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`EXHIBIT 18
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`TO THE DECLARATION OF BRIAN J.
`NISBET IN SUPPORT OF DEFENDANTS’
`OPPOSITION TO NUVASIVE’S MOTION
`FOR PARTIAL SUMMARY JUDGMENT
`AND MOTION TO EXCLUDE
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA – SAN DIEGO DIVISION
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`NUVASIVE, INC., a Delaware corporation,
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` Plaintiff,
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`v.
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`ALPHATEC HOLDINGS, INC., a Delaware
`corporation, and ALPHATEC SPINE, INC., a
`California corporation,
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` Defendants.
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`Case No. 18-cv-00347-MDD-CAB
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`REBUTTAL EXPERT REPORT OF JIM YOUSSEF, MD
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`EXHIBIT 18 - PAGE 325
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`NUVA_ATEC0341114.
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`133.
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`Importantly, the disclosures in the Provisional Application make clear that
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`“implant 10” is intended to be inserted laterally. NUVA_ATEC0020836 (Provisional
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`Application) at FIG. 2. As I discussed in my Implant Opening Report (¶ 99), the receiving
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`aperture 12 in the Figures 2, 3, and 5 of the Provisional Application engages with insertion
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`instrument 20 and defines the distal-proximal direction as the longitudinal length. In addition,
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`the Provisional Application describes “lateral” openings specifically for assessment of the degree
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`of fusion from the “side” perspective of the implant—a POSA would understand that the “side”
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`is the dimension of the implant extending proximally-distally across the disc space.
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`134. As I stated in my Implant Opening Report (¶¶ 92-114, 202-208), the Provisional
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`Application provides sufficient written description for each of the Asserted Claims of the ’334
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`and ’156 patents.
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`XI. DR. SACHS DOES NOT IDENTIFY ANY PUBLIC USE, SALE, OR OFFER TO
`SELL OF ANY EMBODIMENT OF THE ASSERTED CLAIMS PRIOR TO
`MARCH 29, 2003
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`135. Dr. Sachs opines that the NuVasive Cement Restrictor XL/PEEK CR-XL/PEEK
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`CR-X/CoRoent XL implants meets each limitation of the Asserted Claims of the ’334 and ’156
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`patents. Sachs Implant Opening Report at ¶¶ 251-292. I agree that these devices do appear to
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`meet the limitations of the Asserted Claims.4 However, as in my Opening Implant Report and
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`below, I disagree that Dr. Sachs has pointed to any information indicating that there was a
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`“public use” or a “sale” prior to the priority date applicable to the Asserted Claims.
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`136. First, Dr. Sachs bases his conclusion that the Asserted Claims are invalid (due to
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`prior public use and sale) on his opinion that the Asserted Claims are entitled to a priority date no
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`earlier than March 29, 2005. I disagree for the reasons stated in above and for the reasons stated
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`in my Implant Patent Opening Report. Youssef Implant Opening Report at ¶¶ 91-114, 201-208.
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`Dr. Sachs provides no evidence of a prior public use or sale/offer to sell any device that meets
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`the limitations of the Asserted Claims prior to March 29, 2003 (i.e., more than one year before
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`the priority date—which in my opinion is the March 29, 2004 filing date of the Provisional
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`Application). Accordingly, for at least this reason, it is my opinion that Dr. Sachs fails to show
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`that the Implant Patents are invalid due to prior public use or sale/offer to sell.5
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`137. Second, as detailed above and below, Dr. Sachs has pointed to no evidence that
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`the claimed implant was in public use or the subject of a commercial sale or offer to sell in the
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`United States prior to March 29, 2003 (the relevant date) or even March 29, 2004.
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`4 Dr. Sachs cites to numerous documents to support his opinion that Cement Restrictor
`XL/PEEK CR-XL/PEEK CR-X/CoRoent XL are embodying products of the Asserted Claims
`of the ’334 and ’156 patents and meet each claim limitation of the ’334 and ’156 patents. I do
`not address each document cited because it appears these devices meet the claim limitations.
