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 .
Claim Status
Applicant’s remarks and amendments, filed 28 February 2026 in response to the non-final rejection mailed 19 November 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 28 February 2026 replaces all prior versions and listings of the claims.
Claims 1-12 and 14-16 are pending. Claim 13 is canceled by Applicant’s amendment. Claims 1-10, 12, and 14 are amended. Claims 1-12 and 14-16 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s amendments to the specification have overcome the specification objection in regards to Tables 1-4. The objection to the specification has thus been withdrawn.
Applicant’s amendments to Claims 4, 10, and 16 have overcome the claims objection in regards to minor informalities. The objection to the claims has thus been withdrawn.
Applicant’s arguments and amendments, on pages 6-7 of the reply filed 28 February 2026 with respect to the rejection of Claims 1-16 under 35 USC § 112(b) have been fully considered. The rejections of Claims 1, 2, 4-10, 12, and 14, and 16 are withdrawn due to amendment of Claim 1 and the rejection of Claim 13 is withdrawn due to cancellation of the claim.
Claim Rejections - 35 USC § 112(b)
(maintained)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 11, and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 11, it is unclear whether the pH of the lactic acid is 5.5 or whether the pH of the entire composition is 5.5. Phrasing such as “water to 100 grams; and pH adjusting agent wherein the final pH of the composition is 5.5-7.0” or similar would help clarify. For the purpose of examination, Claim 11 is being interpreted as the pH of the composition being adjusted to the claimed range.
Claim 11 recites the limitations “edetate disodium,” “high molecular weight hyaluronic acid,” “medium molecular weight hyaluronic acid,” “low molecular weight hyaluronic acid,” “2-phenoxyethanol,” “carbomer,” and “lactic acid.” There is insufficient antecedent basis for the limitations in the claim.
Regarding Claims 3 and 15, the parenthetical phrases render the claims indefinite because it is unclear whether the limitation within the parenthesis is part of the claimed invention.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. § 112(b) for the reasons set forth above. Clarification is required.
Claim Rejections - 35 USC § 103
(ground modified as necessitated by amendment)
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, 12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Saliou et al. (EP 2248526 A1) in view of Ruksiriwanich et al. (Molecules, 2022, 16 pages).
The instant claims are as of record, drawn to a skincare composition comprising a chelating agent, a moisturizer, niacinamide, Shatavari extract, a preservative, a pH adjusting agent, and water wherein the pH of the composition is 5.5-7.0.
Saliou et al. teach a composition for treating acne and reducing the appearance of oil or pores on the skin, hair, and scalp (skincare composition; care of skin or scalp; Saliou et al., Abstract, page 1; as required for instant Claims 1 and 16) comprising:
Asparagus racemosus (shatavari) extract (Saliou et al., [0022], page 3; as required for instant Claims 1 and 11);
chelating agents such as EDTA (ethylenediaminetetraacetic acid; Saliou et al., [0061], line 10; as required for instant Claims 1 and 2);
moisturizers including amino acids (Saliou et al., [0040], line 25, [0041], line 34; as required for instant Claims 1 and 3);
Vitamin B3 (niacinamide; Saliou et al., [0042]; as required for instant Claims 1 and 11);
preservatives such as parabens (e.g., broadly encompassing methyl paraben and propyl paraben; Saliou et al., [0061], line 10; as required for instant Claim 1 and 4);
hydroxy acids such as lactic acid, glycolic acid, and citric acid (pH adjusting agent; Saliou et al., [0043]; as required for instant Claims 1, 5, 6, and 11);
mineral water (water; Saliou et al., [0062]; as required for instant Claims 1 and 11);
gelling agents such as cellulose derivatives (cellulose or synthetic cellulose; Saliou et al., [0037]; as required for instant Claim 7);
D-panthenol (panthenol; Saliou et al., [0041], line 30; as required for instant Claim 15); and
Vitamin C (L-ascorbic acid; Saliou et al., [0042]; as required for instant Claim 15).
The composition is administered (applying) to the target tissue such as human skin and can be made into gels, lotions, and sprays (Saliou et al., [0028], lines 20-21, [0029]; as required for instant Claim 16).
Saliou does not teach wherein the Shatavari extract has been extracted via co-solvent with 95-97% ethanol and supercritical carbon dioxide or wherein the composition inhibits 5α-reductase.
Ruksiriwanich et al. teach that Asparagus racemosus (Shatavari) extracted with supercritical carbon dioxide fluid extraction and 95% ethanol as a co-solvent (Ruksiriwanich et al., 3.2., page 9; as required for instant Claims 1 and 12) down regulates (inhibits) 5α-reductase gene expression, which leads to reduction of facial sebum production and minimizes pores (Ruksiriwanich et al., Abstract, page 1; as required for instant Claim 16).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide the Shatavari extract of Ruksiriwanich et al. in the composition taught by Saliou because the down regulation of 5α-reductase gene expression provides skin beneficial effects of sebum reduction and pore minimization. A skilled artisan would therefore be motivated to provide the co-solvent extraction product of Ruksiriwanich et al. in the instantly claimed composition and for the instantly claimed method and could do so with a reasonable expectation of success.
