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 1-20 are pending in the instant application.
Claims 1-20 are examined herein.
Priority
The instant application is a CON of U.S. Patent Application No. 17860096, filed on 07 July 2022, which is a continuation-in-part of U.S. Patent Application No. 17159108, filed on 26 January 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 26 January 2021.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 14 August 2025, is acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Claim Interpretation
Claims 1-20 are directed to a composition; as such, the method of extraction (i.e. “extracted from a source of flavonoids”) does not alter the chemical structure(s) of composition and is therefore not further limiting. See MPEP 2113 I:
[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. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
Claim Objections
Claim 1 is objected to because of the following informalities:
Line 6 of claim 1 recites “…dihdrokaempferol…” the claim should read “…dihydrokaempferol…”
Appropriate correction is required.
Claim 3 is objected to because of the following informalities:
Line 3 of claim 3 recites “…an other plant sugar, a syrup sugar, an artificial sugar and an other sugar.” the claim should read “…another plant sugar, a syrup sugar, an artificial sugar, and another sugar.”
Appropriate correction is required.
Claim 13 is objected to because of the following informalities:
Line 1 of claim 13 recites “A additive….” The line should read “An additive…” Line 4 recites“…an other plant sugar, a syrup sugar, an artificial sugar and an other sugar;” the line should read “…another plant sugar, a syrup sugar, an artificial sugar, and another sugar....” Line 10 recites “…dihdrokaempferol…” the line should read “…dihydrokaempferol…”
Appropriate correction is required.
Claim 18 is objected to because of the following informalities:
Line 1 of claim 18 recites “A method of making a additive….” The line should read “A method of making an additive…”
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 3 and 13 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 3 and 13 recites the broad recitation “another plant sugar”, and the claim also recites “cane sugar” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 3 and 13 recites the broad recitation “another sugar”, and the claim also recites “a cane sugar, another plant sugar, a syrup sugar, an artificial sugar” which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18, and 21-22 of U.S. Patent No. 20240023582A1. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, the Patent discloses an additive comprising a sweetener base and one or more flavonoids extracted from a source of flavonoids, wherein said flavonoids are selected from apigenin, flavanones, kaempferol, quercetin, rutin, myricetin, dihydrokaempferol, dihydromyricetin, ampelopsin, epigallocatechin gallate, and taxifolin (claim 1).
Regarding claim 2, the Patent discloses the source of flavonoids is the hovenia plant (claim 2).
Regarding claim 3, the Patent discloses the sweetener base has one or more sweeteners selected from at least one of a cane sugar, an other plant sugar, a syrup sugar, an artificial sugar and an other sugar (claim 3)
Regarding claim 4, the Patent discloses the sweetener additive of claim 1 further comprising an aldehyde reducing component (claim 4).
Regarding claim 5, the Patent discloses the aldehyde reducing component comprises an aldehyde dehydrogenase enzyme (claim 5).
Regarding claims 6 and 11, the Patent discloses the sweetener additive of claim 1 further comprising a glucose reducing component (claim 6).
Regarding claim 7, the Patent discloses the additive of claim 6 further comprising an aldehyde reducing component (claim 8).
Regarding claim 8, the Patent discloses the sweetener additive of claim 1 further comprising an alcohol reducing component (claim 9).
Regarding claim 9, the Patent discloses the sweetener additive of claim 9, wherein said alcohol reducing component comprises at least one of an alcohol dehydrogenase enzyme and an alcohol oxidase enzyme (claim 10).
Regarding claim 10, the Patent discloses the sweetener additive of claim 9 further comprising an aldehyde reducing component (claim 11).
Regarding claim 12, the Patent discloses the sweetener additive for a consumable product wherein said sweetener additive is configured to be added to the consumable product during production of the consumable product and/or after production of the consumable product but before the consumer eats or drinks the consumable product (claim 1).
Regarding claim 13, the Patent discloses a sweetener additive wherein said sweetener additive comprises: a sweetener base having one or more sweeteners, said one or more sweeteners being at least one of a cane sugar, an other plant sugar, a syrup sugar, an artificial sugar and an other sugar; one or more flavonoids combined with said sweetener base, said one or more flavonoids extracted from a source of flavonoids to provide one or more health benefits for the consumer who consumes the consumable product having said sweetener additive, said one or more flavonoids selected from the group comprising at least one of apigenin, flavanones, kaempferol, quercetin, rutin, myricetin, dihydrokaempferol, dihydromyricetin, ampelopsin, epigallocatechin gallate and taxifolin; and an aldehyde reducing component that is selected to stimulate naturally occurring enzymes in the consumer's body in a manner which reduces deleterious effects of aldehydes on the consumer, wherein said sweetener additive is configured to be added to the consumable product during production of the consumable product and/or after production of the consumable product but before the consumer eats or drinks the consumable product (claim 12).
Regarding claim 14, the Patent discloses the source of flavonoids is the hovenia plant (claim 13).
Regarding claims 15 and 17, the Patent discloses the sweetener additive of claim 1 further comprising a glucose reducing component (claim 15).
