DETAILED ACTION
This office action is in response to applicant’s filing dated February 3, 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 .
Status of Claims
Claims 1, 3-9, 11-12, 21-29, 32, 34-37, 40 and 46-48 are pending in the instant application. Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on February 3, 2026 are acknowledged. Claims 3, 21, 22, 34 – 37, 40 and 46 - 48 remain withdrawn, as being drawn to an unelected invention or specie. Acknowledgement is made of Applicant's amendment of 1, 21-23, 25-27, and 32 and cancelation of claim 2.
Claims 1, 4 - 9, 11, 12, 23 - 29 and 32 are under consideration in the instant office action.
Objections and/or Rejections and Response to Arguments
Applicants' arguments, filed on February 3, 2026, have been fully considered.
Acknowledgement is made of the Applicant’s amendment of claim 26. The amendments as shown herein:
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.
Accordingly, objection of claim 26, for having a discrepancies between the labeling of variables on the drawing of chemical structure and description of variables is withdrawn.
Acknowledgement is made of the Applicant’s amendment of claim 32. The amendments as shown herein:
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.
Accordingly, rejection of claim 32, under 35 U.S.C. 112(b) for reciting an exemplary language is withdrawn.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Modified Objections and/or Rejections
Modifications Necessitated by Claim Amendment
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, 4 - 9, 11, 12, 23 - 29 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Luzzio et al (WO 2019/028440 A1, cited in IDS, filed 08/26/2022, hereinafter Luzzio).
Regarding claims 1, 4 – 9, 11, 12 and 23 – 28, drawn to a compound of formula (I-b)
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, where M and P are independently C(R2) or N, R2 is hydrogen; X is N or N(R5c), R5c is H; and Y is C(R5a), R5a is -ORA, A is C1 alkyl; wherein L is -N(R3)-; A is a monocyclic or bicyclic heterocyclyl, such as
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and B is heteroaryl, such as
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. The exemplary compound of formula I-b is compound 287:
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(specification page 94, Table 1). The compounds of genus formula I-b are capable of modulating nucleic acid splicing. Instant claims are further drawn to a pharmaceutical composition comprising compound I-b and a pharmaceutically acceptable excipient.
Luzzio teaches small molecule splicing modulators (SMSMs) of formula (IV)
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(page 2, [0006]), where fragment
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;X is -NR3-, R3 is -CH3 (page 9, [0036]), fragment
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is
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where R, R15, R18 is H, p is 2 (page 9, [0042]);
Q is a 5 or 6 membered monocyclic heteroaryl e.g.
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, which is substituted by a heteroaryl having 5 or 6 ring atoms, 1 or 2 ring heteroatoms independently selected from N, O and S and is substituted with C1-6 alkyl (e.g. heteroaryl P of structure
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) (page 5, [0017]; page 7, [0025] and [0027]); where RB is -OCH3 and m is 1 (page 5, [0016]).
The compound of formula IV, taught by Luzzio, is equivalent to the instantly claimed compound 287 if all the variables of compound of formula IV as defined above. Luzzio further teaches a pharmaceutical composition where the SMSMs are mixed with one or more other chemical components such as carriers or excipients (page 190, [0578]).
Thus, since Luzzio teaches a compound that acts as a nucleic acid splicing modulator where all the structural elements of the molecule are equivalent of those of instant claims, 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 combine structural elements of the molecule, taught by prior art, and make various compounds acting as nucleic acid splicing modulators, to arrive at claimed compounds. The one of ordinary skills would be motivated to do so in search of an active agent, which is capable of modulating nucleic acid splicing and having improved desired properties, with the reasonable expectation of success.
Regarding claims 29 and 32, drawn to a compound of formula I-b, where the compound is capable of altering a target nucleic acid, binding to a target nucleic acid or stabilizing a target nucleic acid, and where the compound increases splicing at splice site on a target nucleic acid, by about 0.5% to 95%, or more, or the compound decreases splicing at splice site on a target nucleic acid, by about 0.5% to 95%, or more, e.g., as determined by qPCR.
