UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS LIFESCIENCES
`LLC, AND EDWARDS LIFESCIENCES AG
`Petitioners
`
`v .
`
`BOSTON SCIENTIFIC SCIMED, INC.
`Patent Owner
`
`Case IPR2016-
`Patent 8,992,608
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`
`U.S. PATENT NO. 8,992,608
`
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42
`
`
`
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`OVERVIEW OF PETITION ........................................................................... 1
`
`II.
`
`STATE OF THE ART AT THE TIME OF THE INVENTION ..................... 3
`
`A.
`B.
`C.
`D.
`
`Surgically Implantable Prosthetic Heart Valves ......................... 3
`Stents ........................................................................................... 5
`Stent Foreshortening ................................................................... 6
`Stent Grafts and Use of Fabric Coverings to
`Prevent Leaking .......................................................................... 7
`Transcatheter Heart Valve Technology ....................................17
`
`E.
`
`III. MANDATORY NOTICES ...........................................................................25
`
`A.
`B.
`C.
`D.
`
`Real Party-In-Interest ................................................................25
`Related Matters .........................................................................25
`Lead and Back-Up Counsel ......................................................26
`Service Information...................................................................26
`
`IV. REQUIREMENTS FOR INTER PARTES REVIEW ....................................27
`
`A. Grounds for Standing ................................................................27
`B.
`Identification of Challenge .......................................................27
`
`V.
`
`SUMMARY OF THE ’608 PATENT ...........................................................27
`
`A. Disclosure of the ’608 Patent ....................................................27
`B.
`Prosecution History of the ’608 Patent .....................................34
`C.
`Claim Construction ...................................................................39
`
`1. “Flaps”(Claims 1-4) ............................................................40
`2. “Pockets” (Claims 2-3) .......................................................44
`
`VI. ORDINARY SKILL IN THE ART ...............................................................45
`
`VII.
`
`IDENTIFICATION OF HOW THE CHALLENGED CLAIMS ARE
`UNPATENTABLE ........................................................................................46
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`A. Ground 1: Claims 1-4 are invalid under 35 U.S.C.
`§ 102(b) over Cribier (Ex. 1003) ..............................................47
`
`1. Claim 1 Preamble ................................................................47
`2. Element 1.1 ..........................................................................47
`3. Element 1.2 ..........................................................................48
`4. Element 1.3 ..........................................................................48
`5. Element 1.4 ..........................................................................49
`6. Element 1.5 ..........................................................................50
`7. Element 1.6 ..........................................................................51
`8. Element 1.7 ..........................................................................52
`9. Element 1.8 ..........................................................................52
`10. Element 1.9 ........................................................................53
`11. Claims 2-3 ..........................................................................53
`12. Claim 4 ..............................................................................54
`
`
`B. Ground 2: Claims 1-4 are invalid under 35 U.S.C.
`§ 103(a) over Cribier (Ex. 1003) in view of
`Spiridigliozzi (Ex. 1010) ...........................................................54
`
`
`C. Grounds 3-4: Claims 1-4 are invalid under 35 U.S.C.
`§ 103(a) over Cribier (Ex. 1003) in view of
`Elliot (Ex. 1005) (Ground 3) or, in the alternative,
`Thornton (Ex. 1019) (Ground 4) ...............................................57
`
`1. Elliot (Ground 3) .................................................................57
`2. Thornton (Ground 4) ...........................................................60
`
`
`D. Ground 5: Claims 1-4 are invalid under 35 U.S.C.
`§ 103(a) over Cribier (Ex. 1003) in view of
`Cook (Ex. 1006) ........................................................................62
`
`
`E.
`
`
`F.
`
`Ground 6: Claims 1-4 are invalid under 35 U.S.C.
`§ 103(a) over Cribier (Ex. 1003) in view of
`De Paulis (Ex. 1021) .................................................................64
`
`Grounds 7-8: Claims 1-4 are invalid under 35 U.S.C.
