spinal fusion implant wherein each marker is
`
`located at a position proximate to the medial plane as required by all claims of
`
`the ’156 patent. Likewise, no reference identified by Petitioner articulates a
`
`-1-
`
`

`

`rationale for incorporating this untaught feature into any implant, much less into an
`
`implant with the several, remaining claimed features.
`
`Both Grounds 1 and 2 also fail specifically with respect to claim 9. Ground
`
`2 fails because Petitioners ignore the Board’s prior findings about the maximum
`
`lateral width of a lateral implant as disclosed by Michelson ’973, the very
`
`reference Petitioners rely upon again here. The Patent Office has repeatedly
`
`considered Michelson ’973 when evaluating the patentability of claim 18,
`
`including during prosecution and in two prior IPRs. When it previously evaluated
`
`claim 18 over Frey ’550 (Ex. 1040) in view of Michelson ’973 (Ex. 1032) and
`
`vertebral body dimensions, the Board rejected the argument that a POSA would
`
`enlarge the implant to match vertebral body dimensions and instead concluded that
`
`a POSA would use the same longitudinal length and maximum lateral width that
`
`Michelson’973 disclosed for lateral lumbar implants. The Board thus concluded
`
`that a modular member for Michelson’s preferred lumbar implant would have a
`
`maximum lateral width of, “at most,” 13 mm. The Federal Circuit agreed.
`
`Even at the top end of Michelson’s width range for a lumbar implant (32
`
`mm), the modular member formed by cutting the implant in half would be at most
`
`16 mm, not approximately 18 mm. Petitioners fail to present any reason why the
`
`Board should abandon its earlier reasoning and adopt an inconsistent conclusion;
`
`-2-
`
`

`

`particularly in light of the Board’s finding that Michelson ’973 taught that further
`
`expansion of the implant presented serious dangers to the patient.
`
`Petitioners’ Ground 2 challenge to claim 9 also fails because Petitioners fail
`
`to explain how cutting Brantigan’s implant in half longitudinally would result in a
`
`modular member satisfying the requirements of claim 1. Petitioners’ Ground 1
`
`challenge to claim 9 fails because Petitioners fail to establish that the disc space
`
`between the T1 and T2 vertebrae has a depth of approximately 18 mm.
`
`For the reasons discussed above, the Petition should be denied on the merits.
`
`The Petition also should be denied under 35 U.S.C. § 325(d) or 35 U.S.C. § 314(a)
`
`because it is cumulative to prior challenges and because revisiting the art and
`
`issues already considered multiple times is a poor use of Board resources.
`
`A. The Challenged Patent
`The claims of U.S. Patent No. 8,361,156 require, among other things,
`
`a spinal implant that is elongated in the direction of insertion and has two
`
`markers located in the sidewalls of the implant near its medial plane.1 As
`
`shown in Petitioners’ annotated Fig. 2 (Pet. 5), the medial plane must be
`
`perpendicular to the longest length of the implant, which longest length must
`
`
`
`1 For the purposes of this preliminary response, NuVasive does not assert a
`
`different level of skill than that asserted (Pet. 28) by Petitioners.
`
`-3-
`
`

`

`run between the proximal and distal ends of the implant (i.e., in the direction
`
`of insertion):
`
`
`
`As explained in the patent, this implant is particularly well suited for
`
`introduction into the lumbar disc space via a lateral (trans-psoas) approach.
`
`Ex. 1001, 5:29-35.
`
`Although the ’156 patent specification describes a number of implants,
`
`including some that have shapes and sizes specifically for cervical spine and/or
`
`insertion from the back of the patient, see Ex. 1001, 2:12-14, 5:29-35, the implants
`
`claimed in the ’156 patent possess features that are specific to lateral, trans-psoas
`
`insertion into the spine. For example, Claim 1 requires, among other things:
`
`[A] distal wall, a proximal wall, a first sidewall, and a second
`sidewall generally opposite from the first sidewall, wherein said distal
`wall, proximal wall, first sidewall, and second sidewall comprise a
`radiolucent material;
`wherein said implant has a longitudinal length extending from a
`proximal end of said proximal wall to a distal end of said distal wall,
`said implant has a maximum lateral width extending from said first
`-4-
`
`

