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 .
Claims 1-5, 7-12, 45-48, 51, 54, 59 and 62 are pending in the application. Preliminary amendment filed 22 November 2023.
Priority
This application is a 371 of PCT/US2022/031403 filed 05/27/2022 which claims the benefit of 63193959 filed 05/27/2021. The parent application 63193959 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1-5, 7-12, 45-48, 51, 54, 59 and 62 of this application.
Information Disclosure Statement
In the IDS filed 02/26/2024, document # 1, by Kim, Jin Woo et al was not considered since it was either not provided or did not load.
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) 1-4, 9, 11 and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khalil et al (The Journal of Antibiotics, 2017, 70, 1097-1103; cited in IDS filed 11/22/2023).
Khalil teaches the following compound (page 1098, Figure 1):
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Compound (2) meets the limitations of the compound having the formula recited in claim 1. Claim 1 recites the proviso that when all of R2a, R3a, and R4a are OH, R2b is not CH2CH2CH2OCH3. In formula (2) of Khalil the sugar moiety attached to the 9 position has an OMe, two OH groups and a methyl group. This corresponds to the substitution Q1 in the formula in claim 1, wherein R5a can be CH3, R4a can be OMe, R3a = R2a = OH. All of R2a, R3a, and R4a are not OH in the instant formula. Therefore, R2b can be CH2CH2CH2OCH3.
The above compound of Khalil meets the limitations of claims 2-4, 9, 11, formula 3c in claim 45.
Therefore, Khalil anticipates claims 1-4, 9, 11 and 45.
Claim Rejections - 35 USC § 103
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 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) 1-5, 7-12, 45-48, 51, 54, 59 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Khalil et al (The Journal of Antibiotics, 2017, 70, 1097-1103; cited in IDS filed 11/22/2023) in view of Murakami et al (The Journal of Antibiotics, 2009, 62, 123-127; cited in IDS filed 07/01/2025).
The teachings of Khalil are set forth above. In addition to the above, Khalil teaches its compounds exhibited significant cytotoxicity toward human colon and lung carcinoma cells (page 1098, third para). This is a suggestion to the artisan that the compound of Khalil can be used in a method of treating cancer in a patient by administering a compound as in claim 1 (method of claim 51). Even though Khalil does not disclose test results on leukemia, one of ordinary skill in the art would still have a reasonable expectation that the compound of claim 1 can be administered in a method of treating the cancers in claim 54.
Murakami et al teaches the structures of ammocidin (page 124, Figure 1; active agent as in claim 59). It is seen that ammocidin is structurally close to the compound of Khalil. Therefore, in view of Khalil one of ordinary skill in the art will administer ammocidin in a method of treating leukemia in a patient as in claim 59 and 62.
The artisan would also make all the other compounds of the formula recited in claim 1 having the substitutions recited in claims 1, 4, 5, 7-12, the compounds of formula 3a and 3b in claim 45-48 also since these are close structural analogs of the compounds of Khalil and Murakami, in order to look for other compounds having enhanced activity toward cancer as in claim 51 and toward leukemia as in claims 54, 59 and 61.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, macrolides that are structurally close are known in the art to exhibit anticancer properties. Thus, it is obvious to at the claimed compounds and use them in a method of treating the cancers as instantly claimed in view of the combined teachings of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
Obviousness based on similarity of structure and function entails motivation to make the claimed compound in expectation that compounds similar in structure will have similar properties. Where prior art compound essentially brackets the claimed compounds and are well known to have anticancer properties, one of ordinary skill in the art would be motivated to make the claimed compounds in searching for new compounds having enhanced anticancer activities. In re Payne, 606 F. 2d 303, 203, USPQ, 245, 254-55 (C.C.P.A. 1979).
Conclusion
Pending claims 1-5, 7-12, 45-48, 51, 54, 59 and 62 are rejected
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693