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 IPR2017- _
`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
`
`
`
`
`
`
`
`
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`OVERVIEW OF PETITION ........................................................................... 1
`
`II.
`
`THE INSTANT PETITION IS DISTINCT FROM EDWARDS’
`FIRST IPR PETITION, AND SHOULD BE INSTITUTED ......................... 6
`
`III. STATE OF THE ART AT THE TIME OF THE INVENTION ..................... 9
`A.
`Stent Structures Were Well Known as of June 2004 ................11
`B.
`Fabric Seals for Use with THVs Were Well Known
`
`as of June 2004 ..........................................................................15
`a. Lazarus (1993) ..........................................................20
`
`b. Lunn (1994) ..............................................................21
`
`c. Thornton (1996) ........................................................22
`
`d. Lawrence-Brown (2001) ...........................................22
`
`e. Cook (2002) ..............................................................23
`
`f. Schlick (2003) ...........................................................24
`
`C.
`
`Commissure Supports and Valves Attached Thereto
`Were Well Known in THV Designs as of June 2004 ...............25
`
`IV. MANDATORY NOTICES ...........................................................................28
`A.
`Real Party-In-Interest ................................................................28
`B.
`Related Matters .........................................................................28
`C.
`Lead and Back-Up Counsel ......................................................28
`D.
`Service Information...................................................................29
`
`V.
`
`REQUIREMENTS FOR INTER PARTES REVIEW ....................................29
`A. Grounds for Standing ................................................................29
`B.
`Identification of Challenge .......................................................29
`
`VI. SUMMARY OF THE ’608 Patent ................................................................30
`A.
`The ’608 Patent’s Claimed Invention .......................................30
`
`B.
`
`Boston Scientific Has Recently Taken the Position that
`Seals with “Sacs” Are Not Mutually Exclusive from
`Seals with “Flaps” and “Pockets” .............................................32
`
`
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`C.
`
`D.
`
`E.
`
`Issuance of the ’608 Patent .......................................................36
`
`Claim Construction ...................................................................37
`
`The ’608 Patent Should Be Afforded a Priority Date
`No Earlier than November 24, 2008, Because the
`Grandparent of the ’608 Patent Does Not Adequately
`Describe the Claims of the ’608 Patent ....................................39
`
`VII. ORDINARY SKILL IN THE ART ...............................................................44
`
`VIII. IDENTIFICATION OF HOW THE CHALLENGED CLAIMS ARE
`UNPATENTABLE ........................................................................................44
`A. Ground 1: Claims 1-9 are invalid under 35 U.S.C.
`§ 102(b) over Haug (Ex. 1135) .................................................44
`
`
`
`Claim 1 (Preamble) .........................................................45
`1.
`Element 1.1 .....................................................................46
`2.
`Elements 1.2-1.3 .............................................................46
`3.
`Element 1.4 .....................................................................47
`4.
`Element 1.5 .....................................................................47
`5.
`Element 1.6 .....................................................................47
`6.
`Element 1.7 .....................................................................48
`7.
`Element 1.8 .....................................................................48
`8.
`Element 1.9 .....................................................................48
`9.
`10. Claims 2-3 .......................................................................48
`11. Claim 4 ............................................................................49
`12. Claims 5-6 .......................................................................49
`13. Claims 7-9 .......................................................................49
`
`B. Ground 2: Claims 1-4 are invalid under 35 U.S.C.
`§ 103(a) over Seguin (Ex. 1150; 1153) in view of
`Lazarus (Ex. 1147) and Lawrence-Brown (Ex. 1149) ..............50
`
`
`
`1.
`2.
`3.
`4.
`5.
`6.
`
`Claim 1 Preamble ...........................................................50
`Element 1.1 .....................................................................50
`Elements 1.2-1.3 .............................................................51
`Element 1.4 .....................................................................54
`Element 1.5 .....................................................................55
`Element 1.6 .....................................................................55
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`Element 1.7 .....................................................................66
`7.
`Element 1.8 .....................................................................67
`8.
`Element 1.9 .....................................................................68
`9.
`10. Claims 2-3 .......................................................................69
`11. Claim 4 ............................................................................72
`
`IX. CONCLUSION ..............................................................................................72
`
`
`
`
`
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`iv
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
`
`EXHIBIT LIST
`
`EXHIBIT 1101 U.S. Patent No. 8,992,608 to Haug et al.
