Attorney Docket No. 11285.0056-01000
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Prior Application Art Unit: 1628
`
`Prior Application Examiner: San Ming R. Hui
`
`Commissioner: This is a request for filing a
`
`[Z Continuation I:I Continuation-in-Part E] Divisional Application under 37 C.F.R.
`§ 1.53(b) of pending prior Application No. 12/285,887 filed October 15, 2008 of John R.
`EVANS and Rosalind U. GRUNDY for FORMULATION.
`
`Enclosed is a complete copy of the prior application including the oath or
`Declaration and 2 sheets of drawings, as filed as a Substitute
`Specification on March 3, 2010, which corresponds to the subject matter
`as originally filed. I hereby verify that the attached papers are a true copy
`of prior Application No. 12/285,887 as filed on March 3, 2010, which
`corresponds to the subject matter as originally filed on October 15, 2008,
`which is incorporated herein by reference.
`
`Enclosed is a Request for Non-Publication of Application and Certification
`Under 35 U.S.C. § 122(b)(2)(B)(i).
`
`A Preliminary Amendment is enclosed.
`
`Enclosed is a Certification and Request for Prioritized Examination Under
`35 U.S.C. § 1.102(e).
`
`1.
`
`IX
`
`I:I
`
`K4
`
`2.
`
`3
`
`4
`
`5.
`
`X The filing fee is calculated on the basis of the claims existing in the prior
`application as amended in the Preliminary Amendment filed herewith.
`
`Basic Utility Application Filing Fee
`
`$380
`
`$
`
`
`
`380.00
`
`
`
`Search Fee
`
`$620
`
`620.00
`
`250.00
`$250
`Examination Fee
`
`
`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 1
`
`

`
`Application No.: Unassigned
`Attorney Docket No.: 11285.0056-01000
`Page 2 of 3
`
`
`
`
`
`
`independent Claims
`2I
`
`I_—_I Presentation of Multiple Dep. Claim(s)
`
`
`_- 100 + 50 = _* X $310
`
`‘Rounded up to next whole number
`
`
`Size Fee: Paper Filing
`Total Application Pages
`(specification, drawings, printed
`sequence or computer listing,
`reliminar amendment
`
`
`
`
`
`Additional Fee for Paper
`Filing New Application
`
`(DELETE if filing new application
`via EFS Web - fee not required for
`EFS new application
`
`submissions
`Size Fee: EFS-Web Filing
`Total Application Pages
`(specification, drawings, printed
`sequence or computer listing,
`reliminar amendment
`
`
`
`
`
`
`
`
`
` Processing Fee under 35 U.S.C. § 1.17(i) .
`Prioritized Examination Fee under 35 U.S.C. § 1.17(c)
`
`Publication Fee under 35 U.S.C. § 1.18(d)
`
`$
`
`$
`
`$
`
`$
`
`130.00
`
`4,800.00
`
`300.00
`
`6,480.00
`
`6.
`
`7.
`
`[XI
`
`PI!
`
`The fee of $ 6,480.00 is submitted herewith.
`
`The Commissioner is hereby authorized to charge any fees which may be
`required, including fees due under 37 C.F.R. § 1.16, and any other fees
`due under 37 C.F.R. § 1.17, or credit any overpayment during the
`pendency of this application to Deposit Account No. 06-0916.
`
`8.
`
`E]
`
`New acceptable drawings are enclosed.
`
`
`
`
`
`
`
` ‘Rounded up to next whole number
`
`25X.75-100+50=0*X$31O
`
`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 2
`
`

