Detailed Action
The present office action is in response to the amendments filed on 27 May 2025.
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 .
Status
Claims 7-8 and 11-12 of the pending application have been examined on the merits. Acknowledgement is made of the amendments filed 27 May 2025. Acknowledgement is made of the cancellation of claims 1-6 and 9-10.
Priority
Applicants identify the instant application, Serial #: 18/286,634, filed 12 Oct 2023, as a National Stage Entry of International Patent Application #: PCT/JP2022/014256, filed 25 Mar 2022, which claims foreign priority from Foreign Application #: JP2021-074323, filed 26 Apr 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 12 Oct 2023, 02 Apr 2025, 11 Jul 2025, and 29 Aug 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Applicant is advised that should claim 7 be found allowable, claim 8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Further, should claim 11 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). In the instant case, the statements found in claim 7 of “promoting immune cell metabolism” and claim 8 of “activating immunity” are both outcomes of administering L-ergothioneine. Taking the same steps necessarily leads to the same outcomes and so claim 8 is a substantial duplicate of claim 7. Claim 12 would be objected to for not remedying the deficiencies found in claim 8 and would thus be a substantial duplicate of claim 11.
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 7-8 and 11-12 rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The following references are cited for evidentiary purposes in support of the analysis below: Paul et al. (Cell Death Differentiation, 2010, 17:1134-1140), hereinafter Paul, Food and Drug Administration, 2017, GRAS Notice 734, hereinafter FDA, and Fryar et al. (Vital Health Stat, 2021, 3, Anthropometric reference data for children and adults: United States, 2015-2018), hereinafter Fryar.
The claims recite “a method of administering L-ergothioneine” in claims 7-8 and further limit the administration of L-ergothioneine to “a human adult in an amount of 2 to 50 mg per day in terms of L-ergothioneine” in claims 11-12. Paul, cited for evidence, teaches that L-ergothioneine is an important amino acid with a dietary origin (Abstract; pg. 1134, column 1). Paul teaches that food such as mushrooms, black beans, red meat, and oats are rich in ergothioneine (pg. 1134, column 1). L-ergothioneine is therefore a natural product and is drawn to a judicial exception. Further, as evidenced by FDA, the mean chronic dietary intake of ergothioneine was estimated to be 0.153 mg per kg bw per day for adult consumers in the United States (pg. 15, final paragraph). Fryar, cited for evidence, teaches that in the United States between 2105-2018, the mean weight in kilograms for adult females was 77.5 kg and the mean weight in kilograms for adult males was 90.6 kg (pg. 7, Table 3; pg. 9, Table 5). By multiplying 0.153 mg/kg by 77.5 kg (for adult females) and 0.153 mg/kg by 90.6 kg (for adult males), it can be seen the mean chronic dietary intake for adults in the United States is 11.9 for females and 13.7 for males. The mean chronic dietary intake thus falls within the range specified in the instant claims.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Based upon analysis with respect to the claims as a whole, claims 7-8 and 11-12 are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 7-8 and 11-12 recite a natural process that is stimulated by the administration of L-ergothioneine in a human adult in an amount between 2 and 50 mg and as such are directed towards a law of nature and a natural phenomenon. The claimed process does not have markedly different characteristics from what occurs in nature, and are a “product of nature” exception. Further, the claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exceptions.
The rationale for this determination is explained below:
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
The claimed subject matter, within the scope of the instant claims is construed as a method of administering 2-50 mg of L-ergothioneine to a human adult. Thus, the answer to Step 1 is yes, the claims are drawn to a process.
Step 2A, Question One: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea?
In the instant case, while claims 7-8 and 11-12 pass the first step by being a method, the claims do not pass the second step in that the claim is directed toward nothing more than a judicial exception of a natural product, in this case, administering 2-50 mg of L-ergothioneine to a human adult. The administration step falls within the bounds of chronic dietary intake as evidenced by Paul, FDA, and Fryar (see above). Regarding the recitation of claims 7-8 of a method of “promoting immune cell metabolism” (claim 7) and “activating immunity” (claim 8), these statements are merely outcomes necessitated by the administration of L-ergothioneine and are not considered to further limit the claims (see “Claim Objections” above). Thus the answer to Step 2A, Question One, is yes, the claim is directed to a natural phenomenon as a product of nature.
Step 2A, Question Two: Does the nature-based product show “markedly different characteristics” from any naturally occurring counterpart(s) in their natural state, based on structure, function and/or properties?