`§ 103(a) over Spenser (Ex. 1004) in view of
`Elliot (Ex. 1005) (Ground 7) or, in the alternative,
`Thornton (Ex. 1019) (Ground 8) ...............................................66
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`1. Claim 1 Preamble ................................................................66
`2. Element 1.1 ..........................................................................67
`3. Element 1.2 ..........................................................................67
`4. Element 1.3 ..........................................................................68
`5. Element 1.4 ..........................................................................68
`6. Element 1.5 ..........................................................................69
`7. Element 1.7 ..........................................................................69
`8. Element 1.8 ..........................................................................69
`9. Element 1.9 ..........................................................................70
`10. Claim 4 ..............................................................................71
`11. Element 1.6 and Claims 2-3 ..............................................71
`
`
`G. Ground 9: Claims 1-4 are invalid under 35 U.S.C.
`§ 103(a) over Spenser (Ex. 1004) in view of
`Cook (Ex. 1006) ........................................................................72
`
`
`H. Ground 10: Claims 1-4 are invalid under 35 U.S.C.
`§ 103(a) over Spenser (Ex. 1004) in view of
`De Paulis (Ex. 1021) .................................................................73
`
`
`I.
`
`Ground 11: Claims 1-4 are invalid under 35 U.S.C.
`§ 102(b) over Spenser (Ex. 1004) .............................................74
`
`VIII. CONCLUSION ..............................................................................................75
`
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`EXHIBIT LIST
`
`EXHIBIT 1001 U.S. Patent No. 8,992,608 to Haug et al.
`
`EXHIBIT 1002
`
`File History of U.S. Application No. 12/492,512
`
`EXHIBIT 1003 WO 98/29057 to Cribier et al.
`
`EXHIBIT 1004 WO 03/047468 to Spenser et al.
`
`EXHIBIT 1005 U.S. Patent App. Pub. No. 2003/0236567 to Elliot
`
`EXHIBIT 1006 U.S. Patent App. Pub. No. 2004/0082989 to Cook et al.
`
`EXHIBIT 1007 Declaration of Dr. Nigel Buller
`
`EXHIBIT 1008 Alain Cribier et al., “Early experience with percutaneous
`transcatheter implantation of heart valve prosthesis for the
`treatment of end-stage inoperable patients with calcific aortic
`stenosis,” J. Am. Coll. Cardiol., 43(4): 698-703 (2004).
`EXHIBIT 1009 U.S. Patent App. Pub. No. 2001/0039450 to Pavcnik et al.
`
`EXHIBIT 1010 U.S. Patent App. Pub. No. 2004/0033364 to Spiridigliozzi et al.
`
`EXHIBIT 1011 U.S. Patent No. 3,365,728 to Edwards
`
`EXHIBIT 1012 Charles T. Dotter, “Transluminally-Placed Coilspring
`Endarterial Tube Grafts,” Investigative Radiology, 329-32
`(1969).
`Frank Ing, “Stents: What’s Available to the Pediatric
`Interventional Cardiologist?” Catheterization and Cardiovascular
`Interventions 57:274-386 (2002).
`EXHIBIT 1014 U.S. Patent No. 6,206,911 to Milo
`
`EXHIBIT 1013
`
`EXHIBIT 1015
`
`Excerpts from Vossoughi et al., Stent Graft Update (2000)
`
`EXHIBIT 1016
`
`Excerpts from Dolmatch et al., Stent Grafts: Current Clinical
`Practice (1999)
`EXHIBIT 1017 Andersen et al., “Transluminal implantation of artificial heart
`valves. Description of a new expandable aortic valve and initial
`results with implantation by catheter technique in closed chest
`pigs,” European Heart Journal, 13:704-08 (1992).
`EXHIBIT 1018 U.S. Patent No. 5,411,552 to Andersen et al.
`
`EXHIBIT 1019 U.S. Patent No. 6,015,431 to Thornton et al.
`
`EXHIBIT 1020 U.S. Patent App. Pub. No. 2001/0021872 to Bailey et al.
