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 8 and 10 are pending in the application. Claims 8 and 10 are rejected.
Election/Restrictions
Applicant’s election without traverse of Group II, now claims 8 and 10, in the reply filed on January 14th, 2026 is acknowledged.
The Examiner acknowledges the preliminary amendment dated May 27th, 2025 that cancelled claims 1-7 and 9 and added new claim 10.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/JP2022/014246, filed March 25th, 2022, which claims priority under 35 U.S.C. 119(a-d) to JP2021-074321, filed April 26th, 2021.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on August 29th, 2025, April 1st, 2025 and September 27th, 2023.
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 8 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) a method of ingesting a naturally occurring product that occurs in food sources. This judicial exception is not integrated into a practical application because the claims do not require more than ingesting the natural product itself. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims embrace processes that can occur in nature.
Applicant is directed to MPEP 2106 regarding criteria for subject matter eligibility.
Step 1
Step 1 in the analysis is “Is the claim to a process, machine, manufacture or composition of matter?” In this situation, the claims are directed to processes (Step 1: YES).
Step 2A: Prong One
The next step (2A) is a two-prong inquiry where prong one is “Does the claim recite an abstract idea, law of nature, or natural phenomenon?” In this situation, the claims recite a method of using a naturally occurring material, i.e. L-ergothioneine. Deiana et al. (Clinical Nutrition 2004, 23, 183-193) teaches on page 184:
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The authors further teach on page 184:
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The claims are directed to administering a naturally occurring compound. Regarding the preamble of claim 8 of “reducing renal function or ameliorating renal function”, MPEP 2111.02(II) notes: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In this situation, the preamble is not considered limiting (other than requiring that the subject possess a kidney) since it does not affect the structure of compound being administered. Regardless, Cohen et al. (J. Nephrol. 2014, 27, 635-641) teach on page 635: “It is common knowledge that renal function declines with age.” The authors further teach the following specific results in the Abstract: “Mean (±standard error) annual rate of decline in eGFR in healthy subjects was 0.97 ± 0.02 ml/min/year/1.73 m2. This decline increased significantly from 0.82 ± 0.22 in age-group 20–30 years to 0.84 ± 0.08, 1.07 ± 0.08 and 1.15 ± 0.12 ml/min/year/1.73 m2 in age groups 31–40, 41–50 and 50 years and older respectively (p<0.001).” Accordingly, the subject (even if considered to only embrace subjects having or experiencing renal function decline or renal function issues) is inclusive of subjects experiencing a natural consequence of aging.
There is no indication or requirement of the instant claims that the material used in the method is different structurally from the composition as found in its natural environment or that anything beyond eating food is required for the claims.
For the reasons above, the instant claims are directed to methods of using a nature-based product. As noted in MPEP 2106.04(b)(II):
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. […]
Furthermore, MPEP 2106.04(c)(II) sets forth the process for performing the markedly different characteristic analysis including the steps of “selecting the appropriate counterpart(s),” “identifying appropriate characteristics for analysis,” and “evaluating characteristics to determine whether they are ‘markedly different’”.
Since the instant claims embrace methods of administering foods that are structurally unchanged from their natural state, the appropriate counterpart is the composition as it occurs naturally.
MPEP 2106.04(c)(II)(B) outlines identifying appropriate characteristics that can include “Biological or pharmacological functions or activities;” “Chemical and physical properties;” and “Structure and form, whether chemical, genetic or physical.” As noted in MPEP 2112.01: ‘"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.’ Since the structure of the naturally occurring compound is identical, any properties observed by Applicant are inherent to the compound as it occurs in nature.
MPEP 2106.04(c)(II)(C) outlines evaluating characteristics and notes:
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception.
In this situation since there are no required changes relative to the naturally occurring counterpart, the instant claims lack markedly different characteristics.
For the reasons above, the instantly claimed product being used does not possess markedly different characteristics relative to the naturally occurring counterpart since it has the same structures and properties of the material that occurs in nature and the methods follow the steps that occur during natural eating processes. (STEP 2A, Prong One: YES).
Step 2A: Prong Two
The second prong of step 2A is (MPEP 2106.04(d)) to determine whether the claim as a whole integrates (or does not integrate) the judicial exception into a practical application. In the instant situation, the claims are generally a method that does not distinguish from the process of eating food containing the natural product.
Regarding instant claim 10, this claim recites a particular subject of an adult human and a particular amount of 2 to 50 mg of L-ergothioneine per day in terms of L-ergothioneine. These amounts, however, do not vary significantly from amounts that would be ingested from gram quantities of, for instance, mushrooms. Kalaras et al. (Food Chemistry 2017, 233, 429-433) disclose the concentration of L-ergothioneine in various mushrooms (Table 1, page 431) where, for instance, porcini mushrooms were measured to contain 7.27 mg/g d.w. of L-ergothioneine. Similarly, consuming 13 grams of portabella mushroom (at a concentration of 0.15 mg/g d.w.) would result in an amount instantly claimed. There is no requirement that the instant method be performed over multiple days and therefore a single meal containing mushrooms could serve as the basis for the instantly claimed method.
