IPR2019-00362
`
`Paper No. 42
`Filed: March 9, 2020
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`
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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. IPR2019-00362
`United States Patent No. 8,361,156
`________________
`
`PETITIONERS’ SUPPLEMENTAL SUR-SUR-REPLY TO PATENT
`OWNER’S RESPONSE
`
`
`
`
`
`Paper No. 42
`Filed: March 9, 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. IPR2019-00362
`United States Patent No. 8,361,156
`________________
`
`PETITIONERS’ SUPPLEMENTAL SUR-SUR-REPLY TO PATENT
`OWNER’S RESPONSE
`
`
`
`
`
`IPR2019-00362
`
`I.
`
`INTRODUCTION1
`
`Patent Owner erroneously categorizes Michelson ’770 (EX1053) and McAfee
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`(EX1054) as “new evidence” that “deviates, or attempts to change the ‘thrust’ of the
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`challenges set forth in the petition.” Paper 41, 1. But, “[a] party also may submit
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`rebuttal evidence in support of its reply.” Consolidated Practice Guide, 73, citing
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`Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1077–78 (Fed. Cir. 2015) (no error in
`
`ruling new declaration was “generally ... in fair reply to [Patent Owner’s expert’s]
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`declaration and/or [Patent Owner’s] response to the revised petition” and “was [not]
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`necessary for [Petitioner] to establish a prima facie case”). Belden applies here—
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`Michelson ’770 and McAfee directly rebut the argument that “Dr. Branch’s
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`characterization of the state of the art is inaccurate and unreliable,” especially as to
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`the modular insertion of implants, and that implementing a “marker configuration
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`[that] ‘allow[s] surgeons to align the markers with the spinous process during and
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`after the implant is inserted laterally’” is “impermissible hindsight.” Paper 27, 9,
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`25–26.
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`“[T]he obviousness ‘analysis requires an assessment of the ‘…background
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`knowledge possessed by a person having ordinary skill in the art.’” Koninklijke
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`Philips N.V. v. Google LLC, 948 F.3d 1330, 1337 (Fed. Cir 2020) (emphasis in
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`original). In Phillips, “the Board relied on expert evidence, which was corroborated
`
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`1 The Board authorized this filing in Paper No. 37, filed February 21, 2020.
`1
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`IPR2019-00362
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`by Hua [prior art not included in a combination], in concluding that pipelining was
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`not only in the prior art, but also within the general knowledge of a skilled artisan.”
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`Id. at 1338.2 Patent Owner does not acknowledge Phillips and has “offered no
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`evidence to rebut the conclusion that a skilled artisan would have known about” the
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`teachings of Michelson ’770 and McAfee. Id. In fact, Michelson ’770 and McAfee
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`were known to and used by Patent Owner years before these proceedings. See, e.g.,
`
`Paper 34, 1–2, 4–5; EX1034, 26–27; EX1038, ¶19; EX1047, 5, 8; Medtronic
`
`Sofamor Danek, USA v. NuVasive, Inc., Case No. 3:08-cv-01512-MMA, Doc. No.
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`358 at 58–62 (Patent Owner introducing Michelson ’770 to cross examine Dr.
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`Michelson in an attempt to invalidate the ’973 patent (EX1032)). Worse, Patent
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`Owner apparently chose not to inform its experts of these prior art references or
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`Patent Owner’s prior proceedings so it could rely on uninformed experts to argue
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`that “Petitioner’s expert overstated and exaggerated developments in the field.” See
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`Paper 41, 4; Paper 34, 2, 4–5; see also EX1050, 23:18–28:9, 30:18–34:17, 37:6–
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`38:3, 48:3–49:11, 53:23–54:15, 56:10–58:20; EX1051, 31:13–16, 54:11–13;
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`EX1052, 23:7–24:22, 35:13–41:1; 62:6–10; 63:18–25. Petitioners could not
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`anticipate Patent Owner’s blatant misrepresentation of a POSA’s general
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`knowledge, especially in light of references that Patent Owner itself previously
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`relied on, which directly rebut Patent Owner’s statements.
`
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`2 Unless otherwise noted, all emphasis is added and all internal cites are omitted.
