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 .
Detail Action
Claims 1-14 are submitted on 9/24/2024 pending for examination.
Claims 1- 14 will be examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/27/2021 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the IDS statement.
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.
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 1-14 are rejected under of 35 U.S.C. 112(b) or 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 and subsequent claims 2-14 are indefinite in reciting “improving” for the following reason:
“Improving” in the production of Erinacine A by a liquid fermentation of Hericium erinaceus is a relative term. The word improving should be relative to other type of production. Applicants may modify the claim by including a quantitative amount in claim 1 which shows applicants method is improving from other process.
Correction is required.
Claim 2 and 8 are rejected being indefinite in reciting “a remaining amount is water.” for the following reason:
What is “remaining amount” not clear.
Applicants may modify the claim by including a quantities amount of total volume of a liquid seed medium ( which may contain water) in term of amount in term of total liquid medium to overcome the rejection.
Correction is required.
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.
Claims 1- 14 are rejected under 35 U.S.C. 103 as being unpatentable over Krzyczkowski et al. (Eng. Life Sci. 2010, 10, No. 5, pp 446-457, IDS), Cheng et al. ( fermentation 2021, 7, 182 IDS) in view of in view of Chang et al. ( Food Sci & technol. 216, 65, pp 100-1108) and Cui et al. Free Radical Biology and Medicine. 2019, 134, pp 555-566) and Orgill et al. ( Biochem. Eng. Journal, 2015, 15, pp 15-21).
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Krzyczkowski et al. describes the validation of an HPLC method for quantitative determination of erinacine A as well as optimization of the culture medium composition for its effective production in submerged culture of the edible and medicinal mushroom Hericium erinaceum. The effects of different medium components were examined by the one-factor-at-a-time method and then by the central composite rotatable design. The most favorable combination of nutrient medium constituents ensuring the highest erinacine A production was found to be: glucose 69.87 g/L, casein peptone 11.17 g/L, NaCl 1.45 g/L, ZnSO4 55.24 mg/L, KH2PO4 1.0g/L, and pH 4.5. The kinetics of metabolite biosynthesis was examined during the cultivation in a 10-L bioreactor. Under the optimal conditions the biomass yield was 13.3 ± 2.6g/L, while the production of erinacine A was 192 42mg/L. The optimal time to obtain the highest production of erinacine A during cultivation of H. erinaceum in a bioreactor was eight days ( see abstract) ( obvious over applicants claim 1-3, 5-10, 12-14)..
Krzyczkowski et al. does not teach potato dextrose agar (PDA) in the growing initial cell seedings..
Cheng et al. ( see Abstract: ) disclose “Hericium crinaceus (HE) is a large edible medicinal fungus. Erinacine A (ErA) is a secondary metabolite presented in the mycelia of HE, with pharmacological effects as a nerve growth factor on the central nervous system. in this study, solid-state cultivation of HE was carried out in Petri dishes and glass jars for the production of mycelial biomass and ErA. The potato dextrose agar (PDA) had the highest mycelial biomass at an optimal temperature of 25 °C, but no ErA was found in the agar media. In glass jar cultivation, the mycelial biomass and specific yield of ErA in different substrates, particle sizes, substrate weights, nitrogen sources, and inorganic salts were investigated. The ErA was purified by a self-pack silica gel column and a semi-preparative HPLC and was identified by liquid chromatography-tandem mass spectrometer. The best conditions for solid-state cultivation of HE when using com kernel as substrate, particle size less than 2.38 mm, and addition of 10mM ZnSO4, 7H2O, mycelial biomass of 50.24 mg cell dry weight/g substrate was obtained, in addition, the specific yield of ErA could reach 165.36 mg/g cell dry weight.” ( obvious over applicants claim 1-3, 5-10, 12-14)
Both Krzyczkowski et al. (Eng. Life Sci. 2010, 10, No. 5, pp 446-457, IDS), Cheng et al. ( fermentation 2021, 7, 182 IDS) do not teach use of an inducer in a liquid fermentation process.
Chang disclose improved production of both biomass of the formation process and ErA using a novel media containing nutrients media used by having anti stress components (as inducer) biomass and using variety of reductive oxygen species such as glutathione ( see abstract) ( obvious over applicants claim 1-3, 5-10, 12-14).,
Cui et al disclose “Reactive oxygen species (ROS) are key signaling intermediates in plant metabolism, defense, and stress adaptation. In plants, both the chloroplast and mitochondria are centers of metabolic control and ROS production, which coordinate stress responses in other cell compartments. The herbicide and experimental tool, methyl viologen (MV) induces ROS generation in the chloroplast under illumination, but is also toxic in non-photo synthetic organisms. We used MV to probe plant ROS signaling in compartments other than the chloroplast. Taking a genetic approach in the model plant Arabidopsis (Arabidopsis thaliana), we used natural variation, QTL mapping, and mutant studies with MV in the light, but also under dark conditions, when the chloroplast electron transport is inactive. These studies revealed a light-independent MV-induced ROS-signaling pathway, suggesting mitochondrial involvement. Mitochondrial Mn SUPEROXIDE DISMUTASE was required for ROS-toler ance and the effect of MV was enhanced by exogenous sugar, providing further evidence for the role of mitochondria “ ( see abstract)..
Orgill et al. disclose “ Methyl viologen (MV) is an electron mediator that has been shown to be beneficial for enhancing product formation in biofuel processes. For example, increased yields have been observed for ethanol and butanol production. MV has also been used in bioremediation processes such as removal of pollutants from groundwater. However, MV has also been shown to have detrimental effects including inhibition of cell growth. Unfortunately, studies have shown little information regarding the MV redox state. A thermodynamic model is presented and validated in order to predict the most likely redox state of MV depending on the redox potential, pH, and degree of MV dimerization. Model results showed that there are narrow potential ranges in which MV can change from one redox state to another. During fermentation processes in which the potential is in these narrow ranges, slight perturbations in the redox potentials can drastically change the redox state of MV. This may explain the observed variations in the positive and negative effects of MV. Thus, caution should be used when applying MV to any biological system. If needed, an electrode system may prove useful for controlling the redox potential and the associated MV redox state. ( abstract) “
It would have been obvious to one of ordinary skill in the art before the effective filing date combine the teaching of Krzyczkowski et al. (Eng. Life Sci. 2010, 10, No. 5, pp 446-457, IDS), Cheng et al. ( fermentation 2021, 7, 182 IDS) in view of in view of Chang et al. ( Food Sci & technol. 216, 65, pp 100-1108) and Cui et al. Free Radical Biology and Medicine. 2019, 134, pp 555-566) and Orgill et al. ( Biochem. Eng. Journal, 2015, 15, pp 15-21 to arrive the claimed invention instant claims 1-14.One would have been motivated to and would have had a reasonable expectation of success for using production method of Krzyczkowski et al. or Chang et al. for
production of Erinacine A by a liquid fermentation of Hericium erinaceus use inoculating a Hericium erinaceus strain on a potato dextrose agar (PDA) slope medium and us an inducer in a liquid fermentation process to induce a fermentation as taught by Chang et al. and use methyl viologen as an inducer as taught by Cui et al. or Orgill et al.
Conclusion
Claims 1-14 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMAD Y MEAH whose telephone number is (571)272-1261. The examiner can normally be reached on monday-friday (8-7).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 4089187584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMAD Y MEAH/ Examiner, Art Unit 1652
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