`

`sidewall to said second sidewall along a medial plane that is generally
`perpendicular to said longitudinal length, and said longitudinal length
`is greater than said maximum lateral width;
`***
`at least first and second radiopaque markers oriented generally
`parallel to a height of the implant, wherein said first radiopaque
`marker extends into said first sidewall at a position proximate to said
`medial plane, and said second radiopaque marker extends into said
`second sidewall at a position proximate to said medial plane.
`Id. at 12:40-67.Claims 2-27 depend directly or indirectly from claim 1.
`
`Contrary to Petitioners’ assertions (Pet. 2), cervical implants, such as
`
`those depicted in Figs. 10-15 and Figs. 22-23 (Ex. 1001, 25; 4:5-32, 4:48-52,
`
`8:66-9:3), are not within the scope of any of claims 1-27 of the ’156 patent
`
`for several reasons. First, the implants depicted in those figures do not
`
`possess a length between the proximal end of the proximal wall and the
`
`distal end of the distal walls (the direction of insertion) that is greater than
`
`the maximum lateral width extending from the first sidewall to the second
`
`sidewall. Id. at 11:67-12:3 (implant 110 in Fig. 22 is “dimensioned
`
`particularly for use in the cervical spine” and has “a width of approximately
`
`11 mm, a height ranging between 5 and 12 mm, and a length of
`
`approximately 14 mm.”). Second, those implants do not comprise a
`
`-5-
`
`

`

`radiopaque marker on each sidewall at a position proximate to the medial
`
`plane.
`
`Figures 18-19 depict a posterior lumbar interbody fusion (PLIF)
`
`implant comprising one radiopaque marker (7, 8) at each of the proximal and
`
`distal ends of the implant. The ’156 patent states that the implant in Fig. 18
`
`is “dimensioned particularly for use in a posterior approach (PLIF) having
`
`(by way of example only) a width ranging between 9 and 11 mm, a height
`
`ranging between 8 and 14 mm, and a length ranging between 25 and 30 mm.”
`
`Id. at 11:50-54. The implants of Figs. 18-19 do not fall within the scope of
`
`the claims of the ’156 patent at least because they have no radiopaque
`
`markers proximate to the medial plane. Id. at 11:48-58.
`
`In contrast, Figs. 20-21 disclose an implant “dimensioned particularly for
`
`use in a lateral lumbar approach (XLIFTM by NuVasive) having (by way of
`
`example only) a width of approximately 18 mm, a height ranging between 8 and 16
`
`mm, and a length ranging between 40 and 45 mm.” Id. at 11:58-63; see also id. at
`
`3:32-61, 4:40-47, 5:15-19 (Figures 1-6 and 18-21 depict lumbar implants). Figures
`
`20-21 depict the implant elongated in the direction of insertion and comprising two
`
`radiopaque markers (7, 8) at each of the proximal and distal ends and two more
`
`radiopaque markers (9) on the medial plane of the implant 10 (for a total of six
`
`markers).
`
`-6-
`
`

`

`B. Claim Construction
`Petitioners assert that the claims should be construed according to the
`
`Phillips standard, should be given their plain and ordinary meaning, and offer no
`
`claim constructions. Pet. 26.
`
`Claim 1 provides, among other things, that the claimed implant comprises:
`
`a longitudinal length extending from a proximal end of said
`proximal wall to a distal end of said distal wall, said implant has a
`maximum lateral width extending from said first sidewall to said
`second sidewall along a medial plane that is generally perpendicular
`to said longitudinal length, and said longitudinal length is greater than
`said maximum lateral width; [and]
`...
`
`at least first and second radiopaque markers oriented generally
`parallel to a height of the implant, wherein said first radiopaque
`marker extends into said first sidewall at a position proximate to said
`medial plane, and said second radiopaque marker extends into said
`second sidewall at a position proximate to said medial plane.
`Ex. 1001, 12:45-51, 12:62-67 (emphases added). Petitioners’
`
`annotated Fig. 2 from the ’156 patent (Pet. 5) illustrate that the claims
`
`require that the medial plane be perpendicular to the longest length of the
`
`implant, which longest length must run between the proximal and distal ends
`
`of the implant (i.e., in the direction of insertion):
`
`-7-
`
`