`
`EXHIBIT 1102
`
`File History of U.S. Application No. 12/492,512
`
`EXHIBIT 1103 WO 98/29057 to Cribier et al.
`
`EXHIBIT 1104 WO 03/047468 to Spenser et al.
`
`EXHIBIT 1105 U.S. Patent App. Pub. No. 2003/0236567 to Elliot
`
`EXHIBIT 1106 U.S. Patent App. Pub. No. 2004/0082989 to Cook et al.
`
`EXHIBIT 1107
`
`First Declaration of Dr. Nigel Buller, Originally Submitted in
`IPR2017-00060
`EXHIBIT 1108 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 1109 U.S. Patent App. Pub. No. 2001/0039450 to Pavcnik et al.
`
`EXHIBIT 1110 U.S. Patent App. Pub. No. 2004/0033364 to Spiridigliozzi et al.
`
`EXHIBIT 1111 U.S. Patent No. 3,365,728 to Edwards
`
`EXHIBIT 1112 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 1114 U.S. Patent No. 6,206,911 to Milo
`
`EXHIBIT 1113
`
`EXHIBIT 1115
`
`Excerpts from Vossoughi et al., Stent Graft Update (2000)
`
`EXHIBIT 1116
`
`Excerpts from Dolmatch et al., Stent Grafts: Current Clinical
`Practice (1999)
`EXHIBIT 1117 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 1118 U.S. Patent No. 5,411,552 to Andersen et al.
`
`EXHIBIT 1119 U.S. Patent No. 6,015,431 to Thornton et al.
`
`EXHIBIT 1120 U.S. Patent App. Pub. No. 2001/0021872 to Bailey et al.
`
`
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`EXHIBIT 1121 U.S. Patent No. 6,352,554 to De Paulis
`
`EXHIBIT 1122
`
`European Patent 2 749 254 B1 to Salahieh et al.
`
`EXHIBIT 1123 American Heritage College Dictionary, 4th Ed. 2002 (definition
`of “flaps”)
`EXHIBIT 1124 Merriam-Webster’s Collegiate Dictionary, 10th ed. (2001)
`(definitions of “flaps” and “pleats”)
`EXHIBIT 1125 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 1126 Gore Excluder Instructions for Use (2002)
`
`EXHIBIT 1127 U.S. Patent No. 5,957,949 to Leonhardt et al.
`
`EXHIBIT 1129
`
`EXHIBIT 1128 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 1130
`
`EXHIBIT 1131 Boston Scientific’s August 24, 2016 Response in Opposition
`Proceedings of EP 2 749 254 B1
`EXHIBIT 1132 Boston Scientific’s August 24, 2016 Reply in German
`Infringement Proceeding 4a O 137/15
`EXHIBIT 1133 U.S. Patent No. 5,855,601 to Bessler et al.
`
`EXHIBIT 1134 U.S. Patent No. 5,476,506 to Lunn
`
`EXHIBIT 1135 US 2005/0283231 to Haug et al.
`
`EXHIBIT 1136
`
`Second Declaration of Dr. Nigel Buller
`
`EXHIBIT 1137
`
`Textbook of Interventional Cardiology, 2d Ed., Chapter 75:
`Percutaneous Expandable Prosthetic Valves (1994)
`EXHIBIT 1138 U.S. Patent No. 5,469,868 to Reger
`
`EXHIBIT 1139 U.S. Patent No. 7,731,742 to Schlick et al.
`
`EXHIBIT 1140
`
`Pavcnik, et al., “Aortic and venous valve for percutaneous
`insertion,” Min. Invas. Ther. & Allied Technol. 9(3/4) 287-292
`(2000)
`EXHIBIT 1141 Moazami et al., “Transluminal Aortic Valve Placement: A
`Feasibility Study With a Newly Designed Collapsiable Aortic
`Valve,” ASAIO J. Vol. 42:5, pp. M383-85 (Sept./Oct. 1996)
`
`
`
`vi
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
`
`EXHIBIT 1142
`
`Prosecution History of U.S. Patent Application No. 10/972,287*
`
`EXHIBIT 1143
`
`Prosecution History of U.S. Patent Application No. 10/870,340
`to Haug et al.*
`Prosecution History of U.S. Patent Application No. 12/269,213
`to Haug et al.*
`Edwards Lifesciences LLC v. Boston Sci. SciMed, Inc. EWHC
`(Pat),Claim No. HC-2015-004574, Boston Scientific’s Closing
`Arguments (Jan. 26, 2017)
`Edwards Lifesciences LLC v. Boston Sci. SciMed, Inc. EWHC
`(Pat), Claim No. HC-2015-004574, Day 7 Trial Transcript (Jan.
