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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US2022/034921, filed 06/24/2022, which claims the priority benefit of PRO Application No. 63/215,243, filed 06/25/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/17/2024, and 08/12/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Application
Claims 1-5, 8-11, 16, 24-32, and 34 are pending and currently under examination. Claims 6-7, 12-15, 17-23, 33, and 35-38 have been cancelled by applicant without prejudice or disclaimer.
Specification
The lengthy specification (166 pages) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 29 is objected to because of the following informalities: the word “give” appears before the compound of 2-((2R,6S)-4-(3-((trans-4-(3-(3-chloro-4-cyanophenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-I-yl)cyclohexyl)oxy)propyl)-2,6-dimethylpiperazin-I-yl)-N-( 4-(2,6-dioxopiperidin-3-yl)phenyl)acetamide, on page 9 of instant claim 29 and appears to be a typo. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 29 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The terms “"Enantiomer 1 of" and “Enantiomer 2 of” on page 8, last two named compounds in claim 29 and is a relative term which renders the claim indefinite. The terms “Enantiomer 1 of" and “Enantiomer 2 of” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitation of "Enantiomer 1 of" and “Enantiomer 2 of”, both of which are cited as 2-((2S,6R)-4-(2-((trans-4-(3-( 4-cyano-3-(trifluoromethyl)phenyl)-5,5- dimethyl-4-oxo-2-thioxoimidazolidin-l-yl)cyclohexyl)oxy)ethyl)-2,6-dimethylpiperazin-l-yl)N-( 4-(3-methyl-2,6-dioxopiperidin-3-yl)phenyl)acetamide in the instant claims and specification are further defined by the applicant with an identical structural rendering. A person of ordinary skill would not be able to determine which enantiomers of applicants compounds 9 and 10 cited in the specification and instant claims is meant by the applicant. There is insufficient antecedent basis for this limitation in the claim.
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Compounds 9 and 10 as listed in specification (Above)
This rejection may be overcome by amending the claim language to clearly identify the specific enantiomers 1 and 2 of compound 2-((2S,6R)-4-(2-((trans-4-(3-( 4-cyano-3-(trifluoromethyl) phenyl)-5,5- dimethyl-4-oxo-2-thioxoimidazolidin-l-yl)cyclohexyl)oxy)ethyl)-2,6-dimethylpiperazin-l-yl)N-( 4-(3-methyl-2,6-dioxopiperidin-3-yl)phenyl)acetamide are meant by applicant.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Instant claims 1-5, 8-11, 16, 24-28, 30-32 and 34 make a contribution over the closest prior art found of Ammirante (US 2020/0199073 A1), who discloses the compound of example 1 as 2-(4-(2-(4-(3-(6-Cyano-5-(trifluoromethyl) pyridin-3-yl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl) phenoxy)ethyl) piperazin-1-yl)-N-(3-((2,6-dioxopiperidin-3-yl)amino)phenyl)acetamide formate.
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Applicant’s formula I (Above)
Ammirante’s compound of example 1 (Below)
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However, Ammirante fails to fairly teach or suggest, a compound which satisfies the structural limitation of formula 1 of the instant claims based on the current record. Specifically, Ammirante differs from applicants formula I of the instant claims where Y is CRN is attached to the hetero ring, whereas Ammirante teaches attachment to a NH group.
Conclusion
Claims 1-5, 8-11, 16, 24-28, 30-32 and 34 are allowable, claim 29 is rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V./Examiner, Art Unit 1623
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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