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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 19, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1 – 16 are examined here-in.
Claim Objections
Claims 3 – 5 and 10 – 12 are objected to because of the following informalities:
Claims 3, 4, 10, and 11 do not have spacing between each number amount and unit. For example, claim 3 has “600mg” which should be “600 mg”.
Line 2 of claim 4 should have a zero before the decimal point of “.1%” to be consistent with the other claims.
Line 9 of claim 4 recites “pine mark extract” which should be “pine bark extract”. This misspelling is also in claim 11.
Line 13 of claim 5 recites “tumeric” which should be “turmeric”. Turmeric is also misspelled in claim 10.
In claim 11, “Beta Carotene” is capitalized, which is inconsistent with the other claims.
Line 13 of claim 12 recites “elianthus annuus extract R” which should be corrected to “helianthus annuus extract R”.
Various informalities appear throughout the claim set and Applicant is requested to carefully review and revise the claims as appropriate. The specific instances highlighted supra are merely exemplary and should be taken to represent a comprehensive list.
Appropriate correction is required.
Claim Interpretation
Claims 1, 2, and 16 are method claims with “configured to” clauses. The “configured to” clauses do not appear to further limit the active method steps defined by the claims (i.e. applying topically, orally consuming).
According to MPEP 2111.04, "a 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim" and "a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited".
In this case, claims 1, 2, and 16 include the terminology "configured to", rather than "whereby" or “adapted to”, however, in the instant case it appears that these terms are synonymous, performing the same grammatical function.
The “configured to” clauses for claims 1, 2, and 16 do not inform the artisan of how the “topically applying” or “orally consuming” steps are performed; rather, the “configured to” clauses merely expresses the intended result of a process step (i.e. “to promote the human user’s systemic protection against the effects of radiation” and “to synergistically promote the human user’s systemic protection against the effects of radiation”).
In other words, the actions of “topically applying” or “orally consuming” are not meaningfully changed by the recitations of “to promote the human user’s systemic protection against the effects of radiation” and this recitation does not further limit the active method steps defined by the claims.
With regards to claims 3, 4, 8, and 10 – 12, which contain recitations of ingredients as “up to 2000 mg of methylsulfonylmethane” or “up to” X amount, this language is interpreted to require the ingredient in the claim in an amount greater than zero and up to the recited amount.
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.
Claims 4, 9, 11, and 13 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 4 and 11 contain several recitations that include amount of an ingredient in milligrams, followed by a percentage such as “up to 200 mg of beta carotene 0.1 to 5%” and “up to 50 mg of resveratrol 10% to 30%”. It is unclear if the percentages listed are a concentration present in the mass amount, or a concentration of ingredient to be included in the composition, or have some other meaning. At present, it appears that there are multiple limitations regarding these ingredients within the same claim. 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, claims 4 and 11 recites the broad recitation “up to 200 mg”, and the claim also recites “0.1 to 5%” which appears to be the narrower statement of the limitation. Claims 4 and 11 contain several addition recitations of mass amounts followed by percentages. The claims 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.
Claims 9 and 13 contains the trademark “Nylon”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b). See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name appears to be used to identify/describe a polymerizable chemical compound and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sene (US 2009/0169623 A1).
Sene teaches compositions for protection of the skin against effects of sunlight or UV irradiation (abstract, claims 1 – 3).
Sene teaches the compositions may be orally or topically administered, in the form of a tablet, serum, or cream (paragraphs 0021 – 0023, 0030, claims 15 – 18). Sene teaches the composition is administered one or more times per day (paragraph 0030). Sene teaches that a composition can be administered alone or in combination with any ingredients (paragraph 0021).
Sene’s teaching for protection of the skin against effects of unlight or UV irradiation by orally administering a tablet and topically administering a serum at least once per day (abstract, paragraphs 0021 – 0023, 0030, claims 1 – 3, 15 – 18) anticipates instant claim 1.
Sene’s teaching for protection of the skin against effects of unlight or UV irradiation by topically administering a cream at least once per day (abstract, paragraphs 0021 – 0023, 0030, claims 1 – 3, 15 – 18) anticipates instant claim 2.
Sene’s teaching for protection of the skin against effects of unlight or UV irradiation by orally administering a tablet and topically administering a serum or cream at least once per day (abstract, paragraphs 0021 – 0023, 0030, claims 1 – 3, 15 – 18) anticipates instant claim 16. Sene’s teaching that a composition for protection of the skin can be administered alone or in combination (paragraph 0021) reads on the recitation of oral and topical administration in the claim.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 1, 2, and 16 are also rejected under 35 U.S.C. 103 below.
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 non-obviousness.