`27, 2017)
`EXHIBIT 1147 U.S. Patent No. 5,693,088 to Lazarus
`
`EXHIBIT 1144
`
`EXHIBIT 1145
`
`EXHIBIT 1146
`
`EXHIBIT 1148
`
`Edwards’ EPO Opposition to EP 2 749 254 (Mar. 16, 2017)
`
`EXHIBIT 1149 U.S. Patent Application Publication No. 2003/0093145 to
`Lawrence-Brown et al.
`EXHIBIT 1150 Certified English Translation of WO 03/003949 to Seguin
`
`EXHIBIT 1151
`
`Third Party EPO Opposition to EP 2 749 254 (Sept. 2, 2015)
`
`EXHIBIT 1152
`
`Edwards’ EPO Opposition to EP 2 926 766 (June 23, 2016)
`
`EXHIBIT 1153 WO 03/003949 to Seguin
`
`EXHIBIT 1154
`
`Edwards Lifesciences LLC v. Boston Sci. SciMed, Inc. EWHC
`(Pat), Claim No. HC-2015-004574, EP 2 749 254 Patent Fig. 23
`with Boston’s Annotations (Jan. 27, 2017)
`
`
`*These prosecution history exhibits do not include copies of the foreign references
`filed during prosecution of the identified application, which are not relevant to the
`issues raised in this Petition.
`
`vii
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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 of claims 1-9 of U.S. Patent No. 8,992,608 (“’608 Patent,” Ex. 1101)
`
`under 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42.100 et seq. This is Edwards’
`
`second petition for inter partes review. Edwards’ first petition, IPR2017-00060,
`
`was instituted on claims 1-4 on March 29, 2017.
`
`The ’608 Patent’s purported invention is directed to a collapsible and
`
`expandable prosthetic heart valve delivered via catheter (“transcatheter heart
`
`valve” or “THV”). Specifically, the ’608 Patent describes a THV implemented
`
`with a straightforward combination of 4 features already well-known in the art,
`
`including:
`
` a stent-based support structure (“anchor”);
`
` commissure support elements attached to the anchor;
`
` a replacement valve with commissure portions attached to the
`
`commissure support elements; and
`
` a fabric seal.
`
`As pictured below, the fabric seal “extends from the distal end of the replacement
`
`valve and back proximally over the expandable anchor,” and has “flaps” and
`
`
`
`1
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`“pockets” that purportedly prevent blood from flowing between the fabric seal and
`
`surrounding heart tissue (i.e., paravalvular leak):
`
`
`
`Ex. 1101 at 2:42-49, 14:21-29, Figs. 32-34. An element-by-element breakdown of
`
`Claims 1-9 is provided in the attached Appendix.
`
`
`
`It is undisputed that THVs and this set of attributes—the anchor, fabric
`
`seal, commissure support elements attached to the anchor, and replacement valve
`
`commissure portions attached to the commissure support elements—were all well
`
`known before the ’608 Patent’s purported June 16, 2004 priority date. Indeed,
`
`even the claim limitation added to purportedly place the ’608 Patent in condition
`
`for allowance—“the fabric seal extends from the distal end of the replacement
`
`valve and back proximally over the expandable anchor”—was a well-known
`
`feature adopted by numerous THV designs. As such, Claims 1-4 purport to claim
`
`
`
`2
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`as Patent Owner’s exclusive property a straightforward THV implementation that
`
`was, at minimum, obvious to any person of ordinary skill, and are accordingly
`
`unpatentable.
