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`U.S. UTILITY Patent Application U.S. UTILITY Patent Application
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`APPL NUM APPL NUM
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`FILING DATE FILING DATE
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`CLASS CLASS
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`10016260 10016260
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`10/30/2001 10/30/2001
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`514 514
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`1614 1614
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`**APPLICANTS: **APPLICANTS:
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`Liu Jie; Pejaver Satish; Owoo George; Liu Jie; Pejaver Satish; Owoo George;
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`1111 1111
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`6528540 6528540
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`EXAMINER EXAMINER
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`**CONTINUING DATA VERIFIED: **CONTINUING DATA VERIFIED:
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`THIS APPLICATION IS A CIP OF 09/759,547 01/12/2001 PAT 6,310,094 THIS APPLICATION IS A CIP OF 09/759,547 01/12/2001 PAT 6,310,094
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`*" (cid:9)*" (cid:9)
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`APPLICATIONS VERIFIED: APPLICATIONS VERIFIED:
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`.1.111101710111111110111911141111•21111111M, .1.111101710111111110111911141111•21111111M,
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`PG-PUF31.00 NOT PUBLISH PG-PUF31.00 NOT PUBLISH
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`priojty claimed priojty claimed
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`35 U (cid:9)35 U (cid:9)
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`RESCIND RESCIND
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`TTORNEY DOCKET NO TTORNEY DOCKET NO
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`214204 214204
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`1 S conditions met 1 S conditions met
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`ani.! Acknowledged Examiners's inti (cid:9)ani.! Acknowledged Examiners's inti (cid:9)
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`TiT: E : Esmoiol formu!ation TiT: E : Esmoiol formu!ation
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`U.S.DEPT. OF com M./PAT & TM-PTO-436L(Rev. 12-94 U.S.DEPT. OF com M./PAT & TM-PTO-436L(Rev. 12-94
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`NOTICE OF ALLOWANCE MAILED ,7" NOTICE OF ALLOWANCE MAILED ,7"
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`CLAIMS ALLOWED CLAIMS ALLOWED
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`ISSUE FEE ISSUE FEE
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`nary Examiner nary Examiner
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`Total Claims Total Claims
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`Print Claim for Print Claim for
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`PREPARED FORISSUE PREPARED FORISSUE
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`WARNING: The information disclosed herein may be restricted. WARNING: The information disclosed herein may be restricted.
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`Unauthorized disclosure may be prohibited by the United States Code (cid:9)Unauthorized disclosure may be prohibited by the United States Code (cid:9)
`itle 35, itle 35,
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`Sections 122, 181 and 368, Possession outside the U.S. Patent & Trademark Sections 122, 181 and 368, Possession outside the U.S. Patent & Trademark
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`Office is restricted to authorized employees and contractors only. (cid:9)Office is restricted to authorized employees and contractors only. (cid:9)
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`FILED WITH: FILED WITH:
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`0 DISK (CRF) (cid:9) q CD-ROM 0 DISK (CRF) (cid:9) q CD-ROM
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`(Attached in pocket on right inside flap) (Attached in pocket on right inside flap)
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`MYLAN ET AL. - EXHIBIT 1004
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`0001
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`10016260 10016260
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`1c51604/01.616.0"O 1c51604/01.616.0"O
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`CONTENTS CONTENTS
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`Date Date
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`Received Received
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`(Ina C..;.of M.) (Ina C..;.of M.)
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`Application (cid:9)Application (cid:9)
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`INITIALS (cid:9)INITIALS (cid:9)
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`or or
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`0002
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`ISSUE SLIP STAPLE AREA (tor additional cross-r frn s . ISSUE SLIP STAPLE AREA (tor additional cross-r frn s .
