UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`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 IPR2014-00111
`Patent 6,482,228
`______________________
`
`PRELIMINARY RESPONSE OF PATENT OWNER TO PETITION
` FOR INTER PARTES REVIEW
`
`
`
`
`
`
`
`
`______________________
`
`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 IPR2014-00111
`Patent 6,482,228
`______________________
`
`PRELIMINARY RESPONSE OF PATENT OWNER TO PETITION
` FOR INTER PARTES REVIEW
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES ...................................................................................................... iii
`
`Exhibit List for Inter Partes Review of U. S. Patent 6,482,228 ............................... vi
`
`I.
`
`Background
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`A.
`
`B.
`
`C.
`
`
`
`
`
`Related Proceedings
`
`The ‘228 Patent
`
`Priority of Invention
`
`1.
`
`2.
`
`Conception
`
`Reduction to Practice
`
`D.
`
`Claim Construction
`
`
`
`
`
`
`
`1.
`
`2.
`
`3.
`
`“ring member”
`
`“tissue”
`
`“means for maintaining”
`
`II.
`
`Analysis
`
`A.
`
`Overview
`
`
`
`
`
`1.
`
`2.
`
`Anticipation
`
`Obviousness
`
`B.
`
`Prior Art Challenges
`
`
`
`1.
`
`Spiegel
`
`
`
`
`
`
`
`
`
`
`
`
`
`i
`
`3
`
`4
`
`5
`
`7
`
`7
`
`9
`
`14
`
`15
`
`16
`
`16
`
`16
`
`16
`
`17
`
`18
`
`20
`
`20
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`Figulla
`
`Fraunhofer
`
`Schreck
`
`Garrison
`
`Ersek
`
`Shu
`
`III.
`
`Conclusion
`
`21
`
`23
`
`24
`
`26
`
`28
`
`30
`
`33
`
`APPENDIX A-1 ...........................................................................................................................37
`
`APPENDIX A-2 ...........................................................................................................................39
`
`APPENDIX A-3 ...........................................................................................................................41
`
`APPENDIX A-4 ...........................................................................................................................44
`
`APPENDIX A-5 ...........................................................................................................................47
`
`APPENDIX A-6 ...........................................................................................................................50
`
`APPENDIX A-7 ...........................................................................................................................52
`
`
`
`
`
`ii
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`
`17, 20, 21, 23, 25, 26, 28
`
`Cases
`
`Advanced Display Sys., Inc. v. Kent State Univ.,
`
`212 F.3d 1272 (Fed. Cir. 2000)
`
`Applied Med. Res. Cor. v. United States Surgical Corp.,
`
`147 F.3d 1374 (Fed. Cir. 1998)
`
`Bayer Schering Pharma AG v. Barr Laboratories, Inc.,
`
`575 F.3d 1341 (Fed. Cir. 2009)
`
`Brown v. Barbacid,
`
`436 F.3d 1376 (Fed. Cir. 2006)
`
`Burroughs Wellcome Co. v. Barr Labs, Inc.,
`
`40 F.3d 1223 (Fed. Cir. 1994)
`
`Christie v. Seybold,
`
`55 Fed. Rep. 69 (6th Cir. 1893)
`
`Connell v. Sears, Roebuck & Co.,
`
`722 F.2d 1542 (Fed. Cir. 1983) ........................................................................... 17
`
`Eibel Process Co. v. Minnesota & Ontario Paper Co.,
`
`261 U.S. 45 (1923)
`
`E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co.,
`
