`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PA'TTEN'I'S
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`wwwuspto.gov
`
`APPLICATION NO.
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`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`11/083, 167
`
`03/17/2005
`
`Elliot Ehrich
`
`4000.3010 US1
`
`8002
`
`38421
`
`7590
`
`01/06/2010
`
`ELMORE PATENT LAWGROUP, PC
`515 Groton Road
`Unit IR
`Westford, MA 01886
`
`CARTER, KENDRA D
`
`1627
`
`MAIL DATE
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`01/06/2010
`
`PAPER NUMBER
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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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`
`Application No.
`
`Applicant(s)
`
`Office Action Summary
`
`11/083,167
`Examiner
`
`EHRICH, ELLIOT
`Art Unit
`
`
`1627 |
`KENDRAD. CARTER
`
`-- The MAILING DATEofthis communication appears on the cover sheet with the correspondence address--
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a).
`In no event, however, may a reply be timely filed
`after SIX (6) MONTHSfrom 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) MONTHSfrom 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).
`Anyreply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`eamedpatent term adjustment. See 37 CFR 1.704(b).
`
`Status
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`1)X] Responsive to communication(s) filed on 05 October 2009.
`2a)L] This action is FINAL.
`2b)X] This action is non-final.
`3)L) Sincethis applicationis in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordancewith the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
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`4)KX] Claim(s) 1-23 and 26 is/are pending in the application.
`4a) Of the above claim(s) 3-5 is/are withdrawn from consideration.
`5)L] Claim(s)___ is/are allowed.
`
`6)X] Claim(s) 1,2,6-23 and 26is/are rejected.
`7)L] Claim(s)__is/are objectedto.
`8)L] Claim(s)___ are subject to restriction and/or election requirement.
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`Application Papers
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`9)L] The specification is objected to by the Examiner.
`
`10) The drawing(s) filed on
`is/are: a)[_] accepted or b)_] 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)L] The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)L] Acknowledgmentis made ofa claim for foreign priority under 35 U.S.C. § 119(a){d) or(f).
`a)_JAIl b)[] Some*c)] Noneof:
`1.0] Certified copies of the priority documents have been received.
`2.L] Certified copies ofthe priority documents have been received in Application No.
`3.01 Copiesofthe certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action foralist of the certified copies not received.
`
`
`
`Attachment(s)
`1) C] Notice of References Cited (PTO-892)
`2) L] Notice of Draftsperson’s Patent Drawing Review (PTO-948)
`3) X] Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 6/22/09.
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08-06)
`
`4) C Interview Summary (PTO-413)
`Paper No(s)/Mail Date. _
`5) L] Notice of Informal Patent Application
`6) CL] Other:
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`Office Action Summary
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`Part of Paper No./Mail Date 20091231
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`Application/Control Number: 11/083,167
`Art Unit: 1627
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`Page 2
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`DETAILED ACTION
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`The Examiner acknowledgesthe applicant’s remarks and arguments of October
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`5, 2009 made to the office action filed May 5, 2009. Claims 1-23 and 26 are pending.
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`Claims 24 and 25 are cancelled and claims 3-5 are withdrawn. Claims 1, 2, 6, 15, 18,
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`20 and 22 are amended and claim 26 is new.
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`The declaration filed October 5, 2009 has been considered and found
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`persuasive. Particularly, the Applicant's application exhibits a serum AUC of naltrexone
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`at least about three times or at least about two times greater than that achieved by 50
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`mg/day oral administration, whereas the formulation of Tice is similar to a 50 mg/day
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`oral administration.
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`In light of the declaration and/or the Applicant’s arguments, the 35
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`U.S.C. 102(b) and 103(a) rejections are withdrawn.
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`In light of the amendmentsto the claims, the 35 U.S.C. 112 second paragraph
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`rejection of claims 6, 18, 20 and 22 is withdrawn.
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`The Examineridentified allowable subject matter, wherein claim 1
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`is amendedto
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`include the polymer of claim 22, but the Applicant's did not agree to the amendments.
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`Application/Control Number: 11/083,167
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`Page 3
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`Due to the withdrawal ofall previous rejections and further consideration, the
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`new 35 U.S.C. 112, first paragraph rejection is below, thus providing a NEW Non-Final
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`rejection.
