DETAILED ACTION
Claims 1-18 are pending in the instant application.
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 .
Priority
The instant application claims priority to REPUBLIC OF KOREA 10-2023-0108099 filed on 08/18/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
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.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (KR 20230052827, Published 04/20/2023), Gu et al. (Plant Exosome-like Nanovesicles: Emerging Therapeutics and Drug Delivery Nanoplatforms, Molecular Therapy, 2021), Yoon et al. (Hydrangea serrata Hot Water Extract and Its Major Ingredient Hydrangenol Improve Skin Moisturization and Wrinkle Conditions via AP-1 and Akt/PI3K Pathway Upregulation, Nutrients, Published May 2023)
Lee discloses hybrid liposomes in which plant-derived extracellular vesicles and coenzyme Q10 liposomes are fused. The hybrid liposome exhibits significantly increased antioxidant activity. It can be used as a material for various cosmetic purposes (Abstract). The plant-derived EV is Centella Asiatica. The hybrid liposome exhibits whitening, wrinkle improvement, anti-aging, and skin elasticity enhancement (See claims). The EV to liposome ratio can be 1:30 (pg 3). The liposome includes lecithin (pg 3) in an amount of about 9% (pg 4, Example 3). The cosmetic composition may be formulated into a conventional cosmetic formulation. The cosmetic composition may be formulated as a solution, suspension, emulsion, paste, gel, lotion, cream, powder, soap, surfactant-containing cleansing, oil, powder foundation, emulsion foundation, wax foundation and spray (pg 4). In addition to the carrier component, the cosmetic composition of the present invention may include antioxidants, stabilizers, solubilizers, moisturizers, pigments, fragrances, sunscreens, coloring agents, surfactants, or mixtures thereof as adjuvants (pg 4). The composition can further include ethanolamide (diethanolamides) (pg 4). EV is defined as vesicles with a size range of 30-1,000 nm, and includes exosomes (pg 3). the term "liposome" as used herein is a material in the form of a small sac formed of a phospholipid bilayer, which exhibits amphiphilicity by appropriately combining hydrophilic and hydrophobic materials, and is mainly used as a carrier for delivering active substances in the body (pg 3).
Gu teaches that plant exosome-like nanovesicles (ELNVs) are natural nanocarriers. Gu discloses that wheat-derived ELNVs induced skin regeneration by triggering proliferative and migratory actions on epithelial, endothelial, and dermal fibroblasts. Moreover, expression of the mRNA level of collagen type I was elevated significantly (pages 20-21). Once ELNVs are topically applied on skin, they will penetrate via a “lipid-rich channel”. ELNVs structurally resemble liposome (pg 22). One of ordinary skill in the art would immediately envisage the advantage of exosomes for skincare products.
Yoon teaches that hydrangea improved skin wrinkles and skin moisturizing levels (Abstract). The effects of Hydrangea serrata hot water extract has also been researched including their anti-inflammation activity, anti-aging effect, anti-obesity activity (pg 3).
Lee teaches that hybrid exosomes derived from plants are routinely used for improving skin. Gu discloses the advantages of exosomes. Yoon discloses the advantages of using hydrangea in skincare. Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to combine the teachings of above to create hybrid exosomes in which exosomes are derived from any and all plant, such as hydrangea. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 2, weight ratio is taught above.
Regarding claim 3, ethanolamide, lecithin, surfactant are taught above.
Regarding claim 4,
Regarding claim 5, lecithin weight % is taught above.
Regarding claim 6, Lee teaches that the composition routinely includes a surfactant. One of ordinary skill in the art would routinely experiment with various concentrations of a surfactant within a cosmetic composition.
Claims 7-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (KR 20230052827, Published 04/20/2023), Gu et al. (Plant Exosome-like Nanovesicles: Emerging Therapeutics and Drug Delivery Nanoplatforms, Molecular Therapy, 2021), Yoon et al. (Hydrangea serrata Hot Water Extract and Its Major Ingredient Hydrangenol Improve Skin Moisturization and Wrinkle Conditions via AP-1 and Akt/PI3K Pathway Upregulation, Nutrients, Published May 2023) as applied to claims 1-6 above, and further in view of Kim et al. (KR 20190081558A) and Park et al. (KR 101712608 B1, Published 2017).
Kim discloses a cosmetic composition comprising a liposome excellent for skin strengthening effect (Abstract). Kim discloses that the composition includes 0.05-5% by weight of ceramide (Claim).
Kim does not explicitly mention terpineol.
Park discloses a cosmetic composition for moisturizing skin, reducing skin wrinkles, inhibiting red spots, and promoting skin elasticity with terpineol as an active ingredient (Abstract). Terpineol has skin moisturizing effect, suppression of erythema and alleviation of skin wrinkles. Terpineol may be contained in an amount of 0.0001 to 20% by weight based on the total weight of the cosmetic. (pg 2). Specifically, the cosmetic composition of the present invention may further comprise a transdermal penetration enhancer. As used herein, the term transdermal penetration enhancer is a composition that allows a desired component to penetrate into vascular cells of the skin at a high absorption rate. But are not limited to, other phospholipid components, liposomal components, and the like, preferably used in lecithin cosmetics (pg 4).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have included ceramide and terpineol within a liposome or a hybrid exosome/liposome composition. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claims 8-9, terpineol is taught above.
Regarding claim 10, diameter is taught above.
Regarding claim 11, Lee teaches that the hybrid liposome exhibits whitening, wrinkle improvement, anti-aging, and skin elasticity enhancement (See claims)
Regarding claim 12, skin condition is discussed.
Regarding claim 13, Lee teaches that the cosmetic composition of the present invention may include 0.1 to 50% by weight of the hybrid liposome (pg 4).
Regarding claim 14, different formulations are discussed above.
Regarding claim 15, Lee discloses that EVs such as exosomes/liposomes are routinely used to deliver active ingredients (pg 3, 1st and 5th paragraph).
Regarding claim 16, Lee discloses that hybrid liposomes according to the present invention may be prepared by fusing the plant-derived extracellular vesicles and Coenzyme Q10 liposomes (pg 3). Likewise, one of ordinary skill in the art would immediately envisage that other plant-derived EVs can be fused with liposomes as well, such as hydrangea.
Regarding claim 17, ratio is taught above.
Regarding claim 18, terpineol is routinely used within a cosmetic liposome formulation as taught by Park.
Conclusion
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615