`2
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`IPR2019-00362
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`II. MICHELSON ’770 REBUTS PATENT OWNER’S ARGUMENT
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`Patent Owner argues that Petitioners advance “several arguments indicating
`
`retreat from its previous reliance on the modularity of Michelson as illustrated in
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`Figs. 18 and 19 in numerous respects.” Paper 41, 2. First, Patent Owner argues that
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`neither McAfee nor Michelson ‘770 “describes a modular implant as in Michelson
`
`nor does Petitioner assert otherwise.” Id., 3. Second, Patent Owner argues that
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`Petitioners’ reply “presents no cogent argument as to how these references relate to
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`the petition arguments based on the modularity of Michelson.” Id. Third, Patent
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`Owner argues that “Petitioner still fails [to] explain how” Michelson’s modularity
`
`teaching “increases safety and minimizes invasiveness.” Id. Fourth, Patent Owner
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`argues that “Petitioner’s expert overstated and exaggerated developments in the field
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`in numerous instances, which called into question the reliability and credibility of
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`the direct testimony.” Id., 4. None of this is true.
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`Michelson ’770 and McAfee describe modular implants. Michelson’s
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`“modularity” teaching expressly does not require “modifying a single implant to a
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`multi-component assembly.” Contra Paper 41, 3. As Petitioners explained,
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`Michelson expressly states that “FIG. 19 is a perspective lateral anterior view of a
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`segment of the spinal column with a plurality of the spinal implants of FIG. 18
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`shown in hidden line inserted from the lateral aspect in a modular fashion in the
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`disc space between two adjacent vertebrae along the transverse width of the
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`3
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`IPR2019-00362
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`vertebrae.” EX1032, 5:34–39, see also Paper 34, 12. If modular components must
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`be assembled prior to insertion, there would be no need for Michelson’s implant
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`1000, which “has a narrower width” than implant 900. Paper 34, 12. Instead,
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`Michelson’s modularity involves implants having “a narrower width such that more
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`than one spinal fusion implant 1000 may be combined in a modular fashion for
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`insertion within the disc space D.” EX1032, 10:52–54, see also claims 21, 34.
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`Michelson’s long-and-narrow, modular implants are placed side-by-side. EX1032,
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`Fig. 19. Although Figure 19 illustrates three long-and-narrow modular implants
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`positioned side-by-side within the disc space, the Federal Circuit commented that
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`the “point” of Figure 19 “is to show more than one” implant. In re NuVasive, Inc.,
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`841 F.3d 966, 974 (Fed. Cir. 2016). In fact, “openings 906” of the implant further
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`illustrate that modularity does not require “modifying a single implant to a multi-
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`component assembly.” Compare Figure 16 implant showing six “openings 906”
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`across the width with Figure 18 implant showing two “openings 906” and Figure 19
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`implant showing five “openings 906”; EX1032, Figs. 16, 18, 19, 10:25–27.
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`Petitioners explain how Michelson ’770 and McAfee both disclose the same long-
`
`and-narrow, modular implants arranged in a side-by-side orientation. See, e.g.,
`
`Paper 34, 1–3, 10–12.
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`Michelson ’770 and McAfee directly relate to the Petition. Consistent with
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`Michelson, which teaches an implant having a depth “that approximates the depth
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`4
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`IPR2019-00362
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`of the vertebrae,” Petitioners argued that a POSA would have known those
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`dimensions based on Berry. With those dimensions, e.g., approximately 37.9 mm
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`for the L4-L5 vertebrae, a POSA would have been motivated to follow Michelson’s
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`suggestion to make a translateral implant modular such that more than one implant
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`could be “inserted into the disc space through a hollow tube” which is “safer to use
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`than implants inserted from the front or back…” EX1032, 3:55–65. To make long-
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`and-narrow, modular implants to be placed sequentially through a hollow tube, a
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`POSA would have been motivated to make the largest of those implants 18.95 mm
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`wide because any other implant needed to “approximate the depth of the vertebrae”
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`would necessarily be narrower than 18.95 mm and could be passed through the
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`hollow tube—without making it any wider—for side-by-side orientation within the
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`disc space, just as taught by Michelson (EX1032) and Michelson ’770 (EX1053).3
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`Petitioners explained increased safety. Patent Owner complains that
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`“Petitioner still fails [to] explain how” a long-and-narrow, modular implant
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`“increases safety and minimizes invasiveness.” Paper 41, 3. Not true. Petitioners
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`explain how inserting long-and-narrow, modular implants would increase safety and
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`minimize invasiveness. Paper 34, 10–11. Indeed, “the ‘long and narrow’ implants
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`proposed in the petition could be inserted in a minimally invasive procedure ‘through
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`3 To the extent Patent Owner argues that the Board’s decision to institute trial is
`limited to the parentheticals Patent Owner cites, Patent Owner is mistaken. See
`Paper 41, 1–2.
