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 .
According to a preliminary amendment filed on Nov. 30, 2023, the applicants have canceled claims 4 and 7-8, amended claims 5 and 9 and furthermore, have added a new claim 10.
Claims 1-3, 5-6 and 9-10 are pending in the application.
Claim Rejections - 35 USC § 112
4. 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.
Claim 3 is 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.
Claim 3 is not being able to make or use the invention without a deposit being on hand. According to 37 CFR 1.808 (a), A deposit must be made under conditions that assume that:
(1). Access to the deposit will be available during the pendency of the patent application making reference to the deposit to one determined by the director to be entitled thereto under # 1.14 and 35 U.S.C. 122, and
(2). Subject to paragraph (b) of this section, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
Claims 5-6 and 9-10 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 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.
It is well known in the art that there are multiple mechanisms involved in the etiology of any disease including cancer as disclosed in table 1 on pages 9740-9741 and figures 2 and 3 on pages 9743-9744 by Sangawan (Naun. Schmeidberg. Arch. Pharmacol.). There is no teaching in the specification or prior art references provided regarding any mechanism of action (such as enzyme inhibition, receptor agonism/antagonism etc.) for the instant compounds for their anticancer effect. The specification demonstrates anticancer effect of instant compounds as shown in table 3 and figures 4 and 6 (see pages 27-28). The data presented in table 3 and figures 4 and 6 shows that compared to control group on last day (23 day), compounds of examples 1 and 2 exhibited tumor growth inhibition by 61.1% and 56.7%, respectively (see page 28) and not 100%. Therefore, based on the teachings in the instant specification, the instant compounds will have therapeutic utility for treating cancer but not preventing cancer.
8. 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 1-2 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 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.
In claim 1, in formula I, when both variables R and R’ represent O, there will be charge on the compound.
Claim 2 recites the limitation "two double bonds in the phenyl ring containing variables R and R’" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
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.
12. 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.
13. Claims 1-3, 5-6 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (Organic Letters, cited on applicant’s form 1449).
Chen teaches that Calixanthomycin A (1) shows potent antiproliferative activity against HCT-116 cells and compound 1B-00208 (2) also shows highly cytotoxic activity against several human tumor cell lines (see first paragraph on page 1769). The compounds A(1) and (2) disclosed in figure 1 (see page 1769) by Chen meet all the limitations of instant claims except that methoxy groups are at different positions of the phenyl ring. However, the instant compounds are positional isomers of compounds disclosed by Chen. The positional isomers are well known in the art to share same property as evidenced by anticancer or antiproliferative activity of compounds A(1) and (2) disclosed by Chen. Therefore, it would have been obvious to one skilled in the art to prepare instant positional isomer compounds without affecting their utility of treating cancer with reasonable expectation of success.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621