`
`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
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`APPLICATION NO.
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`12/537,571
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`23869
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`
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` F ING DATE
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`08/07/2009
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`7590
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`05/02/2012
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`HOFFMANN & BARON, LLP
`6900 JERICHO TURNPIKE
`SYOSSET, NY 11791
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
`
`
`
`
`CONF {MATION NO.
`
`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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`05/02/2012
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`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)
`Page 1
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`BDSI EXHIBIT 1008
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`Page 1
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`

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`Application No.
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`Applicant(s)
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`Office Action Summary
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` 12/537,571 MYERS ET AL.
`Examiner
`Art Unit
`
`1633
`Janet Epps-Smith
`-- 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).
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`Status
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`1)|Zl Responsive to communication(s) filed on 29 February 2012.
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`2a)IZI This action is FINAL.
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`2b)|:l This action is non-final.
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`3)I:I 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 Quay/e, 1935 CD. 11, 453 O.G. 213.
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` Attachment(s)
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`Disposition of Claims
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`5)IZ Claim(s) 1 and 3-31 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)|:| Claim(s) _ is/are allowed.
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`7)|Xl Claim(s) 1 and3—31 is/are rejected.
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`8)|:| Claim(s) _ is/are objected to.
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`9)I:I Claim(s) _ are subject to restriction and/or election requirement.
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`Application Papers
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`10)I:I The specification is objected to by the Examiner.
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`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).
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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)I:I 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)|:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)|:| AII
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`b)|:l Some * c)I:I None of:
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`1.I:I Certified copies of the priority documents have been received.
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`2.|:l Certified copies of the priority documents have been received in Application No. _
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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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`4) I] Interview Summary (PTO-413)
`1) I] Notice of References Cited (PTO-892)
`Paper N0(S )/Mai| Date. _
`2) I] Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`5)I:I Notice 0f Informal Patent Application
`3) IZI Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mai| Date$20126”: Other:—
`U.S. Patent and Trademark Office
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`PTOL-326 (Rev. 03-11)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20120425
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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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`Claims 1 and 3-31 are presently pending for examination.
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`The text of those sections of Title 35, U.S. Code not included in this action can
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`1.
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`2.
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`be found in a prior Office action.
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`Claim Rejections - 35 USC § 1 12
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`3.
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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 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.
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`4.
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`Claims 1-10, 13-14, 16-23, 25-26 are rejected under 35 U.S.C. 112,
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`first
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`paragraph, as failing to comply with the written description requirement. The claim(s)
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`contains subject matter which was not described in the specification in such a way as to
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`reasonably convey to one skilled in the relevant art that the inventor(s), at the time the
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`application was filed, had possession of the claimed invention.
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`(New Matter).
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`5.
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`Applicants have amended the claims to recite “a
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`local pH....to optimize
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`absorption of buprenorphine, wherein said local pH is from about 2 to about 3.5 in the
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`presence of saliva." According to Applicants, support for this amendment could be found
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`at paragraphs [0013-0017].
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`6.
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`According to the specification as filed at 11 [0016] pH 335 is the Cmax of
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`naloxone. Moreover, the specification defines the Cmax as the mean maximum plasma
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`concentration after administration of the composition to a human subject. The claims
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`are drawn to a composition that produces a local pH of about 3.5, this pH represents the
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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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`Cmax of naloxone. However,
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`the claimed compositions are directed to inhibit the
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`absorption of naloxone and optimize absorption of buprenorphine.
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`7.
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`The specification does disclose a local pH of 2-4 as useful for optimizing the
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`absorption of buprenorphine, paragraph [0013]. However, the disclosure of a local pH
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`of 3.5 is clearly disclosed as related to the absorption of naloxone and is not disclosed
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`as specifically related to the absorption of buprenorphine, paragraph [0016]. After
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`reviewing the specification as filed for support for the limitation "about 3.5" as it relates
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`to the absorption of buprenorphine,
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`it
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`is clear that the specification does not provide
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`support for this limitation.
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`Response to Amendment/Arguments
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`Claim Rejections - 35 USC § 102
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`8.
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`The rejection of claims 1, 4, 5, 7-10, 15, 17, and 20-24 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) is withdrawn in response to Applicant’s amendment.
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`Claim Rejections - 35 USC § 103
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`9.
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`Claims
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`1, and 3-31
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`remain rejected under 35 U.S.C. 103(a) as being
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`unpatentable over Oksche et al. (as applied above).
