Case 3:18-cv-00347-CAB-MDD Document 311-16 Filed 02/26/21 PageID.30389 Page 1 of
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`WILSON SONSINI GOODRICH & ROSATI P.C.
`PAUL D. TRIPODI II (SBN 162380)
`ptripodi@wsgr.com
`WENDY L. DEVINE (SBN 246337)
`wdevine@wsgr.com
`NATALIE J. MORGAN (SBN 211143)
`nmorgan@wsgr.com
`633 West Fifth Street, Suite 1550
`Los Angeles, CA 90071
`Telephone: 323-210-2900
`Fax: 866-974-7329
`Hilgers Graben PLLC
`MICHAEL T. HILGERS (Pro Hac Vice)
`mhilgers@hilgersgraben.com
`575 Fallbrook Blvd, Suite 202
`Lincoln, NE 68521
`Telephone: 402-218-2106
`Fax: 402-413-1880
`Attorneys for Plaintiff NuVasive, Inc.
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`SAN DIEGO DIVISION
`NUVASIVE, INC., a Delaware
`)
`CASE NO.: 18-cv-00347-CAB-MDD
`corporation,
`)
`
`PLAINTIFF NUVASIVE, INC’S
`
`)
`OBJECTIONS TO
`)
`DECLARATION OF MATT
`
`)
`CURRAN IN SUPPORT OF
`)
`DEFENDANTS’ OPPOSITION TO
`
`)
`NUVASIVE, INC.’S MOTION
`)
`FOR PARTIAL SUMMARY
`ALPHATEC HOLDINGS, INC., a
`)
`JUDGMENT
`Delaware corporation, and ALPHATEC
`)
`(IMPLANT PATENTS)
`SPINE, INC., a California corporation,
`)
`
`)
`
`Defendants.
`)
`Judge: Hon. Cathy Ann Bencivengo
`)
`Magistrate Judge: Mitchell D. Dembin
`)
`
`)
`
`Plaintiff,
`
`v.
`
`
`Plaintiff NuVasive, Inc. (“NuVasive”) hereby objects to the Declaration of
`Matt Curran in Support of Defendants’ Opposition to NuVasive, Inc.’s Motion for
`Partial Summary Judgment (Implant Patents). Doc. No. 306-8.
`
`
`
`NUVASIVE’S OBJECTIONS TO CURRAN DECL.
`ISO DEFS’ OPP’N TO MOT. FOR PARTIAL
`
`SUMMARY JUDGMENT
`
`-1-
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`18-cv-00347-CAB-MDD
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`NuVasive’s Objections
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`SPECIFIC EVIDENTIARY OBJECTIONS TO CURRAN DECLARATION
`
`Statement in Curran Declaration
`(Doc. No. 306-8)
`¶ 1: “I make the following statements
`based on personal knowledge and if
`called to testify to them, could and
`would do so.”
`¶ 2: “I am the Senior Director of
`Technology Advancement at Alphatec
`Spine, Inc. (“Alphatec”). I have held
`this position since I joined Alphatec in
`December 2017. Before that, I worked
`for NuVasive, Inc. (“NuVasive”) from
`May 2000 until November 2017. I was
`employed in a variety of research and
`development roles during my time at
`NuVasive, working as an engineer on
`numerous products, including, among
`others, NuVasive’s cervical, lumbar,
`and interbody products. My last title
`before leaving NuVasive was Senior
`Director of Global Engineering
`Services.”
`¶ 3: “NuVasive began developing what
`would become the CoRoent XL
`implant in early 2003. I was a lead
`design engineer on the CoRoent
`implant project. In 2003, the CoRoent
`implant-was-also referred to as a PEEK
`Cement Restrictor. “Cement
`Restrictor” is a regulatory term for the
`implant which became marketed as
`CoRoent. NuVasive sometimes
`referred to the implant as PEEK-CR.
`All of these names-PEEK Cement
`Restrictor, PEEK-CR, and
`CoRoent- refer to the same implant
`family, and PEEK Cement Restrictor
`XL, PEEK CR-XL, PEEK CR-X, and
`
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`NUVASIVE’S OBJECTIONS TO CURRAN DECL.
