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`NIMALKA R. WICKRAMASEKERA (SBN: 268518)
`nwickramasekera@winston.com
`DAVID P. DALKE (SBN: 218161)
`ddalke@winston.com
`LEV TSUKERMAN (SBN: 319184)
`ltsukerman@winston.com
`WINSTON & STRAWN LLP
`333 S. Grand Avenue
`Los Angeles, CA 90071-1543
`Telephone: (213) 615-1700
`Facsimile: (213) 615-1750
`
`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
`
`CORINNE STONE HOCKMAN (Pro Hac Vice)
`chockman@winston.com
`WINSTON & STRAWN LLP
`1111 Louisiana Street, 25th Floor
`Houston, TX 77002-5242
`Telephone: (713) 651-2600
`Facsimile: (713) 651-2700
`
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. AND ALPHATEC SPINE, INC.
`
`Plaintiff,
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA - SAN DIEGO DIVISION
`Case No. 3:18-CV-00347-CAB-MDD
`NUVASIVE, INC., a Delaware
`
`corporation,
`[Assigned to Courtroom 4C – Honorable
`
`Cathy Ann Bencivengo]
`
`
`DEFENDANTS’ REPLY IN SUPPORT
`v.
`OF MOTION TO EXCLUDE THE
`
`EXPERT TESTIMONY OF JIM
`ALPHATEC HOLDINGS, INC., a
`YOUSSEF, BLAKE INGLISH, AND
`Delaware corporation and
`STEPHEN G. KUNIN
`ALPHATEC SPINE, INC., a
`
`California corporation,
`
`
`PER CHAMBERS RULES, NO ORAL
`Defendants.
`ARGUMENT UNLESS SEPARATELY
`
`ORDERED BY THE COURT
`
`
`
`
`
`
`DEFENDANTS’ REPLY ISO MOTION TO EXCLUDE THE EXPERT TESTIMONY OF JIM YOUSSEF, BLACK ENGLISH, AND STEPHEN G.
`KUNIN
`
`CASE NO. 3:18-CV-00347-CAB-MDD
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`

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`TABLE OF CONTENTS
`
`I.
`II.
`
`Page
`INTRODUCTION ................................................................................................ 1
`REPORT AND TESTIMONY OF DR. YOUSSEF ............................................ 1
`A. Dr. Youssef’s Opinion on Secondary Considerations is
`Inadmissible. .............................................................................................. 1
`Dr. Youssef’s Opinion and Testimony on Damages ................................. 4
`B.
`III. REPORT AND TESTIMONY OF MR. INGLISH ............................................. 5
`IV. REPORT AND TESTIMONY OF MR. KUNIN................................................. 5
`V.
`CONCLUSION .................................................................................................... 7
`
`
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`DEFENDANTS’ REPLY ISO MOTION TO EXCLUDE THE EXPERT TESTIMONY OF JIM YOUSSEF, BLACK ENGLISH, AND STEPHEN G.
`KUNIN
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`CASE NO. 3:18-CV-00347-CAB-MDD
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`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Cot’n Wash, Inc. v. Henkel Corp.,
`56 F. Supp.3d 626 (D. Del. 2014), aff’d 606 Fed. App’x 1009 (Fed.
