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`UNITED STATES PATENT AND TRADEMARK OEEICE
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`\Ieil 3'. Desai
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`1 “553,339
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`25226
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`10/26/2006
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`7590
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`12/31/2009
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`MORRISON & FOERSTER LLP
`755 PAGE MILL RD
`PALO ALTO, CA 94304-1018
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.0 Box 1450
`Alexandna, Virgmia 22313-1450
`www.uspto gov
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`638772000301
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`3605
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`EWHNER
`TSAY. MARSHAM
`PAPER NUMBER
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`ART UNIT
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`1656
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`MAIL DATE
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`12/31/2009
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`DELIVERY 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 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 1021
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`CIPLA EXHIBIT 1021
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`Application No.
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`11/553,339
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`Examiner
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`Applicant(s)
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`DESAI ET AL.
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`Art Unit
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`
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`Office Action Summary
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`Marsha M. Tsay 1656
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`-- The MAILING DA TE 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 3 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.
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`- 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
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`1)IZ| Responsive to communication(s) filed on 27 October 2009.
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`2a). This action is FINAL.
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`2b)|:| This action is non-final.
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`3)I:I 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 CD. 11, 453 0.6. 213.
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`Disposition of Claims
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`4)IZ 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.
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`5)I:I Claim(s)_ is/are allowed.
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`6)IZ Claim(s) 2-6 10-13 24 and 25 is/are rejected.
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`7)I:I Claim(s)_ is/are objected to.
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`8)I:I Claim(s)_ are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:I The specification is objected to by the Examiner.
`10)I:I The drawing(s) filed on _ is/are: a)I:I accepted or b)I:I 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).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`a)I:I All
`b)I:I Some * c)I:I None of:
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`1.I:I Certified copies of the priority documents have been received.
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`2.I:I Certified copies of the priority documents have been received in Application No. _
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`3.I:I 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)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`4) D Interview Summary (PTO-413)
`1) D Notice of References Cited (PTO-892)
`Paper N0(S)/M3” Date. _
`2) I] Notice of Draftsperson‘s Patent Drawing Review (PTO—948)
`3) IZI Information Disclosure Statement(s) (PTO/SB/08)
`5) I:I Notice of Informal Patent Application
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`Paper No(s)/Mai| Date w.
`6) D Other: _
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08-06)
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`Part of Paper No./Mai| Date 20091228
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`Office Action Summary
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`CIPLA EXHIBIT 1021
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`Application/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 Applicants” remarks received October 27, 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, 24—25 are
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`currently under 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 of 35 U.S.C. l03(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 patcnt may not be obtained though the invention is not identically disclosed or described as set forth in
`section 102 of this 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 ordinaiy 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, 24—25 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Damascelli ct al. (2001 Cancer 92(10): 2592-2602; previously cited) in view of Desai et al. (US
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`6537579; IDS 02.20.08) as evidenced by Ibrahim et a1. (2000 Proc Am Soc Clin Oncol 19:
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`abstract 609F). The Ibrahim et a1. reference is cited as evidence to note that ABI-007 is
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`cremophor—free.
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`Damascelli et a1. disclose ABI-007, a paclitaxel—human albumin nanoparticle having a
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`dimension of 150-200 nm (p. 2593 col. 2, Fig. 1). It is known that ABI-007 is cremophor—fi'ee
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`Application/Control Number: 11/553,339
`Art Unit: 1656
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`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 1:1 to about 9:1.
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`Desai et a1. disclose dosage forms ofABl—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 a1. 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 a1. by determining the optimum weight ratio
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`of albumin to paclitaxel, i.e. 9:1, as suggested by Desai et al. which will result in a composition
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`that will deliver paclitaxel most effectively in an albumin delivery system (claims 2-6, 10-13,
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`25). The motivation to do so is given by Desai et al., which disclose a weight ratio of albumin to
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`paclitaxel of 9: 1. Since Desai et a1. disclose ABI—007 can contain up to 1000 mg of active drug
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`and further disclose that ABI-007 can contain l00 mg of paclitaxel, it would be reasonable for
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`one of ordinary skill to note that a 1000 mg vial of ABI-007 would contain 100 mg paclitaxel
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`and 900 mg albumin, i.e. a weight ratio of 9:1 of albumin to paclitaxel.
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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 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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`Application/Control Number: 11/553,339
`Art Unit: 1656
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`Page 4
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`combination ofpercentages."); In re I-Ioeschele, 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 US. 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). In this instance, since Desai et al. disclose the weight ratio of 9:1 (albumin to paclitaxel),
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`it would be reasonable for one of ordinary skill to want to further determine which other weight
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`ratios would optimize delivery of paclitaxel.
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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 103(a) rejection.
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`Therefore, the claims remain rejected under 103(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. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
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`Applicant is reminded of the extension of time policy as set forth in 37 CFR 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 date of this action. In the event a first reply is filed within TWO
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`Application/Control Number: 11/553,339
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`MONTHS ofthe mailing date ofthis final action and the advisory 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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`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
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`CFR 1.136(a) will be calculated from the mailing date of 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 (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—081 1. 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-direet.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). If you 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.
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`/Maryam Monshipouri/
`Primary Examiner, Art Unit 1656
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`December 28, 2009
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`Marsha Tsay
`Art Unit 1656
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