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
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`APPLICATION NO.
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`F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONF {MATION NO.
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`08/07/2009
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`Garry L. Myers
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`1199-82
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`5630
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`EXAMINER
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`EPPS -SMITH, JANET L
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`ART UNIT
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`1633
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`MAIL DATE
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`08/31/2011
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`PAPER NUMBER
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`DELIVERY MODE
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`PAPER
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`12/537,571
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`23869
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`7590
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`08/31/2011
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`HOFFMANN & BARON, LLP
`6900 JERICHO TURNPIKE
`SYOSSET, NY 11791
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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)
`Page 1
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`BDSI EXHIBIT 1006
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`Page 1
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`

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`Office Action Summary
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`Application No.
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`App|icant(s)
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`1253z5m
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`MYERSETAL
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`Examiner
`JANETL.EPPS—SMHH
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`Art Unit
`1633
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`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 CFR1.136(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).
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`Status
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`1)|:l Responsive to communication(s) filed on
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`.
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`2a)I:I This action is FINAL.
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`2b)IXI This action is non—final.
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`3)|:l An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)|:l Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`5)|XI Claim(s) 1 is/are pending in the application.
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`5a) Of the above claim(s) _ is/are withdrawn from consideration.
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`6)I:I Claim(s) j is/are allowed.
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`7)|Xl Claim(s) 1 is/are rejected.
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`8)I:I Claim(s) _ is/are objected to.
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`9)|:l Claim(s) _ are subject to restriction and/or election requirement.
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`Application Papers
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`10)|:l The specification is objected to by the Examiner.
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`11)I:I The drawing(s) filed on j is/are: a)I:I accepted or b)I:I 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).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`12)|: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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`13)|:l Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
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`a)I:I All
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`b)I:I Some * c)I:l None of:
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`1.I:I Certified copies of the priority documents have been received.
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`2.I:I Certified copies of the priority documents have been received in Application No. j.
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`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) Q Notice of References Cited (PTO-892)
`2) El Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) Q Information Disclosure Statement(s) (PTO/SB/08)
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`Paper No(s)/Mail Date 9-3-09'3-15-11'6-21-11.
`U.S. Patent and Trademark Office
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`4) El Interview Summary (PTO-413)
`Paper N°(3)/IVI-3“ DaT9- L
`5) I:I NOTICQ Of Inform-3' Patent APPIICaTI0“
`6) D Other:
`.
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`PTOL-326 (Rev. 03-11)
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`Office Action Summary
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`Part of Paper No./Mail Date 20110822
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`Page 2
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`Page 2
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`

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`Application/Control Number: 12/537,571
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`Page 2
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`Art Unit: 1633
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`DETAILED ACTION
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`Claim Rejections - 35 USC § 102
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`1.
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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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`2.
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`Claims 1, 4, 5, 7-10, 15, 17, and 20-24 are rejected under 35 U.S.C. 102(b) as
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`being anticipated by Oksche et al. WO2008/025791A1 (Citations are taken from
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`US2010/0087470).
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`3.
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`Instant claim 1
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`is drawn to the following: A film dosage composition comprising:
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`a. A polymeric carrier matrix; b. A therapeutically effective amount of buprenorphine or a
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`pharmaceutically acceptable salt
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`thereof; c. A therapeutically effective amount of
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`naloxone or a pharmaceutically acceptable salt thereof; and d. A buffer in an amount
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`to provide a local pH of said composition of a value sufficient
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`to optimize
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`absorption of said buprenorphine.
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`4.
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`5.
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`See the following embodiments of Oksche et al. at the following paragraphs:
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`[0055] In one embodiment one may use non-gelatin film materials, e.g. films of
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`modified cellulose materials as dosage forms.
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`In this case, buprenorphine and
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`optionally opioid antagonists such as naloxone are incorporated into the film matrix and
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`films thus prepared may be administered orally.
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`6.
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`[0046] The pharmaceutical dosage form in accordance with the invention will be
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`administered such that the maximal dosage per day is 32 mg of buprenorphine. Once a
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`Page 3
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`Page 3
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`Application/Control Number: 12/537,571
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`Page 3
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`Art Unit: 1633
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`patient is enrolled in substitution therapy, the initial dosage will be typically between 2
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`mg to 4 mg of buprenorphine. The formulations may be administered once a day, every
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`two days, preferably every three days or even less frequently.
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`7.
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`[0072] Suitable pH modifiers include citric acid, tartaric acid, phosphoric acid,
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`hydrochloric acid and maleic acid.
