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 of Group I (claims 1 – 16, and 19) drawn to a compound of general formula (A) or a pharmaceutically acceptable salt, stereoisomer or tautomer thereof: Y – W – R3 wherein, Y, W, and R3 are defined and the species election of compound 253 of structure
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in the reply filed on August 28th, 2026 is acknowledged.
Claims 17 – 18, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (a method for preventing and/or treating NLRP3 inflammasome-related diseases), there being no allowable generic or linking claim. Moreover, claims 4 – 6, 8 – 9, and 12 – 14, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected chemical species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 28th, 2026.
However, upon the initial search of the elected species, the elected species of compound 253, that is,
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was found to be free of the prior art. Consequently, the search was expanded to include chemical species of general formula (A) with the structural features of the elected species compound 253 above, where R1 and R2 come together with the carbon to which they are attached to form an unsubstituted phenyl ring; and R5 =
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or
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; and where either X1 and/or X2 = N. Hence claims 4 – 6, 8 – 9, and 13 – 14 that direct to the expanded chemical species of general formula (A) with the structural features of the elected species compound 253 and where R1 and R2 come together with the carbon to which they are attached to form an unsubstituted phenyl ring; and R5 =
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are rejoined. Nevertheless, outside of the above delineated chemical species; the election of species required in the Restriction Requirement mailed May 29th, 2026 is maintained. Moreover, the restriction between Groups I and Group II is maintained in the Restriction Requirement mailed May 29th, 2026 is maintained.
Hence claims 1 – 11, 13 – 16, and 19 are examined on the merits here.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 filed in this Application.
However, applicant cannot rely upon the certified copies of the foreign priority application to overcome this rejection because a translation of said applications has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Specification
The spacing of the lines of the specification is such as making reading difficult. New application papers with lines 1 1/2 or double spaced (see 37 CFR 1.52(b)(2)) on good quality paper are required.
Moreover, the disclosure is objected to because of the following informalities: the text quality is such that, such as making reading difficult. Appropriate correction is required.
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 9 – 11, 13, and 19 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.
Regarding claim 9, the phrase "preferably" in line 5 of the claim renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of where the limitation after the “preferably,” is required or not. Therefore, given the uncertainty around the limitations after the “preferably,” claim 9 is rejected under 35 U.S.C. 112(b). Additionally, claim 127 is included in the rejection for being dependent on claim 126 and failing to address the deficiency.
Regarding claim 10, the phrase "preferably" in line 5 of the claim renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of where the limitation after the “preferably,” is required or not. Therefore, given the uncertainty around the limitations after the “preferably,” claim 10 is rejected under 35 U.S.C. 112(b). Additionally, claims 11, 13, and 19 are included in the rejection for being dependent on claim 10 and failing to address the deficiency.
Claim Rejections - 35 USC § 102
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 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.
Claims 1 – 3, 5 – 11, 13, 15 – 16, and 19 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by International Publication Number WO 2023/028534 A1 to Zhang et.al. (Zhang’853; cited on the IDS dated August 28th, 2026).
Regarding claims 1 – 3, 5 – 11, 13, 15 – 16, and 19, Zhang’853 teach compounds that are useful as inhibitors of NOD-like receptor protein 3 (NLRP3) inflammasome pathway. See page 1 lines 9 – 10. Specifically, Zhang’853 teach compounds of Formula Ia, Ib, Ic, or Id:
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,
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,
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,
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. See page 4 lines 10 – 13. More specifically, Zhang’853 teach compound I-226 of structure
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where examined W =
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; examined X1 = X2 = C; examined R1 and R2 form examined ring A, where examined ring A = phenyl; examined Y = 3‐ethynylphenol; examined R3 = -(C1-6 alkylene)0-NR4R5, where examine R4 = H and examined R5 = N‐methylpiperidine. See page 428 Table row 7. See claim 1 limitation for a compound of general formula (A) Y – W – R3 where W =
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; X1 = X2 = C; R1 and R2 form ring A, where ring A = 6 membered aryl; Y = aryl substituted with C2 alkynyl and hydroxy; R3 = -(C1-6 alkylene)0-NR4R5, where R4 = H and R5 = 6 membered heterocyclyl substituted with a C1 alkyl. See claim 2 limitation for the compound according to claim 1, which has a general formula (I):
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where R1 and R2 form ring A, where ring A = 6 membered aryl; Y = aryl substituted with C2 alkynyl and hydroxy; R3 = -(C1-6 alkylene)0-NR4R5, where R4 = H and R5 = 6 membered heterocyclyl substituted with a C1 alkyl. See claim 3 limitation for the compound according to claim 2, which has a general formula (I):
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where R1 and R2 form ring A, where ring A = 6 membered aryl; Y = aryl substituted with C2 alkynyl and hydroxy; R3 = -(C1-6 alkylene)0-NR4R5, where R4 = H and R5 = 6 membered heterocyclyl substituted with a C1 alkyl. See claim 5 limitation for the compound according to claim 1 which has a structure of general formula (II):
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where the selected ring A = 6 membered aryl. See claim 6 limitation for the compound according to claim 5 where the selected ring A = phenyl. See claim 7 limitation for the compound according to claim 1 where Y = aryl substituted with C2 alkynyl and hydroxy. See claim 8 limitation for the compound according to claim 6 where Y = aryl substituted with C2 alkynyl and hydroxy; and R3 = -NHR5, where R5 = 6 membered heterocyclyl substituted with a C1 alkyl. See claim 9 limitation for the compound according to claim 1 where the selected ring A = aryl. See claim 10 limitation for the compound according to claim 1 where R3 = -NHR5, where R5 = 6 membered heterocyclyl substituted with a C1 alkyl. See claim 11 limitation for the compound according to claim 10 where Y = phenyl substituted with C2 alkynyl and hydroxy. See claim 13 limitation for the compound according to claim 10 where the selected ring A is
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. See claim 15 limitation for the selected compound according to claim 1 that is
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. See claim 19 limitation for the compound according to claim 10 where the selected Y =
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.
