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 .
Status of the Application
Claims 1 and 3-4 are pending in the application as of the response filed 02/11/2026. Claim 2 is cancelled. Claims 3-4 are newly added. Claims 1 and 3-4 are examined herein.
The 35 U.S.C. § 101 rejection of previous record is hereby withdrawn in consideration of the claim amendments to include specific concentrations of isoliquiritigenin and arachidic acid AND in consideration of the evidence in the instant specification that the combination performed better than the individual ingredients alone at the recited concentrations. Table 1 of the instant specification evidences synergistic enhancement of hyaluronic acid production with the combination of isoliquiritigenin and arachidic acid at concentrations of 0.01µM and 0.05 µM each, versus either of them alone. Thus, the presence of isoliquiritigenin and arachidic acid at the recited concentrations in the hyaluronic acid-production promoter composition amounts to significantly more than that found in nature.
The claim amendments overcome the 35 U.S.C. § 102 and 35 U.S.C. § 103 rejections of previous record, which is hereby withdrawn. Claim 1 is allowable.
In view of the pending claims, the following rejections are made.
Information Disclosure Statement
The information disclosure statements submitted on 02/11/2026 and 04/27/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, the claim recites “A food composition comprising isoliquiritigenin, wherein the amount of isoliquiritigenin to be taken per day is from 0.001 to 3.5 g”. The preamble of the claim is drawn to a composition, while the claim further recites daily dosage of isoliquiritigenin to be taken by a subject. This renders the scope of the claim indefinite since it is unclear if the claim is drawn to a composition or to a method wherein the isoliquiritigenin is administered at said dosage.
Claim 4 depends from claim 3 and is similarly rejected since it does not remedy the indefiniteness.
For the purpose of applying prior art, claim 3 has been interpreted to read “A food composition comprising isoliquiritigenin, wherein the [[ amount of]] isoliquiritigenin [[to be taken per day ]]is present in an amount from 0.001 to 3.5 g”.
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 3-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The instant claims recite a food composition comprising isoliquiritigenin, wherein the amount of isoliquiritigenin to be taken per day is from 0.001 to 3.5 g, the composition further comprising arachidic acid (see interpretation of claim 3 above).
Isoliquiritigenin, is a naturally-occurring organic compound obtained from the roots of several Glycyrrhiza species, such as licorice (see Para. [0013] of the instant specification; Wikipedia definition copied below).
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The food composition further comprises arachidic acid. Arachidic acid, also known as icosanoic acid or eicosanoic acid, is a saturated fatty acid with a 20-carbon chain and a natural product commonly found in peanut oil, corn oil, perilla oil, etc.. (see Para. [0016] of the instant specification; Wikipedia definition copied below).
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The food composition of the claims do not require any components other than isoliquiritigenin and arachidic acid. Thus, the claims are directed to a natural product and nothing more. The claimed components of the food composition, isoliquiritigenin and arachidic acid, are not markedly different from its closest naturally occurring counterpart and thus is a product of nature judicial exception. Moreover, the recitation of specific amounts of isoliquiritigenin (claim 3) does not affect this analysis because it does not markedly change the characteristics of isoliquiritigenin in the composition, and it continues to have the same properties in the composition as it did alone.
This judicial exception is not integrated into a practical application because the claims are drawn to natural occurring components, that at its broadest do not have any characteristics that are different from the isoliquiritigenin and arachidic acid that occur in nature.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the claimed components themselves. Therefore, claims 3-4 are deemed patent ineligible subject matter.
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.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Youl et al. (KR 20120032373 A, publication date 05 April 2012, hereinafter Youl) - all citations are to the attached English translation.
Regarding instant claim 3, Youl teaches a food composition that comprises isoliquiritigenin or a salt thereof (Pg. 1, Abstract; Pg. 4, second paragraph). Youl teaches a daily dose of 0.0001 -100mg/kg (Pg. 1, Abstract; Pg. 4, first paragraph). Youl teaches the dosages and regimen may be optimized by those skilled in the art based on the condition and weight of the patient, the extent of the disease, the form of the drug and the route of administration (Pg. 4, first paragraph).
According to 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). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount of isoliquiritigenin, say 0.001 to 3.5 g, in the absence of any criticality of the recited amounts.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Youl et al. (KR 20120032373 A, 05 April 2012, hereinafter Youl) as applied to claim 3 above, in view of Asada et al. (JP 2014024819 A, 06 February 2014, hereinafter Asada) - all citations are to the respective attached English translations.
The teachings of Youl are set forth in the obviousness rejection above and incorporated herein by reference.
Regarding instant claim 4, Youl renders the food composition of instant claim 3 prima facie obvioius. Youl teaches the composition may further contain … stabilizers, … emulsifiers … as necessary (Pg. 3, last paragraph). Youl teaches the composition may contain pharmaceutically inert, organic excipients including organic acids (Pg. 4, third paragraph). Youl do not teach wherein the excipient is arachidic acid.
Asada teaches an emulsified nutritional composition having good emulsion stability (Pg. 1, Abstract). Asada teaches the composition comprises a fatty acid ester wherein the fatty acid is selected from a group that includes arachidic acid (Pg. 1, Claims; Pg. 3, second paragraph).
According to MPEP 2144.07, “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)”. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated a stabilizing agent/emulsifier, such as arachidic acid, into the composition of Youl since these are known and effective pharmaceutically acceptable emulsifiers for use in formulating a food composition, as taught by Asada. The teachings of Youl in view of Asada render the limitations of instant claim 4 prima facie obvious.
Allowable Subject Matter
Claim 1 is free of prior art.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record does not teach or suggest a hyaluronic acid-production promoter, comprising isoliquiritigenin and arachidic acid, wherein isoliquiritigenin and arachidic acid are present at concentrations of 0.01µM and 0.05 µM each. Moreover, the instant specification evidences that the combination of isoliquiritigenin and arachidic acid performed better, i.e., synergistically enhanced hyaluronic acid production, than the individual ingredients alone at the recited concentrations (Table 1).
Conclusion
Claims 3-4 are rejected.
Claim 1 is 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 PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached on 9:00-5:30pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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