`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC
`Petitioner
`
`v.
`
`TROY R. NORRED, M.D.
`Patent Owner
`______________________
`
`Case IPR2014-00395
`Patent 6,482,228
`______________________
`
`PATENT OWNER’S CURRENT EXHIBIT LIST
`PURSUANT TO 37 C.F.R. § 42.63(e)
`
`
`
`
`
`
`
`
`
`
`
`Exhibit Description
`
`110
`
`111
`
`395
`
`Ex. No.
`
`Ex. No.
`
`Ex. No.
`
`University Hospital & Clinics Physicians
`
`2001
`
`2101
`
`2201
`
`Progress Notes with Sketch of Heart Valve
`
`Sketch of Heart Valve
`
`2002
`
`2102
`
`2202
`
`Sketch of Heart Valve notarized in Seminole
`
`2003
`
`2103
`
`2203
`
`County, Oklahoma
`
`Letter – Troy Norred to Dr. Davis re:
`
`2004
`
`2104
`
`2204
`
`Percutaneous Aortic Valve
`
`Sketch of Heart Valve
`
`2005
`
`2105
`
`2205
`
`Letter – Darla Hess, MD to Dr. Troy Norred
`
`2006
`
`2106
`
`2206
`
`re: performance on echo rotation
`
`Document Order of Journals with sketches
`
`2007
`
`2107
`
`2207
`
`Sketch
`
`2008
`
`2108
`
`2208
`
`Sketch of Heart Valve
`
`2009
`
`2109
`
`2209
`
`Percutaneous Aortic Valve Replacement –
`
`2010
`
`2110
`
`2210
`
`Description of Invention with sketches and
`
`computer renderings
`
`
`
`
`
`-2-
`
`
`
`
`
`Citations and Abstracts regarding reference
`
`2011
`
`2111
`
`2211
`
`materials with sketches
`
`Pages from Journal Article and sketches
`
`2012
`
`2112
`
`2212
`
`Letter – Troy Norred to Greg Flaker, MD re:
`
`2013
`
`2113
`
`2213
`
`percutaneous aortic valve
`
`Note from Troy Norred to Jim Kernell re:
`
`2014
`
`2114
`
`2214
`
`Patent Material & Sketch
`
`Citation and Abstract for Porcine Heart Valve
`
`2015
`
`2115
`
`2215
`
`Article
`
`Letter – James Kernell to Dr. Troy Norred re:
`
`2016
`
`2116
`
`2216
`
`Application for Patent
`
`Fax – Dr. Troy Norred to Chip Galaxy re:
`
`2017
`
`2117
`
`2217
`
`Mutual Confidentiality Agreement with
`
`Sketches
`
`Memry Contact Information with notes and
`
`2018
`
`2118
`
`2218
`
`sketches
`
`Notes re: Aorta Modeling for Heart Valve
`
`2019
`
`2119
`
`2219
`
`Invoice from Vivitro Systems, Inc.
