UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONFIRMATION NO.
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`111553,339
`
`10/26/2006
`
`Neil P. Desai
`
`638772000301
`
`3605
`
`04/28/2009
`7590
`25226
`MORRISON & FOERSTER LLP
`755 PAGE MILL RD
`PALO ALTO, CA 94304-1018
`
`EXAMINER
`
`TSAY, MARSHA M
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`ART UNIT
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`PAPER NUMBER
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`1656
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`MAIL DATE
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`DELIVERY MODE
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`04/28/2009
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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 time period for reply, if any, is set in the attached communication.
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`PTOL-90A (Rev. 04/07)
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`CIPLA EXHIBIT 1019
`Page 1 of 5
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`Office Action Summary
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`Application No.
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`11/553,339
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`Examiner
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`Applicant(s)
`
`DESAI ET AL.
`
`Art Unit
`
`1656
`Marsha M. Tsay
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE~ MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
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`Status
`1 )IZ! Responsive to communication(s) filed on 12 January 2009.
`2a)0 This action is FINAL.
`2b)[8J 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 parte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)[8J Claim(s) 2-23 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)[8J 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.
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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/are: a)O accepted or b)O objected to by the Examiner.
`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 required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`11 )0 The oath or declaration is objected to by the Examiner. 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. § 119(a)-(d) or (f).
`a)O All b)O 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.
`
`Attachment(s)
`1) [8J Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) [8Jinformation Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 01.12.09.
`
`4) 0
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`Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
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`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mail Date 20090415
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`CIPLA EXHIBIT 1019
`Page 2 of 5
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`Application/Control Number: 11/553,339
`Art Unit: 1656
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`Page2
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`This Office action is in response to Applicants' remarks received January 12, 2009.
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`Applicants' arguments filed have been fully considered and are deemed to be persuasive
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`to overcome some of the rejections previously applied. Rejections and/or objections not
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`reiterated from previous Office actions are hereby withdrawn.
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`Claim 1 is canceled. Claims 7-9, 14-23 are withdrawn. Claims 2-6, 10-13, to the species
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`anticancer agents, the (sub )species taxanes, and the (sub )species paclitaxel, are currently under
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`examination.
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`Priority: The request for priority to provisional application 60/432317, filed December 9,
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`2002, is acknowledged.
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`Objections and Rejections
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`The following is a quotation of35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in
`section 102 ofthis title, if the differences between the subject matter sought to be patented and the prior art are
`such that the subject matter as a whole would have been obvious at the time the invention was made to a person
`having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the
`manner in which the invention was made.
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`Claims 2-6, 10-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Damascelli et al. (2001 Cancer 92(10): 2592-2602) as evidenced by Ibrahim et al. (2000 Proc
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`Am Soc Clin Oncol19: abstract 609F). Damascelli et al. disclose ABI-007, a paclitaxel-human
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`albumin nanoparticle having 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 (evidenced by Ibrahim et al.). Damascelli et al. do not disclose a
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`weight ratio of albumin to paclitaxel is about 1: 1 to about 5: 1.
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`CIPLA EXHIBIT 1019
`Page 3 of 5
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`Application/Control Number: 11/553,339
`Art Unit: 1656
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`Page 3
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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
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`concentration and/or weight ratio of albumin to paclitaxel that will result in a composition that
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`will deliver paclitaxel most effectively in an albumin delivery system (claims 2-6, 10-13).
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`Generally, differences in concentration or temperature will not support the patentability of
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`subject matter encompassed by the prior art unless there is evidence indicating such
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`concentration or temperature is critical. "[W]here the 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 re Aller, 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 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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`combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969)
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`(Claimed elastomeric polyurethanes which fell within the broad scope of the references were
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`held to be unpatentable thereover because, among other 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 applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804,
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`10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14
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`USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465,43 USPQ2d 1362 (Fed. Cir.
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`1997).
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`CIPLA EXHIBIT 1019
`Page 4 of 5
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`Application/Control Number: 11/553,339
`Art Unit: 1656
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`Page4
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`The previous 103(a) has been withdrawn in view of Applicants' remarks. However, the
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`Damascelli et al. and Ibrahim et al. references are believed to be relevant art under 103(a) as
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`noted above.
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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 examiner by telephone are unsuccessful, the examiner's
`supervisor, Andrew Wang can be reached on 571-272-0811. The fax phone number for the
`organization where this application or proceeding is assigned is 571-273-8300.
`Information regarding the status of an application may be obtained from the Patent
`Application Information Retrieval (PAIR) system. Status information for published applications
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`applications is available through Private PAIR only. For more information about the PAIR
`system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR
`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Ifyou would
`like assistance from a USPTO Customer Service Representative or access to the automated
`information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Maryam Monshipouri/
`Primary Examiner, Art Unit 1656
`
`April15, 2009
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`CIPLA EXHIBIT 1019
`Page 5 of 5
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