DETAILED ACTION
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 .
Herein, "the previous Office action" refers to the final rejection of April 1 2026.
Priority
The instant application 18/392,229 filed on December 21, 2023 is a 371 of PCT/ CN2021/101541 filed on 06/22/2021. It is noted, however, that applicant has not filed a certified copy of the PCT/ CN2021/101541 application as required by 37 CFR 1.55.
Status of Claims
Acknowledgment is made of the receipt and entry of the amendment filed July 1, 2026. Claims 1-20 are pending. Claims 1-3, 5-6, 8, and 15-20 are amended; claims 4, 7, and 9-14 are unchanged. No claims are canceled.
Response to Amendment/Action Summary
The rejection of claims 1-20 under 35 U.S.C. 112(a) for lack of enablement and written description is withdrawn in view of Applicant’s amendments. The amendments remove the open-ended genus of L-Ergothioneine analogs, derivatives, esters, polymers, and acids; narrow the active agent to L-Ergothioneine or a pharmaceutically acceptable salt thereof; replace the broader alleviating/preventing language with treating; and limit the disease context through the newly recited CNV/VEGF-in-RPE/RPE-fibrosis characterization.
The rejection of claims 15-20 under 35 U.S.C. 112(b) as indefinite and the rejection of claims 15-20 under 35 U.S.C. 101 as directed to nonstatutory subject matter are withdrawn. As amended, claims 15-20 recite pharmaceutical compositions and no longer present the product/process ambiguity identified in the previous Office action.
The prior anticipation rejections over Cheah et al. and Borodina et al. are withdrawn. A new rejection of claims 15-20 under 35 U.S.C. 102(a)(1) over Aruoma et al. (WO2003082216A2) is applied below. This new ground is necessitated by Applicant’s amendment converting independent claim 15 from the former use format to a pharmaceutical-composition claim comprising L-Ergothioneine or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier. Claims 16-20 depend from amended claim 15 and incorporate those amended limitations.
With respect to 35 U.S.C. 103, the prior rejection over Cheah in view of Ambati is maintained for claims 1-11, with revisions to address the disease-characterization limitation added to amended claim 1. The same references and the property/inherency rationale previously applied to claims 4-8 are maintained; no new mechanistic reference is introduced for those claims.
Claims 12-14 are rejected under 35 U.S.C. 103 over Cheah et al. in view of Ambati et al., as applied to claim 1 above, and further in view of Borodina et al. Borodina is relied upon for the known daily oral amount of L-Ergothioneine and dosing-frequency limitations of claims 12-14. EFSA is not relied upon in present rejection. Because Borodina itself teaches human oral daily administration amounts 5-25 mg of same L-Ergothioneine active ingredient that falls within the 2–2000 mg/day range recited in claim 12, and also teaches daily administration for seven days, which is sufficient to address the additional limitations of claims 12-14.
As set forth below, claims 1-20 are rejected and no claim is allowed.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/11/2026 was filed after the mailing date of the Non-Final Office Action on April 1, 2026. The information disclosure statement (IDS) submitted on 11/21/2023 was filed . The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
This rejection is necessitated by the claim amendment
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.
(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.
Claims 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aruoma (WO2003082216A2).
Aruoma teaches pharmaceutical compositions comprising a therapeutically effective amount of L-Ergothioneine together with conventional pharmaceutically acceptable carriers, diluents, excipients, or vehicles. Aruoma further teaches pharmaceutically acceptable forms of L-Ergothioneine and oral and parenteral dosage forms including solutions, suspensions, injections, tablets, pills, capsules, powders, films, and syrups ([0020], [0065], [0078]-[0081], [0089]-[0100], and claim 35). Aruoma further teaches administration of L-Ergothioneine for retinal or neural protection in ocular degenerative conditions, including macular degeneration and retinopathies, and reports retinal neuroprotection by L-Ergothioneine in an in vivo retinal model ([0016]-[0021], [0056]-[0058], and [0075]-[0076]).
