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 .
DETAILED ACTION
Status of Claims
The amendments and arguments filed on 07/23/2025 are acknowledged and have been fully considered. Claims 1-4, 6-7, and 9-20 are now pending. Claims 5 and 8 are canceled; claims 1 and 9 are amended; claims 12-13 and 18-20 are withdrawn.
Claims 1-4, 6-7, 9-11, and 14-17 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 1 is objected to because of the following informalities: The claim reads “UV filters powder” which should read “UV filter powder”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6-7, 9-11, and 14-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claim recites the limitation of “solid particles consisting of mineral UV filters powder” however, the disclosure has not described these solid particles previously. As there is no mention of these solid particles previously, it is new matter.
Response to Arguments
Applicant's arguments filed 07/23/2025 have been fully considered and it is noted that the amendment is able to overcome the previous rejection, however the amendment introduces another issue of new matter as it recites that the solid particles consist of mineral UV filters powder, which has not been previously disclosed. It is also noted that it seems that “powder” in general is not disclosed in the specification either, except when referring to a specific company (i.e., Micro Powders; see specification as filed, page 36).
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.
Claim 1-4, 6-7, 9-11, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 8241613 (Candau et al, 2012; as submitted on the IDS of 08/10/2022) in view of IFSCC Monograph (1997) and US Patent 6517816 B1 (Gonzalez, 2003).
Regarding claims 1, 4, 8-11, and 15-16, Candau discloses topically applicable cosmetic/dermatological UV protection compositions having enhanced SPF containing at least one inorganic screening agent and/or organic UV screening agent and a semi-crystalline polymer as well as hollow latex particles (abstract). Candau exemplifies a composition comprising 1 wt.% poly (C10-C30) alkyl acrylates (Intelimer 13-1 from Landec), a water phase comprising 61.65% water and 9.35 wt.% other ingredients, isononyl isononanoate (i.e. emollient), 2 wt.% of emulsifiers including a mixture comprising glyceryl stearate (see example 1; column 44). Candau further teaches its composition comprises inorganic screening agents like titanium oxide (claim 12) and are preferably in the form of an oil-in-water or water-in-oil emulsion (column 17, lines 17-18). Thus, Candau immediately envisages water-in-oil emulsions comprising a water phase, one or more mineral UV filtering agents like titanium dioxide, one or more thickening agents like poly C10-30 alkyl acrylate within the instant amount range, emollients like isononyl isononanoate, and emulsifiers like glyceryl esters within the instant amount range set forth in instant claims 1, 4, 15, and 17. Candau teaches the addition of fatty substances (see column 16, lines 10-14) and suggests the use of jojoba oil (see column 16, lines 26-28). However, as the use of hydrogenated jojoba oil is not required, the limitation of “when hydrogenated jojoba oil is present…” is met by the teachings of Candau.
Further, in regards to claim 1 and 17, Candau teaches its inorganic screening agents including titanium oxide that have a particle size of less than or equal to 500 nm (i.e. solid particles) (see column 13, lines 54-60) and are used in an amount of preferably 1 -30 wt.% by total weight of the composition (column 15, lines 65-67). This amount overlaps with the instant range of mineral UV filtering agent recited in instant claims 1 and 17. According to MPEP 2144.05, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). It also would have been obvious to an artisan of ordinary skill to manipulate and optimize the amount of mineral UV filtering agent. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success. See In re Aller and MPEP 2144.05 above.
In regards to the limitation of the composition comprising at least 10% by weight of the total sunscreen composition of solid particles consisting of mineral UV filters powder, it is pointed out that the titanium oxide particles are used in an amount of 1-30 wt. % (column 15, lines 65-67). Using the broadest reasonable interpretation, the particles are understood as a powder and as such meet the limitation of having solid particles consisting of UV filters powder.
However, Candau et al do not teach a water phase of about 20% to 45% by weight relative to the total weight of the sunscreen composition or the amount of the emollient being from about 15% to 40% by weight relative to the total weight of the sunscreen composition. Candau et al teaches a water phase that is present in an amount of 71 wt.% relative to the total weight of the sunscreen composition.
Regarding the limitations directed to the viscosity range and inflection point recited in instant claims 1-2 ; it should be noted that the instant specification discusses the following in paragraph 0048:
Without being bound by theory, it is believed that a specific range of water phase and oil thickening agents present in the composition, along with the specific ratio of oil thickening agents, together make the inventive compositions exhibit a high shear viscosity transition which occurs at or around skin temperature. This is preferable for the invention in order to provide improved aesthetics of the inventive compositions related to the ease of spreading on skin, and improved distribution of product on skin.