Claims 1, 2, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Sene (as cited above).
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Sene does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by claims 1, 2, and 16 without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Sene thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
As discussed above, Sene teaches compositions for protection of the skin against effects of sunlight or UV irradiation (abstract, claims 1 – 3).
Sene teaches the compositions may be orally or topically administered, in the form of a tablet, serum, or cream (paragraphs 0021 – 0023, 0030, claims 15 – 18). Sene teaches the composition is administered one or more times per day (paragraph 0030). Sene teaches that a composition can be administered alone or in combination with any ingredients (paragraph 0021).
Sene’s teaching for protection of the skin against effects of unlight or UV irradiation by orally administering a tablet and topically administering a serum at least once per day (abstract, paragraphs 0021 – 0023, 0030, claims 1 – 3, 15 – 18) reads on instant claim 1. Sene’s teaching that such a composition can be administered alone or in combination (paragraph 0021) would lead a person of ordinary skill in the art to administer the composition orally and topically, since Sene teaches both are preferred routes (paragraph 0021).
Sene’s teaching for protection of the skin against effects of unlight or UV irradiation by topically administering a cream at least once per day (abstract, paragraphs 0021 – 0023, 0030, claims 1 – 3, 15 – 18) reads on instant claim 2.
Sene’s teaching for protection of the skin against effects of unlight or UV irradiation by orally administering a tablet and topically administering a serum or cream at least once per day (abstract, paragraphs 0021 – 0023, 0030, claims 1 – 3, 15 – 18) reads on instant claim 16. . Sene’s teaching that such a composition can be administered alone or in combination (paragraph 0021) would lead a person of ordinary skill in the art to administer the composition orally and topically, since Sene teaches both are preferred routes (paragraph 0021). Furthermore, Sene teaches that it may be advantageous to administer the composition to match individual characteristics and behavior (paragraph 0031), which would lead a person of ordinary skill in the art to choose topical administration of both a serum and cream, as appropriate.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sene (as cited above)and further in view of Ambrosi (US 2007/0009451 A1), Bojanowski (US 2014/0301958 A1), Puche (US 2023/0301898 A1), Modi (US 2015/0104400 A1), Gupta (US 8,258,343 B1), and Luria (US 8,999,401 B2).
Sene’s teachings are addressed above.
Sene does not teach the tablet composition contains methylsulfonylmethane, bamboo extract, fucoidan, purslane extract, polypodium leucotomos, L-glutathione, rosemary powder, or marigold extract.
Ambrosi teaches a missing element of Sene.
Ambrosi teaches cosmetic and pharmaceutical formulations to protect the skin from solar and ultraviolet radiation which contain dimethyl sulphone (abstract). Dimethyl sulphone is another name for methylsulfonylmethane. Ambrosi teaches that dimethyl sulphone has specific photoprotective action that reduces damage induced by UV radiation types A, B, and C (paragraphs 0012 – 0014).
A person of ordinary skill in the art would have been motivated to combine the teachings of Sene and Ambrosi to include methylsulfonylmethane in an oral or topical composition for photoprotection because Ambrosi teaches that dimethyl sulphone has specific photoprotective action that reduces damage induced by UV radiation (paragraphs 0012 – 0014). The combination of Sene and Ambrosi’s teachings is prima facie obvious according to MPEP 2143(i)(a) combining prior art ingredients according to known methods to yield predictable results.
The combination of Sene and Ambrosi does not teach the tablet composition contains bamboo extract, fucoidan, purslane extract, polypodium leucotomos, L-glutathione, rosemary powder, or marigold extract.
Bojanowski teaches a missing element of the combination of Sene and Ambrosi.
Bojanowski teaches oral compositions to protection of the skin (paragraph 0003). Bojanowski teaches bamboo extract and purslane extract (paragraphs 0027, 0038) as ingredients suitable for the composition.
A person of ordinary skill in the art would have been motivated to combine the teachings of Sene, Ambrosi, and Bojanowski to include bamboo extract and purslane extract in an oral or topical composition for photoprotection because Bojanowski teaches these ingredients have protective effects (paragraphs 0003, 0027, 0038). The combination of Sene, Ambrosi, and Bojanowski’s teachings is prima facie obvious according to MPEP 2143(i)(a) combining prior art ingredients according to known methods to yield predictable results.
The combination of Sene, Ambrosi, and Bojanowski does not teach the tablet composition contains fucoidan, polypodium leucotomos, L-glutathione, rosemary powder, or marigold extract.
Puche teaches a missing element of the combination of Sene, Ambrosi, and Bojanowski.
