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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`
` Case No.: 3:18-CV-347-CAB-MDD
`
`ORDER RE ALPHATEC’S MOTION
`TO EXCLUDE EXPERTS
`
`[Doc. No. 251]
`
`Plaintiff,
`
`NUVASIVE, INC.,
`
`v.
`ALPHATEC HOLDINGS, INC. et al.,
`Defendants.
`
`
`
`Before the Court is Alphatec’s motion to exclude certain testimony of NuVasive’s
`experts. [Doc. No. 251.] NuVasive filed an opposition. [Doc. No. 259.] Alphatec filed a
`reply. [Doc. No. 263.] The Court held argument on March 13, 2020. Having considered
`the submissions of the parties and the arguments of counsel, the Court rules as follows.
`Legal Standard
`I.
`Federal Rule of Evidence 702 provides that a qualified expert may testify if “(a) the
`expert’s scientific, technical, or other specialized knowledge will help the trier of fact to
`understand the evidence or to determine a fact in issue; (b) the testimony is based on
`sufficient facts or data; (c) the testimony is the product of reliable principles and methods;
`and (d) the expert has reliably applied the principles and methods to the facts of the case.”
`Fed. R. Evid. 702. In Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 589
`(1993), the Supreme Court held that Rule 702 requires the district court to act as a
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`Case 3:18-cv-00347-CAB-MDD Document 284 Filed 04/30/20 PageID.26383 Page 2 of 7
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`gatekeeper to “ensure that any and all scientific testimony or evidence admitted is not only
`relevant, but reliable.” See Kumho Tire Co. Ltd., v. Carmichael, 526 U.S. 137, 147 (1999)
`(the basic gatekeeping obligation applies to all expert testimony). Whether the proposed
`testimony meets the Daubert reliability factor in a particular case is a matter that the law
`grants the trial judge broad latitude to determine. Id. at 153.
`“Daubert and Rule 702 are safeguards against unreliable or irrelevant opinions, not
`guarantees of correctness.” i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 854 (Fed. Cir.
`2010). Underlying factual disputes and how much weight to accord an expert’s opinion
`are questions for the jury. Micro Chem., Inc., v. Lextron, Inc., 317 F.3d 1387, 1392 (Fed.
`Cir. 2003).
`Alphatec moves to exclude certain opinions of Dr. Jim Youssef and Blake Inglish,
`and the testimony of Stephen K. Kunin entirely.
`II. Dr. Jim Youssef
`A. Opinions on Secondary Considerations of Nonobviousness
`Dr. Youssef is an orthopaedic surgeon with experience in spine surgery. NuVasive
`has designated him to provide expert opinions on the infringement and validity of the
`patents-at-issue. Concerning Alphatec’s validity challenge based on obviousness, 35
`U.S.C. § 103, Dr. Youssef offers opinions regarding the secondary considerations of
`nonobviousness. See Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 17-18 (1966)
`(secondary considerations such as commercial success, long felt but unresolved needs,
`failure of others, etc., may be indicia of the obviousness or nonobviousness of the subject
`matter patented). “Secondary considerations are only relevant if there is a nexus between
`the secondary considerations and the claimed invention.” Ormco Corp. v. Align Tech, Inc.,
`463 F.3d 1299, 1311-12 (Fed. Cir. 2006); see also Henny Penny Corp. v. Frymaster LLC,
`938 F.3d 1324, 1332 (Fed. Cir. 2019) (to be accorded substantial weight in the obviousness
`analysis, the secondary considerations must have a nexus to the claims). “Ultimately, the
`patentee bears the burden of showing that a nexus exists.” Id.
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`Dr. Youssef opines that secondary considerations including skepticism, industry
`praise, long-felt but unmet need, failure of others, copying, teaching away, and unexpected
`results demonstrate the nonobviousness the patents-at-issue. Dr. Youssef opines that the
`patented inventions are embodied in NuVasive’s commercial surgical platform/procedure,
`to create an operative corridor in a lateral, trans-psoas path to the lumbar spine. In
`conjunction with other aspects of the NuVasive surgical platform/procedure (i.e., the
`neuromonitoring and the large spinal implant), he then considers the various secondary
`considerations applied to the commercial embodiment. [Doc. No. 259-2 at ¶¶ 1329-1367.]
