FILE HISTORY
`09/659,882
`
`INVENTORS: Shlomo Gabbay
`
`TITLE:
`
`Valvular prosthesis and method of using
`same
`
`APPLICATION 091659 882
`NO:
`'
`FILED:
`12 SEP 2000
`
`COMPILED:
`
`10 AUG 2020
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 1 of 134
`
`

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`BEST COPY
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`PT0-2040
`12/89
`
`ORIGINAL
`
`CLASS
`
`I
`I SUBCLASS
`I
`
`INTERNATIONAL CLASSIFICATION
`
`~SSUING CLASSIFICATION
`CROSS REFERENCE(S)
`
`CLASS
`
`SUBCLASS (ONE SUBCLASS PE,:1 BLOCK)
`
`~
`
`I
`
`\
`
`'
`
`D Continued on Issue Slfp Inside FIie Jacket
`
`□ TERMINAL
`DISCLAIMER
`
`DRAWINGS
`
`Sheets Drwg.
`
`Figs. Drwg.
`
`Print Fig.
`
`CLAIMS ALLOWED
`Print Claim for O.G. ;
`
`Total Claims
`
`(date)
`
`0 The term of this patent
`subsequent to
`has been disclaimed.
`0 The term of this patent shell
`not extend beyond the expiration date
`of U.S Patent. No.
`
`0 The terminal _months of
`this patent have been dlsclalmed.
`
`)
`
`(,t.ulatlltlt Examiner) ~
`
`NOTICE OF ALLOWANCE MAILED
`
`(Primary Examiner>
`
`(Date)
`
`ISSUE FEE
`
`Amount Due
`
`Date Paid
`
`ISSUE BATCH NUMBER
`
`(Legal lnatrumelll■ EMamlner) ~
`
`I
`
`'
`
`!
`
`:
`
`)
`\
`I
`
`WARNING:
`The Information dlacloaed herein may be restricted. Unauthorized disclosure mey be prohibited by the United Stales Code Title 35, Sections 122, 181 and 388.
`Poaeeaalon outside the U.S. Patent & Trademark Office la restricted to autt"Klriied employees end contractors only.
`FILED WITH: □ DISK (CRF) □ FICHE □ CD-ROM
`(Attached In pocket on right l118lde llepl
`
`Form PT0-438A
`(RIV, 6199)
`
`(FACE)
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 2 of 134
`
`

`

`09/659,882
`
`Valvular prosthesis and method of using same
`
`Transaction History
`
`Date
`09-12-2000
`10-03-2000
`10-27-2000
`10-27-2000
`11-20-2000
`01-23-2001
`01-23-2001
`09-28-2001
`09-28-2001
`11-07-2001
`11-29-2001
`12-01-2001
`01-22-2002
`01-29-2002
`02-07-2002
`02-07-2002
`04-05-2002
`04-05-2002
`06-25-2002
`07-10-2002
`07-24-2002
`10-21-2002
`10-23-2002
`12-27-2002
`01-06-2003
`01-16-2003
`01-17-2003
`03-04-2003
`07-25-2003
`07-25-2003
`07-31-2018
`
`Transaction Description
`Initial Exam Team nn
`IFW Scan & P ACR Auto Securitv Review
`Application Dispatched from OIPE
`Correspondence Address Change
`Case Docketed to Examiner in GAU
`Information Disclosure Statement (IDS) Filed
`Information Disclosure Statement (IDS) Filed
`Information Disclosure Statement (IDS) Filed
`Information Disclosure Statement (IDS) Filed
`Case Docketed to Examiner in GAU
`Restriction/Election Requirement
`Mail Restriction Reauirement
`Response to Election/ Restriction Filed
`Date Forwarded to Examiner
`Information Disclosure Statement (IDS) Filed
`Information Disclosure Statement (IDS) Filed
`Mail Non-Final Rejection
`Non-Final Rejection
`Correspondence Address Change
`Response after Non-Final Action
`Date Forwarded to Examiner
`Final Reiection
`Mail Final Reiection (PTOL - 326)
`Response after Final Action
`Date Forwarded to Examiner
`Advisorv Action (PTOL-303)
`Mail Advisory Action (PTOL - 303)
`Request for Extension of Time - Granted
`Mail Abandonment for Failure to Respond to Office Action
`Aband. for Failure to Respond to 0. A.
`File Marked Found
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 3 of 134
`
`