`
`EXHIBIT 1021 U.S. Patent No. 6,352,554 to De Paulis
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`EXHIBIT 1022
`
`European Patent 2 749 254 B1 to Salahieh et al.
`
`EXHIBIT 1023 American Heritage College Dictionary, 4th Ed. 2002 (definition
`of “flaps”)
`EXHIBIT 1024 Merriam-Webster’s Collegiate Dictionary, 10th ed. (2001)
`(definitions of “flaps” and “pleats”)
`EXHIBIT 1025 Charles S. Thompson et al., “Endoluminal stent grafting of the
`thoracic aorta: Initial experience with the Gore Excluder,”
`Journal of Vascular Surgery, 1163-70 (June 2002).
`EXHIBIT 1026 Gore Excluder Instructions for Use (2002)
`
`EXHIBIT 1027 U.S. Patent No. 5,957,949 to Leonhardt et al.
`
`EXHIBIT 1029
`
`EXHIBIT 1028 Assignment record for U.S. Patent App. Pub. No. 2003/0236567
`to Elliot
`Lawrence et al., “Percutaneous Endovascular Graft:
`Experimental Evaluation,” Radiology, 163(2): 357-60 (May
`1987).
`European Patent 2 926 766 B1 to Salahieh et al.
`
`Exhibit 1030
`
`Exhibit 1031
`
`Exhibit 1032
`
`Exhibit 1033
`
`Boston Scientific’s August 24, 2016 Response in Opposition
`Proceedings of EP 2 749 254 B1
`Boston Scientific’s August 24, 2016 Reply in German
`Infringement Proceeding 4a O 137/15
`U.S. Patent No. 5,855,601 to Bessler et al.
`
`Exhibit 1034
`
`U.S. Patent No. 5,476,506 to Lunn
`
`vi
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
`
`I.
`
`OVERVIEW OF PETITION
`
`Edwards Lifesciences Corporation, Edwards Lifesciences LLC, and
`
`Edwards Lifesciences AG (collectively, “Edwards”) respectfully request inter
`
`partes review for claims 1-4 of U.S. Patent No. 8,992,608 (the “’608 patent,”
`
`attached as Ex. 1001) in accordance with 35 U.S.C. §§ 311–319 and 37 C.F.R.
`
`§ 42.100 et seq.
`
`The ’608 patent’s purported invention is directed to a collapsible and
`
`expandable prosthetic heart valve delivered via a catheter (“transcatheter heart
`
`valve” or “THV”). Specifically, the ’608 patent describes a retrievable THV that
`
`includes an anchor, commissural support elements attached to the anchor, a
`
`replacement valve with commissures attached to the commissural supports, and a
`
`fabric seal that, upon anchor foreshortening, forms a sealing structure that
`
`purportedly prevents blood from flowing between the fabric seal and heart tissue
`
`(i.e., paravalvular leak). Ex. 1001 at 2:42-49, 14:21-29, Figs. 32-34. An element-
`
`by-element breakdown of Claims 1-4 of the ’608 patent is provided in the
`
`Appendix attached hereto.
`
`
`
`It is undisputed that THVs were well known before the June 16, 2004
`
`priority date of the ’608 patent. Fabric seals on THVs and similar devices were
`
`also well known before the ’608 patent’s priority date. Indeed, the Patent Office
`
`repeatedly rejected claims directed to a THV having a fabric seal, including a
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`fabric seal with “flaps” (issued Claim 1) and “pockets” (issued Claims 2-3). The
`
`claims were allowed only after the applicant added claim language requiring that
`
`“the fabric seal extends from the distal end of the replacement valve and back
`
`proximally over the expandable anchor.” But the examiner’s allowance was
`
`based on the mistaken belief that this added feature was novel and nonobvious. It
`
`was neither. By December 1996, Drs. Alain Cribier and Brice Letac disclosed a
`
`THV with a fabric seal (“cover”) that extends from the distal end of the
`
`replacement valve and back over the expandable anchor:
`
`
`
`See WO 98/29057 to Cribier et al. (“Cribier”, Ex. 1003) at FIG. 6d (annotations
`
`and highlighting added). This feature was disclosed again in 2001 by
`
`Percutaneous Valve Technologies (“PVT”), now owned by Petitioner Edwards, in
`
`the form of a THV having a “cuff portion” that extends from the distal end of the
`
`replacement valve and back over the support stent of the THV:
`
`
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`2
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`
`
`See WO 03/047468 to Spenser et al. (“Spenser,” Ex. 1004) at Fig. 1 (annotations
`
`and highlighting added).
