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 .
Status of Claims
Claims 1-19 are pending and being examined herein on the merits.
Priority
The instant application 18535023, filed on 12/11/2023, claims domestic benefit of 63/386806, filed on 12/09/2022.
Information Disclosure Statement
The information disclosure statement (IDS), filed on 03/01/2024, is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
Examiner.
Claim Objections
Claims 1, 3-4, 6, 11-14 and 16 are objected to because of the following informalities:
Claim 1 recites “d. and”, it is recommended to move the “and” to the end of component c, seen as “c. at least one mineral; and”.
Claim 3 recites “the vitamin is” which has to be revised to plural status “the vitamins are” to keep consistency with that in claim 1.
Claim 4 recites “selected from a group consisting of”, wherein the word “a” should be modified to “the”.
Claims 4-5 and 13: claims 4 and 5 recites “Calcium D-pantothenic acid“ and “D-Calcium pantothenic acid”, respectively, when describing vitamin B5. The uppercase “Calcium” in claim 4 needs to be lowercase, and the format indicating the same compound has to be consistent as “calcium D-pantothenic acid”. Claim 13 recites “D-Calcium Pantothenate”, which is recommended to revise to “Calcium D-Pantothenic Acid” for consistency referring to vitamin B5 throughout the claim set.
Claim 6 recites “and a calcium salt, or any combination thereof”. The word “and” needs to be removed based on the context, indicating each agent is an option.
Claim 11 recites “Phenoxyethanol”, which should change to lowercase “phenoxyethanol”.
Claim 12 recites “less that about” in lines 4-7, containing a typo “that”, which should be “than”.
Claim 13 recites “phytonadione” while in other claims vitamin K1 uses “phytomenadione”. Same compound name is recommended to keep consistency.
Claim 14 recites “uneven skin tone” twice in the same sentence. One duplicate needs removal.
Claim 16 recites “the form of a solids”, wherein the “a” needs to be removed.
Appropriate correction is required.
Claim Interpretation
Claims 1, 13 and 17 are interpreted as below.
Claim 1 is interpreted to recite a “composition” comprising at least four vitamins, at least one electrolyte, at least one mineral, and at least one excipient. The preamble “topical” recites intended use of the claimed composition.
Claim 13 is interpreted to recite a “composition” comprising by wt/wt% of all the listed ingredients. The preamble “topical” recites intended use of the claimed composition.
Claim 17 is interpreted to recite a “method” comprising the following steps: applying to the skin of a subject the topical composition of claim 1. The phrase “improving the condition of the skin of a subject in need” recites intended use of the method or property of the composition, which does not provide additional structural limitation to the method.
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 4-5 and 16 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 4 recites “or a suitable derivative or variant thereof” at the end. The term “suitable” in claim 4 is a relative term which renders the claim indefinite. The term “suitable” 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. It is unclear to what extent or aspect a vitamin derivative or variant can be deemed to be suitable for the composition.
Claim 5 is rejected accordingly because it is depending on claim 4 and it does not further clarify the issue in claim 4 as addressed above.
Claim 16 recites “such as” and information enclosed in parentheses. The phrase "such as" or the information in parentheses each renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 16 also recites “sticks” with quotation marks. It is unclear what the quotation marks mean and whether the term “sticks” is quoted from somewhere.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (natural phenomenon) without significantly more, as evidenced by Healthline (7 potential health benefits of avocado, 2026, PTO-892) and Skinethix (zinc PCA, 2026, PTO-892).
The claims are evaluated below using the “Subject Matter Eligibility Test for Products and Processes” flow chart as shown in MPEP § 2106 III.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
If the answer to the question is “no”, then the claim is not eligible subject matter under 35 U.S.C. 101. If the answer to this question is “yes”, then the analysis proceeds to the second step.
The answer to this question is “yes”. The claims are drawn to a composition of matter, which is one of the four statutory categories. The analysis proceeds.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
If the answer to this question is “no,” then the claim qualifies as an eligible subject matter under 35 U.S.C. 101. If the answer to this question is “yes,” then the analysis proceeds to the third step.
