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 .
Detailed Action
Applicants have amended claims 21-22, 27, 30, 39-40, 43, 46 and 54. Claims 21-22, 27, 30, 33, 39-40, 43, 46 and 54 are pending and are now evaluated on its merits.
Priority
This application claims foreign benefit to application CN2020107047, dated 08/05/2020.
Information Disclosure Statement
The information disclosure statement (IDS) dated 7/13/2026 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file, and the information therein has been considered as to the merits.
Response to Arguments
Applicants’ arguments, see Pages 1-2, filed 07/13/2026, with respect to the 102 rejections of claims 21-22, 27, 30, 33, 39-40, 43, 46 and 54 under Miller et al. (WO 2018106518 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Miller et al. (WO 2018106518 A1).
The teachings of Miller from the previous office action are obvious to the amended claims of claimed invention. Of particular interest the limitations of T1 as TB-C5-50 alkylene-TA is obvious to the teachings of Miller.
Applicants have additionally overcome the 112b rejection of claims 21-22, 27, 30, 39-40, 43 and 46 by an amendment to the claims nevertheless the double patenting rejection of record is maintained as applicant request the rejections be held in abeyance.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 21-22, 27, 30, 33, 39-40, 43, 46 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (WO 2018106518 A1).
Regarding claims 21-22, 27, 30, 33, 39-40, 43, 46 and 54, Miller teaches Novel compounds of structural Formula I
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and the pharmaceutically acceptable salts thereof, as agonists of G-protein coupled receptor 40 (GPR40) and useful in the treatment, prevention and suppression of diseases mediated by the G-protein-coupled receptor 40. Of the diseases Miller teaches Type 2 diabetes mellitus, and of conditions that are often associated with this disease, including obesity and lipid disorders, such as mixed or diabetic dyslipidemia, hyperlipidemia, hypercholesterolemia, and hypertriglyceridemia (abstract). Of particular embodiments Miller teaches
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(example 9),
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(example 13),
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(example 16),
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(example 43) (relevant to claims 21-22, 27 and 40). The above compounds read to the limitations of claimed invention of J1 as
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(relevant to claim 30), J2 as CH(CH3) (relevant to claim 33), J3 as
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substituted with CF3 (relevant to claim 39).
In terms of claims 43, 46 and 54, Miller teaches compound B as an Aryl from the above structures which is unsubstituted or substituted by one or more Rb, wherein Rb is selected from a list which includes CF3, O-CF3, O(CH2)PNRcRd, O(CH2)PC2-5cycloheteroalkyl, wherein NRcRd is selected from a group consisting of H and p is 1-5. Thus, the teaching of Miller encompasses applicants’ limitation of TB-C5-50 alkylene-TA and Tc-TB-C5-50 alkylene-TA-TD wherein TD and TC is a bond, TB is O, and TA is an amine or substituted heteroaryl.
Miller fails to teach the limitations of T1 in the above examples.
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have developed the above compounds taught by Miller wherein compound B of a substituted aryl is substituted with the claimed T1 of TB-C5-50 alkylene-TA and Tc-TB-C5-50 alkylene-TA-TD wherein TD and TC is a bond, TB is O and TA is an amine or substituted heteroaryl. One would have been motivated to do so because Miller teaches compound B of a substituted aryl wherein one or more substitutions are selected from CF3, O-CF3, O(CH2)PNRcRd, O(CH2)PC2-5cycloheteroalkyl, wherein NRcRd is selected from a group consisting of H and p is 1-5. Thus, from the teaching of Miller the Fluoride atom on the phenyl ring of compound
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is replaced with O(CH2)5C2-5cycloheteroalkyl or O(CH2)5NH2.
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 conflicting claims 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); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-22, 27, 30, 33, 39-40, 43, 46 and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 133 and 149 of copending Application No. 18/728,541 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 133 and 149 of copending ‘541 anticipates and is obvious to claims 21-22, 27, 30, 33, 39-40, 43, 46 and 54 of claimed invention. In particular the compounds of claim 149 of
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,
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reads to claimed invention limitations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are 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 MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
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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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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