Puche teaches fucoidan is a natural gum that functions as a thickener or gelling agent (paragraph 0162 – 0163). Puche teaches that thickeners are suitable for improving the rheology of a formulation as necessary (paragraphs 0006, 0160).
A person of ordinary skill in the art would have been motivated to combine the teachings of Sene, Ambrosi, Bojanowski, and Puche to include fucoidan in a composition for photoprotection because Puche teaches that fucoidan is a natural ingredient suitable for attenuating the rheology of a composition as desired (paragraphs 0006, 0160, 0162- 0163). As such, a person of ordinary skill in the art would be motivated to include fucoidan to modulate the desired rheology of a composition. Since fucoidan is a natural product, there would also be the added benefit of avoiding synthetic ingredients. The combination of Sene, Ambrosi, Bojanowski, and Puche’s teachings is prima facie obvious according to MPEP 2143(i)(a) combining prior art ingredients according to known methods to yield predictable results.
The combination of Sene, Ambrosi, Bojanowski, and Puche does not teach the tablet composition contains polypodium leucotomos, L-glutathione, rosemary powder, or marigold extract.
Modi teaches a missing element of the combination of Sene, Ambrosi, Bojanowski, and Puche.
Modi teaches methods and products for administration of stabilized protection agents to inhibit skin damage in response to sun exposure (abstract).
Modi teaches that fern extracts from polypodium have been used as oral supplements to provide protection from sunburn (paragraph 0022) and that polypodium leucotomos extract is suitable for inclusion in photoprotection compositions (paragraphs 0029 – 0030).
A person of ordinary skill in the art would have been motivated to combine the teachings of Sene, Ambrosi, Bojanowski, Puche, and Modi to include polypodium leucotomos extract because Modi teaches that polypodium is known to be an effective oral supplement to provide protection from sunburn (paragraphs 0022, 0029 – 0030). The combination of Sene, Ambrosi, Bojanowski, Puche, and Modi’s teachings is prima facie obvious according to MPEP 2143(i)(a) combining prior art ingredients according to known methods to yield predictable results.
The combination of Sene, Ambrosi, Bojanowski, Puche, and Modi does not teach the tablet composition contains L-glutathione, rosemary powder, or marigold extract.
Gupta teaches a missing element of the combination of Sene, Ambrosi, Bojanowski, Puche, and Modi.
Gupta teaches administration of a composition to control cellular degradation from sun burn (abstract). Gupta teaches glutathione is an ingredient with antioxidant properties suitable for inclusion in the composition (column 41 lines 14 – 37). Gupta teaches that antioxidants function via anti-inflammatory biochemical mechanisms (column 24 lines 30 – 32).
A person of ordinary skill in the art would have been motivated to combine the teachings of Sene, Ambrosi, Bojanowski, Puche, Modi, and Gupta to include glutathione in a composition for photoprotection because Gupta teaches glutathione is an antioxidant with anti-inflammatory activity (column 41 lines 14 – 37, column 24 lines 30 – 32). The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, and Gupta’s teachings is prima facie obvious according to MPEP 2143(i)(a) combining prior art ingredients according to known methods to yield predictable results.
The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, and Gupta does not teach the tablet composition contains rosemary powder or marigold extract.
Luria teaches the missing element of the combination of Sene, Ambrosi, Bojanowski, Puche, Modi, and Gupta.
Luria teaches homeopathic compounds and compositions for treating skin damaged by the harmful rays of the sun (abstract).
Luria teaches rosemary and marigold as known homeopathic agents (Table 1). Luria teaches rosemary hydrosol is an anti-inflammatory agent with mild antiseptic characteristics (column 24 lines 25 – 36, 51 – 52). Luria teaches rosemary may also act as a preservative (column 24 lines 55 – 60, column 25 line 4). Luria teaches that natural ingredients “enhance delivery and promote better health and wellness of the user” (column 25 lines 44 – 46).
A person of ordinary skill in the art would have been motivated to combine the teachings of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, and Luria to include rosemary and marigold extract in a composition for treating skin damaged by the sun because Luria teaches these ingredients are known homeopathic agents with anti-inflammatory properties (Table 1, column 24 lines 25 – 36, 51 – 52). The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, and Luria’s teachings is prima facie obvious according to MPEP 2143(i)(a) combining prior art ingredients according to known methods to yield predictable results.
The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, and Luria’s teachings read on claim 3, as shown in the table below, because each teach the inclusion of the claimed ingredients in a composition for protection of the skin from sun damage. The combination of the claimed ingredients in such a composition would be expected to yield predictable results (i.e. photoprotection). Therefore, claim 3 is prima facie obvious according to MPEP 2143(i)(a).