`Alphatec argues that Dr. Youssef’s opinion may broadly tie NuVasive’s surgical
`platform/procedure to the claimed inventions, he does not adequately tie the secondary
`factors to the claimed inventions at issue in this litigation. Rather, he attributes the various
`secondary considerations to the non-patented aspects of NuVasive’s overall surgical
`platform/procedure.
`There must be a legally and factually sufficient connection between the evidence of
`nonobviousness and the patented invention. If the evidence is “tied to a specific product
`and that product embodies the claimed features and is co-extensive with them” there is a
`rebuttable presumption of nexus. Henny Penny Corp., 938 F.3d at 1332. The NuVasive
`surgical platform/procedure includes methods, systems and devices that are covered by the
`patents-at-issue. Thus, there is a sufficient factual nexus between the claimed inventions.
`See NuVasive Inc. v. Iancu, 752 Fed. App’x 985, 995-996 (Fed. Cir. 2018) (finding a
`sufficient nexus between claims of NuVasive’s U.S. Patent No. 7,691,057 and the
`NuVasive surgical techniques, therefore remanding to the PTAB for further consideration
`of the evidence of nonobviousness).
`Although other features of the NuVasive surgical platform/procedure not covered
`by the patents-at-issue and NuVasive’s education and training programs may contribute to
`recognition and praise for the NuVasive surgical system, that alone does not dictate a
`finding that there is not a nexus to the claimed inventions. The patented components at
`issue in this litigation, which predominantly address the system to create the operative
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`corridor1, are not so small a component of the overall platform/procedure that the rebuttal
`presumption of nexus should not apply. Id.
`Accordingly, the motion to exclude Dr. Youssef’s opinions on the secondary
`considerations of nonobviousness is DENIED. His opinions are best challenged by cross-
`examination rather than exclusion, particularly regarding the opinions Alphatec seeks to
`exclude as contradictory to opinions he has expressed in other litigations.
`B. Opinions Supporting Claims for Convoyed Sales
`Dr. Youssef is also designated to provide opinions supporting NuVasive’s claim for
`damages, including lost profits on certain unpatented components sold by Alphatec, such
`as the spinal fusion implants employed in spinal surgeries performed with the accused
`Alphatec Battalion Lateral System. Dr. Youssef opines that the implants are sold with the
`Battalion System as a functional unit and therefore are convoyed sales subject to a claim
`for lost profits. [See, e.g., Doc. No. 259-3 at ¶¶ 26-29.]
`“To be entitled to lost profits for convoyed sales, the related products must be
`functionally related to the patented product and losses must be reasonably foreseeable.
`Being sold together merely for ‘convenience or business advantage’ is not enough.”
`Warsaw Orthopedics, Inc. v. NuVasive, Inc., 778 F.3d 1365, 1375 (Fed. Cir. 2015).
`Alphatec contends that Dr. Youssef’s opinion is merely a conclusion that the implants are
`functionally related to the patented inventions and that there is evidence that the accused
`systems are sold, or provided, with the purchase of the implants for convenience and
`business advantage. NuVasive contends that a number of the asserted claims include that
`the claimed system is specifically designed to be capable of creating an operative corridor
`dimensioned “so as to pass an implant through the operative corridor along the lateral,
`
`
`1 The Court is less persuaded that evidence of nonobviousness demonstrated by the recognition and praise,
`etc., for the NuVasive surgical platform overall, can support an opinion of nonobviousness of U.S. Patent
`No. 8,753,270 directed only at the spinal shim device, a very discrete component of NuVasive’s platform.
`Before Dr. Youssef provides testimony that any of the secondary considerations that apply to NuVasive’s
`overall system also demonstrate the nonobviousness of the ‘270 patent, the Court will require a more
`specific proffer from the witness.
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`trans-psoas path to the lumbar spine.” [Doc. No. 1-8 at Col. 14:63-Col. 15:3.] Thus,
`according to NuVasive, the implants are therefore functionally related to the claimed
`systems.
`The Court finds that Dr. Youssef’s opinions on the functional relationship of the
`accused systems and the unpatented implants are best challenged by cross-examination
`rather than exclusion. The motion to exclude Dr. Youssef’s opinions supporting the claim
`for convoyed sales is DENIED.
