throbber
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of:
`U.S. Patent No.:
`Issue Date:
`Serial No.:
`Filing Date:
`Title:
`
`James E. Jervis
`6,306,141
`October 23, 2001
`08/483,291
`June 7, 1995
`MEDICAL DEVICES INCORPORATING SIM ALLOY
`ELEMENTS
`
`Submitted via Electronic Filing
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 6,306,141 UNDER 35 U.S.C. §§ 311-319
`
`Edwards Lifesciences Corporation (“Edwards” or “Petitioner”) hereby
`
`requests Inter Partes Review (“IPR”) of Claims 1-22 in U.S. Patent Number
`
`6,306,141 (“the ’141 Patent”) (Exhibit 1001). A detailed statement supporting the
`
`petition follows.
`
`The requisite fee accompanies this request. If any additional fee is necessary,
`
`the Director is authorized to charge Deposit Account No. 50-5226. This document,
`
`together with all exhibits referenced herein, has been served on the patent owner at
`
`the addresses of record for the ’141 Patent as reflected in the accompanying
`
`Certificate of Service.
`
`Medtronic Exhibit 2009
`Cook v. Medtronic
`IPR2019-00123
`Page 00001
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`TABLE OF CONTENTS
`
`REAL PARTY IN INTEREST UNDER 37 C.F.R. § 42.8(b)(1) .................... 1
`
`I.
`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
`
`V.
`VI.
`
`SERVICE INFORMATION UNDER 37 C.F.R. § 42.8(b)(4) ........................ 1
`
`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
`
`A.
`
`B.
`
`C.
`
`D.
`
`Subject Matter of the ’141 Patent .......................................................... 4
`
`Prosecution History: Issuance of the ’141 Patent Based on a
`Misunderstanding of the Properties of SMAs and Nitinol .................... 6
`
`Construction of the ’141 Patent Claim Terms..................................... 11
`
`Invalidity Analysis .............................................................................. 13
`
`a. Claims 1-22 are anticipated by Cragg I under §102(a) .................. 13
`
`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
`
`c. Claims 1-22 are obvious in view of Miyauchi and Cragg I
`under § 103(a) ................................................................................ 17
`
`i
`
`IPR2019-00123 Page 00002
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`d. Claims 1-22 are obvious in view of the’212 Patent and Cragg I
`under § 103(a) ................................................................................ 19
`
`e. Claim chart supporting invalidity grounds 1 through 4 ................. 21
`
`f. Claims 1-22 are invalid for obviousness-type double patenting in
`view of the Jervis ’378 Patent ........................................................ 50
`
`IX. CONCLUSION .................................................................................................. 60
`
`ii
`
`IPR2019-00123 Page 00003
`
`

`

`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`EXHIBIT LIST
`
`U.S. Patent No. 6,306,141 to Jervis
`
`Declaration of Ming H. Wu, Ph.D.
`
`Curriculum Vitae of Ming H. Wu, Ph.D.
`
`A. Cragg et al., Nonsurgical Placement of Arterial Endoprostheses: A
`New Technique Using Nitinol Wire, Radiology, 147: 261-263
`(April 1983)
`
`A. Cragg et al., A New Percutaneous Vena Cava Filter, American
`Journal of Roentgenology, 141: pp. 601-604 (September 1983)
`
`Certified Translation of Japanese Patent Publication No. S58-46923 to
`Miyauchi et al. (filed Sept. 12, 1981; disclosed Mar. 18, 1983)
`
`U.S. Patent No. 3,620,212 to Fannon et al. (Granted Nov. 16, 1971)
`
`H. Ling et al., Phase Transitions and Shape Memory in NiTi,
`Metallurgical Transactions A, 11A: 77-79 (1980)
`
`U.S. Patent No. 4,503,569 to Dotter (Filed Mar. 3, 1983; Granted
`Mar. 12, 1985)
`
