Attorney Docket No. 4000.3010 USI
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`Expedited Procedure under 37 C.F.R. 1.116
`Examining Group 1627
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Applicant:
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`Elliot Ehrich
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`11/083,167
`Application No.
`March 17, 2005
`Filed:
`8002
`Confirmation No.
`For:
`Naltrexone Long Acting Formulations and Methods ofUse
`
`1627
`Group No.
`Examiner: Kendra D. Carter
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`AMENDMENT AFTER FINAL
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`Mail Stop AF
`15 Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Sir:
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`This Amendment is in response to the Final Office action mailed from the U.S. Patent and
`Trademark Office on July 20, 2010, in the above-identified application.
`Please amend the above-identified application as follows:
`Amendments to the Claims are reflected in the listing of claims which begins on page 2 of
`this paper.
`Remarks/Arguments begin on page 5 of this paper.
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`Page 1 of6
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`Amendments to the Claims:
`Please cancel Claims 21 and 22.
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`The Claim Listing below will replace all prior versions of the claims in the application:
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`Claim Listing:
`(Currently Amended) A method for treating an individual in need of naltrexone comprising
`1.
`the step of parenterally administering a long acting formulation comprising naltrexone and
`a biocompatible polymer to the individual wherein the serum AUC of naltrexone is at least
`about three times greater than that achieved by 50 mg/day oral administration and wherein
`the biocompatible polymer is a polylactide-co-glycolide polymer.
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`2.
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`(Previously Presented) The method of claim 1 comprising administering the long acting
`formulation in a dose comprising between about 160 and 240 mg of naltrexone or about
`310 to about 480 mg of naltrexone.
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`3.
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`20
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`25
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`4.
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`5.
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`6.
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`(Withdrawn/Original) A method of treating an individual in need of naltrexone comprising
`administering naltrexone, in the absence of co-administering alcohol, to an individual who
`has not undergone alcohol abstinence within three days, such as five days, prior to the
`naltrexone administration.
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`(Withdrawn/Original) The method of Claim 3 wherein the naltrexone is administered in a
`long acting formulation comprising naltrexone.
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`(Withdrawn/Original) A method of increasing the days prior to occurrence of alcohol
`consumption in an individual in need of naltrexone comprising administering a long acting
`formulation comprising naltrexone, in the absence of co-administering alcohol, to an
`individual who has not abstained from alcohol within three days, such as five days, prior to
`the naltrexone administration.
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`(Previously Presented) The method of claim 1 comprising administering the long acting
`formulation comprising naltrexone in a dosage between about 160 mg to about 480 mg
`naltrexone every four weeks for a period of about 24 weeks or more wherein the individual
`has not used oral naltrexone within five or more days before said administration.
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`7.
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`8.
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`(Original) The method of claim 1 wherein the long acting formulation releases
`naltrexone for a period of at least two weeks.
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`(Original) The method of claim 1 wherein the long acting formulation releases
`naltrexone for a period of about four weeks.
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`9.
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`(Original) The method of claim 1 wherein the long acting formulation is administered in a
`dose of at least about 160 mg of naltrexone.
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`10.
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`11.
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`12.
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`13.
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`(Original) The method of claim 1 wherein the long acting formulation is administered in a
`dose between about 160 and 240 mg of naltrexone.
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`(Original) The method of claim 10 wherein the long acting formulation is administered in a
`dose of about 190 mg of naltrexone.
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`(Original) The method of claim 1 wherein the long acting formulation is administered in a
`dose between about 310 and 480 mg of naltrexone.
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`(Original) The method of Claim 1 wherein the long acting formulation is administered in a
`dose of about 380 mg ofnaltrexone.
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`14.
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`(Original) The method of claim 1 wherein the long acting formulation is administered over
`a period of about 24 week period or longer.
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`15.
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`(Previously Presented) The method of claim 1 further comprising a second administration
`of a long acting formulation comprising naltrexone at least about 7 days after the first
`administration.
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`16.
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`(Original) The method of Claim 15 wherein the second long acting formulation is
`substantially similar to the first long acting formulation.
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`17.
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`18.
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`(Original) The method of Claim 15 wherein the second long acting formulation is the same
`as the first long acting formulation.
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`(Previously Presented) The method of claim 1 wherein the individual is an individual
`afflicted by alcohol dependency.
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`19.
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`20.
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`(Original) The method of claim 1 wherein the individual does not receive an initial oral
`dose of naltrexone.
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`(Previously Presented) The method of claim 1 wherein naltrexone is administered by
`injection.
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`21-22. (Cancelled)
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`23.
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`(Original) The method of claim 1 wherein the naltrexone is present in the long acting
`formulation at a concentration of about 35 % by weight.
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`24-25. (Canceled)
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`26.
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`(Currently Amended) A method for treating an individual in need ofnaltrexone comprising
`the step of parenterally administering a long acting formulation comprising naltrexone and
`a biocompatible polymer to the individual wherein the serum AUC ofnaltrexone is at least
`about two times greater than that achieved by 50 mg/day oral administration and wherein
`the biocompatible polymer is a polylactide-co-glycolide polymer.
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`REMARKS
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`Claims 21 and 22 are cancelled. Claims 1 and 26 are amended to incorporate the subject
`matter of allowable claim 22. Claims 1, 2, 6-20, 23 and 26 are under consideration. Claims 3-5
`have been withdrawn. Claims 1-20, 23, and 26 are pending in the application. Reconsideration is
`respectfully requested.
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`Allowable Subject Matter
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`Applicants thank the Examiner for the indication of allowable subject matter with regard to
`claim 22. Applicants have amended claims 1 and 26 to incorporate the subject matter of claim 22.
`In view of the amendments to the claims, allowance of claims 1, 2, 6-20, 23 and 26 is respectfully
`requested.
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`Claim Rejections -35 U.S.C. § 112
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`The Examiner has maintained the rejection of the claims 1, 2, 6-23 and 26 under 35 U.S.C.
`§ 112, first paragraph. In view of the amendments to claims 1 and 26 and all claims dependent
`thereon, it is believed that the rejection under this section is moot. Applicants respectfully request
`the withdrawal of the rejection.
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`A general authorization is hereby granted to charge Deposit Account No. 502807
`for any fees required under§ 37 C.P.R. 1.16 and 1.17 in order to maintain pendency of this
`application.
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`AMN1008
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`CONCLUSION
`In view of the above amendments and remarks, it is believed that all claims are in condition
`for allowance, and it is respectfully requested that the application be passed to issue. If the
`Examiner feels that a telephone conference would expedite prosecution of this case, the Examiner
`is invited to call the undersigned at (978) 251-3509.
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`Respectfully submitted,
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`ELMORE PATENT LAW GROUP, P.C.
`
`/Darlene A. Vanstone/
`
`Darlene A. Vanstone
`Registration No.
`35,729
`Tel: (978) 251 3509
`Fax: (978) 251 3973
`Telephone: (978) 251-3509
`Facsimile: (978) 251-3973
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`Dated: October 20, 2010
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`AMN1008
`IPR of Patent No. 7,919,499
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