UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC.
`Petitioner
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`v.
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`NUVASIVE, INC.
`Patent Owner
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`
`Case IPR2013-00506
`Patent 8,361,156
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`
`
`
`SECOND DECLARATION OF RICHARD A. HYNES, M.D.
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`---------------------------------------
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`---------------------------------------
`
`MEDTRONIC, INC.
`Petitioner
`
`v.
`
`NUVASIVE, INC.
`Patent Owner
`---------------------------------------
`
`Case IPR2013-00506
`Patent 8,361,156
`---------------------------------------
`
`
`
`SECOND DECLARATION OF RICHARD A. HYNES, M.D.
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`I.
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`INTRODUCTION
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`1.
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`On August 14, 2013, I provided a first Declaration in this matter. See
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`Declaration of Richard A. Hynes, M.D. (Exhibit MSD 1101). This Second
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`Declaration is in rebuttal to statements made in NuVasive, Inc.’s (“NuVasive” or
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`“Patent Owner”) Response (the “Response”) (Paper No. 21) and the accompanying
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`Declaration of Hansen A. Yuan, M.D. (the “Yuan Declaration”) (Exhibit Nuvasive
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`2022) filed on May 22, 2014. In this Second Declaration, I will address some of
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`the errors set forth in the Response and the Yuan Declaration. To the extent that I
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`do not address a certain portion of the Yuan Declaration does not mean that I agree
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`with that portion. Instead, I have limited my comments to what I believe are the
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`most pertinent and egregious errors stated by Dr. Yuan.
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`2.
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`In preparing this declaration, I have reviewed the following
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`documents:
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`a. NuVasive’s Preliminary Response (Paper No. 8);
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`b. NuVasive’s Patent Owner Response (Paper No. 21);
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`c. Declaration of Hansen A. Yuan, M.D. (Exhibit 2020);
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`d. Exhibits 2011, 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019,
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`2021, 2022, 2023, 2024, 2025, 2026, 2027, 2028, 2029, and 2030.
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`e. Transcript of the Deposition of Dr. Hansen A. Yuan (Exhibit MSD
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`1173)
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`ACTIVE 26481542v5 09/05/2014
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`
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`3. I have also reviewed additional references cited in this Declaration.
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`II. REBUTTAL OF DR. YUAN’S TESTIMONY REGARDING
`BACKGROUND
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`4.
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`In ¶ 26 of the Yuan Declaration, Dr. Yuan states that “[h]istorically,
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`ordinary surgeons before 2004 avoided approaching the lumbar spine from the
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`lateral, transpsoas approach because of the fear of neurologic injury associated
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`with penetrating the psoas muscle.” This is incorrect as, prior to 2004, surgeons,
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`such as myself, were not concerned with nor avoided the transpsoas approach, but
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`rather performed surgeries on a regular basis using this approach. In fact, because
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`the lateral transpsoas approach is considered an anterior approach by the North
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`American Spine Society and within the field in general, surgeons have been
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`utilizing transpsoas techniques at least since introduced by Meuler in 1906 when
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`performing a retroperitoneal anterior approach. See NASS Memorandum Re:
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`Lateral Interbody Fusion (XLIF, DLIF) of the Lumbar Spine, dated January 5,
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`2010 (a true and correct copy of which is attached hereto as Appendix A); Rick C.
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`Sasso et al., Anterior Lumbar Fusion, Chapter 10 of “Surgical Management of
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`Low Back Pain”, 2d Edition (2008) (a true and correct copy of which is attached
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`hereto as Appendix B) at 87; U.S. Patent No. 5,313,962 (attached hereto as
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`Appendix C) at 6:1-58; LJ O’Hara and RW Marshall, Far Lateral Lumbar Disc
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`Herniation. The Key to the Intertransverse Approach, 79(6) J. Bone Joint Surg. Br.
