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.
`
`NUVASIVE, INC.,
`Patent Owner.
`_____________________________
`
`Case No. IPR2019-00361
`Patent No. 8,187,334
`_____________________________
`
`PATENT OWNER’S SUR-REPLY
`
`
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`
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`
`
`Filed: March 2, 2020
`
`
`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. IPR2019-00361
`Patent No. 8,187,334
`_____________________________
`
`PATENT OWNER’S SUR-REPLY
`
`
`
`
`
`
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`
`
`TABLE OF CONTENTS
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`III.
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`I.
`II.
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`Page
`INTRODUCTION .......................................................................................... 1
`PETITIONER FAILS TO ESTABLISH ESTOPPEL CAN OR
`SHOULD BE APPLIED ................................................................................ 2
`PETITIONER ABANDONS THE PETITION AND THE
`GROUNDS REFERENCES ........................................................................... 6
`A.
`Petitioner Abandons the Modularity of Michelson .............................. 6
`B.
`Petitioner Abandons Baccelli Marker Positioning ............................. 10
`C.
`Petitioner Abandons Implant Sizing According to Berry .................. 11
`IV. PETITIONER’S BELATED ATTEMPT AT CLAIM
`CONSTRUCTION IS NOT SUPPORTED BY EVIDENCE ...................... 14
`A.
`Longitudinal Length ........................................................................... 15
`B. Medial Support ................................................................................... 16
`V. OBJECTIVE INDICIA CONFIRM PATENTABILITY ............................. 17
`VI. THE PETITION’S MISSING ELEMENTS ................................................ 18
`A. Ground 1 ............................................................................................. 18
`B.
`Ground 2 ............................................................................................. 22
`1.
`Radiopaque Markers ................................................................ 22
`2.
`Fusion Apertures ...................................................................... 23
`VII. CONCLUSION ............................................................................................. 27
`VIII. APPENDIX – LIST OF EXHIBITS ............................................................. 29
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`- i -
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`I.
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`INTRODUCTION
`Petitioner’s Reply repeatedly mischaracterizes the facts, NuVasive’s
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`arguments, and the applicable burden of proof. Petitioner bears the burden of proof
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`and it never shifts to NuVasive. Petitioner nonetheless attempts to require
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`NuVasive to prove that the modular modification proposed by Petitioner would
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`have been less safe and would have increased invasiveness and that alignment of
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`implant markers with the spinous process was a benefit realized after the priority
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`date. But NuVasive need not prove any of these things. It was Petitioner’s burden
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`to prove its case. It failed to do so.
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`It was Petitioner whose proposed reason for the modularity modification was
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`to make the implant safer and less invasive. POR 1-2. NuVasive noted that this
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`argument was wholly unsubstantiated and that there were many reasons a
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`multipiece modular combination would decrease safety and increase invasiveness.
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`POR 12-13, 42-45, 53-54. 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. Instead, Petitioner points to the state of the art as a
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`thinly veiled pretext for attempting to switch obviousness theories to new
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`references and new arguments that were not included with the petition. In the
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`process, Petitioner abandons the obviousness case set forth in the petition and
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`- 1 -
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`betrays the teachings of Frey, Brantigan, and Michelson. This is fatal to
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`Petitioner’s case.
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`It was also Petitioner who relied on Baccelli to provide motivation to place
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`two radiopaque markers in alignment with the spinous process. POR 2, 19-20.
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`Petitioner’s case hinges on a special interpretation of the term longitudinal length
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`that is inconsistent with its plain meaning. POR 4-7. Based on this erroneous
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`construction, Petitioner then misconstrued Baccelli as teaching placement of two
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`radiopaque markers in alignment with the spinous process. POR 19-20, 60-61. The
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`Reply does not meaningfully respond to these fatal deficiencies.
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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 ESTABLISH ESTOPPEL CAN OR
`SHOULD BE APPLIED
`Invoking Rule 42.73(d)(3)(i) and the MaxLinear decision, the petition (at
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`32) asserted with very little explanation that NuVasive is estopped from arguing
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`that claim 1 renders any dependent claim patentable over Frey and Michelson.
