DETAILED ACTION
STATUS OF THE APPLICATION
Receipt is acknowledged of Applicants claimed invention, filed 24 August, 2022, in the matter of Application N 17/802,022. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after August 24, 2022, is being examined under the first inventor to file provisions of the AIA .
No additions, amendments, or cancellations have been made to the originally filed claims. The issue of new matter is moot.
Thus, claims 1-3, and 5-13 represent all claims currently under consideration.
Information Disclosure Statement
Four Information Disclosure Statements (IDS) filed 02/18/2025, 10/09/2024, 07/24/2024, and 07/31/2023, are acknowledged and have been considered.
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.
Claims 1-3, and 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ito et al. (JPH06157280) in view of Tsukasa et al. (JP4716692) and Shendge et al. (Therapeutic Potential of Luffa acutangular: A review on Its Traditional Uses, Phytochemistry, Pharmacology and Toxicological Aspects) and Hiroyuki et al. (JP5946717B2) and Hanson et al. (US20190293628).
Regarding claims 1, 2, and 11, Ito et al. teach the description of the relevant art Brionolic acid can be produced in high quantities by cultivating the cultured cells in the dark. It is known to be present in the roots of plants belonging to the Cucurbitaceae family (See 0002). Depending on the overall amount of the cosmetic or cell growth promoting agent of the current invention, bryonolic acid can be added in amounts ranging from 0.0001 to 10% by weight, preferably 0.0001 to 1.0% by weight. No adequate effect is produced at concentrations of 0.1% or below, and the effect is not amplified and is not cost-effective at concentrations of 10% by weight or more (See 0006).
Regarding claims 3, 5, 6, 7, 8, 9, and 10, Ito et al., teach depending on how much of the cosmetic or cell growth-promoting agent of the current invention is used overall, bryonolic acid can be added in amounts ranging from 0.00001 to 10% by weight (See 0006). Bryonolic acid can be isolated from the roots or culture cells of a Cucurbitaceous plant. It can then be recrystallized to produce a needle-like crystal (purified product) or a crudely purified product that can be used (See Abstract). Therefore, when bryonolic acid’s efficacy was investigated, a cosmetic that contained bryonolic acid and had a great cell growth-promoting action also had a great-skin conditioning effect (See 0003). A traditional technique to produce a suspension culture cell of a Cucurbitaceae plant (melon, loofah, etc.) induces callus. For one to three weeks, the cultured cells are cultivated by rotary shaking in the dark after being inoculated into a liquid medium containing dichlorophenoxyacetic acid. After being collected, the cultivated cells are dried, extracted using chloroform, and dried out. To create needle crystals (bryonolic acid), the extracted material is redissolved in methanol and chloroform and then recrystallized. Additionally, brionolic acid can be extracted from the roots of plants in the Cucurbitaceae family, such as melon, crow cucumber, and similar plants, and then fractionated using a silica gel column and recrystallized (See 0004, [Chemical 1]). Alcohols, esters, fatty acids, oils and fats, waxes, hydrocarbons, and other substances that do not interfere with the effects of bryonolic acid are all included in the cosmetics and cell growth boosters of the current invention. Activators and other raw elements are blendable (See 0006). Example-5 Foundation amount 1. Sorbitan monostearate, polyoxyethylene, stearic acid, cetyl alcohol, Isopropyl myristate, purified water, Brionolic acid, propylene glycol, oil phase, aqueous phase, etc. (See 0007 and examples 1-8).