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`ISSUING CLASSIFICATION , ISSUING CLASSIFICATION ,
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`CROSS REFERENCE(S) CROSS REFERENCE(S)
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`SUBCLASS (ONE SUBCLASS PER BLOCK) SUBCLASS (ONE SUBCLASS PER BLOCK)
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`INTERNATIONAL INTERNATIONAL
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`Non-elected A (cid:9)Non-elected A (cid:9)
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` Interference 0 (cid:9) Interference 0 (cid:9)
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`Claim Claim
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`To c To c
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`'op *c 'op *c
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`0 0
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`Lt OLt O
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`101 - 101 -
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`51 51
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`102 102
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`52 52
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`53 53
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`103 103
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`54 54
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`104 104
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`55 55
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`105 105
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`106 106
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`56 56
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`107 107
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`57 57
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`58 58
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`59 59
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`109 109
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`60 60
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`111 111
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`61 61
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`112 112
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`62 62
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`113 113
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`63 63
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`114 114
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`64 64
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`68 68
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`122 122
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`72 72
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`126 126
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`127 127
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`77 77
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`128 128
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`78 78
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`129 129
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`130 130
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`80 80
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`131 131
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`81 81
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`132 132
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`134 134
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`135 135
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`85 85
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`136 136
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`89 89
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`94 94
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`If more than 150 claims or 9 actions staple additionalsheet here If more than 150 claims or 9 actions staple additionalsheet here
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`A Continued on Issue Slip Inside File Jacket A Continued on Issue Slip Inside File Jacket
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`INDEX OF CLAIMS INDEX OF CLAIMS
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`Rejected - (Through numeral) Canceled Rejected - (Through numeral) Canceled
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`Allowed + (cid:9)Allowed + (cid:9)
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`Restricted Restricted
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`Date Date
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`Claim Claim
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`1 1 it it
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`SEARCH SEARCH
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`Class S b. Date Exmr. Class S b. Date Exmr.
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`SEARCH SEARCH
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`NOTES NOTES
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`(List databases (List databases
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`searched. searched.
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`inside.) inside.)
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`INTERFERENCE SEARCHED INTERFERENCE SEARCHED
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`PATENT APPLICATION SERIAL NO. PATENT APPLICATION SERIAL NO.
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`U.S. DEPARTMENT OF COMMERCE U.S. DEPARTMENT OF COMMERCE
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`PATENT AND TRADEMARK OFFICE PATENT AND TRADEMARK OFFICE
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`FEE RECORD SHEET FEE RECORD SHEET
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`12/19/2001 66EBREGI 00000053 10016260 12/19/2001 66EBREGI 00000053 10016260
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`740.00 OP 740.00 OP
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`01 FC:101 (cid:9)01 FC:101 (cid:9)
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`PTO-1556 PTO-1556
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`(5/87) (5/87)
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`.u.s. GPO: 2000-468-987/39595 .u.s. GPO: 2000-468-987/39595
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`0005
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`Page 1 of 1 Page 1 of 1
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`COMMISSIONER FOR PATENTS COMMISSIONER FOR PATENTS
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`UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES PATENT AND TRADEMARK OFFICE
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`WASHINGTON, D.C. 20231 WASHINGTON, D.C. 20231
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`www.uspto.gov www.uspto.gov
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`
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`CONFIRMATION NO. 7897 CONFIRMATION NO. 7897
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`CLASS CLASS
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`514 514
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`GROUP ART UNIT GROUP ART UNIT
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`1614 1614
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`ATTORNEY ATTORNEY
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`DOCKET NO. DOCKET NO.
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`214204 214204
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`UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES PATENT AND TRADEMARK OFFICE
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`IP,\44 Alfjeol IP,\44 Alfjeol
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`'3 (cid:9)'3 (cid:9)
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`Bib Data Sheet Bib Data Sheet
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`SERIAL NUMBER SERIAL NUMBER
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`10/016,260 10/016,260
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`FILING DATE FILING DATE
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`10/30/2001 10/30/2001
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`RULE RULE
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`APPLICANTS APPLICANTS
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`Jie Liu, Scotch Plains, NJ; • Jie Liu, Scotch Plains, NJ; •
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`Satis'o K. Pejaver, Bridgewater, NJ; Satis'o K. Pejaver, Bridgewater, NJ;
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`George Owoo, North Plainfield, NJ; George Owoo, North Plainfield, NJ;
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`** CONTIN'JI NG DATA ************************* ** CONTIN'JI NG DATA *************************
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`THIS APPLICATION IS A CIP OF 09/759,547 01/12/2001 PAT 6,310,094 THIS APPLICATION IS A CIP OF 09/759,547 01/12/2001 PAT 6,310,094
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`V V
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`** FOREIGN APPLICATIONS ************ FOREIGN APPLICATIONS **********
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`Ou9 Ou9
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`K K
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`IF REQUIRED, FOREIGN FILING LICENSE GRANTED IF REQUIRED, FOREIGN FILING LICENSE GRANTED
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`** 03/11/2002 ** 03/11/2002
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`********** **********
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`Foreign Priority claimed (cid:9)Foreign Priority claimed (cid:9)
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`Zji yes Zji yes
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`35 USC 119 (a-d) conditions (cid:9)35 USC 119 (a-d) conditions (cid:9)
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`Zji yes (cid:9)Zji yes (cid:9)
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`met met
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`___...,117/nc (cid:9)___...,117/nc (cid:9)
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`Verified and (cid:9)Verified and (cid:9)
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`Acknowledged (cid:9)Acknowledged (cid:9)
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`ADDRESS (cid:9)ADDRESS (cid:9)
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`23460 23460
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`Examiner's Signature (cid:9)Examiner's Signature (cid:9)
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`ie ie
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`,,, ,,,
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`Met afterMet after
`
`
`
`/ /
`
`
`STATE OR STATE OR
`
`COUNTRY COUNTRY
`
`
`
`j \ 1 4 , . j \ 1 4 , .
