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
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`111083,167
`
`03/17/2005
`
`Elliot Ehrich
`
`4000.3010US1
`
`8002
`
`38421
`7590
`07/20/2010
`ELMORE PATENT LAW GROUP, PC
`515 Groton Road
`Unit 1R
`Westford, MA 01886
`
`EXAMINER
`
`CARTER, KENDRA D
`
`ART UNIT
`
`PAPER NUMBER
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`1627
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`MAIL DATE
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`07/20/2010
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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.
`
`PTOL-90A (Rev. 04/07)
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`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`11/083,167
`
`Examiner
`
`EHRICH, ELLIOT
`
`Art Unit
`
`1627
`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 05 Mav 2010.
`2a)[8J This action is FINAL.
`2b)0 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.
`
`Disposition of Claims
`4)[8J 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)0 Claim(s) __ is/are allowed.
`6)[8J Claim(s) 1.2.6-23 and 26 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`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.
`
`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.
`
`Attachment(s)
`1) 0 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 5/26/10.
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
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`Part of Paper No./Mail Date 20100706
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`Application/Control Number: 11/083,167
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`DETAILED ACTION
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`The Examiner acknowledges the applicant's remarks and arguments of May 5,
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`2010 made to the office action filed January 6, 2010. Claims 1-23 and 26 are pending.
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`Claims 24 and 25 are cancelled and claims 3-5 are withdrawn. Claim 1 is amended.
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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 AUG 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. 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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`For the reasons in
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`the previous office action and below, the Applicant's
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`arguments of the 35 U.S.C. 112, first paragraph rejection were found not persuasive,
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`thus the rejection is upheld.
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`The Examiner still upholds that there is allowable subject matter, wherein claim 1
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`is amended to include the polymer of claim 22, but the Applicant's still do not agree
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`because the limitation would deny Applicant's the full scope of their invention.
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`In light of the amended claim, the modified 35 U.S.C. 112, first paragraph
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`rejection is below. The Applicant's arguments are also below.
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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:
`
`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 person skilled in the
`art to which it pertains, or with which it 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.
`
`Claims 1, 2, 6-23 and 26 are rejected under 35 U.S.C. 112, first paragraph,
`
`because the specification, while being enabling for treating an individual with a long
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`acting formulation comprising naltrexone and polylactide-co-glycolide polymer wherein
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`the serum AUG is at least about three times greater than that achieved by 50/mg/day
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`oral administration, does not reasonably provide enablement for a formulation
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`comprising any biocompatible polymer. The specification does not enable any person
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`skilled in the art to which it pertains, or with which it is most nearly connected, to use the
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`invention commensurate in scope with these claims.
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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 AUG 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 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 is drawn to "a method for treating an individual in need of naltrexone
`
`comprising the step of parenterally administering a long acting formulation comprising
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`naltrexone and a biocompatible polymer to the individual wherein the serum AUG of
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`naltrexone is at least about three times greater than that achieved by 50 mg/day oral
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`administration."
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`(2) The breadth of the claims:
`
`Claims 1, 2, 6-23 and 26 embrace and read on a long acting naltrexone
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`formulation with any biocompatible polymer. The specification does not enable any long
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`acting naltrexone formulation comprising any biocompatible polymer that gives a serum
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`AUG of naltrexone that is at least about two or three times greater than that achieved by
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`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 comprising
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`any biocompatible polymer providing a serum AUG of naltrexone at least about two or
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`three times greater than that achieved by 50 mg/day oral administration is very low.
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`Tice et al. teach muscular injectable naltrexone microsphere compositions and their use
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`in reducing consumption of heroin and alcohol (see title and abstract). The
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`composition comprises a matrix consisting of the polymer poly-(D,L-Iactide) The
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`naltrexone is released in a controlled manner for greater than 28 or about 32 days.
