DETAILED ACTION
Status of Application
The amendments and response filed 11 May 2026 are acknowledged and have been considered in their entireties. Claim 8 is cancelled, thus, claims 1-7 and 9-16 are pending; Claims 10-16 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.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 1-7 and 9 are subject to examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04 May 2026 has been considered by the examiner. See initialed and signed PTO/SB/08.
Withdrawal of Previous Objections/Rejections
The rejection of claim 6 as indefinite under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s convincing arguments and supporting documentation of Beal et al. (2020).
The rejection of claims 1, 3-4 and 6-7 under 35 U.S.C. 102(a)(1) as being anticipated by Kazuhiro et al. (JP 2004283125 – cited on IDS; English machine translation provided previously) is withdrawn Kazuhiro et al. do not teach extraction of glutathione from yeast with Alcalase or Flavourzyme or any other kind of enzyme.
The rejection of 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 (JP H01-281057 – cited on IDS; English machine translation provided previously) is withdrawn Kazuhiro et al. do not teach extraction of glutathione from yeast with Alcalase or Flavourzyme or any other kind of enzyme.
New Objection
Specification
The use of the term Alcalase, Flavourzyme, Multifect, Protamex and Neutrase, which are all trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
New Rejection(s) – Necessitated by Amendments
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.
Claims 1-7 and 9 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.
Claim 1 contains the trademark/trade names “Alcalase” and “Flavourzyme”, both of which are Trademarked products. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe proprietary compositions comprising various enzymes (Flavourzyme) or compositions comprising at least one enzyme (Alcalase) and, accordingly, the identification/descriptions are indefinite.
Dependent claims 2-7 and 9 are included in this rejection as they do not remedy the indefiniteness of claim 1.
The limitations of the claims will be interpreted as any protease or blend of enzymes.
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) 1-7 and 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 previously) in view of WO 2015151867 – cited on IDS, English Machine Translation cited previously.
Kazuhiro et al. teach: 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).
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) 1-7 and 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 previously) as applied to claims 1, 3-6 above, and further in view of WO 2015151867 – cited on IDS, English Machine Translation cited preiviously.
Schoichi et al. teach 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.
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.
Applicant’s Response(s) and Examiner’s Rebuttal:
The 35 U.S.C. 103 rejections of record (as applied above) are traversed for the same reasons. Namely, neither of the references alone or combined teach the use of Alcalase or Flavourzyme for the extraction of glutathione from yeast (See Remarks, pp. 5-7) and reproduces Tables 3 and 4 from the specification demonstrating various results utilizing various commercial proteases.
The Examiner acknowledges these arguments, however, as noted above, the claims are deemed indefinite because they utilize Tradenames in the claims (as well as throughout the specification). However, it is unclear what the enzymes are that specifically being utilized because, for example, Flavourzyme is a proprietary blend of enzymes. The exact content of the commercial product is not known. This can be extended to Alcalase as the commercial composition is not completely known. As noted in the rejection above, this renders the claims indefinite. In addition, it requires a broad by reasonable interpretation that any protease or blend of enzymes may be utilized. Thus, the suggestion of a generic protease or cell wall lytic enzyme as taught in WO2015151867 meets these limitations.
For these reasons, the rejection of record is maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 10 July 2026
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