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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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`MOTION FOR OBSERVATION REGARDING CROSS-EXAMINATION
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`OF RICHARD A. HYNES, M.D.
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`EXHIBITS
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`Ex. #
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`Exhibit Description
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`NUVA 2101 U.S. Patent No. 7,905,840 to Pimenta et al.
`NUVA 2102 Declaration in Support of the Pro Hac Vice Admission of Michael
`A. Amon; Declaration of Charles Forthaus (Not Filed)
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`NUVA 2103 Vetebral Spacer-PR Brochure (Not Filed)
`NUVA 2104 Forthaus Memo regarding Vertebral Spacer-PR Brochure (Not
`Filed)
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`NUVA 2105 myspinetools.com front page (Not Filed)
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`NUVA 2106 myspinetools.com Terms of Use (Not Filed)
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`NUVA 2107 Launch Binder (Not Filed)
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`NUVA 2108 Webpage Toad MySQL (Not Filed)
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`NUVA 2109 Reserved
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`NUVA 2010 U.S. Patent 8,512,408 (Hynes) (Not Filed)
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`NUVA 2011 Synthes SVS-PR Guide
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`NUVA 2012 Medtronic Sofamor Danek Boomerang brochure
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`NUVA 2013 Hynes Deposition Transcript
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`NUVA 2014 510(k) Summary Medtronic Sofamor Danek K122037
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`NUVA 2015 510(k) Summary Telamon® PEEK Spinal System K110562
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`NUVA 2016 Synthes Vertebral Spacer – AR Brochure
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`NUVA 2017 DePuy Spine Saber Surgical Technique Brochure
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`NUVA 2018 Declaration of Barton L. Sachs, M.D. in IPR2013-00206
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`Attorney Docket No: 13958-0116IP2
`NUVA 2019 Moro, et al., “An Anatomic Study of the Lumbar Plexus with
`Respect to Retroperitoneal Endoscopic Surgery”
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`NUVA 2020 Declaration of Dr. Hansen A. Yuan, M.D.
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`NUVA 2021 Curriculum Vitae of Dr. Hansen A. Yuan, M.D.
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`NUVA 2022 NuVasive - CoRoent XL Brochure
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`NUVA 2023 Redacted Engineering Drawings
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`NUVA 2024 Redacted Deposition of Steven DeRidder
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`NUVA 2025 Clydesdale® Spinal System Brochure
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`NUVA 2026 Clydesdale® Spinal System Images
`NUVA 2027 Medtronic Direct Lateral Interbody Fusion DLIF Surgical
`Technique Brochure
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`NUVA 2028 Medtronic DILF-Direct Lateral Interbody Fusion Brochure
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`NUVA 2029 Clydesdale® Spinal System Image
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`NUVA 2030 Declaration of Patrick Miles
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`NUVA 2031 Declaration of Theodore G. Obenchain, M.D.
`NUVA 2032 The Relationship between Cross Sectional Area and Strength of
`Back Muscles in Patients with Chronic Low Back Pain
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`NUVA 2033 Printout, U.S. News & World Report
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`NUVA 2034 Lumbar Vertebral Body Replacement
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`NUVA 2035 Lumbar – Minimally Invasive Approach (PLIF)
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`NUVA 2036 Mathews Deposition Transcript (non-confidential portion)
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`NUVA 2037 Second Hynes Deposition Transcript
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`NUVA 2038 Josse Deposition Transcript
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`NUVA 2039 Patent Owner’s Objection to Evidence Under 37 CFR §
`42.64(b)(1), dated 9/12/2014
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`NUVA 2040 Email from Michael A. Amon to Jeff E. Schwartz, dated 9/9/2014
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`NuVasive, Inc. (“Patent Owner”) submits this motion for observation regarding
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`cross-examination during the September 30, 2014 deposition of Richard A. Hynes,
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`a reply declarant of Medtronic, Inc. (“Petitioner”). Patent Owner submits the
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`following observations based on Dr. Hynes’ testimony.