Step 2B
The final step (MPEP 2106.05(II)) is “Does the claim recite additional elements that amount to significantly more than the judicial exception?” The same section instructs:
Examiners should answer this question by first identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)).
The method claims do not require anything beyond an animal or human eating a naturally occurring composition.
For this reason, the claims do not require significantly more than the exception itself. (STEP 2B: NO).
Based on the analysis above, the instant claims are deemed to be drawn to subject matter that is ineligible under 35 USC 101.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dare et al. Biomedicine & Pharmacotherapy 2021, 141, 111921, p 1-12, which was available online July 30th, 2021.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Dare et al. teach the following in the abstract:
Therefore, the present study investigated the protective effect of L-egt alone, or combined with metformin, on renal damage in a type-2 diabetic (T2D) rat model. T2D was induced in male Sprague-Dawley rats using the fructose-streptozotocin rat model. L-egt administration, alone or combined with metformin, began after confirming diabetes and was administered orally for seven weeks. […] However, L-egt alleviates these functional and structural derangements in the kidney, while co-administration with metformin reduced hyperglycemia and improves therapeutic outcomes. Furthermore, L-egt treatment significantly increased the expression of major antioxidant transcription factors, cytoprotective genes and decreased the expression of inflammatory genes in the kidney. […]
Accordingly, the prior art teaches administration of L-ergothioneine to a rat subject and (at least) ameliorating renal function.
Claim(s) 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deiana et al. Clinical Nutrition 2004, 23, 183-193.
Deiana et al. teach in the abstract: “Rats were supplemented with L-Ergo prior to the administration of acute dose of ferric-nitrilotriacetate. Kidney and liver levels of L-ergothioneine, glutathione, α-tocopherol, polyunsaturated fatty acids and conjugated dienes were assessed.” The authors further teach the following in the abstract: “Supplementation with L-ergothioneine not only protects the organs against the lipid peroxidation but conserves the consumption of endogenous glutathione and a-tocopherol.” Accordingly, the prior art teaches administration of L-ergothioneine to a rat subject and (at least) ameliorating renal function.
Claim(s) 8 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2021/018774 A1 by Lopez de Heredia Alonso et al.
The prior art teaches administration of L-ergothioneine to cystinuric mice as follows on page 32:
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The prior art further teaches the following results:
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At least since the prior art teaches administration of L-ergothioneine to a subject and reducing the number of mice having cystine stones, i.e. a type of kidney stone, the prior art anticipates instant claim 8.
Claim Rejections - 35 USC § 103
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.
Claim(s) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/018774 A1 by Lopez de Heredia Alonso et al.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches administration of L-ergothioneine to cystinuric mice as follows on page 32:
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The prior art further teaches the following results:
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At least since the prior art teaches administration of L-ergothioneine to a subject and reducing the number of mice having cystine stones, i.e. a type of kidney stone, the prior art anticipates instant claim 8.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art anticipates instant claim 8; however, instant claims 8 and 10 further embrace methods where the subject is a human subject and where (in claim 10) the amount is 2 to 50 mg per day.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
Regarding a more general method, the prior art teaches the following general treatments on page 22:
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Regarding the subject being human, the prior art teaches the following on page 5:
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At least since the prior art teaches application in human patients, a person having ordinary skill in the art would recognize the disclosure on page 22 as being pertinent to humans and would have been motivated to administer ergothioneine to human subjects. Furthermore, while the disclosures of page 22 refer to “ergothioneine,” the prior art teaches the following on page 23:
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Accordingly, and since the prior art teaches positive results using L-ergothioneine in mice, a person having ordinary skill in the art would have been motived to use L-ergothioneine.
Regarding the dosage of instant claim 10, the prior art teaches the following on page 22:
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A person having ordinary skill in the art in applying the prior art method generally would expect to encounter adult patients and where adult human weights ranging from 100 pounds (~45 kg) to, for instance, 300 pounds (~140 kg) would correspond to dosages ranging from ~0.45 mg to ~23,000 mg and ~1.4 mg to ~ 70,000 mg for the broadest range. As noted in MPEP 2144.05(II)(A): “ "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 8 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over (1 of 10) claims 7, 8, 11 and 12 of copending Application No. 18/286,634; (2 of 10) claims 8 and 10 of copending Application No. 18/552,718; (3 of 10) claims 6 and 8 of copending Application No. 18/285,521; (4 of 10) claims 9-12 and 17-20 of copending Application No. 18/285,409; (5 of 10) claims 5 and 7 of copending Application No. 18/286,446; (6 of 10) claims 7-9 and 13-15 of copending Application No. 18/286,601; and (7 of 10) claims 5 and 7 of copending Application No. 18/708,426; each in view of Cohen et al. J. Nephrol. 2014, 27, 635-641.
