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 1, 3-13 and 15-17 are pending.
Claims 1, 3-5, 11-13, and 15-17 are rejected.
Claims 6-10 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 3/16/26 are reviewed by the examiner.
Claim Objections
The objection of Claims 6-10 is still maintained due to being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of Claim 13 under 35 U.S.C. 112, first paragraph, is withdrawn due to the modification of the claim.
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 1,3-5, 11-13, and 15-17 provisionally on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 10-19 of copending Application No. 18/251,074 is still maintained due to applicant’s failure to file the Terminal Disclaimer.
Claim Rejections - 35 USC § 103
Applicants’ arguments filed 3/16/2026 have been fully considered,
However, they are not persuasive at this time.
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.
5. The rejection of Claims 1, 5, 11-13, 17 under 35 U.S.C. 103 as being unpatentable over Choi et al (US 7,879,852 B2) is still maintained due to the lack of the modification of the claim 1.
Applicants argue the following issues:
Applicant asserts that there is no teaching or suggestion in Choi which would be available to the skilled artisan to arrive at the instant compound per se of formula 1, let alone the claimed amorphous solid form. There is simply no plausible impetus beginning from any of the compounds in Choi or its teaching for further chemical modification. The Examiner alleges that Choi teaches
Compound A96, which differs from the instantly claimed compound per se at the R 4 and R5 positions, wherein R 4 is 4,4-dimethylcyclohexyl in lieu of 4-cis-methylcyclohexyl, and R5 is methyl in lieu of C2-Cs alkyl. The Applicant draws the Examiner's attention to Table 18 in Choi, which discloses the halfmaximal effective concentrations (EC50 values) of a small selection of Choi compounds. Applicant underscores that the EC50 value for Compound A96 is 38nM, whereas several other structurally diverse compounds (e.g., Compound A4, EC 50 of 3nM; Compound E10, EC50 of 4 nM) are considerably more potent MC4R agonists. Clearly, the skilled artisan would primarily rely on these compounds first before even considering Compound A96 as a basis for modification.
And even if the skilled artisan were to begin with Compound A96, which he or she would assuredly not, there is no teaching or suggestion in Choi that would permit the skilled artisan to arrive at an amorphous solid form of the compound as in the present claims. Choi does not disclose the isolation or preparation of an amorphous form. It is conventionally known in the art that there are multiple solid forms of a compound, including multiple crystalline polymorphs and multiple amorphous states. There is no explicit or inherent disclosure, let alone a teaching or suggestion, of the claimed amorphous compound. For at least these reasons, Applicant submits that claims 1, 5, 11-13, and 17 are nonobvious under 35 U.S.C. § 103 and respectfully requests expedient withdrawal of the rejection.
Applicants’ arguments have been fully noted. However, the claim 1 is directed to the compound claim regardless of its amorphous form. The use of a term “ amorphous form” does not have any patentable weight over the prior art compound. The main issue is that whether or not the prior art Choi et al can contain the existence of the claimed compound in a broad sense. The answer for that is positive as Applicant mentioned the compound A96 although Choi does not disclose the isolation or preparation of an amorphous form. Furthermore, the claim does not specify the unique characteristics of X-ray powder diffraction pattern for the claimed amorphous compound of formula 1. Moreover, it is a well-known common knowledge in that art that there are multiple solid forms of a compound, including multiple crystalline polymorphs and multiple amorphous states.
In addition, although the prior art does not exemplify the claimed compound having a moiety of 4-methylcyclohexyl and the claimed variable R1 being in the range of C2-C5 alkyl, the prior art does mention that R5’ can represent either CH3 or CH(CH3)2 (see col. 49-50, Example A104); furthermore, R4 represents, inter alia, either 4-methylcyclohexyl or 4,4-dimethylcyclohexyl (see Col. 5, line18-22).
So, if the skilled artisan in the art had desired to form an amorphous compound having a moiety of 4-methylcyclohexyl as an alternative to 4,4-dimethylcyclohexyl with the claimed variable R1 being CH(CH3)2 instead of a methyl group, it would have been obvious to the skilled artisan in the art before the effective filing date of the claimed invention to be motivated to do so by performing a routine experimentation. This is because the skilled artisan in the art would expect such a manipulation to be successful and feasible as guidance shown in the prior art and to be within the purview of the skilled artisan in the art.
Allowable subject matter
The examiner recommends to incorporate either the claim 3 or claim 4 into claim 1 in order to overcome the 103 rejection easily.
Conclusion
Claims 1, 3-5, 11-13, and 15-17 are rejected.
Claims 6-10 are objected.
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 TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 5/6/2026
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