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, 11-12, 22-32, 35, 37-40 and 43-46 are pending. Claims 12, 26-29, 37-40 and 43-46 are withdrawn. Claims 1-2, 4-5, 7-8, 11, 22-25, 31-32 and 35 are rejected. Claim 30 is objected to.
Response to Amendment/Arguments
Applicant’s amendments have overcome the previously presented rejections.
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species found not allowable, the Markush-type claim shall be rejected and claims to the non-elected invention held withdrawn from further consideration.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 claim 30 as well as the scope of claims 1-2, 4-5, 7-8, 11, 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been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention are held withdrawn from further consideration.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, 11, 22-25, 30-32 and 35. Claims 1-2, 4-5, 7-8, 11, 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subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 12, 26-29, 37-40 and 43-46 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.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 applications, Application No. 62/983,541, No. 63/007,333, No. 63/040,484, and No. 63/072,790 fail 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.
Applications ‘541, ‘333, and ‘484 disclose the following genus (page 2):
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The priority documents only provide support for compounds where ring A is directly linked to W whereas instant claims 1-2, 4-5, 7-8, 10, 22, 30, 32 and 35 are generic to compounds where there may be a linker connecting ring A to W.
Regarding instant claim 30, Applications ‘541, ‘333, ‘484, ‘790 fail to disclose compound 213.
For these reasons the earliest priority dates for the claims under examination are as follows:
Claims 1-2, 4-5, 7-8, 10, 31-32 and 35: August 31st, 2020.
Claim 30: December 16th, 2020.
Claims 11 and 23-25: February 28th, 2020.
Claim Objections
Claim 4 is objected to because of the following informalities:
The bond that connects R1 to the nitrogen heteroatom is not visible in the following embodiments,
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and
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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, 4-5, 11, 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 2009/133136 A1 cited in the IDS filed 12/02/2025.
The prior art discloses 5-(5-{3-chloro-4-[(1-methylethyl)oxy]phenyl}-1,2,4-oxadiazol-3-yl)-1-(1-piperazinyl)isoquinoline represented below (page 91):
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The compound above reads on claims 1-2, 4-5, 11, 23-24, 31-32 and 35 and is embraced by instant formula (I) where: A is a nitrogen-containing heterocyclyl,
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, substituted by R1, R1 hydrogen; W is C, X is N, Y and Z are C(R3a) wherein R3a is hydrogen, and the bonds in the ring comprising W, X, Y and Z are double bonds; L1 and L2 are each absent; B is nitrogen containing heteroaryl, substituted by R1, R1 is aryl substituted by two R6, and R6 is halo or -ORA wherein RA is C3-alkyl; 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 compound above and a pharmaceutically acceptable carrier (page 21, lines 15-19).
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(s) 1-2, 4, 7-8, 31-32 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reed et al. ACS Med. Chem. Lett. 2020, 11, 9, 1773–1779. as evidenced by McKim et al. (2008). Dimethyl sulfoxide USP, PhEur in approved pharmaceutical products and medical devices. Pharmaceutical Technology, 32(5), 74.
The prior art discloses the following compound on page 1776:
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The compound above reads on instant claims 1-2, 4, 7-8, 31-32 and 35 and is embraced by instant formula (I) where: A is a nitrogen-containing heterocyclyl,
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, substituted by R1, R1 is aryl substituted by R6, and R6 is halo; W is C, X is C(R3a) wherein R3a is cyano, Y is C(R3a) wherein R3a is hydrogen, Z is N, and the bonds in the ring comprising W, X, Y and Z are double bonds; L1 and L2 are each absent; B is nitrogen containing heteroaryl,
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; M is C(R2) and R2 is hydrogen; additional R2 are absent (m is 0).
Additionally, Reed et al. discloses compounds 26l, 26n and 26o (page S22):
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These compounds read on claims 1-2, 4, 31-32 and 35 and are embraced by instant formula (I) where: A is a nitrogen-containing heterocyclyl,
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, substituted by R1, R1 is aryl substituted by R6, and R6 is halo; W is C, X is C(R3a) wherein R3a is cyano, Y is C(R3a) wherein R3a is hydrogen, Z is N, and the bonds in the ring comprising W, X, Y and Z are double bonds; L1 and L2 are each absent; B is nitrogen containing heteroaryl; M is C(R2) and R2 is hydrogen; additional R2 are absent (m is 0).
Regarding the pharmaceutical composition of instant claim 31, the prior art discloses that an assay was conducted using the compound above wherein the compound was diluted in DMSO (page S25). DMSO is a pharmaceutically acceptable carrier/solvent as evidenced by McKim et al on page 1.
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(s) 1-2, 4, 11, 22-24, 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 and 59:
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The compounds read on claims 1-2, 4, 11, 22-24, 31-32 and 35 and are embraced by instant formula (I) where: A is a nitrogen-containing heterocyclyl,
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, substituted by R1, R1 is C3 alkenyl substituted by R6, and R6 is oxo;
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is
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; L1 and L2 are each absent; B is nitrogen containing heteroaryl substituted by R1 wherein R1 is C1 alkyl; 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 compound above 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, 11, 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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The compounds read on claims 1-2, 4, 11, 22-24, 31-32 and 35 and are embraced by instant formula (I) where: A is a nitrogen-containing heterocyclyl,
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, substituted by R1, R1 is C3 alkenyl substituted by R6, and R6 is oxo;
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is
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; L1 and L2 are each absent; B is nitrogen containing heteroaryl substituted by R1 wherein R1 is C1 alkyl; 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 compound above 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)
The prior art compounds read on instant claims 1-2, 4, 11, 22-24, 31-32 and 35. Additionally, the compounds are analogous to compounds of instant claim 25 but differ 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)
The prior art compounds are embraced by prior art formula Idd and analogous to those of formula Iee (page 42):
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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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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 claim 25. The resulting compound is represented below:
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Allowable Subject Matter
Claim 30 is 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.
Conclusion
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 ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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