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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
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`APPLICATION NO.
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` F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONF {MATION NO.
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`11/553,339
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`10/26/2006
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`Neil P. Desai
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`638772000301
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`3605
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`25226
`7590
`04/28/2009
`MORRISON & FOERSTER LLP
`755 PAGE MILL RD
`PALO ALTO, CA 94304-1018
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`EXAMINER
`TSAY, MARSHAM
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`ART UNIT
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`1656
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`MAIL DATE
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`04/28/2009
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`PAPER NUMBER
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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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`Actavis - IPR201 7-01 1
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`PTOL_90A (Rev. 04/07)
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`Actavis - IPR2017-01104, Ex. 1019, p. 1 of 5
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`Application No.
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`11/553,339
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`Applicant(s)
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`DESAI ET AL.
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`Office Action Summary
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`Examiner
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`Marsha M. Tsay
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`Art Unit
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`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 Q 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)IXI Responsive to communication(s) filed on 12 January 2009.
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`2a)I:I This action is FINAL.
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`2b)IZI 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
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`closed in accordance with the practice under EX parte Quayle, 1935 CD. 11, 453 O.G. 213.
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`. U
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`Disposition of Claims
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`4)IZI Claim(s) fl is/are pending in the application.
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`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)
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`is/are allowed.
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`6)IXI Claim(s) 2-6 and 10-13 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.
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`10)I:I The drawing(s) filed on
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`is/are: a)I:I accepted or b)I:I objected to by the Examiner.
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`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).
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`a)I:I All
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`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
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`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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`Attach ment(s)
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`1) IZI Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) IZI Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 01.12.09.
`.S. Patent and Trademark Office
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`4) D Interview Summary (PTO-413)
`Paper N0(S)/Ma“ Date- _
`5) I:I Notice of Informal Patent Application
`6) D Other:
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`PTOL-326 (Rev. 08-06)
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`Actavis _
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`1 01 9’ p. 2 orgt of Paper No./Mail Date 20090415
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`Actavis - IPR2017-01104, Ex. 1019, p. 2 of 5
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`Application/Control Number: 11/553,339
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`Page 2
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`Art Unit: 1656
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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 fiJlly 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 of 35 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 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 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 a1. (2001 Cancer 92(10): 2592-2602) as evidenced by Ibrahim et al. (2000 Proc
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`Am Soc Clin Oncol 19: abstract 609F). Damascelli et a1. 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 a1. 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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`Actavis - IPR2017-O1104, Ex. 1019, p. 3 of 5
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`Actavis - IPR2017-01104, Ex. 1019, p. 3 of 5
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`Application/Control Number: 11/553,339
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`Page 3
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`Art Unit: 1656
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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 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).
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`Actavis - IPR2017-O1104, Ex. 1019, p. 4 of 5
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`Actavis - IPR2017-01104, Ex. 1019, p. 4 of 5
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`Application/Control Number: 11/553,339
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`Page 4
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`Art Unit: 1656
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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). 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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`April 15, 2009
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`Actavis - IPR201 7-01 1
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`Actavis - IPR2017-01104, Ex. 1019, p. 5 of 5
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