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
Election/Restrictions
Applicant elected, with traverse, Group I, claims 1-8, drawn to a composition comprising at least one sesamin-class compound and ergothioneine or a salt thereof; and sesamin or episesamin as the species of sesamin-class compound, in the reply filed on 06/15/2026.
The traversal is on the ground that claims of Group I and Group II are linked by the product/use relationship expressly contemplated by 37 C.F.R. § 1.475(b). Applicant argues the cited discussion of Chen and Namiki relies on separate disclosures-Chen for ergothioneine-containing compositions and Namiki for sesamin lignans such as sesamin and episesamin- and does not negate the fact that the pending product claims and use claims are linked by the same composition and its use.
Applicant’s argument is fully considered, but NOT persuasive. As explained in the Restriction Requirement mailed on 04/20/2026, Chen teaches ergothioneine-containing compositions method of use, e.g. for improving cell viability, maintaining telomere length, preventing or delaying the aging process, treating oxidative stress-related disorders or telomere-related disorders. Namiki teaches sesamin-class compounds (e.g. sesamin, episesamin) has antiaging effect and other useful functions. As stated in MPEP 2144.06: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846,850, 205 USPQ 1069, 1072 {CCPA 1980). It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of the instant invention to combine Chen’s composition comprising antioxidant ergothioneine with antioxidant sesamin compound taught by Namiki as active ingredient for antiaging use that can be formulated in food or beverage with reasonable expectation of success. As such, the technical feature of composition comprising sesamin-class compound (e.g. sesamin and / or episesamin) and ergothioneine is not novel, does not make contribution over the prior art , and cannot be considered as "special technical features".
The requirement is still deemed proper and therefore made FINAL.
Claims 9-10 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.
Status of Claims
Claims 1-10 are pending.
Claims 9-10 are withdrawn.
Claims 1-8 are currently under examination in this office action.
Priority
The instant application18/699,069 filed on 04/05/2024 is a 371 of PCT/JP2022/037532 filed on 10/07/2022, and claims benefit of JAPAN 2021-168087 filed on 10/13/2021.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of foreign application JAPAN 2021-168087 was submitted on 02/25/2026 in Japanese , no English translation is included in the certified copy of JAPAN 2021-168087 . Applicant’s right of foreign priority is not perfected due to lack of English translation thereof.
Information Disclosure Statement
The information disclosure statements filed 06/20/2024, 09/17/2025, 02/19/2026 and 03/19/2026 are in compliance with the provisions of 37 CFR1.97. Accordingly, the reference listed in IDS are being considered by the Examiner. Reference written in foreign language is considered to the degree of English abstract or patent family of foreign patent by Examiner.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 recites limitation in quotation marks, wherein the quotation marks should be removed.
Appropriate correction is required.
Specification
Instant specification is objected to for lack of cross-references to related applications. See 37 CFR 1.78 and MPEP § 211 et seq.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Claim 8 recites wherein the composition is labeled with at least one selected from the group consisting of "suppressing cellular senescence" , "suppressing conversion into senescent cells", "preventing cellular senescence", "preventing senescent cell formation", "suppressing an increase in senescent cells", "reducing senescent cell accumulation", "delaying cellular senescence", "delaying progression of cellular senescence", "suppressing cellular senescence induction", "increasing percentage of young cells", "extending healthy lifespan", "healthy longevity", "young cells", "youthful as a whole", and "youthful look". Instant specification disclosed working example wherein instant claimed composition comprising a specific combination of sesamin-episesamin (1uM ) and ergothioneine exhibit cellular senescence suppressing effect and lifespan-extending effect on yeast cells (See Example 2 and 3). Instant specification does not fully support the label limitation for "delaying cellular senescence", "preventing senescent cell formation", “extending healthy lifespan” or “ healthy longevity “ in humans, or “youthful as a whole”, etc.
