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`Exhibit A
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA – SAN DIEGO DIVISION
`NUVASIVE, INC., a Delaware corporation,
` Plaintiff,
`v.
`
`Case No. 18-cv-00347-MDD-CAB
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`)))))))))))))
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`ALPHATEC HOLDINGS, INC., a Delaware
`corporation, and ALPHATEC SPINE, INC., a
`California corporation,
` Defendants.
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`OPENING EXPERT REPORT OF JIM YOUSSEF
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`In addition, in paragraphs 87, 1330, above, I addressed how the patented
`1331.
`platform that NuVasive developed allowed surgeons to traverse the psoas muscle by a lateral
`approach in a safe and reproducible manner.
`B. Skepticism
`1332. As described in paragraphs 74, 1321, above, spinal surgeons considered a
`lateral, trans-psoas approach to be unacceptably dangerous, if not impossible, as of 2003. E.g.,
`NUVA_ATEC0245709-714 (Takatomo Moro, et al., An Anatomic Study of the Lumbar Plexus
`with Respect to Retroperitoneal Endoscopic Surgery, SPINE 28(5):423-428 (2003)). In fact,
`spine surgeons were so skeptical that they continued to vastly prefer the conventional ALIF,
`PLIF, and TLIF procedures, despite their significant drawbacks discussed above. Accordingly,
`as also explained in paragraph 91, 1332, 1333, NuVasive faced substantial skepticism from the
`spine surgeon community shortly after introducing XLIF.
`1333.
`I am personally aware of the initial skepticism surrounding XLIF. At the time
`of XLIF’s launch in 2003, I was personally skeptical of the value of a lateral, trans-psoas
`approach to the lumbar spine for conditions such as degenerative disc disease, and many of the
`other conditions now routinely treated using the claimed inventions. I was aware of
`NuVasive’s technology at the time and I was deeply interested in innovative surgical
`techniques – and yet I continued to use traditional surgical techniques rather than the claimed
`systems and methods because I did not believe the lateral, trans-psoas approach to the lumbar
`spine could be done as safely and reproducibly as traditional surgical approaches to the spine.
`1334.
`I have been informed by counsel that Dr. Frank Phillips, M.D. submitted a
`declaration in an inter partes review proceeding. In that declaration, consistent with my
`experience and opinions, Dr. Phillips discussed the fact that NuVasive’s XLIF was met with
`skepticism from spinal surgeons upon release in October 2003. NUVA_ATEC0245805-986
`(Phillips ’535 Declaration at ¶¶ 28-33).
`1335.
`I have been informed by counsel that Mr. Patrick Miles submitted a declaration
`in an inter partes review proceeding. In that declaration, consistent with my experience and
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`opinions, Mr. Miles also addressed the “substantial skepticism” that NuVasive faced from the
`spinal surgeon community shortly after introducing XLIF. NUVA_ATEC0247748-778 (Miles
`’535 Declaration at ¶¶ 12-13); NUVA_ATEC0044915-942 (Miles ’156 Declaration at ¶ 7).
`1336.
`I agree with Mr. Miles’ statement that, at the time of XLIF’s introduction, “the
`industry was not quick to believe that the psoas muscle could really be crossed safely by a
`spine surgeon of ordinary skill.” NUVANUVANUVA_ATEC0247755 (Miles ’535 Declaration
`at ¶ 11).
`I have also reviewed the Declaration of Matthew Link in Support of NuVasive’s
`1337.
`Motion for Preliminary Injunction. (Doc. No. 37-13), where Mr. Link (who I understand is the
`current President of NuVasive) describes, among other things, NuVasive’s experiences
`regarding the development, launch, and growth of XLIF. Mr. Link’s descriptions of how,
`beginning with XLIF’s launch in 2003, members of the spinal community published their
`doubts regarding the safety and efficacy of XLIF in the literature, and that such misgivings
`continued through at least the 2009 timeframe, are consistent with my own experience and
`opinions. Id. at ¶ 20. I further agree with Mr. Link’s statement that, “[o]ther factors also
`hampered the initial adoption of XLIF, including the fact that surgeons are generally reluctant
`to adopt new surgical techniques, especially those for which they have had little training and
`require tools they are not used to using.” Id. at ¶ 21.
`1338. This skepticism is further descripted below in ¶¶ 1338, 1361.
`Industry Praise
`1339.
`In my personal experience, although XLIF was initially met with skepticism, it
`was eventually widely adopted and the subject of copious praise amongst the spine surgeon
`community. See above ¶¶ 51, 1338, 1343. In particular, consistent with my own experience,
`such praise was a result of the substantial commitments made by NuVasive to educate surgeons
`on the safety and reproducibility of XLIF.
`1340.
`I have personally witnessed the substantial commitments made by NuVasive to
`educate surgeons on the safety and reproducibility of XLIF.