`ISO DEFS’ OPP’N TO MOT. FOR PARTIAL
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`SUMMARY JUDGMENT
`
`-2-
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`18-cv-00347-CAB-MDD
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`

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`Case 3:18-cv-00347-CAB-MDD Document 311-16 Filed 02/26/21 PageID.30391 Page 3 of
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`Statement in Curran Declaration
`(Doc. No. 306-8)
`CoRoent XL refer to the same implant.
`“XL” and “X” stand for Extra Large,
`which NuVasive labeled all Cement
`Restrictor, PEEK CR, and CoRoent
`implants that had a length of at least 40
`mm.”
`¶ 4: “NuVasive tasked me with being
`the lead engineer for the project, and in
`that capacity, I led the design and
`development of the CoRoent implant
`systems. Attached here as Exhibit A is
`a true and correct copy of an interoffice
`memo I received that announced my
`position as the “Project Leader” of the
`“development engineering efforts” of
`the PEEK Cement Restrictor product
`lines. NuVasive began developing
`this product because PEEK implants
`were available on the market at that
`time, but NuVasive did not yet offer
`PEEK implants.”
`
`¶ 5: “During the development phase of
`the CoRoent implant, I worked both
`independently and solicited feedback
`from consulting surgeons, the most
`influential and significant of whom was
`Dr. Luiz Pimenta, who had been
`developing a direct lateral procedure
`since 2001.
`
`Dr. Pimenta was the primary
`surgeon consultant who guided
`NuVasive’s efforts to develop the
`XLIF procedure and provided
`concepts, parameters, goals, ideas,
`
`NuVasive’s Objections
`
`Lack of Foundation [FRE 602].
`There is no foundation for Mr.
`Curran’s claims regarding the reason
`that NuVasive began developing the
`CoRoent implant. As such, his
`testimony regarding NuVasive’s
`motivations constitute speculation.
`
`Impermissible Hearsay [FRE
`802].
`To the extent that Mr. Curran derives
`his knowledge of NuVasive’s reasons
`for developing CoRoent from
`conversations with other individuals at
`NuVasive, these are out of court
`statements offered to prove the truth of
`the matter asserted.
`Lack of Foundation [FRE 602].
`There is no foundation for Mr. Curran’s
`claims regarding when Dr. Pimenta
`began developing a direct lateral
`procedure.
`
`Lack of Foundation [FRE 602].
`There is no foundation for Mr.
`Curran’s claims regarding Dr.
`Pimenta’s role in developing XLIF.
`
`
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`NUVASIVE’S OBJECTIONS TO CURRAN DECL.
`ISO DEFS’ OPP’N TO MOT. FOR PARTIAL
`
`SUMMARY JUDGMENT
`
`-3-
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`Case 3:18-cv-00347-CAB-MDD Document 311-16 Filed 02/26/21 PageID.30392 Page 4 of
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`Statement in Curran Declaration
`(Doc. No. 306-8)
`guidance, and feedback on the XLIF
`instruments, including the implants.”
`¶ 6: “As part of my job, I worked with
`Dr. Pimenta to implement his designs
`for the CoRoent implant. Dr.
`Pimenta’s main concern was
`designing an implant that would be
`stable in the disc space. I have
`attached here as Exhibit B a true and
`correct copy of my handwritten notes
`and an email between Dr. Pimenta, Pat
`Miles, and myself that highlights some
`of Dr. Pimenta’s contributions to the
`design of the implant. As illustrated in
`my handwritten notes, Dr. Pimenta
`stressed including anti-migration
`features in the implant See Ex. B at
`NUVA_ATEC0016561. At the time,
`we were - aware of commercially
`available implants that were designed
`with ridges on the top and bottom
`surfaces of the implant, but Dr.
`Pimenta felt these designs did not
`fully resolve issues with the implants
`moving in the disc space once the
`implant was in its final position. Dr.
`Pimenta proposed adding “spikes” to
`the implant to increase stabilization. Id.
