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
This action is responsive to the amended claims of 10/13/2023. Claims 1-33 are pending. Claims 25-33 are withdrawn. Claims 1-24 have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-24) and the species of compound Ex. 19 in the reply filed on 01/29/2026 is acknowledged.
A search for the compound Ex. 19 did not return any prior art (see SEARCH 6 of the attached search notes). Thus, the search was extended to the full scope of the independent claim 1. The search did not return any prior art (see SEARCH 6). Therefore, the election requirement of 07/31/2025 is made moot.
However, the elected Group I claims are still subject to rejections, thus, the restriction requirement remains in place.
Claims 25-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 01/29/2026.
Priority
The effective filing date is 03/30/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/17/2023 and 01/29/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1-24 are objected to because of the following informalities. Appropriate correction is required.
Claims 1, 3, and 8 each recite a listing of structures from which the claimed compound is chosen. Please add a comma following each structure (except the last structure), add the word “or” before the last structure, and add a period to the end of the claim. Dependent claims 2, 4-7, and 9-24 are similarly objected since they do not rectify the underlying issue.
Claims 22-23 are drawn to the compound of claim 1 having the structure of Cpd. 6-1 and Cpd. 8-16, respectively. While “Cpd.” Is understood as common shorthand for compound and the recitation of Cpd. 6-1 and 8-16 clearly refers to the corresponding structures in claim 1, claim 1 does not label structures 6-1 and 8-16 as Cpd. To improve claim consistency, please strike “Cpd.” from each claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 3, and 8 each recite a listing of structures from which the claimed compound is chosen. The structures Ex. 19, 4-431 – 4-522, Ex. 27-29, 5-8 – 5-39, Ex. 31-42, 6-1, and 8-16 are small in size with many of the structures squished so that the atoms/bonding is difficult to read. Further, structures Ex. 31-32 and 38-41 are of poor resolution wherein the bonds/atoms are pixelated/fuzzy. Thus, the structures are unclear. Therefore, the metes and bounds of the claims are undefined rendering the claims indefinite. Dependent claims 2, 4-7, and 9-24 are similarly rejected since they do not rectify the underlying issue.
Note: Ex. 30, on Pg. 12, is clearly visible. It is of good size and resolution. If Applicant adjusts the other structures to mirror the size and resolution of Ex. 30, the above rejection could be overcome.
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, 8-11, and 24 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 12,129,244. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patented claims 1-6 and 13-18 are drawn to compounds 4-464, 5-31, Ex. 30, Ex. 31, and Ex. 32 and pharmaceutically acceptable salt, hydrate, solvate, or isotope thereof. Patented claims 7-12 and 19-36 are drawn to pharmaceutical compositions and unit dosage forms of the compounds 4-464, 5-31, Ex. 30, Ex. 31, and Ex. 32 and pharmaceutically acceptable salt, hydrate, solvate, or isotope thereof further comprising at least one pharmaceutically acceptable excipient. The compounds 4-464, 5-31, Ex. 30, Ex. 31, and Ex. 32 and pharmaceutically acceptable salt, hydrate, solvate, or isotope thereof read on the instantly claimed compounds 4-464, 5-31, Ex. 30, Ex. 31, and Ex. 32 and pharmaceutically acceptable salt, hydrate, solvate, or isotope thereof. Thus, the Patent ‘244 anticipates the instant claims 1,3, and 8-11 drawn to the recited compounds and the instant claim 24 drawn to a pharmaceutical composition thereof.
Claim 1, 3, and 8-11 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 15 and 17-41 of co-pending Application No. 18/896,691 (reference application – amended claims of 09/25/2024). Although the claims at issue are not identical, they are not patentably distinct from each other.
