DETAILED ACTION
STATUS OF THE APPLICATION
Receipt is acknowledged of Applicants claimed invention, filed 07 September, 2023, in the matter of Application N 18/280,829. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after September 07, 2023, 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 1-15 represent all claims currently under consideration.
Information Disclosure Statement
Three Information Disclosure Statements (IDS) filed 17, April 2025, 12 March 2024, and 07 September 2023, are acknowledged and have been considered.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gutmichael et al. (KR20050113669A) in view of Jiaheng et al. (CN110251567A),
Regarding claim 1, Gutmichael disclose L-carnitine salts thereof, or mixtures thereof in a pharmacologically acceptable external vehicle (See abstract and claim 1).
Regarding claim 2. Gutmichael disclose wherein the ideal pH range for the external skin preparation composition is between 3.5 and 8. The topical skin composition has a pH between 3.5 and 6.5 or 7 (See abstract and claims 1 and 2).
Regarding claims 3, and 15, Gutmichael disclose wherein the weight percent is from 0.01-30 by weight of carnitine (See Description paragraph 3). The product usually has an external derma L-carnitine component that works well for exfoliating. Useful dilutions range from 0.001% or 0.01% to 40% by weight concentrate (See Description paragraph 43).
However, Gutmichael et al. do not disclose wherein the carnitine-salicylate is a eutectic mixture of carnitine and salicylate in a carnitine.
Regarding claim 4, Jiaheng et al. describes a type of L-carnitine eutectic solvent that contains water, L-carnitine, and a hydrogen bond donor (See abstract, Description paragraph 1, and claims 1-4) Salicylic acid can act as a hydrogen-bond donor. L-carnitine eutectic solvent, wherein the L-carnitine and hydrogen bond donor Molar ratio be (1:5) :(1:8).
However, Jiaheng et al. do not disclose wherein salicylate molar ratio of 1 to 6:2. Jiaheng et al. disclose wherein the L-carnitine and hydrogen bond donor Molar ratio be (1:5) :(1:8).
It would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the carnitine-containing compositions of Gutmichael et al. to include a hydrogen bond donor at the molar ratios taught by Jiaheng et al. because both references relate to carnitine-based compositions, and Jiaheng et al. provide predictable guidance regarding suitable molar ratios for combining L-carnitine with hydrogen bond donors. A person of ordinary skill in the art would have reasonably expected that incorporating the hydrogen bond donor at the disclosed molar ratios would fall within routine optimization of formulation parameters, particularly given the broad weight percent range of carnitine already taught by Gutmichael et al. Accordingly, the claimed subject matter represents a combination of known elements according to known methods, yielding no more than predictable results.
Regarding claim 5, Gutmichael et al. disclose wherein. L-carnitine may be formulated into the topical skin composition of the invention as a crystalline solid. A crystalline solid can be part of a precipitate (See Description paragraph 18) However, Gutmichael do not disclose wherein the carnitine-salicylate has no precipitate when left at 0 degree Celsius for 4 weeks.
Regarding claims 6, 7, 8, 9, 10, and 11, Gutmichael disclose wherein L-carnitine, its salts, mixes, or combination in a pharmacologically acceptable external vehicle are the subject of the current invention. The external preparation composition can be used to promote skin regeneration, exfoliate the skin, and improve or prevent potentially harmful skin conditions (eg, peeling of the epidermis and lowering skin elasticity). Peeling (desquamation) of the epidermis can be related to acne, both as part of the disease process and as a result of acne treatments. Exfoliation can be part of a skin-soothing effect. An external preparation composition administered for improvement or prevention of harmful skin conditions, exfoliation, promotion of skin regeneration, and/or skin whitening can be part of skin-soothing and inflammation relief. The described external preparation composition can be part of skin soothing for erythema relief. When “harmful skin conditions” are understood as irritation, sensitivity, roughness, dryness, or redness, their improvement or prevention directly aligns with erythema relief. (See abstract, Description paragraphs 1 and 2, and claim 1-3).
Regarding claims 12, 13, and 14, Gutmichael disclose the topical skin composition that contains an effective amount of L-carnitine in a pharmacologically appropriate external vehicle to improve or prevent dangerous skin disorders, exfoliate skin, promote skin regeneration, or whiten the skin. An exterior makeup of the skin that includes a salt or mixture of them (See abstract, claims 1-3, and Description paragraphs 1-2). A concentrate of the external derma L-carnitine compound is typically made before a product containing this composition is manufactured. L-carnitine is combined with water and any additional additives as previously mentioned to create the skin external L-carnitine composition of the current invention. To speed up mixing, the mixture may be heated and/or stirred (See Description concentrate, Paragraph 39). Exfoliation/reparative systems that combine L-carnitine with other hydroxy acids, in this case glycolic acid, are demonstrated by the formulations in examples 1 and 2. An example of a system including L-carnitine can be found in the formulation of example 3 (See Description paragraph 46). The main subclasses of hydroxy acids; Hydroxy acids are typically divided into Beta-hydroxy acids (BHAs). Salicylic acid is the classic example, which is oil-soluble, and penetrate pores and help with acne and inflammation. Salicylic acid is a beta-hydroxy acid. Therefore, salicylic acid is part of the hydroxy acid family. A regenerating/exfoliating cream with an inorganic sunscreen was made, as seen in formulation example 1 below. The components of phase A were combined and heated to 75-80 degree Celsius while mixing. The components of phase B were mixed with each other, heated to 75-80 degree Celsius and phase A was slowly added to phase B with vigorous stirring. The mixture was stirred until homogeneous and cooled with continued mixing. The formulation was stable at 50 degrees Celsius for two months. The pH of the formulation was 4. (See Example 1).
Conclusion
No claim is allowed.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615