DETAILED ACTION
RESPONSE TO AMENDMENT
1. Receipt of Applicants’ arguments/remarks filed 3/4/2026 are acknowledged. The current Office Action will replace the one mailed 11/5/2025.
INFORMATION DISCLOSURE STATEMENT
2. No new Information Disclosure Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections- 35 USC § 103
4. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 86-98, and 102-105 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 20200101002) in view of Bonda et al. (US 20100021403), Itagaki et al. (US 20170095407), Drovetskaya et al. (US patent 9,592,187), Johncock et al. (US 20190374454), Nurse et al. (US 20130028853), and Clear Zinc Oxide In Badger Sunscreens as evidenced Silva et al. “The effect of formulation on the penetration of coated and uncoated zinc oxide nanoparticles into the viable epidermis of human skin in vivo”.
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Shah et al. (US 20200101002).(hereinafter Shah et al.) disclose mineral sunscreen compositions comprising UV filtering agents, one or more stilbenoids (e.g., piceid), ethylhexylmethoxycrylene (SPF booster), diethylhexyl syringylidenemalonate and a carrier (claim 1). These compositions have SPF of at least 50 (Table 3). The mineral UV filtering agents include zinc oxide (claim 2). The mineral agents (zinc oxide) can be present from 1 to 25 % (claim 19). The mineral pigments may be surface treated (para 0058-0060 and para 0078). The composition may contain no organic sunscreen active agents. The film formers are present in amounts that overlap from 1 to 60 % as claimed (para 0116).The carrier can be water (par 0166) and the composition is an emulsion (claim 18).
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have selected various combinations of the various disclosed mineral sunscreen composition of Shah containing, not more than 25 % one or more surface treated zinc oxide, one or more film formers, and SPF boosters where the formulation has SPF of at least 50 to arrive at compositions yielding no more than one would expect from such an arrangement.
Shah et al. has been discussed supra and does not teach the zinc oxide is triethoxycaprylylsilane.
Bonda et al. (US 20100021403) disclose film former (xanthan gum) at 0.35 %, Zinc Oxide (Z-cote HP1) (zinc oxide surface treated with triethoxycaprylylsilane) less than 25 wt % (e.g., 6.20 %) and SPF booster (butyloctyl salicylate at 3.40 % or 1.70 %) (see Examples 3-6). The examples contain water. Bonda et al. discloses the metal oxide (e.g. zinc) can be present in an amount from about 0.1 wt % to about 25 wt % (para 0041). Bonda discloses that a sunscreen dermatological formulation generally includes UV-A and UV-B photoactive compounds in a cosmetically acceptable carrier, optionally including additives, such as emollients, stabilizers, emulsifiers, and combinations thereof. These additives can be used in preparing a UV filter composition in an emulsion (oil-in-water or water-in-oil) from a composition that includes one or more photoactive compounds and a solvent or a solvent combination that includes one or more organic solvents and water. When made, preferably the emulsion is an oil-in-water emulsion, wherein the oil phase is primarily formed from a mixture of an organic and/or inorganic UV filter compound(s) and one or more organic solvents (para 0040). Bonda et al. teaches that Zinc oxides and other metal oxides are chemically and catalytically reactive. Bonda et al. teaches that these metal oxide particles may advantageously be surface-treated (“coated”), the intention being, for example, to form or retain a hydrophilic, amphiphilic or hydrophobic character, and to reduce the reactivity and/or catalytic activity of the metal oxide. This surface treatment may consist of coating the particles by processes known per se with a thin hydrophilic and/or hydrophobic inorganic and/or organic layer (para 0025).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to further include surface treated zinc oxide such as the triethoxycaprylylislane of Bonda et al. for the purposes of providing hydrophobic character to reduce the reactivity.
As demonstrated by Johncock et al. (US 20190374454) ethylhexylmethoxycrylene and butyloctyl salicylate are both UV absorbing SPF boosters. Therefore, it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute one known SPF booster for another with predicable results as both are art recognized SPF boosters.
The modified Bonda et al. has been discussed supra and does not disclose wherein the first triethoxycaprylylsilane surface zinc oxide has a first weight ratio of zinc oxide to triethoxycaprylylsilane of about 96.2:3.8, that the first triethoxycaprylylsilane has a first median particle size D50 of about 1790 nm, wherein the one or more surface treated zinc oxides further comprise a second zinc oxide surface-treated with triethoxycaprylylsilane and has a second weight ratio of zinc oxide to triethoxycaprylylsilane of about 96.6:3.3 and a second median particle size D50 of about 2880 nm, and that the first zinc oxide is present at 18 wt % and the second zinc oxide is present in an amount of about 7 wt %.
Bonda et al. disclose inclusion of Z-COTE HP1 zinc oxide which has approximately 98 % ZnO and 2 % triethoxycaprylylsilane (as evidenced Silva et al. “The effect of formulation on the penetration of coated and uncoated zinc oxide nanoparticles into the viable epidermis of human skin in vivo” (see section 2.1 ZnO nanoparticles)).
