Free Affidavit of Service - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE BOSTON SCIENTIFIC CORPORATION and BOSTON SCIENTIFIC SCIMED, INC.,

Plaintiffs, V.

Civil Action No. 07-765-SLR JURY TRIAL DEMANDED

JOHNSON & JOHNSON, INC. and CORDIS CORPORATION, Defendants.

AFFIDAVIT OF NON-RESIDENCE OF CORDIS CORPORATION PURSUANT TO 10 DEL. C. 3104
STATE OF DELAWARE

COUNTY OF NEW CASTLE
BE IT REMEMBERED that on this 23rd day of January, 2008, the deponent Karen E. Keller, personally appeared before me, a Notary Public for the State and County aforesaid, and deposed and stated as follows: I. I am an attorney with the law firm of Young Conaway Stargatt & Taylor, LLP,

attorneys for the plaintiff in the above captioned matter. 1 The defendant, Cordis Corporation is a non-resident of the State of Delaware, and

on November 27, 2007 and all other times pertinent, was a non-resident of the State of Delaware. The address of the Registered Agent for Cordis Corporation is CT Corporation System, 1200 South Pine Island Road, Plantation, Florida 33324. 3. On December 2, 2007,1 caused to be mailed by registered mail an envelope to

Cordis Corporation at the address above. The envelope contained copies of a Notice in the form

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attached hereto as Exhibit 1, and copies of the Summons and Complaint, attached hereto as Exhibit 2, to the last-known address listed in paragraph 2 of this Affidavit. Attached hereto as Exhibit 3 is the receipt of registered mail from the United States Postal Service Track & Confirm website . The original registered mail receipt was never returned. 4. On December 3, 2007, the United States Postal Service Track & Confirm website

shows a delivery and acceptance of the envelope by Cordis Corporation. Pursuant to Local Rule 4.1(b), said return receipt is attached hereto as Exhibit 3.

SWORN TO AND SUBSCRIBED before me, a Notary Public in and for the State and County aforesaid, on the day and year first above written.

NOTARY PUB LIC ^ STATE OF DELAWARE
My Cor ^riss;cr Y,^i+ April 29= 2010

MAURA C.

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CERTIFICATE OF SERVICE
1, Karen E. Keller, Esquire, hereby certify that on January 23, 2008,1 caused to be electronically filed a true and correct copy of the foregoing document with the Cleric of the Court using CMIECF, which will send notification that such filing is available for viewing and downloading to the following counsel of record: Steven J. Balick, Esquire [sbalick cr ashby-geddes.com] John G. Day, Esquire [[email protected]]
Lauren E. Maguire, Esquire [[email protected]] ASHBY & GEDDES

500 Delaware Avenue, 8`1i Floor Wilmington, DE 19801 I further certify that on January 23, 2008, 1 caused a copy of the foregoing document to be served by e-mail on the above-listed counsel and on the following non-registered participants in the manner indicated:

By E-Mail
David T. Pritikin, Esquire [[email protected]] William H. Baumgartner, Esquire [[email protected] Paul E. Veith, Esquire [[email protected]]
Russell E. Cass, Esquire [rcass a sidley.com] SIDLEY AUSTIN LLP

One South Dearborn Chicago, IL 60603
YOUNG CONAWAY STARGATT & TAYLOR, LLP

/s/ Xare at E. Xefle r
Josy W. Ingersoll (9 1088) Oingersoll @ycst.com] Karen L. Pascale (#2903) [kpascale a ycst.com] Karen E. Keller (#4489) [kkeller a ycst.com] Andrew A. Lundgren (#4429) [alundgren a ycst.com] The Brandywine Building 1000 West Street, 17th Floor Wilmington, Delaware 19801 (302) 571-6600 f(ttorneys fo1 Plaintiffs, Boston Scientific Coiporation and Boston Scientific Schned, Inc.

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EX HIBI T 1

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE BOSTON SCIENTIFIC CORPORATION and BOSTON SCIENTIFIC SCIlAED, INC.,

Plaintiffs,
V.

Civil Action No. 07-765 JURY TRIAL DEMANDED

JOHNSON & JOHNSON, INC. and CORDIS CORPORATION,
Defendants.

NOTICE
TO: CORDIS CORPORATION c/o CT Corporation System

1200 South Pine Island Road Plantation, FL 33324
PLEASE TAKE NOTICE that there has been served upon the Secretary of State of the State of Delaware the original of a Summons and Complaint, copies of which are attached hereto, in which you are named as a defendant in an action brought by Boston Scientific Corporation and Boston Scientific Scimed, Inc. Said Summons and Complaint were served upon the Secretary of State of the State of Delaware on November 27, 2007, and service of process was filed with the United States District Court for the District of Delaware on November 28, 2007. Under the provisions of 10 Del. C. § 3104, service of the original Summons and Complaint upon the Secretary of State as aforesaid is as effectual to all intents and purposes as if it had been made upon you personally within the State of Delaware.

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Failure on your part to obey the command of the within writ could result in a
default judgment being taken against you.

YOUNG CONAWAY STARGATT & TAYLOR, LLP

G&-YlIJosy1W. Ingersoll (# 1088) Karen E. Keller (#4489)
The Brandywine Building, 17'' Floor 1000 West Street Wilmington, DE 19801 [email protected] [email protected] (302) 571-6554

Of Counsel: Richard L. Delucia Paul M. Richter Michael K. Levy Jerry Canada KENYON & KENYON LLP One Broadway

Attorneys for Plaintiffs Boston Scientific Corporation and Boston Scientific Scimed, Inc.

New York, NY 10004 (212) 425-7200

Dated: November 28, 2007

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EXHIBI T 2

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AC 440 (Rev. 10193) Summons in a Civil Action

United States District Court
DISTRICT OF BOSTON SCIENTIFIC CORPORATION and BOSTON SCIENTIFIC SCIMED, INC.,
Plaintiffs,
V.

DELAWARE

SUMMONS IN A CIVIL CASE
CASE NUMBER:

JOHNSON & JOHNSON, INC. and CORDIS CORPORATION,
Defendants.

07 -765

TO:

CORDIS CORPORATION c/o Secretary of State Division of Corporations John G. Townsend Bldg. 401 Federal Street , Suite 4 Dover, DE 19901

YOU ARE HEREBY SUMMONED and required to serve upon PLAINTIFF'S ATTORN EY (name and address) Josy W. Ingersoll, Esquire Karen E. Keller, Esquire Young Conaway Stargatt & Taylor, LLP 1000 West Street, 17tH Floor

P. 0. Box 391 Wilmington, DE 19899-0391
an answer to the complaint which is herewith served upon you, within 20 days after service of this summons upon you, exclusive of the day of service . If you fail to do so, judgment by default will be taken against you for the relief demanded in the complaint. You must also file your answer with the Clerk of this Court within a reasonable period of time after

service.

PETER T. DALL EO
CLERK DATE

(BY) DEPUTY CLERK

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
BOSTON SCIENTIFIC CORPORATION and BOSTON SCIENTIFIC SCIMED, INC.,

Plaintiffs,
V.

Civil Action No.

JURY TRIAL DEMANDED;

JOHNSON & JOHNSON, INC. and CORDIS CORPORATION,
Defendants.