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`Claim Rejections - 35 USC § 112
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`The following is a quotation of the first paragraph of 35 U.S.C. 112:
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`The specification shall contain a written description of the invention, and of the manner and process of
`making and using it, in such full, clear, concise, and exact terms as to enable any personskilled in the
`art to which it pertains, or with whichit is most nearly connected, to make and use the same and shall
`set forth the best mode contemplated by the inventor of carrying out his invention.
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`Claims 1, 2, 6-23 and 26 are rejected under 35 U.S.C. 112, first paragraph, as
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`failing to comply with the enablement requirement. The claim(s) contains subject matter
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`which wasnot described in the specification in such a wayas to enable one skilled in
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`the art to whichit pertains, or with whichit is most nearly connected, to make and/or use
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`the invention.
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`The instant claims are drawn to a method for treating an individual
`
`in need of
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`naltrexone comprising the step of parenterally administering a long acting formulation
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`wherein the serum AUC of naltrexone is at least about three times greater than that
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`achieved by 50 mg/day oral administration. The instant specification fails to provide
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`information that would allow the skilled artisan to fully practice the instant
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`invention
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`without undue experimentation. Attention is directed to In re Wands, 8USPQ2d 1400
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`(CAFC 1988) at 1404 where the court set forth the eight factors to consider when
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`assessing if a disclosure would have required undue experimentation. Citing Ex parte
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`Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
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`(1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art;
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`(4) the predictability or unpredictability of the art; (5) the relative skill of those in the art;
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`(6) the amount of direction or guidance presented; (7) the presence or absence of
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`working examples; and (8) the quantity of experimentation necessary.
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`(1) The nature of the invention:
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`The claim 1
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`is drawn to “a method for treating an individual in need of naltrexone
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`comprising the step of parenterally administering a long acting formulation comprising
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`naltrexone to the individual wherein the serum AUC of naltrexone is at least about three
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`times greater than that achieved by 50 mg/day oral administration.”
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`(2) The breadth of the claims:
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`Claims 1, 2, 6-23 and 26 embrace and reads on any long acting naltrexone
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`formulation. The specification does not enable any long acting naltrexone formulation
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`that gives a serum AUC of naltrexone that is at least about two or three times greater
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`than that achieved by 50 mg/day oral administration.
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`(3) The state of the prior art:
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`The state of the art regarding any long acting naltrexone formulation providing a
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`serum AUC of naltrexone at least about two or three times greater than that achieved by
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`Page 5
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`50 mg/dayoral administration is very low. Tice et al. teach muscular injectable
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`naltrexone microsphere compositions and their use in reducing consumption of heroin
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`and alcohol (seetitle and abstract). The composition comprises a matrix consisting of
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`the polymer poly-(D,L-lactide) The naltrexone is released in a controlled manner for
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`greater than 28 or about 32 days. Smaller doses may be administered after thefirst
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`dose, because on continues to obtain release from the prior injected mirospheresto
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`whichis addedthe releasefrom the lately administered microspheres, or one can enjoy
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`enhancedlevels of the naltrexone without increasing the amountof the microspheres
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`which are administered (see abstract and column 6, lines 19-29). The microspheres are
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`formulated from about 150-350 mg of naltrexone such that the plasma concentrationis
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`in a therapeutic range of at least about 2 ng/mL (see column 4, lines 36-38 and column
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`5, lines 60-63; addresses claims 1, 2, 6 and 9-13). The microsphere formulation gave
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`an AUC of 1.19 times greater than that achieved by 50 mg/day oral administration (see
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`column 14, lines 40-55). Naltrexone is employed in an amount in the range of 15 to 50
`
`weight % (see claim 1).
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`(4) The predictability or unpredictability of the art:
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`The predictability of every long acting naltrexone formulation providing an AUC of
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`naltrexone at least about two or three times greater than that achieved by 50 mg/day
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`oral administration is relatively low.
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`In other words, just becausethere are potential of a
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`long acting formulation of naltrexone to provide an AUC of naltrexone at least about two
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`or three times greater than that achieved by 50 mg/day oral administration, effective
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`elevated AUC serum levels has yet
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`to be completely established. As Tice et al.
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`teaches, every long acting formulation of naltrexone does not give an AUC of naltrexone
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`at
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`least about
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`two or three times greater than that achieved by 50 mg/day oral
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`administration. Therefore, becausethere is a "potential" or reaching the clained AUC
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`serum values,
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`the actual
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`long acting formulation that gives
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`these results
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`is
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`unpredictable.
