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
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONFIRMATION NO.
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`111083,167
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`03/17/2005
`
`Elliot Ehrich
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`4000.3010US1
`
`8002
`
`38421
`7590
`05/05/2009
`ELMORE PATENT LAW GROUP, PC
`515 Groton Road
`Unit 1R
`Westford, MA 01886
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`EXAMINER
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`CARTER, KENDRA D
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`ART UNIT
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`PAPER NUMBER
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`1617
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`MAIL DATE
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`05/05/2009
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`DELIVERY MODE
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`PTOL-90A (Rev. 04/07)
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`Office Action Summary
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`Application No.
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`Applicant(s)
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`11/083,167
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`Examiner
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`EHRICH, ELLIOT
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`Art Unit
`
`1617
`KENDRA D. CARTER
`-- The MAILING DATE 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~ 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 )IZ! Responsive to communication(s) filed on 20 March 2009.
`2a)0 This action is FINAL.
`2b)[8J This action is non-final.
`3)0 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 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)[8J Claim(s) 1-23 is/are pending in the application.
`4a) Of the above claim(s) 3-5 is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)[8J Claim(s) 1.2 and 6-23 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
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`Application Papers
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`9)0 The specification is objected to by the Examiner.
`10)0 The drawing(s) filed on __ is/are: a)O accepted or b)O 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 )0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
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`Priority under 35 U.S.C. § 119
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some* c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 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.
`
`4) 0
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`Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
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`Attachment(s)
`1) [8J Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) [8Jinformation Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 8/29/05;12/01/05;6/23/08:7/9/08:7/17/08.
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mail Date 20090429
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`Continuation Sheet (PTOL-326)
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`Application No.
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`2
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`Application/Control Number: 11/083,167
`Art Unit: 1617
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`Page 2
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`DETAILED ACTION
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`Election/Restrictions
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`Applicant's election with traverse of Group I, claims 1, 2, and 6-23 in the reply
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`filed on March 20, 2009 is acknowledged. The traversal is on the ground(s) that Group I
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`and Group II are not mutually exclusive. One could administer the long acting
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`naltrexone of Group I to an individual in accordance with the method of Group II and
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`achieve the serum AUG levels of naltrexone of Group I. This is not found persuasive
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`because the method of Group I does not require the specific method step of treating
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`alcohol and specific days in which the individual should or should not abstain from
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`alcohol. Thus, claims 3-5 are withdrawn from consideration.
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`The requirement is still deemed proper and is therefore made FINAL.
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`Claim Rejections - 35 USC § 112
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`The following is a quotation of the second paragraph of 35 U.S.C. 112:
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`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
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`Regarding claims 6, 18, 20 and 22, the phrase "such as" renders the claim
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`indefinite because it is unclear whether the limitations following the phrase are part of
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`the claimed invention. See MPEP § 2173.05(d).
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`Claim Rejections- 35 USC§ 102
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless-
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`(b) the invention was patented or described in a printed publication in this or a foreign country or in public
`use or on sale in this country, more than one year prior to the date of application for patent in the United
`States.
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`Claims 1, 2, 6-21 and 23 are rejected under 35 U.S.C. 1 02(b) as being
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`anticipated by Tice et al. (6,306,425 81 ).
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`Tice et al. teach muscular injectable naltrexone microsphere compositions and
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`their use in reducing consumption of heroin and alcohol (see title and abstract;
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`addresses claims 18 and 20). The composition comprises a matrix consisting of the
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`polymer poly-(D,L-Iactide) The naltrexone is released in a controlled manner for greater
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`than 28 or about 32 days. Smaller doses may be administered after the first dose,
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`because on continues to obtain release from the prior injected mirospheres to which is
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`added the release from the lately administered microspheres, or one can enjoy
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`enhanced levels of the naltrexone without increasing the amount of the microspheres
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`which are administered (see abstract and column 6, lines 19-29; addresses claims 1, 7,
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`8 and 14-17). The microspheres are formulated from about 150-350 mg of naltrexone
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`such that the plasma concentration is in a therapeutic range of at least about 2 ng/ml
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`(see column 4, lines 36-38 and column 5, lines 60-63; addresses claims 1, 2, 6 and 9-
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`13). The microsphere formulation gave an AUG of more than 3.3 times greater than that
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`achieved by 50 mg/day oral administration (see column 14, lines 40-55; addresses
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`claim 1 ). Naltrexone is employed in an amount in the range of 15 to 50 weight % (see
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`claim 1; addresses claim 23).
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`In regards to claims 6 and 19, in which the individual has not used oral
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`naltrexone before administration, Tice et al. teach that the primary application for the
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`subject formulations is as an intramuscular injection (see column 5, lines 52-23).
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`Further the invention is designed to avoid oral administration such that compliance of
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`taking medication is achieved (see column 16, lines 55-60).
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`In regards to claim 13, Tice et al. teaches the limitation in which the amount of
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`naltrexone is about 380 mg, because the Examiner reads the about 350 mg of
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`naltrexone that Tice et al. teaches (see column 4, lines 36-38) reads on about 380 mg.
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`Claim Rejections- 35 USC§ 103
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`The following is a quotation of 35 U.S.C. 1 03(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(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.
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`Claim 22 is rejected under 35 U.S.C. 103(a) as being unpatentable over Tice et
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`al. (6,306,425 81) as applied to claims 1, 2, 6-21 and 23 above in further view of
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`Chandrashekar et al. (6, 143,314 ).
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`The teachings of Tice et al. are as those applied to claims 1, 2, 6-21 and 23
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`above.
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`Tice et al. does not teach a polylactide-co-glycolide polymer.
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`Chadrashekar et al. teach a controlled release liquid delivery compositions of
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`active compounds such as naltrexone with polymers such as polylactides and
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`poly(lactide-co-glycollide) as the controlled release additive (see abstract; claims 1 and
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`2; column 7, line 15).
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`To one of ordinary skill in the art at the time of the invention would have found it
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`obvious and motivated to combine the method of Tice et al. and a polylactide-co-
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`glycol ide polymer because it is known in the art that these type of polymers are known
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`to provide controlled release of active ingredients. Since Tice et al. teaches a
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`polylactide as the controlled release additive, it is obvious for one skilled in the art to
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`use other equivalents such as polylactide-co-glycolide polymers as demonstrated by
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`Chadrashekar et al.
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`Conclusion
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`No claims allowed.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to KENDRA D. CARTER whose telephone number is
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`(571 )272-9034. The examiner can normally be reached on 7:30am -4:00pm.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Sreeni Padmanabhan can be reached on (571) 272-0629. The fax phone
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`number for the organization where this application or proceeding is assigned is 571-
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`273-8300.
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`/Kendra D Carter/
`Examiner, Art Unit 1617
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`/SREENI PADMANABHAN/
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`Supervisory Patent Examiner, Art Unit 1617
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