throbber
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________
`
`
`W.L. GORE & ASSOCIATES, INC.
`Petitioner
`
`
`v.
`
`
`LIFEPORT SCIENCES LLC
`Patent Owner
`
`
`Patent No. 6,117,167
`Filing Date: February 9, 1998
`Issue Date: September 12, 2000
`Title: ENDOLUMINAL PROSTHESIS AND SYSTEM FOR JOINING
`__________________
`
`Inter Partes Review No. Unassigned
`__________________
`
`DECLARATION OF ENRIQUE CRIADO, M.D.
`
`INTRODUCTION
`
`I.
`
`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`
`
`1.
`
`I have been retained by W.L. Gore & Associates (“Gore”) to provide a
`
`technical evaluation and report regarding my opinions on topics in this matter
`
`relating to the inventions claimed in U.S. Patent Nos. 6,117,167 (“’167 patent”).
`
`In particular, for the purposes of this report, I have been asked to provide an
`
`analysis of the scope and content of the ’167 patent relative to the state of the art at
`
`US.54716818.02
`
`1
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-1
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`the time of the earliest application underlying the ’167 patent. I have also been
`
`retained to provide analysis regarding what a person of ordinary skill in
`
`intraluminal (or endovascular) graft, stent, and stent graft arts would have
`
`understood at the time of the earliest application underlying the ’167 patent.
`
`2.
`
`This report summarizes the opinions that I have formed to date, and it is
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`based on personal knowledge, skill, experience, and review of materials read and
`
`considered in connection with this opinion. I may modify my opinions if
`
`necessary, based on further review and analysis of information provided to me
`
`subsequent to the serving of this report. If called to testify at a U.S. Patent and
`
`Trademark Office (“PTO”) hearing regarding the contents of this report, I will do
`
`so.
`
`II. EXPERIENCE AND QUALIFICATIONS
`
`3.
`
`I have over 20 years of academic and professional experience in vascular
`
`surgery and endovascular interventions. I have experience in both developing and
`
`making stent grafts, in the surgical placement of grafts, and in the endovascular
`
`placement of stent grafts and stents. My curriculum vitae is attached as Exhibit
`
`1020, and accurately describes my experience, education, employment,
`
`publications, presentations, awards, honors, memberships, and consulting
`
`positions.
`
`US.54716818.02
`
`2
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-2
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`4.
`
`I received my B.S. from the Instituto Nacional de Enseñanza Media
`
`Cervantes, Madrid, Spain. I received my M.D. from the Universitas Complutensis,
`
`School of Medicine, Madrid, Spain.
`
`5. My postdoctoral training occurred at North Carolina Memorial Hospital,
`
`Department of Surgery University of North Carolina at Chapel Hill, and included a
`
`surgery internship from 1985-86, surgery residency from 1986-89, appointment as
`
`chief resident from 1989-90, and vascular surgery fellowship from 1990-91. In
`
`addition, I had a research fellowship at the Division of Cardiothoracic Surgery,
`
`Department of Surgery, University of North Carolina at Chapel Hill.
`
`6.
`
`I have held several academic appointments. I am currently a Professor of
`
`Surgery and the Director of Endovascular Surgery at the University of Michigan,
`
`and have held that position since January 2006. From 2002 to 2005, I was an
`
`Associate Professor of Surgery at the State University of New York at Stony
`
`Brook, where I was also the Chief of the Division of Vascular Surgery, as well as
`
`the Program Director of the Vascular Surgery Training Program. From February
`
`2002 to September 2002, I was an Associate Clinical Professor of Surgery at the
`
`University of Maryland. From 1996 to 1998, I was an Associate Professor of
`
`Surgery (tenured) at the University of North Carolina at Chapel Hill and an
`
`Adjunct, Clinical Professor of Surgery at Duke University Medical Center. In
`
`addition, from 1992 to 1998, I was an Assistant Professor of Surgery at the
`
`US.54716818.02
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`3
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-3
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`University of North Carolina at Chapel Hill. Beforehand, I was a Clinical
`
`Assistant Professor of Surgery, from 1991 to 1992, and Surgery Instructor, from
`
`1990 to 1991, at the University of North Carolina at Chapel Hill.
`
`7.