COMPLAINT FOR DECLARATORY JUDGMENT OF PATENT INVALIDITY AND NONINFRINGEMENT
Plaintiffs Boston Scientific Corporation and Boston Scientific Scimed, Inc. (collectively "BSC"), through their attorneys, bring this complaint against Defendants Johnson & Johnson, Inc. and Cordis Corporation (collectively "J&J") and requests a jury trial on all issues so triable. BSC alleges as follows, upon knowledge with respect to itself and its own acts, and upon information and belief as to the circumstances and facts of others:

NATURE OF THE ACTION
I. This is an action for a declaratory judgment that United States Patent No.

7,300,662 entitled "Drug/Drug Delivery Systems for the Prevention and Treatment of Vascular Disease" (the "Falotico '662 patent") is invalid and not infringed by BSC. The Falotico '662 patent is attached as Exhibit A.

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THE PARTIES 2. Plaintiff Boston Scientific Corporation is a corporation organized under the laws

of the State of Delaware, having its principal place of business at One Boston Scientific Place, Natick, Massachusetts 01760. 3. Plaintiff Boston Scientific Scimed, Inc. is a corporation organized under the laws

of the State of Minnesota, having its principle place of business at One Scimed Place, Maple Grove, Minnesota 55311. 4. Upon information and belief, Defendant Johnson & Johnson, Inc. is a corporation

organized under the laws of the State of New Jersey and has a principal place of business at One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933. 5. Upon information and belief, Defendant Cordis Corporation ("Cordis") is a

corporation organized under the laws of the State of Florida and has a principal place of business in Miami Lakes, Florida. Cordis is a subsidiary of Johnson & Johnson, Inc.

JURISDICTION AND VENUE 6. seq. ). 7. This Court has jurisdiction over the subject matter of all causes of action herein This action arises under the Patent Laws of the United States (35 U.S.C. § 1, et

pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201 and 2202. 8. On information and belief, J&J has systematic and continuous contacts in this

judicial district.
9. On information and belief, J&J regularly avails itself of the benefits of this

judicial district, including the jurisdiction of the courts.

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10. district. 11.

On information and belief, J&J regularly transacts business within this judicial

On information and belief, J&J regularly sells products in this judicial district.

J&J derives substantial revenues from sales in this district. 12. 13. and 1400(b). This Court has personal jurisdiction, general and specific, over J&J. Venue in this judicial district is proper pursuant to 28 U.S.C. §§ 1391(b) and (c)

BACKGROUND 14. BSC is a world renowned leader in the development of intravascular stents used

to treat coronary artery disease. 15. J&J and, in particular, Cordis, directly compete with BSC in the field of

intravascular stents used to treat coronary artery disease. 16. J&J has a well-known history of suing competitors, including BSC, in the field of

intravascular stents for patent infringement. Within the past several years, J&J and/or Cordis have sued BSC in this Court, alleging patent infringement in cases involving intravascular stents used to treat coronary artery disease. BSC has also brought suits for patent infringement against J&J within this judicial district. 17. Pursuant to an agreement between BSC and Abbott Laboratories ("Abbott"), BSC

is presently selling the PROMUSTM Everolimus-Eluting Coronary Stent System ("PROMUS") in Europe and other countries outside the United States. The PROMUS scent is a private-labeled XIENCETM V Everolimus Eluting Coronary Stent System ("XIENCE V") which is manufactured for BSC by Abbott in the United States. The PROMUS stent is an intravascular stent used to

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treat coronary artery disease. It advantageously releases a drug designed to diminish reblocking (restenosis) of the patient's blood vessel into which the stent has been inserted. 18. The PROMUS stent received CE Mark approval in October 2006, which allows

BSC to distribute PROM-US in 27 countries of the European Economic Area. Since that time, BSC has been taking title to the PROMUS stent from Abbott in the United States and then exporting those stents to the European market. BSC intends to begin selling its PROMUS stent in the United States in 2008. 19. In 2006, BSC purchased Guidant Corporation ("Guidant" ). As part of the

agreement governing the Guidant acquisition, Guidant separately sold the rights to its everolimus-eluting stent product to Abbott. BSC separately entered into an agreement with Abbott that permits BSC to sell (under the designation "PROMUS") the everolimus-eluting stents manufactured by Abbott (which Abbott sells on its own as its "XIENCE V" stent). 20. Abbott currently manufactures and sells its own everolimus-eluting stent, the

XIENCE V stent, which is the same product as BSC's PROWS stent, and BSC has made a substantial investment in the PROMUS stent. 21. On May 15, 2007, Cordis filed a Complaint against Abbott in the United States

District Court for the District of New Jersey (Civil Action No. 07-2265), alleging infringement of U.S. Patent No. 7,217,286 (the "Falotico '286 patent" or alternatively, the "'7286 patent"). On May 29, 2007, Cordis filed a Complaint against Abbott in the United States District Court for the District of New Jersey (Civil Action No. 07-2477), alleging infringement of U.S. Patent No. 7,223,286 (the "Wright '286 patent" or alternatively, the "'3286 patent"). On June 12, 2007, Cordis filed a Complaint against Abbott in the United States District Court for the District of New Jersey (Civil Action No. 07-2728), alleging infringement of U.S. Patent No. 7,229,473 (the

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"Wright '473 patent"). Collectively, these three Cordis patents are referred to as "the Asserted Cordis Patents." 22. During the prosecution of each of the Asserted Cordis Patents, Cordis separately

petitioned the United States Patent and Trademark Office for expedited consideration in view of perceived patent infringement in connection with the XIENCE V stent. Upon issuance of these three patents, Cordis promptly asserted the new patents against Abbott. Exactly the same circumstances exist with regard to the Falotico '662 patent: Cordis likewise petitioned for expedited Patent Office review of the application that led to the Falotico '662 patent based, again, on perceived infringement by the XIENCE V stent. The petition of August 7, 2006 is attached as Exhibit B. 23. Cordis' recent pattern of promptly asserting its new patents, and in particular

those patents issuing from an expedited Patent Office evaluation demanded by Cordis because of alleged infringement, has created a present substantial controversy between J&J and BSC concerning the PROMUS stent. J&J, through Cordis, has asserted rights under related patents against the same product as the PROMUS stent, and the alleged infringement of the Asserted Cordis Patents has created an apprehension that Cordis will sue BSC for alleged infringement of the Falotico '662 patent.

