Free Amended Complaint - District Court of Delaware - Delaware

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EXHIBIT A

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I I I I 1 1 1 1 1 11 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 IN 1 11 IN
(la) Patent No.: US 7,300,662 B2 (45) Date of Patent : 'Nov. 27, 2007
Field of Classification Search ........ 4241422-426; 623/1.42-1.48 See application file for complete search history. References Cited U.S. PATENT DOCUMENTS
861,659 A 3,051,677 A 3,279,996 A 3,526,005 A 3,599,641 A 711907 81962 10,11966 911970 811971 Johnston .... ................. 464/147 Rexford ...................... 522,'l 56 Long et al . ................ 424;424 Bokros . ................... 623111.11 Sheridan ..................... 6041256

(12) United States Patent
Falotico et al.
(54) DRUGIDRUG DELIVERY SYSTEMS FOR THE PREVENTION AND TREATMENT OF VASCULAR DISEASE Inventors. Robert Falotico, Belle Mead, NJ (US); Gregory A. Kopin, Hillsborough, NJ (US); Gerard H. Lianos, Stewartsville, NJ (U5) Assignee: Gordis Corporation , Miami Lakes, FL (US) Subject to any disclaimer, the temt of this patent is extended or adjusted under 35 U.S.C. 154(b) by 503 days. This patent is subject to a terminal disclaimer. (21) (22) (65) Appl. No.: 101829,074 Filed: Apr. 21, 2004 Prior Publication Data US 200410260268 Al Dec. 23, 2004

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(75)

(56)

(73)

{) Notice :

(Continued) FOREIGN PATENT DOCUMENTS
DE 3205942 AI 911983

(Continued) OTHER PUBLICATIONS
Boston Scientific , ";Measuring DES Efficacy," WW%v.xxus-stcnt. comousaMiptcacy . htmi, pp. 1-3, copyright 2006.·

Related U.S. Application Data (63) Continuation-in-part of application No. 091850,293, filed on May 7, 2001, now abandoned, which is a continuation-in-part of application No. 091575,480, filed on May 19, 2000. Provisional application No. 601263,979, filed on Jan. 25, 2001, provisional application No. 601263,806, filed on Jan. 24, 2001, provisional application No, 601262,614, filed on Jan. 18, 2001, provisional application No. 60/262,461, filed on Jan. 18, 2001, provisional application No. 60/204,417, filed on May 12, 2000. Int. Cl. (2006.01) A61F 2100 (2006.01) A61F 2106 U.S. CI ...................... 4241424; 623/1.42; 62311.45

(Continued) Primmy %varniner---Sharon E. Kennedy
(74) Attorney, Agent, or Firm--Woodcock Washburn LLP

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ABSTRACT

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(51)

A drug and drug delivery system may be utilized in the treatment of vascular disease. A local delivery system is coated with rapamycin or other suitable drug, agent or compound and delivered intraluminally for the treatment and prevention of neointinial hyperplasia following percutancous transluminaI coronary ongiography. The local delivery of the drugs or agents provides for increased efibctiveness and lower systemic toxicity. 25 Claims, 2 Drawing Sheets

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US 7,300,662 B2
Page 2 U.S. PATENT DOCUMENTS
3,657,744 A 3,744,596 A 3,779,805 A 3,929,992 A 3,932,627 A 3,948,254 A 3,952,334 A 3,968,800 A 4,069,307 A 4,076,285 A 4,292,965 A 4,299,226 A 4,300,244 A 4,312,920 A 4,321,711 A 4,323,071 A 4,390,599 A 4,413,359 A 4,423,183 A 4,441,216 A 4,503,569 A 4,512,338 A 4,550,447 A 4,553,545 A 4,560,374 A 4,562,596 A 4,565,740 A 4,580,568 A 4,613,665 A 4,642,111 A 4,655,771 A 4,656,083 A 4,676,241 A 4,678,466 A 4,687,482 A 4,689,046 A 4,731,054 A 4,733,665 A 4,739,762 A 4,740,207 A 4,749,585 A 4,753,652 A 4,760,849 A 4,768,507 A 4,776,337 A 4,786,500 A 4,787,899 A 4,800,882 A 4,810,784 A 4,856,516 A 4,871,357 A 4,872,867 A 4,876,109 A 4,886,062 A 4,907,336 A 4,916,193 A 4,954,126 A 4,969,458 A 4,990,131 A 4,990,155 A 4,994,071 A 4094,298 A 4,998,923 A 5,015,253 A 5,019,090 A 5,019,096 A 5,029,877 A 5,034,265 A 5,035,706 A 5,041,100 A 5,041,126 A 411972 7/1973 12,11973 12/1975 1/1976 411976 4!1976 711976 111978 211978 10( 1981 1111981 1111981 111982 311982 4!1982 6!1983 1111983 1211983 4! 1984 311985 4! 1985 11/1985 1111985 1211985 111986 U1986 4?1986 9? 1986 2/1987 411987 411987 6/1987 711987 81 1987 811987 311988 3?1988 4!1988 4!1988 6?1988 6!1988 9/ 1988 911988 10?1988 1111988 11/1988 111989 3/1989 81 1989 10/ 1989 10/1989 101989 1211989 311990 4!1990 911990 11/1990 211991 211991 2! 1991 211991 3! 1991 511991 511991 5!1991 711991 711991 7/1991 8/ 1991 8! 1991 Ersck Sandcr ....................... 188/203 Alsbcrg ...................... 4271105 Schgal ct al ................ 4241122 Margraf 7ai3'aroni .................... 1281833 Bokros et al. ........... 623111.11 Vilasi ......................... 6061198 Higuchi et al . ............. 4241432 Martin4z .................... 285,332 Nash ct al. Banks ........................ 6041509 Bokras ...................... 62311.13 Pierce et al .............. 4281425.5 Mano ......... ............... 623/1.43 Simpson et al . ............ 6061194 Broyles ......................4281597 Akiyama et al. ........ 623123.72 Close ......................... 5241546 lonescu et al. Dotter Balko et al. ........ 6061108 Seiler, Jr. ct al........... 62311.32 Maass et al. Hammcrslag ............... 6041509 Kronberg ................... 62311.32 Golandcr et al. ........... 4281409 Gianturco /arm Sakamoto ct al. .......... 424,492 Wallsten Hoffman ct al ............. 4421123 1281207.14 Webb et al. Rosenwald . ................ 4241427 Hanson ..................... 62311.49 Bokros ...................... 62312.31 Billctcr ct al . ........,.. 604193.01 5,047,020 A 5 ,049 , 132 A 5,049,403 A 5,053,048 A 5,059,66 A 5,061,275 A 5,061,750 A
5,1)64,435 A

9/1991 911991 911991 10/199 1011991 1011991 1011991

Palutaz
Pal maz Krcarncr .................... 62311.15

Greco et al ................. 428.'422
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Wilkoff
MacGregor Yasuda ....................... 427,490 Samson et al . ............. 6061194 MacGregor Pinchuk ..................... 62311.15 Fox, Jr. ct al. ............... 600,36 Fedeli ct al. - ......... -. 2771354 Hoffman et al ............. 442,1126 Gianturco Rowl..md ct al. Gianturco

5,092,877 A 5,102,417 A 5,104,404 A 5,116,365 A 5,122,154 A 5,131,908 A 5,133,732 A 5,134,192 A 5,135,536 A 5,163,952 A 5,163,958 A 5,171,217 A 5,171,262 A 5,176,660 A 5,176,972 A 5,178,618 A 5,180,366 A 5,182,317 A 5,185,408 A 5,192,307 A 5,195,984 A 5,202,332 A 5,213,576 A 5,23,898 A 5,217,483 A 5,222,971 A 5,226,913 A 5,234,456 A 5,246,445 A 5,258,020 A 5,258 ,021 A 5,262,451 A 5,266,073 A 5,272,012 A 4,733,665 A 5,275,622 A 5,282,823 A 5,282,824 A 5,283,257 A 5,288,711 A 5,290,305 A 5,292,331 A 5,292,802 A 5,304,121 A 5,304,200 A 5,306,250 A 5,308,862 A 5,308,889 A 5,314,444 A 5,314,472 A 5,328,471 A 5,334,301 A 5,336,518 A 5,338,770 A 5,342,348 A 5,342,387 A 5,342,621 A 5,354,257 A 5,354,308 A 5,356,433 A 5,366,504 A 5,368 ,566 A 5,370,683 A 5,370,691 A 5,375, 612 A

