DETAILED ACTION
This action is in response to Applicant’s submission dated November 17, 2023, in which Applicant amended claims 1-14 and 16-20.
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 .
Information Disclosure Statement
The references contained in the IDS dated December 17, 2025 and November 17, 2023 are made of record.
Claim Rejections - 35 USC § 112
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 19-20 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for treating cancer, does not reasonably provide enablement for preventing 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. Applicants are not enabled for preventing any type of cancer. The only established prophylactics are vaccines or HIV medical formulations not the tricyclic compounds such as present here. In addition, it is presumed that “preventing” the claimed diseases would require a method of identifying those individuals who will develop cancer 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] have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art, and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. 1) As discussed above, preventing cancer requires identifying those patients who will acquire cancer before onset occurs. This would require extensive and potentially open-ended clinical research on healthy subjects. 2) Claim 20 lists the cancer types that Applicant intends to treat. 3) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to clinical oncology medicine and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will become afflicted before the fact. 6) The artisan using Applicants invention would be a Board Certified physician in oncology diseases with an MD degree and several years of experience. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of oncology diseases generally. 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 oncology disorders generally. That is, the skill is so low that no compound effective generally against oncology disorders has ever been found let alone one that can prevent such conditions. 7) 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). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed diseases and on the multitude of compounds embraced by formula (IM).
Examiner suggests deletion of the phrase “and/or preventing” from claim 19.
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 14 is rejected under 35 U.S.C. 112(a) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims must, under modern claim practice, stand alone to define an invention. Ex parte Fressola, 27 USPQ 2d 1608 (1993).
In the instant case, dependent Claim 14 recites m, n, and r and subscripts to options for X and Y as well as a p subscript in an option for R3without providing any numerical definitions whatsoever in the claim. As a result, one must refer back to the specification to define the claimed invention.
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)(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)(2) as being anticipated by Trzoss, et al, WO 2022/225934, which has an effective filing date of April 19, 2021. Trzoss, et al. teaches the preparation of piperazine derivatives as PARP1 inhibitors useful in treatment of cancer, which include instant compounds. Specifically, the compounds: with the structure:
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232
414
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,
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540
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and
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544
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of the reference anticipates the aforementioned claims where X is (CR4aCR4b), Y is O(CR4aCR4b)n, n is 0, G1 is CR6 which is H, G2 is N, G3 is CR6 which is H, R1 is C1-2 alkyl or cycloalkyl (cyclopropyl), R2 is absent because s is 0, R3 is -C(O)NR7aR7b, R7a is methyl, R7b is H, and t is 1. The references compounds exhibit the same activity as the compounds of the instant claims.
Claims 14-15 are rejected by:
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106
246
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and
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110
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
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/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932
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