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`Observation #1
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`In Ex. 2037, at 26:23-29:10 and 185:8-12, Dr. Hynes testified to his financial
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`relationship with Petitioner and in particular at 185:8-12 he testified that he may
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`have been paid $767,000 in a single twelve month period. That testimony is
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`relevant to ¶ 1 of Dr. Hynes’ first declaration where he claims to be an independent
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`expert because it is evidence that Dr. Hynes cannot be a truly independent,
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`unbiased expert on matters involving Medtronic as a party.
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`Observation #2
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`In Ex. 2037, at 176:24-177:11 and 178:2-6, Dr. Hynes testified that he knows Dr.
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`Hal Mathews and thinks highly of him. That testimony is relevant to the expertise
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`and credibility of Dr. Hansen Yuan, who provided expert testimony in Ex. 2020.
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`The testimony is relevant because of Dr. Mathews’ under oath testimony in Ex.
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`2036 (deposition transcript where Dr. Mathews was testifying on behalf of
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`Petitioner in a different proceeding) praising Dr. Yuan’s accomplishments and
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`5
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`Attorney Docket No: 13958-0116IP2
`reputation in the spine surgeon community, testimony that Dr. Hynes did not
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`disagree with. (See Observation # 3, below.)
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`Observation #3
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`In Ex. 2037, at 181:18-24, 182:11-22, 183:24-184:9, and 184:18-24, Dr. Hynes
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`considered and did not disagree with under oath testimony by Dr. Mathews from
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`Ex. 2036 praising Dr. Hansen Yuan as “one of the top 5 or 10 of all surgeons” and
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`“one of the grandfathers of modern day spine surgery.” That testimony is relevant
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`to the expertise and credibility of Dr. Yuan, who provided expert testimony in Ex.
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`2020. Dr. Matthews’ testimony is relevant because it is an unbiased,
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`contemporaneous opinion by one of Petitioner’s former employees that can help a
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`fact finder assess the credibility of Patent Owner’s expert, Dr. Yuan. Moreover, it
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`may help a fact finder make a determination regarding numerous subjects upon
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`which Dr. Yuan and Dr. Hynes present contradictory testimony.
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`Observation #4
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`In Ex. 2037, at 83:11-84:7, 84:16-85:23, 86:15-19, and 90:7-13, Dr. Hynes
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`testified regarding the description of a Vertebral Body Replacement by the
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`Hospital for Special Surgery in Ex. 2034, p. 1-3. That testimony is relevant to
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`Petitioner’s Reply argument, p. 2-3 and 7-8 regarding vertebral body replacements.
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`The testimony is relevant because the description of a Vertebral Body Replacement
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`in Ex. 2034 shows that the size of fusion implants disclosed in Michelson, SVS-
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`PR, and Telamon cannot possibly be used for a vertebral body replacement as
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`falsely implied in Petitioner’s Reply. The information in Ex. 2034 and Dr. Hynes’
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`testimony regarding the information provided by Ex. 2034 also comports and
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`confirms the testimony by Dr. Yuan regarding what one of skill in the art
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`considered a vertebral body replacement. See Yuan Deposition Transcript, Ex.
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`1173,1 at 273:20-279:7.
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`Observation #5
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`In Ex. 2037, at 86:20 to 87:8, Dr. Hynes testified that removing the corpus and the
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`disc above and below the corpus in the lumbar spine during a vertebral body
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`replacement leaves a space, on average, with a height of “[s]omewhere between 40
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`to 60 millimeters.” That testimony is relevant to Petitioner’s Reply argument, p. 2-
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`3 and 7-8 regarding vertebral body replacements. The testimony is relevant
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`because the 40-60 mm height of the void left during a vertebral body replacement
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`cannot be filled by the much shorter interbody fusion implants disclosed in
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`Michelson, SVS-PR, and Telamon as falsely implied in Petitioner’s Reply.
