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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/08/2025 has been entered.
Response to Amendment
Applicant's amendment and argument filed 12/08/2025, in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1, 3-8 are pending and being examined on the merits.
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 and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Park Deok Hoon et. al. (KR2010-0013095A), hereinafter Hoon, and Ohtake and Wang (Trehalose: Current Use and Future Applications, Journal of Pharmaceutical Sciences, Vol. 100, No. 6, May 2011), hereinafter Ohtake. This is a new rejection based on the amendments and arguments filed on 12/08/2025.
Hoon teaches a cosmetic composition for improving skin whitening or anti-wrinkling containing aldiroba oil which also ensures formulation stability without toxicity. The oil can be found in effective amounts ranging from 0.0001-10 weight % (see abstract and claim 1).
Hoon also teaches “In a specific embodiment of the present invention, the andiroba oil of the present invention is excellent in whitening effect by inhibiting the activity of intracellular tyrosinase and inhibiting melanin production, inhibiting collagenase activity and promoting collagen synthesis wrinkle improvement effect is excellent through the molecular mechanism of. Therefore, the andrioba oil is useful as a cosmetic composition for skin whitening and wrinkle improvement. In addition, the cosmetic composition of the present invention is safe on human skin because it does not show a distinctive pattern in the skin accumulation stimulation test” (see page 2 last para.).
Hoon does not specifically teach the composition to comprise of at least one prebiotic sugar.
Ohtake teaches “Trehalose is used in a wide variety of cosmetic products including bath oils, hair growth tonics, and moisturizers; examples include Lux shampoo (Unilever, Tokyo, Japan), skin milk body lotion (Nivea-Kao, Tokyo, Japan), and Pro Tec style deodorant (Lion, Tokyo, Japan). Trehalose and its sulfate forms are used as moisture-retaining agents in several cosmetic creams and lotions, whereas the fatty acid esters of trehalose are thought to act as surface-active agents.
Furthermore, trehalose may be incorporated into cosmetic products to enhance their storage stability and to mask the odor of active ingredient(s) and their degradation products, if any are produced (Table 6). During storage, cosmetics (particularly, cream-based products) may undergo degradation (oxidation) and emit unpleasant odor. As cosmetics are used for skin care, hair care, and makeup, the aroma of these products is a critical factor that can influence its quality and popularity (and thus sales). In one study, the effect of trehalose in suppressing the formation of aldehydes was examined from a variety of oil-based products, including triethylhexanoin, sunflower oil, grape seed oil, and cacao oil. Trehalose was shown to suppress the formation of both short-chain (3–7 carbons) and medium-chain (8–16 carbons) aldehydes and alcohols following storage at 45◦C for up to 4 weeks, in most cases by 50% and in some cases by more than 90%. The effectiveness of trehalose in protecting the cell membrane was described previously for liposomal applications. The outer layer of human skin consists of layers of cells that maintain approximately 20% water, which contribute to the texture (i.e., softness) and malleability of the skin, and create a network of cells that acts as a barrier to dehydration and concurrently, intrusion of foreign material. Thus, the maintenance of water content on the outer layer of skin is essential. In a study by Takeuchi and Banno, human skin cells were dried for several hours after reaching confluency, and the effects of several sugars at various concentrations were examined. Trehalose was demonstrated to improve the survival of these cells to desiccation in a concentration-dependent manner (determined by trypan blue staining); in the presence of 0.25% trehalose, the survival rate after 4 h of desiccation increased from 23% (no trehalose) to 41%, and increased further to 45% at 1% concentration. In comparison with trehalose, sucrose was less effective. Thus, trehalose preserved the integrity of cells upon desiccation, as was observed previously for liposomes. For this reason, trehalose may be an effective ingredient in lotions and moisturizers. The low number of commercial products containing trehalose for this purpose may be attributed to its cost, although with the development of novel production methods, this may present less of a hurdle” (see p 2043, Use in the cosmetic industry).
Therefore it would have been obvious to persons skilled in the art before the effective filing date to combine (andiroba) oil also known to those skilled in the art as Carapa guianensis oil in with the trehalose as a combined cosmetic composition because Hoon teaches that Carapa guianensis oil (aka andiroba oil) has collagen synthesis, collagenase and wrinkle inhibiting properties and is used in topical cosmetic applications. Hoon also teaches the andiroba oil to be stabilizing which would act as a preservative along with trehalose. Additionally, Ohtake teaches trehalose is used in cosmetics as a moisturizing agent and is used in cosmetics to preserve the cosmetic products storability and to mask odors of active ingredients. It would have been obvious to find the effective amount of trehalose to act as a preservative because it is well within the purview of an artisan to do so, especially given the prior art. Ohtake teaches that 0.25% trehalose, the survival rate of skin cells after 4 h of desiccation increased from 23% (no trehalose) to 41%, and increased further to 45% at 1% concentration. Therefore there appears to be a dose-dependent increase between 0.25%-1% trehalose concentration and optimizing within this range would ultimately bring about the prebiotic effect as can be appreciated from the applicant’s own work (see figure 1).
