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 Preliminary amendment filed on 10/26/2023 is acknowledged. C laim s 1-1 9 w ere cancelled and claims 20-33 were newly added . Claims 20-23 are pending in the instant application and are examined on the merits herein. Priority This application is a National Sta g e Application of PCT/ JP2022/011173 , filed on 03/14/2022 and claims foreign priority to JAPAN 2021-093328 filed on 0 6 /03/2021 . Information Disclosure Statement The information disclosure statement s (IDS) dated 11/27/2023 and 09/18/2024 compl y with the provisions of 37 CFR 1.97, 1. 98 and MPEP § 609 . Accordingly, the IDS document ha s been placed in the application file and the information therein has been considered as to the merits. Specification The title of the invention includes the word “NOVEL”. MPEP 606 provides a listing of words that are not considered as part of the title of an invention, should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues . This listing includes the words “ Improved ”, “New”, and “Novel”. In this case the title of the invention will be entered as “ISOFLAVONE COMPOUND ”. Claim Objections Claims 1-5 and 9-11 objected to because of the following informalities: Claim 1 labels the chemical structure as both [Formula 1] and (I). This is inconsistent with the label “formula (I)” sued throughout the claims. Claims, 1-5 and 9-11 recite the chemical structure after the period ending the claim. The chemical structures should be moved to immediately following the label “formula (I)” or the period should appear after the chemical structures as recited. Claim 2 labels the chemical structure as both [Formula 2] and (I). This is inconsistent with the label “formula (I)” used throughout the claims. Claim 3 labels the chemical structure as both [Formula 3] and (I). This is inconsistent with the label “formula (I)” sued throughout the claims. Claim 4 labels the chemical structure as both [Formula 4] and (I). This is inconsistent with the label “formula (I)” sued throughout the claims. Claim 5 labels the chemical structure as both [Formula 5] and (I). This is inconsistent with the label “formula (I)” sued throughout the claims. Claim 9 labels the chemical structure as both [Formula 6] and (I). This is inconsistent with the label “formula (I)” sued throughout the claims. Claim 10 labels the chemical structure as both [Formula 7] and (I). This is inconsistent with the label “formula (I)” sued throughout the claims. Claim 11 labels the chemical structure as both [Formula 8] and (I). This is inconsistent with the label “formula (I)” sued throughout the claims. Appropriate correction is required. 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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more than the judicial exception. The claims are evaluated below using the “Subject Matter Eligibility Test for Products and Processes” flow chart as shown in MPEP § 2106 III. Step 1 : Is the claim to a process, machine, manufacture or composition of matter? Yes. The claim s are drawn to a composition of matter which is one of the four statutory categories. Step 2A, Prong One : Do es the claim recite an abstract idea, law of nature, or natural phenomenon? Yes, the claims are directed to a natural phenomenon. The claim(s) recite(s) “ a compound of formula (I) ” , “ a skin barrier function-improving agent comprising a compound of formula (I)”, “an aquaporin 3 production-promoting agent comprising a compound of formula (I)”, “a filaggrin 2 production-promoting agent comprising a compound of formula (I)”, and “an anti-inflammatory agent comprising a compound of formula (I)” . As evidenced by the instant specification (instant specification paragraph 0016), t he compound represented by the formula (I) is a n isoflavone compound obtained by separation and purification from the extract of pods of locust bean (Ceratonia siliqua) . There is no indication in the record that isolation of formula (I) results in a marked difference in structure, function or other . A s such this is a product of nature exception . Step 2A, Prong Two : Do the claims recite additional elements that integrate the judicial exception into a practical application? No. There are no additional steps recited in the claim that integrate the judicial exceptions into a practical application. Th e judicial exception is not integrated into a practical application because beyond the “ the agent according to claim 2, which is a skin external preparation” or “the agent according to claim 2, which is a cosmetic” wherein claim 2 states “a skin barrier function-improvement agent comprising a compound of instant formula (I)”, the claims do not require the addition of anything beyond the compound of formula (I). Step 2B : Does the claim recite additional elements that amount to significantly more than the judicial exception? Regarding instant claim 1, the instant claim do es not recite additional elements that amount to significantly more than the judicial exception. While instant c laim s 2-5 recite s “a skin barrier function-improving agent comprising a compound of formula (I)”, “an aquaporin 3 production-promoting agent comprising a compound of formula (I)”, “a filaggrin 2 production-promoting agent comprising a compound of formula (I)”, and “an anti-inflammatory agent comprising a compound of formula (I)” , or an skin external preparation or a cosmetic comprising a compound of formula (I), the recited language in the preambles do not add any structural limitations to the claims and the claims are met by the agent of a compound of formula (I) , which is a nature-based product. The specification does not teach a combination of the natural products result ing in a markedly different characteristic. Therefore, the claims do not include additional elements that are sufficient to amount to significantly more than the product of nature exception as those additional elements were well understood, routine and conventional in the field as taught above . Regarding instant claim 6, the claim specifies the concentration of the compound in the agent , but does not teach that concentration range results in an agent with markedly different characteristics. Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the product of nature exception as those additional elements were well understood, routine and conventional in the field as taught above . Thus, the instant claim s 1-10 do not qualify as eligible subject matter. 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. Claims 1 -5 and 7-8 are rejected under 35 U.S.C. 102 FILLIN "Insert either \“(a)(1)\” or \“(a)(2)\” or both. If paragraph (a)(2) of 35 U.S.C. 102 is applicable, use form paragraph 7.15.01.aia, 7.15.02.aia or 7.15.03.aia where applicable." \d "[ 2 ]" (a)(1)(a)(2) as being anticipated by Maestro et al. (US 2010/0028471 A1, published 02/04/2010, see IDS dated 11/27/2023). Maestro is drawn to a cosmetic process for caring for human skin, intended to moisturize it and/or protect it against drying out, comprising the topical application to the skin of a composition containing at least one active agent that stimulates the expression of the matriptase MT/SP1 (claim 22). The active agent may be an extract of Ceratonia siliqua (claim 24). Maestro exemplifies a composition that comprises extract of Ceratona Siliqua that may be applied daily onto dehydrated skin to improve its comfort and appearance (paragraphs 0107-0108). Maestro teaches that the composition may be anti-inflammatory (paragraph 0054). Maestro teaches that the carob pulp extract may be obtained from carob pods which have optionally been dried and preferably been ground (paragraph 0022). Extracts of Ceratonia siliqua may be obtained by alcoholic extraction using a monoalcohol such as ethanol, methanol or isopropanol, optionally mixed with water, and/or a glycol such as propylene glycol (paragraph 0019). Maestro exemplifies the extraction of the carob pulp with ethanol (paragraph 0062). Maestro teaches that the extraction is generally carried out by immersing or gently stirring the ground material in one or more of the solvents, then filtered to remove insoluble plant substances resulting in a carob extract (paragraphs 0023-0024). As evidenced by the instant specification (instant specification paragraph 0016), t he compound represented by the instant formula (I) is an isoflavone compound obtained by separation and purification from the extract of pods of locust bean (Ceratonia siliqua) after extraction with ethanol (Example 1, instant specification page 26-27) . Therefore , an extract of pods of Ceratonia siliqua would necessarily contain the compound of formula (I) and would meet the limitations of an agent comprising the compound of formula (I). Regarding instant claim 3 -5 , the instant specification identifies that the compound of formula (I) is an aquaporin 3-production-promoting agent , a filaggrin 2 production-promoting agent, and an anti-inflammatory agent (instant specification paragraphs 0044 and 0032 ) . Therefore, the extract of pods of Ceratonia siliqua, which contain the compound of formula (I), would meet the limitation of comprising an aquaporin 3-production-promoting agent as this would be a property inherent to the compound of formula (I). MPEP 2112(II) makes clear that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Furthermore, MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Accordingly, the claims are anticipated by the art. 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 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Maestro et al. (US 2010/0028471 A1, published 02/04/2010, see IDS dated 11/27/2023) . Claim 2 is rejected as discussed above. The teachings of Maestro are discussed above. Maestro further teaches that the active ingredient can be used in a proportion of from 0.00001% to 10% by weight relative to the total weight of the composition (paragraph 0017) . Maestro does not directly teach the concentration of the compound represented by formula (I) is 0.001 mM to 1 mM. It would have been prima facie obvious before the effective filing date of the claimed invention to optimize the amount of extract of Ceratonia siliqua in the composition, which contains the compound of formula (I) as taught by the instant specification, to be between 0.00001% to 10% by weight relative to the total weight of the composition, which range would necessarily encompass 0.001 mM to 1 mM of the compound of formula (I), as taught by Maestro to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the amount of the carob pulp extract to be between 0.00001% to 10% by weight relative to the total weight of the composition as taught by Maestro because Maestro teaches that the carob pulp extract may be used between 0.00001%-10% by weight relative to the total weight of the composition and the instant specification indicates that the compound of formula (I) is found in the extract of carob pulp. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). Claim s 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kim ( US 2019/0008748 A 1 , published 01/10/2019 , see PTO-892 ) and Maestro et al. (US 2010/0028471 A1, published 02/04/2010, see IDS dated 11/27/2023) . Kim is drawn to a composition and food for improving skin condition containing exopolysaccharides produced by Ceriporia lacerata , a mycelial culture fluid of Ceriporia lacerata comprising the exopolysaccharides, a dry powder of the mycelial culture fluid or an extract of the mycelial culture fluid as an active ingredient. The composition and the food for improving skin condition have a superior skin whitening effect, wrinkle improving effect, skin moisturizing effect or skin anti-aging effect (abstract). Kim teaches a composition for improving skin condition of the present invention that may further comprise plant extracts known to have a skin condition-improving effect . The plant extracts known to have a skin condition-improving effect may be carob extract (paragraph 0045). The composition food may be in the form of a drink (paragraph 0051). Regarding instant claim 9, it is noted that the prior art does not exemplify the compound can be used in the manner instantly claimed, for improving skin barrier function . However, the cited recitations are considered an “intended use” of the claimed compound. The “intended use” of the claimed compound does not patentably distinguish the compound, per se, since the compound would be capable of performing the intended use. In order to be limiting, the intended use must create a structural difference between the claimed compound and the prior art compound. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting. Regarding instant claim 10, it is noted that the prior art does not exemplify the compound can be used in the manner instantly claimed, for antiinflammation. However, the cited recitations are considered an “intended use” of the claimed compound. The “intended use” of the claimed compound does not patentably distinguish the compound, per se, since the compound would be capable of performing the intended use. In order to be limiting, the intended use must create a structural difference between the claimed compound and the prior art compound. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting. Kim does not exemplify a food or drink comprising the compound of formula (I). The teachings of Maestro are discussed above. It would have been prima facie obvious to combine the teachings of Kim and Maestro before the effective filing date of the claimed invention to add the extract of pods of Ceratonia siliqua that improves skin condition as taught by Maestro to a food and drink composition to improve skin barrier function as taught by Kim to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the food and drink composition taught by Kim to further comprise the extract of pods of Ceratonia siliqua because Kim teaches the compositions may further comprise plant extracts known to have a skin condition-improving effect such as carob extract and Maestro teaches that carob extract can improve the skin condition such as improved comfort and appearance . One of ordinary skill in the art would have a reasonable expectation of success because Kim teaches the compositions may further comprise plant extracts known to have a skin condition-improving effect such as carob extract , and Maestro teaches that carob extract can improve the skin condition such as improved comfort and appearance, and as evidenced by the instant specification, carob (Ceratonia siliqua) extract comprises the compound of instant formula (I). Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Maestro et al. (US 2010/0028471 A1, published 02/04/2010, see IDS dated 11/27/2023) and Shen et al. (CN 109053667 A , published 12/21/2018 , Machine Translation from PE2E accessed 03/11/2026 , see PTO-892) . The teachings of Maestro are discussed above. Maestro further teaches that e xtraction is a normal practice in the plant extract field, and those skilled in the art are capable of adjusting the reaction parameters thereof, on the basis of their general knowledge. These extraction processes can optionally be completed with other fractionation steps, such as a short-path distillation (or molecular distillation) step, liquid/liquid extraction, supercritical fluid extraction, tangential filtration or else fractionated distillation (paragraph 0029) . Maestro does not disclose further subjecting the hydroalcoholic extract to liquid-liquid extraction with petroleum ether and ethyl acetate and separating the compound from the ethyl acetate fractions. Shen is drawn to a separating method of isoflavone derivatives (title). Shen teaches a method to obtain 5-Hydroxy-4, 7 '- dimethoxy-isoflavone from clover, the separation method of dimethoxy isoflavone wherein t he clover is extracted into ethanol solution, heating and refluxing and extracting, concentrating the filtrate to obtain extract, adding water to the extract suspension after dissolving, adding petroleum ether and ethyl acetate extraction, the ethyl acetate part by silica gel column chromatography and gradient elution to obtain colorless crystal, namely, 5-Hydroxy-4, 7'- dimethoxy-isoflavone (page 3) . It would have been prima facie obvious to combine the teachings of Maestro and Shen before the effective filing date of the claimed invention by modifying the method of extracti ng Ceratonia siliqua with a hydroalcoholic solution as taught by Maestro by further subjecting the hydroalcoholic extract , which contains the compound of formula (I) as taught by the instant specification, with a liquid-liquid extraction with petroleum ether and ethyl acetate and separating the compound from the ethyl acetate fraction for isolation of isoflavone compounds as taught by Shen to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the method of extracting Ceratonia siliqua taught by Maestro , which would contain the compound of formula (I) as the instant specification indicated that a hydroalcoholic extraction of Ceratonia siliqua with a would result in the extraction of the compound of formula (I) , by further subjecting the hydroalcoholic extract with a liquid- liquid extraction with petroleum ether and ethyl acetate and separating the compound from the ethyl acetate fraction as taught by Shen because Maestro teaches that extraction of plants is normal practice in the plant extract field and that one of skill in the field are capable of adjusting the reaction parameters and that the extraction method may be completed with other fractionation steps including liquid-liquid extractions. One of ordinary skill in the art would have a reasonable expectation of success because Shen teaches a method of extracting an isoflavone using ethanol and water and further extracting with petroleum ether and diethyl acetate and Maestro teaches that Ceratonia siliqua may be extracted with hydroalcoholic solution and that the extraction method may be completed with other fractionation steps including liquid-liquid extractions , and the instant specification confirms that the compound of formula (I) would have been present in the hydroalcoholic solution extraction . Conclusion No claims allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Enter examiner's name" \* MERGEFORMAT SAMANTHA LYNN SCHACHERMEYER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-5337 . The examiner can normally be reached FILLIN "Work schedule?" \* MERGEFORMAT Monday thru Friday, alternate Fridays off, 7:30AM-5PM EST . 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