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`Paper No. ____
`Filed: March 2, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.,
`Petitioners,
`
`v.
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`NUVASIVE, INC.,
`Patent Owner.
`_____________________________
`
`Case No. IPR2019-00362
`Patent No. 8,361,156
`_____________________________
`
`PATENT OWNER’S SUR-REPLY
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`TABLE OF CONTENTS
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`I.
`II.
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`III.
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`Page
`INTRODUCTION .......................................................................................... 1
`PETITIONER FAILS TO MEET ITS BURDEN ON CLAIM
`CONSTRUCTION ......................................................................................... 2
`PETITIONER CONCEDES THAT BACCELLI DOES NOT
`TEACH THE CLAIMED MARKER CONFIGURATION ........................... 3
`IV. PETITIONER DOES NOT REBUT THAT ITS
`RADIOPAQUE MARKER RATIONALE IS BASED
`WHOLLY ON HINDSIGHT ......................................................................... 6
`PETITIONER ABANDONS ITS GROUNDS REFERENCES
`AND PROPOSED MODIFICATIONS ......................................................... 9
`A.
`Petitioner Abandons Brantigan and Berry ........................................... 9
`B. Modularity of Michelson .................................................................... 12
`VI. PETITIONER FAILS TO ESTABLISH BRANTIGAN
`SATISFIES THE CLAIMED APERTURE DIMENSIONAL
`LIMITATIONS ............................................................................................. 16
`VII. OBJECTIVE INDICIA CONFIRM PATENTABILITY ............................. 19
`VIII. CONCLUSION ............................................................................................. 20
`IX. APPENDIX – LIST OF EXHIBITS ............................................................. 23
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`V.
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`I.
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`INTRODUCTION
`Petitioner has no response for the numerous fatal flaws that NuVasive and
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`the Board identified in the petition. Because the claimed implant is unlike those of
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`the prior art, Petitioner seeks to create confusion to distract from deficiencies of its
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`case-in-chief.
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`The petition relied on Baccelli for the claimed radiopaque marker
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`configuration. In Reply, Petitioner concedes that Baccelli does not teach the
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`radiopaque marker configuration recited by all challenged claims, but then argues
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`that it did not rely on Baccelli for this claim element.
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`As motivation to modify Brantigan to include radiopaque markers, the
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`petition parroted the same rationale that the Federal Circuit determined was
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`hindsight. Petitioner does not dispute this, but pivots to a new reference that has no
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`relevance to radiopaque markers.
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`Petitioner proposed that the reason for modifying Brantigan according to the
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`modular embodiment of Michelson was make the implant safer and less invasive.
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`NuVasive noted that this argument was wholly unsubstantiated and that there were
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`many reasons a multipiece modular combination would decrease safety and
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`increase invasiveness. The Reply fails to substantiate the petition’s proposed
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`motivation and does not dispute that sequential insertion would be more invasive
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`because, for example, it would involve “chewing up the endplate” or using
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`multiple surgical pathways. The Reply states that Petitioner “never” argued for
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`sequential insertion of modular pieces and then pivots to new references and new
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`arguments that were not included with the petition.
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`Petitioner’s remaining reply arguments are likewise improper and
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`unpersuasive. The Board should hold Petitioner failed to prove its case for each
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`challenged claim.
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`II.
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`PETITIONER FAILS TO MEET ITS BURDEN ON CLAIM
`CONSTRUCTION
`Petitioner bears the burden of establishing “how the challenged claim is to
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`be construed.” 37 C.F.R. § 42.104(b)(4); see also In re Magnum Oil Tools Int’l,
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`Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016). The petition however, is devoid of
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`analysis as to the conventional meaning of the claim terms. Petitioner merely
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`professes that the “plain and ordinary meaning” should be applied and cites
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`Phillips. Pet. 26.
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`Petitioner’s expert witness, Dr. Branch, did not apply the plain and ordinary
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`meaning to the challenged claims—that is, the meaning that the ordinary artisan
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`would apply after reading the entire patent. Phillips v. AWH Corp., 415 F.3d 1303,
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`1321 (Fed. Cir. 2005). In particular, Dr. Branch adopted a personal “convention”
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`for the term “longitudinal length” which he described as meaning whatever
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`dimension is between the proximal and distal ends, even if it is the shorter
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`dimension of the implant. EX2022, 52:5-56:9, 116:4-15, 114:3-19 (“my
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`convention”), 117:2 (“If I am going to stick to my convention”).
