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 .
Priority
The instant application was filed 07 June 2024 and is the national stage entry of PCT/US2022/076900 filed 23 September 2022 and the continuation of 18.694,533 filed 22 March 2024. The Applicant claims priority to provisional application 63/247,490 filed 23 September 2021. The effective filing date of the instant application is 23 September 2021.
Election/Restrictions
Applicant’s election without traverse of isoparaffin as the non-polar carrier in the reply filed on 21 August 2026 is acknowledged.
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 21 August 2026.
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 1-4, 6, 7, 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.
Claims 1-4, 6, 7, and 15 recite “green tea” in parenthesis. The parenthetical recitation renders the claim indefinite because it is unclear whether the limitations in the parenthesis are part of the claimed invention or describing an example of preference. Green tea is also not a synonym for Camellia sinensis. See MPEP 2173.05(d).
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.
Claim(s) 1, 6-8, 12-15, 17, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner et al. (US 20160374933 A1) in view of Lesielle (lesielle.com).
Regarding claim 1, Tanner teaches a skin care composition (abs, entire teaching) comprising a sunscreen agent (para. 17), 0.1-5% water (para. 42), a non-aqueous carrier, such as oil (para. 32), and 0.2% of green tea extract (paras. 91, 106). The composition may have a solid-like consistency from wax (paras. 25, 27), which is interpreted as a (solid) stick formulation.
The limitation of “dispersed in a dispersant including a non-aqueous solvent to provide a pre-mix dispersion including the Camellia sinensis (green tea) extract and the dispersant in a non-aqueous dosage form before being added to the composition” is interpreted as a product-by-process limitation, as it is describing how the green tea extract is processed before incorporation into the final composition. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Furthermore, Tanner teaches that oil is used in an amount of 1-20% (para. 32) to disperse materials not suitable or used in water or water-soluble solvents (para. 32). Therefore, it is interpreted that if 0.2% of green tea extract is dispersed in 1% of oil (non-aqueous solvent), the ratio of green tea extract to dispersant is 1:5.
Regarding claim 6, Tanner teaches 5-30% or 6-40% (paras. 22, 24) of an oil phase and 0.2% green tea extract (paras. 91, 106).
Regarding claim 7, Tanner teaches 0.2% of green tea extract (paras. 91, 106).
Regarding claim 8, the composition may comprise a hydrocarbon oil (para. 34).
Regarding claim 12, Tanner teaches 5-30% or 6-40% (paras. 22, 24) of an oil phase (non-aqueous carrier) and waxes derived from animal sources (para. 28) or beeswax (para. 28) in an amount of 1-20% (abs).
Regarding claim 13, the composition may comprise waxes derived from animal sources (para. 28).
Regarding claim 14, the composition may comprise beeswax (para. 28).
Regarding claim 15, Tanner teaches 0.2% of green tea extract (paras. 91, 106) and 1-20% (abs) of wax derived from an animal source (para. 28).
Regarding claim 17, the composition may have a solid-like consistency from wax (paras. 25, 27), which is interpreted as a (solid) stick formulation.
Regarding claim 19, the composition may comprise preservatives (para. 90).
Regarding claim 20, the composition may comprise a hydrocarbon oil (para. 34).
Tanner does not teach ethanol in claim 1.
Lesielle teaches that ethanol is a common solvent that is easily adsorbed into the skin, works well as a solvent to dissolve ingredients, has antimicrobial properties, works as a preservative, protects the skin, and improves product shelf life (pg. 1).
Since Tanner does not teach ethanol in claim 1, one of ordinary skill in the art would have been motivated to use Lesielle’s teaching of ethanol as a common solvent in skin care products with a reasonable expectation of success. A skilled artisan would have been led to combine the teachings because Lesielle teaches that ethanol works as a preservative, improves shelf life, protects the skin, etc. Therefore, it is obvious to use ethanol to improve the quality of Tanner’s skin care composition. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Claim(s) 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner et al. (US 20160374933 A1) in view of Lesielle (lesielle.com), as applied to 1, 6-8, 12-15, 17, 19, and 20 above, and further in view of Paes et al. (US 20190167540 A1).
In regards to claim(s) 1, 6-8, 12-15, 17, 19, and 20, Tanner, as applied supra, is herein applied in its entirety for its teachings of a skin care composition (abs, entire teaching) comprising a sunscreen agent (para. 17), 0.1-5% water (para. 42), a non-aqueous carrier, such as oil (para. 32), and 0.2% of green tea extract (paras. 91, 106).
Regarding claim 2, Tanner teaches 5-30% or 6-40% (paras. 22, 24) of an oil phase (non-aqueous carrier).
Tanner does not teach 0.005 to less than 0.1% of green tea extract in claim 2 and 0.01-0.05% of green tea extract in claim 4.
Paes teaches an oil-in-water emulsion skin composition (abs) comprising an amount of 0.025% green tea extract (Table 1).
Since Tanner does not teach 0.005 to less than 0.1% of green tea extract in claim 2, 0.01-0.05% of green tea extract in claim 4, and 0.05-1% of green tea extract in claim 7, one of ordinary skill in the art would have been motivated to use Paes’ teaching of 0.025% green tea extract (Table 1) with a reasonable expectation of success. Paes also teaches 0.01% of green tea extract (Table 2) and 0.03% of green tea extract (Table 4) depending on the targeted age group and anti-aging properties of the composition. The optimum or workable range of green tea extract can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized amounts of green tea extract as nonobvious.
