DETAILED ACTION
This office action is in response to applicant’s filing dated May 10, 2026.
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 .
Status of Claims
Claims 1-19 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a NADES system that comprises a eutectic solvent system that is useful as an additive to an adjuvant, an anti-freeze product, an antimicrobial product, or as a personal care product system in the reply filed on May 10, 2026 is acknowledged.
Claims 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 10, 2026.
Applicant’s election without traverse of a NADES system (formulation) species comprising menthol, lactic acid, thymol, oleic acid, urea, glucose, water, L-arginine, tartaric acid, citric acid, sodium acetate, glycerol, borneol, sorbitol, betaine, and camphor in the reply filed on May 10, 2026 is acknowledged.
Claims 9-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 10, 2026.
Claims 1-8 are presently under examination as they relate to the elected species: a NADES system (formulation) species comprising menthol, lactic acid, thymol, oleic acid, urea, glucose, water, L-arginine, tartaric acid, citric acid, sodium acetate, glycerol, borneol, sorbitol, betaine, and camphor
Priority
The present application claims benefit of US Provisional Application No. 63/442,122 filed on January 31, 2023.
Drawings
Acknowledgement is made of the drawings received on January 31, 2024. These drawings are accepted.
Claim Objections
Claims 6 and 7 is objected to because of the following informalities:
Claim 6 is missing a comma “,” between the terms “menthol” and “thymol” and between the terms “oleic acid” and “and.”
Claim 7 contains the term “water” twice. One of the instances should be deleted.4
The end of the claims contain a Conclusion paragraph and attorney signature. This should be on a page separate from the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-8 are directed to a NADES system that comprises a eutectic solvent system that is useful as an additive to an adjuvant, an anti-freeze product, an antimicrobial product, or as a personal care product, wherein the eutectic solvent system comprises one or more of the following compounds: menthol, lactic acid, thymol, oleic acid, urea, glucose, water, L-arginine, tartaric acid, citric acid, sodium acetate, glycerol, borneol, sorbitol, betaine, or camphor. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The analysis has been conducted in accordance with the most recent 2014 Interim Guidelines for Subject Matter Eligibility, published by USPTO in the Federal Register on 12/16/2014, http://www.gpo.gov/fdsys/pkg/FR-2014-12-16/pdf/2014-29414.pdf. See information about the Interim Guidelines at http://www.uspto.gov/patents/law/exam/interim_guidance_subject_matter_eligibility.jsp.
Based upon an analysis with respect to the claims as a whole, claims 1-8 are directed to a judicial exception (i.e., law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-8 recite compositions comprising natural products and as such are directed towards a law of nature and a natural phenomenon. The claimed composition does not have markedly different characteristics from what occurs in nature, and are a “product of nature” exception. Further, the claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exceptions.
The rationale for this determination is explained below:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
The elected subject matter, within the scope of the instant claims is construed as a composition comprising: wherein the eutectic solvent system comprises one or more of the following compounds: menthol, lactic acid, thymol, oleic acid, urea, glucose, water, L-arginine, tartaric acid, citric acid, sodium acetate, glycerol, borneol, sorbitol, betaine, or camphor.
So the answer to Step 1 is: Yes, the claims are drawn to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea?
The claimed subject matter appears to describe a composition comprising a wherein the eutectic solvent system comprises one or more of the following compounds: menthol, lactic acid, thymol, oleic acid, urea, glucose, water, L-arginine, tartaric acid, citric acid, sodium acetate, glycerol, borneol, sorbitol, betaine, or camphor.
Because each compound is naturally occurring, each compound or their combination together in a composition is considered a “product of nature,” which falls within each of the categories: “laws of nature” and “natural phenomena”. Thus, the claims are drawn to judicially recognized exceptions. See p74623, left column, of the Federal Registry notice: …Courts have held that naturally occurring products and some man-made products that are essentially no different from a naturally occurring product are ‘‘products of nature’’ that fall under the laws of nature or natural phenomena exception. (Section I (3); pp. 74622-4, of the Federal Registry notice discusses Natural Products.).
The next question within step 2A is: does the nature based product show “markedly different characteristics” from any naturally occurring counterpart(s) in their natural state, based on structure, function and/or properties?
Claims 1-8 recite a composition comprising a natural product. The claimed naturally occurring components exist naturally in a human/animal body. The instant specification teaches natural deep eutectic solvents (NADES) are biologically based deep eutectic solvents which are composed of two or more compounds that are generally plant based primary metabolites, i.e., organic acids, sugars, alcohols, amines and amino acids. Moreover, the claims specify the NADES system comprises one or more of the following naturally occurring eutectic solvents: menthol, lactic acid, thymol, oleic acid, urea, glucose, water, L-arginine, tartaric acid, citric acid, sodium acetate, glycerol, borneol, sorbitol, betaine, or camphor. Thus, the claims encompass a composition comprising one of the naturally occurring compounds. Thus, Applicant’s claimed composition is essentially directed to composition comprising a naturally occurring compound or an aggregation of compounds that occur in nature.
