`
`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 223 1 3- 1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`MORRISON & FOERSTER LLP
`
`TSAY, MARSHAM
`
`PALO ALTO, CA 94304-1018
`
`1656
`DATE MAILED: 06/01/2010
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Neil P. Desai
`10/26/2006
`11/553,339
`TITLE OF INVENTION: COMPOSITIONS AND METHODS OF DELIVERY OF PHARMACOLOGICAL AGENTS
`
`638772000301
`
`3605
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`NO
`
`$1510
`
`$0
`
`$0
`
`$1510
`
`09/01/2010
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION fl THE MERITS E CLOSED. THIS NOTICE OF ALLOWANCE 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.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`STATUTORY PERIOD CANNOT fl EXTENDED.
`SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
`IF AN ISSUE FEE HAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`WILL BE CONSIDERED A REQUEST TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW
`DUE.
`
`HOW TO REPLY TO THIS NOTICE:
`
`I. Review the SMALL ENTITY status shown above.
`
`If the SMALL ENTITY is shown as YES, verify your current
`SMALL ENTITY status:
`
`If the SMALL ENTITY is shown as NO:
`
`A. If the status is the same, pay the TOTAL FEE(S) DUE shown
`above.
`
`A. Pay TOTAL FEE(S) DUE shown above, or
`
`B. If the status above is to be removed, check box 5b on Part B -
`Fee(s) Transmittal and pay the PUBLICATION FEE (if required)
`and twice the amount of the ISSUE FEE shown above, or
`
`B. If applicant claimed SMALL ENTITY status before, or is now
`claiming SMALL ENTITY status, check box 5a on Part B - Fee(s)
`Transmittal and pay the PUBLICATION FEE (if required) and 1/2
`the ISSUE FEE shown above.
`
`II. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE (if required). If you are charging the fee(s) to your deposit account, section "4b"
`of Part B - Fee(s) Transmittal should be completed and an extra copy of the form should be submitted. If an equivalent of Part B is filed, a
`request to reapply a previously paid issue fee must be clearly made, and delays in processing may occur due to the difficulty in recognizing
`the paper as an equivalent of Part B.
`
`III. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
`Mail Stop ISSUE FEE unless advised to the contrary.
`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`
`Actavis - IPR201 7%?116’3? Ex. 1 024, p. 1 of a
`PTOL—85 (Rev. 08/07) Approved for use through 08/31/2010.
`
`Actavis - IPR2017-01104, Ex. 1024, p. 1 of 8
`
`

`

`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`or m (571)-273-2885
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`in icated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for
`maintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change ofaddress)
`
`25226
`
`7590
`
`06/01/2010
`
`&
`755 PAGE MILL RD
`PALO ALTO, CA 94304-1018
`
`LLP
`
`Note: A certificate of _mai1iI_1 _ can only be used for domestic mailings of _the
`Fee(s) Transmlttal. Th1s cert1 1cate cannot be used for any other accompanymg
`fiapers. Each additional paper, such as an assignment or formal drawmg, must
`ave its own certificate of mailing or transmission.
`
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Service with sufficient postage for first class mail in an envelope
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273—2885, on the date indicated below.
`(Depositor's name)
`
`
`
`(Signature)
`
`(Date)
`
`Neil P. Desai
`10/26/2006
`11/553,339
`TITLE OF INVENTION: COMPOSITIONS AND METHODS OF DELIVERY OF PHARMACOLOGICAL AGENTS
`
`638772000301
`
`3605
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`NO
`
`$1510
`
`$0
`
`$0
`
`$1510
`
`09/01/2010
`
`TSAY, MARSHA M
`
`1656
`
`5320—3250000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`
`3 Chan e of correspondence address (or Change of Correspondence
`Address orm PTO/SB/ 122) attached.
`
`3 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03—02 or more recent) attached. Use of a Customer
`Vumber is required.
`
`
`
`2. For printing on the patent front page, list
`(1) the names of up to 3 registered patent attorneys
`or agents OR, alternatively,
`(2) the name of a single firm (having as a member a
`2
`registered attorney or agent) and the names of up to
`2 registered patent attorneys or agents. If no name is
`listed, no name will be printed.
`
`
`
`3
`
`
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`If an assignee is identified below, the document has been filed for
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent.
`recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) :
`
`'3 Individual
`
`'3 Corporation or other private group entity '3 Government
`
`4a. The following fee(s) are submitted:
`3 Issue Fee
`
`3 Publication Fee (No small entity discount permitted)
`3 Advance Order — # of Copies
`
`
`
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`3 A check is enclosed.
`
`3 Payment by credit card. Form PTO—2038 is attached.
`3 The Director is hereby authorized to charge the required fee(s), any deficiency, or credit any
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`
`
`5. Change in Entity Status (from status indicated above)
`:I b. Applicant is no longer claiming SMALL ENTITY status. See 37 CFR 1.27(g)(2).
`:I a. Applicant claims SMALL ENTITY status. See 37 CFR 1.27.
`NOTE: The Issue Fee and Publication Fee (if required) will not be accepted from anyone other than the applicant; a registered attorney or agent; or the assignee or other party in
`interest as shown by the records of the United States Patent and Trademark Office.
`
`Authorized Signature
`
`Typed or printed name
`
`
`Date
`
`Registration No.
`
`This collection of information is required by 37 CFR 1.311. The information is re uired to obtain or retain a benefit by the public which is to file (and by the USPTO to process)
`an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. T is collection is estimated to take 12 minutes to complete, including gathering, preparing, and
`submitting the completed application form to the USPTO. Time will v
`de endin upon the individual case. Any comments on the amount of time you require to complete
`this form and/or suggestions for reducing this burden, should be sent to
`e Cfiief In ormation Officer, US. Patent and Trademark Office, US. Department of Commerce, PO.
`Box 1450, Alexandria, Virginia 22313—1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, PO. Box 1450,
`Alexandria, Virginia 22313—1450.
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`Actavis - IPR201 7-01 1 04, Ex. 1 024, p. 2 of 8
`PTOL—85 (Rev. 08/07) Approved for use through 08/31/2010.
`OMB 0651—0033
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`
`Actavis - IPR2017-01104, Ex. 1024, p. 2 of 8
`
`

