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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
`_____________________________
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`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 SUPPLEMENTAL SUR-REPLY
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`I.
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`INTRODUCTION
`Reply argument based on newly submitted references of Michelson ’770
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`(EX1053) and McAfee (EX1054) is improper and should be treated accordingly.
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`Reply argument is improperly new where it deviates, or attempts to change,
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`the “thrust” of the challenge set forth in the petition. In re NuVasive, Inc., 841 F.3d
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`966, 972 (Fed. Cir. 2016) (citing In re Leithem, 661 F.3d 1316, 1319 (Fed. Cir.
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`2011) (“we have relied on the APA’s requirements to find a ‘new ground’ where
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`‘the thrust of the rejection’ has changed.”). Here, the challenges advanced in the
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`petition relied on modifying Brantigan according the modular assembly in Figs. 18
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`and 19 of Michelson. Argument or evidence in the Reply that deviates from the
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`modularity described by Michelson, or invites the Board to so deviate, is improper.
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`Furthermore, it is well established that attempting to fill in the gaps
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`identified by Patent Owner in the prima facie case presented in the petition with
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`new evidence and argument is improperly new. E.g., Consolidated Practice Guide
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`at 73 (“Petitioner may not submit new evidence or argument in reply that it could
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`have presented earlier, e.g. to make out a prima facie case of unpatentability.”).
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`II.
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`PETITIONER’S ATTEMPTED RETREAT FROM THE
`“MODULARITY” OF MICHELSON IS IMPROPER
`Petitioner repeatedly asserts, throughout the petition materials, that a POSA
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`would have been motivated to modify Brantigan according to the modular
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`embodiment of Michelson (EX1032). E.g., Pet. 14, 72, 74 (“…combined in
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`modular fashion…”), 69 (“inserting the ‘oversized’ implant modularly”), 69 (“for
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`insertion in a modular fashion”), 70 (“make the implants modular”), 73
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`(“Michelson ’973 discloses the same modularity concept Brantigan describes”), 75,
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`FN 12 (at least two 18.95 mm implants).
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`Petitioner’s proffered rationale for adopting the modularity of Michelson to
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`the implants of Frey or Brantigan was “to increase patient safety and minimize
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`invasiveness.” Pet. 69.
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`As required by statute, the Board instituted the case set forth in the petition.
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`Paper 18, 33 (“permit[] a single implant to be inserted by a single procedure into
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`the spine”), 33, 34-35 (“more than one spinal fusion implant 1000 may be
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`combined in a modular fashion”) 35 (“half the width dimensions for various
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`vertebrae implants based on Brantigan’s teaching to make the implants modular ”).
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`The Reply advances several arguments indicating retreat from its previous
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`reliance on the modularity of Michelson as illustrated in Figs. 18 and 19 in
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`numerous respects. For example, the Reply (1) now asserts it never argued
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`sequential insertion of modular members and combination within the disc space.
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`Additionally, the Reply (16) claims Petitioner never suggested an implant up to
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`37.9 mm wide, as would result from a modular implant of two 18.95 mm wide
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`modules (18.95 + 18.95 = 37.9). While such arguments were advanced previously,
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`NuVasive does not oppose Petitioner’s concession of such arguments going
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`forward. To the extent the Reply offers any argument in replacement, however, it
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`should be rejected as untimely and improperly new.
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`The Reply (2-5, 6, 13) cites to McAfee (EX1054) and Michelson ’770
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`(EX1053). Neither reference describes a modular implant as in Michelson nor does
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`Petitioner assert otherwise. Instead, the newly cited references present independent
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`cylindrical cages, which the Reply (5, 12) describes as a “side-by-side”
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`arrangement. Neither reference discusses Michelson, the modular embodiment of
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`Michelson, or even recites the term “modular.” As such, McAfee (EX1054) and
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`Michelson ’770 (EX1053) are irrelevant to the modularity theory described in the
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`petition.
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`The Board’s Order suggests that, to the extent possible, the supplemental
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`briefing address new evidence/argument. The Reply, however, presents no cogent
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`argument as to how these references relate to the petition arguments based on the
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`modularity of Michelson. Whether the modular members are combined prior to
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`insertion as stated in Michelson or inserted sequentially, Petitioner still fails
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`explain how modifying a single implant to a multi-component assembly increases
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`safety and minimizes invasiveness. To the extent Petitioner envisions some pivot
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`away from the modular embodiment of Michelson and toward newly presented
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`“side-by-side” cylindrical cages, none is explained. To the extent Petitioner invites
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`the Board to fashion some new theory on its behalf, that of course is prohibited.
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`
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`Under the guise of responsiveness, the Reply (4) suggests the newly
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`submitted references clarify the state of the art generally, as well as respond to
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`specific arguments regarding the state of the art. But the Reply (e.g., 1) does not
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`address NuVasive’s arguments regarding state of the art either, which are
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`incompletely and inaccurately stated in the Reply. See also Paper 37, 3.