`
`Application No.: Unassigned
`Attorney Docket No.: 11285.0056-01000
`Page 3 of 3
`
`The prior application is assigned of record to: AstraZeneca AB as
`indicated by the assignments recorded at reel 011635, frame 0063 on
`March 27, 2001 and at reel 015906, frame 0402 on October 18, 2004.
`
`Priority of Application No. 0000313.7, filed on January 10, 2000 and
`Application No. 0008837.7, filed on April 12, 2000, both in Great Britain
`are claimed under 35 U.S.C. § 119. A certified copy
`
`CI is enclosed or
`
`is on file in the prior application.
`
`Small entity status is appropriate and applies to this application.
`
`The power of attorney in the prior application is to FINNEGAN,
`HENDERSON, FARABOW, GARRETT & DUNNER, L.L.P., Customer No.
`22,852.
`
`A Listing Under 37 C.F.R. § 1.32(c)(3) of Ten or Fewer Practitioners to
`be Recognized by the PTO as Being of Record is attached.
`
`The power appears in the original declaration of the prior application.
`
`Since the power does not appear in the original declaration, a copy of the
`power in the prior application is enclosed.
`
`10.
`
`11.
`
`12.
`
`13.
`
`14.
`
`15.
`
`16.
`
`El
`
`Please address all correspondence to FINNEGAN, HENDERSON,
`FARABOW, GARRETT and DUNNER, L.L.P., Customer Number 22,852.
`
`If any extension of time is necessary for the filing of this
`PETITION FOR EXTENSION.
`application, including any extension in parent Application No. 12/285,887, filed
`October 15, 2008, for the purpose of maintaining copendency between the parent
`application and this application, and such extension has not othen/vise been requested,
`such an extension is hereby requested, and the Commissioner is authorized to charge
`necessary fees for such an extension to Deposit Account No. 06-0916. A duplicate
`copy of this paper is enclosed for use in charging the deposit account.
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`
`Dated: September 4, 2012
`
`By:
`
`YV\
`
`/
`
`Carlos M. Tellez
`
`Reg. No. 48,638
`(202) 408-4123
`
`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 3
`
`

`
`Attorney Docket No. 11285.0056-01000
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Prior Application Art Unit: 1628
`
`Prior Application Examiner: San Ming R. Hui
`
`Commissioner: This is a request for filing a
`
`[Z Continuation I:I Continuation-in-Part E] Divisional Application under 37 C.F.R.
`§ 1.53(b) of pending prior Application No. 12/285,887 filed October 15, 2008 of John R.
`EVANS and Rosalind U. GRUNDY for FORMULATION.
`
`Enclosed is a complete copy of the prior application including the oath or
`Declaration and 2 sheets of drawings, as filed as a Substitute
`Specification on March 3, 2010, which corresponds to the subject matter
`as originally filed. I hereby verify that the attached papers are a true copy
`of prior Application No. 12/285,887 as filed on March 3, 2010, which
`corresponds to the subject matter as originally filed on October 15, 2008,
`which is incorporated herein by reference.
`
`Enclosed is a Request for Non-Publication of Application and Certification
`Under 35 U.S.C. § 122(b)(2)(B)(i).
`
`A Preliminary Amendment is enclosed.
`
`Enclosed is a Certification and Request for Prioritized Examination Under
`35 U.S.C. § 1.102(e).
`
`1.
`
`IX
`
`I:I
`
`K4
`
`2.
`
`3
`
`4
`
`5.
`
`X The filing fee is calculated on the basis of the claims existing in the prior
`application as amended in the Preliminary Amendment filed herewith.
`
`Basic Utility Application Filing Fee
`
`$380
`
`$
`
`
`
`380.00
`
`
`
`Search Fee
`
`$620
`
`620.00
`
`250.00
`$250
`Examination Fee
`
`
`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 4
`
`

`
`Application No.: Unassigned
`Attorney Docket No.: 11285.0056-01000
`Page 2 of 3
`
`
`
`
`
`
`independent Claims
`2I
`
`I_—_I Presentation of Multiple Dep. Claim(s)
`
`
`_- 100 + 50 = _* X $310
`
`‘Rounded up to next whole number
`
`
`Size Fee: Paper Filing
`Total Application Pages
`(specification, drawings, printed
`sequence or computer listing,
`reliminar amendment
`
`
`
`
`
`Additional Fee for Paper
`Filing New Application
`
`(DELETE if filing new application
`via EFS Web - fee not required for
`EFS new application
`
`submissions
`Size Fee: EFS-Web Filing
`Total Application Pages
`(specification, drawings, printed
`sequence or computer listing,
`reliminar amendment
`
`
`
`
`
`
`
`
`
` Processing Fee under 35 U.S.C. § 1.17(i) .
`Prioritized Examination Fee under 35 U.S.C. § 1.17(c)
`
`Publication Fee under 35 U.S.C. § 1.18(d)
`
`$
`
`$
`
`$
`
`$
`
`130.00
`
`4,800.00
`
`300.00
`
`6,480.00
`
`6.
`
`7.
`
`[XI
`
`PI!
`
`The fee of $ 6,480.00 is submitted herewith.
`
`The Commissioner is hereby authorized to charge any fees which may be
`required, including fees due under 37 C.F.R. § 1.16, and any other fees
`due under 37 C.F.R. § 1.17, or credit any overpayment during the
`pendency of this application to Deposit Account No. 06-0916.
`
`8.
`
`E]
`
`New acceptable drawings are enclosed.
`
`
`
`
`
`
`
` ‘Rounded up to next whole number
`
`25X.75-100+50=0*X$31O
`
`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 5
`
`