The answer to this question is “yes”. As MPEP 2106.04(c) I. A. states that “[w]here the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. “ and “[w]here the claim is to a nature-based product in combination with non-nature based elements (e.g., a claim to "a yogurt starter kit comprising Lactobacillus in a container with instructions for culturing Lactobacillus with milk to produce yogurt"), the markedly different characteristics analysis should be applied only to the nature-based product limitation.”
The instant claims are directed to a nature-based composition comprising at least four vitamins, at least one electrolyte, at least one mineral, and at least one excipient (instant claim 1), the composition of claim 1 comprising at least five, at least six, at least seven or more vitamins (instant claim 2), the composition of claim 1, wherein the vitamin is plant derived (instant claim 3), vitamin species (instant claim 4), vitamin species with amount ranges (instant claim 5), electrolyte species and amounts (instant claims 6-7), specific mineral and amount (instant claims 8-9), excipient species such as oils, fasts, fragrance and others (instant claim 10), excipient species including water, Aloe barbadensis leaf juice and amounts (Claims 11-12), composition comprising vitamin species, electrolyte species, excipient species and amounts (instant claim 13), administering the composition for beneficial effects (instant claims 14-15), composition form of solids, liquids, suspensions, etc. (instant claim 16), a method comprising applying the composition (instant claim 17) to human (instant claim 18), a kit comprising the composition (instant claim 19). All of the components of the claimed ingredients are naturally-occurring. The claims can result in naturally occurring fruits, nuts, and/or plants, e.g., avocado, lychee, almond, coconut, aloe, etc., that can contain multiple plant vitamins, and excipients (such as fragrance, oils), and these nutrients are packed in fruit skins, nutshells as natural kit. For example, as evidenced by Healthline avocado contains vitamin C, E, K, B2, B3, B5, B6, and natural minerals magnesium, potassium, copper, manganese, and natural occurring excipients such as fat. It is known that Salt Lake in Utah, USA has lots of natural salt, which are electrolytes; and it is well known that minerals are abundant in spring water. Zinc PCA is a natural compound found in outmost layer of skin, as evidenced by SkinEthix.
There is no indication in the instant application that the combination of naturally-occurring components exhibits any markedly different characteristics from any naturally occurring counterparts, and thus, is treated as a product of nature judicial exception.
The analysis proceeds to next step.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
If the answer to this question is “yes,” then the claim is an eligible subject matter under 35 U.S.C. 101. If the answer to this question is “no,” then the analysis proceeds to next step.
The answer to this question is “no”. The judicial exception is not integrated into a practical application because the ingredients in instantly claimed composition resemble natural products, and no additional elements are recited to integrate the judicial exception into a practical application. (see MPEP 2106.04(d)). For example, claim 4 recites naturally occurring ingredients; claim 5 recites amounts and the naturally occurring ingredients. It appears the ingredients with the amounts are not markedly different from the naturally occurring counterparts, since variations of natural occurring fruits with different vitamin amounts occur naturally. Similar to salt species and amounts in claims 6-7, mineral and amount in claims 8-9, excipient species and amounts in claims 10-12, and all the ingredients and amounts in claim 13. Administering the composition in instant claims 14-15, or the method of claim 17 are generic method of “applying” the composition. See MPEP 2106.04(d), section I: Merely reciting the words “apply it” (or an equivalent” does not “integrate a judicial exception into a practical application.” In this case, claims 14-15 and 17 only recites “is administered to the surface on the subject” and “applying to the subject the topical composition…” respectively. As all natural ingredients occurring in natural form of solids, liquids, or powders, etc., the answer of this question to claim 16 is also a “no”. As indicated above, these nutrients are naturally packed in fruit skins and nutshells, or in lake beds and fountain pools, in solid or liquid natural forms, that can be considered natural kits comprising the composition, and the composition can be applied on human. Thus, all the claims does not recite additional elements that integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
If the answer to this question is “yes”, then the claim is eligible subject matter under 35 U.S.C. 101. If the answer to this question is “no,” then the claim is not eligible subject matter under 35 U.S.C. 101. End of analysis.
The answer to this question is “no”. MPEP 2106.05.II states “[E]xaminers should answer this question by first identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s))”. In instant claims, there are no additional elements that would amount to significantly more than the judicial exception, because each ingredient in the composition exists in nature, and the combination of these naturally occurring ingredients do not have any indication they would physically change from how they occur in nature as a mixture of naturally-occurring components.