`
`
`
`Moreover, the ’608 Patent’s claims cover both THVs with a plurality of
`
`“commissure support element[s]” and valve “commissure portion[s],” and THVs
`
`with only one “commissure support element” and one valve “commissure
`
`portion.” But the grandparent application to which the ’608 Patent claims priority
`
`(10/870,340 (Ex. 1143)) provides written description support only for the former
`
`(i.e., plurality), thereby resulting in a break in the priority chain. As pictured
`
`below, the embodiments described in the grandparent application include a
`
`plurality of “posts 38” with commissure portions of a trileaflet valve attached
`
`thereto:
`
`See, e.g., Ex. 1143 at Figs. 3B (cross section of THV depicting two of three
`
`commissure support elements and two of three valve commissure portions), 12B
`
`
`
`
`
`3
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
`
`(three-dimensional representation of THV having three commissure support
`
`elements and three valve commissure portions); Ex. 1136 (Second Declaration of
`
`Dr. Nigel Buller), ¶ 41.1 A valve with only a single commissure support element
`
`and a single valve commissure portion would require a completely different and
`
`unique design, which is neither described nor pictured in the grandparent
`
`application. Ex. 1136, ¶ 45. By way of example, other THV patents, including
`
`WO 1998/029057 (“Cribier,” Ex. 1103), include embodiments that, at a
`
`minimum, suggest to a person of ordinary skill in the art how a THV could be
`
`
`1
`In support of this petition, Edwards submits the First Declaration (Ex. 1107)
`
`and Second Declaration (Ex. 1136) of Dr. Nigel Buller. The First Declaration is
`
`the same Declaration Dr. Buller submitted in support of IPR2017-00060. The
`
`Second Declaration adopts and incorporates Dr. Buller’s testimony from his First
`
`Declaration, and is intended to supplement Dr. Buller’s opinions for purposes of
`
`the instant petition. Moreover, Edwards resubmits all exhibits from its first
`
`petition (Exhibits 1001-1034, including Dr. Buller’s First Declaration at Ex. 1007),
`
`but has renumbered each of these Exhibits from 10XX to 11XX numbers in
`
`accordance with Patent Office practice for second petitions. All citations in Dr.
`
`Buller’s First Declaration to 10XX numbers are treated herein as made to the
`
`corresponding 11XX numbers. The remaining Exhibits (1135-1154, including Dr.
`
`Buller’s Second Declaration at Ex. 1136), are new.
`
`
`
`4
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`designed with only a single commissure support element and valve commissure
`
`portion attached thereto:
`
`
`
`See Ex. 1103 at Figs. 11c-e (detailing a valve structure with a semi-rigid part 24’
`
`akin to a commissure support element and a foldable part 23’ that collapses into
`
`the semi-rigid part during diastole). Ex. 1136, ¶ 45. But there is nothing in the
`
`’608 Patent’s grandparent application that contemplates or suggests in any way a
`
`single commissure support element design as suggested by Cribier or otherwise,
`
`and the ’608 claims thus include a broader scope of invention than the
`
`grandparent application supports. Id..
`
`In view of this defect, the ’608 Patent should only be afforded priority to
`
`the earliest disclosure of the full scope of its claims, which was lacking until at
`
`
`
`5
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
`
`least a November 24, 2008 preliminary claim amendment in its parent U.S.
`
`Application No. 12/269,213 (Ex. 1144). Claims 1-9 of the ’608 Patent are
`
`therefore anticipated by earlier publications in its asserted priority chain,
`
`including the 2005 publication of the ’608 Patent’s grandparent application (Ex.
`
`1135).
`
`II. THE INSTANT PETITION IS DISTINCT FROM EDWARDS’ FIRST
`IPR PETITION, AND SHOULD BE INSTITUTED
`
`The instant Petition presents two new grounds of invalidity, neither of which
`
`is based on “substantially the same prior art or arguments previously … presented
`
`to the Office.” See 35 U.S.C. 325(d). Ground 1 presents a new ground of
`
`invalidity based on a break in the ’608 Patent’s priority chain, which results in the
`
`publication of the purported grandparent application becoming anticipatory prior
`
`art against each of Claims 1-9. This ground challenges five claims of the ’608
`
`Patent not previously raised in any prior petition (Claims 5-9), and because a
`
`challenge to these dependent claims necessarily requires addressing the substance
`
`of independent Claim 1, the inclusion of previously-challenged Claims 1-4 in this
`
`new ground does not add meaningfully to the burden on the Board or Patent
`
`Owner. Petitioner respectfully submits the interests of justice and efficiency are
`
`best served by reaching these significant questions together for all claims, and that
`
`for these reasons the Board should not exercise its § 325(d) discretion to deny
`
`institution in this regard.