Saliou is relied upon for the reasons discussed above and based upon the overall beneficial teaching provided by this reference with respect to skincare compositions comprising shatavari extraction in various formulations such as gels, lotions, and sprays disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable masses of ingredients and a skin-suitable pH of instant Claim 1), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Claims 1-8, 10, 12, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Saliou et al. (EP 2248526 A1) in view of Ruksiriwanich et al. (Molecules, 2022, 16 pages) as applied to Claims 1-7, 12, and 16 above, and further in view of Teich (Good Housekeeping, 2021, 17 pages).
The instant claims and teachings of Saliou et al. in view of Ruksiriwanich et al. are as of record.
Saliou et al. and Ruksiriwanich et al. do not teach wherein the composition further comprises a cosmetic wax, cosmetic oil, or ferulic acid.
Teich, however, teaches that ferulic acid improves stability and efficacy in cosmetics containing Vitamin C (Teich, pages 6-7; as required for instant Claim 15). Castor oil hydrates and makes flaky skin feel softer; jojoba oil softens and hydrates skin, diminishes the appearance of wrinkles, and reduces inflammation; and rosehip oil smooths, firms, and brightens skin and fades scars, hyperpigmentation, and stretch marks (cosmetic oil; Teich, pages 12-13; as required for instant Claim 8). Additionally, Teich teaches that petrolatum, beeswax (cosmetic wax), and shea butter are occlusives which help prevent moisture loss and shield skin from external irritants (Teich, page 10; as required for instant Claim 8) and that glycerin (emulsifier; propan-1,2,3,-triol) is a humectant that draws moisture into the skin to help increase moisture content over time (Teich, page 9; as required for instant Claim 10).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to add the ingredients of Teich to the composition of Saliou et al. and Ruksiriwanich et al. in order to arrive at the instant invention. Ferulic acid provides stability to compositions comprising Vitamin C, glycerin draws moisture into the skin, and a skilled artisan could reasonably choose a cosmetic wax or oil with the appropriate skin-improving effects as taught by Teich and described above in order to provide the instantly claimed skincare composition with a reasonable expectation of success.
Claims 1-7, 9, 12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Saliou et al. (EP 2248526 A1) in view of Ruksiriwanich et al. (Molecules, 2022, 16 pages) as applied to Claims 1-7, 12, and 16 above, and further in view of Meckfessel & Brandt (J Am Acad Dermatol, 2014, 177-184).
The instant claims and teachings of Saliou et al. in view of Ruksiriwanich et al. are as of record.
Saliou et al. and Ruksiriwanich et al. do not teach wherein the composition further comprises a ceramide.
Meckfessel & Brandt, however, teach that ceramides are epidermal lipids that are important for skin barrier function and that ceramides 1 and 3 have been formulated into lotions, creams, and moisturizers to improve skin hydration and skin barrier function (Meckfessel & Brandt, CERs 1 and 3, page 182; as required for instant Claim 9).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to add the ceramides of Meckfessel & Brandt to the composition of Saliou et al. and Ruksiriwanich et al. in order to arrive at the instant invention. A skilled artisan would be motivated to include ceramide 1 or 3 in the claimed skincare composition in order to improve skin hydration and skin barrier function and could do so with a reasonable expectation of success.
Claims 1-7, 11, 12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Saliou et al. (EP 2248526 A1) in view of Ruksiriwanich et al. (Molecules, 2022, 16 pages) as applied to Claims 1-7, 12, and 16 above, and further in view of Maylis (Typology, 2022, 6 pages), Special Chem (Disodium EDTA, 2022, 7 pages), Dréno et al. (JEADV, 2019, 15-24), and Fleur & Bee (Carbomer for Skin, 2022, 11 pages).
The instant claims and teachings of Saliou et al. in view of Ruksiriwanich et al. are as of record.
Saliou et al. and Ruksiriwanich et al. do not teach wherein the composition comprises edetate disodium, high, medium, and low weight hyaluronic acid, 2-phenoxyethanol, and carbomer.
Maylis teaches that high molecular weight hyaluronic acid moisturizes the surface of the skin and provides a tightening effect, intermediate (medium) weight hyaluronic acid is stored in the connective tissue of the skin and prevents water evaporation, and low molecular weight hyaluronic acid penetrates deeper into the skin where it revitalizes and plumps the skin and reduces wrinkles (Maylis, page 3; as required for instant Claim 11).
Special Chem teaches that disodium EDTA (edetate disodium) enhances the stability of cosmetics and bonds with metal ions, which prevents deterioration of cosmetics and personal care products (Special Chem, page 1; as required for instant Claim 11).
Dréno et al. teach that 2-phenoxyethanol has a large spectrum of antimicrobial activity and has been widely used as a preservative in cosmetics for decades (Dréno et al., Abstract, page 15; as required for instant Claim 11).