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`Although the burden to establish entitlement to estoppel fell on Petitioner and not
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`on NuVasive, the POR (at 21-41) explained (1) that Rule 42.73(d)(3)(i) is
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`inapplicable, (2) that claim 1 may not be treated as prior art to cancel the
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`challenged clams, (3) that Petitioner failed to establish the required elements of
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`collateral estoppel, (4) that Petitioner’s attempted application of collateral estoppel
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`would be inequitable, (5) that intervening changes in law and procedure render
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`collateral estoppel inapplicable, (6) that Petitioner failed to justify applying judicial
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`estoppel, and (7) that Petitioner failed to show the Board has authority to cancel
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`challenged claims based on estoppel.
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`Petitioner addresses “estoppel” (Reply 6-8), but this discussion abandons
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`rule 42.73(d)(3)(i) and judicial estoppel entirely (arguments 1 and 6), cites no
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`authority for treating a cancelled claim as prior art (argument 2), and fails to
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`establish the Board has common law authority to invalidate challenged claims
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`based on estoppel or address any of the cases cited in the POR showing the Board
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`lacks such common law authority (argument 7). Petitioner’s failures to address
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`arguments 1-2 and 6-7 are fatal to Ground 1.
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`Regarding arguments 3-5, Petitioner’s Reply arguments come too late. It is
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`not enough that these reply arguments be responsive to the POR because
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`entitlement to collateral estoppel was essential to Petitioner’s prima facie case.
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`“Petitioner may not submit new evidence or argument in reply that it could have
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`presented earlier, e.g. to make out a prima facie case of unpatentability.”
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`Consolidated Practice Guide 73. Moreover, as discussed further below, Petitioner’s
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`arguments for estoppel fail on the merits.
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`- 3 -
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`Petitioner argues (Reply 6) that the issue here is identical to the issue in
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`IPR2013-00507 because, allegedly, NuVasive thinks “claim 1 should be relitigated
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`on the same grounds previously asserted in the prior IPR.” NuVasive does not
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`seek to relitigate claim 1.
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`Moreover, the petition asserts different grounds from the prior IPR. Indeed,
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`Petitioner repeatedly stated in the petition that it is presenting a materially different
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`theory compared to those of the prior proceedings. Pet. 25 (“This Petition, and the
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`grounds presented, are not cumulative of previous challenges filed by unrelated
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`parties, without Petitioner’s input, relying on different prior art combinations.”), 25
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`(“the arguments based on Michaelson [sic] are materially different from those
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`presented during the prior IPR proceedings”), 25-26 (“there is no ‘overlap’ in the
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`arguments made in the earlier proceeding”), 26 (“the issues raised in this petition
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`were not previously before the Board”).
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`Petitioner responds that NuVasive “overstates” Petitioner’s argument that
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`the grounds are different. But Petitioner fails to satisfy its burden to demonstrate
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`the asserted grounds are the same. Petitioner attempts to thread the needle by
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`arguing (Reply 7) it “is challenging patentability on different grounds for the
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`challenged claims, but not claim 1.” However, as NuVasive explained, it was
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`Petitioner’s burden to demonstrate that the specific combination of teachings it
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`asserted in its petition renders obvious each challenged claim as a whole. POR 22-
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`- 4 -
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`24 (discussing 35 U.S.C. §§311, 312, 315(e), 316(e), 318(a)-(b), SAS, Stepan,
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`Magnum Oil, General Electric, MaxLinear, and Gillette). Petitioner fails to address
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`any of this authority and also fails to identify any authority permitting it to switch
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`obviousness theories partway through a claim. To the contrary, this piecemeal
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`approach is expressly forbidden. See Gillette Co. v. S.C. Johnson & Son, Inc., 919
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`F.2d 720, 724 (Fed. Cir. 1990).
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`Petitioner argues (Reply 7) that it is “undisputed that the combination of
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`Frey and Michelson rendered claim 1 unpatentable was actually litigated in
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`IPR2013-00507 and was essential to its final judgment.” But whether the petition’s
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`asserted combination of Frey and Michelson was actually litigated in IPR2013-
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`00507 or renders obvious claims 6-9 or 18 is hotly disputed.
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`Petitioner argues (Reply 6-8) that NuVasive is attempting to “relitigate
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`issues it already lost.” But NuVasive is not trying to recapture claim 1 or relitigate
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`the same issues. The patentability of claims 6-9 has never been litigated and the
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`patentability of claim 18 has been litigated twice before with each proceeding
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`confirming its patentability.
