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 .
Claims 10-20 are presented for examination.
Applicants’ information disclosure statement filed June 14, 2023 has been received and entered.
Applicants’ drawings filed December 26, 2023 have been received and entered.
Applicants’ election filed May 18, 2026 in response to the restriction requirement of March 19, 2026 has been received and entered. The applicants elected the invention described in claims 10-14 and 17-20 (Group I) without traverse. However, the Examiner will rejoin claims 15 and 16 for examination purposes.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The phrase “antocyanins” is misspelled. The correct phrase is “anthocyanins”.
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.
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 10-20 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.
Claims 10, 15 and 16 are rendered indefinite by the misspelled phrase “antocyanins”. The correct spelling is “anthocyanin”.
Claims 17-20 are repeating the same steps as set forth in claims 11-14, wherein both these claim sets depend on claim 10.
Claims 10-20 are not allowed.
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.
Claim(s) 10, 11 and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR 20180106797 A, hereby known as Lee et al.
Lee et al. teach a food composition for cancer prevention, inhibition of NHE-1 (sodium hydrogen exchanger-1) with one or more active agent selected from the group consisting of curcumin, quercetin, catechin, resveratrol, anthocyanins, isoflavones, or derivative thereof (see page 1, claim 1 and page 2, claims 5 of enclosed translation). Note the reference teaches the active agent(s) can be combined with a low-carbohydrate diet (see page 2, section [0001]).
As to the active agent(s) inhibition of hypoxia-inducible factor-1 alpha and/or suppression of anticancer drug resistance of cancer cells occurred in a low-carbohydrate state, a product of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. If the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (see In re Spada, 911 F.2d 705, 709, 15 USPQ 2d 1655, 1658 (Fed. Cir. 1990)). In the instant application, the inhibition of hypoxia-inducible factor-1 alpha and/or suppression of anticancer drug resistance of cancer cells occurred in a low-carbohydrate state are anticipated by Lee et al. since the active agent (s) possesses the same identical chemical structure.
Clearly, the cited reference anticipates the applicants’ instant invention; therefore, applicants’ instant invention is unpatentable.
Claims 10, 11 and 14-16 are not allowed.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over KR 20180106797 A, hereby known as Lee et al. in view of Cleare et al. (4,140,707).
Lee et al. were discussed above supra the use of one or more active agent selected from the group consisting of curcumin, quercetin, catechin, resveratrol, anthocyanins, isoflavones, or derivative thereof for suppression of NHE-1 in cancer patients, formulation into a food composition comprising a low-carbohydrate diet, and suppression of anticancer drug resistance of cancer cells occurred in a low-carbohydrate state.
The invention differs from the cited reference in that the cited reference does not teach the addition of anticancer drug with one or more active agents. However, the secondary reference, Cleare et al., teaches malonato platinum anti-tumor compounds such as carboplatin.
Clearly, one skilled in the art would have would have assumed the combination of individual agents, each known to treat very types of cancer, into a single composition will give an additive effect in the absence of evidence to the contrary.
Claims 10-16 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/ Primary Examiner, Art Unit 1629
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