DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of the specie of compound 21 in the reply filed on 12/2/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The outstanding rejection under 35 USC 102 and 103 are withdrawn in view of the amendments filed 3/27/2026 as the claims no longer reciting R3 as hydrogen.
Since compound 21 of the instant specification is found to be free of prior art, the search is extended to tetrahydro-4-methyl-2-methyl-pyrazino[1,2-a]pyrazine-3,6(1H,4H)-dione.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO98/49168 (‘168).
‘168 teaches a genus of compounds encompasses partially what the instant compound of the claims (see claim 2). ‘168 teaches the compounds of (I”) – also the compound of claim 5, when A is absent when n = 0, The R’, R1, R3, R4 as a glycine or alanine side chain moiety, R2 is alanine side chain moiety; R1 can even be a phenylalanine side chain moiety as R’4 in the instant claim can be an arylalkyl (see claim 2, page 9 and 10, Table 1). ‘168 teaches the composition comprising pharmaceutical acceptable carrier and the compounds (see claim 14). ‘168 also teaches the compounds as useful in “effectively inhibit the binding of a radiolabeled enkephalin derivative to the δ and µ opiate receptors” (see page 23, lines 27-28).
‘168 does not expressly teach the specific compound of formula (I”).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ and incorporate the compounds of formula (I”) into a composition to inhibit the binding of a radiolabeled enkephalin derivative to the δ and µ opiate receptors.
One ordinary skill in the art would have been motivated to employ and incorporate the compounds of formula (I”) into a composition to inhibit the binding of a radiolabeled enkephalin derivative to the δ and µ opiate receptors. Since the compounds taught in ‘168 as well-known to be useful to inhibit the binding of a radiolabeled enkephalin derivative to the δ and µ opiate receptors, employing any compounds taught by ‘168, including the compounds of formula (I”), would be reasonably expected to be effective.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with regard to the outstanding rejections filed 3/27/2026, the arguments are considered moot in view of the new ground of rejection.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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 TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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