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
`
`APPLICATION NO.
`
`F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF {MATION NO.
`
`12/537,571
`
`08/07/2009
`
`Garry L. Myers
`
`1199-82
`
`5630
`
`Hoffmann&BaronLLP —
`“W”
`759°
`2””
`6900 Jericho Turnpike
`EPPS -SMITH, JANET L
`ART UNIT
`PAPER NUMBER
`Syosset, NY 11791
`
`1633
`
`MAIL DATE
`
`11/06/2012
`
`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.
`
`PT°L*9°*;,g*5g°‘;/07>
`
`BDSI EXHIBIT 1010
`
`Page 1
`
`

`
`Application/Control Number: 12/537,571
`
`Page 2
`
`Art Unit: 1633
`
`DETAILED ACTION
`
`Claims 1 and 3-31 are presently pending for examination.
`
`The text of those sections of Title 35, U.S. Code not included in this action can
`
`1.
`
`2.
`
`be found in a prior Office action.
`
`Claim Rejections - 35 USC § 1 12
`
`3.
`
`The rejection of claims 1-10, 13-14, 16-23, 25-26 under 35 U.S.C. 112,
`
`first
`
`paragraph, as failing to comply with the written description requirement, is withdrawn in
`
`response to Applicant’s argument.
`
`Response to Amendment/Arguments
`
`Claim Rejections - 35 USC § 103
`
`4.
`
`Claims
`
`1, and 3-31
`
`remain rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Oksche et al. (as applied above).
`
`5.
`
`Applicant's arguments filed 10/22/2012 have been fully considered but they are
`
`not persuasive.
`
`6.
`
`Applicants traversed the instant rejection on the grounds that Oksche et al. does
`
`not disclose the pH range recited in the instant claims, and does not provide any
`
`direction that one of ordinary skill
`
`in the art could follow and come up with the claimed
`
`invention. Moreover, Applicants traversed that they have discovered that a desirable
`
`local pH of a composition including buprenorphine and naloxone is between about 2 to
`
`about 3.5 (page 9, 2”’ 1] of the response filed 10/22/2012). Applicants then argued that
`
`their Examples show significant benefits when a pH of about 3.5 is used as compared to
`
`a pH or 6.5 and 5.5, Example 8 tested products at a pH of from 3.0-3.5 (page 10, 3rd 1]).
`
`Page 2
`
`Page 2
`
`

`
`Application/Control Number: 12/537,571
`
`Page 3
`
`Art Unit: 1633
`
`Applicants then concluded that: “The present inventors have discovered that ata QH of
`
`about 2-3.5, the relative absorptions can be controlled effectively.”
`
`7.
`
`Moreover, Applicants argued that
`
`their definition of the term “optimize” is
`
`expressly an unequivocally defined in the specification. Applicant’s definition appears at
`
`11 [0013] of the specification as filed.
`
`It is noted that Applicant’s definition states that the
`
`"optimum" absorption of the instant invention provides “bioequivalent absorgtion as
`
`administration of the currently available Suboxonell-‘lg tablet. "
`
`8.
`
`Contrary to Applicant’s assertions, Oksche et al. discloses the Suboxone® tablet
`
`which Applicants assert that the presently claimed invention provides an optimized
`
`absorption of buprenorphine, see 1] [0012] of Oksche et al. which teaches: "[A]nother
`
`buprenorphine preparation aimed at preventing this potential possibility of abuse has
`
`recently gained administrative approval
`
`in the United States (Suboxone®).
`
`The
`
`Suboxone® 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.”
`
`9.
`
`Applicant’s argument that the Examples show significant benefits when a pH of
`
`about 3.5 is used as compared to a pH or 6.5 and 5.5, Example 8 tested products at a
`
`pH of from 3.0-3.5,
`
`is not sufficient to provide evidence of unexpected or significant
`
`benefits associated with the full scope of the claimed invention, which recites a “local pH
`
`Page 3
`
`Page 3
`
`

`
`Application/Control Number: 12/537,571
`
`Page 4
`
`Art Unit: 1633
`
`of about 2 to about 3.5 in the Qresence of saliva." Applicant’s showing is not
`
`commensurate in scope with the claimed invention.
`
`10.
`
`As stated in the prior Office Action, contrary to Applicant’s assertions, and in light
`
`of the open range of pH recited in the instant claims (i.e. as it relates to the use of the
`
`term “about” to define the claimed pH range),
`
`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.
`
`11.
`
`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 4
`
`Page 4
`
`

`
`Application/Control Number: 12/537,571
`
`Page 5
`
`Art Unit: 1633
`
`12.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Janet Epps-Smith whose telephone number is (571)272-
`
`0757. The examiner can normally be reached on M-F, 10AM-6:30PM.
`
`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
`
`Page 5
`
`Page 5
`
`

