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 Group I, claims 1-14 and 19-24 in the reply filed on 9/29/2025 is acknowledged.
Specification
The abstract of the disclosure is objected to because it includes legal phraseology. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Status of the Claims
Claims 1-24 are pending. Claims 1-14 and 19-24 are under current examination. Claims 15-18 are withdrawn from consideration.
Claim Objections
Claims 1-14 and 19-24 are objected to because of the following informalities:
The independent claim 1 lacks the article “A” and the dependent claims 2-14 and 19-24 lack the article “The” at the beginning of each claim. See MPEP 608.01 (n)(IV).
Claim 1, line 3, recites “lactic acid, and glycerol, citric acid, maleic acid, and tetrabutylammonium bromide”. This is grammatically incorrect. The claim should be amended to remove the “and” immediately preceding glycerol, as in “lactic acid, glycerol, citric acid, maleic acid, and tetrabutylammonium bromide”.
Claim 1, lines 5 and 6, lists sodium lactate twice in the list of possible second solvents. The claim should be amended so that sodium lactate is only listed once.
Claims 4 and 5 recite the limitation “preferably (1:4-1:3)”. The parentheses are unnecessary and should be eliminated.
Claim 10 recites the limitation “…or tetrabutylammonium bromide and decanoic acid, or maleic acid and ethylene glycol”. The “or” before tetrabutylammonium bromide is unnecessary and should be eliminated.
Claim 19 contains the limitation “up to 1% (w/w) of topical active compound”. This should be amended to read “up to 1% (w/w) of a topical active compound”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-14 and 19-24 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.
Claim 1 recites the limitation “further comprising up to 90% (w/w) in water”. This renders the claim indefinite because it is not clear to which weight the 90% (w/w) in water is relative.
Regarding claim 2, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “20-90% (mol/mol) of the first solvent” and “10-80% (mol/mol) of the second solvent”, and the claim also recites “preferably 30-80% (mol/mol)” and “preferably 12-50% (mol/mol)”, respectively, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 2 recites the limitations “20-90% (mol/mol) of the first solvent; preferably 30-80% (mol/mol)” and “10-80% (mol/mol) of the second solvent; preferably 12-50% (mol/mol)”. This renders the claim indefinite because it is not clear to which mole value the mole value of the first or second solvent is relative.
Claim 3 recites “preferably the natural deep eutectic mixture is a combination of: …or lactic acid and transcutol, glycerol and maleic acid.” This renders the claim indefinite because it is not clear if lactic acid, transcutol, glycerol, and maleic acid must all be present as a combination or if the claim is intending to claim a combination of lactic acid and transcutol or a combination of glycerol and maleic acid.
Regarding claims 3, 4, 5, and 13, the phrases "preferably" and “more preferably” render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 6 recites the limitation “comprising 4:1; lactic acid and sodium citrate”. This renders the claim indefinite because it is not clear if “comprising 4:1;” is intended to be a separate limitation from the phrase “lactic acid and sodium citrate…”. This also renders the claim indefinite because there are no units of measure for the recited ratio.
Claim 7 recites the limitation “comprising 2:1; glycerol and sodium lactate”. This renders the claim indefinite because it is not clear if “comprising 2:1;” is intended to be a separate limitation from the phrase “glycerol and sodium lactate…”. This also renders the claim indefinite because there are no units of measure for the recited ratio.
Claim 8 recites the limitation “comprising 1:2; citric acid and sodium lactate”. This renders the claim indefinite because it is not clear if “comprising 1:2;” is intended to be a separate limitation from the phrase “citric acid and sodium lactate…”. This also renders the claim indefinite because there are no units of measure for the recited ratio.
Claim 11 recites the limitation “comprising 6 to 20% (w/w) in water”. This renders the claim indefinite because it is not clear to which weight the weight of the water is relative.
Regarding claim 12, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation “-55 to -15oC”, and the claim also recites “preferably from -52 to -20oC”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 19, the phrases "preferably" and “such as” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “small acids” in claim 19 is a relative term which renders the claim indefinite. The term “small acids” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Without a clear definition as to what size an acid must be in order to be categorized as a small acid, it is impossible to discern the metes and bounds of the claim.
Claim 19 recites the phrase “diisooctyl phthalate or analogues”. This renders the claim indefinite because it is not clear what compounds would be embraced by a functional analog. The term does not place any structural limits in order to be a functional analog, therefore the substances embraced are unclear.