`

`NT APPLICATION
`· c860 U • S · PTO
`; j 09/659882
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`09659882
`
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`CONTENTS
`Date Received
`(Incl. C. of M.)
`or
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`Date Rec&lved
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`80. _ _ _ _ _ _ _ - - -
`81. _ _ _ _ _
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`
`82. _ _ _ _ _ _ _
`
`(LEFT OUTSIDE)
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 4 of 134
`
`

`

`ISSUE SLIP STAPLE AREA (for additional cross references)
`
`POSITION
`
`INITIALS
`
`IONO.
`
`DATE
`
`FEE DETERMINATION
`0.1.P.E. CLASSIFIER
`FORMALITY REVIEW
`RESPONSE FORMALITY REVIEW
`
`INDEX OF CLAIMS'
`v ................................. Rejected
`N .' ..... :~ ......................... Non-elected
`I .......... ....................... Interference
`................................. Allowed
`(Through numeral) ... Canceled
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`Date
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`iii
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`91
`
`92
`
`93
`94
`95
`96
`97
`98
`99
`100
`
`If more than 150 claims or 1 O actions
`staple additional sheet here
`
`(LEFT INSIDE)
`
`Date
`
`Claim
`
`iii
`iii·&
`"i:
`C:
`t.i: 0
`101
`102
`103
`104
`105
`106
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`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 5 of 134
`
`

`

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`•·,
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`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 6 of 134
`
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`with (stent or frame or support)
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`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 7 of 134
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 8 of 134
`
`

`

`Page 1 of 1
`
`UNITED STATES PATENT AND ThADEMARK OrncE
`
`COMMISSIONl!:.R l"OR PATl!:.NTS
`UNITl!:.O STAT!S PATl!:."-T ANO Th;.CEMARK OFP-IC!:
`~HINOTON, 0.C. 202.31
`v.ww.uspto.gOY
`
`IIDlll lllmllDIU~lllllll~lll!l!I
`
`Bib Data Sheet
`
`CLASS
`623
`
`GROUP ART UNIT
`3738
`
`ATTORNEY
`DOCKET NO.
`SHEP5003US
`
`""" SMALL ENTITY ••
`
`STATE OR SHEETS
`COUNTRY DRAWING
`5
`NJ
`
`TOTAL
`CLAIMS
`25
`
`INDEPENDENT
`CLAIMS
`3
`
`-
`
`SERIAL NUMBER
`09/659,882
`
`FILING DATE
`09/12/2000
`-
`RULE
`
`APPLICANTS
`Shlomo Gabbay, Short Hills, NJ ;
`
`"CONTINUING DATA ........ ~~r•.,••
`~o
`H FOREIGN APPLICATIONS "'0 **** .t' ........... ,,,,,
`{\)f> ~E.,
`IF REQUIRED, FOREIGN FILING LICENSE
`GRANTED** 10/27/2000
`□ yesiZJ no
`~5 USC 119 (a-d) conditions □ yes Ci' no □ Met after
`~owance , .a')
`.~A. .... P .~
`Examiner's Signature O
`Initials
`
`Foreign Priority claimed
`
`met
`Verlfted and
`A.cknowledaed
`ADDRESS
`
`Gary J Pitzer
`Amin Eschweller & Turocy LLP
`:24th Floor National City Center
`1900 East 9th Street
`Cleveland ,OH 44114
`TITLE
`
`rvatvular prosthesis and method of using same
`
`FILING FEE FEES: Authority has been given in Paper
`to charge/credit DEPOSIT ACCOUNT
`RECEIVED No.
`for following :
`No.
`390
`
`I□ All Fees
`I□ 1.16 Fees (Filing}
`□ 1.17 Fees ( Processing Ext. of
`time)
`I□ 1.18 Fees (Issue~
`I□ Other
`I□ Credit
`
`I
`I
`
`I
`I
`I
`
`file://C:\APPS\PreExam\correspondence\ 1 _ A.xml
`
`10/27/00
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 9 of 134
`
`