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`Smaller doses may be administered after the first dose, because on continues to obtain
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`release from the prior injected mirospheres to which is added the release from the lately
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`administered microspheres, or one can enjoy enhanced levels of the naltrexone without
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`increasing the amount of the microspheres which are administered (see abstract and
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`column 6, lines 19-29). The microspheres are formulated from about 150-350 mg of
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`naltrexone such that the plasma concentration is in a therapeutic range of at least about
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`2 ng/ml (see column 4, lines 36-38 and column 5, lines 60-63; addresses claims 1, 2, 6
`
`and 9-13). The microsphere formulation gave an AUG of 1.19 times greater than that
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`achieved by 50 mg/day oral administration (see column 14, lines 40-55). Naltrexone is
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`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
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`long acting naltrexone
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`formulation with any
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`biocompatible polymer providing an AUG of naltrexone of at least about two or three
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`times greater than that achieved by 50 mg/day oral administration is relatively low.
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`In
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`other words, just because there are potential of a long acting formulation of naltrexone
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`comprising a biocompatible polymer to provide an AUG 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 AUG serum levels has yet to be completely established. As Tice et al.
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`teaches, every long acting formulation with a biocompatible polymer and naltrexone
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`does not give an AUG of naltrexone at least about two or three times greater than that
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`achieved by 50 mg/day oral administration. Therefore, because there is a "potential" or
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`reaching the claimed AUG serum values, the actual long acting formulation that gives
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`these results is unpredictable.
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`(5) The relative skill of those in the art:
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`The relative skill in the art is fairly high, with the typical practitioner having a
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`medical degree and/or an advanced degree
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`in
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`the biochemical, chemistry or
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`pharmaceutical-related arts, as evidenced by Tice et al.
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`(6) The amount of direction or guidance presented I 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 AUG of naltrexone at
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`least about two or three times greater than
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`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. In the instant case, the guidance of the specification as to a naltrexone and
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`any biocompatible polymer long acting formulation providing an AUG of naltrexone at
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`least about two or three times greater than
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`that achieved by 50 mg/day oral
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`administration is completely lacking. Particularly, the specification teaches that the long
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`acting formulation comprising DL PLGA (poly(lactide)-co-glycolide polymeric matrix (i.e.
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`MEDISORB; see page 12, line 2; and page 15, line 1) in conjunction with psychosocial
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`treatment is effective in treating heavy drinking (see page 24 in its entirety).
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`In regards
`
`to its comparison to oral naltrexone, a definitive comparison of efficacy can not be made
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`(see page 26, lines 5-1 0), but the Applicants attempted to compare the invention to
`
`other oral administration studies to show that the invention was effective in treating
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`alcohol dependence with psychosocial therapy, than psychosocial therapy alone (see
`
`page 28 in its entirety and page 29, lines 1-5). There was no measurement of the
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`claimed AUG measurements in comparison to the oral administration, just a comparison
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`of treatment.
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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 AUG of
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`naltrexone is at least about three times greater than that achieved by 50 mg/day oral
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`administration. As discussed above the specification fails to provide any support for any
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`long acting formulation wherein the serum AUG of naltrexone is at least about three
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`times greater than that achieved by 50 mg/day oral administration. Applicant fails to
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`provide any information sufficient 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
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`biocompatible polymer and combination of ingredients to comprise a formulation of
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`naltrexone, or at
`
`least a subset with specific
`
`ingredients
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`that
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`is sufficiently
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`representative of specific long acting naltrexone formulations, to determine if each
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`formulation has a serum AUG of naltrexone that is at least about two or three times
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`greater than that achieved by 50 mg/day oral administration. For example, to test for
`
`the claimed AUG, different formulation comprising different biocompatible polymers and
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`other ingredients including naltrexone, would have to be selected, and a suitable animal
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`model and dosage regimen (dose amount, frequency, route of administration since
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`parenteral administration can include several routs) would also have to be selected.
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`Serum AUG measurements would have to be taken and then compared to the oral
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`administration route.
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`If desired serum AUG results did not result, the dosage regime
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`and/or formulation would have to be varied, for example by changing the dosage
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`amount or route of administration, until the desired serum AUG results were achieved.