Claim(s) 3, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner et al. (US 20160374933 A1) in view of Lesielle (lesielle.com) and Paes et al. (US 20190167540 A1), as applied to 1, 2, 4, 6-8, 12-15, 17, 19, and 20 above, and further in view of Buchalter (WO 2020107000 A1) and Pharmabiz (pharmabiz.com).
In regards to claim(s) 1, 2, 4, 6-8, 12-15, 17, 19, and 20, Tanner et al., as applied supra, is herein applied in its entirety for its teachings of a skin care composition (abs, entire teaching) comprising a sunscreen agent (para. 17), 0.1-5% water (para. 42), a non-aqueous carrier, such as oil (para. 32), and 0.2% of green tea extract (paras. 91, 106).
Tanner et al. do not teach green tea extract in an amount of 0.05 to less than 1 % or a propellant/spray in claims 3 and 18.
Buchalter teaches a skin care composition (abs) that may comprise 0.01-2% of green tea extract (para. 29).
Pharmabiz teaches that administrating drugs through use of a propellant to form an aerosol is easy, can be applied directly on desired or affected parts of the skin, and can prevent contamination of the drug (pg. 1).
Since Tanner et al. do not teach using a propellant in claim 3 or in the form of a spray in claim 18, one of ordinary skill in the art would have been led to use Pharmabiz’s teaching of using a propellant to administer a formulation directly to the skin. A skilled artisan would have been led to improve Tanner’s skin composition teaching for ease of use and prevention of contamination of the drug. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Since Tanner et al. do not teach green tea extract in an amount of 0.05 to less than 1 % or a propellant/spray in claim 3, one of ordinary skill in the art would have been motivated to use Buchalter’s teaching of 0.01-2% of green tea extract with a reasonable expectation of success. Buchalter recognizes green tea extract as an antioxidant used to slow the skin’s deterioration (para. 142), where antioxidants may also be used in an amount of 0.1-1% (para. 142). The optimum or workable range of green tea extract can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized amounts of green tea extract as nonobvious.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner et al. (US 20160374933 A1) in view of Lesielle (lesielle.com), Paes et al. (US 20190167540 A1), Buchalter (WO 2020107000 A1), and Pharmabiz (pharmabiz.com), as applied to 1-4, 6-8, 12-15, 17-20 above, and further in view of Paula’s Choice (paulaschoice-eu.com, tetrahexyldecyl ascorbate).
In regards to claim(s) 1-4, 6-8, 12-15, 17-20, Tanner et al., as applied supra, is herein applied in its entirety for its teachings of a skin care composition (abs, entire teaching) comprising a sunscreen agent (para. 17), 0.1-5% water (para. 42), a non-aqueous carrier, such as oil (para. 32), and 0.2% of green tea extract (paras. 91, 106).
Tanner does not teach tetrahexyldecyl ascorbate in their composition in claim 5.
Paula’s Choice teaches that tetrahexyldecyl ascorbate has a greater affinity for skin because of its fatty acid component, which helps aid in penetration. It can also pair well with other ingredients for enhanced effectiveness and anti-aging properties (pg. 1).
Since Tanner does not teach tetrahexyldecyl ascorbate in their composition in claim 5, one of ordinary skill in the art would have been led to use Paula’s Choice’s teaching of tetrahexyldecyl ascorbate as a helpful skin product ingredient. A skilled artisan would have been led to improve Tanner’s skin composition teaching for better skin penetration and enhanced effectiveness with combinations of other skin ingredients. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Claim(s) 10 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner et al. (US 20160374933 A1) in view of Lesielle (lesielle.com), Paes et al. (US 20190167540 A1), Buchalter (WO 2020107000 A1), Pharmabiz (pharmabiz.com), and Paula’s Choice (paulaschoice-eu.com, tetrahexyldecyl ascorbate), as applied to 1-8, 12-15, 17-20 above, and further in view of Paula’s Choice (paulaschoice-eu.com, isoparaffin).
In regards to claim(s) 1-8, 12-15, 17-20, Tanner et al., as applied supra, is herein applied in its entirety for its teachings of a skin care composition (abs, entire teaching) comprising a sunscreen agent (para. 17), 0.1-5% water (para. 42), a non-aqueous carrier, such as oil (para. 32), and 0.2% of green tea extract (paras. 91, 106).
Tanner does not specifically teach isoparaffin (Applicant’s election) in claims 10 and 21.
Paula’s Choice teaches that isoparaffin is a skin emollient, lubricant, and solvent and texture enhancer. Isoparaffin helps ingredients mix cohesively and form aesthetically pleasing formulations (pg. 1).
Since Tanner does not teach isoparaffin in their composition in claims 10 and 21, one of ordinary skill in the art would have been led to use Paula’s Choice’s teaching of isoparaffin as an emollient, lubricant, and texture enhancer. A skilled artisan would have been led to improve Tanner’s skin composition teaching for a more cohesive mixture and aesthetically pleasing formulations. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613