`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)
`
`1012
`
`K. Otsuka et al., Pseudoelastiticy, Metals Forum, 4(3): 142-152
`(1981)
`
`
`
`iii
`
`IPR2019-00123 Page 00004
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`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)
`
`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)
`
`February 26, 2001 BPAI Decision (Excerpt from the ’141 Patent
`Prosecution History)
`
`March 18, 1998 Applicant Remarks to Office Action (Excerpt from
`the ’141 Patent Prosecution History)
`
`April 2, 1997 Applicant Remarks to Office Action (Excerpt from
`the ’141 Patent Prosecution History)
`
`March 18, 1998 Declaration of Dr. Lee Middleman (Excerpt from
`the ’141 Patent Prosecution History)
`
`U.S. Patent No. 5,597,378 to Jervis
`
`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)
`
`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)
`
`D.B. Chernov et al., The Multiplicity of Structural Transitions in
`Alloys Based on TiNi, Soviet Physics Doklady, 24(8): 664-666
`(Aug. 1979)
`
`Original Japanese Patent Publication No. S58-46923 to
`Miyauchi et al. (filed Sep. 12, 1981; disclosed Mar. 18, 1983)
`
`Complete Prosecution History of the ’141 Patent
`
`iv
`
`1013
`
`1014
`
`1015
`
`1016
`
`
`1017
`
`
`1018
`
`
`1019
`
`
`1020
`
`1021
`
`
`1022
`
`
`1023
`
`1024
`
`1025
`
`
`
`IPR2019-00123 Page 00005
`
`

`

`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`Certified Transcript of Deposition of Dr. Lee Middleman, taken
`December 10-11, 2008
`
`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)
`
`T.W. Duerig et al., Ti-Ni Shape Memory Alloys, Materials Properties
`Handbook: Titanium Alloys, 1035-48 (1994)
`
`M. Simon et al., A Vena Cava Filter Using Thermal Shape Memory
`Alloy, Radiology, 125: 89-94 (1977)
`
`U.S. Patent No. 4,425,908 to Simon (Filed Oct. 22, 1981; Granted
`Jan. 17, 1984)
`
`U.S. Patent No. 4,512,338 to Balko et al. (Filed Jan. 25, 1983;
`Granted Apr. 23, 1985)
`
`F.E. Wang et al., The Irreversible Critical Range in the NiTi
`Transition, Journal of Applied Physics, 39(5): 2166-2175 (April 1968)
`
`1033
`
`Complete Prosecution History of U.S. Patent No. 5,597,378
`
`
`
`
`
`
`
`v
`
`IPR2019-00123 Page 00006
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`I.
`
`REAL PARTY IN INTEREST UNDER 37 C.F.R. 42.8(b)(1)
`
`The Petitioner is EDWARDS LIFESCIENCES CORPORATION.
`
`II.
`
`GROUNDS FOR STANDING UNDER 37 C.F.R. 42.104(a)
`
`Petitioner certifies that the ‘141 Patent is available for IPR and that
`
`Petitioner is not barred or estopped from requesting an IPR challenging the patent
`
`claims on the grounds identified herein.
`
`III.
`
`RELATED MATTERS UNDER 37 C.F.R. 42.8(b)(2)
`
`Petitioner is not aware of any current judicial or administrative matters that
`
`would affect, or be affected by, a decision in this proceeding.
`
`IV.
`
`DESIGNATION OF COUNSEL UNDER 37 C.F.R. 42.8(b)(3) and
`42.10(a)-(b)
`
`Lead counsel for the Petitioner is David S. Moreland of Meunier Carlin &
`
`Curfman, LLC, USPTO Reg. No. 60,134. Backup counsel for the Petitioner is
`
`Gregory J. Carlin of Meunier Carlin & Curfman, LLC, USPTO Reg. No. 45,607.
`
`Pursuant to 37 C.F.R § 42.10(b), a Power of Attorney accompanies this petition.
`
`V.
`
`SERVICE INFORMATION UNDER 37 C.F.R. 42.8(b)(4)
`
`Petitioner’s lead counsel may be reached by phone at (678) 869-7749, by
`
`email at
`
`dmoreland@mcciplaw.com
`, and by facsimile at (404) 645-7707.
`
`Petitioner may be served as follows:
`
`David S. Moreland
`MEUNIER CARLIN & CURFMAN, LLC
`817 W. Peachtree Street NW, Suite 500
`Atlanta, GA 30308
`
`1
`
`
`
`IPR2019-00123 Page 00007
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`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`VI.