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`5
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`IPR2019-00362
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`a hollow tube which is engaged to the lateral aspect of the spine through a lateral,
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`anterior, or anterolateral incision making the procedure safe and simple.’” Id., citing
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`EX1032, 3:62–65, 3:55–59.
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`Petitioners did not exaggerate the state of the art. Patent Owner’s assertion
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`that “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
`
`direct testimony,” is false. Paper 41, 4. According to Patent Owner, “[o]ne of
`
`several examples of such exaggerations was the assertion that ‘[b]y the 1990s, the
`
`use of non-bone interbody spinal fusion implants had become common place.” Id.,
`
`citing EX1002, ¶39. Patent Owner concludes that “Petitioner’s own expert conceded
`
`during cross-examination that the first such implant he used was one not available
`
`until 2003.” Paper 41, 4. Not so. Dr. Branch testified that he first used non-bone
`
`implants between approximately 1998–2000. EX2022, 20:5–21:7, 31:2–34:3;
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`EX1002, ¶45. The declaration’s parenthetical dates are commercial launch dates,
`
`not dates of first public use, which preceded commercial launch. See, e.g., EX2022,
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`21:3–7. Dr. Branch’s testimony and declaration are also consistent with the dates of
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`Michelson ’770, McAfee, and the testimony Patent Owner previously obtained
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`regarding public availability of non-bone implants. See, e.g., Paper 34, 5.
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`III. McAFEE REBUTS PATENT OWNER’S ARGUMENT
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`Patent Owner criticized the Petition for failing “to demonstrate that a POSA
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`6
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`IPR2019-00362
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`would have been motived to modify Brantigan to include the radiopaque markers of
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`Baccelli.” Paper 27, 25. Specifically, Patent Owner characterized Petitioners’
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`motivation to combine Brantigan and Baccelli as “recycl[ing] the same argument
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`that was soundly rejected as impermissible hindsight by the Federal Circuit.” Id.
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`Patent Owner misstates the Federal Circuit’s opinion. In In re: NuVasive, Inc., the
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`Federal Circuit noted that “placing radiopaque markers along the medial plane
`
`‘would provide … better alignment of the implant,’” but because the Board relied
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`on the admissions of Patent Owner’s expert regarding benefits recognized after the
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`priority date, the Federal Circuit concluded that the admissions did not address the
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`benefits that could have been obtained by combining the prior art references or the
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`POSA’s motivation to combine at the time of the invention. 842 F.3d. 1376, 1384
`
`(Fed. Cir. 2016).
`
`Petitioners submitted McAfee to rebut Patent Owner’s argument and
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`demonstrate that the benefits of aligning markers with the spinous process were
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`known to POSAs at least as early as 1998 and that it was well-known how multiple,
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`long-and-narrow, non-bone, modular implants could be laterally inserted and
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`situated in a side-by-side orientation consistent with Michelson’s teachings. Paper
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`34, 1–3, 13.
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`IV. CONCLUSION
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`Michelson ’770 and McAfee are proper rebuttal exhibits.
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`7
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`IPR2019-00362
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`Date: March 9, 2020
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`Respectfully submitted,
`
`
`
`/Jovial Wong/
`Jovial Wong
`Reg. No. 60,115
`
`Lead Counsel for Petitioners
`
`
`
`8
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`
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`APPENDIX – LIST OF EXHIBITS
`
`IPR2019-00362
`
`Exhibit No.
`1001
`1002
`1003
`1004
`
`1005
`
`1006
`
`1007
`1008
`1009
`1010
`1011
`1012
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`Brief Description
`U.S. Patent No. 8,361,156 to Curran et al. (“’156 patent”)
`Declaration of Charles L. Branch, Jr., M.D.
`Curriculum Vitae of Charles L. Branch, Jr., M.D.