`

`Page 1 of 1
`
`COMMISSIONER FOR PATENTS
`UNITED STAT!!:S PATENT ANO TRADEMARK 0Ff"ICE
`Wt.SM INOTOII , 0.C. 20231
`www.usplo QCN
`
`CONFIRMATION NO. 5879
`
`CLASS
`623
`
`GROUP ART UNIT
`3738
`
`ATTORNEY
`DOCKET NO.
`SHE-6137
`
`UNITED STATES PATENT AND 1RADEMARK OFFICE
`
`IIIID~IHlll\~fflHIIHl\~MIIIU
`
`Bib Data Sheet
`
`SERIAL NUMBER
`09/659,882
`
`FILING DATE
`09/12/2000
`RULE
`
`APPLICANTS
`Shlomo Gabbay, Short Hills, NJ;
`
`•• CONTINUING DATA **"***'"*** 0 ***'"** 0 ****'"
`
`** FOREIGN APPLICATIONS ••u•••***0 **0 **u
`
`IF REQUIRED, FOREIGN FILING LICENSE GRANTED.,. SMALL ENTITY**
`"'* 10/27/2000
`Dyes D no
`toreign Priority claimed
`~5 USC 11 B (a-d) conditions D yes D no D Met after
`met
`• Allowance
`Verified and
`A.cknowledaed
`ADDRESS
`GARY J. PITZER
`irAROLLI, SUNDHEIM, COVELL, TUMMINO & SZABO L.L.P.
`526 SUPERIOR AVENUE
`1111 LEADER BUILDING
`CLEVELAND ,OH 44114-1400
`
`Examiner's Signature
`
`Initials
`
`STATE OR
`SHEETS
`COUNTRY DRAWING
`NJ
`5
`
`TOTAL
`CLAIMS
`25
`
`INDEPENDENT
`CLAIMS
`3
`
`TITLE
`
`Valvular prosthesis and method of using same
`
`f EES: Authority has been given in Paper
`FILING FEE
`to charge/credit DEPOSIT ACCOUNT
`RECEIVED No.
`for following :
`No.
`390
`
`I□ All Fees
`I□ 1.16 Fees (Filing)
`□ 1.17 Fees ( Processing Ext. of
`time}
`I□ 1.18 Fees (Issue)
`I □ Other
`I □ Credit
`
`I
`I
`I
`I
`I
`I
`I
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 10 of 134
`
`

`

`PATENT APPLICATION SERIAL NO. _ _ _ _ _ _ _ _
`
`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`FEE RECORD SHEET
`
`09/21/2000 NVIUJRI 00000019 09659812
`01 FC1201
`345.00 DP
`02 FC1203
`45.00 OP
`
`PT0-1556
`(5/87)
`·u.s. GPO: 1999-4SG-082/191«
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 11 of 134
`
`

