Case 3:18-cv-00347-CAB-MDD Document 391 Filed 03/04/22 PageID.34767 Page 1 of 9
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`NIMALKA R. WICKRAMASEKERA (SBN: 268518)
`nwickramasekera@winston.com
`LEV TSUKERMAN (SBN: 319184)
`ltsukerman@winston.com
`WILLIAM M. WARDLAW (SBN: 328555)
`wwardlaw@winston.com
`WINSTON & STRAWN LLP
`333 S. Grand Avenue
`Los Angeles, CA 90071-1543
`Telephone: (213) 615-1700
`Facsimile:
`(213) 615-1750
`
`GEORGE C. LOMBARDI (pro hac vice)
`glombardi@winston.com
`BRIAN J. NISBET (pro hac vice)
`bnisbet@winston.com
`SARANYA RAGHAVAN (pro hac vice)
`sraghavan@winston.com
`WINSTON & STRAWN LLP
`35 West Wacker Drive
`Chicago, IL 60601-9703
`Telephone: (312) 558-5600
`Facsimile: (312) 558-5700
`
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. AND ALPHATEC SPINE, INC.
`
`
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA - SAN DIEGO DIVISION
`Case No. 18-CV-00347-CAB-MDD
`NUVASIVE, INC., a Delaware
`
`corporation,
`DEFENDANTS’ BENCH
`
`MEMORANDUM REGARDING
`SECONDARY CONSIDERATIONS
`
`
`v.
`
`
`Judge: Hon. Cathy Ann Bencivengo
`ALPHATEC HOLDINGS, INC., a
`Courtroom: 4C
`Delaware corporation and
`ALPHATEC SPINE, INC., a
`
`
`California corporation,
`
`Defendants.
`
`Plaintiff,
`
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` DEFENDANTS’ BENCH MEMORANDUM REGARDING SECONDARY CONSIDERATIONS
`
`CASE NO. 18-CV-00347-CAB-MDD
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`Alphatec respectfully submits that there is no nexus between the asserted claims
`and NuVasive’s proffered evidence of secondary considerations of non-obviousness
`relating to the XLIF platform and procedure as a whole. A “patent claim is not
`coextensive with a product that includes a ‘critical’ unclaimed feature that is claimed
`by a different patent and that materially impacts the product’s functionality.” Teva
`Pharms. Int’l GmbH v. Eli Lilly & Co., 8 F.4th 1349, 1361 (Fed. Cir. 2021). The
`undisputed evidence in this case—and governing Federal Circuit law—establishes that
`XLIF includes an unclaimed feature—neuromonitoring—that NuVasive and its
`witnesses have admitted is critical and required to perform XLIF, that materially
`impacts the product’s functionality, and that is claimed by other patents in NuVasive’s
`portfolio. Thus, the Court should (1) preclude NuVasive from presenting any evidence
`of secondary considerations, including commercial success, skepticism, industry praise,
`long-felt but unmet need, failure of others, teaching away, and unexpected results, and
`(2) limit NuVasive’s evidence of copying to the patented features. To hold otherwise
`would apply different standards to proving infringement and invalidity. By the language
`of the asserted claims, NuVasive is not required to show that Alphatec’s accused system
`includes all the components of XLIF for a finding of infringement. Yet permitting
`NuVasive to argue that XLIF is the claimed invention forces Alphatec to argue the
`invalidity of XLIF as a whole, as opposed to the asserted claims.
`I.
`ARGUMENT
`The Court cautioned NuVasive that it “cannot establish secondary considerations
`of non-obviousness by talking about the neuromonitoring system [that is part of XLIF]
`but is not part of the claim.” 2/28/2022 Hr’g at 9:20–23; see also id. at 10:14-17
`(“[NuVasive] can’t get over any hump there by saying oh, and then with this
`neuromonitoring, which is not a claim that is asserted here, we have demonstrated that
`this is an advancement in the surgical art.”). Yet NuVasive presented this exact
`argument to the jury during its opening statement, and the Court should preclude further
`attempts to attribute secondary indicia regarding XLIF to the asserted claims. Further,
`
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`DEFENDANTS’ BENCH MEMORANDUM REGARDING SECONDARY CONSIDERATIONS
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`CASE NO. 18-CV-00347-CAB-MDD
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`NuVasive should not be permitted to disguise evidence regarding XLIF simply by
`calling it NuVasive’s “lateral system.”