Claim 3 “wherein the one or more tablets each comprise…”
Reference
Methylsulfonylmethane
Ambrosi abstract
Bamboo extract
Bojanowski paragraph 0038
Fucoidan
Puche paragraph 0163
Purslane extract
Bojanowski paragraph 0027
Polypodium leucotomos
Modi paragraph 0030
L-glutathione
Gupta column 41 line 31
Rosemary powder
Luria column 25 line 4, column 26 line 24, column 34 line 36, column 35 line 2, column 48 line 21, column 49 line 30, column 50 line 3, column 52 line 5, column 53 lines 53 – 54, column 55 line 48
Marigold extract
Luria Table 1 column 10
Claims 4 – 7 are rejected under 35 U.S.C. 103 as being unpatentable over Sene (as cited above) and further in view of Ambrosi (as cited above), Bojanowski (as cited above), Puche (as cited above), Modi (as cited above), Gupta (as cited above), Luria (as cited above), Deshpande (US 2018/0280266 A1), Koch (US 2023/0293409 A1), and Kannan (Kannan and Lim “Photoprotection and vitamin D: a review” Photodermatology, photoimmunology, and photomedicine. 2014: 30: p. 137 – 145).
The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, and Luria’s teachings are addressed above.
Sene also teaches the inclusion of resveratrol, red panax ginseng, tea extract, and vitamin E in a composition for protecting the skin against sunlight or UV irradiation (abstract, paragraphs 0009, 0034). Modi teaches pine bark extract as an antioxidant with protective characteristics (paragraph 0074). Gupta teaches niacinamide, apigenin, quercetin, and luteolin as antioxidant and anti-inflammatory ingredients (column 41 line 22, line 33, line 52, line 58, column 42 line 19).
The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, and Luria’s teachings (as set out above) does not teach the tablet composition further comprises beta carotene, selenium citrate, mulberry fruit powder, vitamin D3, or lycopene.
Deshpande teaches a missing element of the combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, and Luria.
Deshpande teaches methods and composition for protecting the skin from effects of light rays (abstract). Deshpande teaches beta carotene and lycopene are common antioxidant nutrients that combat oxidative stress and prevent skin damage (paragraph 0009). Deshpande teaches bioflavonoid antioxidants extracted from mulberry are a known ingredient for cosmetic products for application to the skin (paragraph 0007).
A person of ordinary skill in the art would have been motivated to combine the teachings of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, and Deshpande to include beta carotene, lycopene, and mulberry extract in a composition for protecting the skin from effects of light rays because Deshpande teaches these ingredients are known to combat oxidative stress and prevent skin damage (paragraph 0009). The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, and Deshpande’s teachings is prima facie obvious according to MPEP 2143(i)(a) combining prior art ingredients according to known methods to yield predictable results.
The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, and Deshpande’s teachings does not teach the tablet composition further comprises selenium citrate or vitamin D3.
Koch teaches a missing element of the combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, and Deshpande.
Koch teaches selenium and derivatives thereof as an antioxidant suitable for inclusion in a cosmetic or pharmaceutical composition (paragraph 0808).
A person of ordinary skill in the art would have been motivated to combine the teachings of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, Deshpande, and Koch to include a selenium derivative in a composition for protecting the skin from sun damage because Koch teaches selenium derivatives have antioxidant properties (paragraph 0808). The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, Deshpande, and Koch’s teachings is prima facie obvious according to MPEP 2143(i)(a) combining prior art ingredients according to known methods to yield predictable results.
The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, Deshpande, and Koch’s teachings does not teach the tablet composition further comprises vitamin D3.
Kannan teaches the missing element of the combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, Deshpande, and Koch.
Kannan teaches vitamin D is important for bone health and other bodily functions (page 143 column 2). Kannan teaches that oral supplementation of vitamin D is recommended over sunlight exposure (page 144 column 2). Kannan teaches that vitamin D3 is more effective for increasing blood serum levels of vitamin D than vitamin D2 (page 140 column 1).
A person of ordinary skill in the art would have been motivated to combine the teachings of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, Deshpande, Koch, and Kannan to include a vitamin D3 in a composition for protecting the skin from sun damage because Kannan teaches that vitamin D3 is more bioavailable than vitamin D2, thus leading to higher blood serum levels of vitamin D (page 140 column 1). The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, Deshpande, Koch, and Kannan’s teachings is prima facie obvious according to MPEP 2143(i)(a) combining prior art ingredients according to known methods to yield predictable results.
The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, Deshpande, Koch, and Kannan’s teachings read on claim 4, as shown in the table below, because each teach the inclusion of the claimed ingredients in a composition for protection of the skin from sun damage. The combination of the claimed ingredients in such a composition would be expected to yield predictable results (i.e. photoprotection). Therefore, claim 4 is prima facie obvious according to MPEP 2143(i)(a).
