DETAILED ACTION
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 .
Claims Status
Claims 1-20 are pending.
Election/Restrictions
Applicant’s election with traverse of the invention of Group I, claims 1-15, in the reply filed on 11/26/2025 is acknowledged. The traversal is on the ground that the claims comply with unity of invention. This is not found persuasive because, the current instant application was not filed under 35 U. S. C. 371 but is a Nonprovisional application under 35 U.S.C. 111 (a). Applicant also argued that the requirement for Species Election for Species Groups I, II, and III all reference claims contain a Markush group that introduces each of the elements in the group and that the claims are sufficiently few in number and/are so closely related that a search and examination of the entire claim can be made without serious burden to the Examiner and therefore requested that the species restriction to be withdrawn. The Examiner proceeded with examination of all members of Species Group I, II, and III in the current instant application.
The requirement is still deemed proper and is therefore made FINAL.
The inventions of Group II, claims 16-19, and of Group III, claim 20, are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/26/2025.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 recites “the group consisting one of” which should be “the group consisting of”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-15 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 (claims 2-15 dependent from) is indefinite in the recitation of “a therapeutically effective amount of one or more first enzymes” and “a therapeutically effective amount of one or more second enzymes different to that of the first enzyme”. It is not clear in the claim language as to what the enzyme(s) are therapeutically effective for and is therefore indefinite.
Claim 6 is indefinite in the recitation “comprising a therapeutically effective amount of a co-factor”. It is not clear in the claim language as to what the co-factor is therapeutically effective for and is therefore indefinite.
Claim 9 (claim 10 dependent on) is indefinite in the recitation of “an effective amount of one or any combination of a sugar and a third enzyme…” The term “an effective amount” is ambiguous as to what the combination is effective for and is therefore indefinite.
Claim 13 is indefinite in the recitation of “a prophylactically effective amount”. It is not clear in the claim language what the composition is prophylactically effective for and is therefore indefinite.
Claim 14 (claim 15 dependent from) is indefinite in the recitation of “wherein a number of units of any one of or any combination of the first enzymes and the second enzymes is based on a value associated with a curve generated by the first and second enzymes, respectively, in a crude extract with a value associated with a curve generated by a pure enzyme preparation”. It is unclear to “what a value associated with a curve generated by the first and second enzymes” is defined by. It is unclear to what “a curve” is defined by. It is unclear to what a “curve generated by a pure enzyme preparation” is defined by and is therefore indefinite.
The limitations of claim 14 (and claim 15 dependent on) appear to be not more than a mental description or potential relationship of the referenced enzymes of the composition and do not appear to further limit the composition of claim 1. Thus the “limitations” of claims 14 and 15 are not given patentable weight.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. Claim 1 (claims 2-15 dependent from) recites a composition for converting alcohol to acetaldehyde and/or acetate, the composition comprising: a therapeutically effective amount of one or more first enzymes; and a therapeutically effective amount of one or more second enzymes different to that of the first enzymes. This judicial exception is not integrated into a practical application because the additional elements do not contribute any meaningful limitation to the natural product. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 1 recites a composition of one or more first enzymes and one or more second enzymes. The claim encompasses a composition of enzymes that are structurally identical to natural occurring enzymes as evidenced by de Shmidt et al. (FEMS Yeast Research, Vol. 8, pg. 967-978, published November 1, 2008) who teach compositions of aldehyde dehydrogenases and alcohol dehydrogenases in Saccharomyces cerevisiae. Because there is no difference in characteristics (structural, functional, or otherwise) between the claimed and naturally occurring composition, the claimed composition does not have markedly different characteristics and thus is a product of nature exception. Accordingly, the product is directed to an exception (Step 2A: Yes). Because the claim does not include any additional features that could add significantly more to the exception (Step 2B: No), the claim does not qualify as eligible subject matter and is rejected.
Claim Rejections - 35 USC § 102
(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.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (International Publication Number WO 2005/123099 A2; published 12/29/2005) hereinafter referred to as Wang as evidenced by Yoshino et al., (Cell Metabolism, Vol. 27, pgs. 513-528, March 6, 2018; Epub: December 14, 2017) hereinafter referred to as Yoshino et al..
With regards to claims 1 (claims 14-15 dependent on; see 112(b) rejection above) and 2-5, Wang teaches a composition and method of use thereof to accelerate the digestion and metabolism of alcohol in the gastric and/or gastrointestinal systems into acetate before the alcohol enters the body’s blood, thereby preventing blood alcohol buildup and avoiding intoxication by alcohol (lines 15-20, pg. 7). Wang further teaches that alcohol metabolism requires one or more of alcohol oxidizing enzymes together with coenzyme NAD (lines 28-30, pg. 10) and that the composition for accelerating the digestion and metabolism of alcohol includes an alcohol metabolizing enzyme such as alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH) and combinations thereof (lines 23-26). Additionally, Wang teaches that the enzymes and coenzymes can be readily obtained or derived from an organism such as yeast in a purified form or as an extract. The extract can be, for example, from yeast (lines 20-25, pg. 9).
With regards to claims 6-8, Wang teaches a composition for reducing blood level of alcohol that further includes a substance (cofactor) selected from coenzymes NAD and its reduced form NADH and its precursors (Claim 25, pg. 42). Claim 7 is rejected on the basis that nicotinamide riboside (NR) and nicotinamide mononucleotide (NMN) are known precursors of NAD as evidenced by Yoshino et al. Furthermore, Wang teaches that the NADH oxidation co-substrates and their precursors are capable of promoting the regeneration of NAD that catalyzes the metabolism of alcohol (Claim 21, pg. 42) and that the compositions can be used for maintaining the concentration of NAD and the NAD/NADH ratio in the body which enhances the alcohol metabolism rate (Lines 5-9, pg. 5).
With regards to claims 9-10, Wang teaches that the composition may further include fructose (Lines 1-3, pg. 8) and can further include at least an NADH-oxidizing enzyme such as sorbitol dehydrogenase Lines 5-7, pg. 10).
With regards to claim 11, Wang teaches that the composition can be formulated into any form suitable for a given mode of delivery to a user such as liquid formulations (Lines 1-5, pg. 16). Wang also teaches the composition can be provided as a nutritional/pharmaceutical composition for accelerating the metabolism of alcohol (Lines 10-12, pg. 5).
With regards to claims 12-13, Wang teaches that the composition may further include protective agents (pharmaceutically acceptable excipient) in an amount effective to preserve (prophylactically effective amount) the enzyme activity after administration to a user (Lines 25-28, pg. 5).
Therefore, claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (WO 2005/123099 A2, published 12/29/2005) as evidenced by Yoshino et al., (Cell Metabolism, Vol. 27, pgs. 513-528, March 6, 2018; Epub: December 14, 2017) hereinafter referred to as Yoshino et al..
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lu, J. et al., “Co-expression of alcohol dehydrogenase and aldehyde dehydrogenase in Bacillus subtilis for alcohol detoxification”, Food and Chemical Toxicology, Vol. 135, 2020, Epub: October 16, 2019.
Wong et al., Dual-Enzyme Composition for Preventing, Treating and/or Alleviating Veisalgia and Symptoms Associated Therewith, US Patent No: US 11,208,631 B1;Ppublished December 28, 2021.
Somberg, John C., Treatment to Aid in the Metabolism of Alcohol, US Patent Application Publication No: US 2009/0060894 A1; published March 5, 2009.
Whitmire, David R. Method for Rapid Enzymatic Alcohol Removal, US Patent Number: 5,759, 539, Published June 2, 1998.
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/G.T.L./Examiner, Art Unit 1652
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652