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
`
`Lombard Medical Technologies PLC (“Lombard” or “Petitioner”) hereby
`
`requests Inter Partes Review (“IPR”) of Claims 1-10 and 18-22 in U.S. Patent
`
`Number 6,306,141 (“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. 16–0605.
`
`This
`
`document, together with all exhibits referenced herein, has been served on the
`
`patent owner at the address of record for the 141 patent, as well as on the counsel
`
`of record for the 141 patent, as reflected in the accompanying Certificate of
`
`Service.
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`TABLE OF CONTENTS
`
`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
`
`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.
`E.
`F.
`
`G.
`
`Subject Matter of the 141 Patent .......................................................4
`Prosecution History Of The 141 Patent: Issuance Based On
`a False Representation Of The Properties Of Nitinol......................6
`The IPR Claims are Obvious in view of Balko, Kirk-
`Othmer, and Foster under § 103(a).................................................12
`The IPR Claims are Anticipated by Dotter under § 102(e) .........22
`Claims 6-10 are Obvious in view of Dotter under § 103(a)...........30
`Claims 1-5 and 18-22 are Anticipated by Cragg under §
`102(a) ..................................................................................................31
`Claims 1-5 and 18-22 are Obvious In View of Miyauchi &
`Cragg under § 103(a) ........................................................................37
`
`ii
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`H.
`
`I.
`
`Claims 6-10 are Obvious in view of Dotter & Miyauchi
`under § 103(a) ....................................................................................43
`The IPR Claims are Invalid For Obvious-Type Double
`Patenting.............................................................................................46
`i.
`The IPR Claims Are Obvious Variants of Claims in
`the ’378 Patent.........................................................................47
`The IPR Claims Are Not Entitled to Safe Harbor...............53
`
`ii.
`
`IX. CONCLUSION ............................................................................................59
`
`iii
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`EXHIBIT LIST
`
`U.S. Patent No. 6,306,141 to Jervis
`
`U.S. Patent No. 4,512,338 to Balko et al.
`
`Schetky, Shape Memory Alloys, Kirk-Othmer Encyclopedia of
`Chemical Technology, Vol. 20 726-736 (3d Ed. 1982)
`
`U.S. Patent No. 4,503,569 to Dotter
`
`A. Cragg et al., Nonsurgical Placement of Arterial Endoprostheses: A
`New Technique Using Nitinol Wire, Radiology, Vol. 147: 261-263
`(April 1983)
`
`Japanese Patent Publication No. S58-46923 (filed Sept. 12, 1981;
`disclosed Mar. 18, 1983) to Miyauchi et al.
`
`Certified Translation of Japanese Patent Publication No. S58-46923 to
`Miyauchi et al.
`
`U.S. Patent No. 5,597,378 to Jervis
`
`Declaration of Scott M. Russell
`
`Curriculum Vitae of Scott M. Russell
`
`U.S. Patent No. 4,307,723 to Finney
`
`Prosecution History of U.S. Patent No. 6,306,141
`
`Prosecution History of U.S. Patent No. 5,597,378
`
`U.S. Patent No. 4,485,805 to Foster
`
`Certified Transcript of Deposition of Dr. Lee Middleman, Dec. 10-11,
`2008.
`
`Inherent Properties Video Presentation by Mr. Scott M. Russell
`
`iv
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`

`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`Double Patenting Video Presentation (Part 1) by Mr. Scott M. Russell
`
`C. Dotter et al., Transluminal Expandable Nitinol Coil Stent Grafting:
`Preliminary Report, Radiology, Vol. 147: 259 (April 1983)
`
`Otsuka et al., Pseudoelastiticy, 4 Metals Forum No. 3, 142 (Aus. Inst.