`

`
`
`These claim terms are discussed in further detail below.
`
`“longitudinal length”
`
`“Longitudinal” means “extending lengthwise.” Ex. 2009, 424. Read as a
`
`whole, claim 1 defines the “longitudinal length” of the implant as meaning “a
`
`dimension of the implant that extends lengthwise and is greater than the maximum
`
`lateral width of the implant.” In the claimed implant, the longitudinal length of the
`
`implant must extend from a proximal end of the proximal wall of the implant to a
`
`distal end of the distal wall of the implant, meaning the dimension of the implant in
`
`the direction of insertion must be greater than the greatest dimension that is
`
`orthogonal to the direction of insertion.
`
`“medial plane”
`
`The plain meaning of “medial” is an adjectival form for “middle.” Ex. 2009,
`
`446. The term “a medial plane” as recited in claim 1 as a whole thus means “a
`
`-8-
`
`

`

`plane that intersects the implant approximately at the midpoint of the longitudinal
`
`length.” In the claimed implant, the medial plane must be “generally perpendicular”
`
`to the longitudinal length of the implant. The term “said medial plane” in claims 1
`
`and 16 has the same meaning as “a medial plane” as just discussed.
`
`This construction is consistent with the Board’s non-institution decision in
`
`IPR2013-00504. The Board stated that the term medial plane means “a plane that
`
`intersects the implant approximately at the midpoint of the longitudinal length.” Ex.
`
`1041 at 5, 8. This construction is also consistent with Petitioners’ agreed
`
`construction of terms of the ’156 patent in their co-pending district court litigation.
`
`In that case, the parties agreed (1) “medial plane that is generally perpendicular to
`
`said longitudinal length” means “plane that is generally perpendicular to and
`
`intersects with said longitudinal length at the midline of the longitudinal length,”
`
`and (2) “said medial plane” means “plane that is generally perpendicular to and
`
`intersects with said longitudinal length at the middle or midline of the longitudinal
`
`length.” Ex. 2010 at 21, 23; see also Pet. 76 (providing case number for co-
`
`pending litigation).
`
`Because the medial plane must be generally perpendicular to the
`
`longitudinal length of the implant, a plane that is parallel to the longitudinal length
`
`of the implant is not a “medial plane” as required by the claims of the ’156 patent.
`
`-9-
`
`

`

`“position proximate to said medial plane”
`
`The plain meaning of “proximate” is “near.” Ex. 2009, 581. The term
`
`“position proximate to said medial plane” as recited in claim 1 as a whole thus
`
`means a “position near the medial plane.”
`
`Because the medial plane is generally perpendicular to the longitudinal
`
`length of the implant and intersects with the longitudinal length of the implant at
`
`the middle of that longitudinal length, a marker positioned at the intersection of
`
`one of the proximal or distal walls and one of the first or second sidewalls of the
`
`implant is not proximate the medial plane.
`
`II.
`
`THE BOARD SHOULD DENY THE PETITION UNDER 35 U.S.C. § 325(D)
`Congress gave the Board express discretion to deny institution where “the
`
`same or substantially the same prior art or arguments previously were presented to
`
`the Office.” 35 U.S.C. § 325(d). As discussed below, the Patent Office previously
`
`considered the same or substantially the same prior art or arguments.
`
`A. The Prosecution History
`The ’156 patent issued on January 29, 2013 from U.S. Application No.
`
`13/441,092. The ’092 application is a continuation of U.S. Application No.
`
`11/093,409 via U.S. Application Nos. 13/440,062 and 13/079,645. These parent
`
`applications resulted respectively in U.S. Patent Nos. 7,918,891, 8,246,686, and
`
`-10-
`
`