Claim 19 recites the limitation “up to 1% (w/w) of topical active compound”. This renders the claim indefinite because it is not clear to which weight the weight of the topical active compound is relative.
Regarding claim 20, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation “0.01-1 (w/w)”, and the claim also recites “preferably from 0.1-0.5 (w/w)”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The Examiner notes that it is presumed that the limitation “preferably 0.01-1 (w/w)” refers to a weight percentage.
Claim 20 recites the limitation “preferably 0.1-0.5 (w/w)”. This renders the claim indefinite because it is not clear if the limitation is directed to a percentage or some other measure. This also renders the claim indefinite because it is not clear to which weight the weight of the topical active compound is relative.
Claim 21 recites the limitation "the extract" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation “up to 90% (w/w) of the natural deep eutectic mixture, up to 10% (w/w) of the extract and up to 1% (w/w) of the topical active compound”. This renders the claim in definite because it is not clear to which weight the weight of each component is relative.
Claim 23 provides for the use of “the composition as described in claim 19” but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Regarding claim 23, the phrases "preferably" and “namely” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 9, 10, 14, 22, and 24, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites the limitation “maleic acid and ethylene glycol”. The independent claim 1 does not recite ethylene glycol, therefore claim 10 broadens the scope of the independent claim 1 and is not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 23 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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.
Claims 1-4 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bakirtzi et. al. (Journal of Applied Research on Medicinal and Aromatic Plants, pg. 120-127, publication year: 2016).
Regarding claims 1 and 3, Bakirtzi discloses a natural deep eutectic solvent composed of lactic acid, glycine, and water in a 3:1:3 molar ratio (pg. 122 Table 1, NADES4). The natural deep eutectic solvent is used to extract polyphenolic compounds from selected Greek medicinal plants (pg. 120, Abstract).
Regarding claims 2, 4, and 11, Bakirtzi discloses a natural deep eutectic solvent composed of lactic acid, glycine, and water in a 3:1:3 molar ratio (pg. 122 Table 1, NADES4).
Regarding claim 12, Bakritzi discloses that the natural deep eutectic solvent is a transparent light brown/pinkish viscous liquid (pg. 122 Table 1, NADES4). With regards to the “liquid at a temperature ranging from…” and “melting point” limitations of instant claim 12, the prior art teaches the same natural deep eutectic solvent as claimed and therefore, the temperature range of the liquid state and the melting point properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claims 13 and 14, Bakritzi do not disclose the pH adjustability, density, or viscosity properties as recited in claims 13 and 14. However, the invention as claimed is not structurally distinguishable from the disclosure of Bakritzi and therefore, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition taught by the prior art. Since the Patent and Trademark Office does not have the facilities for examining and comparing the claimed composition with that of the prior art, the burden of proof is shifted to the Applicants to show an unobvious distinction between the structural and functional characteristics of the claimed composition and the composition of the prior art; i.e., to prove that the properties are not inherent. See In re Best, 562 F.2d 1252, 195 U.S.P.Q. 430 (CCPA 197) and Ex parte Gray, USPQ 2d 1922 (PTO Bd. Pat. App. & Int.). As recited in MPEP §2112.01 (II): “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
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 1-4, 9, 12-14, and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kwon (U.S. Patent Application Publication No. 2022/0287938, filing date: 8/21/2020, available as prior art under 35 U.S.C. 102(a)(2)).
Applicant’s Invention
Applicant’s claim 1 is drawn to 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.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1 and 3, Kwon teaches a eutectic mixture comprising water, an alpha-hydroxy acid (AHA) and an amino acid [0008]. The AHA may be lactic acid or citric acid [0013] and the amino acid used in combination with the AHA may be glycine [0016]. Water may be included in an amount of 25 to 80 parts by weight with respect to the weight of the eutectic mixture [0022]. The claims recite the limitation “for extraction of biocomponents”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the eutectic mixture embraced by Kwon reads on the instant claims. See MPEP 2112.01 (II).