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`Observation #6
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`1 While Ex. 1173 includes only excerpts of the Yuan deposition transcript, the
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`parties have agreed and Petitioner will be filing the full Yuan Deposition
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`Transcript with the Board.
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`In Ex. 2037, at 87:9-88:7 and 91:9-11, Dr. Hynes agreed that the Hospital For
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`Special Surgery (Ex. 2035 at p. 1) and Dr. Yuan consider an interbody fusion to be
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`a procedure in which a degenerative disc between two adjacent vertebrae is
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`removed and the two adjacent vertebrae are fused. That testimony is relevant to
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`Petitioner’s argument, raised for the first time in Reply, at p. 2-3 and 7-8, that the
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`prior art cited in the institution of these IPR matters are vertebral body
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`replacements. Petitioner described the same prior art in the Petition as spinal
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`fusion or interbody fusion implants. See Petition at p. 8 ("The ‘156 patent is
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`directed to a spinal fusion implant"), p. 14 ("the SVS-PR Brochure…discloses a
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`spinal fusion implant"), 22 (same re Michelson), p. 30 (same re Frey and Baccelli),
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`and p. 38 (same re Telamon). This testimony is relevant to explain the difference
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`between a spinal or interbody fusion procedure and a vertebral body replacement –
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`showing that spinal or interbody fusion implants do not have sufficient height to be
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`used as vertebral body replacements, which Petitioner’s Reply incorrectly implies.
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`Observation #7
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`In Ex. 2037, at 77:22-78:5 and 78:14-24, Dr. Hynes testified regarding the U.S.
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`News & World Report rankings identifying the Hospital for Special Surgery as the
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`number 1 Orthopaedics Department in the United States in Ex. 2033. That
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`testimony is relevant to Ex. 2034 and 2035, which are documents from the
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`Hospital For Special Surgery explaining the difference between a vertebral body
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`replacement procedure and a spinal fusion or interbody fusion procedure. The
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`testimony is relevant because it shows the reliability of the Hospital For Spinal
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`Surgery documents in Ex. 2034 and 2035 discussed in Observations 4-6.
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`Observation #8
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`In Ex. 2037, at 94:14-95:6, 96:7-97:5, 98:21-99:1, and 100:16-24, Dr. Hynes
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`testified to a relative lack of expertise regarding FDA procedures and labeling
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`requirements. That testimony is relevant to Dr. Hynes’ testimony in his Second
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`Declaration (Ex. 1157) ¶¶ 6, 15, 19, 20, 24, and 39 where he purports to give
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`expert opinions regarding the effect of statements made during and as a result of
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`FDA procedures. The testimony is relevant because it shows that such matters are
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`beyond Dr. Hynes’ expertise, and it undermines his testimony and conclusions
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`regarding an FDA determination of substantial equivalence to vertebral body
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`replacement devices and the labeling of such on brochures. See The Johns Hopkins
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`University v. Datascope, 543 F.3d 1342, 1349 fn. 3 (Fed Cir. 2008) ("FDA
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`equivalence is irrelevant to patent law.").
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`Observation #9
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`In Ex. 2037, at 108:25-109:13, Dr. Hynes testified to his opinion that the Butterfly
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`implant in Ex. 1123 is an embodiment of the Michelson ‘973 patent, despite having
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`performed no element-by-element analysis for that determination. That testimony
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`is relevant to ¶¶ 12 and 15 of the Second Hynes Declaration where he refers to the
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`Butterfly implant as a “Michelson Butterfly” and a “Michelson-style implant[].”
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`The testimony is relevant because it shows that Dr. Hynes’ opinion that the
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`Butterfly implant is an embodiment of the Michelson ‘973 patent is conclusory and
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`unsupported by any evidence in the record.