`

`Please type e plus sign(+) i~side lhie box ➔ [±J
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`Un
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`A
`PTOISB/05 (4198) +
`
`Approved for use through 09/30/2000. 0MB 0651-0032
`Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
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`
`UTILITY
`PATENT APPLICATION
`Title VALVULAR PROSTHESIS AND METHOD OF USING ...
`TRANSMITTAL
`Only for new nonprov/a/on11/ 11ppl/csllons unrw 31 C.F.R. § 1.53(b) Express Mell Label No. EK24344917 l US
`A■-latant Comml11lonar for Patents
`APPLICATION ELEMENTS
`ADDRESS TO: Box Patent Application
`S88 MPEP cha ter 60D concern! utility patent application contents.
`111
`11
`111
`t--:r.71~=--. F•e'"'e•r•ra•n•s•m-ltta-l F_o.,rm-~""'e'"'.g•., -P•r""'o.""vs•a•:1•17•?-.............. __ 5"'!_ ,=~,M•l-cr_ofi_ch_e_C .. 0
`pu11,11t1,11,er
`1 · ~ (Submit an original and a duplicate for faa procaasing)
`[Total Pagss f'i'o7 I
`2. ~ Specification
`6. Nucleotlde and/or Amino Acid Sequence Submission
`(preferred arrangement sat forth below) ~ (If Spf!_l/csble, BIi necessary)
`- Descriptive !Ille of the Invention
`
`m1
`
`Par~og.wra11i1m..w(A"'p1,1,p.e-nd•ix•~-----1 • ~ fig
`~ =o
`a. D Computer Readable Copy
`b. O · Paper Copy {identical to computer copy)
`c. D Statement verifying Identity of above copies
`7.o Asslgnm~nt Papers (cover sheet & document(s))
`8 □ 37 C.F.R.§3.73(b) Statement D Power of
`9.o English Translation Document (lfspp/Jcsble)
`10 D Information Olsclosure □ Coples of IDS
`·
`Statement (IDS)/PT0-1449
`11.□ Prellmlnary Amendment
`12 r.-,, Return Receipt Postcard (MPEP 503)
`· IJ!:.J (Should be speclflcs//y Itemized)
`• Small Entity
`1..E.J (PTOISBI09-t2
`
`- Cross References to Related Applfcalions
`- Statement Regarding Fed sponsored R & D
`- Reference to Microfiche Appendix
`- Background of the Invention
`- Brief Summary of the Invention
`- Brief Description of the Drawings (If filed)
`- Detailed Description
`-Clalm(s)
`- Abstract of the Disclosure
`
`[Total Shears Di
`3. [iZ] Drawing(s) (35 U.S.C. 113)
`b o Copy from a prior application (37 C.F .R. Ii 1.63(d))
`
`[TotalPagasW J
`4. Oath or Declaration
`a. r:71 Newly executed (orlglnal or copy)
`~
`
`·
`
`(for conllnua~Mlllcmal with Bax 1B complafad)
`□ QELEIIQN OF INYENTORIS)
`Signed statement attached deleting
`lnventor(s) named In the prior application,
`see 37 C.F.R. §§ 1.63(d)(2) and 1.33(b).
`
`ACCOMPANYING APPLICATION PARTS
`
`·
`
`(wh9n thera Is Bn assignee)
`
`Attomey
`
`Citations
`
`13_ 1771 Statement( s) p Stateme~t filed In prior ap~licatlon,
`14 &] Certified Copy of Priority Document(s)
`
`·
`15.
`
`(If foreign priority Is claimed)
`Other: ~.xpress Mail Certificate
`Under 37 CFR 1.10
`
`Status still proper and desired
`
`16. If a CO.NTINUING APPLICATION, check appropriate box, and supply Illa raqulalta information balow and in a preliminary amendment
`0 Contlnuallon O Divisional O Conllnuatlon-ln-part (CIP)
`of priOr appllcaliOn No: ___ , ______ _
`Group/ Art Unit: ________ _
`Prior applicatlcm Information: E'xamlnar___________
`For CONTINUATION or QIY!SfONAL APPS only: The entire dlacloaura of the prior 11ppllc11tlon, from which an oath or declaration 11 aupplled
`under Box 4b, is con1ldo111d e part of the disclosure of the accompanying continuation or dlvlelonal appllcatlon and la hereby hcorpor11t11d by
`reference. The lncorpor11tlon a.!l..9.D.!l be nilled upon when a portion haa been Inadvertently omitted from the aubmlttad appllcatlon parts.
`
`□ Cuatomtll' Number or Bar Code Label
`
`Nama
`
`Amin, Eschweiler
`Ga
`J. Pitzer
`24th Floor, National Cit Center
`1900 East 9th Street
`Cleveland
`
`or
`
`[i2] Correspondence address below
`
`Zip Coda
`
`4411
`
`39,334
`Rag/slralfon No. (Atmm•ylAQenQ
`Dale 9/12/00
`urs to complete. Tims will vary depending upon the needs of lhe individual case. Any
`tak 0.
`Ima e
`comments on !he amount of time you are req
`to complete this form should be sent lo the Chief Information Offic11r, Patent and Trademark Office,
`Washington, DC 20231. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS, SEND TO: Assistant Commissioner for Patents,
`Box Patent Application, Washington, DC 20231.
`
`t
`
`+
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 12 of 134
`
`