`
`In short, by the ’608 patent’s priority date, THVs were well known; fabric
`
`materials used to seal both internal and external surfaces of THVs and other
`
`endovascular prostheses also were well known; and it was well known that these
`
`fabric seals, when used on the external surface of an endovascular prosthesis,
`
`could form flaps and pockets that extend into spaces in the tissue surrounding the
`
`implanted prosthesis to prevent paravalvular leaking. For these reasons, Claims
`
`1-4 of the ’608 patent are anticipated and obvious in view of known THV and
`
`other stent-based vascular prostheses and should be rendered invalid upon inter
`
`partes review.
`
`II.
`
`STATE OF THE ART AT THE TIME OF THE INVENTION
`
`A.
`
`Surgically Implantable Prosthetic Heart Valves
`
`Petitioner Edwards, the worldwide leader in the science of heart valves, was
`
`founded in 1958. Edwards’ earliest work related to prosthetic heart valves
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`implanted surgically. Ex. 1007 at ¶ 37. One of Edwards’ first commercially
`
`available prostheses was a ball-and-cage valve known as the Starr-Edwards valve,
`
`details of which are described in U.S. Patent No. 3,365,728 (Ex. 1011). Notably,
`
`even this early valve prosthesis included a circumferentially oriented sewing ring
`
`that was adapted to extend into spaces in the tissue surrounding the implanted
`
`prosthesis to prevent paravalvular leaking:
`
`
`
`
`
`See Ex. 1011, ’728 Patent at 1:38-46 and 3:12-20 (“The rubber cushion ring 35
`
`conforms to any irregularities of tissue contour which may exist because of disease
`
`or other causes and forms an effective seal against the tissue.”), Figs. 1, 3
`
`(highlighting added); see also Decl. of Nigel Buller (Ex. 1007) at ¶ 38.
`
`Edwards also developed surgically implantable valves with biological valve
`
`leaflets, including Edwards’ Perimount valve. See Ex. 1007 at ¶ 39. The
`
`Perimount valve, first introduced in 1980, included a tri-leaflet bovine pericardial
`
`valve and a frame having a fabric sewing ring akin to the Starr-Edwards valve:
`
`
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`4
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`B.
`
`Stents
`
`
`
`
`
`To trace the evolution of vascular prostheses implantable via a catheter, one
`
`must start with the development of vascular stents. Id. at ¶¶ 40-46. In 1969,
`
`Charles Dotter introduced the concept of vascular stenting through his work
`
`concerning the implantation of stainless steel coils into the peripheral arteries of
`
`dogs. Id. at ¶ 41. He also taught the concept of a self-expanding stent. Id. at ¶ 42.
`
`It was not until the 1980s that stent technology was further developed.
`
`Among other stents designed during this time, the Wallstent was the first self-
`
`expanding stent to be implanted by a non-surgical catheterization technique in a
`
`human coronary artery. Id. at ¶ 45. Like the anchor structure disclosed in the ’608
`
`patent (see Ex. 1001 at 5:45-50, Figs. 32-33), the Wallstent is made with a
`
`collapsible and expandable braided-wire structure:
`
`
`
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`5
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`Ex. 1007 at ¶ 45. Balloon-expandable stents were also developed during this time.
`
`See id. at ¶ 46.
`
`C.