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`Observation #10
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`In Ex. 2037, at 109:14-110:4, Dr. Hynes testified to being aware of the Butterfly
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`Fusion System in Ex. 1123 long before he drafted his first declaration but
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`acknowledged at 113:18-23 that the Butterfly Fusion System was not discussed in
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`his first declaration. That testimony is relevant to ¶¶ 12 and 15 of the Second
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`Hynes Declaration where he relies for the first time on the Butterfly Fusion system
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`as alleged prior art. The testimony is relevant because the Butterfly Fusion System
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`in Ex. 1123 was not filed with the initial petition, it is not part of the instituted
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`grounds, and Patent Owner has not had an opportunity to address this reference
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`and the associated allegations.
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`Observation #11
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`In Ex. 2037, at 115:9-24, Dr. Hynes testified to being aware of the BAK cages
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`identified in Ex. 1118 prior to drafting his first declaration but acknowledged at
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`115:13-24 that the BAK cages were not discussed in his first declaration. That
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`testimony is relevant to ¶¶ 8, 12, 15, 16, and 31 of the Second Hynes Declaration
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`where he for the first time relies on the BAK cages as alleged prior art. The
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`Attorney Docket No: 13958-0116IP2
`testimony is relevant because Ex. 1118 (or any other reference to the BAK
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`implant) was not filed with the initial petition, the BAK and any exhibits related to
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`BAK are not part of the instituted grounds, and Patent Owner has not had an
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`opportunity to address the BAK reference and the associated allegations.
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`Observation #12
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`In Ex. 2037, at 143:12-16, Dr. Hynes testified that he performed no element-by-
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`element analysis comparing the claims of Michelson ‘973 to the BAK cage. That
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`testimony is relevant to the Second Hynes Declaration, ¶ 16 where Dr. Hynes cites
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`Ex. 1159 and gives the opinion that “the BAK cage was an embodiment on an
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`implant commensurate with the claims of Michelson and created by a licensee of
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`Michelson.” The testimony is relevant because it shows that Dr. Hynes’ opinion is
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`conclusory and not supported by any evidence in the record..
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`Observation #13
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`In Ex. 2037, at 173:21-174:19, Dr. Hynes testified that Ex. 1118 was dated July
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`2014, was updated in July 2014, and that he did nothing to confirm whether the
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`sizes listed in Ex. 1118 were available prior to March 2004. That testimony is
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`relevant to the Second Hynes Declaration, ¶ 12, where Dr. Hynes improperly relies
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`on Ex. 1118 as evidence of prior art having a 2.5:1 length-to-width ratio. The
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`testimony is relevant because Ex. 1118 is not authenticated as a document existing
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`prior to March 2004 and there is no testimony by any witness that BAK cages with
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`the dimensions in Ex. 1118 existed prior to March 2004 publicly or otherwise.
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`Observation #14
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`In Ex. 2037, at 175:19-176:1, Dr. Hynes testified Ex. 1118 lists only the “minor
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`diameter” of the BAK cages which is the “inside diameter” and testified at 176:5-
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`23 that Ex. 1118 does not disclose the outer diameter of the BAK cages. That
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`testimony is relevant to the Second Hynes Declaration, ¶ 12, where Dr. Hynes
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`improperly relies on Ex. 1118 as evidence of prior art having a 2.5:1 length-to-
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`width ratio which he referred to as “this claimed length-to-width proportion.” The
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`testimony is relevant because claim 1 of the ‘334 patent requires that the
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`“longitudinal length is at least two and a half times greater than said maximum
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`lateral width” (emphasis added). Dr. Hynes’ admission during deposition is
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`relevant because it undermines Dr. Hynes’ opinion that the BAK cages listed in
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`Ex. 1118 teach the 2.5:1 length-to-width ratio claimed by the ’334 patent
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`Observation #15
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`In Ex. 2037, at 146:10-147:3, Dr. Hynes testified that the implant described in Ex.