In summary, claims 1-3 and 10-11 are directly to laws of nature without significantly more.
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, 6, 10-11 and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mehdi (9 popular homemade fruit packs for glowing skin, 09/20/2017, PTO-892), as evidenced by Healthline (7 potential health benefits of avocado, 2026, PTO-892) and Verywellfit (Kiwi nutrition and benefits, 2026, PTO-892).
Mehdi throughout the reference teaches facial masks using natural products, including fruits papaya and honey, kiwi and avocado, banana, tomato, orange peel, cucumber and milk, strawberry, grapes and apple, mango (e.g., homemade fruit packs for glowing skin list #1-9), which are packed with vitamins, minerals, fragrance, and all the required nutrients that are essential not only for the well-being of the body but also for beautiful, clear, and glowing skin. Mehdi teaches that the fruit facial packs boost the skin with natural goodness, to allow the face have spa-like benefits that relax and de-stress the skin, to give the skin hydrated, healthy, and glowing appearance (e.g., 1st paragraph).
As evidenced by Healthline, avocado contains vitamin C, E, K, B2, B3, B5, B6, and natural minerals magnesium, potassium, copper, manganese, and natural occurring excipients such as fat (1. Excellent source of nutrients), and water.
As evidenced by Verywellfit, kiwis contain vitamin C, potassium, sodium, and fat (Kiwi calories and nutrition data), and it is a winning combination of electrolytes because kiwis are naturally low in sodium and are a good source of potassium (Supports heart health).
Therefore, the natural products present in Mehdi facial compositions applying as facial masks naturally contain the claimed multivitamins (up to seven different vitamins show in avocado), electrolytes such as natural sodium salt and potassium salt, minerals such as magnesium, potassium, copper, and manganese, and excipients such as oil, water, fats.
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.
Claims 1-2, 4-12 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bernard (US20200214945, 07/09/2020), in view of Carle et al. (US20200297600, 09/24/2020).
Bernard throughout the reference describes two topical compositions that can be applied to skin separately in any order or in mixture in forming a cosmetic mask (e.g., Abstract; [0029]; [0037]).
Regarding instant claims 1-4, 6, 8, 10 Bernard teaches that in representative embodiments of the compositions include raw materials that are selected from commercially available materials, for example, calcium pantothenate (vitamin B5, as evidenced by instant claims 4-5 and 13), zinc pyrrolidone carboxylic acid or zinc PCA (as a mineral, evidenced by instant claim 8, corresponding to instant claim 8), calcium chloride (as electrolyte, as evidenced by instant claims 6-7) (corresponding to instant claims 6-7), mineral oil, coconut oil, castor oil (excipient, as evidenced by instant claim 10), fatty compounds hemisqualane, dimethicone, and others [0129] (corresponding to instant claim 10). Bernard teaches that one or more actives in the compositions can be vitamins and vitamin derivatives, such as calcium pantothenate (vitamin B5), tocopherol (vitamin E, as evidenced by instant claim 4), and ascorbic acid (variant of sodium ascorbyl phosphate as vitamin C in instant claim 4), and combinations thereof (e.g., [0116]; [0120]) (corresponding to instant claim 4). Thus, Bernard composition teaches a topical composition comprising a. from one up to three vitamins selected from vitamin B5, C, E; b. at least one electrolyte calcium chloride; c. at least one mineral as zinc PCA; and d. at least one excipient, e.g., oil or fatty compounds (corresponding to instant claim 1).
Regarding instant claim 5, as a dependent claim of claim 4, the vitamins are selected from the designated group in claim 4, and thus NOT all the vitamins in claim 5 are required to present in the composition. It is interpreted whenever the corresponding vitamin is included in the composition, the range of weight percentage must be in the claimed ranges. Bernard indicates that other components such as vitamins, e.g., vitamin B5, C, E and combinations ([0116], [0120]) in the composition can present at amount from about 0.05 to about 50% by by weight, or from about 0.05% to about 25% by weight, or from about 0.1 to about 10%, or from about 0.25% to about 5%, and from about 0.5 to about 3.5%, or any suitable combination (e.g., [0120]), overlapping with vitamin/vitamin variant amount ranges in instant claim, e.g., vitamin C variant sodium ascorbyl phosphate at 0.01-20%, vitamin B5 calcium pantothenate or calcium D-pantothenic acid at 0.01-5%, vitamin E tocopherol and vitamin E variant tocopherol acetate at 0.01-5%.