`

`PTO/SB/17 (2/98)
`Approwd for use lhrou"h 9130/2000. 0MB 0651-0032
`Palent MCI Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Pape!Wllrk ReducUon Act of 1995, no persons ere required to respond to a collection of lnformelion unless It displays a valid 0MB control number.
`r
`Complete If Known
`...
`FIiing Date
`First Named Inventor Shlomo Gabbav
`Exemlner Name
`
`II
`
`FEE TRANSMITTAL Aoollcation Number
`Patent fsu are subject to annual revision on Oclober 1.
`These ere the fae11 effective November 10, 1998.
`Small Entity payments mw be supported by a small en/1/y stalsmsnt,
`olherwlse /erge entity tee, must be pe/d. See Form, PTOISB/OfJ-12.
`See 37 C.F.R. §§ 1.27 and 1.ZB.
`
`"
`
`·~
`
`Fee Paid
`
`Group I Art Unit
`Attorney Docket No. SHEP5003US
`FEE CALCULATION (continued}
`3. ADDITIONAL FEES
`Large EnlltySmall Enltty
`Fee FH Fee Fee
`($)
`65
`
`105 130 205
`
`50 227
`
`25
`
`Fae Description
`
`Surcharge - late filing fee or oath
`Surcharge - late provisional f'IWng fee or
`cover sheet.
`
`\..TOTAL AMOUNT OF PAYMENT
`
`($)
`
`390.00
`
`METHOD OF PAYMENT check one)
`
`Indicated fees and credit any ow,r payments to:
`
`•
`Deposit
`Account
`Number
`Deposit
`Account
`Name
`
`FH Required Under
`37 C.F.R. §§ 1.1hnd 1,17
`
`37 C.F.R, § 1. 18 It the Malling
`of Ille Nollce al Allowance
`
`Oother
`
`Fee Paid
`
`Non-English specification
`139 130 139 130
`147 2,520 147 2,520 For filing a request for reexamination
`112 920' 112 920' Requesting publicetlon of SIR pnor to
`Examiner action
`113 1,840• 113 1,840' RequesUng p_ublicatlon of SIR afler
`Examiner action
`Eictenslon for reply within lirsl month
`Extension for reply within eecond month
`Extene ion tor reply within third month
`
`55
`115 110 215
`116 380 216 190
`870 217 435
`117
`118 1,360 218 680
`
`Extension for reply within fourth month
`Extension for reply with In fifth month
`
`128 1,850 226 925
`
`1 li2I The Commlasloner Is hereby eulhor1zed lo charge
`I Code ($) Code
`~0-1063
`!Amin, Eschweiler & Turocy I 127
`'21 ChargeAnyAddltlanal D Ch ■rg• U'le l11ue Fee Set in
`2, li2J Payment Enclosed:
`121 Check □ ~~;:y
`FEE CALCULATION
`1. BASIC FILING FEE
`Large Entity Small Entity
`Fee Fee FH Fee Fee Da.crrptlo"
`Code ($) Code ($)
`101 690
`206 155 Design filing fee
`106 310
`207 240 Plant fllln9 fee
`107 480
`108 690 208 345 Reissue filing fee
`75 Provisional flllna fee
`114 150 214
`($) 345.00 I
`SUBTOTAL (1)
`2. EXTRA CLAIM FEES
`
`201 345 Utility filing fee § 119 300 219 150 Notice of Appeal
`Total Cielms 00-20" :EB X ~ 144 580 244 290
`
`Filing a brief In support ot en appeal
`120 300 220 150
`Request for oral hearing
`121 260 221 130
`138 1,510 138 1,510 PelHlon to inStitute a pubHc use proceeding
`Petlllon to rellive • una\/Oldeble
`55
`140 110 240
`PBlltlon to revive • unintentional
`141 1,210 241 605
`142 1,210 242 805 Ul~ity Issue fee (or reissue)
`Design Issue fee
`143 430 243 215
`Plant Issue f88
`
`Fee from
`Extra Clelma ~ Fee Paid
`x [I[] .c:::[:J 122 130 122 130
`Independent [I] . 3 .. ., 0
`Multlpla Dependent ~ -o:J 123
`Claims
`50 123
`50
`128 240 126 240
`Submission of lnformat!on Olsclosure Stml
`40 Recording each patent aH ignment per
`proparty (times number of praperliet)
`
`Petitions to the Commissioner
`
`Petitions related to provisional applications
`
`581
`
`40 581
`
`146 780 246 380
`
`mn~;J~~~i;r after floal rejection
`
`149 760 249 380 For each addltlooel Invention to be
`BllBrnlned (37 CFR 1.129(b))
`
`Other fee (specify)
`
`Other fee (specify)
`
`.. o, number previously paid, If greater; For Reluuas, see below
`Large Entity Small Enllty
`Fee F■e FH F■e
`Code ($) Cod• ($)
`9 Claims In excess of 20
`103
`18
`203
`Independent delms In excess rt 3
`78 202 39
`102
`104 280
`204 130 Multiple dependent claim, If not pak1
`.. Reissue independent claims
`209 39
`over original patent
`" Reissue claims In excess of 20
`· and over original patent
`
`Fee Description
`
`109
`
`78
`
`110
`
`18
`
`210
`
`9
`
`SUBTOTAL (2) 1($) 45.00 I ' Reduced by Bee le Filing Fee Paid
`
`SUBTOTAL (3) 1($)
`
`Signature
`
`Cnmnlete (It aooJlcablel
`SUBMITTED BY
`Typed 01
`Gary Jc Pitz'lf
`Reg . Number ~9,334
`-----
`Printed Name
`-
`Deposit Account 50-1063
`~ ~_ :>
`9/12/00 User ID
`joatef
`---=:::i.
`d'to teh 0.2 hOurs to complele. Time will very depending upon the needl of the individual case. Any
`Burden Hour Statement Thie fc~ Is e!tt~
`comments on the amount of tlmci you are r ulrad lo complete this form should be sent to the Chlei Information Officer, Pelent and Trademark Offrce,
`Washington , DC 20231, 00 NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS . SEND TO: Assistant Commissioner for Patents,
`Washington, DC 20231.
`
`1o
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 13 of 134
`
`