`
`Stent Foreshortening
`
`A known property for both self-expanding and balloon-expandable stents is
`
`foreshortening, the degree of which is dependent on the overall stent design. Id. at
`
`¶¶ 47-51. A stent that foreshortens is a stent whose length decreases as the
`
`diameter of the stent increases, and vice versa. Prior to June 16, 2004, it was well
`
`known to those of ordinary skill in the art that stents could be designed to
`
`substantially foreshorten,1 not foreshorten at all, or lengthen upon radial expansion.
`
`Id. at ¶ 49.
`
`For example, a design of a commercial Wallstent has been shown to
`
`foreshorten by 53%:
`
`
`1
`Foreshortening % = (change in length / length of collapsed stent) x 100.
`
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`Id. at ¶ 50 (citing Ex. 1013 (Ing publication)).
`
`THVs, discussed infra, have also used stent designs that foreshorten. See,
`
`e.g., Ex. 1003 (Cribier WO ’057) at 16:11-16 (disclosing a stent with an expanded
`
`length of 10mm and a collapsed length of 20 mm (i.e., 50% foreshortening)).
`
`D.
`
`Stent Grafts and Use of Fabric Coverings to Prevent Leaki ng
`
`Stents were also developed with a covering (now called stent grafts). By
`
`virtue of the covering, stent grafts can be used to isolate and reinforce the wall of a
`
`blood vessel from the lumen of the vessel, prevent leakage between the stent and
`
`vessel, or to prevent exposure of a metallic stent to the surrounding tissue. Ex.
`
`1007 at ¶ 52.
`
`In 1973, Anatoly Kononov performed a series of animal experiments in
`
`which he implanted stent grafts in the aorta. Id. at ¶ 53. These stent grafts had a
`
`pleated covering as pictured below:
`
`Id. (citing Ex. 1015 (Vossoughi textbook)). In 1985, Nicholas Volodos modified
`
`the Kononov stent graft to include a self-expanding stent covered with a Dacron
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`fabric and became the first to place an endovascular graft transluminally to treat a
`
`patient with iliac artery occlusive disease. Ex. 1007 at ¶ 54. Then, in 1990, Huan
`
`Parodi and Julio Palmaz implanted a plastically deformable stent graft to treat an
`
`abdominal aortic aneurysm, whereupon these devices began to attract widespread
`
`interest in the field. Id. at ¶ 55.
`
`Two commercial embodiments of stent grafts that were available in the
`
`1990s are pictured below:
`
`
`
`
`
`
`
`Id. at ¶ 56 (citing Ex. 1016 (Dolmatch et al. textbook)) (EVT Endograft on left;
`
`Talent Endoprosthesis on right). As can be seen in these examples, the fabric
`
`coverings have excess material with wrinkles in the graft’s expanded state.
`
`Also shown on the lower end of the EVT Endograft (pictured above left) is
`
`the well-known use of pre-formed circumferentially oriented pleats in the graft.
`
`This pre-formed, corrugated structure permits the endograft to extend and increase
`
`its length in the longitudinal direction, akin to an accordion. Ex. 1007 at ¶ 57. As
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`discussed infra, Section V.C., these well-known pleats were recognized by the
`
`Patent Office as “flaps” and “pockets” as claimed by the ’608 patent, which the
`
`patent applicants did not dispute. Specifically, during examination of the ’608
`
`patent, the examiner concluded that “[a]n implantable fabric having pleats and
`
`pockets is well known in the art, as taught by De Paulis in Figure 2”:
`
`Ex. 1002 (’608 patent File History), 4/10/14 Non-Final Rejection at 2-3; see also
`
`U.S. Patent No. 6,352,554 to De Paulis (“De Paulis,” Ex. 1021) at Fig. 2.2
`
`
`
`
`2
`The aortic grafts detailed in De Paulis are preferably made with Dacron, and
`
`comprise “circumferentially extending pleats” or “corrugations” that surround the
`
`conduit and “provide a degree of expansion in the longitudinal direction,” thereby
`
`allowing the graft to “significantly increase its length.” See Ex. 1021 at 4:52-5:8,
`
`Figs. 1-2. “The conduit … may be further provided with a prosthetic valve.” Id. at
`
`3:51-52.