`
`In addition, I have held several clinical hospital appointments. Since
`
`January 2006, I have been the Director of Endovascular Surgery at the University
`
`of Michigan. From 2002 to 2005, I was an Attending Surgeon at the Stony Brook
`
`University Hospital as well as an Attending Surgeon at the Northport Veterans
`
`Administration Medical Center, New York. From 2001 to 2002, I was an
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`Attending Surgeon and Medical Director of the Non-invasive Vascular Laboratory
`
`at Mercy Medical Center, Maryland. From 1998 to 2001, I was the Director of
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`Vascular Surgery Service at Fundación Hospital de Alcorcón, Madrid, Spain.
`
`From 1995 to 1998, I was the Chief of the Endovascular Surgery Section of the
`
`Division of Vascular Surgery at the University of North Carolina at Chapel Hill. I
`
`was also an Attending Surgeon at the University of North Carolina Hospital from
`
`1990 to 1998 and an Attending Surgeon at the Durham Veterans Administration
`
`Medical Center (affiliated with Duke University). Finally, I was an Attending
`
`Surgeon in General Surgery at the National Institute of Health, León, Spain from
`
`1983 to 1984 and at the Central Military Hospital, Madrid, Spain from 1982 to
`
`1983.
`
`US.54716818.02
`
`4
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-4
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`8. Moreover, I have served as a reviewer or on the Editorial Board for the
`
`Annals of Vascular Surgery, Journal of Vascular Surgery, Journal of
`
`Endovascular Surgery, Mayo Clinic Proceedings, Vascular Surgery Outlook, and
`
`Archivos de Ciugía Vascular, and currently I am Associate Editor of the Annals of
`
`Vascular Surgery.
`
`9.
`
`As set forth in Exhibit 1020, I have given over 200 scientific presentations,
`
`including presentations related to using stents, grafts, and stent grafts to treat
`
`vascular disease. Representative presentations include, for example:
`
`• Criado E, Marston WA, “Treatment of aortic aneurysms with stented
`endovascular grafts,” University of North Carolina at Chapel Hill,
`Department of Surgery Grand Rounds, August 17, 1994.
`
` •
`
` Criado E, “Endovascular treatment of peripheral aneurysms,
`pseudoaneurysms and arterio-venous fistulae,” Fifth Annual Symposium on
`Current Therapy in Vascular Surgery, The Friday Center, University of
`North Carolina at Chapel Hill, Chapel Hill North Carolina, November 10,
`1995.
`
` •
`
` Criado E, “Endovascular treatment of aortic aneurysms,” University of
`North Carolina at Chapel Hill, Symposium on Current Therapy in Vascular
`Surgery, September 10, 1994.
`
` •
`
` Criado E, “Developments in endovascular stents and grafts,” University of
`North Carolina at Chapel Hill, Department of Surgery Grand Rounds, April
`12, 1995.
`
` •
`
` Marston WA, Criado E, Risley JL, McHugh P, Keagy BA, “Mechanical
`characteristics of dilated PTFE used for covered stents and stent grafts,”
`XXI Annual meeting of The Peripheral Vascular Surgery Society,
`Swisshotel, Chicago, Illinois, June 7, 1996.
`
`
`
`US.54716818.02
`
`5
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-5
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`• Criado E, “Endovascular treatment of iliac artery pathology,” Annual
`Symposium on New Developments in Vascular Surgery, The Friday Center,
`University of North Carolina at Chapel Hill, Chapel Hill, North Carolina,
`November 8, 1996.
`
` •
`
` Criado E, Marston W, Ligush J, Burnham SJ, Keagy BA, “Endovascular
`treatment of lesions involving branches of the aortic arch,” XXI Annual
`Winter Meeting of the Peripheral Vascular Surgery Society, Park City, Utah,
`January 12, 1996.
`
` •
`
` Criado E, “Endovascular treatment of peripheral aneurysms,” Advances in
`the diagnosis and treatment of vascular disease, postgraduate course,
`Pontificia Universidad Catolica de Chile, Santiago de Chile, Chile, August
`10, 2002.
`
`
`10. As set forth in Exhibit 1020, I have authored or co-authored over 140
`
`publications, including publications related to using stents, grafts, and stent grafts
`
`to treat vascular disease. Representative publications include, for example:
`
`• Marston WA, Criado E, Mauro M, Keagy BA, “Transbrachial repair of an
`axillary artery pseudoaneurysm using a PTFE covered stent,” Journal of
`Endovascular Surgery, 1995; 2(2):172-176.