`Cir. 2015) ................................................................................................................... 1
`DataTreasury Corp. v. Wells Fargo & Co.,
`No. 2:06–CV–72 DF, 2010 WL 3912264 (E.D. Tex. Sept. 13, 2010) ...................... 1
`Daubert v. Merrell Dow Pharmaceuticals, Inc.,
`509 U.S. 579 (1993)................................................................................................... 1
`Demaco Corp. v. F. Von Langsdorff Licensing, Ltd.,
`851 F.2d 1387 (Fed. Cir. 1988) ................................................................................. 2
`Juicy Whip, Inc. v. Orange Bang, Inc.,
`382 F.3d 1367 (Fed. Cir. 2004) ................................................................................. 4
`NuVasive, Inc. v. Iancu,
`752 F. App’x 985 (Fed. Cir. 2018) ........................................................................ 1, 2
`Ormco Corp. v. Align Tech., Inc.,
`No. SACV 03-16 CAS (ANx), 2009 WL 10668458 (C.D. Cal. May
`12, 2009) .................................................................................................................... 6
`Reno v. U.S.,
`283 F. App’x 502 (9th Cir. 2008) .............................................................................. 5
`Sundance, Inc. v. DeMonte Fabricating Ltd.,
`550 F.3d 1356 (Fed. Cir. 2008) ................................................................................. 5
`The Medicines Co. v. Mylan Inc.,
`No. 11–cv–1285, 2014 WL 1758135 (N.D. Ill. May 2, 2014) .................................. 6
`U.S. v. Sandoval-Mendoza,
`472 F.3d 645 (9th Cir. 2006) ..................................................................................... 6
`
`
`DEFENDANTS’ REPLY ISO MOTION TO EXCLUDE THE EXPERT TESTIMONY OF JIM YOUSSEF, BLACK ENGLISH, AND STEPHEN G.
`KUNIN
`
`CASE NO. 3:18-CV-00347-CAB-MDD
`ii
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`Whitewater W. Indus., Ltd. v. Pac. Surf Designs, Inc.,
`No. 3:17-cv-01118-BEN-BLM, 2019 WL 4452986 (S.D. Cal. Sept.
`16, 2019) .................................................................................................................... 6
`Other Authorities
`37 C.F.R. §1.56 ............................................................................................................... 6
`
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`DEFENDANTS’ REPLY ISO MOTION TO EXCLUDE THE EXPERT TESTIMONY OF JIM YOUSSEF, BLACK ENGLISH, AND STEPHEN G.
`KUNIN
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`CASE NO. 3:18-CV-00347-CAB-MDD
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`I.
`
`INTRODUCTION
`The opinions of Dr. Youssef, Mr. Inglish, and Mr. Kunin should be excluded.
`II. REPORT AND TESTIMONY OF DR. YOUSSEF
`A. Dr. Youssef’s Opinion on Secondary Considerations is Inadmissible.
`Dr. Youssef’s Nexus Testimony is Inadmissible.
`1.
`NuVasive contends that Alphatec is wrong on the law, but does not explain how
`or why Alphatec is incorrect. (Doc. No. 259 at 7–8.) NuVasive’s main complaint is
`that Alphatec cited cases addressing “the merits as to whether nexus was established,”
`suggesting that experts failing to establish nexus as a matter of law cannot be excluded
`at the Daubert stage. (Doc. No. 259 at 8.) Of course that is not true. Daubert v. Merrell
`Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993); see also Cot’n Wash, Inc. v.
`Henkel Corp., 56 F. Supp.3d 626, 650–651 (D. Del. 2014), aff’d 606 Fed. App’x 1009
`(Fed. Cir. 2015) (excluding expert opinions of commercial success and industry praise
`for lack of nexus); DataTreasury Corp. v. Wells Fargo & Co., No. 2:06–CV–72 DF,
`2010 WL 3912264, at *4 (E.D. Tex. Sept. 13, 2010) (likewise excluding expert opinion
`when there was no support “for a nexus between industry success . . . on one hand and
`the merits of the claimed inventions on the other.”).
`NuVasive also contends that Alphatec is wrong on the facts. (Doc. No. 259 at 8–
`9.) Dr. Youssef presumes nexus based on his opinion that the asserted claims are co-
`extensive with XLIF. (Id.) However, it is undisputed that XLIF also requires spinal
`implants and a dedicated neuromonitoring platform, both of which are not embodied
`and not claimed by the asserted patents. NuVasive, Inc. v. Iancu, 752 F. App'x 985,
`995 (Fed. Cir. 2018) (“And the 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.”); (Doc. Nos. 259 at 9; 259-2 at ¶
`91.) Indeed, none of the alleged infringing combinations of Alphatec’s accused
`
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`DEFENDANTS’ REPLY ISO MOTION TO EXCLUDE THE EXPERT TESTIMONY OF JIM YOUSSEF, BLACK ENGLISH, AND STEPHEN G.