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`Petitioner argues (Reply 8) NuVasive was somehow obligated to construe
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`“spinal fusion implant” in the earlier IPRs. This misapprehends the burden for
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`construing the claims, which falls squarely on Petitioner. 37 C.F.R. §42.104(b)(3);
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`In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016).
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`- 5 -
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`Petitioner’s argument also fails to address the changed claim construction standard.
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`It is undisputed the prior IPRs were governed by the BRI standard, the present
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`proceedings are governed by the Phillips standard, and the present petition
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`provided no claim constructions. Pet., 26. Petitioner has thus failed to satisfy its
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`burden.
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`Petitioner admits (Reply 8) that PPC Broadband forbids the Board from
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`ignoring the presumption of nexus but argues that Petitioner here has rebutted that
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`presumption. Petitioner thus implicitly concedes that objective indicia must be
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`relitigated. It would be particularly inequitable to apply collateral estoppel to bar
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`NuVasive from defending different claims against different grounds while
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`permitting Petitioner to relitigate the issues where the Board improperly placed the
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`burden of proof on NuVasive in the prior IPR.
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`III. PETITIONER ABANDONS THE PETITION AND THE GROUNDS
`REFERENCES
`A.
`Petitioner Abandons the Modularity of Michelson
`The petition embraced a theory for both grounds of challenge that explicitly
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`relies on the modification of Frey or Brantigan such that these implants may be
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`inserted “in a modular fashion as taught by Michelson.” E.g., Pet. 5; see also id., 2-
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`3, 12, 30, 41, 62 (all pointing to Michelson Figs. 18-19 and associated text as
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`teaching a modular implant). According to the petition, a POSA would have been
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`motivated to modify Frey or Brantigan according to the modular embodiment of
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`Michelson “to increase patient safety and minimize invasiveness.” Pet. 30, 47. The
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`petition did not explain why increased patient safety and minimized invasiveness
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`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 modular members.
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`EX2022, 121:15-122:7 (“my concept of modular is you put one in, you move it in
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`position, you put a second one in, you kind of push it up against that other one”).
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`NuVasive established that Michelson’s modularity does not teach sequential
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`insertion of multiple implants. Drs. Youssef and McMillin explained that
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`Michelson touts the benefits of insertion of a single implant through a single
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`procedure (including by using a hollow tube). POR 14-15 (citing EX1032, 3:46-49;
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`EX2055, ¶¶42-43; EX2057, ¶¶33-34). Michelson’s modular implant is also
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`inserted as a single implant—that is, the modular members are combined for
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`insertion. Id. (quoting EX1032, 10:50-53).
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`Whether modules are combined before or after insertion, NuVasive
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`explained in detail that the proposed modification undermines the proposed
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`motivation. POR 43-45, 53-54. Dr. Youssef stated that he “struggle[s] to identify
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`any way in which the proposed combination would increase safety and decrease
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`invasiveness,” EX2055, ¶109, and provided several independent reasons why the
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`proposed modification would not increase safety nor minimize invasiveness. POR
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`43-45, 53-54. Petitioner provides no meaningful rebuttal and fails to substantiate
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`that the proposed modification would increase safety and minimize invasiveness.
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`The Board can confirm the patentability of the challenged claims on this basis
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`alone.
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`Rather than address NuVasive’s arguments, Petitioner falsely asserts (Reply
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`1) that “[i]t is undisputed that Frey (EX1040), Michelson (EX1032), and Brantigan
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`(EX1007) teach modular implants.” Petitioner provides no citation for this
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`statement, presumably because Frey does not teach modular implants and
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`Petitioner has never before argued that it does. Petitioner also points (Reply 9) to
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`generic disclosure in Frey of inserting multiple implants and use of guide sleeves
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`or tubes, but this argument is not responsive. Frey discloses insertion of multiple
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`annular implants. EX1040, Fig. 46. But the petition asserted that a POSA would
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`have been motivated “to create the long-and-narrow implant of Frey in a modular
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`fashion as taught by Michelson” by modifying Frey’s boomerang implants 1000 or
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`1400. E.g., Pet. 5, 29-30.