`
` •
`
` Criado E, Marston WA, Woosley JT, Ligush J, Chuter T, Baird C, Keagy
`BA, “An aortic aneurysm model for the evaluation of endovascular
`exclusion prostheses,” Journal of Vascular Surgery, 1995; 22:306-315.
`
` •
`
` Marston WA, Criado E, Baird C, Keagy BA, “Reduction of aneurysmal
`pressure and wall stress after endovascular repair of abdominal aortic
`aneurysms in canines,” Annals of Vascular Surgery, 1996; 10:166-173.
`
` •
`
` Criado E, Marston WA, Woosley JT, Reddick R, “Endothelial cell
`coverage of endovascular dacron grafts in canines,” Journal of Vascular
`Surgery, 1996; 23:736-737.
`
`
`US.54716818.02
`
`6
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-6
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`• Marston WA, Risley GL, Criado E, McHugh P, Reddick RL, Woosley JT,
`Keagy BA, “Mechanical characteristics of dilated PTFE used for covered
`stents and stent grafts,” Annals of Vascular Surgery, 1997; 11:68-73.
`
` •
`
` Criado E, Marston WA, Ligush J, Mauro MA, Keagy BA, “Endovascular
`Repair of Peripheral Aneurysms, Pseudoaneurysms and Arteriovenous
`Fistulas,” Annals of Vascular Surgery, 1997; 11:256-263.
`
` •
`
` Fontcuberta J, Criado E, Doblas M, Orgaz A, Lopez-Beret P, “Reparacion
`endovascular de una fistula femoral post-traumatica con un stent cubierto,”
`Archivos de Cirugia Vascular XI; 2002; 3:170-173.
`
`
`11.
`
`I find this experience helpful in allowing me to understand how one skilled
`
`in the art would interpret the limitations of the claims at issue and how they would
`
`be applied in determining validity.
`
`III. COMPENSATION
`
`12.
`
`I am being compensated at the rate of $400 per hour for my time spent on
`
`this matter. I am being reimbursed for authorized travel and related consultation
`
`expenses. This compensation and these reimbursements are not contingent on my
`
`performance, my opinions, the outcome of this matter, or any other issues involved
`
`in or related to this matter. I have no financial interest in W.L. Gore Associates,
`
`Inc. In addition, I have been informed that LifePort Sciences LLC purports to own
`
`the ’167 patent. I have no financial interest in LifePort Sciences LLC.
`
`US.54716818.02
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`7
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-7
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`IV. MATERIALS REVIEWED
`
`13. A list of the materials that I have reviewed in conjunction with this
`
`declaration is below:
`
`• U.S. Patent No. 5,716,365, Goicoechea et al.
`• U.S. Patent No. 6,051,020, Goicoechea et al.
`• U.S. Patent No. 6,117,167, Goicoechea et al.
`• U.S. Patent No. 5,716,365 file history
`• U.S. Patent No. 6,051,020 file history
`• U.S. Patent No. 6,117,167 file history
`• U.S. Patent No. 4,562,596, Kornberg
`• U.S. Patent No. 4,580,568, Gianturco
`• U.S. Patent No. 4,830,003, Wolff et al.
`• U.S. Patent No. 5,064,435, Porter
`• U.S. Patent No. 5,226,913, Pinchuk
`• U.S. Patent No. 5,236,446, Dumon
`• U.S. Patent No. 5,366,504, Andersen et al.
`• U.S. Patent No. 5,405,377, Cragg
`• U.S. Patent No. 5,575,817, Martin
`• U.S. Patent No. 5,871,536, Lazarus
`
`US.54716818.02
`
`8
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-8
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`• U.S. Patent No. 8,206,427, Ryan et al.
`• FR 2 678 508, Chevillon
`• FR 2 678 508, Chevillon (English translation)
`• Gunther, R., et al., Venous Stenoses in Dialysis Shunts: Treatment with Self-
`
`expanding Metallic Stents, Radiology, Vol. 170, No. 2, pp. 401-405, Feb.
`
`1989
`
`• Schaer, J. et al., Treatment of malignant esophageal obstruction with
`
`silicone-coated metallic self-expanding stents, Gastrointestinal Endoscopy,
`
`Vol. 38, No. 1, 1992, pp. 7-11.
`
`• Chuter, T., et al., Transfemoral endovascular aortic graft placement, J.