Luzzio teaches small molecule splicing modulators (SMSMs) of formula (IV) (see the structure above) wherein splicing modulators bind to a target RNA (page 195, [0603]), and wherein the SMSMs modulate splicing at a splice site sequence of a pre-mRNA and wherein a total amount of the mRNA is increased at least about 10% compared to the total amount of the mRNA encoding the target protein or functional RNA produced in control cells (page 11, [0077]), or wherein the SMSMs modulate splicing at a splice site sequence of a pre-mRNA, and wherein a total amount of the mRNA and/or the functional RNA is at least 10% lower than the total amount of the mRNA and/or the functional RNA in control cells (page 11, [0078]). Luzzio teaches that the levels of various mRNA targets of the SMSMs were determined by performing qPCR (page 380, [01073]). The value “about 10%” of increased total amount of the mRNA compared to the total amount of the mRNA encoding the target protein or functional RNA produced in control cells after contacting with splicing modulators (SMSMs), as well as “10% lower” than the total amount of the mRNA, or the functional RNA in control cells fall within the claimed ranges (see above). MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Therefore, 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.
Response to Arguments
Applicant argues:
- Luzzio (WO 2019/028440 A1) discloses nearly 360 tetracyclic compounds, mostly comprising a phenoxy-pyridazine core, functionalized with -[O, C(O), or N(alkyl)]-heterocyclyl, and -heteroaryl, if present, for use as splicing modulators. In contrast, the pending claims recite compounds containing a pyridinyl-pyridazine core, further substituted with -[absent, -O-, or -N(R³)]-heterocyclyl and -heteroaryl, for use as nucleic acid splicing modulator compounds.
- The instant claims recite compounds of Formula (I-b) in which X is always N, placing the lone pair of the nitrogen in the plane of the ring, in closer proximity to the target. The phenolic -OH is a strong hydrogen bond donor and a weak acceptor, while the pyridinyl nitrogen is a hydrogen bond acceptor, driven by the lone pair. These stereoelectronic effects result in substantial differences in the binding interactions of the compounds which could not be merely predicted by one of skill in the art.
- A skilled person in the art of organic chemistry would understand that taken together, the differences between the compounds of the amended claims and the Luzzio compounds are distinct and would lead to considerable distinctions in binding interactions at a target.
Examiner’s response:
Applicant's arguments have been fully considered but they are not persuasive because: although exemplary compounds disclosed by Luzzio have a phenoxy-pyridazine core (
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), while compounds of instant invention require pyridinyl-pyridazine core (
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), Luzzio still teaches compounds of pyridinyl-pyridazine core, since ring Q in the compound for Formula (IV), taught by Luzzio, can be a substituted pyridinyl such as
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, which makes the core consisting of substituted pyridine ring connected to substituted pyridazine ring. All the substituents taught by Luzzio are also equivalent to those of instantly claimed structures. Thus, Luzzio teaches compounds, where all the structural elements are equivalent to instantly claimed compounds. Thus, since Luzzio teaches compounds of the same structure as instantly claimed, all necessary properties are inherently present, because compounds of identical or similar composition cannot exert mutually exclusive properties (see also MPEP 2112.01).
Therefore, teachings of Luzzio constitute prior art, although the compounds having a pyridinyl-pyridazine core are not a preferred embodiment. MPEP 2123 states: "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Therefore, Applicant’s arguments are not persuasive and the rejection of claims 1, 4 - 9, 11, 12, 23 - 29 and 32 as obvious over teachings of Luzzio is maintained.
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, 4 - 9, 11, 12 and 23 - 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 66, 70, 86, 100, 111, 121, 125, 140 and 171 of copending Application No. 18/688,098 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are directed to a compound of formula (I-b)
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(e.g. compound of formula:
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or formula
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), where M and P are independently C or N; X is N or N(R5c), R5c is H; and Y is C(R5a), R5a is -ORA, A is C1 alkyl; wherein L is -N(R3)-; A is a monocyclic or bicyclic heterocyclyl, such as
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or
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and B is heteroaryl, such as
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. The exemplary compound of formula I-b is compound 287
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(specification page 94, Table 1). The compounds of genus formula I-b are capable of modulating nucleic acid splicing. Instant claims are further drawn to a pharmaceutical composition comprising compound I-b and a pharmaceutically acceptable excipient.
The copending claims are drawn to a compound of formula:
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(II) (e.g. compound of formula:
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), where D, E, M, P, X and Y are independently C or N, wherein at least one of D, E, M, P is N, wherein X and Y cannot be both C; wherein L is -N(R3)-; A and B is independently cycloalkyl, heterocyclyl, aryl, or heteroaryl, e.g. A is
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,
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or
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, B is
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. The exemplary compound of formula II is compound 940
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(specification page 187, Table 2). The copending claims are further drawn to a pharmaceutical composition comprising compound II and a pharmaceutically acceptable excipient.
