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 .
DETAILED ACTION
This is a response to Applicant’s communication filed on November 27, 2024. Application No. 18/638,481, filed April 17, 2024, is Continuation of PCT/US2022/078418, filed October 20, 2022, and claims the benefit of U.S. Provisional application No. 63/270,297, filed October 21, 2021. In a preliminary amendment filed November 27, 2024, Applicant cancelled claims 1-76, 80, 90-93, 95, 97, 98, 100, 102, 103, 106-114, 116-122, 124, 128-135, 140, 142, 143, 145-147, and 149-396. Claims 77-79, 81-89, 94, 96, 99, 101, 104, 105, 115, 123, 125-127, 136-139, 141, 144, and 148 are pending.
Claim Rejections - 35 USC § 112(a)
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.
Claims 77-79, 81-89, 94, 96, 99, 101, 104, 105, 115, 123, 125-127, 136-139, 141, 144, and 148 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for the following:
A method of treating a cancer, wherein the cancer comprises a PTEN loss-of-function PIK3Cα mutation, in a subject in need thereof, the method comprising administering to the subject:
a) an insulin suppressing meal;
b) about 100 to about 900 mg of the PIK3Cα inhibitor serabelisib; and
c) a therapeutically effective amount of the taxane-based chemotherapeutic agent nab-paclitaxel thereby treating the cancer in the subject.
The specification does not reasonably provide enablement for a method for treating any cancer with any other insulin pathway receptor inhibitor and any chemotherapeutic agent along with an insulin suppressing diet (ISD). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Factors to be considered when determining whether claims in an application for patent are enabling include (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.08, citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims are generally drawn to a method of treating cancer with an insulin suppressing diet, in combination with an insulin pathway receptor inhibitor and a taxane based chemotherapeutic agent. However, the specification only presents data for the safety, feasibility and pharmacokinetic impact of modulated dosing for serabelisib co-administered with an insulin suppressed diet (ISD) while being treated with nab-paclitaxel, wherein the tumor contains a PIK3Cα mutation having PTEN loss of function. (See Specification, p. 43-119, para. [0160]-[0310], Examples 1-3; see also Fig. 1-4.) In addition, the prior art fails to provide compensatory guidance. There is no correlation between treating a cancer generally with any other insulin pathway inhibitor, an ISD, and any other taxane based chemotherapeutic agent presented in either the present specification or the prior art. Accordingly, it would require undue experimentation for the artisan to practice the invention as broadly claimed.
Claim Rejections - 35 USC § 103(a)
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 77-79, 81-89, 94, 96, 99, 101, 104, 105, 115, 123, 125-127, 136-139, 141, 144, and 148 are rejected under 35 U.S.C. 103 as being unpatentable over Cantley et al., US2021/0236501 A1, in view of Goncalves et al,. WO2020/191356 A1 (publ’d September 24, 2020) (cited on the November 27, 2024, IDS) (citing to US2022/0400732 for the English/U.S. equivalent). Cantley teaches a method of treating a cancer in a subject in need thereof, the method comprising administering to the subject: a) an insulin suppressing meal (ISD); and b) about 100 to about 900 mg of a therapeutically effective amount of an inhibitor of at least one kinase in the an insulin receptor/PI3K/AKT/mTOR pathway. See Cantley et al., US ‘501 Publc’n, claims 1-25. The difference between the prior art and present invention is the disclosure of a method of treating cancer in a single embodiment as co-administered with an ISD, and insulin pathway receptor inhibitor, along with a traditional chemotherapeutic agent.
Nonetheless, Goncalves teaches the use of traditional therapies including taxane based chemotherapeutics like paclitaxel. See Goncalves et al., US ‘’732 Publc’n, p. 36-37, para. [0187]-[0188]. Accordingly, all the elements of the present invention were known in the art at the time of the invention.
It would have been obvious to the ordinary artisan at the time of the invention to combine the overlapping methods taught by both Cantley and Goncalves at the time of the invention to yield the best results as a matter of routine optimization.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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