`
`STATEMENT OF PRECISE RELIEF REQUESTED UNDER 37
`C.F.R. §§ 42.22(a)(1) and 42.104(b)(1)-(2)
`
`For the reasons presented herein, Petitioner seeks the following relief:
`
`(Ground #1) Invalidation of Claims 1-22 of the ‘141 Patent (“the ’141
`
`Patent Claims”) under 35 U.S.C. § 102(a) as being anticipated by Cragg et al.,
`
`Nonsurgical Placement of Arterial Endoprostheses: A New Technique Using
`
`Nitinol Wire, 147 Radiology No. 1, 261-263 (April 1983) (“Cragg I,” Exhibit
`
`1004);
`
`(Ground #2) Invalidation of Claims 1-22 of the ’141 Patent under 35 U.S.C.
`
`§ 102(a) as being anticipated by Cragg et al., A New Percutaneous Vena Cava
`
`Filter, 141:601-604 (September 1983) (“Cragg II,” Exhibit 1005) or, alternatively,
`
`under 35 U.S.C. § 103(a) as being obvious in view of Cragg I and Cragg II.
`
`(Ground #3) Invalidation of Claims 1-22 of the ‘141 Patent under 35 U.S.C.
`
`§ 103(a) as being obvious in view of Japanese Patent Publication No. S58-46923 to
`
`Miyauchi et al. (“Miyauchi,” Japanese publication at Exhibit 1024, and certified
`
`English translation at Exhibit 1006) in view of Cragg I.
`
`(Ground #4) Invalidation of Claims 1-22 of the ‘141 Patent under 35 U.S.C.
`
`§ 103(a) as being obvious in view of U.S. Patent No. 3,620,212 to Fannon (“the
`
`’212 Patent,” Exhibit 1007) in view of Cragg I.
`
`(Ground #5) Invalidation of Claims 1-22 of the ’141 Patent under the
`
`doctrine of obviousness-type double patenting over the claims of U.S. Patent No.
`
`
`
`2
`
`IPR2019-00123 Page 00008
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`5,597,378 to Jervis (“the ’378 Patent,” Exhibit 1007), filed October 2, 1992;
`
`issued on January 28, 1997; and expired on May 4, 2004.
`
`VII.
`
`HOW THE CHALLENGED CLAIMS ARE TO BE CONSTRUED
`UNDER 37 C.F.R. § 42.104(b)(3)
`
`The ’141 Patent Claims should be accorded their “broadest reasonable
`
`construction” in light of the specification of the ‘141 Patent. 37 C.F.R. § 42.100(b).
`
`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)
`
`The ’141 Patent Claims are invalid in light of several prior art references and
`
`in view of an expired patent to the same inventor covering the same subject matter.
`
`As will be explored, the ‘141 Patent claims issued because the PTAB was provided
`
`incorrect information regarding the material properties of shape-memory alloys, in
`
`particular Nitinol, through a declaration of an “expert” in stress induced martensite
`
`submitted by the Applicant Medtronic during the prosecution of the ’141 Patent.
`
`This declarant has since admitted that he is not and never was an expert in the
`
`relevant subject matter. But for this declaration, the ’141 Patent would not have
`
`issued. When viewed under a clear lens, the ’141 Patent is even more undeniably
`
`invalid in view of the prior art.
`
`Further, the ‘141 Patent claims priority to U.S. Appl. No. 06/541,852 (“852
`
`Application”), filed October 13, 1983. As a result of terminal disclaimers based on
`
`
`
`3
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`IPR2019-00123 Page 00009
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`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`obviousness-type double patenting rejections, the other patents issuing from the
`
`’852 Application all expired on May 4, 2004. The ‘141 Patent, however, was
`
`improperly granted without requiring a surrender of the patent term past this date.
`
`As such, the ’141 Patent now exists as an improper extension of the patent
`
`monopoly and is invalid on those grounds too.
`
`A. Subject Matter of the ‘141 Patent
`
`The ’141 Patent Claims are generally directed to a medical device that
`
`includes (i) a shape memory alloy (SMA) element capable of displaying stress-
`
`induced martensite (SIM) at body temperature, and (ii) a placement device for
`
`delivery of the SMA element into a mammal (see ‘141 Patent (Exhibit 1001) at
`
`2:59 to 3:4 and 10:59 to 14:23). SMAs display a “martensitic” phase and an
`
`“austenitic” phase. Just as water can transform between various phases (e.g., vapor,
`
`liquid, ice), SMAs can reversibly transform between their austenitic and
`
`martensitic phases/states.