`
`2020
`
`2120
`
`2220
`
`Packing Slip – NDC to Troy Norred
`
`2021
`
`2121
`
`2221
`
`-3-
`
`
`
`
`
`Invoice – Shape Memory Applications to Troy
`
`2022
`
`2122
`
`2222
`
`Norred
`
`Packing Slip – Shape Memory Applications to
`
`2023
`
`2123
`
`2223
`
`Troy Norred
`
`Packing Slip – NDC to Troy Norred
`
`2024
`
`2124
`
`2224
`
`Experiment Information
`
`2025
`
`2125
`
`2225
`
`Equilasrs Contact Information
`
`2026
`
`2126
`
`2226
`
`Information from Equilasers website
`
`2027
`
`2127
`
`2227
`
`Packing Slip – NDC to Troy Norred
`
`2028
`
`2128
`
`2228
`
`Letter – James Kernell to Dr. Troy Norred re:
`
`2029
`
`2129
`
`2229
`
`Application for Patent
`
`U.S. Patent 6,482,228
`
`2030
`
`2130
`
`2230
`
`BETAPACE AF Dosing Algorithm for in-
`
`2031
`
`2131
`
`2231
`
`hospital initiation with sketches
`
`Citations and Abstracts regarding reference
`
`2032
`
`2132
`
`2232
`
`materials
`
`Contact Information for Ken Evans, Dave
`
`2033
`
`2133
`
`2233
`
`Rarison, Mike Griffin, Thomas Stilwell, Ed
`
`Treacy
`
`-4-
`
`
`
`
`
`Contact Information for Wayne Applegate,
`
`2034
`
`2134
`
`2234
`
`Bob Stanton, J. Choi
`
`Letter – Troy Norred to Greg Flaker, MD re:
`
`2035
`
`2135
`
`2235
`
`percutaneous aortic valve
`
`Outline of Description of Invention Document
`
`2036
`
`2136
`
`2236
`
`Percutaneous Aortic Valve Proposal/Protocol
`
`2037
`
`2137
`
`2237
`
`Percutaneous Aortic Valve Proposal/Protocol
`
`2038
`
`2138
`
`2238
`
`with Notes
`
`Percutaneous Aortic Valve Proposal/Protocol
`
`2039
`
`2139
`
`2239
`
`with Notes
`
`Percutaneous Aortic Valve Replacement –
`
`2040
`
`2140
`
`2240
`
`Anatomy, Dynamics & Physics
`
`Percutaneous Aortic Valve Replacement –
`
`2041
`
`2141
`
`2241
`
`Description of Invention
`
`Percutaneous Aortic Valve Replacement –
`
`2042
`
`2142
`
`2242
`
`Description of Invention
`
`Percutaneous Aortic Valve Replacement –
`
`2043
`
`2143
`
`2243
`
`Description of Invention
`
`
`
`
`
`-5-
`
`
`
`
`
`Percutaneous Aortic Valve Replacement –
`
`2044
`
`2144
`
`2244
`
`Description of Invention
`
`Percutaneous Aortic Valve Replacement –
`
`2045
`
`2145
`
`2245
`
`Description of Invention
`
`Percutaneous Aortic Valve Replacement –
`
`2046
`
`2146
`
`2246
`
`Description of Invention
`
`Percutaneous Aortic Valve Replacement –
`
`2047
`
`2147
`
`2247
`
`Description of Invention
`
`Percutaneous Aortic Valve Replacement –
`
`2048
`
`2148
`
`2248
`
`Description of Invention
`
`Percutaneous Aortic Valve Replacement –
`
`2049
`
`2149
`
`2249
`
`Description of Invention
`
`Percutaneous Aortic Valve Replacement –
`
`2050
`
`2150
`
`2250
`
`Description of Invention
`
`Percutaneous Aortic Valve Replacement –
`
`2051
`
`2151
`
`2251
`
`Description of Invention
`
`Percutaneous Aortic Valve Replacement –
`
`2052
`
`2152
`
`2252
`
`Summary
`
`
`
`
`
`-6-
`
`
`
`
`
`Percutaneous Aortic Valve Replacement –
`
`2053
`
`2153
`
`2253
`
`Summary & Notes