`
`Application No.: Unassigned
`Attorney Docket No.: 11285.0056-01000
`Page 3 of 3
`
`The prior application is assigned of record to: AstraZeneca AB as
`indicated by the assignments recorded at reel 011635, frame 0063 on
`March 27, 2001 and at reel 015906, frame 0402 on October 18, 2004.
`
`Priority of Application No. 0000313.7, filed on January 10, 2000 and
`Application No. 0008837.7, filed on April 12, 2000, both in Great Britain
`are claimed under 35 U.S.C. § 119. A certified copy
`
`CI is enclosed or
`
`is on file in the prior application.
`
`Small entity status is appropriate and applies to this application.
`
`The power of attorney in the prior application is to FINNEGAN,
`HENDERSON, FARABOW, GARRETT & DUNNER, L.L.P., Customer No.
`22,852.
`
`A Listing Under 37 C.F.R. § 1.32(c)(3) of Ten or Fewer Practitioners to
`be Recognized by the PTO as Being of Record is attached.
`
`The power appears in the original declaration of the prior application.
`
`Since the power does not appear in the original declaration, a copy of the
`power in the prior application is enclosed.
`
`10.
`
`11.
`
`12.
`
`13.
`
`14.
`
`15.
`
`16.
`
`El
`
`Please address all correspondence to FINNEGAN, HENDERSON,
`FARABOW, GARRETT and DUNNER, L.L.P., Customer Number 22,852.
`
`If any extension of time is necessary for the filing of this
`PETITION FOR EXTENSION.
`application, including any extension in parent Application No. 12/285,887, filed
`October 15, 2008, for the purpose of maintaining copendency between the parent
`application and this application, and such extension has not othen/vise been requested,
`such an extension is hereby requested, and the Commissioner is authorized to charge
`necessary fees for such an extension to Deposit Account No. 06-0916. A duplicate
`copy of this paper is enclosed for use in charging the deposit account.
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`
`Dated: September 4, 2012
`
`By:
`
`YV\
`
`/
`
`Carlos M. Tellez
`
`Reg. No. 48,638
`(202) 408-4123
`
`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 6
`
`

