`U.S. Patent No. 6,306,141
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`Paper No. _____
`Submitted: May 12, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
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`EDWARDS LIFESCIENCES COPRORATION
`Petitioner
`v.
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`MEDTRONIC, INC.
`Patent owner
`_____________________
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`CASE IPR 2014-00362
`PATENT 6,306,141
`_____________________
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`CORRECTED PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 6,306,141 UNDER 35 U.S.C. §§ 311-319
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`Edwards Lifesciences Corporation (“Edwards” or “Petitioner”) hereby
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`submits a corrected petition (pursuant to Paper No. 10) seeking Inter Partes
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`Review (“IPR”) of Claims 1-22 in U.S. Patent Number 6,306,141 (“the ’141
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`Patent”) (Exhibit 1001). A detailed statement supporting the petition follows.
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`This document has been served on counsel of record for Patent Owner as
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`reflected in the accompanying Certificate of Service.
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 6,306,141
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`TABLE OF CONTENTS
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`I.
`REAL PARTY IN INTEREST UNDER 37 C.F.R. § 42.8(b)(1) .................... 1
`II. GROUNDS FOR STANDING UNDER 37 C.F.R. § 42.104(a) ..................... 1
`III. RELATED MATTERS UNDER 37 C.F.R. § 42.8(b)(2) ............................... 1
`IV. DESIGNATION OF COUNSEL UNDER 37 C.F.R. § 42.8(b)(3)
`and 42.10(a)-(b) ............................................................................................... 1
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`V.
`SERVICE INFORMATION UNDER 37 C.F.R. § 42.8(b)(4) ........................ 1
`VI. STATEMENT OF PRECISE RELIEF REQUESTED UNDER
`37 C.F.R. §§ 42.22(a)(1) and 42.104(b)(1)-(2) ............................................... 2
`VII. HOW THE CHALLENGED CLAIMS ARE TO BE
`CONSTRUED UNDER 37 C.F.R. § 42.104(b)(3) ......................................... 3
`VIII. REASONS FOR THE RELIEF REQUESTED UNDER 37 C.F.R. §
`42.22(a)(2) and 42.104(b)(4) SHOWING THAT THERE IS A
`REASONABLE LIKELIHOOD THAT THE PETITIONER
`WILL PREVAIL UNDER 35 U.S.C. § 314(a) ............................................... 3
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`A.
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`B.
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`C. Construction of the ’141 Patent Claim Terms..................................... 11
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`D.
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`Subject Matter of the ’141 Patent .......................................................... 4
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`Prosecution History: Issuance of the ’141 Patent Based on a
`Misunderstanding of the Properties of SMAs and Nitinol .................... 6
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`Invalidity Analysis .............................................................................. 13
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`a. Claims 1-22 are anticipated by Cragg I under §102(a) .................. 13
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`b. Claims 1-22 are anticipated by Cragg II under § 102(a) or obvious
`in view of Cragg II and Cragg I under § 103(a) ............................ 15
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`c. Claims 1-22 are obvious in view of Miyauchi and Cragg I
`under § 103(a) ................................................................................ 17
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`d. Claims 1-22 are obvious in view of the’212 Patent and Cragg I
`under § 103(a) ................................................................................ 19
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`e. Claim chart supporting invalidity grounds 1 through 4 ................. 21
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`f. Claims 1-22 are invalid for obviousness-type double patenting in
`view of the Jervis ’378 Patent ........................................................ 50
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`IX. CONCLUSION .................................................................................................. 60
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`iii
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`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`EXHIBIT LIST
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`U.S. Patent No. 6,306,141 to Jervis
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`Declaration of Ming H. Wu, Ph.D.
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`Curriculum Vitae of Ming H. Wu, Ph.D.