Regarding claims 2, 4, and 9, Kwon teaches that the AHA and amino acid may be included in the eutectic mixture at a weight ratio of 1:0.1 to 1:10 [0019]. Kwon also teaches that in the eutectic mixture, a ratio between materials required for the eutectic mixture may be determined according to the charge of the molecules of the components, the type and number of functional groups of the molecule, and the polarity of the molecule or functional group. The ratio between materials may also be determined according to the size or similarity of the molecules [0034]. Kwon also teaches that the eutectic phenomenon is a phenomenon in which the melting point drops while two or more materials are mixed, so even though each component contained in the mixture shows a solid state at room temperature the mixture may become an anhydrous solution rather than a solid crystal, which is due to Van der Waals interactions or hydrogen bonding between the components [0004]. When AHA is contained in the eutectic mixture, the eutectic mixture may be prepared by mixing the AHA with an amino acid, which is a component that can be bound by dipole-dipole interaction between polar molecules, a dipole-induced dipole interaction, a hydrogen bond or a Van der Waals interaction. In this case, the AHA may act as a hydrogen bond donor, and the amino acid may act as a hydrogen bond acceptor [0016].
Regarding claim 12, Kwon teaches that the eutectic mixture is clear and homogenous and maintains its liquid state and transparency even after being subjected to a cooling process [0048]. With regards to the “clear and liquid at a temperature ranging from 15 to 30oC” and “melting point” limitations of instant claim 12, the prior art teaches the same eutectic mixture as claimed and therefore, the liquid state and melting point temperature ranges are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claim 13, Kwon teaches that the acidity of the eutectic mixture may be adjusted to have a value of pH 3.5 to pH 10 [0037]. Kwon do not disclose that the pH may be adjusted by changing the molar ratio between the two solvents or by the addition of sodium hydroxide properties as recited in claim 13. However, the invention as claimed is not structurally distinguishable from the disclosure of Kwon and therefore, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition taught by the prior art. Since the Patent and Trademark Office does not have the facilities for examining and comparing the claimed composition with that of the prior art, the burden of proof is shifted to the Applicants to show an unobvious distinction between the structural and functional characteristics of the claimed composition and the composition of the prior art; i.e., to prove that the properties are not inherent. See In re Best, 562 F.2d 1252, 195 U.S.P.Q. 430 (CCPA 197) and Ex parte Gray, USPQ 2d 1922 (PTO Bd. Pat. App. & Int.). As recited in MPEP §2112.01 (II): “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
Regarding claim 14, Kwon do not disclose the density or viscosity properties as recited in claim 14. However, the invention as claimed is not structurally distinguishable from the disclosure of Kwon and therefore, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition taught by the prior art. Since the Patent and Trademark Office does not have the facilities for examining and comparing the claimed composition with that of the prior art, the burden of proof is shifted to the Applicants to show an unobvious distinction between the structural and functional characteristics of the claimed composition and the composition of the prior art; i.e., to prove that the properties are not inherent. See In re Best, 562 F.2d 1252, 195 U.S.P.Q. 430 (CCPA 197) and Ex parte Gray, USPQ 2d 1922 (PTO Bd. Pat. App. & Int.). As recited in MPEP §2112.01 (II): “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
Regarding claim 19, Kwon teaches a cosmetic composition that may include the eutectic mixture [0051] and an oily component [0052].
Regarding claim 20, Kwon teaches a cosmetic composition that may include the eutectic mixture [0051] and may further include all kinds of components usable in typical cosmetics, such as a moisturizing agent, sunscreen, pH adjusting agent, preservative, antioxidant, skin conditioning agent, surfactant, a fragrance, or colorant [0061]. Each component included in a cosmetic composition may be included in the composition, preferably within the range not exceeding the maximum amount stipulated in the "Cosmeceutical Safety and Technical Code" prescribed by the Chinese government [0062]. The instant specification defines a topical active compound as a compound that may be used in a topical treatment, namely on skin/hair ([0036] of the instant spec). The Examiner therefore considers the moisturizing agents, sunscreen, antioxidants, and skin conditioning agents of Kwon to read on the instant claim.
