DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9 in the reply filed on 15 January 2026 is acknowledged. The requirement is deemed proper and therefore made Final.
Status of Application
Claims 1-16 are pending; Claims 10-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 1-9 are subject to examination on the merits.
Priority
The instant application is a 371 of PCT/KR2021/019679 filed 23 December 2021 which claims benefit of foreign priority document KR 10-2020-0188450 filed 30 December 2020 is acknowledged. Said document has been received.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03 September 2024 and 08 June 2023 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Claim Rejections - 35 USC § 112(b)
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 6 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claim recites that the cell concentration of the suspension has “50 to 500 of an optical density (OD) value measured at 600 nm.” However, as discussed in Tip Biosystems (2019, cited herein), the following problems exist with spectrophotometer measurement of yeast samples:
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Thus, given the vastly different readings for yeast cell samples, the change in readings can vary drastically even for the exact same yeast samples and as such, the true metes and bounds of the claim limitations cannot be identified. The claims will thus be interpreted as any cell concentration.
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.
(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.
Claim(s) 1, 3-4 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kazuhiro et al. (JP 2004283125 – cited on IDS; English machine translation provided herein).
Kazuhiro et al. teach:
Regarding claims 1, 3-4, 7, a method of hot water extraction of glutathione (GSH) from the yeast Candida utilis by adding water to the yeast cells and heating to 90Co for two minutes. This is followed by spray-drying the extract containing said GSH, wherein GSH content is a total of 27.22% or 25.9% by weight (See Examples 1 and 2).
Claim(s) 1 and 3-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schoichi et al. (JP H01-281057 – cited on IDS; English machine translation provided herein).
Shoichi et al. teach:
Regarding claims 1 and 3-5, a method of hot water extraction of glutathione (GSH) from the brewers yeast (e.g. S. cerevisiae) by adding water to yeast cells, heating to 70Co for 10 minutes to obtain a GSH containing solvent extract – See Example 1, comprising 7.8% GSH by dry weight (e.g. 1g dry weight of cells and 78 mg GSH), further extractions followed and then the extract comprising GSH was freeze-dried and comprised 2.1% GSH; or in Example 2 water was added to said bakers yeast cells and heated to 70Co for 30 minutes to obtain a GSH containing solvent extract –comprising 2.8% GSH by dry weight (300g dry weight cells and 8.4g GSH); additional extractions followed and then the extract comprising GSH was freeze-dried and comprised 0.8% GSH.
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.
Claim(s) 2 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kazuhiro et al. (JP 2004283125 – cited on IDS; English machine translation provided herein) as applied to claims 1, 3-4 and 6-7 above, and further in view of WO 2015151867 – cited on IDS, English Machine Translation cited herein.
The teachings of Kazuhiro et al. are described above and incorporated into the instant rejection. Kazuhiro et al., however, do not teach further extracting the cell suspension with a proteolytic enzyme and water.
WO2015151867 – teaches extraction of GSH from yeast comprising: “Extraction from yeast cells after cell culture. The extraction method is not particularly limited, but can generally be performed by an autolysis method, a hot water extraction method, an enzyme extraction method, an acid or alkali extraction method, or a combination thereof.”; and, specifically, in Example 1: “(Extraction of yeast extract) The wet yeast cells after cell culture were suspended in distilled water and washed by repeated centrifugation. After washing, the wet cells were suspended again in distilled water, or the dried cells freeze-dried or hot-air dried were suspended in distilled water, and the extract was extracted by adjusting to the following conditions.
Self-digestion: Adjust to pH 5.0 with 1N HCl and stir enzyme extraction at 55 ° C. for 4 hours: Adjust to pH 7 with 1N NaOH, then stir to extract with cell wall lytic enzyme (tunicase) or protease at 55 ° C for 4 hours. Acid extraction: 1N Adjust to pH 2 or lower with sulfuric acid, then extract with stirring at 65 ° C for 2 minutes. Extraction with alkali: Adjust to pH 13 with 2N NaOH, then extract with stirring at 70 ° C for 20 minutes.”
It would therefore be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to perform any one or more extraction methods of WO2015151867 in combination with the hot water extraction method of Kazuhiro et al. because the goal is to obtain the high concentration of GSH extraction from yeast cells as possible and because WO2015151867 suggests performing combination extractions to achieve just this. One skilled in the art would be motivated to combine various extraction methods including enzyme protease extraction methods because the as noted, the goal is to obtain the highest concentration of GSH possible for both Kazuhiro et al. and WO2015151867. One skilled in the art would have a reasonable expectation of success in achieving this combination of hot water extraction and enzyme protease extraction of yeast cells for obtaining GSH extracts because both Kazuhiro et al. and WO2015151867 detail the exact methods and steps in order to obtain said GSH yeast extracts.
Claim(s) 2 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Schoichi et al. (JP H01-281057 – cited on IDS; English machine translation provided herein) as applied to claims 1, 3-6 above, and further in view of WO 2015151867 – cited on IDS, English Machine Translation cited herein.
The teachings of Schoichi et al. are described above and incorporated into the instant rejection. Schoichi et al., however, do not teach further extracting the cell suspension with a proteolytic enzyme and water.
WO2015151867 – teaches extraction of GSH from yeast comprising: “Extraction from yeast cells after cell culture. The extraction method is not particularly limited, but can generally be performed by an autolysis method, a hot water extraction method, an enzyme extraction method, an acid or alkali extraction method, or a combination thereof.”; and, specifically, in Example 1: “(Extraction of yeast extract) The wet yeast cells after cell culture were suspended in distilled water and washed by repeated centrifugation. After washing, the wet cells were suspended again in distilled water, or the dried cells freeze-dried or hot-air dried were suspended in distilled water, and the extract was extracted by adjusting to the following conditions.
Self-digestion: Adjust to pH 5.0 with 1N HCl and stir enzyme extraction at 55 ° C. for 4 hours: Adjust to pH 7 with 1N NaOH, then stir to extract with cell wall lytic enzyme (tunicase) or protease at 55 ° C for 4 hours. Acid extraction: 1N Adjust to pH 2 or lower with sulfuric acid, then extract with stirring at 65 ° C for 2 minutes. Extraction with alkali: Adjust to pH 13 with 2N NaOH, then extract with stirring at 70 ° C for 20 minutes.”
It would therefore be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to perform any one or more extraction methods of WO2015151867 in combination with the hot water extraction method of Schoichi et al. because the goal is to obtain the high concentration of GSH extraction from yeast cells as possible and because WO2015151867 suggests performing combination extractions to achieve just this. One skilled in the art would be motivated to combine various extraction methods including enzyme protease extraction methods because the as noted, the goal is to obtain the highest concentration of GSH possible for both Schoichi et al. and WO2015151867. One skilled in the art would have a reasonable expectation of success in achieving this combination of hot water extraction and enzyme protease extraction of yeast cells for obtaining GSH extracts because both Schoichi et al. and WO2015151867 detail the exact methods and steps in order to obtain said GSH yeast extracts.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 06 February 2026
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