`849 F.2d 1430 (Fed. Cir. 1988)
`
`Eli Lilly v. Zenith Goldline Pharm.,
`
`471 F.3d 1369 (Fed. Cir. 2006)
`
`Frazier v. Schlegel,
`
`498 F.3d 1283 (Fed. Cir. 2007)
`
`17, 30
`
`19
`
`10
`
`8, 9
`
`7
`
`8
`
`15
`
`19
`
`9
`
`
`
`iii
`
`
`
`
`
`
`
`Gasser Chair Co. v. Infanti Chair Mfg. Corp.,
`
`60 F.3d 770 (Fed. Cir. 1995)
`
`Graham v. John Deere Co.,
`
`383 U.S. 1 (1966)
`
`Heart Failure Technologies, LLC v. Cardiokinetix, Inc.,
`
`Case IPR2013-00183, 2013 WL 418227
`
`Patent Tr. & App. Bd. July 31, 2013
`
`In re Guess,
`
`347 Fed.Appx. 558 (Fed. Cir. 2009)
`
`In re Kahn,
`
`144 F.3d 977 (Fed. Cir. 2006)
`
`In re Klein,
`
`647 f.3d 1343 (Fed. Cir. 2011)
`
`In re Mathews,
`
`408 F.2d 1393 (1969)
`
`In re Ruskin,
`
`347 F.2d 843 (1965)
`
`In re Translogic Tech., Inc.,
`
`504 F.3d 1249 (Fed. Cir. 2007)
`
`KSR Int’l Co. v. Teleflex Inc.,
`
`550 U.S. 398 (2007)
`
`Net Moneyin, Inc. v. Verisign, Inc.,
`
`545 F.3d 1359 (Fed. Cir. 2008)
`
`Pacific Coast Marie Windshields Ltd. v. Malibu Boats, LLC,
`
`No. 2013-1199, WL 53904
`
`(Fed. Cir. Jan. 8, 2014)
`
`
`iv
`
`8
`
`18, 19
`
`30
`
`21, 22, 24, 26, 27
`
`18
`
`31
`
`18
`
`18
`
`15
`
`19, 32
`
`17
`
`21, 22, 24, 26, 27
`
`
`
`
`
`Price v. Symsek,
`
`988 F.2d 1187 (Fed. Cir. 1993)
`
`Renishaw PLC v. Marposs Societa’ per Azioni,
`
`158 F.3d 1243 (Fed. Cir. 1998)
`
`Richardson-Vicks, Inc. v. Upjohn Co.,
`
`122 F.3d 1476 (Fed. Cir. 1997)
`
`Singh v. Brake,
`
`317 F.3d 1334 (Fed. Cir. 2003)
`
`
`
`Statutes
`
`37 C.F.R. § 42.100
`
`37 C.F.R. § 42.107
`
`37 C.F.R. § 42.108
`
`35 U.S.C. § 102
`
`35 U.S.C. § 103
`
`35 U.S.C. § 313
`
`35 U.S.C. § 314
`
`
`
`Other Authorities
`
`J. Butany and M.J. Collins, Analysis of Prosthetic Cardiac Devices:
`
`A Guide for the Practicing Pathologist, J. Clin. Pathol.
`
`2005 58:133-124
`
`Office Patent Trial Practice Guide,
`
`77 Fed. Reg. 48756 (Aug. 14, 2012)
`
`v
`
`7, 8
`
`15
`
`18
`
`7
`
`14
`
`1
`
`4
`
`1, 3, 7, 17, 20, 23, 24, 26
`
`3, 18, 31
`
`1
`
`3, 4
`
`21
`
`14, 15
`
`
`
`
`
`
`
`Exhibit List for Inter Partes Review of U. S. Patent 6,482,228
`
`Exhibit Description
`
`Ex. No.
`
`University Hospital & Clinics Physicians progress notes with
`
`2101
`
`sketch of heart valve
`
`Sketch of heart valve
`
`Sketch of heart valve notarized in Seminole County,
`
`Oklahoma
`
`Letter – Troy Norred to Dr. Davis
`
`Re: Percutaneous aortic valve
`
`Sketch of heart valve
`
`Letter – Darla Hess, MD to Dr. Troy Norred
`
`Re: Performance on echo rotation
`
`Document Order of Journals with sketches
`
`Sketch
`
`Sketch of heart valve
`
`Percutaneous Aortic Valve Replacement –
`
`Description of invention with sketches and computer
`
`renderings
`
`
`
`
`
`vi
`
`2102
`
`2103
`
`2104
`
`2105
`
`2106
`
`2107
`
`2108
`
`2109
`
`2110
`
`
`
`
`
`Citations and Abstracts regarding reference materials with
`
`2111
`
`sketches
`
`Pages from Journal Article and sketches
`
`Letter – Troy Norred to Greg Flaker, MD
`
`Re: Percutaneous aortic valve
`
`Note from Troy Norred to Jim Kernell
`
`Re: Patent material & sketch
`
`Citation and Abstract for Porcine Heart Valve Article
`
`Letter – James Kernell to Dr. Troy Norred
`
`Re: Application for patent
`
`Fax – Dr. Troy Norred to Chip Galaxy
`
`Re: Mutual Confidentiality Agreement with sketches
`
`Memry contact information with notes and sketches
`
`Notes re: Aorta Modeling for Heart Valve
`
`Invoice from Vivitro Systems, Inc.