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`The examiner further concluded that, in view of De Paulis, it would have been
`
`obvious to modify a sealing structure “to include pleats as an obvious alternative
`
`design choice.” Ex. 1002, 4/10/14 Non-Final Rejection at 2-3.
`
`These fabric coverings serve essentially the same purpose on stents as did
`
`the sealing rings on surgical heart valve prostheses—they reduce the risk of blood
`
`leaking between the prosthesis and the surrounding tissue (i.e., “endoleaks”). Ex.
`
`1007 at ¶ 59. Aiding in preventing such endoleaks is the selection of fabric that
`
`can conform to the surrounding tissue:
`
`
`
`Id. (citing Ex. 1015 (Vossoughi et al. textbook)) (Hemobahn stent graft).
`
`The graft material’s ability to conform to the surrounding tissue is furthered
`
`because the target location typically is smaller in diameter than the stent graft’s
`
`maximum diameter. Under these conditions, unless the covering is completely
`
`elastic, a stent graft made, for example, with Dacron fabric will have excess graft
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`material that surrounds the stent at least when the stent is deployed short of its
`
`maximum diameter. Ex. 1007 at ¶ 60. This typically results in the formation of
`
`longitudinally oriented pleats in the graft material. Id. at ¶ 61 (citing Ex. 1029
`
`(Lawrence et al.) at 358 (“The Dacron grafts, most of which were larger in
`
`diameter than the native lumen, were longitudinally ‘pleated’ inside the vessel
`
`lumen.”).
`
`Well before the June 2004 effective filing date of the ’608 patent, multiple
`
`graft designs were contemplated to further enhance the external seal to prevent
`
`blood from flowing between the seal and surrounding cardiovascular tissue.
`
`For example, U.S. Patent No. 6,015,431 to Thornton (“Thornton,” Ex.
`
`1019),3 which was filed on December 23, 1996, discloses a “tubular member-seal
`
`member combination ... [that] has utility in the prevention of leakage flow around
`
`the outer surfaces of implantable endolumenal medical devices.” Ex. 1019 at 7:5-
`
`9. “The seal member is secured to the outer surface and is adapted to occlude
`
`leakage flow externally around the tubular wall between the outer surface and the
`
`endolumenal wall when the tubular member is deployed within the endolumenal
`
`body space.” Id. at 4:6-13. This means that the seal member will conform to the
`
`
`3
`The Thornton prior art reference was not disclosed to the Patent Office
`
`during prosecution of the ’608 patent.
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`irregular surface of the surrounding tissue. Ex. 1007 at ¶ 63. Sealing members 20
`
`and 30 are depicted, for example, in Figure 1:
`
`
`
`Ex. 1019 at Fig. 1 (annotations added). The sealing members can be formed with
`
`Dacron fabric, among other materials, and their flared construction can be imparted
`
`by the flow of blood in a particular direction. Id. at 7:20-42, 8:31-54, 8:65-67.
`
`Thornton further discloses that multiple sealing members may be used, for
`
`example in series to provide a sufficient seal. Id. at 8:65-9:3. The Thornton
`
`prosthesis was commercialized by W.L. Gore & Associates, Inc. and sold as the
`
`Gore Excluder stent graft. See Ex. 1007 at ¶ 64.
`
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`U.S. Patent Application Publication 2003/0236567 to Elliot (“Elliot,” Ex.
`
`1005),4 filed on June 25, 2002, similarly discloses a tubular prosthesis having a
`
`stent and one or more fabric “skirts” to seal against endoleaks:
`
`
`
`
`
`
`
`
`
`
`
`Ex. 1005 at Figs. 5a-5e. The “skirt 16 terminates in a peripheral edge 18 that is
`
`spaced from a juncture between the skirt 16 and the tubular body 12. ...