`KUNIN
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`CASE NO. 3:18-CV-00347-CAB-MDD
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`products include Alphatec’s implants or a neuromonitoring system. (Ex. 23 at n.3–9.)1
`NuVasive misleads in suggesting that claimed dilators having a “stimulation
`electrode” constitute the neuromonitoring used in the XLIF procedure. (Doc. No. 259
`at 9.) In fact, stimulated dilators do nothing unless plugged into NuVasive’s
`Neurovision® System through another unclaimed component called the Dynamic
`Stimulation Clip. (Doc. No. 260-10 at 20.) The Neurovision® System—which, again,
`is not stimulated dilators, but a control center that is not claimed in the asserted
`patents—accomplishes the neuromonitoring function in the XLIF procedure. (Id.)
`(“The Neurovision System assists with safe passage past these nerves and/or
`confirmation of their posterior location via evoked-EMG monitoring.”); (Doc. 259-2 at
`¶ 100; see also ¶¶ 87, 189.) (“NuVasive’s proprietary neuromonitoring technology, . . .
`provides surgeons with real-time, precise and reliable information regarding the
`proximity, location and direction of nerves in the lumbar plexus in the psoas muscle.”)
`In short, the asserted claims are not co-extensive with XLIF, and Nuvasive is not
`entitled to a presumption of nexus to objective indicia evidence. Demaco Corp. v. F.
`Von Langsdorff Licensing, Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988). Dr. Youssef’s
`opinion, which is based on that presumption, is not reliable and should be excluded.
`NuVasive asserts the “Federal Circuit rejected Alphatec’s lack of nexus
`argument.” (Doc. No. 259 at 9–10.) Quite the contrary. As noted, the Federal Circuit
`in NuVasive, Inc. v. Iancu, 752 F. App’x 985 (Fed. Cir. 2018) expressly recognized that
`XLIF comprised spinal implants and neuromonitoring, which are not claimed in the
`asserted patents here. Importantly, those technologies are covered by the ’057 patent
`at issue in that case, and for that reason, the Federal Circuit vacated a PTAB finding of
`no nexus. (Doc. No. 259 at 10.) But far from rejecting Alphatec’s position, the Federal
`Circuit proved Alphatec’s point in affirmatively holding that XLIF involves
`technologies well beyond those in the asserted patents. NuVasive asks the Court to
`
`1 All exhibits are to the Declaration of Brian J. Nisbet in Support of Defendants’
`Reply in Support of Motion to Exclude the Expert Testimony of Jim Youssef, Blake
`
`Inglish, and Stephen G. Kunin, filed concurrently herewith.
`DEFENDANTS’ REPLY ISO MOTION TO EXCLUDE THE EXPERT TESTIMONY OF JIM YOUSSEF, BLACK ENGLISH, AND STEPHEN G.
`KUNIN
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`ignore that and reach the opposite conclusion, and allow Dr. Youssef to testify that the
`claimed
`inventions, which do not cover NuVasive’s spinal
`implants or
`Neuromonitoring System, are co-extensive with the XLIF procedure.
`Dr. Youssef’s opinions as to each secondary consideration fail.
`2.
`Skepticism and Industry Praise: NuVasive responds that “Dr. Youssef mapped
`each patent to the MAS Platform access tools used in XLIF and the advantages they
`provide.” (Doc. No. 259 at 11.) But that is insufficient. Dr. Youssef failed to link the
`novel features of the claimed invention to skepticism or industry praise. And, contrary
`to NuVasive’s assertion, affirmative statements by Dr. Youssef that unpatented
`features, like NuVasive’s education program, are responsible for industry praise of
`XLIF additionally prevents a finding of nexus. (Doc. No. 259-2 at ¶ 1339.)