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`1117 is not an SVS-PR implant, a Telamon implant, or a Frey boomerang-style
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`implant, and that this study was performed using pig cadavers. That testimony is
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`relevant to the Second Hynes Declaration ¶ 19 where Dr. Hynes relies on Ex. 1117
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`for the proposition that implants can be inserted in different directions. The
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`12
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`testimony shows that the procedures described in Ex. 1117 have little relevance as
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`to what procedures can be performed with the very different SVS-PR, Telamon,
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`and Frey boomerang-style implants, and what procedures can be performed on live
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`human patients (vs. pig cadavers).
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`Observation #16
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`In Ex. 2037, at 147:22-24, Dr. Hynes testified that there is no evidence that the
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`MectaLIF brochure in Appendix H to Ex. 1157 was available prior to March 2004
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`and at 152:20-24 testified that Ex. 1132 is also not evidence of what a person of
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`skill would have known prior to March 2004. That testimony is relevant to ¶ 5 of
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`the Second Hynes Declaration that relies on Appendix H and Ex. 1132. The
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`testimony is relevant because these are two of a number of exhibits relied upon by
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`Dr. Hynes even though they disclose implants and/or procedures that were not
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`known prior to March 2004.
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`Observation #17
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`In Ex. 2037, at 154:3-16 and 155:12-156:3, Dr. Hynes testified that he considered
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`motor vehicles regulations to be evidence of what would have been obvious to a
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`person of skill in the art in designing spinal implants in 2004, yet at 153:15-18 he
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`testified that he was not aware of 49 CFR 571.108, at 156:4-14 he testified that he
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`does not know if the code section was in effect in 2004. That testimony is relevant
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`to ¶ 21 of the Second Hynes Declaration relying for the first time in these IPR
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`proceedings on motor vehicle regulations to show what would have been obvious
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`for fusion implants. The testimony is relevant because Dr. Hynes never cites any
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`evidence in his First Declaration (Ex. 1101) or any other evidence in his Second
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`Declaration for why an implant designer would have been motivated to include
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`two radiopaque markers in the medial plane of an elongated implant. This vehicle
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`C.F.R. code section argument was raised for the first time in Reply. The fact that
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`Dr. Hynes considers vehicle regulations to be probative undermines his opinion
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`that the claimed marker positioning was known to implant designers.
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`Observation #18
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`In Ex. 2037, at 159:8-17, Dr. Hynes testified that he does not know when he first
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`conceived of the idea that the addition of two markers along the medial plane
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`would inform the surgeon of the implant being askew or whether he knew it before
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`his first declaration. That testimony is relevant to the end of ¶ 21 of the Second
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`Hynes Declaration where Dr. Hynes proposes this argument for the first time. The
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`testimony is relevant because adding new arguments for reasons to combine claim
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`elements after the Petition creates a moving target that prejudices Patent Owner’s
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`ability to address such arguments. Moreover, this is not a credible argument
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`without any evidence that it was known to a person skilled in the art prior to March
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`2004.
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`Observation #19
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`In Ex. 2037, at 157:16-19 and 157:22-158:7, Dr. Hynes testified that the medial
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`markers added to the drawing provided after ¶ 21 of the Second Hynes Declaration
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`are not actually needed to determine whether the implant is askew. That testimony
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`is relevant to the argument in ¶ 21 of the Second Hynes Declaration that “the
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`addition of a second marker along the medial plane of the implant would inform
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`the surgeon as to whether the implant was askew after insertion in the disc space.”
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`The testimony undermines Dr. Hynes’ alleged reason to combine, raised for the
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`first time in his Second Declaration.
