DETAILED ACTION
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 was filed 04/18/2024 and is a 371 of PCT/CN2022/113055 (08/17/2022) and claims foreign priority to CN 202110956760.X (08/19/2021). Claims 1-10 were canceled by paper dated 09/26/2024 and new claims 11-29 are before the Examiner.
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.
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.
Claims 11-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention for preventing diseases. 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 of these diseases. The only established prophylactics are vaccines not the compounds such as presently claimed. In addition, it is presumed that “prevention” of the claimed diseases would require a method of identifying those individuals who will develop the claimed diseases before they exhibit the 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 a) the quantity of experimentation necessary, b) the amount of direction or guidance presented, c) the presence or absence of working examples, d) the nature of the invention, e) the state of the prior art, f) the relative skill of those in that art, g) the predictability or unpredictability of the art, h) 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. a) As discussed above, preventing diseases required identifying those patients who will acquire the disease before the disease occurs. This would require extensive and potentially open-ended clinical research on healthy subjects. B) The passage spanning pages 1 of the instant specification, lists the diseases applicant intends to prevent. C) There are no working examples of such preventive procedure in a man or animal in the specification. D) The claims rejected are drawn to the medical prevention and are therefore physiological in nature. E) The state of the art is that no general procedure is art-recognized for determining which patients generally will become afflicted with disease before the fact. F) The artisan using Applicant’s invention would be a board-certified physician who specializes in treating diseases. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of 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 the practitioners in that art, Genetech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent diseases generally. That is, the skill is so low that no compound effective generally against diseases has ever been found let alone one that can prevent such conditions. G) 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, 214 (CCPA 1970). H) 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 (I).
The Examiner suggests deletion of the word “prevention”.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20, 23, 25 and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter s which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. These claims are vague due to their repeated use of a range within a range. Specifically, “more preferably” makes the specific range of numeric value ambiguous. Clarification is required.
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.
Claims 11-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 11952353 Reigan and US Patent 9456998 Ben-David. Both Reigan and Ben-David teach the use of compounds of formula (I) for the treatment of various types of cancer. Reigan and Ben-David do not teach NNMT, DNA methylase or UHRFI or other expressions as instantly claimed. However, these are inherently encompassed by the patents. The patents teach the same compound treating the same conditions/disease/cancer in the same patient population with the same outcome. Due to this, the various NNMT gene ratios and other expressions listed in the instant claims must inherently be present. Same compound. Same patients. Same disease. Same outcome.
Claims 11-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gao, Misera, Lawai, Kleszcz and Jin. Gao teaches on page 2703 the treatment of various cancers with a compound that fits within the scope of formula (I). Misera teaches a compound that falls under the scope of formula (I) the treatment of cancer in scheme 1. Lawal teaches niclosamide treating cancer on page 11. Kleszcz teaches on page 662 a compound that fits within the scope of formula (I) treating carcinomas. Jin teaches on page 2524 niclosamide treating cancers. The articles teach the same compound treating the same conditions/disease/cancer in the same patient population with the same outcome. Due to this, the various NNMT gene ratios and other expressions listed in the instant claims must inherently be present. Same compound. Same patients. Same disease. Same outcome.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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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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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
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