`C. Opinions on Interchangeability and Non-Infringing Alternatives
`Dr. Youssef also offers opinions in support of NuVasive’s damages theories
`regarding other competing surgical components and systems on the market, and whether
`customers of the Alphatec accused systems and devices would consider these as acceptable
`alternatives. In short, Dr. Youssef opines based on his experience and review of available
`materials, that if the Alphatec systems and devices were not available, other competing
`devices and systems would not be acceptable alternatives to NuVasive’s commercial
`embodiment of the patented inventions. Alphatec contends his opinions are superficial and
`contradicted by the evidence and therefore should be excluded.
`The Court finds these arguments go to the weight to be afforded Dr. Youssef’s
`opinions about the acceptability of non-infringing alternatives, not the admissibility. They
`are best challenged by cross-examination rather than exclusion. The motion to exclude Dr.
`Youssef’s opinions regarding the interchangeability and acceptability of other competing
`surgical components and systems is DENIED.
`III. Blake Inglish
`Mr. Inglish has been designated as an expert by NuVasive to provide an opinion on
`the commercial success of NuVasive’s MAS Platform/XLIF procedure in support of
`NuVasive’s damages theory. [Doc. No. 255-5, at ¶ 5.] Evidence of commercial success of
`NuVasive’s surgical platform/procedure is “only significant if there is a nexus between the
`claimed inventions [claims at issue in this litigation] and the commercial success.” Ormac
`Corp. v. Align Tech, Inc., 463 F.3d 1299, 1311-12 (Fed. Cir. 2006). “If the commercial
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`success is due to an unclaimed feature of the device [or system], the commercial success
`is irrelevant.” Id.
`It is not enough, therefore, for Mr. Inglish to demonstrate that NuVasive’s surgical
`platform/procedure is commercially successful. To be relevant, that success must be
`related to the inventions of the patents-at-issue. Mr. Inglish, however, acknowledged in
`his expert report that he had “no opinions as to whether a nexus exists between the success
`of NuVasive’s MAS Platform/XLIF procedure and the merits of the claimed inventions
`taught by the patents-in-suit.” [Doc. No. 255-5 at ¶ 5, fn. 4.] That nexus, he understood,
`would be provided by the expert testimony of Dr. Youssef. Id. Thus, Alphatec moves to
`exclude Mr. Inglish’s testimony about the commercial success of the NuVasive surgical
`platform/procedure because no nexus evidence was provided by Dr. Youssef.
`Dr. Youssef did not include commercial success as one of the secondary
`considerations of nonobviousness in his validity opinion. [Doc. No. 259-2 at ¶¶1329-1367.]
`In his expert report supporting NuVasive’s damage theories [Doc. No. 259-3], however,
`Dr. Youssef opines on the “primary criteria surgeons consider when using/adopting a
`lateral platform” and then addresses the patented inventions embodied in the NuVasive
`(and Alphatec) platforms/procedures that, in his opinion, provide these critical aspects that
`the customers want, i.e., the drivers of the commercial success of the platforms/procedures.
`[Id., at ¶¶ 16-24.] Dr. Youssef’s opinion and analysis is not labeled “nexus between the
`patented inventions and the commercial success of the NuVasive (and Alphatec)
`platforms/procedures.” The opinion, however, is present in his report and provides
`foundation for the relevance of Mr. Inglish’s analysis of the commercial success of
`NuVasive’s surgical platform/procedure.
`The motion to exclude Mr. Inglish’s testimony on the commercial success of
`NuVasive’s MAS Platform/XLIF procedure is therefore DENIED.
`IV. Stephen Kunin
`Mr. Kunin, a consultant on patent practice and a former deputy commissioner with
`the PTO, was designated by NuVasive to provide expert testimony on patent office practice
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`and procedures regarding the duty of disclosure and Alphatec’s inequitable conduct
`allegations. As NuVasive noted this defense is entirely equitable in nature and thus not an
`issue for a jury to decide. [Doc. No. 259, at 20.] The Court has bifurcated the inequitable
`conduct defense and will hold a bench trial on this issue if needed following the jury trial.
`Consequently, Mr. Kunin will not be called to testify in the jury proceedings. The motion
`to exclude his testimony is deemed moot. Whether Mr. Kunin may provide testimony in
`the bench trial is reserved for a later time.
`V. Conclusion
` As discussed above, it is hereby ORDERED that Alphatec’s motion is DENIED
`as to the testimony of Dr. Youssef and Mr. Inglish, and deemed MOOT as to the testimony
`of Mr. Kunin.
`It is SO ORDERED.
`Dated: April 30, 2020
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