Tsukasa et al. teach loofah root extract has anti-inflammatory properties, including the ability to reduce UV-induced erythema. The invention includes the following exterior anti-inflammatory skin preparation. Item 1: An external anti-inflammatory skin preparation that contains a loofah root extract. Item 2: According to Item 1, the external preparation for anti-inflammatory skin contains an extract of loofah root that is made from at least one solvent chosen from the group that includes water, ethanol, and butanol. Item 3: The external anti-inflammatory skin preparation in accordance with items 1 or 2, when the inflammation is UV-induced. Item 4: Any one of items 1 through 3 can be used to describe the anti-inflammatory external skin preparation, which is a skin cosmetic, the presence of a loofah root extract distinguishes the current invention’s anti-inflammatory exterior skin preparation. One herb that is a member of the Cucurbitaceae family is Luffa cylindrica M. Roemen. Although the loof root portion can be extracted in its current state, it is best to do so after completing an extraction-appropriate procedure, such as grinding, drying, and chopping. Loofah roots, whether treated or not, are often extracted by standing, shaking, ultrasonic irradiation heating, pressurization, or a combination of these methods after coming into contact with an extraction solvent. Ideally, it involves turning, shaking, or immersion. Water, an organic solvent, or something similar is typically employed as the extraction solvent, either by itself or in combination with two or more. Typically, the organic solvent consists of petroleum ether, cyclohexane, toluene, a polyhydric alcohol like propylene glycol, 1,3-butylene glycol, or dipropylene glycol, a lower alcohol like methanol, ethanol, propanol, isopropanol, or butanol, hydrocarbons like benzene; ethers like ethyl ether and propyl ether; halogenated hydrocarbons like dichloromethane, chloroform, and carbon tetrachloride; esters like ethyl acetate and butyl acetate; ketones like acetone and methyl ethyl ketone. The preferred extraction solvents are water, ethanol, and butanol, which can be used separately or in combination with two or more. Ethanol, water, and hydrous ethanol are the more favored extraction solvents. The concentrated, dried, freeze-dried product can be dissolved in water, an organic solvent, etc., but the extract made using the aforementioned extraction solvent can be utilized exactly as is in the current invention as the extract of the loof root. Additionally, those acquired through liquid/liquid distribution, fractionation treatment by column chromatography, and similar purification procedures, such as decolorization, deodorization, desalting, etc., can be used within the range that does not compromise the anti-inflammatory effect (See paragraphs 5-8).
Regarding claims 11, and 12, Tsukasa et al. teach the amount of Loofah root extract that can be blended into the current invention’s anti-inflammatory skin external preparation is not restricted as long as the anti-inflammatory action is present. However, when a solvent extract is used, it is typically between 0.0001 and 5% by weight, preferably between 0.01 and 1% by weight, and more ideally between 0.05 and 0.6% by weight. A dry solid of the solvent extract is typically between 0.0001 and 0.03% by weight when it is utilized. Ideally, between 0.0005 and 0.018% by weight (See paragraph 11, and formulation example 1). The loofah root extract suitable for inclusion in the anti-inflammatory external skin preparation of the present invention is not restricted in form, source, or composition, so long as it demonstrates anti-inflammatory efficacy. The extract is utilized in methods for enhancing skin characteristics, including improving firmness, tonicity, and elasticity.
Shendge et al. teach about 50 compounds, including flavonoids, anthraquinones, proteins, fatty acids, saponin triterpene, volatile components, and other phytoconstituents, have been isolated and identified as a consequence of the phytochemical research (Table 1). Pharmacological activity of extracts and fractions of Luffa acutangular: Triglycerides, ethyl acetate, vegetable oil (Linoleic acid, etc.), alcohols, glycols, and a mixture thereof (See tables 1 and 2).
Regarding claim 11, Tsukasa et al. teach an extract from a loofah root is used in the current invention to create an external anti-inflammatory skin preparation that effectively reduces UV inflammation (See paragraph 1). The purpose of ultraviolet scattering agents and ultraviolet absorbers is to shield the skin from UV radiation; however, compounds that mitigate the negative effects of UV radiation on the skin have also been researched. The quantity of UV scattering and UV absorber can be decreased by blending these materials into sunscreens, and the impact of UV rays on the skin can be lessened by blending them into skin care products. However, a variety of plant extracts are combined in skin care cosmetics since it is widely believed that plant-derived ingredients are less irritating to the skin (See paragraph 3). The current invention’s anti-inflammatory skin external preparation can prevent or suppress skin inflammation, and it works especially well to prevent or suppress inflammation brought on by UV radiation (such as erythema from UV radiation) (See paragraph 12, and Example 1 (anti-inflammatory effect of loofah root extract), and formulation example 1-14).