`Teaching Away: The fact is in one proceeding NuVasive relied on the Jacobson
`reference to prove the lateral, trans-psoas approach to the lumbar spine was safe and
`reproducible since 1995 when invalidating a competitor patent, but here Dr. Youssef
`wants this Court to believe that the lateral, trans-psoas approach was “virtually
`impossible” and “unacceptably dangerous” as of 2002 when defending the validity of
`its own patents. (See, e.g., Doc. No. 260 at 45–46.) NuVasive excuses its double speak
`by blaming the competitor patent owner for never arguing “whether the prior art
`(including the Jacobson technique) taught away from a direct lateral approach to the
`spine.” (Doc. No. 259 at 12.) But this deflection does not erase NuVasive’s prior
`(successful) statements to the PTAB and Federal Circuit about the state of the art. Dr.
`Youssef’s (million dollar) opinions now to the contrary should be excluded.
`Unexpected Results: As noted, Dr. Youssef’s statements about XLIF are
`irrelevant. (Doc. No. 259 at 12.) At bottom, Dr. Youssef fails to tie the novel features
`of the claimed invention to the secondary consideration of unexpected results.
`Copying: Copying is only relevant when there is evidence showing “the
`replication of a specific product.” (Doc. 255-1 at 11.) NuVasive contends that Dr.
`Youssef met his burden “by citing Alphatec’s own internal documents and testimony
`
`DEFENDANTS’ REPLY ISO MOTION TO EXCLUDE THE EXPERT TESTIMONY OF JIM YOUSSEF, BLACK ENGLISH, AND STEPHEN G.
`KUNIN
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`of surgeons.” (Doc. 259 at 11.) But, this “evidence” relates to a dilator holder—an
`element that is not claimed and therefore cannot possibly relate to nexus. (Doc. 255-1
`at 12.)
`B. Dr. Youssef’s Opinion and Testimony on Damages
`No functional relationship to support lost profits.
`1.
`NuVasive’s reliance on Juicy Whip, Inc. v. Orange Bang, Inc., 382 F.3d 1367
`(Fed. Cir. 2004) is misplaced. (Doc. No. 259 at 13–14.) In Juicy Whip, the claimed
`invention covered a beverage dispenser that stored “syrup concentrate and water
`separately and mixe[d] them together just before being dispensed.” Id. at 1370. The
`court found a functional relationship between the patented dispenser and the unpatented
`syrup because “[t]he dispenser and the syrup are in fact analogous parts of a single
`assembly or a complete machine, as the syrup functions together with the dispenser to
`produce the visual appearance that is central to [the asserted patent].” Id. at 1372.
`That is not the case here, where the central purpose of the claimed system is to
`create an “operative corridor” using access tools like a retractor. Only after this process
`is complete—after the accused access tools have fully executed their function—is an
`implant inserted through the operative corridor. But an implant has no impact on the
`performance of the accused products. An implant is not needed to infringe any asserted
`claim, nor is it needed for the accused devices to function or achieve their desired
`purpose—to create a “operative corridor.” In other words, unlike in Juicy Whip, the
`unaccused implants are not “central” to the purpose of the asserted patents, but rather
`are sold together simply for convenience—namely, to provide a one stop shop for spine
`surgeons. (Doc. No. 255-1 at 15.) As such, because there is no functional relationship
`between the two, NuVasive cannot recover lost profits based on unpatented implants,
`and Dr. Youssef’s ipse dixit opinion to the contrary should be excluded.
`Also, it is irrelevant that implants are tied to licensing because access tools are
`not sold but loaned to surgeons. In any event, that coincidence has no bearing on a lost
`profits analysis that requires a “functional relationship” between the unaccused implant
`
`DEFENDANTS’ REPLY ISO MOTION TO EXCLUDE THE EXPERT TESTIMONY OF JIM YOUSSEF, BLACK ENGLISH, AND STEPHEN G.
