"' ... "'" ~ U N ITED STATES P ATENT AND TRADEMARK O FFICE
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`APPLICATION " 0
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`FIU :-;ODATE
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`ATIORi'\cV DOCKET ,,"0
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`CO:"(FIKMATION 1'>0.
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`I lf~.53.339
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`10/26/2006
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`.'\'eil 1'. Desai
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`6.l877 2000JOI
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`I2IJlf2009
`25226
`1S90
`MORRISON & FOERSTER LLP
`755 PAGE MIU~ RD
`PALO AI.TO. C'A 94104· IOIS
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`"""
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`TSAY. :>1ARSHAM
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`ARTt.iNIT
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`PAPER ;"'UMllEK
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`""
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`MAil DATE
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`12l3 1/l009
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`D€L1 VCRY MODE
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The lime period for reply, if any, is set in the attached comm un ication.
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`I'TOI.-<)OA ( Rev. ()..I/07)
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`Apotex v. Abraxis - [PR20 18-00 151 , Ex. 1021 , p.O 1 of 6
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`

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`Office Action Summary
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`Application No.
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`111553,339
`
`Examiner
`
`Applicant(s)
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`DESAI ET AL.
`
`Art Unit
`
`Marsha M. Tsay
`1656
`The MAILING DATE of this comm unication appears on the cover sheet with the correspondence address
`Period for Re ply
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET T O EXPIRE J MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of lime may be 8vaiable under !tie provisions 01 37 CFR 1.136(8). In 00 event, however. may 8 reply be limely fi le<l
`atler SI X (6) MON f HS lrom the maiing date 01 this conlTOJnication.
`If NO period lor repty ;, speeifie<l aOOve. the maxinum statul(lry period will ewly and will expire SIX (6) MONfHS lrom the ma ilirlo\j date 01 tIlis communication
`Failure to reply wltlin Ill'! set o r extended period for reply will, by statute, cause the awlication to become ABANDONED (35 U.S.C. § 133)
`Any O'eply MoaNed by the Office later than three month\ atler the mailing date 01 thi ~ commun ication, even ~ timely filed. may reduce any
`ea rn&<! patent term adju.\lmen t See 37 CFR 1.704(b)
`
`Status
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`Responsive to communication(s) filed on 27 October 2oo9.
`1)0
`2a)0
`This action is FINAL.
`2b)0 This action is non-final.
`3)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parle Quayle , 1935 C.D. 11 , 453 O.G. 213.
`
`Disposition of Claims
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`4)['8] Claim{s) 2-25 is/are pending in the application
`4a) Of the above claim(s) 7-9 and 14-23 is/are withdrawn from consideration.
`5)0 Claim{s) __ is/are allowed.
`6)[8) Claim{s) 2-6 10-13 24 and 25 is/a re rejected.
`7)0 Claim{s) __ is/are objected to.
`8)0 Claim{s) __ are subject to restriction and/or election requirement.
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`Application Papers
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`9)0 The specification is objected to by the Examiner.
`10)0 The drawing{s) filed on __ is/a re: a)O accepted or b)O objected to by the Exam iner
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheel(s) including the correction is req uired if the drawing(s) is objected 10. See 37 CFR 1.121(d).
`11)0 The oath or declaration is objected to by the Exam iner. Note the attached Office Action or form PT0-152.
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`Priority under 35 U.S.C. § 119
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`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 11 9{aKd) or (f).
`a)D All b)D Some· c)O None of:
`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» .
`• See the attached detailed Office action for a list of the certified copies not received.
`
`4 ) 0 Interview S ummary (PT0413)
`Paper No(s)IMa~ Date. __
`5) 0 Notce of Informal Patent Applicaton
`6) 0 Othe r: __
`
`Allachment(s)
`1) 0 Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) [8) Information Disclosure SUlIement(s) (PTO/SB/OS)
`Paper No(s}/Mail Dale 'J!)J2]Jfll
`u.S. P....,. . nd T...., ..... rk orr~
`PTOL-326 (Rev. 08-(6)
`
`Offi<:e Action Summary
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`Part of Paper No.lMai( Date 20091228
`
`Apotex v. Abraxis - [PR20 18-00 151 , Ex. 1021, p.02 of 6
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`

