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 .
Current Status
This action is responsive to the amended claims of 12/22/2023. Claims 1, 3-5, 18, 20-21, 23, 26-32, 35-38, and 40 are pending and have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of
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and castration resistant prostate cancer in the reply filed on 06/04/2026 is acknowledged.
A search for the elected species did not retrieve any art. The Markush search was extended to the full scope of Formula (I) and did not return any prior art (see SEARCH 6 of the attached search notes). Thus, the election requirement is rendered moot.
Priority
The effective filing date is 06/25/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/20/2024, 08/07/2025, and 06/04/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 35-38 and 40 are objected to because of the following informalities. Appropriate correction is required.
Claim 35 contains a typo in line 2 “the group consisting have”; please replace with “the group consisting of”.
Claim 35 (on Pg. 12) recites
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.” No other chemical names are preceded by a number identifier, for consistency, please strike the “28:”.
Claim 36 recites a pharmaceutical composition comprising a compound of claim 1 or a “tautomer, isotopologue, or stereoisomer thereof”. While, claim 1 does not recite a “tautomer, isotopologue, or stereoisomer thereof,” claim 36 is drafted as an independent claim incorporating elements of claim 1 and introduces the “tautomer, isotopologue, or stereoisomer thereof” using “a”. Thus, currently, there is no true 112b/d issue. However, when the “tautomer, isotopologue, or stereoisomer thereof” is chosen, the compounds encompassed by claim 1 are not chosen. To keep consistency amongst related independent claims, Examiner suggests striking “tautomer, isotopologue, or stereoisomer” from claim 36 as was previously done in the other pending compound claims, including claim 1. Dependent claim 38 is similarly rejected since it does not rectify the issue.
Claims 37-38 recite “wherein the androgen mediated disease is prostate cancer”. Please add the word “receptor” so the phrasing is consistent with the preamble of each claim: “wherein the androgen receptor mediated disease is prostate cancer.” Dependent claim 40 is similarly objected to since it does not fix the issue.
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 35 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.
Claim 35 recites, on Pg. 10:
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(the 2nd and 3rd compounds) and
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(the 5th and 6th compounds). Both sets recite “enantiomer 1 of” and “enantiomer 2 of”. The 2nd and 3rd compound have the exact same name with the exact same stereochemical identifiers: (2R, 6S). The 5th and 6th compounds have the same name and same stereochemical identifiers: (2R, 6S). For each set of compounds, there are 4 possible enantiomers based on the total possible R and S configurations: (2R, 6S), (2R, 6R), (2S, 6S), and (2S, 6R). Since the stereochemical identifiers are the same for both “enantiomer 1” and “enantiomer 2” it is unclear what configuration either one refers to. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
To overcome: please consider striking the phrases “enantiomer 1 of” and “enantiomer 2 of”. If the chemical names of each enantiomer are supported by the original disclosure, Applicant could replace the current text with such names. If not, please also strike the 3rd and 6th compounds (as annotated above) so there are no duplicates.
Conclusion
Claim 35 is rejected.
Claims 36-38 and 40 are objected to.
Claims 1, 3-5, 18, 20-21, 23, and 26-32 are allowable.
The following is an examiner’s statement of reasons for finding of allowable subject matter: The close art is AMMIRANTE (WO 2020/132014). AMMIRANTE teaches compounds of formula I
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(Pg. 2 ¶9) such as
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(Pg. 118 Example 2). The compounds of AMMIRANTE have at least 3 structural differences compared to the instant (as annotated in the exemplary compound). The left-most phenyl is a cyclohexane in the instant, the right-most phenyl is a pyridine with the N at the annotated position in the instant, and the annotated NH is just a bond in the instant. Thus, the teachings of AMMIRANTE cannot anticipate nor make obvious the instant compounds.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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