`
`1
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`r=oa PATENT APPLICATION
`,.
`ORIGINAL/SUBSTITUTEISUPPLEMENTAL
`IN THE UNITED STATES PATENT AND TRADEMARK OFEICE
`’
`DECLARATIONS
`As a below named Inventor. I hereby declare that my residence. post office address and
`are as stated below next to my name. and I
`believe I am the original. first and sole inventor (ll only one name is listed below) or an original. first and joint inventor (if plural names are listed
`below) ol the subject matter which is claimed and lor which a patent is sought on the ]NVEN'l1ON ENTITLED
`FORMULATION
`the specification of which (gfi_Eg_applicable &)$flE_§)_1
`A. CI is attached hereto.
`x
`' as U.S. Application No.
`-)
`B. C] was filed on
`BOX(ES)
`-) C. [3 was liled as PCT international Application No. PCTI
`I
`-)
` mmmNm
`any arnendrncrtt relei-red to
`ltterebystetetttatlheve revlewedandunderstandttreoontentsdttIeeboveIdentlfiedspodt'ncauorLktdudngtnedains.esunendedoy
`IsdefinedlrI37C.F.R. 1.56. Eneeptes noted below. lllerebyclaim
`above. Iocltnowtedge the dutyhedsolose ell tnlorrnation known to me to be material Iopat
`lorelen priority benefits under 35 U.S.C. 119(3)-(rl) or3s5(b) of any lorelgn application(s) lor-patent orinventrxs certificate. or 365(e) ol any P01’ lrttemaflenal
`Apptiation whlctfdeslgnated at least one other country
`thantheunitedstats.BstedbelmvandluveelsoldertGfiedbelowenyloreigneppur:aflonlorpatemerhIvertto(s -
`certificate.orPCTlnternationalAppl'ncation.filodbyrneorrnyasslgneedisclosingtheubfednunerdaknedhmiseppEoa6onu\dhavhgafiEngdate(1)belomflIatol
`meepp6mGononwNdtpdoritylsdalmed.or(2)llmpdoritydairnod.beloretheliingdatoolthisepplicatlorr:i
`
`ERIOR FOREIGN APPLICATIONISI
`Umb
`Coung
`0000313 . 7
`GB
`0008837 . 7
`GB
`
`Day_IMON'l'l-llYear Filed
`10 January 2000
`12 April 2000
`
`Date jrrst Lald-
`open or Pttbllshg
`'
`
`Date Patented
`or Granted
`
`gfiorlgx NOT Claimed
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`defined in 37 C.F.R. 1.56 which became available betweenthe filing date of eadt sud: prior Bppiialiotlfind the national or PCT International filing date at this
`._....__.=u1r:li¢aIion:__._._._.___._.___..___..__
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`APPLICATION S
`ONP OVISIONAL AND/OR
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`Application No. (sefies codelserlai no.)
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`thereby declare that all Staten-renulrnadelilierelnolrrryowrtlcnosvledge are trueondtnatellmternents madeonlnlorrnationendbellelere believedtol.-aetn.re:and
`lurmertnaunase statements wurerrtadewiththelrnowledge tlntwlltlullalsestaternentsendmeikesomadeareptmisttablebyfinemhrpdsumtentorbocu under
`section 1001 ot‘l"rtle laolttieunitedstatescodecrtdtttetsucttwilllttllalsestaternerttsntayleoperdize tttevalldityollhe epplicationorartypatentlssuedtttereon.
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`AndlherebyappolntPil1sburyMadsorI lsutm LLP. lrttelletaual Property Group. 1100 New York Avenue. N.W.. Ninth Floor. EastTo\vcr.Washi0910fl. D.C. 200056918.
`telephonenun-tber(202) 36144000(mwhaneIcmmumloe6orsnmmbetfJreded).endmebdow«arnedpersors(dtlw sameaddress) incfividualtyandculiectivelymy
`ettorneystoprosectrtetlnisappllatiorlartdtolransadallbusinesslnt1IePaterItnndTr-adernarkolliceoonneaedtlterewithendwiththerostmingpaterttutdlhereby
`euthorlzetlxerntodeletenemeslnurnbersbdowolpersonsnobngawimmdrflmutdtoectuurdymkstmdiuuhunerdoamurfiamdredlywkhuu
`pusaveaignadauomeylfimvmgantzaoonmuhwidrfirstseruslsemflsmsemmanmdbyvmornhnddrlherebydedamthatlhaveoonsentedelterluflfidowm
`toberepnssentedunlasluntilhsuuauteabofiefimartdlorabelowanmaeyhwritirtgaomecomrary.
`Paul N. Kokulis
`16773
`Dale 8. Lazar
`28872
`Mark G. Paulson
`30793 Midraei R. Ozwontzyk
`36787
`Raymond F. Uppitt
`17519
`Paul E. White, Jr.
`32011
`Stephen C. Giafier
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`32456.
`G. Lloyd Knight
`17698
`Glenn J. Perry
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`Pat! F. Mccuado
`31542
`Jacks. Banrfka
`37087
`Carl G. Love
`18781
`Kendnew H. Cotton
`3368
`Ruth N. Mordudt
`31044
`Adam R. Hess
`41835
`Kevin E. Joyce
`20508
`G. Paul Edgell
`24233
`Richard H. Ztitlen
`27243
`George M. Sirllla
`18221
`Lyrm E Eodeston
`35861
`Roger R. Wise
`31204
`Donald J. Bird
`25323
`Tu'nofl':y J. Klirna
`34352
`Jay M. Ftrkelstdn
`21082
`PeterW.Gawdey'
`25872
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`$95
`AnitaM.l0tlq:Ian'icl<
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`INVENTOR‘S SIGNATURE:
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`- FOR ADDITIONAL INVENTORS. ‘X’ box D and proceed on the attached page to list each additional inventor.
`D See additional foreign priorities on attached page (incorporated herein by reference).
`Atty. Dkt. No.
`
`PM
`
`'
`
`(Wt)
`
`___._
`PAT-I16 tussr
`
`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 7
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Attorney Docket No. 11285.0056-00000
`
`PATENT
`
`ln re Application of:
`
`John R. Evans et al.
`
`Application No.2 12/285,887
`
`Filed: October 15, 2008
`
`For:
`
`FORMULATION
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`Group Art Unit: 1628
`
`Examiner: HUI, San Ming R.
`
`Confirmation No.: 1199
`
`sax/\/x/xaxax/xax/V
`
`REVOCATION OF POWER OF ATTORNEY
`
`STATEMENT UNDER 37 C.F.R. § 3.73(b)
`AND GRANT OF NEW POWER OF ATTORNEY
`
`The undersigned, a representative authorized to sign on behalf of the assignee
`
`owning all of the interest in this patent application, hereby revokes all previous powers
`
`of attorney or authorization of agent granted in this application before the date of
`
`execution hereof.
`
`As required by 37 C.F.R. § 3.73(b), the undersigned verifies that Astrazeneca AB
`
`is the assignee of the entire right, title, and interest in the patent application identified
`
`above by virtue of an assignment from the inventors recorded in parent Application
`
`No. 10/872,784 in the U.S. Patent and Trademark Office at Reel 015906, Frame 0402.
`
`The undersigned representative of the Assignee hereby grants its power of
`
`attorney to the patent practitioners associated with FINNEGAN, HENDERSON,
`
`FARABOW, GARRETT & DUNNER, L.L.P., Customer Number 22,852, to prosecute
`
`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 8
`
`

