`
`U~' [TEI) STATES DEI'ARTME.-:TOF COM,\WW.C.:
`I! B;'cd SIn'" [''''C''' ~ ,." T . .. I."...-k on;,."
`AM "", ('OMMlssrO~F.N FOR PATF,r-TS
`P,U ,,,,",I'W
`A1._~ .. V~"'l:!llJ · 14.w
`~".-~""
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`"'"
`25226
`O6IOJ/:!OlO
`MORR ISON & FOERSTER LLP
`755 PAGE MILL RO
`PA1.O AI.TO, CA 94304-101S
`
`TSA Y MARSHA M
`
`ARTu:-;rr
`
`PAPER KUM BER
`
`DAn~ MAlLEI): 06101120 10
`
`""
`
`API'LICATION :SO
`
`FILL'\G OAlT
`
`FlRST :"lAMED L"IYEr. TOR
`
`A'ITOR1'''EY r.xx:K1:'I'O.
`
`CO:-'1'1RMA TION NO.
`
`11 1553,339
`Neil P. n.:~i
`IDLE O F lNVENTIOi\: CO)'lPOS IT IONS MD METHODS OF DELIVERY OF ]'HARM.ACOLOGICAL AGEl\-rS
`
`6)R772OO(l301
`
`J ffi5
`
`A1'1.'L"I , TYI'E
`
`nonprovisional
`
`NO
`
`[ssut:: ['Hi ,DUI::
`
`$J5J O
`
`I'UllLlCATlON t-lOlo DUb
`so
`
`l'REV. PAID lSSVt; FEE
`
`"lUTALHz(S.DUE
`
`DATb lJUJ:;
`
`SO
`
`$J5 10
`
`OO/O I/20JO
`
`THt: API'LiCATlON IDENTIFIED A80VE HAS BEEN EXAMINED AND IS ALLOWED t"OR ISS()ANCE AS A I'ATENT.
`"ROSFCl JTlQN!lliIJ..lE MFRITS IS C! 0SFD. TIIJS NOT ICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`TlUS APPLI(;ATION IS SIJBJEcr TO WITHDRAWAL ."ROM ISSUE AT Tll[ INITIAT IV[ Of TlU: OFFICE OR UI'ON
`l'E.."f ITION nv TI lE Alll' LiCANT. SEE 37 Cf'R 1.313 AND MPE!' 1308.
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`'J'IlIS
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`IF AN ISS UE n :E IlAS
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`
`PT01 ... S~ (Rev_ (8107) ApprQ",d for u;c throogh 0lII3 1120 10
`
`Page 10f 3
`
`Apotex v. Abraxis - [PR20 18-00 153, Ex. 1024, p.O 1 of 8
`
`
`
`'-ART R - n:E(S) TRANSI\'IITTAL
`Complete and send this form, together with appliCHble fec(s) , to: Mail Mail Stop ISS UE FEE
`Commissioner for '-alenls
`)'_0. nox 1450
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`orUtx
`INS TRUCl'IONS: 'rhi < form should be u,\.ed for transmilling the ISS UE IH , and I'IJIIUCATIO ...... I:EE (if required). lIlocks I through 5 should be compl eted where
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`urtificu lr of _'1u il ing or Tl"llrlSlIIlssinn
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`Sl:ltes POS l:lI Se rvICe WIth su (flCornl fXl$la;:e for firsl class ma!1 m an envd <:JP.e
`ad(b·~5,~d 10 Ih~ ;\-1.1 ,1 Sl op ISSLJ E 1'££ address ,~'e. or belns f~c,"",le
`transmitted 10 the LJS I'fU (57 1) 273-2H1I5. on lhe dale mdic3tcd below.
`
`API'l..JCATION:">O
`
`FILL'\G DAlT
`
`FlRST :">AMED L"IYEr. TOR
`
`CO:-'1'1RMA TION NO.