Hsu ........................... 604/266 Sh a lTer et at Larm et al ................... 42712.1 Pinchuk Fischelt el al . ................ 60013 Wallsten et al. Feijen et al. 1111991 Porter 311992 Pinchuk 411992 Palmaz 411992 Wolff 511992 Hillstead 611992 Rhodes 7/1992 Dardik et al. 711992 Wiktor 711992 Fcijen et al. 811992 Hillstead 11/1992 Froix 1111992 Pinchuk 12/1992 March ct al . ............... 6041507 12` 1992 MacGregor 1.'1993 Tntckai 111993 Bloom ct al , ................. 430114 111993 liandapa 1/1993 Woods 111993 Winters et al. 211993 Tang et al. 311993 Wall 311993 Schalz 411993 Ilughes et al. .............. 5141291 511993 Abiuso et al. 5/1993 Larm et al .................. 4281422 6/1993 Tower 6!1993 Willard et al. 7/1993 Pinchuk 811993 Silvestrini 9/1993 Yachin ct al. 1111993 Froix 1111993 Duna( I tl1993 Winters et al. 11,993 Wall 1211993 Opolski ................... 428;4231 111994 Palmaz ....................... 6061108 111994 Lazarus ct al. 11994 Schwartz et al. 211994 Gianturco 211994 Gregory et al. 21994 Mitchell et al. 311994 Inoue 3/1994 Aoneau 311994 Rhee ct al. 411994 Sahatjian 411994 Spaulding 4/1994 Match et al. 511994 Ohlstein 511994 Rhee ct al. 511994 Gianturco 511994 Fontaine 711994 Slcpian 811994 Heinkc ct al. 811994 Pallassana et al. 8/1994 Winters et al. 811994 Kaplan 8!1994 Summers 8/1994 Eury 1011994 Roubin et al. 10,11994 Simon et al. 1011994 Rowland et al. 11/1994 Andersen et al. 11/1994 Crocker 1,'1994 Fontaine 121994 Samson 1/1994 Cottenceau ct al.

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5,376,112 A 5,378,475 A 5,380,299 A 5,382,261 A 5,383,853 A 5,383,928 A 5,387,235 A 5,389,106 A 5,391,730 A 5,393,772 A 5,395,390 A 5,397,355 A 5,399,352 A 5,403,341 A 5,405,377 A 5,409,696 A 5,411,549 A 5,415,619 A 5,417,969 A 5,419,760 A D359,802 S 5;121,955 A 5,423,885 A 5,429,618 A 5,429,634 A 5,439,446 A 5,441,515 A 5,441,516 A 5,441,947 A 5,443,458 A 5,443,477 A 5,443,496 A 5,443,498 A 5,443,500 A 5,447,724 A 5,449,372 A 5,449,373 A 5,449.382 A 5,464,450 A 5,464,540 A 5,464,650 A 5,474,563 A 5,486,357 A 5,496,365 A 5,500,013 A 5,504,091 A 5,510,077 A 5,512,055 A 5,516,781 A 5,519,042 A 5,523,092 A 5,527,354 A 5,545,208 A 5,551,954 A 5,554,182 A 5,554,954 A 5,556,413 A 5,559,122 A 5,562,922 A 5,563,146 A 5,569,197 A 5,569,295 A 5,569,462 A 5,569,463 A 5,571,089 A 5,571,166 A 5,574,059 A 5,575,818 A 5,578,075 A 5,580,873 A 5,580,874 A 5,591,140 A 5,591,197 A 1211994 Duran 111995 Smith at al ................. 424/473 111995 Fimmot ct al. 111995 Patrnaaz 1/1995 Jung, el at .............. 6041103.04 1!1995 Scott ct al. 211995 Chuter 211995 Tower 211995 Skotnicki at al. ........... 5401456 211995 Yoe et al. 311995 Simon at al. 311995 Mann et al. 311995 Hanson ......................4241423 4/1995 Solar 41995 Crngg 411995 Narayanan at al. 511995 Peters 511995 Lee at it. 511995 Hsu at al ................. 424/7Q7 511995 Nlarciso, Jr. W1995 Fontaine 6.'1995 Lau 611995 Williams 7/1995 Keogh 711995 Narciso 811995 Barry 8.!1995 Khosravi at al. 811995 Wang el al. 811995 Dodge et al. 811995 Eury 811995 Maria at .d. &11995 Schwartz at al. 8!1995 Fontaine 811995 Sigwart 911995 Heimus at al. 9/1995 Schmaltz ct at. 9!1995 Pinchasik at al. 911995 Dayton 1111995 Busccmi at al. 1111995 Friesen at al. .............. 210,640 1111995 Berg at al. 1211995 Myler et al. ................ 606!108 1/1996 Narayanan 311996 Sgro 311996 Busccmi at ,d. 41996 Molnar-Kimbcr at al. .. 5141291 4/1996 Dinh at it. 411996 Domb at al ................. 604/265 511996 Morris ct al. 511996 Morris et al ................ 5141378 611996 Hanson at al. 6!1996 Fontaine cc al. 8!1996 WolITal al. 911996 Busccmi at al. 911996 Dinh ct at. 911996 Takahashi 911996 L..= 9?1996 Nelson ct al . .............. 5141291 10?1996 Lambert 10!1996 Morris at al. 1011996 Helmus at al. 1011996 Lain 1011996 Martinson ct al.....,..... 4241423 10!1996 Helmus et al . ............. 424/426 1111996 Crocker ................. 604./103.01 1111996 Dinh at nt. 11/1996) Regunathan at al. 1111996 Pinchuk ..................... 62311.15 1111996 Dayton 1211996 Bianco ct al, 1211996 Bianco et al. 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5,792,772 A 5,798,372 A 5,799,384 A 5,800,507 A 5,800,508 A 5,807,861 A 5,811,447 A 5,820,917 A 5,820,918 A 5,824,048 A 5,824,049 A 5,827,587 A 5,833,651 A 5,837,008 A 5,837,313 A 5,843,120 A 5,843,166 A 5,843 ,172 A 5,849,034 5,851,217 5,851,231 5,858,990 5,861,027 5,865,811 5,871,535 5,873,904 5,876,433 5,877,224 5,879,697 5,882,335 5,891,108 5,893,840 5,897,911 5,900,246 5,902,266 5,912,253 5,916,910 5,922,393 5,922,730 A 5,932,243 A 5,932,299 A 5,932,580 A 5,951,586 A 5,957,971 A 5,968,091 A 5,972,027 A 5,976,534 A 5,977,163 A 5,980,553 A 5,980,566 A 5,980,972 A 5,981,568 A 5,985,307 A 5,997,468 A 6,004,346 A 6,015,432 A 6,015,815 A 6,039,721 A 6,059,813 A 6,071,305 A 6,074,659 A 6,080,190 A 6,096,070 A 6,120,536 A 6,120,847 A 6,136,798 A 6,140,127 A 6,146,358 A 6,153,252 A 6,159,488 A 6,171,232 BI 6,171,609 B1 6,177,272 Bt 811998 Bianco al at. 811998 Davies at al. 911998 Schwartz ct al. 911998 Schwartz 9?1998 Goicocchea ct al. 9?1998 Klein et al. 911998 Kunz at at. 1011998 Tuch 1011998 Ronan et al. 10?1998 Tuch 1011998 Ragheb at at. 1011998 Fukushi ..................... 428136.6 1111998 Donovan el it, 1111998 Berg at al, 1111998 Ding et at. 1211998 Israel eta] ................. 623.11.15 12/1998 Lentz et al. ............... 623/1.13 1211998 Yan 1711998 Schwartz 12,11998 Wolff ct al. 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2005!0106210 Al 200510187611 Al 200510208200 Al 200610088654 Al 2006+0089705 Al 5.12005 812005 9.72005 412006 412006 Ding at al . ................. 4241423 Ding at al . ................ 62311.15 Ding at it, ................ 42712.25 Ding or al, ................ 42712.21 Ding cl al . ................ 62311,15 1VO WO NO WO WO WO WO WO WO 01187372 Al 01187373 Al WO 01187376 Al 022126139 Al 02126271 Al 02/26280 Al 02/26281 Al 031015664 Al 03i057218 Al IU2001 1112001 1112001 412002 4/2002 412002 412002 2x2003 7/2003