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`A. Cragg et al., Nonsurgical Placement of Arterial Endoprostheses: A
`New Technique Using Nitinol Wire, Radiology, 147: 261-263
`(April 1983)
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`A. Cragg et al., A New Percutaneous Vena Cava Filter, American
`Journal of Roentgenology, 141: pp. 601-604 (September 1983)
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`Certified Translation of Japanese Patent Publication No. S58-46923 to
`Miyauchi et al. (filed Sept. 12, 1981; disclosed Mar. 18, 1983)
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`U.S. Patent No. 3,620,212 to Fannon et al. (Granted Nov. 16, 1971)
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`H. Ling et al., Phase Transitions and Shape Memory in NiTi,
`Metallurgical Transactions A, 11A: 77-79 (1980)
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`U.S. Patent No. 4,503,569 to Dotter (Filed Mar. 3, 1983; Granted
`Mar. 12, 1985)
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`L. Delaey et al., Thermoelasticity, Pseudoelasticity and the Memory
`Effects Associated with Martensitic Transformations. Part
`1: Structural and Microstructural Changes Associated with
`the Transformations, Journal of Materials Science, 9: 1521-
`1535 (1974)
`
`R.V. Krishnan et al., Thermoplasticity, Pseudoelastiticy and the
`Memory Effects Associated with Martensitic Transformations. Part 2:
`The Macroscopic Mechanical Behavior, Journal of Materials Science,
`9: 1536-1544 (1974)
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`1012
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`K. Otsuka et al., Pseudoelastiticy, Metals Forum, 4(3): 142-152
`(1981)
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`J.R. Patel et al., Criterion for the Action of Applied Stress in the
`Martensitic Transformation, Acta Metallurgica, 1: 531-538 (1953)
`
`L.M. Schetky, Shape Memory Alloys, Scientific American, 241(5):
`74-82 (1979)
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`K. Otsuka et al., Stress and Strain Induced Martensitic
`Transformations, Proceedings of the Int’l Conference on Martensitic
`Transformations: ICOMAT 1979, 607-618 (Jun 1979)
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`February 26, 2001 BPAI Decision (Excerpt from the ’141 Patent
`Prosecution History)
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`March 18, 1998 Applicant Remarks to Office Action (Excerpt from
`the ’141 Patent Prosecution History)
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`April 2, 1997 Applicant Remarks to Office Action (Excerpt from
`the ’141 Patent Prosecution History)
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`March 18, 1998 Declaration of Dr. Lee Middleman (Excerpt from
`the ’141 Patent Prosecution History)
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`U.S. Patent No. 5,597,378 to Jervis
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`T.L. Lopes et al., Fatigue Performance of Nitinol Tubing with Af of
`25ºC, Proceedings of the International Conference on Shape
`Memory and Superelastic Technologies, 311-320 (2003)
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`M. Wu et al., What is the Big Deal About the Af Temperature?,
`Proceedings of the International Conference on Shape Memory and
`Superelastic Technologies, 143-154 (May 2006)
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`D.B. Chernov et al., The Multiplicity of Structural Transitions in
`Alloys Based on TiNi, Soviet Physics Doklady, 24(8): 664-666
`(Aug. 1979)
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`Original Japanese Patent Publication No. S58-46923 to
`Miyauchi et al. (filed Sep. 12, 1981; disclosed Mar. 18, 1983)
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`Complete Prosecution History of the ’141 Patent
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`iv
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`1013
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`1014
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`1015
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`1016
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`1017
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`1018
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`1019
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`1020
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`1021
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`1022
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`1023
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`1024
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`1025
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`1026
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`1027
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`1028
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`1029
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`1030
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`1031
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`1032
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`Certified Transcript of Deposition of Dr. Lee Middleman, taken
`December 10-11, 2008
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`G.B. Kauffman et al., The Story of Nitinol: The Serendipitous
`Discovery of the Memory Metal and Its Applications, The Chemical
`Educator, 2(2): 1-21 (1996)
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`T.W. Duerig et al., Ti-Ni Shape Memory Alloys, Materials Properties
`Handbook: Titanium Alloys, 1035-48 (1994)
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`M. Simon et al., A Vena Cava Filter Using Thermal Shape Memory
`Alloy, Radiology, 125: 89-94 (1977)
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`U.S. Patent No. 4,425,908 to Simon (Filed Oct. 22, 1981; Granted
`Jan. 17, 1984)
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`U.S. Patent No. 4,512,338 to Balko et al. (Filed Jan. 25, 1983;
`Granted Apr. 23, 1985)
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`F.E. Wang et al., The Irreversible Critical Range in the NiTi
`Transition, Journal of Applied Physics, 39(5): 2166-2175 (April 1968)
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`1033
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`Complete Prosecution History of U.S. Patent No. 5,597,378
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`REAL PARTY IN INTEREST UNDER 37 C.F.R. 42.8(b)(1)
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`I.