`
`
`
`6
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
`
`Grounds 2 raises prior art and arguments different from those previously
`
`presented and rests on circumstances that have changed since the October 2016
`
`filing of Edwards’ first petition. This Ground is premised on claim construction
`
`positions asserted by Boston Scientific in a January 2017 trial in the United
`
`Kingdom involving a European counterpart patent to the ’608 Patent. Despite the
`
`U.S. Patent Office’s express conclusion during prosecution of the ’608 Patent that
`
`the various embodiments of sealing structures described therein—e.g., “sacs”
`
`(Figs. 15-16), “flaps and pockets” (Figs. 32-34), and “expandable foam” (Figs. 27-
`
`31)—are mutually exclusive (Ex. 1102 at 331-32), a position Boston Scientific
`
`conceded at the time by electing to prosecute “flaps and pockets” claims without
`
`traverse (id. at 337, 352), Boston Scientific now argues to the contrary. Boston’s
`
`new position is that “flaps and pockets” and “sacs” are not mutually exclusive, and
`
`that embodiments described in the patent have both. See Ex. 1145, ¶ 137; Ex. 1146
`
`at 1067:8-10 (“[Y]ou can be within both patents, or you can be in the bunched-up
`
`and not the sac, or the sac and not the bunched up.”). Boston illustrated this new
`
`claim interpretation as follows (red highlighting added by Boston):
`
`
`
`7
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
`
`See Ex. 1146 ((Transcript, Day 7) at 1063-65 (arguing that the above figure is the
`
`
`
`“epitome of bunching-up” in the form of flaps and pockets, but suggesting
`
`that it also includes a “sac” (in red)). If Boston’s disclosed sealing structures
`
`are not mutually exclusive (as Boston now argues), it logically follows that
`
`“sac” related prior art is now available for consideration with respect to
`
`Boston’s “flaps and pockets” claims. One such example is WO 03/003949
`
`(“Seguin,” Ex 11502), which describes seals that comprise sac-type
`
`“peripheral inflatable chambers,” and which now must be considered in the
`
`context of the ’608 Patent’s “flaps and pockets” claims. Seguin is the
`
`primary reference in Ground 2.
`
`
`2
`Exhibit 1150 is a certified English translation of WO 03/003949, which was
`
`originally published in French. The original French version is separately provided
`
`at Exhibit 1153. All citations herein to WO 03/003949 are to the certified English
`
`translation.
`
`
`
`8
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
`
`In sum, the two new grounds of invalidity are not redundant of any grounds
`
`presented in Edwards’ first petition, they include additional claims of the ’608
`
`Patent beyond those identified in the first petition, they are based on different prior
`
`art, and they rest on circumstances that did not exist at the time of Edwards’ first
`
`petition in October 2016. Edwards therefore respectfully submits that,
`
`notwithstanding the provisions of § 325(d), the circumstances here warrant
`
`institution of these additional grounds and, as requested in Edwards’ Motion for
`
`Joinder filed concurrently herewith, resolution of these serious new questions of
`
`validity together with the instituted grounds in Edwards first petition, IPR2017-
`
`00060.
`
`III. STATE OF THE ART AT THE TIME OF THE INVENTION
`
`The primary features of the THV described and claimed by the ’608
`
`Patent—the stent (i.e., “anchor”), fabric seal, commissure support elements
`
`attached to the anchor, and replacement valve with commissure portions attached
`
`to the commissure support elements—were each well-known attributes in the art as
`
`of June 2004, and regularly employed by practitioners in THV technology. Ex.
`
`1107, ¶¶ 40-46, 52-87; Ex. 1136, ¶¶ 26-31, 33-36.
`
`Notably, in 1994—10 years prior to the purported priority date of the ’608
`
`Patent—Steven Bailey published a chapter in The Textbook of Interventional
`
`Cardiology titled Percutaneous Expandable Prosthetic Valves, recognizing the
`
`
`
`9
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`

`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
`
`early THV work of Dr. Henning Andersen as “[t]he most exciting published work
`
`in this area to date.” Ex. 1137 at 1276; see also Ex. 1118 (U.S. Patent No.
`
`5,411,552 (“Andersen”)); Ex. 1117 (Andersen European Heart Journal
`
`publication). Bailey also recognized, however, that in 1994 “[c]urrent mechanical
`
`and prosthetic valves suffer from a number of problems . . . including the
`
`predisposition to thrombus formation and embolization, perivalvular leak,
`
`infection, difficulty sizing valve to annulus, valve degeneration, and pannus
`
`formation. The designer of any percutaneously placed valve will need to consider
`
`these issues during its design and development in order to minimize these
`
`problems.” Ex. 1137 at 1271 (emphasis added).
