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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`MOTION FOR OBSERVATION REGARDING CROSS-EXAMINATION
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`OF RICHARD A. HYNES, M.D.
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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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`i
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`Case IPR2013-00506
`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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`ii
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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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`iii
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`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 agreed that “over a 12-
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`month period ending in June 2013, Medtronic paid you and your L.L.C. $767,000
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`for designing new products, training and other services.” That testimony is
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`relevant because at ¶ 1 of Dr. Hynes’ first declaration, he testifies he is an
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`independent expert.
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`Observation #2
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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 the following statements: “If we were to write
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`it up today, Dr. Yuan would be one of the top 5 or 10 of all surgeons” and “Dr.
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`Yuan is pretty much one of the grandfathers of modern day spine surgery.” That
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`testimony is relevant to the credibility of Dr. Yuan.
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`Observation #3
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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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`1
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`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 suitable sizes for vertebral body replacements.
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`Observation #4
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`In Ex. 2037, at 87:9-88:7 and 90:19-91:15, Dr. Hynes “agree[d] with Dr. Yuan that
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`the interbody fusion is to induce bone growth between two adjacent vertebra[l]
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`bodies.” That testimony is relevant when comparing Petitioner’s argument in
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`Reply, at p. 2-3 and 7-8 that the prior art cited in the institution of these IPR
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`matters are vertebral body replacements with Petitioner’s argument in the Petition
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`describing the same prior art as spinal fusion or interbody fusion implants. See
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`Petition at p. 8 ("The ‘156 patent is directed to a spinal fusion implant"), p. 14 ("the
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`SVS-PR Brochure…discloses a spinal fusion implant"), 22 (same re Michelson), p.
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`30 (same re Frey and Baccelli), and p. 38 (same re Telamon).
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`Observation #5
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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 “I don’t know the exact difference” between “a Class 2 and a Class 3
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`medical device under FDA regulations,” “I don’t know for a fact” whether “both of
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`those require a 510(k) approval,” “I don’t know the definition of the term”
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`substantial equivalence, “That's going beyond my expertise” regarding “what is
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`required to get approval from the FDA to use a Class 3 medical device,” and “I
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`really don't know what was required in 2004” regarding “if companies are
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`required to state what FDA approval they have obtained for spinal implants, such
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`as the Saber, on brochures.” That testimony is relevant because at ¶¶ 6, 15, 19, 20,
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`24, and 39 of Dr. Hynes’ Second Declaration (Ex. 1157), he purports to give expert
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`opinions regarding the effect of statements made during and as a result of FDA
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`procedures.
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`Observation #6
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`In Ex. 2037, at 108:25-109:13, Dr. Hynes testified that it is his “opinion that the
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`Butterfly Fusion System is an embodiment of the Michelson '973 patent” but that
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`he did not “do an element-by-element analysis comparing the Butterfly Fusion
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`System to the claims of the '973.” That testimony is relevant because at ¶¶ 12 and
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`15 of the Second Hynes Declaration, he refers to the Butterfly implant as a
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`“Michelson Butterfly” and a “Michelson-style implant[].”
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`Observation #7
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`In Ex. 2037, at 109:14-110:4, Dr. Hynes testified that he was “aware of the
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`Butterfly Fusion System implant when [he] drafted [his] first declaration in these
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`IPRs” but acknowledged at 113:18-23 that the “Butterfly Fusion System” did not
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`appear in his first declaration. That testimony is relevant because at ¶¶ 12 and 15
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`3
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`of the Second Hynes Declaration, he relies on the Butterfly Fusion system as
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`alleged prior art.
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`Observation #8
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`In Ex. 2037, at 115:9-24, Dr. Hynes testified that he “knew about the BAK-cage
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`prior to being involved in these IPR proceedings” but acknowledged at 115:13-24
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`that the BAK cages “do not appear anywhere in that discussion” of Michelson in
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`his first declaration. That testimony is relevant because at ¶¶ 8, 12, 15, 16, and 31
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`of the Second Hynes Declaration, he relies on the BAK cages as alleged prior art.
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`Observation #9
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`In Ex. 2037, at 143:12-16, Dr. Hynes testified that he did not “do an element-by-
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`element analysis comparing the claims of the Michelson '973 patent to the BAK
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`cage.” That testimony is relevant because at ¶ 16 of the Second Hynes
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`Declaration, he 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.”
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`Observation #10
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`In Ex. 2037, at 173:21-174:19, Dr. Hynes testified regarding Ex. 1118, stating that
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`he did not “personally pull this document down from the FDA Web site,” that
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`“Exhibit 1118 has a print date in the lower right-hand corner of July 31st, 2014,”
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`that it has a “Page last updated" date of “July 28, 2014,” and that he did not “do
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`anything to independently verify that the sizes of implants disclosed in Exhibit
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`1118 were -- were, in fact, available prior to March 2004.” That testimony is
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`relevant because at ¶ 12 of the Second Hynes Declaration, he relies on Ex. 1118 as
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`evidence that implants having a 2.5:1 length-to-width ratio were available prior to
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`March 2004.
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`Observation #11
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`In Ex. 2037, at 175:19-176:1, Dr. Hynes testified regarding the dimensions in Ex.
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`1118, stating:
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`Q. Okay. Do you know what the minor diameter refers to in these
`implants?
`A. I know what minor diameter is.
`Q. Well, what is minor diameter?
`A. It's the inside, inside diameter of the screws, the shaft. The outer
`diameter is the thread. So it's probably the body, and the thread would
`be the outer diameter.