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`Appl ication/Control Number: 11/553,339
`Art Unit : 1656
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`Page 2
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`This Office action is in response to Appl icants' remarks received October 27, 2009.
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`App licants ' arguments fi led have been fu ll y considered and are deemed to be persuasive
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`to overcome some of the rejections previously appl ied. Rejections and/or objections not
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`reiterated from previous Office actions are hereby withdrawn.
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`Claim I is. canceled. Claims 7-9,1 4-23 are withdrawn. Cl ai ms 2-6, 10-13, 24-25 arc
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`currently under ex amination.
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`Priority: The request for priority to provisional app li cation 60/432 317, fi led December 9,
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`2002, is acknowledged.
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`Objections a nd Rejections
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`The follo wing is a quotation of 35 U.s.C. 103(a) which fonns the basis fo r all
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`obviousness rejec tions sct fort h in th is Office action:
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`(1I) A patl-"llt may not be ohtaineu though the iml-1ltion is not iuentieally disd oSl-oU or dcS(;ribed as ;;ct forth in
`;;cetion 102 orlhi;; lille. if the dilTercnccs betwl-'Cn lhe subject matter sought to be patented and the prior art arc
`such thallhe subjeci mallcr as a whole would havc been obvious at the time the invcntion was made to a person
`having ordinal)' skill in the art 10 which said subject matter pertains. PalCntabil ity shall not be negatived by the
`manner in which the invention was made
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`Claims 2-6,10-13,24-25 are rejected under 35 U.S.c. 103(a) as being unpatentable over
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`Damascell i et al. (200 I Cancer 92( I 0): 2592-2602; previously cited) in view of Desai ct al. (US
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`6537579; IDS 02.20.08) as cvidenccd by Ibrahim ct al. (2000 Proc Am Soc Clin Oncol 19:
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`abstract 609F). The Ibrahim et al. reference is cited as evi dence to note that ABI-007 is
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`cremophor-free.
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`Damascelli et al. disclose ABI-007, a paclitaxel-human albumi n nanoparticle having a
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`dimension or 150-200 nm (p. 2593 col. 2, Fig. 1). 1l is known thaI AB1--007 is cremo phor-rrcc
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`Apotex v. Abraxis - [PR20 18-00 15 1, Ex. 102 1, p.03 of 6
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`

`

`Application/Control Number: 11/553,339
`Art Unit: 1656
`
`Page 3
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`(evidenced by Ibrahim et al.). Damascelli et al. do not disclose a weight ratio of albumin to
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`paclitaxel is about I: I to about 9: I.
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`Desai et al. disclose dosage fonns of AB I-007 contain 30 mg, 100 mg, or 300 mg of
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`paclitaxel in a vial (col. 14 lines 4-5). Desai et al. further disclose that unit vessels of ABI -007
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`may contain between 1 mg to 1000 mg of active drug (col. 15 lines 39-40).
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`It would have been obvious to one of ordinary skill in the art at the time the invention
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`was made to modify the teachings of Damascelli et al. by determining the optimum weight ratio
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`of albumin to paclitaxel, i.c. 9: I, as suggcsted by Desai et al. which will result in a composition
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`that wi ll deliver paclitaxel most effectively in an albumin del ivery system (claims 2-6, 10-13,
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`25). The motivation 10 do so is given by Desai el ai., which disclose a weight ratio of albumin 10
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`paclitaxelof9:1. Since Desai et al. disclose AB I-007 can contain up to 1000 mgofaetive drug
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`and further disclose that ABI-007 can contain 100 mg ofpaclitaxel, it would be reasonable for
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`one of ordinary skill to note that a 1000 mg vial of ABI -007 would con tain 100 mg pacl itaxel
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`and 900 mg albumin, i.c. a weight ratio of9: 1 of albumin to paclitaxcl.
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`Regarding the ratio of 5: 1 (albumin to paclitaxcl) recited in claim 24, it should be noted
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`that generally, differences in concentration or temperaTUre will not support the patcntability of
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`subject matter encompas..<;.ed by the prior art unless there is evidence indicating such
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`concentration or temperature is critica l. "[\v]herc thc general conditions of a claim are disclosed
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`in the prior art, it is not inventive to discover the optimum or workable ranges by routine
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`experimentation." In I·e Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) ("The
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`nonnal desire of scientists or artisans to improve upon what is already generally known provides
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`the motivation to determine where in a disclosed set of percentage ranges is the optimum
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`Apotex v. Abraxis - [PR20 18-00 151 , Ex. 1021 , p.04 of 6
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`