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`Nevertheless, and despite not bearing the burden, NuVasive provided a
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`detailed explanation of how the challenged claims should be construed. POR 4-8.
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`For example, NuVasive relied on the specification of the ’156 patent, the prior art
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`references, medical dictionaries, and the testimony of Drs. Youssef and McMillin
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`to establish that the ordinary meaning of “longitudinal” is the longest dimension of
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`the object. POR 4-8. NuVasive also showed that based on the specification of the
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`’156 patent, dictionaries, and the testimony of Drs. Youssef and McMillin that the
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`“medial plane” and “medial support” are located approximately at the midpoint of
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`the longitudinal length of the implant. POR 8-9.
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`Petitioner offers no rebuttal. Consequently, NuVasive’s evidence as to the
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`plain and ordinary meaning of “longitudinal length,” “medial plane,” and “medial
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`support” is conclusive. The Board may confirm the patentability of the challenged
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`claims on this basis alone.
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`III. PETITIONER CONCEDES THAT BACCELLI DOES NOT TEACH
`THE CLAIMED MARKER CONFIGURATION
`The petition relies on Baccelli for teaching a first and second radiopaque
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`marker proximate the medial plane, as required by all challenged claims. Pet. 49-
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`52. Petitioner pointed to spikes 24 of Baccelli and argued that these spikes are
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`located in the medial plane. Pet. 50-51 (annotated figures reproduced below).
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`At institution, the Board concluded that “Petitioner fails to demonstrate
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`sufficiently that Baccelli’s medial plane is located as recited in claim 1—
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`‘generally perpendicular to said longitudinal length’ and ‘is greater than said
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`maximum lateral width” that “extend[s] … along [the] medial plane’ (EX1001,
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`47–51)—and thus that Baccelli’s markers 24 (see Pet. 49–50 (citing Ex. 1008 ¶¶
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`41, 50–51, Figs. 1–2 (annotated)) are located ‘proximate to said medial plane’ (Ex.
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`1001, 12:63–67) as recited in claim 1.” Paper 18, 26-27. The Board went on to say
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`that “Petitioner needs to show Baccelli teaches or suggests the recited radiopaque
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`markers proximate the medial plane, which is (a) generally perpendicular to the
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`longitudinal length and (b) along where the maximum lateral width extends as
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`claim 1 recites.” Id., 27 (citing EX1001, 12:47–51).
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`NuVasive responded (POR 21) that the evidence the Board identified as
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`lacking is essential to the prima facie case and therefore represents a fatal defect in
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`Petitioner’s challenge. Nevertheless, NuVasive explained (POR 22-23) that the
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`dimension the petition identifies on the Baccelli implant as the longitudinal length
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`is not greater than the maximum lateral width. NuVasive also explained (POR 23)
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`that the alleged radiopaque spikes 24 are not on a plane perpendicular to the
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`longitudinal length as is required by claim 1. That is, NuVasive established that the
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`elements identified by the Board as missing from the petition are not taught by
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`Baccelli.
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`Petitioner does not even attempt to remedy the deficiencies identified by the
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`Board and NuVasive. Instead, Petitioner concedes (Reply 7) that it “is not asserting
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`that the Baccelli implant has a ‘longitudinal length that is greater than its maximum
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`lateral width.’” NuVasive accepts this concession and it is outcome determinative.
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`The Board may confirm the patentability of all challenged claims on the basis that
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`Baccelli does not disclose or teach the claimed radiopaque marker configuration.
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`Petitioner argues (Reply 7-8) that what Baccelli teaches is somehow related
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`to the direction in which Brantigan’s implants are inserted. But Baccelli discloses
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`that spikes 24 are “disposed symmetrically to each other about the sagittal
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`midplane.” EX1007, ¶41. The sagittal midplane divides the body into right and left
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`halves and is agnostic as to the direction of insertion of any implant. See, e.g.,
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`EX1002, ¶¶29-30.