`IPR2013-00506, Final Written Decision, Paper No. 47 (“IPR506
`FWD”)
`In re: NuVasive, Inc., No. 2015-1670, Opinion, (Fed. Cir. Dec. 7,
`2016) (“IPR2013-00506 CAFC Opinion”)
`IPR2013-00506, Judgment Granting Joint Motion to Terminate
`after Remand from the Court of Appeals for the Federal Circuit,
`Paper No. 57
`U.S. Patent No. 5,192,327 to Brantigan (“Brantigan”)
`U.S. Patent App. Pub. No. 2003/0028249 to Baccelli et al.
`(“Baccelli”)
`Synthes Vertebral Spacer-PR Brochure (“SVS-PR”)
`Telamon Verte-Stack PEEK Vertebral Body Spacer Brochure
`(“Telamon Brochure”)
`Telamon Implantation Guide (“Telamon Guide”)
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 2013-1576, -1577,
`Joint Appendix, Docket No. 52-1 (Fed. Cir. June 16, 2014)
`Prosecution History of the ’156 patent, U.S. App. No. 13/441,092
`IPR2013-00208, Corrected Petition for Inter Partes Review of
`United States Patent No. 8,251,997, Paper No. 5 (“IPR208
`Petition”)
`IPR2013-00206, Corrected Petition for Inter Partes Review of U.S.
`Patent No. 8,251,997, Paper No. 5 (“IPR206 Petition”)
`IPR2013-00206, Petitioner’s Reply to Patent Owner’s Response,
`Paper No. 43, (“IPR206 Reply”)
`IPR2013-00206, Final Written Decision, Paper No. 65 (“IPR206
`FWD”)
`IPR2013-00208, Final Written Decision, Paper No. 62 (“IPR208
`FWD”)
`In re: Warsaw Orhtopedic, Inc., Nos. 2015-1050, 2015-1058 (Fed.
`Cir. Aug. 9, 2016) (“IPR208 CAFC opinion”)
`
`
`
`1
`
`
`
`
`
`Exhibit No.
`1020
`1021
`1022
`
`1023
`
`1024
`
`1025
`1026
`1027
`1028
`1029
`
`1030
`
`1031
`1032
`1033
`1034
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`Brief Description
`Prosecution History of U.S. Patent No. 7,918,891, U.S. App. No.
`11/093,409
`U.S. Patent No. 8,251,997 to Michelson (“Michelson ’997”)
`Berry et al. “A Morphometric Study of Human Lumbar and
`Selected Thoracic Vertebrae,” 12 SPINE, 362-367 (1987) (“Berry”)
`Prosecution History of U.S. Patent No. 8,187,334, U.S. App. No.
`13/079,645
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 3:08-cv-1512
`CAB-MDD, NuVasive Inc,’s Memorandum of Points and
`Authorities in Support of its Renewed Motion for Judgment as a
`Matter of Law or a new Trial, Docket No. 407-1 (S.D. Cal. Oct. 27,
`2011) (“Warsaw JMOL”)
`Prosecution History of U.S. Patent No. 8,246,686, U.S. App. No.
`13/440,062
`U.S. Provisional Patent App. No. 60/557,536, filed March 29, 2004
`RESERVED
`U.S. Patent No. 5,127,912 to Ray et al.
`U.S. Patent No. 5,514,180 to Heggeness et al.
`Amonoo-Kuofi, “Age-Related Variation in the Horizontal and
`Vertical Diameters of the Pedicles of the Lumbar Spine,” 186 J.
`ANAT., 321-328 (1995)
`IPR2013-00506 Decision to Institute, Paper No. 9
`U.S. Patent No. 5,860,973 to Michelson (“Michelson ’973”)
`IPR2013-00504, Decision Denying Institution, Paper No. 8
`IPR2013-00506, Petition, Paper No. 1
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 2013-1576, -1577,
`NuVasive’s Opening Brief, Docket No. 33 (Fed. Cir. Feb. 3, 2014)
`Panjabi et al., “Complexity of the Thoracic Spine Pedicle
`Anatomy,” 6 EUR. SPINE J., 19-24 (1997)
`Kopperdahl et al., “Yield Strain Behavior of Trabecular Bone,” 31
`J. BIOMECHANICS, 601-608 (1998)
`IPR2013-00208, Declaration of Dr. Paul McAfee, M.D., M.B.A.,
`Paper No. 1001
`NuVasive Inc. v. Medtronic, Inc., No. 2015-1670, Corrected
`NuVasive’s Opening Brief, Docket No. 19 (Fed. Cir. July 23, 2015)
`
`2
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`
`Exhibit No.