`These spikes would extend above and
`below the surface of the implant to
`grip the vertebrae and hold the
`implant in place in its final position
`in the disc space. Dr. Pimenta also
`suggested that the “[t]eeth [be] more
`aggressive” to further increase the
`stability of the implant. Id. These anti-
`migration features were implemented in
`the design of the CoRoent implant.”
`
`NUVASIVE’S OBJECTIONS TO CURRAN DECL.
`ISO DEFS’ OPP’N TO MOT. FOR PARTIAL
`
`SUMMARY JUDGMENT
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`NuVasive’s Objections
`
`Lack of Foundation [FRE 602].
`There is no foundation for Mr.
`Curran’s claims regarding Dr.
`Pimenta’s concerns or motivations
`with respect to development of the
`CoRoent implant.
`
`Impermissible Hearsay [FRE
`802].
`To the extent that Mr. Curran derives
`his knowledge of Dr. Pimenta’s
`concerns or motivations with respect to
`development of the CoRoent implant
`from conversations with Dr. Pimenta,
`these are out of court statements offered
`to prove the truth of the matter asserted.
`
`Lack of Foundation [FRE 602].
`There is no foundation for Mr.
`Curran’s statements regarding the
`“commercially available implants” that
`he and Dr. Pimenta were aware of.
`
`Impermissible opinion testimony by
`lay witness [FRE 701, 702].
`Mr. Curran was put forward only as a
`fact witness. His testimony regarding
`the clinical role of “teeth” and “spikes”
`on the surface of the implant is opinion
`testimony and thus impermissible.
`
`Furthermore, on their face, these
`opinions clearly are “based on
`scientific, technical, or other
`specialized knowledge within the
`scope of Rule 702.” FRE 701(c).
`Alphatec has not disclosed Mr. Curran
`18-cv-00347-CAB-MDD
`-4-
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`Statement in Curran Declaration
`(Doc. No. 306-8)
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`NuVasive’s Objections
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`as an expert witness under Federal
`Rule of Civil Procedure 26(a)(2)(C).
`So even if Mr. Curran were qualified
`to offer these opinions, the opinions
`should be excluded as not properly
`disclosed. Fed. R. Civ. P. 37(c)(1).
`Alphatec has retained Dr. Sachs, a
`spine surgeon, as its technical expert.
`If Alphatec wished to put forward
`these opinions, it needed to do so
`through Dr. Sachs.
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`¶ 7: “While at NuVasive, I assisted in a
`supporting role with the company’s
`510(k) submissions to the U.S. Food
`and Drug Administration (“FDA”) for
`the CoRoent implant. For example, I
`created the engineering drawings that
`were submitted with NuVasive’s
`510(k) submissions for the Cement
`Restrictor and CoRoent System to the
`FDA. I have attached here as Exhibit C
`a true and correct copy of my drawings
`submitted with NuVasive’s June 2004
`510(k) submission for the CoRoent
`System.”
`¶ 8: “I also helped NuVasive formulate
`responses to the FDA’s questions and
`issues that arose during that
`submission. I have attached here as
`Exhibit D a true and correct copy of an
`email NuVasive received on August
`10, 2004 from the FDA regarding
`“questions and issues” that arose
`during the review of NuVasive’s June
`2004 510(k) submission for the
`CoRoent System and my proposed
`response.”
`
`NUVASIVE’S OBJECTIONS TO CURRAN DECL.
`ISO DEFS’ OPP’N TO MOT. FOR PARTIAL
`
`SUMMARY JUDGMENT
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`-5-
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`NuVasive’s Objections
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`Lack of Foundation [FRE 602].
`There is no foundation for Mr.
`Curran’s claim that the FDA examiner
`“expressed confusion.”
`
`Lack of Foundation [FRE 602].
`There is no foundation for Mr.
`Curran’s claim that NuVasive
`implemented his suggestions. Mr.
`Curran does not have personal
`knowledge of NuVasive’s response to
`the FDA.
