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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-11 and 20 in the reply filed on March 12th, 2026 is acknowledged. Claims 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. The requirement is deemed proper and is therefore made FINAL.
Applicant’s election without traverse of species VI) hydroxypinacolone retinoate and DL-alpha tocopheryl acetate, in the reply filed on March 12th, 2026 is acknowledged. Claims 2-6 and 8-11 are withdrawn as being drawn to non-elected species.
Claims 1, 7, and 20 are pending and were examined on the merits.
Information Disclosure Statement
The information disclosure statement filed August 2nd, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because of partial illegibility in some of the documents (see crossed out documents on the IDS). Illegibility may be a result of inadequate scanning resolution and conversion of color or grayscale to black-and-white. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement (IDS) submitted on March 12th, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on February 28th, 2024. These drawings are acceptable.
Specification
The use of the terms Algogel, Azeclair, GHK-Cu, Jeechem, and Solagum, each of which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. In instant claims 1, 7, and 20; mass percent and weight percent are reasonably equivalent because the components of the instantly claimed composition are reasonably in the same gravitational environment. From the ingredients listed in claims 1, 7, and 20; it is also reasonable that, at least in certain embodiments of the invention, the only volatile component is water.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 7, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (CN 114948800 A), abbreviated below as "Wu" and further in view of Thornton et al. (US 20200054771 A1), abbreviated "Thornton"; Saleh and Leahy (US 6387382 B1), abbreviated "Saleh"; Ruth and Mammone (Journal of Investigative Dermatology 2018, 138 (5), Supplement, S223), abbreviated "Ruth"; and Zecchino et al. (US 6497887 B1), abbreviated "Zecchino".
Claim 1 recites: an article for use as a cosmetic or pharmaceutical, comprising: a molded, dried preparation comprising greater than zero and up to fifty percent water by weight, the dried preparation formed by drying a liquid preparation, the liquid preparation comprising: a base material comprising one or more of: alginate, chitosan, collagen, sodium hyaluronate, and trehalose; an active ingredient comprising one or more of: amino acids, enzymes and coenzymes, sugars, saccharides, glycols, polyols, nutrients, phenols, plant extracts, peptides, proteins, ultraviolet (UV) filters, vitamins, organic compounds, inorganic compounds, antioxidants, prebiotics, probiotics, postbiotics, fatty acids, glycerol, triglycerides, monoglycerides, diglycerides, phospholipids, steroids, sterols, sphingolipids, alpha hydroxy acid (AHA), a beta hydroxy acid (BHA), or a polyhydroxy acid (PHA), and oils; and an inactive ingredient, comprising one or more of: amino acids, alcohols, sugars, saccharides, polyols, glycols, polymers, acids, esters, solvents, proteins, surfactants, buffers, chelating complexes, and inorganic salts; wherein the dried preparation is configured to be rehydrated with an aqueous based solvent, solution or emulsion to form a ready-to-use liquid or semi-solid topical product.
Claim 7 recites: the article of claim 1, wherein the base material of the liquid preparation comprises one of more of alginate, chitosan, sodium hyaluronate, or collagen, and active ingredients comprising hydroxypinacolone retinoate, and DL-alpha tocopheryl acetate, wherein the dried preparation comprises 10 - 30 % water by weight, 50 - 70 % active ingredients by weight, 1 - 10 % base material by weight; and 10 -20% dextran by weight.
Claim 20 recites: a preparation for use as a topical cosmetic or pharmaceutical, comprising: a base material comprising one or more of: alginate, chitosan, collagen, sodium hyaluronate, and trehalose; an active ingredient comprising one or more of: amino acids, enzymes and coenzymes, sugars, saccharides, glycols, polyols, nutrients, phenols, plant extracts, peptides, proteins, ultraviolet (UV) filters, vitamins, organic compounds, inorganic compounds, antioxidants, prebiotics, probiotics, postbiotics, fatty acids, glycerol, triglycerides, monoglycerides, diglycerides, phospholipids, steroids, sterols, sphingolipids, alpha hydroxy acid (AHA), a beta hydroxy acid (BHA), or a polyhydroxy acid (PHA), and oils; and an inactive ingredient, comprising one or more of: amino acids, alcohols, sugars, saccharides, polyols, glycols, polymers, acids, esters, solvents, proteins, surfactants, buffers, chelating complexes, and inorganic salts; wherein the base material, active ingredient, and inactive ingredient are prepared as a liquid preparation; wherein the liquid preparation is freeze dried to form a molded, dried preparation comprising greater than zero and up to thirty percent water by weight; and wherein the dried preparation is configured to be rehydrated with an aqueous based solvent, solution or emulsion to form a ready-to-use liquid or semi-solid topical preparation.
Wu summarizes their invention: “The invention relates to the technical field of freeze-dried composition, specifically to a freeze-dried composition containing skeleton molecule and macromolecular carrier and application thereof” (Description, Technical field, paragraph 1).
Wu recites the utility of their invention: “The invention claims a facial skin care product, which is a cosmetic for face, wherein the facial skin care product contains relatively precious functional components, such as plant extract and so on, so that the skin care product has functions of anti-aging, anti-wrinkle, moisturizing, whitening and freckle removing” (Description, Background technology, paragraph 1).
Wu recites that the invention aims to provide a freeze-dried composition with little water content, implying that some water may be present after drying:
“Aiming at the defect of the existing technical solution, the invention aims to provide a freeze-dried preparation with high effective component load, high compatibility of oily component and aqueous component, multi-dimensional skin feel, good experience, little water content, light weight, no need to add chemical synthetic oil, skin feel regulator and preservative and so on” (Description, content of the invention, paragraph 1; instant claims 1 and 20).