`
`Photo with Sketch
`
`2054
`
`2154
`
`2254
`
`Sketch regarding valve
`
`2055
`
`2155
`
`2255
`
`Sketch regarding valve construction
`
`2056
`
`2156
`
`2256
`
`Sketch
`
`2057
`
`2157
`
`2257
`
`Sketch regarding valve construction
`
`2058
`
`2158
`
`2258
`
`Sketch regarding valve with measurements
`
`2059
`
`2159
`
`2259
`
`Sketch regarding valve
`
`2060
`
`2160
`
`2260
`
`Sketch
`
`2061
`
`2161
`
`2261
`
`Sketch regarding valve construction
`
`2062
`
`2162
`
`2262
`
`Sketch regarding valve
`
`2063
`
`2163
`
`2263
`
`Sketch regarding valve
`
`2064
`
`2164
`
`2264
`
`Sketch regarding valve with calculations
`
`2065
`
`2165
`
`2265
`
`Sketch regarding valve
`
`2066
`
`2166
`
`2266
`
`Sketch regarding valve and flow
`
`2067
`
`2167
`
`2267
`
`Sketch regarding valve and placement
`
`2068
`
`2168
`
`2268
`
`Sketch regarding details of valve
`
`2069
`
`2169
`
`2269
`
`Color rendering of inserted valve
`
`2070
`
`2170
`
`2270
`
`-7-
`
`
`
`
`
`Blue pen sketch of ring view of valve
`
`2071
`
`2171
`
`2271
`
`Blue pen sketch of ring view of valve
`
`2072
`
`2172
`
`2272
`
`Red pen sketch of side view of valve
`
`2073
`
`2173
`
`2273
`
`Red pen sketch of side view of valve
`
`2074
`
`2174
`
`2274
`
`Red pen sketch of side view of valve
`
`2075
`
`2175
`
`2275
`
`Red pen sketch of ring view of valve
`
`2076
`
`2176
`
`2276
`
`Various telephone numbers and contacts
`
`2077
`
`2177
`
`2277
`
`Various telephone numbers and contacts
`
`2078
`
`2178
`
`2278
`
`Various telephone numbers and contacts
`
`2079
`
`2179
`
`2279
`
`U.S. Pub. No. 2011/0251675
`
`2080
`
`2181
`
`2281
`
`U.S. Pub. No. 2011/0172765
`
`2081
`
`2182
`
`2282
`
`Norred notes from Dr. Richard Davis phone
`
`2082
`
`2183
`
`2284
`
`call
`
`Letter dated February 7, 2013 from David L.
`
`N/A
`
`N/A
`
`2283
`
`Marcus to Nicholas Mathews
`
`Dr. Greg Flaker letter to Norred regarding
`
`2083
`
`2184
`
`2285
`
`meeting
`
`Dr. Stephen J. Lombardo initial draft of
`
`2084
`
`2185
`
`2286
`
`equation
`
`-8-
`
`
`
`
`
`Final version of Norred’s proposal
`
`2085
`
`2186
`
`2287
`
`Boston Scientific meeting documents
`
`2086
`
`2187
`
`2288
`
`Boston Scientific meeting documents
`
`2087
`
`2188
`
`2289
`
`Andersen HR, “History of Percutaneous
`
`2088
`
`2189
`
`2290
`
`Aortic Valve Prosthesis”, Herz 2009; 34:343-
`
`6
`
`J. Butany and M.J. Collins, “Analysis of
`
`2089
`
`2180
`
`2280
`
`prosthetic cardiac devices: a guide for the
`
`practicing pathologist”, J. Clin. Pathol. 2005
`
`58: 113-124
`
`Thrubikar, Mano. (1990). “The Aortic Valve”.
`
`2090
`
`2190
`
`2291
`
`Florida: CRC Press. (Pages 191-203).
`
`Depictions of device from CD
`
`2091
`
`2191
`
`2292
`
`Dr. Carl T. Rutledge Curriculum Vitae
`
`2092
`
`2192
`
`2298
`
`Declaration of Troy R. Norred, M.D.
`
`2093
`
`2193
`
`2293
`
`Declaration of James J. Kernell
`
`2094
`
`2194
`
`2294
`
`Declaration of Timothy T. Catchings, M.D.