`
`
`
`
`Statement in Curran Declaration
`(Doc. No. 306-8)
`¶ 9: “In the August 10, 2004 email, the
`FDA examiner expressed confusion
`about the function and purpose of
`spikes and markers shown in my
`engineering drawings. The FDA
`examiner observed that “[w]ithin the
`engineering drawings provided in
`Appendix I of [NuVavise’s]
`submission, [i]t is noted that two
`components - a titanium marker (part
`numbers 101085x, 101086x) and a
`titanium spike (part numbers
`101151x,101152x) - are included.
`These components are not mentioned
`within the text of the device
`description. Please provide a detailed
`description of these components,-
`including-their functions and
`relationships to the CoRoent system.”
`Ex. D at NUVA_ATEC0337623.”
`¶ 10: “I prepared an internal memo as
`to how to respond to the FDA. Id. at
`NUVA ATEC0337625. In response to
`the FDA’s question about the function
`and relationship of the spikes and
`markers in the CoRoent System, I
`distinguished the spikes and the
`markers to help the FDA understand
`their respective features. I suggested
`that NuVasive respond by stating: “See
`Section IV, A ‘Device Description’ of
`submission — ‘Small spikes or teeth
`on each end of the device serves to grip
`the endplates of the adjacent vertebrae
`to resist migration and expulsion of the
`device.’ In addition, we can add that
`the markers that do not protrude from
`the surfaces of the PEEK (all of which
`
`NUVASIVE’S OBJECTIONS TO CURRAN DECL.
`ISO DEFS’ OPP’N TO MOT. FOR PARTIAL
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`SUMMARY JUDGMENT
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`-6-
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`Statement in Curran Declaration
`(Doc. No. 306-8)
`have integral teeth to resist
`migration/expulsion) serve as
`radiopaque markers so the location and
`orientation of the PEEK device may be
`seen radiographically during and after
`the procedure.” Id. I understand that
`NuVasive implemented my
`comments explaining the differences
`between the spikes and markers in
`its device description included in the
`subsequent application in December
`2004 of the CoRoent System to the
`FDA.”
`¶ 11: “I was aware that NuVasive
`sold the PEEK Cement Restrictor /
`CoRoent Extra Large implant, which
`included implants dimensioned 18
`mm (width) x 40 mm (length) and 18
`mm (width) x 45 mm (length), before
`filing the provisional application on
`March 29, 2004 because I built the
`sets of the PEEK Cement
`Restrictor/CoRoent implants that
`were sold and distributed to
`hospitals and surgeons. Although
`these implants were not initially
`cleared for the spine by the FDA, I as
`well as others at the company were
`aware that, surgeons were using them
`for that purpose as that is what these
`implants were designed for.”
`¶ 12: “I also was part of the team that
`got the PEEK Cement Restrictors ready
`for widespread availability which was
`announced on March 2, 2004. I have
`attached here as Exhibit E a true and
`correct copy of an email I received
`from Bryan Cornwall congratulating-
`
`NuVasive’s Objections
`
`Lack of Foundation [FRE 602].
`There is no foundation for Mr.
`Curran’s claim that NuVasive sold
`PEEK Cement Restrictor/CoRoent
`Extra Large implant before filing the
`Provisional Application. Mr. Curran
`purports only to have personal
`knowledge of building implants not
`sales of implants.
`
`Lack of Foundation [FRE 602]. Mr.
`Curran provides no foundation for his
`opinion for the Mr. Copp
`announcement. NuVasive’s sales of
`PEEK Cement Restrictors.
`
`NUVASIVE’S OBJECTIONS TO CURRAN DECL.
`ISO DEFS’ OPP’N TO MOT. FOR PARTIAL
`
`SUMMARY JUDGMENT
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`-7-
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`Case 3:18-cv-00347-CAB-MDD Document 311-16 Filed 02/26/21 PageID.30396 Page 8 of
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`Statement in Curran Declaration
`(Doc. No. 306-8)
`our team for getting the PEEK Cement
`Restrictors ready for launch. This
`email was forwarded to me after
`Matt Copp announced the early
`availability of the PEEK Cement
`Restrictor sets on March 2, 2004 to
`provide the sales team with more
`information about the implant to
`increase the awareness for surgeons
`and hospitals. This included the Extra
`Large PEEK Cement Restrictor /
`CoRoent implant. Ex. E at
`NUVA_ATEC0341054.”