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 1-8 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is directed to a composition comprising: at least one sesamin-class compound; and ergothioneine or a salt thereof, wherein a ratio of a weight of the sesamin-class compound to a weight of ergothioneine or a salt thereof in terms of ergothioneine, i.e., sesamin-class compound/ergothioneine, is 0.05 to 50. “in terms of ergothioneine” should be based on ergothioneine. “The phrase “i.e.” is indefinite because it is unclear whether the following sesamin-class compound/ergothioneine is further defining or merely an example. It is not clear if numerator sesamin-class compound is combined or single compound weight if more than one sesamin-class compound is present. The ratio of sesamin-class compound/ergothioneine is indefinite for not clearly setting forth the metes and bounds of the patent protection desired.
Dependent claims 2-8 are also rejected due to their dependency on claim 1.
Claims 6-8 recite intended function of instant claimed composition. Claim 8 recites wherein the composition is labeled with at least one selected from the group consisting of "suppressing cellular senescence" ... "preventing cellular senescence", "increasing percentage of young cells",... and "youthful look". As stated in MPEP 2173.05: “Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”. It’s not clear how the labels contribute to the structural limitation of instant claimed composition.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6-8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 6-8 are drawn to intended function of the composition of claim 1 which do not impart any further physical or otherwise material characteristic to the composition of claim 1. Claim 8 recites “wherein the composition is labeled with at least one...” indicating printing material which does not impart any further structural limitation to the composition of claim 1.
In order to overcome this ground of rejection, Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. Instant claims recite compositions comprising natural product sesamin-class compound and ergothioneine or a salt thereof that are present in natural source. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, instant claims recite sesamin-class compound and ergothioneine that are naturally occurring and therefore patent ineligible judicial exceptions (natural products) under 35 USC 101.
MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”. Instantly claimed sesamin-class compound and ergothioneine in a mixture of composition is not markedly different from their naturally occurring counterpart because there is no indication that mixing/combining process has caused the instantly claimed sesamin-class compound and/or ergothioneine to have any characteristics that are markedly different from the naturally occurring counterpart. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. Claim 1 recites weight ratio of sesamin-class compound to ergothioneine. This element is not sufficient to integrate the judicial exception into a practical application. The answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.”. Claim 3 recites “oral composition”, claim 4 recites “food or beverage”, claim 5 recites element “cosmetic” , claims 6-8 recite intended function “ suppressing cellular senescence” or “anti-senescence” , etc. Instant claims recite combination of sesamin-class compound and ergothioneine at a weight ratio that do not constitute “additional elements that amount to significantly more than the JE” as mixing components are insignificant extra-solution activities that add nothing more than an effort to combine the naturally occurring components in different ratio/amount. Formulating a composition in food/beverage or for cosmetic use constitute well-understood, routine, conventional activities known to the industry, as a skilled artisan in the industry knows how to select specific component and mix with other components. The intended use in food or beverage, cosmetic or intended function of “suppressing cellular senescence” “anti-senescence “ do not contribute to the structural limitation of the compositions. Instant claims do not provide any limitations beyond the judicial exceptions or provide anything that adds significantly more to the judicial exceptions. Thus, the answer to Step 2B is No.
Consequently, the claims are not directed to patent eligible subject matter.
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 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 non-obviousness.
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 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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO2021158601A , hereafter “Chen’ 601”, Applicant’s IDS dated 06/20/2024), in view of Endo et al. ( US10159740 B2).
Regarding the active ingredient ergothioneine, Chen’ 601 teaches a composition comprising antioxidant ergothioneine or salt thereof, and method of using ergothioneine, e.g. for improving cell viability, maintaining telomere length, preventing or delaying the aging process, treating oxidative stress-related disorders or telomere-related disorders (e.g. cancer, neurodegenerative disease, chronic fatigue syndrome, etc. ) (See abstract, page 1, page 12, 2nd para; page 18 to 19, Examples 3- 6; claims 1-44). Chen’ 601 teaches various amount/ concentration of ergothioneine or salt thereof, from about 0.04 mg/g to about 50mg/g, 1 mg/g to about 10 mg/g, and doses at about 5 mg per day to about 50 mg per day, etc. (See page 17, para 1-3; Examples 3-5; claims 36-37, 41-43).
