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`U.S. UTILITY Patent Applil.:aiion
`PATENT DATE
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`NOV 13 2001
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`EXAM IN&~_
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`Sheets Drwg.
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`WARNING:
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`POBB6sslon out11Jde the U.S. Patent & Trademark Office Is reetrlcted to authorized employees and contractor~ only.
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`Form PT0·438A
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`CONTENTS
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`(LEFT OUTSIDE)
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`CFAD VI 1002-0002
`
`
`
`PATENT APPLICATION SERIAL NO . - - - - - - - - -
`
`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`FEE RECORD SHEET
`
`10/2&/2000 JBALIHAH 00000014 09&94217
`01 FC:101
`710.00 OP
`02 FC:103
`21G.OO OP
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`PT0-1556
`(5/87)
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`·u.s. GPO: 1~4eo-oe211SH4
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`J
`
`______________ ...........
`
`CFAD VI 1002-0003
`
`
`
`Page 1 of 1
`
`COMMIS!l\ON~R !"OR PATEN""P.J
`UN!T~D STATES PAT~NT AND TAADI::.MARK OFF\0~
`Yio.8HING'ItCN, Q_C, ;2023\
`www.uspto.gov
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`
`SERIAL NUMBER
`09/694,217
`
`FILING DATE
`10/23/2000
`RULE
`-
`
`CLASS
`600
`
`GROUP ART UNIT
`3"136
`
`ATTORNEY
`DOCKET NO.
`CELG-0188
`
`p.PPLICANTS
`Bruce A. Williams, Flemington, NJ ;
`Joseph K. Kaminski, Hampton, NJ ;
`
`~"CONTINUING DATA"'***"'****"'"***"'"'"'**""""''""*
`Yc 11 P n..:=
`Vlt OREIGN APPLICATIONS *U***"""'***"""**""""'"'
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`Forolgn Priority claimed Q yos (Sa no
`>5 USC 119 (a·d) conditions ~ yos IBJ no D Met altar
`Vorlflod end ~~ -
`ltfv
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`Acknowledged
`~DDRESS
`
`....
`
`"Signature
`
`Initials
`
`.-
`
`met
`
`Wohn W. Caldwell
`~OODCOCK WASHBURN KURTZ
`MACKIEWICZ & NORRIS LLP
`One Liberty Place-46th Floor
`Philadelphia , PA 19103
`
`-
`
`B4~LL btrrr~
`
`STATE OR
`COUNTRY
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`
`SHEETS
`DRAWING
`-
`
`TOTAL
`CLAIMS
`32
`
`-
`
`INDEPENDENT
`CLAIMS
`1
`
`-
`
`TITLE
`Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or
`!Suspected of being caused ~the drl!_g_
`
`FILING FEE FEES: Authority has been given in Paper
`RECEIVED No.
`to charge/credit DEPOSIT ACCOUNT
`No.
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`926
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`jQ All Fees
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` -:!: -0 DOCKET NO. : CELG-0188
`I~ C
`
`IN THE UNITE:O STATES PATENT AND TRADEMARK OFFICE
`
`In Re Application of:
`Bruce A. Williams and Joseph K. Kaminski
`
`Serial No.: Not assigned
`
`Group Art Unit: Not assigned
`
`Filing Date: October 23, 2000
`
`Examiner: Not assigned
`
`For; METHODS FOR DELIVERING A DRUG TO A PATIENT WHILE AVOIDING
`THE OCCURRENCE OF AN ADVERSE SIDE EFFECT KNOWN OR
`SUSPECTED OF BEING CAUSED BY THE DRUG
`
`EXPRESS MAIL LABEL NO: EV5680267~5US
`DATE OF DEPOSIT: October 23,2000
`
`Box
`
`181 Patent Application
`D Provisional 0 Design
`
`Assistant Commissioner for Patents
`Washington DC 20231
`
`Sir:
`
`PATENT APPLICATION TRANSMITTAL LETTER
`
`Transmitted herewith for filing, please find
`
`A Utility Patent Application under 37 C.F.R. 1.53(b).
`
`It is a continuing application, as follows:
`
`D continuation 0 divisional 0 continuation-in-part of prior application number
`_! ___ _
`
`D
`D
`
`A Provisional Patent Application under 37 C.F.R. 1.53(c).
`
`A Design Patent Application (submitted in duplicate).