FOREIGN PATENT DOCUMENTS
DE EP FP EP EP EP EP EP EP FP EP EP EP EP 19723723 Al 0 145 166 A2 0 177 330 A2 0 193 372 Al 0 221 570 A2 0 421 729 A2 0 540 290 A2 0 568 310 Al 0 604 022 Al 0 621 015 Al 0 623 354 Al 0 734 698 A2 0 712 615 Al 0 716 836 Al 0 800 801 At 0 734 721 Al 0 747 069 A2 0 761 251 Al 0 830 853 At 0 540 290 BI 0 815 803 At 0 850 651 A2 0 938 878 A3 0950386 B1 0 968 688 Al 0 633 032 BI 1 192 957 A2 1 588 726 Al 1 588 727 Al 0 566 807 Al 1 205 743 2 135 585 A 0 662 307 A2 660689 1457921 89/03232 Al WO9lil2779 Al WO 92115286 Al WO 94101056 At WO 94/21308 At WO 94121309 At WO 94124961 Al WO 96/00272 A[ WO 96126689 Al WO 96132907 Al WO 96134580 At 96141807 Al WO 97/25000 Al WO 97133534 Al 97135575 Al 98/08463 At WO 98113344 At WO 98!19628 At 98123244 Al WO 98123228 Al WO 98134669 At WO 98/36784 At WO 98147447 At WO 98156312 Al 00121584 At 00127455 Al WO 00127445 Al 00132255 At 00138754 At 01187342 A2 1211998 611985 411986 6/1986 511987 411991 1011992 11/1993 611994 1011994 1111994 311996 511996 611996 811996 1011996 1211996 311997 711997 111998 711998 711998 911999 10/1999 112000 212001 412002 1012005 1012005 411992 911970 911984 1211994 511979 211989 411989
911991

OTHER PUBLICATIONS
U.S. Appi. No. 071819,314, filed Jau, 9, 1992, ](Morris. U.S. Appl. No. 081424,884, filed Apr. 19, 1995, Helmus et at, U.S. Appl. No. 081526,273, filed Sep. 11, 1995, Ding. U.S. Appl. No. 081730,542, filed Oct. 11, 1996, Helutus. U,S. Appl. No. 091575,480, filed May 19, 2000, Kopia. U.S. Appl. No. 10/431,059, filed May 7, 2003, Falotico. Abraham, R. T., "Mammalian target of rapanycin : Irmmunosupressive drugs offer new insight into cell growth regulation," Progress in Inflammation Research , 2000, Switzerland. Alvarado, R. cl al., "Evaluation of Polymer -coated Balloon -expandable Stents in Bile Ducts," Radiology, 1989, 170, 975-978.

EP
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Badimon, J. J. et al., "Inhibitory Effects of Rapamycin on Intimal
Hypetplasia Afier PTCA," J ACC, Mar. 1998. Bailey at al., "Polymer Canting of Palma,-Schatz Stent Attenuates Vascular Spasm after Stent Placement," Circulation , 82;111-541

EP
EP EP EP EP

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EP
EP EP EP FR GB GB GB SU Su WO WO

WO
WO WO WO WO WO WO WO WO WO WO WO WO WO WO WO WO WO

WO
WO WO WO WO WO WO WO WO WO

911992 111994 911994 9/1994 11/1994 1/1996 911996 1011996 1111996 1211996 711997 911997 10!1997 3; 1998 411998 5/1998 611998 6/1998 8/1998 811998 10/1998 12/1998 412000 5/2000 512000 612000 712000 11/2001

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Fluococarbon Elastomers , p. 257.267 , Mar. 1989. Farb, A. ct it., "Vascular smooth muscle cell cytotoxicily and sustained inhibition of ncointirnal formation by fibroblast growth factor 2-saporin fusion protein," Cirr.. Res., 1997, 80, 542-550. Ferns, G. A. A. at at., "Inhibition of Neointimal Smooth Muscle Accumulation Alter Angioplasty by an Antibody to PDGF," Science, 1991, 253, 1129-1132.

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Fischman, D. L. ct al., "A Randomized Comparison of CoronaryStent Placement and Balloon Angioplasty in the 'treatment of Coronary Arteryl)iseasc," N. Eng. J Afed., Aug. 25, 1994, 331(8), 496.501. Franklin, S. M. et al., "Pharmacologic prevention of restenosis alter coronary angioplasty: review of the randomized clinical trials," Coronary Artery Disease Mar. 1993, 4(3), 232-242. Fukuyama, J. et al., "Tranilast suppresses the vascular intimal hyperplasia after balloon injury in rabbits fed on a high-cholesterol diet;" Ear, J. Pharrnacol., 1996, 318, 327-332. Gregory, C. R. et al., "Rapamycin Inhibits Arterial intimal Thickening Caused by Both Alloiramune and Mechanical Injury," Transplmuation, Jun. 1993, 55(6), 1409-1418. Gregory, C. R. et al, "`treatment with Rapamycin and Mycophenolic Acid Reduces Arterial Intimal Thickening Produced by Mechanical Injury and Allows Eudolhclial Replacement," Transplantation, Mar. 15, 1995, 59(5), 655-661.
Guyton, J. R. et al, "Inhibition of rat arterial smooth muscle cell proliferation by heparin. In vivo studies with anticoagulant and nonanticoagulant heparin;" Circ. Res., 1980, 46, 625-634.

Hansson, G. R. et al., "Interferon=! Inhibits Arterial Stenosis After Injury," Circa, 1991, 84, 1266-1272. Ilashemolhosseini, S. et al., "ILapnmycin Inhibition of the G1 to S Transition Is Mediated by Effects on Cyclin Di mRNA and Protein Stability," J Diol Client, Jun. 5, 1998, 273, 14424-14429. Jonasson, J. ct al., "Cyclosporin A inhibits smooth muscle prolif_ cration in the vascular response to injury," Pror.. Natl., Acad. SN., 1988, 85, 2303-2306. Kuhnc, M, et al., "Microbial Conversion of Rapamycin," Enzyme and Microbial Tech nobs,, 1997, 21, 405.412. Lange, R. A. MD ct al., "Restenosis Alter Coronary Balloon Angioplasty," Anna, Rev, Afed., 1991, 42, 127-132. Liu, M. W. et al., "Trapidil in Preventing Rcstcnosis After Balloon Angioplasty in the Atherosclerotic Rabbit," Circ., 1990, 81, 10891093, Liu, M. W., NID et al., "Restenosis After Coronary Angioplasty Potential Biologic Determinants and Role of Intimal I lyperplasia," Circularion, 1989, 79, 1374-1387. Lundergan, C. F. ct al., "Peptide inhibition of Myointimal Prolit cration by Angiopeptin, a Somatostatia Analogue," JACC, May 1991, 17(6), 1328-136B. Majesky, M. W. et al, "heparin regulates smooth muscle S phase entry in the injured rat carotid artery," Circ. Res., 19S7.61, 296-300. Mars, S. Q. et it., "Map-vrsycin-FKBP Irtribiis Cell Cycle Regulators of Proliferation in Vascular Smooth Muscle Cells," Circ. Res., 1995, 76, 412417. Nemecek, G. M. et ,it., "Terbinafinc Inhibits the Milogenic Response to Platelet-Derived Growth Factor in Vitro and Neoinimal Proliferation in Vivo," J. PharmacoL E.ip. Thera., 1989, 248, 1167-1174. Okada, T. et al., "Localized Release of Perivascitlar llep tnn Inhibits Intimal Proliferation alter Endothelial Injury without Systemic Anlicoagulalion," Aleurosurgery, 1989, 25, 892-899. Poon, M. ct al., "Rapamycin Inhibits Vascular Smooth Muscle Cell Migration," J Clin hivesr., Nov. 1996, 98(10), 2277-2283, Popma, J. J. et al., "Clinical trials of restenosis after coronary angioplasty," Circulation, Sep. 1991, 84(3), 1426-1436. Powell, J. S. et al., "Inhibitors of Angiotensin-Converting Enzyme Prevent Myuintimal Proliferation After Vascular Injury," Science, 1989, 245, 186-188. Rcnsing, B. J, ct al., Coronary restenosis elimination with a sirolimus eluting steni, European Heart Journal, 2001, 22, 21252130. Rodeck, C. et al., "Methods fur the Transcmical Collection of Fetal Cells During the First Trimester of Pregnancy," Prnnratal Diagnosis, 1995, 15, 935-942. Serruys, P. W. el at., "A comparison of balloon-expandible-stem implantation with balloon angioplasty in patients with coronary artery disease," N Engl J Afed, Aug. 25, 1994; 331(8), 489-495. Serruys, P. NV. ct al., "Evaluation of kclanscrin in the prevention of restenosis after percutancous transluminal coronary angioplasty. A multicenter randomized double-blind placebo-controlled trial," Circulation. Oct. 1993; 88(4 N 1), 1588-1601.

