DETAILED ACTION
This office action is in response to applicant’s filing dated September 21, 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on September 21, 2026 has been entered.
Status of Claims
Claims 1, 3-9, 11-12, 21-29, 32, 34-37, 40 and 46-48 are pending in the instant application. Acknowledgment is made of Applicant’s amendments filed September 21, 2026. Claims 3, 21, 22, 34 – 37, 40 and 46 - 48 are withdrawn, as being drawn to an unelected invention or species.
Claims 1, 4 - 9, 11, 12, 23 - 29 and 32 are under consideration in the instant office action.
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 select and combine known structural elements of the molecule, and make various structural analogs 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's compounds are distinct from the claimed compounds. A major differentiating factor between the instantly claimed compounds and the Luzzio compounds is the requirement that the core ring containing X and Y is heteroaryl (wherein X is N or N(R5c) and Y is C(R5a)) and is further substituted with B (a heteroaryl), which is not exemplified in any of the Luzzio compounds.
- Office has failed to meet requirements to establish a prima facie case of obviousness. The Office must show that an available prior art reference or combination of references meets three criteria: 1) there must be some suggestion or motivation, either in the reference or in the general knowledge available to one or ordinary skill, to modify the reference or combine the reference teachings; 2) the person of ordinary skill must have a reasonable expectation of success; and 3) the reference (or references when combined) must teach or suggest all of the claim limitations. The teaching or suggestion to make the claimed combination and the reasonable expectation of success must both be found in the prior art, and not based on the applicant's disclosure.
- The genus of Luzzio is overly broad and allows for multiple differences over the
claimed compounds. However, the compounds actually disclosed in Luzzio are considerably more narrow than the genus allows for. None of the instantly claimed compounds, in which X is N or N(R5c) and Y is C(R5a), are disclosed in Luzzio. Ring Q in Luzzio can be selected from monocyclic aryl, bicyclic aryl, monocyclic heteroaryl or fused bicyclic heteroaryl, but none of the 357 exemplified compounds in Luzzio comprise a 6-membered monocyclic heteroaryl Ring Q, as necessitated in the instant claims.
Examiner’s response:
Applicant's arguments have been fully considered but they are not persuasive because: as set forth above, Luzzio teaches structural analogs of the instantly claimed compounds where ring Q is exemplified as having a structure:
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, RB is -OCH3, and where ring Q is substituted with group
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. Thus, Luzzio recites all the structural elements of the instantly claimed fragment:
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(see the circled), as well as the element of structure:
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, equivalent to the ring A in the instantly claimed compounds and group -NR3- (R3 is CH3), which is equivalent to the variable L in the instantly claimed compounds.
Thus, Luzzio teaches structurally similar compounds of the same utility as instantly claimed, where all the corresponding structural elements are described (see the rejection section above), thereby rendering the claimed compounds obvious to one of ordinary skill in the art. It is within the skills in the art to select and combine known elements by ordinary methods. MPEP 2143.I(B): "structural similarity can provide the necessary reason to modify prior art teachings. Such a modification would be driven by a reasonable expectation of success that the resulting compounds would possess similar or improved chemical and biological properties.
The argument about exemplary compounds disclosed in Luzzio, which do not comprise a 6-membered monocyclic heteroaryl Ring Q, is not persuasive because prior art teachings are not limited to the illustrated examples. As noted in MPEP 2123: "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). Thus, the skilled artisan, when evaluating a series of compounds of common utilities and similar desired properties would consider not only the specific illustrated examples disclosed in the prior art reference, but also the generic structure of the compounds. In the instant case, the generic Formula (I-b) significantly overlaps with the genus formula (IV) taught by Luzzio.
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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, 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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or
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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, since provisional nonstatutory double patenting rejection 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.
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