Claim 4 “the one or more tablets each further comprising…”
Reference
Beta carotene
Deshpande paragraph 0009
Niacinamide
Gupta column 41 line 33
Resveratrol
Sene paragraph 0034
Red panax ginseng
Sene paragraph 0009
Green tea
Sene “tea extract” paragraph 0034
Modi paragraph 0030
Selenium citrate
Koch paragraph 0808 “selenium and derivatives thereof”
Vitamin E (AKA tocopherol)
Sene paragraph 0034
Pine bark extract
Modi paragraph 0074
Mulberry fruit powder
Deshpande “mulberry extract” paragraph 0007
Vitamin D3
Kannan “Photoprotection and vitamin D: a review”
Apigenin
Gupta column 41 line 52, column 42 line 19
Lycopene
Deshpande paragraphs 0009, 0012, 0016, 0017, 0019
Quercetin
Gupta column 41 line 22, line 58
Luteolin
Gupta column 42 line 19
Sene teaches panax ginseng extract, glycerin, resveratrol, vitamin E (which reads on mixed tocopherols), and xanthan gum (paragraphs 0009, 0034, 0057). Bojanowski teaches bakuchiol and bamboo extract (paragraph 0038). Puche teaches Silybum marianum extract, carrageenan (which reads on chondruis crispus extract), tara gum (which reads on Caesalpinia spinosa gum), phenethylalcohol, and ethylhexylglycerin (paragraphs 0163, 0174). Modi teaches green tea extract and pine bark extract (paragraphs 0030, 0074). Gupta teaches niacinamide, squalene, and acacia gum (column 34 line 10, column 41 line 33, column 42 line 44). Luria teaches turmeric extract, marigold extract, and rosemary extract (column 6 line 57, Table 1). Deshpande teaches beta carotene, tocopherols, kojic acid, ascorbic acid and/or its salt, hyaluronic acid (which reads on sodium hyaluronate), and licorice extract (paragraphs 0004, 0007, 0009, 0016, 0026). Koch teaches calcium ketogluconate and tetrasodium glutamate diacetate (paragraphs 0625, 0626, 0810, 0841, 0842).
The combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, Deshpande, Koch, and Kannan’s teachings also reads on instant claim 5, as shown in the table below, because each teaches the inclusion of the claimed ingredients in a composition for protection of the skin from sun damage. The combination of the claimed ingredients in such a composition would be expected to yield predictable results (i.e. photoprotection). Therefore, claim 5 is prima facie obvious according to MPEP 2143(i)(a).
Claim 5 “The method of claim 4, the serum comprising…”
Reference
Glycerin
Sene paragraph 0057
Squalene
Gupta column 34 line 10
Resveratrol
Sene paragraph 0034
Bakuchiol
Bojanowski paragraph 0038
Silybum marianum fruit extract
Puche paragraph 0174
Niacinamide
Gupta column 41 line 33
Mixed tocopherols
Sene paragraph 0034
Deshpande paragraphs 0009, 0026
Kojic acid
Deshpande paragraph 0007
Sodium ascorbyl phosphate
Sene “ascorbic acid or a derivative thereof” paragraph 0034
Deshpande “ascorbic acid and/or its salt” paragraphs 0007, 0016, 0026
Sodium hyaluronate
Deshpande “hyaluronic acid” paragraph 0004
Chondruis crispus extract (AKA irish moss or carrageenan moss)
Puche paragraph 0163
Turmeric extract
Luria column 6 line 57, Table 1 columns 9 -10, 11
Licorice extract
Deshpande paragraph 0007
Green tea extract
Modi paragraph 0030
Brazilian bamboo extract
Bojanowski paragraph 0038
Pine bark extract
Modi paragraph 0074
Red panax ginseng extract
Sene paragraph 0009
Marigold extract
Luria Table 1 column 10
Beta carotene
Deshpande paragraph 0009
Calcium ketogluconate
Koch paragraph 0810
Tetrasodium glutamate diacetate
Koch paragraph 0625, 0626, 0841, 0842,
Rosemary extract
Luria column 25 line 4, column 26 line 24, column 34 line 36, column 35 line 2, column 48 line 21, column 49 line 30, column 50 line 3, column 52 line 5, column 53 lines 53 – 54, column 55 line 48
Caesalpinia spinosa gum (AKA tara gum)
Puche paragraph 0163
Acacia senegal gum
Gupta column 42 line 44
Xanthan gum
Sene paragraph 0057
Phenethylalcohol
Puche paragraph 0174
Ethylhexylglycerin
Puche paragraph 0174
Instant claims 6 and 7 recite the serum further comprises purified water. Luria teaches purified water specifically as an ingredient for inclusion in a composition to protect the skin from sun damage (abstract, column 25 lines 44 – 46, column 26 line 1), reading on instant claims 6 and 7.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sene (as cited above) and further in view of Gupta (as cited above), Luria (as cited above), Koch (as cited above), and Burnam (US 2016/0367676 A1).