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`
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`3
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`
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`943, 943-47 (1997) (a true and correct copy of which is attached hereto as
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`Appendix D); Ex. 1153. During his deposition, even Dr. Yuan testified that he had
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`been performing surgeries using the transpsoas approach for the last 30 years. See
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`Yuan Deposition, at 110-111. Accordingly, contrary to Dr. Yuan’s statement,
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`lateral transpsoas approaches are not a recent development, but instead are just
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`similar to other anterior approaches that surgeons have been doing for quite some
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`time (and prior to 2004).
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`5.
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`In ¶ 35 of the Yuan Declaration, Dr. Yuan states that “[t]he maximum
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`possible length for an implant that is inserted from either the front or the back of
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`the patient is limited to the depth of the vertebrae, measured from the anterior to
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`posterior end of the vertebrae.” At the relevant time, this statement is incorrect
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`because it overlooks the common occurrence, and prior art teachings, and very real
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`possibility of inserting the implant at an angle (when beginning in the front or back
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`of the patient). The maximum length of the implant depends on the starting point
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`and the angle at which the surgeon inserts the implant, and the tools the surgeon
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`uses in doing so. The maximum length that can be accommodated safely is dictated
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`by the side-to-side (or “transverse”) width of the vertebrae and the diagonal depth.
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`In fact, Dr. Yuan’s own article, in which an X-ray image shows an implant inserted
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`obliquely, demonstrates that his noted statement is not true, because the length of
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`the implant is plainly not limited by the depth of the vertebrae. See Ex. 1117 at 3.
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`4
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`
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`Simple geometry dictates that the hypotenuse of the right triangle formed by the
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`transverse width and depth is longer than the depth. Further, Dr. Yuan admitted
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`his error during his deposition when he admitted that implants greater than 40 mm
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`would fit in the disc space if inserted at an angle from the back. See Yuan
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`Deposition at 245:9-16. Indeed I regularly perform oblique procedures, on average
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`5 or 6 per week over the last three to five years. Recently, I have been performing
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`these procedures using the OLIF procedure as depicted in the brochure (attached
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`hereto as Appendix E) and have taught at least 50 other surgeons how to perform
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`this procedure. This is a completely safe procedure. Oblique procedures like the
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`OLIF have been performed since the late 1990s and allow the use of a longer
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`implant, such as with the Medtronic Clydesdale, which is accused of infringing the
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`‘156 patent claims. This oblique approach allows the use of a longer and wider
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`implant and such larger implants are often preferred, especially considering that
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`those of ordinary skill in the art have known since at least 2003 that a single long
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`implant inserted obliquely may be preferable to a pair of shorter parallel implants
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`inserted posteriorly. See Shih-Tien Wang et al., Comparison of Stabilities between
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`Obliquely and Conventionally Inserted Bagby and Kuslich Cages as Posterior
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`Lumbar Interbody Fusion in a Cadaver Model, 66 J. CHIN. MED. ASSOC. 676, 676-
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`681 (2003) (filed with the Reply as Ex. 1136) (concluding that obliquely inserted
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`implant is preferable to pair of posteriorly inserted implants, and as it provides
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`5
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`
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`same stability while requiring less exposure, enabling precise implantation, and
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`costing less); see also U.S. Patent No.
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`6,626,905 (attached hereto as Appendix F) at
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`9:32-39; Jie Zhao et al., Posterior Lumbar
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`Interbody Fusion Using One Diagonal Cage
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`With Transpedicular Screw/Rod Fixation, 12
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`EUR. SPINE J. 173, 175-77 (2003) (a true and
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`correct copy of which is attached hereto as Appendix G). I, along with many other
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`surgeons, also routinely approach the spine anterior to the psoas at the L4/L5 level
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`using this and other MIS approaches. Numerous long spinal fusion implants that
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`are inserted using this oblique technique are commercially available, including
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`Medacta’s MectaLIF oblique intervertebral body fusion device. These MectaLIF
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`oblique implants are offered at lengths up to 40 mm. See Medacta MectaLIF
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`Brochure (a true and correct copy of which is attached hereto as Appendix H) at 6,
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`18. Such oblique procedures are also very popular overseas, including, for
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`example, in Japan, because no neuromonitoring is involved. I also note that
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`NuVasive promotes a similar approach with its MAS TLIF device and approach
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`and the implant, as mentioned in the associated patent, was at least considered in
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`sizes up to 45 mm. See NuVasive Maximum Access Surgery Tranforaminal
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`Lumbar Interbody Fusion Booklet (filed with the Reply as Ex. 1132); U.S. Patent
`
`6
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`
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`
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`
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`No. 8,623,088 (filed with the Reply as Ex. 1131), at 5:32-35. Similarly, NuVasive
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`has admitted that its CoRoent XL can be used in TLIF and Posterior Lateral
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`Approaches. See Excerpt of Transcript of Deposition of Patrick Miles, taken
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`November 8, 2010 (filed with the Reply as Ex. 1172), at 85:1 to 86:25.