`1040
`1041
`1042
`1043
`1044
`1045
`1046
`
`1047
`1048
`1049
`1050
`1051
`1052
`1053
`1054
`
`1055
`
`1056
`1057
`1058
`1059
`
`1060
`
`1061
`
`1062
`
`1063
`
`1064
`
`1065
`
`Brief Description
`U.S. Patent Application No. 2002/0165550 to Frey et al.
`IPR2013-00504, Petition, Paper No. 3
`IPR2014-00487, Petition, Paper No. 1
`IPR2013-00506, Patent Owner Response, Paper No. 21
`IPR2014-00487, Decision Denying Institution, Paper No. 8
`RESERVED
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 2013-1576, 2013-
`1577, Opinion, Docket No. 77 (Fed. Cir. March 2, 2015)
`IPR2013-00208, Petitioner’s Reply to Patent Owner’s Response,
`Paper No. 40
`Declaration Of Nimalka R. Wickramasekera
`RESERVED
`Transcript of Deposition of Dr. Jim A. Youssef, January 9, 2020
`Transcript of Deposition of Dr. Carl McMillin, January 8, 2020
`Transcript of Deposition of Matthew Link, January 7, 2020
`U.S. Patent No. 6,241,770 to Michelson
`IPR2014-00075, Ex. 2065 (“McAfee”)
`Exhibit DTX-5150-R in Case No. 3:08-cv-01512-CAB-MDD,
`Brantigan & Steffe, “A Carbon Fiber Implant to Aid in Interbody
`Lumbar Fusion,” 18 SPINE., 2106–2117 (1993)
`Trial transcript in Case No. 3:08-cv-01512-CAB-MDD
`RESERVED
`RESERVED
`Excerpt of Transcript of Deposition of Dr. Jim A. Youssef, January
`10, 2020
`Excerpt of Petitioner’s Reply to Patent Owner’s Response in
`IPR2013-00206
`Expert Report of Jim Youssef re Damages dated November 8, 2019
`in Case No. 3:08-cv-01512-CAB-MDD
`Order re Motion to Dismiss Counts VII and VIII dated May 14,
`2018 filed in Case No. 3:18-cv-00347-CAB-MDD
`Exhibit 5, Consulting Agreement Memo dated October 26, 2017
`filed in Case No. 3:18-cv-00347-CAB-MDD
`Dr. Jim A. Youssef entry – openpaymentsdata.cms.gov (as of Dec.
`3, 2019)
`Declaration of Matthew Link in Support of Motion for Preliminary
`Injunction
`
`3
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`
`
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), I certify that, on March 9, 2020,
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`true and correct copies of the foregoing PETITIONERS’ SUPPLEMENTAL
`
`SUR-SUR-REPLY TO PATENT OWNER’S RESPONSE was served by via
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`email to the following counsel for the Patent Owner:
`
`Michael T. Rosato (Reg. No. 52,182)
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`Tel.: 206-883-2529
`Fax: 206-883-2699
`Email: mrosato@wsgr.com
`
`Paul D. Tripodi II (Reg. No. 40,847)
`WILSON SONSINI GOODRICH & ROSATI
`633 West Fifth Street, Suite 1550
`Los Angeles, CA 90071
`Tel.: 323-210-2902
`Fax: 866-974-7329
`Email: ptripodi@wsgr.com
`
`Sonja R. Gerrard (Reg. No. 72,802)
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`Tel.: 206-883-2649
`Fax: 206-883-2699
`Email: sgerrard@wsgr.com
`
`Jad A. Mills (Reg. No. 63,344)
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`Tel.: 206-883-2554
`Fax: 206-883-2699
`
`4
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`Date: March 9, 2020
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`Email: jmills@wsgr.com
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`Respectfully submitted,
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`
`
`
`
`/Jovial Wong/
`Jovial Wong (Reg. No. 60,115)
`Lead Counsel for Petitioners
`
`5
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