`
`Application No.: 12/285,887
`Attorney Docket No.: 112850056-00000
`
`this application and to transact all business in the Patent and Trademark Office
`
`connected therewith, and to receive the Letters Patent.
`
`Please send all future correspondence concerning this application to Finnegan,
`
`Henderson, Farabow, Garrett & Dunner, L.L.P., Customer No. 22,852.
`
`Dated:
`
`27 May 2011
`
`By:
`
`
`
`‘
`
`Name:
`
`DR ALLEN F GILES
`
`Title:
`
`AUTHORISED REPRESENTATIVE
`
`Astrazeneca AB
`
`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 9
`
`

`
`I—
`
`FFirst Named Inventor
`
`Title
`of Invention
`
`John R. Evans
`
`FORMULATION
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`UNDER 37 CFR 1.102131
`TNonprovisiona| Application
`
`Number (fliowm;
`
`Unknown
`
`
`
`—\
`
`Z‘
`
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUEST PRIORITIZED EXAMINATION
`FOR THE ABOVE-IDENTIFIED APPLICATION.
`
`1.
`
`2.
`
`3.
`
`i.
`
`The processing fee set forth in 37 CFR 1.17(i), the prioritized examination fee set forth in 37 CFR
`1.17(c), and if not already paid, the publication fee set forth in 37 CFR 1.18(d) have been filed with
`the request. The basic filing fee, search fee, examination fee, and any required excess claims and
`application size fees are filed with the request or have already been paid.
`
`The application contains or is amended to contain no more than four independent claims and no
`more than thirty total claims, and no multiple dependent claims.
`
`The applicable box is checked below:
`
`I. Q Ori
`
`inal A
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`Iication Track One - Prioritized Examination under 1.102 e 1
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`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a).
`This certification and request is being filed with the utility application via EFS-Web.
`__-oR___
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`(b) The application is an original nonprovisional plant application filed under 35 U.S.C. 111(a).
`This certification and request is being filed with the plant application in paper.
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`ii.
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`An executed oath or declaration under 37 CFR 1.63 is filed with the application
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`ll. El Reguest for Continued Examination - Prioritized Examination under 1.102(e)(2[
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`A request for continued examination has been filed with, or prior to, this form.
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`lfthe application is a utility application, this certification and request is being filed via EFS-Web.
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`The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a), or is a
`national stage entry under 35 U.S.C. 371.
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`This certification and request is being filed priorto the mailing of a first Office Action responsive to
`the request for continued examination.
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`No prior request for continued examination has been granted prioritized examination status under
`37 CFR 1.102(e)(2).
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`i.
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`ii.
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`iii.
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`iv.
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`v.
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`The Commissioner is hereby authorized to charge any additional filing fees, including any fees necessary
`to complete the Track 1 requirements, to Deposit Account No. 06-0916.
`/‘
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`/KJ)v\./ M “_’ :/
`
`Carlos M.Tel|ez
`Reg No.: 48 638
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`202-408-4000
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`o4-s1=:<>- zon.
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`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 10
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`