`
`Packing Slip – NDC to Troy Norred
`
`Invoice – Shape Memory Applications to Troy Norred
`
`2112
`
`2113
`
`2114
`
`2115
`
`2116
`
`2117
`
`2118
`
`2119
`
`2120
`
`2121
`
`2122
`
`Packing Slip – Shape Memory Applications to Troy Norred
`
`2123
`
`Packing Slip – NDC to Troy Norred
`
`2124
`
`vii
`
`
`
`
`
`Experiment information
`
`Equilasers contact information
`
`Information from Equilasers website
`
`Packing Slip – NDC to Troy Norred
`
`Letter – James Kernell to Dr. Troy Norred
`
`Re: Application for patent
`
`U. S. Patent 6,482,228
`
`2125
`
`2126
`
`2127
`
`2128
`
`2129
`
`2130
`
`BETAPACE AF Dosing Algorithm for in-hospital initiation
`
`2131
`
`with sketches
`
`Citations and Abstracts regarding reference materials
`
`Contact Information for Ken Evans, Dave Rarison,
`
`Mike Griffin, Thomas Stilwell, Ed Treacy
`
`2132
`
`2133
`
`Contact Information for Wayne Applegate, Bob Stanton,
`
`2134
`
`J. Choi
`
`Letter – Troy Norred to Greg Flaker, MD
`
`Re: Percutaneous aortic valve
`
`Outline of description of invention document
`
`Percutaneous Aortic Valve Proposal/Protocol
`
`Percutaneous Aortic Valve Proposal/Protocol with notes
`
`viii
`
`2135
`
`2136
`
`2137
`
`2138
`
`
`
`
`
`Percutaneous Aortic Valve Proposal/Protocol with notes
`
`Percutaneous Aortic Valve Replacement – Anatomy,
`
`2139
`
`2140
`
`Dynamics and Physics
`
`Percutaneous Aortic Valve Replacement – Description of
`
`2141
`
`invention
`
`Percutaneous Aortic Valve Replacement – Description of
`
`2142
`
`invention
`
`Percutaneous Aortic Valve Replacement – Description of
`
`2143
`
`invention
`
`Percutaneous Aortic Valve Replacement – Description of
`
`2144
`
`invention
`
`Percutaneous Aortic Valve Replacement – Description of
`
`2145
`
`invention
`
`Percutaneous Aortic Valve Replacement – Description of
`
`2146
`
`invention
`
`Percutaneous Aortic Valve Replacement – Description of
`
`2147
`
`invention
`
`Percutaneous Aortic Valve Replacement – Description of
`
`2148
`
`invention
`
`ix
`
`
`
`
`
`Percutaneous Aortic Valve Replacement – Description of
`
`2149
`
`invention
`
`Percutaneous Aortic Valve Replacement – Description of
`
`2150
`
`invention
`
`Percutaneous Aortic Valve Replacement – Description of
`
`2151
`
`invention
`
`Percutaneous Aortic Valve Replacement – Summary
`
`2152
`
`Percutaneous Aortic Valve Replacement – Summary & notes
`
`2153
`
`Photo with Sketch
`
`Sketch regarding valve
`
`Sketch regarding valve construction
`
`Sketch
`
`Sketch regarding valve construction
`
`Sketch regarding valve with measurements
`
`Sketch regarding valve
`
`Sketch
`
`Sketch regarding valve construction
`
`Sketch regarding valve
`
`Sketch regarding valve
`
`x
`
`2154
`
`2155
`
`2156
`
`2157
`
`2158
`
`2159
`
`2160
`
`2161
`
`2162
`
`2163
`
`2164
`
`
`
`
`
`Sketch regarding valve with calculations
`
`Sketch regarding valve
`
`Sketch regarding valve and flow
`
`Sketch regarding valve and placement
`
`Sketch regarding details of valve
`
`Color rendering of inserted valve
`
`Blue pen sketch of ring view of valve
`
`Blue pen sketch of ring view of valve
`
`Red pen sketch of side view of valve
`
`Red pen sketch of side view of valve
`
`Red pen sketch of side view of valve
`
`Red pen sketch of ring view of valve
`
`Various telephone numbers and contacts
`
`Various telephone numbers and contacts
`
`Various telephone numbers and contacts
`
`2165
`
`2166
`
`2167
`
`2168
`
`2169
`
`2170
`
`2171
`
`2172
`
`2173
`
`2174
`
`2175
`
`2176
`
`2177
`
`2178
`
`2179
`
`J. Butany/M.J. Collins, Analysis of Prosthetic Cardiac Devices:
`
`2180
`
`A Guide for the Practicing Pathologist, J. Clin. Pathol. 2005
`
`U. S. Publication No. 2011/0251675
`
`U. S. Publication No. 2011/0172765
`
`2181
`
`2182
`
`xi
`
`
`
`Pursuant to 35 U.S.C. § 313 and 37 C.F.R. § 42.107, Patent Owner
`
`Troy R. Norred, M. D. (“Norred”) submits his Preliminary Response to
`
`the Petition for inter partes review filed by Medtronic, Inc., Medtronic
`
`Vascular, Inc. and Medtronic CoreValve, LLC (collectively, “Medtronic”
`
`or “Petitioner”). The Board should decline to institute an inter partes
`
`review because the purported prior art cited by Medtronic does not
`
`anticipate claims 20-24 of U. S. Patent No. 6,482,228 (the “‘228 Patent”),
`
`nor are claims 20-24 of the ‘228 Patent obvious in light of any
`
`combination of these prior art references. The following points are of
`
`particular significance:
`
`
`
`Of the seven references set forth in the Petition, four
`
`were filed after Norred invented the aortic valve
`
`described in the ‘228 Patent. Accordingly, these
`
`devices do not constitute prior art under 35 U.S.C.