`
`
`SHEETS SHEETS
`
`DRAWING DRAWING
`
`
`TOTAL TOTAL
`
`CLAIMS CLAIMS
`
`16 16
`
`
`INDEPENDENT INDEPENDENT
`
`CLAIMS CLAIMS
`
`3 3
`
`
`
`Initials Initials
`
`
`
`TITLE TITLE
`
`
`
`Esmolol formulation Esmolol formulation
`
`
`FILING FEE FILING FEE
`
`RECEIVED RECEIVED
`
`870 870
`
`
`FEES: Authority has been given in Paper FEES: Authority has been given in Paper
`
`to charge/credit DEPOSIT ACCOUNT to charge/credit DEPOSIT ACCOUNT
`
`No. (cid:9)No. (cid:9)
`
`No. (cid:9)No. (cid:9)
`
`for following: for following:
`
`
`lj All Fees lj All Fees
`
`0 1.16 Fee's ( Filing ) 0 1.16 Fee's ( Filing )
`
`0 1.17 Fees ( Processing Ext. of 0 1.17 Fees ( Processing Ext. of
`
`time ) time )
`
`0 1.18. Fees ( I,c;ue ) 0 1.18. Fees ( I,c;ue )
`
`0 Other 0 Other
`
`0 Credit 0 Credit
`
`0006
`
`

`
`
`fY fY
`
`UT UT
`
`PATENT APPLICATION PATENT APPLICATION
`
`TRANSMITTAL TRANSMITTAL
`
`
`
`Attorney Docket No. Attorney Docket No.
`
`
`
`214204 214204
`
`
`First Inventor I Jie LIU First Inventor I Jie LIU
`
`Title ESMOLOL FORMULATION Title ESMOLOL FORMULATION
`
`
`
`new nonprovisional applications under 37 CFR 1.53(b)) new nonprovisional applications under 37 CFR 1.53(b))
`
`
`
`ADDRESS TO: ADDRESS TO:
`
`
`Express Mail Label No. EL 643543875 US Express Mail Label No. EL 643543875 US
`
`Commissioner for Patents Commissioner for Patents
`
`Box Patent Application Box Patent Application
`
`Washington, DC 20231 Washington, DC 20231
`
`ACCOMPANYING APPLICATION PARTS ACCOMPANYING APPLICATION PARTS
`
`10. q A• pplicant requests early publication. 10. q A• pplicant requests early publication.
`
`(include publication fee under 37 CFR 1.18(d)) (include publication fee under 37 CFR 1.18(d))
`
`11. q A• ssignment Papers 11. q A• ssignment Papers
`
`(cover sheet and document(s)) (cover sheet and document(s))
`
`12. q 3• 7 CFR 3.73(b) Statement (when there is 12. q 3• 7 CFR 3.73(b) Statement (when there is
`
`an Assignee) an Assignee)
`
`13. q P• ower of Attorney 13. q P• ower of Attorney
`
`14. q E• nglish Translation Document (if 14. q E• nglish Translation Document (if
`
`applicable) applicable)
`
`15. q Information DiscloSure Statement (IDS) 15. q Information DiscloSure Statement (IDS)
`
`q F• orm PTO-1449 q F• orm PTO-1449
`
`q C• opies of Listed Documents q C• opies of Listed Documents
`
`16. q P• reliminary Amendment 16. q P• reliminary Amendment
`
`N Return Receipt Postcard N Return Receipt Postcard
`
`17. 17.
`
`(Should be specifically itemized) (Should be specifically itemized)
`
`18. q C• laim of Priority & Certified Copy of 18. q C• laim of Priority & Certified Copy of
`
`Priority Document(s) Priority Document(s)
`
`19. q R• equest & Certification Under 35 USC 19. q R• equest & Certification Under 35 USC
`
`122(b)(2)(B)(i) (Form PTO/SB/35 or its 122(b)(2)(B)(i) (Form PTO/SB/35 or its
`
`equivalent must be submitted with this application equivalent must be submitted with this application
`
`to prevent publication at 18 months) to prevent publication at 18 months)
`
`20. q O• ther: 20. q O• ther:
`
`
`
`APPLICATION ELEMENTS APPLICATION ELEMENTS
`
`
`Utility Patent Application Transmittal Form Utility Patent Application Transmittal Form
`
`q Applicant claims small entity status. See q Applicant claims small entity status. See
`
`37 CFR 1.27. 37 CFR 1.27.