Regarding claims 3-5, Chen’ 601 teaches ergothioneine in oral formulation, may be used in food, beverages, cosmetic or the like (See page 10, last para; page 11, 1st para; page 24, 2nd last para; page 25, 2nd and 3rd para).
Regarding claims 6-8, Chen’ 601 teaches use of ergothioneine for treating variety of disease/disorder/condition. Chen’ 601 and incorporated reference teach telomere shortening in humans can induce replicative senescence, which blocks cell division, and progressive shortening of telomeres may lead to senescence, apoptosis, or oncogenic transformation of somatic cells (See page 12, last two para). Chen’ 601 teaches ergothioneine at physiological concentrations demonstrated beneficial effects by decreasing the rate of telomere shortening and preserving telomere length under oxidative stress conditions which support a potential role for ergothioneine in healthy aging (See Example 3, page 32, last para; page 33 , first para; claims 15-17, 23, 31).
Chen’ 601 collectively teaches a composition comprising antioxidant ergothioneine for treating a variety of disease/disorder/conditions (e.g. suppressing cellular senescence, antiaging, anti-fatigue, etc.).
Chen’ 601 is silent about sesamin-class compounds.
Endo teaches composition comprising at least one sesamin-class compound, and method of treating variety of disease, disorder/conditions with aforementioned sesamin-class compound composition(See abstract; Col. 2, lines 9-67; Col. 3, lines 1-50; Table 1 and 2, Formulation 2-4; claims 1-8). Endo teaches sesamin-class compound as antioxidant for preventing biooxidation, preventing or improving hyperlipidemia, improving hepatic function, preventing or improving hyper
tension, preventing aging, lowering blood LDL cholesterol , lowering blood neutral lipid , treating
thrombosis , preventing arteriosclerosis , improving learning capacity or memory , preventing senile dementia , protecting gastric mucosa , regulating endocrine , regulating autonomic nerve , improving psychophysiologic disorders , maintaining cardiac function , improving blood stream , suppressing
platelet aggregation , improving vascular endothelial function , maintaining visual function , improving stress disorders , improving depressive symptoms , improving posttraumatic stress disorders , improving stamina , producing energy , improving frailty , maintaining skin health , maintaining hair health , or extending longevity in the subject (See Col. 2, lines 8-67; Col. 3, lines 1-40; claim 8).
Regarding claim 2, Endo teaches variety of sesamin-class compounds, e.g. sesamin , episesamin , sesaminol, etc. at various amount ( e.g. 10mg, 200mg, etc. ) (See Col. 4, lines 8-19; Col. 12, Formulation 2-4; Table 1A, 1B and 2).
Regarding claims 3-4 , Endo teaches oral formulation comprising sesamin-class compound (e.g. capsule), and embodiments in food or beverages (See Col. 2, lines 23-29, 52; claim 4).
Endo teaches other nutrient component, antioxidants, e.g. fish oil, wheat germ oil, vitamin, etc. may be incorporated the composition comprising sesamin-class compound.(See Col. 6, lines 33-41; Formulation 1-3). Endon teaches a ratio of the total weight of all sesamin- class compounds to the fish oil is 1:1 to 1:100 etc. (See Col. 6, lines 17-37; claims 1-2).
Endo collectively teaches composition comprising antioxidant sesamin-class compound and method of treating variety of disease, disorder/conditions, e.g. antiaging, anti-fatigue, etc..
As stated in MPEP 2144.06: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846,850, 205 USPQ 1069, 1072 {CCPA 1980).
