`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
`
`APPLICATION NO.
`
`12/537,571
`
`23869
`
`
`
`
` F ING DATE
`
`08/07/2009
`
`7590
`
`08/31/2011
`
`HOFFMANN & BARON, LLP
`6900 JERICHO TURNPIKE
`SYOSSET, NY 11791
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`CONF {MATION NO.
`
`Garry L. Myers
`
`1199—82
`
`5630
`
`EXAMINER
`
`EPPS -SMITH, JANET L
`
`ART UNIT
`
`1633
`
`MAIL DATE
`
`08/31/2011
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL—90A (Rev. 04/07)
`Page 1
`
`BDSI EXHIBIT 1006
`
`Page 1
`
`
`
`
`
`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`
` 12/537,571 MYERS ET AL.
`Examiner
`Art Unit
`JANET L. EPPS -SMITH
`1633
`
`-- The MAILING DA TE 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 3 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 () 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)|:I Responsive to communication(s) filed on
`
`
`
`.
`
`2a)|:l This action is FINAL.
`
`2b)IXI This action is non-final.
`
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
`
`; the restriction requirement and election have been incorporated into this action.
`
`4)|:l 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 Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
` Attachment(s)
`
`Disposition of Claims
`
`5)IZ Claim(s) 1-31 is/are pending in the application.
`
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`
`6)|:| Claim(s) _ is/are allowed.
`
`7)|Xl Claim(s) 1-_31is/are rejected.
`
`8)|:| Claim(s) _ is/are objected to.
`
`9)I:I Claim(s) _ are subject to restriction and/or election requirement.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`
`11)I:| 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).
`
`12)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`13)|:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`a)|:| AII
`
`b)|:l Some * c)I:I None of:
`
`1.I:I Certified copies of the priority documents have been received.
`
`2.|:l Certified copies of the priority documents have been received in Application No. _
`
`3.I:I 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.
`
`1) IZI Notice of References Cited (PTO-892)
`2) I] Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) IZI Information Disclosure Statement(s) (PTO/SB/08)
`
`Paper No(s)/Mai| Date 9-3-09'3-15-11'6-21-11.
`U.S. Patent and Trademark Office
`
`4) I] Interview Summary (PTO-413)
`Paper N0(S )/Mai| Date. _
`5)I:I NOTICQ 0f Informal Patent Application
`6)I:I Other:—
`
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20110822
`
`Page 2
`
`Page 2
`
`
`
`Application/Control Number: 12/537,571
`
`Page 2
`
`Art Unit: 1633
`
`DETAILED ACTION
`
`Claim Rejections - 35 USC § 102
`
`1.
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(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.
`
`2.
`
`Claims 1, 4, 5, 7-10, 15, 17, and 20-24 are rejected under 35 U.S.C. 102(b) as
`
`being anticipated by Oksche et al. W02008/025791A1 (Citations are taken from
`
`US2010/0087470).
`
`3.
`
`Instant claim 1
`
`is drawn to the following: A film dosage composition comprising:
`
`a. A polymeric carrier matrix; b. A therapeutically effective amount of buprenorphine or a
`
`pharmaceutically acceptable salt
`
`thereof; c. A therapeutically effective amount of
`
`naloxone or a pharmaceutically acceptable salt thereof; and d. A buffer in an amount
`
`to provide a local pH of said composition of a value sufficient
`
`to optimize
`
`absorption of said buprenorphine.
`
`4.
`
`5.
`
`See the following embodiments of Oksche et al. at the following paragraphs:
`
`[0055] In one embodiment one may use non-gelatin film materials, e.g. films of
`
`modified cellulose materials as dosage forms.
`
`In this case, buprenorphine and
`
`optionally opioid antagonists such as naloxone are incorporated into the film matrix and
`
`films thus prepared may be administered orally.
`
`6.
`
`[0046] The pharmaceutical dosage form in accordance with the invention will be
`
`administered such that the maximal dosage per day is 32 mg of buprenorphine. Once a
`
`Page 3
`
`Page 3
`
`
`
`Application/Control Number: 12/537,571
`
`Page 3
`
`Art Unit: 1633
`
`patient is enrolled in substitution therapy, the initial dosage will be typically between 2
`
`mg to 4 mg of buprenorphine. The formulations may be administered once a day, every
`
`two days, preferably every three days or even less frequently.
`
`7.
`
`[0072] Suitable pH modifiers include citric acid, tartaric acid, phosphoric acid,
`
`hydrochloric acid and maleic acid.
`
`Suitable sweeteners include aspartame and
`
`thaumatin. Suitable taste-masking agents include sodium bicarbonate,
`
`ion-exchange
`
`resins, cyclodextrin inclusion compounds, adsorbates or microencapsulated actives.
`
`8.