`

`8,187,334.2 The prosecution of these parent applications is informative with
`
`respect to the prior art and the novelty of the ’156 patent claims.
`
`Prosecution of the ’409 application
`1.
`During prosecution of the ’409 application, the examiners repeatedly
`
`scrutinized the claims. Pending claims were rejected variously over U.S. Patent
`
`Nos. 5,860,973 to Michelson (Ex. 1032), 6,830,570 to Frey et al. (Ex. 2004),
`
`4,349,921 to Kuntz (Ex. 2005), and 6,159,211 to Boriani et al. (Ex. 2006). Ex.
`
`1020 at 245, 247-50, 271-73. The examiner relied on Kuntz for disclosure of an
`
`implant made of a radiolucent material and which comprises a radiopaque marker
`
`
`
`2 The ’156 patent claims priority to Application No. 60/557,536. Petitioners
`
`assert their grounds do not require a determination of this priority date, but also
`
`argue that the claims lack entitlement to this priority date. Pet. 14-15, 26.
`
`Petitioners are incorrect. The claims are supported by the provisional. Ex. 1026 at
`
`7:18-21, 10:1-20, 14:5-14 (lumbar implant 10 of Figs. 1-5 with longest dimension
`
`“ranging between 25 and 45 mm”); Id. at 16:11-14 & 33-37 Figs. 1-5 (depicting
`
`longest dimension between the proximal side 22 and the distal side 16); Id. at 14:8-
`
`11, 16:1-4, 17:11-14. 17:17-21, 34-38 Figs. 2-6 (describing x-ray of radiolucent
`
`PEEK implant and using radiopaque spikes on the medial plane).
`
`
`
`-11-
`
`

`

`to confirm the position of the prosthesis radiologically. Id. at 249, 274-75.
`
`Applicants responded by amending the claims to require radiopaque markers in the
`
`distal side, proximal side, and medial support. Id. at 224-26, 230. On February 16,
`
`2011, after nearly six years of prosecution, the examiner allowed the issued claims.
`
`Id. at 105-109.
`
`Prosecution of the ’645 application
`2.
`During prosecution of the ’645 application, the examiner “contacted
`
`Applicants’ representative to discuss differences between the present claims and
`
`the allowed claims in the parent application.” Ex. 1023 at 211. The examiner
`
`subsequently issued a notice of allowance. Id. at 212-13.
`
`Prosecution of the ’062 application
`3.
`During prosecution of the ’062 application, the examiner considered U.S.
`
`Patent No. 5,192,327 to Brantigan (Ex. 1007), Michelson ’973 (Ex. 1032), and
`
`Berry (Ex. 1022), cited additional references from his own prior art search, and
`
`indicated that he had reviewed the search from the parent cases. Ex. 1025 at 120,
`
`123, 128, 111-14. He also called Applicants’ representative to discuss Garcia and
`
`Villiers, respectively U.S. Patent Application Publication Nos. 2008/0015701 (Ex.
`
`2007) and 2012/0078374 (Ex. 2008). Id. at 104, 112. Garcia discloses an implant
`
`made of PEEK , which is substantially transparent to X-Rays. Ex. 2007, [0076].
`
`Garcia also states that X-ray sensitive material may be located near the anterior and
`
`-12-
`
`