`
`§ 102.
`
`
`
`Of the three references set forth in the Petition that
`
`were published before Norred invented the aortic
`
`valve described in the ‘228 Patent, two reflect devices
`
`that must be surgically implanted. These devices lack
`
`
`
`1
`
`
`
`
`
`the primary novelty associated with Norred’s
`
`invention,
`
`namely,
`
`nonsurgical/percutaneous
`
`implantation.
`
`
`
`There is just one reference set forth in the Petition
`
`that (a) was published before Norred invented the
`
`aortic valve described in the ‘228 Patent, and (b)
`
`reflects
`
`a device
`
`than
`
`can be
`
`implanted
`
`nonsurgically/percutaneously. However, that device
`
`differs in material respects from Norred’s invention.
`
`Among other things, it lacks a “ring member” to seal
`
`the device against the aortic wall, and is held in place
`
`with barbs rather than a stent system.
`
`
`
`None of the references set forth in the Petition seal
`
`against the aortic wall or anchor in place in the same
`
`manner as Norred’s invention.
`
` Neither do they
`
`disclose a “ring member” or a stent structure that
`
`expands against the inner walls of the aorta.
`
`2
`
`
`
`
`
`For these reasons, as more fully set forth herein, it is highly unlikely that
`
`Petitioner will prevail on any of the challenged claims.
`
`I.
`
`BACKGROUND
`
`Medtronic filed a Petition requesting inter partes review of
`
`the ‘228 Patent on October 31, 2013. Medtronic challenges the
`
`patentability of claims 20-24 of the ‘228 Patent on the ground that these
`
`claims are anticipated by and obvious in view of prior art. Medtronic’s
`
`prior art references are as follows:
`
`Reference
`
`Basis
`
`Claims Challenged
`
`Spiegel (Exs. 1003, 1004)
`
`§§ 102(a), 103
`
`Figulla (Exs. 1005, 1006)
`
`§§ 102(b), 103
`
`Fraunhofer (Ex. 1007-08)
`
`§§ 102(a), 103
`
`Schreck (Ex. 1009)
`
`§§ 102(e), 103
`
`Garrison (Ex. 1010)
`
`§§ 102(e), 103
`
`Ersek (Ex. 1011)
`
`§§ 102(b), 103
`
`Shu (Ex. 1012)
`
`§ 103
`
`
`
`20-24
`
`20-24
`
`20-24
`
`20-24
`
`20-24
`
`20-24
`
`20-23
`
`The standard for instituting an inter partes review is set
`
`forth in 35 U.S.C. § 314(a), which provides:
`
`3
`
`
`
`
`
`THRESHOLD. -- The Director may not authorize an inter
`
`partes review
`
`to be
`
`instituted unless
`
`the Director
`
`determines that the information presented in the petition
`
`filed under section 311 and any response filed under
`
`section 313 shows that there is a reasonable likelihood that
`
`the petitioner would prevail with respect to at least 1 of the
`
`claims challenged in the petition.
`
`
`35 U.S.C. § 314(a); See also 37 C.F.R. § 42.108(c) (inter partes review is
`
`only instituted if “there is a reasonable likelihood that the petitioner
`
`would prevail with respect to at least one of the claims challenged in the
`
`petition.”). In determining whether this standard is satisfied, the Board
`
`considers both the Petition and the Preliminary Response of the Patent
`
`Owner. Id.
`
`A.
`
`Related Proceedings
`
`The ‘228 Patent is the subject of a patent infringement
`
`action styled, Troy R. Norred, M. D. v. Medtronic, Inc., et al, Case No.
`
`13-CV-2061, presently pending in the United States District Court for
`
`the District of Kansas. In addition, claims 16-19 of the ‘228 Patent are
`
`the subject of Petition for inter partes review in IPR2014-00110, which
`
`was filed concurrently with the instant Petition on October 31, 2013.
`
`4
`
`
`
`
`
`
`
`B.
`
`The ‘228 Patent
`
`The ‘228 Patent describes a percutaneous aortic heart valve
`
`that is placed by catheter and held in place with a stent system. (Norred,
`
`Abstract). The stent system is expanded in the aorta to anchor the valve
`
`in the aortic channel above the native aortic valve. Id. Because this
`
`device can be placed and held in place non–surgically, it finds particular
`
`application in patients suffering aortic stenosis who are not physically
`
`able to withstand the stresses of open heart surgery. Norred, col. 1,
`
`ll. 15-27.
