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 .
Current Status
This action is responsive to the amended claims of 02/25/2026. Claims 1-4, 8, 13-20, 25-27, and 32 are pending. Claims 2, 4, 13-19, 25, and 32 are withdrawn. Claims 1, 3, 8, 20, 26, and 27 have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-4, 8, 13-20, and 26-27) and the species of Formula (I) that is compound 480 in the reply filed on 02/25/2026 is acknowledged.
A search for the compound 480
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did not return any prior art. Thus, the search has been extended to the following species:
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,
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, and
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. This search retrieved prior art. Therefore, per Markush search practice, the Markush search will not be extended unnecessarily to additional species in this Office Action. The above species read on claims 1, 3, 8, 20, 26, and 27.
Claims 25 and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/25/2026.
Claims 2, 4, and 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 02/25/2026.
Priority
The effective filing date is 11/30/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/14/2023 and 02/25/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
In this case, the abstract does not provide information regarding the general nature of the compound, e.g., pyrrolidine derivatives exemplified by a chosen species of Formula (I) or (II). Please amend the abstract to reflect such information.
Claim Objections
Claims 1, 3, 8, 20, 26, and 27 are objected to because of the following informalities. Appropriate correction is required.
Claim 1: under scenario I), please add the word “or” before option iv), since iv) is the last option from which R2 is chosen. Further, under scenario II), please add the word “and” before the final wherein clause (i.e., at the arrow:
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). Dependent claims 3, 8, 20, 26, and 27 are similarly objected since they do not rectify the issue.
Claims 3 and 8 similarly require the word “and” before the final wherein clause (see above).
Applicant is advised that should claim 3 be found allowable, claim 8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 3 and 8 are both drawn to the same compound of Formula (I) II) as defined in parent claim 1. The only difference in the two claims is that claim 3 utilizes i)-v) to denote the options for R1 and claim 8 uses (a)-(e) to denote the same options. Otherwise, the genus of compound defined by these claims is identical.
Claim 26: under scenario I), please add the word “or” before option vi) since vi) is the final option from which R2 is chosen. Further under scenario II), please add the word “and” before the final wherein clause (see above).
Withdrawn claims 2, 4, and 19 would be objected to if not withdrawn. To expedite prosecution Examiner asks that Applicant address the following issues:
Claim 2: please add “or” before option iv) under R2.
Claim 4: this claim appears to be a substantial duplicate of claim 2, similar to claims 3 and 8, above. Both are drawn to the same compound of Formula (I) I) as defined in parent claim 1. The only difference in the two claims is that claim 2 utilizes i)-iv) to denote the options for R2 and claim 4 uses (a)-(d) to denote the same options. Otherwise, the genus of compound defined by these claims is identical.
Claim 19 recites “The compound of claim 1, or a pharmaceutically acceptable salt thereof”. The claim then recites species of compound and stereoisomers thereof. For consistency with parent claim 1, please add the phrase “or a stereoisomer or tautomer thereof” to the preamble.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 8, 20, 26, and 27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by FUHRMANN (WO 2022/103411, provided in IDS of 09/14/2023). The priority document US 63/112,609 filed 11/11/2020 is referenced below as “PD” to show support for the earlier filed compounds.
Regarding claims 1, 3, 8, and 26, FUHRMANN teaches 3 compounds which fall under Formula (I) II) and Formula (II) II) of the instant claims.
FUHRMANN teaches Compound 24
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(Pg. 180 ¶384; PD Pg. 62 specification) wherein L2-R2 is cyclopropyl, L1 is C1 alkylene (-CH2-), and R1 is C6 aryl substituted with one Rs, Rs is 5 membered heteroaryl which has one annular atom selected from N. Note the instant recitation of “has one or more annular atoms, independently selected from N and O” does not limit the heteroatoms of the heteroaryl to only N and O, it simply requires that at least one of the heteroatoms is N or O.
FUHRMANN also teaches compound
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(Pg. 253 final compound; PD Pg. 70 specification) wherein L2-R2 is cyclopropyl, L1 is C1 alkylene (-CH1-) substituted with one Re, Re is C1 alkyl (Me), R1 is C6 aryl substituted with one Rs, Rs is 5 membered heteroaryl which has one annular atom selected from N which is further substituted with one Rt, and Rt is C1 alkyl (Me). FUHRMANN teaches a stereoisomer thereof
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(Pg. 234 claim 9; PD claim 9).
FUHRMANN also teaches compound
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(Pg. 254 row 2 1st compound; PD Pg. 71 specification) wherein L2-R2 is cyclopropyl, L1 is C1 alkylene (-CH1-) substituted with one Re, Re is C1 alkyl (Me), R1 is C6 aryl substituted with two independently chosen Rs, Rs is Cl and Rs is 5 membered heteroaryl which has one annular atom selected from N which is further substituted with one Rt, and Rt is C1 alkyl (Me). FUHRMANN teaches a stereoisomer thereof
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(Pg. 235 claim 11; PD claim 11).
Regarding claims 20 and 27, FUHRMANN teaches a pharmaceutical composition comprising any one of the above compounds, or a stereoisomer, or tautomer thereof, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients (Pg. 258 claim 38; PD claim 38).
The applied reference has a common Inventor and Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
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 1, 3, 8, 20, 26, and 27 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1, 36-38, and 40-42 of copending Application No. 18/195,134 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims 36 and 37 recite species of formula (I) (ref. claim 1) including
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and
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and stereoisomers thereof
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and
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. These species read on instant Formula (I) II) and Formula (II) II), as described in ¶18, above. Reference claim 38 is drawn to a pharmaceutical composition comprising said species and one or more pharmaceutically acceptable excipients. Reference claims 40-42 are drawn to methods of use thereof. Thus, the reference claims are drawn to species of the instant claims and therefore anticipate instant claims 1, 3, 8, 20, 26, and 27.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are presently allowable as written.
Note, the co-pending Application No. 18/195,141 was briefly considered for double patenting but was ultimately not applied. The reference claims are drawn to compounds analogous to the instant Formula (I) or (II), but ultimately the recited species contain 1, 2, or more structural differences. Further, the reference claims recite a laundry list of species (never narrowing to a smaller selection), thus, the artisan would have to engage in picking and choosing led by hindsight reasoning to even choose a lead compound to modify to fall under the instant Formulas. Further, the reference species have at least 2 substantial structural differences from the species taught by FUHRMANN above. Thus, the artisan would not find the instant compound obvious even by combination of the co-pending application and FUHRMANN.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625