`
`Specification (including claims and Specification (including claims and
`
`abstract) (cid:9)abstract) (cid:9)
`
`[Total Pages 11] [Total Pages 11]
`
`q D• rawings (cid:9)q D• rawings (cid:9)
`
`[Total Sheets [Total Sheets
`
`q C• ombined Declaration and q C• ombined Declaration and
`
`Power of Attorney [Total Pages Power of Attorney [Total Pages
`
`a. q N• ewly executed a. q N• ewly executed
`
`b. q Copy from prior application b. q Copy from prior application
`
`[Note Box 6 below] [Note Box 6 below]
`
`i. (cid:9) q D• eletion of Inventor(s) Signed i. (cid:9) q D• eletion of Inventor(s) Signed
`
`statement attached deleting inventor(s) statement attached deleting inventor(s)
`
`named in the prior application named in the prior application
`
`Incorporation by Reference: The entire Incorporation by Reference: The entire
`
`disclosure of the prior application is disclosure of the prior application is
`
`considered as part of the disclosure of the considered as part of the disclosure of the
`
`accompanying application and is hereby accompanying application and is hereby
`
`incorporated by reference. incorporated by reference.
`
`Application Data Sheet. See 37 CFR Application Data Sheet. See 37 CFR
`
`1.76 1.76
`
`q C• D-ROM or CD-R in duplicate, large q C• D-ROM or CD-R in duplicate, large
`
`table or Computer Program (Appendix) table or Computer Program (Appendix)
`
`Nucleotide and/or Amino Acid Sequence Nucleotide and/or Amino Acid Sequence
`
`Submission Submission
`
`q C• omputer Readable Form (CRF) q C• omputer Readable Form (CRF)
`
`a. a.
`
`b. (cid:9) Specification Sequence Listing on: b. (cid:9) Specification Sequence Listing on:
`
`q C• D-ROM or CD-R (2 copies); or q C• D-ROM or CD-R (2 copies); or
`
`i. i.
`
`ii. q P• aper Copy ii. q P• aper Copy
`
`c. (cid:9) q S• tatement verifying identity of above c. (cid:9) q S• tatement verifying identity of above
`
`copies copies
`
`
`
`FR, FR,
`
`
`
`21. (cid:9)21. (cid:9)
`
`
`If a CONTINUING APPLICATION, check appropriate box and supply the requisite information If a CONTINUING APPLICATION, check appropriate box and supply the requisite information
`
`below: below:
`
`Continuation-in-part of prior application no. 09/759,547. Continuation-in-part of prior application no. 09/759,547.
`
`q Continuation q Divisional (cid:9)q Continuation q Divisional (cid:9)
`
`Prior application information: Examiner Ray Henley; Group Art Unit: 1614 Prior application information: Examiner Ray Henley; Group Art Unit: 1614
`
`
`
`APPLICATION FEES APPLICATION FEES
`
`
`
`$740.00 $740.00
`
`
`BASIC FEE BASIC FEE
`
`NUMBER FILED NUMBER FILED
`
`CLAIMS CLAIMS
`
`-20= -20=
`
`16 (cid:9)16 (cid:9)
`
`Total Claims Total Claims
`
`- 3= - 3=
`
`3 (cid:9)3 (cid:9)
`
`Independent Claims Independent Claims
`
`q Multiple Dependent Claim if applicable (cid:9)q Multiple Dependent Claim if applicable (cid:9)
`
`
`q Assignment fee if applicable q Assignment fee if applicable
`
`q Early publication fee if applicable q Early publication fee if applicable
`
`
`
`NUMBER EXTRA NUMBER EXTRA
`
`
`0 0
`
`0 0
`
`
`RATE RATE
`
`x $18.00 $0.00 x $18.00 $0.00
`
`x $84.00 $0.00 x $84.00 $0.00
`
`+$280.00 $0.00 +$280.00 $0.00
`
`Total of above calculations = $740.00 Total of above calculations = $740.00
`
`) )
`
`Reduction by 50% for filing b (cid:9) small entity = $( (cid:9)Reduction by 50% for filing b (cid:9) small entity = $( (cid:9)
`
`+ $40.00 $ + $40.00 $
`
`+ $300.00 $ + $300.00 $
`
`TOTAL = $740.00 TOTAL = $740.00
`
`
`
`[Page 1 of 2] [Page 1 of 2]
`
`0007
`
`

`
`
`Attorney Docket No. 214204 Attorney Docket No. 214204
`
`UTILITY PATENT APPLICATION TRANSMITTAL UTILITY PATENT APPLICATION TRANSMITTAL
`
`. .