`

`Atty. Docket No. SHEP5003US
`
`VALVULAR PROSTHESIS AND
`METHOD OF USING SAME
`
`by
`
`Shlomo Gabbay
`
`CERTIFICATION UNDER 37 CFR 1.10
`I hereby certify that the attached patent application (along with any other paper referred to as
`being attached or enclosed) is being deposited with the United States Postal Service on this
`date September 12. 2000, in an envelope as "Express Mail Post Office to Addressee"
`Mailing Label Number EK243449171US
`addressed to the: Box Patent Application, Assistant
`Commissioner for Patents, Washington, D.C. 20231.
`
`· Jennifer C. Safranek
`(Typed or Printed Name of Person Mailing Paper)
`
`S: \G Pitzer\Shelh igh\Patent Matters\P 5 003 us\expresscvr. wpd
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 14 of 134
`
`

`

`Docket No.: SHf
`
`·oo3US
`
`Expre:
`
`lail No. EK243449171US
`
`Title: VALVULAR PROSTHESIS AND METHOD OF USING SAME
`
`The present invention relates to an implantable prosthetic device and, more
`
`5
`
`particularly, to a valvular prosthesis and to a method of using the prosthesis.
`
`Technical Field
`
`Background
`
`It is well known to utilize mechanical heart valves, such as the ball check
`
`valve, and natural tissue cardiac valves to replace defective aortic and mitral
`
`1 O
`
`valves in human patients. One type of natural tissue heart valve typically employs
`
`a porcine valve for implantation in a human, as they are very similar to human
`
`valves of appropriate size and generally are easy to procure. Typically, the porcine
`
`valve is fixed by chemically treating it, such as with an appropriate glutaraldehyde
`
`solution. The treated porcine valve further may be mounted into a stent to support
`
`15
`
`the valve at a fixed position.
`A stent typically is formed of a resilient material, such as a plastic (e.g.,
`
`DELRIN). Examples of various stent structures are disclosed in U.S. Patent No.
`
`3,983,581, U.S. Patent No. 4,035,849. The stent usually is covered with a fabric
`
`material, such as DACRON or a suitable textile material. The fabric material
`
`20
`
`provides structure for securing the valve relative to the stent. The stented heart
`
`valve prosthesis may be implanted into a patient for a heart valve replacement.
`
`In order to surgically implant a heart valve into a patient, the patient typically
`
`is placed on cardiopulmonary bypass during a complicated, but common, open
`
`chest procedure. In certain situations, an individual requiring a heart valve
`
`25
`
`replacement may be sufficiently ill, such that placing the individual on
`
`cardiopulmonary bypass may pose too great a risk. Such individuals may
`
`correspond to a class of patients who may have a non-functioning pulmonary valve
`
`or severe aortic valve insufficiency. In particular, older patients having a deficient
`
`aortic valve may be too ill to survive conventional open-heart surgery.
`
`30
`
`Another class of individuals may be suffering from vascular degeneration
`
`associated with the lower extremities. Such degeneration may include inoperative
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 15 of 134
`
`