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`IV. PETITIONER DOES NOT REBUT THAT ITS RADIOPAQUE
`MARKER RATIONALE IS BASED WHOLLY ON HINDSIGHT
`The petition relied on Baccelli as allegedly teaching radiopaque markers in
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`the medial plane of the implant. According to the petition, a POSA would have
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`been motivated to apply such a configuration to Brantigan in order to align the
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`markers with the spinous process. Pet. 31.
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`In Response (POR 25-26), NuVasive noted Baccelli does not teach or
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`suggest placing two markers proximate the medial plane and that the petition’s
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`rationale is based on nothing more than ipse dixit. Moreover, this rationale was
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`copied from the rationale rejected by the Federal Circuit as based wholly on
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`hindsight. In re NuVasive, Inc., 842 F.3d 1376, 1384 (Fed. Cir. 2016); see also
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`EX2028, ¶60; EX2017, 7:9-8:13.
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`Petitioner offers no meaningful rebuttal. Instead, Petitioner relies (Reply 7-
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`8) primarily on the claims of the challenged patent to provide “the coordinates”
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`needed to motivate translating Baccelli’s marker configuration into the claimed
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`marker configuration. Petitioner’s argument relies on the false premise that
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`Baccelli teaches the location of the spikes 24 depends on the direction of insertion
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`of the implant. But, as explained above, Baccelli has no such teaching. See Section
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`III.
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`Tacitly acknowledging that Baccelli fails to teach the claimed marker
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`configuration, Petitioner pivots (Reply 13) to new arguments based on “general
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`knowledge” and the new McAfee reference. These new arguments are improper.
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`As the Federal Circuit explained “[i]t is of the utmost importance that petitioners in
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`the IPR proceedings adhere to the requirement that the initial petition identify
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`‘with particularity’ the ‘evidence that supports the grounds for the challenge to
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`each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359,
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`1369 (Fed. Cir. 2016). “[T]he expedited nature of IPRs bring with it an obligation
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`for petitioners to make their case in their petition[.]” Id. A reply argument is thus
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`improper even if relies on the originally-cited grounds references but provides a
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`“new rationale” for their combination or modification. Id.; see also In re Leithem,
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`661 F.3d 1316, 1319 (Fed. Cir. 2011). A reply argument also is improper if it relies
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`on an embodiment of the prior art or an “obviousness theory” that was not
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`discussed in the petition. Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324,
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`1329-31 (Fed. Cir. 2019); Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d
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`1359, 1367 (Fed. Cir. 2015). Petitioner’s “general knowledge” and McAfee
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`arguments are improper new arguments and an improper attempt to fill a hole in
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`Petitioner’s prima facie case.
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`Indeed, where a petitioner wishes to rely on “the general knowledge” of a
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`POSA to supply a claim limitation or motivation to modify or combine, it must do
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`so expressly in the petition and must provide the evidence corroborating the
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`assertion in the petition. See Koninklijke Philips N.V. v. Google LLC, 2019-1177,
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`948 F3.d 1330, 1335-38 (Fed. Cir. 2020) (“it is the petition, not the Board’s
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`‘discretion,’ that defines the metes and bounds of an inter partes review”).
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`Conclusory assertions of an expert are insufficient. Id. at 1338 (discussing Arendi
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`S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1361-63, 1366 (Fed. Cir. 2016)).
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`Even if considered on the merits, Petitioner fails to demonstrate McAfee
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`supports its case. As an initial matter, the BAK cage disclosed by McAfee is itself
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`radiopaque and has no radiopaque markers. Therefore, McAfee does not teach
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`placement of markers proximate the medial plane or anywhere else. McAfee is
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`simply irrelevant to the petition’s argument, which was that Baccelli teaches and
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`motivates the claimed marker placement. Furthermore, the image in McAfee that
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`Petitioner relies on is a post-operative image that was not used to position the
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`implant and does not demonstrate alignment with the spinous process. EX1054, 3
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`(Fig. 1 “radiographs were obtained after the procedure”).
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`That there is no motivation to modify Brantigan according to Baccelli is
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`sufficient reason to confirm the patentability of all challenged claims.
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`V.
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`PETITIONER ABANDONS ITS GROUNDS REFERENCES AND
`PROPOSED MODIFICATIONS
`A.