`
`The Textbook design considerations in this 1994 reference are reflected in
`
`the THV claimed by the ’608 Patent, but the fifteen years between the work of Dr.
`
`Andersen and the filing of the ’608 Patent’s purported priority application had
`
`already yielded numerous THV design improvements that addressed these
`
`considerations and became state of the art well before any ’608 priority date. Ex.
`
`1107, ¶¶ 58-69, 74-87; Ex. 1136, ¶¶ 27-31, 35-36. For example, stent designs that
`
`were better sized for the target annulus and that reduced the risk of embolization,
`
`valve designs and valve support structures that reduced the risk of valve
`
`degeneration, and external sealing structures that reduced the risk of paravalvular
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`leak were each known prior to any claimed priority date of the ’608 Patent. See,
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`e.g., Ex. 1103 (WO 98/29057 (“Cribier”)), Ex. 1104 (WO 03/047468 (“Spenser”)),
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`Ex. 1150 (Seguin), Ex. 1109 (U.S. Patent App. Pub. No. 2001/0039450
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`(“Pavcnik”)), Ex. 1120 (U.S. Patent App. Pub. No. 2001/0021872 (“Bailey”)),3 Ex.
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`1133 (U.S. Patent No. 5,855,601 (“Bessler”)). Because prior to June 2004 these
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`features were among the already well-understood implementation choices for any
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`THV and, as detailed herein, would have been known by a person of skill to be
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`predictably, beneficially, and straightforwardly applied together in the
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`combinations claimed by Patent Owner, the Claims are unpatentable as obvious.
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`Ex. 1107, ¶¶ 51, 75-87, 106, 109-12; Ex. 1136, ¶¶ 23-24, 36.
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`A.
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`Stent Structures Were Well Known as of June 2004
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`Stents trace their roots to the 1969 work of Charles Dotter, which involved
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`implantation of stainless steel coils in an animal model. Ex. 1107, ¶¶ 41-43. A
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`multitude of stent designs have been developed since, with millions implanted in
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`patients. Ex. 1107, ¶¶ 44-46. By 2004, stents were commonly used in
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`interventional procedures to provide a scaffold capable of holding open a diseased
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`vessel. Ex. 1107, ¶¶ 40-46. Stents were implanted—and still are implanted—bare,
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`with a covering (including stent grafts and coated stents), or as a support structure
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`3
`The named co-inventor on U.S. Patent App. Pub. No. 2001/0021872, Steven
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`Bailey, is the same Steven Bailey that authored the THV chapter in the Textbook
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`of Interventional Cardiology discussed above. See Ex. 1137.
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`for a valve. See, e.g., Ex. 1107, ¶¶ 45-46, 52-69, 71-87; Ex. 1136, ¶¶ 27-31, 36. In
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`each case, stents are generally made of a metallic material, e.g., stainless steel or
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`nickel-titanium (Nitinol), and generally designed to be self-expanding or
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`plastically deformable. Ex. 1107, ¶¶ 41, 43, 46. As seen below, depending on the
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`desired end use, the same stent designs have been used for bare stents, coated
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`stents, stent grafts, and transcatheter valves, sometimes modified to match the
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`anatomy in which they are implanted:
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`
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`Wallstent (Ex. 1107, ¶¶ 42, 45)
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`
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`Palmaz Stent (Ex. 1107, ¶ 46)
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`AneuRX Stent Graft (Ex. 1116)
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`
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`Cook Stent Graft (Ex. 1134)
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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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`Cribier THV (Ex. 1103)
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`Schlick Stent Valve
`(Ex. 1139)
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`A known property for both self-expanding and plastically deformable stents
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`is foreshortening, the extent of which depends on the overall stent design. Ex.
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`1107, ¶¶ 47-51, 67-68; Ex. 1136, ¶¶ 21-24. A stent that foreshortens is a stent
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`whose length decreases as the diameter of the stent increases, and vice versa. Prior
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`to June 16, 2004, it was well known to those of ordinary skill in the art that stents
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`could be designed to substantially foreshorten, not foreshorten at all, or actually
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`lengthen upon radial expansion. Ex. 1107, ¶ 49.
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`For example, a design of a commercial braided-wire Wallstent has been
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`shown to foreshorten by 53%:
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`Ex. 1107, ¶ 50 (citing Ex. 1113 (Ing publication)); see also Ex. 1139 (U.S. Patent
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`
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`No. 7,731,742 (“Schlick”)) at 4:30-51(“the stent 40 can be lengthened in the
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`direction of arrows 47 and subsequently be expanded in a radial direction and
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`shortened in a longitudinal direction”); Ex. 1136, ¶¶ 21-24.