`
`2095
`
`2195
`
`2295
`
`Declaration of Dr. Stephen J. Lombardo
`
`2096
`
`2196
`
`2296
`
`Declaration of Dr. Carl T. Rutledge
`
`2097
`
`2197
`
`2297
`
`-9-
`
`
`
`
`
`U.S. Patent 6,440,164 – DiMatteo et al
`
`N/A
`
`2198
`
`2325
`
`U.S. Patent 6,454,799 – Schreck
`
`2098
`
`N/A
`
`2299
`
`U.S. Patent 5,957,949 – Leonhardt et al
`
`2099
`
`2199
`
`
`
`U.S. Patent 3,755,823 – Hancock
`
`2100
`
`2200
`
`2300
`
`U.S. Patent 3,548,417 – R.G. Kischer
`
`N/A
`
`2201
`
`2302
`
`U.S. Patent 4,084,268 – Ionescu et al
`
`2101
`
`2202
`
`2303
`
`U.S. Patent 4,477,930 – Totten et al
`
`2102
`
`2203
`
`2304
`
`U.S. Patent 4,506,394 – Bedard
`
`2103
`
`2204
`
`2305
`
`U.S. Patent 5,163,953 – Vince
`
`2104
`
`2205
`
`2306
`
`U.S. Patent 5,549,665 – Vesely et al
`
`2105
`
`2206
`
`2307
`
`U.S. Patent 5,928,281 – Huynh et al
`
`2106
`
`2207
`
`2309
`
`U.S. Patent 5,935,163 – Gabbay
`
`2107
`
`2208
`
`2310
`
`U.S. Patent 6,264,691 – Gabbay
`
`2108
`
`2209
`
`2311
`
`U.S. Patent 6,338,740 – Carpentier
`
`2109
`
`2210
`
`2312
`
`U.S. Patent 6,350,282 – Eberhardt
`
`2110
`
`2211
`
`2313
`
`U.S. Patent Application Publication
`
`2111
`
`2212
`
`2314
`
`2001/0002445 – Vesely
`
`U.S. Patent 4,030,142 – Wolfe
`
`N/A
`
`2213
`
`2315
`
`U.S. Patent 3,657,744 – Ersek
`
`2112
`
`N/A
`
`N/A
`
`-10-
`
`
`
`
`
`U.S. Patent 6,059,827 – Fenton, Jr.
`
`2113
`
`2214
`
`2316
`
`U.S. Patent 6,139,575 – Shu et al
`
`2114
`
`N/A
`
`2317
`
`U.S. Patent 5,397,351 – Pavenik et al
`
`2115
`
`2215
`
`2318
`
`U.S. Patent 5,411,552 – Andersen et al
`
`2116
`
`2216
`
`N/A
`
`U.S. Patent 5,554,185 – Block et al
`
`2117
`
`2217
`
`2319
`
`U.S. Patent 5,824,064 – Taheri
`
`2118
`
`2218
`
`2320
`
`U.S. Patent 5,855,597 – Jayaraman
`
`2119
`
`2219
`
`N/A
`
`U.S. Patent 5,855,601 – Bessler et al
`
`2120
`
`2220
`
`2321
`
`European Patent Application EP 1 088 529
`
`2121
`
`2221
`
`2322
`
`A2
`
`U.S. Patent 6,299,637 – Shaolian et al
`
`N/A
`
`2222
`
`2323
`
`U.S. Patent 6,425,916 – Garrison et al
`
`2122
`
`N/A
`
`2324
`
`U.S. Patent 6,458,153 – Bailey et al
`
`2123
`
`2223
`
`2340
`
`German Patent – Markus Ferrari
`
`2124
`
`N/A
`
`N/A
`
`Spiegel Article – “A Foldable, Artificial Heart
`
`2125
`
`N/A
`
`2326
`
`Valve”
`
`U.S. Patent 5,716,417 – Girard et al
`
`N/A
`
`2224
`
`2308
`
`
`
`
`
`-11-
`
`
`
`
`
`“Failure of Hancock Preicardial Xenografts: Is
`
`N/A
`
`2225
`
`2301
`
`Prophylactic Bioprosthetic Replacement
`
`Justified?” by Uberto Bortolotti, MD et al
`
`German Patent – Fraunhofer
`
`2126
`
`2239
`
`2327
`
`Illustration of Schreck valve
`
`2129
`
`2240
`
`2328
`
`Illustration of Schreck valve
`
`2130
`
`2241
`
`2329
`
`Illustration of Schreck valve
`
`2131
`
`2242
`
`2330
`
`Illustration of DiMatteo valve
`
`2132
`
`2243
`
`2331
`
`Illustration of DiMatteo valve
`
`2133
`
`2244
`