`
`Vasc. Surg., Vol. 18, No. 2, pp. 185-198, Aug. 1993
`
`14.
`
`In connection with any testimony I am asked to give to the PTO, I may use
`
`as exhibits various documents that relate to matters set forth in this report.
`
`
`
`V.
`
`SUMMARY OF OPINIONS
`
`15. Based on my experience, consideration of the materials and information
`
`listed in Section IV above, and my understanding of the applicable law regarding
`
`patent validity, it is my opinion that:
`
`US.54716818.02
`
`9
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-9
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`• Claims 2, 4-6, 8, 10-18, 24, 26, 28-31, 51-58, 64, 66, and 68-77 are
`
`anticipated under 35 U.S.C. § 102(e) by U.S. Patent No. 8,206,427
`
`(“Ryan”).
`
`• Claims 13, 18-22, 24-29, 31, 33, 38-42, 44-49, 51, 52, 58-62, 64-69, 71, 72,
`
`77-80, and 82 are anticipated under 35 U.S.C. § 102(e) by U.S. Patent No.
`
`5,575,817 (“Martin”)
`
`• Claims 1-3, 5-10, 12, 34-37 and 50 are obvious under 35 U.S.C. § 103 over
`
`Martin in view of Ryan.
`
`• Claims 23, 32, 43, 63, and 81 are obvious under 35 U.S.C. § 103 over
`
`Martin in view of U.S. Patent No. 4,830,003 (“Wolff”).
`
`• Claim 3 is obvious over Martin in view of Ryan and U.S. Patent No.
`
`5,226,913 (“Pinchuk”).
`
`16. The detailed reasons supporting my opinions regarding the above claims are
`
`provided below.
`
`VI. DETAILED STATEMENT OF OPINIONS
`
`A. Overview of the Relevant Technology
`
`1. Overview of the ’167 Patent
`
`17. The ’167 patent is at issue in this petition for inter partes review. George
`
`Goicoechea, John Hudson, Claude Mialhe, Andrew Cragg, and Michael Dake are
`
`US.54716818.02
`
`10
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-10
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`the named inventors. The ’167 patent is a continuation of U.S. Patent No.
`
`5,716,365 (Ex. 1001) and claims priority to U.S. Patent Application Ser. No.
`
`08/312,881, filed on September 27, 1994. I understand that Gore contends the
`
`’365 patent is not entitled to claim priority to EP 94400284 (“EP ‘284”) or
`
`EP94401306 (“EP ‘306”) based on the outcome of an interference proceeding and
`
`subsequent district court and Federal Circuit litigation. The clinical purpose of this
`
`technology is to provide an intraluminal treatment option for treating diseased or
`
`damaged bodily conduits.
`
`18. The ’167 patent relates to “bifurcated endoluminal prosthesis for use in a
`
`bifurcated blood vessel such, for example, as the infrarenal portion of a
`
`mammalian aortic artery where it bifurcates to the common iliac arteries” and “a
`
`stent connecting means for connecting a stent . . . to another stent.” (Ex. 1001 at
`
`1:19-24.) The stated goal of the technology is to eliminate “the requirement for
`
`by-pass surgery associated with the use of the prior art prosthesis in juxtaposition
`
`with a bifurcation in an artery.” (Id. at 2:18-20.)
`
`19. The ’167 patent claims and describes stent joining means for and methods
`
`relating to joining a first endoluminal stent to a second endoluminal stent. In
`
`particular, the patent claims and describes using a radially compressible male
`
`engaging portion on the first stent that is capable of expanding to engage a female
`
`US.54716818.02
`
`11
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-11
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`cooperating portion on the second stent. This achieves a continuous lumen through
`
`the two stents. (Id. at 2:28-29.)
`
`a. Male Engaging Portion/Female Portion
`
`20. Using a catheter, the “second stent” is intraluminally delivered in a radially
`
`compressed state to the diseased or damaged portion of the blood vessel to be
`
`treated. Once located at the site of treatment, the stent is deployed such that it
`
`expands and engages the endoluminal surface of the blood vessel. (Ex. 1001 at
`
`2:67-3:657.) The second stent includes a “distal female cooperation portion.” (Id.
`
`at 2:41-43.)1 The “first stent” is then intraluminally delivered in a radially
`
`compressed state to the site of treatment. The first stent includes a “proximal male
`
`engaging portion.” (Id. at 2:42-43.) The first stent “is entered into the female
`
`cooperating portion of the second stent” and then deployed, “allowing the first
`
`stent to re-expand such that the male engaging portion engages in the female
`
`cooperating portion of the second stent.” (Id. at 2:66-3:3.)
