Case 3:18-cv-00347-CAB-MDD Document 307-8 Filed 02/16/21 PageID.29785 Page 1 of 11
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`EXHIBIT 7
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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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`CORRECTED OPENING EXPERT REPORT OF JIM YOUSSEF, MD REGARDING
`U.S. PATENT NOS. 8,361,156 (‘156 PATENT) AND 8,187,334 (‘334 PATENT)
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`Case No. 18-cv-00347-MDD-CAB
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`EXHIBIT 7 - PAGE 135
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`29, 2004, provides adequate written description for each of the Asserted Claims of the Implant
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`Patents, such that a POSA can clearly conclude that the inventors invented the claimed invention
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`March 29, 2004 filing date of the Provisional Application, (b) whether or not Alphatec’s
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`Accused Implants meet the limitations of any of the Asserted Claims, (c) whether or not
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`NuVasive’s own implants meet the limitations of any of the Asserted Claims, (d) whether or not
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`there were any acceptable, non-infringing alternatives to the accused implants during the period
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`of Alphatec’s infringement, (e) whether Alphatec’s Lateral Platform is interchangeable with
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`NuVasive’s MAS Platform, the technical and clinical contributions of the asserted implant
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`patents, surgeon choice of platform, and Analysis of patents and technology included in
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`agreements produces in this case, and (f) whether the public would be harmed by the removal of
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`Alphatec’s accused products from the market.
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`39.
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`Based on my study to date, it is my opinion that the March 29, 2004 Provisional
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`Application for the Implant Patents, U.S. Patent Application No. 60/557,536 (the “Provisional
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`Application”), provides adequate written description for the Asserted Claims such that a POSA
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`can clearly conclude that the inventors invented the claimed invention March 29, 2004 filing date
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`of the Provisional Application. My bases for that opinion are explained in detail in this report.
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`40.
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`Based on my study to date, it is my opinion that various Alphatec implants
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`infringe the Asserted Claims of the Asserted Implant Patents. My bases for that opinion are
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`explained in detail in this report.
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`41.
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`Based on my study to date, it is my opinion that there were no acceptable,
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`available non-infringing alternatives to Alphatec’s accused implants during the period of
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`Alphatec’s infringement. My basis for this opinion is explained in detail in this report.
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`49.
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`Spinal interbody fusion implants are thus designed to support and share the heavy
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`loads placed on the spine, to align and alleviate pain caused by misalignment of the spine, to
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`resist movement in the disc space after insertion, and to promote fusion of the two adjacent
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`vertebrae. The implant size is limited by the anatomy of the vertebral space, the surgical
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`approach in inserting such devices, as well as the anatomy along the intended surgical path.
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`50.
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`It is critically important that interbody fusion implants can be inserted along the
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`intended insertion path, can be positioned in the disc space, support the intended load, stay in
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`place after insertion, align the spine, and allow fusion of the vertebrae. Failure in any one of
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`these areas mean that the implant is unsuitable for that procedure.
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`51.
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`As explained in my Access Patent Opening Report, before the introduction of
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`NuVasive’s lateral XLIF system and procedure, spine surgeons commonly performed spinal
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`fusion surgeries utilizing either a posterior approach via the patient’s back (PLIF or TLIF), or an
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`anterior approach to the lumbar spine via the patient’s abdomen (ALIF). See ¶¶ 65-68
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`(explaining the ALIF, PLIF, and TLIF surgeries). Given the unique considerations (and
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`limitations) of these approaches, surgeons used (and still use) implants specifically tailored to
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`each approach.
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`52.
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`Implants for TLIF and PLIF posterior procedures are ultimately defined by the
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`annulotomy that can safely be achieved within the adjacent neural and bony anatomy (e.g., the
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`cauda equina and the bones of the spinal column, as can be seen in the images below). As a
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`result, and as further explained below, TLIF and PLIF implants are limited in width. See
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`ATEC_LLIF000004957-58, at ATEC_LLIF000004958 (disclosing PLIF implants with widths
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`between 8 mm and 14 mm); ATEC_LLIF000178830-35, at ATEC_LLIF000178831 (disclosing
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`TLIF implants with widths of 11 mm and 13 mm).
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`97.
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`The Provisional Application describes the “width” of the implant as ranging
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`between 25 and 45 mm, with the “length” of the implant ranging between 9 and 18 mm – i.e., it
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`describes a “width” that is greater than the “length” of the implant, including a “width” of greater
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`than 40 mm. This disclosure facially differs from the Asserted Claims, which recite the opposite
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`dimensions: a “longitudinal length” that is greater than the “maximum lateral width,” including
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`a “longitudinal length” that is greater than 40 mm. However, as explained below, the
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`surrounding context of this disclosure in the Provisional Application makes it clear to a POSA
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`that the difference is merely one of nomenclature and not of substance: i.e., the Provisional
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`Application adequately describes the invention recited in the Asserted Claims, including the
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`specifically claimed dimensions.