`
`HY2lJ200f>
`Neil P. n.:~i
`11 1553.339
`IDLE OF lNVENTIOi\: CO)'l POSITIONS MD METHODS OF DELIVERY OF I'HARM.ACOLOGICAL AGEl\"rS
`
`63R772OO(lJOI
`
`A1'1.'L"I . TYI'E
`
`nonprovisional
`
`NO
`
`ISSUI:: I'I::I:;DUI::
`
`$1510
`
`A R T UN IT
`
`I'UllLlCATlON I-lOlo DUb
`so
`
`I'REV.I'A1D 1~ ~UI:: FEE
`
`'lUTALI-Eb(~' DUI::
`
`DATbDUb
`
`SO
`
`$ 15 10
`
`0')/01/2010
`
`TSA Y. MARSH A M
`
`I. ~h"nl!<' ..,r ,,-,,",,,~pondcn<-.; mlJ",ss or i nJi< ~Ii<.>" ..,r"Fec Addn'u" (37
`a 'R I.J(,3).
`
`""
`o a,:u!g~..,f '·OI.Te'E':'"<kJl<",, ~Jd",ss (or C h""&,, <.>f O.l" e'(>OIIJe n,."
`o ·T..,e Address" indicalion (or "f"",e Ad dre"- Indicalion form
`
`Addr,,,, form I'TOI~HJ 122) atl:lChed .
`
`I'TO IS8147: Re,' 03·02 or mon. ...... ."m ) ,,\la,'hed. V.., .. r" Cusl.o",,·r
`N",\lber i.< rtqllirf:<!.
`
`53().35OOC1O
`
`F<.r prinling <.>rl Ihc ""Icn l rl"<.>l\l p"ge. list
`0) the narne~ of up (0 ) registered palenl attornrys
`<.>r "&"nts OR. aItefllll liwly.
`(2) .the naTOO of a Sing le fi nn (h,,'ing as • me mbe r a
`n:gl,lt:n'tl aUu,",,"Y <.>r agem) • .ud Ihe n.meS uf UI' I.)
`It "" name IS
`2 "'gISle",d paten.1 a nome¥" or ag<: nL.
`hSI,·d. no name WIll be pnnled.
`
`,--------
`
`3. ASSlCiNEE NAME Al\"D RESIOENCE f)A TA TO rlE PRIN'l1:.D ON 'IlIE PATENT (prinl or Iype)
`PLEM;;£ NOTE: Vnless .n assignee is ide nl ifi«l helow,. nQ assignee dala wiH aPlX"at on lhe p31en L If an assignee is ide nlifled hdO'>'·. Ih e dorumenl has bttn filoo for
`ICcOfd.!!on as s~1 forth In 37 C"l{ J. I I . Comple!!on <.>f Ihls fo nn IS NOT ~ SU bsUlU I~ fOf fihn g ~n as"sn nwm.
`(A) NA ME O F ASSIG~ EE
`(II ) RI ~<;ll)ENCE: (CITY a nd STA·ll'. Of{ CO lJ"ITf{Y)
`
`Please check Ihe "",prop-i"le . ssignee (:llegory or calegories (will nOlIx- prinlro on Ihe patenl): D lndivid",!! 0 Corporalion orother privale group enlily 0 Governmenl
`
`4.', The f"llowing f~e(~)a .... ~" hm iu ed
`
`5. C hang" in Enlil}" Stat us (from Sla luS indi cated above)
`
`o I"u~ Fe""
`o Publ ication Fee ("';0 small emil >' d iSCQU m p;,-nn illl-d)
`o Ad'·.nec Order · Ii of Copies
`o a. Applicant cb ims SYlAU.. E..,"':rrrY statu •. See J, CFR 1.21. o b. Applicanl is nO lon ge r cJ:timing SMAlL E!\"ITY status. See 37 C FR 1.27(g)(2).
`
`4h. PaymeHI nfr~e(~) (1'1 .. ,,, .. Ii ..,.! """ppl,. "ny prt">"i""'l y p"id i",,~ r.,.. "'own " ... ".~)
`
`o A ",,"," k is ~ndosed.
