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 .
DETAILED ACTION
Pursuant to the amendment dated 03/18/2026, claims 9 was amended, claims 1-8 and 10 were canceled and claims 17-20 were newly added. Claims 9 and 11-20 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a National State Application of PCT/KR2020/011318, filed on 08/25/2020.
Withdrawn Rejections
Applicant’s amendment, filed on 03/18/2026, with respect to the rejection of claims 9-16 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Chen et al. (CN 110559418 A, published 12/13/2019, see PTO-892), has been fully considered and is persuasive. Applicant has amended claim 9 to remove specnuezhenide rendering the rejection moot. The rejection is hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) necessitated by Applicants' amendment, filed on
03/18/2026, wherein instant independent claim 9 was amended to alter the breadth and scope of the claim, and wherein the remaining pending claims 11-20 depend from said independent claim 9.
New Grounds of Rejection
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.
Claims 9, 11-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (KR 20180037086 A, published 04/11/2018, see PTO-892) and Bang et al. (Molecules, published 11/25/2015, see PTO-892).
Lee is drawn to compositions for preventing hair loss or stimulating hair growth containing natural extract (title). Lee teaches a composition for promoting an activity of Wnt/β-catenin signaling which has excellent effects on enhancing scalp condition, regenerating follicular cells, preventing hair loss, promoting hair growth and general hair growth by activating Wnt/β-catenin by administration of natural substance extracts to stimulate stem cells under the skin (abstract). Lee teaches a composition comprising a natural extract of Peucedanum preaeruptorum Dunn (claim 1). Lee teaches that the Peucedanum preaeruptorum Dunn was extracted with 70% ethanol (page 4). Lee exemplifies the administration of the extract to rats and the treated groups showed hair growth compared to the untreated groups (page 8). Lee teaches that the extracts act as powerful Wnt/β-catenin signaling up-regulators (page 6 and Fig. 18).
Regarding instant claims 13-15, the extract may be formulated in a hair tonic (page 12).
Regarding instant claim 16, a hair tonic would meet the limitations of a hair care agent.
Lee doesn’t teach that the Peucedanum praeruptorum Dunn extract contains praeruptorin B.
Bang is drawn to a study of pyranocoumarins from Root extracts of Peucedanum praeruptorum Dunn (title). Bang exemplifies a 70% ethanol extraction of Peucedanum praeruptorum Dunn root that contains praeruptorin B in the extract (page 20967).
It would have been prima facie obvious before the effective filing date of the claimed invention to combine the teachings of Lee and Bang by administering a composition comprising an ethanolic extract of Peucedanum praeruptorum Dunn root that contains praeruptorin B as taught by Bang in an amount effective to promote the activity of the Wnt/β-catenin signaling pathway to promote hair growth as taught by Lee to arrive at the claimed invention. It would have been prima facie obvious to administer a composition comprising praeruptorin B in an amount effective to promote the activity of the Wnt/β-catenin signaling pathway to promote hair growth because Lee teaches the administration of a composition comprising an ethanolic extract of Peucedanum praeruptorum Dunn root for hair growth and shows that the extract is a Wnt/β-catenin activator and Bang teaches that an ethanol extract of Peucedanum praeruptorum Dunn root contains praeruptorin B. One of ordinary skill in the art would have a reasonable expectation of success because Lee exemplifies the administration of a composition comprising an ethanolic extract of Peucedanum praeruptorum Dunn root that contains praeruptorin B as taught by Bang in an amount effective to promote the activity of the Wnt/β-catenin signaling pathway and was able to promote hair growth.
Regarding instant claims 11 and 12, it is noted that Lee does not specifically teach that the composition promotes the proliferation of dermal papilla cells and increases the expression of β -catenin in dermal papilla cells. However, since the teachings of the prior art suggests administration of the same active, extract of Peucedanum preaeruptorum Dunn and shows that it promoted the activity of the Wnt/β-catenin signaling pathway, to the same population experiencing hair loss, the result of promoting the proliferation of dermal papilla cells, and increase the expression of β-catenin in dermal papilla cells would necessarily flow, thereby meeting the instant claim limitations. The “promotes the proliferation of dermal papilla cells”, and “increases the expression of β -catenin in dermal papilla cells” is merely a mechanism of action resulting from the administration step. MPEP 2112(II) makes clear that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Furthermore, MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Applicant’s recitation of a new mechanism of action for the prior art method would not, by itself, distinguish the instant claims over the prior art teaching the same or nearly the same method steps.
Claims 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (CN110664703 A, published 01/10/2020, see PTO-892) and Kumar et al. (Asian Journal of Pharmacy and Pharmacology, published 06/22/2019, see PTO-892).
Zhang is drawn to an anti-hair loss shampoo product that comprises an extract of black sesame seed (abstract and claim 1). The black sesame seed was extracted with ethanol (claim 4). Zhang teaches the administration to a subject in need and showed the reduction of hair loss in an experimental group compared to an untreated control group (pages 5-6).
Zhang does not teach that the alcohol sesame seed extract contains the active ingredient sesamoside.
Kumar is drawn to the study of the antiulcer activity of ethanolic extract of Sesamum indicum (title). Kumar teaches that an ethanol extraction of black sesame seed (Sesamum indicum) contains sesamoside (page 1145).