Serruys, P. NV. ct it., "Heparin-coated Palmaz-Schntz stents in human coronary arteries. Early outcome of the Senescent-11 Pilot Study," Circnlatfon, Feb. 1, 1996; 93(3), 412422. Siekierka, J. J., "Probing T -Cell Signal Transduction Pathways with the Immunosupressive Drugs, FK-506 and Rapamycin," Inrmunologic Research, 1994, 13, 110-116. Sigwan, et al., "Intravascular Stenos to Prevent Occlusion and Rcstcnosis After Transluminal Angioplasty," N. EngL J Afcd., Mar. 19, 1987, 316, 701-706. Simons, M. et al., "Antisense c-myb oligonucleotides inhibit intimal arterial smooth muscle cell accumulation in vivo," Nature, 1992, 359, 67-70, Snow, A. D. et a1., "Heparin modulates the composition of the extracellular matrix, domain surrounding arterial smooth muscle cells," Ant. J Parhol., 1990, 137, 313-330. Sollott, S. J. et al., "Thxol Inhibits Neoicttimal Smooth MUSCIe Cell Accumulation after Angioplasty in the Rat," J. Ulm Invest., 1995, 95, 1869-1876. van Der Giessen, et al, "Self-expandable Mesh Stents: an Expcrimental Study Comparing Polymer Coated and Uncoated Wallstent Stents in the Coronary Circulation of Pigs," Circulation 1990, 82(suppl. 111):111-542. van Der Giessen, W. J, ct al, "Coronary stenting with polymercoated and uncoated self-expanding endoprosthescs in pigs ' Coron. Art. Disease 1992; 3, 631-640. Vasey, C. G. ul a., "Clinical Cardiology: Stress Echo and Coronary Flow", , Circulation, Oct. 1989, 80(4) Supplement 11, 11-66. Verwcire, E. et al., "Evaluation of Fluorinated Polymers As Coronary Stent Coating," Jonu·ual of tfarerials Science: %farerials in medicine, Apr. 2000. Weinberger, J. et al, "Intracoronary irradiation: dose respoase for the prevention of restenosis in swine," her. J. Rad. One. Biol. PGys., 1996, 36, 767-775. Preliminary Amendment in ILS, Appl. No. 071258,189, May 22, 1989. Trial Transcript from Nov. 6, 2000 ai 185-90 and 235-36 (Attorney's opening remarks regarding '984 patent).
Trial Transcript from Nov. 7, 2000 at 274-301, 307-315, 320-28 and 332 (Cordis expert testimony regarding the Palrnaz-Schntz scent); 370-379, 490-496 (J. Palmaz testimony regarding the PalmazSchatz dent, the '984 patent and the connected z-stent art).

Trial Transcript from Nov. 8, 2000 at 547-63, 657-63, 674.722, 782-85 (Cordis expert testimony regarding the Palmaz-Schatz stent, the '984 patent and the connected z-stent art). Trial Transcript from Nov. 9, 2000 at 819-23, 921 (Cordis expert testimony regarding lhe'984 patent); 926.941 . (R, Croce testimony re Palmaz-Schatz scent); 1033-1053. (It, Schatz testimony). Trial Transcript from Nov. 13, 2000 at 1086-1134, (R. Schatz testimony); 1275.1305 (Cordis expert testimony regarding the '984 patent). Trial T=script from Nov. 14, 2000 at 1390-140.7, 1448-1454, 1486-1500 (Cordis expert testimony regarding the '984 patent). Trial Transcript from Nov. 15, 2000 at 1686-87, 1724-42, 1828-34, 1850-54, 1887-92 (AVE expert testimony regarding the '984 patent). Trial Transcript from Nov. 16, 2000 at 2077-198 (AVE expert testimony regarding the alleged obviousness of the '984 patent). Trial Transcript from Nov. 17, 2000 at 2331-34 (jury instructions as to the meaning of the limitations of the claims of the '984 patent). Trial Transcript from Nov. 20, 2000 al 244148, 2499.2500, 254650, 2552.56 (Attorney's closing arguments regarding the '984 patent),
Trial Transcript from Nov. 21, 2000 at 2592-94 (reading of jury verdict).

Trial Transcript from Dec, 18, 2000 at 2750.95 (Cordis expert testimony regarding the Palmaz -Schatz stcnt during the damages phase). Trial Transcript from Dec, 20, 2000 at 3421-88 (AVE expert testimony regarding the Palmaz-Schatz stent during the damages phase). Jury verdict, dated Nov. 21, 2000. District Court decisions on post-trial motions (194 F. Supp. 2d 323). Court of Appeal for the Federal Circuit decision (339 Fad 1352).

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Trial Transcript from Mau. 4, 2005 at 133-135, 171-173 and 192-96 (Attorney's opening remarks reguding '984 validity). Trial Transcript from Max. 7, 2005 at 275.31 1 (Cordis expert testimony regarding the Patmaz- Schatz stent); 342-46, 353-59, 416-425 Q. Palmaz testimony regarding the Palmaz-Schatz stem, the '984 patent and the connected z-stent art); 430-449, 452-58, 462492 (R. Croce testimony regarding the Palmaz-Schatz stent); 500-507 (Cordis expert testimony regading the '984 patent). Trial Transcript from Mar. 8, 2005 at 609 (Cordis expert testimony regarding the ' 984 patent ), 628-73, 724.740, 773, 801-839 (Cordis expert testimony regarding the '984 patent, the prior art and the Palmaz-Schatz stmt). Trial Transcript from Mar. 9, 2005 at 93649,968-69 (Cordis expert testimony regarding the '984 patent , the prior art and the PalniaazSchatz stent). Trial Transcript from Mar. 10, 2005 at 1427.74, 178-1509, 1514-23 (AVE expert t estimony regarding the alleged obviousness of the '984 patent); 1566.93 (AVE expert testimony regarding PalmazSchatz stmt); 163449 (R. Schatz testimony). Trial Transcript from Mar. It, 2005 at 184647, 1891-1900, 1919 (Attorneys' closingarguments regarding ' 984 obviousness). Trial Transcript from Mar, 14, 2005 at 1964-67 (reading of jury verdict). Jury verdict dated Mar. 14, 2005. Medtronic Vascular Inc.'s Opening Brief in Support of Its Motion for Judgment As A Infringement Ctaim dated Apr. 19, 2005. Medtronic Vascular Inc.'s Opening Brief in Support of Its Motion for a New Trial dated Apr. 19, 2005. D.I. 1407, Cordis' Combined Answering Brief In Opposition to AVE's Motion for JyIOL on Infringement of the Palmaz '762 and Schatz '984 Patents and Its Motion for a New Trial tilled May 5, 2005. D.I. 1414, Medtronic Vascular Inc.'s Combined Reply Brief In Support of Its Motion for Judgment as a Matter of Law on Cordis Corp.'s Patent Infringement Claims and Its Motion for a New'frial dated May 19, 2005. Trial Transcript from Feb. 8, 2001 at 372412, 449.469 (B. Tobor testimony regarding the prosecution of the '417, '984 and '332 patents); 510-13 (J. Milnamow testimony regarding the prosecution of the '332 patent); 558-604 (J. Paltin az testimony regarding the prosecution of the '417, '984 and '332 patents and the prior ail), Trial Transcript from Feb. 9, 2001 at 63745, 662-672, 682-85 (J. Palmaz testimony regarding the prior art); 699-742 (R. Schatz testimony); 769-770, 790.95 (Cordis exper testimony regarding prior art). D.I. 1067, Medtronic AVE, Inc.'s Pnst-Trial Brier Relating to the Unenforccability of the '762 and '984 Patents Due to Inequitable Conduct. D.I. 1077, Cordis' Combined Answering Brief in Opposition to AVE's BSC's Post-Hering Briefs on Alleged Inequitable Conduct Concerning the '762, '984 and '332 Patents. D.I. 1089, Reply Brief In Support of Medtronic AVE, Int.'s Contention that the '762 ,and '984 Patents :are Unenforceable Due to Inequitable Conduct dated May 7, 2001. C.A. No. 00-886-SLR, Answer and Counterclaims of Def, Medtronic AVE, Inc. To First Amended Complaint of Plaintiff Cordis Corp. BSC's Opening Post-Trial Brief in Support of Its Defcnse That the Patents in Suit Are Unenforceable, dated Mar. 16, 2001. Reply Brief in Support of BSC's Defense That the Patents in Suit Are Unenforceable, dated May 7, 2001. Court's Decision on allegations of inequitable conduct (194 R Supp. 2d 323) Mar. 28, 2002. Trial -Transcript from Nov. 21, 2000 at 155-57 nod 180-84 (Attorncys' opening remarks regarding '332 patent). Trial Truascript from Nov. 27, 2000 at 227-51, 260-300 (Cordis expert testimony regarding the Palmy..-Schatz scent); 343-60, 36367, 424-33 (J. Patmaz testimony regarding the Palmaz -Schatz stcnt and the '332 patent). Trial Transcript from Nov. 28, 2000 at 649-71. Trial Transcript from Nov. 29, 2000 at 791.816, 859-870, 953-62 (Cordis expert testimony regarding the '332 patent and the PalmazSchatz stent). Trial Transcript from Nov. 30, 2000 at 1018 (Cordis expert testimony rcguding the '332 patent); 1062-80, 1108-1I l l (R. Cracc testimony regarding the Palm'tz-Schatz stent); 1169-70, 1205-17, 1236.45 (Cordis expert testimony regarding the '332 patent). Trial Transcript from Dec. 1, 2000 at 1352.54 (Cordis expert testimony regarding the '332 patent); 1364-1442 (R. Schatz testimony); 1493.1508, 1552.69 (BSC expert testimony regarding the '332 patent and the Palmaz-Scham.. scent). Trial Transcript from Dec. 4, 2000 at 1602-12, 1638-51, 1713-14, 1730.61, 1811-14, 1823-36 (BSC expert testimony regarding the alleged obviousness of the '332 patent, the prior art and the Palmaz-Schal'z stent). Trial Transcript from Dec. 6, 2000 at 2318-27, 2342-58 (BSC expert testimony regarding the '332 patent).
Trial Transcript from Dec. 7, 2000 at 2549-52 (Cordis expert testimony regarding the '332 patent); 2575.2579, 2591-92, 263031, 2649, 2669-71, 2684-85, 2688, 2708-10, 2725.27 (Attorney closing argument regarding '332 portent); 2742-46 Q'wy instructions as to the meaning of the limitations to the claims of the '332 patent).