Fleur & Bee teaches that carbomer keeps skin products consistent, acts as a thickener, provides a smooth feel, acts as an emulsifier, works well with all skin types, and is safe for use for the general population (Fleur & Bee, pages 3-4; as required for instant Claim 11).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to include the ingredients of Maylis, Special Chem, Dréno et al., and Fleur & Bee in the composition of Saliou et al. in order to arrive at the instant invention. The various positive skin enhancing, stability, and preservative properties of the ingredients as described above provides motivation for a skilled artisan to choose and include edetate disodium, high, medium, and low weight hyaluronic acid, 2-phenoxyethanol, and carbomer in a skincare composition with the Shatavari extract, niacinamide, lactic acid, and water of Saliou et al. with a reasonable expectation of success.
Saliou, Maylis, Special Chem, Dréno et al., and Fleur & Bee are relied upon for the reasons discussed above and based upon the overall beneficial teaching provided by this reference with respect to skincare compositions comprising shatavari extraction in various formulations such as gels, lotions, and sprays disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable masses of ingredients and pH of instant Claim 11), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Claims 1-7, 12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Saliou et al. (EP 2248526 A1) in view of Ruksiriwanich et al. (Molecules, 2022, 16 pages) as applied to Claims 1-7, 12, and 16 above, and further in view of Liu et al. (Int J Pharmaceut, February 2023, 15 pages).
The instant claims and teachings of Saliou et al. in view of Ruksiriwanich et al. are as of record.
Saliou et al. and Ruksiriwanich et al. do not teach wherein the Shatavari extract was extracted with 70% ethanol and a surfactant.
Liu et al. teach that addition of a surfactant is a solubility-enhancing method for poorly water-soluble molecules (Liu et al., Introduction, page 1) and can be used for extraction of plant proteins, such as gliadin which is extracted with 70% ethanol (Liu et al., 3.3., page 5).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application provide a Shatavari extract prepared by the method of Liu et al. in the composition taught by Saliou and Ruksiriwanich et al. because adding a surfactant increases the solubility of poorly water-soluble molecules (e.g., 70% ethanol is 30% water), thereby increasing extraction yield of particular molecules. A skilled artisan would therefore be motivated to use the extraction method of Liu et al. in order to provide a Shatavari extract for the claimed composition and could do so with a reasonable expectation of success. Additionally, the adjustment of particular conventional working conditions (e.g., extraction solvent of 70% ethanol), 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 the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, 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).
Response to Arguments
Applicant's arguments filed 28 February 2026 have been fully considered but they are not persuasive.
Applicant argues that because Saliou et al. only mentions Shatavari within a general list of extracts and does not provide specific details or formulations comprising the ingredients of the claimed composition, the reference fails to disclose or suggest the composition of instant Claim 1. Applicant additionally argues that Teich, Meckfessel & Brandt, Maylis, Special Chem, Dréno et al., and Fleur & Bee do not disclose or suggest the claimed formulation. It is also argued that the references do not disclose the extraction methods amended into instant Claim 1.
The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP § 2111.03). The disclosure of Saliou et al., however, comprises all of the ingredients of instant Claim 1 and Ruksiriwanich et al. further provides motivation not only for selection of Shatavari from the list of Saliou et al., but also for use of the specific extraction method of supercritical carbon dioxide fluid extraction and 95% ethanol as a co-solvent because this specific extract down regulates (inhibits) 5α-reductase gene expression, which leads to reduction of facial sebum production and minimizes pores. Finally, it is noted that the disclosures of Saliou et al., Ruksiriwanich et al., Teich, Meckfessel & Brandt, Maylis, Special Chem, Dréno et al., and Fleur & Bee in combination reasonably teach or suggest the combination of the instant invention and are relied upon for the reasons described in the rejections above, and a skilled artisan would therefore be motivated to include various additional ingredients in the composition.
Applicant additionally argues that the extraction method for obtaining the Shatavari extract results in unique and advantageous effects which are fundamentally different from those produced using other techniques known in the art. Applicant goes on to argue that the concentration ranges recited in the claims are, narrow precise ranges which are not disclosed or suggested by the cited references and there is no reason for a skilled artisan to modify the teachings of the cited references to arrive at the instant invention.
Ruksiriwanhich et al., however, disclose that extraction of Shatavari using supercritical carbon dioxide fluid extraction and 95% ethanol as a co-solvent produces an extract which down regulates (inhibits) 5α-reductase gene expression, leading to reduction of facial sebum production and minimizes pores. This provides motivation and reasonable expectation of success for a skilled artisan to select the extract produced using the specific method of Ruksiriwanhich et al. for use in the skincare composition of Saliou et al. and also for a skilled artisan to reasonably provide a weight range of Shatavari extract for inclusion in a product which would be useful as skincare composition. Additionally, Liu et al. disclose that addition of a surfactant is a solubility-enhancing method for poorly water-soluble molecules and can be used for extraction of plant proteins, such as gliadin which is extracted with 70% ethanol. A skilled artisan would therefore be motivated to use this method because adding a surfactant increases the solubility of poorly water-soluble molecules (e.g., 70% ethanol is 30% water), thereby increasing extraction yield of particular molecules.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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