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`THV stent designs incorporating diamond-like stent patterns naturally
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`exhibit a degree of foreshortening. Ex. 1136, ¶¶ 23-24. Seguin, for example,
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`teaches that a diamond-shaped cell is elongated when compressed, and
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`foreshortens when deployed:
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`Ex. 1150, Figs. 5, 7 & at 6 (“Figure 5 is a view of another detail of the stent, on an
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`enlarged scale, in a state of non-expansion of the stent” & “Figure 7 is a view
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`similar to Figure 5, in a state of expansion of the stent”); see also Ex. 1103 (Cribier
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`WO ’057) at 16:11-16 (disclosing a stent with an expanded length of 10mm and a
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`collapsed length of 20 mm (i.e., 50% foreshortening)); Ex. 1120 (Bailey) at ¶
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`[0021] (disclosing laser-cut diamond-cell and woven-wire stent structures); Ex.
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`1136, ¶ 22. As explained by Seguin, “[t]he material from which the stent 2 is made
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`is such that these meshes can pass from a contracted configuration, in which the
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`filaments are near one another, giving the meshes an elongated shape, to an
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`expanded configuration, shown in Figure 1 and in detail in Figure 7, in which the
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`filaments are spaced apart from one another.” Ex. 1150 at 7.
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`B.
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`Fabric Seals for Use with THVs Were Well Known as of June
`2004
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`The concept of providing an external sealing structure on a replacement
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`heart valve to address leakage and other concerns is far from new, as it too traces
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`its roots to the 1960s. Ex. 1107, ¶¶ 38-39. One of Petitioner Edwards’ first
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`commercially available prostheses was a surgically implantable ball-and-cage
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`valve known as the Starr-Edwards valve, described in U.S. Patent No. 3,365,728
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`(Ex. 1111, “Starr-Edwards”). This early valve prosthesis included a
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`circumferentially oriented sewing ring that was adapted to extend into spaces in the
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`tissue surrounding the implanted prosthesis to prevent paravalvular leaking:
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`See Ex. 1111, ’728 Patent at 1:38-46 and 3:12-20 (“[R]ubber cushion ring 35
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`
`
`
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`conforms to any irregularities of tissue contour which may exist because of disease
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`or other causes and forms an effective seal against the tissue.”), Figs. 1, 3
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`(highlighting added); Ex. 1107, ¶ 38.
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`
`
` Surgically implantable biologic valves were similarly known to include
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`external sealing structures. For example, U.S. Patent No. 5,469,868 (“Reger”) (Ex.
`
`1138) details use of an external sealing structure with circumferential ridges in the
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`form of sewing rings (100, 102) and an “interfacing portion 104,” all covered by a
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`fabric “brim cover 105” “made from a material which is permissive to tissue in-
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`growth so that a degree of adhesion improves adhesion of the grafted valve within
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`the native excised valve orifice”:
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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. 1138 at Figs. 1, 17 (“each brim cover 105 and 286 is formed from a hollow
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`cylinder 330”) and 10:26-58, 16:19-31; Ex. 1136, ¶ 18. The “interfacing portion
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`104 . . . is compressible, but . . . comprises memory which responsively expands to
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`fill space previously vacated and unfilled by the remainder of stent 30 when
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`compressive pressures are relieved.” Id. at 10:26-31.
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`A person of ordinary skill in the art designing a THV would have been
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`aware of surgical prosthetic heart valves and the known sealing structures adopted
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`to conform to and fill spaces in the surrounding tissue, and would have recognized
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`the desirability of adopting sealing structures in THV designs that could similarly
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`minimize the risk of paravalvular leak. Ex. 1136, ¶¶ 26, 35, 96.
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`Because, since the advent of prosthetic valve technology, it was well known
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`to incorporate sealing structures to seal valve prostheses against the surrounding
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`tissue, it is of no surprise that even the earliest THV designs included fabric seals.
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`Ex. 1107, ¶¶ 38-39; Ex. 1136, ¶¶ 18-19. There are multiple examples of THVs
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`with fabric seals that predate June 2004—including fabric seals extending from the
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`Petition for Inter Partes Review of U.S. Patent No. 8,992,608
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`distal end of the valve portion a