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`6.
`
`In ¶ 39 of the Yuan Declaration, Dr. Yuan states that
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`the Telamon implant referenced in the Telamon literature cited by
`Petitioner and Dr. Hynes was designed to be used as a posterior or
`PLIF implant. That is, the implant was designed to be inserted from
`the posterior (or back) side of the patient in a posterior-anterior
`direction. This is confirmed by the surgical technique guide for the
`Telamon that shows the implant being inserted in a direct posterior-
`anterior direction via a PLIF procedure.
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`While the surgical technique guide cited by Dr. Yuan shows the Telamon implant
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`being used in this manner, in my experience, the implant is not limited to a direct
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`PLIF approach. In fact, the Telamon implant was initially approved as part of the
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`Vertestack system, as indicated on the Telamon Brochure. See Telamon Brochure
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`(Exhibit MSD 1107), at 1. The Vertestack System Brochure, submitted in this
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`proceeding as Exhibit MSD 1120, as well as the 510k approval for the Vertestack
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`System issued by the FDA, submitted in this proceeding as MSD 1134, sets out
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`that the components of the Vertestack System can be inserted by anterior, oblique,
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`or lateral approaches. See Ex. 1120, at 8, 11. Accordingly, one of ordinary skill in
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`the art who had experience implanting the components of the Vertestack system
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`would have known that not only could the Telamon Vertestack Vertebral Body
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`
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`7
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`
`
`
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`Spacer be inserted by anterior, oblique, or lateral approaches, but also that the use
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`of such insertion techniques would have been proper and safe according to the
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`FDA. Moreover, surgeons are entitled to perform surgeries off label (in a manner
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`other than or in addition to those approved for marketing by the FDA) that the
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`surgeon determines to be safe for their patients and would be motivated to do so in
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`the appropriate situations.
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`7.
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`In ¶ 40 of the Yuan Declaration, Dr. Yuan states that “small changes
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`in design . . . can have significant impacts on the functionality of the implant as
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`used by the surgeon and the clinical benefits of the implant to the patient
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`population.” This is an over exaggeration of the effect that certain small changes
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`to an implant may have, especially when those changes are explicitly taught in the
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`prior art, yield predictable and expected results, and involve nothing more than the
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`application of common sense to obtain entirely predictable results. Small
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`dimensional changes, such as those proposed in my first declaration, will not affect
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`or change the function of the implant as the implant will still fit in the patient and
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`will still promote fusion of the vertebrae and create stability in the disc space of the
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`patient. Accordingly, the proposed changes do not create a problem and Dr. Yuan
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`has not presented anything to substantiate his contrary opinion that goes against
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`common sense and routine skill and understanding of a person of skill in this field
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`of endeavor.
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`
`
`8
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`
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`8.
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`In ¶ 41 of the Yuan Declaration, Dr. Yuan states that
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`[s]pinal interbody fusion implants have to be designed to support the
`heavy loads placed on the spine, to help align the spine and alleviate
`pain caused by misalignment, to prevent ejection from the disc space
`after insertion, and to promote fusion of the two adjacent vertebrae.
