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
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`38421
`7590
`12/01/2010
`ELMORE PATENT LAW GROUP, PC
`515 Groton Road
`Unit lR
`Westford, MA 01886
`
`EXAMINER
`
`CARTER, KENDRA D
`
`ARTUNIT
`
`PAPERNUMBER
`
`1627
`DATE MAILED: 12/0112010
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`11/083,167
`Elliot Ehrich
`03117/2005
`TITLE OF INVENTION: NALTREXONE LONG ACTING FORMULATIONS AND METHODS OF USE
`
`4000,3010 US1
`
`8002
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`nonprovisiona1
`
`NO
`
`$1510
`
`$300
`
`$0
`
`$1810
`
`DATE DUE
`
`03/0112011
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS 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 BE EXTENDED. SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`IF AN ISSUE FEE HAS
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
`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:
`
`L Review the SMALL ENTITY status shown above,
`If the SMALL ENTITY is shown as YES, verify your current
`SMALL ENTITY status:
`A, If the status is the same, pay the TOTAL FEE(S) DUE shown
`above,
`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
`
`If the SMALL ENTITY is shown as NO:
`
`A, Pay TOTAL FEE(S) DUE shown above, or
`
`B, If applicant claimed SMALL ENTITY status before, or is now
`claiming SMALL ENTITY status, check box Sa on Part B- Fee(s)
`Transmittal and pay the PUBLICATION FEE (if required) and 112
`the ISSUE FEE shown above,
`
`IL 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,
`
`IlL 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.
`
`PTOL-85 (Rev, 08/07) Approved for use through 08/3112010,
`
`Page 1 of 3
`
`AMN1009
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`

`

`PART B- FEE(S) TRANSMITTAL
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or Fax
`(571)-273-2885
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks l through 5 should be completed where
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`indicated unless corrected below or directed otherwise in Block l, 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 of address)
`
`Note: A certificate of mailing can only be used for domestic mailings of the
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
`have 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.
`
`7590
`38421
`12/01/2010
`ELMORE PATENT LAW GROUP, PC
`515 Groton Road
`Unit 1R
`Westford, MA 01886
`
`I
`
`APPLICATION NO.
`
`FILING DATE
`
`I
`
`I
`
`FIRST NAMED INVENTOR
`
`ll/083,167
`Elliot Ehrich
`03117/2005
`TITLE OF INVENTION: NALTREXONE LONG ACTING FORMULATIONS AND METHODS OF USE
`
`(Depositor's name)
`
`(Signature)
`
`(Date)
`
`I ATTORNEY DOCKET NO. I CONFIRMATION NO.
`
`4000.3010 US!
`
`8002
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`NO
`
`$1510
`
`$300
`
`$0
`
`$1810
`
`03/0l/20ll
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`CARTER, KENDRA D
`
`1627
`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.
`0 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Number is required.
`
`514-282000
`
`2. For printing on the patent front page, list
`(I) 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
`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.
`
`2 ________________________ _
`
`3 ________________________ _
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. If an assignee is identified below, the document has been filed for
`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) :
`
`0
`
`Individual 0 Corporation or other private group entity 0 Government
`
`4a. The following fee(s) are submitted:
`0
`Issue Fee
`0 Publication Fee (No small entity discount permitted)
`0 Advance Order- #of Copies _________ __
`
`4b. Payment ofFee(s): (Please first reapply any previously paid issue fee shown above)
`0 A check is enclosed.
`0 Payment by credit card. Form PT0-2038 is attached.
`0The Director is hereby authorized to charge the required fee(s), any deficiency, or credit any
`(enclose an extra copy of this form).
`overpayment, to Deposit Account Number
`
`5. Change in Entity Status (from status indicated above)
`0 b. Applicant is no longer claiming SMALL ENTITY status. See 37 CFR l.27(g)(2).
`0 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 _______________________ _
`
`Dille _____________________ __
`
`Typed or printed name ______________________ __
`
`Registration No. ________________ _
`
`This collection of information is required by 37 CFR 1.311. The information is required 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. This collection is estimated to take 12 minutes to complete, including gathering, preparing, and
`submitting the completed application form to the USPTO. Time will vary depending 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 the Chief Information Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O.
`Box 1450, Alexandria, Virginia 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. 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.
`
`PTOL-85 (Rev. 08/07) Approved for use through 08/3112010.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`AMN1009
`IPR of Patent No. 7,919,499
`
`

`

`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
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`11/083,167
`
`03117/2005
`
`Elliot Ehrich
`
`4000.3010 US1
`
`8002
`
`38421
`7590
`12/01/2010
`ELMORE PATENT LAW GROUP, PC
`515 Groton Road
`Unit 1R
`Westford, MA 01886
`
`EXAMINER
`
`CARTER, KENDRA D
`
`ARTUNIT
`
`PAPERNUMBER
`
`1627
`DATE MAILED: 12/0112010
`
`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 899 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 899 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
`or
`the Customer Service Center of the Office of Patent Publication at 1-(888)-786-0 101
`directed to
`(571)-272-4200.
`
`PTOL-85 (Rev. 08/07) Approved for use through 08/3112010.
`
`Page 3 of 3
`
`AMN1009
`IPR of Patent No. 7,919,499
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`