`of Metals 1981)
`
`Delaey, et al., Thermoelasticity, pseudoelasticity and the memory
`effects associated with martensitic transformations. Part 1:
`Structural and microstructural changes associated with the
`transformations, 9 Journal of Materials Science 1521 (1974)
`
`Krishnan, et al., Thermoplasticity, pseudoelastiticy and the memory
`effects associated with martensitic transformations. Part 2: The
`macroscopic mechanical behavior, 9 Journal of Materials Science
`1536 (1974)
`
`U.S. Patent No. 3,890,977 to Wilson
`
`European Patent Publication No. 0129634 to Drettner
`
`Canadian Patent No. 1001034 to McWhorter
`
`U.S. Patent No. 4,401,433 to Luther
`
`Double Patenting Video Presentation (Part 1) by Mr. Scott M. Russell
`
`Kauffman et al., The Story of Nitinol: The Serendipitous Discovery of
`the Memory Metal and Its Applications, Vol. 2, No. 2 The Chemical
`Educator 1, 4-6
`
`Ling et al., Phase Transitions and Shape Memory in NiTi, 11A
`Metallurgica Transactions A 77, 77-79 (1980)
`
`Schetky, Shape-Memory Alloys, 241:5 Scientific American 74-82
`(November 1979)
`
`Patel et al., Criterion for the Action of Applied Stress in the
`Martensitic Transformation, 1 Acta Metalurgica 531-538 (1953)
`
`v
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`1031
`
`1032
`
`Otsuka et al., Stress and Strain Induced Martensitic Transformations,
`Proceedings of the Int’l Conference on Martensitic Transformations:
`ICOMAT 1979, Cambridge, MA Jun 1979, 607.
`
`Miyazaki, et al., Transformation Pseudoelasticity and Deformation
`Behavior in a Ti-50.6at%Ni Alloy, 15 Scripta Metallurgica 287, Fig. 1
`(1981)
`
`vi
`
`

`
`I.
`
`REAL PARTY IN INTEREST UNDER 37 C.F.R. § 42.8(b)(1)
`
`The real party in interest
`
`for Petitioner
`
`is LOMBARD MEDICAL
`
`TECHNOLOGIES PLC.
`
`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 Steven D. Hemminger of Alston & Bird
`
`LLP, USPTO Reg. No. 30,755. Backup counsel for the Petitioner is Christopher
`
`B. Kelly of Alston & Bird LLP, USPTO Reg. No. 62,573. 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 650-838-2029, by
`
`email at steve.hemminger@alston.com, and by facsimile at 650-838-2001.
`
`Petitioner may be served as follows:
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`Steven D. Hemminger
`ALSTON & BIRD LLP
`275 Middlefield Road, Suite 150
`Menlo Park, CA 94025-4008
`
`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 1-10 and 18-22 of the 141 patent (the
`
`IPR Claims) under 35 U.S.C. § 103(a) as being obvious in view of U.S. Patent No.
`
`4,512,338 to Balko et al. (“Balko,” Exhibit 1002); Schetky, Shape Memory Alloys,
`
`20 Kirk-Othmer Encyclopedia of Chemical Technology 726-736 (3d Ed. 1982)
`
`(“Kirk-Othmer,” Exhibit 1003); and U.S. Patent No. 4,485,805 to Foster (“Foster,”
`
`Exhibit 1014).
`
`(Ground #2) Invalidation of The IPR Claims under 35 U.S.C. § 102(e) as
`
`being anticipated by U.S. Patent No. 4,503,569 to Dotter (“Dotter,” Exhibit 1004)
`
`or—alternatively—under 35 U.S.C. § 103(a) as being obvious in view of Dotter.
`
`(Ground #3) Invalidation of Claims 1-5 and 18-22 of the 141 patent 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," Exhibit 1005);
`
`(Ground #4) Invalidation of Claims 1-5 and 18-22 of the 141 patent under
`
`35 U.S.C. § 103(a) as being obvious in view of Japanese Patent Publication No.
`
`2
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`S58-46923 to Miyauchi et al. (“Miyauchi,” original Exhibit 1006, and certified
`
`English translation Exhibit 1007) and Cragg.
`
`(Ground #5) Invalidation of Claims 6-10 of the 141 patent under 35 U.S.C.
`
`§ 103(a) as being obvious in view of Dotter and Miyauchi.
`
`(Ground #6) Invalidation of The IPR Claims under the doctrine of obvious-
`
`type double patenting over the claims of U.S. Patent No. 5,597,378 to Jervis, filed
`
`October 2, 1992 and issued on January 28, 1997 ("the ’378 Patent", Exhibit 1008).