`While it is generally true that interbody fusion implant designers try to
`design implants with large surface areas, i.e., large footprints, the size
`of such implants remain limited by the above-described anatomical
`limitations and the original intended use (for example, the original
`intended use of Telamon as a PLIF implant). The large surface area
`of the implant can provide greater structural support and restoring
`proper spacing between the vertebrae. It is critically important that
`interbody fusion implants can be inserted along the intended insertion
`path, can be positioned in the disc space, support the intended load,
`stay in place after insertion, align the spine, and allow fusion of the
`vertebrae.
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`Dr. Yuan’s opinion regarding the size of an implant being limited by its supposed
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`“original intended use,” and his opinion that it is “critically important that
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`interbody fusion implants can be inserted along the intended insertion path,” is
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`without logical support and in fact is inconsistent with my knowledge and routine
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`experiences. As Dr. Yuan and I agree, the goal of interbody fusion “is to induce
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`bone growth between two vertebrae into a single bony bridge.” See Yuan
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`Declaration at ¶ 31. Accordingly, the intended purpose of any spinal fusion
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`implant is to achieve this goal, and while proper positioning of the implant in the
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`disc space is important, surgeons of ordinary skill in the art knew that there existed
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`multiple insertion paths for a single type of implant, and that the use of one
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`particular path over another was dependent upon the patient’s anatomy, and the
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`
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`9
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`
`
`
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`specific physiological problem being addressed. Indeed, Dr. Yuan’s experience
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`shows that one implant, the Spine Tech BAK, although originally designed for
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`PLIF or ALIF use was easily modified by elongation to be used by him in the
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`angled/oblique approaches and laterally. Similarly, the NuVasive Triad implant
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`was promoted for use laterally, posteriorly, and in postero-lateral procedures. See
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`NuVasive XLIF 90 Surgical Technique Brochure (filed with the Reply as Ex.
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`1175); Malberg M., Extreme Lateral Interbody Fusion (XLIF), in Regan J,
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`Lieberman I, eds. Atlas of Minimal Access Surgery, 2nd ed. St Louis: Quality
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`Medical Publishing, 2004 (filed with the Reply as Ex. 1176); TLIF Surgical
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`Technique Brochure (filed with the Reply as Ex. 1177); First Amendment to
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`Agreement 550002080 By and Between the County of Santa Clara and NuVasive,
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`Inc., dated October 25, 2011 (filed with the Reply as Ex. 1178), at 3. NuVasive
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`has also indicated its CoRoent XL can be used posteriorly, anteriorly, and as a
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`TLIF. See Ex. 1172, at 85:1 to 86:25.
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`9.
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`In ¶ 45 of the Yuan Declaration, Dr. Yuan tries to take my deposition
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`testimony out of context in stating that “[t]he complication with using markers, as
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`identified by Dr. Hynes, is that the implant can have too many of them.” It is
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`important to note that the number of markers (four) in the proposed modified
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`implants would not be too many. In particular, the placement of two markers
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`along the medial plane of an implant is an obvious modification particularly when
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`10
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`
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`the implant is made longer, because the markers provide additional information on
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`the location and orientation of the implant that can assist the surgeon in properly
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`positioning the larger implant. As Dr. Yuan testified, such placement of the
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`markers would lead to the predictable result of being able to see the markers in an
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`X-ray image of the implant. See Yuan Deposition at 319:8 to 320:6.
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`10.
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`In ¶ 46 of the Yuan Declaration, Dr. Yuan states that “the strategic
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`placement of radiopaque markers is essential to making radiolucent implants safe
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`and effective for use in the human spine.” There is no reason to think that the
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`proposed addition of two markers would impact the safety or effectiveness of the
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`implant, nor did I ever say so in my declaration or deposition testimony. In fact,
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`Baccelli discloses the placement of the two markers along the medial plane. The
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`addition of a marker along the medial plane of the implant is merely an obvious
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`variant if one needs or otherwise wants to know where the middle of the implant is
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`located and/or how the implant is oriented during or after the implant is placed in
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`the disc space. By having two markers along the medial plane, the surgeon is able
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`to tell if the implant has been inserted at an angle. Additionally, Dr. Yuan’s
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`statement is not true because it is not essential for some uses to have these markers,
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`for example when used in scoliosis or other deformity applications or when no
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`lamina is present or the vertebrae are otherwise misaligned and therefore cannot
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`reliably be compared to the location of the markers. The markers are merely an
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`11
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`
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`option that may be nice to have, are sometimes helpful, and that a person of skill in
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`the art would include when wanting the information they provide.
