`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313-1450
`wwwnsptogov
`
`APPLICATION NO.
`
`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`
`CONF {MATION NO.
`
`11/553,339
`
`10/26/2006
`
`Neil P. Desai
`
`638772000301
`
`3605
`
`25226
`7590
`12/31/2009
`MORRISON & FOERSTER LLP
`755 PAGE MILL RD
`PALO ALTO, CA 94304-1018
`
`EXAMINER
`TSAY, MARSHAM
`
`ART UNIT
`
`1656
`
`MAIL DATE
`
`12/3 1/2009
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Actavis - IPR201 7-01 1
`
`PTOL_90A (Rev. 04/07)
`
`Actavis - IPR2017-01103, Ex. 1021, p. 1 of 6
`
`

`

`
`
`Office Action Summary
`
`Application No.
`
`11/553,339
`
`Examiner
`
`Marsha M. Tsay
`
`Applicant(s)
`
`DESAI ET AL.
`
`Art Unit
`
`1656 -
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`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.
`-
`- 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).
`
`Status
`
`1)IXI Responsive to communication(s) filed on 27 October 2009.
`
`2a)IZI This action is FINAL.
`
`2b)I:I This action is non-final.
`
`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 O.G. 213.
`
`Disposition of Claims
`
`4)IZI 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)I:I Claim(s) _ is/are allowed.
`
`6)IXI Claim(s) 2-6 10-13 24 and 25 is/are rejected.
`
`7)I:I Claim(s) _ is/are objected to.
`
`8)I:I Claim(s) _ are subject to restriction and/or election requirement.
`
`Application Papers
`
`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).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`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:
`
`1.I:I Certified copies of the priority documents have been received.
`
`2.I:I Certified copies of the priority documents have been received in Application No.
`
`
`
`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)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`4) D Interview Summary (PTO-413)
`1) D Notice of References Cited (PTO-892)
`Paper N0(S)/Ma“ Date- _
`2) D 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
`
`Paper No(s)/Mail Date 10/27/09.
`6) D Other:
`.
`U.S. Patent and Trademark Office
`
`PTOL-326 (Rev. 08-06)
`
`Office Acti
`Summary
`Part of Paper No./Mail Date 20091228
`Actavis - IPR2017-01I’1103, Ex. 1021, p. 2 of 6
`
`Actavis - IPR2017-01103, Ex. 1021, p. 2 of 6
`
`

`

`Application/Control Number: 11/553,339
`
`Page 2
`
`Art Unit: 1656
`
`This Office action is in response to Applicants’ remarks received October 27, 2009.
`
`Applicants' arguments filed have been fiJlly considered and are deemed to be persuasive
`
`to overcome some of the rejections previously applied. Rejections and/or objections not
`
`reiterated from previous Office actions are hereby withdrawn.
`
`Claim 1 is canceled. Claims 7-9, 14-23 are withdrawn. Claims 2-6, 10-13, 24-25 are
`
`currently under examination.
`
`Priority: The request for priority to provisional application 60/432317, filed December 9,
`
`2002, is acknowledged.
`
`Objections and Rejections
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(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.
`
`Claims 2-6, 10-13, 24-25 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Damascelli et al. (2001 Cancer 92(10): 2592-2602; previously cited) in view of Desai et al. (US
`
`6537579; IDS 02.20.08) as evidenced by Ibrahim et al. (2000 Proc Am Soc Clin Oncol 19:
`
`abstract 609F). The Ibrahim et al. reference is cited as evidence to note that ABI-007 is
`
`cremophor-free.
`
`Damascelli et al. disclose ABI-007, a paclitaxel-human albumin nanoparticle having a
`
`dimension of 150-200 nm (p. 2593 col. 2, Fig. 1). It is known that ABI-007 is cremophor-free
`
`Actavis - IPR2017-O1103, Ex. 1021, p. 3 of 6
`
`Actavis - IPR2017-01103, Ex. 1021, p. 3 of 6
`
`