`

`posterior (distal and proximal) ends of the implant so that “the position of an
`
`implant [can] be visualized using X-ray imaging.” Id.; see also id., [0091]. Figures
`
`7 and 8 of Garcia are reproduced below:
`
`
`
`Villiers relates to a “spinal midline indicator” that has a body of radiolucent
`
`materials for insertion between two adjacent vertebrae and a radiographic marker
`
`(12) located centrally with the body to indicate the position of the spinal midline
`
`(22) in anterior-posterior images when the body is centrally located between the
`
`vertebrae. Ex. 2008, abstract. Villiers states: “By ensuring that the markers 16 are
`
`equidistantly laterally spaced from the osseous edges 23 of the vertebrae, i.e. that
`
`the distance 25 is the same on both sides, the surgeon can ensure that the body 14
`
`and handle 12 are centrally positioned.” Id. at [0021]. Villiers states that central
`
`positioning of the body and handle are important for “cage or spinal disc
`
`replacement procedure[s] carried out anteriorly[.]” Id. at [0019].
`
`-13-
`
`

`

`The Examiner stated that he discussed an amendment with applicants to
`
`“recite the specific placement of the marker parallel to the height of the implant, in
`
`contrast to the perpendicular markers of Villiers” in order to “overcome the
`
`teaching of Villiers regarding a medially placed marker.” Ex. 1025 at 104. The
`
`examiner amended the claims accordingly via examiner amendment and issued a
`
`notice of allowance. Id. at 106-07.
`
`Prosecution of the ’156 patent
`4.
`During prosecution of the ’156 patent, examiner Stuart S. Bray again
`
`considered Brantigan (Ex. 1007), Michelson ’973 (Ex. 1032) and Berry (Ex. 1022).
`
`Ex. 1013 at 393, 396, 401. He also considered Kuntz (Ex. 2005), Garcia (Ex.
`
`2007), and Villiers (Ex. 2008). Ex. 1013 at 196, 200-01. Consistent with the
`
`parent prosecution histories, the examiner’s statement of allowance noted: “the
`
`claims in the instant application have not been rejected using prior art because no
`
`reference or reasonable combination thereof could be found which disclose or
`
`suggest a spinal fusion implant with a longitudinal length that is greater than the
`
`maximum width and with two radiopaque markers parallel to an implant heights, in
`
`the sidewalls of the implant.” Id. at 193.
`
`B.
`The Becton, Dickinson Factors
`The Board has identified six factors to consider when determining whether
`
`to exercise its discretion under 35 U.S.C. § 325(d). Becton, Dickinson and Co. v. B.
`
`-14-
`
`

`

`Braun Melsungen AG, IPR2017-01586, Paper 8, at 16-18 (informative).
`
`Petitioners did not identify or analyze the Becton Dickinson factors, but argue that
`
`the “grounds for trial are not cumulative.” Pet. 25-26. Petitioners are incorrect.
`
`The Board should exercise its discretion to deny institution.
`
`Brantigan, Berry, and Michelson ’973 Were Previously
`1.
`Considered
`The first factor is the similarities and material differences between the
`
`asserted art and the previously-considered art. The ’156 patent cites Brantigan (Ex.
`
`1007), Michelson ’973 (Ex. 1032) and Berry (Ex. 1022). Ex. 1001 at 2-3. Only
`
`Baccelli was not cited during prosecution but, as discussed below, Baccelli is
`
`cumulative. In this case, the first factor favors denying institution under § 325(d).
`
`See Cultec, Inc. v. Stormtech LLC, IPR2017-00777, Paper 7, at 8-13 (informative)
`
`(denying institution where reference was used to reject a related patent and
`
`references were listed on IDS).
`
`Brantigan and Baccelli are Cumulative
`2.
`The second factor is whether the asserted references are cumulative to
`
`previous references. The Patent Office issued the challenged claims after a
`
`thorough review of the prior art failed to turn up any reference disclosing the
`
`claimed marker configuration for the claim implant. Petitioners place great weight
`
`on their argument that Baccelli was not considered during prosecution and that
`
`Brantigan was not a basis of rejection. Pet. 25-26. But the examiner considered at
`
`-15-
`
`