It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of the instant invention to combine anti-aging/antioxidant ergothioneine taught by Chen’ 601 with antioxidant sesamin-class compound taught by Endo as active ingredient, to formulate an anti-aging/antioxidant composition that can be used in food or beverage with reasonable expectation of success. At the time of instant application was made, it was already known composition comprising antioxidant ergothioneine was made for treating a variety of disease/disorder/conditions (e.g. suppressing cellular senescence, antiaging, etc.) as taught by Chen’ 601. It was also known composition comprising antioxidant sesamin-class compound was made for treating variety of disease, disorder/conditions , e.g. antiaging, preventing or improving fatigue, etc. as taught by Endo. A skilled artisan would be motivated to combine sesamin-class compound with ergothioneine based on the beneficial teaching of prior art, and reasonably expect composition comprising sesamin-class compound with ergothioneine have enhanced antioxidant/antiaging and other health beneficial effect.
Regarding the ratio of sesamin-class compound / ergothioneine, Chen’ 601 teaches various amount/dose of ergothioneine ( e.g. 50mg), Endo teaches sesamin-class compound at various amount (e.g. 10mg), the calculated ratio of sesamin-class compound / ergothioneine could be 1:5 (10mg/50mg). Endo also teaches ratio of sesamin-class compound to other antioxidant (e.g. fish oil) , e.g. 1:1 to 1:100. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05. A person of ordinary skill in the art would have known to explore and optimize variables of the active ingredients ( amount and ratio, etc.) based on the combined teachings of prior art and general knowledge of antiaging/antioxidant composition and arrive at variations /embodiments thereof.
One of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of active ingredients for antioxidant/antiaging nutraceutical composition. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Chen’ 601 et al. (WO2021158601A , “Chen’ 601”, Applicant’s IDS dated 06/20/2024), in view of Akimoto et al. ( JPH0551388A, Applicant’s IDS dated 06/20/2024, machine-translated copy by Google).
The collective teachings of Chen’ 601 is elaborated in preceding 103 rejection and applied as before. Chen’ 601 collectively teaches a composition comprising antioxidant ergothioneine for treating a variety of disease/disorder/conditions (e.g. suppressing cellular senescence, antiaging, etc.).
Chen’ 601 is silent about sesamin-class compounds.
Akimoto teaches anti-aging agent and lipid peroxide production inhibitor containing sesamin and / or episesamin as an active ingredient (See abstract, [0009], Examples 1-4, claims 1 and 2).
Regarding claim 2, Akimoto teaches sesamin-class compound is sesamin, and /or episesamin (See abstract, claims 1 and 2). Akimoto teaches various amount of sesamin, and /or episesamin, e.g. 1-100mg for oral administration (See abstract, [0009], Examples 1-4).
Regarding claim 3 and 4, Akimoto teaches embodiments as food or drink (See [0009]).
As stated in MPEP 2144.06: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846,850, 205 USPQ 1069, 1072 {CCPA 1980).
It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of the instant invention to combine anti-aging/antioxidant ergothioneine taught by Chen’ 601 with anti-aging sesamin-class compound taught by Akimoto, further explore variables of active and inactive ingredients through experiment/optimization (amount, ratio thereof, etc.), and arrive at the instantly claimed invention with reasonable expectation of success. A person of ordinary skill in the art would be motivated to formulate anti-aging/antioxidant composition comprising sesamin-class compound and ergothioneine based on the beneficial teachings of Chen’ 601 and Akimoto, and reasonably believe the two may complement each other when consumed together. Regarding the ratio of sesamin-class compounds/ ergothioneine, Chen’ 601 teaches various amount/dose of ergothioneine ( e.g. 50mg), Akimoto teaches sesamin and/or episesamin at various amount (e.g. 1-100mg), the calculated ratio of sesamin-class compound / ergothioneine could be 1:50 (1 mg/50mg). Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05. A person of ordinary skill in the art would have known to further explore and optimize variables of the active ingredients ( amount and ratio, etc.) based on the combined teachings of prior art and general knowledge of sesamin-class compounds and ergothioneine.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the teachings of prior art and general knowledge of antioxidant/antiaging composition. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Takemoto et al. et al. ( US 8,653,130 B2) in view of Chen et al. (WO2021158601A , “Chen’ 601”, Applicant’s IDS dated 06/20/2024).