`o Paym,·nt by credil card. Form PTO· l03& is IIltached
`
`O The Di","or is h......-!:>y aUln.;,riu:d IQ charge t he requ hd feds). an>' defiricocy. or cred il. a n",
`o,"",.p"y"",m. Iv De!""" Account N umt.:r
`(enrl",e all exlnt <"'I'Y oflhlS raem).
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`NOTE: 'The IS$ u(· Fee and Publication Fet·. (if requ ired) will not be accepted from anyone ", h,'r than the applicant; a registered anomey or age nt: or the ass igoce orotber ]>arty in
`inlereSI as shown by Ihe ""cords Q/"Ihc I;n. l<:t! SIMes Pa lenl and Trade mArk 0fTi ~.
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`Aulhoriz.cd Sig D~ lure __ __ ___ __ ____ _ _ __ _ ___ _
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`O alt __________________________ ___
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`Typed or prinl~d name
`This ,011<'<, lion of inf"nllation i.S "''l ui",d br 37 CI' R 1.3 1 I. The infvrmat
`an arr ltcallon. Confjdenll~hty , .• s",'emoo I>y 3.~ U.S.C. 122 and J, CFR 1.14. Th, s col lecu on IS ""u ma led 10 I"ke 12 nllnut", 10 complele, ,nel oo lng gmhen ng .. p"'ra" ng. and
`. io n is fl"'lU .. in'tl 10 <.>blain or ",l:lin ~ IxMfil by Ihe public which is 10 fik Illn.J by the US PTO 10 pro<;~>s)
`.
`i ubmlU ing the co mpleled apph"at.IQn fom. t.o the I;S I'1O. Time w,1l vary dependIn g upon. Ib.c individual casc o Any Com nle"IS on IllC amounl of ume)"ou "'gUlre 10 compl ete
`th IS form and/or sugsesltoos fCO" R'ducmg th IS t:.",je n. ! hou ld be .... ntlO the Ch ief Informallon O ffio:e r. U.S. Pat~nl and Tr:uiem:trk Off,ce. U.S . DepamncDl of Commerce.1'.o.
`Jl.u~ ]450, Akxandna, Virgj nia 2.23 13- 1450. DO :-:OT SEND FEES OR CO)"l PLETED FORMS TO TIllS ADDRESS. Sr:J";D TO: C",,,",i,si,,,,~ .. f'>ll' Palents. P.O II..,,, ]450,
`Alexandna . V'rg, n,a 22.113-1450
`Under the ]'apor ... « k Reductio n Act of 1995. no persons arc required 10 respond 10 a COllection of in formation unJc s~ il displays a --.Iid OMS control number.
`
`R~gi'tr.!io" No.
`
`1'1"01..-83 (R,·v. 08/07) ,\pprQ"ed for uS/.' through 0813 1120 10.
`
`OYl806.'i1 -OO33
`
`U .S. Palent and Tr.ldemark Office: U.S. DEI'ART;>'-ffiNT OF CO.YIJ'-1E RCE
`
`Apotex v. Abraxis - [PR20 18-00 153, Ex. 1024, p.02 of 8
`
`
`
`",.<'"~ ~l U ,ITED S TATES PArENT AND TRADEMARK O I·neE
`
`U~' [TEI) STATES DEI'ARTME.-:TOF COM,\WW.C.:
`I! B;'cd SIn'" [''''C''' ~ ,." T . .. I."...-k on;,."
`AM "", ('OMMlssrO~F.N FOR PATF,r-TS
`P,U , ,,,",I'W
`A1._~ .. V~"'l:!llJ · 1 4.w
`~".-~""
`
`APPLICATION :-;O
`
`F1LI:'O DAIT
`
`A TIOR."'EY DlXKET NO.
`
`CO:-''FIRMA nON NO.
