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 .
Election/Restrictions
Applicant’s election without traverse filed June 16, 2026 is acknowledged. Applicant’s election without traverse of Group I and compound I-11
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Claims 5, 6, and 9-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as drawn to non-elected species.
Status of the Claims
Claims 1-17, 20, 21, and 23 are pending. Claims 18 and 19 were previously canceled. Claim 22 has been canceled filed June 16 2026. Claim 23 has been added.
Claims 1-4, 7-8, 12-17, 20, 21, and 23 are examined to the extent they read on the elected species.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e), which claims priority to, and the benefits of U.S. Provisional Application No. US63/427,339, filed on November 22 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/06/2024 and 07/01/2026, The submissions 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-4, 7-8, 12-17, 20, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Vandeusen et al. (WO2021178488A1), in view of CAS RN 2061755-92-6 in STN (Jan. 30 2017).
Vandeusen et al. teaches compounds and pharmaceutically acceptable compositions useful as inhibitors of eIF4E. Vandeusen et al. teaches that eIF4E inhibitors and compositions thereof are useful for treating eIF4E-associated disorders, including cellular proliferative disorders such as cancer(see e.g. p. 2 [0006]).
Vandeusen et al. teaches a genus of eIF4E inhibitor compounds including compounds of Formula I
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and related subgeneric formulae. Vandeusen et al. further teaches that the variable groups, L2 is a -Cy-, -Cy- is an optionally substituted bivalent ring selected from phenylene, a 5-6 membered monocyclic heteroaromatic ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, and sulfur. R3 is a 5-6 membered monocyclic heteroaromatic ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, and sulfur. R2 is R which is optionally substituted C1-6 aliphatic groups, and L1 is a bond, or an optionally substituted C1-8 bivalent straight or branched hydrocarbon chain, wherein 1, 2, 3, or 4 methylene units of the hydrocarbon chain(see e.g. p. 2 [0007]).
Vandeusen et al. teaches exemplary compounds in Table 1. including compounds such as I-308
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, I-324
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, I-327
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through I-333
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, those compounds having the same general 2-aminonicotinic acid / thiophene / aminothiazole core as the elected compound I-11 (see e.g., p. 32, Table 1). In particular, Vandeusen et al. teaches compounds having a 5-(thiophen-2-yl)nicotinic acid moiety connected through an amino linkage to a substituted thiazole ring (see e.g., p. 31, [00115] and Table 1).
Regarding claims 1-4, 7-8, and 12-17, Vandeusen et al. teaches the same eIF4E-inhibitor scaffold and expressly teaches an isobutyl substituent at the thiazole position corresponding to R2 of elected compound I-11. Vandeusen et al., however, does not expressly teach the complete substitution pattern of elected compound I-11. Specifically, at the adjacent carbon of the aminothiazole ring corresponding to the circled position shown in Formulas III/IV, Vandeusen teaches a benzyl/aryl-containing substituent, rather than an aliphatic substituent such that both adjacent carbon positions of the 2-aminothiazole ring are substituted with aliphatic groups as in elected compound I-11. Thus, Vandeusen et al. does not expressly disclose the dialkyl-substituted aminothiazole arrangement of elected compound I-11, in which both adjacent carbon positions of the 2-aminothiazole ring having aliphatic substituents.
CAS RN 2061755-92-6 in STN
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teaches a substituted 2-aminothiazole having aliphatic substituents at both of the adjacent 4- and 5-carbon positions of the thiazole ring. Thus, the STN compound demonstrates that the carbon position at which Vandeusen employs a benzyl/aryl-containing substituent was known to accommodate an aliphatic substituent, while the neighboring carbon of the same 2-aminothiazole ring also bears an aliphatic substituent. The reference therefore teaches the 4,5-dialkyl-2-aminothiazole structural arrangement that is not expressly disclosed by Vandeusen.
Regarding claim 20, Vandeusen et al. teaches the eIF4E inhibitor scaffold and the isobutyl substituent discussed above, but does not expressly disclose elected compound I-11 having the claimed dialkyl substitution pattern. CAS RN 2061755-92-6 in STN teaches the missing dialkyl aminothiazole as discussed above.
Regarding claims 21 and 23, Vandeusen et al. further teaches pharmaceutical compositions comprising its eIF4E inhibitor compounds together with a pharmaceutically acceptable carrier, adjuvant, or vehicle (see e.g., p. 48 [00120]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the structurally related eIF4E inhibitor taught by Vandeusen by replacing the benzyl/aryl-containing substituent at the thiazole carbon adjacent to R² with an aliphatic substituent as taught by CAS RN 2061755-92-6 in STN, while retaining Vandeusen et al.’s expressly disclosed isobutyl substituent at R². Vandeusen establishes the eIF4E-active aminonicotinic acid–aminothiazole pharmacophore and expressly demonstrates that the R² position accommodates the same isobutyl group present in elected compound I-11, while CAS RN 2061755-92-6 in STN establishes that a 2-aminothiazole may contain aliphatic substituents simultaneously at both adjacent 4- and 5-carbon positions of a 2-aminothiazole ring was known in the art. The combined teachings therefore provide a reason to prepare the corresponding dialkyl analog of Vandeusen et al. as an additional member of its aminothiazole series while retaining the remainder of Vandeusen et al.’s eIF4E pharmacophore. One of ordinary skill in the art therefore would have had a reasonable expectation that the resulting compound would retain useful eIF4E inhibitory activity. Regarding claims 21 and 23, one of ordinary skill in the art further would have been motivated to formulate such compound with the pharmaceutically acceptable carrier, adjuvant, or vehicle taught by Vandeusen et al. to provide a pharmaceutical composition suitable for administration, with a reasonable expectation of success. Accordingly, the subject matter of claims 1-4, 7-8,12-17, 20, 21, and 23 would have been obvious over the combined teachings of Vandeusen et al. and CAS RN 2061755-92-6 in STN.
Therefore, the claimed invention is obvious to one of ordinary skill in the art at the time the application was filed, absent factual 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, 20, 21, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 and 18 of copending U.S. Application No. 18/961,990.
Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claim 20 recites a compound selected from a group including compounds I-1 and I-2. Claim 17 of copending U.S. Application No. 18/961,990 recites compounds selected from a group including compounds I-139 and I-140. Compounds I-139 and I-140 of U.S. Application No. 18/961,990 correspond to instant compounds I-2 and I-1, respectively. Therefore, instant claim 20 encompasses compounds already claimed in claim 17 of copending U.S. Application No. 18/961,990.
Instant claim 1 is generic to and encompasses the same compounds. A later claim to a genus that encompasses species claimed in a conflicting application is not patentably distinct from the claimed species. Accordingly, instant claim 1 is not patentably distinct from claim 17 of copending U.S. Application No. 18/961,990.
Instant claims 21 and 23 recite pharmaceutical compositions comprising the compounds of claim 1 or claim 20, respectively, or pharmaceutically acceptable salts thereof, with a pharmaceutically acceptable carrier, adjuvant, or vehicle. Claim 18 of copending U.S. Application No. 18/961,990 recites a pharmaceutical composition comprising the compound of claim 1, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, adjuvant, or vehicle. Because the same compounds are claimed in claim 17 of U.S. Application No. 18/961,990, instant claims 21 and 23 are not patentably distinct from claim 18 of U.S. Application No. 18/961,990.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENBIN SHI whose telephone number is (571)272-8796. The examiner can normally be reached Mon-Fri, 8:00am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.S./Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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