`5 I note that, Dr. Sachs opines that the Cement Restrictor XL/PEEK CR-XL/PEEK CR-
`X/CoRoent XL implants were “ready for patenting” before March 29, 2004. Sachs Implant
`Opening Report at ¶¶ 304-309. I understand from counsel that “ready for patenting” means that
`the claimed implant was either in use or sufficient preparations had been made by the inventor
`to enable one of skill in the art to practice the invention. I agree with Dr. Sachs that the
`claimed implant of the ’334 and ’156 patent was enabled as of the March 29, 2004 filing date
`of the Provisional Application.
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`A.
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`Dr. Sachs Cites No Evidence of Public Use At Any Time
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`138. Dr. Sachs’ opinions are flawed at least because he does not identify any evidence
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`of public use. I understand from counsel that to be invalidating, such a use must be public and
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`without confidentiality restriction.
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`139. Dr. Sachs opines that products that meet the limitations of the Asserted Claims
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`were in public use at least as early as December 2003. Sachs Implant Opening Report at ¶ 294.
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`As I stated above and stated in my Implant Opening Report (¶¶ 91-114, 201-208), the priority
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`date for the ’334 and ’156 patents is March 29, 2004. Thus, Dr. Sachs has not cited any evidence
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`of a public use more than one year before the priority date (i.e., before March 29, 2003).
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`140. At ¶ 299 of his report, Dr. Sachs states that he has not seen evidence that the pre-
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`March 29, 2004 “uses” of the claimed implants that he discusses “were intended to be
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`confidential or experimental.” I understand from counsel that it is Alphatec’s burden to identify
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`evidence of prior public use, not NuVasive’s burden to identify the absence of public use. I
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`disagree with Dr. Sachs that there is no evidence that the pre-March 29, 2004 “uses” were
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`intended to be “confidential or experimental.” As discussed above it is clear that Matt Copp’s
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`December 5, 2003 email discussed an ALPHA launch, not a commercial launch.
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`141. As discussed above in Section IX., Dr. Sachs cites a number of documents, none
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`of which support his opinion that an implant that meets the limitations of the claims of the ’334
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`and ’156 patents was in “public use” more than one year prior to the priority date. I address each
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`document in turn below.
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`i.
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`Annual Spine Evolution Nucleus (“SEN”) Clinicians Meeting held on
`June 27-30, 2002
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`142. Dr. Sachs cites an email from Dr. McAfee to Pat Miles and Alex Lukianov and
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`implies that there was a “prior public use.” Sachs Implant Opening Report at ¶ 300;
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`NUVA_ATEC0016575. I disagree.
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`143. As I discuss above (¶¶ 48-50), Dr. Sachs does not provide any support for his
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`conclusion that the “lateral cage” mentioned in this document meets the limitations of the
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`Asserted Claims. In addition, the email does not indicate whether the existence of the “lateral
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`cage” was publicly known.
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`ii.
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`Pimenta Sketch
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`144. Dr. Sachs cites the Pimenta Sketch collection of documents and concludes this
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`was a “prior public use.” Sachs Implant Opening Report at ¶ 300; NUVA_ATEC016561. I
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`disagree.
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`145. As I discuss above (¶¶ 52-63), Dr. Sachs does not cite any information indicating
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`that these drawings were ever publicly disclosed. Furthermore, April 2003 is less than one year
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`before March 29, 2004 so the drawings dated April 2003 do not constitute “public use” more
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`than one year prior to the priority date.
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`iii.
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`NuVasive’s 510k Submission of July 16, 2003
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`146.
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`I discuss NuVasive’s July 16, 2003 510k submission above (¶¶ 64-66). Sachs
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`Implant Opening Report at ¶¶ 84-86.
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`147.
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`It is unclear whether Dr. Sachs is asserting the 510(k) submission in July 16, 2003
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`is a “prior public use.” I note that Dr. Sachs does not cite any information indicating that 510(k)
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`submissions are publicly available when they are submitted, or any information about when/if
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`such submissions can become publicly available. Dr. Sachs cites no information indicating that
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`NuVasive publicly disclosed the 510(k) submission or that the submission was, or could have
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`been, accessed by the public with a FOIA request.