Aruoma does not teach age-related visual degeneration and age-related visual degeneration is characterized by subretinal CNV, VEGF level in RPE, or epithelial fibrosis in RPE, does not expressly recite every disease or symptom characterization set forth in claims 19-20, and does not expressly identify each property of L-Ergothioneine recited in claim 18.
Regarding claims 15, 19, and 20, it is respectfully pointed out that the recitation “for treating age-related visual degeneration in a mammal” and the recitations further characterizing that age-related visual degeneration have not been given patentable weight to the extent that they merely state the purpose or intended use of the claimed pharmaceutical composition. These recitations occur in composition claims whose structural limitations—L-Ergothioneine or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier—are able to stand alone and are expressly disclosed by Aruoma.
Such a recitation is generally not accorded patentable weight where it merely recites the purpose or intended use of a structure and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976), and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). Accordingly, the recitations of age-related visual degeneration, including the subretinal-CNV/VEGF-in-RPE/RPE-fibrosis characterization of claim 15 and the additional disease or symptom characterizations of claims 19 and 20, do not distinguish the otherwise identical L-Ergothioneine pharmaceutical composition disclosed by Aruoma.
Regarding claim 16, Aruoma teaches several of the alternatively recited pharmaceutical forms, including solutions, liquid suspensions, parenteral solutions, injections, tablets, pills, powders, films, syrups, and related conventional formulations ([0079], [0081], [0089]-[0091], and [0100]). Because claim 16 is satisfied by any one of the recited alternative forms, Aruoma anticipates claim 16.
Regarding claim 17, Aruoma Example 3 expressly discloses male Sprague-Dawley rats having starting weights of 225 ± 25 g, i.e., approximately 200-250 g, administered L-Ergothioneine by gavage at 70 mg/kg once daily for four days [0174]. A 0.200-kg rat receiving 70 mg/kg receives 14 mg of L-Ergothioneine per rat per day, and a 0.250-kg rat receives 17.5 mg per rat per day. Thus, Aruoma expressly discloses approximately 14-17.5 mg of L-Ergothioneine per rat per day, which falls within the claimed range of 2-2000 mg per day. The inherited age-related-disease language from claim 15 states the intended use of the composition and does not alter the disclosed amount or structure of the L-Ergothioneine composition. Accordingly, Aruoma anticipates claim 17.
Regarding claim 18, Aruoma does not expressly identify each property of L-Ergothioneine using the terminology recited in claim 18. Claim 18, however, recites the claimed results as capabilities of L-Ergothioneine in the pharmaceutical composition rather than as additional structural ingredients of that composition. Aruoma discloses the same L-Ergothioneine active ingredient in the same type of pharmaceutical composition.
A compound and its properties are inseparable. Products of identical chemical composition cannot have mutually exclusive intrinsic properties. Therefore, where the prior art discloses the same L-Ergothioneine composition, the intrinsic properties and capabilities possessed by that L-Ergothioneine are necessarily present even if the prior art did not recognize or describe the same downstream biological consequences by the terminology used in claim 18. See MPEP §§ 2112 and 2112.01; In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Accordingly, the property/capability recitations of claim 18 do not distinguish Aruoma’s otherwise identical L-Ergothioneine pharmaceutical composition.
Regarding claim 19, the recitation that the age-related visual degeneration is further characterized by one or more of eyestrain, blurred vision, dry eyes, eye fatigue, or blindness states the patient or disease context in which the pharmaceutical composition is intended to be used and does not impose an additional structural limitation on the L-Ergothioneine pharmaceutical composition. For the intended-use reasons set forth above, this language does not distinguish Aruoma.
Regarding claim 20, the recitation that the age-related visual degeneration is characterized by one or more of retinal effusion, retinal hemorrhage, macular oedema, accumulation of lipofuscin and drusen deposits, Bruch’s membrane thickening, CNV, or increased inflammatory proteins in RPE likewise states the disease context for the intended use of the pharmaceutical composition and does not alter its structure. For the same intended-use reasons set forth above, this language does not distinguish Aruoma.