`A. The asserted claims do not require neuromonitoring
`NuVasive asserts three patents against Alphatec: the ’531 patent, the ’801 patent,
`and the ’832 patent. None of the asserted claims require neuromonitoring, a necessary
`component of NuVasive’s XLIF platform and procedure. See ’531 patent at claims 1,
`39; ’801 patent at claims 1, 2, 15, 16, 26; ’832 patent at claims 1, 3, 9, 10. There is only
`one independent claim remaining in the case that remotely relates to neuromonitoring,
`and even that only requires conventional sequential dilators equipped with stimulation
`electrodes untied to any system with functionality that stimulates the electrodes,
`receives feedback, and actually monitors the nerves in the psoas muscle. See ’832
`patent, claim 1 (“wherein at least one instrument from the group consisting of said
`elongate inner element and said dilators includes a stimulation electrode that outputs
`electrical stimulation for nerve monitoring when the at least one instrument is
`positioned in the psoas muscle”). One dependent claim of the ’801 patent requires the
`same. See ’801 patent, claim 15 (“each of the plurality of sequential dilators includes a
`stimulation electrode at a distal region”). Notably, the asserted claims of the ’531 patent
`simply recite a collection of known instruments without any capability of connecting to
`a neuromonitoring system.
`The lack of neuromonitoring in the asserted claims is further highlighted by the
`fact that there are other claims in the asserted patents that do require neuromonitoring.
`See, e.g., ’801 patent, claim 7 (“further comprising a control unit capable of electrically
`stimulating said at least one stimulation electrode, sensing a response of a nerve
`depolarized by said stimulation, determining at least one of proximity and direction
`between said at least one stimulation electrode and said depolarized nerve based upon
`the sensed response, and communicating said at least one of proximity and direction to
`a user”), ’832 patent, claim 11 (“further comprising a monitoring system that delivers
`an electrical stimulation signal to the stimulation electrode of the initial dilator, monitors
`
`2
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`DEFENDANTS’ BENCH MEMORANDUM REGARDING SECONDARY CONSIDERATIONS
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`CASE NO. 18-CV-00347-CAB-MDD
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`electromyographic activity detected by a set of sensor electrodes in leg muscle
`myotomes associated with nerves in the vicinity of the targeted spinal disc, and displays
`information on a display screen in response to the detection of said electromyographic
`activity via said set of sensor electrodes in said leg muscle myotomes”). None of these
`claims are asserted in this case.
`B.
`There is no nexus between the asserted claims and XLIF
`The Federal Circuit has previously concluded that NuVasive’s XLIF Surgical
`Technique requires the NeuroVision® System:
`
`[T]he Guide specifically identifies the MaXcess® II Access System,
`MaXcess® XLIF System, and NeuroVision® System as part of the
`required instruments to successfully complete the technique… While
`the Guide does list the components of the ‘XLIF Instrument System,’ it
`is very clear that the actual XLIF surgical technique requires more
`than just these instruments; it utilizes the MaXcess® II Access,
`MaXcess® XLIF, and NeuroVision® Systems in addition to general
`surgical tools such as nerve retractors, disc cutters, and curettes that are
`traditionally employed in interbody fusion procedures.
`NuVasive, Inc. v. Iancu, 752 F. App’x 985, 995–996 (Fed. Cir. 2018) (emphasis added).
`NeuroVision® is NuVasive’s proprietary neuromonitoring system that “allows
`surgeons to monitor the placement of the surgical instruments relative to nearby neural
`structures.” Id. at 989. The trial record reflects the same: NuVasive’s XLIF Surgical
`Technique (PTX-2763) expressly states that “[t]o successfully complete this technique,
`the following patient positioning supplies, instruments, implants, and fixation options
`are required . . . NVM5® . . . NVM5 EMG Module.” Id. at 4 (emphasis added). Step
`5 of the XLIF Surgical Technique stresses the “importance of neuromonitoring.” Id. at
`12. It confirms that neuromonitoring is “critical to the safety and reproducibility of any
`lateral transpsoas approach due to the lumbar plexus’ positioning within the psoas.”
`Id. at 13 (emphasis added). “The XLIF® Procedure relies on the clinically validated
`dynamic EMG nerve avoidance mode of NVM5® to identify a safer docking position
`and working area.” Id. at 12; see also PTX-59 at 17.
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`DEFENDANTS’ BENCH MEMORANDUM REGARDING SECONDARY CONSIDERATIONS
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`CASE NO. 18-CV-00347-CAB-MDD
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`NuVasive’s documents confirm that “the primary benefits of XLIF compared to
`conventional surgical approaches” and the “critical, differentiating factors that help to
`make XLIF reproducible” include the “use of automated, directionality stimulated
`electromyography (NVJJB®/M5®) with discrete threshold responses which provide
`information on the location and distance of instrumentation to motor nerves.” PTX-
`2879 at 1. As confirmed by NuVasive’s witness, Kyle Malone, this system includes a
`separately “patented Hunting Algorithm.”