`

`least three references discussing the use of radiopaque markers on radiolucent
`
`spinal implants. After extensive consideration of the prior art, including Brantigan,
`
`Berry, Michelson ’973, Kuntz, Garcia and Villiers, the examiner allowed the
`
`claims of the ’156 patent because no reference disclosed the claimed marker
`
`configuration for the claimed implant. Ex. 1013, 190-93.
`
`Brantigan and Baccelli are cumulative to the references considered during
`
`prosecution because they too do not disclose the claimed marker configuration for
`
`the claimed implant. As discussed below in § IV.A, Baccelli discloses markers
`
`only on the proximal and distal ends of the implant, with the marker on the
`
`proximal end being offset from the marker on the distal end and located on the left
`
`side of the implant (as viewed in the posterior-anterior direction). Baccelli
`
`discloses that spikes 24 can be placed in these locations, but does not disclose,
`
`teach, or suggest placing markers where the spikes 24 are depicted in Baccelli’s
`
`figures or employing Baccelli’s marker configuration on a lateral, lumbar implant.
`
`Baccelli and Brantigan are cumulative of Kuntz, which reference the
`
`examiner considered during prosecution of the ’156 patent. Ex. 1013, 201. Claims
`
`in the parent ’409 application had previously been rejected over Kuntz in
`
`combination with Michelson ’973. Ex. 1020 at 245, 247-50, 271-73. The
`
`examiner had relied on Kuntz to disclose the use of a radiopaque marker to
`
`confirm the position of an implant made of a radiolucent material. Id. at 274-75;
`
`-16-
`
`

`

`Ex. 2005, 7:56-60. But applicants traversed Kuntz. Ex. 1020 at 224-26, 230, 97,
`
`108-10. Petitioners state that the examiner allowed the parent claims because
`
`Kuntz did not specify placing the radiopaque marker in the claimed configuration.
`
`Pet. at 15-16.
`
`During prosecution of the ’156 patent, the examiner also considered
`
`radiopaque markers in the Garcia and Villiers references. Ex. 1013 at 196. During
`
`prosecution of the related ’062 application, the examiner indicated that he had
`
`reviewed the search from the parent cases, cited Garcia and Villiers, and called
`
`Applicants’ representative to discuss Garcia and Villiers. Ex. 1025 at 104, 112,
`
`114.
`
`Brantigan and Baccelli are cumulative to Garcia. Garcia discloses a PLIF
`
`implant that is “substantially transparent to X-rays” when made from PEEK and
`
`the “use of X-ray sensitive material” in openings 68 on the distal and proximal
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`ends, as shown below. Ex. 2007, [0060], [0076], Figs. 7-8; see also id. at [0074],
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`[0090].
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`-17-
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`
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`Baccelli, like Garcia, SVS-PR and Telamon, discloses markers at the distal and
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`proximal ends of the implant, not on the sidewalls proximate the medial plane.
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`Brantigan and Baccelli are also cumulative to Villiers. Villiers states that
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`central positioning of the body and handle are important for “cage or spinal disc
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`replacement procedure[s] carried out anteriorly[.]” Ex. 2008, [0019]. Baccelli, like
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`Villiers, does not disclose the claimed marker configuration and does not disclose
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`any marker configuration for the claimed implant. See §§ IV.A-D, infra. Villiers,
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`like Baccelli, addresses alignment considerations for anterior implants. Neither
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`Baccelli nor any known reference teaches that markers on laterally- or posteriorly-
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`inserted implants should be aligned with the spinous process.
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`The cumulative nature of the asserted art, and Petitioners’ failure to address
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`it, favors non-institution. Sandoz, Inc. v. Genentech, Inc., IPR2017-02036, Paper
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`13, at 5-9 (denying institution because “Petitioner has not explained why such
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`discretion should not be exercised”).
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`Extent of Consideration
`3.
`The third factor is the extent to which the same or cumulative references
`
`were evaluated during examination. As discussed above, each of Brantigan, Berry,
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`and Michelson ’973 were considered by an active and engaged examiner during
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`prosecution of the ’156 patent. Furthermore, identical (Michelson ’973) or
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`cumulative references (Garcia, Villiers, Kuntz) were asserted by the examiners
`
`during prosecution of the parent applications. This factor likewise weighs against
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`non-institution.
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`Overlap of Arguments
`4.
`The fourth factor is the overlap between the arguments during examination
`
`and how petitioners rely on the prior art. Petitioners advance the same argument
`
`that disclosure of different radiopaque marker configurations on different implants
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`renders the claimed radiopaque marker configuration obvious on the claimed
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`implant. This is the same issue the Patent Office disposed of during examination.
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`This factor weighs against institution.
`
`No Demonstration of Examiner Error
`5.
`The fifth factor is whether petitioners have demonstrated the examiner erred
`
`in evaluating the asserted art. Petitioners identify no error. Baccelli does not
`
`disclose radiopaque markers on the medial plane of the claimed implant. See §
`
`IV.A, infra. Baccelli does not teach or suggest the markers for its horseshoe-
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`shaped, anteriorly-inserted cervical implants should be applied to implants such as
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`