`
`VII. HOW THE CHALLENGED CLAIMS ARE TO BE CONSTRUED
`UNDER 37 C.F.R. § 42.104(b)(3)
`
`The IPR 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 priority to U.S. Appl. No. 06/541,852 (“852
`
`Application”), filed in October of 1983. As a result of terminal disclaimers based
`
`on obviousness type double patenting rejections, the other 4 patents issuing from
`
`that application all expired on the same date as the first patent issuing from the 852
`
`Application, May 4, 2004. As a result, the 141 patent claims represent the last
`
`gasp of its owner Medtronic, Inc. to exclude others in the medical device industry
`
`from using technology known in the art for more than 30 years.
`
`3
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`In fact, as explained further below, the only reason the 141 patent claims
`
`issued is because the PTAB relied on a declaration of an “expert” in stress induced
`
`martensite, who has since admitted that he is not and never was an expert in that
`
`field.
`
`In addition, the IPR Claims are unpatentable over various prior art
`
`references that were not before the USPTO during prosecution.
`
`Subject Matter of the 141 Patent
`A.
`The IPR 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. 141 patent, 2:59 to 3:4, 10:59 to 14:23. All
`
`SMA elements, such as Nitinol, include a “martensite” phase and an “austenite”
`
`phase. These phases refer to different crystalline structures of the SMA, each of
`
`which has different inherent properties.
`
`Just as water can transform between
`
`various phases (e.g., vapor, liquid, ice), all SMAs are capable of transforming
`
`between the austenite phase and the martensite phase; the former a comparatively
`
`rigid solid (useful for maintaining the patency of a blood vessel) and the later a
`
`more malleable solid (useful for delivery through a catheter).
`
`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); if when an
`
`4
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`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 often referred to
`
`as “thermally induced martensite” or “TIM.” Likewise, if an SMA can change
`
`state as a result of temperature, the application of sufficient stress to the SMA
`
`when in its austenite phase, will transform the SMA to its martensite phase. This
`
`transformation as a result of stress is often referred to as “stress induced
`
`martensite” or “SIM.” 141 patent, 1:52-53. An important inherent property of
`
`every SMA that can transform to martensite thermally, is that it can transform to
`
`martensite through the application stress—i.e., if TIM then SIM. This inherent
`
`property was never disclosed in the application. More importantly for this petition,
`
`Medtronic,
`
`in the appeal during prosecution of the 141 patent application,
`
`Medtronic not only did not disclose this inherent property, but misled the board in
`
`to reaching the conclusion that not all SMAs that exhibit TIM exhibit SIM, and on
`
`that basis allowed the claims.
`
`SMAs also have a “shape memory” property that enables them to memorize
`
`their austenitic shape. This is exhibited in two ways:
`
`thermal shape memory and
`
`mechanical shape memory (also referred to as “pseudoelasticity”). Thermal shape
`
`memory generally refers to when one cools austenite to form martensite, deforms
`
`the martensite, and then heats the alloy so that it reverts back to its undeformed
`
`austenitic state. Mechanical shape memory refers to the same process, but wherein
`
`5
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`martensite is formed by the application of stress, rather than by cooling, and the
`
`release of stress allows the austenite phase to be restored without any change in
`
`temperature.
`
`tin this is an inherent property of Nitinol, one of the SMAs used in
`
`most medical devices in the late 1970’s and early 1980’s.
`
`To assist the Board in understanding these SMA properties, Petitioners have
`
`submitted the declaration of Mr. Scott M. Russell—an expert in shape memory
`
`alloys—providing a detailed explanation of the inherent properties of SMAs
`
`(“Expert Report” or “ER,” Exhibit 1009), as well as a video presentation by Mr.
`
`Russell providing further explanation of these inherent properties (“Inherent
`
`Properties Video,” Exhibit 1016). Mr. Russell focuses on the properties of
`
`“Nitinol,” a shape memory alloy formed of nickel and titanium. Nitinol is the most
`
`widely used shape memory alloy in medical applications, is referenced throughout
`
`the 141 patent, and is the SMA disclosed in all of the prior art references discussed
`
`herein. 141 patent, 9:14 to 10:7. As discussed in detail below, an understanding of
`
`the inherent properties of Nitinol will be important in assessing validity of the IPR
`
`Claims.
`
`B.