Regarding instant claims 7 and 9, Bernard teaches zinc PCA and calcium chloride are catalysts in the composition (e.g., [0082]; [0129]), while catalysts can present in the composition range from about 0.1% up to about 6.5% (e.g., [0083]), overlapping with the calcium chloride amount of about 0.01 to about 2% in instant claim 7, or zinc PCA amount of about 0.01 to about 4% in instant claim 9.
Regarding instant claims 10-11, Bernard teaches compositions can comprise excipients including solvents [0108] including water [0112] humectants [0116] including glycerin, thickeners and fragrances [0117], preservatives [0120], one or more solvents, and one or more fatty compounds (e.g., Claim 19; [0101]-[0106]]).
Regarding instant claim 12, Bernard teaches water may present by weight in the composition from about 1 to about 70% (e.g.[0112]; [0114]), and the excipient components, e.g., humectants [0116], penetrants, thickeners, fragrances (e.g., [0117]), preservatives [0120], can present in the range from about 0-about 50% or other ranges (e.g., [0118], [0120]). Bernard teaches that humectants including glycols such as glycerine [0116] can be included in the composition present at range from about 0 to about 50%, or from about 0.5 to about 30%, or from about 1.5 to about 20% (e.g., [0118]), overlapping with glycerine about 1.5-2% in instant claim.
Regarding instant claim 14-15 and 17-18, Bernard teaches the topical compositions provide brightening effect to skin (e.g., [0069]), which means to improvement in radiance, glow effect and lightening effect to keratinous tissue, skin brightness related to luminosity, providing smoothing effect and glow to the skin (e.g., [0068];[0072], thus indicating the effect to prevent or improve uneven skin tone, reduce wrinkles, and enhance brightness. Bernard teaches the method of topical delivery to deliver to a skin surface dissolved oxygen (e.g., [0004]) and for brightening the skin comprising applying to a region of skin the disclosed compositions (e.g., Claim 14). Bernard addresses human body oxygen uptake, indicating the topical delivery of the compositions is designated for human subjects (e.g., [0003]), as evidenced by facial mask image of Fig. 1.
Regarding instant claim 16, Bernard specifies the composition can be in a form including a suspension, lotion, cream, serum, essence, gel, stick, spray, ointment, paste, foam, mousse, cream, wipe, patch, strip, film-forming product [0127].
Regarding instant claim 19, Bernard teaches that in accordance with various skincare embodiments, the composition may be provided in a kit of manufacture [0123].
Bernard does not teach at least four vitamins as recited in instant claim 1, or at least five vitamins in instant claim 2, since Bernard only teaches three vitamins including vitamin C ascorbic acid, vitamin B5 calcium pantothenate, and vitamin E tocopherol as discussed above. Bernard does not explicitly teach the claimed vitamin variants, vitamin C sodium ascorbyl phosphate, vitamin E variant tocopheryl acetate and other vitamin species, e.g., vitamin F, vitamin B3, vitamin D3, vitamin K1 as recited in instant claims 4-5. Bernard does not teach to include instructions of use in the kit as recited in instant claim 19.
Carle throughout the reference teaches topical compositions comprising niacinamide for reducing oxidative damage of skin (e.g., Abstract), significantly improving overall skin appearance, decreasing facial and neck fine lines, wrinkles, improving radiance/luminosity, texture/smoothness, skin tone, firmness and elasticity (e.g., [0158]).
