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 .
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.
Election/Restrictions
Applicant election of species in the reply filed on 09/29/2025 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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Examiner found prior art of applicant elected species. Therefore, Markush search was not extended further to other species.
Claims 9 and 23-25 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/29/2025.
Claims 1-8, 10,18-22 and 26-27 are examined in this office action.
Current Status of 18/007,369
This Office Action is in response to the amended claims of 09/29/2025.
Claims 5-8 are original; claims 1-4, 10, 18-22, and 26-27 are previously presented; and claims 9 and 23-25 are withdrawn.
Claims 1-8, 10,18-22 and 26-27 are examined in this office action.
Priority
Effective filing date is 08/04/2020.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 05/04/2023, 09/30/2024, and 04/16/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
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.
Claim(s) 1-8, 10,18-22 and 26-27 are rejected under 35 U.S.C. 103 as being obvious over
Rew et.al (J. Med. Chem. 2018, 61, 7767−7784, published August 9, 2018)
In view of
Crew et.al. (US 2018/0099940, published Apr. 12, 2018)
1. Determining the scope and contents of the prior art.
Rew teaches a method of treating wide range of cancer, including prostate cancer, in a subject in need thereof with
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ORIC-101 (28) (abstract; and page 7767)(teaching instant claim 8), a highly potent steroidal GR antagonist with reduced androgen receptor (AR) agonistic activity (pg 7767, col 1, para 2). Rew et. al further teaches treating castration-resistant prostate cancer (CRPC)(examiner interpret this as both metastatic and non-metastatic CRPC)(5-7) with enzalutamide (first androgen receptor inhibitor) has poor outcome because of elevated levels of GR protein (pg 7767) thus partially teaching claim 1.
Rew further teaches wherein one or more cells comprising prostate cancer in the subject exhibits an elevated expression of glucocorticoid receptor (GR) prior to the administration of the therapeutically effective amount of the glucocorticoid receptor (GR) antagonist and the androgen receptor (AR) degrader (pg 7767, col 1, para [2]) thus partially teaching claim 2.
Crew et.al. teaches that androgen receptor degrader is an important driver of tumor growth in prostate cancer (para [0010]) therefore elimination AR should lead to therapeutically beneficial response. Crew et.al. further teaches the synthesis of androgen receptor degrader
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(applicant’s elected species of androgen receptor degrader) (page 233 paragraph [0379]), teaching instant claim 10.
2. Ascertaining the differences between the prior art and the claims at issue.
Rew does not teach treating prostate cancer with combination of GR inhibitor and AR degrader.
Crew et.al. does not teach prostate cancer with combination of GR inhibitor and AR degrader.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment modality for prostate cancer.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to combine the teaching of Crew et.al. with Rew because prior art of Rew teaches a treatment of various cancer, including prostate cancer (page 7767) with ORIC-101 (28) (Rew et.al. abstract) and prior art of Crew et.al. teaches that AR is an important driver of tumor growth in prostate cancer (Crew et.al. para [0010]). A person skilled in the art would be expected to combine androgen receptor (AR) degrader such as
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(applicant’s elected species of androgen receptor degrader) (claim 10) (Crew et.al. page 233 paragraph [0379]) with ORIC-101 (28) (Rew et. al. abstract) because the combination is expected to enhance the effectiveness of the treatment of prostate cancer with ORIC-101 (28) by eliminating AR with AR degrader (Crew et.al. para [0010]).
Rew et. al further teaches treating castration-resistant prostate cancer (CRPC)(examiner interpret this as both metastatic and non-metastatic CRPC )( 5-7) with enzalutamide (first androgen receptor degrader) has poor outcome because of elevated levels of GR protein (Rew et. al pg 7767) (claims 20-22 and 26). Therefore, it would be obvious for a person skilled in the art to use 2nd androgen receptor degrader after the 1st androgen receptor degrader with GR inhibitor to improve treatment of both metastasis and non-metastasis prostate cancer with GR inhibitor, because 2nd AR degrader is expected to eliminate AR, since AR is an important driver of tumor growth in prostate cancer (Crew et.al. para [0010) and GR inhibitor will lower the of elevated levels of GR protein. It would be obvious for a person skilled in the art to try different (claims 19 and 27) or same (claim 18) 2nd AR degrader as the 1st AR degrader through routine experimentation to treat prostate cancer. Thus, teaching all element of claims 1-2, 5-8, 10,18-22 and 26-27.
Regarding claims 3-4 it would have been obvious to a person having ordinary skill in the art to administer the compounds GR inhibitor and AR degrader compound consecutively or concurrently by routine experimentation in order to develop effective combination therapy thus teaching claims 3-4.
Applicants are asked to provide evidence of secondary considerations, such as surprising/unexpected results, that encompass the full scope of independent claim 1 in order to mitigate the chance that future obviousness rejections can be made.
Conclusion
No claims are allowed as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625