`
`Including the following:
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`Provisional App licarion Cover Sheet.
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`New or Revised Specification, including pages j_ to __lL containing:
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`181
`0
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`Specification
`
`Claims
`
`Abstract
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`Substitute Specification, including Claims and Abstract.
`
`D
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`The present application is a continuation application of Application
`No.
`filed
`. The present application includes the
`Specification of the parent application which has been revised in
`accordance with the amendments filed in the parent application. Since
`none of those amendments incorporate new matter into the parent
`application, the present revised Specification also does not include new
`matter.
`
`The present application is a continuation application of Application
`, which in turn is a continuation-in-part of
`No.
`filed
`Application No.
`filed
`. The present application
`includes the Specification of the parent application which has been
`revised in accordance with the amendments filed in the parent
`application. Although the amendments in the parent C-1-P application
`may have incorporated new matter, since those are the only revisions
`included in the present application, the present application includes no
`new matter in relation to the parent application.
`
`A copy of earlier application Serial No.
`Filed------
`including Specification, Claims and Abstract {pages 1 - @@), to which no new
`matter has been added TOGETHER WITH a copy of the executed oath or declara~ion
`for such earlier application and all drawings and appendices. Such earlier application
`is hereby incorporated into the present application by reference.
`
`Please enter the following amendment to the Specification under the Cross-Reference
`to Related Applications section (or create such a section) : "This Application:
`D is a continuation of 0 is a divisional of 0 claims benefit ofU.S. provision~!
`Application Serial No.
`f i l ed - - - - - - - - - - - -
`
`CFAD VI 1002-0006
`
`
`
`DOCKET NO. : CELG-0188
`
`-3-
`
`PATENT
`
`D
`
`0
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`D
`
`D
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`0
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`Signed Statement attached deleting inventor(s) named in the prior application.
`
`A Preliminary Amendment.
`
`Sheets of 0 Formal D Informal Drawings.
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`Petition to Accept Photographic Drawings.
`
`0
`
`Petition Fee
`
`An 181 Executed 0 Unexecuted Declaration or Oath and Power of Attorney.
`
`An Associate Power of Attorney.
`
`AnD Executed 0 Copy of Executed Assignment ofthe Invention to __ __ _
`
`D A Recordation Farm Cover Sheet.
`0 Recordation Fee- $40.00.
`The prior application is assigned of record to - - - - - -
`
`Priority is claimed under 35 U.S.C. § 119 of Patent Application No. _____ _
`filed
`m
`(country).
`0
`A Certified Copy of each of the above applications for which priority is
`claimed:
`0 is enclosed.
`D has been filed in prior application Serial No. ___ filed _ _ _
`
`An 0 Executed or 0 Copy of Executed Earlier Statement Claiming Small Entity
`Status under 37 C.F.R. 1.9 and 1.27
`D is enclosed.
`D has been filed in prior application Serial No.
`said status is still proper and desired in present case.
`
`filed --~
`
`CFAD VI 1002-0007
`
`
`
`DOCKET NO. : CELG-0188
`
`-4-
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`Diskette Containing DNA/ Amino Acid Sequence Information.
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`Statement to Support Submission ofDNA/Amino Acid Sequence Information.
`
`The computer readable form in this application
`, is identical with that filed in
`Application Serial Number
`, filed
`In accordance with 37 CFR
`1.82l(e), please use the D first-filed, D last-filed or D only computer readable
`form filed in that application as the computer readable form for the instant
`application. It is understood that the Patent and Trademark Office will make the
`necessary change in application number and filing date for the computer readable
`form that will be used for the instant application. A paper copy of the Sequence
`Listing is D included in the originally-filed specification of the instant application,
`D included in a separately filed preliminary amendment for incorporation into the
`specification.
`
`Information Disclosure Statement.
`D
`D
`
`Attached Form 1449.
`
`Copies of each of the references listed on the attached Form PT0-1449 are
`enclosed herewith.
`
`A copy of Petition for Extension ofTime as filed in the prior case.
`
`Appended Material as follows: - - - - - - - - - - - - - - - - - -
`
`Return Receipt Postcard (should be specifically itemized).
`
`Other as follows: - - - - - - - - - - - - - - - - - - - - - -
`
`CFAD VI 1002-0008
`
`
`
`DOCKET NO. : CELG-0188
`
`- 5-
`
`PATENT
`
`FEE CALCULATION:
`
`D
`
`of the prior application before
`Cancel in this application original claims
`calculating the filing fee. (At least one original independent claim must be retained
`for filing purposes.)