“The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. When there is no naturally occurring counterpart to the nature based product, the comparison should be made to the closest naturally occurring counterpart. In the case of a nature-based combination, the closest counterpart may be the individual nature-based components that form the combination, i.e., the characteristics of the claimed nature-based combination are compared to the characteristics of the components in their natural state”.
Establishment of a marked difference cannot be based on some inherent or innate characteristic of the naturally occurring counterpart. See p. 74623, footnote 28:
“To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (‘‘[The inventor did] not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable.’’); In re Marden, 47 F.2d 958 (CCPA 1931) (eligibility of a claim to ductile vanadium held ineligible, because the ‘‘ductility or malleability of vanadium is . . . one of its inherent characteristics and not a characteristic given to it by virtue of a new combination with other materials or which characteristic is brought about by some chemical reaction or agency which changes its inherent characteristics’’). Further, a difference in a characteristic that came about or was produced independently of any effort or influence by applicant cannot show a marked difference. Roslin, 750 F.3d at 1338 (Because ‘‘any phenotypic differences came about or were produced ‘quite independently of any effort of the patentee’ ’’ and were ‘‘uninfluenced by Roslin’s efforts’’, they ‘‘do not confer eligibility on their claimed subject matter’’ (quoting Funk Bros.)).
In the instant case, there seems to be no indication in the specification that the combination of all of the above natural products has any characteristics (structural, functional or other properties) that are different from the naturally occurring counterpart in its natural state. Thus the composition does not have markedly different characteristics from what occurs in nature, and is a “product of nature exception”.
So the answer to Step 2A is: Yes, the claims are drawn to a natural composition.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exemption?
The claims have no additional elements (other than “purified from at least one natural source”). Because the claim does not include any additional features that could add “significant more” to the exception the answer to Step B is: No, the claims do not recite additional elements that amount significantly more than the judicial exception.
In sum, applicant’s claims are not directed to a composition that is markedly different in structure from a naturally-occurring product. Therefore, the claims are not directed to patent-eligible subject matter.
The claims do not qualify as eligible subject matter, and are properly rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Cavaco Paulo (WO 2022/101490 A1).
While the examination has not been expanded beyond the elected species: NADES system (formulation) species comprising menthol, lactic acid, thymol, oleic acid, urea, glucose, water, L-arginine, tartaric acid, citric acid, sodium acetate, glycerol, borneol, sorbitol, betaine, and camphor (as the NADES system species), the following rejection is made to further prosecution with regards to the claims which read on the elected species, and that are being anticipated by the prior art (Cavaco Paulo) with regard to the broader genus of “NADES system”.
Regarding claim 1-7, Cavaco Paulo teaches a natural deep eutectic mixture for extraction of biocomponents comprising two different solvents, wherein a first solvent is selected from a list consisting of: lactic acid, and glycerol, citric acid, maleic acid, and tetrabutylammonium bromide and a second solvent is selected from a list consisting of:, sodium lactate, sodium citrate, transcutol, glycine, glycerol, oleic acid, sodium lactate, decanoic acid; further comprising up to 90% (w/w) in water; the disclosure also relates to compositions comprising the NADES and the use of said compositions as cosmetic formulations (abstract). Cavaco Paulo teaches NADES composition 2 contains lactic acid and glycerol (page 12, Table 1). A cosmetic formulation reads on a personal care product.
Regarding claims 2, 4, and 5, the wherein limitations of these claims are directed to an intended use of the composition, for use in enhancing qualities of a product that is a personal care product (instant claim 2); for an anti-freeze product (instant claim 4), for an antimicrobial product (instant claim 5). Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the intended use as an adjuvant for enhancing qualities of a product that is a personal care product; for an anti-freeze product, for an antimicrobial product.
Regarding claim 8, Cavaco Paulo teaches in an embodiment, the composition may be used in skin care treatment, namely skin care products, preferably skin creams.
Thus, the teachings of Cavaco Paulo anticipate the NADES system of claims 1-8.
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.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Cavaco Paulo (WO 2022/101490 A1).
While the examination has not been expanded beyond the elected species: NADES system (formulation) species comprising menthol, lactic acid, thymol, oleic acid, urea, glucose, water, L-arginine, tartaric acid, citric acid, sodium acetate, glycerol, borneol, sorbitol, betaine, and camphor (as the NADES system species), the following rejection is made to further prosecution with regards to the claims which read on the elected species, and that are being anticipated by the prior art (Cavaco Paulo) with regard to the broader genus of “NADES system”.