`
`b. Prevent Longitudinal Separation
`
`21. The specification further describes that “the interengagement of the male
`
`engaging portion and the female cooperating portion serves to resist longitudinal
`
`
`1 The specification defines “proximal” as “nearest to the heart” and “distal” as
`
`“furthest from the heart.” (Id. at 2:23-25.)
`
`US.54716818.02
`
`12
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-12
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`separation of the two stents one from the other.” (Ex. 1001 at 2:37-40.) The
`
`specification teaches two ways to “resist such longitudinal separation”: “[b]arbs or
`
`hooks on the second stent 40 and/or an frustoconical proximal part 42.” (Id. at
`
`11:54-56.)
`
`22. Flared Stent/Tapered Stent Combination. The patent describes that “[t]he
`
`male engaging portion may be flared radially outwardly towards its extremity and
`
`the female cooperating portion may be tapered radially inwardly towards its
`
`extremity.” (Id. at 2:43-46.) Referring to Figure 1 below, the patents describe that
`
`in use “the outer surface of the frustoconical proximal part 42 [highlighted below
`
`in blue] engages the interior surface of the second frustoconical part 18
`
`[highlighted below in red] of the bifurcated stent 10.” (Id. at 11:41-43.) “The
`
`tapered configurations of the second frustoconical part 18 of the bifurcated stent 10
`
`and of the proximal frustoconical part 42 of the second stent 40 are such that in the
`
`fitted position as described, the prosthesis are locked together to resist longitudinal
`
`separation in service.” (Id. at 11:49-55 (emphasis added).)
`
`US.54716818.02
`
`13
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-13
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`Proximal frustoconical
`part 42
`
`Second frustoconical
`part 18
`
`
`
`23. Barbs or Hooks. The specification further describes that “[t]he male
`
`engaging portion for the first stent may be provided with circumferentially spaced
`
`hooks or barbs on its external surface to engage the internal surface of said female
`
`cooperating means, thereby to reinforce the connecting means against longitudinal
`
`separation of the stents one from the other in the service.” (Id. at 5:66-6:4
`
`(emphasis added).)
`
`24. Barbs or hooks may be provided on both flared and substantially cylindrical
`
`male engaging portions. For example, referring to Figure 1, the specification
`
`describes that “[a]s with other stents described herein, the frustoconical proximal
`
`US.54716818.02
`
`14
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-14
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`part 42 may be formed with circumferentially spaced barbs or hooks 43, as shown
`
`in FIG. 1b [highlighted in green], which engage in the wire skeleton of the second
`
`frustoconical part 18 of the bifurcated stent 10. When barbs 43 are on proximal
`
`portion 12, they engage the inner wall of the artery.” (Id. at 11:43-48.)
`
`Spaced barbs or hooks 43
`
`
`
`25. As another example, referring to Figure 7, the specification describes that
`
`the second stent includes a “female engaging portion which is adapted to receive a
`
`generally cylindrical male engaging portion of a second elongate prosthesis (not
`
`shown).” (Id. at 12:51-55.) The specification further describes that the first stent
`
`includes a “male engaging portion [that] is equipped with circumferentially spaced
`
`US.54716818.02
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`15
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-15
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`external barbs to engage in the female cooperating portion in service.” (Id. at
`
`12:55-57.)
`
`
`
`c. Shape Memory Stents
`
`26. The specification describes that the first and second stents are self-
`
`expanding nitinol stents. (See id. at 3:46-51; 8:64-66.) For example, it describes
`
`that “[t]ypically, each stent may be made from a shape memory nitinol (nickel-
`
`titanium) wire.” (Id. at 3: 46-51.) More specifically, the specification states that
`
`“[s]aid nitinol wire may be type “M” nitinol wire which is martensitic at
`
`temperatures below about l3°C, and is austenitic at temperatures above about
`
`25°C; it will be appreciated therefore that the type “M” wire will be austenitic at
`
`body temperature of 37°C.” (Id. at 3:55-59.) Referring to Figure 1, the
`
`specification teaches that “[e]ach of the four parts of the bifurcated stent 10 is
`
`made in substantially the same way by winding a shape memory nitinol wire,
`
`typically nitinol type M wire, onto a mandrel 46.” (Id. at 8:64-67.) As stated in
`
`US.54716818.02
`
`16
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-16
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`the specification, “[a]n advantage of using Nitinol wire to form the stent in
`
`accordance with the present invention is that the nitinol wire is ‘super elastic’ in its
`
`austenitic state; the radial outward force exerted by the stent on the wall of the
`
`blood vessel in use is therefore substantially constant irrespective of the diameter
`
`of the vessel and the expanded stent.” (Id. at 3:65-4:463.)