Regarding claim 21, Kwon teaches that the cosmetic composition may include the eutectic mixture in an amount of 0.01 to 50 parts by weight [0049]. The oily component may include vegetable oil, avocado oil, wheat germ oil, rosehip oil, shea butter, almond oil, olive oil, macadamia oil, argan oil, meadowfoam oil, sunflower oil, castor oil, camelia oil, corn oil, safflower oil, soybean oil, rapeseed oil, macadamia nut oil, jojoba oil, palm oil, palm kernel oil or coconut oil [0058]. Kwon also teaches that the content of the oily component is not particularly limited and may be included as the remaining content expect for the eutectic mixture [0060]. The Examiner has interpreted the claim to read on any extract of any kind, including the oils extracted from plants embraced by Kwon, because no clear definition has been provided for what the extract embraced by the instant claim 21 may be. Kwon also teaches a cosmetic composition that may include the eutectic mixture [0051] and may further include all kinds of components usable in typical cosmetics, such as a moisturizing agent, sunscreen, pH adjusting agent, preservative, antioxidant, skin conditioning agent, surfactant, a fragrance, or colorant [0061]. Each component included in a cosmetic composition may be included in the composition, preferably within the range not exceeding the maximum amount stipulated in the "Cosmeceutical Safety and Technical Code" prescribed by the Chinese government [0062]. The instant specification defines a topical active compound as a compound that may be used in a topical treatment, namely on skin/hair ([0036] of the instant spec). The Examiner therefore considers the moisturizing agents, sunscreen, antioxidants, and skin conditioning agents of Kwon to read on the instant claim.
Regarding claim 22, Kwon teaches that the composition may contain hyaluronic acid [0061].
Regarding claim 23, Kwon teaches that the cosmetic composition according to the present invention may be prepared in any formulation typically prepared in the art . For example, the cosmetic composition may include a lotion such as a flexible lotion or a nourishing lotion, a spray type lotion, an emulsion such as a facial lotion or a body lotion, a cream such as a nourishing cream, a moisture cream, and an eye cream, a stick, an essence, a cosmetic ointment, spray, gel, a pack, sunscreen, makeup base, a foundation such as liquid or spray type, a powder, a cleansing lotion, a makeup remover such as cleansing oil, a cleansing agent such as cleansing foam, soap, and body wash [0063].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1 and 3, Kwon does not teach a single embodiment or example meeting all limitation of the invention of claims 1 and 3.
Regarding claims 2, 4, and 9, Kwon does not teach a mol percentage or molar ratio of the AHA for amino acid present in the eutectic mixture.
Regarding claims 20 and 21, Kwon does not teach a weight percentage of topical active compound present in the composition.
Regarding claim 21, Kwon does not teach a weight percentage of the extract present in the composition.
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1 and 3, within the broader scope of Kwon all of the limitations of the invention of claims 1 and 3 are met. It would have been prima facie obvious for one having ordinary skill in the art to choose the limitations in the instant claims from those disclosed by Kwon and arrive at this conclusion because such was contemplated by Kwon.
Regarding the mol percentage and molar ratio of the first and second solvent as specified in claims 2, 4, and 9, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, Kwon teaches that they hydrogen bonding between the AHA and amino acid is directly responsible for the eutectic phenomenon [0004 and 0016]. The Applicants' specification provides no evidence that the selected mol percentages in claim 2 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to the direct relationship between the hydrogen bonding between the AHA and amino acid and the eutectic properties of the mixture, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the mol percentage of the first and second solvent present in the mixture. One of ordinary skill in the art would have been motivated to change the mol percentage as this could be expected to be advantageous for optimizing the eutectic properties of the composition.
Regarding claims 20 and 21, the weight percentage of the topical active compound is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight percentage in order to best achieve the desired results as such would provide advantageous treatment effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Kwon teaches that the additional agent may be a moisturizing agent, sunscreen, pH adjusting agent, preservative, antioxidant, skin conditioning agent, surfactant, a fragrance, or colorant [0061]. The Examiner considers it prima facie obvious to optimize the weight percentage of the topical active compound present, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amount of additional agent present would have a direct effect on the moisturizing, sun protection, antioxidant, or skin conditioning properties of the composition and therefore be an optimizable variable.
Regarding claim 21, the weight percentage of the extract is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight percentage of the extract in order to best achieve the desired results as such would provide advantageous stability effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Kwon teaches that the oily component is included in the composition to be present in the external phase of the eutectic mixture, thereby helping the eutectic mixture to be stable in the composition [0052]. The Examiner considers it prima facie obvious to optimize the weight percentage of the oily component, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the oily component would have a direct effect on the stability of the eutectic mixture in the composition and therefore be an optimizable variable.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Kwon (U.S. Patent Application Publication No. 2022/0287938, effective filing date: 8/21/2020, available as prior art under 35 U.S.C. 102(a)(2)), as applied to claims 1-4, 9, 12-14, and 19-23 above, and further in view of Tubby Todd Bath Co. (available 6/12/2018), as evidenced by PubChem (Menthol, available 3/25/2005).
