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 a preliminary amendment filed on Sep. 3, 2024, the applicants have canceled claims 17-31; amended claims 2-5, 7-8, 10, 12, 14 and 16 and furthermore, have added new claims 32-35.
Claims 1-16 and 32-35 are pending in the application.
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 9 and 33 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Ferrari (WO 2021/130682 A2, cited on applicant’s form 1449).
Ferrari discloses Biomarkers for cancer therapy. The induction of sensitivity to MDM2 antagonist (chemotherapeutic agent) in acute myeloid leukemia cell line by Tolinapant (see example 7 on page 186 and claims 44-45) disclosed by Ferrari clearly anticipates the instant claims.
Claims 9 and 33 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Ward (Blood, cited on applicant’s form 1449).
Ward discloses Tolinapant in combination with a DNA hypomethylating agent for cancer therapy. The induction of sensitivity to decitabine (chemotherapeutic agent) in mouse and human T-cell lymphoma cell line by Tolinapant disclosed by Ward clearly anticipates 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.
8. 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.
9. Claims 1-8, 12-13, 16, 32 and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto (Nature Cancer, cited on applicant’s form 1449) in view of Samaniego (Hemotological Oncol., cited on applicant’s form 1449).
Hashimoto teaches that combined inhibition of XIAP by AZD 5582 and Bcl-2 by venetoclax drives maximal therapeutic efficacy in acute myeloid leukemia (Cancer). Hashimoto meets all the limitations of instant claims except that XIAP inhibitor is AZD 5582 instead of instant Tolinapant. However, Samaniego teaches that Tolinapant is also a XIAP antagonist. Therefore, it would have been obvious to one skilled in the art to treat cancer by combination of Tolinapant (a XIAP inhibitor) and venetoclax (Bcl-2 inhibitor) with reasonable expectation of success.
Allowable Subject Matter
10. Claims 10-11 and 14-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
11. 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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