Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
The Amendments filed on 5/29/2026 has been received and entered.
Currently, Claims 32 and 34-39 are pending. Claims 32 and 34-39 are examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated below are hereby withdrawn.
Election/Restrictions
Applicant’s election without traverse of Psoralea corylifolia, seeds in the reply filed on Feb. 7, 2023 is acknowledged.
Response to Amendment
Claim Rejections - 35 USC § 103
Claims 32, and 33-39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Murali et al. (from IDS) in view of Harrison et al. (GB 2108844 A) for the reasons set forth in the previous Office Action, which is set forth below. All of Applicant's arguments regarding this ground of rejection have been fully considered but are not persuasive. Claims 32, and 34-39 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Murali et al. (from IDS) in view of Harrison et al. (GB 2108844 A). This is not a new rejection.
Murali et al. teaches Psoralea corylifolia seeds extracted with methanol for 10-15 minutes with reflux (page 77, 2.3 Extraction of Plant Material). The percentage recovery of bakuchiol was 100.4 (page 78, 2.9 Estimation of psoralen, bakuchicin and bakuchiol in samples and recovery studies). HPLC is used to standardization of Psoralea corylifolia bioactive compound of bakuchiol as markers (page 78, 3. Results and Discussion). The concentration of bakuchiol would be 100% because markers are pure of free of contaminants and bakuchiol are separated from psoralen and bakuchicin. Psoralen is a furanocoumarin. Psoralea corylifolia are useful for leukoderma, ulcers, scables, leprosy, dermatitis, exhibiting anti-inflammatory, antipyretic, analgesic and antifungal activities (page 76, Introduction, left column). Furanocoumarin impurities would be converted into salts of carboxylic acids and removed from the composition because the bakuchiol is pure and has no contaminants.
However, Murali et al. does not teach 65-95% paraffin, up to 7% lanolin or a lanolin derivative, range of about 14-30% bakuchiol.
Harrison et al. teaches a composition for treating dermatological condition such as dermatitis with 15-90% by weight of a carrier, for example, paraffin, lanolin (page 7, lines 67-105).
The reference also does not specifically teach formulating the composition in the forms claimed by applicant and using 65-95% paraffin, up to 7% lanolin or a lanolin derivative. These pharmaceutical forms are well known in the art to be acceptable means of administering a pharmaceutically active substance. Based on this knowledge, a person of ordinary skill in the art would have had a reasonable expectation that formulating the composition taught by the references in the claimed forms would be successful. Therefore, an artisan of ordinary skill would have been motivated to formulating the composition taught by the reference in the forms claimed by applicant.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising about 14-30% bakuchiol of the for the following reasons. The reference does teach the composition for treating skin. Murali et al. teaches Psoralea corylifolia are useful for leukoderma, ulcers, scables, leprosy, dermatitis, exhibiting anti-inflammatory, antipyretic, analgesic and antifungal activities (page 76, Introduction, left column). Thus, it would have been obvious to make a concentrated composition containing both flavonoids and tocotrienols for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Response to Arguments
Applicant argues that there is no teaching of converting furanocoumarin into salts of carboxylic acids.
In response to Applicant’s argument, the claim is drawn toward a product of bakuchiol extract without furanocoumarin. Murali et al. teaches Psoralea corylifolia seeds extracted with methanol for 10-15 minutes with reflux (page 77, 2.3 Extraction of Plant Material). The percentage recovery of bakuchiol was 100.4 (page 78, 2.9 Estimation of psoralen, bakuchicin and bakuchiol in samples and recovery studies). The isolated bakuchiol extract does not have impurities. The conversion of furanocoumarins is for removing the impurities. The claim is for pure bakuchiol; therefore, an isolated bakuchiol free of impurities would meet the limitation as claimed.
Applicant argues that the reference does not teach isolation of the bakuchiol.
In response to Applicant’s argument, Murali et al. teaches Psoralea corylifolia seeds extracted with methanol for 10-15 minutes with reflux (page 77, 2.3 Extraction of Plant Material). The percentage recovery of bakuchiol was 100.4 (page 78, 2.9 Estimation of psoralen, bakuchicin and bakuchiol in samples and recovery studies). Thus, isolation of pure bakuchiol is taught.
Applicant argues that a large scale production is not taught.
In response to Applicant’s argument, the claims are drawn toward a topical composition. There is no claim for production in a large scale.
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.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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