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 .
Response to Amendment
Applicant's amendment and argument filed 03/20/2026 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-9, 11-18 are pending of which claims 12-15 and 18 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/2025.
Claims 1-9, 11 and 16-17 are being examined on the merits.
Claim Rejections - 35 USC § 102
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 –
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yasuhito Mori et. al. (From IDS, JP2019019077A). This rejection is maintained with slight modifications to take into account the amendments filed on 03/20/2026.
Mori discloses a composition comprising royal jelly extract and (acrylates / alkyl acrylate (C10-30)) cross-polymer (see Table 2) and discloses wherein the composition is a blended mix of extracts for the purpose of external use compositions. Here Mori describes that the components within the composition are blended together and so the method of enhancing a royal jelly penetration into skin by blending acrylates / alkyl acrylate (C10-30) with royal jelly is anticipated (see table 2).
As the cosmetic, any of basic cosmetics, hair cosmetics, makeup cosmetics and the like can be applied. The following examples are described as preferred examples of the formulation of the composition for external use on skin (see before table 1). Here Mori teaches applying to the skin the formulation comprising royal jelly and acrylates / alkyl acrylate (C10-30) thus the claim is anticipated.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Maroula G. Kokotou et. al. (Study of the Royal Jelly Free Fatty Acids by Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS), Metabolites 2020, 10, 40, 1-12) and John Kung et. al. (US20020006418A1). This is a new rejection to take into account the amendments filed on 03/20/2026.
Kokotou teaches that “Royal jelly (RJ), a secretion from the hypopharyngeal and mandibular glands of worker bees, has been used since ancient times in traditional medicine, and it is currently used as a functional food and in the pharmaceutical and cosmetic fields” (see Introduction, 1st para.).
Kokotou teaches that royal jelly has bioactive properties such as antibacterial, immunomodulatory, wound-healing, growth promoting, vasodilative and hypotensive, anti-inflammatory and antitumor activities. Many of the biological properties of royal jelly are attributed to its unusual bioactive fatty acid components, in particular to 10-HAD (trans-10-hydroxy-2-decenoic acid).
More recently, the in vitro anti-inflammatory effects of these RJ fatty acids as well as sebacic acid (decanedioic acid) was evaluated and compared in lipopolysaccharide-stimulated RAW264.7 macrophages (see bottom of page 1, top of page 2).
Kokotou teaches royal jelly comprises of 10-hydroxy-2-decenoic acid, decenedioic acid, or sebacic acid (see table 1).
Kokotou does not specifically teach bending the royal jelly with acrylates/ (C10-30) alkyl acrylate.
Kung teaches a composition and method which is used to enhance the permeation of topical skin agents (see abstract).
Kung teaches “Polymeric emulsifiers, particularly those which have been hydrophobically-modified, are useful in the compositions of this invention. In both pharmaceutical and cosmetic compositions, lotions and creams have been used as popular delivery vehicles for applying topical actives. Emulsions are two-phase systems that contain two immiscible liquids, typically oil and water. In order to stabilize oil in water, ionic or non-ionic surfactants may be used to reduce interfacial surface tensions creating oil droplets dispersed in water. Unlike traditional emulsifiers, polymeric emulsifiers operate by creating gels around the oil droplets. When these droplets come near each other, they are repelled by the gel layers. Preferably, a nonionic polymeric emulsifier, more preferably a hydrophilic cross-polymer which has been hydrophobically modified and most preferably, a hydrophobically-modified polyacrylic acid emulsifier having from about 10 to about 30 carbon atoms is used in the products and compositions of this invention. Most preferably, the polymeric emulsifier should be Pemulen*, an acrylate/C10-30 alkyl acrylate crosspolymer commercially available from B.F. Goodrich Specialty Chemicals of Cleveland, Ohio. Surprisingly, delivery systems containing lipophilic topical active ingredients formulated in the compositions of this invention in conjunction with Pemulen* provided enhanced penetration of the lipophilic topical active ingredient.