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`The Petitioner is EDWARDS LIFESCIENCES CORPORATION.
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`II.
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`GROUNDS FOR STANDING UNDER 37 C.F.R. 42.104(a)
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`Petitioner certifies that the ‘141 Patent is available for IPR and that
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`Petitioner is not barred or estopped from requesting an IPR challenging the patent
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`claims on the grounds identified herein.
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`III.
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`RELATED MATTERS UNDER 37 C.F.R. 42.8(b)(2)
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`Petitioner is not aware of any current judicial or administrative matters that
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`would affect, or be affected by, a decision in this proceeding.
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`IV.
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`DESIGNATION OF COUNSEL UNDER 37 C.F.R. 42.8(b)(3) and
`42.10(a)-(b)
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`Lead counsel for the Petitioner is David S. Moreland of Meunier Carlin &
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`Curfman, LLC, USPTO Reg. No. 60,134. Backup counsel for the Petitioner is
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`Gregory J. Carlin of Meunier Carlin & Curfman, LLC, USPTO Reg. No. 45,607.
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`Pursuant to 37 C.F.R § 42.10(b), a Power of Attorney accompanies this petition.
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`V.
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`SERVICE INFORMATION UNDER 37 C.F.R. 42.8(b)(4)
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`Petitioner’s lead counsel may be reached by phone at (678) 869-7749, by
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`email at
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`, and by facsimile at (404) 645-7707.
`dmoreland@mcciplaw.com
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`Petitioner may be served as follows:
`
`David S. Moreland
`MEUNIER CARLIN & CURFMAN, LLC
`817 W. Peachtree Street NW, Suite 500
`Atlanta, GA 30308
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`STATEMENT OF PRECISE RELIEF REQUESTED UNDER 37
`C.F.R. §§ 42.22(a)(1) and 42.104(b)(1)-(2)
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`VI.
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`For the reasons presented herein, Petitioner seeks the following relief:
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`(Ground #1) Invalidation of Claims 1-22 of the ‘141 Patent (“the ’141
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`Patent Claims”) under 35 U.S.C. § 102(a) as being anticipated by Cragg et al.,
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`Nonsurgical Placement of Arterial Endoprostheses: A New Technique Using
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`Nitinol Wire, 147 Radiology No. 1, 261-263 (April 1983) (“Cragg I,” Exhibit
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`1004);
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`(Ground #2) Invalidation of Claims 1-22 of the ’141 Patent under 35 U.S.C.
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`§ 102(a) as being anticipated by Cragg et al., A New Percutaneous Vena Cava
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`Filter, 141:601-604 (September 1983) (“Cragg II,” Exhibit 1005) or, alternatively,
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`under 35 U.S.C. § 103(a) as being obvious in view of Cragg I and Cragg II.
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`(Ground #3) Invalidation of Claims 1-22 of the ‘141 Patent under 35 U.S.C.
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`§ 103(a) as being obvious in view of Japanese Patent Publication No. S58-46923 to
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`Miyauchi et al. (“Miyauchi,” Japanese publication at Exhibit 1024, and certified
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`English translation at Exhibit 1006) in view of Cragg I.
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`(Ground #4) Invalidation of Claims 1-22 of the ‘141 Patent under 35 U.S.C.
