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 . Claims 3-6 and 8-9 filed March 25, 2026 are currently pending.
Status of Claims
As indicated in the Office Action of 03/25/2026, Applicant’s election without traverse of Group (II) claims 3-9 in the reply filed on 11/05/2025 is acknowledged. Claims 3-6 and 8-9 are the subject matter of this Office Action.
Response to Amendment
Applicant’s amendments, filed 03/25/2026 are acknowledged. Claim 7 has been canceled in its entirety.
Claim 3 has been amended as follows: A method for improving skin condition, comprising applying an anti-inflammatory composition comprising araliadiol or a pharmaceutically acceptable salt thereof as an active ingredient to a subject's skin, wherein the composition reduces at least one of NO production, PGE2 production, IL-la expression, and TNF-a expression
Claim 5 has been amended as follows: A method for treating an inflammatory skin disease, comprising administering an anti-inflammatory composition comprising araliadiol or a pharmaceutically acceptable salt thereof as an active ingredient to a subject in need thereof, wherein the subject requires reducing at least one of NO production, PGE2 production, IL-la expression, and TNF-a expression.
Claim 8 has been amended as follows: A method for improving skin condition associated with inflammation, comprising consuming a food composition comprising an anti-inflammatory composition comprising araliadiol or a pharmaceutically acceptable salt thereof as an active ingredient, wherein the composition reduces at least one of NO production, PGE2 production, IL-la expression, and TNF-a expression.
Applicant's arguments, filed 03/25/2026 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and objections presently being applied to the instant application.
Claim Rejections - 35 USC § 102-Rejection Maintained
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.
Claim(s) 3-5 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rittinghausen (US2004/0131706 published 07/08/2004).
Rittinghausen is directed to the treatment of inflammatory skin diseases such as urticaria, pruritis, atopic eczema, neurodermatitis and psoriasis in a subject in need comprising administering a therapeutically effective amount of an alcoholic extract of centella asiatica ([0046]-[0048], claims 1-2). Said inflammatory skin disorders of urticaria, pruritic, atopic eczema, neurodermatitis and psoriasis read on the genus of “inflammatory skin disorders” found in page 9 of the instant specification and the present claims. As evidenced by Johns Hopkins Medicine neurodermatitis is a species of the genus dermatitis (Table 1). Topical administration of said alcohol extract of centella asiatica to the afflicted subject is embodied within the teachings of Rittinghausen, including creams and gels. Regarding claim 8, oral administration of said extract in tablet or solution form is also embodied within the teachings of Rittinghausen ([0053]-[0055], claims 8, 12-13). Rittinghausen additionally teaches extracting centella asiatica with a range of ≥30% ethanol and ≤70% water ([0028]-[0031]).
As evidenced by page 3 paragraph 1 of the instant specification, the claimed araliadiol is a natural substance obtained from centella asiatica. As further evidenced by Hara (WO2021/085232 published 05/06/2021 with English translation found in US2022/0401377 published 12/22/2022),the claimed araliadiol or Formula (I)) is isolated from the centella asiatica/Gotu kola plant using ≥30% ethanol/water mixture ([0034], [0050]-[0058], [0067]). As such, the administered centella asiatica extract isolated with a ≥30% ethanol and ≤ 70% water solution taught by Rittinghausen must comprise the claimed araliadiol as Hara teaches that the claimed araliadiol or Formula (I)) is present and isolated from the same centella asiatica/Gotu kola plant using ≥30% ethanol/water mixture found in Rittinghausen ([0003], [0023], [0070]-[0073]) ([0028]-[0031]).
Regarding the limitation of “wherein the composition reduces at least one of NO production, PGE2 production, IL-1alpha expression and TNF alpha expression”, such a limitation is not given patentable weight as it simply expresses the intended result of the administered centella asiatica extract isolated with a ≥30% ethanol and ≤ 70% water solution taught by Rittinghausen to the patient with the inflammatory skin disorder. See MPEP 2111.04 wherein a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.