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`11.
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`In ¶ 47 of the Yuan Declaration, Dr. Yuan states that “[t]he claims of
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`the ‘156 patent are directed to a combination of features for spinal interbody fusion
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`implants particularly suited for insertion in a lateral, transpsoas surgical approach
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`to the spine.” Dr. Yuan omits that the specification of the ‘156 patent states that
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`implant may also “be introduced in a variety of approaches, such as posterior,
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`anterior, antero-lateral, and postero-lateral . . . .” ‘156 patent, at 5:31-33. In fact,
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`Dr. Yuan later admitted that he now understands that the claims of the ‘156 patent
`
`do not require that implant to be inserted using a transpsoas approach. See Yuan
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`Deposition at 94:17 to 97:13.
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`12. Additionally in ¶ 47 of the Yuan Declaration , Dr. Yuan incorrectly
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`states “that the ‘156 patent presents novel dimensions and length-to-width
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`proportions for implants that are greater than 40mm in length . . . .” With the
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`assumption that Dr. Yuan was referring to the claimed length to width ratio of
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`2.5:1 as the “novel” length to width proportion, spinal implants greater than 40 mm
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`in length and having this claimed length-to-width proportion have been known
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`since at least 1997 as shown in BAK PMA Supplemental Decision (filed as Ex.
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`1118 with the Reply) (a Michelson disclosed implant), which lists approved spinal
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`fusion implants having length-to-width dimensions of 44 mm x 15 mm and 44 mm
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`12
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`
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`x 17 mm. See Ex. 1118. Additionally, the Michelson Butterfly was offered in that
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`same size ratio of 2.5:1. See Exs. 1116 and 1123 filed with Reply.
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`13.
`
`In ¶ 48 of the Yuan Declaration, Dr. Yuan states that “[p]rior to
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`March 29, 2004, the vast majority, if not all, commercially available spinal
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`implants on the market were designed for insertion into the disc space in posterior
`
`or anterior approach, not a lateral approach.” This statement is misleading. Prior
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`to March 29, 2004, many implants could be inserted by an anterior or lateral
`
`approach. Indeed, as explained by NASS, a lateral approach is merely a variant of
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`an anterior approach and is coded the same for purposes of reimbursement. See
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`NASS Memorandum dated January 5, 2010, entitled “Re: Lateral Interbody Fusion
`
`(XLIF, DLIF) of the Lumbar Spine” (Exhibit MSD 1119); NuVasive 2014
`
`Reimbursement Guide (a true and correct copy of which is attached hereto as
`
`Appendix I), at 3.
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`14.
`
`In ¶ 49 of the Yuan Declaration, Dr. Yuan states that “the direct
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`lateral approach to the lumbar spine presents complications because of the
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`presence of the psoas muscle.” This statement is misleading because a direct
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`lateral approach to the spine is not particularly complicated in comparison to other
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`types of approaches, and surgeons trained to perform anterior surgeries, such as
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`myself, should generally feel comfortable using such a lateral approach as of the
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`time of this invention. This approach was often used to treat tuberculosis or other
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`13
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`
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`spinal infection, tumors, or scoliosis, in conjunction with direct visualization as the
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`nerves that a surgeon needs to avoid using this approach are clearly visible. See
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`e.g.,Yuan Dep. at 109:20 to 111:1. Additionally, there was no need to perform a
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`lateral surgery by going through the transpsoas muscle, as it was well known to be
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`safe and effective to retract the psoas muscle when using a lateral approach prior to
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`2004, including in the lower lumbar region. See, e.g., Paul C. McAfee et al.,
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`Minimally Invasive Anterior Retroperitoneal Approach to the Lumbar Spine, 23
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`SPINE 1476, 1478 (1998) (a true and correct copy of which is attached hereto as
`
`Appendix J).