`
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`SMALL ENTI1Y
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`RATE
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`RATE
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`FEE
`
`PROVISIONAL APPLICATION
`
`DESIGN APPLICATION
`
`UTTLI1Y APPLICATIONS BASE FEE
`
`UTILI1Y APPLICATION; ALL CLAIMS
`CALCULATED AFTER ENTRY OF ALL
`AMENDMENTS
`
`$75.00
`
`$160.00
`
`$355.00
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`No, Filed
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`No. Extra
`
`32-20-
`
`12
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`TOTAL
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`INDEP.
`CLAIMS
`
`FIRST PRESENT A TTON OF MULTIPLE
`DEPENDENT CLAIM
`
`$135
`
`ADDITIONAL FILING FEE
`
`TOTAL FILING FEE DUE
`
`$
`
`$
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`$
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`$
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`$
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`$
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`$
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`$926.00
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`A Check is enclosed in the amount of$ 926.00 .
`
`181
`
`The Commissioner is authorized to charge payment of the following fees and to
`refund any overpayment associated with this communication or during the pendency
`of this application to deposit account 23-3050. This sheet is provided in duplicate.
`
`0
`
`181
`
`D
`
`The foregoing amount due.
`
`Any additional filing fees required, including fees for the presentation of extra
`claims under 3 7 C.F .R. 1.16.
`
`Any additional patent application processing fees under 37 C.F.R. 1.17 or
`1.20(d).
`
`The issue fee set in 3 7 C.F .R. 1.18 at the mailing of the Notice of Allowance.
`
`18]
`
`The Commissioner is hereby requested to grant an extension oftime for the -
`appropriate length oftime, should one be necessary, in connection with this filing or
`any future filing submitted to the U.S. Patent and Trademark Office in the above-
`
`CFAD VI 1002-0009
`
`
`
`DOCKET NO. : CELG-0188
`
`-6-
`
`PATENT
`
`identified application during the pendency of this application. The Commissioner is
`further authorized to charge any fees related to any such extension of time to deposit
`account 23-3050. This sheet is provided in duplicate.
`
`SHOULD ANY DEFICIENCIES APPEAR with respect to this application, including
`deficiencies in payment of fees, missing parts of the application or otherwise, the United
`States Patent and Trademark Office is respectfully requested to promptly notify the
`
`undersigned.
`
`Date:
`
`Woodcock Washburn Kurtz
`Mackiewicz & Norris LLP
`One Liberty Place - 46th Floor
`Philadelphia PA 19103
`Telephone: (215) 568-3100
`Facsimile: (215) 568-3439
`
`(ll997WWKMN
`
`CFAD VI 1002-0010
`
`
`
`DOCKET NO. : CELG-0188
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In Re Application of:
`Bruce A. Williams and Joseph K. Kaminski
`
`Serial No.: Not assigned
`
`Group Art Unit: Not assigned
`
`Filing Date: October 23, 2000
`
`Examiner: Not assigned
`
`For: METHODS FOR DELIVERING A DRUG TO A PATIENT WHILE AVOIDING
`THE OCCURRENCE OF AN ADVERSE SIDE EFFECT KNOWN OR
`SUSPECTED OF BEING CAUSED BY THE DRUG
`
`EXPRESS MAIL LABEL NO: EL5680267~~US
`DATE OF DEPOSIT: October 23, 2000
`
`Box
`
`181 Patent Application
`D Provisional D Design
`
`Assistant Commissioner for Patents
`Washington DC 20231
`
`Sir:
`
`PATENT APPLICATION TRANSMITTAL LETTER
`
`Transmitted herewith for filing, please find
`
`A Utility Patent Application under 37 C.F.R. 1.53(b).
`
`It is a continuing application, as follows:
`
`D continuation D divisional D continuation-in-part of prior application number
`_ / ___ _
`
`D
`D
`
`A Provisional Patent Application under 37 C.F.R. 1.53(c).
`
`A Design Patent Application (submitted in duplicate).
`
`Including the following:
`
`CFAD VI 1002-0011
`
`
`
`DOCKET NO. : CELG-0188
`
`-2-
`
`PATENT
`
`D
`
`181
`
`D
`
`D
`
`Provisional Application Cover Sheet.