`Petitioner Abandons Brantigan and Berry
`The petition argued in Ground 1 that a POSA would have been motivated to
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`modify the Brantigan implant according to Berry for insertion in the interbody
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`space at T2. Pet. 56. According to the petition, such a modified implant would
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`have a “longitudinal length of approximately 29.8 mm and a lateral width of
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`approximately 18.1 mm.” Id.
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`NuVasive explained in response that Petitioner had failed to demonstrate a
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`POSA would have wanted to make an implant of any size for insertion laterally at
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`T2. POR 28-29 (citing EX2055, ¶¶120-24; EX2043, 27). NuVasive also pointed
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`out that Petitioner failed to demonstrate that the T1/T2 disc space is large enough
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`to accommodate an 18-mm implant. POR 29. Petitioner has no rebuttal to these
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`arguments.
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`The petition asserted for ground 2 that a POSA would have taken the
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`average width of L5, added the standard deviation, and divided by two to create
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`two individual pieces (“calculated as (35.1 mm + 2.8 mm) / 2 = 18.95 mm”). Pet.
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`74-75 n. 12.
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`NuVasive responded that an implant comprising two pieces that are as wide
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`as 18.95 mm (i.e., 18.95 + 18.95 = 37.9 mm) would be absurdly wide. POR 33-34
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`(citing EX2057, ¶¶19, 23-29); see also POR 41 (describing skepticism as to the
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`large width of the 18 mm CoRoent XL implant). NuVasive noted that the
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`dimensions reported by Berry do not include the annulus, which decreases the
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`space available for an implant. POR 11-12, 33. NuVasive also noted that
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`Brantigan’s implants were sized in view of Berry and were, at largest, 28 mm in
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`the A-P dimension. POR 32.
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`Petitioner concedes (Reply 14) that Brantigan’s embodiments fit within the
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`annulus fibrosis and fails to identify any embodiment of Brantigan that extends
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`beyond the annulus fibrosis. Petitioner complains (Reply 8-9, 14-15) that in a prior
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`proceeding concerning the Michelson ’973 patent, NuVasive did not argue that
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`Brantigan’s implants were designed to fit within the annulus. Petitioner is wrong.
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`In those proceedings (IPR2013-00206, -00207), NuVasive did present evidence
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`from Dr. Brantigan that the Brantigan (EX1007) implants were sized to fit within
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`the annulus. Petitioner elected to submit with its Reply only six pages of Dr.
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`Brantigan’s testimony (EX1056). NuVasive has submitted the remainder of the
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`document as authorized by F.R.E. 106 (EX2060). The full document makes clear
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`that Dr. Brantigan’s testimony fully supports NuVasive’s arguments. EX2060,
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`23:12-18 (implants designed to “stretch the annulus…as high as we could”); 40:8-
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`23 (“We do not remove the annulus, no.”); see also id., 41:13-23, 47:15-22, 49:10-
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`15 (similar); id., 19:20-20:8, 24:4-25:4, 26:21-27:3, 34:23-37:21, 69:12-25 (max
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`A-P implant dimension of 28 mm in accordance with teachings of Brantigan ’327
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`patent); id., 47:23-48:9 (implant must be wide enough to avoid “sinking into the
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`bone” like a knife). This testimony corroborates the Brantigan patent and the
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`testimony of Drs. Youssef and McMillin that the Petition’s implant sizing is
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`inconsistent with the prior art and background knowledge of a POSA.
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`Contrary to Petitioner’s baseless accusations (Reply 9, 14), NuVasive’s
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`assertion of Brantigan in an earlier IPR never depended on establishing the implant
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`extended beyond the annulus fibrosis onto the apophyseal ring. EX1019, 6 (i.e., In
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`re Warsaw Orthopedic, Inc., 832 F.3d 1327, 1331 (Fed. Cir. 2016)) (“Warsaw’s
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`argument assumes that the limitation ‘substantially the full transverse
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`width’…means that the length of the patented implant must extend beyond a
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`vertebra’s endplate to include the apophyseal ring. However, the PTAB properly
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`concluded that ‘[Warsaw] does not show that claim 1 also recites an implant being
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`sized to extend onto the apophyseal ring[.]’”).