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`§ 103(a) as being obvious in view of U.S. Patent No. 3,620,212 to Fannon (“the
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`’212 Patent,” Exhibit 1007) in view of Cragg I.
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`(Ground #5) Invalidation of Claims 1-22 of the ’141 Patent under the
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`doctrine of obviousness-type double patenting over the claims of U.S. Patent No.
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`5,597,378 to Jervis (“the ’378 Patent,” Exhibit 1007), filed October 2, 1992;
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`issued on January 28, 1997; and expired on May 4, 2004.
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`VII.
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`HOW THE CHALLENGED CLAIMS ARE TO BE CONSTRUED
`UNDER 37 C.F.R. § 42.104(b)(3)
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`The ’141 Patent Claims should be accorded their “broadest reasonable
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`construction” in light of the specification of the ‘141 Patent. 37 C.F.R. § 42.100(b).
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`VIII. REASONS FOR THE RELIEF REQUESTED UNDER 37 C.F.R. §
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`42.22(a)(2) and 42.104(b)(4) SHOWING THAT THERE IS A
`REASONABLE LIKELIHOOD THAT THE PETITIONER WILL
`PREVAIL UNDER 35 U.S.C. § 314(a)
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`The ’141 Patent Claims are invalid in light of several prior art references and
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`in view of an expired patent to the same inventor covering the same subject matter.
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`As will be explored, the ‘141 Patent claims issued because the PTAB was provided
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`incorrect information regarding the material properties of shape-memory alloys, in
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`particular Nitinol, through a declaration of an “expert” in stress induced martensite
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`submitted by the Applicant Medtronic during the prosecution of the ’141 Patent.
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`This declarant has since admitted that he is not and never was an expert in the
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`relevant subject matter. But for this declaration, the ’141 Patent would not have
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`issued. When viewed under a clear lens, the ’141 Patent is even more undeniably
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`invalid in view of the prior art.
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`Further, the ‘141 Patent claims priority to U.S. Appl. No. 06/541,852 (“852
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`Application”), filed October 13, 1983. As a result of terminal disclaimers based on
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`obviousness-type double patenting rejections, the other patents issuing from the
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`’852 Application all expired on May 4, 2004. The ‘141 Patent, however, was
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`improperly granted without requiring a surrender of the patent term past this date.
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`As such, the ’141 Patent now exists as an improper extension of the patent
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`monopoly and is invalid on those grounds too.
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`A. Subject Matter of the ‘141 Patent
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`The ’141 Patent Claims are generally directed to a medical device that
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`includes (i) a shape memory alloy (SMA) element capable of displaying stress-
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`induced martensite (SIM) at body temperature, and (ii) a placement device for
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`delivery of the SMA element into a mammal (see ‘141 Patent (Exhibit 1001) at
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`2:59 to 3:4 and 10:59 to 14:23). SMAs display a “martensitic” phase and an
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`“austenitic” phase. Just as water can transform between various phases (e.g., vapor,
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`liquid, ice), SMAs can reversibly transform between their austenitic and
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`martensitic phases/states.
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`The transformation between these phases can occur as a result of a change in
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`temperature or stress. For example, just like when H2O is in its liquid phase (water)
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`and is sufficiently cooled, it transforms to its solid state (ice). When a SMA is in
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`its austenite phase and it is sufficiently cooled, it transforms to its martensite
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`phase. This transformation as a result of temperature is referred to as “thermally
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`induced martensite” or “TIM.” Likewise, the application of sufficient stress to a
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`SMA when in its austenite phase will transform the SMA to its martensite phase.
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`This transformation as a result of stress is referred to as “stress induced
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`martensite” or “SIM” (see ‘141 Patent at 1:52-53). Importantly, every SMA that
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`exhibits TIM also exhibits SIM. That is, these martensitic transformations are
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`equivalent and inherent material properties of the SMA. This fact was never
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`disclosed by the Applicant. To the contrary, the Board of Patent Appeals and
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`Interferences (“the Board”) was misled into concluding that not all SMAs that
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`exhibit TIM exhibit SIM (i.e., that additional processing is required to exhibit
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`SIM) (see generally Exhibit 1019). Moreover, the Board allowed the ’141 Patent
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`Claims based on this incorrect belief (see generally Exhibit 1016).
