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
This application is a 371 of PCT/KR2021/002046.
Election/Restrictions
Applicant elected without traverse of Group I in the reply filed on February 13, 2025.
During a telephone conversation with Christopher J. Maier on April 15, 2025, Applicant elected the species aldehyde dehydrogenase derived from Saccharomyces cerevisiae Kwon P-1.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 13, 2025.
Status of Claims
Claims 6 and 8-11 are pending.
Claims 8-10 are withdrawn.
Claims 6 and 11 are under examination.
Declaration of availability and maintenance of microorganism
Applicants state that Saccharomyces cerevisiae Kwon P-1 KCTC13925BP has been deposited under the provisions of the Budapest Treaty and that the strain will be available to the public.
Response to Amendments/Arguments
Claim Objections
Applicant’s arguments, see pages 4-5 of the Remarks, filed March 20, 2026, with respect to claim 7 have been fully considered and are persuasive. Claim 7 has been cancelled and incorporated into claim 6, wherein “Saccharomyces cerevisiae” has been italicized. Therefore, the objection of claim 7 has been withdrawn.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see page 5 of the Remarks, filed March 20, 2026, with respect to claim 7 have been fully considered and are persuasive. Claim 7 has been cancelled and incorporated into claim 6. Applicant has provided a statement that Kwon P-1 KCTC13925BP has been deposited and will be publicly available. Therefore, the rejection of claim 7 under 35 U.S.C. 112(a) has been withdrawn.
Claim Rejections - 35 USC § 102
Applicant’s arguments, see pages 5-8 of the Remarks, filed March 20, 2026, with respect to claim 6 have been fully considered and are persuasive. Claim 6 has been amended to recite that the glutathione and aldehyde dehydrogenase are derived from a lysate or extract of a mutant S. cerevisiae yeast, wherein the mutant S. cerevisiae yeast is S. cerevisiae Kwon P-1 KCTC13925BP, which is not disclosed by Pico Entech Co LTD (KR 10-2017-0046540 – form PTO-1449 and English Translation of KR 10-2017-0046540. Retrieved on 4/14/2025. – cited previously on form PTO-892. Therefore, the rejection of claim 6 under 35 U.S.C. 102(a)(1) as being anticipated by Pico Entech Co LTD has been withdrawn.
Claim Rejections - 35 USC § 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.
Maintained Rejection
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Pico Entech Co LTD (KR 10-2017-0046540 – form PTO-1449 and English Translation of KR 10-2017-0046540. Retrieved on 4/14/2025. – cited previously on form PTO-892. English Translation of KR 10-2017-0046540 is used for specific passage of Pico Entech Co LTD) and Zhao (CN 106387917 – cited previously on form PTO-892 and English Translation of CN 106387917. Retrieved on 4/15/2025. English Translation of CN 106387917 is used for specific passages of Zhao) and evidenced by Kwon (US 11,618,889 – cited previously on form PTO-892)
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.' MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”.
In the instant case regarding the limitation “glutathione …derived from..” recited in claim 6, the structure of the claimed glutathione implied is the same whether glutathione is derived from any source or the lysate or extract of a mutant S. cerevisiae, or Saccharomyces cerevisiae Kwon P-1 since the structure of the resulting glutathione remains identical.
Regarding the limitation “aldehyde dehydrogenase.. derived from..” recited in claim 6, the structure of the claimed aldehyde dehydrogenase implied is the same whether aldehyde dehydrogenase is derived from the lysate or extract of a mutant S. cerevisiae or Saccharomyces cerevisiae Kwon P-1 since the structure of the resulting S. cerevisiae aldehyde dehydrogenase remains identical. Further, the specification of the instant application discloses that Saccharomyces cerevisiae Kwon P-1 is described in Korean Patent Application No. 10-2020-0019858 (paragraph [81]). Kwon (US 11,618,889 – form PTO-892) claims priority to said Korean Patent Application No. 10-2020-0019858. Kwon discloses that Saccharomyces cerevisiae Kwon P-1 is a mutant S. cerevisiae selected for its ability for high production of aldehyde dehydrogenase without alteration in the structure of the aldehyde dehydrogenase. Therefore, the structure of the aldehyde dehydrogenase derived from Saccharomyces cerevisiae Kwon P-1 is identical to an aldehyde derived from S. cerevisiae.