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`Observation #20
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`In Ex. 2037, at 148:24-151:24, Dr. Hynes testified that he considers the implant on
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`the sixth page of Ex. 1132 to include a marker in the medial plane as the term is
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`used in claim 1 of the ‘156 patent. That testimony is relevant to Dr. Hynes
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`opinions regarding where it would have been obvious to place markers in a given
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`implant, such as the testimony in ¶¶ 9-10 of the Second Hynes Declaration and ¶
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`68 of the First Hynes Declaration. The testimony shows that Dr. Hynes does not
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`have a clear understanding of certain patent terms, including “medial plane”. This
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`undermines Dr. Hynes’ opinions regarding whether one skilled in the art would
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`have found it obvious to add markers to the medial plane of the SVS-PR or
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`Telamon implants.
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`Observation #21
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`15
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`In Ex. 2037, at 119:11-17, 119:22-120:8, 124:8-14, 125:6-18, 128:14-129:11,
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`134:12-21, 135:2-5, and 137:4-20, Dr. Hynes testified regarding an x-ray image at
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`Appendix K to the Second Hynes Declaration, and that the x-ray image shows an
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`old threaded metal cylindrical cage implant at the L4-5 level and a newer
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`Medtronic Clydesdale PEEK implant with multiple radiopaque markers at the L3-4
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`level. That testimony is relevant to ¶ 15 of the Second Hynes Declaration where
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`Dr. Hynes discusses Appendix K. The testimony shows that Dr. Hynes failed to
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`identify and describe both implants in Appendix K and one might have otherwise
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`not noticed the second, Clydesdale implant. Moreover, Appendix K shows the
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`novel differences between the prior art and the inventions of the ‘156 patent.
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`Observation #22
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`In Ex. 2037, at 130:9-18, 130:23-131:2, 131:19-132:7, 132:12-15, 133:9-15, 138:2-
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`12, and 139:14-23, Dr. Hynes testified that Appendix K does not confirm the date
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`of insertion of the cylindrical metal cage implant, that he did not attach the
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`patient’s medical report, that he does not know who inserted the cylindrical cage
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`implant, that he does not know the name of the patient, and that he was unable to
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`obtain the operative report for that procedure. That testimony is relevant to ¶ 15 of
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`the Second Hynes Declaration where Dr. Hynes alleges that the cylindrical cage
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`was inserted in 2001. The testimony undermines Dr. Hynes testimony and opinion
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`that the cylindrical cage implant in Appendix K was in fact inserted into a patient
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`in 2001.
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`Observation #23
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`In Ex. 2037, at 62:23-64:2, Dr. Hynes acknowledges that Dr. Obenchain, the
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`named inventor of U.S. Patent No. 5,313,962 attached as Appendix C to the
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`Second Hynes Declaration, previously testified that the psoas muscle was avoided
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`like an alligator-infested swamp. That testimony is relevant to ¶ 4 of the Second
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`Hynes Declaration where Dr. Hynes cites Dr. Obenchain’s patent for the
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`proposition that transpsoas techniques were well known. The testimony shows that
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`Dr. Hynes’ testimony that the transpsoas approach to the lumbar spine was
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`routinely done is incorrect, especially given that Dr. Obenchain’s patent is the only
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`reference Dr. Hynes cites that even references a transpsoas approach.
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`Respectfully submitted,
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`
` /Stuart A. Nelson/
`Stuart A. Nelson
`Reg. No. 63,947
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`Date: 10/6/2014
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`Customer Number 26171
`Fish & Richardson P.C.
`Telephone: (612) 337-2508
`Facsimile: (612) 288-9696
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.6(e)(4)(iii), the undersigned
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`certifies that on October 6, 2014, a complete and entire copy of this Motion for
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`Observation Regarding Cross-Examination of Richard A. Hynes, M.D. was
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`provided via email to the Petitioner by serving the email correspondence address of
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`record as follows:
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`Jeff E. Schwartz
`Seth A. Kramer
`Fox Rothschild LLP
`1030 15th Street, NW
`Washington, DC 20005
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`Email: jeschwartz@foxrothschild.com
`Email: skramer@foxrothschild.com
`Email: ipdocket@foxrothschild.com
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` /Diana Bradley/
`Diana Bradley
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
` (858) 678-5667
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