Claims 7-8 and 11-12 recite a method of administering L-ergothioneine which is a natural product (see above). As evidenced by Paul, the natural products include mushrooms, black beans, red meat, and oats (pg. 1134, column 1). There seems to be no indication in the claims that the method of administering L-ergothioneine has any characteristics that are different from the naturally occurring counterpart in its natural state. Thus, the process does not have markedly different characteristics from what occurs in nature, and is a “product of nature exception.” Taken together, the claims read on any human adult eating mushrooms, black beans, red meat, and oats. Thus, the answer to Step 2A, Question Two is no, the nature-based process does not show “markedly different characteristics” from its naturally occurring counterparts.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
As the claims do not include any additional features that could add “significantly more” to the exception, the answer to Step 2B is no, the claims do not recite additional elements that amount to significantly more than the judicial exception.
In sum, applicant’s claims are not directed to a process that is markedly different in structure and steps than a naturally-occurring product or process. Therefore, the claims are not directed to patent-eligible subject matter and are rejected under 35 U.S.C. § 101.
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) 7-8 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by FDA in light of Fryar.
The instant claims are drawn to a method of promoting immune cell metabolism by administering L-ergothioneine and a method of activating immunity by administering L-ergothioneine (claims 7 and 8). The claims further limit the administration of L-ergothioneine to human adults in an amount between 2 and 50 mg.
FDA teaches the dietary intake of ergothioneine in the US population comes from mushrooms, beans, meat organs, and oatmeal and that the chronic dietary intake of ergothioneine was estimated to be 0.153 mg per kg bw per day for adult consumers (pg. 15, final paragraph). Fryar, cited for evidence, teaches that in the United States between 2105-2018, the mean weight in kilograms for adult females was 77.5 kg and the mean weight in kilograms for adult males was 90.6 kg (pg. 7, Table 3; pg. 9, Table 5). By multiplying 0.153 mg/kg by 77.5 kg (for adult females) and 0.153 mg/kg by 90.6 kg (for adult males), it can be seen the mean chronic dietary intake for adults in the United States is 11.9 mg/day for females and 13.7 mg/day for males. The mean chronic dietary intake thus falls within the range specified in the instant claims.
The statements found in claim 7 of “promoting immune cell metabolism” and claim 8 of “activating immunity” are both outcomes of administering L-ergothioneine. Taking the same steps necessarily leads to the same outcomes. Thus, by teaching that adults have a mean chronic dietary intake of 11.9 mg/day for females and 13.7 mg/day for males, FDA teaches a method which necessarily has the same outcome as the instant claims, thus anticipating the claims.
Claim(s) 7-8 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) et al. (EFSA J, 2016, 14:e04629), hereinafter EFSA.
EFSA teaches that it is safe to administer a novel food product as a food supplement containing up to 5 mg/serving of synthetic L-ergothioneine with a daily dose of up to 30 mg/day for adults (Abstract).
The statements found in claim 7 of “promoting immune cell metabolism” and claim 8 of “activating immunity” are both outcomes of administering L-ergothioneine. Taking the same steps necessarily leads to the same outcomes. Thus, by teaching a serving of up to 30 mg/day for adults of a novel food product containing L-ergothioneine, EFSA teaches the same steps as the instant claims which necessarily leads to the same outcomes. Therefore, EFSA anticipates the instant claims.
Statutory Double Patenting
Claims 7-8 and 11-12 of this application is patentably indistinct from claims 5 and 7 of Application No. 18/708,426. Claims 7-8 and 11-12 of this application is patentably indistinct from claims 7-9 and 13-15 of Application No. 18/286,601. Claims 7-8 and 11-12 of this application is patentably indistinct from claims 5 and 7 of Application No. 18/286,446. Claims 7-8 and 11-12 of this application is patentably indistinct from claims 9-12 and 17-20 of Application No. 18/285,409. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 7-8 and 11-12 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 5 and 7 of copending Application No. 18/708,426 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Reference claim 5 is drawn to a method of inhibiting histamine-N-methyltransferase, the method comprising administering L-ergothioneine or a salt thereof. Reference claim 7 further limits reference claim 5 to being administered to a human adult in an amount of 2 to 50 mg per day in terms of L-ergothioneine. Inhibition of histamine-N-methyltransferase is the outcome of administering L-ergothioneine and does not further limit the claim. Thus, reference claims 5 and 7 have the same scope as and are patentably indistinct from instant claims 7-8 and 11-12.