Therefore, claim 6 encompasses a hangover relieving composition comprising glutathione and S. cerevisiae aldehyde dehydrogenase.
Regarding claim 6, Pico Entech Co LTD discloses a hangover relieving composition comprising glutathione and aldehyde dehydrogenase (page 2, 2nd full paragraph to 8th full paragraph, and Manufacture examples 2-3 at page 4).
Pico Entech Co LTD does not disclose a composition comprising a S. cerevisiae aldehyde dehydrogenase.
Regarding claim 6, Zhao discloses a sobering-up composition (reading on a hangover relieving composition) comprising an aldehyde dehydrogenase derived from S. cerevisiae (abstract and page 3, 2nd full paragraph). Zhao discloses that separation and extraction aldehyde dehydrogenase from the liver, pancreas or stem cell mitochondria of animal is limited and expensive and Zhao provides an advantageous method of mass production of aldehyde dehydrogenase using S. cerevisiae (page 2, 4th full paragraph and page 3, 2nd full paragraph).
Therefore, in combining the teachings of Pico Entech Co LTD and Zhao, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to replace the prior art aldehyde dehydrogenase of Pico Entech Co LTD with other known aldehyde dehydrogenase, such as the S. cerevisiae aldehyde dehydrogenase of Zhao, because one of ordinary skill in the art would have been able to carry out such a substitution and the results were reasonably predictable. The rationale to support a conclusion that the claims would have been obvious is that the substitution of one known element (aldehyde dehydrogenase) for another (S. cerevisiae aldehyde dehydrogenase) yields predictable results (relieving a hangover) to one of ordinary skill in the art since Zhao discloses a hangover composition comprising S. cerevisiae aldehyde dehydrogenase). See MPEP 2143. Also, one of ordinary skill in the art would have been motivated to substitute the aldehyde dehydrogenase of Pico Entech Co LTD with the S. cerevisiae aldehyde dehydrogenase of Zhao since Zhao discloses mass production of aldehyde dehydrogenase from S. cerevisiae. One of ordinary skill in the art would have had a reasonable expectation of success since Pico Entech Co LTD discloses a hangover relieving composition comprising glutathione and aldehyde dehydrogenase and Zhao discloses a hangover relieving composition comprising S. cerevisiae aldehyde dehydrogenase.
Therefore, the above references render claim 6 prima facie obvious.
Applicant's arguments filed March 20, 2026 have been fully considered but they are not persuasive.
Applicant argues that Kwon ‘540 (Pico Entech Co LTD (KR 10-2017-0046540 – form PTO-1449 and English Translation of KR 10-2017-0046540. Retrieved on 4/14/2025. – cited previously on form PTO-892) does not teach or suggest all of the limitans of clam 6 because Kwon ‘540 does not teach or suggest the lysate or extract of S. cerevisiae employed for the preparation of the hang over reliever composition. Applicant argues that the paragraph [81] of page 13 of the specification discloses that “.. the active ingredient of the hangover relieving composition… is a dry powder, lysate, or ALDH-containing extract of Saccharomyces cerevisiae Kwon P-1 (KCTC13925BP)..”.
This is not found persuasive. Claim 6 does not recite a hangover relieving composition comprising lysate or extract comprising glutathione and aldehyde dehydrogenase. Instead, claim 6 recites a hangover relieving composition comprising a glutathione and aldehyde dehydrogenase, wherein both glutathione and aldehyde are derived from a lysate or extract of a mutant S. cerevisiae. As discussed above, MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”. In the instant case regarding the limitation “glutathione …derived from..” recited in claim 6, the structure of the claimed glutathione implied is the same whether glutathione is derived from any source or the lysate or extract of a mutant S. cerevisiae, or Saccharomyces cerevisiae Kwon P-1 since the structure of the resulting glutathione remains identical. Regarding the limitation “aldehyde dehydrogenase.. derived from..” recited in claim 6, the structure of the claimed aldehyde dehydrogenase implied is the same whether aldehyde dehydrogenase is derived from the lysate or extract of a mutant S. cerevisiae or Saccharomyces cerevisiae Kwon P-1 since the structure of the resulting S. cerevisiae aldehyde dehydrogenase remains identical. Further, the specification of the instant application discloses that Saccharomyces cerevisiae Kwon P-1 is described in Korean Patent Application No. 10-2020-0019858 (paragraph [81]). Kwon (US 11,618,889 – form PTO-892) claims priority to said Korean Patent Application No. 10-2020-0019858. Kwon discloses that Saccharomyces cerevisiae Kwon P-1 is a mutant S. cerevisiae selected for its ability for high production of aldehyde dehydrogenase without alteration in the structure of the aldehyde dehydrogenase. Therefore, the structure of the aldehyde dehydrogenase derived from Saccharomyces cerevisiae Kwon P-1 is identical to an aldehyde derived from S. cerevisiae. Therefore, claim 6 encompasses a hangover relieving composition comprising glutathione and S. cerevisiae aldehyde dehydrogenase, which is taught by the combined teachings of the cited references.
