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 .
Claim Status
Claims 1-2, 4-5, 7-8, 12, 22-25, 28-32, 35, 37-40 and 43 are pending. Claims 12, 28-29, 37-40, and 43 are withdrawn. Claims 1-2, 4, 7-8, 22-25, 31-32 and 35 are rejected. Claims 5, 7-8 and 30 are objected to.
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 21st, 2026 has been entered.
Response to Amendment
Rejections and objections not reiterated below have been overcome by Applicant’s amendments to the claims therefore arguments drawn to these matters will not be addressed.
Regarding the 35 USC 103 rejection over the 512’ application, Applicant traverses the rejection stating:
[T}he '512 application discloses compounds for use as G12C mutant KRAS, HRAS and/or NRAS protein modulators for the treatment of disorders such as cancer. In contrast, the pending claims recite compounds for use as nucleic acid splicing modulator compounds. Applicant submits that the claims are not obvious over the '512 application, as one skilled in the art would not look to the G12C mutant KRAS, HRAS and/or NRAS protein modulator compounds of the '512 application to then develop nucleic acid splicing modulators of the present application. There is no logical connection between the use of the G12C mutant KRAS, HRAS and/or NRAS protein modulator compounds in connection with the splicing modulation activity of the instantly claimed compounds. As such, Applicant submits the pending claims are not obvious over the '512
application…
Applicant’s argument is unpersuasive as the prior art does not need to provide the same motivation for preparing compounds as the instant invention. A person of ordinary skill would be motivated to prepare compounds to use in the prior art utility and the instant claims are obvious in view of these compounds given that compounds are embraced by the instant formula and a compound and its properties are inseparable.
Election/Restrictions
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species appears free of the art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the non-elected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the scope of claims 5, 7-8, and 30 as well as the scope of claims 1-2, 4, 22-25, 31-32 and 35 where the compound is one of the following rejected under 35 USC 102 or 103. Any subject matter discussed outside this scope was discovered incidental to the expanded search and is presented in the interest of compact prosecution.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention are held withdrawn from further consideration. Examination has been limited to claims embracing the elected species which are claims 1-2, 4-5, 7-8, 22-25, 30-32 and 35. Claims 1-2, 4, 22-25, 31-32 and 35 have been examined to the extent that they are readable on the elected embodiment and the nonelected species identified below. Since the nonelected species has not been found allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 12, 28-29, 37-40 and 43 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Priority
Applicant’s claim for the benefit of a prior-filled application under U.S.C. 119(e) or under 35 U.S.C. 120, 121 or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application of the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 35 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application 62/983,541, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C 112, first paragraph for one or more claims of this application.
Regarding instant claim 30, Application ‘541 fails to disclose compounds such compounds 103 and 107.
For these reasons the earliest priority dates for the claims under examination are as follows:
Claims 1-2, 4-5, 7-8, 22-25, 31-32 and 35: February 28th, 2020.
Claim 30: August 31st, 2020.
Claim Objections
Claims 7 and 8 are objected to because of the following informalities:
Claim 7 contains duplicate instances of
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Claim 8 contains duplicate instances of
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106
138
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and
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104
140
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.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 4, 23-24, 31-32 and 35 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2018/140512 A1 cited in the IDS filed 12/02/2025.
The prior art discloses the following compounds on pages 57:
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234
562
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Compound 7 reads on instant claims 1-2, 4, 23-24, 31-32 and 35 and is embraced by instant formula (I) where: A is a nitrogen-containing heterocyclyl,
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98
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, substituted by R1, R1 is -C(O)RD, and RD is C2 alkenyl; L1 and L2 are each absent; B is nitrogen containing heteroaryl substituted by R1 wherein R1 is C1 alkyl; W is C, X and Z are C(R3a) where R3a is hydrogen, Y is N, M is C(R2) and R2 is hydrogen; additional R2 are absent (m is 0).
Regarding instant claim 31, the prior art discloses a pharmaceutical composition comprising the prior art compound and a pharmaceutically acceptable carrier (page 63, lines 2-4).
Regarding instant claims 32 and 35, a compound and its properties are inseparable therefore the instant claims are anticipated by the prior art compound which is embraced by instant formula (I).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 4, 22-25, 31-32 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over by WO 2018/140512 A1 cited in the IDS filed 12/02/2025.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art discloses the following compounds on pages 57 and 59:
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262
750
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Compound 7 reads on instant claims 1-2, 4, 23-24, 31-32 and 35 and is embraced by instant formula (I) where: A is a nitrogen-containing heterocyclyl,
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98
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, substituted by R1, R1 is -C(O)RD, and RD is C2 alkenyl; L1 and L2 are each absent; B is nitrogen containing heteroaryl substituted by R1 wherein R1 is C1 alkyl; W is C, X and Z are C(R3a) where R3a is hydrogen, Y is N, M is C(R2) and R2 is hydrogen; additional R2 are absent (m is 0).
Compound 19 is analogous to a compound of instant formula (I) where: A is a nitrogen-containing heterocyclyl,
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, substituted by R1, R1 is -C(O)RD, and RD is C2 alkenyl; L1 and L2 are each absent; B is nitrogen containing heteroaryl substituted by R1 wherein R1 is C1 alkyl; W is C, X is C(R3a) where R3a is hydrogen, Y is N, M is C(R2) and R2 is hydrogen; additional R2 are absent (m is 0).
Regarding instant claim 31, the prior art discloses a pharmaceutical composition comprising the prior art compound and a pharmaceutically acceptable carrier (page 63, lines 2-4).
Regarding instant claims 32 and 35, a compound and its properties are inseparable therefore the instant claims are anticipated by the prior art compound which is embraced by instant formula (I).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Compound 7 reads on instant claims 1-2, 4, 23-24, 31-32 and 35. Compound 19 is analogous to a compound of instant claims 1-2, 4, 22-25, 31-32 and 35 but differs by having a nitrogen heteroatom in the position corresponding to instant variable Z instead of in the position corresponding to instant variable X.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Compound 19 is embraced by prior art formula Idd and analogous to those of formula Iee (page 42):
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404
218
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The prior art discusses the activity of the compounds above and reports that compound 19 has binding activity up to 5% (page 98).
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774
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Accordingly, a person of ordinary skill seeking to prepare and test additional compounds in order to improve KRAS binding activity would have been motivated to modify compound 19 and develop analogous compounds wherein the core structure is that of Formula Iee as required by instant claims 1-2, 4, 11, 22-25, 31-32 and 35. The resulting compound is represented below:
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Allowable Subject Matter
Claims 5 and 30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 7 and 8 are objected to for informalities discussed above and further objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and corrected to remove the informalities.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.C./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