Trial Transcript from Dec. 11, 2000 at 2817. 72 (reading of jttiy verdict). Jury verdict, dated Dec. 11, 2000. D.I. 699, Motion by Defcndant BSC and Scimed Life Systems, Inc. For Summary Judgment of Invalidity of U.S. Patent No. 5,902,332 dated Apr. 4, 2000. D.I.896, Order Denying Motion for Summary.ludgment of Invalidity and Unenforceability of Claims 1, 3, and 5 of the U.S. Patent No. 5,902,332 Denying (699-11 Motion for Summary Judgment of Invalidity of U.S. Patent No. 5,902,332 dated Oct. 12, 2000. Wright el al., Percutaneous Endovascular Stent: An Experimental Study (Abstract), RSNA Meeting (Nov. 28, 1984). Hearing Transcript from Feb. 10, 1998 at 122-32, 146-80 (Attorneys' opening remarks regarding '417 patent); 180-312 (R. Schatz testimony) [Portions of "This Transcript Have Been Removed As Confidential]. licaring Transcript from Feb. 1 1, 1998 at 427-575, 577.651 (Cordis expert testimony regarding the '417 patent, the prior art and the Palmaz-Schatz stmt). Hearing Transcript frorrn Feb. 13, 1998 :d 1121-1261 (Guidant expert testimony regarding, the alleged obviousness of the '417 patent, the prior art and the Palmaz-Schatz stent). [Portions of This Transcript Have Been Removed As Confidential]. Order by J. Robinson denying Cordis' Motion for a Preliminary Injunction Against ACS dated Jug. 17, 1998. ACS, Int.'s and C,uidant Corp.'s Opening Brief in Support ofThcir Motion for Summary Judgment of Invalidity of U.S. Patent No. 5,102,417 dated Aug. 27, 1998. Plaintiffs' Answering Brief in Opposition to ACS' and BSC' Motion for Summary Judgment on Obviousness dated Sep. 24, 1998. Order &acd Mar. 31, 2000, Schatz Deposition Testimony; May 15, 1996: 79-83,89-92,105-107 and 153-161. Schatz Deposition Testimony; May 16, 1996: 555.564, 569-572, Schatz Deposition Testimony; Jan. 18, 1998: 67.73, 108-110. Schatz Deposition Testimony; Jul. 14, 1998; 59-77, 108-112, 119123. Schatz Deposition Testimony, Jul. 12, 1999: 88-91, 132-135, 144149, 218.223, 231-242. Schatz Deposition Testimony; Jul. 13, 1999: 251-334, 339.345, 374-416. Schatz Deposition Testimony; Jul. 14, 1999: 454-550. Schatz Deposition Testimony; Jul. 15, 1999: 560.614. Schatz Deposition Testimony; Dec, 2, 1999: 906-911, 928-942, 945-963, 976-978, 1029-1034, 1038-1042. Palmaz Deposition Testimony, Nov. 5, 1991: 160-172. Palmaz Deposition Testimony, Feb. 5, 1995: 710.727. Patmaz Deposition Testimony, Jul. 16, 1998: 55-56; 81-82. Palmaz Deposition Testimony, Jul. 28, 1999: 560-568, 570-579. Palmaz Depositioo 'T'estimony, Jul. 29, 1999; 778.785. Palmaz Deposition Testimony, Aug. 31, 1999: 1403-1452. Palmaz Deposition Testimony, Sep. 2, 1999: 1953-1960.