Although the art is silent on wherein the composition would act as a prebiotic or directly on firmness and elasticity through acting on collagen, elastin, glcyosaminoglycans and metalloproteinase modulation, or for antiaging, or through acting on IL- 6, IL-8, IL-10, and PGE2 synthesis, the composition would inherently also have these properties because these are inherent to those specific ingredients within certain ranges as can be appreciated by the applicants own testing (see instant figures 1-12B). The same inherent property would have been reached from the same optimization as argued above because the applicant shows effective ranges of andiroba oil that are within the ranges being claimed as effective in the prior art (see Figures 4A-D-10A-D) and persons having ordinary skill in the art would optimize the andiroba oil to be in these amounts as they are shown to be effective for inhibiting collagenase activity, promoting collagen synthesis and wrinkle improvement effects at these amounts.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Park Deok Hoon et. al. (KR2010-0013095A), hereinafter Hoon, and Ohtake and Wang (Trehalose: Current Use and Future Applications, Journal of Pharmaceutical Sciences, Vol. 100, No. 6, May 2011) as applied to claims 1 and 3-7 above, and further in view of Arroteia et al. (EP3038715B1). This is a new rejection based on the amendments filed on 12/08/2025.
Hoon and Ohtkae’s combined teaching teach a prebiotic composition comprising of trehalose and andiroba oil however are silent on the composition further comprising guacatonga extract.
Regarding claim 8, Arroteia teaches “a cosmetic composition, characterized by comprising 0.0001 to 10%, by weight of the total composition, of guaçatonga extract (Casearia sylvestris), 0.00005 to 10%, by weight of the total composition, of aroeira extract (Schinus terebinthifolius raddi) and cosmetically acceptable adjuvants” (see claim 1). Arroteia teaches that guaçatonga extract at different concentrations can increase LOX, tropoelastin, fibulin-5, MMP-12 gene expression relative to non-treated cells (see fig. 1, 2, 6, 7, 9 etc.) and has ability to increase collagen type 1, elastin and hyaluronic acid (see fig. 10 and 15-16).
Arroteia teaches adding 20% silicone dioxide as a preserving agent (see detailed description of the invention, third para.).
Therefore it would have been obvious to persons skilled in the art before the effective filing date to combine (andiroba) oil also known to those skilled in the art as Carapa guianensis oil in with the trehalose as a combined cosmetic composition because Hoon teaches that Carapa guianensis oil (aka andiroba oil) has wrinkle inhibiting effects along with collagen synthesis and collagenase inhibiting effects and is used in topical applications. Additionally, Ohtake teaches trehalose is used in cosmetics as a moisturizing agent and is used in cosmetics to preserve the cosmetic products storability and to mask odors of active ingredients. It would have been obvious to include guaçatonga extract in a cosmetic composition because Arroteia teaches this extract can treat aging skin and has beneficial properties such as increasing elastin, collagen type 1, and hyaluronic acid expression. Additionally, including a preservative such as silicone dioxide, which is not trehalose would have been obvious to preserve the cosmetic composition, as discussed by Arroteia.
Response to Arguments
Applicant's arguments filed 12/08/2025 have been fully considered but they are not persuasive. The applicant argues that the prebiotic effect of the trehalose of the instant invention has unexpected and not necessarily inherent properties. The applicant argues that the inherency argument relied upon by the Office did not show that the effect would necessarily flow from the active ingredients. The applicant recites (claims) that the trehalose sugar is indeed a prebiotic sugar (see claim 1) and yet argues it is not in all cases. The applicant should amend the claims to be commensurate in scope with any activity being claimed.
The applicant’s test show’s that trehalose acts as a prebiotic at 0.5% but selectively for selectively favored the growth of S. xylosus and S. epidermidis (see Figure 1 and para. 0064). Additionally, babassu palm starch (polisens) selectively favored S. xylosus, S. warneri and S. captis. and Crabwood (andiroba) oil fostered the growth of S. xylosus at all tested concentrations (0.1%, 1% and 2%), and S. epidermidis at a concentration of 1%. Moriche (buriti) palm oil fostered the growth of S. xylosus at all tested concentrations (0.1%, 1% and 2%), and S. epidermidis as from 0.1% (see 0063-0069). Therefore, the broadly claimed composition is not commensurate in scope to the activities being argued/claimed. The activities appear to be only with specific components in certain amounts, not any combination of ingredients claimed without effective amounts. As just argued in the rejection, the art teaches that that 0.25% trehalose, the survival rate of skin cells after 4 h of desiccation increased from 23% (no trehalose) to 41%, and increased further to 45% at 1% concentration. Therefore there appears to be a dose-dependent increase between 0.25%-1% trehalose concentration and optimizing within this range would ultimately bring about the prebiotic effect as can be appreciated from the applicant’s own work (see figure 1).
Although the art is silent on wherein the composition would act as a prebiotic or directly on firmness and elasticity through acting on collagen, elastin, glcyosaminoglycans and metalloproteinase modulation, or for antiaging, or through acting on IL- 6, IL-8, IL-10, and PGE2 synthesis, the composition would inherently also have these properties because these are inherent to those specific ingredients as can be appreciated by the applicants own testing (see instant figures 1-12B). However the same inherent property would have been reached from the same optimization as argued above because applicant shows effective ranges of andiroba oil that are within the ranges being claimed as effective in the prior art (see Figures 4A-D-10A-D) and persons having ordinary skill in the art would optimize the andiroba oil to be in these amounts as they are shown to be effective for inhibiting collagenase activity, promoting collagen synthesis and wrinkle improvement effects at these amounts. Additionally, the applicant’s arguments are not commensurate in scope with their claims. There is currently no claimed effective amounts or ranges for the active ingredients or the activities stemming from those ingredients.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655