Drovetskaya et al. (US patent 9,592,187) disclose that nano-sized zinc oxide may have high surface reactivity which increases the interaction between adjacent particle which can cause particle agglomeration in the formulation and that ways to overcome this are to surface coat the metal oxide to provide hydrophobicity. The weight percent of the coating or surface treatment of the zinc oxide ranges from 0.01 to about 5 wt. %, preferably about 0.1 to about 3 wt. %, and most preferably about 0.2 to about 2 wt. % based on the coated zinc oxide. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to optimize the amount of surface coating triethoxycaprylylsilane to zinc oxide. One would have been motivated to do so for the purpose of providing hydrophobicity and avoiding agglomeration.
Itagaki et al. (US 20170095407) (hereinafter Itagaki et al.) disclose zinc oxide surface coated (abstract and para 0054). The surface coating can be triethoxycaprylylsilane (para 0068). Itagaki et al. disclose the average particle sizes can be from 50 nm to 2000 nm and that when the average particle diameter is 50 nm or less, the particle of the included zinc oxide also becomes small, and there is a concern that scattering in the ultraviolet range may become relatively small on the long wavelength side. On the other hand, when the average particle diameter exceeds 2,000 nm, in a case in which the silicon oxide-coated zinc oxide is used for a cosmetic or the like, there is a concern that friction or the like may be caused and thus the feeling during the use of the cosmetic or the like may deteriorate (paras 0057-0058). The amount of surface treatment can be from 1 to 20 % (para 0068). Two or more silicone resins may be used (para 0172) and these include silicone oxide coated zinc oxide (para 0038).
While Itagaki et al. does not disclose having particle sizes above 2000 nm, “Clear Zinc Oxide In Badger Sunscreens” disclose micronized zinc oxide aggregates and that light scatter analysis of the finished product show a particle size range of 565 nm to 19,000 nm with an average article size of 3400 nm and no detectable nanoparticles. These aggregates are porous, almost like a sea sponge, so they don’t reflect light in the same way as non-nano particles. The result: you get the less-whitening properties of nanoparticles with the safety and efficacy of larger particles. It would have been prima facie obvious to optimize the size of the particle sizes to include microparticles of large size to achieve less-whitening properties with safety and efficacy.
With regards to butyloctyl salicylate, Nurse et al. (US 20130028853) (hereinafter Nurse et al. disclose that photo stabilizers are included to enhance SPF values of the composition (abstract). Photostabilizers are inclusive of butyloctyl salicylate (para 0014-0015). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include butyloctyl salicylate in the compositions of Shah et al. One would have been motivated to do so because it is recognized as a photo stabilizer that enhances the SPF value of the sunscreen as taught by Nurse et al.
5. Claims 86, and 99-101 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 20200101002) in view of Bonda et al. (US 20100021403), Itagaki et al. (US 20170095407), Drovetskaya et al. (US patent 9,592,187), Johncock et al. (US 20190374454), Nurse et al. (US 20130028853), and Clear Zinc Oxide In Badger Sunscreens as evidenced Silva et al. “The effect of formulation on the penetration of coated and uncoated zinc oxide nanoparticles into the viable epidermis of human skin in vivo”applied to claims 86-98, and 102-105 above, and further in view of SurfaTech Products for Personal Care.
The modified Bonda et al. has been discussed supra and disclose xanthan gum film former but does not disclose the film former is bis-octyldodecyl dimer dilinoleate/propanediol copolymer.
Shah et al. disclose sunscreen compositions and film formers may be incorporated into sunscreen compositions to ensure even coverage of UV filters and can be used to render the composition water resistant. The film former is typically a hydrophobic material that imparts film forming and/or water proofing characteristics (title, abstract and para 0114). The amount of film forming may be from about 0.1 to about 40 % based on the weight of sunscreen (para 0116). Shah et al. does not disclose bis-octyldodecyl dimer dilinoleate/propanediol copolymer however, SurfaTech Products for Personal Care, disclose that Bis-octyldodecyl dimer dilinoleate/propanediol copolymer (CosmoSurf© DDG 20) is a film former for sun-care products (table of page 3). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to incorporate Bis-octyldodecyl dimer dilinoleate/propanediol copolymer as the film forming agent in the composition of Shah et al. One would have been motivated to do so because this is a film former for use in sun care cosmetics and film formers are incorporated to ensure even coverage of UV filters and can be used to render the composition water resistant.
RESPONSE TO ARGUMENTS
6. Applicants’ arguments have been fully considered and are not persuasive for the reasons below.
Applicants argue that the subject matter of claims 65 and 79 was not rejected under 35 U.S.C § 103.
In response, the Examiner respectfully submits that previous claim 65 recited zinc oxide surface-treated with an ethoxylated alkyl silane. While these claims were accidentally omitted, Bonda et al. disclose film former (xanthan gum) at 0.35 %, Zinc Oxide (Z-cote HP1) (zinc oxide surface treated with triethoxycaprylylsilane). The Office Action has been made Non-Final in light of the typographical mistake omitting these claims. Surface treated tritheoxycparylsilane has been known in the prior art. The combined teachings of Drovetskaya et al., Itagaki et al. and “Clear Zinc Oxide In Badger Sunscreens” address the particle sizes.
CORRESPONDENCE
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (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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/DANAH AL-AWADI/Primary Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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