`
`Prosecution History Of The 141 Patent: Issuance Based On
`a False Representation Of The Properties Of Nitinol
`
`The 141 patent characterizes the improvement of its claimed medical device
`
`as “the substitution of an alloy element which displays stress-induced martensite at
`
`6
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`body temperature.” Id. at 3:1-4 (emphasis added).
`
`In particular, the 141 patent
`
`suggests that the known shape memory elements in medical devices only exhibited
`
`TIM, which rendered them more difficult to deliver into the body due to the
`
`requirement for temperature control.
`
`Id. at 1:26 to 2:54; 9:14 to 10:7.
`
`In
`
`particular the specification identifies the desirability of “a way to in which the
`
`advantageous property of shape memory alloys, i.e., their ability to return to an
`
`original shape after relatively substantial deformation, could be used in the medical
`
`devices without requiring the delicacy of alloying control and/or the temperature
`
`control of placement or removal needed by present shape memory alloy devices.”
`
`Id. at 2:48-54. This passage incorrectly states that the Nitinol SMA devices in the
`
`prior art listed in the Background did not already possess those properties – they
`
`did. The statement that by “substituting” an alloy element exhibiting SIM for one
`
`that exhibits TIM, the shape memory alloy element is more easily deliverable and
`
`therefore a significant improvement over the prior art (Abstract & 2:59 to 3:4) is at
`
`best misleading.
`
`During prosecution, the Examiner issued a Final Office Action rejecting the
`
`IPR Claims as being obvious in view of Balko, Kirk-Othmer, and Foster.
`
`Prosecution History of 141 patent (“141 History,” Exhibit 1012), Final OA, Sept.
`
`15, 1997, pp. 2-3. The Examiner found that Balko disclosed every feature of
`
`independent Claims 1, 6, and 18—a shape memory alloy in the form of a Nitinol
`
`7
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`wire graft (22) and a hollow placement device in the form of a sheath (50)—but
`
`lacked specific disclosure that its Nitinol wire was pseudoelastic and capable of
`
`exhibiting stress-induced martensite.1 The Examiner recognized that Kirk-Othmer
`
`discloses that Nitinol is inherently capable of exhibiting pseudoelastic behavior,
`
`that
`
`it was therefore obvious that Balko’s Nitinol device has pseudoelastic
`
`properties, because it was well known in the art that pseudoelastic Nitinol could
`
`inherently exhibit a stress-induced martensite state at body temperature. Id. at 2.
`
`Medtronic Appealed to the Board and submitted with its arguments a
`
`declaration by Dr. Middleman, whom Medtronic represented was “an expert in the
`
`field of stress-induced martensite (SIM) alloy elements.” 141 History, Appeal
`
`Brief, Jun. 18, 1998, p. 18 and Middleman Dec. Dr. Middleman stated:
`
`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 . . . . Id. at Middleman Dec, p. 4 (emphasis added).
`
`1 The Examiner also felt Balko lacked sufficient disclosure of a guide wire, and
`
`pointed to Foster for disclosure of this feature. Id. at 3.
`
`8
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`In its Decision,
`
`the Board reversed the Examiner’s rejections, relying
`
`principally 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
`
`because in the ex parte appeal process Medtronic represented he was an expert in
`
`SIM with knowledge of Nitinol processing, the reality is that Dr. Middleman has
`
`since admitted that he is not an expert in SIM.
`
`In 2007, Medtronic sued AGA Medical Corp. (“AGA”) for infringement of,
`
`inter alia, the 141 patent. Medtronic, Inc. et al. v. AGA Medical Corporation, Case
`
`No. C07 00567 MMC (N.D.C.A.) (settled and dismissed in 2010). During the
`
`course of litigation, Dr. Middleman was deposed. Deposition of Dr. Middleman,
`
`Dec. 10-10, 2008 (“Middleman Deposition,” Exhibit 1015).
`
`Contrary to
`
`Medtronic’s representation to the Board that Dr. Middleman was an expert in the
`
`field of SIM, Dr. Middleman testified that, not only was he not an expert in SIM,
`
`but that he could not even recall the meaning of SIM.