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`15.
`
`In ¶ 50 of the Yuan Declaration, Dr. Yuan states that he
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`would find it surprising if someone had used one of Dr. Michelson’s
`illustrated implants to attempt a fusion on a live human patient
`because, in my opinion, the lumbar implants described by Dr.
`Michelson . . . were not useful and would have been readily
`recognized in March 2004 as being unnecessarily risky for use in a
`live human patient based on the surgical techniques practiced at the
`time.
`
`This is an unexpected and uninformed opinion considering that Medtronic had
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`commercialized a Michelson ‘973 implant that was inserted using a lateral
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`technique as early as 2001. As one example, Medtronic’s Butterfly Fusion System,
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`first made available in 2001 utilized a variety of Michelson-style implants, with
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`widths ranging from 14 to 16 mm, and lengths ranging from 30 to 40 mm. See
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`Butterfly Fusion System Surgical Guide (Ex. 1123), at 2, 19. Additionally, long
`
`14
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`
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`BAK cages were commercialized well before 2004 and were approved by the
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`FDA. Presumably the FDA, along with the surgeons who used these Michelson
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`implants, did not think they were unnecessarily risky. Additionally, Dr. Yuan
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`testified that it was reasonable given the level of knowledge in the late 1990s for
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`him and Dr. McAfee to use such implants on living patients on at least two
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`occasions. Yuan Dep. at 60:13 to 61:2. Further, I have personally treated a patient
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`with a long lateral implant that was originally inserted in 2001. Attached hereto as
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`Appendix K is a true and correct copy of an X-ray image of this patient.
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`16.
`
`In ¶ 51 of the Yuan Declaration, Dr. Yuan states he “perform[ed] a
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`handful of lateral fusion procedures using the BAK cage,” but that “those
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`procedures were performed using a retracted psoas approach to the spine,” “the
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`implants were not commercially available,” and the “results were not what we
`
`hoped for.” To provide context to this statement, it is important to note that the
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`BAK cage was an embodiment of an implant commensurate with the claims of
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`Michelson and created by a licensee of Michelson. See Sulzer Spine-Tech 2000
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`Price List (filed with the Reply as Ex. 1159). Additionally, whether true or not, the
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`assertions that these procedures were performed with a retracted psoas and that the
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`implants were not commercially available, and whether the results were not what
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`Dr. Yuan hoped for, are immaterial. What is important is that Dr. Yuan has
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`admitted that such lateral procedures were being performed prior to 2004 with
`
`15
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`
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`implants that were historically inserted using an anterior or posterior approach and
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`that when motivated to do so he and others obtained customized elongated PLIFs
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`or ALIFs or used longer versions of those implants for lateral or angled
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`approaches. See Yuan Dep. at 42:17 to 50:18; id at 62:14-19. Dr. Yuan also
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`admitted that at the time, in the late 1990s, it was reasonable and believed to be
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`safe by those reviewing the procedure, for him to proceed with implanting these
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`devices in human patients using this approach. See Yuan Deposition at 60:13 to
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`61:2.
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`17.
`
`In ¶ 60 of the Yuan Declaration, Dr. Yuan states that “having two
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`radiopaque markers also allows a surgeon to see . . . whether the implant is askew
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`and the degree to which the implant is askew. These uses were not disclosed in the
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`cited prior art references.” This is an incorrect statement as the cited prior art
`
`reference Baccelli discloses the use of markers in this manner. See Baccelli at
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`FIG. 2. Moreover, these markers provide an entirely predictable and expected
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`result, as Dr. Yuan also admitted in his deposition. Yuan Dep. at 319:8 to 320:6.
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`There is nothing new or nonobvious about using markers in the middle of the
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`implant.
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`18.