`
`The ‘228 Patent was granted with 24 claims. Medtronic
`
`challenges the validity of independent claim 20 and dependent claims
`
`21-24. Claims 20-24 are reproduced below:
`
`20. An aortic valve for controlling a blood flow
`
`through an aortic channel upon placement therein, said
`
`valve comprising:
`
`a tissue valve having an interior member made of a
`
`tissue material and presenting an opening movable
`
`between open and closed positions;
`
`a ring member surrounding said tissue valve, said
`
`ring member having an outer circumference
`
`adapted to seat said ring member about an aortic
`
`wall surrounding an aortic channel;
`5
`
`
`
`
`
`means for maintaining said ring member in said
`
`seated position about the aortic wall,
`
`said tissue valve interior member responsive to
`
`changes of conditions within
`
`the aorta
`
`for
`
`movement of said opening between a first closed
`
`position and a second open position.
`
`21. The aortic valve as claimed in claim 20 wherein
`
`said tissue valve interior member is responsive to changes
`
`in blood pressure in the aorta whereby to move said tissue
`
`valve between said first and second positions.
`
`22. The aortic valve as claimed in claim 21 wherein
`
`said tissue valve interior member moves to said second
`
`position in response to systolic ejection of blood from the
`
`left ventricle in which the blood pressure in the left
`
`ventricle in greater than the blood pressure in the aortic
`
`channel.
`
`23. The aortic valve as claimed in claim 21 wherein
`
`said tissue valve interior member moves to said first
`
`position in response to diastolic filing of the left ventricle
`
`whereby the blood pressure in the aortic channel is greater
`
`than the blood pressure in the left ventricle.
`
`24. The aortic valve as claimed in claim 20 wherein
`
`said ring member contacts the wall of the aortic channel and
`
`seals said ring against the aortic channel wall to reduce
`
`blood flow therearound.
`
`
`
`
`
`6
`
`
`
`
`
`C.
`
`Priority of Invention
`
`In the United States, the person who first reduces an
`
`invention to practice is “prima facie the first and true inventor.” Christie
`
`v. Seybold, 55 Fed. Rep. 69, 76 (6th Cir. 1893). However, the person
`
`“who first conceives, and, in a mental sense, first invents . . . may date his
`
`patentable invention back to the time of its conception if he connects
`
`the conception with its reduction to practice by reasonable diligence on
`
`his part, so that they are substantially one continuous act.” Id. Stated
`
`another way, priority of invention “goes to the first party to reduce an
`
`invention to practice unless the other party can show that it was the
`
`first to conceive the invention and that it exercised reasonable diligence
`
`in later reducing that invention to practice.” Price v. Symsek, 988 F.2d
`
`1187, 1190 (Fed. Cir. 1993); 35 U.S.C. § 102(g) (pre-AIA).
`
`1.
`
`Conception
`
`“Conception is the formation in the mind of the inventor of a
`
`definite and permanent idea of the complete and operative invention, as
`
`it is therefore to be applied in practice.” Singh v. Brake, 317 F.3d 1334,
`
`1340 (Fed. Cir. 2003). An idea is sufficiently definite for conception
`
`“when the inventor has a specific, settled idea, a particular solution to
`
`7
`
`
`
`
`
`the problem at hand, not just a general goal or research plan he hopes to
`
`pursue.” Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228
`
`(Fed. Cir. 1994). A finding of conception does not require perfection;
`
`conception is complete when “the idea is so clearly defined in the
`
`inventor’s mind that only ordinary skill would be necessary to reduce
`
`the
`
`invention
`
`to practice, without
`
`extensive
`
`research or
`
`experimentation.” Id.
`
`Where a party seeks to show conception through the oral
`
`testimony of the inventor, corroboration is required. Price, 988 F.2d at
`
`1195. This rule arose out of a concern that inventors would be tempted
`
`to remember facts favorable to their case by the lure of protecting their
`
`patent or defeating another’s patent. Eibel Process Co. v. Minnesota &
`
`Ontario Paper Co., 261 U.S. 45, 60 (1923); Gasser Chair Co. v. Infanti
`
`Chair Mfg. Corp., 60 F.3d 770, 776 (Fed. Cir. 1995). Notably, however,
`
`corroboration is not required where a party seeks to prove conception
`
`through the use of physical exhibits. Price, 988 F.2d at 1195. Rather,
`
`when physical exhibits are put before the Board to prove conception,
`
`the Board can make its own determinations as to what this evidence
`
`discloses. Id.
`
`8
`
`
`
`
`
`Norred conceived of his invention no later than December
`
`1998. This is shown by the drawing attached hereto as Exhibit 2103.
`
`See Burroughs, 40 F.3d at 1228 (conception is shown “when the
`
`inventor has a specific, settled idea, a particular solution to the problem
`
`at hand”). This drawing is signed and notarized and bears a date of
`
`“12/21/98.” This drawing clearly depicts a percutaneous aortic heart
`
`valve held in place with a stent system. It bears a striking similarity to
`
`Figure 4 of the ‘228 Patent, as shown below:
`
`
`
`
`
`
`
`
`
`2.
`
`Reduction to Practice
`
`Norred reduced his invention to practice on November 14,
`
`2000, when he filed his application for the ‘228 Patent. See Frazier v.