Regarding claim 1-7, Cavaco Paulo teaches a natural deep eutectic mixture for extraction of biocomponents comprising two different solvents, wherein a first solvent is selected from a list consisting of: lactic acid, and glycerol, citric acid, maleic acid, and tetrabutylammonium bromide and a second solvent is selected from a list consisting of:, sodium lactate, sodium citrate, transcutol, glycine, glycerol, oleic acid, sodium lactate, decanoic acid; further comprising up to 90% (w/w) in water; the disclosure also relates to compositions comprising the NADES, the obtained extract and/or a topical active compound and the use of said compositions as cosmetic formulations (abstract). A cosmetic formulation reads on a personal care product. Moreover, Cavaco Paulo teaches a natural deep eutectic mixture comprises a first solvent selected from lactic acid, glucose, citric acid, menthol, sodium acetate, sorbitol, tartaric acid, oleic acid; and a second solvent selected from glycerol, glucose, oleic acid, sodium acetate [0012]. Cavaco Paulo further teaches the extract comprises fatty acids and oils such as borneol; sugars, such as D-sorbitol; or mixtures thereof [0045]; in an embodiment, the topical active compound is menthol [0048]; and in an embodiment, the composition may further comprise thymol and urea or mixtures thereof.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to arrive at a composition comprising menthol, lactic acid, thymol, oleic acid, urea, glucose, water, tartaric acid, citric acid, sodium acetate, glycerol, borneol, and sorbitol from the teachings of Cavaco Paulo. One would have been motivated to do so because of each of the compounds have been individually taught in the prior art to be suitable for producing a cosmetic composition comprising an NADES, the obtained extract and a topical active compound. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by combining the disclosed solvents, extract, and topical active compounds, one would have achieved a cosmetic composition comprising an NADES, the obtained extract and a topical active compound.
Regarding claims 2, 4, and 5, the wherein limitations of these claims are directed to an intended use of the composition, for use in enhancing qualities of a product that is a personal care product (instant claim 2); for an anti-freeze product (instant claim 4), for an antimicrobial product (instant claim 5). Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the intended use as an adjuvant for enhancing qualities of a product that is a personal care product; for an anti-freeze product, for an antimicrobial product.
Regarding claim 8, Cavaco Paulo teaches in an embodiment, the composition may be used in skin care treatment, namely skin care products, preferably skin creams.
Taken together, all this would result in the NADES system of claims 1-8 with a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/095,795 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a NADES system that comprises a eutectic solvent system that is useful as an additive to an adjuvant, an anti-freeze product, an antimicrobial product, or as a personal care product, wherein the eutectic solvent system comprises one or more of the following compounds: menthol, lactic acid, thymol, oleic acid, urea, glucose, water, L-arginine, tartaric acid, citric acid, sodium acetate, glycerol, borneol, sorbitol, betaine, or camphor.
The copending claims are directed to a personal care product formulation that comprises an active ingredient and a NADES composition, wherein the NADES composition comprises one or more of a) L-arginine, L-carnitine, and water, b) L-arginine, maltodextrin, and water, c) L-arginine, urea, and water, d) L-arginine, glycerol, and water, e) lactic acid, dextrose, and water, f) citric acid, glycerol, and water, g) betaine and lactic acid, h) glucose, glycerol, and water, i) L-arginine, lactic acid, and water, j) L-arginine, citric acid, and water, k) betaine, urea, and water, l) coconut betaine and citric acid, m) decyl glucoside and lactic acid, n) citric acid and dodecyl glucoside, or o) decyl glucoside, glycerol, and citric acid.
The composition of the copending claims would anticipate the NADES system of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/093,744 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a NADES system that comprises a eutectic solvent system that is useful as an additive to an adjuvant, an anti-freeze product, an antimicrobial product, or as a personal care product, wherein the eutectic solvent system comprises one or more of the following compounds: menthol, lactic acid, thymol, oleic acid, urea, glucose, water, L-arginine, tartaric acid, citric acid, sodium acetate, glycerol, borneol, sorbitol, betaine, or camphor.
The copending claims are directed to a NADES that consists of:
lactic acid, dextrose, and water
urea, glycerol, and water
urea and lactic acid
lactic acid and glycerol
betaine and lactic acid
L-arginine, citric acid, and water
L-arginine, lactic acid, and water
betaine, glycerol, and dextrose
betaine, polyethylene glycol and water
lactic acid, sorbitol, and water
choline chloride and lactic acid
betaine and lactic acid, or
glycerol, lactic acid, and oxalic acid.
The NADES of the copending claims would anticipate the NADES system of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/427,859 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a NADES system that comprises a eutectic solvent system that is useful as an additive to an adjuvant, an anti-freeze product, an antimicrobial product, or as a personal care product, wherein the eutectic solvent system comprises one or more of the following compounds: menthol, lactic acid, thymol, oleic acid, urea, glucose, water, L-arginine, tartaric acid, citric acid, sodium acetate, glycerol, borneol, sorbitol, betaine, or camphor.
The copending claims are directed to a method of extracting and/or isolating a natural product from a source, said method comprising using a NADES to extract the natural product from the source, wherein the NADES comprises one or more of a) thymol and lactic acid, b) lactic acid, glucose and water, c) citric acid, glycerol and water, d) citric acid, sorbitol, and water, e) lactic acid and glycerol, f) lactic acid, D-glucose, and D-xylose, g) xylitol and D-xylose, h) urea, glycerol and water i) camphor and thymol j) urea and lactic acid, k) lactic acid, glucose, and water 1) menthol and lactic acid and/or m) camphor and menthol.
The NADES of the copending claims would anticipate the NADES system of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-8 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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