Thus, the compounds of the copending claims would anticipate the instantly claimed compounds.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4 - 9, 11, 12, 23 - 29 and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 13, 20, 22, 28, 35, 46, 51, 56 ,58, 65, 173 – 174 and 177 of copending Application No. 18/688,098 in view of Luzzio et al (WO 2019/028440 A1, cited in IDS, filed 08/26/2022).
instant claims are directed to a compound of formula (I-b)
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(e.g. compound of formula:
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or formula
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), where M and P are independently C or N; X is N or N(R5c), R5c is H; and Y is C(R5a), R5a is -ORA, A is C1 alkyl; wherein L is -N(R3)-; A is a monocyclic or bicyclic heterocyclyl, such as
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or
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and B is heteroaryl, such as
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. The exemplary compound of formula I-b is compound 287
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(specification page 94, Table 1). The compounds of genus formula I-b are capable of modulating nucleic acid splicing. Instant claims are further drawn to a pharmaceutical composition comprising compound I-b and a pharmaceutically acceptable excipient. The compound of instant claims is capable of altering a target nucleic acid, binding to a target nucleic acid or stabilizing a target nucleic acid, and where the compound increases splicing at splice site on a target nucleic acid, by about 0.5% to 95%, or more, or the compound decreases splicing at splice site on a target nucleic acid, by about 0.5% to 95%, or more, e.g., as determined by qPCR.
The copending claims are drawn to a compound of formula (I)
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, wherein
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is
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or
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, where M and P are independently C or N; wherein L is -N(R3)-; A and B is independently cycloalkyl, heterocyclyl, aryl, or heteroaryl, e.g. A is
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,
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or
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, B is
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. The compounds of genus formula (I) are capable of modulating nucleic acid splicing. The copending claims are further drawn to a pharmaceutical composition comprising compound of formula (I) and a pharmaceutically acceptable excipient. The compound of copending claims is capable of altering a target nucleic acid, binding to a target nucleic acid or stabilizing a target nucleic acid, and where the compound increases splicing at splice site on a target nucleic acid, by about 0.5% to 95%, or more, or the compound decreases splicing at splice site on a target nucleic acid, by about 0.5% to 95%, or more, e.g., as determined by qPCR.
Although instant claims do not recite compound of formula (I) where
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is
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or
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, Luzzio teaches small molecule splicing modulators (SMSMs) of formula (IV)
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(page 2, [0006]), where fragment
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or
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; X is -NR3-, R3 is -CH3 (page 9, [0036]), fragment
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is
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where R, R15, R18 is H, p is 2 (page 9, [0042]);
Q is a 5 or 6 membered monocyclic heteroaryl e.g.
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, or 6-5 fused heteroaryl of structure
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which is substituted by a heteroaryl having 5 or 6 ring atoms, 1 or 2 ring heteroatoms independently selected from N, O and S and is substituted with C1-6 alkyl (e.g. heteroaryl P of structure
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) (page 5, [0017]; page 7 - 8, [0025], [0027] and [0029]); where RB is C1-6 alkyl, -OCH3 and m is 0 or 1 (page 5, [0016]).
Thus, since Luzzio teaches compounds, acting as nucleic acid splicing modulators and having a structure equivalent to instantly claimed compounds and compounds of copending claims, where all the variables are the same as or similar to instantly claimed, 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 combine teachings of prior art and make various compounds acting as nucleic acid splicing modulators to arrive at claimed compounds. The one of ordinary skills would be motivated to do so in search of an active agent capable of modulating nucleic acid splicing, possessing improved desired properties with the reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argues:
Applicant respectfully requests that the double patenting rejections be held in abeyance until a determination of allowable subject matter in the instant application is made.
Examiner’s response:
Applicant's arguments have been fully considered but they are not persuasive because: as set forth above in the double patenting rejection section, the instant claims are not patentably distinct form claims of copending application. Although copending application has a later filing date, MPEP 804 states: “If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent. Since provisional nonstatutory double patenting over claims of copending application No.18/688,098 is not the only rejection of the instant application, the argument is not found persuasive.
Therefore, Applicant’s arguments are not persuasive and provisional rejection of claims 1, 4 - 9, 11, 12, 23 - 29 and 32 on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No.18/688,098 is maintained.
Conclusion
Claims 1, 4 - 9, 11, 12, 23 - 29 and 32 are rejected. No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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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/E.V.V./ Examiner, Art Unit 1691
/SAVITHA M RAO/ Primary Examiner, Art Unit 1691
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