` PTX-2535 at 2;
`see also
`https://www.nuvasive.com/resources/virtual-patent-marking/.
`Dr. Youssef has also told the jury that the “XLIF procedure has a very rote
`approach to the system, meaning you do each step, like I just described, which is very
`specific to that procedure.” Trial Day 3 Rough Tr. (Youssef) at 101:2–4. Indeed, his
`demonstration
`to
`the
`jury on
`the XLIF procedure specifically referenced
`neuromonitoring using directional stimulated dilators. Trial Day 3 Rough Tr. at 31:9–
`18 (“that line is then emitting an impulse and you can hook up neuromonitoring … so
`I’m looking at the X-ray machine and I’m responding to the information I’m getting
`from the EMG machine.”), 32:5–10 (“I’m placing the second dilator on and turning this
`on, once again, 360 degrees, confirming that no nerve is in the way… using the same
`neuromonitoring, I’m confirming I’m not near a nerve or on a nerve.”).
`In NuVasive, Inc. v. Iancu, the Federal Circuit found that nexus existed between
`the invention in U.S. Patent No. 7,691,057 and NuVasive’s XLIF. However, unlike the
`asserted claims in this case, the ’057 patent expressly claimed “neuromonitoring” (i.e.,
`“monitoring for resulting electromygraphic (EMG) activity after emission of each
`stimulation signal”) by coupling the dilators equipped with stimulation electrode “to a
`control unit of a neuromonitoring system”:
`performing neuromonitoring … wherein the neuromonitoring
`comprises causing the emission of a plurality of electrical stimulation
`signals from a stimulation electrode provided on a distal portion of at
`least one component of the distraction assembly and monitoring for
`resulting electromyographic (EMG) activity after the emission of
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`DEFENDANTS’ BENCH MEMORANDUM REGARDING SECONDARY CONSIDERATIONS
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`CASE NO. 18-CV-00347-CAB-MDD
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`each stimulation signal, and
`wherein the component of the distraction assembly is coupled to a
`control unit of a neuromonitoring system that is capable of displaying
`to a user an indication of at least one of proximity and direction of a
`nerve to the stimulation electrode provided on the component of the
`distraction
`assembly
`based
`on
`the monitored
`resulting
`electromyographic (EMG) activity.
`Id. at 988 (’057 patent, claim 17) (emphasis added).
`By contrast, none of the asserted claims require neuromonitoring. While some of
`the asserted claims (claim 1 of the ’832 patent and claim 15 of the ’801 patent) require
`dilators equipped with a stimulation electrode, the claimed dilators are not coupled to
`any neuromonitoring system that “caus[es] the emission of a plurality of electrical
`stimulation signals from [the] stimulation electrode” and then “monitor[s] for resulting
`electromygraphic (EMG) activity after the emission of each stimulation signal.” Id.
`Rather, the claimed dilators of the asserted patents are simply equipped with a piece of
`metal that is capable of conducting electricity. But without being coupled to a
`neuromonitoring system (e.g., NeuroVision®), they are no different than conventional
`dilators and cannot contribute to the alleged inventiveness of XLIF—creating an
`operative corridor to the spine using a lateral transpsoas approach through the nerve-
`dense psoas muscle. Id. at 989 (“EMG electrodes mounted on the surgical instruments
`and connected to NuVasive’s Neurovision system allows surgeons to monitor the
`placement of the surgical instruments relative to nearby neural structure.”) NuVasive
`does not—because it cannot—argue that Neurovision is unimportant. Magseis FF LLC
`v. Seabed Geosolutions (US) Inc., 860 F. App’x 746, 751–52 (Fed. Cir. 2021) (affirming
`finding of no nexus because “Magseis does not argue that those unclaimed components
`are insignificant.”).
`C. NuVasive’s evidence of secondary considerations relates only to XLIF
`NuVasive intends to have its expert, Dr. Jim Youssef, present evidence relating
`to secondary considerations of non-obviousness based on the XLIF platform as a whole.
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`CASE NO. 18-CV-00347-CAB-MDD
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`His testimony should be excluded, and NuVasive should be precluded from presenting
`any additional evidence or argument on objective indicia.