Further, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the active ingredient of the hangover relieving composition… is a dry powder, lysate, or ALDH-containing extract of Saccharomyces cerevisiae Kwon P-1 (KCTC13925BP”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that although Zhang discloses an anti-alcohol product, Zhang is silent to suggest the hangover relieving composition containing the lysates or extract derived from Saccharomyces cerevisiae Kwon P-1 (KCTC13925BP).
This is not found persuasive. As discussed above, claim 6 does not recite a hangover relieving composition comprising lysate or extract comprising glutathione and aldehyde dehydrogenase. Instead, claim 6 recites a hangover relieving composition comprising a glutathione and aldehyde dehydrogenase, wherein both glutathione and aldehyde are derived from a lysate or extract of a mutant S. cerevisiae. Claim 6 encompasses a hangover relieving composition comprising glutathione and S. cerevisiae aldehyde dehydrogenase (see the claim interpretation of claim 6 above), which is taught by the combined teachings of the cited references.
Applicant argues that Kwon ‘540 and Zhao do not suggest any motivation of the conception and do not suggest the lysate or extract, the technical feature of hangover reliever composition of the present invention.
This is not found persuasive. One of ordinary skill in the art would have been motivated to substitute the aldehyde dehydrogenase of ‘Kwon ‘549 (Pico Entech Co LTD) with the S. cerevisiae aldehyde dehydrogenase of Zhao since Zhao discloses mass production of aldehyde dehydrogenase from S. cerevisiae.
Hence the rejection has been maintained.
New Rejection
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pico Entech Co LTD (KR 10-2017-0046540 – form PTO-1449 and English Translation of KR 10-2017-0046540. Retrieved on 4/14/2025. – cited previously on form PTO-892. English Translation of KR 10-2017-0046540 is used for specific passage of Pico Entech Co LTD) and Zhao (CN 106387917 – cited previously on form PTO-892 and English Translation of CN 106387917. Retrieved on 4/15/2025. English Translation of CN 106387917 is used for specific passages of Zhao) and evidenced by Kwon (US 11,618,889 – cited previously on form PTO-892) as applied to claim 6 above, and further in view of Wang (US 2005/0271739 – form PTO-892).
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.' MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”.
In the instant case regarding the limitation “NAD.. added from an external source” recited in claim 11, the structure of the claimed NAD implied is the same whether the NAD is added from an external source or another source since the structure of the resulting NAD remains identical. Therefore, claim 11 encompasses a hangover relieving composition comprising glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD.
Pico Entech Co LTD and Zhao do not disclose a hangover relieving composition comprising NAD added from an external source as recited in claim 11.
Regarding clam 11, Wang discloses a composition for accelerating the metabolic of alcohol to prevent/reduce alcohol intoxication, drunkenness and hangover, wherein the composition comprises an aldehyde dehydrogenase and NAD ([0043] and claims 2-3 and 6). Wang discloses that increasing or maintaining the concentration of coenzyme NAD and the NAD/NADH ratio (i.e., redox state) in the body, enhances the alcohol metabolism rate and prevents the drinker from developing alcohol-drinking related diseases and alcoholic syndrome ([0017]).