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`Brantigan’s or for implants adapted for lateral insertion. See § IV.B, supra. The
`
`examiner’s statement of reasons for allowance (Ex. 1013 at 193) remains true
`
`today in light of the prior art asserted in the Petition, including Baccelli.
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`Petitioners’ failure to demonstrate examiner error weighs against institution.
`
`No New Petition Evidence
`6.
`The sixth factor is whether new petition evidence warrants reconsideration.
`
`As discussed above, Petitioners’ argument impermissibly relies upon post-filing
`
`date arguments made by NuVasive as evidence of what would have been known by
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`a POSA and cites no evidence other than unsupported ipse dixit to support its
`
`conclusion. Petitioners rely on Baccelli as new evidence, but this reference is
`
`cumulative as discussed above. Moreover, Petitioners failed to support their
`
`assertions about Baccelli even though they had reviewed an expert declaration in
`
`their district court litigation with NuVasive that pointed out that Baccelli’s markers
`
`are not on the sidewalls along the medial plane and that Baccelli provides no
`
`motivation to employ the claimed marker configuration for a lateral or posterior
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`implant. Ex. 2015, ¶¶ 232-236, 269-273, 308-311, 368-371. Petitioners’ failure to
`
`provide new evidence weighs against institution.
`
`Accordingly, NuVasive respectfully requests that the Board exercise its
`
`discretion and deny institution under 35 U.S.C. § 325(d).
`
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`

`

`III. THE BOARD SHOULD DENY THE PETITION UNDER 35 U.S.C. § 314
`35 U.S.C. § 314(a), (d) afford the Board unreviewable discretion to deny
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`institution. Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1366 (Fed. Cir.
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`2016); see also SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018). As
`
`discussed below, instituting this Petition would not be an efficient use of Board
`
`resources because the Petition contradicts, without adequate justification, prior
`
`findings of the Board that were affirmed by the Federal Circuit and because the
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`Petition fails to address major defects in its case despite having improperly
`
`obtained strategic advantage by reviewing NuVasive’s briefing in prior IPRs
`
`challenging this very same patent using many of the same references.
`
`A.
`Prior Petitions Challenging ’156 Patent
`The present petition is the fourth IPR petition filed to challenge the same
`
`claims of the ’156 patent. Each of the three previous IPR petitions failed. The first
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`two—IPR2013-00504 and IPR2014-00487—were denied institution.
`
`In the one petition that accomplished institution—IPR2013-00506—the
`
`Board instituted the IPR based on SVS-PR in combination with Baccelli for claims
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`1-4, 7, 8, 10-14, 19, 20, 23, 24, 26, and 27, in further combination with
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`Michelson ’973 for claims 5, 6, 9, and in further combination with Telamon for
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`claim 25. Ex. 1031 at 12, 14-15. Also, the Board instituted review of claims 1-4, 7,
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`10-14, 19, 20, and 23-27, based on Telamon and Baccelli, and in further
`
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`

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`combination with Michelson ’973 for claims 5, 6, 8, and 9. Id. at 19. Following
`
`trial, the Board issued a fin