`
`9
`
`

`
`Middleman Deposition, p. 100:
`
`Middleman Deposition, p. 100:
`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`Middleman Deposition, p. 29:
`
`Middleman Deposition, p. 146-148:
`
`Middleman Deposition, p. 29:
`
`Middleman Deposition, p. 34:
`
`Middleman Deposition, p. 229:
`
`Middleman Deposition, p. 29:
`
`10
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`Id. at pp. 29, 34, 100, 146-148, 229.2
`
`As explained by Mr. Russell, an actual expert in SMAs, all Nitinol alloys
`
`that can exhibit thermally-induced martensite (TIM) can inherently also exhibit
`
`stress-induced martensite (SIM). ER, pp. 11-16. This follows fundamental
`
`thermodynamic principles and, in fact, no special treatment is required for a
`
`Nitinol alloy that exhibits TIM to also exhibit SIM. Id. As such, the Examiner
`
`was correct that Balko’s Nitinol wire—which exhibits TIM—would inherently be
`
`capable of exhibiting SIM. See Balko, 3:30 to 4:47 (thermal transformation from
`
`martensite to austenite). The requirement for “special treatment” set forth by Dr.
`
`Middleman—and upon which the Board based its Decision on Appeal—is quite
`
`simply false. Id. at 11-16 and 27-31.
`
`Given that
`
`the Board’s reliance on the Middleman Declaration was
`
`misplaced, the IPR Claims should be invalidated as being obvious under § 103(a)
`
`in view of the references relied on by the Examiner—Balko, Kirk-Othmer, and
`
`Foster. In addition, other references disclose all of the features of Claims 1-10 and
`
`18-22, some of which—Dotter and Miyauchi—were not considered during
`
`prosecution of the 141 patent.
`
`2 Statements indicated “A” were made by Dr. Middleman; statements indicated
`
`“Q” were made by AGA’s counsel Mr. Steve Hemminger.
`
`11
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`All of the prior art reference discussed below use a Nitinol alloy element in a
`
`medical device. In considering them, it is important to bear in mind three inherent
`
`properties of Nitinol alloys in assessing the validity of the IPR Claims:
`
` Nitinol alloys that exhibit TIM also inherently exhibit SIM.
` In such Nitinol alloys, martensite is martensite and there is no
`difference between martensite formed by changing temperature
`and martensite formed by changing stress.
` Any Nitinol material that can exhibit TIM will be pseudoelastic if
`stressed between AS and MD temperatures.
`
`The scientific basis for each of these inherent properties is described in
`
`detail in Petitioner’s Expert Report and Inherent Properties Video.
`
`C.
`
`The IPR Claims are Obvious in view of Balko, Kirk-
`Othmer, and Foster3 under § 103(a)
`
`Balko discloses various embodiments of a Nitinol coil (24) configured for
`
`insertion into a human body. As shown in Fig. 6 below, the Nitinol coil (24) is
`
`configured to be deformed to a martensitic state in which it is a “relatively straight
`
`length of wire” for delivery into a human body through a sheath. Balko, 3:54-63.
`
`3 Balko was filed on Jan. 25, 1983 and issued on Apr. 23, 1985, and thus qualifies
`
`as prior art under § 102(e). Kirk-Othmer was published in 1982 and thus qualifies
`
`as prior art under § 102(a). Foster was filed on Aug. 24, 1982 and issued on
`
`Dec. 4, 1984, and thus qualifies as prior art under § 102(e).
`
`12
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`Upon extrusion out of the sheath and into a blood vessel, the Nitinol wire (24)
`
`reverts back to its austenitic coil configuration to maintain the patency of the
`
`vessel. Id. at 3:54-63; Figs. 1-8.
`
`Balko Figure 6
`
`Balko’s Nitinol coil (24) is inherently capable of exhibiting the same
`
`behavior as the memory alloy element and stent recited in the IPR Claims. For
`
`example, Balko teaches that
`
`its Nitinol coil
`
`(24)
`
`is capable of
`
`thermal
`
`transformation between its austenitic and martensitic states (i.e., the coil exhibits
`
`TIM).
`
`Id. at 3:30 to 4:12. Because any Nitinol alloy that exhibits TIM is
`
`inherently capable of exhibiting SIM, Balko’s Nitinol coil (24) can inherently
`
`exhibit SIM. See ER, pp. 11-16. Moreover, Balko teaches that its coil can be
`
`alloyed to have an AF temperature below body temperature. Balko, 3:54 to 4:12.