Therefore, in combining the teachings of the above references, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to add NAD to a hangover relieving composition comprising glutathione and S. cerevisiae aldehyde dehydrogenase. One of ordinary skill in the art would have been motivated to add NAD in order to further improve efficacy of the hangover relieving composition because NAD enhances alcohol metabolism. One of ordinary skill in the art would have had a reasonable expectation of success since Pico Entech Co LTD discloses a hangover relieving composition comprising glutathione and aldehyde dehydrogenase, Zhao discloses a hangover relieving composition comprising S. cerevisiae aldehyde dehydrogenase, and Wang discloses a hangover relieving composition comprising NAD and aldehyde dehydrogenase.
Therefore, the above references render claims 6 and 11 prima facie obvious.
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.
Maintained/Amended Rejection
Claims 6 and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim interpretation
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.' MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”.
In the instant case regarding the limitation “glutathione …derived from..” recited in claim 6, the structure of the claimed glutathione implied is the same whether glutathione is derived from any source or the lysate or extract of a mutant S. cerevisiae, or Saccharomyces cerevisiae Kwon P-1 since the structure of the resulting glutathione remains identical.
Regarding the limitation “aldehyde dehydrogenase.. derived from..” recited in claim 6, the structure of the claimed aldehyde dehydrogenase implied is the same whether aldehyde dehydrogenase is derived from the lysate or extract of a mutant S. cerevisiae or Saccharomyces cerevisiae Kwon P-1 since the structure of the resulting S. cerevisiae aldehyde dehydrogenase remains identical. Further, the specification of the instant application discloses that Saccharomyces cerevisiae Kwon P-1 is described in Korean Patent Application No. 10-2020-0019858 (paragraph [81]). Kwon (US 11,618,889 – form PTO-892) claims priority to said Korean Patent Application No. 10-2020-0019858. Kwon discloses that Saccharomyces cerevisiae Kwon P-1 is a mutant S. cerevisiae selected for its ability for high production of aldehyde dehydrogenase without alteration in the structure of the aldehyde dehydrogenase. Therefore, the structure of the aldehyde dehydrogenase derived from Saccharomyces cerevisiae Kwon P-1 is identical to an aldehyde derived from S. cerevisiae.
Claim 6 is directed to a hangover relieving composition comprising glutathione, which occurs in nature, and S. cerevisiae aldehyde dehydrogenase, which occurs in nature.
Claim 11 is directed to a hangover relieving composition comprising glutathione, which occurs in nature, S. cerevisiae aldehyde dehydrogenase, which occurs in nature, and NAD, which occurs in nature.
Therefore, claims 6 and 11 are directed to a hangover relieving composition comprising (A) a nature-based product, glutathione, and (B) a nature-based product, S. cerevisiae aldehyde dehydrogenase, and (C) a natured-based product, NAD.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category (see MPEP 2106.03). Since the claims are directed to a composition comprising nature-base product, the claims are directed to a composition of matter, which is one of the statutory categories of invention. (Step 1: YES)
Step 2A Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception (see MPEP 2106.04). The glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD comprised in the claimed composition are not considered to have markedly different characteristics from what occurs in nature, a naturally occurring glutathione, naturally occurring S. cerevisiae aldehyde dehydrogenase, and naturally occurring NAD, and are considered to be a law of nature exception. There is no indication in the specification that placing glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD into a composition result in the glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD having any characteristics (structural, functional, or otherwise) that are different from the naturally occurring glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD respectively. Because there is no difference in characteristics (structural, functional, or otherwise) between the glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD comprised in the claimed composition and the naturally occurring glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD, respectively, the claimed composition comprising glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD is directed to a judicial exception.
Step 2A Prong 2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. There is no indication in the specification that combining glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD in a composition result in a transformation of the glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD (Step2 A: YES)
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05). The claim only recites the laws of nature and do not include any additional elements that could add significantly more to the judicial exceptions. Because the component elements (glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD) do not occur together in nature as claimed and are not markedly changed by their combination into a composition, each component is considered as an additional element to the other to determine whether their combination results in significantly more than the products of nature. Combining glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD does not markedly change the characteristics of either component, because each component continues to have the same properties in the mixture as it had alone. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD comprised in the composition is not markedly different form its naturally occurring counterpart because it conveys the same structural and functional information. Thus, the combination of glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD does not meaningfully limit the claims, and the claims as a whole do not amount to significantly more than each “product of nature by itself (Step 2B: NO).
As such, the claims do not qualify as eligible subject matter.
Applicant's arguments filed March 20, 2026 have been fully considered but they are not persuasive.
