DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 06, 2024, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 03/06/2024 in the matter of Application N° 18/689,457. Said documents are entered on the record. The Examiner further acknowledges the following:
Thus, claims 24-46 represent all claims currently under consideration.
Information Disclosure Statement
One Information Disclosure Statement, filed on 04/25/2024 is acknowledged and have been considered.
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 24-46 are rejected under 35 U.S.C. 103 as being unpatentable over Heitmann et al., (WO2021099090A1), in view of Lademann et al. (WO2019043450A2),
Regarding claims 24, 31, 35, 41, 45, and 46, Heitmann et al. disclose wherein the invention is related to a composition of cosmetic sunscreen that contains zinc oxide, titanium dioxide, and bis-ethylhexyloxyphenol methoxyphenyl triazine (INCI: bis-ethylhexyloxyphenol methoxyphenyl triazine) (See Abstract, and paragraphs 18 and 19). Heitmann et al. also disclose cosmetic or sunscreen preparations comprising inorganic UV filters such as titanium dioxide and/or zinc oxide. Heitmann et al. further teach that titanium dioxide and/or zinc oxide may be present in the preparation in an amount of about 1 to 30% by weight, based on the total weight of the preparation. Heitmann et al. additionally disclose advantageous use concentrations of zinc oxide ranging from about 0.5 to 25% by weight of the total preparation (See paragraphs 15 and 18).
Regarding claim 25, Heitmann et al. disclose cosmetic or sunscreen preparations comprising inorganic UV filters such as titanium dioxide and/or zinc oxide. Heitmann et al. further teach that these metal oxide particles may have a primary particle size ranging from about 10 to 200 nm, and that such particles are used in cosmetic formulations to protect the skin from radiation, particularly in the wavelength range of 401-500 nm (See Description, paragraph 1, and claims 1 and 2). Because the particle size range disclosed by Heitmann et al. (10-200 nm) falls well within the claimed limitation of a number-average elementary particle diameter of less than 1000 nm, the reference teaches or at least renders obvious the particle size requirement recited in claim 25.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the present application to utilize titanium dioxide and/or zinc oxide particles having diameters below 1000 nm in the sunscreen or daily care composition of claim 24, as such particle sizes were already known and routinely employed in cosmetic UV-filter compositions to provide effective protection against radiation.
Regarding claims 26, and 37, Heitmann et al. disclose wherein the titanium dioxide is coated with silica (silicon dioxide and/or silicic acid). Zinc oxide is advantageously coated with triethoxycaprylylsilane (See paragraphs 11-13).
Regarding claims 27, and 38, Heitmann et al. disclose cosmetic or sunscreen preparations comprising inorganic UV filters such as titanium dioxide and/or zinc oxide. Heitmann et al. further teach that titanium dioxide and/or zinc oxide may be present in the preparation in an amount of about 1 to 30% by weight, based on the total weight of the preparation. Heitmann et al. additionally disclose advantageous use concentrations of zinc oxide ranging from about 0.5 to 25% by weight of the total preparation (See paragraphs 15 and 18). Because Heitmann et al. teach broad concentration ranges for titanium dioxide and zinc oxide within sunscreen compositions, the relative proportions of these UV filters may vary widely depending on formulation requirements. Selecting specific relative amounts of titanium dioxide and zinc oxide within the ranges disclosed by Heitmann et al. would inherently result in weight ratios that fall within the claimed ratios of 4:1 to 1:3. Likewise, adjusting the amounts of inorganic UV filters relative to other sunscreen agents in the composition would reasonably produce ratios of (TiO2 + ZnO) to bis-ethylhexyloxyphenol methoxyphenyl triazine within the claimed range of 1:1 to 20:1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to select amounts of titanium dioxide and zinc oxide within the ranges disclosed by Heitmann et al. thereby arriving at the claimed ratios through routine optimization of known sunscreen formulation parameters.
Regarding claim 28, Heitmann et al. disclose wherein the invention is related to a composition of cosmetic sunscreen that contains bis-ethylhexyloxyphenol methoxyphenyl triazine (INCI: bis-ethylhexyloxyphenol methoxyphenyl triazine) (See paragraphs 18 and 19). Heitmann et al. disclose cosmetic and sunscreen preparations comprising inorganic UV filters such as titanium dioxide and/or zinc oxide in cosmetically acceptable formulations for protection against ultraviolet radiation. Such sunscreen compositions conventionally contain both inorganic UV filters and organic UV absorbers dispersed within appropriate cosmetic vehicles (See paragraphs 18 and 19). Bis-ethylhexyloxyphenol methoxyphenyl triazine is a well-known lipophilic organic UV filter commonly used in sunscreen compositions and is typically incorporated into the oil phase of an emulsion system due to its oil-soluble nature. As recognized in the cosmetic formulation art, oil soluble UV filters are routinely dissolved or dispersed in the oil phase prior to emulsification to ensure proper distribution and stability of the sunscreen composition.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to incorporate bis-ethylhexyloxyphenol methoxyphenyl triazine in the oil phase of the sunscreen composition of Heitmann et al. since selecting the appropriate phase for incorporating a lipophilic UV filter represents routine formulation practice and optimization of known cosmetic preparation techniques.