Furthermore, although Rittinghausen is silent on said properties, the compound (a greater than 30% ethanol extract of centella asiatica/Gotu kola plant art-recognized as containing the claimed araliadiol), the active step of administration, the route of administration (topical or oral) and the same patient population (a patient with the skin inflammatory disorder such as urticaria, pruritis, atopic eczema, neurodermatitis and psoriasis) are identical to that of instantly claimed. Therefore, the property of the compound to " reduce at least one of NO production, PGE2 production, IL-1a expression or TNF-alpha expression” in the treated patient must necessarily be present in the prior art regimen of Rittinghausen, because products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the prior art teaches the identical chemical or physical structure of the composition, (i.e., the same active agent, a ≥30% ethanol extract of centella asiatica/Gotu kola plant art-recognized as containing the claimed araliadiol), and the composition is used in the same manner (i.e., administered in the same topical manner to the same dermatitis subject), the properties that Applicant discloses and/or claims must necessarily be present. Furthermore, as stated in MPEP 2112.02, “[u]nder the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered anticipated by the prior art device.”
Lastly, regarding the limitation of claim 5 wherein the subject requires reducing at least one of NO production, PGE2 production, IL-1a expression or TNF-alpha expression, as evidenced by Sand (Journal of Allergy Vol. 2013 pages 1-4 published 2013), the pathogenesis of chronic urticaria involves TNF-alpha, wherein TNF-alpha is upregulated in patients with chronic urticaria compared to healthy controls. TNF-alpha is also expressed in lesional and non-lesional skin of patients with chronic urticaria but not in skin of healthy control patients (page 3 right col.). As such, the examiner has interpreted that the patient with urticaria embodied within the teachings of Rittinghausen comprises upregulated TNF-alpha is a subject that requires reducing TNF-alpha expression, which reads on the presently claimed methodology.
Applicant traverses. Applicant’s argues that Rittinghausen does not disclose any specific extraction conditions for Centella asiatica but merely describes use of an alcohol tincture containing mixture of various components. Applicant further argues that Rittinghausen does not identify which component of the tincture is responsible for any of the therapeutic effect on skin disorders, let alone effects obtained by reducing at least one of NO production, PGE2 production, IL-1a expression or TNF-alpha expression.
Response to Arguments
Applicant’s arguments, filed 03/25/2026 are acknowledged and have been carefully considered. Regarding Applicant’s contention that Rittinghausen does not disclose any specific extraction conditions for Centella asiatica but merely describes use of an alcohol tincture containing mixture of various components, this argument is unpersuasive.
Rittinghausen is directed to the treatment of the same inflammatory skin diseases embodied within the present claims comprising topically administering a therapeutically effective amount of an alcoholic extract of centella asiatica obtained by extracting with a solvent combination of ≥30% ethanol and ≤70% water (([0028]-[0031] [0046]-[0048], claims 1-2). As evidenced by page 3 paragraph 1 of Applicant’s own specification, the claimed araliadiol is a natural substance obtained from centella asiatica. As further evidenced by Hara (WO2021/085232 published 05/06/2021 with English translation found in US2022/0401377 published 12/22/2022),the claimed araliadiol or Formula (I)) is isolated from the centella asiatica/Gotu kola plant using ≥30% ethanol/water mixture ([0034], [0050]-[0058], [0067]). As such, the administered centella asiatica extract isolated with the ≥30% ethanol and ≤ 70% water solution taught by Rittinghausen must comprise the claimed araliadiol as Hara teaches that the claimed araliadiol or Formula (I)) is present and isolated from the same centella asiatica/Gotu kola plant using ≥30% ethanol/water mixture found in Rittinghausen ([0003], [0023], [0028]-[0031], [0070]-[0073]).
Regarding Applicant assertion that Rittinghausen does not identify which component of the tincture is responsible for any of the therapeutic effect on skin disorders, let alone effects obtained by reducing at least one of NO production, PGE2 production, IL-1a expression or TNF-alpha expression, this argument is unavailing. The administered centella asiatica extract isolated with the ≥30% ethanol and ≤ 70% water solution taught by Rittinghausen comprising the claimed araliadiol must be responsible for treating the inflammatory skin disorders as claimed as products of identical chemical composition cannot have mutually exclusive properties." 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. Please see MPEP 2112 and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Thirdly, the limitation of “wherein the composition reduces at least one of NO production, PGE2 production, IL-1alpha expression and TNF alpha expression” is not given patentable weight as it simply expresses the intended result of the administered centella asiatica extract isolated with a ≥30% ethanol and ≤ 70% water solution taught by Rittinghausen to the patient with the inflammatory disorder. See MPEP 2111.04 wherein a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.
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.