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`If the desired serum AUG measurements were shown with a particular formulation, then
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`another formulation would have to be selected and the process would have to be
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`repeated, including determining the optimum dosage regimen and animal model and/or
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`toxicity levels for evaluation. Thus, the skilled artisan would have to undergo exhaustive
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`studies to evaluate each formulation to determine if the formulation has a serum AUG of
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`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 carry out the invention.
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`Genetech, 108 F. 3d at 1366 states that " a patent is not a hunting license.
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`It is not a
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`reward for search, but compensation for its successful conclusion" and "patent
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`protection is granted in return for an enabling disclosure of an invention, not for vague
`
`intimation of general ideas that may or may not be workable.
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`In conclusion, the applicant is enabled for a long acting formulation comprising
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`naltrexone and polylactide-co-glycolide polymer to provide an AUG of naltrexone at
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`least about two or three times greater than
`
`that achieved by 50 mg/day oral
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`administration, but not for any biocompatible polymer.
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`Response to Arguments
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`Applicant's arguments have been fully considered but they are not persuasive.
`
`Applicant's argue that Tice is not a reasonable example of unpredictability
`because Tice's objective was to show that naltrexone delivered
`intramuscularly was comparable to taking 50 mg oral tablets of naltrexone
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`for one month. Thus, it can not be concluded that Tice failed to achieve a
`formulation of the present claims. Further, Example 3 provides a working
`example, and the Declaration of Ehrich filed Ocotber 5, 2009 provides
`further enablement. In regards to Examiner's statement of undue
`experimentation, any number of variables including AUG and testing the
`biocompatible polymer delivery systems are standard techniques that are
`provided in the art. Thus, it is well within the ability of the skilled person to
`adjust the various components of the polymer delivery systems such as
`excipients that alter erosion rates and time of release and systematically
`test several of these formulations to determine the effect on the desired
`feature.
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`The Examiner disagrees because Tice et al. provides evidence that not all
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`biocompatible polymers provide an AUG of naltrexone at least about tree times greater
`
`than that achieved by 50 mg/day oral administration. As the Applicant's admits, there
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`are numerous biocompatible polymers, not to mention those that have not been created
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`yet. There is no predictability that every biocompatible polymer will give the same
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`claimed effects, which is evidenced by Tice et al. Thus, there is unpredictability as well
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`as undue experimentation. Although tests are known to acquire AUG measurements,
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`one skilled in the art must test the biocompatible polymer, which could differ in structure
`
`and size, to see if when combined with naltrexone and administered parenterally
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`provides the claimed effects. The Applicant's do not give a sub-genus of biocompatible
`
`polymers or even test this sub-genus to provide a sense of predictability such that
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`undue experimentation would not be necessary. A search of the art did not produce a
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`known group of biocompatible polymers that give a predictable AUG for drugs such as
`
`naltrexone. In regards to Example 3, the example simply demonstrates the
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`effectiveness of treatment of the claimed formulation, but for the claimed composition to
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`provide naltrexone at least about tree times greater than that achieved by 50 mg/day
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`oral administration. The Declaration further provides support of the claimed invention,
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`but it is not commensurate in scope to the claim. It is noted that evidence of
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`unexpected results is required to be reasonably commensurate in scope with the
`
`claimed invention. See, e.g., In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056,
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`1058 (Fed. Cir. 1990); In re Grasselli, 713 F.2d 731, 743, 218 USPQ 769, 777 (Fed. Cir.
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`1983).
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`Conclusion
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`Applicant's amendment necessitated the new ground(s) of rejection presented in
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`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
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`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
`
`CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date of this action. In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action. In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the date of this final action.
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`Application/Control Number: 11/083,167
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`No claims allowed.
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`Page 12
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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
`
`(571 )272-9034. The examiner can normally be reached on 9:00am-5:00pm.
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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.
`
`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
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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.
`
`/Kendra D Carter/
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`Application/Control Number: 11/083,167
`Art Unit: 1627
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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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