Regarding claims 29, and 39, Heitmann et al. disclose cosmetic and sunscreen preparations comprising inorganic UV filters such as titanium dioxide and/or zinc oxide in cosmetic formulations for protection against ultraviolet radiation (See paragraphs 18 and 19). Sunscreen compositions in the cosmetic art commonly include multiple UV filters in order to provide broad-spectrum protection across different wavelength ranges. At the same time, formulations containing a single UV filter are also well known and routinely employed depending on the desired formulation characteristics.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to formulate the sunscreen composition of Heitmann et al. either with additional UV filters to broaden UV protection or without additional UV filters depending on formulation requirements. The recitation that the composition either includes or excludes a further UV filter merely represents an obvious design choice within the ordinary skill of cosmetic formulators and does not impose a structural or compositional limitation that distinguishes the claimed composition from the prior art.
Regarding claims 30, and 40, Heitmann et al. disclose wherein the sunscreen or daily care composition comprises diethylhexyl syringylidenemalonate (See paragraph 36).
Regarding claims 34, and 44, Heitmann et al. disclose sunscreen or cosmetic compositions comprising inorganic UV filters such as titanium dioxide and/or zinc oxide for protection against ultraviolet radiation (paragraphs 18 and 19). Lademann et al. further teaches sunscreen compositions containing conventional UV filters capable of providing high sun protection factors (e.g. SPF 30 or SPF 50) and recognize that the performance and cosmetic properties of sunscreen formulations depend on the selection and combination of UV filters used in the composition (See page 16, paragraphs 33-35). Bis-ethylhexyloxyphenolol methoxyphenyl triazine is a well-known broad-spectrum organic UV filter used in sunscreen formulations and is recognized in the cosmetic formulation art for its high photostability and compatibility with other UV filters, including inorganic filters such as titanium dioxide and zinc oxide. Cosmetic formulators routinely incorporate such organic UV filters into sunscreen compositions containing inorganic filters in order to improve overall; sunscreen performance and formulation characteristics.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to incorporate bis-ethylhexyloxyphenol methoxyphenyl triazine into a sunscreen composition containing titanium dioxide and zinc oxide as taught by Heitmann et al. with a reasonable expectation that doing so would enhance photostability and improve other formulation characteristics of the sunscreen compositions. The recited improvements in properties such as reduced stickiness, reduced gloss, improved water resistance, and improved film homogeneity represent inherent or expected results of routine sunscreen formulation optimization and do not impart patentable distinction over the prior art.
Regarding claim 36, Heitmann et al. disclose sunscreen and cosmetic preparations comprising inorganic UV filters such as titanium dioxide and/or zinc oxide for protection against ultraviolet radiation. Heitmann et al. further teach that these metal oxide particles may have primary particle sizes ranging from about 10 nm to about 200 nm for use in cosmetic preparations (See Description, paragraph 1, and claims 1 and 2). Because the particle size range disclosed by Heitmann et al. (10-200 nm) falls entirely within the claimed limitation of less than 1000 nm, the reference teaches particle sizes encompassed by the claimed limitation. Selecting titanium dioxide or zinc oxide particles having diameters below 1000 nm would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the present application.
However, Heitmann et al. do not disclose wherein the sunscreen daily care composition, providing a SPF of more than 15 or a SPF of more than 50 or a SPF of more than 90 and/or providing a photostability of more than 85%.
Regarding claims 32, 33, 42, and 43, Lademann et al. teach conventional agents which have very high sun protection factors of SPF 30 or 50. What matters is not a large number of filters and, thus, as it may seem, the sun protection factor SPF, but the balance between UV filters, pigments, radical scavengers and a cooling agent (See page 16, paragraphs 33-35).
Regarding claim 41, the claim recites that the sunscreen or daily care composition comprises bis-ethylhexyloxyphenol methoxyphenyl triazine in an amount of from about 1 wt% to about 10 wt%.
Lademann et al. disclose sunscreen compositions comprising UV filters capable of providing high sun protection factors (e.g. SPF 30 or SPF 50) and recognize that the performance of sunscreen compositions depends on the selection and concentration of UV filters used in the formulation. Sunscreen compositions conventionally contain organic UV filters in amounts sufficient to provide effective UV protection, and such filters are commonly used within ranges comparable to those recited in the present claim. Because the concentration of UV filters in sunscreen formulations is a result-effective variable affecting SPF performance and photostability, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to select an amount of bis-ethylhexyloxyphenol methoxyphenyl triazine within the claimed range of 1-10 wt% in order to achieve the desired level of UV protection. Determining an appropriate concentration within this range would have involved routine experimentation and optimization of known sunscreen formulation parameters. Therefore, the claimed concentration of 1-10wt% bis-ethylhexyloxyphenol methoxyphenyl triazine represents an obvious variation of known sunscreen compositions and does not render the claimed composition patentable over the teachings of Lademann et al.
Conclusion
No claim is allowed.
Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615