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`Furthermore, Petitioner knew at the time of the petition that Brantigan sized
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`his implants according to Berry to have a lateral width between 24 and 28 mm.
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`EX2061; EX2029, 8. Petitioner seeks to distract attention from this fatal defect in
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`its petition, by arguing (Reply 15-16) that an individual patient (i.e., JC) received
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`an implant that was only 8 mm narrower than the average width of the L1
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`vertebrae of the skeletons measured by Berry. That JC received such an implant
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`does not establish motivation to make an implant larger than the average
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`dimensions of the L5 vertebra as asserted in the petition. Pet. 74-75 n. 12.
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`Petitioner’s reliance on the insertion procedure for the CoRoent XL implant (i.e.,
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`the commercial embodiment of the claimed implant) is nothing more than
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`hindsight. Reply, 16 (citing EX1052, 57:15-60:17). Furthermore, even if the 18
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`mm wide CoRoent XL implant is inserted without removal of the annulus, this
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`does not establish motivation to insert a two-piece modular implant as large as 37.9
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`mm as described in the petition.
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`Petitioner claims (Reply 16) that it did not suggest in the petition that a
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`“lumbar implant for the L4/L5 disc space should have a width of 37.9 mm.” This
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`abandons the argument made in the petition.
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`B. Modularity of Michelson
`The petition embraced a theory in ground 2 that explicitly relies on the
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`modification of Brantigan according to Michelson such that these implants may be
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`inserted “in a modular fashion.” E.g., Pet. 60; see also id., 14, 72, 74 (all pointing
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`to Michelson Figs. 18-19 and associated text as teaching a modular implant).
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`According to the petition, a POSA would have been motivated to modify Brantigan
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`according to the modular embodiment of Michelson “to increase patient safety and
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`minimize invasiveness.” Pet. 69. The petition did not explain why increased patient
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`safety and minimized invasiveness would result.
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`Petitioner’s expert explained during deposition that he understands the
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`modularity taught by Michelson involves sequential insertion of at least two
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`modular members. EX2022, 121:15-122:7 (“my concept of modular is you put one
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`in, you move it in position, you put a second one in, you kind of push it up against
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`that other one”).
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`NuVasive noted that Michelson does not teach sequential insertion of
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`multiple implants. Drs. Youssef and McMillin explained that Michelson touts the
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`benefits of insertion of a single implant through a single procedure (including by
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`using a hollow tube). POR 18 (citing EX1032, 3:46-49; EX2055, ¶¶40-46;
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`EX2057, ¶¶33-34). Michelson’s modular implant is also inserted as a single
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`implant—that is, “combined in a modular fashion for insertion.” Id. (quoting
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`EX1032, 10:50-53).
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`NuVasive also explained in detail why the proposed modifications would
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`undermine the proposed motivation. POR 34-36. Dr. Youssef stated that he
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`“struggle[s] to identify any way in which the proposed combination would increase
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`safety and decrease invasiveness,” EX2055, ¶109, and provided several
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`independent reasons why the proposed modification would not increase safety nor
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`minimize invasiveness. POR 34-36. Petitioner’s Reply (10-12, 14-16) provides no
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`meaningful rebuttal and fails to substantiate that the proposed modification would
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`increase safety and minimize invasiveness. Petitioner argues without support
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`(Reply 10-11) that “lateral insertion of multiple implants” instead of one 32 mm
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`wide implant “would lead to increased patient safety and decreased invasiveness
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`because the incision would be smaller.” Petitioner also argues that the first implant
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`would not be moved “out of the way.” Id. To the extent Petitioner now makes the
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`new argument that two lateral 16 mm incisions for two 16 mm lateral implants are
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`better than one lateral 32 mm incision for one lateral implant, this argument is
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`simply unsupported, unfounded, and contradicted by the testimony of all three
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`experts who have testified in this case. POR 34-36 (discussing EX2055, ¶¶86-91,
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`98, 131-35; EX2057, ¶¶16, 35-38, 41-43; EX2022, 69:22-70:24, 85:21-24, 97:10-
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`98:24).