`
`1115.53.339
`
`1(y2612006
`
`Ndl P. Desai
`
`638772000301
`
`3005
`
`"'"
`25226
`O6IOJ/:!OlO
`MORR ISON & FOERSTER LLP
`755 PAGE MILL RO
`PA1.O AI.TO, CA 94304-101S
`
`TSA Y. MARSHA M
`
`ARTu:-;rr
`
`PAPER KUM BER
`
`DAn~ MAlLEI): 06101120 10
`
`""
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment to date is 0 day(s). If the issue fee is paid on the date that is three months after the
`mailing date of thi s notice and the patent issues on the Tuesday before the date that is 28 weeks (six and a half
`month s) after the mailing date of th is notice. the Patent Term Adjustment wi ll be 0 day(s).
`
`If a Continued Prosecution Application (CPA) was filed in the above-identified application. the fili ng date that
`determines Patent Telm Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Infonnatiol1 Retrieval
`(PArR) WEB site (http://pair.uspto.gov).
`
`Any questions regarding the Patent Term Extension or Adjustment determin.ltion should be directed to the Office of
`Patent Legal Administration at (571 )-272-7702. Questions re lating to issue and publication fee payments shoul d be
`directed
`to
`the Customer Service Center of the Office of Patent Publication at 1-(888)-786-0 I 0 I
`or
`(57 1 )-272-4200.
`
`PT01 ... S~ (Rev. (8107) ApprQ",d for u;c throogh 0lII3 1120 10
`
`Page3 0f 3
`
`Apotex v. Abraxis - [PR20 18-00 153, Ex. 1024, p.03 of 8
`
`
`
`Notice of AllowabUity
`
`Application No.
`
`111553,339
`Examiner
`
`Applicant(s )
`
`DESAI ET AL.
`Art Unit
`
`Marsha M. Tsay
`
`1656
`
`.. The MAILING DATE of this communication appears on the cover sheet with the correspondenc e address-(cid:173)
`A il claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAI NS ) CLOSED in th is application. If not included
`herew ith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed indue course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon peti tion by the applicant. See 37 CFR 1.313 and MPEP 1306.
`1. 181 This communication is responsive to AppUcaQfs' response in the form ofp ReE recejved April 14 2010.
`2. IZI The allowed claim(s) isJare 24 13-16 18-20 and 24-26.
`3. D Acknow ledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a }-(d) or (f).
`a) 0 A ll
`c) 0 None oflhe:
`b) 0 Some-
`1 0 Certified copies of the priority documents have been received.
`2. 0 Certified copies of the priority documents have been received in Application No. __
`3. 0 Copies of the certified copies of the priority documents have been received in this national stage application from the
`International Bureau (PCT Rule 17.2(a)) .
`• Certified copies not received: __ .
`
`Applicant has THREE MONTHS FROM THE "MAILING DATE- of this communicabon to file a reply complying with the requirements
`noted below. Failure to timely comply w ill result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`4. 0 A SUBSTITUTE OATH OR DECLARATION must be submitled. Note the attached EXAMINER'S AMENDMENT or NOTICE OF
`INFORMAL PATENT APP LI CAT ION (PT0-1 52) which gives reason(s) why the oath or declaration is deficient.
`5. D CORRECTED DRAWINGS ( as "replacement sheets") must be submitted.
`(a) 0 including changes req uire d by the Notice 01 Dra ftsperson's Palent Drawing Review ( PTO·948) attached
`1) 0 hereto or 2) 0 to Paper No.fMaii Date __ .
`including changes required by the attached Examiner's Amendment f Comment or in the Office action of
`Paper No.lMail Date __
`Identifyi ng indicia such as the application numb4:!r (see 37 CFR 1.84{c)) should bewrillen on the drawings in the front (not the back) of
`each sheet, Replacement sheet(s) should be labeled as such in too header according to 37 CFR 1,121 (d),
`6. D DEPOSIT OF andlor IN FORMAT ION about the deposit of BIOLOG ICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`(b) 0
`
`Anachment(s)
`1. 0 Notice of References Cited (PTO·892)
`2. 0 Notice of Draftperson's Patent Drawing Review (PTQ.948)
`
`3. ~ Infonnation Disclosure Statements (PTO/SB/08),
`Paper No.lMaii Date 04/ 14 /10
`4. 0 Examiner's Comment Regard ing Requirement for Deposit
`of Biological Material
`
`5. D Notice of Informal Patent Application
`6. 0
`Interview Summary (PT0-4 13),
`Paper No.lMail Date __ .
