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 .
All previous objections and rejections not reiterated herein were overcome by claim amendments and arguments, filed February 3rd, 2026, have been fully considered and found persuasive. As such all objections and rejections not reiterated herein have been withdrawn.
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, 8 – 9, 13, 23, 81 – 83, 85, 91 – 92, and 141 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2017/201069 A1 to Chan et. al. (herein after Chan’069; cited on the ISR).
Regarding claims 1, 8 – 9, 13, 23, 81 – 83, 85, 91 – 92 and 141, Chan’069 teach the species compound 59 of structure
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(pages 135 - 136, paragraph 0527) which is embraced by instant formula (I)
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wherein instant U and Y are -C=; instant V is -C(R4)=, wherein instant R4 is
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, and instant Q is
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; wherein instant X is attached to L-RE wherein instant L1 is linker of the structure
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; instant RE is
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(claim 81 – 83, 85, and 91 – 92); wherein instant R1 and R3 are H; and instant R2 is
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(claims 13 and 23). Additionally, Chan’069 teach embodiments for pharmaceutical compositions comprising compounds of the disclosure and at least one pharmaceutically acceptable carrier (claim 141)(page 71 paragraph 0275).
However, Chan’069 fails to teach a compound wherein instant R2 is an C1-6 alkyl substituted with Q wherein Q is C6-4 aryl further substituted with instant Qa wherein Qa are halogens (claim 1).
Nevertheless, the only difference between the prior art compound species 59 and the compounds of the instant application is a methyl unit between the amino and halogenated aromatic ring as circled here:
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. Thus since the only difference between the instant application and the prior art compound is a methyl linker, both the prior art compound 56 and the instant application compounds are homologs. Hence for homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)(MPEP 2144.09(II)).
Claims 10 – 12, 24, 34 – 35, 84, and 86 – 89 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2017/201069 A1 to Chan et. al. (herein after Chan’069; cited on the ISR) in view of Ali et. al. (2014) Input of Isosteric and Bioisosteric Approach in Drug Design, J. Chem. Soc. Pak., 36, page 150-169.
The teachings of Chan’069 as they relate to claims 1, 8, and 83, from which claims 10 – 12, 24, 34 – 35, 84, and 86 – 89 depend, are given previously in this office action and are fully incorporated here.
However, Chan’069 fails to teach a compound wherein instant L-RE feature is attached at different positions of the rings (claims 10, 11, 24, and 35), instant V is N (claim 12), instant R2c is a
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(claims 34 and 35), wherein instant AE is attached to the linker at the carbon adjacent to C-RE5 (claim 84), and wherein ring AE is
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(claims 86 – 89).
In regards to the instant claims 10, 11, 24, and 35, recitation wherein instant L-RE feature is attached at different positions of the rings, given that that only difference between the instant compounds and the compounds of Chan’069 is the position of the L-RE feature the compounds of both the instant application and copending Chan’069 are positional isomers. Therefore compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)(MPEP 2144.09(II)).
In regards to the instant claim 84, recitation wherein instant AE is attached to the linker at the carbon adjacent to C-RE5, given that that only difference between the instant compounds and the compounds of Chan’069 is the position of the AE – L connection, the compounds of both the instant application and copending Chan’069 are positional isomers. Therefore compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)(MPEP 2144.09(II)).
Nevertheless, Ali et. al. teach Isosterism or bioisosterism is one of the approaches most frequently used in the design of new molecules (page 150 column 1 paragraph 1). Furthermore, Ali et. al. teach that bioisosterism is a well-established technique in modern drug design, extensively studied for modification of drug target selectivity, bioactivity, efficacy, potency, membrane permeability, biotransformation pathways and toxicity profile (page 150 column 1 paragraph 1). Moreover, Ali et. al. teach that the isosteric replacement approach is a practical and, possibly, better substitutes to recent lead optimization techniques (page 150 column 1 paragraph 1). Specifically, Ali et. al. teach the idea of Benzene ring equivalents in Table 7 page 158, wherein benzene ring equivalents are
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(page 158). Thus Ali et. al. suggest
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(claim 12) and
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(claims 34 and 35 and claims 86 – 89) as known in the prior art ring equivalents to benzene.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the prior art compound 56 of Chan’069 in view of Ali et. al. to use a
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in the R2c position or the AE ring, or to use
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that is, have instant V as a N. One of ordinary skill in the art would have been motivated to make this modification to modify a drug target selectivity, bioactivity, efficacy, potency, membrane permeability, biotransformation pathways and toxicity profile. One or ordinary skill in the art would have had a reason expectation of success because
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and
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as known in the prior art ring equivalents to benzene and are therefore, bioisosteres.
Response to Arguments
Applicant's arguments filed February 3rd, 2026, with regards to prior art rejections of claims 1, 8 – 13, 23 – 24, 34 – 35, 81 – 89, 91 – 92, and 141 have been fully considered but they are not persuasive.
Applicant argues that the compounds of the instant application are SOS1 protein degraders and that the prior art of Chan’069 directs to protein function modulators (see applicant remarks page 34 paragraph 3). Moreover applicant argues that the prior art of Chan’069 fails to teach compounds of its disclosure as SOS1 protein degraders (see applicant remarks page 34 paragraph 3).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., SOS1 protein degraders) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, as the instant claims are compound claims; where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).(MPEP 2112.01(I)). As stated above, the prior art compound species 59 and the compounds of the instant application are structural homologs. Hence for homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)(MPEP 2144.09(II)). Therefore, the prior art rejections of instant claims 1, 8 – 13, 23 – 24, 34 – 35, 81 – 89, 91 – 92, and 141 are maintained, deemed proper and made final.
