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 .
According to paper filed on July 17, 2026, the applicants have elected species I (Mifepristone) for further prosecution.
Claims 1-5, 7-14, 20-21, 27, 35, 37-38, 91, 93-94, 120, 122-123, 140 and 143 are pending in the application.
Claim Rejections - 35 USC § 112
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7-14, 20-21, 35, 37-38, 91, 93-94, 120, 122-123, 140 and 143 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no written description for treating pancreatic cancer using every known glucocorticoid receptor antagonist in the art. The only written description is for using only Mifepristone as glucocorticoid receptor antagonist as disclosed on page 4, line 2 as well as paragraph [0099] on page 32 and paragraph [0100] on page 34 of specification.
Claim Rejections - 35 USC § 102
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.
Claims 1-5, 7-14, 20, 27, 35, 91 and 120 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Hunt (WO 2017/151613 A1).
Hunt discloses treating cancer including pancreatic cancer (see page 4, line 12) by combination of SGRM antagonists including Mifepristone (see paragraph 0009 on page 3) and check point inhibitors (see summary on page 3). Hunt also discloses various check point inhibitors which can be used (see paragraph 0078 on page 22 to paragraph 0083 on page 23. The method of treating cancer (see claims 1-16) including pancreatic cancer (see claim 13) by combination of SGRM antagonist, mifepristone (see claim 7) and check point inhibitors disclosed by Hunt anticipate the instant claims when SGRM antagonist is represented by mifepristone in the instant claims.
Claims 1-5, 7-14, 20, 35, 91 and 120 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Hunt (U.S. Patent 10,980,797, cited on applicant’s form 1449).
Hunt discloses treating cancer including pancreatic cancer (see claim 9)) by combination of SGRM antagonists and check point inhibitors. The method of treating cancer by combination of SGRM antagonists and various check point inhibitors disclosed in claims 1-13 by Hunt anticipate the instant claims when SGRM antagonist is represented by CORT 125134 or CORT 125281 in the instant claims.
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.
11. 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.
12. Claims 21, 37-38, 93-94, 122-123, 140 and 143 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt (WO 2017/151613 A1).
Hunt discloses treating cancer including pancreatic cancer (see page 4, line 12) by combination of SGRM antagonists including Mifepristone (see paragraph 0009 on page 3) and check point inhibitors (see summary on page 3). Hunt also discloses various check point inhibitors which can be used (see paragraph 0078 on page 22 to paragraph 0083 on page 23. The method of treating cancer (see claims 1-16) including pancreatic cancer (see claim 13) by combination of SGRM antagonist, mifepristone (see claim 7) and check point inhibitors disclosed by Hunt meet all the limitations of the instant claims when SGRM antagonist is represented by mifepristone in the instant claims except that Hunt does not mention specific doses of check point inhibitors or % reduction in tumor size. However, Hunt does teach range of using various doses (see paragraph 0153 on page 53 to paragraph 0155 on page 54) and further teaches reduction of tumor size including complete (100 %) reduction of tumor by combination treatment (see paragraph 0170 on pages 58-59). Therefore, it would have been obvious to one skilled in the art to select specific doses of check point inhibitors for reducing tumor size to various percentages by reasonable expectation of success.
13. Claims 21, 37-38, 93-94, 122-123, 140 and 143 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt (U.S. Patent 10,980,797, cited on applicant’s form 1449).
Hunt discloses treating cancer including pancreatic cancer (see claim 9)) by combination of SGRM antagonists and check point inhibitors. The method of treating cancer by combination of SGRM antagonists and various check point inhibitors disclosed in claims 1-13 by Hunt meets all the limitations of the instant claims when SGRM antagonist is represented by CORT 125134 or CORT 125281 in the instant claims except that Hunt does not mention specific doses of check point inhibitors or % reduction in tumor size. However, Hunt does teach range of using various doses (see col. 41, lines 16-60) and further teaches reduction of tumor size including complete (100 %) reduction of tumor by combination treatment (see col. 44, lines 12-20). Therefore, it would have been obvious to one skilled in the art to select specific doses of check point inhibitors for reducing tumor size to various percentages by reasonable expectation of success.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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