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`Petitioner further argues (Reply 11-12), without evidentiary support, that
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`Michelson’s “dimensions” (plural) for a single piece implant refers to only the
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`length of the implant — that is, the dimension corresponding to what Michelson
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`calls the “transverse width.” Petitioner argues that the modular embodiment has the
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`same transverse width as the single piece implants but differs with respect to the
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`lateral width. This argument as to the scope and content of Michelson may be
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`rejected as based solely on attorney argument. See Outside the Box Innovations,
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`LLC v. Travel Caddy, Inc., 695 F.3d 1285, 1298 (Fed. Cir. 2012) (“[O]bviousness
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`depends on evidentiary facts found and evaluated from the viewpoint of a person in
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`the field of the invention, as of the time of the invention.”). Moreover, it is also
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`contradicted by unrebutted witness testimony. POR 18-19, 34 (discussing EX2055,
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`¶¶40-46, 54-57, 87-89; EX2057, ¶¶32-38.
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`Petitioner argues (Reply 12) that reading Michelson according to its plain
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`meaning would render it meaningless. This argument has no evidentiary support
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`and is directly contradicted by the testimony of Drs. McMillin and Youssef, who
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`both explained that modular implants were contemplated for assembling an
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`implant with optimal dimensions by pre-insertion combination of off-the-shelf
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`modules. EX1051, 20:17-21:8; EX1050, 45:23-46:9; see also EX1007, 2:34-43
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`(“rings can be supplied in sets of different heights to be stacked to the exact height
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`required”).
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`Petitioner’s remaining arguments (Reply 12-13) address side-by-side
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`placement of implants according to the improper new exhibit Michelson ’770
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`(EX1054). But EX1054 has nothing to do with the modularity of Michelson
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`(EX1032). Even if the Board were permitted to consider improper new arguments
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`or the improper McAfee (EX1053) and Michelson ’770 (EX1054) exhibits (it is
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`not), it would have to restart briefing to permit NuVasive to submit expert
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`testimony to address Petitioner’s mischaracterizations of these references.
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`VI. PETITIONER FAILS TO ESTABLISH BRANTIGAN SATISFIES
`THE CLAIMED APERTURE DIMENSIONAL LIMITATIONS
`The petition identified as a first fusion aperture in Brantigan (1) the central
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`aperture of the unassembled device depicted in Figure 1; and (2) an aperture with a
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`longitudinal length that is orthogonal to the longitudinal length as depicted in the
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`implant of Figure 6. Pet. 46-47 & annotated Figs. 1, 6. The petition relied on the
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`implant’s dimensions being “in the same ratio as normal vertebral bodies” to
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`establish the dimensions of the central aperture 11d. Pet. 47-48.
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`NuVasive explained in response (POR 27-28) that neither Figure 1 nor
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`Figure 6 have a first fusion aperture according to the claims. With respect to Figure
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`6, NuVasive explained (POR 27) that the longitudinal aperture length of the first
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`fusion aperture identified by Petitioner is perpendicular to the longitudinal length
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`of the implant. EX2055, ¶¶110-115. With respect to Figure 1, NuVasive explained
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`that it depicts an unassembled precursor that is designed to receive a connecting
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`bar. EX2055, ¶¶54-57, 112-15; EX2057, ¶52; EX1007, 4:23-27, 4:27-37, 4:50-53
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`(“central aperture 11d is separated by the bar 15 into two side-by-side chambers.”).
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`NuVasive also pointed out that the petition acknowledges that the assembled
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`implant of Figure 1 has a connecting bar. POR 28 (citing Pet. 31).
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`Petitioner fails to rebut meaningfully that Figure 6 does not have a first
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`fusion aperture according to the challenged claims. Petitioner essentially concedes
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`(Reply 9-10) that Brantigan’s “illustrated embodiment” in Figure 6 does not
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`comprise a longitudinal aperture length for the first fusion aperture that is generally
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`parallel to the longitudinal length of the implant. Petitioner merely argues without
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`explanation that if Brantigan’s implants “are dimensionally similar to normal
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`vertebral bodies” that implants designed for the lumbar region “would include a
`
`medial support such that the requisite dimensions for the second fusion aperture
`
`are met.” Id. This response is baseless, unsupported, and incorrect.