`

`Application/Control Number: 11/553,339
`
`Page 3
`
`Art Unit: 1656
`
`(evidenced by Ibrahim et al.). Damascelli et al. do not disclose a weight ratio of albumin to
`
`paclitaxel is about 1:1 to about 9:1.
`
`Desai et al. disclose dosage forms of ABI-007 contain 30 mg, 100 mg, or 300 mg of
`
`paclitaxel in a vial (col. 14 lines 4-5). Desai et a1. fiarther disclose that unit vessels of ABI-007
`
`may contain between 1 mg to 1000 mg of active drug (col. 15 lines 39-40).
`
`It would have been obvious to one of ordinary skill in the art at the time the invention
`
`was made to modify the teachings of Damascelli et al. by determining the optimum weight ratio
`
`of albumin to paclitaxel, i.e. 9:1, as suggested by Desai et al. which will result in a composition
`
`that will deliver paclitaxel most effectively in an albumin delivery system (claims 2-6, 10-13,
`
`25). The motivation to do so is given by Desai et al., which disclose a weight ratio of albumin to
`
`paclitaxel of 9: 1. Since Desai et a1. disclose ABI-007 can contain up to 1000 mg of active drug
`
`and fiarther disclose that ABI-007 can contain 100 mg of paclitaxel, it would be reasonable for
`
`one of ordinary skill to note that a 1000 mg vial of ABI-007 would contain 100 mg paclitaxel
`
`and 900 mg albumin, i.e. a weight ratio of 9:1 of albumin to paclitaxel.
`
`Regarding the ratio of 5 :1 (albumin to paclitaxel) recited in claim 24, it should be noted
`
`that generally, differences in concentration or temperature will not support the patentability of
`
`subject matter encompassed by the prior art unless there is evidence indicating such
`
`concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed
`
`in the prior art, it is not inventive to discover the optimum or workable ranges by routine
`
`experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) ("The
`
`normal desire of scientists or artisans to improve upon what is already generally known provides
`
`the motivation to determine where in a disclosed set of percentage ranges is the optimum
`
`Actavis - IPR2017-O1103, Ex. 1021, p. 4 of 6
`
`Actavis - IPR2017-01103, Ex. 1021, p. 4 of 6
`
`

`

`Application/Control Number: 11/553,339
`
`Page 4
`
`Art Unit: 1656
`
`combination of percentages"); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969)
`
`(Claimed elastomeric polyurethanes which fell within the broad scope of the references were
`
`held to be unpatentable thereover because, among other reasons, there was no evidence of the
`
`criticality of the claimed ranges of molecular weight or molar proportions). For more recent
`
`cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804,
`
`10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 US. 975 (1989); In re Kulling, 897 F.2d 1147, 14
`
`USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir.
`
`1997). In this instance, since Desai et al. disclose the weight ratio of 9:1 (albumin to paclitaxel),
`
`it would be reasonable for one of ordinary skill to want to further determine which other weight
`
`ratios would optimize delivery of paclitaxel.
`
`In view of Applicants’ amendments and remarks, the Desai et al. reference has been
`
`added to the 103(a) rejection.
`
`Therefore, the claims remain rejected under 103(a) for the reasons noted above.
`
`No claim is allowed.
`
`Applicant's amendment necessitated the new ground(s) of rejection presented in this
`
`Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
`
`Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date of this action. In the event a first reply is filed within TWO
`
`Actavis - IPR2017-O1103, Ex. 1021, p. 5 of 6
`
`Actavis - IPR2017-01103, Ex. 1021, p. 5 of 6
`
`

`

`Application/Control Number: 11/553,339
`
`Page 5
`
`Art Unit: 1656
`
`MONTHS of the mailing date of this final action and the advisory action is not mailed until after
`
`the end of the THREE-MONTH shortened statutory period, then the shortened statutory period
`
`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
`
`CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event,
`
`however, will the statutory period for reply expire later than SIX MONTHS from the date of this
`
`final action.
`
`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.
`
`/Maryam Monshipouri/
`Primary Examiner, Art Unit 1656
`
`December 28, 2009
`
`Marsha Tsay
`Art Unit 1656
`
`Actavis - IPR201 7-01 1
`
`Actavis - IPR2017-01103, Ex. 1021, p. 6 of 6
`
`