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 .
Priority
The instant application is the national stage entry of PCT/KR2019/015926 filed 20 November 2019. Acknowledgement is made of the Applicant’s claim of foreign priority to foreign application KR10-2018-0144467 filed 21 November 2018. A certified translation was provided on 7 April 2025. The effective filing date of the instant claims is 21 November 2018.
Examiner’s Note
Applicant's amendments and arguments filed 24 November 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 24 November 2025, it is noted that no claims have been amended and no new matter or claims have been added.
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.
Claims 1-3 stand rejected under 35 U.S.C. 102a1 as being anticipated by Kang et al. (US 2015/0164754) as evidenced by Lotion Definition (https://dictionary.cambridge.org/us/dictionary/english/lotion).
The Applicant claims, in claim 1, a method for moisturizing skin comprising administering dehydroabietic acid to a subject with reduced moisture in stratum corneum of the skin wherein the dehydroabietic acid increases expression of at least one of filaggrin gene, TGase 1 gene, or HAS2 gene and wherein the dehydroabietic acid is present in 0.001-10 wt%. Claims 2-3 are similar methods with the same active steps but have different intended outcomes on the skin. Since all humans have skin, the patient population is interpreted as being literally any human subject with dry skin. These functional limitations of claims 1-3 are considered inherent in the application of dehydroabietic acid, which is the only agent in the composition. Claims 1-3 further require wherein the composition is a cosmetic or pharmaceutical composition, which is an intended use of the composition that does not impart a structural difference or active step to the claimed method and is thus given minimal patentable weight (See MPEP 2111.02 (II)).
Kang teaches a lotion-type formulation comprising dehydrogenated abietic acid (interpreted as being analogous to dehydroabietic acid) in 3.00 wt% [0049]. Lotion Definition defines a lotion as “a liquid that you put on your skin in order to protect it, improve its condition, or make it smell pleasant” (pg 1). As such it can be at once envisaged that the lotion of Kang is to be used to apply to the skin of a subject, since the definition of a lotion recites application to the skin. The purpose of skin lotion is to improve its condition, which includes improving skin moisture and reducing dry skin, thus typically it applied to dry skin. By applying the lotion to the dry skin, the dehydroabietic acid, which is applied in a concentration which is required in the instant claims, is inherently providing the functional properties as recited in instant claims 1-3. It is noted that “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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Thus claims 1-3 are anticipated by the prior art.
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.
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.
Claims 1-3 stand rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (US 2015/0164754) as evidenced by Lotion Definition (https://dictionary.cambridge.org/us/dictionary/english/lotion).
The Applicant claims, in claim 1, a method for moisturizing skin comprising administering dehydroabietic acid to a subject with reduced moisture in stratum corneum of the skin wherein the dehydroabietic acid increases expression of at least one of filaggrin gene, TGase 1 gene, or HAS2 gene and wherein the dehydroabietic acid is present in 0.001-10 wt%. Claims 2-3 are similar methods with the same active steps but have different intended outcomes on the skin. Since all humans have skin, the patient population is interpreted as being literally any human subject with dry skin. These functional limitations of claims 1-3 are considered inherent in the application of dehydroabietic acid, which is the only agent in the composition. Claims 1-3 further require wherein the composition is a cosmetic or pharmaceutical composition, which is an intended use of the composition that does not impart a structural difference or active step to the claimed method and is thus given minimal patentable weight (See MPEP 2111.02 (II)).
Kang teaches a skin ageing prevention composition comprising dehydrogenated abietic acid (interpreted as being analogous to dehydroabietic acid) (abstract). The acid can be present in amounts from 0.0001-10 wt% [0015]. The acid can be provided in the form of an isomer, precursor, hydrate, or solvate [0006]. The formulation can be a skin lotion, hand cream, or other topical compositions including moisturizing lotions [0032] and can be used cosmetically or pharmaceutically [0029]. Kang specifically exemplifies a lotion-type formulation comprising dehydrogenated abietic acid in 3.00 wt% [0049]. Lotion Definition defines a lotion as “a liquid that you put on your skin in order to protect it, improve its condition, or make it smell pleasant” (pg 1).
It would have been prima facie obvious to prepare the lotion of Kang and use it as a cosmetic or pharmaceutical formulation in a method for treating the skin of a subject. By applying the moisturizing lotion to the skin, the dehydroabietic acid, which is applied in a concentration which is required in the instant claims, is inherently providing the functional properties as recited in instant claims 1-3. It is noted that “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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). Claims 1-3 are accordingly obvious in view of the prior art.
Response to Arguments
Applicant's arguments filed 24 November 2025 have been fully considered but they are not persuasive. The Applicant argues, on pages 5 of their remarks, that the Office has not established that the claimed gene expression effects of claims 1-3 are necessarily present if dehydroabietic acid was applied according to Kang. The Applicant further argues that Kang is targeting different biological pathways in different tissue layers of skin.
In response, first, the instant claims do not provide any specific steps or requirements related to treating only the keratinocytes in the epidermis. Second, the epidermis is top layer of skin that covers over the dermis, thus any treatment of the dermis would necessarily require treatment of the epidermis as well. The moisturizing lotion of Kang is applied to the skin using a concentration of dehydroabietic acid that falls within the claimed range, thus the outcome of application is inherent in the properties of the composition that is applied. Even if the intention of Kang was to target something other than the claimed gene expression, the instantly claimed effects would necessarily occur based on the application of dehydroabietic acid to the skin. The Applicant has not claimed any further modifications to the structure or the composition that would differentiate from the prior art.
The Applicant, on page 6 of their remarks, points to experimental data using HaCaT cells (keratinocytes) and demonstrates specific gene expression changes not taught by Kang.
In response, instant claims 1-3 are all methods of applying a composition to a subject, which implies in vivo application as opposed to the in vitro study cited by the Applicant. Moreover, keratinocytes are in the outer layer of skin and would necessarily be affected by the prior art composition being applied to the skin the same as the claimed invention being applied to the skin. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Conclusion
THIS ACTION IS MADE FINAL. 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 ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613