RELATED CASES PENDING IN THE DISTRICT OF DELAWARE 24. There are now five cases pending in the District of Delaware that are related to

the instant case, as set forth in the below paragraphs. 25. On September 29, 2006, Abbott filed a declaratory judgment action against J&J,

alleging that other Cordis-owned patents - U.S. Patent Nos. 6,585,764 (the "'764 patent"), 6,776,796 (the "'796 patent"), and 6,808,536 (the "'536 patent") - are invalid and not infringed

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by Abbott's manufacture and/or use of the XTENCE V stent in the Unites States. (See Ex. C, the complaint in Civil Action No. 06-613-SLR).' Although on August 8, 2007, Cordis granted Abbott a covenant not to sue on those patents, that action remains active in view of pending motions to amend the complaint, as explained below. 26. On May 15, 2007, Abbott filed a declaratory judgment action against Cordis in

the United States District Court for the District of Delaware relating to U.S. Patent No. 7,217,286 (the "Falotico 286 patent"). (See Ex. D, the complaint in Civil Action No. 07-259-SLR). Abbott alleges in its May 15 complaint that the Falotico '286 patent is invalid and not infringed by Abbott's manufacture and/or use of the XIENCE V stem in the Unites States. (Id. at p. 17). Abbott's declaratory judgment action against the Falotico '286 patent, which is currently pending in this judicial district, is the first filed action concerning the Falotico '286 patent. Also on May 15, 2007, Abbott filed a motion for leave to file a supplemental complaint or in the alternative to consolidate related cases in Civil Action No. 06-613-SLR pending before the United States District Court for the District of Delaware. (See Ex. E, Abbott's motion for leave to file a supplemental complaint or consolidate related cases). Abbott's motion requests leave to file a supplemental complaint to add a claim for declaratory judgment of invalidity and noninfringement of the Falotico '286 patent. (Id. at p. 2). 27. On May 25, 2007, BSC filed a declaratory judgment action against Cordis in the

United States District Court for the District of Delaware relating to the Falotico '286 patent. (See Ex. F, the complaint in Civil Action No. 07-333-SLR). BSC asserts in that May 25

' The exhibits originally filed with Exhibits C-L herein have not been attached. Exhibits C-K correspond to Exhibits C-K filed with the compliant in Civil Action No. 07-409-SLR and Exhibit L is the complaint in Civil Action No. 07-409-SLR Should the Court require a copy of these exhibits, Plaintiffs are available to do so.

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complaint that the Falotico '286 patent is invalid and not infringed by BBC's above-recited activities regarding the PROWS stent. (Id. at p. 6). 28. On May 29, 2007, Abbott filed a supplemental motion for leave to file a

supplemental complaint or in the alternative to consolidate related cases in Civil Action No. 06613-SLR pending before the United States District Court for the District of Delaware. (See Ex. G, Abbott' s motion for leave to file a supplemental complaint or to consolidate related cases). Also on May 29, 2007, Abbott filed a motion for leave to file a supplemental complaint in Civil Action No. 07-259-SLR pending before the United States District Court for the District of Delaware. (See Ex . H, Abbott's supplemental motion for leave to file a supplemental complaint). Abbott's motions request leave to file supplemental complaints to add claims for declaratory judgment of invalidity and noninfringement of U, S. Patent No. 7,223,286 (the "Wright '286 patent"). (Ex. G at p. l; Ex. H at p. 1). 29. On June 1, 2007, BSC filed a declaratory j udgment action against J&J in the

United States District Court for the District of Delaware relating to the Wright ' 286 patent. (See Ex. 1, the complaint in Civil Action No. 07-348-SLR). BSC asserts in its June 1 complaint that the Wright ' 286 patent is invalid and not infringed by BBC' s above-recited activities regarding the PROWS scent. (Id. at p. 7). 30. On June 12, 2007, Abbott filed a second supplemental motion for leave to file a

supplemental complaint or in the alternative to consolidate related cases in Civil Action No. 06613-SLR pending before the United States District Court for the District of Delaware . (See Ex. J, Abbott's second supplemental motion for leave to file a supplemental complaint or to consolidate related cases). Also on June 12, 2007, Abbott filed a supplemental motion for leave to file a supplemental complaint in Civil Action No. 07-259-SLR pending before the United

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States District Court for the District of Delaware. (See Ex. K, Abbott's supplemental motion for leave to file a supplemental complaint). Abbott's motions request leave to file supplemental complaints to add claims of invalidity and noninfringement of U.S. Patent No. 7,229,473 (identified as the "Wright '473 patent" ). (Ex. J at p. 1; Ex. K at p. 1). 31. On June 22, 2007, B S C filed a declaratory judgment action against J&J in the

United States District Court for the District of Delaware relating to the Wright '473 patent. (See Ex. L, the complaint in Civil Action No. 07-409-SLR). BSC asserts in its June 22 complaint that the Wright '473 patent is invalid and not infringed by BSC's above-recited activities regarding the PROMUS stent. (Id, at p. 8). 32. The instant action by B S C against J&J is related to Abbott's September 29, 2006

action because at least the Falotico '796 patent is part of the same patent family as the Falotico '662 patent, the prior art to both patents is related, and the products at issue in the September 29, 2006 action (Abbott's XIENCE V) and this action (BSC's PROMUS) are related. Also, as discussed above, Abbott has also recently filed motions to amend its complaint in the September 29, 2006 action to include the Falotico '286 patent, the Wright '286 patent, and the Wright '473 patent or, in the alternative, consolidate its September 29, 2006, May 15, May 29, and June 12 actions. 33. The instant action by BSC against J&J is related to Abbott's May 15 complaint

and supplemental complaint and BSC's May 25 complaint on the Falotico '286 patent, Abbott's May 29 supplemental complaints and BSC's June I complaint on the Wright '286 patent, and BS C's June 22 complaint on the Wright '473 patent, because the patents involved all have claims purporting to cover similar subject matter, the prior art to the those patents is related, and the products of the declaratory judgment plaintiffs, XIENCE V (Abbott) and PROMUS (BSC), are

8
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related . Essentially identical Scheduling Orders have been entered in Abbott's declaratory judgment case (Civil Action No. 06-613-SLR, D. I. 85) and BSC ' s declaratory judgment cases (Civil Action No. 07-333-SLR, D.I. 19; Civil Action No. 07-348-SLR, D.I. 17; Civil Action No. 07-409-SLR, D. I. 18).

COUNTI INVALIDITY AND NONINFRINGEMENT OF U.S. PATENT NO.7 ,300,662 34. BSC repeats and realleges each and every allegation contained in paragraphs 1-33

of this Complaint as though fully set forth herein. 35. Each of the claims in the Falotico '662 patent is invalid for failure to comply with

one or more of the requirements of Title 35, United States Code, including, but not limited to, 35 U.S.C. §§ 102, 103 and 112. 36. The PROM-US stent does not infringe any valid claim of the Falotico '662 patent.

PRAYER FOR RELIEF WHEREFORE, BSC prays that this Court enter judgment as follows, ordering that: (a) (b) Each and every claim of U.S. Patent No. 7,300,662 is invalid; Plaintiffs are not liable for directly, contributorily or inducing infringement of any

claim of U.S. Patent No. 7,300,662; (c) Defendants and their officers, agents, employees, representatives, counsel and all

persons in active concert or participation with any of them, directly or indirectly, be enjoined from threatening or charging infringement of, or instituting any action for infringement of U.S. Patent No. 7,300,662 against Plaintiffs, its suppliers, customers, distributors or users of its products;

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(d)

Defendants pay to Plaintiffs the costs and reasonable attorney's fees incurred by

Plaintiffs in this action; and (e) proper. Plaintiffs be granted such other and further relief as this Court deems just and

DEMAND FOR JURY TRIAL
Plaintiffs demand a trial by jury on all issues so triable.