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`Attorney Docket No. 11285.0056-01000
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`PATENT
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In re Application of:
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`John R. EVANS, et al.
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`Application No.: To be Assigned
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`Filed: Herewith
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`For:
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`FORMULATION
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`Commissioner for Patents
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`P.O. Box 1450
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`Alexandria, VA 22313-1450
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`Commissioner:
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`\/\./\y\/\/\/\/\y\J
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`Parent Group Art Unit: 1628
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`Parent Examiner: San Ming R. Hui
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`VIA EFS-WEB
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`PRELIMINARY AMENDMENT
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`Please amend the above-identified patent application as follows:
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`Amendments to the Specification are included in this paper.
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`Amendments to the Claims are reflected in the listing of claims in this paper.
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`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 11
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`

`
`Application No.: Unassigned
`Attorney Docket No.: 11285.0056-01000
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`AMENDMENTS TO THE SPECIFICATION
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`Please amend this application, by replacing the paragraph on page 1, line 4-8
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`with the following paragraph:
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`This application is a Continuation Application of copending U.S. Patent
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`Application No. 12/285,887, filed on October 15, 2008, which claims benefit of U.S.
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`Patent Application No. 10/872,784, filed June 22, 2004, now U.S. Patent No. 6 774 122
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`which claims benefit of U.S. Patent Application No. O9fl56,291, filed January 9, 2001,
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`now U.S. Patent No. 7 456 160 which claims the benefit of Great Britain Application No.
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`0008837.7 filed April 12, 2000 and Great Britain Application No. 000313.7 filed January
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`10, 2000, all ef—whish five applications are incorporated herein by reference in their
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`entireties.
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`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 12
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`

`
`Application No.: Unassigned
`Attorney Docket No.: 11285.0056-01000
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`AMENDMENTS TO‘ THE CLAIMS
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`Please add new claims 24-43. Please also cancel claims 1-23 without prejudice
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`or disclaimer. This listing of claims will replace all prior versions and listings of claims in
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`the application.
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`Claims 1-23 (Cancelled)
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`24.
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`(New) A method for treating a hormonal dependent benign or malignant disease
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`of the breast or reproductive tract comprising administering intramuscularly to a
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`human in need of such treatment a formulation comprising:
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`about 50 mgml" of fulvestrant;
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`a mixture of from 17 — 23% w/v of ethanol and benzyl alcohol;
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`12 - 18% w/v of benzyl benzoate; and
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`a sufficient amount of castor oil vehicle;
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`wherein the method achieves a blood plasma fulvestrant concentration of at least
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`2.5 ngml“ for at least two weeks.
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`25.
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`(New) The method of claim 24, wherein formulation comprises a mixture of
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`from 19 — 21% w/v of ethanol and benzyl alcohol and 14 - 16% w/v of benzyl
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`benzoate.
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`26.
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`(New) The method of claim 24, wherein formulation comprises:
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`about 10% w/v of ethanol;
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`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 13
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`

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`Application No.: Unassigned
`Attorney Docket No.: 11285.0056-01000
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`about 10% w/v of benzyl alcohol; and
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`about 15% w/v of benzyl benzoate.
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`27.
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`28.
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`29.
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`30.
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`31.
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`32.
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`33.
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`(New) The method of claim 24, wherein the blood plasma fulvestrant
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`concentration is at least 8.5 ngml".
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`(New) The method of claim 24, wherein the hormonal dependent benign or
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`malignant disease of the breast or reproductive tract is breast cancer.
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`(New) The method of claim 24, wherein the blood plasma fulvestrant
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`concentration is attained for at least four weeks.
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`(New) The method of claim 24, wherein the method comprises administering
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`intramuscularly to a human in need of such treatment 5 ml of the formulation.
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`(New) The method of claim 24, wherein the method further comprises once
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`monthly administration of the formulation.
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`(New) The method according to claim 24, wherein the formulation is
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`administered in a divided dose.
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`(New) The method of claim 26, wherein the hormonal dependent benign or
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`malignant disease of the breast or reproductive tract is breast cancer and the
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`blood plasma fulvestrant concentration is attained for at least 4 weeks.
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`34.
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`(New) A method for treating a hormonal dependent benign or malignant disease
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`of the breast or reproductive tract comprising administering intramuscularly to a
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`human in need of such treatment a formulation consisting essentially of:
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`-4-
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`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 14
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`

