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 3-9 filed November 05, 2025 are currently pending. Claims 3, 5 and 8 are independent.
Election/Restrictions
Applicant’s election without traverse of Group (II) claims 3-9 in the reply filed on 11/05/2025 is acknowledged. Claims 3-9 are the subject matter of this Office Action.
Priority
Acknowledgement is made of the continuation PCT/KR2023/021224 filed 12/27/2023 which claims foreign priority to Application 10-2023-0005504 filed 01/13/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/10/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 3-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheon (KR10-2017-0061805 published 06/07/2017; machine translation provided).
Claim 3 is directed to a method for preventing dermatitis and 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.
Claim 5 is directed to a method for preventing or 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. Applicant is reminded of MPEP 2111.03 wherein the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). In the present case, the pending claims do not exclude additional unrecited elements such as additional therapeutic agents including neomycin or salicylic acid.
Prevention reads on preventing the recurrence of a disease or disorder as recited in page 9 of the instant specification. Thus, the examiner has interpreted the phrasing of “preventing dermatitis and improving skin condition” in claim 3 to read on preventing the reoccurrence of the disorder and suppressing the progression of the dermatological disorder. In addition, “improving” in page 8 of the specification reads on suppress the progression or worsening the symptoms to stop advancement of damage. Thus, the examiner has interpreted that treating symptoms of dermatitis reads on “improving skin condition”.
Cheon (KR10-2017-0061805 published 06/07/2017; machine translation provided) teaches treating atopic dermatitis in a subject in need comprising topically administering a composition comprising 0.1-1.5 g of an alcoholic extract of centella asiatica, neomycin sulfate an salicylic acid (claims 1-2, page 17). As evidenced by John’s Hopkins Medicine (published 2025), atopic dermatitis is a species of the genus dermatitis (Table 1). Topical administration of said composition in the form of an emulsion or cream is embraced within the teachings of Cheon (page 17).
As shown in Figures 9-10 and Table 1, topical administration of said centella asiatica extract results in improved symptoms including a reduction of itching as well as improving skin regeneration (page 18). Preventing the reoccurrence of said atopic dermatitis with the centella asiatica extract is also embodied within the teachings of Cheon (page 16). 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 an ethanol/water mixture ([0034], [0050]-[0058], [0067]). As such, the administered centella asiatica extract isolated with alcohol as taught by Cheon 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 of Cheon using an ethanol/water mixture. Accordingly, the topically administered alcoholic extract of centella asiatica treating atopic dermatitis in the regimen of Cheon reads on the topical administration of araliadiol to treat dermatitis in a subject in need and prevent reoccurrence of the disorder, which anticipates the present claims.
Lastly, regarding claim 7 and the limitation wherein the subject requires reducing at least one of NO production, PGE2 production, IL-1alpha expression or TNF-alpha expression, the examiner has interpreted that the atopic dermatitis patient treated with the alcoholic extract of centella asiatica embodied within the teachings of Cheon reads on the presently claimed patient population.
Claim(s) 3-8 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 neurodermatitis comprising administering a therapeutically effective amount of an alcoholic extract of centella asiatica ([0046]-[0048], claims 1-2). As evidenced by John’s Hopkins Medicine neurodermatitis is a species of the genus dermatitis (Table 1). Rittinghausen teaches extracting centella asiatica with a range of ≥30% ethanol and ≤70% water ([0028]-[0031]).
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).
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]).
Although the property of preventing dermatitis is not explicitly described in the cited prior art of Rittinghausen, 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 neurodermatitis) are identical to that of instantly claimed. Therefore, the property of the compound to "prevent the reoccurrence of dermatitis” 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 wherein the subject requires reducing at least one of NO production, PGE2 production, IL-1a expression or TNF-alpha expression, the examiner has interpreted that the patient comprising the inflammatory skin disorder of neurodermatitis embraced within Rittinghausen reads on the presently claimed.
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) 3-9 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Rittinghausen (US2004/0131706 published 07/08/2004) and Takahashi (WO2022/202748 published 09/29/2022 with English translation found in US2024/1089233 published 06/13/2024).
Rittinghausen (US2004/0131706 published 07/08/2004) is directed to the treatment of inflammatory skin diseases such as neurodermatitis comprising administering a therapeutically effective amount of an alcoholic extract of centella asiatica ([0046]-[0048], claims 1-2). As evidenced by Johns Hopkins Medicine neurodermatitis is a species of the genus dermatitis (Table 1). Rittinghausen teaches extracting centella asiatica with a range of ≥30% ethanol and ≤70% water ([0028]-[0031]).
Topical administration of said alcohol extract of centella asiatica to the afflicted subject is embodied within the teachings of Rittinghausen, including creams and gels. Oral administration of said centella asiatica extract in tablet or solution form is also embraced within the teachings of Rittinghausen ([0053]-[0055], claims 8, 12-13).
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 ≥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 greater than 30% ethanol/water mixture ([0003], [0023], [0070]-[0073]).
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 US2024/1089233 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.
Conclusion
In view of the rejections set forth above, no claim is allowed.
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/Examiner, Art Unit 1621