`
`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
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`25226
`7590
`02/13/2014
`MORRISON & FOERSTER LLP
`755 PAGE MILL RD
`PALO ALTO, CA 94304-1018
`
`EXAMINER
`
`LOVE, TREVOR M
`
`ART UNIT
`
`PAPER NUMBER
`
`1611
`
`DATE MAILED: 02/13/2014
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`11/520,479
`
`09112/2006
`
`Neil P, Desai
`
`638772000109
`
`8972
`
`TITLE OF INVENTION: Novel formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`05/13/2014
`
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`PTOL-85 (Rev, 02/11)
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`Page 1 of3
`
`Actavis - IPR2017-01100, Ex. 1025, p. 1 of 7
`
`
`
`PART B- FEE(S) TRANSMITTAL
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`MORRISON & FOERSTER LLP
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`(Signature)
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`(Date)
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`APPLICATION NO.
`
`FILING DATE
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`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`ll/520,479
`
`09112/2006
`
`Neil P. Desai
`
`63 8772000109
`
`8972
`
`TITLE OF INVENTION: Novel formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
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`$0
`
`$960
`
`05/13/2014
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`LOVE, TREVOR M
`
`l6ll
`
`514-183000
`
`l. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`0 Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
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`PTOL-85 Part B (10-13) Approved for use through 10/3112013.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`Page 2 of3
`
`Actavis - IPR2017-01100, Ex. 1025, p. 2 of 7
`
`
`
`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
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`11/520,479
`
`09112/2006
`
`Neil P. Desai
`
`638772000109
`
`8972
`
`25226
`7590
`02/13/2014
`MORRISON & FOERSTER LLP
`755 PAGE MILL RD
`PALO ALTO, CA 94304-1018
`
`EXAMINER
`
`LOVE, TREVOR M
`
`ART UNIT
`
`PAPER NUMBER
`
`1611
`
`DATE MAILED: 02/13/2014
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
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`The Patent Term Adjustment to date is 108 day(s). If the issue fee is paid on the date that is three months after the
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`If a Continued Prosecution Application (CPA) was filed in the above-identified application, the filing date that
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`PTOL-85 (Rev. 02/11)
`
`Page 3 of3
`
`Actavis - IPR2017-01100, Ex. 1025, p. 3 of 7
`
`
`
`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
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`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
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`
`Actavis - IPR2017-01100, Ex. 1025, p. 4 of 7
`
`
`
`Notice of Allowability
`
`Application No.
`11/520,479
`Examiner
`TREVOR LOVE
`
`Applicant(s)
`DESAI ET AL.
`Art Unit
`1611
`
`AlA (First Inventor to
`File) Status
`No
`
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address-(cid:173)
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application. If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOW ABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. [gl This communication is responsive to 11101/2013.
`D A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on ___ .
`2. D An election was made by the applicant in response to a restriction requirement set forth during the interview on __ ; the restriction
`requirement and election have been incorporated into this action.
`
`3. [gl The allowed claim(s) is/are 66-68.70-72 and 74-94. As a result of the allowed claim(s), you may be eligible to benefit from the Patent
`Prosecution Highway program at a participating intellectual property office for the corresponding application. For more information,
`please see ~;t!;Q:i/www.us_Qto.gov/gatentsiinit events/Qgh/indexjs.Q or send an inquiry to PPHfeedback@'uS(Qto.aov .
`4. D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. ยง 119(a)-(d) or (f).
`Certified copies:
`*c) D None of the:
`a) D All
`b) D Some
`1. D Certified copies of the priority documents have been received.
`2. D Certified copies of the priority documents have been received in Application No. __ .
`3. D 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)).
`* Certified copies not received: __ .
`
`Applicant has THREE MONTHS FROM THE "MAILING DATE" of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`5. D CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`D including changes required by the attached Examiner's Amendment I Comment or in the Office action of
`Paper No./Mail Date __ .
`Identifying indicia such as the application number {see 37 CFR 1.84{c)) should be written on the drawings in the front {not the back) of
`each sheet. Replacement sheet{s) should be labeled as such in the header according to 37 CFR 1.121 {d).
`6. 0 DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. D Notice of References Cited (PT0-892)
`2. [gilnformation Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date 11/01/2013
`3. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. D Interview Summary (PT0-413),
`Paper No./Mail Date __ .
`
`/TREVOR LOVE/
`Examiner, Art Unit 1611
`
`5. D Examiner's Amendment/Comment
`6. [gl Examiner's Statement of Reasons for Allowance
`7. D Other __ .
`
`U.S. Patent and Trademark Off1ce
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20140207
`
`Actavis - IPR2017-01100, Ex. 1025, p. 5 of 7
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 2
`
`The present application is being examined under the pre-AlA first to invent
`provisions.
`
`REASONS FOR ALLOWANCE
`
`Acknowledgement is made to Applicant's response filed 11/01/2013.
`
`Claims 66-68, 70-72, and 74-94 are pending.
`
`Claims 79-84 are rejoined herein.
`
`Claims 66-68, 70-72, and 74-94 are allowed herein.
`
`Reasons for Allowance
`
`The following is an examiner's statement of reasons for allowance: The closest
`
`prior art remains Desai et al (US 5,439,686) and Shively (US 5,407,683). Said prior art,
`
`while teaching a composition that overlaps with the instantly claimed composition, does
`
`not provide sufficient evidence in view of the declaration filed 11/01/2013. Said
`
`declaration clearly shows the unexpected nature of the instant invention by providing
`
`data which shows the unexpected superiority of drug loading (5-15 mg/ml) for
`
`nanoparticles which have a solid paclitaxel core with an albumin coating where the
`
`nanoparticles have a size of less than 400nm. The declaration shows that when no
`
`detectable percentage of the nanoparticles (not merely the median diameter) are within
`
`the instantly claimed range (less than 400 nm), the composition is able to achieve stable
`
`high drug loading as can be observed in exhibit 1. Therefore, since the evidence in
`
`support of non-obviousness is greater than any previously presented arguments of
`
`obviousness, the instant claims are free of the prior art.
`
`Actavis - IPR2017-01100, Ex. 1025, p. 6 of 7
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 3
`
`Any comments considered necessary by applicant must be submitted no later
`
`than the payment of the issue fee and, to avoid processing delays, should preferably
`
`accompany the issue fee. Such submissions should be clearly labeled "Comments on
`
`Statement of Reasons for Allowance."
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to TREVOR LOVE whose telephone number is (571 )270-
`
`5259. The examiner can normally be reached on Monday-Thursday 7:30-5:30.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Daniel Sullivan can be reached on 571-272-0779. 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
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`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/TREVOR LOVE/
`Examiner, Art Unit 1611
`
`Actavis - IPR2017-01100, Ex. 1025, p. 7 of 7
`
`