`
`New or Revised Specification, including pages _1_ to ...12_ containing:
`
`181
`181
`181
`D
`
`Specification
`
`Claims
`
`Abstract
`
`Substitute Specification, including Claims and Abstract.
`
`D
`
`D
`
`The present application is a continuation application of Application
`No.
`filed
`. The present application includes the
`Specification of the parent application which has been revised in
`accordance with the amendments filed in the parent application. Since
`none of those amendments incorporate new matter into the parent
`application, the present revised Specification also does not include new
`matter.
`
`The present application is a continuation application of Application
`No.
`filed
`, which in tum is a continuation-in-part of
`Application No.
`filed
`. The present application
`includes the Specification of the parent application which has been
`revised in accordance with the amendments filed in the parent
`application. Although the amendments in the parent C-1-P application
`may have incorporated new matter, since those are the only revisions
`included in the present application, the present application includes no
`new matter in relation to the parent application.
`
`A copy of earlier application Serial No. ______ Filed _____ _
`including Specification, Claims and Abstract (pages 1 - @@), to which no new
`matter has been added TOGETHER WITH a copy of the executed oath or declaration
`for such earlier application and all drawings and appendices. Such earlier application
`is hereby incorporated into the present application by reference.
`
`Please enter the following amendment to the Specification under the Cross-Reference
`to Related Applications section (or create such a section) : "This Application:
`
`Dis a continuation of Dis a divisional of D claims benefit of U.S. provisional
`Application Serial No.
`f i l ed - - - - - - - - - - - -
`
`CFAD VI 1002-0012
`
`
`
`DOCKET NO. : CELG-0188
`
`- 3-
`
`PATENT
`
`D
`
`D
`
`D
`
`D
`
`18]
`
`18]
`
`Signed Statement attached deleting inventor(s) named in the prior application.
`
`A Preliminary Amendment.
`
`Sheets of D Formal D Informal Drawings.
`
`Petition to Accept Photographic Drawings.
`
`D
`
`Petition Fee
`
`An 18] Executed D Unexecuted Declaration or Oath and Power of Attorney.
`
`An Associate Power of Attorney.
`
`D
`
`AnD Executed D Copy ofExecuted Assignment of the Invention to ____ _
`
`D
`0
`
`D A Recordation Form Cover Sheet.
`D Recordation Fee- $40.00.
`The prior application is assigned of record to - - - - - -
`
`Priority is claimed under 35 U.S.C. § 119 ofPatent Application No . - - - - - -
`filed
`m
`(country).
`D
`A Certified Copy of each of the above applications for which priority is
`claimed:
`D is enclosed.
`D has been filed in prior application Serial No. ___ filed __ _
`
`D
`
`AnD Executed or D Copy of Executed Earlier Statement Claiming Small Entity
`Status under 37 C.F.R. 1.9 and 1.27
`
`is enclosed.
`D
`0 has been filed in prior application Serial No.
`said status is still proper and desired in present case.
`
`filed -~-
`
`CFAD VI 1002-0013
`
`
`
`DOCKET NO. : CELG-0188
`
`-4-
`
`PATENT
`
`0
`
`D
`
`D
`
`0
`
`0
`
`D
`
`181
`
`0
`
`Diskette Containing DNN Amino Acid Sequence Information.
`
`Statement to Support Submission of DNA/ Amino Acid Sequence Information.
`
`The computer readable form in this application
`, is identical with that filed in
`Application Serial Number
`, filed
`In accordance with 37 CPR
`1.821(e), please use the 0 frrst~filed, D last-filed or 0 only computer readable
`fmm filed in that application as the computer readable form for the instant
`application. It is understood that the Patent and Trademark Office will make the
`necessary change in application number and filing date for the computer readable
`form that will be used for the instant application. A paper copy of the Sequence
`Listing is 0 included in the originally-filed specification of the instant application,
`D included in a separately filed preliminary amendment for incorporation into the
`specification.
`
`Infmmation Disclosure Statement.
`D
`D
`
`Attached Form 1449.
`Copies of each ofthe references listed on the attached Form PTO~ 1449 are
`enclosed herewith.
`
`A copy of Petition for Extension ofTime as filed in the prior case.
`
`Appended Material as follows: ---~---~----------
`
`Return Receipt Postcard (should be specifically itemized).
`
`Other as fol1ows:
`
`--------------......
