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 .
Election/Restrictions
Applicant’s election without traverse of the following species:
PNG
media_image1.png
66
138
media_image1.png
Greyscale
in the reply filed on 10/31/2025 is acknowledged. A search of the prior art did not teach or suggest the claimed compound. Accordingly, the species election has been withdrawn.
Claims 1-19 and 26-32 are currently pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements filed on 5/31/2023 and 10/31/2025 have been considered except where lined through.
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.
Claims 1-19 and 31-32 are 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.
Regarding claim 1, claim 1 recites a compound of formula (I) or a pharmaceutically acceptable salt thereof and goes on to define Rings A, Ring B and Ring C and other variables thereof. In addition to defining the rings and variables, the claims recite a number of “when” statements for ring B with the corresponding “then” statement for ring A. The indefinite occurs when defining ring C, and the other variables because it is unclear if the “then” statement applies to the C ring and the other variables or if the first recitation of defining the C ring applies to the C ring in general. If the second is the case, it is unclear if the C ring can only be 3 groups or if it can be 4 groups as recited in the second definition of C. In other words, it is difficult to determine where the “then” statement stops and what it applies to other than the A ring.
Claim 1 is further indefinite because claim 1 defines A when B is
PNG
media_image2.png
73
62
media_image2.png
Greyscale
to include a number of heterocyclic groups including
PNG
media_image3.png
66
50
media_image3.png
Greyscale
,
PNG
media_image4.png
68
149
media_image4.png
Greyscale
PNG
media_image5.png
68
59
media_image5.png
Greyscale
. NOTE: the NH. Accordingly, it is presumed that the nitrogen is only substituted with a hydrogen group. However, when looking at, for example, claims 14 and 16-19 it appears that the hydrogen does not have to be present, wherein the groups can be bonded through the nitrogen or the nitrogen can be substituted with something other than a hydrogen. Accordingly, it is unclear what the meets and bounds of the invention encompass. For prior art purposes, the claims are interpreted broadly to encompass a bond occurring with nitrogen other than a hydrogen bond.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14 and 16-19 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. All of the above claims ultimately depend from claim 1, which defines A when B is
PNG
media_image2.png
73
62
media_image2.png
Greyscale
to include a number of heterocyclic groups including
PNG
media_image3.png
66
50
media_image3.png
Greyscale
,
PNG
media_image4.png
68
149
media_image4.png
Greyscale
PNG
media_image5.png
68
59
media_image5.png
Greyscale
. NOTE: the NH. As such, it is presumed that the bond connecting the groups to “L” or “B” or substitution by R1 and R2 would all have to come through one of the carbons and not the nitrogen since the nitrogen is already substituted with a NH. The above claims recite A groups which bond “L” through the nitrogen such as
PNG
media_image6.png
77
42
media_image6.png
Greyscale
,
PNG
media_image7.png
77
75
media_image7.png
Greyscale
which do not appear to further limit claim 1 since the nitrogen is already substituted with a hydrogen. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Note: Some of the specific compounds claimed in claim 19 have the nitrogen substituted, for example, compound 43 and 63.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-5, 9-13 and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Reg. Number 2460061-75-8 (2020-08-20).
CAS Reg. Number 2460061-75-8 has the following structure which reads on the generic formula I as claimed:
PNG
media_image8.png
130
275
media_image8.png
Greyscale
.
Claim(s) 1-6, 9-13 and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Reg. Number 2405169-81-3 (2020-01-12).
CAS Reg. Number 2405169-81-3 (2020-01-12) has the structure:
PNG
media_image9.png
154
315
media_image9.png
Greyscale
which reads on the instant compound of Formula (I).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Karimaa et al. Mol. Cancer Ther 2022; 21: 1765-1776).
Claims 26-30 as specifically drawn to a method of treating a steroid receptor dependent condition or disease comprising administering a compound of formula (I) are free of the prior art and allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
BRANDON J. FETTEROLF
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626