`¶ 13: “Further, I was aware of the
`sales of the PEEK Cement Restrictor
`/ CoRoent implant because of my
`involvement with editing related
`sales spreadsheets. For example, I
`have attached here as Exhibit F a true
`and correct copy of an email and excel
`spreadsheet I received from Scot
`Martinelli asking me to add part
`volumes to a CoRoent Sales Forecast. I
`am familiar with the contents of the
`spreadsheet as I responded to that
`email and included the part volumes. I
`have attached here as Exhibit G a true
`and correct copy of my response and
`accompanying spreadsheet with the
`part volumes, which indicate the
`amount of graft that a surgeon can put
`in the aperture for each implant.”
`¶ 14: “As noted in the spreadsheet,
`NuVasive sold 15 CoRoent Extra
`Large implants, including 7 CoRoent
`Extra Large implants dimensioned
`18 mm (width) x 40 mm (length) and
`8 CoRoent Extra Large implants
`
`NuVasive’s Objections
`
`Lack of Foundation [FRE 602].
`There is no foundation for Mr.
`Curran’s claim that he was “aware of
`sales.” Mr. Curran only purports to
`have personal knowledge of “sales
`forecasts” for CoRoent implants.
`
`Lack of Foundation [FRE 602].
`There is no foundation or
`corroboration for Mr. Curran’s claim
`that “NuVasive sold” the listed
`implants. Mr. Curran does not purport
`to have personal knowledge of the
`
`NUVASIVE’S OBJECTIONS TO CURRAN DECL.
`ISO DEFS’ OPP’N TO MOT. FOR PARTIAL
`
`SUMMARY JUDGMENT
`
`-8-
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`Case 3:18-cv-00347-CAB-MDD Document 311-16 Filed 02/26/21 PageID.30397 Page 9 of
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`NuVasive’s Objections
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`alleged sales. As such, his testimony
`regarding the “sales” of CoRoent
`implants.
`
`Statement in Curran Declaration
`(Doc. No. 306-8)
`dimensioned 18 mm (width) x 45 mm
`(length), to hospitals and surgeons in
`February 2004. Ex. F at
`NUVA_ATEC0341168. As described,
`these “actual sales” do not “include
`sample, lab, [or] demo consumption.”
`Id. To the best of my knowledge, these
`sales figures accurately reflect the sales
`at that time.”
`
`Dated: February 26, 2021 WILSON SONSINI GOODRICH & ROSATI, P.C.
`
`
`By:
`Paul D. Tripodi II (SBN162380)
`Wendy L. Devine (SBN 246337)
`Natalie J. Morgan (SBN 211143)
`
`HILGERS GRABEN PLLC
`Michael T. Hilgers, pro hac vice
`
`Attorneys for Plaintiff NuVasive, Inc.
`
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`NUVASIVE’S OBJECTIONS TO CURRAN DECL.
`ISO DEFS’ OPP’N TO MOT. FOR PARTIAL
`
`SUMMARY JUDGMENT
`
`-9-
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`18-cv-00347-CAB-MDD
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`CERTIFICATE OF SERVICE
`The undersigned certifies that a true and correct copy of the foregoing
`document has been served on this date to all current and/or opposing counsel of
`record, if any to date, who are deemed to have consented to electronic service via
`the Court’s CM/ECF system per Civ.L.R. 5.4(d). Any other counsel of record will
`be served by electronic mail, facsimile and/or overnight delivery.
`I declare under penalty of perjury under the laws of the United States of
`America that the above is true and correct. Executed this 26th day of February
`2021 at San Diego, California.
`
`
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`
`
`By: / s/ Arlene Apodaca
`ARLENE APODACA
`
`
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`CERTIFICATE OF SERVICE
`
`
`-1-
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`18-cv-00347-CAB-MDD
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