`

`
`
`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
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`11/553,339
`
`10/26/2006
`
`Neil P. Desai
`
`638772000301
`
`3605
`
`MORRISON & FOERSTER LLP
`
`TSAY’ MARSHAM
`
`PALO ALTO, CA 94304-1018
`
`1656
`DATE MAILED: 06/01/2010
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment to date is 0 day(s). If the issue fee is paid on the date that is three months after the
`mailing date of this notice and the patent issues on the Tuesday before the date that is 28 weeks (six and a half
`months) after the mailing date of this notice, the Patent Term Adjustment will be 0 day(s).
`
`If a Continued Prosecution Application (CPA) was filed in the above—identified application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information Retrieval
`(PAIR) WEB site (http://pair.uspto.gov).
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)—272—7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of
`the Office of Patent Publication at
`1—(888)—786—0101
`or
`(571)-272-4200.
`
`Actavis - IPR201 7%??6’3? Ex. 1 024, p. 3 of a
`PTOL—85 (Rev. 08/07) Approved for use through 08/31/2010.
`
`Actavis - IPR2017-01104, Ex. 1024, p. 3 of 8
`
`

`

`
`
`Notice of Allowability
`
`Application No.
`
`11/553,339
`Examiner
`
`Applicant(s)
`
`DESAI ET AL.
`Art Unit
`
`Marsha M. Tsay
`
`1656
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`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 ALLOWABILITY 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. IXI This communication is responsive to Applicants'resgonse in the form of a RCE received April 14, 2010.
`
`
`2. IZI The allowed claim(s) is/are 2 4 13—16 18-20 and 24-26.
`
`3. El Acknowledgment is made ofa claim forforeign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a) D All
`b) D Some*
`c) D None
`of the:
`
`1. El Certified copies of the priority documents have been received.
`
`2. El Certified copies of the priority documents have been received in Application No.
`
`3. 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)).
`
`* 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.
`
`4. D A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER’S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PTO-152) which gives reason(s) why the oath or declaration is deficient.
`
`5. El CORRECTED DRAWINGS (as “replacement sheets”) must be submitted.
`(a) I] including changes required by the Notice of Draftsperson’s Patent Drawing Review ( PTO-948) attached
`
`
`1) D hereto or 2) I] to Paper No./Mai| Date
`
`(b) I] including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
`
`Paper No./Mai| 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. El 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. El Notice of References Cited (PTO-892)
`
`2. El Notice of Draftperson's Patent Drawing Review (PTO-948)
`
`3. IX Information Disclosure Statements (PTO/SB/08),
`Paper No./Mai| Date 04/14/10
`4. I] Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`5. El Notice of Informal Patent Application
`
`6. El Interview Summary (PTO-413),
`Paper No./Mai| Date
`.
`7. IX Examiner's Amendment/Comment
`
`8. X Examiner's Statement of Reasons for Allowance
`
`9. D Other
`
`.
`
`U.S. Patent and Trademark Office
`
`PTOL-37 (Rev. 08-06)
`
`wabil
`Actavis _ IPR201h+ogcffBflloEXI #3624, p. 4 of 8
`
`Part of Paper No./Mai| Date 20100520
`
`
`
`Actavis - IPR2017-01104, Ex. 1024, p. 4 of 8
`
`