`
`In ¶ 63 of the Yuan Declaration, Dr. Yuan notes that “the CoRoent
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`XL spinal fusion implants are available with a longitudinal length greater than
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`40mm (e.g., 45mm, 50mm, and 55mm) extending from a proximal end of the
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`16
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`
`
`
`
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`proximal wall to a distal end of the distal wall.” Dr. Yuan, however, fails to note
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`that 25% of the CoRoent XL spinal fusion implant sizes that have been offered by
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`NuVasive have a longitudinal length of only 40 mm, and because these implants
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`have lateral width of 18 mm, the implants have a length-to-width ration of 2.2 to 1.
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`These facts contradict Dr. Yuan’s earlier statement that the claimed longitudinal
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`length of greater than 40 mm and length-to-width ratio of 2.5 to 1 are necessary to
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`allow the implant to be inserted using a lateral, tranpsoas approach.
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`II. REBUTTAL OF DR. YUAN’S TESTIMONY REGARDING THE
`PRIOR ART RELIED ON BY THE PTAB FOR INSTITUTING IPR
`
`19.
`
`In ¶ 79 of the Yuan Declaration, Dr. Yuan states that “the SVS-PR
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`was designed to be an interbody spacer that is inserted using a PLIF (posterior)
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`procedure in a direct posterior-anterior direction in the disc space,” and that “a
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`person of ordinary skill in the art would have recognized this fact.” This is an
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`incorrect and misleading statement based on a significant underestimation of the
`
`skill level of those of ordinary skill in the art and ignoring the description on the
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`brochure and its relationship to the FDA clearance of this product. One of ordinary
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`skill in the art, depending on the patient and the physiological condition to be
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`corrected, would have known that besides being inserted in a “direct anterior-
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`posterior direction in the disc space,” the implant could also be inserted at an angle
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`or laterally if desired. In fact, this angled approach was the technique utilized and
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`17
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`described in a journal article authored by Dr. Yuan. See Ex. 1117, at 1-6.
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`Additionally, I also note that this implant was originally cleared by the FDA as a
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`vertebral body replacement device, which, as Dr. Yuan noted, can also be put in
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`anteriorly, laterally, or obliquely just like the CoRoent XL, which was also cleared
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`as a vertebral body replacement device. See Yuan Dep. at 154:1-7; CoRoent 510k
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`(Ex. 1143); Synthes Vertebral Spacer 510k (Ex. 1146); Miles Dep. Transcript 2010
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`(Ex. 1172), at 75:1-76:26; id. at 81:1 to 82:25; id. at 85:1 to 86:25. Further, as
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`previously mentioned, surgeons are entitled to perform surgeries off label (in a
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`manner other than or in addition to those approved for marketing by the FDA) that
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`the surgeon determines to be safe for their patients and would be motivated to do
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`so in the appropriate situations.
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`20.
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`In ¶ 80 of the Yuan Declaration, Dr. Yuan states “a person of ordinary
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`skill in the art would have recognized that the SVS-PR implant was intended for a
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`PLIF procedure for final placement in a direct anterior posterior direction by the
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`dimensions in which the SVS-PR was available.” Again, as stated above, this is
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`incorrect because one of ordinary skill in the art would have understood at the time
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`of invention that the SVS-PR could be used not just as a PLIF, but also as an ALIF
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`or laterally, as it was explicitly promoted in the brochure and as indicated by its
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`FDA approval.
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`18
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`21.
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`In ¶ 81 of the Yuan Declaration, Dr. Yuan states that “the pair of
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`markers at the posterior and distal walls [of the SVS-PR] would provide surgeons
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`with all of the requisite orientation and positioning information for a PLIF
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`procedure.” This statement is incorrect. The noted markers alone do not provide
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`all of the requisite information a surgeon may desire. For example, the inclusion
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`of marker along the medial plane of the implant allows the surgeon to accurately
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`track the positioning of the implant as it inserted into the patient. In this way, the
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`middle marker may be analogized to the light found at the center of a long vehicle,
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`such as a stretch limousine, to indicate the presence of a long vehicle. See e.g., 49
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`C.F.R. 571.108 at Table I-A - Required Lamps and Reflective Devices (requiring
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`placement of intermediate side marker lamps “on each side [of a vehicle over 30
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`feet] located at or near the midpoint between the front and rear side marker
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`lamps”); Trucks, Buses, MPVs: Federal Lighting Equipment Location
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`Requirements,
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`http://www.nhtsa.gov/Vehicle+Safety/Other+Equipment/Trucks,+Buses,+MPVs:+
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`Federal+Lighting+Equipment+Location+Requirements (last visited Sept. 2, 2014)
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`(noting “functional purpose” of intermediate side marker lamps on vehicles 30 feet
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`or longer is to “indicate presence of a long vehicle.”).