`
`Schlegel, 498 F.3d 1283, 1288 (Fed. Cir. 2007) (“The filing of a patent
`
`application is a constructive reduction to practice of the invention
`
`9
`
`
`
`
`
`disclosed therein”). The documentary evidence demonstrates that
`
`Norred exercised reasonable diligence between the date of conception
`
`and the date his patent application was filed. See Brown v. Barbacid, 436
`
`F.3d 1376, 1380-81 (Fed. Cir. 2006) (due diligence shown through
`
`documentary evidence). This documentary evidence is attached hereto
`
`and summarized in the following table:
`
`Ex. No. Description
`
`Date
`
`2101
`
`University Hospital & Clinics Physicians
`
`Oct. 1998
`
`Progress Notes with sketch of heart valve
`
`2102
`
`Sketch of heart valve
`
`Nov. 1998
`
`2103
`
`Sketch of heart valve notarized in Seminole
`
`12/21/1998
`
`County, Oklahoma
`
`2104
`
`Letter – Troy Norred to Dr. Davis
`
`5/26/1999
`
`Re: Percutaneous aortic valve
`
`2105
`
`Sketch of heart valve
`
`May 1999
`
`2106
`
`Letter – Darla Hess, MD to Dr. Troy Norred
`
`3/10/2000
`
`Re: Performance on echo rotation
`
`10
`
`
`
`
`
`2107
`
`Document order of Journals with sketches
`
`4/19/00
`
`2108
`
`Sketch
`
`2109
`
`Sketch of heart valve
`
`4/28/00
`
`4/28/00
`
`2110
`
`Percutaneous Aortic Valve Replacement –
`
`5/5/00
`
`Description of invention with sketches and
`
`computer renderings
`
`2111
`
`Citations and Abstracts regarding reference
`
`5/15/00
`
`materials with sketches
`
`2112
`
`Pages from journal article and sketches
`
`5/31/00
`
`2113
`
`Letter – Troy Norred to Greg Flaker, MD
`
`6/4/00
`
`Re: Percutaneous aortic valve
`
`2114
`
`Note from Troy Norred to Jim Kernell
`
`6/12/00
`
`Re: Patent material and sketch
`
`2115
`
`Citation and Abstract for porcine heart valve
`
`6/15/00
`
`article
`
`
`
`
`
`11
`
`
`
`
`
`2116
`
`Letter – James Kernell (Chase & Yakimo, LC) to
`
`9/22/00
`
`Dr. Troy Norred
`
`Re: Application for patent
`
`2117
`
`Fax – Dr. Troy Norred to Chip Galaxy
`
`9/26/00
`
`Re: Mutual Confidentiality Agreement with
`
`sketches
`
`2118
`
`Memry contact information with notes and
`
`4/30/01
`
`sketches
`
`2119
`
`Notes Re: Aorta Modeling for Heart Valve
`
`6/6/01
`
`2120
`
`Invoice from Vivitro Systems, Inc.
`
`6/13/01
`
`2121
`
`Packing Slip – NDC to Troy Norred
`
`6/27/01
`
`2122
`
`Invoice – Shape Memory Applications to
`
`7/9/01
`
`Troy Norred
`
`2123
`
`Packing Slip – Shape Memory Applications to
`
`7/9/01
`
`Troy Norred
`
`2124
`
`Packing Slip – NDC to Troy Norred
`
`7/13/01
`
`12
`
`
`
`
`
`2125
`
`Experiment information
`
`2126
`
`Equilasers contact information
`
`7/19/01
`
`7/20/01
`
`2127
`
`Information from Equilasers website
`
`7/20/01
`
`2128
`
`Packing Slip – NDC to Troy Norred
`
`7/26/01
`
`2129
`
`Letter – James Kernell (Chase & Yakimo, LC) to
`
`9/7/01
`
`Dr. Troy Norred Re: Application for patent
`
`2130
`
`U. S. Patent 6,482,228
`
`11/19/02
`
`2131
`
`BETAPACE AF: Dosing Algorithm for In-
`
`Undated
`
`hospital Initiation with sketches
`
`2132
`
`Citations and Abstracts regarding reference
`
`Undated
`
`materials
`
`2133
`
`Contact information for Ken Evans, Dave
`
`Undated
`
`Raridon, Mike Griffin, Thomas Stilwell,
`
`Ed Treacy
`
`2134
`
`Contact information for Wayne Applegate,
`
`Undated
`
`Bob Stanton, J. Choi
`
`13
`
`
`
`
`
`2135
`
`Letter – Troy Norred to Greg Flaker, MD
`
`Undated
`
`Re: Percutaneous aortic valve
`
`2136
`
`Outline of description of invention document
`
`Undated
`
`2137 -
`
`Percutaneous Aortic Valve Proposal/Protocol
`
`Undated
`
`2153
`
`2154 -
`
`Miscellaneous sketches and photos
`
`Undated
`
`2176
`
`2177 -
`
`Various telephone numbers and contacts
`
`Undated
`
`2179
`
`
`
`Although a number of exhibits above are undated, they show the
`
`inventor’s effort and diligence from the date of invention to filing of the
`
`patent application. Based on this evidence, the Board should find that
`
`the date of invention of the aortic device described in the ‘228 Patent is
`
`no later than December 21, 1998.