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`C.
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`Indeed, I am the Past-President of SOLAS, and I have been involved in research
`1341.
`and education regarding lateral, trans-psoas spinal surgery since its inception. As such, I am
`personally aware of over 150 articles discussing the significant benefits of XLIF
`1342. Also, as Mr. Miles described, and I experienced myself (as set forth in
`paragraphs 104, 129, 136, 143, 152, 160 above), NuVasive made substantial commitments to
`educating surgeons on the safety and reproducibility of XLIF. NUVA_ATEC0247748-78
`(Miles ’535 Declaration at ¶¶ 14,16).
`1343. As evidenced by this extensive literature clinically validating XLIF, the advent
`of the claimed inventions in the asserted patents was truly revolutionary. NuVasive’s XLIF
`procedure and associated suite of tools, which are claimed in the asserted patents, have changed
`spine surgery dramatically. Spine surgeons had long known that traditional approaches for
`spinal fusion surgery, such as anterior approaches and posterior approaches were far from ideal.
`It was not until NuVasive commercialized the inventions of the asserted claims that surgeons
`were provided with a viable, and in fact superior, surgical approach that addressed the
`shortcomings of both the traditional anterior and posterior approaches as well as the other
`rarely attempted (and unsuccessful) lateral approaches pre-dating XLIF (which I have
`discussed in detail in paragraphs 87-104 above).
`1344. Consistent with my experience and opinions, Dr. Phillips also discussed the fact
`that NuVasive’s XLIF received considerable praise after being adopted by the surgical
`community. NUVA_ATEC_0245805-986 (Phillips Declaration at ¶¶ 50-53).
`1345.
`I have been informed by counsel that Mr. Matthew Link submitted a declaration
`in this matter. In that declaration, Mr. Link also discussed praise consistent with my experience
`and opinions. Doc. No. 37-13 (Link PI declaration at ¶¶ 30-32).
`1346. Moreover, I personally praise XLIF in view of the outcomes that I have
`witnessed in my patients, including my wife. When she was only 14, my wife endured surgery
`to address scoliosis. XLIF was not available at that time, and the surgery resulted in a slow and
`painful recovery. Several years later, in 2007, my wife began to experience back pain again,
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`which eventually negatively affected her quality of life. I evaluated her spine, and discovered
`that her L2-3 disc was worn out and compressing her nerves. After consultation with several
`colleagues, we decided that the best treatment for my wife was XLIF, which was performed in
`August of 2008. Within hours after her XLIF, my wife was up and walking. She was
`discharged from the hospital less than 24 hours after the procedure. My wife resumed her active
`lifestyle three months after her XLIF; a lifestyle that continues today.
`1347. The positive clinical results that resulted in widespread industry praise for XLIF
`are a direct result of the patented components of XLIF. Specifically, it is only the pairing of
`specifically claimed: (a) neuromonitoring-enabled access equipment that allows for safe
`traversing of the psoas, (b) retractor system that can create a customizable operative corridor
`with minimal retraction of adjacent tissues and nerves that also allows a surgeon to adequately
`visualize the disc space and place an implant, and (c) large implant that provide stable fusion,
`as embodied by XLIF, that provides the safe, reproducible, and effective lateral spinal fusion
`surgery reported in the literature, directly leading to widespread adoption and industry praise.
`D. Long-Felt Unmet Need / Failure of Others
`1348. As described in detail in paragraphs 87-104 above, attempts at a lateral approach
`to the lumbar spine that came before XLIF did not include the benefits associated with XLIF,
`minimally invasive approach, and were often exceedingly dangerous. Indeed, many surgeons
`were not comfortable with a transpsoas approach to the spine because of the presence of the
`lumbar plexus. NUVA_ATEC0245709-714 (Takatomo Moro, et al., An Anatomic Study of the
`Lumbar Plexus with Respect to Retroperitoneal Endoscopic Surgery, SPINE 28(5):423-428
`(2003). In contrast, XLIF provides a minimally invasive, lateral approach to the spine that ‘by
`virtue of the extent and means of surgical technique results in less collateral damage, resulting
`in measurable decrease in morbidity and more rapid functional recovery than traditional
`exposures, without differentiation in the intended surgical goal.” NUVA_ATEC0245729-793
`(Ex. AD to Youssef Reply PI Declaration)).
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`1349. Moreover, as discussed above in ¶¶ 87-104, 1278, the inventions of the patents-
`in-suit, which are embodied by NuVasive’s MAS platform and NuVasive’s XLIF surgical
`technique, opened up the possibility of treating the spinal pathology of certain patients via
`interbody fusion where conventional methods (e.g., ALIF, PLIF, TLIF) might be
`contraindicated or the morbidity too great.