`
`charge my Deposit Account No. 12-1216 in the amount of $ (cid:9)charge my Deposit Account No. 12-1216 in the amount of $ (cid:9)
`
`Please Please
`
`q q
`
`22. 22.
`
`
`
`23. 23.
`
`
`
`24. 24.
`
`
`
`25. 25.
`
`
`
`A A
`
`
`
`check in the amount of $1,300.00 is enclosed. check in the amount of $1,300.00 is enclosed.
`
`
`is hereby authorized to credit overpayments or charge any additional fees of is hereby authorized to credit overpayments or charge any additional fees of
`
`Commissioner Commissioner
`
`The The
`
`types to Deposit Account No. 12-1216: types to Deposit Account No. 12-1216:
`
`
`
`the following the following
`
`a. a.
`
`Fees required under 37 CFR 1.16. Fees required under 37 CFR 1.16.
`
`► 1 ► 1
`
`b. b.
`
`► 1 ► 1
`
`Fees required under 37 CFR 1.17. Fees required under 37 CFR 1.17.
`
`
`Commissioner is hereby generally authorized under 37 CFR 1.136(a)(3) to treat any Commissioner is hereby generally authorized under 37 CFR 1.136(a)(3) to treat any
`
`The The
`
`reply in this or any related application filed pursuant to 37 CFR 1.53 requiring an reply in this or any related application filed pursuant to 37 CFR 1.53 requiring an
`
`future future
`
`of time as incorporating a request therefor, and the Commissioner is hereby of time as incorporating a request therefor, and the Commissioner is hereby
`
`extension extension
`
`authorized to charge Deposit Account No. 12-1216 for any fee that may be due authorized to charge Deposit Account No. 12-1216 for any fee that may be due
`
`specifically specifically
`
`connection with such a request for an extension of time. connection with such a request for an extension of time.
`
`in in
`
`
`
`
`
`
`
`► 1 Customer ► 1 Customer Number. Number.
`
`
`
`23460 23460
`
`
`26. CORRESPONDENCE ADDRESS 26. CORRESPONDENCE ADDRESS
`
`, Reg. No. , Reg. No.
`
`q q
`
`Leydig, Voit & M Leydig, Voit & M
`
`Ltd. (cid:9)Ltd. (cid:9)
`
`TwoPrudential Plaza, SuiteTwoPrudential Plaza, Suite
`
`180 North Stetson 180 North Stetson
`
`Chicago, Illinois 60601-6780 Chicago, Illinois 60601-6780
`
`(312) 616-5600 (telephone) (312) 616-5600 (telephone)
`
`(312) 616-5700 (facsimile) (312) 616-5700 (facsimile)
`
`
`
`
`
`III III III III
`II II
`
`
`
`I II I II II II II II
`
`23460 23460
`
`
`
`4900 4900
`
`
`
`PATENT PATENT
`
`
`
`TRADEMARK TRADEMARK
`
`
`
`OFFICE OFFICE
`
`
`
`Name Name
`
`
`
`Steven H. Sklar, Registration No. 42,154 Steven H. Sklar, Registration No. 42,154
`
`
`
`Signature Signature
`
`
`
`'rl/L2Y—(3 'rl/L2Y—(3
`
`
`
`Date Date
`
`
`
`October 30, 2001 October 30, 2001
`
`
`
`1T4 1T4
`
`
`
`Certificate of Mailing Under 37 CFR 1.10 Certificate of Mailing Under 37 CFR 1.10
`
`
`I hereby certify that this Utility Patent Application Transmittal and all accompanying documents are I hereby certify that this Utility Patent Application Transmittal and all accompanying documents are
`
`being deposited with the United States Postal Service "Express Mail Post Office To Addressee" being deposited with the United States Postal Service "Express Mail Post Office To Addressee"
`
`Service under 37 CFR 1.10 on the date indicated below and is addressed to: Commissioner for Service under 37 CFR 1.10 on the date indicated below and is addressed to: Commissioner for
`
`Patents, Box Patent Application, Washington, D.C. 20231. Patents, Box Patent Application, Washington, D.C. 20231.
