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 22 March 2024 and is the national stage entry of PCT/US2022/0766900 filed 23 September 2022 and continuation of 18/694,533 filed 07 June 2024. The Applicant claims priority to provisional application 63/247,490 filed 23 September 2021. Therefore, the effective filing date of the instant application is 23 September 2021.
Claim Objections
Claims 55 and 56 are objected to because of the following informalities: Claims 55 and 56 are dependent from canceled claim 53. 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 41-46, 49, 52, 54, 56 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 41-46, 49, 52, 54, 56 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. See MPEP 2173.05(d). Green tea is also not an exact synonym for Camellia sinensis, since several different types of tea extracts may come from this plant.
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) 41-47, 49-52, 54, 55, 57, 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner et al. (US 2016/0374933 A1).
Tanner teaches a skincare composition that may comprise an organic or inorganic sunscreen active (entire teaching; abs; para. 82), 20-85% water (abs), silicone emulsifiers (para. 80), green tea extract in an amount of 0.2% (para. 106), and a polymer thickener in an amount of 0.1% (para. 106), addressing claims 42 and 44 and partially claim 41. The composition may include vitamin c or derivatives in an amount of 0.0001-50% (para. 86), addressing claim 55. The ratio of green tea extract to vitamin c derivative may be 1:1 if both amounts are 0.1%, addressing the ratio in claim 45. Carbomers (para. 4) and ascorbyl glucoside (para. 86) may be optionally included, addressing claims 43, 47, and partially addressing claims 45 and 46. The green tea extract may be included in the water phase (para. 106), addressing claim 49. The composition may also include silicone elastomer particles (claim 17), silica (mineral thickeners, para. 25 of instant specification; para. 85 of Tanner), xanthan gum in an amount of 0.1% (para. 106), and acrylates/C10-30 alkyl acrylate crosspolymer (para. 72), addressing claim 50. The emulsifiers include silicone emulsifiers (para. 80) and may further include a silicone elastomer gel agent (claim 17), addressing claim 51. The composition comprising a sunscreen agent (para. 82), 20-85% of water (abs), a silicone emulsifier (para. 80), and 0.2% of green tea extract (para. 106) addresses claims 52 and 58. The composition comprising a silicone elastomer gel agent (claim 17), a silica mineral thickener (para. 85), xanthan gum (para. 106), and acrylates/C10-30 alkyl acrylate crosspolymer (para. 72) addresses claims 41, 57, and 58.
The limitations of the green tea extract initially dispersed in an aqueous solvent to provide a pre-mix in claims 41 and 52 are interpreted as product-by-process limitations. The claim is interpreted as the end product of green tea extract in an aqueous solvent (para. 106), addressing claim 53 and partially claim 54. "[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).
Tanner does not specifically teach an exact combination of a sunscreen filter, water, an emulsifier, a polymer thickener, and green tea extract in claim 41. Tanner also does not teach less than 0.2% of green tea extract in claims 46 and 54.
In regards to selecting the combination of a sunscreen filter, water, an emulsifier, a polymer thickener, and green tea extract in at least claim 41, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
The claimed invention is directed towards a composition comprising a sunscreen filter, water in an amount of 50-90%, an emulsifier with a HLB value of 7 or greater, a polymer thickener, and green tea extract in an amount of 0.005-0.2%. Since Tanner teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
In regards to the amount of green tea extract in claims 46 and 54, Tanner teaches an amount of 0.2% (para. 106). The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. “[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). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Therefore, it would be obvious to adjust the amount of green tea extract to product an improved composition for the intended purpose, e.g. for consumption or as a dietary supplement, food ingredient or additive, a medical food or a nutraceutical.
Claim(s) 41-47, 49-52, 54-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner et al. (US 2016/0374933 A1) and Park (Hexane extract of green tea (Camellia sinensis) leaves is an exceptionally rich source of squalene, Food Sci Biotechnol, 2020).
In regards to claim(s) 41-47, 49-52, 54, 55, 57, 58, Tanner, as applied supra, is herein applied in its entirety for its teachings of a skincare composition that may comprise an organic or inorganic sunscreen active (entire teaching; abs; para. 82), 20-85% water (abs), silicone emulsifiers (para. 80), green tea extract in an amount of 0.2% (para. 106), and a polymer thickener in an amount of 0.1% (para. 106).
Tanner does not specifically teach green tea extract dispersed in an aqueous solvent and hydrocarbon solvent in claim 56.
Park teaches that a hydrocarbon solvent helps to extract squalene, an antioxidant (abs). The green tea is infused in water first, then the nonpolar components may be extracted with hexane. Water and hexane may be used to extract unsaponifiable components (pg. 770, right column).
Claim 56 is interpreted as a product-by-process limitation. The claim is interpreted as the end product of green tea extract in an aqueous solvent and hydrocarbon solvent. "[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).
Tanner teaches green tea extract in an amount of 0.2% (para. 106). Since Tanner does not specifically teach using hydrocarbon and aqueous solvents in claim 56, one of ordinary skill in the art would have been motivated to use Park’s teaching with a reasonable expectation of success. A skilled artisan would have recognized the benefit of utilizing a hydrocarbon solvent to extract components, such as squalene antioxidant, that an aqueous solvent alone would not be able to extract. A skilled artisan would have also been led to combine the teachings since Tanner teaches oil and water solvents (abs, para. 32) and use of antioxidants from vitamins and non-vitamins (paras. 86 and 90). Therefore, extracting a full spectrum of antioxidants from green tea would improve Tanner’s teaching.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613