Claim(s) 3-6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Rittinghausen (US2004/0131706 published 07/08/2004), Akyol (WO2019/132850 published 07/04/2026) and Takahashi (WO2022/202748 published 09/29/2022 with English translation found in US2024/1089233 published 06/13/2024).
Rittinghausen is directed to the treatment of inflammatory skin diseases such as urticaria, pruritis, atopic eczema, neurodermatitis and psoriasis in a subject in need comprising administering a therapeutically effective amount of an alcoholic extract of centella asiatica ([0046]-[0048], claims 1-2). Said inflammatory skin disorders of urticaria, pruritic, atopic eczema, neurodermatitis and psoriasis read on the genus of “inflammatory skin disorders” found in page 9 of the instant specification and the present claims. Topical administration of said alcohol extract of centella asiatica to the afflicted subject is embodied within the teachings of Rittinghausen, including creams and gels. Regarding claim 8, oral administration of said extract in tablet or solution form is also embodied within the teachings of Rittinghausen ([0053]-[0055], claims 8, 12-13). Rittinghausen additionally teaches extracting centella asiatica with a range of ≥30% ethanol and ≤70% water ([0028]-[0031]).
As evidenced by page 3 paragraph 1 of the instant specification, the claimed araliadiol is a natural substance obtained from centella asiatica. As further evidenced by Hara (WO2021/085232 published 05/06/2021 with English translation found in US2022/0401377 published 12/22/2022),the claimed araliadiol or Formula (I)) is isolated from the centella asiatica/Gotu kola plant using ≥30% ethanol/water mixture ([0034], [0050]-[0058], [0067]). As such, the administered centella asiatica extract isolated with a ≥30% ethanol and ≤ 70% water solution taught by Rittinghausen must comprise the claimed araliadiol as Hara teaches that the claimed araliadiol or Formula (I)) is present and isolated from the same centella asiatica/Gotu kola plant using ≥30% ethanol/water mixture found in Rittinghausen ([0003], [0023], [0070]-[0073]) ([0028]-[0031]).
Regarding the limitation of “wherein the composition reduces at least one of NO production, PGE2 production, IL-1alpha expression and TNF alpha expression”, such a limitation is not given patentable weight as it simply expresses the intended result of the administered centella asiatica extract isolated with a ≥30% ethanol and ≤ 70% water solution taught by Rittinghausen to the patient with the inflammatory skin disorder. See MPEP 2111.04 wherein a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.
Additionally, while Rittinghausen is silent on said properties, the compound (a greater than 30% ethanol extract of centella asiatica/Gotu kola plant art-recognized as containing the claimed araliadiol), the active step of administration, the route of administration (topical or oral) and the same patient population (a patient with the skin inflammatory disorder such as urticaria, pruritis, atopic eczema, neurodermatitis and psoriasis) are identical to that of instantly claimed. Therefore, the property of the compound to " reduce at least one of NO production, PGE2 production, IL-1a expression or TNF-alpha expression” in the treated patient must necessarily be present in the prior art regimen of Rittinghausen, because products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the prior art teaches the identical chemical or physical structure of the composition, (i.e., the same active agent, a ≥30% ethanol extract of centella asiatica/Gotu kola plant art-recognized as containing the claimed araliadiol), and the composition is used in the same manner (i.e., administered in the same topical manner to the same dermatitis subject), the properties that Applicant discloses and/or claims must necessarily be present. Furthermore, as stated in MPEP 2112.02, “[u]nder the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered anticipated by the prior art device.”
Regarding the limitation of claims 5-6 wherein the subject requires reducing at least one of NO production, PGE2 production, IL-1a expression or TNF-alpha expression, as evidenced by Johns Hopkins Medicine neurodermatitis is a species of the genus dermatitis (Table 1). Akyol (WO2019/132850 published 07/04/2019) additionally teaches that TNF-alpha is a cytokine that is critical for induction of inflammation in dermatological disorders including neurodermatitis (lichen simplex chronicus; see Medical News Today), pruritis, atopic eczema, neurodermatitis and psoriasis (page 7 lines 1-20). As such, the examiner has interpreted that the patient with neurodermatitis or pruritic or atopic eczema embodied within the teachings of Rittinghausen comprises upregulated TNF-alpha is a subject that requires reducing TNF-alpha expression, which reads on the presently claimed methodology.