Hiroyuki et al. teach everyday skin is exposed to various chemical and physical stresses such as ultraviolet rays, heat, coldness, dryness, and drugs. As a result, the skin function is reduced, various skin aging phenomena become apparent. Wrinkles are one of the signs of aging skin. Dermal wrinkles and epidermal wrinkles are the two recognized types of wrinkles. Fine wrinkles, also known as epidermal wrinkles, are transient wrinkles brought on by dry skin that reduces the amount of water in the epidermal stratum corneum. The application of hydrating cosmetics is a popular technique for reducing fine wrinkles. On the other hand, dermal wrinkles are those that are primarily caused by the UV rays found in sunlight. The creation mechanism combines UV-induced reduction in cutaneous fibroblasts capacity to produce collagen and matrix metalloprotease-induced stimulation of collagen breakdown. Dermal wrinkles brought on by UV radiation and epidermal wrinkles brought on by dryness have different histological morphologies, onset mechanisms, and therapeutic approaches. Sunlight- induced wrinkles on the skin are brought on by the use of hydrating cosmetics. Hydrolyzed almonds are an active ingredient in a skin wrinkle prevention/improvement product designed to improve wrinkles brought on by UV radiation. Ginseng, tenki, and jojobakei extract are useful components. A treatment to improve wrinkles brought on by UV radiation. In order to prevent or improve the production of wrinkles caused by UV rays, the current invention aims to provide a skin wound healing booster and an agent that prevents or ameliorates its production. To solve the problem, the inventor of the present application has conducted extensive research and as a result, bryonolic acid or a salt thereof, or bryonolic acid dicarboxylic acid ester or a salt thereof, or bryonolic acid dicarboxylic acid ester or a salt thereof increases the production of type 3 collagen in dermal fibroblasts it was discovered that an excellent wrinkle formation prevention/improvement effect and a skin wound healing promoting effect were exhibited (See paragraphs 2, 3, 5, and 7).
Regarding claim 13, Tsukasa et al. teach an extract from a loofah root is used in the current invention to create an external anti-inflammatory skin preparation that effectively reduces UV inflammation (See paragraph 1). It is particularly effective in preventing or suppressing inflammation brought on by UV radiation (such as erythema from UV radiation), the anti-inflammatory skin external preparation of the current invention can prevent or suppress skin inflammation (See paragraph 12, and claims 1-3).
Response to Arguments
Applicant's arguments filed March 30, 2026 have been fully considered but they are not persuasive.
Ito et al. explicitly disclose bryonolic acid concentrations up to 10% by weight, which overlaps with the claimed lower limit at least 10%. It is well-established that overlapping ranges are sufficient to establish anticipation where no criticality or unexpected results are demonstrated. The specific recitation of a “liquid form” and particular solvents constitutes a selection of known formulation options. Ito et al. broadly disclose cosmetic compositions comprising conventional carriers, including oils, esters, and related excipients, which reasonably encompass the claimed solvent systems. Ito et al. disclose compositions that may include additional components such as fatty acids, oils, and waxes, thereby encompassing the presence of other metabolites or ingredients that do not interfere with bryonolic acid activity. The alleged biological effects (e.g., skin conditioning, cell viability, anti-aging effects) are inherent to compositions comprising bryonolic acid, as Ito et al. already teach its cell growth-promoting and skin-conditioning properties.
With respect to the Applicant’s argument regarding aeroponic cultivation and stimulation steps, these process limitations are not positively recited in all rejected claims, or alternatively, do not impart structural differences sufficient to distinguish over the prior art product. A product that is identical or substantially identical to that disclosed in the prior art is not patentable merely because it is produced by a different process.
Finally, the Applicant’s assertion that the claimed extract requires bryonolic acid to be “naturally present” in a specific amount is not persuasive, as Ito et al. teach both natural occurrence and methods of increasing yield, including culture-based production techniques.
Ito et al. disclose, either expressly or inherently, all elements of the claimed invention arranged as required by the claims. The differences asserted by the Applicant relate to non-limiting features, overlapping ranges, or inherent properties of the disclosed compositions.
Conclusion
No claim is allowed.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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