`
`D.
`
`Claim Construction
`
`During an inter partes review, claims are given their
`
`broadest reasonable interpretation in view of the specification of which
`
`they are part. 37 C.F.R. § 42.100(b); See also Office Patent Trial Practice
`
`14
`
`
`
`
`
`Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012). Claim terms are also given
`
`their ordinary and customary meaning as would be understood by one
`
`of ordinary skill in the art in the context of the entire disclosure. In re
`
`Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). If a feature
`
`of the invention is not necessary to give meaning to what the inventor
`
`means by a claim term, it is “extraneous” and should not be read into the
`
`claim. Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1249
`
`(Fed. Cir. 1998); E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co.,
`
`849 F.2d 1430, 1433 (Fed. Cir. 1988). The construction that stays true
`
`to the claim language and most naturally aligns with the inventor’s
`
`description is likely the correct interpretation. See Reinshaw, 158 F.3d
`
`at 1250.
`
`1.
`
`“ring member”
`
`The term “ring member,” as used in claims 20-24, means a
`
`ring made of a pliable, biocompatible material which seals against the
`
`aorta to reduce peri-valvular leaks. This definition derives from the
`
`specification. Norred, col. 6, ll. 1-9. This is necessary to enable the
`
`artificial valve to be inserted percutaneously, to lock in place, and to
`
`perform in the manner intended. Norred, col. 1, ll. 26-51.
`
`15
`
`
`
`
`
`2.
`
`“tissue”
`
`The term “tissue” is a “biological tissue, such as cadaver and
`
`porcine tissue.” Norred, col. 5, ll. 64-65.
`
`3.
`
`“means for maintaining”
`
`The term “means for maintaining” is the stent system 28
`
`(Norred, Abstract, “The stent system is expanded in the ascending aorta
`
`to anchor the valve in the aortic channel.”; Norred, col. 1, ll. 29-31,
`
`59-67; col. 5, ll. 22-25, 48-51). Thus the “means for maintaining” is the
`
`stent system or an equivalent structure.
`
`II.
`
`ANALYSIS
`
`
`
`A.
`
`Overview
`
`Medtronic contends that claims 20-24 are anticipated by
`
`Spiegel, Figulla, Fraunhofer, Shreck, Garrison, and Erseck. Medtronic
`
`contends that claims 20-23 are obvious over Spiegel in view of Shu, are
`
`obvious over Figulla in view of Shu, are obvious over Fraunhofer in view
`
`of Shu, are obvious over Garrison in view of Shu, and are obvious over
`
`Ersek in view of Shu.
`
`
`
`
`
`16
`
`
`
`
`
`1.
`
`Anticipation
`
`A patent may be found invalid as anticipated if “the
`
`invention was described in . . . a patent granted on an application for
`
`patent by another filed in the United States before the invention thereof
`
`by the applicant for patent.” See 35 U.S.C. § 102(e). A claim is
`
`anticipated when “the four corners of a single, prior art document
`
`describe every element of the claimed invention, either expressly or
`
`inherently, such that a person of ordinary skill in the art could practice
`
`the invention without undue experimentation.” Advanced Display Sys.,
`
`Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000).
`
`“Because the hallmark of anticipation is prior invention, the
`
`prior art reference—in order to anticipate under 35 U.S.C. § 102—must
`
`not only disclose all elements of the claim within the four corners of the
`
`document, but must also disclose those elements ‘arranged as in the
`
`claim.’” Net Moneyin, Inc. v. Verisign, Inc., 545 F.3d 1359, 1369 (Fed. Cir.
`
`2008) (citing Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed.
`
`Cir. 1983)). A prior art device does not anticipate “simply by possessing
`
`identically named parts, unless these parts also have the same structure
`
`or otherwise satisfy the claim limitations.” Applied Med. Res. Cor. v.
`
`17
`
`
`
`
`
`United States Surgical Corp., 147 F.3d 1374, 1380 (Fed. Cir. 1998).
`
`Moreover, even where a prior art device is the “functional equivalent” of
`
`a patented product, it does not anticipate unless it discloses the
`
`structure required by the asserted claims. In re Ruskin, 347 F.2d 843,
`
`846 (1965). Finally, a reference patent anticipates an invention only if
`
`the reference patent’s effective filing date is before the date of the
`
`invention. See In re Mathews, 408 F.2d 1393 (1969).
`
`
`
`2.