Furthermore, Zhang’853 teach that the compounds of the disclosure, which include, compound I-226 can be formulated into pharmaceutical compositions comprising one or more pharmaceutically acceptable excipients. See page 156 lines 22 – 26. Moreover, Zhang’853 teach that the term "pharmaceutically acceptable excipient" includes carriers, solvents, stabilizers, adjuvants, diluents, etc. See page 157 lines 15 – 16. See claim 16 limitation for a pharmaceutical composition comprising the compound according to claim 1 and a pharmaceutically acceptable carrier.
Claims 1, 4, 10, 14, 16, and 19 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by International Publication Number WO 2020/163409 A1 to Luzzio et.al. (Luzzio’409; cited on the IDS dated July 2nd, 2024).
Regarding claims 1, 4, 10, 14, 16, and 19, Luzzio’409 teach novel small molecule splicing modulators. See page 2 paragraph 0005. Specifically, Luzzzio’409 teach compounds of Formula (VI) of structure
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. See page 2 paragraph 0006. More specifically, Luzzio’409 teach SMSM# 1A-2 of structure
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where examined W =
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; examined X1 = C and X2 = N; examined R1 = H and R2 = absent; examined Y = 3‐(1H‐imidazol‐1‐yl)phenol; examined R3 = -(C1-6 alkylene)0-NR4R5, where examine R4 = H and examined R5 = piperidine. See claim 1 limitation for a compound of general formula (A) Y – W – R3 where W =
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; X1 =C; X2 = N; R1 = H; R2 = absent; Y = aryl substituted with 5 membered heteroaryl and hydroxy; R3 = -(C1-6 alkylene)0-NR4R5, where R4 = H and R5 = 6 membered heterocyclyl. See claim 4 limitation for the compound according to claim 1, which has a general formula (B):
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where R1 = H; R2 = absent; and Y = aryl substituted with 5 membered heteroaryl and hydroxy. See claim 10 limitation for the compound according to claim 1 where R3 = -NHR5, where R5 = 6 membered heterocyclyl substituted with a C1 alkyl. See claim 14 limitation for the compound according to claim 4 where the selected Y =
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. See claim 19 limitation for the compound according to claim 10 where the selected Y =
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. Furthermore, Luzzio’409 teach that the small molecule splicing modulators described herein, which includes SMSM# 1A-2, can be formulated as pharmaceutical compositions with a pharmaceutically acceptable diluent, carrier or excipient. See page 252 paragraph 0436. See claim 16 limitation for a pharmaceutical composition comprising the compound according to claim 1 and a pharmaceutically acceptable carrier.
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 – 11, 13 – 16, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, 5, 7 – 8, 10 – 11, 14 – 15, and 18 of copending Application No. App. 18/566865 to Li et. al. (reference application; Li’865).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to the genus of NLRP3 inflammasome inhibitors of the formula Y-W-R3. The genus of the compounds recited in (reference) claim 1 of Li’865 anticipate the compound species of (examined) claim 1. Furthermore, the reference claims of Li’865 exemplify species within the examined claimed genus. In particular, Li’865 recite compounds of general formula (I), or a pharmaceutically acceptable salt, stereoisomer or tautomer thereof:
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where R1-3, and Y are defined. See reference claim 1. See examined claim 1. Additionally, Li’865 recite additional compounds species of (reference) claim 1 which anticipate general (A) of examined claim 1. See reference claim 2– 3, 5, 7 – 8, 10 – 11, 14 – 15, and 18. See examined claims 2 – 11, 13 – 15, and 19. Moreover, Li’865 recite a pharmaceutical composition, comprising the compound, or the pharmaceutically acceptable salt, the stereoisomer or the tautomer thereof according to (reference) claim 1, and a pharmaceutically acceptable carrier. See reference claim 15. See examined claim 16.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 11, 13 – 16, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 5, and 7 – 17 of copending Application No. 19/125837 to Li et. al. (reference application; Li’837).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to the genus of NLRP3 inflammasome inhibitors of the formula Y-W-R3. The genus of the compounds recited in (reference) claim 1 of Li’837 anticipate the compound species of (examined) claim 1. Furthermore, the reference claims of Li’837 exemplify species within the examined claimed genus. In particular, Li’865 recite represented by general formula (A') or a pharmaceutically acceptable salt, a stereoisomer or a deuteride thereof: Y-W-R3 where the selected W is
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where R1-3, and Y are defined. See reference claim 1. See examined claim 1. Additionally, Li’865 recite additional compounds species of (reference) claim 1 which anticipate general (A) of examined claim 1. See reference claim 1 – 5, and 7 – 16. See examined claims 2 – 11, 13 – 15, and 19. Moreover, Li’865 recite a pharmaceutical composition, comprising the compound, or the pharmaceutically acceptable salt, the stereoisomer or the deuteride thereof according to (reference) claim 1, and a pharmaceutically acceptable carrier. See reference claim 17. See examined claim 16.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1 – 11, 13 – 16, and 19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
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