`
`
`Vanessa Quail Vanessa Quail
`
`Name of Person Signing Name of Person Signing
`
`
`
`Utility Transmittal (Revised 10/18/01) Utility Transmittal (Revised 10/18/01)
`
`
`
`Signatu -e Signatu -e
`
`
`October 30, 2001 October 30, 2001
`
`Date Date
`
`
`
`[Page 2 of 2] [Page 2 of 2]
`
`0008
`
`

`
`
`Application Data Sheet Application Data Sheet
`
`APPLICATION INFORMATION APPLICATION INFORMATION
`
`
`Application Number:: Application Number::
`
`Filing Date:: (cid:9)Filing Date:: (cid:9)
`
`
`Application Type:: (cid:9)Application Type:: (cid:9)
`
`Subject Matter:: (cid:9)Subject Matter:: (cid:9)
`
`Suggested classification:: Suggested classification::
`
`
`
`Suggested Group Art Unit:: Suggested Group Art Unit::
`
`
`
`CD-ROM or CD-R?:: (cid:9)CD-ROM or CD-R?:: (cid:9)
`
`
`
`Number of CD Disks: Number of CD Disks:
`
`
`Number of Copies of CDs:: Number of Copies of CDs::
`
`Sequence Submission?:: Sequence Submission?::
`
`
`
`10/30/01 10/30/01
`
`
`
`Regular Regular
`
`
`
`Utility Utility
`
`
`
`None None
`
`
`
`Computer Readable From (CRF)?:: No Computer Readable From (CRF)?:: No
`
`
`Number of Copies of CRF:: Number of Copies of CRF::
`
`Title:: (cid:9)Title:: (cid:9)
`
`Attorney Docket Number:: (cid:9)Attorney Docket Number:: (cid:9)
`
`
`
`ESMOLOL FORMULATION ESMOLOL FORMULATION
`
`
`
`214204 214204
`
`
`
`Request for Early Publication?:: No Request for Early Publication?:: No
`
`
`
`Request for Non-Publication?:: No Request for Non-Publication?:: No
`
`
`
`Suggested Drawing Figure:: Suggested Drawing Figure::
`
`
`Total Drawing Sheets:: Total Drawing Sheets::
`
`Small Entity?:: (cid:9)Small Entity?:: (cid:9)
`
`Latin Name:: Latin Name::
`
`
`
`Variety denomination name:: Variety denomination name::
`
`
`Petition Included?:: (cid:9)Petition Included?:: (cid:9)
`
`Petition Type:: Petition Type::
`
`
`
`No No
`
`
`
`No No
`
`
`
`Licensed US Govt. Agency:: Licensed US Govt. Agency::
`
`
`Contract or Grant Numbers:: Contract or Grant Numbers::
`
`Secrecy Order in Parent Appl.?:: No Secrecy Order in Parent Appl.?:: No
`
`
`
`Page 1 (cid:9)Page 1 (cid:9)
`
`
`
`10/30/01 10/30/01
`
`0009
`
`

`
`
`
`APPLICANT INFORMATION APPLICANT INFORMATION
`
`
`
`Applicant Authority Type:: (cid:9)Applicant Authority Type:: (cid:9)
`
`
`
`Primary Citizenship Country:: (cid:9)Primary Citizenship Country:: (cid:9)
`
`
`
`Status:: (cid:9)Status:: (cid:9)
`
`
`
`Given Name:: (cid:9)Given Name:: (cid:9)
`
`
`
`Middle Name:: Middle Name::
`
`
`
`Family Name:: (cid:9)Family Name:: (cid:9)
`
`
`
`Name Suffix:: Name Suffix::
`
`
`
`City of Residence:: (cid:9)City of Residence:: (cid:9)
`
`
`
`State or Prov. of Residence:: (cid:9)State or Prov. of Residence:: (cid:9)
`
`
`
`Country of Residence:: (cid:9)Country of Residence:: (cid:9)
`
`
`
`Street of mailing address:: (cid:9)Street of mailing address:: (cid:9)
`
`
`
`City of mailing address:: (cid:9)City of mailing address:: (cid:9)
`
`
`
`Inventor Inventor
`
`
`
`China China
`
`
`
`Full Capacity Full Capacity
`
`
`
`Jie Jie
`
`
`
`LIU LIU
`
`
`
`Scotch Plains Scotch Plains
`
`
`
`New Jersey New Jersey
`
`
`
`US US
`
`
`
`95 Tusssel Lane 95 Tusssel Lane
`
`
`
`Scotch Plains Scotch Plains
`
`
`
`State or Province of mailing address:: New Jersey State or Province of mailing address:: New Jersey
`
`
`
`Country of mailing address:: (cid:9)Country of mailing address:: (cid:9)
`
`
`
`US US
`
`
`
`Postal or Zip Code of mailing address:: 07076 Postal or Zip Code of mailing address:: 07076
`
`
`
`ru (cid:9)ru (cid:9)
`
`
`
`Inventor Authority Type:: (cid:9)Inventor Authority Type:: (cid:9)
`
`
`
`Primary Citizenship Country:: (cid:9)Primary Citizenship Country:: (cid:9)
`
`
`
`Status:: (cid:9)Status:: (cid:9)
`
`
`
`Given Name:: (cid:9)Given Name:: (cid:9)
`
`
`
`Middle Name:: Middle Name::
`
`
`
`Family Name:: (cid:9)Family Name:: (cid:9)