`

`Application/Control Number: 11/553,339
`
`Page 2
`
`Art Unit: 1656
`
`A request for continued examination under 37 CFR 1.114, including the fee set forth in
`
`37 CFR 1.17(e), was filed in this application after final rejection. Since this application is
`
`eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e)
`
`has been timely paid, the finality of the previous Office action has been withdrawn pursuant to
`
`37 CFR 1.114. Applicant's submission filed on April 14, 2010 has been entered.
`
`Claims 2, 4, 13, 24-26 are directed to an allowable product. Pursuant to the procedures
`
`set forth in MPEP § 821 .04(B), claims 14-20, directed to the process of making or using an
`
`allowable product, previously withdrawn from consideration as a result of a restriction
`
`requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
`
`Because all claims previously withdrawn from consideration under 37 CFR 1.142 have
`
`been rejoined, the restriction requirement as set forth in the Office action mailed on
`
`November 20, 2007, is hereby Withdrawn. In view of the withdrawal of the restriction
`
`requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a
`
`continuation or divisional application is anticipated by, or includes all the limitations of, a claim
`
`that is allowable in the present application, such claim may be subject to provisional statutory
`
`and/or nonstatutory double patenting rejections over the claims of the instant application. Once
`
`the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer
`
`applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See
`
`also MPEP § 804.01.
`
`Actavis - IPR2017-01104, Ex. 1024, p. 5 of 8
`
`Actavis - IPR2017-01104, Ex. 1024, p. 5 of 8
`
`

`

`Application/Control Number: 11/553,339
`
`Page 3
`
`Art Unit: 1656
`
`An examiner’s amendment to the record appears below. Should the changes and/or
`
`additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR
`
`1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the
`
`payment of the issue fee.
`
`Authorization for this examiner’s amendment was given in a telephone interview with C.
`
`Polizzi, PhD. on May 20, 2010.
`
`The application has been amended as follows:
`
`In the claims:
`
`2. (currently amended) A pharmaceutical composition for injection comprising paclitaxel and a
`
`pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier comprises
`
`albumin, wherein the albumin and the paclitaxel in the composition are formulated as
`
`Hafiopaftieles particles, wherein the Hafiopartieles particles have a particle size of less than about
`
`200 nm, and wherein the weight ratio of albumin to paclitaxel in the composition is about 1:1 to
`
`about 9: 1.
`
`14. (currently amended) A method of treating a disease comprising administering an effective
`
`
`amount of a pharmaceutical composition of claim 2 wherein the disease is cancer arthritis or
`
`restenosis.
`
`17. canceled
`
`18. (currently amended) The method of claim -1—7- M, wherein the disease is restenosis.
`
`19. (currently amended) The method of claim 14, wherein the composition is administered
`
`intravenously, intraarterially, intrapulmonafiz intrapulmonarily, orally, by inhalation,
`
`Actavis - IPR2017-01104, Ex. 1024, p. 6 of 8
`
`Actavis - IPR2017-01104, Ex. 1024, p. 6 of 8
`
`

`

`Application/Control Number: 11/553,339
`
`Page 4
`
`Art Unit: 1656
`
`intravasieul—arly intravesicularly, intramuscularly, intra-tracheally, subcutaneously, intraocularly,
`
`intrathecally, or transdermally.
`
`The following is an examiner’s statement of reasons for allowance: claims 2, 4, 13-16,
`
`18-20, 24-26 are drawn to a pharmaceutical composition comprising paclitaxel and a
`
`pharmaceutically acceptable carrier, wherein the pharmaceutically carrier comprises albumin,
`
`wherein the albumin and the paclitaxel in the composition are formulated as particles having a
`
`size of less than about 200 nm and wherein the weight ratio of albumin to paclitaxel in the
`
`composition is about 1:1 to about 9:1, as well as to methods of treating cancer, arthritis, or
`
`restenosis comprising administering an effective amount of said pharmaceutical composition.
`
`The declaration under 37 CFR 1.132 filed April 14, 2010, and Applicants’ remarks are sufficient
`
`to overcome the 103(a) rejection based upon Damascelli et al. in view of Desai et al., as
`
`evidenced by Ibrahim et al., in the Office action mailed December 31, 2009. A search of the
`
`prior art reveals that the instant claims are novel. Further, the prior art does not suggest the
`
`invention as claimed and therefore said invention is non-obvious.
`
`Claims 2, 4, 13-16, 18-20, 24-26 are allowed.
`
`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.”
`
`Actavis - IPR2017-01104, Ex. 1024, p. 7 of 8
`
`Actavis - IPR2017-01104, Ex. 1024, p. 7 of 8
`
`

`

`Application/Control Number: 11/553,339
`
`Page 5
`
`Art Unit: 1656
`
`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, Manjunath N. Rao can be reached on 571-272-0939. 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/
`
`May 20, 2010
`
`M. Tsay
`Art Unit 1656
`
`Primary Examiner, Art Unit 1656
`
`Actavis - IPR201 7-01 1
`
`Actavis - IPR2017-01104, Ex. 1024, p. 8 of 8
`
`