Each of the copending cases recites a generic of method of administering L-ergothioneine and a dependent claim recites that the method involves administration to a human adult in an amount of 2 to 50 mg per day in terms of L-ergothioneine, which is the subject and amount of instant claim 10. Cohen et al., however teach on page 635: “It is common knowledge that renal function declines with age.” The authors further teach the following specific results in the Abstract: “Mean (±standard error) annual rate of decline in eGFR in healthy subjects was 0.97 ± 0.02 ml/min/year/1.73 m2. This decline increased significantly from 0.82 ± 0.22 in age-group 20–30 years to 0.84 ± 0.08, 1.07 ± 0.08 and 1.15 ± 0.12 ml/min/year/1.73 m2 in age groups 31–40, 41–50 and 50 years and older respectively (p<0.001).” Accordingly, a person having ordinary skill in the art would recognize that administration to human adults would entail administration to subjects experiencing a natural renal function decline. The instant claims do not require any particular effectiveness level or any particular result relative to the otherwise normal renal function decline.
These are provisional nonstatutory double patenting rejections.
(8 of 10) Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/699,069 in view of Cohen et al. J. Nephrol. 2014, 27, 635-641. The claims of the copending case recite oral compositions comprising L-ergothioneine (claim 3 of the copending case) and methods of administering (claim 7 of the copending case). Cohen et al., however teach on page 635: “It is common knowledge that renal function declines with age.” The authors further teach the following specific results in the Abstract: “Mean (±standard error) annual rate of decline in eGFR in healthy subjects was 0.97 ± 0.02 ml/min/year/1.73 m2. This decline increased significantly from 0.82 ± 0.22 in age-group 20–30 years to 0.84 ± 0.08, 1.07 ± 0.08 and 1.15 ± 0.12 ml/min/year/1.73 m2 in age groups 31–40, 41–50 and 50 years and older respectively (p<0.001).” Accordingly, a person having ordinary skill in the art would recognize that administration to a range of subjects embraced by the copending case would entail administration to subjects experiencing a natural renal function decline. The instant claims do not require any particular effectiveness level or any particular result relative to the otherwise normal renal function decline.
This is a provisional nonstatutory double patenting rejection.
(9 of 10) Claims 8 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 7-16 of copending Application No. 17/772,374 in view of Cohen et al. J. Nephrol. 2014, 27, 635-641.
The claims of the copending case recite a method of improving sleep by administering L-ergothioneine and a dependent claim recites that the method involves administration to a human adult in an amount of 5 to 50 mg per day per 60 kg of body weight per day in terms of L-ergothioneine, which range overlaps with the subject and dosage amount of instant claim 10. Cohen et al., however teach on page 635: “It is common knowledge that renal function declines with age.” The authors further teach the following specific results in the Abstract: “Mean (±standard error) annual rate of decline in eGFR in healthy subjects was 0.97 ± 0.02 ml/min/year/1.73 m2. This decline increased significantly from 0.82 ± 0.22 in age-group 20–30 years to 0.84 ± 0.08, 1.07 ± 0.08 and 1.15 ± 0.12 ml/min/year/1.73 m2 in age groups 31–40, 41–50 and 50 years and older respectively (p<0.001).” Accordingly, a person having ordinary skill in the art would recognize that administration to human adults would entail administration to subjects experiencing a natural renal function decline. The instant claims do not require any particular effectiveness level or any particular result relative to the otherwise normal renal function decline.
This is a provisional nonstatutory double patenting rejection.
(10 of 10) Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/728,706 in view of Cohen et al. J. Nephrol. 2014, 27, 635-641. The claims of the copending case recite oral compositions comprising L-ergothioneine (claim 5 of the copending case) and methods of inhibiting microorganisms in oral compositions (claim 7 of the copending case). Cohen et al., however teach on page 635: “It is common knowledge that renal function declines with age.” The authors further teach the following specific results in the Abstract: “Mean (±standard error) annual rate of decline in eGFR in healthy subjects was 0.97 ± 0.02 ml/min/year/1.73 m2. This decline increased significantly from 0.82 ± 0.22 in age-group 20–30 years to 0.84 ± 0.08, 1.07 ± 0.08 and 1.15 ± 0.12 ml/min/year/1.73 m2 in age groups 31–40, 41–50 and 50 years and older respectively (p<0.001).” Accordingly, a person having ordinary skill in the art would recognize that administration to a range of subjects embraced by the copending case would would entail administration to subjects experiencing a natural renal function decline. The instant claims do not require any particular effectiveness level or any particular result relative to the otherwise normal renal function decline.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626