`
`
`
`Name Suffix:: Name Suffix::
`
`
`
`City of Residence:: (cid:9)City of Residence:: (cid:9)
`
`
`
`State or Prov. of Residence:: (cid:9)State or Prov. of Residence:: (cid:9)
`
`
`
`Country of Residence:: (cid:9)Country of Residence:: (cid:9)
`
`
`
`Street of mailing address:: (cid:9)Street of mailing address:: (cid:9)
`
`
`
`City of mailing address:: (cid:9)City of mailing address:: (cid:9)
`
`
`
`Inventor Inventor
`
`
`
`US US
`
`
`
`Full Capacity Full Capacity
`
`
`
`Satish Satish
`
`
`
`PEJAVER PEJAVER
`
`
`
`Bridgewater Bridgewater
`
`
`
`New Jersey New Jersey
`
`
`
`US US
`
`
`
`49 Huntley Way 49 Huntley Way
`
`
`
`Bridgewater Bridgewater
`
`
`
`State or Province of mailing address:: New Jersey State or Province of mailing address:: New Jersey
`
`
`
`Country of mailing address:: (cid:9)Country of mailing address:: (cid:9)
`
`
`
`US US
`
`
`
`Postal or Zip Code of mailing address:: 08807 Postal or Zip Code of mailing address:: 08807
`
`
`
`Page 2 (cid:9)Page 2 (cid:9)
`
`
`
`10/30/01 10/30/01
`
`0010
`
`

`
`
`
`Applicant Authority Type:: Applicant Authority Type::
`
`
`
`Primary Citizenship Country:: Primary Citizenship Country::
`
`
`
`Status:: Status::
`
`
`
`Given Name:: Given Name::
`
`
`
`Middle Name:: Middle Name::
`
`
`
`Family Name:: Family Name::
`
`
`
`Name Suffix:: Name Suffix::
`
`
`
`Inventor Inventor
`
`
`
`US US
`
`
`
`Full Capacity Full Capacity
`
`
`
`George George
`
`
`
`0 W 0 0 0 W 0 0
`
`
`
`City of Residence:: City of Residence::
`
`
`
`State or Prov. of Residence:: State or Prov. of Residence::
`
`
`
`North Plainfield North Plainfield
`
`
`
`New Jersey New Jersey
`
`
`
`Country of Residence:: Country of Residence::
`
`
`
`US US
`
`
`
`Street of mailing address:: Street of mailing address::
`
`
`
`208 Harding Avenue 208 Harding Avenue
`
`
`
`City of mailing address:: City of mailing address::
`
`
`
`North Plainfield North Plainfield
`
`
`
`State or Province of mailing address:: State or Province of mailing address::
`
`
`
`New Jersey New Jersey
`
`
`
`Country of mailing address:: Country of mailing address::
`
`
`
`US US
`
`
`
`Postal or Zip Code of mailing address:: Postal or Zip Code of mailing address::
`
`
`
`07063 07063
`
`
`
`CORRESPONDENCE INFORMATION CORRESPONDENCE INFORMATION
`
`
`
`Correspondence Customer Number:: Correspondence Customer Number::
`
`
`
`23460 23460
`
`
`
`• •
`
`
`
`Phone:: Phone::
`
`
`
`Fax:: Fax::
`
`
`
`E-mail Address:: E-mail Address::
`
`
`
`(312) 616-5600 (312) 616-5600
`
`
`
`(312) 616-5700 (312) 616-5700
`
`
`
`mail@leydig.com mail@leydig.com
`
`
`
`REPRESENTATIVE INFORMATION REPRESENTATIVE INFORMATION
`
`
`
`Representative Customer Number:: 23460 Representative Customer Number:: 23460
`
`
`
`Representative Designation:: Representative Designation::
`
`
`
`Registration Number:: (cid:9)Registration Number:: (cid:9)
`
`
`
`Representative Name:: Representative Name::
`
`
`
`Page 3 Page 3
`
`
`
`10/30/01 10/30/01
`
`0011
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`
`
`
`DOMESTIC PRIORITY INFORMATION DOMESTIC PRIORITY INFORMATION
`
`
`Application:: (cid:9)Application:: (cid:9)
`
`This application is a (cid:9)This application is a (cid:9)
`
`
`Continuity Type:: (cid:9)Continuity Type:: (cid:9)
`
`Continuation in part of (cid:9)Continuation in part of (cid:9)
`
`
`Parent Application:: (cid:9)Parent Application:: (cid:9)
`
`09/759,547 (cid:9)09/759,547 (cid:9)
`
`
`Parent Filing Date:: Parent Filing Date::
`
`01/12/01A 01/12/01A
`
`
`
`FOREIGN APPLICATION INFORMATION FOREIGN APPLICATION INFORMATION
`
`
`
`Country:: Country::
`
`
`
`Application Number:: Filing Date:: (cid:9)Application Number:: Filing Date:: (cid:9)
`
`
`
`Priority Claimed Priority Claimed
`
`
`
`ASSIGNEE INFORMATION ASSIGNEE INFORMATION
`
`
`Baxter International Inc. Baxter International Inc.