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Palmaz Deposition Testimony, Oct. 14, 1999: 2201-9209; 22752342; 2371-2411. Palmaz Deposition Testimony, Oct. 15, 1999: 2424-2497; 25082589. Palmaz Deposition Testimony, Oct. 16, 1999: 2853-2860. Tobor Deposition Testimony, Jun. 17, 1999: 837-958. Tobor Deposition Testimony, Jun. 18, 1999: 1095-1184. Tabor Deposition Testimony, Dec. 1, 1999: 1217-1371. Tobor Deposition Testimony, Dec. 2, 1999: 1398-1414; 1444-1508; 1532-1548. Tobor Deposition Testimony, Dec, 3, 1999: 1652-1653; 1662-1672; 1683-1694. Kula Deposition Testimony, Apr. 20, 1999: 268.169. Kula Deposition Testimony, Nov. 16, 1999: 660.675; 680-694; 748-755; 774-821. Kula Deposition Testimony, Nov. 18, 1999; 176-223. Expert Report of Dr. Rodney S. Badger an Behalf of Medtronic AVE, Inc. (Jan. 31, 2000). Expert Report of Dr. Joseph Bonn on Behalf of Medtronic AVE, inc. (Jan. 31, 2000). Deposition of Dr. Joseph Bonn dated Mar. 14, 2000. Rebuttal Expert Report of Nigel Buller, B.Sc., M.D., F.R.C,P. (Mar. 2000). Second Supplemental Rebuttal Expert Report ofNigel Buller, B.Sc., M.B., F.R.C.P. (Aug, 17, 2004). Rebuttal Expert Report of John M. Collins, PH.D. (Feb. 2000). Expert Report of David C. Cumberland, M.D. (Jan. 24, 2000), Expert Report of John T. Goolkasian (Feb. 2000). Deposition of Richard R. Heuser, M.D. (Sep. 7, 2004). Deposition of Henry R. Pichler (Sep. 10, 2004). Deposition of Ronald J, Solar (Mar, 22, 2000). Deposition of Ronald J. Solar (.Mar. 23, 2000), Deposition of Ronald J. Solar (Apr. 12, 2000). Export Report of Dr. Arina Van Breda on Behalf of Medtronic AVE, Inc. (Jan. 31, 2000). Deposition of Anna Van Breda (Mar. 24, 2000). Deposition of Arina Van Breda (Aug. 21, 2004). Expert Report of John F. Witherspoon (Jan. 24, 2000). Supplemental Expert Report of Jahn F. Witherspoon (Oct. 27, 2000). Deposition of John F. Witherspoon (Mar. 8, 2000). Palmaz et al., Attictc; Normal and Stenotic Rcnal Arteries: Experimental Balloon Expandable Intraluminnl Scenting, Radiology, Sep. 1987. (AVE 84). Julio C. Palmaz, Article: "Expandable vascular endoprosthesis." (AVE 132). Duprat ct. al., Artiele: Flexible Balloon-Expandable Stent for Small Vessels Dupmt et. al. Radiology, vol. 162, pp. 276-278,1987. (AVE 134). Coons et, al., Article: "Large-Bore, Long Biliauy Endoprosthesis (Biliary Steals) for Improved Drainage," Radiology, vol. 148, pp. 89-94, 1983. (AVE 143). Honickman el it., Article: "Malposilioned Biliary Endoprosthesis, Technical Developments And Instrumentation," vol. 144, No. 2., 1982. (AVE 144). Harries-Jones, cl al., Article: "Repositioning of Biliary Endoprosthesis with Gruntzig Balloon Catheters," AJR, vol. 138, pp. 771-772, 1982. (AVE 153). Charnsangavej ct al., Article "Stenosis of the Vena Cava: Preliminary Assessment of Treatment with Expandable Metallic Stents," Radiology, vol. 161, pp. 295-298, 1986. (AVE 359). Article "Tracheobronchial Tree: Expandable Metallic Stems Used in Experimental and Clinical Applications," Radiology, vol. 158, pp. 309-32, 1986. (AVE 364). T. Yoshioka, ct al., AIR Article: "Self-Expanding Endovascular Graft: An Experimental Study in Dolts", vul. 151, pp. 673.676, 1983. (AVE 438). Article: "Expandable Intraluminal Vascular Graft: A Feasibility Study," Surgery, vol. 99, pp. 199205, 1986. (AVE 461). Lawrence et al., Article: "Percutaneous Endovescular Graft: Experimental Evaluation." Radiology, vol. 163, pp. 357-360, 1987. (AVE 671). Palmaz ct al., Article: Expandable Intraluminal Graft: A Preliminary Study, Nov. 17-22, 1985, Radiology, vol. 156, pp. 73-77, 1985. (AVE 1224). Fallone ct al., "Llastic Characteristics of the Self-Expanding Metallie Stents;" Investigative Radiology, vol. 23, pp, 370-376, 1988. (AVE 1953). Palmaz Paper Entitled "Research Project Expandable Vascular Fntloprosthcsis" May 18, 1983, Rousseau, et al., Publication: "Percutaneous Vascular Stcnt: Experimental Studios & Preliminary Clinical Results in Peripheral Arterial Diseases," in Inter. Angio, vol. 6, 153-161, 1987. (AVE 3301). Rousseau , et al., Publication: "Self-Expanding Endavascular Prostcsis: An Experimental Study," Radiology, vol. 164, pp. 709714, 1987. (AVE 3303). Wallace, et al., Article: "Tracheobronchial Tree: Expandable Metallic Steals Used in Experimental and Clinical Applications," Radiology, vol. 58, pp. 309-312, 1986, (DBX 2938). Palmaz et al., Article: "Expandable Intraluminal Graf; A Preliminary Study," Radiology, vol. 156, pp. 73-77 (DBX 4595). Program for the 12th Annual Course on Diagnostic Angiogaphy and Interventional Radiology Mar. 23-26, 1987 sponsored by The Society of Cardiovascular and Interventional Radiology (DBX 6235). Preliminary Motion for Judgment rc Woltr claims 1 , 2-S. 10, 15 and 19 (DBX6759). Palmaz Declaration (DBX 7069). Letter from C:alemd to Dr. Palmaz dated Jul. 5, 1988 with attached document entitled: "Segmented, balloon-expandable stens." (DBX 7160). Duprat et al., Article: "Flexible Balloon-Expandable Stent For Small Vessels," Radiology, vol. 168, pp. 276-278, 1987 (PX 82). Drawing Sent to Bodic on Mar. 17, 1986 (PX 374). Letter from Dr. Palmaz. to R. Bowman enclosing a model of the [cxible coronary graft dated Mar. 17, 1986 (PX 337). Lab Notebook pages dated Jul. 30, 1987 from Rodney Wolff (COR 185596-597)(PX62[A). Charnsangavej, el al., Article: "Sleoosis of The Vena Cava Prelimlmnary Assessment of Treatment with expandable Metallic Stems," Radiology, vol. 161, No. 2, pp. 295-298 with attached photographs, 1986. (AP[ 72). J. Palmaz: The Current Status of Vascular Prostheses, published by SCIR in the Twelfth Annual Course on Diagnostic Angiogaphy And lntervcntional Radiology Mar. 23-26, 1987. (API 73). Amendment in Response to Office Action of Oct. 18, 1988 in re: Application of Julio Palmaz SrN 174,246. (API 152). Article: Wallace, c1 al., Tracheobronchial Tree: Expandable Metallic Steals Used in Experimental and Clinical Applications Work In Progress, Radiology, val. 158, pp. 309.312. (API 295). Reply of Senior Party Schatz To Patentee Wolffs Opposition To The Belated Motion For Judgment Of Applicant Schatz With Regard To Wolff Claims 1, 2-8,10, It, 13-17, And 19 (COR IW50.455)(API 310). Brief Of Senior Party Schatz At Final Hearing (API 313).

Letter from Ron Sickles to Ben Tobor dated Feb. 10, 1988 (Exhibit 42).
Letter from R.O. Sickles to Mike Tallow dated May 12, I988 (Exhibit 43). Letter from R. 0. Sickles to Richard Schatz dated Jun. 2, 1988 (Exhibit 44). Letter from Richard Schatz to Raimund Erbel dated Jun. 3, 1983 (Exhibit 45). Letter from Richard Schatz to Mike Schuler dated Aug. 29, 1991 (Exhibit 48). Minutes ofJ&J Stent Project Review Meeting dated Jan. 21, 1988 (Exhibit 7). Preliminary Motion for Judgment with Regard to Wolff Claims 1, 2-8, 10, 11, 13-17, and 19. (Exhibit 67). Declaration of Richard A Schatz. (Exhibit 75), Belated Motion for Judgement with Regard to Wolff Claims 1, 2-8, 10, It, 13-17 and 19. (Schatz-Exhibit 77). Letter from Dr. Schatz to Mr. Tobor, dated Jun. 3, 1988. (Exhibit
172).