`
`As discussed in the Expert Report, an alloy’s AF temperature is inherently above its
`
`AF temperature. ER, pp. 16-20. Accordingly, the coil (24) inherently can form
`
`SIM at and below body temperature. Balko, 3:54 to 4:12; see also ER, pp. § 2. As
`
`taught in Kirk-Othmer and explained in Russell’s Expert Report, Balko’s Nitinol
`
`13
`
`

`
`coil (24) is inherently capable of exhibiting pseudoelastic behavior. K-O, 727-28,
`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`731, Table 1; see also ER, pp. 16-22.
`
`A detailed chart showing where each feature of the IPR Claims is disclosed
`
`in Balko, Kirk-Othmer, and Foster follows. For the each of the claim charts below,
`
`Petitioner notes that reference can be made to the corresponding claim charts in the
`
`attached Expert Report (Exhibit 1009) for the opinions of Mr. Scott M. Russell.
`
`Kirk-Othmer discusses properties of shape memory alloys, while Foster
`
`discloses a guide wire to insert a medical device into a human body. Thus, a
`
`person of ordinary skill would have found motivation to look to and utilize their
`
`respective teachings with Balko’s teachings of the benefits of a shape memory
`
`medical device.
`
`141 Patent:
`Claims 1-10 & 18-22
`1. A medical device for
`insertion into a
`mammalian body, the
`device comprising
`(a) a hollow placement
`device;
`(b) a memory alloy
`element
`
`formed at least partly
`
`Balko (Exh. 1002) + Kirk-Othmer (Exh. 1003)
`+ Foster (Exh. 1014)
`Non-limiting preamble. However, Balko discloses a
`Nitinol wire coil (24) configured for insertion into a
`human vessel, such as an artery. Abstract; 2:27 to
`6:16; Figs. 1-8.4
`Balko discloses a hollow placement device in the
`form of a sheath (20). 3:4-29.
`Balko discloses a memory alloy element in the form
`of a Nitinol wire coil (24/24a/26/26a, collectively
`“24”). 3:30 to 6:7; Figs. 1-8.
`Balko discloses a Nitinol coil (24) having a transition
`
`4 Column, line, page numbers and the like in each claim chart refer to a respective
`
`chart’s lead reference unless otherwise indicated.
`
`14
`
`

`
`from pseudoelastic
`shape-memory alloy,
`
`the alloy displaying
`reversible stress-induced
`martensite at about body
`temperature such that it
`has a stress-induced
`martensitic state and an
`austenitic state,
`
`the memory alloy
`element having (i) a
`deformed shape when
`the alloy is in its stress
`induced martensitic state
`and (ii) a different
`unstressed shape when
`the alloy is in its
`austenitic state; and
`
`(c) a guide wire;
`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`temperature (AF) at which the coil will thermally
`transform from martensite to austenite. 3:30 to 4:47.
`Above AF, Balko’s Nitinol coil (24) is inherently
`pseudoelastic. Expert Report (herein “ER”), § II.
`Kirk-Othmer also recognizes the inherent
`pseudoelasticity of Balko’s Nitinol coil. Kirk-Othmer
`(“K-O”), 727-28, 731, Table 1.
`Balko’s Nitinol coil can be thermally transformed
`between austenite and martensite (i.e., the coil can
`exhibit TIM). 3:30 to 4:12. All Nitinol alloys that
`exhibit TIM inherently can exhibit SIM. ER, § II.
`Balko’s coil (24) is alloyed such that it will thermally
`transform from martensite to austenite at a
`transformation temperature (AF) that is “somewhat
`below the normal body temperature.” 3:54 to 4:12.
`Accordingly, at body temperature (above AF), the
`Nitinol coil (24) can inherently be transformed to its
`martensitic state by stress (i.e., stress-induced
`martensitic state). Id. At body temperature and
`absent stress, the Nitinol coil (24) will inherently
`revert to back to its austenitic state (i.e., reversible
`transformation). ER, § II; K-O, 726-29, 731. For
`Balko’s Nitinol coil (24), martensite is martensite and
`there is no difference between martensite formed by
`applying stress and martensite formed by adjusting
`temperature. ER, § II.
