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 Claims
Claims 1-2 are pending in the application. Claims 1-2 are examined herein.
Priority
This application is a 371 of PCT/JP2022/027489 filed 07/13/2022 and claims foreign priority to JAPAN 2021-117168 filed 07/15/2021.
It is noted that Applicants have not provided an English translation of the certified copy of the foreign priority application as required by 35 U.S.C. 119(b). Without the English translation, one cannot ascertain if the instant invention is supported in the Japanese application. Therefore, art prior to the PCT date, but not before the date of the Japanese application may be cited against the claims. Accordingly, claims 1-2 have been afforded an effective filing date of 07/13/2022, the filing date of the PCT application.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements filed on 10/20/2023, 10/20/2025 and 10/29/2025 have been considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
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 1-2 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 hyaluronic acid-production promoter, the promoter being isoliquiritigenin. 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 hyaluronic acid-production promoter 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 promoter 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 promoter, isoliquiritigenin and arachidic acid, are not markedly different from its closest naturally occurring counterpart and thus is a product of nature judicial exception.
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 1-2 are deemed patent ineligible subject matter.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paek (WO 2011/108821 A2, publication date 09 September 2011).
Regarding instant claim 1, Paek teaches a skin care composition comprising isoliquiritigenin as the active ingredient (Abstract; Pg. 2, second full paragraph). Paek teaches a skin care composition can be formulated in the form of an emulsion (Pg. 6, eighth paragraph).
Even though Paek does not explicitly teach the limitation “A hyaluronic acid-production promoter”, it is an inherent property of the active ingredient, isoliquiritigenin.
According to MPEP 2141.02(V), In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) ("From the standpoint of patent law, a compound and all its properties are inseparable.").
See also MPEP 2112.01(II), “Products of identical chemical composition can not have mutually exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). In the instant case, the isoliquiritigenin in the composition of Paek, by virtue of its inherent property would function as a hyaluronic acid-production promoter. The recitation of the open-ended transitional phrase “comprising” does not exclude presence of other elements in the claim. Therefore, the disclosure of Paek anticipates instant claim 1.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (CN102488674A, publication date 13 June 2012).
Regarding instant claim 1, Wang teaches an isoliquiritigenin eye drop preparation (Pg. 1, second paragraph, Description). Wang teaches preparing a concentrated solution of isoliquiritigenin by dissolving isoliquiritigenin dry powder in ethanol (Pg. 2, twentieth paragraph).
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Even though Wang does not explicitly teach the limitation “A hyaluronic acid-production promoter”, it is an inherent property of the active ingredient, isoliquiritigenin.
According to MPEP 2141.02(V), In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) ("From the standpoint of patent law, a compound and all its properties are inseparable.").
See also MPEP 2112.01(II), “Products of identical chemical composition can not have mutually exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). In the instant case, the isoliquiritigenin preparation of Wang, by virtue of its inherent property would function as a hyaluronic acid-production promoter. Therefore, the disclosure of Wang anticipates instant claim 1.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Paek (WO 2011/108821 A2, publication date 09 September 2011) in view of Lee et al. (WO 2014/084670 A1, publication date 05 June 2014, hereinafter Lee).
The teachings of Paek are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claim 2, Paek anticipates the hyaluronic acid-production promoter of instant claim 1. Paek teaches the composition may comprise a fatty acid as an additional active ingredient (Pg. 7, first paragraph). Paek do not teach wherein the fatty acid is arachidic acid.
Lee teaches compositions for application to the skin (Title; Abstract). Lee teaches the compositions comprise a fatty acid (Claim 1), wherein the fatty acid is arachidic acid (Claim 7). Lee teaches short carbon chain fatty acids are not preferred as they destabilize the composition (Pg. 3, third paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Paek and Lee to have included arachidic acid into the skin care composition of Paek to arrive at the hyaluronic acid-production promoter of claim 2 with a reasonable expectation of success. The motivation being to provide a stable hyaluronic acid-production promoter (Lee, Pg. 3, third paragraph).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (CN102488674A, publication date 13 June 2012) in view of Lee et al. (WO 2014/084670 A1, publication date 05 June 2014, hereinafter Lee).
The teachings of Wang are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claim 2, Wang anticipates the hyaluronic acid-production promoter of instant claim 1. Wang do not teach the hyaluronic acid-production promoter comprises arachidic acid.
Lee teaches compositions for application to the skin (Title; Abstract). Lee teaches the compositions comprise a fatty acid (Claim 1), wherein the fatty acid is arachidic acid (Claim 7). Lee teaches short carbon chain fatty acids are not preferred as they destabilize the composition (Pg. 3, third paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Wang and Lee to have included arachidic acid into the eye drop preparation of Wang to arrive at the hyaluronic acid-production promoter of claim 2 with a reasonable expectation of success. The motivation being to provide a stable hyaluronic acid-production promoter (Lee, Pg. 3, third paragraph).
Conclusion
Claims 1-2 are rejected.
No claims are allowed.
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/P.S.R./
Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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