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Letter from Dr. Schatz o Mr. Romano, dated Nov. 28, 1988. (Exhibit 131). Letter from Mr. Sickles to Mr. Tobor, dated Feb. 10, 1988 (Exhibit 145). Richard A. Schatz, Article tilled: "A View of Vascular Steals" Circulation, vol. 79, No. 2, pp. 445457, 1989. (Exhibit 194). Senior Party Schatz's reply to Palente WolEfs Opposition to the Preliminary Motion Of Applicant Schatz for Judgment with regard to Wolff Claims 1, 2-8, 10, 11, and 13-17. (Exhibit 69). Wallace, et al., Article: "Tracheabronchial True; Expandable Metallic Stents Used in Experimental and Clinical Applications ' Work In Progress," Radiology, vol, 158, pp. 309-312, 1986. (Exhibit 165), Chamsangavej , et al., :article: "Stcaosis of The Vena Cava Prelimimnary Assessment of Treatment with expandable Metallic Steals," Radiology. vol, 161, No. 2, pp. 295-298 with attached photographs, 1986. (Exhibit 167). David D. Lawrence ct al., Publication ; Pcrcutaneous Endoyascular Grail: Experimental Evaluation', Radiology, pp- 357-360, 1987. (Exhibit 173). Charles E. Putnam, M.D., Cover and article from " Investigative Radiology",vol. 23. No. 5, May 1988. (Exhibit 177). Robert N. Berk, Cover and article from "American Journal of Roeniology", pp. 673-676, 1988. (Exhibit 178). Declaration of John S. Kula Under 37 CFR § 1.672. (Kula-Exhibit 77). Yoshioka et al., Article: "Self-Expanding Endovascular Graft: An Experimental Study in Dogs" AM vol. 151, pp. 673-676, 198 S. (PX 100). Palmaz, et al., Article: Expandable Inlrnluminal Grail: A Preliminary Study Work in Progress', Radiology, vol. 156, No. 1, pp. 73-77, 1985. (PX 101). Declaration of Richard Schatz Under 37 C.F.R.§ 1.672. (PX 106). Charnsangavej et al., Article: "Stenosis of the Vena Cave: Preliminary Assessment of Treatment with Expandable Metallic Sients," Radiology, vol. 161, pp. 295-298, 1986. (PX 143), Wallace, et al., Article: Trachcobronchial Tree: Expandable Metallic Stents Used in Experimental and Clinical Applications Work in Progress', Radiology, vol, 158, pp. 309-312,1986. (PX 144). Gina Kolata, News Articlc: NY Times, "Devices That Opens Clogged Arteries Gets a Falling Grade in a New Study" pp. 16-18, Jan, 3, 1991. (PX 186). Dupral, et al., Article: "Flexible Balloon- Expanded Steat for Small Vessels Work in Progress'", Radiology, vol. 162, pp. 276-278,1987, (PX 207). Leiter from Palmaz to Bowman dated Mar. 17, 1986. (PX 350). Memo re: Minutes of Slent Project Review- San Antonia- Mar. 15, 1988.(PX 651). Kuntz, ct al ., Article: Clinical Cardiology Frontiers : " Defining Coronary Restenosis, Newer Clinical and Angiographic Paradigms", Circulation, Sep. 1993, vol, 8S, No, 3, pp. 1310-1323. (PX 854). Belated Motion for Judgment with regard to Wolff Claimst , 2-8, 10, 11, 13-17, and 19. (PX A 10). Drawing of Sprial Stcnt (sent to Bodic Mar. 17, 1986), (PX2933). Wright et al., Article: "Porcutncous Endnvascular Stents: An Experimental Evaluation," Radiology, vol. 156, pp. 69-72, 1985. (PX 3093). Charnsangavej ct al., Article: "A New Expandable Metallic Stent for Dilation or Sicnotic Tubular Structures: Experimental and Clinical Evaluation," Houston Medical Journal, vol. 3, pp. 41-51, Jun. 1987. (PX 3207). In re Application of Wiktor, Appln. No. 69,636, Response to Office Acton tated Mar. 17, 1988. (PX3236). Transmittal Letter of Response to First Ollicc.Action in'417 patent. (PX 3993). Letter from B. Tuber to R. Schatz dated Jul. 23, 1991. (PX 3996). Mullins et al., Article : "Implantation of balloon-expandable intravascul,ar gratis by catherizalion in pulmonary arteries and systemic veins ," Circulation, vol. 77, No. 1, pp. 188.189,1988. (PX4049). Schatz el al., Article: "Intravascular Stents for Angioplasty," Cardio, 1997. (PX 4050). Schatz et al., Artiele; "New Technology in Angioplasty BalloonExpandable Intravascular Stcnts, New Developments in Medicine," vol. 2, No. 2 pp 59-75, 1987. (PX4051). Richard A. Schatz, Article : "Introduction to Intravascular Stents;" Cardiology Clinics, vol. 6, No. 3, pp. 357-372, 1988. (PX 4052). Richard A. Schatz, Article: "A View of Vascular Stents;" Circulation, vol. 79, No. 2, pp. 445457, 1989. (PX4053). Wang ci al., Article: "An Update on Coronary Stcnts;" Cardio, pp. 177486, 1992. (PX 4054). Richard A. Schatz, Article: "New Technology in Angioplasty: Balloon-Expandable Starts," Medicamundi, vol. 33, No. 3, pp. 112-116, 1988 . (PX 4055). Letter from Tobor to Schatz dated Sep. 29, 1988. (PX 1395). Verified Statement of Facts by Unnamcd Inventor R.A. Schatz document fried in U.S. Patent and Trademark Office on Sep . 8, 1989. (PX 3677). Declaration of John S. Kula Under 37 CFR § 1.672 (Exhibit 329). Letter to Mike Schular from R.A. Schatz dated Aug. 29, 1991. (Exhibit 402). Articulated, Balloon-Expandable Stents, (DBX 7159). J. Rosch et al ., Experimental Intraimpatic Portacaval Aaastomosis: Use of Expandable Giamurco Stents, Radiology, vol. 162, pp. 481-485, 1987. J. Rosch et al., Modified Gianturco Expandable Wire Stents In Experimental and Clinical Use, Arut Radial, vol. 31, No. 2, pp. 100-103, 1987. J. Rosch et al., Gianturco Expandable Stents In the Treatment of Superior Venn Cava Syndrome Recurring After Vcna Cava Syndrome Recurring After Ma-xinum-Tolerance Radiadon, Cancer, vol. 60, pp . 1243-1246, 1987. I.E. Gordon, Structures or Why Things Don't Fail Down, Penguin Books, pp. 45-59, 132-148, 210-244, 377-383. Maass et al., Radiological Follow-up of Trunsluminally Inserted Vascular Endoprasthcscs7 An Experimental Study Using Expanding Spirals, Radiology, vol. 152, pp. 659.663, 1984, Argument submitted re EP 861 15473 dated Jan. 20, 1995. (AVE 2478). Verified Statement of Facts by Julio C. Palmaz dated Aug. 4, 1989. (PX 3662). Papanicolaou et al., Insertion of a Biliary Endoprosthesis Using A Balloon Dilatation Catheter, Gastrointest Radiology, vol. 10, pp. 394-396, 1985. Palmaz c al., Atheroscierotic Rabbit Aortas: Expandable Intraluminal Grafting, Radiology , vol. 168, pp . 723-726, 1986. Palmaz, The Current Status of Vascular Prostheses; Rosch el al., Gianturco, Fxpandable Sleets in Expcrimentat and Clinical Use, SCIVR, pp. 118-124, 1987. Rosch ct al ., Abstract: Modified Gianturco Expandable Wire Stents in Experimental and Clinical Use, CIRSE, Porto Cervo, Sardinia, May 25-29, 1987. Rosch ct al., Gianturco Expandable Wire Stcnts in the Trcatmvnt of Superior Vena Cava Syndrome Recurring After Maximum-Toler. -race Radiation , Cancer, vol . 60, pp . 1243.1246, 1987. Mirich et al., Percutaneously Placed EndovascularGrafts for Aortic Aneurysms: Feasibility Study, Radiology, vol. 170, pp. 1033-1037, 1989. Dotter, Transluminally-placed Coilspring Endarterial Tube Grafts, Investigative Radiology, vol. 4, Sept.-Oct., pp. 329.332, 1969. Pamirz et al., Abstract: Expandable tntraluminal Graft: A Prelirninary Study, Radiology, vol. 153 (P), Nov. 1983: 7015 Scientific Assembly and Annual Meeting. Crngg et al, Nonsurgical Placement of Ancrial Endoprostheses: A New Technique Using Nitinol Wire, Radiology, vol. 147, pp. 261-263, Apr. 1983. J. Rosch et al., Giaiturco Expandable Stents in Experimental and Clinical Use, Program: "fwclfth Annual Course on Dignostic Angiography and Interventional Radiotogy" (Society of Cardiovascular and Interventional Radiology, Pittsbutgh, PA), Mar. 23-26, 1987 (the second Monofilament Article). Uchida et al., Modifications of Gianturco Expandable Wire Stents, AIR, vol. 150, pp. 1185-1187,1988. Palmaz, Balloon-Expandable Inlravascular Stent, AJR, vol. 1510, pp. 1263-1269.