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`Regarding Brantigan, NuVasive disputes that Brantigan’s hemi-oval
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`implants embody the “same modularity concept” as Michelson. Pet. 61; POR 18.
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`Furthermore, the petition asserted a POSA would have been motivated to modify
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`the full-oval Brantigan device (i.e., plug 11 or 30), not the hemi-oval device. Pet.
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`47-70; Paper 19, 41. Regarding Michelson, there is no dispute that Petitioner points
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`to Michelson Figs. 18-19 and associated text as teaching a modular implant. Pet. 2-
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`3, 12, 30, 41, 62.
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`Petitioner’s assertion that none of the modular implants requires assembly is
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`wrong. Both Michelson and Brantigan teach assembly of modular implants as
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`NuVasive explained in detail in its response. POR 14-19, 43, 53. For example,
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`Michelson discloses that pieces of the modular implant are “combined in a
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`modular fashion for insertion.” EX1032, 10:53-54. As Drs. McMillin and Dr.
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`Youssef explained, the Brantigan modular implant must be assembled prior to
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`insertion in the disc space. POR 53; EX2057, ¶¶35-40; EX2055, ¶¶60-65, 144-47;
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`see also EX1051, 49:18-50:5 (explaining that modular devices “fit or snap together
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`somehow to form a single implant”).
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`Petitioner argues (Reply 10) that “[i]f modular components must be
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`assembled before insertion, there is no use for implant 1000[.]” This argument has
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`no evidentiary support and is directly contradicted by the testimony of Drs.
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`McMillin and Youssef, who explained that modular implants were contemplated
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`for assembling an implant with optimal dimensions by pre-insertion combination
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`of off-the-shelf modules. EX1051, 20:17-21:8; EX1050, 45:23-46:9; EX1007,
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`2:34-43 (“rings can be supplied in sets of different heights to be stacked to the
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`exact height required”).
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`Petitioner’s remaining arguments (Reply 10) address side-by-side placement
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`of implants according to the improper new exhibit Michelson ’770 (EX1054).
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`EX1054 has nothing to do with the modularity of Michelson (EX1032) that was
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`asserted in the petition. E.g., 5, 30, 47.
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`B.
`Petitioner Abandons Baccelli Marker Positioning
`The petition embraced a theory in Ground 2 that relies on Baccelli as
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`allegedly teaching “radiopaque markers in the distal and proximal walls, as well as
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`the central region of the implant.” Pet. 45. Based on this alleged arrangement of
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`markers in Baccelli, Petitioner argued that a POSA would have wanted to modify
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`Brantigan “to allow surgeons to align the markers with the spinous process and the
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`lateral ends of the vertebrae.” Pet. 45 (citing EX1002, ¶199).
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`NuVasive established (POR 61) that this rationale is based on nothing more
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`than ipse dixit. Moreover, this rationale was copied from the rationale rejected by
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`the Federal Circuit as based wholly on hindsight. Pet. 55 (EX1013, 18; EX2017,
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`7:9-8:13).
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`Petitioner (Reply 16) invites the Board to make the same error as before. Dr.
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`Branch’s unsupported parroting of the same rationale the Federal Circuit
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`determined was hindsight is no less hindsight now than it was when originally
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`uttered by Dr. Yuan. POR 55-56 (EX2028, ¶60; EX2017, 7:9-8:13); see also In re
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`NuVasive, Inc., 842 F.3d 1376, 1384 (Fed. Cir. 2016). Petitioner’s Reply also
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`mischaracterizes the sagittal midplane of the body, which is agnostic as to the
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`direction of insertion of any implant. See, e.g., EX1002, ¶¶29-30.
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`Petitioner’s remaining arguments abandon Baccelli in favor of the improper
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`new McAfee reference.1 McAfee is simply irrelevant to the Petition’s argument,
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`which was that Baccelli motivated the claimed marker placement. Moreover,
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`McAfee’s BAK cage is itself radiopaque, has no radiopaque markers, and does not
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`teach placement of markers in the central region or anywhere else. Furthermore,
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`the image relied upon 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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`C.
`Petitioner Abandons Implant Sizing According to Berry
`The petition asserted a POSA would have been motivated to size implants
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`according to the “direct dimensional measurements” for human vertebrae reported
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`in Berry. Pet. 41, 47-48, 62-63. The petition then asserted that a POSA would have
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`taken the average width of L5, added the standard deviation, and divided by two to
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`1The Board may not rely upon Petitioner’s improper new exhibits (e.g.,
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`EX1053-EX1054), much less without restarting briefing and affording NuVasive
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`the opportunity to present expert testimony.