Regarding active ingredient sesamin-class compound, Takemoto teaches composition comprising at least one sesamin-class compound and arachidonic acid class compounds, and a method of treating fatigue with aforementioned composition (See abstract; Examples 1-2 ; claims 1-8). Takemoto teaches physiological activity of sesamin-class compound and health benefit thereof, e.g. inhibiting metabolism of cholesterol, scavenging active oxygen, ameliorating inflammatory disease, protecting against infection, etc. (See Col. 1, lines 37-67). Takemoto teaches various amount /concentration of sesamin-class compounds, e.g. from 1 to 50 wt %, in a dose of 1-100mg, 1 to 60 mg, etc. (See Col. 5, lines 29-67; Example 1 and 2; Table 1).
Regarding claim 2, Takemoto teaches variety of sesamin-class compounds, e.g. sesamin , episesamin, sesaminol, or mixture thereof (See Col. 3, lines 47-67; claims 1 and 5).
Regarding claims 3-4, Takemoto teaches oral formulation comprising sesamin-class compound (e.g. capsule), and embodiments in food or beverages as health foods (See Col. 3, lines 1-5; Example 1 and 2; Col. 6, lines 26-60; claim 3-4 and 7-8).
Takemoto collectively teaches composition comprising sesamin-class compound and arachidonic acid as anti-fatigue agent .Takemoto teaches the ratio of a total weight of the arachidonic acid class compound as calculated for arachidonic acid to a total weight of the sesamin-class compound is 8:1 to 16:1 (See Table 1, claim 1 and 5). Takemoto teaches other physiologically active ingredients such as vitamins , nutritional ingredients, antioxidants, etc. (See Col. 6, lines 15-25).
Takemoto is silent about ergothioneine.
The collective teachings of Chen’ 601 is elaborated in preceding 103 rejection and applied as before. Chen’ 601 collectively teaches a composition comprising antioxidant ergothioneine that can be use in food/beverage or cosmetic (which reads on instant claims 3-5), for treating a variety of disease/disorder/conditions (e.g. antiaging, anti-fatigue, suppressing cellular senescence, etc.) (which also reads on instant claims 6-8).
It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of the instant invention to modify anti-fatigue composition comprising sesamin-class compound and arachidonic acid compound taught by Takemoto with ergothioneine taught by Chen’ 601, further explore variables of active and inactive ingredients through experiment/optimization (amount, ratio thereof, etc.) based on the general knowledge of composition comprising sesamin-class compound and ergothioneine, and arrive at the instantly claimed invention with reasonable expectation of success. At the time instant application was made, it was already known composition comprising sesamin-class compound and arachidonic acid exhibit enhanced anti-fatigue activity for treating fatigue as taught by Takemoto. It was also known composition comprising antioxidant ergothioneine was made for treating a variety of disease/disorder/conditions (e.g. anti-fatigue, antiaging, suppressing cellular senescence, etc.) as taught by Chen’ 601. Chen’ 601 further teaches ergothioneine has other biological activity, e.g. suppressing cellular senescence, antiaging, etc. A skilled artisan would be motivated to formulate antifatigue composition comprising sesamin-class compound with ergothioneine based on the beneficial teaching of Takemoto and Chen’ 601, and reasonably expect composition comprising sesamin-class compound and ergothioneine have enhanced anti-fatigue activity and other health beneficial effect as taught by Chen’ 601.
Regarding the ratio of sesamin-class compounds/ ergothioneine, Takemoto teaches various amount /concentration of sesamin-class compounds (e.g. 1 to 60 mg), Chen’ 601 teaches various amount/dose of ergothioneine ( e.g. 50mg), the calculated ratio of sesamin-class compound / ergothioneine could be 1:50 (1 mg/50mg). Takemoto also teaches ratio of sesamin-class compound to arachidonic acid compound, e.g. 1:8 to 1:16. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05. A person of ordinary skill in the art would have known to further explore and optimize variables of the active ingredients ( amount and ratio, etc.) based on the combined teachings of prior art and general knowledge of sesamin-class compounds, and ergothioneine.