Claims 7-8 and 11-12 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 7-9 and 13-15 of copending Application No. 18/286,601 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
The reference claims a method of increasing at least one of leukocytes or basophils (ref claim 7), inhibiting EGFR tyrosine kinase (ref claim 8), and activating innate immunity (ref claim 9) by administering L-ergothioneine. The reference further limits each method to being administered in a human adult in an amount of 2 to 50 mg per day in terms of L-ergothioneine (ref claims 13-15). Increasing at least one of leukocytes or basophils, inhibiting EGFR tyrosine kinase, and activating innate immunity are the outcomes of administering L-ergothioneine and do not further limit the claims. Thus, reference claims 7-9 and 13-15 have the same scope as and are patentably indistinct from instant claims 7-8 and 11-12.
Claims 7-8 and 11-12 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 5 and 7 of copending Application No. 18/286,446 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Reference claim 5 is drawn to a method of promoting lipolysis, the method comprising administering L-ergothioneine or a salt thereof. Reference claim 7 further limits reference claim 5 to being administered to a human adult in an amount of 2 to 50 mg per day in terms of L-ergothioneine. Promoting lipolysis is the outcome of administering L-ergothioneine and does not further limit the claim. Thus, reference claims 5 and 7 have the same scope as and are patentably indistinct from instant claims 7-8 and 11-12.
Claims 7-8 and 11-12 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 9-12 and 17-20 of copending Application No. 18/285,409 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
The reference claims a method of increasing at least one of red blood cell count or hemoglobin level (ref claim 9), preventing or reducing anemia (ref claim 10), improving endurance (ref claim 11), and reducing alleviating, or preventing fatigue or recovering from fatigue (ref claim 12) by administering L-ergothioneine. The reference further limits each method to being administered in a human adult in an amount of 2 to 50 mg per day in terms of L-ergothioneine (ref claims 17-20). Increasing at least one of red blood cell count or hemoglobin level, preventing or reducing anemia, improving endurance, and reducing alleviating, or preventing fatigue or recovering from fatigue are the outcomes of administering L-ergothioneine and do not further limit the claims. Thus, reference claims 9-12 and 17-20 have the same scope as and are patentably indistinct from instant claims 7-8 and 11-12.
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 7-8 are provisionally rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claims 7-10 of copending Application No. 18/728,706 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims 7-10 claim a method of inhibiting microorganism growth in an oral composition comprising adding L-ergothioneine and quercetin to an oral composition. The limitations of the instant claims are met by the reference claims by administering L-ergothioneine and so the reference claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 7-8 are provisionally rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claims 1 and 9 of copending Application No. 18/728,706 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 is drawn to a composition comprising at least on sesamin-class compound and ergothioneine or a salt thereof where the weight-to-weight ratio of sesamin-class compound to ergothioneine is 0.05 to 50. Reference claim 9 to a method of suppressing cellular senescence comprising administering the composition of reference claim 1. Suppressing cellular senescence is the outcome of administering the composition of reference claim 1. Thus the reference claims meet the limitations of the instant claims and the instant claims are anticipated by the reference claims.
Claims 7-8 are provisionally rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/552,715 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 8 is drawn to a method of reducing renal function decline or ameliorating renal function, the method comprising administering L-ergothioneine or a salt thereof to a subject. Reducing renal function decline or ameliorating renal function is the outcome of administering L-ergothioneine and does not further limit the claim. The method of the instant claims is taught by the reference and so the reference claims anticipate the instant claims.
Claims 7-8 and 11-12 are provisionally rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claims 6 and 8 of copending Application No. 18/285,521 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 6 is drawn to a method of preventing or reducing an anxiety symptom comprising administering L-ergothioneine or a salt thereof to a human. Reference claim 8 further limits the claims to administering 2-50 mg of L-ergothioneine to a human adult. Preventing or reducing an anxiety symptom is the outcome of administering L-ergothioneine and does not further limit the claim. The method of the instant claims is taught by the reference and so the reference claims anticipate the instant claims.
Claims 7-8 and 11-12 are provisionally rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claims 8 and 10 of copending Application No. 18/552,718 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 8 is drawn to a method of improving a blood cholesterol level comprising administering L-ergothioneine or a salt thereof to a human. Reference claim 10 further limits the claims to administering 2-50 mg of L-ergothioneine to a human adult. Improving a blood cholesterol level is the outcome of administering L-ergothioneine and does not further limit the claim. The method of the instant claims is taught by the reference and so the reference claims anticipate the instant claims.
Claims 7-8 and 11-12 are provisionally rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 17/772,374 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 5 is drawn to a method of improving sleep comprising administering 5 to 50 mg of L-ergothioneine or a salt thereof per 60 kg of body weight per day to a human adult where the human adult is a healthy person. Improving sleep is the outcome of administering L-ergothioneine and does not further limit the claim. The method of the instant claims is taught by the reference and so the reference claim anticipates the instant claims.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625