Applicant argues that Applicant argues that since claim 6 is amended to a hangover relieving composition wherein the glutathione and aldehyde dehydrogenase are derived from a lysate or extract of a mutant S. cerevisiae, S. cerevisiae Kwon P-1 KCTC13925BP, the claimed limited when views as a whole are directed toward significantly more than the alleged judicial exception.
This is not found persuasive. Claim 6 does not recite a hangover relieving composition comprising lysate or extract comprising glutathione and aldehyde dehydrogenase. Instead, claim 6 recites a hangover relieving composition comprising a glutathione and aldehyde dehydrogenase, wherein both glutathione and aldehyde are derived from a lysate or extract of the mutant S. cerevisiae Kwon P-1 KCTC13925BP. As discussed above, MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”. In the instant case regarding the limitation “glutathione …derived from..” recited in claim 6, the structure of the claimed glutathione implied is the same whether glutathione is derived from any source or the lysate or extract of a mutant S. cerevisiae, or Saccharomyces cerevisiae Kwon P-1 since the structure of the resulting glutathione remains identical. Regarding the limitation “aldehyde dehydrogenase.. derived from..” recited in claim 6, the structure of the claimed aldehyde dehydrogenase implied is the same whether aldehyde dehydrogenase is derived from the lysate or extract of a mutant S. cerevisiae or Saccharomyces cerevisiae Kwon P-1 since the structure of the resulting S. cerevisiae aldehyde dehydrogenase remains identical. Further, the specification of the instant application discloses that Saccharomyces cerevisiae Kwon P-1 is described in Korean Patent Application No. 10-2020-0019858 (paragraph [81]). Kwon (US 11,618,889 – form PTO-892) claims priority to said Korean Patent Application No. 10-2020-0019858. Kwon discloses that Saccharomyces cerevisiae Kwon P-1 is a mutant S. cerevisiae selected for its ability for high production of aldehyde dehydrogenase without alteration in the structure of the aldehyde dehydrogenase. Therefore, the structure of the aldehyde dehydrogenase derived from Saccharomyces cerevisiae Kwon P-1 is identical to an aldehyde derived from S. cerevisiae. Thus, claim 6 is directed to a hangover relieving composition comprising glutathione, which occurs in nature, and S. cerevisiae aldehyde dehydrogenase, which occurs in nature. As such, the claims do not qualify as eligible subject matter.
Applicant argues that S. cerevisiae Kwon P-1 KCTC13925BP is a mutant S. cerevisiae, which does not exist in nature and the claimed S. cerevisiae strains are isolated using a special method, which are non-natural while featuring a different characteristic compared to the naturally occurring counterpart.
This is not found persuasive. Claim 6 does not recite a hangover relieving composition comprising S. cerevisiae Kwon P-1 KCTC13925B. Instead, claim 6 recites a hangover relieving composition comprising a glutathione and aldehyde dehydrogenase, wherein both glutathione and aldehyde are derived from a lysate or extract of the mutant S. cerevisiae Kwon P-1 KCTC13925BP. The specification of the instant application discloses that Saccharomyces cerevisiae Kwon P-1 is described in Korean Patent Application No. 10-2020-0019858 (paragraph [81]). Kwon (US 11,618,889 – form PTO-892) claims priority to said Korean Patent Application No. 10-2020-0019858. Kwon discloses that Saccharomyces cerevisiae Kwon P-1 is a mutant S. cerevisiae selected for its ability for high production of aldehyde dehydrogenase without alteration in the structure of the aldehyde dehydrogenase. Therefore, the structure of the aldehyde dehydrogenase derived from Saccharomyces cerevisiae Kwon P-1 is identical to an aldehyde derived from S. cerevisiae. Thus, claim 6 is directed to a hangover relieving composition comprising glutathione, which occurs in nature, and S. cerevisiae aldehyde dehydrogenase, which occurs in nature. As such, the claims do not qualify as eligible subject matter.
Therefore, the rejection has been maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Maintained Rejection
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US Patent No. 11,618,889 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because they are claiming common subject matter, as follows:
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.' MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”.