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`148. Even if Dr. Sachs provided information indicating a public disclosure (which he
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`did not), the implant described in engineering drawings in the 510k Submission of July 16, 2003
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`does not describe the claimed invention as the implant does not have radiopaque markers
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`proximate the medial plane or in the central region.
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`149. Moreover, July 16, 2003 is less than one year before March 29, 2004 so the July
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`16, 2003 FDA submission does not constitute public use more than one year prior to the priority
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`date.
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`iv.
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`December 5, 2003 Email from Matt Copp
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`150. Dr. Sachs cites a December 5, 2003 email from Matt Copp. Sachs Implant
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`Opening Report at ¶ 296; NUVA_ATEC0340867. It is unclear whether Dr. Sachs is asserting
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`that the December 5, 2003 email constitutes a prior public use. To the extent Dr. Sachs is
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`implying a prior public use, I disagree.
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`151. As I discuss above (¶¶ 68-70), Dr. Sachs does not point to any information
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`indicating that this email was publicly disseminated. Also, there is no information indicating that
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`the “targeted individuals” for the ALPHA launch were not party to confidentiality agreements
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`with NuVasive.
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`152. Moreover, December 5, 2003 is less than one year before March 29, 2004 so the
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`December 5, 2003 email from Matt Copp does not constitute public use more than one year prior
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`to the priority date.
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`v.
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`Archive.org Screen-Capture
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`153. Dr. Sachs cites an email from Christina Dashe dated November 6, 2020 to
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`Alphatec counsel that attaches an Archive.org Screen Capture and concludes this was a prior
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`public use. Sachs Implant Opening Report at ¶ 302; NUVA_ATEC0342156. I disagree.
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`154. As discussed above (¶¶ 71-75), other than Ms. Dashe’s email, Dr. Sachs does not
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`point to any information indicating that the Archive.org Screen Capture accurately reflects a
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`website that was publicly available in February 2004.
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`155. Moreover, Archive.org Screen Capture is dated February 2004, which is less than
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`one year before March 29, 2004, so even if this website were publicly available, it does not
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`constitute public use more than one year prior to the priority date.
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`vi.
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`Spreadsheets Listing 2003-2004 Procedures
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`156. Dr. Sachs cites spreadsheets summarizing surgeries and concludes this was a prior
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`public use. Sachs Implant Opening Report at ¶ 297; NUVA_ATEC0115139;
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`NUVA_ATEC0288461. I disagree.
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`157. As discussed above (¶¶ 79-83), nothing in these spreadsheets describes the details
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`of a device that meets the limitations of the asserted claims. Dr. Sachs does not point to
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`information indicating that any device mentioned in the spreadsheets meets the limitations of the
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`Asserted Claims. Furthermore, with the exception of a procedure involving allograft (which
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`does not meet the limitations of the Asserted Claims), the dates of the procedures are less than
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`one year before March 29, 2004 so this does not constitute public use more than one year prior to
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`the priority date.
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`vii. March 29, 2004 Email
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`158. Dr. Sachs cites a March 29, 2004 email that references a surgical procedure done
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`by Dr. Peterson on March 26, 2004 and concludes this was a prior public use. Sachs Implant
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`Opening Report at ¶ 298; NUVA_ATEC0341066. I disagree.
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`159. As discussed above (¶¶ 84-86), Dr. Sachs does point to any information indicating
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`that the device utilized in the March 26, 2004 surgery meets the limitations of the Asserted
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`Claims.
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`160. Moreover, March 26, 2004 is less than one year before March 29, 2004 so the
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`March 26, 2004 surgical procedure, regardless of whatever device was used, does not constitute
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`public use more than one year prior to the priority date.