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`SMAs have a “shape memory” property that enables them to memorize their
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`austenitic shape. That memory can be exhibited in several ways: thermal shape
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`memory, pseudoelasticity, and mechanical shape memory. Thermal shape memory
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`refers to when one sufficiently cools an SMA containing austenite to form
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`thermally induced martensite, deforms the martensite, and then heats the alloy so
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`that it reverts from thermally induced martensite back to its undeformed austenitic
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`state (’141 Patent at 2:23-28). Pseudoelasticity refers to the conversion of austenite
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`to martensite, but where the martensite is formed by the application of stress
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`(rather than by significant cooling), and the release of stress allows the austenite
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`phase to be restored (’141 Patent at 1:52—2:1). Mechanical shape memory is
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`similar to pseudoelasticity, in that martensite is formed by the application of stress,
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`but the stress-induced martensite is stable until the austenite transformation start
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`temperature (As) of the SMA is reached (see id.).
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`Each of the shape memory properties described above may exist as natural
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`material properties of Nitinol. Nitinol is a well-known SMA formed of nickel and
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`titanium, and was frequently used in self-expanding medical devices in the late
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`1970’s and early 1980’s. Nitinol is disclosed in all of the prior art references
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`discussed herein (and is discussed in detail in the ’141 Patent (see ‘141 Patent at
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`9:14 to 10:7)).
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`An understanding of the material properties of Nitinol and its transformation
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`temperatures is important in assessing the validity of the ’141 Patent Claims. To
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`assist the Board in that regard, Petitioners have submitted the declaration of Dr.
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`Ming H. Wu (“Expert Report” or “ER,” Exhibit 1002). Dr. Wu has extensive
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`knowledge of SMAs, including over 30 years of experience in the use of SMAs in
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`medical devices. Dr. Wu specifically addresses the material properties of Nitinol,
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`the prior art disclosing the use of Nitinol in medical devices, and the relevance of
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`these disclosures to the ’141 Patent Claims.
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`B. Prosecution History: Issuance of the ’141 Patent Based on a
`Misunderstanding of the Properties of SMAs and Nitinol
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`The ‘141 Patent characterizes its alleged improvement as a medical device
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`using “the substitution of an alloy element which displays stress-induced martensite
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`at body temperature” in place of using thermally induced martensite to achieve
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`the same result (see ’141 Patent at 3:1-4 (emphasis added)). Thus, the basic
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`premise of the ’141 Patent (in its own terms) is to substitute one well-known SMA
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`material property, stress induced martensite (SIM), for another well-known and
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`equivalent material property, thermally induced martensite (TIM) (see ’141 Patent
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`at 1:52-59 (admitting that SMAs that exhibit SIM were well known in the art)).
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`Indeed, the Applicant recognized the alleged invention’s lack of novelty, conceding
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`it was only a “basic improvement” that “uses stress-induced martensite material in
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`place of conventional [thermally induced] shape memory alloy material” (Remarks
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`to Office Action (Exhibit 1017) at 3).
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`Under KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) and its progeny,
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`substitution of a known material element to obtain a predictable result fails the
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`threshold for patentability.1
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` See, e.g., Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d
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`1352, 1361 (Fed. Cir. 2011) (“[D]esign need and market pressure may dictate a
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`commonsensical path using a finite number of identified predictable solutions to
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`one of ordinary skill….”); see also In re Chevalier, 500 Fed. Appx. 932, 935 (Fed.
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`Cir. 2013) (ruling that “recognized equivalents performing the same function”
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`rendered claims obvious based on KSR’s recognition that “when a patent claims a
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`1 The ’141 Patent was granted on October 23, 2001, thus before the Supreme
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`Court’s April 30, 2007 KSR decision.