`
`Application No.: Unassigned
`Attorney Docket No.: 11285.0056-01000
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`about 50 mgml" of fulvestrant;
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`a mixture of from 17 — 23% w/v of ethanol and benzyl alcohol;
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`12 - 18% w/v of benzyl benzoate; and
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`a sufficient amount of castor oil vehicle;
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`wherein the method achieves a blood plasma fulvestrant concentration of at least
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`2.5 ngml" for at least two weeks.
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`(New) The method of claim 34, wherein formulation consists essentially of a
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`mixture of from 19 — 21% w/v of ethanol and benzyl alcohol and 14 - 16% w/v of
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`benzyl benzoate.
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`(New) The method of claim 34, wherein formulation consists essentially of:
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`about 10% w/v of ethanol;
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`about 10% w/v of benzyl alcohol; and
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`about 15% w/v of benzyl benzoate.
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`(New) The method of claim 34, wherein the blood plasma fulvestrant
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`concentration is at least 8.5 ngml".
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`(New) The method of claim 34, wherein the hormonal dependent benign or
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`malignant disease of the breast or reproductive tract is breast cancer.
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`(New) The method of claim 34, wherein the blood plasma fulvestrant
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`concentration is attained for at least four weeks.
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`35.
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`36.
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`37.
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`38.
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`39.
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`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 15
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`

`
`Application No.: Unassigned
`Attorney Docket No.: 11285.0056-01000
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`40.
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`41.
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`42.
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`43.
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`(New) The method of claim 34, wherein the method comprises administering
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`intramuscularly to a human in need of such treatment 5 ml of the formulation.
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`(New) The method of claim 34, wherein the method further comprises once
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`monthly administration of the formulation.
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`(New) The method according to claim 34, wherein the formulation is
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`administered in a divided dose.
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`(New) The method of claim 36, wherein the hormonal dependent benign or
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`malignant disease of the breast or reproductive tract is breast cancer and the
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`blood plasma fulvestrant concentration is attained for at least 4 weeks.
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`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 16
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`

`
`Application No.: Unassigned
`Attorney Docket No.: 11285.0056-01000
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`I. Amendments to the specification
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`REMARKS
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`Applicants amended the specification to insert the required reference to the
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`priority applications, for which benefit is claimed.
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`ll. Status of the claims and amendments
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`Upon entry of the instant amendments, claims 24-43 will be pending in this
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`application. Claims 1-23 are being cancelled in this Preliminary Amendment without
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`prejudice or disclaimer. Claims 24-33 are directed to methods for treating a hormonal
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`dependent benign or malignant disease of the breast or reproductive tract comprising
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`administering intramuscularly to a human in need of such treatment a formulation
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`comprising various components. Claims 34-43 are identical to claims 24-33 except that
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`the phrase “formulation consisting essentially of’ replaces the phrase “formulation
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`comprising’ the various components.
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`New claim 24 finds support, for example, in original claim 21. The recitation in
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`claim 24 regarding “5O mg ml“ of fu|vestrant” finds support, for example, in the
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`specification at p. 18, line 12. The recitation regarding “a mixture of from 17 — 23% w/v
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`of ethanol and benzyl alcohol” finds support, for example, in the specification at p. 9.
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`ll. 18-26. The recitation regarding “12 - 18% w/v of benzyl benzoate” finds support, for
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`example, in the specification at p. 10, I. 22 to p. 11, I. 9. The recitation regarding “a
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`sufficient amount of castor oil vehic|e” finds support, for example, in the specification at
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`_ 7 _
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`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 17
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`

`
`Application No.: Unassigned
`Attorney Docket No.: 11285.0056-01000
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`p. 8, II. 14-20. The recitation regarding “significant blood plasma fulvestrant
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`concentration of at least 2.5 ngml“ for at least two weeks” finds support, for example, in
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`the specification at p. 8, II. 14-20 and p. 12, II. 20-23.
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`New claim 25 finds support, for example, in the specification at p. 9, II. 13-26.
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`New claim 26 finds support, for example, in the specification at p. 18, ll. 9-11. New
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`claim 27 finds support, for example, in the specification at p. 12, II. 20-23. New claim
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`28 finds support, for example, in the specification at p. 16, II. 20-27. New claim 29 finds
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`support, for example, in the specification at p. 12, II. 24-28. New claim 30 finds support,
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`for example, in the specification at p. 12, II. 29-31. New claim 31 finds support, for
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`example, in the specification at p. 7, II. 14-19. New claim 32 finds support, for example,
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`in the specification at p. 12, II. 29-31. New claim 33 finds support, for example, in the
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`specification at p. 16, II. 20-27 and p. 12, II. 24-28.
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`Because claims 34-43 are identical to claims 24-33 except for the transitional
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`phrase (“consisting essentially of” instead of “comprising”), the same disclosure from the
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`instant specification cited above for claims 24-33 provides support for claims 34-43.
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`The instant amendments do not add new matter.
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`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 18
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`