`As demonstrated by each of NuVasive’s witnesses to date, NuVasive’s evidence
`of secondary considerations relates to XLIF as a whole and is primarily directed to the
`alleged inventiveness of its neuromonitoring system, NeuroVision®1. For example,
`NuVasive’s first witness, Kyle Malone admitted that “the key steps of the lateral
`procedure
`that NuVasive have
`include what’s called
`triggered or evoked
`electromyography through the psoas muscle,” and that NuVasive “created a platform
`that uses standard technology for neuromonitoring, and then one of the things we did
`was utilize just an interface of providing that information in a new way on a computer
`screen.” Trial Tr. (Malone) 48:23–49:10. See also id. at 21:1–6 (“we have these ideas
`of procedural solutions of specialized instruments, of utilizing neuromonitoring);
`23:4–8 (“then that dilator is enabled and integrated with neuromonitoring”); 31:15–
`21 (“this is an example of that narrow monitoring [sic] being applied through the
`dilator”). PTX-2967 at NUVA_ATEC0286510 (including NeuroVision® computer
`output).
`Dr. Youssef’s secondary considerations opinions are also inextricably wedded to
`the XLIF platform as a whole, which indisputably includes NuVasive’s proprietary and
`patented neuromonitoring system. For example, Dr. Youssef disclosed XLIF-based
`opinions that include skepticism: “NuVasive faced substantial skepticism from the
`spine surgeon community shortly after introducing XLIF.” (Ex. A, Youssef Open Rpt.
`¶ 1332); industry praise: “In particular, consistent with my own experience, such
`praise was a result of substantial commitments made by NuVasive to educate surgeons
`on the safety and reproducibility of XLIF.” (Ex. A, Youssef Open Rpt. ¶ 1339); long-
`felt unmet need/failure of others: “Furthermore . . . when compared to interbody
`
`
`1 While there are various trade names for NeuroVision®, including NVM5, NuVasive’s
`witness Kyle Malone testified that each refers to a version of the same NuVasive
`proprietary Neuromonitoring system.
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`fusion performed by other approaches, the systems used in XLIF procedures offer a
`number of benefits, including: XLIF is minimally disruptive to the soft tissues; XLIF is
`associated with a shorter revovery time and less hospital time . . .” (Ex. A, Youssef
`Open Rpt. ¶ 1350); “teaching away”: “For reasons discussed above, the Jacobson
`technique as discussed in Friedman and Kanter articles teaches away from a lateral
`approach to the lumbar spine and evidences the long-felt need for XLIF, which enabled
`a safe, lateral, trans-psoas approach to the spine.” (Ex. A, Youssef Open Rpt. ¶ 1363.)
`Mr. Blake Inglish—who relies on Dr. Youssef to establish nexus—will be offered by
`NuVasive to testify to commercial success. His opinion is also rooted in the XLIF
`procedure. (Ex. B, 2019-11-1 Inglish Commercial Success Rep. at ⁋ 17) (“NuVasive’s
`revenue attributable to its XLIF procedure has continued to grow, such that it has
`generated approximately $130 million to $143 million annually from 2013-2018.”)
`Because NuVasive’s secondary considerations evidence is tied to XLIF, which
`requires NeuroVision® by NuVasive’s own admissions, rather than the claimed K-wire,
`sequential dilators, retractor, and/or intradiscal shim, these opinions should be excluded.
`II. CONCLUSION
`It is indisputable that XLIF requires neuromonitoring to achieve its benefits and
`that the asserted claims do not require neuromonitoring. Because this functionality
`“materially impacts” XLIF and because NuVasive has no evidence of secondary
`considerations of the claimed instruments, Alphatec respectfully requests the Court to
`preclude NuVasive from presenting any evidence of secondary considerations at trial.
`
`Dated: March 4, 2022
`
`WINSTON & STRAWN LLP
`
`
`
`By: /s/ Nimalka R. Wickramasekera
`NIMALKA R. WICKRAMASEKERA
`
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. AND
`ALPHATEC SPINE, INC.
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`DEFENDANTS’ BENCH MEMORANDUM REGARDING SECONDARY CONSIDERATIONS
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`CASE NO. 18-CV-00347-CAB-MDD
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`CERTIFICATE OF SERVICE
`I hereby certify that the foregoing document was filed with the Court’s CM/ECF
`system which will provide notice to all counsel deemed to have consented to electronic
`service. All other counsel of record not deemed to have consented to electronic service
`were served with a true and correct copy of the foregoing document by mail on this day.
`I declare under penalty of perjury under the Laws of the United States of America
`that the above is true and correct. Executed this 4th day of March 2022 at San Diego,
`California.
`
`Dated: March 4, 2022
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`WINSTON & STRAWN LLP
`
`By: /s/ Nimalka R. Wickramasekera
`
`NIMALKA R. WICKRAMASEKERA
`
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`DEFENDANTS’ BENCH MEMORANDUM REGARDING SECONDARY CONSIDERATIONS
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`CASE NO. 18-CV-00347-CAB-MDD
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