"' ... "'" ~ 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:"(FIK MATION 1'>0.
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`Ilf~.53.339
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`10/26/2006
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`.'\'eil 1'. Desai
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`6.l877 2000JO I
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`1).<128/2009
`25226
`1S90
`MORRISON & FOERSTER LLP
`755 PAGE MIU~ RD
`PALO AI.TO. C'A 94104· IOIS
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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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`(Hl2812009
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`D€L1VCRY 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 - IPR2018-00153, Ex. 1019, p.OI of5
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`

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`Office Action Summary
`
`Application No.
`
`111553,339
`
`Examiner
`
`Applicant(s)
`
`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 TO 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 mailirlo\j date 01 tIlis communication
`Failure to reply wltlin Ill'! set or extended period for reply will, by statute, cause the awlication to become ABANDON ED (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 12 January 2009.
`1)0
`2al0
`This action is FINAL.
`2b)(gI 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
`
`4)(gI Claim{s) 2-23 is/are pendin9 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 and 10-13 is/are rejected .
`7)0 Claim{s) __ is/are objected to.
`8)0 Claim{s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`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 sheet(s) including the correction is req uired if the drawing(s) is objected to. 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 Summary (PT0-41 3)
`Poper NO(s)IMoil Datc. __
`5) 0 Nobce of Informal Patent ApplicabOll
`6) 0 Other: __
`
`AIIBchment(s)
`t ) ~ Notice of References Cited (pT0.892)
`2) 0 Notice of Oraftspen,;on's P<l tlmt Drawing Review (PTO-948)
`3) ~ Information Disclosure Statement(s) (PTD/SB/OS)
`Paper No(s )/MaiT Date lli2...Qll:
`u.s. Pat .... . n~T,.oe ... ' k OlIO.
`PTOL-326 (Rev 08.()6)
`
`OffiCB Action Summary
`
`Part of Paper No.lMail Date 20090415
`
`Apotex v. Abraxis - lPR201 8-00153, Ex. 101 9, p.02 of5
`
`

`

`Application/Control Number: 11/553,339
`Art Unit: 1656
`
`Page 2
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`This Office action is in response to Appl icants ' remarks received January 12,2009.
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`Applicants' arguments filed have been fu ll y considered and are deemed to be persuasi ve
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`to overcome somc 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 7-9,14-23 are withdrawn. Clai ms 2-6, 10-13, to the spccies
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`anticancer agents , the (sub)spec ics taxanes, and the (sub)species paelitaxel, are currently under
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`examination.
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`Priority: The request for priority to provisional application 60/43 23 17, filed December 9,
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`2002, is acknowledged.
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`Objections and Rejections
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`Thc following is a quotation of 35 U. S.C. 103(a) which fonns the basis for all
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`obviousness rejcctions set fort h in this Office action:
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`(a) A patent may not he ohtaioed though the invention is not identically disclosed ordcserihcd as set forth in
`section 102 of thi;; title. if the dillcrt"TlcCS between the sllbject m~lIcr sOllghtto be p~lCntl,.xI and the prior ~ rI ~rc
`such thatthc subject malle·r as a whole would have been otn ·iolls at the time the invention was made to a person
`having ordinal)' skill inlhc arllO whieh said subjcct mailer IX'rtains. Patentability sha lluot be negatived by the
`lIlallilIT in whid] the inn."11lion was lluwe.
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`Claims 2-6, 10- \3 are rejected under 35 U.S.C. I 03(a) as be ing unpatentable over
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`Damaseel li ct al. (200 I Cancer 92( 10): 2592-2602) as evidenced by Ibrahim ct al. (2000 Proc
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`Am Soc Clin Oneol19: abstract 609F). Damascelli ct al. disclose AB I-007, a paclitaxcl-human
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`albumin nanop<lrticie h<lving a dimension of 150-200 nm (p. 2593 col. 2, Fig. 1). It is known that
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`ABI-007 is cremophor-free (evid enced by Ibrahim el al.). Damasce ll i el al. do nol disclose a
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`weight ratio oralbumin to pac1itaxc1 is about I : 1 to about 5:1.
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`Apotex v. Abraxis - IPR201 8-00153 , Ex. 1019, p.03 of5
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`

`

`Application/Control Number: 11/553,339
`Art Un it : 1656
`
`Page 3
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`It would have been obvious 10 one of ordinal)' skill in the art at the time the invention
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`was made to modify the teachings of Dam ascelli et al. by determining the optimum
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`concentration and/or weight ratio of albumin to pacl itaxc\ that will result in a composition that
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`wi ll deliver paclilaxc\ most effectively in an albumin delivery system (claim .. 2-6, 10- 13).
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`Generally, differences in concentrdtion or temperature wil l not support the patentability of
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`subject matter encompassed by the prior art unless there is evidence indicati ng suc h
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`concentration or temperature is critica l. " [W]here the general cond it ions 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 re Alfer, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) ("The
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`normal desire of scientists or artisans to improve upon what is already general ly 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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`combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969)
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`(Claimed elastomcric polyurethanes which fel l withi n the broad scope of the references were
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`held to be unpatentable thercover because, among ot her reasons, there was no evidence of the
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`criticality of the claimed ranges of molecular weight or molar proportions.). For more recent
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`cases app lying this princi ple, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F .2d 804,
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`10 US PQ2d 1843 (Fed. Cir. ), cerro denied, 493 U.S. 975 (1989); In re Klil/ing, 897 F.2d 1147, 14
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`USPQ2d 1056 (Fed. Cif. 1990); and In re Geisler, 11 6 F J d 1465, 43 US PQ2d 1362 (Fed. Ci r.
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`1997).
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`Apotex v. Abraxis - IPR2018-00153, Ex. 1019, p.04 of5
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`

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`Application/Control Number: 11/553,339
`Art Unit: 1656
`
`Page 4
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`Thc previous 103(a) has been withdrawn in view of Applicants ' remarks. However, the
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`Dama. .. celli et al. and Ibrah im et al. references are bel ieved to be relevant art under 103(a) a.<;
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`noted abovc.
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`No claim is allowed.
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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 (571)272-2938. The
`examiner can normally be reached on M-F, 9:00am-5:00pm.
`If attempts to reach the exami ner by telephone are unsuccessrul, the examiner's
`supervisor, Andrew Wang can be reached on 57 1-272-0811. The fax phone number for the
`organization where this appl ication or proceeding is assigned is 571-273-8300.
`Inrormation regarding the status or an application may be obtained rrom the Patent
`Application Information Retrieva l (PAIR) system. Status informa tion for published applications
`may be obtained from either Private PA IR or Public PA JR. Status infonnation for unpubl ished
`applications is available through Private PAIR only. For more infonnation about the PAIR
`system, sec http://pair-dircct. uspto.gov. Should you have questions on aecess to the Private PAIR
`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
`like assistance from a US PTO Customer Service Represen tative or access to the automated
`information system, call 800-786-9 199 (IN USA OR CANADA) or 57 1-272-1000.
`
`IMaryam MonshipouriJ
`Primary Examiner, Art Unit 1656
`
`April i5, 2009
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`Apotex v. Abraxis - lPR2018-00 153, Ex. 10 19, p.05 of5
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`