Preferably, the polymeric emulsifier should be present in the compositions of this invention an amount of from about 0.01 to about 20% by weight of the composition. More preferably, they should be present in an amount of from about 0.1 to about 5 weight percent of the composition. Most preferably, they should be present in an amount of from about 0.1 to about 1 weight percent of the composition.” (see 0012).
Therefore it would have been obvious to persons having ordinary skill before the effective filing date to use acrylates/C10-30 alkyl acrylates in a cosmetic formulation of royal jelly because Kokotou teaches that many of the biological properties of royal jelly are attributed to its unusual bioactive fatty acid components and that royal jelly is used in cosmetic formulations. Kung teaches that “acrylate/C10-30 alkyl acrylate crosspolymer commercially available as Pemulen* provided enhanced penetration of the lipophilic topical active ingredient.
Optimizing the acrylates to royal jelly to be at the instantly claimed range of 0.01% by mass or more to about 20% by mass or less would have been obvious because kung teaches effective amounts of this permeation enhancer within this instantly claimed range.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Maroula G. Kokotou et. al. (Study of the Royal Jelly Free Fatty Acids by Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS), Metabolites 2020, 10, 40, 1-12) John Kung et. al. (US20020006418A1) as applied to claims 1-9 and 11 above, and further in view of Cho Yun Hi et. al. (KR20160037612A) and Asakura Takayuki et. al. (JP5750404B2). This is a new rejection to take into account the amendments filed on 03/20/2026.
Kokotou and Kung teach a composition comprising a blend of royal jelly and acrylates/C10-30 alkyl acrylate, however are silent on the royal jelly being obtained by filtering enzymatically treated royal jelly solution through a filter having a pore size of 3 um and wherein the cosmetic composition comprises butylene glycol, pentylene glycol, and phenoxyethanol.
Hi teaches a cosmetic composition capable of enhancing skin moisturizing effects by containing freeze-dried royal jelly which is treated with protease enzymes (see abstract).
Hi teaches use of the composition on skin (see 1st para, page 10, example 5).
Hi teaches “inactivating royal jelly which has been enzymatically reacted in the above production method may be followed by a step of filtering the mesh for removal of foreign substances” (see page 7).
Hi does not specifically teach the composition to include butylene glycol, pentylene glycol, and phenoxyethanol.
Takayuki teaches of antibacterial agents in cosmetics (see abstract).
Takayuki teaches of cosmetic compositions which comprise of royal jelly extract, butylene glycol, pentylene glycol and phenoxyethanol (see page 10, example 1) and teaches this plurality of combined components can act as mositurizers, thickeners, preservatives, emulsifiers, medicinal components, emulsion stabilizers etc. (see page 6 para. 3).
Therefore it would have been obvious to persons having ordinary skill before the effective filing date to use enzyme treated royal jelly as taught by Hi to increase the moisturizing properties of the royal jelly and to use butylene glycol, pentylene glycol and phenoxyethanol as additional cosmetic combined agents to act as emulsion stabilizers, moisturizers, thickeners and preservatives etc. It would have also been obvious to select the filter size as being 3um as this is an optimization well within any skilled artisan for a means of not letting contaminants through in the final product.
Response to Arguments
Applicant's arguments filed 03/20/2026 have been fully considered but they are not persuasive. The applicant argues that in order to anticipate a claim every limitation needs to be disclosed. The applicant argues that Mori does not teach applying the combined royal jelly and acrylate/C10-30 alkyl acrylate crosspolymer to skin. Additionally, the applicant believes that there was a picking and choosing done in order to satisfy the anticipation rejection. This however is not the case. Mori indeed teaches wherein the acrylate/C10-30 alkyl acrylate crosspolymer and royal jelly are combined in a cosmetic composition and then applied to skin (see the above rejection).
The applicant argues that Fiume teaches against the use of acrylate/C10-30 alkyl acrylate crosspolymers for enhancing permeation of products to skin. The Office no longer relies upon Fiume and relies on Kung to teach that the acrylate/C10-30 alkyl acrylate crosspolymer indeed can be used for enhancing permeation of topical components to skin.
Conclusion
Currently 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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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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