`
`CFAD VI 1002-0014
`
`
`
`DOCKET NO. : CELG-0188
`
`- 5-
`
`PATENT
`
`FEE CALCULATION:
`
`D
`
`Cancel in this appli~ation original claims
`of the prior application before
`calculating the filing fee. (At least one original independent claim must be retained
`for filing purposes.)
`
`~
`P.J 1-.
`ui~
`::j\:D
`..
`
`~
`
`SMALL ENTITY
`
`NOT SMALL ENTITY
`
`RATE
`
`FEE
`
`RATE
`
`FEE
`
`PROVISIONAL APPLICATION
`
`DESIGN APPLICATION
`
`UTILITY APPLICATIONS BASE FEE
`
`UTILITY APPLICATION; ALL CLAIMS
`CALCULATED AFTER ENTRY OF ALL
`AMENDMENTS
`
`$75.00
`
`$160.00
`
`$355.00
`
`No. Filed
`
`No. Extra
`
`32-20 =
`
`12
`
`$9 each
`
`1 -3-
`
`0
`
`$40 each
`
`TOTAL
`CLAIMS
`
`INDEP.
`CLATMS
`
`FIRST PRESENTATION OF MULTIPLE
`DEPENDENT CLAIM
`
`$135
`
`ADDITIONAL FILING FEE
`
`TOTAL FILING FEE DUE
`
`$
`
`$
`
`$
`
`$
`
`$
`
`$
`
`$
`
`$
`
`$150.00
`
`$320.00
`
`$
`
`$
`
`$710.00
`
`$710.00
`
`$18 each
`
`$216.00
`
`$80 each
`
`$ 0
`
`$270
`
`$
`
`$
`
`$926.00
`
`181
`181
`
`181
`
`A Check is enclosed in the amount of$ 926.00 .
`
`The Commissioner is authorized to charge payment of the following fees and to
`refund any overpayment associated with this communication or during the pendency
`of this application to deposit account 23-3050. This sheet is provided in duplicate.
`
`D
`181
`
`181
`
`D
`
`The foregoing amount due.
`
`Any additional filing fees required, including fees for the presentation of extra
`claims under 37 C.F.R. 1.16.
`
`Any additional patent application processing feea under 3 7 C.F .R. 1.17 or
`1.20(d).
`
`The issue fee set in 37 C.F.R. 1.18 at the mailing of the Notice of Allowance.
`
`The Commissioner is hereby requested to grant an extension of time for the
`appropriate length of time, should one be necessary, in connection with this filing or
`any future filing submitted to the U.S. Patent and Trademark Office in the above-
`
`.:i.'l.):j
`
`CFAD VI 1002-0015
`
`
`
`DOCKET NO. : CELG-0188
`
`-6-
`
`PATENT
`
`identified application during the pendency of this application. The Commissioner is
`further authorized to charge any fees related to any such extension of time to deposit
`account 23-3050. This sheet is provided in duplicate.
`
`SHOULD ANY DEFICIENCIES APPEAR with respect to this application, including
`deficiencies in payment of fees, missing parts of the application or otherwise, the United
`States Patent and Trademark Office is respectfully requested to promptly notify the
`undersigned.
`
`Date:
`
`S. Mauri
`Registration No. 43,966
`
`Woodcock Washburn Kurtz
`Mackiewicz & Norris LLP
`One Liberty Place - 46th Floor
`Philadelphia P A 19103
`Telephone: (215) 568-3100
`Facsimile: (215) 568-3439
`
`IC 1997 WWKMN
`
`CFAD VI 1002-0016
`
`
`
`CELG-0188
`
`PATENT
`
`METHODS FOR DELIVERING A DRUG TO A PATIENT
`WHILE AVOIDI~G THE OCCURRENCE OF AN ADVERSE SIDE
`EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY THE DRUG
`
`FIELD OF THE INVENTION
`
`5
`
`The present invention relates to improved methods for delivering a drug to a
`
`patient. More particularly, the present invention relates to novel methods for delivering
`
`a teratogenic or other potentially hazardous drug to a patient in need of the drug, while
`
`avoiding the occurrence of known or suspected side effects of the drug. The novel
`
`methods permit the distribution to patients of drugs, particularly teratogenic drugs, in
`
`10
`
`ways wherein such distribution can be carefully monitored and controlled.