`KUNIN
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`and the accused retractor and access tools. And, it is irrelevant that another expert, that
`Alphatec is not relying on, testified in another case on behalf of Medtronic about
`different patents that covered implants, retractors and other access tools.
`Dr. Youssef’s opinions on interchangeability and non-
`2.
`infringing alternatives are entirely conclusory and unreliable.
`By NuVasive’s own documents, the several alternative surgical platforms on the
`market have many features in common with the XLIF procedure, and importantly, all
`of them may be used to successfully perform interbody fusion. (Doc. No. 259-2 at ¶¶
`1276-1328, Ex. 25 (“Lateral Single Position Surgery”) at 317080–81.) And yet, Dr.
`Youssef, without citing any corroborating evidence whatsoever, contends that these
`alternatives are not acceptable or less “interchangeable” than Alphatec’s accused
`products. (Id.) Dr. Youssef’s opinions are mere naked and conclusory statements,
`rooted in speculation, and must be excluded as unreliable. Reno v. U.S., 283 F. App’x
`502, 503 (9th Cir. 2008).
`III. REPORT AND TESTIMONY OF MR. INGLISH
`Mr. Inglish’s report on commercial success, which relied exclusively on Dr.
`Youssef to establish nexus, should be excluded as unreliable. In its opposition,
`NuVasive summarily states that “Dr. Youssef addressed (i) nexus for all objective
`indicia (including commercial success).” (Doc. No. 259 at 18.) But he didn’t. Notably,
`NuVasive fails to even cite a single paragraph from Dr. Youssef’s report on commercial
`success, because there are none. The void in Dr. Youssef’s opinion means Mr. Inglish’s
`report on commercial success must be excluded due to a lack of nexus.
`IV. REPORT AND TESTIMONY OF MR. KUNIN
`First, Mr. Kunin’s own words, which put the thumb on the scale for a finding of
`validity, show that his expected testimony will surpass the neutral overview of the
`Patent Office’s practices and procedures allowed in the cases NuVasive cited. (Doc.
`No. 255-1 at 20.); see also Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356,
`1361 n.2 (Fed. Cir. 2008) (allowing a patent attorney was “qualified to testify as to
`
`DEFENDANTS’ REPLY ISO MOTION TO EXCLUDE THE EXPERT TESTIMONY OF JIM YOUSSEF, BLACK ENGLISH, AND STEPHEN G.
`KUNIN
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`patent office procedure generally,” but not more.); Ormco Corp. v. Align Tech., Inc.,
`No. SACV 03-16 CAS (ANx), 2009 WL 10668458, at *19 (C.D. Cal. May 12, 2009)
`(allowing an expert to testify about “patent office procedures, and what documents
`would be before a patent officer,” but did not allow the expert to “offer an ultimate
`opinion on whether a party’s actions were reasonable.”)
`Second, NuVasive concedes that Mr. Kunin’s proposed testimony about legal
`standards and legal interpretation is inappropriate. (Doc. No. 259 at 20.) See, e.g., The
`Medicines Co. v. Mylan Inc., No. 11–cv–1285, 2014 WL 1758135, at *6 (N.D. Ill. May
`2, 2014) (experts may not give “general testimony interpreting patent law”).
`Third, NuVasive makes the incredible assertion that Mr. Kunin does not provide
`any ultimate legal conclusions. In particular, NuVasive contends that “the PTO duty of
`disclosure under 37 C.F.R. §1.56 is not the applicable legal standard under
`Therasense—thus, Mr. Kunin’s opinions regarding Alphatec’s failure to show a
`violation of 37 C.F.R. § 1.56 are not legal conclusions.” (Doc. No. 259 at 21.) If that
`is true, then Mr. Kunin’s testimony is wholly irrelevant. U.S. v. Sandoval-Mendoza,
`472 F.3d 645, 654 (9th Cir. 2006) (expert testimony is relevant when “the knowledge
`underlying [the testimony] has a valid … connection to the pertinent inquiry”). The fact
`finder need not hear testimony applying an inapplicable legal standard. But in any
`event, NuVasive totally ignores Mr. Kunin’s opinion where he repeatedly and expressly
`draws the ultimate legal conclusion applying the legal standard under Therasense.