`2332
`
`Illustration of DiMatteo valve
`
`2134
`
`2245
`
`2333
`
`Illustration of Bailey valve
`
`2136
`
`2246
`
`2334
`
`Illustration of Bailey valve
`
`2137
`
`2247
`
`2335
`
`Illustration of malalignment of Leaflets
`
`2138
`
`2248
`
`2336
`
`Illustration of Leonhardt valve
`
`2139
`
`2249
`
`2337
`
`Illustration of Leonhardt valve
`
`2140
`
`2250
`
`2338
`
`Illustration of Leonhardt valve
`
`2141
`
`2251
`
`2339
`
`Article “Anatomy of the aortic root:
`
`2224
`
`2237
`
`2341
`
`Implications for valve-sparing surgery” by
`
`Charitos and Sievers
`
`-12-
`
`
`
`
`
`Excerpt from book “Heart Valves From
`
`2225
`
`2238
`
`2342
`
`Design to Clinical Implantation”
`
`Excerpts from book “The Aortic Valve” by
`
`2226
`
`2226
`
`2343
`
`Mano Thubrikar
`
`Medtronic Press Release “Medtronic
`
`2227
`
`2227
`
`2344
`
`CoreValve System Obtains Early FDA
`
`Approval on Exceptional Clinical
`
`Performance”
`
`CoreValve US Important Safety Information
`
`2228
`
`2228
`
`2345
`
`U.S. Patent 8,323,336 – Hill
`
`2229
`
`2229
`
`2346
`
`Photo – Aortic Valve
`
`2230
`
`2230
`
`2347
`
`Photo – Aortic Valve with cusps and annulus
`
`2231
`
`2231
`
`2348
`
`Printout from University of Minnesota
`
`2232
`
`2232
`
`2349
`
`website of mitral and aortic valves
`
`Printout from University of Minnesota
`
`2233
`
`2233
`
`2350
`
`website of Chordae Tendineae
`
`2014 ESC Guidelines on the diagnosis and
`
`2234
`
`2234
`
`2351
`
`treatment of aortic diseases
`
`U.S. Patent 7,914,569 – Nguyen et al
`
`2235
`
`2235
`
`2352
`
`-13-
`
`
`
`
`
`Transcript of the Deposition of Alexander Hill
`
`2236
`
`2236
`
`2353
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/s/ James J. Kernell
`
`
`
`
`
`
`
`James J. Kernell, Reg. No. 42720
`
`ERICKSON KERNELL DERUSSEAU
`
`& KLEYPAS, LLC
`
`8900 State Line Road, Suite 500
`
`Leawood, Kansas 66206
`
`Telephone: (913) 549-4700
`
`Facsimile: (913) 549-4646
`
`Email: jjk@kcpatentlaw.com
`
`-and-
`
`David L. Marcus (pro hac vice)
`
`BARTLE & MARCUS LLC
`
`1100 Main Street, Suite 2730
`
`Kansas City, Missouri 64105
`
`Telephone: (816) 256-4699
`
`Facsimile: (816) 222-0534
`
`Email: dmarcus@bmlawkc.com
`
`Attorneys for Patent Owner
`
`Troy R. Norred, M.D.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`-14-
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify this 12th day of December 2014, that the
`
`foregoing Patent Owner’s Current Exhibit List Pursuant to 37 C.F.R.
`
`§ 42.63(e) has been served electronically through the Patent Trial and
`
`Appeals Board’s Patent Review Processing System (PRPS) upon the lead
`
`and back-up counsel for the Petitioner, JACK BARUFKA and EVAN
`
`FINKEL, both of Pillsbury Winthrop Shaw Pittman LLP.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ James J. Kernell
`Attorney for Patent Owner
`
`-15-