YOUNG CONAWAY STARGATT & TAYLOR, LLP

3osy W. Ingersoll (#1088 Karen E. Keller (#4489) The Brandywine Building, 17'' Floor 1000 West Street Wilmington, DE 19801 [email protected] [email protected] (302) 571-6554

Of Counsel:
Richard L. Delucia Paul M. Richter Michael K. Levy Jerry Canada KEN-YON & KENYON LLP One Broadway New York, NY 10004 (212) 425-7200

Attorneys for Plaintiffs Boston Scientific Corporation and Boston Scientific Scimed, .Inc.

Dated: November 27, 2007

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EXHIBIT A

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h mii ^Nim i uM^
(32)

J

Im

United States Patent
Falotico et al.
DRUG/DRUG DELIVERY SYSTEMS FOR THE PREVENTION AND TREATMENT OF VASCULAR DISEASE Inventors: Robert Falotico , Belle Mead, NJ (US); Gregory A. Kopla, Hillsborough, NJ (US); Gerard El. LIanos, Stewartsville, NJ (US) Assignee: Cordis Corporation , Miami Lakes, FL (US) Notice: Subject to any disclaimer, the term 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.

( io) Patent No.:
(45) Date o f Patent :
(58)

US 7,300,662 B2
*Nov. 27, 2007

(54)

Field of Classification Search ........ 424/4 22-426; 62 311. 42-1.48 See application file for complete sear ch hist ory. References Cited U.S. PATENT DOCUMENTS
86 1,65 9 A 3 ,05 1,677 A 3 ,279,996 A 3 ,526,00 5 A 3 ,599,64 1 A 711907 Johnston .............. ....... 4641147 811962 Rexford ........... .... ....... 5221156 1011966 Long et al ........ ... ....... 4241424 911970 Bokros ............ .... .... 623111.11 811971 Sheridan ..... ..... .... ....... 6041256

(75)

(56)

(73) (·)

(Continued)

F OREI GN PATENT DOCUMEN T S
DE 3205942 Al 911983

(21) (22) (65)

Appl. No.: 101829,074 Filed: Apr. 21, 2004 Prior Publication Data US 200410260268 Al Dec. 23, 2004 (Continued) OTHER PUBLICATIONS
Boston Scientific, "Measuring DES Efficacy," www.tams-sent. corn/usalaf5cacy.html, 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. 60/262,614, filed on Jan. 18, 2001, provisional application No. 60/262,461, filed on Jan. 18, 2001, provisional application No. 601204,417, filed on May 32, 2000. Int. Cl. (2006.01) A61F 2100 A61F 2106 (2006.01) U.S. Cl ...................... 424/424; 623/1.42; 62311.45

(Continued) Primary Examiner--Sharon E. Kennedy (74) Attorney, .agent, or Firm-Woodcock Washburn LLP (57) ABSTRACT

(60)

(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 intrrluminally for the treatment and prevention of neointimal hyperplas'ta following percutaneous transluminal coronary angiography. The local delivery of the drugs or agents provides for increased effectiveness and lower systemic toxicity. 25 Claims, 2 Drawing Sheets

(52)

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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 4,512,336 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 4,796,500 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 4,994,298 A 4,998,923 A 5,015,253 A 5,019,090 A 5,019,096 A 5,029,677 A 5,034,265 A 5,035,706 A 5,041,100 A 5,041,126 A 411972 Ersek 711973 Sander ....................... 188P_03 1211973 Alsbetg ...................... 4271105 1211975 Sebgal et at ................ 4241122 111976 Margraf 411976 Zaffaroni .................... 1281833 411976 Bokros et al. ........... 623111,11 711976 Blasi ......................... 6061198 111978 Higuchi at al .............. 4241432 211978 Martinez .................... 2851332 1011981 Nash at al. 1111981 Banka ........................ 604/509 1111981 Bokros ..... ................. 62311.13 111982 Pierce at at . ............. 4281425.5 311982 Mano ........................ 62311,43 411982 Simpson et al ............. 6061194 611983 Broyles ...................... 4281597 1111983 Akiyama at al. ........ 623123.72 1211983 Close ......................... 524/546 411984 ionescu et al. 311965 Dotter 411985 Balko et al ................. 6061108 1111985 Seiler, Jr. at al ........... 62311.32 1111985 Maass ct al. 1211985 Hammerslag ............... 6041509 111986 Kronberg .. ................. 62311.32 1/1986 Golander et al. ........... 4281409 411986 Gianturco 911986 Gum 211987 Sakamato et al, .......... 4241492 411987 Wallsten 411987 Hoffman at al ............. 4421123 6/1987 Webb at al, ........... 1281207.14 7/1987 Rosenwald .................4241427 811987 Hanson ..................... 62311,49 811987 Bokros ...................... 62312.31 311986 Billeter at al ............ 604193.01 311988 Palmaz 411986 Palntaz 411988 Kreamer .................... 623/1.15 611988 Greco et al ................. 428!422 611988 Langer et al . ............. 623/1.42 811988 Kropf ......................... 6061191 911988 Fischell et al . ............ 62311.11 1011968 Palm= 1111988 Wong ......................... 4241422 1111988 Lazarus ..................... 62311.11 111989 Gianturco 311989 Lurn .......................... 536/20 8/ 989 Hillstead 1011989 Hsu at al .................... 6041266 1011989 Joh 1011989 Mayer et al, ............... 6041269 211989 Wiktor 311990 Gianturco 411990 Tang at al. 911990 Wallsten 1111990 Wiklor 211991 Dardik 211991 Wilkoff 211991 MacGregor 211991 Yasuda ....................... 427/490 311991 Samson at al . ............. 6061194 511991 MacGregor 511991 Pinchuk ..................... 623/1.15 511991 Fox, Jr. at al. ............... 600136 711991 Fedeli at al ................. 2771354 711991 Hoffman at al, ............ 442/26 711991 Giaoturco 811991 Rowland at al. 811991 Gianturco
5,047,020 A 5,049,132 A 5,049,403 A 5,053,048 A 5,059,166 A 5,061,275 A 5,061,756 A 5,064,435 A 5,092,677 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 5,213,898 A 5,217,483 A 5,222,97t 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 5,314,477 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 5,354,306 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 911991 911991 911991 1011991 1011991 1011991 1011991 11/1991 311992 411992 411992 511992 611992 711992 711992 711992 811992 1111992 1111992 1211992 1211992 111993 111993 1/1993 111993 111993 211993 3/1993 3/1993 411993 511993 511993 611993 611993 711993 811993 911993 1111993 1111993 1111993 1111993 1211993 111994 1/1994 2/1994 211994 711994 21994 311994 311994 311994 411994 411994 411994 $11994 511994 5/1994 511994 711994 811994 811994 811994 6/1994 811994 811994 1011994 10/1994 1011994 1111994 1111994 1211994 1211994 1211994

Hsu ...........................6041266 Shaffer at al. Larm at al ................... 42712.1 Pinchuk Fischell at al . ................ 60013 Wallsten at al. Feijan et al. Porter Pinchuk Palmaz Wolff Hillstead Rhodes Dardik et al, Wiiktor Feijen et al. Hillstead Froix Pinchuk March et al. ............... 6041507 MacGregor Trucltai Bloom et al. ........ ..... 430114 Kandarpa Woods W'nlters at al. Tang at al. Wall Schatz ..5141291 Hughes et al. ...... Abiuso at al, Larm et al .................. 428/422 "Power Willard at al. Pinchuk Sitvestrini Yachia at al. Froix Duran Winters ct al. Wall Opolski ................... 4281423.1 Palmaz ....................... 6061108 Lazarus at al. Schwartz et al. Gianturco Gregory at al. Mitchell et al. Inoue Boncau Rhee at al. Sabaljian Spaulding March et al. Oblstein Rhea at al. Gianturco Fontaine Slepian Heinke at al. Pallassana ct al. Winters at al. Kaplan Summers Eury Roubin ct al. Simon at al. Rowland et al. Andersen at al. Crocker Fontaine Samson Cottenceau at al.