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`viii. NuVasive’s Registration Statements (Form S-1)
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`161. Dr. Sachs cites Amendment No. 2 to Registration Statement Under the Securities
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`Act of 1933 (Form S-1) dated April 26, 2004 (ATEC_LLIF000966310), NuVasive, Inc.’s
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`Registration Statement Under the Securities Act of 1933 (Form S-1) dated March 5, 2004
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`(ATEC_LLIF000965979), and NuVasive’s, Inc.’s Amendment No. 3 to Registration Statement
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`Under the Securities Act of 1933 (Form S-1) dated May 4, 2004 (ATEC_LLIF000966507) and
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`concludes this was a prior public use. Sachs Implant Opening Report at ¶ 301. I disagree.
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`162. First, as discussed above (¶ 90), Dr. Sachs provides no details to show that the
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`April 26, 2004, March 5, 2004, and May 4, 2004 Registration Statements disclose any device
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`that meets the limitations of the Asserted Claims.
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`163. Moreover, the April 26, 2004, March 5, 2004, and May 4, 2004 Registration
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`Statements are after the priority date (March 29, 2004) so this does not constitute prior public
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`use.
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`B.
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`Dr. Sachs Cites No Evidence of Commercial Sale or Offer To Sell At Any
`Time
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`164. Dr. Sachs opines that products meeting the limitations of the Asserted Claims
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`were on sale at least as early as January 2004. Sachs Implant Opening Report at ¶ 312. I
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`disagree.
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`165. Dr. Sachs’ opinions are flawed because he does not identify any evidence of an
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`actual sale or offer to sell. I understand from counsel that to be an invalidating sale or offer,
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`there must be an agreement between parties to give and pass rights to property for consideration
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`which the buyer pays or promises to pay the seller for the thing bought and sold. Dr. Sachs does
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`not identify any such information. For example, he does not identify any customer, any sale
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`price, and date of sale, any terms offered for a potential sale, etc.
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`166. As I stated above and stated in my Implant Opening Report (¶¶ 91-114, 201-208),
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`the priority date for the ’334 and ’156 patents is March 29, 2004. Dr. Sachs provides no
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`information indicating that a sale of any device that meets the limitations of the Asserted Claims
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`(or offer to sell such a device) occurred prior to March 29, 2003.
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`167. As discussed above in Section IX., Dr. Sachs cites a number of documents in an
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`effort to show the Asserted Claims are invalid because of a sale or offer to sell more than one
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`year prior to the priority date. I address each document in turn below.
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`ix. March 2, 2004 Email Correspondence
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`168. Dr. Sachs cites a March 2, 2004 email from Matt Copp to the NuVasive sales
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`team and concludes that it shows a prior sale. Sachs Implant Opening Report at ¶¶ 319-321;
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`NUVA_ATEC0341048. I disagree.
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`169. As discussed above (¶ 76), it is unclear whether this “release date” statement in
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`this email refers to any sort of ALPHA or BETA limited launch or to a commercial launch. It is
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`also not clear whether this scheduled release actually happened.
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`170. Also, March 2, 2004 is less than one year before March 29, 2004 so the March 2,
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`2004 email from Matt Copp does not show a sale more than one year prior to the priority date.
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`171. Dr. Sachs next cites a March 2, 2004 email from Brett Lanuti to Matt Copp and
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`concludes that it shows a prior sale. Sachs Implant Opening Report at ¶ 322;
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`NUVA_ATEC0341055. I disagree.
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`172. As discussed above (¶ 77), the Brett Lanuti email recognizes the early success
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`with the “NuVasive PEEK Cement Restrictors,” but does not state that anyone received or used
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`such devices and under what circumstances.
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`173. Also, March 2, 2004 is less than one year before March 29, 2004 so the March 2,
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`2004 email from Brett Lanuti (NUVA_ATEC0341055) does not indicate a sale more than one
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`year prior to the priority date.
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`x.
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`March 10, 2004 Email from Matt Copp
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`174. Dr. Sachs cites a March 10, 2004 email from Matt Copp to the NuVasive sales,
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`marketing, operations, customer service, and “independent agent” teams and concludes that it
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`shows a prior sale. Sachs Implant Opening Report at ¶¶ 323-324; NUVA_ATEC0332451. I
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`disagree.