The reference claims 15 and 17 are drawn to a method of treatment comprising administering compounds 4-464, 5-31, Ex. 30, Ex. 31, and Ex. 32 or a pharmaceutically acceptable salt, hydrate, solvate, or isotope thereof. Reference claim 30 recites wherein the compound is compound no. 5-30. These compounds correspond to the instantly claimed compounds 4-464, 5-30, 5-31, Ex. 30, Ex. 31, and Ex. 32 and pharmaceutically acceptable salt, hydrate, solvate, or isotope thereof. Reference claims 18-29 and 31-41 correspond to further use of these compounds. In order to practice the method of the reference claims 15 and 17-41, the practitioner would have to be in possession of the claimed compounds. Thus, the reference claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Note: the reference claims also appear to anticipate many of the targets/diseases/conditions treated in withdrawn instant claims 25-33.
Claims 1-23 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-16 of co-pending Application No. 19/182,440 (reference application – claims of 04/17/2025). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 16 is drawn to a method of treatment comprising administering a MRGPRX2 modulator with the structure
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or a pharmaceutically acceptable salt, hydrate, solvate, or isotope thereof. The reference compound corresponds to the instant compound Ex. 30. Reference claim 15 is drawn to a method of treatment comprising administering a MRGPRX2 modulator compound of Table 1 or a pharmaceutically acceptable salt, hydrate, solvate, or isotope thereof. As it appears in the reference disclosure, Table 1 recites the instant compounds Ex. 19, 4-431 – 4-522, Ex. 27-29, 5-8 – 5-39, Ex. 30-42, 6-1, and 8-16. Reference claims 15-16 depend from reference claim 1-14 which recite the broader method of treatment administering the MRGPRX2 modulator. Thus, the reference claims recite all of the instant compounds. In order to practice the method of the reference claims 1-16, the practitioner would have to be in possession of the claimed compounds. Thus, the reference claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-24 are rejected.
While the instant claims are subject to a 112(b) rejection regarding unclear chemical structures, a search was carried out based on the Examiner’s best attempt at interpreting the claimed chemical moieties. The search for the compounds of independent claim 1 did not return any prior art (see SEARCH 6 of the attached search notes). The closest art may be considered: LANIER (WO 2022/067094, pub. 03/31/2022, effectively filed 09/25/2020, provided in IDS of 11/17/2023), OGASAWARA (Ogasawara et al., J. Leukoc. Biol., July 2019, 106, 1069-1077; provided in IDS of 11/17/2023), and CHO (WO 2003/074490).
LANIER teaches MRGPRX2 modulators (Pg. 1 Abstract) such as
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(Pg. 269 Example 19) which corresponds to the instant Ex. 37. However, LANIER is published after the instant EFD and, while it is effectively filed before the instant EFD, LANIER is not by another. Thus, it cannot qualify as prior art and can only be close art.
OGASAWARA teaches MRGPRX2 antagonist compounds 1 & 2:
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and
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(Pg. 1072 Fig. 2). However, the compounds 1 & 2 differ greatly in structure from the instant compounds. Due to these extensive structural differences, OGASAWARA can neither anticipate nor make obvious the instantly claimed compounds.
Only upon extension of the Markush search to the following structure did the search retrieve art published before the EFD and/or art by another:
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. This search retrieved CHO which teaches 9-aminoacridine derivatives for treatment of neurodegenerative disease (Pg. 1 title abstract), such as
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(Pg. 19 Ex. 18) which shares a similar (but not equivalent) core structure with the instant compounds and contains many more additional moieties than the instantly claimed compounds. Due to these great structural differences, CHO can neither anticipate nor make obvious the instantly claimed compounds.
Note: US Patents 11,919,864, 12,129,243, and 12,275,707 were briefly considered for double patenting, but these references do not recite any species of the instant claims. US Patent 11,919,864 recites hundreds of species which have at least one structure difference from the instant compounds. Due to the vast number of species recited, the artisan would have to pick and choose a lead compound and modify such compound in a manner most likely lead by hindsight reasoning to arrive at the instant. US Patent 12,129,243 recites only 1 compound which differs at the annotated cycle
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(i.e., structural difference with no motivation to modify). US Patent 12,275,707 does not recite any species of compound; thus, the artisan would have to engage in picking and choosing led by hindsight reasoning to arrive at the instant.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625