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
Status of Claims
Claims 1-13 are cancelled. Claims 14-25 are pending and currently under examination and the subject matter of the present Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/04/2024 and 06/24/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements were considered by the Examiner.
Claim Objections
Claims 20-22 are objected to because of the following informalities:
Claims 20-22 recite “thereby to obtain the food composition”, which is improper grammar, and should be changed to “thereby obtaining…” or something similar.
Appropriate corrections are required.
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)(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 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kimura et al. (CA 2631850 A1), hereinafter Kimura.
Kimura discloses equol-containing fermented soybean hypocotyl material useful for foods, obtained by fermenting soybean hypocotyls with microorganisms to obtain equol using daidzein compounds (Abstract).
Regarding Claim 14, Kimura expressly teaches mixing powdered soybean hypocotyls, arginine, and water to prepare soybean hypocotyl solutions; the soybean hypocotyl solution was inoculated with Lactococcus 20-92 and cultivated; the fermented liquid sterilized, dried, and powdered to give equol-containing powdered fermented soybean hypocotyl materials (Examples 1-3; Table 1). The pH of the fermented liquid for Example 1 is 7 (Table 1).
Kimura also teaches food containing the fermented soybean hypocotyl material, such as dietary supplement, and can be in the form of drink, granules, powder, dairy product, pudding etc. (Claims 7-8; p. 13, lines 19-23). As such, Claim 15 is also anticipated.
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Regarding Claim 16, Kimura teaches 0.25g powdered soybean hypocotyl in 5 mL water, which is equivalent to the claimed 50 g powdered in 1 L water, i.e. 0.05 g/mL (Example 1 in Table 1).
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 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.
Claims 17-18 and 20-24 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kimura, as applied to Claims 14-16 above, and in view of Katase et al. (WO 2016/027300 A1), hereinafter Katase.
The teachings of Kimura have been set forth supra.
Regarding Claims 17-18, Kimura does not teach the claimed hydroxides.
Katase also teaches culturing bacterium and fermenting product of protein-containing food by-products (Claims 1-8; Example D1). Katase recognizes the fermentation of soybean hypocotyls for use as health food material, and fermentation of soybean hypocotyl with equol-producing microorganisms (p. 6, last paragraph to p. 7, 1st paragraph). Katase teaches adjusting the pH of its fermented product to pH 7 with sodium hydroxide solution (Example D1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use the sodium hydroxide solution for adjusting the pH of Kimura’s product to 7 or higher, e.g. for Ex. 2 and 3 of Kimura, which have pH slightly below 7 (Table 1), based on the teachings of Katase with reasonable expectation of success. Applying a known technique to a known method ready for improvement to yield predictable results is the rationale supporting obviousness. See MPEP § 2143 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007). As such, the claimed features of Claims 23-24 are also rendered obvious.
Regarding Claims 20-22, Kimura teaches inoculation of soybean hypocotyl solution with Lactococcus 20-92, and shows the pre-fermentation and post-fermentation of the soybean isoflavones, specifically the decrease in daidzein compounds, and appearance of equol at post fermentation, rendering step (A) obvious (Example 4; Table 2).
Regarding step (B), as above, if pH needs to be adjusted, one skilled in the art would have know to use the method of adjusting pH using sodium hydroxide per the teaching of Katase (Example D1).
Regarding step (C), Kimura teaches drying the fermented product to obtain a dry solid product, which has improved storage stability, for use as an ingredient for food etc. (p. 12, lines 23-30). Kimura teaches using a homogenizer to obtain a powder (p. 17, lines 4-8).
Claim 19 is rejected under 35 U.S.C. 103(a) as being unpatentable over Kimura, as applied to Claims 14-16 above, and in view of Komatsu et al. (JP 6486529 B1, machine translated in IP.com), hereinafter Komatsu.
The teachings of Kimura have been set forth supra.
Regarding Claim 19, Kimura teaches addition of usable nutritional ingredients including phosphate, carbonate, sulfate, and other mineral salts, but does not teach salt of an alkaline earth metal (p. 9, lines 2-5).
Komatsu discloses an intestinal flora-improving health food by increasing and activating equol-producing bacteria, wherein the food contains bittern, magnesium and calcium (Abstract). The bittern is generated by concentrating seawater (p. 9, last 2 paragraphs). As such, the bittern comprises salts from seawater. Komatsu relates that intestinal flora improved by intaking such food compositions with bittern, which increases and activate equol-producing bacteria (p. 3, last 3 paragraphs). The food composition is a healthy processed soy food with a magnesium content of 2500 -6000 mg and a calcium content of 500-2000 mg per 100 g product (p. 4, first 5 paragraphs).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to add bittern from seawater containing magnesium and calcium to the food composition of Kimura to obtain an intestinal flora-improving health food, with the bittern increasing and activating equol-producing bacteria per the teaching of Komatsu.
Claim 25 is rejected under 35 U.S.C. 103(a) as being unpatentable over Kimura in view of Katase, as applied to Claims 17-18 and 20-24 above, and in view of Komatsu.
The teachings of Kimura, Katase, and Komatsu have been set forth supra.
Regarding Claim 25, which depends from Claim 20, the claimed feature has been rendered obvious supra.
Brifely, Kimura teaches addition of phosphate, carbonate, sulfate, and other mineral salts, but does not teach salt of an alkaline earth metal (p. 9, lines 2-5). Komatsu discloses an intestinal flora-improving health food by increasing and activating equol-producing bacteria, wherein the food contains bittern, magnesium and calcium, from seawater
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to add bittern from seawater containing magnesium and calcium to the food composition of Kimura to obtain an intestinal flora-improving health food, with the bittern increasing and activating equol-producing bacteria per the teaching of Komatsu.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Uchiyama et al. (CN 1826059 B), provides a composition containing an equol-producing lactic acid bacterium to metabolize at least 1 daidzein compound selected from the group consisting of daidzein glycoside, daidzein, and dihydrodaidzein.
Hayashi et al. (JP 2021-52607 A) discloses production of the functional substance, equol, using an anaerobic microorganism capable of producing the equol from the daidzein, and mixing the equol with food or drink raw materials.
No claims are allowed.
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/JANICE Y SILVERMAN/Examiner, Art Unit 1792
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