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IV1994 Duran 5,376,112 A 5,378,475 A 111995 Smith at al ................. 4241473 111995 Fearnot at at, 5,380,299 A 111995 Palmaz 5,382,261 A 111995 Jung et al, ............. 6041103.04 5,383,853 A 111995 Scott at al. 5,383,928 A 5,387,235 A 211995 Chuter 211995 Tower 5,389,106 A 211995 Skotnicki at al............ 5401456 5,391,730 A 211995 Yuc at al. 5,393,772 A 311995 Simon at al. 5,395,390 A 311995 Marin at al. 5,397,355 A 311995 Hanson . ..................... 4241423 5,399,352 A 411995 Solar 5,403,341 A 411995 Cragg 5,405,377 A 411995 Narayanan at al. 5,409,696 A 511995 Peters 5,411,549 A 511995 Lee at al. 5,415,619 A 511995 Hsu at al ................. 424178.27 5,417,969 A 5/1995 Narciso, Jr. 5,419,760 A 611995 Fontaine 17359,802 S 611995 Lau 5,421,955 A 611995 Williams 5,423,885 A 711995 Keogh 5,429,618 A 711995 Narciso 5,429,634 A 8/1995 Barry 5,439,446 A 811995 Khosravi at al. 5,44,515 A 811995 Wang at al. 5,441,516 A 811995 Dodge et al. 5,441,947 A 811995 Eury 5,443,458 A 811995 Marin at al. 9,443,477 A 811995 Schwartz at al. 5,443,496 A 811995 Fontaine 5,443,496 A 811995 Sigwart 5,443,500 A 911995 Hcimus at al. 5,447,724 A 911995 Schmaltz at al. 5,449,372 A 5,449,373 A 911995 Pinchasik d al. 911995 Dayton 5,449,382 A 1111995 Buscemr at al. 5,464,450 A 1111995 Friesen at al ............... 210/640 5,464,540 A 11/1995 Berg, et al. 5,464,650 A 1211995 Myler et al. ................ 6061108 5,474,563 A 111996 Narayanan 5,486,357 A 311996 Sgm 5,496,365 A 311996 Buscemi at al. 5,500,013 A 411996 Molnar-Kimber at al. .. 5141291 5,504,091 A 411996 Dinh et a1. 5,510,077 A 411996 Domb et al ................. 60,41265 5,512,055 A 511996 Morris at al. 5,916,781 A 511996 Morris at al ................ 5141378 5,519,042 A 611996 Hanson at Al. 5,523,092 A 611996 Fontaine at al. 5,527,354 A 811996 Wolff at al. 5,545,208 A 911996 Buseemi at al. 5,551,954 A 911996 Dinh at al. 5,554,182 A 911996 Takahashi 5,554,954 A 9/1996 Larn. 5,556,413 A 911996 Nelson at al, .............. 5141291 5,559,122 A 5,562,922 A 1011996 Lambert 1011996 Morris at al. 5,563,146 A 1011996 Helmus at al. 5,569,197 A 10/1996 Lam 5,569,295 A 1011996 Martinson at al........... 4241423 5,569,462 A 1011996 Helmus at al . ............. 4241426 5,569,463 A 1111996 Crockcr ................. 6041103.01 5,571,089 A 1111996 Dinh at al. 5,571,166 A 1111996 Pegunathan at al. 5,574,059 A 1111996 Pinchuk ..................... 623/1.15 5,575,818 A 11/1996 Dayton 5,578,075 A 1211996 Bianco et al. 5,580,873 A 1211996 Bianco at al. 5,580,874 A 111997 Narayanan at al. 5,591,140 A 111997 firth at al. 5,591,197 A 5,591,224 A 5,591,227 A 5,599,352 A 5,603,722 A 5,604,283 A 5,605,696 A 5,607,463 A 5,607,475 A 5,609,629 A 5,616,608 A 5,620,984 A 5,621,102 A 5,622,975 A 5,624,411 A 5,628,785 A 5,629,077 A 5,629,315 A 5,632,763 A 5,632,771 A 5,632,776 A 5,632,840 A 5,635,201 A 5,637,113 A 5,643,312 A 5,643,939 A 5,646,160 A 5,648,357 A 5,649,952 A 5,649,977 A 5,651,174 A 5,652,243 A 5,653,747 A 5,653,992 A 5,662,609 A S,665,591 A 5,665,728 A 9,667,764 A 5,669,924 A 5,670,506 A 5,672,638 A 5,674,242 A 5,679,400 A 5,679,659 A 5,664,061 A 5,691,311 A 5,693,089 A 5,697,967 A 5,697,971 A 5,700,286 A 5,707,385 A 5,709,874 A 5,713,949 A 5,716,981 A 5,725,549 A 5,725,567 A 5,728,150 A 5,728,420 A 5,731,326 A 5,733,327 A 5,733,920 A 5,733,925 A 5,735,897 A 5,739,138 A 5,755,734 A 5,755,772 A 5,759,205 A 5,769,883 A 5,776,184 A 5,780,462 A 5,780,476 A 5,782,908 A 5,788,979 A 5,792,106 A 1/1997 Schwartz at al. 111997 Dinh at al. 211997 Dinh at al. 211997 Phan at al. 2/1997 Wada at al . ................ 5241236 211997 Eury at al. 311997 Schwartz at al. 311997 Cahalan at al. 311997 Feamot at al. 411997 Kinsella at al .............. 5141449 411997 Bianco at al. 4/1997 Bianco at al. 411997 Singh et al. 411997 Tuch 511997 Schwartz at al. 511997 Turnlund at al. 511997 Bianco at al. 511997 Glastra 511997 Boatman at d . ........... 62311.15 511997 Kurumatani at al.......... 4241423 511997 Campbell 611997 Falco .......................... 4241443 611997 Tastagiia ct al. 711997 Fischcil et al. 7/1997 Ohlstein 711997 Morris at al. 7!1997 Bianco at al. 711997 Lam 711997 Campbell 711997 Schwartz at al. 711997 Bianco at al. 8/1997 Dereume ................... 62311.54 811997 Bczwada at al. 911997 Slepian 911997 Sonenshein at al. ........ 4351375 911997 Morris at al. 911997 Kopia at al ................ 42411.45 911997 Shaknovich 911997 Leigh at al. 911997 Wthoeven at al. ......... 5231112 1011997 Phan at al . ................. 6061198 1011997 Tuch 1011997 Verboeven at al. 1111997 Ohnishi at al . ............. 5231114 1111997 Maraganore at al. ......... 514112 12/1997 Buirgc at al. 12/1997 Dinh at al. 12/1997 Fischell at al. 1211997 Tartaglia at al. 111998 Williams 11998 Hanson at al. 211998 Jayamman ................. 62311.12 21 1998 Hunter at al ................ 5141449 311998 Lam 311998 %1117 et al. 3/1998 McDonald at al. 311998 Keogh 311998 Hart ct al. 311998 lgaki at al. 311998 Mansuri at al. 311998 Kunz at al. 411998 Buirge 411998 Bianco at al. 511998 Richter at al. 511998 Evans at al ................. 1281898 611998 Valcntini ....................4331173 611998 Buscami at al. 711998 Tuch 711998 Lee at al . ................... 5141183 711998 Underiner at al, 711998 Cahalan et al. 811998 Alt 811998 Mische .................. 604110101