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`98.
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`In particular, it is clear to a POSA that the inventors simply changed the point of
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`reference used to describe the “length” and “width” of the disclosed implant between the
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`Provisional Application and the Asserted Claims, which reversed what would be considered the
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`“length” and the “width” of the implant without actually changing the relevant features,
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`dimensions, or intended use. The Provisional Application specifically discusses the dimensions
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`of the implant in the context of a “lumbar” spinal fusion implant (10) as depicted in, inter alia,
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`Figures 2-4. See NUVA_ATEC0020809 (Provisional Application) at 4:18-21,
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`NUVA_ATEC0020816-20, 11:5-15:15; NUVA_ATEC0020836-38, Figs. 2-4. Put simply, the
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`nomenclature difference does not alter the properties of the disclosed lumbar spinal fusion
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`implant (10) which are the same in provisional and nonprovisional filings.
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`Fl .2
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`4
`6
`7, 8, 9
`10
`12
`14
`16
`22
`31
`33
`50
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`JJ
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`lD
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`Visualization apertures
`Ridges
`Spike elements
`Spinal fusion implant
`Threaded receiving aperture
`Lateral sides
`Distal side
`Proximal side
`Top surface
`Bottom surface
`Medial support
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`Fl
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`. 2
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`4
`6
`7, 8, 9
`10
`12
`14
`16
`22
`31
`33
`50
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`I)
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`Visualization apertures
`Ridges
`Spike elements
`Spinal fusion implant
`Threaded receiving aperture
`Lateral sides
`Distal side
`Proximal side
`Top surface
`Bottom surface
`Medial support
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`Provisional Appln.: 13:11-15:20
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`156 Patent: 6:5-59
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`99.
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`Importantly, the disclosures regarding this “lumbar” implant make clear that it is
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`intended to be inserted laterally, with the longest dimension (i.e., the longitudinal length)
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`extending in the distal-proximal direction across the disc space. For example, the Provisional
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`Application describes a “threaded receiving aperture 12 in the proximal sidewall 22 of the spinal
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`fusion implant 10 of the present invention.”5 Provisional Application at 15:19-20; see also,
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`5 I note that Asserted Claim 5 of the ’156 patent further recites “at least one receiving
`aperture position” at the proximal wall. As can be seen in Figure 2 and this quotation from the
`Provisional Application regarding “the threaded receiving aperture” located in the “proximal
`(continued...)
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`B.
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`Alphatec’s IdentiTi™ implant
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`275.
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`I understand from counsel that Alphatec has identified its IdentiTi implant.11 I
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`note that the IdentiTi implant is a porous titanium implant that was Alphatec announced on
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`October 22, 2019.12
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`276. Although there has been some adoption of titanium implants by spine surgeons,
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`my experience has been that there remains a substantial portion of surgeons who still prefer
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`PEEK based on its proven benefits and long track record. Based on my experience, there is
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`substantial value in the proven benefits and track record of PEEK because they help lead to safe
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`11 https://atecspine.com/lif-identiti-lif/.
`12 https://www.globenewswire.com/news-release/2019/10/22/1933280/0/en/Alphatec-
`Enhances-its-Lateral-Portfolio-With-the-Commercial-Launch-of-Approach-Specific-
`Innovation.html.
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`and reproducible, minimally-invasive, successful lateral fusion procedures. Accordingly, many
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`surgeons who prefer PEEK would not be comfortable switching to a technology like titanium
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`because it has not generated the same track record in lateral lumbar interbody fusion procedures.
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`This would be one barrier to switching for the surgeons who prefer PEEK. Other barriers are
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`caused by drawbacks of the material and design of a titanium implant like the IdentiTi implant.
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`Thus, there are numerous reasons that a surgeon would not consider the IdentiTi implant to be an
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`acceptable substitute for NuVasive’s XLIF Procedure / MAS Platform with CoRoent XL
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`implants, especially for surgeons who have already been trained on NuVasive’s XLIF Procedure
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`/ MAS Platform with CoRoent XL implants and have become comfortable with the safety profile
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`of CoRoent XL implants.