It would have been prima facie obvious to combine the teachings of Zhang and Kumar by administering a composition comprising an ethanolic extract of black sesame seed that contains sesamoside as taught by Kumar in an amount effective to promote hair growth as taught by Zhang to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to select sesamoside as an active ingredient in a composition for promoting hair growth because Zhang teaches a composition that promotes hair growth comprising an ethanol extract of black sesame seed and Kumar teaches that an ethanol extract of black sesame seed contains sesamoside. One of ordinary skill in the art would have a reasonable expectation of success because Zhang teaches a composition that promotes hair growth comprising an ethanol extract of black sesame seed and Kumar teaches that an ethanol extract of black sesame seed contains sesamoside.
Regarding instant claim 9 it is noted that Zhang does not expressly teach that administration of composition would result in promoting the activity of Wnt/β-catenin signaling pathway. However, since the teachings of the prior art teach the administration of the same actives, sesamoside, in an amount to promote hair growth to a subject in need of hair growth, the results would necessarily flow, thereby meeting the instant claim limitations. The instantly claimed results are merely a mechanism of action resulting from the administration step. MPEP 2112(II) makes clear that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Furthermore, MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Applicant’s recitation of a new mechanism of action for the prior art method would not, by itself, distinguish the instant claims over the prior art teaching the same or nearly the same method steps.
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 109820945 A, published 05/31/2019, see PTO-892) and Wu et al. (J. Nat. Med., published 09/24/20016, see PTO-892).
Chen is drawn to a medicine for promoting skin would healing and growth of hair and its preparation method. Chen exemplified applying the composition to a test subject. Chen teaches that the composition comprises an extract of paris polyphylla powder extracted with 75% alcohol (claim 3).
Chen does not teach that the alcohol paris polyphylla extract contains the active ingredient polyphyllin VII.
Wu is drawn to the study of the quantity of polyphyllin I, II, VI, and VII in Paris polyphylla (title). Wu exemplified a methanol extraction of Paris polyphylla (page 141) and showed that the methanol extract contains polyphyllin VII (Fig. 2 page 143).
It would have been prima facie obvious to combine the teachings of Chen and Wu by administering a composition comprising an alcoholic extract of paris polyphylla that contains polyphyllin VII as taught by Wu in an amount effective to promote hair growth as taught by Chen to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to select polyphyllin VII as an active ingredient in a composition for promoting hair growth because Chen teaches a composition that promotes hair growth comprising an alcohol extract of paris polyphylla and Wu teaches that an alcohol extract of paris polyphylla contains polyphyllin VII. One of ordinary skill in the art would have a reasonable expectation of success because Chen teaches a composition that promotes hair growth comprising an alcohol extract of paris polyphylla and Wu teaches that an alcohol extract of paris polyphylla contains polyphyllin VII.
Regarding instant claim 9 it is noted that Chen does not expressly teach that administration of composition would result in promoting the activity of Wnt/β-catenin signaling pathway. However, since the teachings of the prior art teach the administration of the same actives, polyphyllin VII, in an amount to promote hair growth to a subject in need of hair growth, the results would necessarily flow, thereby meeting the instant claim limitations. The instantly claimed results are merely a mechanism of action resulting from the administration step. MPEP 2112(II) makes clear that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Furthermore, MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Applicant’s recitation of a new mechanism of action for the prior art method would not, by itself, distinguish the instant claims over the prior art teaching the same or nearly the same method steps.
Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Omari et al. (JP 2005206475 A, published 05/04/2005, see PTO-892) and Popav et al. (Phytochemistry, published 02/22/1974, see PTO-892).
Omari is drawn to compositions for the scalp and hair (title). The composition was evaluated on subjects and showed to reduce hair loss (page 10). The composition may comprise valerian extract (Formulation example 2, page 16). Omari teaches that the plant extracts may be extracted with a variety of solvents including chloroform (page 5).
Omari does not teach that the valerian extract contains the active ingredient valechlorine.
Popov is drawn to the study of valeportriates found in valeriana officialis (title). Popov teaches that valechlorine is found in a chloroform extract of valeriana officialis (abstract and page 2817).
It would have been prima facie obvious to combine the teachings of Omari and Popov by administering a composition comprising an chloroform extract of valerian that contains valechlorine as taught by Popov in an amount effective to reduce hair loss as taught by Omari to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to select valechlorine as an active ingredient in a composition for reducing hair loss because Omari teaches a composition that reduces hair loss may comprise a chloroform extract of valerian and Popov teaches that a chloroform extract of valerian contains valechlorine. One of ordinary skill in the art would have a reasonable expectation of success because Omari teaches a composition that reduces hair loss may comprise a chloroform extract of valerian and Popov teaches that an chloroform extract of valerian contains valechlorine.
Regarding instant claim 9 it is noted that Omari does not expressly teach that administration of composition would result in promoting the activity of Wnt/β-catenin signaling pathway. However, since the teachings of the prior art teach the administration of the same actives, valechlorine, in an amount to reduce hair loss to a subject in need, the results would necessarily flow, thereby meeting the instant claim limitations. The instantly claimed results are merely a mechanism of action resulting from the administration step. MPEP 2112(II) makes clear that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Furthermore, MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Applicant’s recitation of a new mechanism of action for the prior art method would not, by itself, distinguish the instant claims over the prior art teaching the same or nearly the same method steps.
Response to Arguments
Applicant's arguments filed 03/18/2026 have been fully considered, but they are not persuasive.
Applicant’s arguments with respect to claims 9, 11-16 and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 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.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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