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Page 4

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 A 5,851,217 A 5,851,231 A 5,858,990 A 5,861,027 A 5,865,814 A 5,871,535 A 5,873,904 A 5,876,433 A 5,877,224 A 5,879,697 A 5,882,335 A 5,891,108 A 5,893,640 A 5,897,911 A 5,900,246 A 5,902,266 A 5,912,253 A 5,916,910 A 5,922,393 A 5,922,730 A 5,932,243 A 5,932,299 A 5,932,580 A 5,951,986 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 6,159,486 A 6,171,232 B1 6,171,609 BI 6,177.272 BI

8/1998 Bianco at al. 811998 Davies at al. 911998 Schwartz at al. 911996 Schwartz 911998 Goicoechea at al. 911998 Klein at al. 911998 Kunz at al. 1011998 Tuch 1011998 Ronan at al. 1011998 Tuch 1011996 Raghcb at al. .... 428136.6 1011998 Fukushi .......... 1111998 Donovan at al. 1111998 Berg at al. 1111998 Ding et al. 1211998 Israel at al ................. 62311.15 1211998 Lentz at al. ............... 62311.13 1211998 Yan 1211998 Schwartz 1211998 Wolff at al. 1211998 Wolff et al. 111999 Walsh 111999 Trapp 211999 Tuch 211999 Wolff et al. 211999 Ragheb at al. 311999 Lunn 3/1999 Brocchini at al. ....... 514P172.2 311999 Ding at al. 311999 Leone at al. 411999 Leone at al. 411999 Hull at al . ............. 6041103.02 411999 Loef ar ..................... 42712.25 511999 Lambert 511999 Leone at al. 611999 Cotten at al ............... 514/291 611999 Lai ............................ 5141423 711999 7ayaraman .................. 42712.3 711999 Hu at al ..................... 5141291 811999 Fricknr ct al . .............. 4241450 811999 Katoot ....................... 4271508 VIM Levitzki at al .............. 1811152 911999 Berg at al. 911999 Schwartz 10/1999 Pinchuk at al ............. 62311.16 1011999 Johnson 1111999 Hart et W. 1111999 Li at al. 1111999 Gray at al. 11/1999 Alt at al. 1111999 Ding 1111999 Kunz at al. 1111999 Hanson at al. 1211999 Wolff at al, 1211999 Wolff' at al. 112000 Rakos at al ................ 62311.13 112000 Mollison . ................... 5141291 312000 Johnson at al. 512000 Vrba at al. 612000 Brown at al. 612000 Kunz at al. 612000 Schwartz 812000 Ragheb et al. 912000 Dinge at al. 912000 Yang at al . ................. 4271335 1012000 Cody at al. 1012000 Sprague 1112000 Rowe 1112000 Hossainy at al. 1212000 Nagier at al, - ............. 4241423 112001 Papandreou et al. 112001 Kunz 112001 Nabel at al.

6,179,817 Bl 6,187,757 Bl 6,193,746 Bl 6,214,901 BI 6,225,346 Bl 6,240,616 Bl 6,245,537 BI 6,251,920 BI 6,254,632 Bl 6,254,634 31 6,258,121 BI 6,268,390 BI 6,273,913 B1 6,284,305 BI 6,287,320 131 6,287,628 B 6,299,604 BI 6,306,144 BI 6,306,166 BI 6,306,176 BI 6,306,421 BI 6,309,380 BI 6,309,660 Bl 6,313,264 BI 6,316,018 Bl 6,335,029 BI 6,358,556 Bl 6,369,039 BI 6,379,362 B1 6,387,121 B1 6,403,635 B1 6,407,067 B1 6,517,858 BI 6,517,889 Bt 6,545,097 B2 6,585,764 B2 6,620,194 B2 6,746,773 B2 6,776,796 S2 6,808,536 B2
20 0 110 0 07 0 83 Al 2 0 0 1100 293 5 1 Al 200 110 0296 60 Al 200 11003 20 14 Al 2001/0034363 Al 200110037145 Al 200210010418 Al 200210032477 Al 20 0 21004 1 8 9 9 Al 200 2100 6 1 3 26 Al 2002(0068969 Al 200 210 0 7 1 9 02 Al 200210082660 Al 200210082685 Al 20 0 2100 9 14 33 Al 200210095114 Al 2002/0099438 At 200710103526 Al 2002/0119178 Al 2002/0123505 Al 200710127327 Al 200210133222 Al 2002/0133224 Al 20 0 2101 65 6 08 Al 200210193475 Al 2003/0065377 Al 200310216699 Al 200410049265 Al 200410243097 Al 200410260268 Al 200510002986 Al 200510004663 Al 20 0 5/0033 26 1 Al

112001 212001 212001 412001 512001 612001
612001 612001 712001

Zhong ........................ 6041265 Clackson at a1 . ............. 514131 Strecker .................... 62311.13 Chudzik at al. Tang at al . ................. 5141523 Yan
Williams at al ............. 4551135 Grainger at al ............. 5141319 Wu et al.

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200510106210 Al 2005/0187611 Al 200510208200 Al 200610088654 Al 200610089705 At 512005 812005 912005 4/2006 4/2006 Ding et al . ....... .... 4241423 Ding et al . ................ 62311.15 Ding er al . ................ 42712.25 Ding et al . ................ 42712.21 Ding et ai . ................ 62311.15 WO WO WO WO WO WO WO WO WO 01/87372 Al 01/87373 Al WO 01/87376 Al 02/26139 Al 02/26271 Al 02/26280 Al 02126281 Al 031015664 Al 031057218 Al 11/2001 11/2001 11/2001 4/2002 412002 412002 412002 212003 7/2003