Please note instant claims are drawn to composition comprising sesamin-class compound and ergothioneine, wherein the intended function of instant claimed composition does not necessarily contribute to the structural limitation of the composition product. The biological/pharmaceutical activities are the properties of a pharmaceutical combination/composition comprising sesamin-class compound and ergothioneine, and the products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999).
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the teachings of prior art and general knowledge of active ingredients in energy drink. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8,653,130 B2, in view of Chen et al. (WO2021158601A , “Chen’ 601”, Applicant’s IDS dated 06/20/2024).
Reference claims are drawn to composition comprising at least one sesamin-class compound and at least one arachidonic acid class compound, wherein a ratio of a total weight of the arachidonic acid class compound as calculated for arachidonic acid to a total weight of the sesamin-class compound is 8:1 to 16:1, wherein the sesamin-class compound is sesamin, episesamin, or a mixture thereof.
Reference claims 3-4 recite oral use and a food or a beverage.
Reference claim 5 teaches method of treating fatigue comprising administering an anti-fatigue composition comprising at least one sesamin-class compound and at least one arachidonic acid class compound to a subject in need thereof.
Reference claims are silent about ergothioneine.
The collective teachings of Chen’ 601 is elaborated in preceding 103 rejection and applied as before. Chen’ 601 collectively teaches a composition comprising antioxidant ergothioneine that can be used in food/beverage or cosmetic (which read on instant claims 3-5), for treating a variety of disease/disorder/conditions (e.g. antiaging, anti-fatigue, suppressing cellular senescence, etc.) (which also reads on instant claims 6-8).
It would have been prima facie obvious to one of ordinary skilled in the art to modify anti-fatigue composition comprising sesamin-class compound and arachidonic acid compound taught by reference claims with ergothioneine taught by Chen’ 601 and further explore variables of active and inactive ingredients (amount, ratio thereof, etc.) through experiment/optimization. A skilled artisan would be motivated to formulate antifatigue composition comprising sesamin-class compound with ergothioneine based on the beneficial teaching of Chen’ 601, and reasonably expect composition comprising sesamin-class compound with ergothioneine have enhanced anti-fatigue activity and other health beneficial effect (e.g. suppressing cellular senescence ) as taught by Chen’ 601.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10159740 B2 in view of Chen et al. (WO2021158601A , “Chen’ 601”, Applicant’s IDS dated 06/20/2024).
Reference claims are drawn to an oil or fat composition containing at least one sesamin- class compound, and a fish oil, wherein a ratio of the total weight of all sesamin-class compounds to the fish oil is 1:1 to 1: 100.
Regarding instant claim 2, reference claim 2 recites at least one sesamin - class compound is sesamin and / or episesamin.
Regarding instant claims 3-4, reference claim 4 recites a food or a beverage.
Reference claim 8 teaches method for improving biooxidation, preventing aging , improving fatigue, etc. comprising administering to a subject the reference composition.
Reference claims are silent about ergothioneine.
The collective teachings of Chen’ 601 is elaborated in preceding 103 rejection and applied as before. Chen’ 601 collectively teaches a composition comprising antioxidant ergothioneine that can be use in food/beverage or cosmetic (which read on instant claims 3-5), for treating a variety of disease/disorder/conditions (e.g. antiaging, anti-fatigue, suppressing cellular senescence, etc.) (which also reads on instant claims 6-8).
It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of the instant invention to modify reference composition comprising sesamin-class compound and fish oil with ergothioneine taught by Chen’ 601 and further explore variables of active and inactive ingredients(amount, ratio thereof, etc.) through experiment/optimization. A skilled artisan would be motivated to formulate antioxidant/antiaging composition comprising sesamin-class compound with ergothioneine based on the beneficial teaching of Chen’ 601, and reasonably expect composition comprising sesamin-class compound with ergothioneine have enhanced anti-aging/ anti-fatigue activity and other health beneficial effect (e.g. suppressing cellular senescence, etc.) as taught by Chen’ 601.
Conclusion
No claims are allowed.
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/L.M./Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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