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`structure already known in the prior art that is altered by the mere substitution of
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`one element for another known in the field, the combination must do more than
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`yield a predictable result.”) (citing KSR, 550 U.S. at 416).
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`Moreover, as explained by Dr. Wu, no substitution was required. The ‘141
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`Patent incorrectly suggests that the known shape memory elements in medical
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`devices only exhibited thermally induced martensite (TIM) (’141 Patent at 1:26—
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`2:54, 9:14—10:7). However, the prior art expressly recognized and relied upon the
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`SMA material property of stress induced martensite (SIM) and its conversion back
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`to austenite (see, e.g., ER §VII). In other words, the prior art disclosed the use of
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`SIM (rather than TIM) to obtain the desired shape memory property in self-
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`expanding medical devices. The ’141 Patent Claims are invalid in view of such
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`prior art.
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`In prosecuting the ’141 Patent, the Applicant Medtronic argued that all
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`Nitinol SMAs that exhibit thermally induced martensite (TIM) do not exhibit stress
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`induced martensite (SIM). More particularly, the Examiner issued a Final Office
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`Action rejecting the ’141 Patent Claims as obvious (Final OA, Sept. 15, 1997
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`(Exhibit 1025) at 2-3). Medtronic appealed and submitted a declaration by Dr. Lee
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`Middleman, whom Medtronic represented as “an expert in the field of stress-
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`induced martensite (SIM) alloy elements” (141 History, Appeal Brief, Jun. 18,
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`1998 (Exhibit 1025) at 18). Dr. Middleman stated:
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`Although nitinol can exhibit properties of an SIM material, it
`can do so only if it undergoes a treatment process to make it
`exhibit the properties of an SIM material.
` This process requires
`an extensive, time consuming, and expensive procedure. Where
`is the suggestion in Balko or any of the other references to use
`nitinol exhibiting SIM behavior rather than less expensive
`conventional Nitinol? There is no such suggestion....
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`(Middleman Decl. (Exhibit 1019) at 4 (emphasis added)).
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` The Board in turn reversed the Examiner’s decisions, relying inter alia on
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`Dr. Middleman’s declaration:
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`As shown by Kirk-Othmer and the Middleman declaration,
`nitinol does not exhibit SIM properties unless it receives
`additional treatment,
` of which there is no suggestion in Balko.
`We therefore conclude that the examiner has not made out a
`prima facie case that the SMAs disclosed by Balko would
`inherently display SIM properties.
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`(Id. at Decision on Appeal, Feb. 26, 2001, p. 6 (emphasis added).)
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`While the Board understandably accepted Dr. Middleman’s representations
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`in the ex parte process (because Medtronic represented that Middleman was an
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`expert in SIM with knowledge of Nitinol processing), the reality is that Dr.
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`Middleman was not then and is not now an expert in SIM or Nitinol. Indeed,
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`during the course of subsequent litigation regarding the ’141 Patent, Dr.
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`Middleman admitted that he is not an expert in either (see Middleman Deposition
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`(Exhibit 1028) at pp. 29, 34, 100, 146-148, 229 (testifying that he “was definitely
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`not an expert in Nitinol” and was “absolutely not” an expert in “stress-induced
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`martensite”)).
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`In contrast, Dr. Wu (an actual expert in SMAs), explains that all SMAs
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`including Nitinol that can exhibit thermally induced martensite (TIM) can also
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`exhibit stress induced martensite (SIM) (ER §§IV-VII). This follows fundamental
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`thermodynamic principles, and no special treatment is required for a Nitinol alloy
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`that exhibits TIM to also exhibit SIM (ER §§IV-VII). The requirement for “an
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`additional treatment” process that is “extensive, time-consuming and expensive,”
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`as set forth in the Middleman declaration is quite simply incorrect (see ER VI).
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`All of the prior art references relied on herein use a Nitinol alloy element in
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`a self-expanding medical device. In considering them, it is important to keep in
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`mind the following fundamental material properties of SMAs:
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`• Shape memory alloys that are capable of exhibiting TIM are also capable
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`of exhibiting SIM (see, e.g., ER §IV).