Regarding claim 16, the Patent discloses the sweetener additive of claim 1 further comprising an aldehyde reducing component (claim 17).
Regarding claim 18, the Patent discloses the method of making an additive comprising (a) providing a source of flavonoids; (b) extracting one or more flavonoids from said source of flavonoids, said one or more flavonoids selected from the group comprising at least one of apigenin, flavanones, kaempferol, quercetin, rutin, myricetin, dihydrokaempferol, dihydromyricetin, ampelopsin, epigallocatechin gallate and taxifolin; (c) providing a sweetener base having one or more sweeteners; and
(d) combining said one or more flavonoids with said sweetener base to produce said sweetener additive (claim 21).
Regarding claim 19, the Patent discloses the method wherein said sweetener additive is configured to be added to the consumable product during production of the consumable product and/or after production of the consumable product but before the consumer eats or drinks the consumable product (claim 22).
Regarding claim 20, the Patent discloses the sweetener additive further comprising a glucose reducing component (claim 6), an aldehyde reducing component (claim 8), and an alcohol reducing component (claim 9).
Claims 1-3, and 12 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 and 2 of co-pending Application No. 17860096 (reference). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, the co-pending application recites an additive (claim 1) comprising a sweetener (claim 2), and one or more flavonoids comprising dihydromyricetin (claim 1).
Regarding claim 2, the co-pending application recited the flavonoids are sourced from the hovenia plant (claims 3).
Regarding claim 3, the co-pending application recites erythritol and xylitol (claim 2).
Regarding claim 12, the co-pending application recites addition of the additive to the base product before the consumer eats or drinks the product (claim 1).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (US2011280977) as evidenced by Meng et al. (Plant Foods Hum Nutr.b2016;71:444–449), Sweiss et al. (Toxicology Reports. 2018;5:808–8).
Regarding claims 1 and 2, Park discloses a composition for relieving and preventing a hangover comprising a Hovenia dulcis Thunb fruit extract concentrate (claim 1). Park does not disclose the components of the extract, however Meng does. Meng explains the main chemical components of H. dulcis Thunb. are flavonoids. This includes kaempferol, apigenin, myricetin, quercetin, dihydromyricetin and anthraquinones emodin. (Introduction, page 2). Park teaches the composition can be formulated to include a pharmaceutically acceptable additive including a sweetener (paragraph [0046]).
Regarding claim 3, Park discloses the additive can be sweeteners such as sucrose, liquid fructose, crystalline fructose, sucralose, sorbitol, aspartame, etc. (paragraph [0047]).
Regarding claims 4, 7-8, and 10, Park discloses nicotinic acid amide as part of the composition. Nicotinic acid amide assists in the activation of alcohol dehydrogenase and aldehyde dehydrogenase, thereby being an aldehyde and alcohol reducing component.
Regarding claim 5, Park discloses the composition is to treat hangovers in humans. As aldehyde dehydrogenase is a natural component of the human body addition of the enzyme vs addition of a co-enzyme (nicotinic acid) to assist the natural aldehyde dehydrogenase would lead to the same effect.
Regarding claims 6 and 10, Park discloses the composition comprising Hovenia dulcis Thunb fruit extract concentrate, which includes dihydromyricetin (as evidenced by Meng), a glucose reducing component.
Regarding claim 9, Park discloses the composition is to treat hangovers in humans. As alcohol dehydrogenase is a natural component of the human body addition of the enzyme vs addition of a co-enzyme (nicotinic acid) to assist the natural alcohol dehydrogenase would lead to the same effect.
Regarding claims 12 and 19, Park discloses the process of formulating a drink comprising the H. dulcis Thunb. additive wherein the additive is added during the production of the consumable product but before consumed by the consumer (paragraph [0052]).
Regarding claims 13, 14, and 16, Park discloses a composition comprising Hovenia dulcis Thunb fruit extract concentrate, which contains includes kaempferol, apigenin, myricetin, quercetin, dihydromyricetin and anthraquinones emodin (as evidenced by Meng). The composition can be formulated with a sweetener (paragraph [0046]), including sugars such as sucrose, liquid fructose, crystalline fructose, sucralose, sorbitol, aspartame, etc. (paragraph [0047]). The composition also includes the aldehyde and alcohol reducing component nicotinic acid amide (claim 1). Park discloses the process of formulating a drink comprising the H. dulcis Thunb. additive wherein the additive is added during the production of the consumable product but before consumed by the consumer (paragraph [0052]).
Regarding claims 15 and 17, Park discloses the composition comprising Hovenia dulcis Thunb fruit extract concentrate, which includes dihydromyricetin (as evidenced by Meng), a glucose reducing component.
Regarding claim 18, Park discloses the method of preparing a composition comprising preparing an extraction of H. dulcis Thunb (paragraph [0050]). And adding refined sugar to said extract (paragraph [0052]).
Regarding claim 20, Park discloses addition of nicotinic acid amide, an alcohol and aldehyde reducing component (paragraph [0052]).
Conclusion
Claims 1-20 are rejected.
Claims 1, 3, 13, and 18 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621