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`175. As discussed above (¶ 78), it is unclear whether this “availability” statement in
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`this email refers to “availability” to some group of “targeted individuals” (like those referred to
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`in Mr. Copp’s December 23, 2003 email) or to commercial “availability.”
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`176. Also, March 10, 2004 is less than one year before March 29, 2004 so the March
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`10, 2004 email from Matt Copp does not indicate a sale more than one year prior to the priority
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`date.
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`xi.
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`NuVasive’s “Sales” Spreadsheets
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`177. Dr. Sachs cites “Sales” sheet (NUVA_ATEC0341358) and “Graph” sheet
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`(NUVA_ATEC0341358) which are attachments to November 8, 2004 email from Matt Copp
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`(NUVA_ATEC0341357) and concludes they show a prior sale. Sachs Implant Opening Report
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`at ¶¶ 316-318. Dr. Sachs also cites a July 8, 2004 email entitled “Sales Inventory Analysis –
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`2004” (NUVA_ATEC0341176) and an attached spreadsheet (NUVA_ATEC0341177)) and
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`concludes they show a prior sale. Sachs Implant Opening Report at ¶ 318. I disagree.
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`178. As stated above (¶ 87), none of these documents contain a description of all the
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`relevant features of the listed products or devices (indeed, they appear to simply contain
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`undefined product names, and some appear to further list the dimensions of those products), nor
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`do they contain any description of the circumstances surrounding what Dr. Sachs opines was
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`their use or sale. Moreover, Dr. Sachs does not cite any information that supports his opinions
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`regarding what he believes is reflected in these documents.
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`179. Also, January and February 2004 and July 8, 2004 are less than one year before
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`March 29, 2004 so the “Sales” sheet (NUVA_ATEC0341358) and the “Graph” sheet
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`(NUVA_ATEC0341358) do not indicate a sale more than one year before to the priority date.
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`180. Dr. Sachs also cites a sales spreadsheet and concludes that it shows a prior sale.
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`Sachs Implant Opening Report at ¶ 315; NUVA_ATEC0341168. I disagree.
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`181. As stated above (¶ 88), this document does not provide a description of the
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`relevant features of the referenced devices, nor does it contain any description of the
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`circumstances surrounding what Dr. Sachs opines was their use or sale. Moreover, Dr. Sachs
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`does not cite any information that supports his opinions regarding what he believes is reflected in
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`these documents.
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`182. Also, February 2004 is less than one year before March 29, 2004 so this sales
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`spreadsheet does not indicate a sale more than one year prior to the priority date.
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`xii. May 21, 2004 Email
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`183. Dr. Sachs cites to a May 21, 2004 email (NUVA_ATEC0341150) and an
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`attachment (NUVA_ATEC0341153) and concludes they show a prior sale. Sachs Implant
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`Opening Report at ¶ 314. I disagree.
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`184. As stated above (¶ 89), these documents do not provide a description of the
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`relevant features of the referenced devices, nor do they contain any description of the
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`circumstances surrounding what Dr. Sachs opines was their use or sale. Moreover, Dr. Sachs
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`does not cite any information that supports his opinions regarding what he believes is reflected in
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`these documents.
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`185. Also, February 2004 and March 2004 are less than one year before March 29,
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`2004 so the May 21, 2004 email (NUVA_ATEC0341150) and accompanying attachment
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`(NUVA_ATEC0341153) do not indicate a sale more than one year prior to the priority date.
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`XII. THE ASSERTED CLAIMS ARE NOT INDEFINITE
`A.
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`Claims 1 and 16 of the ’334 Patent are not Indefinite—“central region” and
`“generally parallel”
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`186. Dr. Sachs contends that claims 1 and 16 of the ’334 patent are indefinite because
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`the claim language “central region” would not inform a POSA of the scope of the claims. Sachs
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`Implant Opening Report at ¶ 329. I disagree. For the reasons set forth below, a POSA reading
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`the claim language “central region” in the context of the claims and the specification would
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`understand the scope of the claims.
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`Date: December 18, 2020
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`Jim9?.;:
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