`Q. And -- and would the outer diameter be major diameter? Is that
`another way to describe it?
`A. That's fair.
`Q. Okay. The sizes listed here don't disclose the outer diameter,
`correct?
`A. That's correct.
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`5
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`That testimony is relevant because at ¶12 of the Second Hynes Declaration, he
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`relies on Ex. 1118 as evidence that implants having a 2.5:1 length-to-width ratio
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`were available prior to March 2004.
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`Observation #12
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`In Ex. 2037, at 146:10-147:3, Dr. Hynes testified that the study described in Ex.
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`1117 “did not involve the use of an SVSPR-style implant,” “didn't involve the use
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`of a Telamon implant,” and “didn't involve the use of a Frey boomerang-style
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`implant.” That testimony is relevant because at ¶19 of the Second Hynes
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`Declaration, he relies on Ex. 1117 for the proposition that the SVS-PR implant
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`could be inserted in different directions.
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`Observation #13
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`In Ex. 2037, at 147:22-24, Dr. Hynes testified regarding the MectaLIF brochure in
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`Appendix H to Ex. 1157 and agreed that “there is no indication that this document
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`was available before March of 2004” and at 152:20-24 testified regarding Ex. 1132
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`and agreed that “the document itself, given the fact that it's got a 2013, that's not
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`evidence of what a person of skill would have known prior to March 2004.” That
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`testimony is relevant because at ¶ 5 of the Second Hynes Declaration, he relied on
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`Appendix H and Ex. 1132 to allegedly show what one of skill in the art would have
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`known before March 2004.
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`Observation #14
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`In Ex. 2037, at 154:3-16 and 155:12-156:3, Dr. Hynes testified regarding vehicle
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`regulations, and that he did “consider these vehicle regulations to be evidence of
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`what would have been obvious when designing implants in 2004” even though at
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`153:15-18 he testified that he was not “aware of 49 CFR 571.108 prior to preparing
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`and reviewing that code section for [his] second declaration” and at 156:4-14 he
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`testified that he did not know “know if that code section was in effect in 2004.”
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`That testimony is relevant because at ¶ 21 of the Second Hynes Declaration, he
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`relied on motor vehicle regulations to show what would have been obvious for
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`fusion implants prior to March 2004.
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`Observation #15
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`In Ex. 2037, at 157:16-19 and 157:22-158:7, Dr. Hynes testified regarding the
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`medial markers added to the drawing provided after ¶ 21 of the Second Hynes
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`Declaration as follows:
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`Q. All right. If the markers that you've identified being in the middle
`weren't there, could you determine whether the implant was askew by
`viewing that implant from the top of the image or the bottom of the
`image?
`MR. SCHWARTZ: Objection to form.
`THE WITNESS: Probably.
`That testimony is relevant because at ¶ 21 of the Second Hynes Declaration, he
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`testified that the addition of a second marker along the medial plane of the implant
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`Attorney Docket No: 13958-0116IP2
`was required to “inform the surgeon as to whether the implant was askew after
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`insertion in the disc space.”
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`Observation #16
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`In Ex. 2037, at 148:24-151:24, Dr. Hynes testified regarding the implant on the
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`sixth page of Ex. 1132 as follows:
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`Q. Well, that was my question: Is -- as the [‘156] patent describes it,
`does it show any markers in the medial plain?
`A. Yes.
`That testimony is relevant because it shows Dr. Hynes’ misunderstanding of the
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`‘156 patent’s “medial marker” requirement. It is also relevant to Dr. Hynes’
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`opinions at ¶¶ 9-10 of the Second Hynes Declaration and ¶ 68 of the First Hynes
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`Declaration.
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`Observation #17
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`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 that the x-ray image at
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`Appendix K to the Second Hynes Declaration shows “the L4-5 level, which has the
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`appearance of a long cylinder cage, is threaded, and it has apertures throughout the
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`-- the cage” and shows an “implant at L3-4 [that] is PEEK and it has multiple
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`markers in it” by Medtronic called the “Clydesdale” implant. That testimony is
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`relevant to ¶ 15 of the Second Hynes Declaration where Dr. Hynes discusses
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`Appendix K as evidence of prior art implants.
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`8
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`Observation #18
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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 regarding Appendix K that “I don't believe
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`the image tells us what date the operation was done,” that he is not “the surgeon
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`who operated and inserted the cage that is reflected in Appendix K,” that he “did
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`not attach the patient's medical report regarding the prior surgery,” that he did not
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`“do anything to confirm that that cage was actually inserted in 2001” except to “try
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`to get the op report” which he had “not been able to obtain.” That testimony is
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`relevant because at ¶ 15 of the Second Hynes Declaration, he asserts that the
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`cylindrical cage in the x-ray in Appendix K was inserted in 2001.
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`Respectfully submitted,
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` /Stuart A. Nelson/
`Stuart A. Nelson
`Reg. No. 63,947
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`9
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`Date: 10/16/2014
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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 42.205(b), the undersigned certifies
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`that on October 16, 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 correspondence email address of
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`record as follows:
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`Jeff E. Schwartz
`Fox Rothschild LLP
`1030 15th Street, NW
`Washington, DC 20005
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`Seth A. Kramer
`Fox Rothschild LLP
`2000 Market Street, 20th Floor
`Philadelphia, PA 19103
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`Email: jeschwartz@foxrothschild.com
`Email: skramer@foxrothschild.com
`Email: ipdocket@foxrothschild.com
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`/Diana Bradley/
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`Diana Bradley
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(858) 678-5667
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`10
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