Carle teaches skin care compositions comprising ingredients shared by instant invention. Carle exemplifies compositions comprising vitamins, e.g., 1% niacinamide (vitamin B3), 0.1% tocopheryl acetate (vitamin E acetate) (e.g., Table 17), 0.3% sodium chloride (as evidenced by instant claim 7 as electrolyte), trace metals (or minerals) such as zinc and selenium (e.g., [0079]), excipients including solvents (as evidenced by instant claim 10) like water and glycerin (e.g., Table 17). Carle teaches that vitamins, for example, vitamin B, C, D, E, F, and K can be included in the composition (e.g., [0079], [0084]), niacinamide (vitamin B3) can be skin lightening and conditioning agent in the composition (e.g., [0066]; [0079]) at amount 0.001-3% (e.g., Claim 5); tocopherol (vitamin E) (e.g., [0079]), magnesium ascorbyl phosphate (vitamin C variant) [0086] can be used as antioxidants; linoleic acid, linolenic acid (vitamin F) can be used as moisturizing agents [0084], corresponding to vitamin species in instant claims 4-5.
Carle teaches that the composition can include at least four, five, or more, or all of the ingredients, including water, vitamin moisturizing agent, preservative, thickening agent, essential oil, with amounts of such ingredients range from 0.0001% to 99.9% by weight of the composition (e.g., [0036]). Carle indicates that it is contemplated that the compositions can include any number of combinations of additional ingredients and at any amounts of the ingredients as discussed in the specification [0074]. Therefore, Carle teaches the composition can comprise four vitamins, or five and more vitamins, corresponding to in instant claims 1 and 2 respectively. Carle thus also teaches vitamin amounts in the composition overlapping with ranges of linoleic acid/linolenic acid (vitamin F) 0.01-2%, niacinamide (vitamin B3) 0.01-5%, tocopherol (vitamin E) 0.01-5%, as recited in instant claim 5.
Carle teaches that the composition can be used as a kit (e.g., [0111]) including instructions for employing the kit components as well the use of any other compositions included in the container [0112], which reads into instant claim 19.
It would have been obvious for a person with ordinary skills in the art to incorporate Carle’s teaching into the Bernard’s topical composition to arrive at current invention. Because both Carle’s and Bernard’s compositions share common ingredients, e.g, vitamins, and same intended use, while Carle teaches more vitamin species with detailed functional roles of the specific vitamins in the composition, it would have motivated artisans in the field to combine the prior art and maximize the benefit of combining more vitamin ingredients in the composition, covering broader spectrum of skin care functions of nurturing, lightening and conditioning, antioxidizing, and moisturizing, which would have resulted from multiple vitamins, e.g., at least four or more vitamins. Therefore, the claimed invention is a simple combination of reagents known to be obvious materials that all already taught in prior art and discussed above. The idea for combining them flows logically from them having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, all the ingredient amounts including vitamins, electrolyte, mineral, and excipient, overlap with those in prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bernard (US20200214945, 07/09/2020) in view of Carle et al. (US20200297600, 09/24/2020), as applied to claims 1-2, 4-12 and 14-19 above, further in view of Fabado et al. (Trends in Plant Sciences, Cell Press, October 2010, Vol. 15, No. 10, Pg. 582-592, PTO-892).
Bernard and Carle combined teaching teaches skin care topical compositions that can comprise four or more vitamins, e.g., lincleic acid and linolenic acid (vitamin F), niacinamide (vitamin B3), tocopherol (vitamin E), tocopheryl acetate (vitamin E acetate), calcium pantothenate (vitamin B5); at least one electrolyte, e.g., calcium chloride or sodium chloride; at least one mineral, e.g., zinc PCA; at least one excipient, e.g., solvents, oil, or fatty compounds, as applied to instant claims 1-2, 4-12 and 14-19 as discussed above in great detail and incorporated herein.
Combined teaching of Bernard and Carle does not teach the vitamins are plant derived as recited in instant claim 3.
Fabado throughout the reference teaches that vitamins are compounds that cannot be synthesized by humans (Pg. 582, Left column, first paragraph). Fabado indicates that vitamins occur within plant kingdom, including the strong antioxidant water soluble vitamins B and C, and lipid-soluble vitamins A, E and K, and that plant-derived vitamins play an essential role in human nutrition and health (e.g., Abstract).