`
`The transformation between these phases can occur as a result of a change in
`
`temperature or stress. For example, just like when H2O is in its liquid phase (water)
`
`and is sufficiently cooled, it transforms to its solid state (ice). When a SMA is in
`
`its austenite phase and it is sufficiently cooled, it transforms to its martensite
`
`phase. This transformation as a result of temperature is referred to as “thermally
`
`induced martensite” or “TIM.” Likewise, the application of sufficient stress to a
`
`
`
`4
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`IPR2019-00123 Page 00010
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`

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`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`SMA when in its austenite phase will transform the SMA to its martensite phase.
`
`This transformation as a result of stress is referred to as “stress induced
`
`martensite” or “SIM” (see ‘141 Patent at 1:52-53). Importantly, every SMA that
`
`exhibits TIM also exhibits SIM. That is, these martensitic transformations are
`
`equivalent and inherent material properties of the SMA. This fact was never
`
`disclosed by the Applicant. To the contrary, the Board of Patent Appeals and
`
`Interferences (“the Board”) was misled into concluding that not all SMAs that
`
`exhibit TIM exhibit SIM (i.e., that additional processing is required to exhibit
`
`SIM) (see generally Exhibit 1019). Moreover, the Board allowed the ’141 Patent
`
`Claims based on this incorrect belief (see generally Exhibit 1016).
`
`SMAs have a “shape memory” property that enables them to memorize their
`
`austenitic shape. That memory can be exhibited in several ways: thermal shape
`
`memory, pseudoelasticity, and mechanical shape memory. Thermal shape memory
`
`refers to when one sufficiently cools an SMA containing austenite to form
`
`thermally induced martensite, deforms the martensite, and then heats the alloy so
`
`that it reverts from thermally induced martensite back to its undeformed austenitic
`
`state (’141 Patent at 2:23-28). Pseudoelasticity refers to the conversion of austenite
`
`to martensite, but where the martensite is formed by the application of stress
`
`(rather than by significant cooling), and the release of stress allows the austenite
`
`phase to be restored (’141 Patent at 1:52—2:1). Mechanical shape memory is
`
`
`
`5
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`IPR2019-00123 Page 00011
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`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`similar to pseudoelasticity, in that martensite is formed by the application of stress,
`
`but the stress-induced martensite is stable until the austenite transformation start
`
`temperature (As) of the SMA is reached (see id.).
`
`Each of the shape memory properties described above may exist as natural
`
`material properties of Nitinol. Nitinol is a well-known SMA formed of nickel and
`
`titanium, and was frequently used in self-expanding medical devices in the late
`
`1970’s and early 1980’s. Nitinol is disclosed in all of the prior art references
`
`discussed herein (and is discussed in detail in the ’141 Patent (see ‘141 Patent at
`
`9:14 to 10:7)).
`
`An understanding of the material properties of Nitinol and its transformation
`
`temperatures is important in assessing the validity of the ’141 Patent Claims. To
`
`assist the Board in that regard, Petitioners have submitted the declaration of Dr.
`
`Ming H. Wu (“Expert Report” or “ER,” Exhibit 1002). Dr. Wu has extensive
`
`knowledge of SMAs, including over 30 years of experience in the use of SMAs in
`
`medical devices. Dr. Wu specifically addresses the material properties of Nitinol,
`
`the prior art disclosing the use of Nitinol in medical devices, and the relevance of
`
`these disclosures to the ’141 Patent Claims.
`
`B. Prosecution History: Issuance of the ’141 Patent Based on a
`Misunderstanding of the Properties of SMAs and Nitinol
`
`The ‘141 Patent characterizes its alleged improvement as a medical device
`
`using “the substitution of an alloy element which displays stress-induced martensite
`6
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`IPR2019-00123 Page 00012
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`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`at body temperature” in place of using thermally induced martensite to achieve
`
`the same result (see ’141 Patent at 3:1-4 (emphasis added)). Thus, the basic
`
`premise of the ’141 Patent (in its own terms) is to substitute one well-known SMA
`
`material property, stress induced martensite (SIM), for another well-known and
`
`equivalent material property, thermally induced martensite (TIM) (see ’141 Patent
`
`at 1:52-59 (admitting that SMAs that exhibit SIM were well known in the art)).