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`Suitable sweeteners include aspartame and
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`thaumatin. Suitable taste-masking agents include sodium bicarbonate,
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`ion-exchange
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`resins, cyclodextrin inclusion compounds, adsorbates or microencapsulated actives.
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`8.
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`[0085]
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`In order to allow absorption of buprenorphine over the mucosa of the
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`mouth, and particularly sublingually,
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`in one embodiment
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`the dosage forms may
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`additionally use agents that enhance absorption of
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`the active agent,
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`i.e.
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`so—called
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`permeation enhancers.
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`9.
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`[0092] The polymer amount within the matrix may be between approximately 3%
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`by weight and approximately 98% by weight and preferably between 7 and 80% by
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`weight and even more preferably between 20 and 50% by weight,
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`the weight
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`percentages being based on the total weight of the dosage forms.
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`Claim Rejections - 35 USC § 103
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`10.
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`The following is a quotation of 35 U.S.C. 103(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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`Application/Control Number: 12/537,571
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`Page 4
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`Art Unit: 1633
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`11.
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`Claims 1-31 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Oksche et al. (as applied above).
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`12.
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`Oksche et al. as describe above is incorporated here. However, the disclosure of
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`this reference does not teach formulations buprenorphine and naloxone, where the
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`buffer
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`is present
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`in an amount sufficient
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`to inhibit
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`the absorption of naloxone.
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`Furthermore, the cited reference does not teach the specific range of pH recited in the
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`instant claims.
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`13.
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`According to the specification as filed, the buffer is present in such an amount so
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`as to provide optimal release from the film and/or absorption into the body an amount of
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`the agonist and the antagonist, see paragraph [OO67]. Additionally,
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`the reference
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`specification as filed teaches that any buffer system may be used, as desired, however
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`they preferably include sodium citrate, and citric acid. These features are already
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`disclosed in Oksche et al., see 1]
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`[OO72], which states that buprenorphine/naloxone
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`formulations may comprise the citric acid as a pH modifier.
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`The following embodiments of Oksche et al. are also disclosed:
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`[0012] Another
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`buprenorphine preparation aimed at preventing this potential possibility of abuse has
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`recently gained administrative approval
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`in the United States (Suboxone.RTM.). The
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`Suboxone.RTM.
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`preparation comprises buprenorphine hydrochloride and the opioid
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`antagonist naloxone hydrochloride dihydrate. The presence of naloxone is intended to
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`prevent parenteral abuse of buprenorphine as parenteral
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`co-administration of
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`buprenorphine and naloxone in e.g. an opioid-dependent addict will
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`lead to serious
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`withdrawal symptoms.
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`Application/Control Number: 12/537,571
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`Art Unit: 1633
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`[0013] However,
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`there remains a need for other diversion and/or abuse-resistant
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`dosage forms of buprenorphine, which can be used in drug substitution therapy as
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`described above.
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`Additionally,
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`it would be desirable to have a buprenorphine
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`preparation available which is diversion and/or abuse-resistant
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`in cases where the
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`preparation is used for drug substitution therapy and which could also provide efficient
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`analgesia in cases where the preparation is administered to alleviate pain in a patient.
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`It is clear that the sublingual film formulations of Oksche et al. are designed so as to
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`prevent development of dependency. Thus, it would have been obvious to the ordinary
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`skilled artisan, at the time of the instant invention, to modify their teachings so as to
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`identify the optimal range of pH/dosage in an effort to identify formulations that would
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`provide optimal absorption of both agonist and antagonist. As per MPEP 2144.05 [R-5],
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`since the general conditions of the instantly claimed invention are disclosed in the prior
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`art,
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`identification of
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`the optimal pH/dosage appears to be a matter of
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`routine
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`experimentation.
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`Regarding the rationale for combining prior art elements according to known
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`methods to yield predictable results, all of the claimed elements were known in the prior
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`art and one skilled in the art could have combined the element as claimed by known
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`methods with no change in their respective functions, and the combination would have
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`yielded predictable results to one of ordinary skill in the art at the time of the invention.
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`Application/Control Number: 12/537,571
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`Page 6
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`Art Unit: 1633
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to JANET L. EPPS —SMlTH whose telephone number is
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`(571)272-0757. The examiner can normally be reached on M—F, 10:00 AM through 6:30
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`PM.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Joseph Woitach can be reached on 571-272-0739. The fax phone number
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`for the organization where this application or proceeding is assigned is 571-273-8300.
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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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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll—free).
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`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.
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`JANET L. EPPS —SMlTH
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`Primary Examiner
`Art Unit 1633
`
`/JANET L. EPPS —SMITH/
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`Primary Examiner, Art Unit 1633
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`Page 7
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