`
`[P]ortion(s) of the peripheral edge 18 can be displaced to contact, and form a seal
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`with a surrounding wall. Irregularities and/or wall displacement ... can be
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`responded to by the skirt 16 in minimizing endoleaks about the prosthesis 10.” Id.
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`at ¶¶ [0024], [0036] – [0038]. Like Thorton, Elliot also discloses the use of
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`multiple sealing members and that the flared construction of the sealing members
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`can be imparted by the flow of blood in a particular direction. Id. at ¶¶ [0026],
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`[0038], [0040].
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`4
`Elliot, which later issued as U.S. Patent No. 7,044,962, was owned by
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`Boston Scientific until December 2012 but was never disclosed to the Patent
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`Office during prosecution of the ’608 patent. See Ex. 1028 (assignment record).
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`U.S. Patent Application Publication 2004/0082989 to Cook et al. (“Cook,”
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`Ex. 1006), which claims priority to an August 20, 2002 provisional application,
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`also recognized the potential for endoleaks. Ex. 1006 at ¶ [0004].5 To address this
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`problem, Cook discloses a stent graft having a “cuff portion [15] compris[ing] an
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`external sealing zone that extends around the main body portion to help prevent
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`leakage”:
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`
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`Id. at Abstract, Figs. 1, 6. Cook explains that the cuff portion can by formed with
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`at least one “free edge 17” that is “unattached to the main body 12 so that it is
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`allowed to extend or flair outward to comprise a lip that serves as an external
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`sealing zone 21.” Id. at ¶ [0026]. This cuff portion can be formed by either
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`“folding [ ] excess material over upon itself,” or it can be formed with a separate
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`piece of graft material “such that the proximal edges of the main body and cuff
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`portions 13, 16 each comprise ‘cut’ or free edges rather than a single folded edge.”
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`5
`The Cook prior art reference was not disclosed to the Patent Office during
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`prosecution of the ’608 patent.
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`Id. Cook also discloses that the cuff portion could be folded over “to produce a
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`fold 44 that creates gutter-like pocket 45 that is able to collect any blood passing
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`around the leading edge 16 of the graft 11 to prevent an endoleak and promote
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`thrombus formation.” Ex. 1006 at [0036].
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`As with bare stents, foreshortening was a known property of stent grafts.
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`See U.S. Patent No. 6,206,911 to Milo (“Milo”, Ex. 1014) at 1:7-11, 1:33-38; U.S.
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`Patent Application Publication No. 2004/0033364 to Spiridigliozzi et al.
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`(“Spiridigliozzi”, Ex. 1010) at ¶¶ [0014], [0089]; Ex. 1007 at ¶ 67. It was also
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`known that a degree of stent graft foreshortening can form wrinkles in the graft
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`material, and, separately, that pleats can be created in the graft material to
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`compensate for axial elongation and longitudinal foreshortening of the stent graft.
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`Ex. 1007 at ¶ 67. For example, Milo recognizes that when stents have external
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`coverings, “wrinkling” of the cover may occur upon a certain degree of
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`foreshortening. See Ex. 1014 at 1:33-38; 7:18-25. Spiridigliozzi further
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`recognizes that a number of circumferentially oriented pleats can be incorporated
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`into the expanded graft structure (shown below), whereby the pleats can unfold to
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`compensate for axial elongation during delivery and generally return to pleated
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`form due to foreshortening of the stent when deployed:
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`
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`Ex. 1010 at ¶¶ [0014] (“The number and length of the pleated sections can vary to
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`control the resultant axial elongation, plastic deformation, longitudinal
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`foreshortening and radial shrinkage of the graft material”), [0019], [0089], [0095]
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`– [0098], and Figs. 9-10.6
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`Depending on the desired properties of the stent graft, the foreshortening
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`could be maintained or instead minimized through stent design. See, e.g., Ex. 1014
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`at 1:16-55; Ex. 1007 at ¶ 68. For those stent grafts designed to foreshorten, a non-
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`uniform surface may form along the length of the graft material upon
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`foreshortening. Id. The degree and dimension of any non-uniformities (if any)
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`formed along the length of the graft are related to the degree of stent
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`foreshortening, physical properties and dimensions of the graft material, and the
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`attachment between the graft and stent. Id. For example, as discussed infra,
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`6
`The Milo and Spiridigliozzi prior art references were not disclosed to the
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`Patent Office during prosecution of the ’608 patent.