`
`Application No.: Unassigned
`Attorney Docket No.: 11285.0056-01000
`
`Please grant any extensions of time required to enter this paper and charge any
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`additional required fees to Deposit Account No. 06-0916.
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`Respectfully submitted,
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
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`Dated: September 4, 2012
`
`By: Cal»
`
`M J:
`
`/
`
`Carlos M. Téllez
`
`Reg. No. 48,638
`(202) 408-4123
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`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 19
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`

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`Z70635
`
`FORMULATION
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`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`This application is a Continuation Application of copending U.S. Patent Application
`
`5
`
`No. 10/872,784, filed June 22, 2004, which claims benefit of U.S. Patent Application No.
`
`09/756,291, filed January 9, 2001 which claims the benefit of Great Britain Application No.
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`0008837.7 filed April 12, 2000 and Great Britain Application No. 0000313.7, filed January
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`10, 2000, all of which are incorporated herein by reference in their entireties.
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`V10
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`BACKGROUND OF THE INVENTION
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`Field of the Invention
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`The invention relates to a novel sustained release pharmaceutical formulation adapted
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`for administration by injection containing the compound
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`70t-[9-(4,4,5,5,5-pentafluoropentylsulphiny1)nonyl]oestra-1,3 ,5(10)-triene—3, 17B-diol.
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`15
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`20
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`25
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`30
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`Description of the Related Art
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`Ocstrogen deprivation is fundamental to the treatment of many benign and malignant
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`diseases of the breast and reproductive tract. In premenopausal women, this is achieved by
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`the ablation of ovarian function through surgical, radiotherapeutic, or medical means, and, in
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`postmenopausal women, by the use of aromatase inhibitors.
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`An alternative approach to oestrogen withdrawal is to antagonise oestrogens with
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`antioestrogens. These are drugs that bind to and compete for oestrogen receptors (ER)
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`present in the nuclei of oestrogen-responsive tissue. Conventional nonsteroidal
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`» antioestrogens, such as tamoxifen, compete efficiently for ER binding but their effectiveness
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`is often limited by the partial agonism they display, which results in an incomplete blockade
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`of oestrogen-mediated activity (Furr and Jordan 1984, May and Westley 1987).
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`The potential for nonsteroidal antioestrogens to display agonistic properties prompted
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`the search for novel compounds that would bind ER with high affinity without activating any
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`of the normal transcriptional hormone responses and consequent manifestations of oestrogens.
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`Such molecules would be “pure” antioestrogens, clearly distinguished from tamoxifen-like
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`ligands and capable of eliciting complete ablation of the trophic effects of oestrogens. Such
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`compounds are referred to as Estrogen Receptor-Downregulators (E.R.D.). The rationale for
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`MYLAN PHARMS. INC. EXHIBIT 1002 PAGE 20
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`

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`Z70635
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`the design and testing of novel, pure antioestrogens has been described in: Bowler et al 1989,
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`Wakeling 1990a, 1990b, 1990c. Wakeling and Bowler 1987, 1988.
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`Steroidal analogues of oestradiol, with an alkylsulphinyl side chain in the 7ot position,
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`provided the first examples of compounds devoid of oestrogenic activity (Bowler et al 1989).
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`One of these, 70¢-[9-(4,4,5,5,5-pentafluoropentyl sulphinyl)nonyl]oestra-1,3,5-(l0)triene—
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`10
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`15
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`3,l7B-diol was selected for intensive study on the basis of its pure oestrogen antagonist
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`activity and significantly increased antioestrogenic potency over other available
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`antioestrogens. In vitro findings and early clinical experience with
`7ot-[9—(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-l,3-5(l0)-triene-3,17B-diol have
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`promoted interest in the development of the drug as a therapeutic agent for oestrogen-
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`dependent indications such as breast cancer and certain benign gynaecological conditions.
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`70c-[9—(4,4,5,5 ,5-Pentafluoropentylsulphinyl)nonyl]oestra- 1,3 -5(l0)-triene-3 ,1 7 B-diol,
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`or ICI 182,780, has been allocated the international non-proprietary name fulvestrant, which
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`is used hereinafter. When referring to fulvestrant we include pharmaceutically-acceptable
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`salts thereof and any possible solvates of either thereof.
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`Fulvestrant binds to ER with an affinity similar to that of oestradiol and completely
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`blocks the growth stimulatory action of oestradiol on human