`
`BACKGROUND OF THE INVENTION
`
`Many beneficial drugs are known or suspected of producing adverse side effects
`
`in certain individuals. These side effects may be manifest in the patient taking the drug,
`
`in a foetus (i.e. fetus) carried by the patient, or in a recipient (or foetus carried by a
`
`15
`
`recipient) of the bodily fluids of the patient. In some cases, administration of the drug
`
`may be acceptable in some patients, but absolutely contraindicated in other patients.
`
`For example, drugs known or suspected of causing birth defects if taken by a pregrtant
`
`woman (i.e. teratogenic drugs), may nonetheless be beneficial for treating certain
`
`conditions. However, because of the teratogenic properties of the drug, administration
`
`20
`
`to pregnant women must be avoided. Other drugs are known which may be beneficially
`
`employed in the general population, but must be avoided by individuals having a certain
`
`.I-
`
`----------------.........
`
`CFAD VI 1002-0017
`
`
`
`CELG-0188
`
`-2-
`
`PATENT
`
`preexisting condition, or those concurrently taking certain other medication(s), due to
`
`adverse side effects which may develop in those individuals.
`
`One such drug which is known to produce adverse side effects, but which may
`
`nevertheless be beneficially employed in certain patients is thalidomide. Thalidomide is
`
`5
`
`a drug which was first synthesized in Germany in 1957. Beginning in 1958, it was
`
`marketed in many countries for use as a sedative, although it was never approved for
`
`use in the United States. After reports of serious birth defects, thalidomide was
`
`withdrawn from all markets by 1962. However, during the years it was used, it was
`
`found to be effective in treating erythema nodosum leprosum (ENL ), a condition of
`
`10
`
`leprosy, and the U.S. Food and Drug Administration (FDA)has made the drug available
`
`for this specific use via a program of the Public Health Service. More recently,
`
`investigators have found that thalidomide may be effective in treating AIDS wasting
`
`and aphthous ulcers occurring in AIDS patients. In addition, treatments for other
`
`diseases, such as a number of neoplastic diseases including cancers, rheumatoid
`
`15
`
`arthritis, and macular degeneration, are also believed to be possible. The FDA has
`
`recently approved an application by Celgene Corporation, which is the assignee ofthe
`
`present patent application, to market thalidomide for the treatment ofENL. The
`
`medical community anticipates that thalidomide will be used for treatment of additional
`
`conditions and diseases, including those set forth above. However, due to the severe
`
`20
`
`teratogenic risk of thalidomide, methods are needed to control the distribution of this
`
`drug so as to preclude administration to foetuses.
`
`In this regard, U.S. Patent No. 6,045,501, to Elsayed et al., provides methods for
`
`delivering a drug to a patient while preventing the exposure of a foetus or other
`
`contraindicated individual to the drug. According to the methods of this patent,
`
`25
`
`prescriptions for the drug are filled only after a computer readable storage medilllJI: has
`
`been consulted to assure that the prescriber is registered in the medium and qualified to
`
`prescribe the drug, that the pharmacy is registered in the medium and qualified to fill
`
`the prescription for the drug, and the patient is registered in the medium and approved
`
`to receive the drug. Improvements to this method may be useful, however, to minimize
`
`30
`
`and simplify the demands on the pharmacy, thereby improving compliance with the
`
`0
`~tr
`111
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`~ ". '11,1
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`----------------........
`
`CFAD VI 1002-0018
`
`
`
`0
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`.r. ru
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`
`CELG-0188
`
`-3-
`
`PATENT
`
`system of distribution, and reducing the risk that the drug will be dispensed to a
`
`contraindicated individual.
`
`Methods formonitoring and educating patients to whom a drug is distributed
`
`have been developed in connection with Accutane (isotretinoin). Accutane, which is a
`
`5
`
`known teratogen, is a uniquely effective drug for the treatment of severe, recalcitrant,
`
`nodular acne. A pregnancy prevention program was developed, and the Slone
`
`Epidemiology Unit of Boston University designed and implemented a survey to
`
`evaluate these efforts. The survey identified relatively low rates of pregnancy during
`
`Accutane treatment, which suggests that such a program can be effective. With more
`
`10
`
`than about 325,000 women enrolled to date in the Accutane survey, it is also clear that
`such a large-scale study can be conducted. Enrollment in the Accutane survey is
`voluntary, however. Accordingly, assessing the representativeness ofthe women who
`
`have been enrolled in the survey has been problematic, and it has been difficult to
`
`determine whether the survey results can be generalized to all female Accutane users.