It would have been obvious for one with ordinary skills of art prior to filing date to incorporate Fabado and select plant derived vitamins into the composition taught by Bernard and Carle. Because Fabado teaches that vitamins are widely distributed in plant kingdom (Pg. 589, Concluding Remarks), and Carle implements natural botanical anti-oxidants such as green tea or grape seed extracts as antioxidants in the composition (e.g., [0086]), suggesting natural botanical antioxidants is suitable; plus, it is well known that routine skin care customers consider organic and natural products as constituting higher safety and quality in the market, it would have motivated artisans in the field to implement plant derived vitamins in the composition for reasonable expectation of improvement and success. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bernard (US20200214945, 07/09/2020), in view of Carle et al. (US20200297600, 09/24/2020) and Carle Lucie (hereafter “Lucie”, WO2013149323, 10/10/2013, PTO-892).
Bernard and Carle combined teaching teaches skin care topical compositions that can comprise four or more vitamins, e.g., lincleic acid and linolenic acid (vitamin F), niacinamide (vitamin B3), tocopherol (vitamin E), tocopheryl acetate (vitamin E acetate), calcium pantothenate (vitamin B5); at least one electrolyte, e.g., calcium chloride or sodium chloride; at least one mineral, e.g., zinc PCA; at least one excipient, e.g., solvents, oil, or fatty compounds, as discussed above in great detail and incorporated herein.
Bernard teaches water amount from 1-70% in the composition, vitamins and derivatives/ variants, e.g., vitamin C ascorbic acid (corresponding to its variant sodium ascorbyl phosphate in instant claim), vitamin B5 calcium pantothenate (corresponding to calcium D-pantohenate), tocopherol (vitamin E), present at amount from about 0.05 to about 50% by by weight, or from about 0.05% to about 25% by weight, or from about 0.1 to about 10%, or from about 0.25% to about 5%, and from about 0.5 to about 3.5%, or any suitable combination (e.g., [0120]), overlapping with sodium ascorbyl phosphate <1%, calcium D-pantothenate 0.01-5%, tocopheryl acetate 0.01-5%, and tocopherol <1% in instant claim 13. As discussed above, Bernard teaches zinc PCA and calcium chloride can present in the composition range from about 0.1% up to about 6.5% (e.g., [0082-0083]; [0129]), overlapping with zinc PCA <1% and calcium chloride <1% in instant claim 13. Bernard teaches that one or more actives including glycols such as glycerine [0116] can be included in the composition present at range from about 0 to about 50%, or from about 0.5 to about 30%, or from about 1.5 to about 20%, and from about 5 to about 15% (e.g., [0118]), overlapping with glycerin 3-6% in instant claim.
Carle also teaches vitamin B, C, D, E, F, and K can be included in the composition [0079] as discussed above in detail, such as, niacinamide (vitamin B3) (e.g., [0066]; [0079], Table 17), tocopheryl acetate (vitamin E acetate) (e.g., Table 17), tocopherol (vitamin E) (e.g., [0079]), linoleic acid, linolenic acid (vitamin F) [0084], magnesium ascorbyl phosphate (vitamin C variant) [0086], sodium chloride, solvents such as water and glycerine (e.g., Table 17), in addition to the specified amounts shown above in detail, Carle indicates that the general ingredient amount range in the composition can be at from 0.0001% to 99.9% by weight of the composition (e.g., [0036]). Carle thus teaches vitamin amounts in the composition overlapping with ranges of linoleic acid/linolenic acid (vitamin F) 0.01-2%, niacinamide (vitamin B3) 0.01-5%, tocopherol (vitamin E) 0.01-5%, phytonadione (vitamin K1) amount 0.01-2%, and vitamin D3 cholecalciferol amount at 0.01-2% recited in instant claim 13.
