throbber
Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`
`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. 5,716,365
`Filing Date: June 5, 1995
`Issue Date: February 10, 1998
`Title: BIFURCATED ENDOLUMINAL PROSTHESIS
`__________________
`
`Inter Partes Review No. Unassigned
`__________________
`
`DECLARATION OF ENRIQUE CRIADO, M.D.
`
`INTRODUCTION
`
`I.
`
`
`
`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. 5,716,365 (“’365 patent”).
`
`In particular, for the purposes of this report, I have been asked to provide an
`
`analysis of the scope and content of the ’365 patent relative to the state of the art at
`
`the time of the earliest application underlying the ’365 patent. I have also been
`
`US.54707959.02
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`1
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-1
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`

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`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`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 ’365 patent.
`
`2.
`
`This report summarizes the opinions that I have formed to date, and it is
`
`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
`
`1018, and accurately describes my experience, education, employment,
`
`publications, presentations, awards, honors, memberships, and consulting
`
`positions.
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`US.54707959.02
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`2
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-2
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: 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.54707959.02
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`3
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-3
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: 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
`
`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
`
`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.54707959.02
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`4
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-4
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: 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 1018, 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 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.
`
` •
`
` 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.
`
` •
`
` 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.54707959.02
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`5
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-5
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: 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 1018, 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.54707959.02
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`6
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-6
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: 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 ’365 patent. I have no financial interest in LifePort Sciences LLC.
`
`IV. MATERIALS REVIEWED
`
`US.54707959.02
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`7
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-7
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`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.54707959.02
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`8
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-8
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: 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:
`• Claims 1, 3-8, 10, 12-22, and 24 are anticipated under 35 U.S.C. § 102(e) by
`
`U.S. Patent No. 8,206,427 (“Ryan”).
`
`US.54707959.02
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`9
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-9
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`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`• Claims 1-24 are obvious under 35 U.S.C. § 103 over U.S. Patent No.
`
`5,575,817 (“Martin”) in view of Ryan.
`• Claims 11 and 23 are 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 ’365 Patent
`
`17. The ’365 patent is at issue in this petition for inter partes review. George
`
`Goicoechea, John Hudson, Claude Mialhe, Andrew Cragg, and Michael Dake are
`
`the named inventors. The ’365 patent 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.
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`US.54707959.02
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`10
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-10
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`18. The ’365 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
`
`1:9-15.) 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 2:9-12.)
`
`19. The ’365 patent claims and describes stent joining means for and methods
`
`relating to joining a first endoluminal stent to a second endoluminal stent. In
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`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
`
`cooperating portion on the second stent. This achieves a continuous lumen through
`
`the two stents. (Id. at 2:20-21.)
`
`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
`
`2:53-57.) The second stent includes a “distal female cooperation portion.” (Id. at
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`US.54707959.02
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`11
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-11
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`2:32-34.)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 2:32-34.) 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 2:58-65.)
`
`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
`
`separation of the two stents one from the other.” (Ex. 1001at 2:18-31.) 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
`
`11:49-51.)
`
`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 2:35-43.) Referring to Figure 1 below, the patents describe that
`
`
`1 The specification defines “proximal” as “nearest to the heart” and “distal” as
`
`“furthest from the heart.” (Id. at 2:15-17.)
`
`US.54707959.02
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`12
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`W.L. Gore & Associates, Inc.
`Exhibit 1017-12
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`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`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 11:34-37.) “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 11:45-49 (emphasis added).)
`
`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
`
`
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`US.54707959.02
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`13
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`W.L. Gore & Associates, Inc.
`Exhibit 1017-13
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`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`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 5:60-63
`
`(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
`
`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 11:39-44.)
`
`US.54707959.02
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`14
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-14
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`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 12:47-50.) The specification further describes that the first stent
`
`includes a “male engaging portion [that] is equipped with circumferentially spaced
`
`external barbs to engage in the female cooperating portion in service.” (Id. at
`
`12:50-52.)
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`US.54707959.02
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`15
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-15
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`
`
`c. Shape Memory Stents
`
`26. The specification describes that the first and second stents are self-
`
`expanding nitinol stents. (See id. at 2:47-52; 8:59-62.) For example, it describes
`
`that “[t]ypically, each stent may be made from a shape memory nitinol (nickel-
`
`titanium) wire.” (Id. at 3:38-39.) More specifically, the specification states that
`
`“[s]aid nitinol wire may be type “M” nitinol wire which is martensitic at
`
`temperatures below about 13°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 3:47-51.) 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 8:59-62.) As stated in
`
`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
`
`US.54707959.02
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`16
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-16
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`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 3:57-63.)
`
`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 2:66-3:3.) 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 3:4-7.) 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 3:20-23.)
`
`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
`
`embodiments the graft layer may be disposed internally of the stent.” (Id. at 4:63-
`
`5:3.) The specification further describes an embodiment of a bifurcated “second
`
`US.54707959.02
`
`17
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-17
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`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-
`
`37.)
`
`f. ’365 Patent
`
`29. The ’365 patent includes 24 claims, including 6 independent (claims 1, 19,
`
`20, 22, 23, 24) and 18 dependent claims.
`
`30.
`
`Independent claims 1, 19, and 20 relate to stent joining means that require a
`
`first stent that is entered into a second stent and thereafter thermally induced to
`
`expand so that the outer surface of the first stent frictionally engages the inner
`
`surface of the second stent to prevent longitudinal movement of the first stent
`
`relative to the second stent.
`
`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:
`
`US.54707959.02
`
`18
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-18
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
` a
`
` male engaging portion on said first endoluminal stent which has an
`outer surface and can be compressed radially inwardly; 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 thermally induced to expand in the female portion
`and wherein a frictional inter-engagement between said outer
`surface of the male engaging portion and said inner surface of the
`female portion prevents longitudinal movement of the first
`endoluminal stent relative to the second endoluminal stent.
`
`(emphasis added).
`
`32. Claim 19 claims:
`
`
`A method of joining a first endoluminal stent having an outer surface
`with a second endoluminal stent having an inner surface within the
`vasculature of a body comprising the steps of inserting an end of said
`first endoluminal stent at least partially into an end of said second
`endoluminal stent, and allowing said end of said first endoluminal
`stent to expand by thermal transformation and contact said end of
`said second endoluminal stent such that said outer surface of said first
`endoluminal stent frictionally engages said inner surface of said
`second endoluminal stent to prevent relative longitudinal
`movement of said first and second endoluminal stents.
`
`(emphasis added).
`
`33. Claim 20 claims:
`
`
`A method of forming an endoluminal stent within the vasculature of a
`body comprising inserting an end of a first stent portion having an
`outer surface at least partially into an end of a second stent portion
`
`US.54707959.02
`
`19
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-19
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`having an inner surface, and allowing said end of said first stent
`portion to expand by thermal transformation and contact said end
`of said second stent portion such that said outer surface of said first
`stent frictionally engages said inner surface of said second stent to
`prevent relative longitudinal movement of said first and second
`stents.
`
`
`(emphasis added).
`
`34.
`
`Independent claims 22 and 24 relate to stent joining means that require a
`
`male engaging portion on a first stent having an external graft layer, which is
`
`entered into a female portion of a second stent having an internal graft layer or
`
`inner sleeve, and thereafter expands to engage the second stent so as to prevents
`
`separation of the first stent relative to the second stent.
`
`35. Claim 22 claims:
`
`
`A stent joining means for joining a first endoluminal stent to a second
`endoluminal stent comprising:
`
` a
`
` male engaging portion on said first endoluminal stent, having a first
`graft layer disposed externally of said male engaging portion,
`wherein the male engaging portion can be compressed radially
`inwardly; and
`
` a
`
` female portion on said second endoluminal stent cooperating with
`said male engaging portion and having a second graft layer disposed
`internally of said female portion;
`
`wherein the male engaging portion can be entered into the female
`portion in a radially compressed state and thereafter caused or allowed
`to expand in the female portion and wherein a frictional inter-
`engagement of the first graft layer of the male engaging portion and
`the second graft layer of the female portion prevents relative
`
`US.54707959.02
`
`20
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-20
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`
`movement of the first endoluminal stent and the second
`endoluminal stent.
`
`
`(emphasis added).
`
`36. Claim 24 claims:
`
`
`A stent joining means for joining a first endoluminal stent to a second
`endoluminal stent comprising:
`
` a
`
` first stent including a radially inwardly compressible male engaging
`portion, having a first graft layer disposed externally of said male
`engaging portion; and
`
` a
`
` second stent including a female portion cooperating at a distal end
`with a proximal end of said male engaging portion and having a
`second graft layer disposed externally of said female cooperating
`portion and which folds over the distal end of said female engaging
`portion to form an inner sleeve which contacts said first graft layer to
`form a substantially blood-tight seal;
`
`wherein the male engaging portion can be entered into the female
`portion in a radially compressed state and thereafter caused or allowed
`to expand in the female cooperating portion and wherein the inter-
`engagement of the first graft layer of the male engaging portion and
`the inner sleeve of the female cooperating portion resists
`longitudinal separation of the first stent from the second stent.
`
`(emphasis added).
`
`37.
`
`Independent claim 23 relates to a stent joining means that requires a male
`
`engaging portion defining a frustoconical wall that is flared radially outwardly, is
`
`entered into a female portion that is tapered radially inwardly, and expands in the
`
`female portion so as to achieve a frictional engagement that prevents relative
`
`movement of the first stent relative to the second stent.
`
`US.54707959.02
`
`21
`
`W.L. Gore & Associates, Inc.
`Exhibit 1017-21
`
`