Accordingly, claims 15-20 are anticipated by Aruoma.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 nonobviousness.
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 in order 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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Cheah et al. (Redox Biology 42 (2021) 101868, “Cheah”), in view of Ambati et al. (Neuron 75(1) (2012), 26-39, “Ambati”). These are the same references relied upon in the prior Office action.
Cheah teaches that L-Ergothioneine is a naturally occurring dietary antioxidant accumulated by the body (see e.g., p. 1, abstract) and that its antioxidant and cytoprotective properties are particularly relevant to ocular tissues exposed to high levels of oxidative stress (see e.g., p. 4, 3.3.2 Ocular health). Cheah expressly discusses L-Ergothioneine in the context of ocular health and age-related ocular disease, including age-related macular degeneration (AMD), and describes dietary/oral sources and administration of L-Ergothioneine compositions (see e.g., p. 6, Sources of ergothioneine). Thus, Cheah itself identifies AMD as an age-related ocular disease. Ambati further describes AMD as a progressive disorder affecting the macular region of the retina and as a leading cause of blindness in the elderly. Taken together, the teachings establish that AMD is an age-related visual degenerative condition affecting vision and therefore falls within the scope of the recited “age-related visual degeneration.”
Cheah does not expressly identify the amended claim 1 disease as being characterized by subretinal CNV, VEGF level in RPE, or epithelial fibrosis in RPE, and does not expressly identify each of the molecular capabilities recited in claims 4-8.
Ambati teaches that AMD is an age-related ocular disease and that neovascular AMD involves choroidal neovascularization (see e.g., p. 26, introduction). More particularly, in the section “RPE Vascular Response,” Ambati teaches that blockade of VEGF-A is the basis of therapies for neovascular AMD and that the RPE produces and secretes VEGF-A in response to complement and oxidative stress; oxidative stress also potentiates RPE secretion of VEGF-A (see e.g., p.28, right col.). Ambati further describes drusen as a characteristic AMD feature and identifies AMD as a leading cause of blindness in the elderly (see e.g., p. 26, introduction). Thus, Ambati directly teaches at least the amended claim 1 alternative requiring the age-related visual degeneration to be characterized by VEGF level in the mammal’s RPE. Because claim 1 requires “at least one of” the three disease characterizations, the rejection does not depend on construing Ambati’s general CNV disclosure as an express disclosure of the separate “subretinal CNV” alternative.
It would have been obvious to one of ordinary skill in the art before the effective filing date to administer L-Ergothioneine as taught by Cheah to a mammal having AMD in the RPE/VEGF disease context taught by Ambati. One of ordinary skill in the art would have been motivated to do so because Cheah teaches that L-Ergothioneine’s antioxidant properties are particularly relevant to ocular oxidative stress and identifies AMD as an age-related ocular disorder in which L-Ergothioneine may have a protective role, while Ambati teaches that oxidative stress in the RPE promotes VEGF-A production and secretion in neovascular AMD. The combined teachings therefore would have suggested using the known ocular antioxidant L-Ergothioneine in the same oxidative-stress-associated AMD setting. One of ordinary skill in the art would have had a reasonable expectation of success because the proposed combination does not require a different active ingredient or a new route of action; it applies Cheah’s known L-Ergothioneine antioxidant treatment to an established molecular/pathologic manifestation of the same age-related ocular disease described by Ambati.
Regarding claim 2, Ambati expressly teaches AMD as a leading cause of blindness in the elderly. Blindness is one of the alternatively recited phenomena in claim 2. Therefore, Ambati’s express teaching of blindness satisfies the limitation of claim 2.
Regarding claim 3, Ambati teaches drusen as a characteristic pathologic feature of AMD. Drusen deposits are one of the alternatively recited characteristics in claim 3. Therefore, the combination teaches the additional limitation of claim 3.