`
`Indeed, the Applicant recognized the alleged invention’s lack of novelty, conceding
`
`it was only a “basic improvement” that “uses stress-induced martensite material in
`
`place of conventional [thermally induced] shape memory alloy material” (Remarks
`
`to Office Action (Exhibit 1017) at 3).
`
`Under KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) and its progeny,
`
`substitution of a known material element to obtain a predictable result fails the
`
`threshold for patentability.1
` See, e.g., Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d
`
`1352, 1361 (Fed. Cir. 2011) (“[D]esign need and market pressure may dictate a
`
`commonsensical path using a finite number of identified predictable solutions to
`
`one of ordinary skill….”); see also In re Chevalier, 500 Fed. Appx. 932, 935 (Fed.
`
`Cir. 2013) (ruling that “recognized equivalents performing the same function”
`
`rendered claims obvious based on KSR’s recognition that “when a patent claims a
`
`1 The ’141 Patent was granted on October 23, 2001, thus before the Supreme
`
`Court’s April 30, 2007 KSR decision.
`
`
`
`7
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`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`structure already known in the prior art that is altered by the mere substitution of
`
`one element for another known in the field, the combination must do more than
`
`yield a predictable result.”) (citing KSR, 550 U.S. at 416).
`
`Moreover, as explained by Dr. Wu, no substitution was required. The ‘141
`
`Patent incorrectly suggests that the known shape memory elements in medical
`
`devices only exhibited thermally induced martensite (TIM) (’141 Patent at 1:26—
`
`2:54, 9:14—10:7). However, the prior art expressly recognized and relied upon the
`
`SMA material property of stress induced martensite (SIM) and its conversion back
`
`to austenite (see, e.g., ER §VII). In other words, the prior art disclosed the use of
`
`SIM (rather than TIM) to obtain the desired shape memory property in self-
`
`expanding medical devices. The ’141 Patent Claims are invalid in view of such
`
`prior art.
`
`In prosecuting the ’141 Patent, the Applicant Medtronic argued that all
`
`Nitinol SMAs that exhibit thermally induced martensite (TIM) do not exhibit stress
`
`induced martensite (SIM). More particularly, the Examiner issued a Final Office
`
`Action rejecting the ’141 Patent Claims as obvious (Final OA, Sept. 15, 1997
`
`(Exhibit 1025) at 2-3). Medtronic appealed and submitted a declaration by Dr. Lee
`
`Middleman, whom Medtronic represented as “an expert in the field of stress-
`
`induced martensite (SIM) alloy elements” (141 History, Appeal Brief, Jun. 18,
`
`1998 (Exhibit 1025) at 18). Dr. Middleman stated:
`
`
`
`8
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`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`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....
`
`(Middleman Decl. (Exhibit 1019) at 4 (emphasis added)).
`
` The Board in turn reversed the Examiner’s decisions, relying inter alia on
`
`Dr. Middleman’s declaration:
`
`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.
`
`(Id. at Decision on Appeal, Feb. 26, 2001, p. 6 (emphasis added).)
`
`While the Board understandably accepted Dr. Middleman’s representations
`
`in the ex parte process (because Medtronic represented that Middleman was an
`
`expert in SIM with knowledge of Nitinol processing), the reality is that Dr.
`
`Middleman was not then and is not now an expert in SIM or Nitinol. Indeed,
`
`during the course of subsequent litigation regarding the ’141 Patent, Dr.
`
`Middleman admitted that he is not an expert in either (see Middleman Deposition
`
`
`
`9
`
`IPR2019-00123 Page 00015
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`(Exhibit 1028) at pp. 29, 34, 100, 146-148, 229 (testifying that he “was definitely
`
`not an expert in Nitinol” and was “absolutely not” an expert in “stress-induced
`
`martensite”)).
`
`In contrast, Dr. Wu (an actual expert in SMAs), explains that all SMAs
`
`including Nitinol that can exhibit thermally induced martensite (TIM) can also
`
`exhibit stress induced martensite (SIM) (ER §§IV-VII). This follows fundamental
`
`thermodynamic principles, and no special treatment is required for a Nitinol alloy
`
`that exhibits TIM to also exhibit SIM (ER §§IV-VII). The requirement for “an
`
`additional treatment” process that is “extensive, time-consuming and expensive,”
`
`as set forth in the Middleman declaration is quite simply incorrect (see ER VI).
