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
Claims 1-10 are pending.
Claims 6-10 are newly added.
Claims 1-5 are currently amended.
Claims 1-10 are under examination on the merits.
Rejections Withdrawn
Nonstatutory Double Patenting
The nonstatutory double patenting rejections of record have been withdrawn in view of the submission and approval of terminal disclaimers, filed 08/19/2026.
35 U.S.C. 102(a)(1)
The rejection of claim(s) 1-5 under 35 U.S.C. 102(a)(1) as being anticipated by Kwon (US PG PUB 20210254023, publication date: 08/19/2021) is withdrawn in view of the amendments to the claims, dated 08/19/2026. As indicated by Applicant in Applicant Arguments, dated 08/19/2026, Kwon does not specifically teach lysates of the claimed Saccharomyces cerevisiae strains, as instantly claimed.
New Grounds for Rejection
35 U.S.C. 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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kwon (US PG PUB 20210254023, publication date: 08/19/2021).
The instant claims are drawn to a product that comprises one or more of a lysate of Saccharomyces cerevisiae KCTC13925BP, KCTC14122BP, KCTC14123BP, KCTC14983BP, KCTC14984BP, and KCTC14985BP. At the Abstract, Kwon teaches “a yeast strain producing glutathione (GSH) and aldehyde dehydrogenase, and more specifically, the yeast strains Saccharomyces cerevisiae Kwon P-1 KCTC13925BP, Saccharomyces cerevisiae Kwon P-2 KCTC14122BP, and Saccharomyces cerevisiae Kwon P-3 KCTC14123BP, which produce both glutathione and aldehyde dehydrogenase.”
At [0003]-[0008], Kwon teaches that “[g]lutathione has been known to serve as an important antiviral agent in vivo by enhancing immune activity through leukocytogenesis. Glutathione acts as a substrate for glutathione S-transferase (GST) to bind to toxic substances, such as xenobiotics, which are harmful to the living body, in a conjugated form, thereby playing a key role in detoxification… Glutathione also serves to prevent the damage and necrosis of cell membranes, nucleic acids, and cell structures caused by oxidation in cells and to mitigate toxicity of reactive oxygen species (ROS), a cause of aging. Reactive oxygen species are formed during various biological metabolisms, including superoxides, peroxides, hydroxy radicals, and the like, and are classified into endogenous reactive oxygen species generated from biological metabolites of substances and exogenous reactive oxygen species resulting from tobacco, radioactivity, and the like… Oxidative stress due to reactive oxygen species may impair cognitive function (Liu et al. 2002), destroy sperm DNA to cause male infertility (Wright et al. 2014), damage cellular proteins, lipids, and nucleic acids to cause cancer, and lower physiological functions to act as a causative factor of various diseases and aging. Therefore, antioxidants that serve to perform disease prevention, immunity enhancement, aging prevention, and the like are very important in our body, and the functions of glutathione, which acts as an antioxidant in cells, are receiving attention in many medical fields including enzymology, pharmacology, therapies, toxicology, endocrinology, and microbiology… This glutathione is basically synthesized in the body, but with the progress of abnormal conditions, such as disease occurrence, lowered immunity, and aging, the absolute content of glutathione decreases in the human body, resulting in deterioration in health. Therefore, the glutathione supplied from the outside can remove reactive oxygen species in cells to maintain health and slow down aging. Owing to these physiologically active factors of glutathione in the human body, glutathione is currently used for food, cosmetics, feeds, and pharmaceuticals, and the usage thereof is increasing. Glutathione is currently produced using edible microorganisms, but the inherent content of glutathione that can be produced from microorganisms is very low, and thus studies are being actively conducted to mass-produce glutathione through high-content glutathione-producing strains by increasing the glutathione content of microorganisms through mutation and recombination technology and applying this technology to fermentation techniques.”
Therefore Kwon suggests that glutathione levels decrease with various conditions, including aging, and exogenous glutathione, which helps to maintains health and slow aging, may be applied through edible organisms.
At [0011], Kwon teaches that “among Koreans, excessive aldehyde residues in the body, produced by alcohol intake, have been reported to cause diseases resulting from oxidation, such as cardiovascular diseases, diabetes, neurodegenerative diseases, upper digestive and respiratory tract cancers, radiation dermatitis, Fanconi anemia, peripheral nerve damage, inflammation, osteoporosis, and aging…”
At [0013], [0014], and [0016], Kwon teaches that “[i]n order to solve these social problems, research and experiments on many substances capable of reducing toxicity of ethanol or inhibiting expression of toxicity thereof are being conducted, leading to the development of various health supplement-related goods. The alcohol entering the body is absorbed into the stomach or small intestine to enter the blood vessels, transferred to the liver, and decomposed and detoxified therein… Alcohol dehydrogenase (ADH) present in hepatocytes first oxidizes alcohol into acetaldehyde, and the acetaldehyde is again decomposed into acetic acid by acetaldehyde dehydrogenase (ALDH) in hepatocytes, and then acetic acid is transferred to muscles and adipose tissues in the body and finally decomposed into carbonic acid gas and water. Acetaldehyde, the first metabolite of ethanol, is the main cause of hangovers and alcoholic liver disorders due to very high reactivity and strong toxicity compared with ethanol… Since acetaldehyde, a hangover causing substance produced in the in vivo ethanol metabolism, is most effectively converted to acetic acid, the removal of aldehydes is very important for human health… In addition, aldehyde dehydrogenase 2 is used in the metabolism of not only acetaldehyde but also aldehydes, such as aliphatic aldehydes, aromatic aldehydes, and polycyclic aldehydes, to remove toxic substances in the body...”
