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 .
This office action is in response to the reply filed 7/15/2025
Response to Arguments
Applicant’s arguments and the declaration of Anthony Pegard filed 7/15/2025 have been fully considered.
Rejections under 103
In view of the amendments and filed declaration, Applicant arguments regarding the JP’558 are persuasive, as such the rejection is withdrawn and new 103 rejections are presented below.
Applicant argues that the claims are amended in view of Examiner comments regarding synergism only being shown for a specific composition.
While the claim are narrower in scope, the data presented by Applicant is still not persuasive as it does not have a nexus to the claimed invention. For example, the data presented tests essential oils in a medium, but no indication is given as to what this medium is. This it’s unclear if the extract would have the same effect when present in any and all compositions embraced by the claims. Furthermore, it seems the essential oil combinations are used in concentrations ranging from 30-16ppm however, the claims do not recite any concentration amounts and do not recite a minimal amount of extract that needs to be used to produce the desired effect. It is also noted that in all working examples the different extracts are used in a 1:1 ratio, but the claims are not limited to this. Applicant have also not explained how the results obtained are significant and unexpected. The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992), the data must be different in kind and not merely in degree from the results of the prior art. Two of the claimed extracts are taught by the prior art to be effective at improving hair growth, therefore, even if we agreed that the claimed method provided synergistic results, more would be required to show nonobviousness, as synergism is not per se unexpected. See In re Diamond, 360 F. 2d 214, 218 ( CCPA 1966). (“What section 103 requires is ‘unexpected synergism’ ... “ (pg. 216, n.7); “we attribute no magic status to synergism per se since it may be expected or unexpected"” (pg. 218)(emphasis added)).
New 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.
Claim(s) 1, 4 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR100848800 and Legge (US 2016/0256509). Legge is newly cited.
KR’800 discloses a cosmetic composition comprising 0.0001-5% pepper oil extracted from Schinus terebinthifolius and teaches the composition to be used to inhibit hair loss and promote hair growth, which reads on promoting hair growth. The composition is also has anti-inflammatory and anti-oxidant properties (Abs). KR’800 teaches the essential oil of the fruit to be separated by steam distillation, reading on essential oil of instant claim 1. KR’800 teaches topical application to be preferred (pg. 4) and teaches application of the composition to treat hair loss (Ex. 11).
KR’800 teaches that additional ingredients commonly used in cosmetics can be added, such as antioxidants, stabilizers, skin absorption promoting agents, etc. (pg. 3).
However, KR’800 does not teach the presence of black pepper (i.e. Piper Nigrum) oil.
Legge discloses topically administrable vasodilator formulation that comprises arginine and/or one or more derivatives thereof, black pepper extract and/or one or more components or derivatives thereof; and peppermint extract and/or one or more components or derivatives thereof (Abs). Legge teaches black pepper is preferably an essential oil and is used in amounts ranging from 0.01-25% [0094 and 0115]. Legge teaches black pepper essential oil to comprise terpenes that can enhance the permeation of both hydrophilic and lipophilic drugs. Black pepper essential oil induces a warming sensation when applied to the skin due to local dilation of microcirculation to the skin, which is capable of enhancing percutaneous absorption of the active ingredients [0118]. Legge teaches compositions for reducing hair loss and enhancing hair regrowth and these comprise black pepper essential oil (table 4).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of KR’800 with those of Legge. One of skill in the art would have been motivated to add black pepper essential oil to the composition of KR’800 as Legge teaches black pepper essential oil to be a suitable ingredient for use in hair growth promoting compositions and teaches black pepper essential oil to be effective at enhancing percutaneous absorption of the active ingredients. One of skill in the art would have a reasonable expectation of success as both KR’800 and Legge teaches methods of promoting hair growth comprising essential oils and KR’800 teaches that additional cosmetically active ingredients, such as absorption enhancers can be effectively added.
Regarding claim 8: As discussed above, the prior art makes obvious a composition comprising two of the claimed extracts for promoting hair growth and given that the concentration of these extracts can only be present in identical or different amounts, both are obvious and the limitations of the claimed have been met.
Claim(s) 1, 3, 4, 5-6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR100848800 and Legge (US 2016/0256509), as applied to claims 1, 4 and 8, and further in view of Mothana (2017) and Plant Therapy (2017). Mothana is newly cited.
As discussed above, KR’800 and Legge make obvious a method of promoting hair growth by applying a composition comprising essential oils of Piper nigrum and Schinus terebenthifolius, however, they do not teach the inclusion of an essential oil of Piper cubeba.
Mothana teaches the essential oil of Piper cubeba to possess significant antioxidant and anti-inflammatory activities and Plant Therapy teaches that the essential oil of Piper Cubeba can be topically applied to the skin.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of KR’800 and Legge with those of Mothana and Plant Therapy. One of skill in the art would have been motivated to add Piper Cubeba essential oil to the composition of KR’800 and Legge as Monthana teaches Piper Cubeba essential oil to be an effective antioxidant and anti-inflammatory agent. One of skill in the art would have a reasonable expectation of success as KR’800 teaches that additional cosmetically active ingredients, such as antioxidants can be effectively added and Plant Therapy teaches that piper cubeba essential oil can be effectively used in topical applications.
Conclusion
No claims are allowable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613