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 without traverse of Group II, claims 21-22, 27, 30, 33, 39-40, 43, 46 and 54 drawn to a compound of Formula II
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in the reply filed on 03/09/2026 is acknowledged. Claims 1-3, 9, 14-18, 20, 56-60 and 62-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/09/2026.
Claims 21-22, 27, 30, 33, 39-40, 43, 46 and 54 is pending and is now evaluated on its merits.
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.
Claims 21-22, 27, 30, 39-40, 43 and 46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 21, 39 and 46 the phrase "example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 22, 27, 40 and 43 the phrase " J1-J3, T1, RA, RB, p1, p2 and R100-R101 " renders the claim indefinite because it is unclear whether the limitations of the above are of the same limitations as claim 21 in which the claims depend from. For prior art purposes examiner is interpreting the above limitations as being the same as independent claim 21.
Claim 30 recites the limitation "the compound of claim 29" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 29 is a cancelled claim thus not knowing its limitations. For prior art purposes examiner is interpreting the above limitations as being “the compound of claim 21”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-22, 27, 30, 33, 39-40, 43, 46 and 54 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by 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) and T1 is Tc-G, wherein TC is a bond and G is Hydrogen (relevant to claim 46).
In terms of claim 43, the limitation of TB as N(R100), O, C(=O), or
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merely further limits the TB but does not state the T1 is option 2 or 3 which includes TB. Thus, the teaching of Miller applies to the claim.
In terms of claim 54, the limitation of TA as OH, amine, amidine, guanidine, phosphate, sulfate, carboxylic acid, sugar alcohol, amino alcohol, a short peptide, monosaccharide, disaccharide, polysaccharide, or a basic optionally substituted heterocycle or heteroaryl merely further limits TA but does not state the T1 is option 1 or 2 which includes TA. Thus, the teaching of Miller applies to 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 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
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.
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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
Prosecution Insights