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`create individual pieces having widths up to 18.95 mm. Pet. 42, 63, 74. These
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`pieces would “nest” together in the disc space. Pet. 42-43.
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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 42, 64
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`(citing EX2057, ¶27); see also POR 67 (describing skepticism as to the large width
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`of the 18 mm CoRoent XL implant). NuVasive noted that the dimensions reported
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`by Berry do not include the annulus, which decreases the space available for the
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`implant. POR 11-12, 17, 42-43, 51, 63-64. NuVasive also noted that Brantigan’s
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`implants were sized in view of Berry and were, at largest, 28 mm in the A-P
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`dimension. POR 64.
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`In Reply (9-10), Petitioner asserts that it “never suggested manufacturing or
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`inserting an implant that is ‘up to 37.9 mm wide.’” This abandons the argument
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`made in the petition.
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`Petitioner also states (Reply 17) that NuVasive “never argued, as it does
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`now, that Berry should be modified because Brantigan was designed to fit within
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`the annulus fibrosis.” In the very same proceedings (IPR2013-00206, -00207) that
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`Petitioner references, NuVasive did present evidence from Dr. Brantigan that the
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`Brantigan (EX1007) implants were sized to fit within the annulus. Petitioner
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`elected to submit with its Reply only six pages of Dr. Brantigan’s testimony
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`(EX1056). NuVasive has submitted the remainder of the document as authorized
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`by F.R.E. 106 (EX2060). The full document makes clear that Dr. Brantigan’s
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`testimony fully supports NuVasive’s arguments. EX2060, 23:12-18 (implants
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`designed to “stretch the annulus…as high as we could”); 40:8-23 (“We do not
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`remove the annulus, no.”); see also id., 41:13-23, 47:15-22, 49:10-15 (similar); id.,
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`19:20-20:8, 24:4-25:4, 26:21-27:3, 34:23-37:21, 69:12-25, 47:23-48:9. This
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`testimony corroborates the Brantigan patent and the testimony of Drs. Youssef and
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`McMillin that the Petition’s implant sizing is inconsistent with the prior art and
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`background knowledge of a POSA.
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`Petitioner knew at the time of the petition that Brantigan implants were sized
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`according to Berry to have A-P dimensions between 24 and 28 mm. EX2061;
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`EX2029, 8. Petitioner seeks to distract attention from this fatal defect in its petition,
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`by arguing (at 17) that an individual patient (i.e., JC) received an implant that was
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`only 8 mm narrower than the average width of the L1 vertebrae of the skeletons
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`measured by Berry. That JC received such an implant does not establish motivation
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`to make an implant larger than the average dimensions of the L5 vertebra as
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`asserted in the petition. Petitioner’s reliance on the insertion procedure for the
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`CoRoent XL implant (i.e., the commercial embodiment of the claimed implant) is
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`nothing more than hindsight. Reply, 17 (citing EX1052, 57:15-60:17). Furthermore,
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`even if the 18 mm wide CoRoent XL implant is inserted without removal of the
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`annulus, this does not establish motivation to insert a two-piece modular implant as
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`large as 37.9 mm as described in the petition.
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`IV. PETITIONER’S BELATED ATTEMPT AT CLAIM
`CONSTRUCTION IS NOT SUPPORTED BY EVIDENCE
`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 Magnum Oil, 829 F.3d at 1380 .
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`The petition however, is devoid of analysis as to the conventional meaning of the
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`claim terms. Petitioner merely professes that the “plain and ordinary meaning”
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`should be applied under 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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`The analysis should end here as Petitioner has not met its burden to establish
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`the plain and ordinary meaning of the challenged claims. The Board can confirm
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`the patentability of the challenged claims on this basis alone.
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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 4-9.
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`For example, NuVasive relied on the specification of the ’334 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 implant. POR 4-8. NuVasive also showed that based on the specification of the
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`’334 patent, dictionaries, the testimony of Drs. Youssef and McMillin, and the
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`construction of a related term in a co-pending case concerning the ’156 patent, that
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`the “medial support” is located approximately at the midpoint of the longitudinal
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`length of the implant. POR 8-9.