`
`15
`
`Thus, an improved survey is needed which would be representative of all users of a
`
`particular drug, such as thalidomide, who obtain the drug through legal distribution
`
`channels. There are also no mechanisms provided to assure compliance with the
`
`program or to limit distribution ofthe drug to participants in the survey.
`
`Because drug sharing may frequently occur among AIDS patients, which may
`
`20
`
`result in placing a foetus at risk, a program is needed which can be used to educate men
`
`and women about the risk of teratogenic drugs, such as thalidomide. In addition, a
`
`system is needed for the controlled distribution of a drug, in which of all users of the
`
`drug, including prescribers, pharmacies, and patients, may be accountable for their
`
`compliance with methods that may be established to minimize the risk that a
`
`25
`
`contraindicated individual will be exposed to the drug. The present invention is
`
`directed to these, as well as other important ends.
`
`SUMMARY OF THE INVENTION
`
`The present invention is directed to improved methods for delivering a drug to a
`
`patient in need of the drug, while avoiding the occurrence of an adverse side effect
`
`30
`
`known or suspected ofbeing caused by the drug, of the type in which prescriptions for
`
`--... ·-
`
`-
`
`CFAD VI 1002-0019
`
`
`
`CELG-0188
`
`- 4-
`
`PATENT
`
`the drug are filled only after a computer readable storage medium has been consulted to
`
`assure that the pres~riber is registered in the medium and qualified to prescribe the drug,
`
`that the pharmacy is registered in the medium and qualified to fill the prescription for
`
`the drug, and the patient is registered in the medium and approved to receive the dmg.
`
`5
`
`In one embodiment of the invention, there are provided improved methods comprising
`
`the steps of:
`
`a.
`
`defming a plurality of patient risk groups based upon a predefined set of
`
`risk parameters for the drug;
`
`b.
`
`defining a set of information to be obtained from the patient, which
`
`10
`
`information is probative of the risk that such adverse side effect is likely
`
`to occur if the drug is taken by the patient;
`
`in response to the information set, assigning the patient to at least one of
`
`the risk groups; and
`
`entering the risk group assignment in the medium before the patient is
`
`c.
`
`d.
`
`15
`
`approved to receive the drug.
`
`The improved methods described herein provide advantageous and effective
`
`means for monitoring, controlling and authorizing the distribution to patients of drugs
`
`known or suspected of causing adverse side effects. The methods of the present
`
`invention include a variety of checks and balances which serve to limit unauthorized
`
`20
`
`and possibly inappropriate distribution of the drug. These methods are particularly
`
`applicable to distribution of teratogenic drugs, in which case the checks and balances
`
`may be particularly advantageous for preventing distribution of the drug to patients
`
`whose use of the dmg may pose an unacceptable risk that a foetus carried by the patient
`
`or a recipient of the bodily fluids of the patient will be exposed to such drugs.
`
`25
`
`Accordingly, the present methods may be advantageously used to avoid exposure of
`
`foetuses to teratogenic drugs, thereby avoiding the terrible birth defects which may
`
`result from such exposure.
`
`The invention is not limited to the distribution of teratogenic drugs; other
`
`potentially hazardous drugs may also be distributed in accordance with embodiments of
`
`30
`
`this invention and such drugs may be distributed in such a fashion that persons for
`
`CFAD VI 1002-0020
`
`
`
`CELG-0188
`
`-5-
`
`PATENT
`
`whom such drugs are contraindicated will not receive them. These and other aspects of
`
`the invention will become more apparent from the present description and claims.
`
`DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
`
`The present invention is directed generally to methods for the delivery of drugs
`
`5
`
`known or suspected of causing an adverse side effect, especially teratogenic drugs, to
`
`patients. The term "drug," as used herein, refers to any substance which is intended for
`
`use in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the
`
`structure or function of the body. The term "side effect" refers to any abnormality,
`
`defect, mutation, lesion, degeneration or injury which may be caused by taking the
`
`10
`
`drug. The side effect may be one which is likely to arise in the patient or in a foetus
`
`(i.e., fetus) carried by the patient. The side effect may also be one which is likely to
`
`arise in a recipient of the bodily fluid of the patient, or foetus carried by such recipient.
`
`The term "likely to arise" means that the si