FOREIGN PATENT DOCUMENTS DE EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP EP FR GB GB GB SU 19723723 Al 0 145 166 A2 0 177 330 A2 0 183 372 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 At 0 734 698 A2 0 712 615 Al 0 716 836 Al 0 800 801 Al 0 734 721 Al 0 747 069 A2 0 761 251 Al 0 830 853 Al 0 540 290 B1 0 815 803 Al 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 At 1 588 727 At 0 566 807 Al 1 205 743 2 135 585 A 0 662 307 A2 660689 1457921 89103232 Al WO 91/12779 Al WO 92115286 Al WO 94101056 Al WO 94121308 Al WO 94/21309 Al WO 94124961 Al WO 96100272 Al WO 96/26689 At WO 96/32907 Al WO 96/34580 At 96141807 Al WO 97125000 Al WO 97/33534 Al 97/35575 Al 98108463 Al WO 98113344 Al WO 98/19628 Al 98/23244 Al WO 98123228 Al WO 98/34669 Al WO 98/36784 Al WO 98147447 Al WO 98156312 Al 0012584 Al 00127455 Al WO 00127445 Al 00132255 Al 00138754 Al 01187342 A2 1211998 611985 411986 611986 54987 411991 1011992 1111993 611994 10/1994 1111994 311996 5/1996 611996 811996 1011996 12/1996 3/1997 7/1997 111998 711998 711998 911999 1011999 112000 2/2001 4/2002 1012005 1012005 411992 911970 911984 1211994 511979 211989 411989 911991 911992 111994 911994 911994 111994 111996 911996 1011996 1111996 12/1996 7/1997 911997 1011997 311998 4/1998 S/1998 611998 611998 811998 811998 1011998 1211998 412000 512000 512000 6/2000 712000 1112001

OTHER PUBLICATIONS
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Fischman, D. L. at a., "A Randomized Comparison of CoronaryStent Placement and Balloon Angioplasty in the Treatment of Coronary Artery Disease," N. Eng. J. Med., Aug. 25, 1994 , 331(8), 496-501. Franklin, S . M. at al., "Pharmacologic prevention of restenosis after coronary angioplasty : review of the randomized clinical trials," Coronary Artery Disease Mar. 1993, 4(3), 232.242. Fukuyama, J. at al ., "1'ranilast suppresses the vascular intimal hyperplasia after balloon injury in rabbits fed on a high -choesterol diet," Ear. J. Pharmacol., 1996, 318, 327-332. Gregory, C. R. at al., "Rapamycin Inhibits Arterial Intimal Thickening Caused by Both Alloimmune and Mechanical Injury," Drumplantation , Jun. 1993 , 55(6), 1409-1418. Gregory, C. R. at a1, "Treatment with Rapamycin and Mycophenolic Acid Reduces Arterial Fatima] Thickening Produced by Mechanical Injury and Allows Endothelial Replacement ," Transplantation, Mar. 15, 1995, 59(5), 655.661. Guyton, J. R. at 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. K. at al., "Interferon-y Inhibits Arterial Stenosis After Injury," Circ., 1991, 84, 1266-1272. Hashemolhosseini, S. at A ., " Rapamycin Inhibition of the Gl to S Transition Is Mediated by Effects on Cyclin Dl mMA and Protein Stability," J. Biol Chem, Jun. S. 1998, 273, 14424-14429. Jonasson, J. et al., "Cyclosporin A inhibits smooth muscle proliferation in the vascular response to injury," Proc. Natl.- Acad. Sci., 198x, 95, 2303-2306. Kuhnt, M. ct al., "Microbial Conversion of Rapamycin," Enzyme and Microbial Technology, 1997, 21, 405412. Lange, R. A. Nil) et al,, "Restenosis After Coronary Balloon Angioplasty," Annu. Rev. Med., 1991, 42, 127-132. Liu, M. W. at al., "Trapidil in Preventing Restenosis After Balloon Angioplasty in the Atherosclerotic Rabbit," Circ., 1990, 81, 10891093. Liu, M. W., MD et al., "Restenosis After Coronary Angioplasty Potential Biologic Determinants and Role of Intimal Hyperplasia," Circulation, 1989, 79, 1374-1387. Lundergan, C. F. at al., "Peptide inhibition of Myointimal Pmliferation by Angiopeptin, a Somatostatia Analogue," JACC, May 1991, 17(6), 132E-136B. Majesky, M. W. at al., "Heparin regulates smooth muscle S phase entry in the injured rat carotid artery," Circ. Res., 987, 61, 296.300. Marx, S. O. ct al., "Rapamycin-FKBP Inhibits Cell Cycle Regulators of Proliferation in Vascular Smooth Muscle Cells," Circ. Res,, 1995, 76, 412.417. Nemecek, G. M. at al., "Terbina5ne Inhibits the Mitogenic Response to Platelet-Derived Growth Factor in Vitro and Ncoinirnal Proliferation in Vivo," J. Pharmacol. Exp. I3rera., 1989, 248, 1167-1174, Okada, T. et al ., "Localized Release afPerivascular Heparin Inhibits Intimal Proliferation alter Endothelial Injury without Systemic Anticoagulation;" Neurosurgery , 1989, 25, 892-898. Poon, M. at al., "Rapamycin Inhibits Vascular Smooth Muscle Cell Migration," J. Clin Invest., Nov. 996, 98 (10), 2277-2283. Popma, J. J. at al., "Clinical trials of restenosis after coronary angioplasty," Circulation , Sep, 1991, 84 (3), 1426-1436. Powell, J. S. at al., "Inhibitors of Angiotensin-Converting Enzyme Prevent Myoindmal Proliferation After Vascular Injury," Science, 1989, 245, 186-188. Rensing, B . J. et al., Coronary restenosis elimination with a sirolmus eluting scent, European Heart journal, 200I, 22, 21252130. Rodeck, C. at al,, "Methods for Lha Transcervical Collection of Fetal Cells During the First Trimester of Pregnancy,".Prenatal Diagnosis, 1995, 15, 933.942. Serruys, P. W. at al ., "A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease," NEngl J Mad, Aug. 25, 1994; 331(8), 489495. Scmrys, P. W. at al., "Evaluation of ketanserin in the prevention of restenosis after percutaneous translumiaal coronary angioplasty. A multicenter randomized double-blind placebo-control led trial," CirculatFoet. Oct. 1993; 88(4 Pt 1), 1588-1601.