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`19
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`This is an especially apt comparison as it comports with NuVasive comparing its
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`large CoRoent implants with stretch limousines. See NuVasive Press Release re:
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`60 mm CoRoent XL Implants (a true and correct copy of which is attached hereto
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`as Appendix L).
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`20
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`
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`Further, as depicted below, the addition of a second marker along the medial plane
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`of the implant would inform the surgeon as to whether the implant was askew after
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`insertion in the disc space.
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`22.
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`In ¶ 82 of the Yuan Declaration, Dr. Yuan states that as proof of the
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`SVS-PR’s use as a PLIF only “[t]here are no instrument sets listed [in the SVS-PR
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`Size and Instrument Set Brochure] for an anterior approach, let alone for a lateral
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`approach.” This fact is irrelevant, as it does exclude implantation of the SVS-PR
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`using a different technique, such as an anterior, lateral or oblique technique.
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`23.
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`In ¶ 85 of the Yuan Declaration, Dr. Yuan states that the “length and
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`width dimensions are far smaller than what would be normally required for a
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`21
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`lateral, trans-psoas implant in the lumbar spine, and the width is much smaller than
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`typical anterior insertion lumbar implants.” This is irrelevant because there is no
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`requirement in the claims of the ‘156 patent that the claimed implant be inserted
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`using a lateral trans-psoas (or any other type of) approach and no reason why you
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`could not apply the teachings of this reference to implants you might use or that are
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`usable for such an approach. This statement also ignores the explicit disclosure on
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`this brochure that it is also a vertebral replacement device, and like the similarly
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`sized NuVasive Triad, could be inserted in various approaches including laterally
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`and anteriorly. See Telamon Brochure (Ex. 1107), at 1; NuVasive XLIF 90
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`Surgical Technique Brochure; Malberg M., Extreme Lateral Interbody Fusion
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`(XLIF), in Regan J, Lieberman I, eds. Atlas of Minimal Access Surgery, 2nd ed. St
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`Louis: Quality Medical Publishing, 2004; TLIF Surgical Technique Brochure; First
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`Amendment to Agreement 550002080 By and Between the County of Santa Clara
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`and NuVasive, Inc., dated October 25, 2011, at 3; Deposition Transcript of Patrick
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`Miles, taken September 4, 2014 (filed in Reply as Ex. 1174), at 121-124].
`
`24.
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`In ¶ 85 of the Yuan Declaration, Dr. Yuan also states that
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`the Telamon implants are designed with a 3° lordosis sloped
`downwardly in the direction of the trailing end that mates with the
`inserter tool, thereby further indicating to a person of ordinary skill I
`the art that the Telamon implant should be inserted in a posterior path.
`If a Telamon implant were inserted laterally across the vertebrae, it
`would create a scoliotic deformity in the patient due to the sloped
`surface.
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`22
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`This statement is based on a substantial underestimation of the skill and knowledge
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`of one of ordinary skill in the art. The proposed modification to the Telamon, as
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`well as the SVS-PR, is to make the implant longer, thereby increasing its stability.
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`One of ordinary skill in the art would have found it obvious to adjust the slope of
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`the implant in the proper direction depending on how the modified implant was
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`inserted. One of the functions of these types of implants is to restore the height of
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`disc space. Therefore, one of ordinary skill in the art would have understood that
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`if, for example, the implant was to be inserted using a lateral approach, one would
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`simply change the relationship of the opposing side walls to make one side wall
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`taller than the other, as was well known and common at the time of invention.
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`Indeed, PLIF implants are rarely actually inserted straight. Rather they are
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`typically inserted at a
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