`
`Petitioner also fails to rebut meaningfully that Figure 1 (assembled with
`
`connecting bar 15) does not have a first fusion aperture according to the challenged
`
`claims. Petitioner argues (Reply 8) that Brantigan describes Figure 1 as illustrating
`
`“a full oval prosthetic device” and that this implies the device will not be
`
`assembled. To the contrary, Brantigan simply describes a “full oval” as opposed to
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`- 17 -
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`a “hemi-oval” device. EX1007, 3:19-22. Brantigan discloses that both
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`embodiments are assembled by placing the connecting bar in the slot. EX1007,
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`3:29-32, 4:23-41. Besides lacking merit, Petitioner’s argument regarding the scope
`
`and content of the prior art may be rejected as based solely on attorney argument.
`
`Outside the Box Innovations, 695 F.3d at 1298.
`
`Petitioner also relies on claims 12 and 13 reciting a central aperture and
`
`claims 10-11 reciting a connecting bar (Reply 15) to establish Brantigan teaches
`
`the interbody fusion implant lacking the connecting bar. This is an improper new
`
`argument. The petition relied on the connecting bar being in place to identify the
`
`medial plane where the radiopaque markers allegedly should be added. Pet. 31-32,
`
`43-44. Petitioner may not now pivot to this new argument.
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`Moreover, contrary to Petitioner’s argument, claims 12 and 13 do not
`
`disclose an assembled implant lacking a connecting bar, but merely disclose that
`
`bone packing material can be packed into the implant through peripheral slots (11e
`
`in Figures 1 and 4) as well as through the side-by-side openings on the top and
`
`bottom of the implant. EX1007, 4:10-14, 4:23-27, 4:50-56, 4:67-5:8. Claiming that
`
`the central aperture and the end wall slots of a prosthetic device are “adapted to be
`
`packed with bone graft material” does not teach that the connecting bar should be
`
`omitted in the spinal fusion implant.
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`- 18 -
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`
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`Finally, as explained above, Figure 6 does not have a first fusion aperture
`
`according to claim 1. Petitioner’s arguments with respect to Figure 1 abandon any
`
`reliance on that embodiment as supplying a medial support or second fusion
`
`aperture. This is fatal to its challenge to claims 15-18 which require a medial
`
`support and/or a second fusion aperture.
`
`VII. OBJECTIVE INDICIA CONFIRM PATENTABILITY
`Petitioner argues (Reply 18-19) that NuVasive “does not isolate the
`
`contribution owed to CoRoent® XL” because other devices (e.g., retractors,
`
`dilators, etc.) are used in the procedure but only the CoRoent XL is “tied to the
`
`challenged claims.” Petitioner’s admission of nexus between the CoRoent XL
`
`implant and the challenged claims is noted and appreciated, but Petitioner’s
`
`arguments miss the mark because NuVasive has not simply relied on all XLIF
`
`revenue to establish non-obviousness. To the contrary, NuVasive provided sales
`
`figures specifically for the 18 mm wide CoRoent XL implant. POR, 68. Petitioner
`
`bears the burden of demonstrating unpatentability, has admitted nexus between the
`
`CoRoent XL implant and the challenged claims, and that evidence alone is strong
`
`evidence of non-obviousness.
`
`Petitioner argues (Reply 18-19) that access tools, neuromonitoring, and
`
`physician training facilitate sales of CoRoent XL implants. But Petitioner has
`
`- 19 -
`
`
`
`
`
`failed to demonstrate that the specific sales figures NuVasive relied upon are
`
`driven by any of these factors.
`
`Petitioner does not rebut testimony from its own employee that the industry
`
`was skeptical of an 18-mm wide lateral implant, but merely argues (Reply 19) that
`
`this dimension was “smaller than several known and disclosed spinal implants”
`
`and related merely to “the access path.” Petitioner’s argument misses the point. An
`
`implant having a maximum A-P dimension of 18 mm was simultaneously viewed
`
`as being too small to adequately support the full weight conveyed through the
`
`spine and also being too wide to be inserted through a direct lateral approach
`
`between the L4 and L5 vertebrae, as proposed by Petitioner.