`Balko discloses that its Nitinol coil (24) can be
`deformed in its martensitic state to a “relatively
`straight length of continuous wire” (deformed shape)
`and returns to a continuous coil shape (unstressed
`shape) when in its austenitic state. 3:54-63, Figs. 1-8.
`As discussed above, the transformation between these
`shapes can be caused by stress or temperature and—
`for Balko’s coil—there is no difference between
`martensite formed by changing stress and martensite
`formed by changing temperature. ER, § II; K-O,
`726-27, 731.
`Balko discloses a guide wire in the form of its
`member (52), which is a “wire” element configured to
`help a surgeon manipulate the sheath (20). 4:38-47.
`
`15
`
`

`
`the memory alloy
`element being within the
`hollow placement
`device, and
`the placement device
`being guidable by the
`guide wire,
`
`the hollow placement
`device stressing the
`memory alloy element at
`a temperature greater
`than the AS of the alloy
`so that the memory alloy
`element is in its
`deformed shape,
`
`wherein the memory
`alloy element can be
`extruded from the
`hollow placement device
`by the guide wire at a
`temperature greater than
`the AS of the alloy to
`transform at least a
`portion of the alloy from
`its stress-induced
`martensitic state so that
`the memory alloy
`
`Petition for Inter Partes Review of U.S. Patent No. 6,306,141
`Filed May 6, 2013
`
`Foster discloses use of a guide wire in the form of a
`stylette (16) configured for guiding a medical device
`into a body cavity. Foster, 3:62 to 4:51, 5:21-46.
`Balko discloses that its Nitinol wire coil (24)
`(memory alloy element) is configured for placement
`in its sheath (20) (hollow placement device). 4:4-36;
`col. 5:13-47; Figs. 5-8.
`The sheath (20) is inserted by “conventional
`techniques,” which one of ordinary skill would know
`includes guiding by a guide wire. 3:4-13; Fig. 1.
`Balko also states the wire member (52) enables
`positioning of the sheath (20). 4:38-47. Foster
`discloses its stylette (16) enables positioning of a
`medical device in a body cavity. Foster, 3:62 to 4:51,
`5:21-46.
`The Nitinol coil (24) in its coiled shape has a
`diameter sufficient to maintain the patency of a blood
`vessel, while the sheath (20)—through which the coil
`(24) is fed—has a smaller diameter for insertion into
`a blood vessel. 3:4-29; 4:13-57. When positioned
`within the sheath (20) and delivered into the body, the
`coil (24) heats to body temperature (just above the
`coil’s AF and inherently above AS) and thus
`inherently attempts to revert from its deformed
`martensitic shape back to its larger austenitic state.
`K-O, 726-27, 729; ER, § II. The coil remains in its
`deformed shape because the sheath (20) constrains it
`by applying stress as the coil attempts to expand. Id.
`As noted above, it would have been obvious to a
`person of ordinary skill to use a guide wire to extrude
`the Nitinol coil (24) from the sheath (20), and Balko
`discloses the coil (24) can be extruded by the wire
`member (52) or “further wire.” 4:13 to 5:40; see also
`Foster, 3:62 to 4:51, 5:21-46. In Balko’s AF = below
`body temperature embodiment, the Nitinol coil (24)
`since it is restrained in the sheath (20) is still held in a
`martensitic state by stress as it is passed through the
`sheath (20) at body temperature. 3:54 to 4:57; K-O,
`726-731. When the coil (24) is extruded from the
`sheath (20) into the blood vessel, the coil (24) stays at
`
`16
`
`

`
`element transforms from
`its deformed shape to its
`unstressed shape,
`
`and wherein the alloy is
`selected so that the
`transformation can occur
`without any change in
`temperature of the
`placement device or the
`memory alloy element.
`
`2. The device of claim 1
`wherein the memory
`alloy element is a stent.
`3. The device of claim 2,
`including a guide wire
`for endarterial placement
`of a stent graft.
`
`4. The invention of claim
`1 wherein the
`transformation occurs
`without any change in
`the state of the
`placement device.
`5. The device of claim 1,
`wherein the hollow
`placement device is a
`cathet

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