`
`d. Bifurcated Stent Embodiments
`
`27. The specification further describes embodiments that include a “second
`
`stent” with “two transversely spaced distal female cooperating portions; the second
`
`stent may therefore constitute a bifurcated stent for use in juxtaposition with a
`
`bifurcation in a blood vessel.” (Id. at 3:7-11.) More specifically, the specification
`
`describes that “[e]ach of the two transversely spaced distal female cooperating
`
`portions may be adapted for connection to a first male stent which, in use, extends
`
`across the bifurcation into a respective one of the branched blood vessels.” (Id. at
`
`3:12-15.) The specification also states that “the bifurcated stent can be connected
`
`in situ to the other stent” according to the method described above in section VI A
`
`1 a. (Id. at 3:32-33.)
`
`e. Stent Graft Embodiments
`
`28.
`
`In addition to bare metal stents, the specification describes attaching a graft
`
`layer or multiple graft layers to the first and second stents. It states that
`
`“[t]ypically the graft layer may be disposed externally of the stent” but “in some
`
`US.54716818.02
`
`17
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-17
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`embodiments the graft layer may be disposed internally of the stent.” (Id. at 5:5-
`
`8.) The specification further describes an embodiment of a bifurcated “second
`
`stent” having a frustoconical female cooperating portion at its distal end and a graft
`
`on its exterior surface that is folded over to its interior surface at the distal end of
`
`the stent. In addition, the specification describes a “first stent” having a
`
`frustoconical male engaging portion at its proximal end and a graft on its exterior
`
`surface. When the male engaging portion of the first stent engages the female
`
`cooperating portion of the second stent, the graft layer on the exterior surface of
`
`the male engaging portion contacts the graft layer on the interior surface of the
`
`female cooperating portion to form a substantially blood-tight seal. (Id. at 12:27-
`
`44.)
`
`f. ’167 Patent
`
`29. The ’167 patent includes 82 claims, including 13 independent (claims 1, 2,
`
`3, 4, 5, 13, 31, 32, 33, 51, 52, 71, and 72) and 69 dependent claims.
`
`Claims Relating to “Stent Joining Means”:
`
`30.
`
`Independent claims 1-5 relate to stent joining means and require a first stent
`
`and second stent made of a shape memory alloy. The first stent includes a male
`
`engaging portion that is entered into a female portion of the second stent and
`
`thereafter expanded to engage the female portion of the second stent so as to
`
`prevent separation. The claims require that either the male engaging portion is
`
`US.54716818.02
`
`18
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-18
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`flared radially outwardly (claims 1 and 3), the female portion is tapered radially
`
`inwardly (claims 2 and 4), or the second stent is bifurcated (claim 5).
`
`31. Claim 1 claims:
`
`
`A stent joining means for joining a first endoluminal stent to a second
`endoluminal stent to define a continuous lumen through the first and
`second endoluminal stents, said stent joining means comprising:
`
` a
`
` male engaging portion on said first endoluminal stent which has an
`outer surface and can be compressed radially inwardly, wherein said
`male engaging portion is flared radially outwardly towards a
`proximal end; and
`
` a
`
` female portion on said second endoluminal stent cooperating with
`said male engaging portion, said female portion having an inner
`surface;
`
`wherein said first endoluminal stent and said second endoluminal
`stent consist of a shape memory alloy and the male engaging portion
`can be entered into the female portion in a radially compressed state
`and thereafter expanded in the female portion and wherein said outer
`surface of the male engaging portion and said inner surface of the
`female portion are inter-engaged to resist longitudinal movement to
`prevent separation of the first and second endoluminal stents in
`service.
`
`
`(emphasis added.)