With regard to claims 4-8, claims 4-8 do not positively recite an additional treatment step, a different active ingredient, a different route of administration, or additional administration conditions. Rather, the claims characterize the administration of L-ergothioneine required by claim 1 in terms of biological capabilities or consequences attributed to that administration step. Because the combined prior art references render obvious administration of the same active ingredient, L-ergothioneine, to the same claimed or an obvious patient population for the treatment of the same age-related ocular condition, the substantial identical administration would necessarily possess the same inherent biological capabilities. Merely recognizing or reciting an inherent mechanism, property, or result of an otherwise obvious method does not render the method nonobvious.
Regarding claims 9-11, Cheah teaches dietary and oral administration of L-Ergothioneine through foods or nutritional compositions and conventional orally administered forms. Claim 9 is satisfied by the nutritional/food alternatives; claim 10 is satisfied by the oral-administration alternative; and claim 11 is satisfied by the food/beverage or other conventional oral-form alternatives. Accordingly, the additional limitations of claims 9-11 do not render the claimed method nonobvious.
Claims 12–14 are rejected under 35 U.S.C. 103 as being unpatentable over Cheah et al. (Redox Biology 42 (2021) 101868, “Cheah”), in view of Ambati et al. (Neuron 75(1) (2012), 26–39, “Ambati”), as applied to claims 1–11 above, and further in view of Borodina et al. (Nutrition Research Reviews 33 (2020), 190–217, “Borodina”).
The teachings of Cheah and Ambati have been discussed above and are incorporated herein. Cheah and Ambati do not expressly teach the oral daily-dose and dosing-frequency limitations recited in claims 12–14.
Borodina teaches oral administration of L-Ergothioneine and specifically reports administration of 5–25 mg daily doses of L-Ergothioneine to human volunteers for seven days (see e.g., p. 198, Metabolism and excretion). Thus, Borodina teaches a known human oral daily amounts of same L-Ergothioneine active ingredient that falls within the 2–2000 mg/day range recited in claim 12, and also teaches daily administration for seven days.
It would have been obvious to one of ordinary skill in the art before the effective filing date to administer the L-Ergothioneine treatment of Cheah and Ambati using the known oral daily amounts taught by Borodina. One of ordinary skill in the art would have been motivated to administer L-ergothioneine treatment suggested by Cheah and Ambati using the known human oral daily amounts taught by Borodina because those references provide established oral administration amounts for the same active ingredient in humans. Selection of such previously administered amounts would have represented the predictable use of known L-ergothioneine dosing conditions in carrying out the suggested treatment, with a reasonable expectation that the compound could be orally administered at those amounts.
Regarding claim 12, Borodina teaches 5–25 mg daily doses of L-Ergothioneine, which falls within the claimed range of 2–2000 mg/day.
Regarding claim 13, the claimed daily dose is alternatively administered as a single dose or as multiple divided doses. These alternatives collectively encompass administration of the daily amount either in one administration or in more than on administration. Accordingly, Borodina’s administration of a daily dose necessarily falls within one of the alternatively recited dosing schedules of claim 13.
Regarding claim 14, Borodina teaches administration of L-Ergothioneine on a daily basis for seven days. Accordingly, Borodina teaches administration at least once a day, which satisfies one of the alternatives recited in claim 14.
Accordingly, claims 12–14 would have been obvious over the combination.
Response to Arguments
Applicant’s arguments filed July 1, 2026 have been fully considered.
Applicant’s arguments regarding the rejections under 35 U.S.C. §§ 112(a), 112(b), and 101 are persuasive in view of the amendments. Claim 1 was narrowed to treatment with L-Ergothioneine or a pharmaceutically acceptable salt thereof, and claims 15-20 were converted to pharmaceutical-composition claims. Those rejections are withdrawn.
Applicant’s arguments concerning the prior anticipation rejections over Cheah and Borodina are moot because those specific grounds are withdrawn.