Sene, Gupta, Luria, and Koch’s teachings are addressed above.
Sene also teaches the inclusion of C12 – C15 alkyl benzoate and tocopherol for inclusion in a composition that protects the skin from irradiation (abstract, paragraphs 0034, 0057). Gupta teaches niacinamide and allantoin as antioxidants (column 41 line 18, line 22, line 33). Gupta teaches triglycerides are an emollient that contribute to the soft, smooth, and pliable appearance of skin (column 34 lines 28 – 45) and that sodium chloride is an inorganic salt typically used in formulations (column 42 lines 36 – 51). Luria teaches zinc oxide, jojoba esters, helianthus annuus extract, lecithin, and silica as natural ingredients suitable for a composition to treat skin damaged by harmful rays of the sun (abstract, column 3 line 24, column 19 line 10, column 23 line 9, line 16, column 25 line 63). Koch teaches the inclusion of polyglyceryl-4-isostearate, propanediol, coco-caprylate, polyglyceryl-2, oryza sativa bran extract, caprylyl glycol, polyglyceryl-3, Nylon-12, bisabolol, tetrasodium glutamate diacetate, phenylpropanol, and sodium hydroxide as antimicrobials, anti-inflammatories, oils, and polyglycerol esters suitable for inclusion in a cosmetic composition (paragraphs 0625, 0626, 0763, 0780, 0792, 0795, 0796, 0836, 0841, 0842, Tables 3, 6, 12, 14, 15, 25 -28, and 33 – 37).
The combination of Sene, Gupta, Luria, and Koch’s teachings (as set out above) does not teach the cream composition comprises methylpropanediol or tridecyl salicylate.
Burnam teaches the missing elements of the combination of Sene, Gupta, Luria, and Koch.
Burnam teaches stable emulsions of active ingredients (abstract). Burnam teaches methylpropanediol and tridecyl salicylate as ingredients that are water-soluble (paragraph 0019).
A person of ordinary skill in the art would have been motivated to combine the teachings of Sene, Gupta, Luria, Koch, and Burnam to include methylpropanediol and tridecyl salicylate as ingredients in a emulsion composition because Burnam teaches these ingredients are water-soluble and suitable for stable emulsions (abstract, paragraph 0019). The combination of Sene, Gupta, Luria, Koch, and Burnam’s teachings is prima facie obvious according to MPEP 2143(i)(a) combining prior art ingredients according to known methods to yield predictable results.
The combination of Sene, Gupta, Luria, Koch, and Burnam’s teachings reads on claims 8 and 9, as shown in the tables below, because each teach the inclusion of the claimed ingredients in a composition for protection of the skin from sun damage. The combination of the claimed ingredients in such a composition would be expected to yield predictable results (i.e. photoprotection). Therefore, claims 8 and 9 are prima facie obvious according to MPEP 2143(i)(a).
Claim 8 “the cream comprising…”
Reference
Zinc oxide
Luria column 3 line 24, column 4 line 51, column 6 line 17, column 18 line 25, column 22 line 23,
column 26 line 11, column 33 line 31, column 36 lines 24, 33, 44, Table 10, column 39 line 30, column 42 line 2, column 43 line 62, column 45 line 41, column 46 line 27, column 47 line 51, column 50 line 65, column 52 line 56, column 54 line 35
C12-C15 alkyl benzoate
Sene paragraph 0057
Jojoba esters
Luria column 23 line 9, column 25 lines 61 – 62, column 39 line 13
Triglycerides
Gupta column 34 lines 35 - 37
Polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate
Koch Polyglyceryl-4 isostearate paragraph 0836
Propanediol
Koch paragraph 0625 and others
Niacinamide
Gupta column 41 line 33
Methylpropanediol
Burnam paragraph 0019
Coco-caprylate
Koch paragraph 0795, 0796
Polyglyceryl-2
Koch paragraph 0836
Helianthus annuus extract R
Luria column 23 line 16, column 26 line 4, column 46 line 41
Rosemary extract
Luria column 25 line 4, column 26 line 24, column 34 line 36, column 35 line 2, column 48 line 21, column 49 line 30, column 50 line 3, column 52 line 5, column 53 lines 53 – 54, column 55 line 48
Tocopherol
Sene paragraph 0034
Deshpande paragraphs 0009, 0026
Allantoin
Gupta column 41 line 18
Oryza sativa bran extract
Koch paragraph 0780
Caprylyl glycol
Koch tables 6, 14, 15, 25 – 28, 33, 36, 37
Polyglyceryl-3
Koch paragraph 0836
Hydrogenated lecithin
Luria column 25 line 63
Tridecyl salicylate
Burnam paragraph 0019
Claim 9 “the cream further comprising…”
Reference
Silica
Luria column 19 line 10
Nylon-12
Koch table 3
Bisabolol
Koch paragraph 0625, 0763
Tetrasodium glutamate diacetate
Koch paragraph 0625, 0626, 0841, 0842,
Phenylpropanol
Koch paragraph 0625, 0792
Sodium chloride
Gupta column 42 line 51
Sodium hydroxide
Koch tables 12, 14, 28, 34, 35, 36
Claims 10 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sene (as cited above) and further in view of Ambrosi (as cited above), Bojanowski (as cited above), Puche (as cited above), Modi (as cited above), Gupta (as cited above), Luria (as cited above), Deshpande (as cited above), Koch (as cited above), Kannan (as cited above), and Burnam (as cited above).