Carle further teaches skin conditioning and moisturizing agents, e.g., aloe extracts [0079] or Aloe barbadensis, Aloe barbadensis extract [0084] (corresponding to Aloe barbadensis leaf juice), allantoin, ethylhexylglycerin (e.g., [0079]), glyceryl stearate, hexylene glycol, sodium hyaluronate, Zea mays (corn) oil, jojoba oil [0084], with glyceryl stearate and glycerine amount specified at 0.1-10% (e.g., Claim 7, overlapping with glyceryl stearate 1.5-2.5% in instant claim 13), jojoba esters 0.5% (e.g., Table 15; [0042], falling within range of jojoba esters <1% in instant claim 13), thickening agents including carbomer [0101], waterproofing agent magnesium stearate [0079], other agents including sodium chloride 0.3% (Table 18) or 0.01-1% (Claim 9) (falling within or overlapping with sodium chloride <1% respectively, as recited in instant claim 13), phenoxyethanol 0.7% (Table 15, falling within phenoxyethanol <1% in instant claim 13), caprylyl glycol at 0.01-3% (Claim 6, overlapping with caprylyl glycol <1% in instant claim 13). Carle also teaches olive oil, sorbitan oleate, sorbitan laurate, sorbitan palmitate, sorbitan stearate as moisturizing agents (e.g., [0084]), however, Carle does not teach sorbitan olivate.
Carle further specifies that the amounts of ingredients can be any amount from 0.0001-99% (e.g., [0074]), and a person of ordinary skill in the art would understand that the concentrations can vary depending on the addition, substitution, and/or subtraction of ingredients in a given composition (e.g., [0074]). Thus Carle teaches all above ingredients with amounts overlapping the claimed ranges including aloe at 1-3%, allantoin <1%, hexylene glycol <1%, sodium hyaluronate <1%, magnesium stearate <1%, zea mays (corn) oil <1%, carbomer <1%, as recited in instant claim 13.
Combined teaching of Bernard and Carle does not teach the specific ingredients and their amounts in the composition of sorbitan olivate 0.5-1%, magnesium chloride and potassium chloride each <1% as recited in instant claim 13. Combined teaching of Bernard and Carle does not teach vitamin C variant as sodium ascorbyl phosphate, and Aloe barbadensis as Aloe barbadensis leaf juice as recited in instant claim 13.
Lucie throughout the reference teaches natural product compositions for skin protection and rejuvenation (e.g., Title, Abstract, [0011]).
Lucie teaches the composition can comprise at least one hydrophilic supplement including, vitamins, e.g., vitamin B, C, D, F, K (e.g., Pg. 81, Claim 2; Pg. 3, [0013]), sodium ascorbyl phosphate, calcium pantothenate, tocopheryl acetate; botanical extract, e.g., Aloe barbadensis leaf juice (e.g., Pg. 3, [0013]), magnesium chloride (e.g., Pg. 83, Claim 2; Pg. 4, [0013]; Pg. 28, [0076]), potassium chloride (e.g., Pg. 83, Claim 2; Pg. 17, [0034]), sorbitan olivate (e.g., Pg. 86, Claim 4; Pg. 8, [0015]). Lucie exemplifies supplements total amount at 18.5%, with each individual amounts, e.g., vitamin species, at 0.05-25% (Pg. 66, Example 21, facial hydrophilic care for nighttime application), magnesium chloride at 0.1-2.0% (Pg. 67, Example 22, facial hydrophilic care for daytime application).
It would have been obvious for one with ordinary skills of art prior to filing date to incorporate Lucie’s teaching to select specific ingredients into the composition taught by Bernard and Carle. Because Lucie shares common ingredients and same intended use as the composition taught by Bernard and Carle, and Carle teaches these ingredients suitable for the natural skin care products, it is commonly known that generally people consider organic and natural products with higher safety and quality, it would have motivated artisans in the field to choose plant derived vitamins in the composition taught by Bernard and Carle. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D). Moreover, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the ingredients taught by Bernard, Carle and Lucie overlap with those in instant claim. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). Although prior art does not explicitly teach phytonadione as vitamin K1 and cholecalciferol as vitamin D3, Carle and Lucie teaches vitamin species including vitamin K and vitamin D, and it would be convenient for an artisan in the field to implement vitamin K1 and vitamin D3 variants. Similarly, potassium chloride and sorbitan olivate amounts are not specified in prior art, Bernard teaches calcium chloride and Lucie teaches magnesium chloride, while Carle teaches sodium chloride and many sorbitan species along with ingredient amounts in the composition, a person with ordinary skill in the art would be able to refer to amounts corresponding to similar compounds to arrive at instantly claimed amount ranges with reasonable expectation of success. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983), and "A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments." Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), and "Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments." In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Conclusion
No claim is allowed.
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/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616