DETAILED ACTION
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
Receipt is acknowledged of Applicants’ amendment and remarks, filed on 10/02/2025, in which claims 1-5 are amended and claims 6-11 are canceled.
Claims 1-5 are pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/KR2021/005465 04/29/2021, which claims foreign priority to KR 10-2020-0114895 filed on 09/08/2020, and KR-10-2020-0114893 filed on 09/08/2020.
Rejections Withdrawn
Applicant’s amendment and remarks, filed 10/02/2025, with respect that claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rho has been fully considered and is persuasive, as claims 1-5 have been amended to specify a method of use and claim 6 has been canceled. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/02/2025, with respect that claims 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Rho has been fully considered and is persuasive, as claims 7-11 are canceled. This rejection has been withdrawn.
The following are new grounds of rejection necessitated by Applicant’s amendment, in which claims 1-5 are amended to recite a method of use.
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Dhariwala et al. (J Cosmet Dermatol. 2019; PTO-892 07/17/2025) in view of Rho et al. (Journal of Ethnopharmacology, 2019; PTO-892 07/17/2025).
Dhariwala teaches methods of treatment for Androgenetic alopecia (AGA), which is also known as male pattern hair loss (page 966, paragraph 1). Dhariwala teaches that AGA is generally an androgen hormone‐dependent process in which testosterone is converted into an active androgen dihydrotestosterone (DHT) by enzyme 5‐alpha‐reductase. DHT binds to androgen receptors present in the hair follicles triggering a process diminishing the anagen phase and over a period of time the terminal hair converts into a thinner and shorter vellus hair. (paragraph bridging pages 966-967). AGA needs long‐term treatment, and there are side effects and toxicities associated with the conventional FDA approved drugs. Herbal sources can provide beneficial treatment along with minimum side effects when compared to the conventional marketed drugs (paragraph bridging pages 966-967). Dhariwala teaches that herbal drugs can be more advancing than conventional when used topically on the scalp (paragraph bridging pages 974-975). Dhariwala demonstrates that topical treatments including topical cream and shampoo are used as formulations for alopecia treatment (table 4). Finasteride is used to treat AGA but its oral treatment has been found to show adverse effects (page 967, paragraph 3). Finasteride inhibits the enzyme 5‐alpha‐reductase preventing the conversion of testosterone to DHT (paragraph bridging pages 974-975).
Dhariwala does not teach the treatment of alopecia using catechin 7-O-β-apiofuranoside (instant claim 1).
Rho investigates the therapeutic potential of extracts of Ulmus macrocarpa Hance (UMH) in the treatment of benign prostatic hyperplasia (BPH) (page 116, paragraph 2). Rho teaches that sex steroid hormone mediated alterations in prostate growth have emerged as a core factor in BPH development. In particular, the prostate synthesizes dihydrotestosterone (DHT) from circulating testosterone via 5-alpha reductase. DHT then binds to androgen receptors (ARs) and promotes protein synthesis and growth of prostate cells (page 116, paragraph 1). Because the enzyme 5-alpha reductase converts testosterone to DHT, many studies have sought to reduce DHT levels by inhibiting 5-alpha reductase (paragraph bridging pages 121-122). The serum concentrations of testosterone and DHT decrease with age in healthy men, but DHT production is significantly elevated in men with BPH. Given the importance of DHT in the development of BPH, specific inhibitors of 5-alpha reductase, such as finasteride and dutasteride, are used to treat BPH (page 116, paragraph 1).
Several experimental studies have shown that UMH has many biological activities, including anti-oxidation, anti-inflammatory, anti-tumor, anti-allergic, and anti-platelet properties (page 116, paragraph 2). Extracts of U. macrocarpa include the components catechin 7-O-β-apiofuranoside, catechin, and catechin 3-O-α-L-rhamnopyranoside (page 116, paragraph 6 and figure 1, reproduced below).
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Oral treatment of BPH rats with UMH extracts showed that the prostatic DHT level was higher in the BPH group than in the negative control group, but lower in the finasteride and UMH groups compared to the BPH group, with the DHT level significantly reduced in the UMH group compared to the BPH group (page 118, paragraph 1 and figure 4). Thus the present study confirmed that finasteride and UMH reduced DHT levels and that UMH inhibits the pathogenesis of BPH in rats by a reduction in DHT level (paragraph bridging pages 121-122).
One of ordinary skill in the art would have been motivated to substitute the topical administration of finasteride as disclosed by Dhariwala, with the oral administration of the UMH extract of Rho, which comprises catechin 7-O-β-apiofuranoside, in the treatment of AGA because Dhariwala teaches that finasteride treats AGA by inhibiting the enzyme 5‐alpha‐reductase and thereby preventing the conversion of testosterone to DHT, and Rho teaches that both finasteride and UMH extracts significantly reduced DHT levels in rats. One of ordinary skill in the art would have had a reasonable expectation of success in treating AGA using the UMH extract of Rho because Dhariwala teaches that treatment of AGA using finasteride has been found to show adverse effects whereas herbal sources can provide beneficial treatment along with minimum side effects when compared to the conventional marketed drugs.
Regarding instant claims 2 and 4, the instant claims recite wherein the compound catechin 7-O-β-apiofuranoside has an activity of inhibiting production of DHT form testosterone or of inhibiting apoptosis caused by oxidative stress in dermal papilla cells, respectively. However, the cited recitations are considered a property of the chemical compound 7-O-β-apiofuranoside, and are necessarily present in the 7-O-β-apiofuranoside taught by Rho. MPEP 2112.01(II) states 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. Thus the composition in the method suggested by Dhariwala and Rho necessarily contains the properties recited in instant claims 2 and 4.
Response to Arguments
Applicant's arguments filed 10/02/2025 have been fully considered but they are not persuasive.
Insofar as Applicant’s arguments are applicable to the current rejections, Applicant argues that because Dhariwala teaches the use of topical finasteride and does not recommend oral administration of finasteride as the treatment of AGA using oral finasteride has been found to show adverse effects, one of ordinary skill in the art would therefore have no motivation for exchanging the treatment of topical finasteride with the treatment of oral catechin 7-O-β-apiofuranoside (remarks, paragraph bridging pages 5-6). This is not persuasive.
As demonstrated in the above grounds of rejection, Dhariwala teaches that finasteride treats AGA by inhibiting the enzyme 5‐alpha‐reductase and thereby preventing the conversion of testosterone to DHT, and Rho teaches that both finasteride and UMH extracts significantly reduced DHT levels in rats and teaches that the UMH extract, which comprises catechin 7-O-β-apiofuranoside, is orally administered. Therefore one of ordinary skill in the art would have orally administered the catechin 7-O-β-apiofuranoside containing composition, and would have had a reasonable expectation of success in treating hair loss by doing so because it is demonstrated to reduce DHT levels. Furthermore, Dhariwala teaches that herbal sources for the treatment of treatment of AGA can provide beneficial treatment along with minimum side effects when compared to the conventional marketed drugs, and thus one of ordinary skill in the art would not expect that administration of the oral catechin 7-O-β-apiofuranoside would necessarily result in the same side effects observed in the administration of finasteride.
Because Applicant’s arguments are not persuasive, the instant claims are rejected for the reasons of record with modifications made to account for the claim amendments filed 10/02/2025.
Conclusion
No claims are 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 extension fee 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 date of this final action.
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/S.G.H./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693