`
`[0085]
`
`In order to allow absorption of buprenorphine over the mucosa of the
`
`mouth, and particularly sublingually,
`
`in one embodiment
`
`the dosage forms may
`
`additionally use agents that enhance absorption of
`
`the active agent,
`
`i.e. so-called
`
`permeation enhancers.
`
`9.
`
`[0092] The polymer amount within the matrix may be between approximately 3%
`
`by weight and approximately 98% by weight and preferably between 7 and 80% by
`
`weight and even more preferably between 20 and 50% by weight,
`
`the weight
`
`percentages being based on the total weight of the dosage forms.
`
`Claim Rejections - 35 USC § 103
`
`10.
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(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.
`
`Page 4
`
`Page 4
`
`
`
`Application/Control Number: 12/537,571
`
`Page 4
`
`Art Unit: 1633
`
`11.
`
`Claims 1-31 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Oksche et al. (as applied above).
`
`12.
`
`Oksche et al. as describe above is incorporated here. However, the disclosure of
`
`this reference does not teach formulations buprenorphine and naloxone, where the
`
`buffer
`
`is present
`
`in an amount sufficient
`
`to inhibit
`
`the absorption of naloxone.
`
`Furthermore, the cited reference does not teach the specific range of pH recited in the
`
`instant claims.
`
`13.
`
`According to the specification as filed, the buffer is present in such an amount so
`
`as to provide optimal release from the film and/or absorption into the body an amount of
`
`the agonist and the antagonist, see paragraph [0067]. Additionally,
`
`the reference
`
`specification as filed teaches that any buffer system may be used, as desired, however
`
`they preferably include sodium citrate, and citric acid. These features are already
`
`disclosed in Oksche et al., see 1] [0072], which states that buprenorphine/naloxone
`
`formulations may comprise the citric acid as a pH modifier.
`
`The following embodiments of Oksche et al. are also disclosed:
`
`[0012] Another
`
`buprenorphine preparation aimed at preventing this potential possibility of abuse has
`
`recently gained administrative approval
`
`in the United States (Suboxone.RTM.). The
`
`Suboxone.RTM.
`
`preparation comprises buprenorphine hydrochloride and the opioid
`
`antagonist naloxone hydrochloride dihydrate. The presence of naloxone is intended to
`
`prevent parenteral abuse of buprenorphine as parenteral
`
`co-administration of
`
`buprenorphine and naloxone in e.g. an opioid-dependent addict will
`
`lead to serious
`
`withdrawal symptoms.
`
`Page 5
`
`Page 5
`
`
`
`Application/Control Number: 12/537,571
`
`Page 5
`
`Art Unit: 1633
`
`[0013] However,
`
`there remains a need for other diversion and/or abuse-resistant
`
`dosage forms of buprenorphine, which can be used in drug substitution therapy as
`
`described above.
`
`Additionally,
`
`it would be desirable to have a buprenorphine
`
`preparation available which is diversion and/or abuse-resistant
`
`in cases where the
`
`preparation is used for drug substitution therapy and which could also provide efficient
`
`analgesia in cases where the preparation is administered to alleviate pain in a patient.
`
`It is clear that the sublingual film formulations of Oksche et al. are designed so as to
`
`prevent development of dependency. Thus, it would have been obvious to the ordinary
`
`skilled artisan, at the time of the instant invention, to modify their teachings so as to
`
`identify the optimal range of pH/dosage in an effort to identify formulations that would
`
`provide optimal absorption of both agonist and antagonist. As per MPEP 2144.05 [R-5],
`
`since the general conditions of the instantly claimed invention are disclosed in the prior
`
`art,
`
`identification of
`
`the optimal pH/dosage appears to be a matter of
`
`routine
`
`experimentation.
`
`Regarding the rationale for combining prior art elements according to known
`
`methods to yield predictable results, all of the claimed elements were known in the prior
`
`art and one skilled in the art could have combined the element as claimed by known
`
`methods with no change in their respective functions, and the combination would have
`
`yielded predictable results to one of ordinary skill in the art at the time of the invention.
`
`Page 6
`
`Page 6
`
`
`
`Application/Control Number: 12/537,571
`
`Page 6
`
`Art Unit: 1633
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to JANET L. EPPS -SMITH whose telephone number is
`
`(571)272-0757. The examiner can normally be reached on M-F, 10:00 AM through 6:30
`
`PM.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Joseph Woitach can be reached on 571 -272—0739. The fax phone number
`
`for the organization where this application or proceeding is assigned is 571-273-8300.
`
`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
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272—1000.
`
`JANET L. EPPS -SMITH
`
`Primary Examiner
`Art Unit 1633
`
`/JANET L. EPPS -SMITH/
`
`Primary Examiner, Art Unit 1633
`
`Page 7
`
`Page 7
`
`