The difference between the presently claimed methodology and that of Rittinghausen is that Rittinghausen does not specifically teach oral administration of araliadiol in the alcohol extract of centella asiatica, wherein the alcohol extract of centella asiatica is administered in a food composition.
Takahashi (WO2022/202748 published 09/29/2022 with English translation found in US2024/0189233 published 06/13/2024) teaches preparation of functional foods and beverages comprising araliadiol, extracted from centella asiatica/Gotu kola plant using greater than 30% ethanol/water mixture ([0003], [0023], [0044], [0052]-[0053], [0060]-[0061] [0070]-[0073]). Takahashi teaches that araliadiol is difficult to formulate into a food or beverage on its own, due to its poor dispersibility in water ([0044]). Takahashi teaches formulating said araliadiol into a powder with dextrin followed by formulating said araliadiol-powder into a beverage ([0044], [0052]-[0053], [0060]-[0061]).
Therefore, one of ordinary skill in the art of treating the inflammatory skin disorder neurodermatitis in a subject, knowing that topical and oral administration of an ≥30% ethanol/water mixture extract of centella asiatica is efficacious at treating the inflammatory skin disorder neurodermatitis in a subject coupled with the knowledge that the claimed araliadiol is present and isolated from the same centella asiatica/Gotu kola plant using 30% ethanol/water mixture as taught by Hara, said skilled artisan would have found it prima facie obvious to formulate the ≥30% ethanol/water mixture extract of centella asiatica containing araliadiol in a powder form with dextrin and add said powder to a beverage for administration in view of Takahashi.
MPEP 2143 provides rationale for a conclusion of obviousness including (A): Combining prior art elements according to known methods to obtain predictable results;
In the present case, it was known in the art to formulate araliadiol, present in the centella asiatica/Gotu kola plant extract, into a powder with dextrin followed by formulating said araliadiol-powder into a beverage, as araliadiol is difficult to formulate into a food or beverage on its own due to its poor dispersibility in water ([0044], [0052]-[0053], [0060]-[0061]). Accordingly, said skilled artisan would have applied to araliadiol-beverage formulation strategy of Takahashi to the orally administered neurodermatitis treating centella asiatica extract of Rittinghausen, arriving at the claimed therapeutic regimen with a reasonable expectation of success.
Applicant traverses. Applicant asserts that neither Rittinghausen nor Takahashi teach the inhibition of NO production, PGE2 production, IL-1a expression or TNF-alpha expression by the ethanolic centella asiatica extract containing araliadiol administered to the patient with inflammatory skin disorders. Applicant further argues that there would be no reasonable expectation that the combination would effectively reduce the production or expression of these inflammatory factors.
Response to Arguments
Applicant’s arguments, filed 03/25/2026 are acknowledged and have been carefully considered. Arguments directed to the teachings of Rittinghausen have been addressed above. Regarding Applicant’s contention that neither Rittinghausen nor Takahashi teach the inhibition of at least one of NO production, PGE2 production, IL-1a expression or TNF-alpha expression by the ethanolic centella asiatica extract containing araliadiol administered to the patient with neurodermatitis, nor that there would be no reasonable expectation that the combination would effectively reduce the production or expression of these inflammatory factors, these arguments are unpersuasive.
Applicant is reminded that the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. See MPEP 2112 and Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).. In the present case, Rittinghausen teaches topical or oral administration of the same ethanolic extract of centella asiatica that contains araliadiol as evidenced by Applicant’s own specification and Hara above, to treat the inflammatory disorder of neurodermatitis. As such, said araliadiol containing centella asiatica extract must inhibit NO production, PGE2 production, IL-1a expression or TNF-alpha expression as 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. It is also noted that MPEP 2112 discussed the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
In the present case, the burden was shifted in the previous Office Action to Applicant to prove that the same ethanolic extract of centella asiatica that contains araliadiol as evidenced by Applicant’s own specification and Hara above, administered in the same therapeutically effective amount to treat the dermatological inflammatory disorder neurodermatitis as taught by Rittinghausen above does not inhibit NO production, PGE2 production, IL-1a expression or TNF-alpha expression in the administered patient. However, Applicant has not provided any objective evidence that said administered composition does not inhibit NO production, PGE2 production, IL-1a expression or TNF-alpha expression in the administered patient. Therefore, the rejection of record is maintained.
Conclusion
In view of the rejections set forth above, no claim 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 GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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