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`277. First, titanium is radiopaque, not radiolucent like NuVasive’s CoRoent line of
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`implants. This presents numerous drawbacks that a surgeon would consider important when
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`selecting a lateral platform. Titanium implants are radiopaque so them make it harder to
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`determine with standard fluoroscopy during a procedure whether there is damage to the vertebral
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`endplates, whether the implant has gone beyond the confines of the interbody space, and whether
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`the implant is aligned correctly. Additionally, titanium causes scatter in CT and MRI imaging,
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`which makes it very difficult for a surgeon to assess whether fusion has occurred in post-op
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`imaging. The scatter caused by titanium also makes it difficult to see other problems or potential
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`problems near the surgical site. For example, scatter interferes with a surgeon’s ability to follow
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`the orientation of the implant and determine alignment. It also interferes with a surgeon’s ability
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`to see an end plate fracture, subsidence, or whether the implant is impacted into bone. A
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`radiolucent material like PEEK, however, allows the surgeon to see through the implant to
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`confirm fusion has occurred in post-op imaging and better assess the area around the surgical site
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`for potential problems.
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`278. Second, titanium has inferior material properties when compared to a radiolucent
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`material like PEEK. Titanium has a higher modulus of elasticity than bone—basically it is stiffer
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`than bone—which can lead to problems. Once fusion has occurred and the fused vertebrae are
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`loaded, the load will not be shared equally between a titanium implant and the bone growth.
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`PEEK, on the other hand, has a modulus of elasticity that is much closer to bone to produce
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`optimal load-sharing.
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`279. Third, some people are allergic to titanium, which makes a titanium implant
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`inappropriate for certain patients. Although the portion of the patient population that is allergic to
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`titanium is low, if someone who is allergic has a procedure where a medical device made of
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`titanium is implanted it can lead to serious consequences.13 For example, an additional surgical
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`intervention may be necessary to remove the titanium implant and replace it with an implant
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`made of a different material. The additional surgery is typically much more invasive and
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`obviously increases the risk of complications. That risk can be exacerbated if the second surgery
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`must occur before the patient has fully healed from the first one. A need to screen patients for
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`titanium allergies before using a titanium implant has been recognized in the literature.14 While it
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`is possible to screen for titanium allergies, that adds an additional preoperative step to a surgical
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`procedure, one that is not necessary with PEEK.
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`280.
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`I note that the IdentiTi is a porous titanium implant. While porous titanium
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`implants were developed to improve the imaging characteristics and modulus of elasticity, those
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`13 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4192797/.
`14 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4248517/.
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`problems remain. Porous titanium also introduces an additional drawback—it is more abrasive.
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`Thus, during insertion of the implant there is higher chance of causing subsidence as compared
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`to PEEK.
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`281. The CoRoent XL implant has a long track record and established safety profile. It
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`provides a battle-tested marker configuration for determining and confirming placement. I note
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`that some surgeons decided to use porous titanium implants but, based on my experience, there
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`remains a sizable group of surgeons that use PEEK and do not consider porous titanium to be an
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`acceptable substitute. This is particularly true for surgeons that have trained in XLIF using the
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`CoRoent XL implants and become comfortable using a platform with a PEEK implant. For such
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`surgeons, there would be additional barriers to change to a platform with implants made from
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`titanium, such as Alphatec’s IdentiTi.
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`282. Accordingly, Alphatec’s IdentiTi is not an acceptable non-infringing alternative.
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`C.
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`Stryker Spine implants
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`283.
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`I understand that Alphatec has identified the Cascadia implant by Stryker Spine. I
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`have reviewed Stryker’s publicly-available materials regarding Cascadia implants, including the
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`webpage Alphatec produced at ATEC_LLIF000965814. That webpage lists seven Stryker
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`implants with Cascadia in the product name: Cascadia AL 3D, Cascadia AN 3D, Cascadia AN
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`Lordotic 3D, Cascadia AN Lordotic Oblique 3D, Cascadia Cervical 3D, Cascadia Lateral 3D,
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`and Cascadia TL 3D.
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`284. Four of the Cascadia implants appear to be implants designed for a PLIF
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`procedure (Cascadia AL 3D, Cascadia AN 3D, Cascadia AN Lordotic 3D, and Cascadia AN
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`Lordotic Oblique 3D). I addressed PLIF fusion surgeries and the way that XLIF solved the
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`problems associated with PLIF in paragraphs 65–69, 87–102, and 1278 of my Opening Report.
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`also has lateral implants also made of non-PEEK substrates that will be available for surgeons to
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`use in a lateral, trans-psoas surgery.
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`471. Finally, based on my own personal inspection of Alphatec’s Accused Products, in
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`conjunction with my review of photographs and videos from NuVasive’s counsel’s inspection of
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`Alphatec’s Accused Products, as well as Alphatec’s surgical and implant guides for the Accused
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`Products, I have identified no additional unique features or benefits of Alphatec’s Accused
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`Products that are not similarly present in the CoRoent® XL implant or any other lateral spinal
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`fusion surgery product available on the market.
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`Date: November 20, 2020
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`JimSt;::
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