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`Petitioner offers no meaningful response to NuVasive’s claim construction
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`arguments and evidence. During deposition, Petitioner did not question Drs.
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`Youssef or McMillin regarding their understanding of the terms “longitudinal” and
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`“medial support.” In Reply (5-6), Petitioner offers nothing beyond attorney
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`argument, mischaracterizations of Drs. Youssef’s and McMillin’s testimony, and a
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`factually erroneous and legally misplaced theory based on a Federal Circuit
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`decision concerning an unrelated patent.
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`A. Longitudinal Length
`Petitioner argues (Reply 5) that the “insertion end” and “trailing end”
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`defines the “longitudinal length” of an implant and that Dr. Youssef uses this
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`terminology. This is simply not true. Dr. Youssef was not even asked about his
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`understanding of the term “longitudinal length.” Rather, Dr. Youssef was asked to
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`identify the proximal and distal walls and to confirm that the Baccelli implant is
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`inserted anteriorly. EX1050, 49:17–50:9. None of his testimony supports
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`Petitioner’s argument.
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`Petitioner also argues (Reply 5) that its definition of “longitudinal length” is
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`supported by Dr. McMillin’s testimony that the term “width” can be used in
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`different ways depending on the context. That the meaning of a different term (i.e.,
`
`width) may depend on context is of no moment.
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`Finally, Petitioner argues (Reply 5, 16) that the Federal Circuit “adopted” a
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`construction that the longitudinal length is “define[d]…based on the ‘insertion end’
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`to the trailing end.’” This is not correct. Furthermore, the Federal Circuit decision
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`concerns an unrelated patent (Michelson ’997) that does not use the term
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`“longitudinal.” EX1019, 4-5 (i.e., In re Warsaw Orthopedic, Inc., 832 F.3d 1327,
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`1330 (Fed. Cir. 2016)). If anything, this case supports NuVasive’s position that
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`Petitioner is improperly reading the term “longitudinal” out of the claims.
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`B. Medial Support
`Petitioner feigns confusion (Reply 5-6) as to NuVasive’s discussion of
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`“medial support,” but offers no meaningful rebuttal. As the Board explained and
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`Petitioner accepts, in the context of the same specification, the “medial plane” “is
`
`- 16 -
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`
`
`
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`located approximately at the midpoint of the longitudinal length.” Likewise, a
`
`“medial support” is located approximately at the midpoint of the longitudinal
`
`length. POR 8-9. There is no conflict with the medial support being located within
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`a region that encompasses the midpoint of the longitudinal length (i.e., the central
`
`region).
`
`V. OBJECTIVE INDICIA CONFIRM PATENTABILITY
`Petitioner argues (Reply 18-19) that NuVasive “does not isolate the
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`contribution owed to CoRoent® XL” because other devices (e.g., retractors,
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`dilators, etc.) are used in the procedure but only the CoRoent XL is “tied to the
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`challenged claims.” Petitioner’s admission of nexus between the CoRoent XL
`
`implant and the challenged claims is noted and appreciated, but Petitioner’s
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`arguments miss the mark because NuVasive has not simply relied on all XLIF
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`revenue to establish non-obviousness. To the contrary, NuVasive provided sales
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`figures specifically for the 18 mm wide CoRoent XL implant. POR 68. Petitioner
`
`bears the burden of demonstrating unpatentability, has admitted nexus between the
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`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
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`- 17 -
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`
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`
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`failed to demonstrate that the specific sales figures NuVasive relied upon are
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`driven by any of these factors.
`
`Petitioner does not rebut testimony from its own employee that the industry
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`was skeptical of an 18-mm wide lateral implant, but merely argues (Reply 19) that
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`this dimension was “smaller than several known and disclosed spinal implants”
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`and related merely to “the access path.” Petitioner’s argument misses the point. An
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`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
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`spine and also being too wide to be inserted through a direct lateral approach
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`between the L4 and L5 vertebrae, as proposed by Petitioner.
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`Petitioner argues (Reply 19-20) that infringement is not necessarily evidence
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`of copying. As explained in the POR, however, Petitioner elected to market
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`implants that are strikingly similar to the CoRoent XL implant. POR 68-69. In
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`contrast, no such implant is found in the prior art. Petitioner’s copying of
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`NuVasive’s product provides strong evidence of nexus and of non-obviousness.