The teachings of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, Deshpande, Koch, Kannan, and Burnam are discussed above.
A person of ordinary skill in the art would have been motivated to combine the teachings of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, Deshpande, Koch, Kannan, and Burnam to include each of the claimed ingredients in a composition for protecting the skin from sun damage because each teaches that these ingredients are effective in sun protection or well-known formulation ingredients. Therefore, the combination of Sene, Ambrosi, Bojanowski, Puche, Modi, Gupta, Luria, Deshpande, Koch, Kannan, and Burnam’s teachings is prima facie obvious according to MPEP 2143(i)(a) combining prior art ingredients according to known methods to yield predictable results.
Instant claim 10 is directed to a system for promoting protection against the effects of radiation which comprises one or more tablets (which comprise many ingredients) and a serum (which comprises many ingredients). This claim is interpreted as a “kit” or product claim and as such the components of the system are considered to be the limitations of the claim (MPEP 2112.01). The limitation “for promoting a human’s systemic protection against the effects of radiation in the ultraviolet, visible, and infrared spectra” appears to be an intended use limitation. The prior art references for compositions with ingredients for protecting the skin from sun damage appear to be capable of meeting the intended use of “promoting a human’s system protection against the effects of radiation” because each of the ingredients are the same. Each ingredient of the compositions is shown in the table below. Since the combination of the claimed ingredients would yield predictable results (i.e. compositions containing known ingredients for photoprotection) claim 10 is prima facie obvious according to MPEP 2143(i)(a).
Claim 10 “A system… comprising…”
Reference
“one or more tablets each comprising”
Methylsulfonylmethane
Ambrosi abstract
Bamboo extract
Bojanowski paragraph 0038
Fucoidan
Puche paragraph 0163
Purslane extract
Bojanowski paragraph 0027
Polypodium leucotomos
Modi paragraph 0030
L-glutathione
Gupta column 41 line 31
Rosemary powder
Luria column 25 line 4, column 26 line 24, column 34 line 36, column 35 line 2, column 48 line 21, column 49 line 30, column 50 line 3, column 52 line 5, column 53 lines 53 – 54, column 55 line 48
Marigold extract
Luria Table 1 column 10
“and a serum comprising..”
Glycerin
Sene paragraph 0057
Squalene
Gupta column 34 line 10
Resveratrol
Sene paragraph 0034
Bakuchiol
Bojanowski paragraph 0038
Silybum marianum fruit extract
Puche paragraph 0174
Niacinamide
Gupta column 41 line 33
Mixed tocopherols
Sene paragraph 0034
Deshpande paragraphs 0009, 0026
Kojic acid
Deshpande paragraph 0007
Sodium ascorbyl phosphate
Sene “ascorbic acid or a derivative thereof” paragraph 0034
Deshpande “ascorbic acid and/or its salt” paragraphs 0007, 0016, 0026
Sodium hyaluronate
Deshpande “hyaluronic acid” paragraph 0004
Chondruis crispus extract (AKA irish moss or carrageenan moss)
Puche paragraph 0163
Turmeric extract
Luria column 6 line 57, Table 1 columns 9 -10, 11
Licorice extract
Deshpande paragraph 0007
Green tea extract
Sene “tea extract” paragraph 0034
Modi paragraph 0030
Brazilian bamboo extract
Bojanowski paragraph 0038
Pine bark extract
Modi paragraph 0074
Red panax ginseng extract
Sene paragraph 0009
Marigold extract
Luria Table 1 column 10
Beta carotene
Deshpande paragraph 0009
Calcium ketogluconate
Koch paragraph 0810
Tetrasodium glutamate diacetate
Koch paragraph 0625, 0626, 0841, 0842,
Rosemary extract
Luria column 25 line 4, column 26 line 24, column 34 line 36, column 35 line 2, column 48 line 21, column 49 line 30, column 50 line 3, column 52 line 5, column 53 lines 53 – 54, column 55 line 48
Caesalpinia spinosa gum (AKA tara gum)
Puche paragraph 0163
Acacia Senegal gum
Gupta column 42 line 44
Xanthan gum
Sene paragraph 0057
Phenethylalcohol
Puche paragraph 0174
Ethylhexylglycerin
Puche paragraph 0174
Claim 11 recites the system of claim 10, further comprising additional ingredients, as shown in the table below.