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Serruys, R W, et al ., " Heparin-coated Pahnaz-Schatz stents in human coronary arteries . Early outcome of the Bencstetnt-Il Pilot Study," Ctrcularlon, Feb. 1, 1996; 93(3), 412422. Siekierkn, J. J., "Probing T-Cell Signal Transduction Pathways with the Immunosupressive Drugs, FK-506 and Rapamycin," Immunologic Reward:, 1994, 13, 110-116. Sigwart, at al ., "Intravascular Stents to Prevent Occlusion and Restenosis After Transluminal Angioplasty," N. Engl. J. ]lied., Mar. 19, 1987, 316, 701.706, Simons, M . at al., "Antisense c-myb oligonuclemides inhibit intimal arterial smooth muscle cell accumulation in vivo," Nature, 1992, 359,67-70, Snow, A, D. at al., "Heparin modulates the composition of the extracellular matrix domain surrounding arterial smooth muscle cells," Am. J Parhol., 1990, 137, 313-330. Soliott, S. J. at al., "faxol Inhibits Neointimal Smooth Muscle Cell Accumulation after Angioplasty in the Rat," J Clin. Invest,, 1995, 95, 1869-1876, van Der Giessen, ct al., "Self-expandable Mesh Stents: an Experimental Study Comparing Polymer Coated and Uncoated Wallstent Stents in the Coronary Circulation of Pigs," Circulation 1990, 82(suppl. III):III-542. van Der Giessen, W. J, at al., "Coronary slanting with polymercoated and uncoated self-expanding endoprostheses in pigs;"Coron. Att. Disease 1992; 3, 631-640. Vasty, C. G. at a., "Clinical Cardiology: Stress Echo and Coronary Flow", , Circulation , Oct. 1989, 80 (4) Supplement 11, I1-66. Vcrweire, E. at al., "Evaluation of Fluorinated Polymers As Coronary Stent Coating," Journal of Materials Science: Materials in medicine, Apr. 200x. Weinberger, J. at al., "Intracomnary irradiation: dose response for the prevention of restenosis in swine," Int. J. Rod Onc. Dial, Phys., 1996, 36, 767-775. Preliminary Amendment in U.S. Appl. No. 07/258,189, May 22, 1989. Trial Transcript from Nov. 6, 2000 at 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 Palmaz-Schatz stmt); 370-379, 480496 (J. Palmaz testimony regarding the PalmazSchatz stent, the '984 patent and the connected z-stmt 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 the'984 patent); 926-941 . (R- Croce testimony re Palmaz-Schatz stmt); 1033-1053. (R. Schatz testimony). Trial Transcript from Nov. 13, 2000 at 1086-1134. (R. Schatz testimony); 1275-1305 (Gordis expert testimony regarding the '984 patent). Trial Transcript from Nov. 14, 2000 al 1390-1404, 1448-1454, 1486-1500 (Gordis expert testimony regarding the '984 patent). Trial Transcript from Nov. 15, 2000 at 1686-87, 172442, 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 Tsanscript 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 at 2441-48, 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 (Gordis expert testimony regarding the Palmaz-Schatz stent 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, doled 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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Trim Transcript from Mar. 4, 2005 at 133-135, 171-173 and 192-96 (Attomey's opening remarks regarding '984 validity). Trial Transcript from Mar. 7, 2005 at 275.31 1 (Cordis expert testimony regarding the Palmaz -Schatz scent); 34216, 353-59, 416425 (J. Palmaz testimony regarding the Palmaz-Schatz stent, the '984 patent and the connected z-scent art ); 430449, 452-58, 462-492 (R. Croce testimony regarding the Palmaz-Schatz stent); 500-507 (Cardin expert testimony regarding 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 an and the Palmaz-Schatz stent). Trial Transcript from Mar. 9, 2005 at 936-49, 968-69 (Cordis expert testimony regarding the '984 patent, the prior art and the PalmazSchatz stmt). Trial Transcript from Mar. 10, 2005 at 1427-74, 178-1509, 1514-73 (AVE expert testimony regarding the alleged obviousness of the '984 patent); 1566-93 (AVE expert testimony regarding PalmazSchatz stent); 163449 (1L Schatz testimony). Trial Transcript from Mar. 11, 2005 at 1846-47, 1891-1900, 1919 (Attorneys' closing arguments 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 Claim dated Apr. 19, 2005, Medtronic Vascular Inc.'s Opening Brief in Support of Its Motion for a New Trial dated Apr. 19, 1005. D.I. 1407, Cordis' Combined Answering Brief In Opposition to AVE's Motion for JMOL on Infringement of the Palmaz '762 and Schatz '984 Patents and Its Motion for a New Trial dated May 5, 2005. D.I. 1414, Medtronic Vascular loc.'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 Trial dated May 19, 2005. Trial Transcript from Feb. 8, 2001 at 372.412, 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 latent); 558.604 (J. Patmaz testimony regarding the prosecutioa of the '417, '984 and '332 patents and the prior tut). Trial Transcript from Feb. 9, 2001 at 637-45, 662-672, 682-85 (J. Palmaz testimony regarding the prior art); 699.742 (R. Schatz testimony); 769-770, 790-95 (Cordis expert testimony regarding prior art). D.I. 1067, Medtronic AVE, Inc.'s Post-Trial Brief Relating to the Unenforccabitity 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-Hearing Briefs on Alleged Inequitable Conduct Concerning the '762, '984 and '332 Patents. D.I. 1089, Reply Brief In Support of Medtrooic AVE, Inc. 's Contention thatthe'762 and'984 Patents are Unenforceable Due to Inequitable Conduct dated May 7, 2001. C.A. No. 00.886-ST R, Answer and Counterclaims of Def. Medtronic AVE, Inc. To First Amended Complaint of Plaintiff Cordis Corp. BSC's Opening Post-Trial Bricf in Support of Its Defense 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 and 180-84 (Attorncys'opening remarks regarding '332 patent). Trial Transcript from Nov. 27, 2000 at 227-51, 260-300 (Cordis expert testimony regarding the Palmaz-Schatz stent); 343.60, 36367, 424-33 (J. Palmaz testimony regarding the Paitri z-Schatz stent 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 stmt). Trial Transcript from Nov. 30, 2000 at 1018 (Cordis expert testimony regarding the '332 patent); 1062-80, 1108-1111 (R. Croce testimony regarding the Palmaz-Schatz stmt); 1169.70, 1205-17, 123645 (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- Schatz stunt). ']Vial Transcript From Dec. 4, 2000 at 1602-12, 1638-51, 171344, 1730-61, 1811-14, 1823-36 (BSC expert testimony regarding the alleged obviousness of the '332 patent, the prior art and the Palmaz-Schatz stent). Trig] Transcript from Dec. 6, 2000 at 231&27,2342-58 (BSC expert testimony regarding the '332 patent). Trial Transcript from Dec. 7, 2000 at 2549-52 (Cordis expert testimooy regarding the '332 patent); 2575-2579, 2591-92, 263031, 2649, 2669-71, 2684-85, 2688, 2708-10, 2725-27 (Attorney closing argument regarding '332 patent), 274246 Q'ury instructions as to the meaning of the limitations fn the claims of the '332 patent). Trial Transcript from Dec. 11, 2000 at 2817-22 (reading of jury verdict). Jury verdict, dated Dec. 11, 2000. DJ, 699, Motion by Defendant BSC and Scimed Life Systems, Inc. For Summary Judgment of Invalidity of U.S. Patent No. 5,902,332 dated Apr. 4, 2000. D1.896, Order Denying Motion for Summary Judgment 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 at al., Percutaneous Endovascular Scant: 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 testimany) jPortions of This Transcript Have Been Removed As Conlidentiall. Bearing Transcript £mm Feb. 11, 1998 at427.575, 577.651(Cordis expert testimony regarding the '417 patent, the prior an and the Palmaz-Schatz stem). Hearing Transcript from Feb. 13, 1998 at 112L-1261 (Guidant expert testimony regarding the alleged obviousness of the '417 patent, the prior art and the Paimaz-Schatz stent). [Portions of This Transcript Have Been Removed As Confidential]. Order by L Robinson denying Cordis' Motion for a Preliminary Injunction Against ACS dnted Jul. 17, 1998. ACS, Inc.'s and Guidant Corp.' s Opening Brief in Support ofTheir 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 Scp. 24, 1998. Order dated 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; Ian. 18, 1998: 67-73, 108-110. Schatz Deposition Testimony; Jul. 14, 1998: 69-77, 108-112, 119123. Schatz Deposition T