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 .
Priority
The instant application is a continuation of 371 National Stage Entry of PCT/EP2021/066725 filed on June 21, 2021 which claims priority to foreign application No. EP20181341.7 filed on June 22, 2020.
Status of Claims
Acknowledgement is made of previously presented (34, 40, 55), amended (1, 21, 25, 29, 35, 48-49, 51), cancelled (2-20, 22-24, 26-28, 30-33, 36-39, 41-47, 50, 52-54, 56-61) claims filed March 9, 2026. Claims 1, 21, 25, 29, 34-35, 40, 48-49, 51, and 55 are pending. Claim 55 stands withdrawn. Claims 1, 21, 25, 29, 34-35, 40, 48-49, and 51 are presently examined.
Response to Arguments
Applicant’s amendments filed March 9, 2026 have overcome the following:
the 35 USC 112(b) rejection of claims 1, 3, 5-8, 15-16, 21, 25, 29, 34, 40, 43, 47-48, 51,
the 35 USC 112(d) rejection of claim 48, and
the 35 U.S.C. 102(a)(1) of claims 1, 5, 7, 8, 29, 40, 43, over STN1.
The above have been withdrawn. The 35 USC 102(a)(1)/102(a)(2) rejection over Alam has been modified in light of claim amendments.
Applicant’s arguments filed March 9, 2026 regarding have been considered but are not persuasive.
Regarding the specification, the Examiner cannot hold an objection to the specification in abeyance. The specification remains objected to for lack of proper headings.
Regarding the double patenting rejection(s), the Examiner acknowledges it is difficult to compare the scope of claims in copending applications undergoing prosecution. Regrettably, the Examiner cannot hold the rejection in abeyance until allowable subject matter has been determined. The rejection has been modified in light of claim amendments in the instant application.
Regarding the Alam rejection, as discussed in the modified rejection below, Alam still teaches compounds of Formula IIId (see Alam claim 4), including anticipatory species Example 263. Instantly claimed species (instant claims 48 and 49) differ from Alam only by obvious modifications such as NH2 vs NHMe or isomerism. Absent unexpected results commensurate in scope with the claims comparing to the closest species of Alam, the instant invention is obvious over Alam as discussed below.
Maintained/Modified Objections and Rejections
Election/Restriction
The elected species is understood to be CAS# 2756703-34-9. In claims 48 and 49 the elected species is listed as “4-amino-1-(2-chloropyridin-3-yl)-7-cyclopropylpyrido[2,3-d]pyrimidin-2(1H)-one”.
Following extensive search and examination, the elected species was deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III), claims directed to non-elected species have been withdrawn.
Compact Prosecution: During the search and examination of the originally elected species, art pertinent to other non-elected species was incidentally discovered. Although examination has not been extended beyond the non-elected species identified above per MPEP § 803.02, as a courtesy to the Applicant, this art has been applied below.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
The specification currently has no section headings.
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.
(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.
Claim(s) 1, 21, 25, 29, 34-35, 40, 51 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2020/123395 A1 to Alam et. al.2
Regarding claims 1, 21, 25, 29, 34-35, 40, and a compound of instant Formula I’, Alam teaches MAT2A inhibitors of Formula IIId, corresponding with the cores of instant Formula I’ (see Alam at Abstract and at claim 4). Alam teaches Example 263 (see Alam at p. 73), also known as CAS# 2439279-47-5.
Alam
Instant
CAS# 2439279-47-5
Example 263
Formula IIId
Formula I
Formula I’
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CAS# 2439279-47-5 reads on instant Formula I’ when R1 is pyridinyl, substituted with one ortho R1d and R1d is (C1-C6)alkyl specifically methyl (also reading on instant claims 21 and 25 “2-methylpyridin-3-yl”), R2 is halo(C1-C6)alkyl specifically trifluoromethyl (also reading on instant claim 34 “trifluoromethyl”, and claim 35 because R2a is not required), X1 is N, and X3 is CR3 and R3 is H.
Regarding claim 51 and a composition, Alam teaches a composition comprising a compound of Formula IIId with a pharmaceutically acceptable excipient (see Alam at claim 49).
Claim Rejections - 35 USC § 103
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.
Claim(s) 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Alam as applied to claims 1, 21, 25, 29, 34-35, 40, 51 above.
Alam teaches Example 715 (see Alam at p. 138), also known as CAS# 2439275-55-3.
The prior art differs from the instant claims as follows, CAS# 2439275-55-3 differs from the instantly elected species in that X1 is CR3 and R3 is H in lieu of X1 is N, and in isomeric connectivity of the pyridine.
Alam
Instant
CAS# 2439275-55-3
Example 715
Formula IIIa and IIId
Formula I’
Elected Species
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However,
Alam discloses the core formulas IIIa (corresponding with X1 is CR3) and IIId (corresponding with instant X1 is N) (see Alam claim 4).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding CH vs N, per MPEP § 2143(I)(B), a prima facie case of obviousness exists for simple substitution of one known element for another to obtain predictable results. It would have been obvious to one skilled in the art to swap CH for N on a species taught by Alam such as CAS# 2439275-55-3 because Alam teaches this as an alternative change in compound core Formulas IIIa and IIIb.
Regarding isomerism, per MPEP § 2144.09(I)-(II), “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities” because “[c]ompounds which are…isomers…are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties” (see, e.g., MPEP § 2144.09(I)-(II)), and the Court has stated that “[i]f a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR, 127 S.Ct. at 1740. Here, the prior art teaches highly similar structural isomers of the instantly claimed invention, wherein such isomers have the same, exact utility as the instantly claimed species; accordingly, an artisan would readily appreciate that such compounds could be utilized in the inhibition of MAT2A, exactly as taught and suggested in view of the prior art.
Furthermore, it is well-within the ordinary skill in art to incorporate the same taught substituents on one taught core in lieu of another taught core.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in 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.
Claims 1, 21, 25, 29, 34-35, 40, 48-49, and 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-8, 10-11, 13-29 of copending Application No. 18/654,989 (reference application), a continuation of instant application. Although the claims at issue are not identical, they are not patentably distinct from each other.
The examiner notes the scope matching of the claims is difficult due to App’989 claim dependencies on “claim 0”. Nevertheless, “claim 0” is treated as claim 1.
The claims are drawn to compounds of the same generic formula with the same structural limitations, and compositions comprising said compounds.
Instant Formula I’
App’989 Formula I’
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The copending applications also claim same species such as 4-amino-1-(2-chloropyridin-3-yl)-7-cyclopropylpyrido[2,3-d]pyrimidin-2(1H)-one (compare instant claims 48, 49 with App’989 claims 23-24).
Instant Claims 48, 49 Species
App’989 Claims 23, 24 Species
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The specification is objected to.
Claims 1, 21, 25, 29, 34-35, 40, 48-49, and 51 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1CAS 604-50-2, CAS Registry File Accessed August 11, 2025 from STN, entered into STN November 16, 1984. Cited in previous Office Action.
2 Published June 18, 2020 and filed December 9, 2019. Cite No. 18 in the IDS filed 4/5/233. Hereinafter Alam. Cited in previous Office Action.