DETAILED ACTION
This office action is in response to applicant’s filing dated July 17, 2026.
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 .
Notice of Change of Examiner
Please note that the Examiner prosecuting this application has been changed to Examiner Elena Vishnyakova of Art Unit 1691. Please address all future correspondences to Examiner Vishnyakova.
Status of claims
Claims 1 – 3, 6, 7, 12 – 25 and 27 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 6, 7 and 12-25, drawn to a compound of formula 1 where R 1A is A1 or Al' in the reply filed on July 17, 2026 is acknowledged.
Claim 27 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 July 17, 2026.
Applicant’s election without traverse of species (A) (R¹A is represented by formula A1 in the reply filed on Species (A) (R¹A is represented by formula A1) is acknowledged.
Upon performing the search of prior art Examiner detected compounds related to non-elected species. Hence, the election of species has been withdrawn and examination will proceed to the full scope of claims 1-3, 6, 7 and 12-25, Group I invention.
Claims 1-3, 6, 7 and 12-25 are under consideration in the present office action as related to the elected invention.
Priority
The present application is a 371 of PCT/GB2022/051462, filed June, 10, 2022 and claims the benefits of priority to UK patent application No. GB2108383.7, filed June 11, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/09/2023 and 08/06/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6, 7 and 12-25 are rejected under 35 U.S.C. 103 as being unpatentable over Morley et al (WO 2018/167269 A1, cited in IDS, filed 12/09/2023).
Instant claims are drawn to a compound of formula 1:
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, where R1A is:
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, such as
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,
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or
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, where each R2A, R3A, R4A and R5A is the same or different and is independently selected from hydrogen or C1-C6 alkyl; each A-B or B-X bond is saturated or unsaturated C-C, C-N, N-C or N-N bond. The exemplary compound of formula 1 is:
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. Instant claims are further drawn to a pharmaceutical composition comprising the compound of formula 1 and a pharmaceutically acceptable excipient.
Morley teaches compound of formula I:
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, where Y1 is
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, R and R"' is each independently a hydrogen; R1, R3, R4, R5 and R6 are each independently selected from hydrogen and C1-3 alkyl; R2 is hydroxyl; X is NH, R7 and R8 are taken together with the intervening nitrogen atom to form a 4-7 membered heterocycloalkyl ring, such as piperidinyl:
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, where piperidinyl is substituted with one or more R10; R10 is L1-L2-R11, where L1 is a linker of the formula -[CR12R13]n-, where n is an integer of from 0 to 3 and R12 and R13 are each independently a H, L2 is absent and R11 is 3 - 10 membered heterocycloalkyl optionally substituted with one or more R14; R14 is =O (pages 12 – 14, 17 and 23). Morley defines "heterocycloalkyl" and "heterocycloalkyl group" refer to 3 to15 membered (such as 3 to 7 or 5 to 7 ring atoms) monocyclic, bicyclic, and tricyclic non-aromatic saturated or unsaturated, substituted or unsubstituted ring systems, which contain, in addition to carbon atom(s), at least one heteroatom (such as N, O, S or P). Heterocycloalkyl groups may be bridged, spiro, and/or fused ring systems. Representative examples of “heterocycloalkyl" group include pyrrolidinyl, pyrrolinyl, imidazolidinyl, imidazolinyl, pyrazolidinyl, pyrazolinyl, piperidyl, dihydropyridinyl, dihydropyrimidinyl (page 9, [0041]). One of the exemplary compounds taught by Morley is:
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(page 31, page 85 1BR). Morley further teaches a pharmaceutical composition which comprises a compound of formula I or a pharmaceutically acceptable salt, hydrate or solvate thereof, and one or more pharmaceutically acceptable excipients (page 35, § 76). Thus, formula I, taught by Morley, recite all the corresponding structural elements of instantly claimed compound of formula 1. Compound 1BR of Morley and instantly claimed exemplary compound (see structure above) are positional isomers (different point of attachment of N-methyl-2-pyridone ring), thereby compounds presumably possess similar properties. MPEP 2144.09: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Thus, since Morley teaches structurally similar compounds of the same functionality as instantly claimed compounds, where all structural elements, taught by Morley, are equivalent to the same of instantly claimed compounds, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify known compounds and make various structural analogs, by selecting and combining known structural fragments to arrive at claimed compounds. The one of ordinary skills would be motivated to do so in search of an active agent to inhibit PRMT5 of improved efficacy and other desired properties with the reasonable expectation of success.
Therefore, taking all together, taught by prior art, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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, 6, 7 and 12-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 8,10, 14, 15, 17, 18 and 20 of U.S. Patent No. US 11485731 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims and claims of the instant application disclose structurally similar compounds having the same utility.
E.g.: exemplary compound of patented claims:
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;
Exemplary compound of instant claims:
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. Exemplary compound of patented claims and instantly claimed exemplary compound (see structure above) are positional isomers (different point of attachment of N-methyl-2-pyridone ring), thereby presumably possessing similar properties. MPEP 2144.09: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Thus, instantly claimed compounds would be obvious variants of patented compounds anticipate.
Conclusion
Claims 1-3, 6, 7 and 12-25 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RENEE CLAYTOR can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V.V./ Examiner, Art Unit 1691
/SAVITHA M RAO/ Primary Examiner, Art Unit 1691
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