`

`Notice of Allowability
`
`Application No.
`
`11/083,167
`Examiner
`
`Applicant(s)
`
`EHRICH, ELLIOT
`Art Unit
`
`KENDRA D. CARTER
`
`1627
`
`-- The MAILING DATE 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 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. 1Zl This communication is responsive to 20 October 2010.
`2.1Z! The allowed claim(s) is/are 1, 6-8, 11, 13-20, 23 and 26 (renumbered 1-15).
`3. D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a) D All
`b) D Some*
`c) D None
`of the:
`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.
`4. 0 A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER'S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PT0-152) which gives reason(s) why the oath or declaration is deficient.
`5. D CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`(a) D including changes required by the Notice of Draftsperson's Patent Drawing Review ( PT0-948) attached
`1) D hereto or 2) D to Paper No./Mail Date __ .
`(b) 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. D Notice of Draftperson's Patent Drawing Review (PT0-948)
`3. [gilnformation Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date 8/29/05
`4. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`5. D Notice of Informal Patent Application
`6. D Interview Summary (PT0-413),
`Paper No./Mail Date __ .
`7. [gl Examiner's AmendmenUComment
`
`8. [gl Examiner's Statement of Reasons for Allowance
`9. D Other __ .
`
`/Kendra D Carter/
`Examiner, Art Unit 1627
`
`U.S. Patent and Trademark Off1ce
`PTOL-37 (Rev. 08-06)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20101118
`
`AMN1009
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`

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`Application/Control Number: 11/083,167
`Art Unit: 1627
`
`Page 2
`
`DETAILED ACTION
`
`EXAMINER'S AMENDMENT
`
`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 Darlene Vanstone on November 19, 201 0.
`
`The application has been amended as follows:
`
`1.
`
`In claim 1, line 2, after "formulation comprising" insert "about 310 mg to about
`
`480 mg of'; and in line 3 after "naltrexone is" delete "at least".
`
`2.
`
`Cancel claims 2-5.
`
`3.
`
`In claim 6, line 2, after "naltrexone" delete "in a dosage between about 160 mg to
`
`about 480 mg naltrexone".
`
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`Application/Control Number: 11/083,167
`Art Unit: 1627
`
`4.
`
`Cancel claims 9 and 10.
`
`Page 3
`
`5.
`
`In claim 11, line 1, after "claim" delete "1 0" and insert "26".
`
`6.
`
`Cancel claim 12.
`
`7.
`
`In claim 13, line 2, after "naltrexone", insert "wherein the serum AUG is about 3.3
`
`times greater than that achieved by 50 mg/day oral administration".
`
`8.
`
`In claim 26, line 2, after "formulation comprising" insert "about 190 mg to about
`
`240 mg of'; and in line 3 after "naltrexone is" delete "at least".
`
`EXAMINER'S STATEMENT OF REASONS FOR ALLOWANCE
`
`Applicant's amendments to the claims and arguments filed October 20, 2010 has
`
`been fully considered. In light of the Applicant's amendments and Examiner's
`
`amendments, claims 1, 6-8, 11, 13-20, 23 and 26 are allowed and renumbered to
`
`claims 1-15.
`
`In light of the amendment to the claims and unexpected results, the 35 U.S.C.
`
`112, first paragraph rejection is withdrawn.
`
`AMN1009
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`

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`Application/Control Number: 11/083,167
`Art Unit: 1627
`
`Page 4
`
`The following is an examiner's statement of reasons for allowance: The claims 1,
`
`6-8, 11, 13-20, 23 and 26 are drawn to a method for treating an individual in need of
`
`naltrexone comprising parenterally administering a long acting formulation comprising
`
`about 310 to about 480 mg of naltrexone and polylactide-co-glycolide polymer wherein
`
`the serum AUG of naltrexone is about three times greater than that achieved by 50
`
`mg/day oral administration. There is no prior art disclosing the applicant's composition
`
`and effect, particularly an AUG about three times greater than that achieved by 50
`
`mg/day oral administration. The closest art is Tice et al. (6,306,425 81 ). Tice et al.
`
`teach muscular injectable naltrexone microsphere compositions and their use in
`
`reducing consumption of heroin and alcohol (see title and abstract; addresses claims 18
`
`and 20). The composition comprises a matrix consisting of the polymer poly-(D,L-
`
`lactide) The naltrexone is released in a controlled manner for greater than 28 or about
`
`32 days. The microsphere formulation was reported to be comparable whether taking
`
`daily 50 mg tablets for one month or one 300 mg microencapsulated naltrexone by
`
`intramuscular injection once monthly (see column 14, lines 59-64 ). Since the
`
`Applicant's have demonstrated in a declaration filed October 5, 2009 in Exhibit C, the
`
`claimed invention demonstrates the claimed properties over those of Tice et al. the
`
`invention is 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
`
`AMN1009
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`Application/Control Number: 11/083,167
`Art Unit: 1627
`
`Page 5
`
`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 Kendra D. Carter whose telephone number is (571) 272-
`
`9034. The examiner can normally be reached on 9:30am-6:00pm.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Sreeni Padmanabhan can be reached on (571) 272-0629. 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).
`
`/Kendra D Carter/
`Examiner, Art Unit 1627
`
`AMN1009
`IPR of Patent No. 7,919,499
`
`

`

`Application/Control Number: 11/083,167
`Art Unit: 1627
`
`/SREENI PADMANABHAN/
`Supervisory Patent Examiner, Art Unit 1627
`
`Page 6
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