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Case Title

Inter Partes Review of U.S. Pat. 6,306,141

Docket Number

IPR2013-00269

Court

Patent Trial and Appeal Board

Document Title

Petition 1: Petition for Inter Partes Review of USPN 6,306,141

Date Filed

05/06/2013
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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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