`1350. Furthermore, as discussed above in ¶¶ 87-104, 1278, when compared to
`interbody fusion performed by other approaches, the systems used in XLIF procedures offer a
`number of benefits, including:
`1. XLIF is minimally disruptive to the soft tissues;
`2. XLIF is associated with a shorter recovery time and less time in the hospital;
`3. XLIF has a lower complication rate;
`4. XLIF results in less blood loss;
`5. XLIF does not require a second (access) surgeon; and
`6. XLIF is associated with an extremely low risk of retrograde ejaculation.
`It is my opinion that the inventions of the patents-in-suit (which are embodied in
`1351.
`the MAS platform and XLIF) satisfied long felt unmet need for a safe, reproducible lateral
`spinal fusion technique and instruments that enable performance of that technique.
`1352. Moreover, it is my opinion that prior to the inventions of the patents-in-suit,
`others (e.g., Jacobson, discussed in paragraphs 78-84 above) attempted and failed to perform
`safe, reproducible lateral spinal surgery.
`1353. As discussed above (¶ 70-86), although a small handful of surgeons tried a
`minimally invasive approach to the spine through (or skirting around) the psoas, they failed to
`develop a safe and reproducible lateral spinal fusion surgery. It was not until XLIF was
`introduced (and NuVasive invested significant time and resources into clinically validating
`XLIF) that the average surgeon felt comfortable traversing the psoas to place an implant for
`spinal fusion.
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`1354. Moreover, even after NuVasive introduced its patented XLIF procedure, others
`tried and failed to create an equally safe and reproducible lateral surgery using other types of
`access equipment.
`1355. For example, as discussed in Section 19 above, several companies have
`developed lateral spinal fusion surgery platforms that are inferior to XLIF.
`1356. Another example is Alphatec itself. Prior to copying NuVasive’s patented
`technology, Alphatec attempted to create its own lateral product that did not copy XLIF called
`“GLIF.” NUVA_ATEC0288766-89 (Alphatec GLIF Portal Access System Guide Lumbar
`Interbody Fusion Surgical Technique Guide). It was a failure. See ¶¶ 1320-1323, supra.
`E. Copying
`1357. As shown in detail in paragraphs 120-1275 above (and in corresponding
`Exhibits A-G), Alphatec has essentially copied the patented inventions claimed in the asserted
`patents.
`1358. Moreover, based on my review of Alphatec’s R&D documents as well as the
`deposition transcript of Alphatec’s corporate representative, Scott Robinson, it is apparent that
`Alphatec specifically copied XLIF because its attempts to create a non-infringing access system
`failed.
`1359. For example, as discussed in Section 19 above, certain Alphatec research and
`development documents state that a two-bladed retractor was “generally not perceived as being
`very good,” see ATEC_LLIF000003810 (Market Need/Assessment Request dated April 17,
`2013), and Alphatec ultimately chose to develop the infringing three-bladed design. I further
`understand Alphatec’s decision to utilize the infringing three-bladed design was based on
`feedback from its design surgeons, including Dr. Payam Moazzaz and Dr. Mohammed
`Etminan, both of whom I understand were previous XLIF users and familiar with the patented
`features of XLIF. See Robinson Depo Tr. at 128:9-19, 191:10-24, 211:5-8, 257:1-6. Relatedly,
`I have reviewed a surgeon feedback form regarding the accused access system that appears to
`contain feedback from Dr. Moazzaz, including a suggestion to “copy NuVasive.”
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`from 2014. See ATEC_LLIF000186202, -206 (Protocol: Evaluation of Tyber Medical &
`In’Tech Medical Lateral Lumbar Interbody Fusion Systems). The In’Tech access system, like
`some other third-party lateral access systems discussed in Section 19 above, utilized a “Neural
`Monitoring Probe” that was inserted into the dilator in order to navigate through the psoas
`(rather than utilizing dilators equipped with directional electrodes, like the claimed dilators).
`Id. at -204-205. Within that document is what appears to be a surgeon survey of the access
`system, where the surgeon stated that the “Neural monitor popped through” the dilators while
`being inserted along the lateral, trans-psoas path to the lumbar spine. Id. at 219. In my
`opinion, this is one of the significant drawbacks of utilizing a neuromonitoring probe, rather
`than electrode equipped dilators, since the probe both is an inferior neuromonitoring
`mechanism and also poses heightened risk of injury to the patient. Accordingly, it is also not
`surprising to me that Alphatec ultimately did not use a neuromonitoring probe inserted into its
`dilators, but instead copied the patented dilators with their integrated electrodes (thus
`eliminating these significant problems). Relatedly, another Alphatec research and development
`document indicates Alphatec considered the “shallow docking” approach, but ultimately used
`neuromonitoring enabled dilators. See MOAZZAZ000066 (LLIF: Global Development Project
`Meeting) at 16. As discussed above, because this approach involves significantly heightened
`risk of neurological injury, it is not surprising to me that Alphatec instead chose to copy and
`thus infringe upon the patented dilators rather than using “shallow docking.”