`(Doc. No. 255-1 at 22.) For these reasons, Mr. Kunin’s testimony should be excluded.
`See, e.g., Whitewater W. Indus., Ltd. v. Pac. Surf Designs, Inc., No. 3:17-cv-01118-
`BEN-BLM, 2019 WL 4452986, at *2 (S.D. Cal. Sept. 16, 2019) (“To permit any such
`testimony would be to commit error, as it is well-known that matters of law are
`generally inappropriate subjects for expert testimony.”).
`NuVasive cites to Whitewater to assert that this Court has previously denied
`similar requests for “broad unsupported relief”—i.e., to exclude the entirety of an
`expert’s report and testimony. (Doc. No. 259 at 19.) To clarify, this Court in
`
`DEFENDANTS’ REPLY ISO MOTION TO EXCLUDE THE EXPERT TESTIMONY OF JIM YOUSSEF, BLACK ENGLISH, AND STEPHEN G.
`KUNIN
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`Whitewater excluded some improper testimony (e.g., testimony as to intent, credibility,
`and hypothetical behavior of the PTO) and admitted other testimony it found to be
`reliable or helpful. Here, stripping out the inadmissible portions of Mr. Kunin’s 274-
`paragraph report leaves nothing else.
`Also, both cases NuVasive cites to support its position that Mr. Kunin should be
`able to provide “helpful factual context” are distinguishable. (Doc. No. 259 at 21.)
`Here, NuVasive has made clear that Mr. Kunin is not opining on materiality or the
`sufficiency of NuVasive’s disclosures, nor is he opining on intent. (Doc. No. 259 at 21
`see also Ex. 24 at 119:18–120:2, 121:14–122:21.) Also, Mr. Kunin does not offer the
`Court any insight into the prosecution history of the asserted patents beyond what is
`already apparent from the public record. (Ex. 24 at 120:3-121:4.) In fact, he readily
`admits that he did not speak with any of the examiners or attorneys who were involved
`with the prosecution of the patents. (Id.) Thus, any “factual context” offered by Mr.
`Kunin is pure speculation and must be excluded.
`V. CONCLUSION
`For at least these reasons, Dr. Youssef’s, Mr. Inglish’s, and Mr. Kunin’s reports
`and testimony should thus be excluded in their entirety.
`
`Dated: February 14, 2020
`
`WINSTON & STRAWN LLP
`
`
`By: /s/ Nimalka R. Wickramasekera
`NIMALKA R. WICKRAMASEKERA
`BRIAN J. NISBET
`DAVID P. DALKE
`SARANYA RAGHAVAN
`CORINNE STONE HOCKMAN
`LEV TSUKERMAN
`
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. AND
`ALPHATEC SPINE, INC.
`
`
`DEFENDANTS’ REPLY ISO MOTION TO EXCLUDE THE EXPERT TESTIMONY OF JIM YOUSSEF, BLACK ENGLISH, AND STEPHEN G.
`KUNIN
`
`CASE NO. 3:18-CV-00347-CAB-MDD
`7
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`Case 3:18-cv-00347-CAB-MDD Document 263 Filed 02/14/20 PageID.25959 Page 12 of 12
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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 14th day of February, 2020 at Los
`Angeles, California.
`
`Dated: February 14, 2020
`
`
`
`WINSTON& STRAWN LLP
`
`By: /s/ Nimalka R. Wickramasekera
`NIMALKA R. WICKRAMASEKERA
`
`
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`DEFENDANTS’ REPLY ISO MOTION TO EXCLUDE THE EXPERT TESTIMONY OF JIM YOUSSEF, BLACK ENGLISH, AND STEPHEN G.
`KUNIN
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`CASE NO. 3:18-CV-00347-CAB-MDD
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