Wu recites “A freeze-dried composition containing skeleton molecule and macromolecular carrier, wherein The lyophilized composition comprises the following components according to weight percentage: 60-80 percent of skeleton molecule and 20-40 percent of macromolecular carrier” (Wu, claim 1; instant claims 1 and 20, inactive ingredient).
Wu recites “The lyophilized composition according to claim 1, wherein the skeleton molecule is selected from two or combination of more than two of glycine, trehalose, hydrolyzed xylan, mannitol and rhamnose; the macromolecular carrier is selected from one or more of fibroin, sodium caseinate, glyceryl stearate, collagen and lactalbumin” (Wu, claim 4), where the macromolecular carrier of Wu compares with the instantly claimed base material (instant claims 1, 7, and 20), and the skeleton molecule of Wu compares with the instantly claimed inactive ingredient (instant claims 1, 7, and 20).
Wu recites the inclusion of “vitamin” in the cosmetic freeze-fried preparation: “A cosmetic freeze-dried preparation, comprising the freeze-dried composition according to any one of claims 1 to 6 and one or more of grease component, polyalcohol component, unstable component easy to decompose, gel component easy to form after drying, vitamin, thickening agent and active component” (Wu, claim 8; instant claims 1, 7, and 20). Dextran is known in the art as a physiologically-tolerable thickening agent (Thornton, paragraph [0013]; instant claim 7); this thickening agent is also reasonably the inactive ingredient of instant claims 1 and 20. As of record above, the invention of Wu is drawn to a skin care product, having an anti-aging function in at least certain embodiments. It would be obvious to one of skill in the art that the vitamin recited by Wu reasonably encompasses DL-alpha tocopheryl acetate (a form of vitamin E), because of the antioxidant activity of this vitamin, useful for minimizing skin aging (Saleh, paragraph (31); instant claim 7). It would also be obvious to one of skill in the art that the active ingredient recited by Wu (claim 8) reasonably encompasses hydroxypinacolone retinoate, known to have an anti-aging effect on skin models (Ruth, Abstract; instant claim 7).
Wu further recites steps in preparing the composition before freeze drying:
“The preparation method of the cosmetic lyophilized preparation according to any one of claims 8-9, wherein The method comprises the following steps: (1) weighing the skeleton molecule, vitamin, thickening agent and active component of the prescription dosage, uniformly mixing and sieving to obtain the mixture A; (2) adding the macromolecular carrier of the prescription dosage into water and adding the mixture A in the step (1) to obtain the mixture B; (3) loading one or more of grease component, polyalcohol component and unstable and easily decomposed component and easily gel after drying into the mixture B obtained in the step (2), ultrasonically emulsifying to obtain the mixture C; then shaping the mixture C to obtain the shaped mixture C; (4) freeze-drying the shaped mixture C obtained in the step (3) to obtain the freeze-dried preparation” (Wu, claim 10; instant claims 1, 7, and 20).
After combining the skeleton molecule, vitamin, thickening agent, and macromolecular carrier; the mixture is emulsified (Wu, claim 10, step 3) implying that this mixture is in a liquid phase before freeze-drying (instant claims 1 and 20). Although Wu does not explicitly recite molding the composition, molding is broadly understood as a means of shaping a material (Wu, claim 10, steps 3 and 4; instant claims 1 and 20).
Wu recites freeze drying technology as useful for storing cosmetic substances, sometimes resulting in a powder-form substance (Background technology, paragraphs 1 and 2). Although not explicitly recited by Wu et al., Zecchino recites a freeze-dried material for topical application to the skin, that can be returned to a dissolvable gel form using a wetting agent, and rubbed into the skin, thereby delivering active agents and leaving substantially no residue to be removed from the application area (Zecchino, paragraph (8)). The wetting agent can be a wetting solution or water (Zecchino, paragraph (16)), or a water and oil emulsion (Zecchino, paragraph (17)). Therefore, it would be obvious to one of skill in the art to wet (hydrate), the freeze-dried composition of Wu, before applying it to skin as a semi-solid product (instant claims 1 and 20).
Wu does not explicitly recite the weight percentage of the dried composition, as recited in claims 1, 7, and 20. However, the weight percentages of these materials could be adjusted by one of skill in the art as follows. One of skill in the art could use a balance instrument to measure the masses of the ingredients of the composition before they are combined. The drying step could be calibrated to produce a composition with a certain weight percent water by correlating drying time with the loss of mass of the composition, under known temperature and pressure conditions. Knowing both the weight percent water in the dried composition and the weight percentages of other ingredients in the dried composition, one of skill in the art could adjust the weight percentages of water, base material, and an inactive ingredient (such as dextran) such that the composition is in solid phase but retains its shape, rather than breaking apart into powder (Wu, claim 10; instant claims 1, 7, and 20). One of skill in the art could also adjust the weight percentages of active ingredients such that these ingredients are present in sufficient concentration in the rehydrated product to be clinically useful, for instance for anti-aging purposes, of record above (instant claims 1, 7, and 20). Therefore, it would be within routine optimization for one of skill in the art to achieve the weight percentages of components of the composition(s) recited in claims 1, 7, and 20.
Wu, Thornton, Saleh, Ruth, and Zecchino are relied upon for the reasons discussed above. If not
expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the water content, base material, active ingredient, and inactive ingredient; the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the cosmetic or pharmaceutical composition), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the
skilled artisan.
From the teachings of Wu in view of Thornton, Saleh, Ruth, and Zecchino, the invention as a whole, drawn to a cosmetic or pharmaceutical composition as described in Claims 1, 7, and 20, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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