`7. 181 Examiner's Amendment/Comment
`
`8. [8J Examiner's Statement of Reasons for Allowance
`
`9. 0 Other
`
`.
`
`u.s . Patent . od T,.demo'" Offioo
`PTOL·37 (Re~. 08-(6)
`
`Notice of Allowability
`
`Part 01 Paper No.lMaii Date 20100520
`
`Apotex v. Abraxis - [PR20 18-00 153, Ex. 1024, p.04 of 8
`
`
`
`Application/Control Number: 11/553,339
`Art Un it : 1656
`
`Page 2
`
`A request fo r continued examination under 37 CFR I 114, incl uding the fee set forth in
`
`37 CFR 1.1 7(e), was filed in th is application after fi nal rejection. Si nce this application is
`
`cligible for continued examination under 37 CFR 1.1 14, and the fcc set fort h in 37 CFR 1.1 7(e)
`
`ha.o;; been timely paid, the final ity of the previous OfTi ce action has been withdrawn pursuanlto
`
`37 CF R 1.114. Applicant's subm ission filed on April 14,20 10 has been entered.
`
`Claims 2, 4, 13, 24-26 arc directed to an allowable product. Pursuant to the procedures
`
`set forth in MPEP § 821.04(8), cla ims 14-20, directed to the process of making or using an
`
`allowable product, previously withdrawn from consideration as a result of a restriction
`
`requiremcnt, are hereby rejoined and fully exami ned for patcntabil ity under 37 CFR 1.104.
`
`Because a ll claims previously withdrawn fro m consi deration under 37 CFR 1.1 42 have
`
`been rejoined, the restriction requirement as set forth in the Office action mailed on
`
`November 20, 2007, is hereby withdrawn . In view of the withdrawal of the restriction
`
`requirement as to the rejoined inventions, appl ieant(s) are advised that if any claim presented in a
`
`continuation or div isional application is anticipated by, or includes all the limitations of, a claim
`
`that is allowable in the present application, such claim may be subj ect to provisional statutory
`
`and/or nonstatutory double patenting rejections over the claims of the instant application. Once
`
`the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 arc no longer
`
`applicable. See In re Ziegler, 443 F.2d 1211 , 1215, 170 US PQ 129, 131-32 (CCPA 1971). See
`
`also MPE P § 804.0 1.
`
`Apotex v. Abraxis - [PR20 18-00 153, Ex. 1024, p.OS of 8
`
`
`
`Application/Control Number: 11/553,339
`Art Unit: 1656
`
`Page 3
`
`An examiner 's amendment to the record appears below. Should the changes and/or
`
`additions be unacceptable to appl icant, an am endment may he fil ed as provided by 37 e FR
`
`1.3 12. To ensure consideration of such an amendment, it MUST be submitted no later than the
`
`payment of the issue fcc .
`
`Authorization for this examiner's amendment was given in a telephone interview with C.
`
`Po lizzi, PhD. on May 20, 20 I O.
`
`The application has been amended as follows:
`
`In the claims:
`
`2. (current ly amended) A phannaceutical composition for injection comprising paclitaxel and a
`
`pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier comprises
`
`albumin, wherein the album in and the pacl itaxel in the composition are formul ated as
`
`Aalte~af'tieles particles, wherein the hSReJ3sAieles particles have a particle size of less than about
`
`200 nm, and wherein the weight ratio of album in to pac litaxel in the composition is about I: I to
`
`about 9: I.