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, 8 – 11, 13, 22 – 24, 34 – 35, 76 – 92, 129, and 139 – 141 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 23 of U.S. Patent No. US 12419962 B2 to Erdman et. al. (herein after Erdman‘962).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and the invention of Erdman‘962 direct to a compound of Formula (I)
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or an enantiomer, a mixture of enantiomers, a diastereomer, a mixture of two or more diastereomers, a tautomer, a mixture of two or more tautomers, or an isotopic variant thereof (reference claims 1, 4, and 5; instant claims 1, 8, 11, and 24).
In regards to the instant dependent claims wherein the L-RE feature is attached at different positions of the ring as recited in instant claims 9 – 10, 23, 78 – 79, and 140; given that that only difference between the instant compounds and the compounds of Erdman‘962 is the position of the L-RE feature the compounds of both the instant application and copending Erdman‘962 are positional isomers. Therefore compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)(MPEP 2144.09(II)).
Claim 1, 8 – 13, 22 – 24, 34 – 35, 76 – 92, 129, and 139 – 141 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 8 – 11, 22 – 23, 40 – 45, 50 – 53, and 139 – 140 of copending Application No. 18/542628 to Chan et. al. (reference application; herein after Chan’628).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and the invention of Erdman‘962 direct to a compound of Formula (I)
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or an enantiomer, a mixture of enantiomers, a diastereomer, a mixture of two or more diastereomers, a tautomer, a mixture of two or more tautomers, or an isotopic variant thereof (reference claims 1, 8 – 11, 22 – 23, 40 – 45, 50 – 53; instant claims 1, 8 – 10, 12, 23, 78 – 79, and 140).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 8 – 13, 22 – 24, 34 – 35, 76 – 92, 129, and 139 – 141 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4, 16, 95, 105, and 107 of copending Application No. 18/550960 to Chourasia et. al.(herein after Chourasia’960) in view of Boichenko et. al. ((2018), Chemical Ligand Space of Cereblon, ACS Omega, 3, 11163 – 11171).
Chourasia’960 recite a compound of Formula (II)
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or an enantiomer, a mixture of enantiomers, a diastereomer, a mixture of two or more diastereomers, a tautomer, a mixture of two or more tautomers, or an isotopic variant thereof (reference claims 1, 8 – 11, 22 – 23, 40 – 45, 50 – 53; instant claims 1, 8 – 10, 12, 23, 78 – 79, and 140) wherein reference R4 is -L-RB wherein reference RB that is instant RE, is C2-6 fluoroalkyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, C7-15 aralkyl, heteroaryl, or heterocyclyl (reference claim 1).
However, Chourasia’960 fail to recite whether reference RB that is instant RE, is an E3 ubiquitin ligase binding moiety (instant claim 1).
Nevertheless, Boichenko et. al. teach thalidomide and related IMiDs mediate their effects by binding to the protein cereblon, a substrate receptor of the CRL4A E3 ubiquitin ligase complex (page 11163 column 1 paragraph 2). Furthermore, Boichenko et. al. teach a variety of E3 ubiquitin ligase binding compounds that are 5 – 6 membered rings containing N and O atoms and are heterocyclic (see Figures 2a-b, Figure 3 and Figure 4 page 11165). Thus Boichenko et. al. suggest E3 ubiquitin ligase binding species that are heterocyclic.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the compound of copending Chourasia’960 to include a heterocyclic ring that in view of Boichenko et. al. is a E3 ubiquitin ligase binding moiety. One of ordinary skill in the art would have made this modification and have reasonable expectation of success to bind to the protein cereblon, a substrate receptor of the CRL4A E3 ubiquitin ligase complex.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed February 3rd, 2026, with regards to the provisional nonstatutory double patenting (NSDP) and NSDP rejections of instant claims 1, 8 – 13, 22 – 24, 34 – 35, 76 – 92, 129, and 139 – 141 over claims 1 – 23 of U.S. Patent No. US 12419962 B2 to Erdman et. al. (herein after Erdman‘962); claim 1, 8 – 11, 22 – 23, 40 – 45, 50 – 53, and 139 – 140 of copending Application No. 18/542628 to Chan et. al. (reference application; herein after Chan’628); and claim 1, 4, 16, 95, 105, and 107 of copending Application No. 18/550960 to Chourasia et. al. (herein after Chourasia’960) have been fully considered but they are not persuasive.
Applicant request that the provisional NSDP and NSDP rejections be held in abeyance (see applicant’s remarks page 38 paragraph 2).
The examiner contends that a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. (MPEP 804)
Moreover, as filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. (MPEP 804(I)B1). Therefore, the provisional nonstatutory double patenting (NSDP) and NSDP rejections of instant claims 1, 8 – 13, 22 – 24, 34 – 35, 76 – 92, 129, and 139 – 141 is maintained, deemed proper and made final.
Conclusion
Claims 1, 8 – 13, 22 – 24, 34 – 35, 76 – 92, 129, and 139 – 141 are rejected.
THIS ACTION IS MADE FINAL. 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 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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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682