Claim 11 “the one or more tablets each further comprising…”
Reference
Beta carotene
Deshpande paragraph 0009
Niacinamide
Gupta column 41 line 33
Resveratrol
Sene paragraph 0034
Red panax ginseng
Sene paragraph 0009
Green tea
Sene “tea extract” paragraph 0034
Modi paragraph 0030
Selenium citrate
Koch paragraph 0808 “selenium and derivatives thereof”
Vitamin E (AKA tocopherol)
Sene paragraph 0034
Pine bark extract
Modi paragraph 0074
Mulberry fruit powder
Deshpande “mulberry extract” paragraph 0007
Vitamin D3
Kannan “Photoprotection and vitamin D: a review”
Apigenin
Gupta column 41 line 52, column 42 line 19
Lycopene
Deshpande paragraphs 0009, 0012, 0016, 0017, 0019
Quercetin
Gupta column 41 line 22, line 58
Luteolin
Gupta column 42 line 19
Claim 12 recites the system of claim 10, further comprising a cream comprising ingredients as shown in the table below.
Claim 12 “the cream comprising…”
Reference
Zinc oxide
Luria column 3 line 24, column 4 line 51, column 6 line 17, column 18 line 25, column 22 line 23,
column 26 line 11, column 33 line 31, column 36 lines 24, 33, 44, Table 10, column 39 line 30, column 42 line 2, column 43 line 62, column 45 line 41, column 46 line 27, column 47 line 51, column 50 line 65, column 52 line 56, column 54 line 35
C12-C15 alkyl benzoate
Sene paragraph 0057
Jojoba esters
Luria column 23 line 9, column 25 lines 61 – 62, column 39 line 13
Triglycerides
Gupta column 34 lines 35 - 37
Polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate
Koch Polyglyceryl-4 isostearate paragraph 0836
Propanediol
Koch paragraph 0625 and others
Niacinamide
Gupta column 41 line 33
Methylpropanediol
Burnam paragraph 0019
Coco-caprylate
Koch paragraph 0795, 0796
Polyglyceryl-2
Koch paragraph 0836
Helianthus annuus extract R
Luria column 23 line 16, column 26 line 4, column 46 line 41
Rosemary extract
Luria column 25 line 4, column 26 line 24, column 34 line 36, column 35 line 2, column 48 line 21, column 49 line 30, column 50 line 3, column 52 line 5, column 53 lines 53 – 54, column 55 line 48
Tocopherol
Sene paragraph 0034
Deshpande paragraphs 0009, 0026
Allantoin
Gupta column 41 line 18
Oryza sativa bran extract
Koch paragraph 0780
Caprylyl glycol
Koch tables 6, 14, 15, 25 – 28, 33, 36, 37
Polyglyceryl-3
Koch paragraph 0836
Hydrogenated lecithin
Luria column 25 line 63
Tridecyl salicylate
Burnam paragraph 0019
Claim 13 recites the system of claim 12, the cream further comprising ingredients as shown in the table below.
Claim 13 “the cream further comprising…”
Reference
Silica
Luria column 19 line 10
Nylon-12
Koch table 3
Bisabolol
Koch paragraph 0625, 0763
Tetrasodium glutamate diacetate
Koch paragraph 0625, 0626, 0841, 0842,
Phenylpropanol
Koch paragraph 0625, 0792
Sodium chloride
Gupta column 42 line 51
Sodium hydroxide
Koch tables 12, 14, 28, 34, 35, 36
Instant claims 14 and 15 recite the serum further comprises purified water. Luria teaches purified water specifically as an ingredient for inclusion in a composition to protect the skin from sun damage (abstract, column 25 lines 44 – 46, column 26 line 1), reading on instant claims 14 and 15.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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