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Cordis corporation v, Advanced Codlovascrilar Systems, hic., Guidant Corporation, A rterial Vascular Engineering, Inc.. Boston Scierrtifc Corporation and SCAMED Life System, Inc ., Plaintiffs Complaint, Oct. 23, 1997 (Case No, 97-550-SLR). Aricrial Vascular Engineering, Inc, v. Cordis Corporation, Johnson & Jobnson and Expandable-Grafts Partnership, Plaintiffs First Amended Complaint for Declaratory Relief of Patent Validity, 1Jncnfarccability, Nonintiingement , and for Antitrust Violations, Jan. 27, 1998 (Civil Action No. 97-700). :lrter'dal Vascular l»nghieering. Inc. v. Cordis Corporation, Johnson & Johnson and Expandable-Grafts Partnership, Cordis Corporation and Johnson & Johnson's Ansiver mid Counterclaim, Feb. 27, 1998 (Civil Action No. 97-700-SLR). Arterial Vascular Engineering, Inc. v. Cordis Corporation, Johnson & Johnson mid Expandable-Grafts Partnership, Expandable-Graft Partnership's Answer, Feb. 27, 1998 (Civil Action No. 97-700SI.11), ascular Engineering. Irrc. v. Cordis Corporation, Johnson frterial V & Johnson and Evpardablo-Grafts Partnership, Reply of Plaintiff Arterial Vascular Engineering , Inc. To Counterclaims of Defendant Cordis Corporation, Mar. 31, 1998 (Civil Action No. 97-700-SLR). :frtcrial V ascular Engineering, hie. v. Cordis Corporation. Johnson & Johnson and L·ipandable-Grafts Partnership, Reply of Plaintiff Arerial Vascular Engineering , Inc. To Countercl aims of Defendant rNpandable Grafts Partnership, Mar. 31, 1998 (Civil Action No. 97-700-SLR). Candis Corporation V. Advaired Carxlrovasrular S}:stems, loc. and Guldant CorporatiorCordis Corporation ' s Motion for a Preliminary Injunction, Oct. 8, 1997 (Civil Action No, 97-550). Cordis Corporation v. Advanced Cardiovascular Sysremu, hw,, Guidon Corporation Arterial Niscidar Engineering, Irrc.. Boston Scieutifrc Corporation and SCJJV1ED, hic., Cordis 's Motion Jar Preliminary hlwre don Against Arterial Vascular Engineering. Inc., Dec. 29, 1997 (Case No. 97-550-SI.R). Deposition of R. Schatz, M.D. in Cordis Corporation v..9dvanced Cardiovascular Systems, Irrc., Laken on Jan. 8, 1998 (Civil Action No. 97.550 SLR). Deposition of Lce P. Bendel in Cordis Corporation v. Advanced Cardiovascular Syslerns, hir.., taken on Jan. 22, 1998 (Civil Action No. 97-550 SLR). Deposition of Julio Cesar Palmaz in Cordis Corporation v. Advatrced Caiiliovascular Sysrenrs, Inc., taken an Dec. 29, 1997 (Civil Action No. 97-550 SLR). Deposition of Richard A. Bowman in Cordis Corporation v. Advanced Cardiovascular Systenrs, Inc., taken on ,tan. 9, 1996 (Civil Action No. 97-550 SLR), Deposition of Gary Schneiderman in Cordis Corporation v. Advanced Cardiovascular Systems, hic., taken on Jan. 16, 1998 (Civil Action No. 97-550 SLR). Deposition of David Pcarle, M.D. in Cordis Corporation v. Advanced Cardiovascular Systems, hre,, taken on Jul. 10, 1998 (Civil Action No. 97-550 SLR). Preliminary Injuclion hearing testimony taken on Feb. 9-13, 1998 (Civil Action No. 97-550 SLR). Cordis Corporation v, Advanced Caidiovascidar Systems, hit., et al., (Civil Action No. 97-550 SLR) and Cordis Corporation v. Advanced Cardiovascular Systems, Inc. Et al. (Civil Action No. 98-65-SLR), Opening Post Hearing Brief of Plaintiff Cordis Corponlion in Support of Motion for Preliminary Injunction, Mar. 6, 1998 (Portions relevant to patent claim construction and patent validity issues). Cordis Corporation and Expandable Grafts Partnership v. ;fdvanced CarrdiovascularSystenrs, Inc. et al., Post-Hearing Reply Brief of Plaintiff Curd'is Corporation in Support of Its Motion for Preliminary Injunction, Apr. 10, 1998 (Case No. 97.550 SLR) (Portions relevant to patent validity issues). Cordis Corporation and Etpandable Grafts Partnership v. Advanced Cardiovascular S)steurs, Inc., et al., Plaintiffs Motion for a Preliminary Injunction Against Bos t on Scientific Corporation and SCLMED Life Systems, Inc. And Memorandum is Support, Apr. 13, 1998 (Case No. 97-550-SLR). Cordis Corporation and Expandable Grafts Partnership v, Advanced Cardiovascular Systems, fac., et al., Judge Robinson's Order Denying Plaintiffs Motion for a Preliminary Injunction, Jul. 17, 1998 (Civil Action No. 97-550 SLR). Cordis Corporation and Expandable Grafts Partnership v. Advanced Cardiovascular Systems, hic ., et al., Defendant Boston Scientific Corporation and SCTMED Life Systems, Inc.'s Motion for Summary Judgment of ]nvalidity of U.S. Patent No. 5,102,417, Aug. 27, 1998 (Civil Action No. 97-550-SLR). Boston 56entdfrc Linrlted, ct al. v. Expandable Grafts Partnership, Plaintiff's Statement of Claim. Mar. 13, 1997 (UK Action No. 1493). Boston Scienlifnc Limited, et it, v. L·rpandable Grafts Partnership, Defendant's Amended Defense and Counterclaim, Aug. 14, 1997 (UK Action No. 1493). Boston Scientific Limited, et al. v. Expandable Grafts Partnership, Petition for Revocation , Mar. 13, 1997 (UK Action No. 1497). Boston Scienlifrc Lirnlled, et M. v. ExIiardable Grafts Partnership, Ruliculars of Objections, Mar. 13, 1997 (Eta{ Action No. 1497). Boston Scientific Limited, ct al, v, Expandable Grafts Partnership and Boston Scientific Linried et al ., v. Julio C. Palma;, Boston's Skeleton Argtrrnent (UK Action Nos. 1493, 1495, 1496, and 1497). Boston Scientific Limited, ct al, v. Julio C. Palmas and Expandable Grafts Partnership, Skeleton Argument of Palmaz/EGP, Mar. 19, 1998 (UK Action Nos. 1493, 1495, 1496 and 1497). Boston Scientific Limited, et al, v. Jidio C. Palma: and Expandable Grafts Partnership, EGP's Final Submissions, Apr. 2, 1998 (UK Action Nos. 1493, 1495, 1496 and 1497). Boston Sricntdfic Lindred, et al. v..hdio C. Palma: and Expandable Grafts Partnership, Judgment, Jun. 26,199 8 (UK Action Nos. 1493, 1495, 1496 and 1497). Rosch, Modified Gianturco Expandable Wire Stents in Expcrimental and Clinical Use, CJJR.SE 1987 Presentation: see Witness Statement of Josef Rosch from U.K. Proceeding. Statement of Claim by Boston Scientific ct al, against Expandable Grails Partnership et al., in EPG 0 al., v. Bostotr ,Scientifw et al. in Netherlands (Mar. 13, 1997). Motion for Joinder of Actions, Change of Claim and Statement of Claim filed by Expandable Grafts Partnership ct al. in EPG et al. v. Bostan Scientific et al. In Netherlands (Apr. 22, 1997). Opinion of K.J. Mcrman fled in FPG cl al. v. Barton Sriwafir ct ,it. in Netherlands (Aug. 29, 1997). Expert report of Dr. Nigel Buller in EPG et al. v. Boslon Scientific et al. in Netherlands (Aug. 28, 1997). Expert report of Lee P. Bendel in EPG cc al. v. Boston Scientific ct al, in Netherlands (Aug. 28, 1997), Memorandum or Oral Pleading in EPG el al. v. Boston Scientific ct al. in Netherland (Sep. 12, 1997). Plea Notes of 1? A.M. in EPG et at. v. Boston Scientific et al. in Netherlands (Mar. 10, 1999). Decision of Court of Appcals in EPG ci al. v. Boston Scientific ct al. In Netherlands (Apr. 23, 1998). Translation of Nullity Action Against EPO 0 364 787 by Biotronik in Germany. Tnuislatinn or Nullity Action Against EPO 0 335 341 by Biotronik in Germany. Translation of EPG Response to Nullity Action Against EP 0 364 787 by Biotronik in Germany. Translation of EPG Response to Nullity Action EP 0 335 341 by Biotronik in Germany. Nullity Suit Against EP-BI-0 335 341 Brought by Boston Scientific in Germany. 't'ranslation of Opposition filed by Tsntmo Corp . Against Japan Patent No. 2680901. Translation of Decision an Opposition Against Japan Patent No. 2680901. Memorandum Order of the Court dated Sep. 7, 2000, concerning disputed claim construction. Translntion of Judgment in Nullity Action Against FP 0 364 787 by Biotronik in Germany. Translation of Judgment in Nullity Action Against EP O 335 341 by Biotronik in Germany. Trial transcript from Mar. 17, 2005 at 171.172, 191-192. Trial transcript from Mar. 18, 2005 a 282-285, 325.327, 349-351. Trial transcript from Mar. 21, 2005 at 721-726.

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Triad trmnscript from Mar. 24, 2005 at 1387, Trial uanscript from Jul. 26, 2005. BSC's