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 .
Priority
This application is a 371 of PCT/US2022/037783 (07/21/2022)
PCT/US2022/037783 has PRO 63/224,112 (07/21/2021).
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 129(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/224,112, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) for one or more claims of this application. The priority document does not provide written description of the claims because the claim language is not present in the prior-filed documents and one of skill in the art would not have recognized possession of the instant claim scope, particularly treating cancer with any Bak activator or the scope of Formula (I) or (II) or similar composition. Thus, the effective filing date of claims 1-20 is that of the application, 7/21/2022.
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.
Claim 18 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 18 has the language “in the form of a … table”. Which appears to be a typographical error rendering the claim ambiguous as to whether a “tablet” is meant.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (Theranostics 2021, published 2021-07-25, v. 11, iss. 17, 8500-8516, cited in IDS 2025-06-17).
Park teaches BKA-073 for treating lung cancer (Abstract, Fig. 1) which anticipates the claims.
Claims 1-11, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Creech et al. (Journal of Medicinal Chemistry (1972), 15(7), 739-46).
Creech teaches antitumor compounds including the following (Tables 1-2):
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which anticipates the 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.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Karin et al. (WO2021146258, EFD 2020-01-14) in view of Oien (Seminars in Cancer Biology 68 (2021) 21–30, published 25 September 2019), Creech et al. (Journal of Medicinal Chemistry (1972), 15(7), 739-46), and Preston et al. (Journal of Medicinal Chemistry (1964), 7(4), 471-80).
Karin teaches combination of agents as cancer therapies including quinacrine and obatoclax wherein the cancer is non-small cell lung cancer (Abstract, claims 2, 5, 22). Karin teaches the subject is human (claim 23), formulation as a tablet or for injection ([00163]-[00166]) in a buffered solution including with sucrose ([00155]).
Karin does not teach the combination of formula (I).
Oien teaches quinacrine useful for treating in treating lung cancer (Abstract, p. 23) including the mechanism via BAX/Bcl-XL, wherein quinacrine has the structure (Fig. 1):
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Oien teaches quinacrine in combination with chemotherapies and the compound is in clinical trials for cancer studies (p. 26).
Preston teaches antitumor activities of a series of compounds include such as the following compound (Abstract, Table I):
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Creech teaches antitumor compounds including the following (Tables 1-2):
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One of ordinary skill in the art following the combined teaching of the art would have considered combinations of known antitumor compounds for combination therapies as taught by Karin and Oien. One of ordinary skill in the art would have considered selecting compounds such as taught by Preston and Creech for modification as done therein and arrive at the claimed invention because the prior art teaches the homologous compounds as having the same utility. One of ordinary skill in the art would have had a reasonable expectation of success in the combination because each of the prior art are in the same field of endeavor of anticancer compounds and such modifications are routine in the art as evidenced by Preston and Creech.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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