`
`Petitioner argues (Reply 19-20) that infringement is not necessarily evidence
`
`of copying. As explained in the POR, however, Petitioner elected to market
`
`implants that are strikingly similar to the CoRoent XL implant. POR, 68-69. In
`
`contrast, no such implant is found in the prior art. Petitioner’s copying of
`
`NuVasive’s product provides strong evidence of nexus and of non-obviousness.
`
`VIII. CONCLUSION
`NuVasive respectfully submits Petitioner has failed to satisfy its burden of
`
`demonstrating the challenged claims are unpatentable.
`
`- 20 -
`
`
`
`
`
`
`
`
`Date: March 2, 2020
`
`
`
`Respectfully submitted,
`
`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
`
`
`
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`- 21 -
`
`
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`
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`CERTIFICATE OF COMPLIANCE
`
`Pursuant to § 42.24(d), the undersigned certifies that this paper contains no
`
`more than 5,600 words, not including the portions of the paper exempted by §
`
`42.24(b). According to the word-processing system used to prepare this paper, the
`
`paper contains 4,201 words.
`
`
`
`
`Date: March 2, 2020
`
`
`
`Respectfully submitted,
`
`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
`
`
`
`
`
`
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`- 22 -
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`
`
`IX. APPENDIX – LIST OF EXHIBITS
`
`
`Exhibit No.
`
`Description
`
`2001
`
`Williams, Peter L., Gray’s Anatomy (Churchill Livingston 38th ed
`1995) (reprinted in 1999)
`
`2002
`
`Declaration of Patrick Miles in Case No. IPR2013-00206
`
`2003
`
`Executive Team – Alphatec Spine, obtained from:
`https://atecspine.com/executive-team/ on March 15, 2019
`
`2004
`
`U.S. Patent No. 6,830,570 to Frey et al.
`
`2005
`
`U.S. Patent No. 4,349,921 to Kuntz et al.
`
`2006
`
`U.S. Patent No. 6,159,211 to Boriani et al.
`
`2007
`
`U.S. Patent Publication No. 2008/0015701 to Garcia.
`
`2008
`
`U.S. Patent Publication No. 2012/0078374 to Villiers.
`
`2009
`
`The Merriam-Webster Dictionary New Edition (2004) (excerpts)
`
`2010
`
`2011
`
`Appendix B4 Joint Claim Construction Worksheet for U.S. Patent
`No. 8,361,156 in Case No. 3:18-cv-00347-CAB-MDD
`
`Exhibit 1053 from Declaration of Patrick Miles in Case No.
`IPR2013-00206
`
`- 23 -
`
`
`
`
`
`2012
`
`Reserved
`
`2013
`
`2014
`
`2015
`
`2016
`
`
`2017
`
`2018
`
`2019
`
`
`2020
`
`
`2021
`
`Declaration of Jim A. Youssef, M.D. in Case No. 3:18-cv-0347-
`CAB-MDD
`
`Appendix F to Declaration of Jim A. Youssef, M.D. in Case No.
`3:18-cv-0347-CAB-MDD
`
`Reply Declaration of Jim A. Youssef, M.D. in Case No. 3:18-cv-
`0347-CAB-MDD
`
`Intentionally Left Blank
`
`Transcript of Federal Circuit Oral Argument in Case No. 2015-
`1670
`
`Luiz Pimenta: Executive Profile & Biography – Bloomberg,
`obtained from: https://www.bloomberg.com/research/stocks/
`people/person.asp?personid=52029107&privcapid=21766771 on
`April 9, 2019
`
`Intentionally Left Blank
`
`Intentionally Left Blank
`
`Mid Lumbar Axial View diagram from Deposition of Charles
`Branch (September 24, 2019)
`
`2022
`
`Transcript of Deposition of Charles L. Branch, September 24, 2019
`
`2023
`
`“Longitudinal” and “Medial,” Taber’s Cyclopedic Medical
`Dictionary, Edition 19 (2001)
`
`- 24 -
`
`
`
`
`
`2024
`
`2025
`
`2026
`
`2027
`
`“Longitudinal” and “Medial,” Mosby’s Medical, Nursing, & Allied
`Health Dictionary, 6th Edition (2002)
`
`“Longitudinal” and “Medial,” PDR Medical Dictionary, First
`Edition (1995)
`
`“Longitudinal”
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