Applicant argues that Cheah acknowledges that only “few studies” investigated the protective role of L-Ergothioneine in AMD and describes that role as “suspected,” and therefore would not have provided a motivation to treat the claimed age-related ocular disease or a reasonable expectation of success.
The argument is not persuasive. The rejection does not rely on Cheah as establishing conclusive clinical efficacy. Cheah positively teaches L-Ergothioneine as an antioxidant and cytoprotectant of particular relevance to ocular oxidative stress and expressly identifies AMD among the age-related ocular disorders in which L-Ergothioneine may have a protective role. Ambati independently teaches that oxidative stress in the RPE drives VEGF-A production and secretion in neovascular AMD. Thus, the cited art supplies both a reason to administer the known ocular antioxidant and the relevant AMD/RPE-VEGF disease context. A statement that relatively few studies have been performed does not criticize, discredit, or discourage the proposed use, and a reasonable expectation of success does not require absolute predictability or certainty. See MPEP § 2143.02.
Applicant next argues that Cheah and Ambati do not expressly teach the mechanistic limitations of the dependent claims, including the Nrf2, VEGF, VEGFR1, hif-1α, vegfaa, and oxidation-induced EMT/fibrosis limitations.
With respect to claim 5, the Examiner agrees that Cheah and Ambati do not expressly identify each downstream molecular event recited in the claim. This, however, does not distinguish the claimed method. Claim 5 does not require administration of an additional active agent or performance of a separate treatment step to produce the recited effects. Rather, it characterizes biological capabilities of the same L-Ergothioneine administration required by claim 1. The combined prior art administers the same active ingredient in the same claimed age-related ocular disease context. The rejection therefore does not depend on Cheah or Ambati having recognized the particular Nrf2, VEGF, hif-1α, or vegfaa pathways. The previous Office action applied the same capability/inherency principle to claims 4-8. Under MPEP § 2112, recognition of a previously unappreciated property or mechanism of known subject matter does not render that subject matter patentably distinct where there is a sound basis for concluding that the prior-art subject matter necessarily possesses the recited property.
Here, Applicant’s specification itself describes Nrf2 activation, reactive oxygen species scavenging, VEGF reduction, and reduction of hif-1α or vegfaa as biological effects resulting from administration of L-Ergothioneine. Those limitations are presented as consequences of L-Ergothioneine treatment rather than as independently imposed treatment conditions. Because the applied prior art administers the same active ingredient in the claimed ocular-disease context, there is a sound factual basis for concluding that the administration possesses the biological capabilities recited in claim 5. The fact that Cheah and Ambati do not expressly identify the molecular pathways does not, by itself, distinguish the method.
Regarding claim 6, Applicant similarly argues that Cheah and Ambati do not expressly teach decreasing VEGFR1 gene-expression level, hif-1α gene-expression level, or vegfaa gene-expression level in RPE. This argument is unpersuasive for substantially the same reason. Claim 6 characterizes additional biological effects of administering the same L-Ergothioneine; it does not require a different active ingredient or an additional treatment step.
Regarding claim 7, the recited activation of Nrf2-mediated antioxidant genes by lowering oxidative-stress damage in RPE likewise characterizes a capability of the same L-Ergothioneine administration. Cheah expressly teaches the antioxidant relevance of L-Ergothioneine to ocular tissues exposed to oxidative stress, and the further Nrf2 characterization does not require a different active ingredient or a separate treatment step. The same capability/inherency rationale therefore applies.
Regarding claim 8, Applicant argues that Cheah and Ambati do not teach inhibition of oxidation-induced EMT to prevent epithelial fibrosis in RPE. Cheah and Ambati do not expressly describe EMT. Nevertheless, claim 8 likewise recites inhibition of EMT as a capability of administering L-Ergothioneine rather than requiring an additional anti-EMT agent or separate treatment step. The capability/inherency rationale previously applied to claim 8 is therefore maintained.
