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 .
Status of the Application
This Office Action is in response to Applicant's Restriction Requirement remarks filed on April 1, 2026. Claim(s) 176-194 are pending. Claim(s) 179, 182, 186, 187, and 189-192 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claim(s) 176-178, 180, 181, 183-185, 188, 193, and 194 are examined herein insofar as they read on the elected invention.
Response to Arguments
In view of applicant’s amendments, the following rejections are hereby withdrawn:
Claims 176-178, 180, 181, 183-185, 188, 193, and 194 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Homan (Molecular Pharmacology, 2013) of record.
Claims 176-178, 180, 181, 183-185, 188, 193, and 194 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Larsen (WO 2016/210403) of record.
Claims 176-178, 180, 181, 183-185, 188, 193, and 194 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Patil (Indian Drugs, 1998).
The following rejections are hereby overcome, due to Applicant’s filing of Terminal Disclaimers:
Claims 176-178, 180, 181, 183-185, 188, 193, and 194 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,246,436.
Claims 176-178, 180, 181, 183-185, 188, 193, and 194 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,465,980.
Any rejection from the previous Office action not set forth on record below is hereby withdrawn.
The new or maintained/modified rejections are made in the Final Office action below as necessitated by amendment.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 176-178, 180, 181, 183-185, 188, 193, and 194 are rejected under 35 U.S.C. 103(a) as being unpatentable over Homan (Molecular Pharmacology, 2013) of record.
Homan discloses a structural and functional analysis of G protein-coupled receptor kinase inhibition by paroxetine and a rationally designed compound, CCG-205584 (page 238, Figure 1) and pharmaceutical compositions thereof (page 239, column 1, 1st full paragraph):
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163
246
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.
Compound CCG-206584 is a compound of Formula I as claimed in the instant claim 1 and pharmaceutical compositions thereof (instant claim 34), or Formula V as claimed in the instant claim 2, wherein Z is O (instant claim 8); R41 absent (instant claim 10); one of R36 or R37 is hydrogen and the other is F (instant claim 11); q is 0 (instant claim 16); R61 is H (instant claim 25); R35 is H and R34 is:
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325
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wherein Xa is C; R39 is H; R40 is H; and R42 is H (instant claim 22).
Homan does not teach R35 as C2-C6 alkyl.
It would have been obvious to one of ordinary skill in the art at the time of filing to have prepared compounds wherein R35 is H, as taught by Homa and also envisioned preparing the alkyl derivative. Compounds that differ only by the presence of an extra methyl group are homologues which are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. The homologue is expected to be preparable by the same method and to have the same properties. This expectation is then deemed the motivation for preparing homologues. Homologues are obvious even in the absence of a specific teaching to methylate, In re Wood 199 USPQ 137; In re Hoke 195 USPQ 148; In re Lohr 137 USPQ 548; In re Magerlein 202 USPQ 473; In re Wiechert 152 USPQ 249; Ex parte Henkel 130 USPQ 474; In re Fauque 121 USPQ 425; In re Druey 138 USPQ 39. In all of these cases, the close structural similarity of two compounds differing by only one (or two) methyl groups sufficed; no specific teaching to methylate was present or required. None of these cases has been overruled and indeed the examiner is unaware of any post Lohr case in which motivation is required to put a methyl group on an old compound. Therefore, based on the foregoing reasons, the instant claims are deemed anticipated over the cited art.
Claims 176-178, 180, 181, 183-185, 188, 193, and 194 are rejected under 35 U.S.C. 103(a) as being unpatentable over Larsen (WO 2016/210403) of record.
Larsen teaches a compound of Formula I and pharmaceutical compositions thereof (claim 1):
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Larsen specifically teaches (claim 41; [0019]):
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Larsen does not teach R35 as C2-C6 alkyl.
It would have been obvious to one of ordinary skill in the art at the time of filing to have prepared compounds wherein R35 is H, as taught by Larsen and also envisioned preparing the alkyl derivative. Compounds that differ only by the presence of an extra methyl group are homologues which are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. The homologue is expected to be preparable by the same method and to have the same properties. This expectation is then deemed the motivation for preparing homologues. Homologues are obvious even in the absence of a specific teaching to methylate, In re Wood 199 USPQ 137; In re Hoke 195 USPQ 148; In re Lohr 137 USPQ 548; In re Magerlein 202 USPQ 473; In re Wiechert 152 USPQ 249; Ex parte Henkel 130 USPQ 474; In re Fauque 121 USPQ 425; In re Druey 138 USPQ 39. In all of these cases, the close structural similarity of two compounds differing by only one (or two) methyl groups sufficed; no specific teaching to methylate was present or required. None of these cases has been overruled and indeed the examiner is unaware of any post Lohr case in which motivation is required to put a methyl group on an old compound.
Based on the foregoing reasons, the instant claims are deemed anticipated over the cited art.
Claims 176-178, 180, 181, 183-185, 188, 193, and 194 are rejected under 35 U.S.C. 103(a) as being unpatentable over Patil (Indian Drugs, 1998).
Patil teaches compounds of formula I and pharmaceutical compositions thereof.
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Patil does not teach R35 as C2-C6 alkyl.
It would have been obvious to one of ordinary skill in the art at the time of filing to have prepared compounds wherein R35 is H, as taught by Patil and also envisioned preparing the alkyl derivative. Compounds that differ only by the presence of an extra methyl group are homologues which are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. The homologue is expected to be preparable by the same method and to have the same properties. This expectation is then deemed the motivation for preparing homologues. Homologues are obvious even in the absence of a specific teaching to methylate, In re Wood 199 USPQ 137; In re Hoke 195 USPQ 148; In re Lohr 137 USPQ 548; In re Magerlein 202 USPQ 473; In re Wiechert 152 USPQ 249; Ex parte Henkel 130 USPQ 474; In re Fauque 121 USPQ 425; In re Druey 138 USPQ 39. In all of these cases, the close structural similarity of two compounds differing by only one (or two) methyl groups sufficed; no specific teaching to methylate was present or required. None of these cases has been overruled and indeed the examiner is unaware of any post Lohr case in which motivation is required to put a methyl group on an old compound. Based on the foregoing reasons, the instant claims are deemed anticipated over the cited art.
Conclusion
Claims 176-178, 180, 181, 183-185, 188, 193, and 194 are not allowed.
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 extension fee 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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
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