`
`Assignee name:: (cid:9)Assignee name:: (cid:9)
`
`Street of mailing address:: One Baxter Parkway Street of mailing address:: One Baxter Parkway
`
`DF3-23 DF3-23
`
`Deerfield Deerfield
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`10/30/01 10/30/01
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`LVM 214204 LVM 214204
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`1 1
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`ESMOLOL FORMULATION ESMOLOL FORMULATION
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`CROSS-REFERENCE TO RELATED PATENT APPLICATIONS CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
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`This patent application is a continuation-in-part ofoopeneling-U.S. Patent This patent application is a continuation-in-part ofoopeneling-U.S. Patent
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`Application No. 09/759,547, filed January 12, 2001, issued as U.S. Patent 6,310,094. Application No. 09/759,547, filed January 12, 2001, issued as U.S. Patent 6,310,094.
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`BACKGROUND OF THE INVENTION BACKGROUND OF THE INVENTION
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`Esmolol hydrochloride is a short-acting beta-blocker used for treatment or Esmolol hydrochloride is a short-acting beta-blocker used for treatment or
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`prophylaxis of cardiac disorders in mammals. Most of the currently available beta-blockers prophylaxis of cardiac disorders in mammals. Most of the currently available beta-blockers
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`are stable drugs which can be administered to cardiac patients over relatively long periods are stable drugs which can be administered to cardiac patients over relatively long periods
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`of time. However, it is often desirable in the critical care setting to quickly reduce heart of time. However, it is often desirable in the critical care setting to quickly reduce heart
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`work or improve rhythmicity during a cardiac crisis, e.g., during or shortly after a work or improve rhythmicity during a cardiac crisis, e.g., during or shortly after a
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`myocardial infarction. Conventional beta-blocking agents can be employed for such myocardial infarction. Conventional beta-blocking agents can be employed for such
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`treatment, but their long durations of action can cause undesirable side effects. treatment, but their long durations of action can cause undesirable side effects.
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`Esmolol hydrochloride contains an ester functional group and possesses the typical Esmolol hydrochloride contains an ester functional group and possesses the typical
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`beta-adrenergic blocking activity. However, it differs from conventional beta-blocking beta-adrenergic blocking activity. However, it differs from conventional beta-blocking
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`compound in that esmolol hydrochloride has a short duration in vivo due to the presence of compound in that esmolol hydrochloride has a short duration in vivo due to the presence of
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`the ester group. Thus, esmolol hydrochloride is advantageous compared to the conventional the ester group. Thus, esmolol hydrochloride is advantageous compared to the conventional
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`beta-blockers because of its unique short-acting activity. However, the ester group in beta-blockers because of its unique short-acting activity. However, the ester group in
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`esmolol hydrochloride is found to be unstable in an aqueous environment because of it esmolol hydrochloride is found to be unstable in an aqueous environment because of it
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`extreme susceptibility to hydrolytic degradation. extreme susceptibility to hydrolytic degradation.
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`The stability of esmolol in water is mediated by the rate of acid/base hydrolysis of The stability of esmolol in water is mediated by the rate of acid/base hydrolysis of
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`the labile aliphatic methyl ester group. In the past, the rate of degradation of esmolol the labile aliphatic methyl ester group. In the past, the rate of degradation of esmolol
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`hydrochloride has been reduced by the use of acetate as a buffer, maintaining the pH as hydrochlori