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`10.
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`Applicant's arguments filed 02/29/2012 have been fully considered but they are
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`not persuasive.
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`11.
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`Applicants traverse the instant rejection on the grounds that the buffering system
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`used in the instant claims is sufficient to "optimize" the absorption of buprenorphine.
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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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`Moreover, Applicants argue that a pH of about 5.5 may be useful for maximizing the
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`absorption of buprenorphine, however not to “optimize” the absorption of buprenorphine
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`(see 1St 11 on page 9 of reply filed 2/29/2012). The use of the term “optimize” according
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`to Applicants is based upon their definition of the term as set forth in the specification as
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`filed at [0013]. However, contrary to Applicant's assertions, in response to applicant's
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`argument that the references fail to show certain features of applicant’s invention,
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`it is
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`noted that the features upon which applicant relies (i.e.,
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`the definition of the term
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`“optimize”) are not recited in the rejected claim(s). Although the claims are interpreted
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`in light of the specification, limitations from the specification are not read into the claims.
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`See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant’s
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`definition of the term “optimize” provided in the specification is not sufficiently precise
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`and definite such that the ordinary skilled artisan would be able to adequately be
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`apprised of the full scope of the claimed invention.. For example, the specification as
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`filed recites: “optimizing the absorption” does not refer to reaching the maximum
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`absorption of the composition, and rather refers to reaching the optimum level of
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`absorption at a pH of about 2 to about 4. Further, the specification teaches that "M
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`'optimum' Cmax of buprenorphine is about0.67 to about 5.36 mg/ml at dosages of from
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`2-16 mg buprenorphine at a given pH. The definition here appears to provide an
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`example of optimum buprenorphine (an optimum). Moreover,
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`the use of the term
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`"about" provides an open range (i.e. non-precise) regarding the level of buprenorphine
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`concentration.
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`Application/Control Number: 12/537,571
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`Page 5
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`Art Unit: 1633
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`12.
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`Furthermore, Applicants argued the following (see 1St full 1] on page 11 of reply
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`filed 2/29/2012): “As can be seen, one must consider a number of variables and
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`consider many different
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`features
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`in order
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`to
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`consider
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`the absorption of
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`the
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`buprenorphine "optimized", as presently claimed, so as to provide a bioeguivalent
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`release level as that of a Suboxone® tablet having similar levels of buprenorphine. The
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`particular buffering levels and amount play a critical
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`role
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`in determining the
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`effectiveness of the composition. The buffer capacity must be considered so as to
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`provide the desired absorption levels of both actives. The discovery of the desirable
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`buffer capacity was certainly not contemplated in Oksche and would not have been
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`predictable.”
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`13.
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`Contrary to Applicant’s assertions, Oksche et al. discloses the Suboxone® tablet
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`which Applicants assert that the presently claimed invention provides an optimized
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`absorption of buprenorphine, see 11 [0012] of Oksche et al. which teaches: "[A]nother
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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®).
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`The
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`Suboxone® 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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`14.
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`As stated in the prior Office Action, contrary to Applicant’s assertions, and in light
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`of the open range of pH recited in the instant claims (i.e. as it relates to the use of the
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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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`term “about” to define the claimed pH range),
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`it
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`is clear that
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`the sublingual
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`film
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`formulations of Oksche et al. are designed so as to prevent development of
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`dependency. Thus,
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`it would have been obvious to the ordinary skilled artisan, at the
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`time of the instant invention, to modify their teachings so as to identify the optimal range
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`of pH/dosage in an effort to identify formulations that would provide optimal absorption
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`of both agonist and antagonist. As per MPEP 2144.05 [R-5], since the general
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`conditions of the instantly claimed invention are disclosed in the prior art, identification
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`of the optimal pH/dosage appears to be a matter of routine experimentation.
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`15.
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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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`Conclusion
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`16.
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action.
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`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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`Application/Control Number: 12/537,571
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`Page 7
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`Art Unit: 1633
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`the advisory action.
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`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the mailing date of this final action.
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`17.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Janet Epps-Smith whose telephone number is (571 )272—
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`0757. The examiner can normally be reached on M-F, 1OAM-6:3OPM.
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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—O739. 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
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`(PAIR)
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`system.
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`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 -SMITH/
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`Primary Examiner, Art Unit 1633
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`Page 8
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`Page 8
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