`
`Inter Partes Review No. Unassigned
`Exhibit 1017: Declaration of Enrique Criado, M.D.
`August 18, 2014
`
`38. Claim 23 claims:
`
`
`A stent joining means for joining a first endoluminal stent having a
`male portion end to a second endoluminal stent having a female
`portion end comprising:
`
` a
`
` male engaging portion on said male portion end of said first
`endoluminal stent, defining a first frustoconical wall which is flared
`radially outwardly towards said male portion end, and which can be
`compressed radially inwardly; and
`
` a
`
` female portion on said female portion end of said second
`endoluminal stent cooperating with said male engaging portion and
`defining a second frustoconical wall which is tapered radially
`inwardly towards said female portion end;
`
`wherein the male engaging portion can be entered into the female
`portion in a radially compressed state and thereafter caused or allowed
`to expand in the female portion and wherein a frictional inter-
`engagement of the male engaging portion and the female portion
`prevents relative movement of the first stent and the second stent.
`
`(emphasis added).
`
`
`2. State of the Art as of September 1994
`
`39. By the claimed priority date of the ’365 patent, several implantable devices
`
`had been created to treat diseased or damaged vessels, including grafts, stents, and
`
`stent grafts.
`
`40. Synthetic vascular grafts were available as early as the 1950’s and became
`
`increasingly used in the 1970’s for vascular repair. Vascular grafts are usually
`
`used to replace a portion of blood vessel. They are made from biocompatible
`
`materials such as polytetrafluoroethylene (PTFE), expanded
`
`US.54707959.02
`
`22
`
`

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