`
`_
`_
`Advisory Action
`Before the Filing of an Appeal Brief
`
`Application No.
`12/537,571
`Examiner
`Janet Epps—Smith
`
`App|icant(s)
`MYERS ET AL.
`Art Unit
`1633
`
`--The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`THE REPLY FILED 22 October 2012 FAILS TO PLACE THIS APPLICATION IN CONDITION FOR ALLOWANCE.
`NO NOTICE OF APPEAL FILED
`
`1. IX The reply was filed after a final rejection. No Notice of Appeal has been filed. To avoid abandonment of this application, applicant must timely file
`one of the following replies: (1) an amendment, affidavit, or other evidence, which places the application in condition for allowance;
`(2) a Notice of Appeal (with appeal fee) in compliance with 37 CFR 41.31 ; or (3) a Request for Continued Examination (RCE) in compliance with
`37 CFR 1.114 if this is a utility or plant application. Note that RCEs are not permitted in design applications. The reply must be filed within one of
`the following time periods:
`a) IE The period for reply expires Qmonths from the mailing date of the final rejection.
`b) D The period for reply expires on: (1) the mailing date of this Advisory Action; or (2) the date set forth in the final rejection, whichever is later.
`In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of the final rejection.
`C) D A prior Advisory Action was mailed more than 3 months after the mailing date of the final rejection in response to a first after-final reply filed
`within 2 months of the mailing date of the final rejection. The current period for reply expires
`months from the mailing date of
`the prior Advisory Action or SIX MONTHS from the mailing date of the final rejection, whichever is earlier.
`Examiner Note: If box 1 is checked, check either box (
`), (b) or (c). ONLY CHECK BOX (b) WHEN THIS ADVISORY ACTION IS THE
`FIRST RESPONSE TO APPL|CANT'S FIRST AFTER-FINAL REPLY WHICH WAS FILED WITHIN TWO MONTHS OF THE FINAL
`REJECTION. ONLY CHECK BOX (c) IN THE LIMITED SITUATION SET FORTH UNDER BOX (c). See MPEP 706.07(f).
`Extensions of time may be obtained under 37 CFR 1.136(a). The date on which the petition under 37 CFR 1.136(a) and the appropriate
`extension fee have been filed is the date for purposes of determining the period of extension and the corresponding amount of the fee. The
`appropriate extension fee under 37 CFR 1.17(a) is calculated from: (1) the expiration date of the shortened statutory period for reply originally
`set in the final Office action; or (2) as set forth in (b) or (c) above, if checked. Any reply received by the Office later than three months after the
`mailing date of the final rejection, even if timely filed, may reduce any earned patent term adjustment. See 37 CFR 1.704(b).
`NOTICE OF APPEAL
`
`. A brief in compliance with 37 CFR 41.37 must be filed within two months of the date of filing the
`2. D The Notice of Appeal was filed on
`Notice of Appeal (37 CFR 41 .37(a)), or any extension thereof (37 CFR 41 .37(e)), to avoid dismissal of the appeal. Since a Notice of
`Appeal has been filed, any reply must be filed within the time period set forth in 37 CFR 41 .37( ).
`AMENDMENTS
`
`3. D The proposed amendments filed after a final rejection, but prior to the date of filing a brief, will n_ot be entered because
`a) I] They raise new issues that would require further consideration and/or search (see NOTE below);
`b) I] They raise the issue of new matter (see NOTE below);
`c) I] They are not deemed to place the application in better form for appeal by materially reducing or simplifying the issues for
`appeal; and/or
`d) D They present additional claims without canceling a corresponding number of finally rejected claims.
`NOTE: j. (See 37 CFR 1.116 and 41 .33( )).
`4. D The amendments are not in compliance with 37 CFR 1.121. See attached Notice of Non-Compliant Amendment (PTOL-324).
`5. E AppIicant’s reply has overcome the following rejection(s): See Continuation Sheet.
`would be allowable if submitted in a separate, timely filed amendment canceling the non-
`6. D Newly proposed or amended c|aim(s)
`allowable c|aim( ).
`7. D For purposes of appeal, the proposed amendment(s): (a) D will not be entered, or (b) D will be entered, and an explanation of how the
`new or amended claims would be rejected is provided below or appended.
`AFFIDAVIT OR OTHER EVIDENCE
`
`8. [I The affidavit or other evidence filed after final action, but before or on the date of filing a Notice of Appeal will n_ot be entered because
`applicant failed to provide a showing of good and sufficient reasons why the affidavit or other evidence is necessary and was not earlier
`presented. See 37 CFR1.116( ).
`9. El The affidavit or other evidence filed after the date of filing the Notice of Appeal, but prior to the date of filing a brief, will n_ot be entered
`because the affidavit or other evidence failed to overcome a_H rejections under appeal and/or appellant fails to provide a showing of good
`and sufficient reasons why it is necessary and was not earlier presented. See 37 CFR 41 .33(d)(1).
`10. E] The affidavit or other evidence is entered. An explanation of the status of the claims after entry is below or attached.
`REQUEST FOR RECONSIDERATION/OTHER
`
`1 1. IX The request for reconsideration has been considered but does NOT place the application in condition for allowance because:
`See attached document.
`
`12. D Note the attached Information Disclosure Statement(s). (PTO/SB/08) Paper No( ).
`13. El Other:
`.
`TATUS OF CLAIMS
`
`14. The status of the c|aim(s) is (or will be) as follows:
`C|aim(s) allowed:
`.
`C|aim(s) objected to:
`C|aim(s) rejected: 1 and 3-31.
`C|aim(s) withdrawn from consideration:
`
`U.S. Patent and Trademark Office
`
`PTOL-303 Rev. 09-€010)
`age
`
`Advisory Action Before the Filing of an Appeal Brief
`
`Part of Paper No. 20121101
`
`/Janet Epps—Smith/
`Primary Examiner, Art Unit 1633
`
`Page 6
`
`

`
`Continuation Sheet (PTOL-303)
`
`Application No. 12/537,571
`
`Continuation of 5. Applicants reply has overcome the following rejection(s): The rejection of claims 1-10, 13-14, 16-23, 25-26 under 35
`U.S.C. 112, first paragraph, as failing to comply with the written description requirement, is withdrawn in response to Applicant's argument..
`
`Page 7
`
`Page 7