In the instant case, regarding the limitation “derived from a lysate or extract” recited in claim 6, the structure of the claimed glutathione and aldehyde dehydrogenase implied is the same whether glutathione and aldehyde dehydrogenase is derived from Saccharomyces cerevisiae Kwon P-1 or the lysate or extract of Saccharomyces cerevisiae Kwon P-1 since the structure of the resulting glutathione and aldehyde dehydrogenase remains identical.
Therefore, claim 6 encompasses a hangover relieving composition comprising glutathione and S. cerevisiae aldehyde dehydrogenase.
Regarding claim 6 of the instant application, claims 1 and 6 of the reference patent recites a method of producing a composition comprising glutathione and aldehyde dehydrogenase derived from Saccharomyces cerevisiae Kwon P-1. The resulting composition inherently has hangover relieving properties (see Column line 49 through Column 3, line 17 of the reference patent and the abstract of the instant application). Therefore, claim 6 of the instant application is anticipated by claims 1 and 6 of the reference patent.
Therefore, the conflicting claims are not patentably distinct from each other.
Applicant's arguments filed March 20, 2026 have been fully considered but they are not persuasive.
Applicant argues that the subject matter of amended claim 6 distinguishes over the cited reference patent.
This is not found persuasive. Regarding the limitation “derived from a lysate or extract” recited in claim 6, the structure of the claimed glutathione and aldehyde dehydrogenase implied is the same whether glutathione and aldehyde dehydrogenase is derived from Saccharomyces cerevisiae Kwon P-1 or the lysate or extract of Saccharomyces cerevisiae Kwon P-1 since the structure of the resulting glutathione and aldehyde dehydrogenase remains identical.
Hence the rejection has been maintained.
New Rejection
Claims 6 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US Patent No. 11,618,889 (reference patent) in view of Wang (US 2005/0271739 – form PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because they are claiming common subject matter, as follows:
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.' MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”.
In the instant case regarding the limitation “derived from a lysate or extract.” recited in claim 6, the structure of the claimed glutathione and aldehyde implied is the same whether glutathione and aldehyde dehydrogenase is derived from Saccharomyces cerevisiae Kwon P-1 or the lysate or extract of Saccharomyces cerevisiae Kwon P-1 since the structure of the resulting glutathione and aldehyde dehydrogenase remains identical.
Regarding the limitation “NAD.. added from an external source” recited in claim 11, the structure of the claimed NAD implied is the same whether the NAD is added from an external source or another source since the structure of the resulting NAD remains identical. Therefore, claim 11 encompasses a hangover relieving composition comprising glutathione, S. cerevisiae aldehyde dehydrogenase, and NAD.
Regarding claim 6 of the instant application, claims 1 and 6 of the reference patent recites a method of producing a composition comprising glutathione and aldehyde dehydrogenase derived from Saccharomyces cerevisiae Kwon P-1. The resulting composition inherently has hangover relieving properties (see Column line 49 through Column 3, line 17 of the reference patent and the abstract of the instant application).
The claims of the reference patent do not recite a hangover relieving composition comprising NAD.
Regarding clam 11, Wang discloses a composition for accelerating the metabolic of alcohol to prevent/reduce alcohol intoxication, drunkenness and hangover, wherein the composition comprises an aldehyde dehydrogenase and NAD ([0043] and claims 2-3 and 6). Wang discloses that increasing or maintaining the concentration of coenzyme NAD and the NAD/NADH ratio (i.e., redox state) in the body, which enhances the alcohol metabolism rate and prevents the drinker from developing alcohol-drinking related diseases and alcoholic syndrome ([0017]).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the claims of the reference patent by adding NAD to a hangover relieving composition comprising glutathione and S. cerevisiae aldehyde dehydrogenase. One of ordinary skill in the art would have been motivated to add NAD in order to further improve efficacy of the hangover relieving composition because NAD enhances alcohol metabolism. One of ordinary skill in the art would have had a reasonable expectation of success since the claims of the reference patent recites a composition comprising glutathione and S. cerevisiae aldehyde dehydrogenase and Wang discloses a hangover relieving composition comprising NAD and aldehyde dehydrogenase.
Therefore, the conflicting claims are not patentably distinct from each other.
Conclusion
Claims 6 and 8-11 are pending.
Claims 8-10 are withdrawn.
Claims 6 and 11 are rejected.
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 YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YONG D PAK/Primary Examiner, Art Unit 1652
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