`
`Obviousness
`
`Obviousness is a legal question based on underlying factual
`
`determinations. 35 U.S.C. § 103(a); Richardson-Vicks Inc. v. Upjohn Co.,
`
`122 F.3d 1476, 1479 (Fed. Cir. 1997). An obviousness analysis
`
`measures the difference between the claimed invention and the prior
`
`art to determine whether “the subject matter as a whole would have
`
`been obvious at the time the invention was made” to a person having
`
`ordinary skill in the art. In re Kahn, 441 F.3d 977, 985 (Fed. Cir. 2006).
`
`The factual underpinnings, often referred to as the Graham factors,
`
`include 1) the scope and content of the prior art; 2) the level of ordinary
`
`skill in the art; 3) the differences between the claimed invention and the
`
`prior art; and 4) evidence of secondary factors, also known as objective
`
`18
`
`
`
`
`
`indicia of non-obviousness. Graham v. John Deere Co., 383 U.S. 1, 17-18
`
`(1966).
`
`Obviousness requires more than a mere showing that the
`
`prior art includes separate references covering each separate limitation
`
`in a claim under examination. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
`
`418 (2007). Instead, obviousness requires the additional showing that
`
`a person of ordinary skill at the time of the invention would have
`
`selected and combined those prior art elements in the normal course of
`
`research and development to yield the claimed invention. Id. at 421. To
`
`render a claim obvious, prior art cannot be “vague” and must
`
`collectively guide an artisan of ordinary skill towards a particular
`
`solution. Bayer Schering Pharma AG v. Barr Laboratories, Inc., 575 F.3d
`
`1341, 1347 (Fed. Cir. 2009). The claimed invention is not obvious if a
`
`person of ordinary skill would not select and combine the prior art
`
`references to reach the claimed composition or formulation. Eli Lilly v.
`
`Zenith Goldline Pharm, 471 F.3d 1369, 1380 (Fed. Cir. 2006).
`
`
`
`
`
`19
`
`
`
`
`
`B.
`
`Prior Art Challenges
`
`1.
`
`Spiegel
`
`The Spiegel article was published on March 3, 2000,
`
`approximately 15 months after Norred invented the aortic valve
`
`described in the ‘228 Patent. (Exs. 1003, 1004, 2103.) Accordingly,
`
`Spiegel does not constitute prior art and cannot serve as a basis to
`
`invalidate the ‘228 Patent pursuant to 35 U.S.C. § 102(b).
`
`Moreover, even if Spiegel did constitute prior art, it could
`
`not serve as a basis to invalidate the ‘228 Patent because it does not
`
`expressly or inherently describe every element of the claimed invention.
`
`See Advanced Display Sys., 212 F.3d at 1282. While Spiegel discloses a
`
`tissue valve, there is no disclosure of any “ring member,” i.e., a ring
`
`made of a pliable, biocompatible material that seals against the aorta to
`
`reduce peri-valvular leaks. The structure identified as the “ring
`
`member” by Petitioner is simply the tissue valve itself. See Ex. 1004.
`
`Finally, Spiegel does not disclose a “means for maintaining said ring
`
`member in said seated position about the aortic wall.”
`
`This last point warrants additional emphasis. The “means
`
`for maintaining” disclosed in Norred is a stent structure that expands
`
`20
`
`
`
`
`
`against the inner walls of the aorta. Norred, col. 3, ll. 7-10 (Ex. 2130).
`
`Spiegel, in contrast, teaches that the tissue valve is anchored to the
`
`vessel wall with barbs. Exs. 1003 and 1004. These are not equivalents.
`
`Because barbs pierce the wall of the aorta, the use of barbs is associated
`
`with complications such as infection. J. Butany and M. J. Collins, Analysis
`
`of Prosthetic Cardiac Devices: A Guide for the Practicing Pathologist,
`
`J. Clin. Pathol. 2005 58:113-124 attached hereto as Exhibit 2180 (see p.
`
`123). For that reason, the use of barbs is nowhere mentioned in the
`
`specification for the ‘228 Patent and, accordingly, Spiegel cannot be said
`
`to anticipate Norred. See In re Guess, 347 Fed. Appx. 558 (Fed. Cir.
`
`2009) (means-plus-function limitation encompasses all the structures in
`
`the specification that perform the recited function and equivalents
`
`thereof); Pacific Coast Marine Windshields Ltd. v. Malibu Boats, LLC, No.
`
`2013-1199, 2014 WL 53904, at *2 (Fed. Cir. Jan. 8, 2014) (structures are
`
`equivalent if there are only “insubstantial differences” between them).
`
`2.
`
`Figulla
`
`Figulla cannot not serve as a basis to invalidate the ‘228
`
`Patent because it does not expressly or inherently describe every
`
`element of the claimed invention. See Advanced Display Sys., 212 F.3d at
`
`21
`
`
`
`
`
`1282. While Figulla discloses a tissue valve, there is no di
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