`

`Docket No.: SHE-
`
`03US
`
`or otherwise ineffective venous valves resulting in one or more undesirable
`
`indications.
`
`These and other conditions would benefit from an improv~d valvular
`
`prosthesis that may be implanted by a less invasive and/or less time-consuming
`
`5
`
`implantation procedure.
`
`Summary
`
`The present invention relates to a valvular prosthesis operable to mitigate
`
`valvular insufficiency. The prosthesis includes a valve apparatus located within a
`
`1 O
`
`stent apparatus to form a stented valve. The stented valve is deformable between a
`
`first condition and a second condition, which second condition has a cross-sectional
`
`dimension that is less than a cross-sectional dimension of the stented valve when in
`
`the first condition. Accordingly, the stented valve may be deformed to the second
`
`condition to facilitate implantation, such as to replace an insufficient heart valve or
`
`an insufficient venous valve.
`
`In accordance with one aspect, the stented valve may be deformed to the
`
`second condition and maintained in the second condition by a retaining-mechanism,
`
`such as a generally cylindrical enclosure of a catheter apparatus. The enclosure
`
`may be employed to position the stented valve at a desired position and then
`
`20
`
`discharge the prosthesis from the enclosure. The stented valve then expands
`
`toward the first condition and at least a portion of the outer surface of the stent
`
`engages surrounding tissue to inhibit axial movement of the stented valve relative to
`
`the surrounding tissue.
`
`25
`
`Brief Description of the Drawings
`
`To the accomplishment of the foregoing and related ends, certain illustrative
`
`aspects of the invention are described herein in connection with the following
`
`description and the annexed drawings. These aspects are indicative, however, of
`
`but a few of the various ways in which the principles of the invention may be
`
`30
`
`employed and the present invention is intended to include all such aspects and their
`
`equivalents. Other advantages and novel features of the invention will become
`
`2
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 16 of 134
`
`

`

`Docket No.: SHE-
`
`03US
`
`apparent from the following detailed description of the invention when considered in
`conjunction with the drawings, in which:
`Fig. 1 is an exploded isometric view of a valve and stent apparatus that may
`be utilized to form a prosthesis in accordance with the present invention;
`Fig. 1A in enlarged view of part of the stent of Fig. 1 in a first condition;
`Fig. 1 Bis enlarged view of part of the stent of Fig. 1, similar to Fig. 1A,
`illustrating the part of the stent in a second condition;
`Fig. 2 is an example of a valvular prosthesis in accordance with the present
`invention;
`Fig. 3 is another example of valvular prostheses in accordance with the
`present invention;
`Fig. 4 is an example of the valvular prostheses of Fig. 3 implanted within a
`tubular member in accordance with the present invention;
`Fig. 5 is another example of a stent apparatus in accordance with the present
`invention;
`Fig. 6A is an example of the stent of Fig. 5 mounted within an enclosure in
`accordance with the present invention;
`Fig. 6B is an example of valvular prostheses having the stent of Fig. 5
`mounted therein in accordance with the present invention;
`Fig. 7 is an example of a valvular prosthesis, illustrating an outer sheath over
`the prosthesis of Fig. 68 in accordance with the present invention;
`Fig. 8 another example of a valvular prosthesis, illustrating an outer sheath
`over the prosthesis of Fig. 6B in accordance with the present invention;
`Fig. 9A is an example of enclosure that may be utilized for implanting a
`valvular prosthesis in accordance with the present invention;
`Fig. 98 is an example of another enclosure catheter mechanism that may be
`utilized for implanting a valvular prosthesis in accordance with the present invention;
`Fig. 1 O is an example of a valvular prostheses implanted in an aortic position
`of a heart in accordance with the present invention; and
`Fig. 11 is an example of a valvular prostheses implanted in a pulmonic
`position of a heart in accordance with the present invention.
`
`3
`
`5
`
`15
`
`20
`
`25
`
`30
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 17 of 134
`
`

