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 .1
Status of Claims
Claims 4 and 92-110 are pending. Claims 92-94,101,104 and 110 are withdrawn. Claims 4, 95-100,102-103 and 105-109 are under Examination.
Election/Restrictions
Claims 92-94,101,104 and 110 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II and species of compound there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 15 2026.
Applicant’s election without traverse of Group I and the below species in the reply filed on June 15 2026 is acknowledged.
(1-(4-(4H-1,2,4-triazol-3-yl)phenyl)-1H-pyrrolo[2,3-b]pyridin-5-yl)(4,4-difluoropiperidin-1-yl)methanone aka Compound B-26 of Table 1, page 41
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Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 9/11/2024, 3/25/2026, 5/14/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Closest Prior Art
Based on the Examiner’s multiple SciFinder compound structure searches, accompanying this office action, the following compounds are recognized as the closest prior art.
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Both compounds are taught by WO 2021151014 A1 (WO 014), published 07-29-2021, with earliest priority to Jan 23 2020 (note, US 11891389 B2 is the US member of the WO 014 extended patent family). The examined Application claims earliest priority to 7/28/2021.
CAS Reg. No. 2673406-01-2 (identified therein as MF-DH-575) is taught page 153, Table 3.
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See also page 262, paragraph 741.
CAS Reg. No.2673406-01-2 differs from the claimed compounds as it has a cyano and does not have heteroaryl at a position equivalent to where X3 is CR3B, where R3B is a 5-10 heteroaryl (unsubstituted or substituted).
CAS Reg. No. 2673405-92-8 is found at page 145 and identified therein as MF-DH-514.
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See also page 258, paragraph 734.
CAS Reg. No. 2673405-92-8 differs from the claimed compounds as it has a halogen (Fluoro) at position equivalent to R5, where the claimed invention claims R5 is H, C1-C6 alkyl or -C(O)R10.
Also noted is compound ML-148 of Duveau et al. (see NPL Ref. 001 of IDS dated Mar 25 2026) 2, cited by the Supplemental European Search Report for EP 22 850 242.3 discloses compound ML-148,
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ML148 differs from the claimed compounds by virtue of having a methyl substituted on a carbon, at a position equivalent to formula V’s X3 moiety, where X3 is CR3B, where R3B can only be 5-10 membered heteroaryl. Accordingly, the compounds of formula V of claim 4 are free of the prior art.
Claim Objections
Claims 98 and 100 is objected to because of the following informalities:
Claim 98 is objected for reciting “R15” rather than “R15.”
Claim 100 is missing the parentheses “(“ before the term “Previously.” Appropriate correction is required.
Allowable Subject Matter
Claim 108 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4, 95-100,102-103, 105-107 and 109 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Claimed Invention
The claimed invention (claim 4) is directed to a compound of formula V, as detailed above, where R1, R2, R6, X2, X3, X4, W, m, n, and q are broadly claimed as recited therein.
Certain narrower embodiments of the claimed invention are presented in various dependent claims. Some of these claims further limit the claimed groups and substituents as detailed therein. Claim 108 recites the claimed and elected species and other individual species. Claim 108 is NOT rejected for written description.
The Supporting Disclosure
Applicants’ supporting disclosure contains certain descriptions and embodiments of the claimed invention.
In the present case, the important factors leading to a conclusion of inadequate written description is the absence of sufficient working examples of the invention as claimed, and the lack of predictability in the art.
In the present case there is no disclosure of compounds having the broad and full scope definitions of the groups and substituents of claim 4. In fact, the scope of compounds that provide adequate written description are the 59 compounds of claim 108 and also found in on Table 1 starting at pages 40-41 of the specification.
In contrast to the broad claimed scope of R1, R2, R6, X2, X3, X4, W, m, n, and q of the claims, the supporting disclosure (claim 108, pages 9-10; Table 1 and the inhibition and induction data of Tables 43 and 5 at paragraphs 436 and 440), are limited to the following:
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R1 is limited to hydrogen or methyl;
R2 is limited to hydrogen;
R6 is limited to H, methyl, methoxy, ethoxy, hydroxyl, halogen (fluoro), CF3, morpholine, cyclopropyl, -N(CH3)2;
R7 is limited to hydrogen;
X2 and X4 are limited to where both are -CH-, or where of R3A and R3C where one is hydrogen and the other where the other is CN, methyl, methoxy, Cl or F;
X3 is limited where of CR3B, R3B is to 5 membered heteroaryl with nitrogen, such as pyrrole, pyrazole, imidazole, and triazole, unsubstituted or substituted with NH2, ethyl, isopropyl, CF3;
W is limited to -CR6R6-, O and S;
m and n are limited to where the sum of m and n is where with the nitrogen and remainer of -CH2- they are attached to form a 5-6 membered heterocycle, with heteroatoms S, O and N; and
q is limited to 0-2 and can only be 3, when R6 is hydrogen.
Applicant’s disclosure of the 59 compounds of claim 108 specification Table 1, is not a sufficient representation of all the claimed compounds of claim 4 (and rejected dependent claims) as presently pending.
Other than the working examples of the specification (59 compounds of claim 108 and Table 1 of the specification; and Tables 4 and 5 biological data), Applicant has not reasonably described a scientific or “systematic” approach to synthesize the full scope of claim 4 and claims dependent. See MPEP 2163.02, the standard for determining compliance with the written description.4
Although Applicant has written description support for the 59 compounds of Table 1 of the specification (see also claim 108), Applicant has not provided reasonably provided a description the support the broader scope of the claimed compounds of formula V.
Accordingly, Applicants have not adequately described the invention for the breadth that is claimed. It thus appears that Applicants were not in possession of the claimed invention at the time the application was filed, the full scope of compounds of formula I, and that Applicants’ species do not support the claimed genus.
Conclusion and Correspondence
In summary no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/
Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 CONTINUING DATA
This application is a 371 of PCT/US2022/038548 07/27/2022
PCT/US2022/038548 has PRO 63/226,670 07/28/2021
2 Duveau et al. Structure–activity relationship studies and biological characterization of human NAD+-dependent 15-hydroxyprostaglandin dehydrogenase inhibitors Bioorganic & Medicinal Chemistry Letters
Volume 24, Issue 2, 15 January 2014, Pages 630-635
3 Note Table 4 is limited to compounds B-1 to B-31; B-33 to B-45; B-47 to B-49; B-54 to B-62; B-65 B-66; B-69 to B-85; B-88 B-89; B-91 to B-96; B-102; B-104; B-110; B-111; B-113 B-114; B-126; B-127; B-226 to B-261; B-263; B-265 to B-274; B-315-B-316, with inhibitory activity defined as A and B.
4 Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68,119 S.Ct. 304,312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"
Prosecution Insights