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`(5) The relative skill of those in the art:
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`The relative skill
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`in the art is fairly high, with the typical practitioner having a
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`medical degree and/or an advanced degree in
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`the biochemical, chemistry or
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`pharmaceutical-related arts, as evidenced byTiceetal.
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`(6) The amount of direction or guidance presented / working examples:
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`The specification as filed does not speak on or show any working examples any
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`studies performed that any long acting formulation provides an AUC of naltrexone at
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`least about
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`two or
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`three times greater than that achieved by 50 mg/day oral
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`administration. Note that lack of a working example, is a critical factor to be considered,
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`especially in a case involving an unpredictable and undeveloped art. See MPEP
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`2164.02.
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`In the instant case, the guidance of the specification as to any long acting
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`formulation providing an AUC of naltrexone at least about two or three times greater
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`than that achieved by 50 mg/day oral administration tration is completely lacking.
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`Page 7
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`Particularly, the specification teaches that the long acting formulation comprising DL
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`PLGA(poly(lactide)-co-glycolide polymeric matrix (i.e. MEDISORB; see page 12, line 2;
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`and page 15, line 1) in conjunction with psychosocial treatment is effective in treating
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`heavy drinking (see page 24 in its entirety).
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`In regards to its comparison to oral
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`naltrexone, a definitive comparison of efficacy can not be made (see page 26, lines 5-
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`10), but the Applicants attempted to compare the invention to other oral administration
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`studies to show that the invention was effective in treating acohol dependence with
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`psychosocial therapy, than psychosocial therapy alone (see page 28 in its entirety and
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`page 29, lines 1-5).
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`(7) The quantity of experimentation necessary:
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`The instant claims read on any long acting formulation wherein the serum AUC of
`
`naltrexone is at least about three times greater than that achieved by 50 mg/day oral
`
`administration. As discussed abovethe specification fails to provide any support for any
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`long acting formulation wherein the serum AUC of naltrexone is at least about three
`
`times greater than that achieved by 50 mg/day oral administration. Applicant fails to
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`provide any information sufficient
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`to practice the claimed invention, absent undue
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`experimentation.
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`Particularly,
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`the skilled practitioner would have to test each and every one of
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`polymer and combination of ingredients to comprise a formulation of naltrexone, or at
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`least a subset with specific ingredients that is sufficiently representative of specific long
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`acting naltrexone formulations, to determine if each formulation has a serum AUC of
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`naltrexone that is at least about two or three times greater than that achieved by 50
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`mg/day oral administration.
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`For example,
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`to test for the claimed AUC, different
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`formulation comprising different polymers and other ingredients including naltrexone,
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`would have to be selected, and a suitable animal model and dosage regimen (dose
`
`amount, frequency, route of administration since parenteral administration can include
`
`several routs) would also haveto be selected. Serum AUC measurements would have
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`to be taken and then compared to the oral administration route.
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`If desired serum AUC
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`results did not result, the dosage regime and/or formulation would have to be varied, for
`
`example by changing the dosage amount or route of administration, until the desired
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`serum AUC results were achieved.
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`If the desired serum AUC measurements were
`
`shownwith a particular formulation, then another formulation would have to be selected
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`and the process would have to be repeated, including determining the optinum dosage
`
`regimen and animal model and/ortoxicity levels for evaluation. Thus, the skilled artisan
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`would have to undergo exhaustive studies to evaluate each formulation to determine if
`
`the formulation has a serum AUC of naltrexone that is at least about two or three times
`
`greater than that achieved by 50 mg/day oral administration, in order to be able to fully
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`carry out the invention. Genetech, 108 F. 3d at 1366 states that “ a patent is not a
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`hunting license.
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`It
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`is not a reward for search, but compensation for its successful
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`conclusion” and “patent protection is granted in return for an enabling disclosure of an
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`invention, not for vague intimation of general ideas that may or may not be workable.
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`In conclusion, the applicant is not enabled for a long acting formulation provides
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`an AUC of naltrexone at least about two or three times greater than that achieved by 50
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`mg/dayoral administration
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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 whosetelephone number is
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`(571)272-9034. The examiner can normally be reached on 9:00 am - 5:00 pm.
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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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`Application/Control Number: 11/083,167
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`Page 10
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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
`
`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.
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`/Kendra D Carter/
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`Examiner, Art Unit 1627
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`/SREENI PADMANABHAN/
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`Supervisory Patent Examiner, Art Unit 1627
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