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 of 17/757,492
This Office Action is responsive to the amended claims and Applicant remarks of 03/30/2026. Claims 1-2, 5, 7-9, 13-16, 19, 21, 23-24, 29, 32-33, 35-36, and 39 are pending and have been examined on the merits. Claims 36 and 39 are withdrawn from consideration pursuant to the restriction requirement of 11/05/2025.
Priority
The instant application is a national stage entry of PCT/US2020/065593, international filing date 12/17/2020, which claims priority to U.S. Provisional Patent Application No. 62/949,160, filed 12/17/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicants’ election without traverse of Group I and the species of Example 5 in the reply filed 11/05/2025 are acknowledged.
The elected species was free of the prior art and the initial election of species was withdrawn. An expanded search using the Markush group for the compound of formula (Ia) of claim 1 was conducted and prior art and double patenting art was retrieved. The provisional non-statutory double patenting rejection was the only rejection of the non-final rejection of 12/29/2025. Pursuant to MPEP §804(I)(B)(1)(b)(i). However, prior art reading on the instantly claimed compounds was retrieved. Applicants have request rejoinder of claim 36 and 39. The previous restriction requirement is maintained claims 36 and 39 remain withdrawn.
Response to Arguments
The only rejection in the non-final rejection of 12/29/2025 was a provisional non-statutory double patenting rejection of instant claim 1 over claims 1-3 of co-pending Application No. 18/560,663. Applicants requested withdrawal of the rejection pursuant to MPEP §804(I)(B)(1)(b)(i). Applicants’ argument have been fully considered but is not persuasive. The cited MPEP provision applies where the provisional non-statutory double patenting rejection is the only rejection remaining in the application. In the present application, claims [***-***] are rejected under 35 U.S.C. § 102/103 over Masada, which discloses compounds reading on the instantly claimed compounds, as discussed in detail below. Accordingly, the condition identified in the MPEP is not met, and the provisional nonstatutory double patenting rejection is maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 23 and 24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 23 depends from claim 16 which requires a compound of formula I with the following structure
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. Claim 23 requires the following structure
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which does not include the pyridine ring of claim 16’s compound. Claim 23 therefore fails to limit the scope of the claimed compound. Claim 24 depends from 23 and inherits these deficiencies. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1, 21, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masada (US20130018073, found in IDS filed 03/16/2022).
Masada teaches compounds of formula (I)
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(Claim 1). The reference teaches example compound 2
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[0571] which has the following substitutions reading on the instantly claimed compounds: X1-X3 are CR4, R4 is H; R6 is H; R1 is H; R11 is H; R13 is H; R12 is C4 hydrocarbyl; R5 is a 6 membered carbocycle substituted with a C4 alkoxy group. Thus, Masada discloses each of the limitations of the claimed compounds of claim 1.
The Examiner notes that the presently claimed Marksuh structure encompasses an indole embodiment when X1-X3 are each CR4. As discussed above, this embodiment reads on the compounds of Masada. To advance prosecution, Applicant may wish to consider amending claim 1 to limited the claimed compound to
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or
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, corresponding to the pyrrolopyridine embodiments where X1 is N and X2/X3 are CR4, or X2 is N and X1/X3 are CR4, wherein R4 is H. Such an amendment would more clearly distinguish the claimed compounds from the indole compounds of the prior art.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/560,663 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed compounds of the instant application and the copending application overlap significantly in their scopes. From the disclosure, it is possible to arrive at the compounds of claims 1-3 of the copending application. The compound of formula Ia
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can be made into the compound of formula I
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with the following substitutions: R11 is CH3; X3 is CR4, R4 is H; R12 and R13 are H. This provides the following structure for Ia:
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. When R6 of Ia is H, this reads on the compound of formula I’s X2 when X2 is CH. When R1 of Ia is C1 alkyl (methyl), this reads on the compound of formula I’s R2 when R2 is methyl. With these substitutions the shared core of the two compounds is
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. X1, X2, and R5 of Ia correspond to X3, X1, and R3 of I, respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. In both applications, the X substituents can be N or CH. R5 is selected from a group which includes 5:6 carbocycle or heterocycle and bicyclic 6:6 carbocycle or heterocycle, each of which may be optionally substituted. These are the same allowed substitutions of R3 in claim 1 of the copending application. Based on the foregoing, the subject matter presently claimed is not patentably distinct from, and therefore overlaps with, the subject matter in the copending application.
Conclusion
Claims 1, 21, 23, 24, and 33 are rejected.
Claims 2, 5, 7-9, 13-16, 19, 29, 32, and 35 are objected to for being dependent upon a rejected base claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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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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/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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