`
`All of the prior art references relied on herein use a Nitinol alloy element in
`
`a self-expanding medical device. In considering them, it is important to keep in
`
`mind the following fundamental material properties of SMAs:
`
`• Shape memory alloys that are capable of exhibiting TIM are also capable
`
`of exhibiting SIM (see, e.g., ER §IV).
`
`• All Nitinol SMAs exhibit SIM between their Mf and Md temperatures
`
`(see, e.g., ER §IV). (The Mf temperature is the temperature at which the
`
`SMA is fully martensitic based solely on the temperature; the Md
`
`temperature is the temperature above which martensite will no longer
`
`form under stress (see id.)).
`
`10
`
`
`
`IPR2019-00123 Page 00016
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`• All Nitinol SMAs exhibit pseudoelasticity between As and Md
`
`temperatures (see, e.g., ER §IV). (The As temperature is the temperature
`
`at which martensite begins to revert back to austenite—whether formed
`
`through stress or temperature (see id.)).
`
`• All Nitinol SMAs are thus indisputably pseudoelastic shape memory
`
`alloys (see, e.g., ER §§IV-VIII).
`
`Dr. Wu, an acknowledged expert in SMA’s, states the scientific bases for
`
`these fundamental properties in his declaration attached as Exhibit 1002.
`
`C. Construction of the ’141 Patent Claim Terms
`
`The claims are construed as a person of ordinary skill in the art would
`
`understand them and are to be given their broadest reasonable construction. For
`
`example, Claim 1 recites that “the alloy is selected so that the transformation can
`
`occur without any change in temperature of the placement device or the memory
`
`alloy element.” The “transformation” in the claim is the transformation of the
`
`medical device from stress-induced martensite (SIM) to austenite. The time of
`
`transformation (as dictated by the claims) is when the medical device is released
`
`from the placement device inside the mammal. Thus, to one of ordinary skill in the
`
`art, the SMA selected must merely be capable of transforming (note use of phrase
`
`“can occur”) from SIM to austenite when placed in the body “without any change
`
`
`
`11
`
`IPR2019-00123 Page 00017
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`in temperature of the … memory alloy element” (ER §VIII).2
` This limitation is met
`
`when an alloy is selected that has an As temperature below body temperature (id.).
`
`With such an As temperature, the memory alloy device self-expands when released
`
`in the body without requiring a change in temperature, which is exactly what is
`
`disclosed in the prior art (ER §§VII-VIII).
`
`Other claim terms and limitations should similarly be given their broadest
`
`reasonable construction. For example, consistent with this approach, the patent
`
`teaches a broad definition of “catheters” to include “cannulas” (see ’141 Patent at
`
`5:60-62 (“both [terms] being included hereinafter in the word “catheter”)).
`
`
`
`2 Non-limiting language as it relates to the “change in temperature” limitation is
`
`similarly used throughout the independent claims: Claim 11 (“without any change
`
`in temperature … being required”); Claim 15 (“selected so that the transformation
`
`can occur without any change in temperature”); Claim 16 (“can occur without a
`
`change in temperature”); Claim 18 (“selected so the transformation can occur
`
`without any change in temperature”). Such limitations similarly require only that
`
`the selected SMA be capable of transforming from SIM to austenite when released
`
`in the body without a change in temperature, not that the SMA actually transform
`
`without a change in temperature (even though the prior art does disclose such a
`
`transformation without a change in temperature) (ER §§VII-VIII).
`
`
`
`12
`
`IPR2019-00123 Page 00018
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`D. Invalidity Analysis
`
`a. Claims 1-22 are anticipated by Cragg I under § 102(a)
`
`Cragg I discloses a Nitinol coil stent configured for delivery into a human
`
`
`
`body using a catheter (261-62, Fig. 1). Cragg I is prior art under 35 U.S.C § 102(a)
`
`(published at least as early as March 22, 1983) and was admitted as prior art in the
`
`’141 Patent. Cragg I discloses a Nitinol coil stent that can be deformed to a straight
`
`wire and placed in a catheter (261-62). When the Nitinol coil is extended out of the
`
`catheter into the blood vessel, it transforms back to an unstressed austenitic state to
`
`maintain the patency of the vessel (261-62):
`
`Cragg I Figure 1
`
`Cragg I’s Nitinol coil stent meets the limitations of the’141 Patent Claims.