The Examiner recognizes that inherency cannot be established merely because a result may occur. The claimed characteristic must necessarily flow from the applied prior art, and the record must provide a sound factual or technical basis for that conclusion. See MPEP § 2112. Here, the basis is the substantially identical administration of the same L-Ergothioneine active ingredient in the claimed ocular-disease context, together with Applicant’s own characterization of the recited molecular effects as consequences or capabilities of that administration rather than as additional treatment requirements.
Applicant further relies on asserted unexpected results, including approximately 45% scavenging of reactive oxygen species, approximately 50% reduction in VEGF, downregulation of VEGFR1, hif-1α, and vegfaa, inhibition of oxidation-induced EMT, histopathological improvement in zebrafish retinal tissue, and improved CNV control relative to aescin and digitalis double glucoside eye drops.
The asserted results have been fully considered but are not persuasive to overcome the prima facie case. First, evidence that L-Ergothioneine produces the recited Nrf2, ROS, VEGF, hif-1α, vegfaa, or EMT effects does not, without more, establish that those effects are unexpected rather than previously unrecognized consequences of the same L-Ergothioneine treatment. A newly recognized mechanism or latent property of known subject matter does not by itself confer patentability.
Second, the comparison with aescin and digitalis double glucoside eye drops is not a comparison with the closest applied prior-art L-Ergothioneine treatment. The comparative data therefore do not establish that the claimed L-Ergothioneine treatment produces an unexpected result relative to the closest prior art. Applicant has not shown that L-Ergothioneine administered according to the applied prior-art teachings would fail to produce, or would reasonably have been expected not to produce, the recited molecular and cellular effects. Further, the evidence is limited to particular experimental models and conditions and does not establish unexpected results across the full scope of the claimed mammalian subjects, pharmaceutically acceptable salts, treatment alternatives, and administration forms. See MPEP § 716.02(d).
Accordingly, Applicant’s arguments concerning the rejection of claims 1-11 over Cheah in view of Ambati, including the asserted unexpected results, are not persuasive.
Applicant argues that Borodina and EFSA do not teach treatment of age-related visual degeneration characterized by CNV, VEGF level in RPE, or epithelial fibrosis in RPE. The argument does not overcome the present rejection of claims 12-14. The underlying age-related visual-degeneration limitations of claim 1 are addressed by Cheah and Ambati in the rejection of claims 1-11 above. In the present dependent-claim rejection, Borodina is relied upon only for the additional dosing limitations of claims 12-14. Borodina reports 5-25 mg daily doses of L-Ergothioneine administered to human volunteers for seven days, which directly addresses the claimed daily amount and frequency limitations.
Applicant’s arguments directed specifically to EFSA are moot because EFSA is not relied upon in the present rejection. Borodina independently provides the human oral dosing teaching needed for claims 12-14.
Applicant additionally argues that Borodina and EFSA do not teach the functional limitations of claim 5. That argument does not require further resolution under the present rejection of claims 12-14 because claim 5 is rejected over Cheah in view of Ambati, and Applicant’s arguments concerning the specific limitations of claim 5 have been addressed above.
Applicant further argues that the prior dosing evidence does not render the broad 2-2000 mg/day therapeutic range obvious. The argument is not persuasive because Borodina expressly reports human administration of 5-25 mg L-Ergothioneine daily for seven days, and those amounts fall squarely within the claimed range. The therapeutic reason for administering L-Ergothioneine is supplied by Cheah and Ambati, while Borodina supplies a known human oral dosing condition for the identical active ingredient. Claim 13 expressly encompasses either a single dose or multiple divided doses, and claim 14 encompasses administration at least once or multiple times per day. Applicant has not demonstrated unexpected criticality attributable to the claimed dosage or frequency limitations.
Accordingly, Applicant’s arguments do not overcome the rejections set forth in this action.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENBIN SHI whose telephone number is (571)272-8796. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, AMY L. CLARK can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000./G.S./Examiner, Art Unit 1628
/JEAN P CORNET/ Primary Examiner, Art Unit 1628
Prosecution Insights