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`Section V.A., when a Dacron graft is secured at a series of locations along its
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`length to a stent, extensive stent foreshortening (e.g., 50% or more) will create
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`circumferentially oriented “flaps” and “pockets” as claimed in the ’608 patent.
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`Moreover, graft structures of the type taught by Thornton, Elliot, Cook, and De
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`Paulis detail the use of circumferentially oriented “flaps” and “pockets” regardless
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`of whether the stent foreshortens. Ex. 1007 at ¶ 69.7 And, under Boston
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`Scientific’s broad interpretation of “flaps” and “pockets,” discussed infra Section
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`V.C.1., each of these references disclose extra “excess material so that the seal can
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`at least partially be distanced from the outer surface of the [stent]” and thus further
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`prevent blood from flowing between the seal and surrounding tissue. See, e.g., Ex.
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`1007 at ¶ 69 (citing Ex. 1031 (Boston Scientific’s August 24, 2016 Response in
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`Opposition Proceedings of EP 2 749 254 B1)).
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`E. Transcatheter Heart Valve Technology
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`In 1989, Dr. Henning Rud Andersen conceived of the seminal invention of a
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`permanently implanted transcatheter bioprosthetic heart valve, the subject of the
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`’608 patent. That year, Dr. Andersen built the first prototype by hand. Id. at ¶ 71.
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`7
`Although each of Thornton, Elliot, Cook, and Spiridigliozzi are
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`characterized herein as exemplary stent grafts, each of these disclosures is not
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`limited to stent grafts and broadly applies to a range of devices, including THVs.
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`See Ex. 1007 at ¶¶ 63 n.1, 65 n.2, 66 n.3, 67 n.5.
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`It was a balloon-expandable THV formed with a folded-wire stent and a pig valve.
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`His Danish team successfully implanted the prototype in pigs via a catheter and
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`published the results in a 1992 European Heart Journal article. See id. at ¶ 72; see
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`also Ex. 1017 (Andersen European Heart Journal publication). This work also led
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`to a series of patents, including U.S. Patent No. 5,411,552. (“Andersen,” Ex.
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`1018). The Andersen patent expands on the early prototypes built by the Danish
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`team, and broadly details a THV comprising a valve mounted within a collapsible
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`and expandable stent structure. Id. at 5:9-28. The Andersen patent describes
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`multiple THV embodiments, including embodiments having additional tubular
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`graft material that can be used along the external and internal surface of the THV.
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`Id. at 2:56-60, 4:3-17, 7:17-29, Figs. 11-12 (“[T]he stent may be made with a
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`relatively great height and with a cylinder surface which is closed by a suitable
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`material. Thus, a vascular prosthesis known per se is formed wherein the valve is
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`mounted.”); Ex. 1007 at ¶ 73.
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`As with stent grafts, the covers proposed to be used with THVs were
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`designed to conform to the surface of the surrounding tissue. Ex. 1007 at ¶ 74.
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`These covers could be made with low-porosity woven fabric materials, as
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`described by U.S. Patent No. 5,957,949 to Leonhardt et al. (“Leonhardt,” Ex.
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`1027), which issued on September 28, 1999:
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`Graft material 24 is a thin-walled biocompatible, flexible and
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`expandable, low-porosity woven fabric, such as polyester or PTFE. It
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`is capable of substantially conforming to the surface of the living tissue
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`to which stent 26 coerces it.