Thus, because Candau et al teach the specific oil thickening agents at the amount discussed in the instant claims and it would have been obvious to manipulate and optimize the amount of water phase in the compositions of Candau et al to meet the range recited in the instant claims; an ordinary skilled artisan would have a reasonable expectation that the composition would exhibit the instant viscosity, the inflection point and high shear viscosity transition temperature recited in the instant claims. The properties would naturally flow from the combined teachings of the prior art and therefore, would be obvious because the prior art suggests all the ingredients and the amounts of ingredients of the composition recited in the instant claims. "The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). The claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). According to MPEP 2112.02, products of similar chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present as In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Alternatively, it would have been obvious to an artisan to an artisan of ordinary skill before the effective filing date to manipulate and optimize the viscosity of the composition. One would have been motivated to do so depending on the desired properties of the composition and the feel, thickness or consistency of the composition on the skin. See In re Aller and MPEP 2144.05 above. Further, it is known in the art that “in O/W emulsions, the internal oil phase is normally held to levels below about 30 % to avoid a greasy after-finish. The reverse is true in W/O emulsions in which a higher water content lowers greasiness” (see IFSCC Monograph, page 35, 3.3 Water-in-oil emulsions). Further, Gonzalez teaches water-in-oil emulsion that comprises a water phase that is present from about 10 wt % to about 90 wt % (see Gonzalez, abstract; col. 3, lines 37-41 and col. 4, lines 10-15). As such, the amount of the water phase would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention as it is known that the “greasiness” of the composition can be changed when changing the water content. Further, the claimed amount of water is known in the art and is well within the range of optimization as shown in Gonzalez. As such, without showing unexpected results, the claimed amount of water phase cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, amount of water phase in Candau et al to obtain the desired balance between the greasiness as taught by IFSCC Monograph (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Further in regards to the amount of emollient, it is taught that the composition of Gonzalez teaches that the composition comprises a co-solvent, such as dicapryl ether in a ratio of 1:1 with the sunscreen(see Gonzalez, column 5, lines 1-22). The sunscreen active is taughtto be from 0.5 wt% to about 30 wt.% based on the total weight of the composition (see Gonzalez, paragraph bridging columns 3-4). As such, the amount of the co-solvent is understood to be the same. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding instant claim 3, Candau does not require compositions comprising silicone and thus meet the limitation, “wherein the sunscreen composition is free of silicone”.
Regarding instant claims 6-7, Candau’s exemplified Intelimer 13-1 from Landec has a melting temperature of 49°C (column 8, lines 58-62), which falls within the instant melting temperature range.
Regarding instant claim 14, Candau suggests its emulsifiers could include PEG-30 dipolyhydroxystearate (column 17, lines 40-43).
In regards to claims 1-4, 6-7, 9-11, and 14-17, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Candau with the teachings of IFSCC Monograph and Gonzalez to formulate a sunscreen composition as instantly claimed. Particularly, it would be obvious to one with ordinary skill in the art to use the teachings of IFSCC Monograph and Gonzalez to optimize the water amount in the composition to balance the greasiness of the composition and amount of emollient as discussed above. One with ordinary skill in the art would be motivated to combine the teachings of Candau with the teachings of IFSCC Monograph and Gonzalez according to the known method of formulating sunscreen compositions (see Candau, examples 1-4) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Response to Arguments
Applicant's arguments filed 07/23/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
Applicant argues that the instant claims recite limitations that are not taught in the prior art such as the amount of emollient and the solid particles consisting of mineral UV filter powder. However as discussed above, the art does teach solid particles in the instantly claimed range. Further it seems like applicant meant to amend the claim to recite “solid particles consisting of UV filters and powders” not “UV filters powder”. However even with the broadest reasonable interpretation, the particles of Candau would be understood as a powder as well. Further, applicant argues that the examples that are taught in Candau et al do not teach a water phase of about 20% to about 45% by weight, it is pointed out that because Candau et al teach the specific oil thickening agents at the amount discussed in the instant claims and it would have been obvious to manipulate and optimize the amount of water phase in the compositions of Candau et al to meet the range recited in the instant claims; an ordinary skilled artisan would have a reasonable expectation that the composition would exhibit the instant viscosity, the inflection point and high shear viscosity transition temperature recited in the instant claims. The properties would naturally flow from the combined teachings of the prior art and therefore, would be obvious because the prior art suggests all the ingredients and the amounts of ingredients of the composition recited in the instant claims. This would further mean that the amount of water is not limited by the examples presented in Candau et al, but would lead one with ordinary skill in the art to optimize the amount of water, as instantly claimed. As written now, there is no reason to believe that the amount of water is critical to the invention and as such is rendered obvious from the teachings of Candau et al. Additionally, Candau et al. disclose water in oil emulsions. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). Without a showing of data or tests, the amount of water claimed is deemed not critical in light of the teachings of Candau et al. As such, the limitations of the claim are met as discussed in the 103 obviousness rejection above, meaning that the rejection is maintained.
Further, the rejection is over Candau et al in view of IFSCC Monograph and Gonzalez. Using the teachings of these references, as discussed above, it would be obvious to one with ordinary skill in the art to use the teachings of IFSCC Monograph and Gonzalez to optimize the water amount in the composition to balance the greasiness of the composition as discussed above. One with ordinary skill in the art would be motivated to combine the teachings of Candau with the teachings of IFSCC Monograph and Gonzalez according to the known method of formulating sunscreen compositions (see Candau, examples 1-4) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611