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 .
Claim Status
Applicants’ amendments and arguments filed 12/01/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Claim 13 is canceled.
Claims 1-4, 6-11, and 14 are amended.
Claim 14 remains withdrawn.
Claims 1-12 are examined on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/19/2025 and 10/22/2025 are being considered by the examiner. The non patent document “Neues aus Dermatologie” found in the IDS filed on 10/22/2025 does not have an English translation, therefore, this document is not being considered by the examiner.
Claim Interpretation
As to the limitations of Claim 12, applicant is reminded this is a composition/product claim and the prior art teaches a topical composition comprising a microfine zinc oxide from with a particle size of less than 300 nm and with a surface coating of triethoxycaprylylsilane, bis-ethylhexyloxyphenol methoxyphenyl triazine, 2-phenylbenzimidazole-5-sulfonic acid, and diethylhexyl butamido traizone thereby since a product is not separable from its physical properties then it necessarily teaches the composition has an SPF of at least 20.
Maintained Rejections
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.
Claims 1-2, 4, 6, and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kolbe et al. (US20050276764A1, published 12/15/2005, found in the IDS filed 09/03/2024, hereafter Kolbe) and as evidenced Hong et al. (Yin, Hong & Coleman, Victoria & Casey, P.s & Angel, Brad & Catchpoole, Heather & Waddington, Lynne & McCall, Maxine. (2015). A comparative study of the physical and chemical properties of nano-sized ZnO particles from multiple batches of three commercial products. Journal of Nanoparticle Research. 17. 96. 10.1007/s11051-014-2851-y, hereafter Hong).
As evidenced by Hong, Z-COTE has a particle size range of 70-200 nm with a mean of 100nm and Z-COTE HP1 has a particle size range of 90-190 nm with a mean of 130nm (page 96, table 1).
Kolbe teaches a topical, anti-inflammatory cosmetic, dermatological, or medical preparation (claim 1; according to the claim limitations of the instant claim 1). Kolbe teaches the preferred use of such preparation involves application of the preparations to the sun exposed skin ([0049]; according to the claim limitations of the instant claim 1). Kolbe teaches an emulsion example comprising cetyldimethicone copolyol at 2.5 parts, Dimethicone polydimethylsiloxane at 4.0 parts, 2,4-bis-(4-(2-ethylhexyloxy-)2-hydroxyl)-phenyl)-6-(4-methoxyphenyl)-(1,3,5)-triazine at 2.5 parts, diethylhexylbutamidotriazone at 1.0 parts, and zinc oxide at 1.0 parts (example 2, [0227]; according to the claim limitations of the instant claims 1 and 4). Other examples by Kolbe teaches the addition of phenylbenzimidazolesulfonic acid at 0.5, 2.0, and 3.0 parts and further teaches 2-phenylbenzimidazole-5-sulfronic acid as a UV-B and broadband filter ([0224], [0227], [0229], and [0117]; according to the claim limitations of the instant claim 1). Kolbe teaches the total amount of one or more inorganic pigments, specifically zinc oxide, in the finished preparation is advantageously chosen from the range 0.1-25% by weight, preferably 0.5-18% by weight ([0068]; according to the claim limitations of the instant claim 4). Kolbe teaches that O/W emulsions can be advantageously chosen and provides example creams ([0141] and [0225]; according to the claim limitations of the instant claim 6). Furthermore, Kolbe teaches the zinc oxide particles suitable according to the invention have a particle size of <300nm ([0067]; according to the claim limitations of the instant claims 1-2). Furthermore, Kolbe provides a list of zinc oxide products useable in the present invention to include Z-Cote and Z-Cote HPL, the further states that Z-Cote HP1 from BASF is particularly preferred ([0067-0068]; according to the claim limitations of the instant claims 1-2). Kolbe then teaches market available zinc oxide that is coated in dimethicone ([0067]; according to the claim limitations of the instant claim 1). Kolbe teaches both titanium dioxide and zinc oxide as inorganic pigment metal oxides and teaches metal oxides to have various coatings to include stearic acid, octyltrimethylsilane, dimethicones ([0062] and [0065]; according to the claim limitations of the instant claim 1). Kolbe’s O/W cream examples further teach the addition of C12-15 alkylbenzoate ([0226]; according to the claim limitations of the instant claim 8). Furthermore, Kolbe teaches the use of dicaprylyl carbonate in multiple examples ([0224, 0227, 0229]; according to the claim limitations of the instant claim 8). Kolbe teaches the addition of preservatives such as phenoxyethanol and ethanol [0215]; according to the claim limitations of the instant claim 9). Kolbe teaches multiple examples including O/W examples with the addition of xanthan gum ([0225-0226] and [0229-0230]; according to the claim limitations of the instant claim 10). Kolbe further teaches the addition of acrylates/C10-30-alkyl acrylate crosspolymer in the examples ([0229-0230]; according to the claim limitations of the instant claim 10). Kolbe teaches the advantageous addition of a fatty alcohol ethoxylate selected from a group of ethoxylated stearyl alcohols, cetyl alcohols, and cetylstearyl alcohols ([0172]; according to the claim limitations of the instant claim 11).
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5].
“[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”. Therefore, it would be of obviousness to teach the composition of the instant Claims 1-2, 4, 6, and 8-12 as outlined by Kolbe.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kolbe et al. (US20050276764A1, published 12/15/2005, found in the IDS filed 09/03/2024, hereafter Kolbe) in view of Tanaka et al. (US20100203118A1, published 08/12/2010, after Tanaka), and as evidenced Hong et al. (Yin, Hong & Coleman, Victoria & Casey, P.s & Angel, Brad & Catchpoole, Heather & Waddington, Lynne & McCall, Maxine. (2015). A comparative study of the physical and chemical properties of nano-sized ZnO particles from multiple batches of three commercial products. Journal of Nanoparticle Research. 17. 96. 10.1007/s11051-014-2851-y, hereafter Hong).