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`• All Nitinol SMAs exhibit SIM between their Mf and Md temperatures
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`(see, e.g., ER §IV). (The Mf temperature is the temperature at which the
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`SMA is fully martensitic based solely on the temperature; the Md
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`temperature is the temperature above which martensite will no longer
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`form under stress (see id.)).
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`• All Nitinol SMAs exhibit pseudoelasticity between As and Md
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`temperatures (see, e.g., ER §IV). (The As temperature is the temperature
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`at which martensite begins to revert back to austenite—whether formed
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`through stress or temperature (see id.)).
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`• All Nitinol SMAs are thus indisputably pseudoelastic shape memory
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`alloys (see, e.g., ER §§IV-VIII).
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`Dr. Wu, an acknowledged expert in SMA’s, states the scientific bases for
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`these fundamental properties in his declaration attached as Exhibit 1002.
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`C. Construction of the ’141 Patent Claim Terms
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`The claims are construed as a person of ordinary skill in the art would
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`understand them and are to be given their broadest reasonable construction. For
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`example, Claim 1 recites that “the alloy is selected so that the transformation can
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`occur without any change in temperature of the placement device or the memory
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`alloy element.” The “transformation” in the claim is the transformation of the
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`medical device from stress-induced martensite (SIM) to austenite. The time of
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`transformation (as dictated by the claims) is when the medical device is released
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`from the placement device inside the mammal. Thus, to one of ordinary skill in the
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`art, the SMA selected must merely be capable of transforming (note use of phrase
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`“can occur”) from SIM to austenite when placed in the body “without any change
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`in temperature of the … memory alloy element” (ER §VIII).2
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` This limitation is met
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`when an alloy is selected that has an As temperature below body temperature (id.).
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`With such an As temperature, the memory alloy device self-expands when released
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`in the body without requiring a change in temperature, which is exactly what is
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`disclosed in the prior art (ER §§VII-VIII).
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`Other claim terms and limitations should similarly be given their broadest
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`reasonable construction. For example, consistent with this approach, the patent
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`teaches a broad definition of “catheters” to include “cannulas” (see ’141 Patent at
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`5:60-62 (“both [terms] being included hereinafter in the word “catheter”)).
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`2 Non-limiting language as it relates to the “change in temperature” limitation is
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`similarly used throughout the independent claims: Claim 11 (“without any change
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`in temperature … being required”); Claim 15 (“selected so that the transformation
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`can occur without any change in temperature”); Claim 16 (“can occur without a
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`change in temperature”); Claim 18 (“selected so the transformation can occur
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`without any change in temperature”). Such limitations similarly require only that
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`the selected SMA be capable of transforming from SIM to austenite when released
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`in the body without a change in temperature, not that the SMA actually transform
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`without a change in temperature (even though the prior art does disclose such a
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`transformation without a change in temperature) (ER §§VII-VIII).
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`D. Invalidity Analysis
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`a. Claims 1-22 are anticipated by Cragg I under § 102(a)
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`Cragg I discloses a Nitinol coil stent configured for delivery into a human
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`body using a catheter (261-62, Fig. 1). Cragg I is prior art under 35 U.S.C § 102(a)
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`(published at least as early as March 22, 1983) and was admitted as prior art in the
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`’141 Patent. Cragg I discloses a Nitinol coil stent that can be deformed to a straight
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`wire and placed in a catheter (261-62). When the Nitinol coil is extended out of the
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`catheter into the blood vessel, it transforms back to an unstressed austenitic state to
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`maintain the patency of the vessel (261-62):
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`Cragg I Figure 1
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`Cragg I’s Nitinol coil stent meets the limitations of the’141 Patent Claims.
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`
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`For example, the As temperature of the Cragg I device is 25° C, and its Af
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`temperature is about body temperature (approximately 36-38° C) (262, ER §VII).