At [0031], [0032], [0034], and [0035], Kwon teaches that “the use of both glutathione and aldehyde dehydrogenase is highly efficient in order to remove chemical substances, such as reactive oxygen species and various aldehydes, among various harmful substances accumulated in the human body, but the development of strains producing both glutathione and aldehyde dehydrogenase was not reported in the investigation so far… In the present disclosure, strains capable of producing both aldehyde dehydrogenase and glutathione with high efficiency were developed by firstly creating mutant strains through chemical mutation and secondarily selecting selection factor-adapted strains… Mutant strains overproducing both glutathione and aldehyde dehydrogenase have been reported to be generally recognized as safe (GRAS) in the use of food, health food, feeds, cosmetics, and medicines, and wild Saccharomyces cerevisiae, which has already been known to produce both glutathione and aldehyde dehydrogenase, albeit with low production efficiency, was selected and used… As such, Saccharomyces cerevisiae sp., which is a novel modified strain having both an enhanced ability to produce glutathione and an enhanced ability to produce aldehyde dehydrogenase, was secured through mutation, and therefore, the present disclosure has been completed.”
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to administer the mutant Saccharomyces cerevisiae strains of Kwon to humans, because said strains produce both glutathione and aldehyde dehydrogenase, both of which “remove chemical substances, such as reactive oxygen species and various aldehydes, among various harmful substances accumulated in the human body.” Therefore administering the mutant Saccharomyces cerevisiae strains of Kwon to humans would reasonably be expected to promote general health. Furthermore at Example 3, Kwon teaches a method for measuring aldehyde dehydrogenase activity, which involves preparing a lysate of microorganisms to be measured. As such one of ordinary skill in the art would appreciate that lysates of the mutant Saccharomyces cerevisiae strains of Kwon comprise aldehyde dehydrogenase, and, presumably, glutathione. As such one of ordinary skill in the art would have been motivated to prepare lysates of the mutant Saccharomyces cerevisiae strains of Kwon, because there would have been a reasonable expectation that said lysates could be administered to humans to promote general health. The invention of Kwon meets the limitations of claims 1-5.
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kwon (US PG PUB 20210254023, publication date: 08/19/2021), as applied to claims 1-5, and further in view of von der Haar (PLoS One, 10(e1078): 1-8, 2007).
As indicated above one of ordinary skill in the art would have been motivated to prepare lysates of the mutant Saccharomyces cerevisiae strains of Kwon, because there would have been a reasonable expectation that said lysates could be administered to humans to promote general health. Kwon does not teach or suggest preparing lysates of Saccharomyces cerevisiae by alkaline lysis and bead beating; however these deficiencies are remedied by von der Haar.
Von der Haar teaches a novel method for protein extraction from Saccharomyces cerevisiae, see Abstract. Said method involves alkaline lysis, as indicated at p. 1, second column, and bead beating, see p. 7, first column.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to administer the mutant Saccharomyces cerevisiae strains of Kwon to humans, because said strains produce both glutathione and aldehyde dehydrogenase, both of which “remove chemical substances, such as reactive oxygen species and various aldehydes, among various harmful substances accumulated in the human body.” Therefore administering the mutant Saccharomyces cerevisiae strains of Kwon to humans would reasonable be expected to promote general health. Furthermore at Example 3, Kwon teaches a method for measuring aldehyde dehydrogenase activity, which involves preparing a lysate of microorganisms to be measured. As such one of ordinary skill in the art would appreciate that lysates of the mutant Saccharomyces cerevisiae strains of Kwon comprise aldehyde dehydrogenase, and, presumably, glutathione. As such one of ordinary skill in the art would have been motivated to prepare lysates of the mutant Saccharomyces cerevisiae strains of Kwon, because there would have been a reasonable expectation that said lysates could be administered to humans to promote general health. The invention of Kwon meets the limitations of claims 1-5.
Furthermore in view of the teachings of von der Haar, one of ordinary skill in the art would appreciate that lysates of Saccharomyces cerevisiae strains may be obtained by alkaline lysis and bead beating. Therefore one of ordinary skill in the art would have been motivated to obtain the Saccharomyces cerevisiae lysates of Kwon via alkaline lysis and bead beating, because said lysates could be administered to humans to promote general health. The invention of Kwon and von der Haar meets the limitations of claims 6-10.
Conclusion
No claims are 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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