`

`Docket No.: SHE-
`
`'03US
`
`Description of the Invention
`
`Fig. 1 is an exploded view of a valvular prosthesis 10 in accordance with a~
`
`aspect of the present invention. The prosthesis 1 0 includes a valve portion 12 and
`
`5
`
`a stent portion 14 that may be assembled to form the valvular prosthesis 10, such
`
`as shown in Fig. 2.
`
`The valve portion 12 includes inflow and outflow ends 16 and 18 spaced
`
`apart from each other by a length of a generally cylindrical sidewall portion 20.
`
`While the inflow and outflow ends 16 and 18 are illustrated as being annular in Figs.
`
`10
`
`1 and 2, those skilled in the art will understand and appreciate that other
`
`configurations (e.g., generally sinusoidal ends) also could be used in accordance
`
`with the present invention.
`
`The valve portion 12 also includes one or more leaflets 22, 24, and 26 that
`
`are attached to and extend from an interior of the sldewall portion 20. In the
`
`example illustrated in Fig. 1 and 2, the valve portion 12 includes three leaflets 22,
`
`24 and 26, although other numbers of leaflets, such as a single leaflet or two
`
`leaflets, also could be used.
`
`The valve portion 12 may be formed of any substantially biocompatible valve
`
`apparatus. By way of example, the valve portion 12 may include an animal heart
`
`20
`
`valve (e.g., pulmonic or aortic), a manufactured valve device (e.g., a valve as shown
`
`and described in U.S. Patent No. 4, 759,758 or U.S. Patent No. 5,935,163) a
`
`venous valve (e.g., ~ bovine or equine jugular venous valve). Those skilled in the
`
`art will understand and appreciate that the foregoing list is not intended to be
`
`exhaustive but, instead, is intended illustrate a few examples of the types of valves
`
`25
`
`that may be utilized in a valvular prosthesis 1 0 in accordance with an aspect of the
`
`present invention.
`
`If the valve portion 12 is formed of a natural tissue material, such as an
`
`animal heart valve, a venous valve, or a composite valve manufactured of natural
`
`tissue, the valve should be chemically fixed, such as in a suitable solution of
`
`30
`
`glutaraldehyde in a closed condition (as is known in the art). The fixation process
`
`facilitates closure of the valve 12 under application of back flow pressure, while
`
`4
`
`Edwards Lifesciences Corporation, et al. Exhibit 1015, p. 18 of 134
`
`

`

`Docket No.: SHE-
`
`'03US
`
`remaining open during normal foiward blood flow through the valve 12. By way of
`
`example, the natural tissue valve may be cross-linked with glutaraldehyde and
`
`undergo a detoxification process with heparin bonding, such as according to a NO(cid:173)
`
`REACT® treatment process from Shelhigh, Inc. of Millburn, New Jersey. The NO-
`
`5
`
`REACT® treatment improves biocompatibility of the valve apparatus 12 and
`
`mitigates calcification and thrombus formation.
`
`In accordance with an aspect of the present invention, the valve portion 12
`
`exhibits structural memory. That is, if the valve apparatus 12 is com.pressed, such
`
`as to a reduced diameter at the time of being implanted, it will return substantially to
`
`its original shape and configuration upon removal of radially inward forces. As a
`
`result, the valve apparatus 12 is able to maintain coaptation of the leaflets 22, 24,
`
`and 26 even after being deformed. The memory feature of the valve is further
`
`improved by mounting it within the stent portion 14.
`
`Turning now to the stent portion 14, such as shown in Figs. 1 and 2, the stent
`
`includes an inflow end 30 and an outflow end 32. In this example, the inflow and
`
`outflow ends 30 and 32 are spaced apart from each other a distance that is greater
`
`than the distance between the corresponding ends 18 and 16 of the valve 12. In
`
`this way, the ends of the stent 30 and 32 may extend beyond the respective ends
`
`18 and 16 of the valve 12 (e.g., by about a few millimeters), such as shown in Fig.
`
`20
`
`2. The stent portion 14 also may include outwardly turned portions at the inflow and
`
`outflow ends 30 and 32 of the stent, which, when implanted, may engage and/or be
`
`urged into the surrounding tissue to mitigate movement thereof.
`
`According to an aspect of the present invention, the stent 14 may deformable
`
`between first and second conditions, in wh