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`Application/Control Number: 11/553,339
`Art Unit: 1656
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`Page 4
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`combination of percentages."); In re f1oeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969)
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`(Claimed elastomeric polyurethanes which fell withi n the broad scope of the references were
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`held to bc unpatentable thereover because, among other reasons, there was no evidence of the
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`cri ticality of the claimed ranges of molecular weight or molar proportions.). For more recent
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`cases applying this principle, sec Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F .2d 804,
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`10 US PQ2d 1843 (Fed. Ci L), cerl. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14
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`USPQ2d 1056 (Fed. CiL 1990); and In re Geisler. 11 6 F.3d 1465,43 US PQ2d 1362 (Fed. CiL
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`1997). In Ihis instance, since Desai el al. disclose the weight ntlio of 9: L (albumin to paclilaxel),
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`it would be reasonable for one of ordinary sk ill to want to further determine which other weight
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`ratios would optimize delivery of pacl itaxe l.
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`In view of Applicants' amendments and remarks. the Desai et al. reference has been
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`added to the I03(a) rejection.
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`Therefore. the claims remain rejected under 1 03(a) for the reasons noted above.
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`No claim is allowed.
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`Applicant's amendment necessitated the new ground(s) of rejection presented in this
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`Office action. Accordi ngly, T HI S ACTION IS MADE FI NAL. See MPEP § 706.07(a).
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`Applicant is reminded of the extension of time potiey as set forth in 37 eFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing dale oflhis action. In the even t a first reply is filed within TWO
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`Apotex v. Abraxis - [PR20 18-00 15 1, Ex. 102 1, p.05 of 6
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`

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`Application/Control Number: 11/553,339
`Art Unit: 1656
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`Page 5
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`MONTHS of the mai ling date of this final action and the adviso!), action is not mailed until after
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`the end of the THREE-MONTH shortened statutory period, then the shortened statutory period
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`wi ll expire on the date the advisory action is mailed, and any extension fee pursuant to 37
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`CFR \. 136(a) will be calculated from the mai ling date o f the advisory action. In no event,
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`however. will the statutory period for reply expire later than SIX MONTHS from the date of this
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`final action.
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`Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Marsha M. Tsay whose telephone number is (57 1)272-2938. The
`examiner can normally be reached on M-F, 9:00am-5:00pm.
`Ifaltempts to reach the exami ner by telephone are unsuccessful. the examiner's
`superv isor. Andrew Wang can be reached on 57 1-272-0811. The fax phone number for lhe
`organization where this appl ication or proceeding is assigned is 571-273-8300.
`Information regarding th e status of an application may be obtain ed from th e Patent
`Appl ication Infonnation Retri eval (PAIR) system. Status infonnation for published appli cations
`may bc obtained from either Private PAIR or Public PAIR. Status information for unpublishcd
`applications is available through Private PAIR only. For more information about the PAIR
`system, see http://pair-direct.uspto.gov.Shou ldyouhavequestions on access to the Pri vate PAIR
`system, contact the Electronic Business Center (EBC) at 866-217 -9197 (toll-free). If you would
`like assistance from a USPTO Customer Service Representative or access to the automated
`inform ation system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`IMaryam Monshipouril
`Primary Examiner, Art Unit 1656
`
`December 28, 2009
`
`Marsha Tsay
`Art Unit 1656
`
`Apotex v. Abraxis - [PR20 18-00 151 , Ex. 1021 , p.06 of 6
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`