`
`
`
`For example, the As temperature of the Cragg I device is 25° C, and its Af
`
`temperature is about body temperature (approximately 36-38° C) (262, ER §VII).
`
`Further, Cragg I teaches annealing the Nitinol wire, so that its Ms and Mf
`
`temperatures are well below 0° C (ER §VII). Therefore, the Cragg I Nitinol alloy
`
`has the following martensite and austenite transformation temperatures (ER §VII):
`
`
`
`13
`
`IPR2019-00123 Page 00019
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`SIM Not
`Possible
`(On ly TIM)
`
`SIM
`Poss ible
`
`Mr =< 00
`
`Ar = 38°
`
`Md = > 150°
`
`y
`
`Range for Pse udoelasticity
`
`Temperature
`
`
`
`Cragg I further discloses that its Nitinol stent is cooled in ice water and then
`
`deformed (261). The temperature of the coil when deformed is thus necessarily
`
`above the wire’s Ms temperature (i.e., above 0° C). The deformation of the coil
`
`causes stress-induced martensite (ER §VII). The deformed Nitinol is then placed
`
`in a catheter and delivered to a blood vessel. As the delivery catheter is positioned
`
`in the human body, the Nitinol stent temperature rises to and remains at body
`
`temperature (i.e., above the As and Af temperatures) (262, ER §VII). When
`
`extended from the catheter, the wire transforms from SIM to austenite without
`
`requiring a change in temperature (262, ER §VII). Accordingly, Cragg I discloses
`
`utilizing SIM and a pseudoelastic stent, which is what is recited in the ’141 Patent
`
`Claims. This is set forth more fully in the claim chart at the end of this petition
`
`(Section VIII.C.e.).3
`
`
`
`
`
`
`3 A more detailed claim chart accompanies Dr. Wu’s expert report (Exhibit 1002).
`
`
`
`14
`
`IPR2019-00123 Page 00020
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`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)
`
`Cragg II, which was not before the Patent Office during the examination of
`
`
`
`the ’141 Patent, is prior art under 35 U.S.C § 102(a) (published at least as early as
`
`August 25, 1983). It discloses a Nitinol wire coil filter that displays stress-induced
`
`martensite (SIM) when deformed within a catheter while being positioned for
`
`placement in a human blood vessel (ER §VII). Specifically, the Cragg II filter is a
`
`self-expanding Nitinol wire coil delivered by a Teflon catheter (601, FIG. 1B):
`
`Cragg II FIG. 1B
`
`
`
`The coil is annealed and then cooled in ice water, at which time it is stressed
`
`into a straightened (i.e., deformed) shape (602). Cragg II provides that the
`
`“transition temperature” (i.e., the Af temperature) is “about 30°C for the alloy used
`
`in this study” (601, ER §VII). Also, because the wire is annealed, the Ms and Mf
`
`temperatures are well below 0° C (ER §VII). Hence, the wire coil disclosed in
`
`Cragg II exhibits the following temperature ranges (ER §VII):
`
`
`
`15
`
`IPR2019-00123 Page 00021
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed January 17, 2014
`
`SIM Not
`Possible
`(Only TIM)
`
`SIM
`Possible
`
`Mr = < 00
`
`Ms = < 00
`
`Md = > 150°
`
`As =~15o Ar =30o
`\
`
`y
`
`Temperature
`
`Range for Pseudo elasticity
`
`
`
`Because the ice water temperature is higher than even the most conservative
`
`MS temperature (minus 4° C, see ER §VII), drawing the wire filter into the catheter
`
`would straighten the Nitinol wire into a deformed shape through the formation of
`
`stress-induced martensite (and not through the formation of thermally induced
`
`martensite). That is, the initial deformation of the wire coil when drawn into the
`
`catheter necessarily causes SIM – not TIM.
`
`Cragg II further provides that the “catheter with the loaded wire [filter] …
`
`was deposited in the vena cava by withdrawing the catheter over the adapting
`
`wire” (602). As the wire is deployed, the Cragg I filter resumes its coil shape
`
`(602). Because the temperature of the wire in the catheter necessarily reaches and
`
`remains at its As temperature upon insertion into the body, when extended from the
`
`catheter the Nitinol alloy wire filter in Cragg II goes from a SIM state to an
`
`unstressed austenitic state (the transformation from SIM to austenite oc

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