`
`14 . (currently amended) A method of treating a disease comprising administering an effectivc
`
`amount of a pharmaceutical composit ion of clai m 2. where in the disease is ca ncer, arthritis. or
`
`restenosis.
`
`17. canceled
`
`18. (currently amended) The method of claim -I-f H, wherei n the di sease is restenosis.
`
`19. (currently am ended) The method of claim 14, wherein the composition is administered
`
`intravenously, intraarterially, iHtfafH:timsAar, intrapulmonari ly, orally, by inhalation,
`
`Apotex v. Abraxis - [PR20 18-00 153, Ex. 1024 , p.06 of 8
`
`
`
`Application/Control Number: 11/553,339
`Art Unit: 1656
`
`Page 4
`
`ifltm, esiettlarl) intravesicularly, intramuscularly, intra-tracheal ly, subcutaneously, intraocularly,
`
`intmthccally, or transdermally.
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`The following is an examiner's statement of reasons fo r allowance: claims 2, 4, 13- 16,
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`18-20.24-26 arc drawn to a pharmaceutica l composi tion comprising paciitaxcl and a
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`pharmaceutically acceptable carrier, wherein the pharmaceutically catTier compriscs albumin,
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`wherein the albumin and thc pael itaxel in the composition arc formulated as particles having a
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`size of less than about 200 nm and where in the weight ratio of albumin to paelitaxel in the
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`composition is about I: I to about 9: I, as well as to methods of treati ng cancer, arthritis, or
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`restenosis comprising administcring an elTcclivc amount of said pharmaceut ical composition.
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`The declaratioll und er 37 CFR 1. 132 filed April 14, 20 10, and Appl icants' remarks are s uffi cient
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`to overcome the I 03(a) rejection based upon Damascelli et al. in view of Desai et aI., as
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`evidenced by Ibrah im et aI. , in the Offi ce action mai led December 3 1, 2009. A search of the
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`prior art reveals that the instant elaims arc novel. Further. the prior art docs not suggest the
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`invcntion as cl aimed and therefore said invention is non-obvious.
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`Claims 2. 4.13-16. 18-20,24-26 are allowed.
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`Any comments considered necessary by applicant must be submitted no later than the
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`payment of the issue fee and, to avoid processing delays, should preferably accompany th e issue
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`fcc. Such submissions shou ld be clearly labeled "Comments on Statement of Reasons fo r
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`Al lowance."
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`Apotex v. Abraxis - [PR20 18-00 153, Ex. 1024, p.07 of 8
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`
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`Application/Control Number: 11/553,339
`Art Un it : 1656
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`Page 5
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`Any inquiry concerning this commun ication or earlier communi cations from the
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`cxaminer should be directed to Marsha M . Tsay whose telephone number is (571)272-2938 . The
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`examinerean normally be reached on M-F, 9:00am-5:00pm.
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`Ifattempts to reach the examiner by telephone arc unsucccssful. the examiner's
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`supelvisor. Manjunath N. Rao can be reached on 57 1-272-0939. The fax phone number for the
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`organization where th is application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the Patent
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`Application Infonnation Retrieva l (PAIR) system. Status infonnation for published applications
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`may be obtained from either Pri vate PAIR or Public PA IR. Status information for unpublished
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`applications is available through Pri vate PA IR only. For more infonnation about the PA IR
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`system, see http://pair-dircct. uspto.gov. Should you have questions on access to the Private PAIR
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`system, contact the Electronic Business Cen ter (EBC) at S66-217-9197 (toll -free). If you would
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`likc assistance from a USPTO Customer Service Representative or access to the automated
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`information system, call 800-786 -9 199 (IN USA OR CANADA) or 57 1-272-1000.
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`/Mal)'am MonshipouriJ
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`Primal)' Examiner, Art Unit 1656
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`May 20, 2010
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`M . Tsay
`Art Unit 1656
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`Apotex v. Abraxis - [PR20 18-00 153, Ex. 1024, p.08 of 8
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`