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 .
Final Rejection
The Status of Claims:
Claims 7-9, 11-14, 16-25 are pending.
Claims 7-9, 12-14, 17-25 are rejected.
Claims 11 and 16 are objected.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
IDS
The IDS filed on 3/25/26 were reviewed by the examiner.
Claim Objections
Claims 11 and 16 are 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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.
The rejection of Claims 1-17 under 35 U.S.C. 112, first paragraph, is withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
The rejection of Claims 7-9, 12-14 and 17-25 provisionally on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7,9-12, 15-16, 18-20 of copending Application No. 18/258,653 is still maintained due to the failure to file the Terminal Disclaimer.
The rejection of Claims 7-9, 12-14 and 17-25 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 10-12 of copending Application No. 18/251,074 is still maintained due to the failure to file the Terminal Disclaimer.
The rejection of Claims 7-9, 12-14 and 17-25 provisionally on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 11-13 of copending Application No. 18/258,705 is still maintained due to the failure to file the Terminal Disclaimer.
The rejection of Claims 7-9, 12-14 and 17-25 provisionally on the ground of nonstatutory double patenting as being unpatentable over claims 1-7,11 of copending Application No. 18/547,800 is still maintained due to the failure to file the Terminal Disclaimer.
The rejection of Claims 7-9, 12-14 and 17-25 provisionally on the ground of nonstatutory double patenting as being unpatentable over claims 1-7,16 of copending Application No. 17/619,893 is still maintained due to the failure to file the Terminal Disclaimer.
Claim Rejections - 35 USC § 103
Applicants’ argument filed 3/25/26 have been fully considered, and they
are persuasive.
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.
The rejection of Claims 1-3, 6-9, 12-14, 17 under 35 U.S.C. 103 as being unpatentable over Choi et al (US 7,879,852 B2) ) in view of Wikipedia (Genetics of Obesity, Dec. 2020, p.8) is withdrawn due to the cancelation and the modification of the claims.
Applicants argue the following issues:
Applicant submits that the combination of cited art provides no teaching, suggestion, or motivation to arrive at the present claims with a reasonable expectation of success. None of the compounds in Choi would serve as a suitable template for chemical modification in the eyes of the skilled artisan. The Office nonetheless contends that Compound A96 would be an exemplary compound, despite contrary indicia: (A96),
which differs from the claimed formula 1 by having a 4,4-dimethylcyclohexyl moiety at the R4 position in lieu of a cis-4-methylcyclohexyl moiety and a methyl group in place of a C2-Cs alkyl at the Rs position. Applicant solicits the Examiner to consider Table 18 in Choi, which illustrates the ability of some of the Choi compounds to agonize the melanocortin-4 receptor. The half-maximal effective concentration (ECso) for Compound A96 is 38 nM, whereas several other structurally diverse compounds, e.g., Compounds A4 (3 nM), El0 (4 nM), and ES-2 (5 nM), have more robust MC4R activity.
If the skilled artisan were to read Choi in view of Wikipedia, he would certainly be more drawn to chemically modify these alternative compounds before even considering Compound A96. And even if the skilled artisan were to contemplate beginning with Compound A96, which he or she would certainly not consider, there are no other compounds with a 4,4-dimethylcyclohexyl moiety or a C2-Cs alkyl group at the R4 and Rs positions, respectively, which are highly active MC4R agonists assayed in Table 18 (i.e., having low-nM EC50 concentrations).
Further, Wikipedia is an online reference that cursorily provides a general survey of the state of the art and provides no reasonable expectation of success that any compound potentially gleaned from Choi could be formulated as a pharmaceutical composition for treating genetic obesity associated with an impaired melanocortin-4 receptor pathway.
For at least these reasons, Applicant submits that the present claims are nonobvious over the prior art, especially Choi in view of Wikipedia.
Applicants’ arguments have been noted. They are persuasive.
However, the application is not ready for allowance yet due to the lack of filing the Terminal Disclaimers with respect to the nonstatutory double patenting rejections.
Conclusion
Claims 7-9, 12-14, 17-25 are rejected.
Claims 11 and 16 are objected.
THIS ACTION IS MADE FINAL. 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 TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 5/22/2026
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