Applicant’s Invention
Kwon renders obvious the relevant limitations of claims 1 and 19 above. Applicant’s claim 24 further adds the limitation of a composition according to claim 19 wherein the topical active compound is selected from a list comprising: opioid peptide, secretory leukocyte protease inhibitor; various structures of compounds; or mixtures thereof.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Kwon teaches a cosmetic composition that may include the eutectic mixture [0051] and may further include all kinds of components usable in typical cosmetics, such as a moisturizing agent, sunscreen, pH adjusting agent, preservative, antioxidant, skin conditioning agent, surfactant, a fragrance, or colorant, and the component is not limited [0061].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Kwon does not specifically teach the inclusion of any compound embraced by the instant claim 24. However, this deficiency is cured by Tubby Todd Bath Co.
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Tubby Todd Bath Co. teaches that menthol is used to condition skin and add fragrance to skincare products (pg. 1). PubChem teaches that the structure of menthol is:
(pg. 3, 1.1 2D Structure).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
The idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional skin conditioning and fragrance compounds used in cosmetic compositions. It would follow that the recited claims define prima facie obvious subject matter. See MPEP 2144.06.
Claims 1 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Skiff (WO 2015/165738, publication year: 2015).
Applicant’s Invention
Applicant’s claim 1 is drawn to 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.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1 and 5-8, Skiff teaches a natural deep eutectic system (pg. 3 line 6) comprised of a first component selected from malic acid, citric acid, maleic acid, lactic acid, tartaric acid and sorbic acid (pg. 3 lines 16-18). An additional component may be a food grade salt (pg. 3 line 9) selected from sodium citrate or sodium lactate (pg. 6 line 11). The system may also include a food grade solvent such as glycerol (pg. 6 line 23). In a three component solvent system, the three components may be present in a ratio of about 1:1:1 to about 6:4:1 (pg. 4 lines 7-8). The system comprises 7% or less water (pg. 1 line 28). The claims recite the limitation “for extraction of biocomponents”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the eutectic mixture embraced by Skiff reads on the instant claims. See MPEP 2112.01 (II).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1 and 5-8, Skiff doesn’t teach a single embodiment or example meeting all limitation of the invention of claims 1 and 5-8.
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1 and 5-8, within the broader scope of Skiff all of the limitations of the invention of claims 1 and 5-8 are met. It would have been prima facie obvious for one having ordinary skill in the art to choose the limitations in the instant claims from those disclosed by Skiff and arrive at this conclusion because such was contemplated by Skiff.
Claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Siriwardana (WO 2018/167130, publication year: 2018).
Applicant’s Invention
Applicant’s claim 1 is drawn to 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.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1 and 10, Siriwardana teaches a deep eutectic mixture that consists of a mixture of a hydrogen bond acceptor (A) selected from a Cat+X- salt and a hydrogen bond donor compound (B). A and B are present in a molar ratio of 1:10 to 10:1 (pg. 4 lines 12-23). The Cat+X- salt may be tetrabutylammonium bromide (pg. 8 line 17) and the hydrogen bond donor compound may be oleic acid (pg. 10 line 15). It is noted that Siriwardana is silent with regards to the presence of water in the deep eutectic mixture and therefore reads on the “further comprising up to 90% (w/w) in water” limitation of instant claim 1, which encompasses a water content of 0% (w/w). The claims recite the limitation “for extraction of biocomponents”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the eutectic mixture embraced by Siriwardana reads on the instant claims. See MPEP 2112.01 (II).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1 and 10, Siriwardana doesn’t teach a single embodiment or example meeting all limitation of the invention of claims 1 and 10.
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1 and 10, within the broader scope of Siriwardana all of the limitations of the invention of claims 1 and 10 are met. It would have been prima facie obvious for one having ordinary skill in the art to choose the limitations in the instant claims from those disclosed by Siriwardana and arrive at this conclusion because such was contemplated by Siriwardana.
Conclusion
No claims are allowed.
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/ELIZABETH ANNE MEYERS/Examiner, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614