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`VI. THE PETITION’S MISSING ELEMENTS
`A. Ground 1
`Ground 1 relied on modifying Frey implants 1000 and 1400. Pet. 32-43. For
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`the first fusion aperture, the petition identified only upper opening 1018a in
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`implant 1000 and first chamber 1418 in implant 1400. Pet. 37-40. For the second
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`- 18 -
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`
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`
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`fusion aperture, the petition identified only upper opening 1018b in implant 1000
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`and second chamber 1420 in implant 1400. Id. For the medial support, the petition
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`identified only “upper strut 1019” in implant 1000 and first and second “struts”
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`1424 and 1426 of implant 1400. Id. 33-36, 38-39.
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`NuVasive responded that the identified features do not satisfy the limitations
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`of the challenged claims because Petitioner failed to establish that (1) the
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`longitudinal length of the first fusion aperture asserted by the petition is generally
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`parallel to the longitudinal implant length; (2) upper openings 1018a and 1018b
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`extend “through said upper surface and lower surface” as required by claims 6-9;
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`(3) upper strut 1019 separates the first and second fusion apertures as defined by
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`claims 8 and 9; and (4) struts 1424 and 1426 extend between the first and second
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`sidewalls proximate to the midpoint of the longitudinal length of the implant. POR
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`46-51.
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`Petitioner asserts for the first time (Reply 11) that the petition does not rely
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`on specific embodiments of Frey. As discussed above, this is not correct. That a
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`petitioner might rely on a reference for all that it discloses does not excuse the
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`Petitioner from its statutory obligation to identify, with particularity, the basis of its
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`challenge in the petition. 35 U.S.C. § 312(a)(3). Despite any suggestion to the
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`contrary (Paper 19, 21), even the Board is not authorized to waive this statutory
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`requirement.
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`- 19 -
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`
`
`
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`Petitioner’s improper new argument (Reply 11-12) that openings 1018a and
`
`1018b in combination with lower openings 1020a and 1020b, respectively,
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`“together comprise fusion apertures that ‘extend[] through said upper surface and
`
`said lower surface’ as required by the claims” must be rejected. This argument
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`regarding the scope and content of the prior art may be rejected as based solely on
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`attorney argument. See Outside the Box Innovations, LLC v. Travel Caddy, Inc.,
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`695 F.3d 1285, 1298 (Fed. Cir. 2012). Moreover, it lacks merit. Dr. Branch
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`confirmed during his deposition that openings 1018a, 1018b, 1020a, and 1020b are
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`each “separate fusion apertures.” EX2022, 94:7-96:9. Petitioner’s new argument is
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`also contradicted by Dr. Youssef’s testimony. POR 47-49; EX2055, ¶¶121-29.
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`Petitioner provides no meaningful rebuttal. It is of no moment whether the claims
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`require “precisely one single fusion aperture.” Petitioner failed to satisfy its burden
`
`to identify in the petition the first fusion aperture arranged as claimed in each
`
`challenged claim.
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`Petitioner argues (Reply 12) that “struts 1424 and 1426” are located at
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`“approximately the midpoint” because they “lie adjacent to middle portion and
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`middle chamber.” Id. Petitioner’s attorney argument that a medial support is any
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`strut that is “adjacent” to a middle chamber of an implant is an improper new
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`argument that is not supported by expert testimony or any other evidentiary
`
`- 20 -
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`
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`support. It is contrary to the unrebutted testimony of Dr. Youssef (EX2055, ¶¶36-
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`37, 121-32) and should be rejected.
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`Regarding claim 7, Petitioner argues (Reply 12) that struts 1424 and 1425
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`need not be positioned on a course parallel to the central region because the central
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`region is “not a point.” But NuVasive has never argued that the central region is “a
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`point.” Petitioner also argues that the patent’s specification states fusion apertures
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`may be provided in any of a variety of suitable shapes, but this argument conflates
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`the scope of the specification with the scope of individual claims. Petitioner’s
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`statement (Reply 13) that “in embodiments including non-rectangular-shaped
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`fusion apertures, the medial support would not be ‘on a course parallel to the
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`central region’” is a bin
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