`F. Teaching Away
`1362. As discussed in paragraphs 70-86 above, the prior art taught away from using
`any sort of access equipment to access the spine via a lateral approach. In fact, the prevailing
`wisdom against utilizing the lateral approach was so strong that before XLIF, surgeons instead
`chose to perform interbody fusion procedures (such as the ALIF and PLIF procedures
`discussed above) that had severe drawbacks relative to a lateral procedure, an d even after
`XLIF was introduced, NuVasive was met with severe skepticism that was not overcome until
`after NuVasive spent years clinically validating the procedure.
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`1363. For reasons discussed above, the Jacobson technique as discussed in the
`Friedman and Kanter articles teaches away from a lateral approach to the lumbar spine and
`evidences the long-felt need for XLIF, which enabled a safe, lateral, trans-psoas approach to
`the spine.
`1364. Regarding LETRA, even Dr. Pimenta, who was an extraordinarily skilled
`surgeon, was reporting neurological complications. These outcomes would have led a POSA to
`avoid a transpsoas lateral approach to the spine. Moreover, even if LETRA did suggest a
`lateral approach, it taught away from using a retractor (because Dr. Pimenta was using
`endoscopic tube). In fact, Dr. Pimenta himself told NuVasive that the endoscopic tubes used in
`his LETRA procedure “work well” and felt that developing a retractor-like instrument was
`simply “getting too complicated.” NUVA_ATEC0016231-40 (Jun 2002 SEN Minutes at 4).
`1365. Other surgeons confirmed the perceived inadvisability of the lateral approach as
`of the 2003 timeframe. For example, the well-known surgeon Hallet Matthews published an
`article in March 2003 (prior to the launch of XLIF later that year) explaining that “t]he lumbar
`plexus represents the most important structure in the psoas that could be injured, and the
`anatomic variations and locations of these structures have yet to be clearly defined” and that
`“[t]he lateral transpsoatic approach is thought by many to be the least invasive endoscopically
`at L4-L5 and above; however, surgeons have not felt comfortable with dissecting the psoas
`because of the presence of the lumbar plexus.” NUVANUVANUVA_ATEC0245709-14
`(Takatomo Moro, et al., An Anatomic Study of the Lumbar Plexus with Respect to
`Retroperitoneal Endoscopic Surgery, SPINE 28(5):423-428 (2003)).
`1366.
` As an additional example, I have been informed by counsel that Dr. Theodor
`Obenchain submitted a declaration in an inter partes review proceeding. In that declaration,
`Dr. Obenchain further confirmed the common wisdom at the time advising against using the
`lateral, trans-psoas approach:
`“My view, which was consistent with the common wisdom among spine surgeons
`at that time, discouraged or ‘taught away’ from traversing the psoas muscle in an
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`approach to the spine. Had someone told me that they were planning to go
`through the main part of the psoas in an approach to the spine, I would have
`strongly advised them against such an action, likening it to traversing the murky
`waters of an alligator-infested swamp, i.e., taking on an unnecessarily blind risk
`when other acceptable approaches to the disc space existed.”
`NUVANUVANUVA_ATEC0247545-66 (Obenchain ’782 Declaration). Dr. Obenchain's
`testimony further supports my own view that the conventional wisdom at the time—that is,
`prior to NuVasive’s introduction of a lateral, trans-psoas procedure using nerve monitoring
`enabled tools—was to avoid the psoas altogether.
`G. Unexpected Results
`1367. Based on the state of the prior art, it was unexpected that any lateral approach
`would work, let alone one that utilized a large, 3-bladed retractor (in light of the fact that
`endoscopic surgeries – which had a significantly narrower footprint – still resulted in a high
`level of complications).
`21.PUBLIC INTEREST
`1368.
`It is my opinion that the public would not be disserved should the Court grant
`NuVasive’s request to preclude Alphatec from offering its Accused Products. As I have set
`forth in detail throughout this report, Alphatec’s Accused Products incorporate each of the key
`features and details of NuVasive’s patented XLIF system, which I have been informed by
`counsel will still be readily available to hospitals and surgeons. Thus, because hospitals and
`surgeons will still be able to use XLIF, the effect of preventing sales of Alphatec’s Accused
`Products would not affect any patient’s ability to receive a safe, reproducible, and effective
`minimally invasive lateral spinal fusion surgery.
`1369. Additionally, I have reviewed the deposition transcript of Alphatec’s corporate
`representative, Mr. Scott Robinson, and note that he identified a number of features within
`Alphatec’s accused products that “had never been done before.” Robinson Depo Tr. at 223:5-
`226:13. As set forth in detail below, it is my opinion that the absence of any of these identified
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