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`Further, Cragg I teaches annealing the Nitinol wire, so that its Ms and Mf
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`temperatures are well below 0° C (ER §VII). Therefore, the Cragg I Nitinol alloy
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`has the following martensite and austenite transformation temperatures (ER §VII):
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`Cragg I further discloses that its Nitinol stent is cooled in ice water and then
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`deformed (261). The temperature of the coil when deformed is thus necessarily
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`above the wire’s Ms temperature (i.e., above 0° C). The deformation of the coil
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`causes stress-induced martensite (ER §VII). The deformed Nitinol is then placed
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`in a catheter and delivered to a blood vessel. As the delivery catheter is positioned
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`in the human body, the Nitinol stent temperature rises to and remains at body
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`temperature (i.e., above the As and Af temperatures) (262, ER §VII). When
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`extended from the catheter, the wire transforms from SIM to austenite without
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`requiring a change in temperature (262, ER §VII). Accordingly, Cragg I discloses
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`utilizing SIM and a pseudoelastic stent, which is what is recited in the ’141 Patent
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`Claims. This is set forth more fully in the claim chart at the end of this petition
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`(Section VIII.C.e.).3
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`3 A more detailed claim chart accompanies Dr. Wu’s expert report (Exhibit 1002).
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`b. Claims 1-22 are anticipated by Cragg II under § 102(a) or
`rendered obvious in view of Cragg II and Cragg I under § 103(a)
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`Cragg II, which was not before the Patent Office during the examination of
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`
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`the ’141 Patent, is prior art under 35 U.S.C § 102(a) (published at least as early as
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`August 25, 1983). It discloses a Nitinol wire coil filter that displays stress-induced
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`martensite (SIM) when deformed within a catheter while being positioned for
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`placement in a human blood vessel (ER §VII). Specifically, the Cragg II filter is a
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`self-expanding Nitinol wire coil delivered by a Teflon catheter (601, FIG. 1B):
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`Cragg II FIG. 1B
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`
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`The coil is annealed and then cooled in ice water, at which time it is stressed
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`into a straightened (i.e., deformed) shape (602). Cragg II provides that the
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`“transition temperature” (i.e., the Af temperature) is “about 30°C for the alloy used
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`in this study” (601, ER §VII). Also, because the wire is annealed, the Ms and Mf
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`temperatures are well below 0° C (ER §VII). Hence, the wire coil disclosed in
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`Cragg II exhibits the following temperature ranges (ER §VII):
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`Because the ice water temperature is higher than even the most conservative
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`MS temperature (minus 4° C, see ER §VII), drawing the wire filter into the catheter
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`would straighten the Nitinol wire into a deformed shape through the formation of
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`stress-induced martensite (and not through the formation of thermally induced
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`martensite). That is, the initial deformation of the wire coil when drawn into the
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`catheter necessarily causes SIM – not TIM.
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`Cragg II further provides that the “catheter with the loaded wire [filter] …
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`was deposited in the vena cava by withdrawing the catheter over the adapting
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`wire” (602). As the wire is deployed, the Cragg I filter resumes its coil shape
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`(602). Because the temperature of the wire in the catheter necessarily reaches and
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`remains at its As temperature upon insertion into the body, when extended from the
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`catheter the Nitinol alloy wire filter in Cragg II goes from a SIM state to an
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`unstressed austenitic state (the transformation from SIM to austenite occurring
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`without a change in temperature) (602, ER §VII).
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`Further, Cragg II discloses using the pseudoelastic properties of the Nitinol
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`alloy when repositioning the wire filter. As stated, “[i]f the position of the filter
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`was not optimal, it could be withdrawn into the catheter and positioned again ….
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`In two animals, the original placement of the filters was not optimal. These filters
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`were withdrawn into the catheter and successfully repositioned” (602). This
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`repositioning thus also discloses that the catheter stresses the Nitinol wire filter
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`into a deformed shape at body temperature, causing the SMA to transform from
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`austenite to SIM (ER §VII). Then, when the filter is re-delivered into the body, the
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`filter is at body temperature and above its As and Af temperatures. This again
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`cau