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`Petitioner’s expert overstated and exaggerated developments in the field in
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`numerous instances, which called into question the reliability and credibility of the
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`direct testimony. POR 13-19; EX2055, ¶¶36-66. One of several examples of such
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`exaggerations was the assertion that “[b]y the 1990s, the use of non-bone interbody
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`spinal fusion implants had become common place.” EX1002, ¶39. Petitioner’s own
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`expert conceded during cross-examination that the first such implant he used was
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`one not available until the 2003. EX2022, 20-21, 31-34; EX1002, ¶45.
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`III. PETITIONER’S SUBMISSION OF MCAFEE IS A BELATED
`ATTEMPT TO FILL A VOID IN THE PRIMA FACIE CASE
`The petition relied exclusively on Baccelli as teaching the claimed
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`arrangement of radiopaque markers. The petition states that “Baccelli instructs a
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`POSA to include radiopaque markers in the middle of the sidewalls of the implant
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`relative to the direction in which the implant is inserted” Pet. 31. The petition
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`further states, based on Baccelli, that “POSA have found it obvious to position two
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`markers in the middle (widest portion) of Brantigan’s sidewalls to allow surgeons
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`to align the markers with the spinous process during and after the implant is
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`inserted laterally.” Id. (citing EX1002, ¶ 125).
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`NuVasive established that Petitioner had misapprehended the content of
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`Baccelli, including incorrectly labeling the dimensions of the Baccelli implant and
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`that Baccelli does not teach any markers proximate the medial plane. POR 20-24
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`(citing EX2055, ¶¶101-109). Moreover, while Petitioner relied on the spikes 24 of
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`Baccelli, it ignored Baccelli’s express instruction that spikes 24 are to be disposed
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`symmetrically about the sagittal midplane. POR 24. As such, importing the
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`positioning of spikes 24 of Baccelli into other implants would not result in the
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`marker configuration claimed in the challenged patent.
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`NuVasive also challenged the rationale of the petition as conclusory, lacking
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`evidentiary support, and parroting the same rationale that had previously been
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`rejected by the Federal Circuit. POR 25-26.
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`These deficiencies in the petition challenge as to the prima facie case cannot
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`be cured in Reply. The petition relied on the deficient content of Baccelli, ignored
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`disclosure in that reference that undermined its assertions, and attempted to recycle
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`the same conclusory rationale that previously failed. Any attempt to cure such
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`shortcomings by now turning to McAfee is improper.
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`Under the guise of responsiveness, and in attempt to improperly shift the
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`burden, the Reply (2-3) mischaracterizes NuVasive’s argument as somehow
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`attempting to prove that alignment of markers with the spinous process and the
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`lateral ends of a vertebrae was a benefit realized after the priority date. See also
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`Paper 37, 3. This is not what NuVasive argued. Instead, NuVasive correctly
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`pointed out that Petitioner’s conclusory assertion was merely repeating a rationale
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`that had already been rejected by the Federal Circuit as impermissible hindsight.
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`POR 25-26 (citing In re NuVasive, Inc., 842 F.3d 1376, 1384 (Fed. Cir. 2016).
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`In Reply (6), Petitioner argues that McAfee shows that POSAs knew the
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`benefits of “aligning markers with the spinous process and lateral ends of the
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`vertebrae.” Even if McAfee did show such an alignment — and it does not— this
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`reference does not address whether a POSA would have found it obvious to
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`position markers in the middle of Brantigan’s sidewalls, as well as in the leading
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`and trailing ends of the implant, to allow surgeons to align the markers with the
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`spinous process and the lateral ends of the vertebrae as argued in the petition.
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`Petitioner asserts (at 2-3) that its McAfee-based arguments are not based on
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`“impermissible hindsight,” even if true (and it is not) this assertion is irrelevant to
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`the Baccelli-based arguments of the petition.
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`Even if considered on the merits, McAfee fails to cure the deficiencies of
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`Baccelli or the arguments in the petition regarding radiopaque marker positioning.
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`Based on attorney argument, Petitioner claims McAfee shows radiopaque implant
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`markers based on alleged areas of differing intensity in the reproduced radiograph.
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`McAfee does not teach radiopaque markers at all, much less radiopaque markers in
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`the claimed configuration. McAfee also does not disclose benefits of alignment
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`with the spinous process or lateral ends of a vertebrae. There is no spinous process
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`visible in the identified figures and Petitioner’s attorney argument does not
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`demonstrate otherwise.
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`IV. CONCLUSION
`Petitioner’s Reply arguments that rely on Michelson ’770 (EX1053) and
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`McAfee (EX1054) should be disregarded or stricken from the record.
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`Date: March 2, 2020
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`
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`Respectfully submitted,
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`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
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`CERTIFICATE OF SERVICE
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`This is to certify that I caused to be served a true and correct copies of the
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`foregoing Patent Owner’s Supplemental Sur-Reply, on this 2nd day of March,
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`2020, on the Petitioner at the correspondence address of the Petitioner as follows:
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`Jovial Wong
`Nimalka R. Wickramasekera
`David P. Dalke
`WINSTON & STRAWN LLP
`Alphatec-IPRs@winston.com
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`Date: March 2, 2020
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`
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`Respectfully submitted,
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`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
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