`
`32. Claim 2 claims:
`
`
`A stent joining means for joining a first endoluminal stent to a second
`endoluminal stent to define a continuous lumen through the first and
`second endoluminal stents, said stent joining means comprising:
`
` a
`
` male engaging portion on said first endoluminal stent which has an
`outer surface and can be compressed radially inwardly; and
`
`
`US.54716818.02
`
`19
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-19
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`a female portion on said second endoluminal stent cooperating with
`said male engaging portion, said female portion having an inner
`surface, wherein the female portion is tapered radially inwardly
`towards a distal end;
`
`wherein said first endoluminal stent and said second endoluminal
`stent consist of a shape memory alloy and the male engaging portion
`can be entered into the female portion in a radially compressed state
`and thereafter expanded in the female portion and wherein said outer
`surface of the male engaging portion and said inner surface of the
`female portion are inter-engaged to resist longitudinal movement to
`prevent separation of the first and second endoluminal stents in
`service.
`
`
`(emphasis added.)
`
`33. Claim 3 claims:
`
`
`A stent joining means for joining a first endoluminal stent to a second
`endoluminal stent to define a continuous lumen through the first and
`second endoluminal stents, said stent joining means comprising:
`
` a
`
` a
`
` male engaging portion on said first endoluminal stent which has an
`outer surface and can be compressed radially inwardly, wherein the
`male engaging portion comprises a frustoconical wall flaring
`outwardly towards a longitudinal extremity; and
`
` female portion on said second endoluminal stent cooperating with
`said male engaging portion, said female portion having an inner
`surface;
`
`wherein said first endoluminal stent and said second endoluminal
`stent consist of a shape memory alloy and the male engaging portion
`can be entered into the female portion in a radially compressed state
`and thereafter expanded in the female portion and wherein said outer
`surface of the male engaging portion and said inner surface of the
`female portion are inter-engaged to resist longitudinal movement to
`prevent separation of the first and second endoluminal stents in
`service.
`
`US.54716818.02
`
`20
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-20
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`(emphasis added.)
`
`34. Claim 4 claims:
`
`
`A stent joining means for joining a first endoluminal stent to a second
`endoluminal stent to define a continuous lumen through the first and
`second endoluminal stents, said stent joining means comprising:
`
`male engaging portion on said first endoluminal stent which has an
`outer surface and can be compressed radially inwardly; and
`
` female portion on said second endoluminal stent cooperating with
`said male engaging portion, said female portion having an inner
`surface, wherein the female portion comprises a frustoconical wall
`tapering radially inwardly towards a longitudinal extremity;
`
`wherein said first endoluminal stent and said second endoluminal
`stent consist of a shape memory alloy and the male engaging portion
`can be entered into the female portion in a radially compressed state
`and thereafter expanded in the female portion and wherein said outer
`surface of the male engaging portion and said inner surface of the
`female portion are inter-engaged to resist longitudinal movement to
`prevent separation of the first and second endoluminal stents in
`service.
`
` a
`
` a
`
`
`(emphasis added.)
`
`35. Claim 5 claims:
`
`
`A stent joining means for adjoining a first endoluminal stent to a
`second endoluminal stent to define a continuous lumen through the
`first and second endoluminal stents, said stent joining means
`comprising:
`
` male engaging portion on said first endoluminal stent which has an
`outer surface and can be compressed radially inwardly; and
`
`
`US.54716818.02
`
`21
`
`W.L. Gore & Associates, Inc.
`Exhibit 1019-21
`
`

`

`Inter Partes Review No. Unassigned
`Exhibit 1019: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`two transversely spaced female portions on said second
`endoluminal stent, at least one female portion on said second
`endoluminal stent cooperating with said male engaging portion, said
`female portion having an inner surface;
`
`wherein said first endoluminal stent and said second endoluminal
`stent consist of a shape memory alloy and the male engaging portion
`can be entered into the female portion in a radially compressed state
`and thereafter expanded in the female portion and wherein said outer
`surface of the male engaging portion and said inner surface of the
`female portion are inter-engaged to resist longitudinal movement to
`prevent separation of the first and second endoluminal stents in
`service.
`
`
`(emphasis added.)
`
`36.
`
`Independent claim 72 also relates to a stent joining means that requires a
`
`first stent with two transversely spaced female portions and a second stent with a
`
`male engaging portion that is entered into one of the female portions on the first
`
`stent and thereafter expanded to engage the female portion so as to prevent
`
`separation of the first stent relative to the second stent. A graft is disposed
`
`between the female portion of the first stent and the male portion of the second
`
`stent

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