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
Filing Receipt and Priority
The filing receipt mailed 10/07/2024 states that the instant application is a 371 of PCT/CN2022/134614, filed 11/28/2022. The filing receipt also states that the instant application claims foreign benefit of CN 202111426502.7, filed 11/27/2021.
The foreign application supports the instant claims. Therefore the effective filing date is 11/27/2021.
Information Disclosure Statement
The information disclosure statements submitted 05/17/2024, 02/09/2026, 05/27/2026 have been considered.
Restriction/Species Election
Applications election of compound 29, shown below, in the remarks submitted 07/01/2026 is acknowledged.
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Rejections
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.
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.
Scope of Enablement – Prevention
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of prostate cancer, does not reasonably provide enablement for prevention of prostate cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The following Wands factors have been considered if not explicitly discussed: (A) The breadth of the claims, (B) The nature of the invention, (C) The state of the prior art, (D) The level of one of ordinary skill, (E) The level of predictability in the art, (F) The amount of direction provided by the inventor, (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Claims 1, 6, and 12 are drawn to methods for treating and/or preventing prostate cancers.
The term “treatment” is defined in para. [0080] of the specification. Prevention is not defined. A non-limiting example is found in para. [0083] which states “The objective of the adjuvant treatment is to prevent cancer relapse and thus reduce the chance of cancer-related death.” Considering the lack of a definition, the broadest reasonable interpretation includes complete prevention of the prostate cancer.
It is presumed “prevention” of the claimed disease would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted.
The factors to be considered in making an enablement rejection were summarized above. As discussed above, preventing diseases requires identifying those patients who will acquire the disease before the prostate cancer occurs. This would require extensive and potentially open-ended clinical research on healthy subjects.
There is no working example of such a preventive procedure in man or animal in the specification.
The state of the art is that no general procedure is art-recognized for determining which patients generally will suffer from prostate cancer before the fact. 6) The artisan using Applicants invention would be a Board-Certified physician in oncological diseases with an MD degree. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of prostate cancer. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent prostate cancer. That is, the skill is so low that no compound is effective generally against the prevention of prostate cancer.
It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved" and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
As claims 2-5 and 7-11 are dependent on claim 1, they are also rejected.
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and 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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US 10,889,586, published 01/12/2021) in view of Assi (Oncol. Res. Treat, 2020;43:299-306).
Independent claims 1, 6, and 12 are drawn to methods of treating prostate cancer comprising administering a compound, shown above. Claim 6 specifies a “a composition or combination product comprising the compound”. Claim 12 specifies the specific compound elected, above.
Dependent claims 2-5 claim specific substituents (claims 2-3) or specific compounds (claims 4-5). Claims 7-11 are drawn to specific types of prostate cancers which include early-stage or advanced prostate cancer (claim 7), metastatic or non-metastatic prostate cancer (claim 8), castration sensitive prostate cancer or castration resistant prostate cancer (Claim 9), non-metastatic castration resistant prostate cancer or metastatic castration resistant prostate cancer (claim 10), and prostate cancer that has failed standard therapy or that has not received standard therapy.
Regarding independent claims 1, 6, and 12 and dependent claims 2-5, Wu in col. 16, teaches compound 29, which is identical to the elected compound.
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Wu in col. 26, l. 66-col. 27 l. 14 contemplates compositions comprising the compound above.
Wu in col. 27 contemplates methods of treating cancer, including prostate cancer (l. 55).
Regarding claims 7-11, Wu does not explicitly discuss advanced stage, metastatic, castrate resistant, or cancer that has failed cancer therapy. This is addressed by Assi.
Assi is drawn to the anti-prostate cancer medication Docetaxel being readministered to treat metastatic prostate cancer. Assi in the sec. Conclusion states “Based on the published retrospective data, [docetaxel rechallenge] may be effective in patients who initially responded to docetaxel and maintained a PFI exceeding 6 months. Additionally, based on the available data, DR does not seem to increase the risk of grade 3-4 adverse events.” Essentially, Assi argues that readministering an anti-cancer medication can be effective in treating advanced caner (metastatic and castration resistant cancer includes). Additionally, it is not clear from the claims or specification how the status of the prostate cancer affects the efficacy of anti-cancer compounds in treatment. That is, one of ordinary skill would find it obvious to administer a compound that can be effective in treating general prostate cancer to advanced prostate cancer, metastatic, castration sensitive prostate cancer or castration resistant prostate cancer, non-metastatic castration resistant prostate cancer or metastatic castration resistant prostate cancer, and prostate cancer that has failed standard therapy or that has not received standard therapy.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art to have taken compound 29, as a sole compound or in a composition, from Wu and use it in methods of treating prostate cancer or metastatic castration resistant prostate cancer. One of ordinary skill would be motivated as the art contemplates said administration.
Conclusion
No claims allowed.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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