As outlined above Kolbe evidenced by Hong, teaches a topical composition comprising a microfine zinc oxide with a particle size of less than 300 nm and with a surface coating (such as dimethicone), bis-ethylhexyloxyphenol methoxyphenyl triazine, 2-phenylbenzimidazole-5-sulfonic acid, and diethylhexyl butamido traizone, however it fails to teach triethyoxycaprylylsilane as the zinc oxide coating as in the instant claim 3. Tanaka remedies this deficiency.
Tanaka teaches a collapsible water-containing capsules that has a skin benefit agent dissolved or dispersed in the water phase or the powder components in which the capsule is used to treat the skin ([0034] and claim 19). Tanaka teaches the addition of a metal oxide to give coverage to the skin and UV protection to the skin ([0053]). Tanaka teaches the metal oxide is from about 5-20 % of the composition and has a particle size of about 25-130nm ([0052]). Tanaka teaches that zinc oxide coated in triethoxycaprylylsilane is a commercially available inorganic UV protection agent ([0080]). Furthermore, Tanaka teaches the metal oxides coated in dimethicone (page 10, table 1). Furthermore, Tanaka teaches the SPF of the product to be at least 15 ([0073]).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a topical composition comprising a microfine zinc oxide from 30-22 nm with a surface coating (such as dimethicone), bis-ethylhexyloxyphenol methoxyphenyl triazine, 2-phenylbenzimidazole-5-sulfonic acid, and diethylhexyl butamido traizone as outlined by Kolbe with the simple substitution of triethyoxycaprylylsilane as outlined by Tanaka. Simple substitution of one zinc oxide coating for another is within the purview of the skilled artisan and would yield predictable results.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kolbe et al. (US20050276764A1, published 12/15/2005, found in the IDS filed 09/03/2024, hereafter Kolbe) in view of Schade et al. (US9808410B2, published 11/07/2017, PG publication of this patent found in IDS filed on 05/03/2022, hereafter Schade), and as evidenced Hong et al. (Yin, Hong & Coleman, Victoria & Casey, P.s & Angel, Brad & Catchpoole, Heather & Waddington, Lynne & McCall, Maxine. (2015). A comparative study of the physical and chemical properties of nano-sized ZnO particles from multiple batches of three commercial products. Journal of Nanoparticle Research. 17. 96. 10.1007/s11051-014-2851-y, hereafter Hong).
As outlined above Kolbe as evidenced by Hong teaches a topical composition comprising a microfine zinc oxide with a particle size of less than 300 nm, specifically and preferably an average of 130nm, and with a surface coating (such as dimethicone), bis-ethylhexyloxyphenol methoxyphenyl triazine, 2-phenylbenzimidazole-5-sulfonic acid, and diethylhexyl butamido traizone, however it fails to teach the composition is free of 3-(4-methylbenzylidene)camphor, oxybenzone, and octocrylene as in the instant claim 5. Schade remedies this deficiency.
Schade teaches an octocrylene-free sunscreen composition with low stickiness (title). Schade teaches the composition is a cosmetic sunscreen compositon a UV filter combination of a) 4-(tert-butyl)-4′-methoxydibenzoylmethane b) 2,4,6-tris[anilino(p-carbo-2′-ethyl-1′-hexyloxy)]-1,3,5-triazine (INCI: Ethylhexyl Triazone), c) 2,4-bis{[4-(2-ethylhexyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine (INCI: Bis-Ethylhexyloxyphenol methoxyphenyl Triazine), and 2-phenylbenzimidazole-5-sulfonic acid and/or one or more salts thereof (abstract and claim 1). Schade teaches the composition may or may not contain zinc oxide (column 2, line 50). Claim 1 of Schade further claims the composition contains no 2-hydroxy-4-methoxybenzophenone (INCI: Oxybenzone) and no ethylhexyl 2-cyano-3,3-diphenylacrylate (INCI: Octocrylene). Furthermore, Schade teaches that studies have given octocrylene a negative evaluation suggesting that might have hormonal activity (column 2, lines 13-25). Further, Schade teaches it is preferred in accordance with the invention if the preparation contains no 3-(4-methylbenzylidene)camphor, 2-hydroxy-4-methoxybenzophenone (INCI: Oxybenzone), and ethylhexyl 2-cyano-3,3-diphenylacrylate (INCI: Octocrylene), therefore being free of these ingredients (column 2, lines 46-51).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a topical composition comprising a microfine zinc oxide with a particle size of less than 300 nm and with a surface coating (such as dimethicone), bis-ethylhexyloxyphenol methoxyphenyl triazine, 2-phenylbenzimidazole-5-sulfonic acid, and diethylhexyl butamido traizone as outlined by Kolbe with the ready for improvement with the known technique of the composition containing no of 3-(4-methylbenzylidene)camphor, oxybenzone, and octocrylene as outlined by Schade for the reason above. Removing the forementioned components from a topical UV composition as claimed by instant claim 5 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kolbe et al. (US20050276764A1, published 12/15/2005, found in the IDS filed 09/03/2024, hereafter Kolbe) in view of Lange et al. (US882142B2, published 09/02/2014, PGpub found in IDS filed on 09/03/2024, hereafter Lange), and as evidenced Hong et al. (Yin, Hong & Coleman, Victoria & Casey, P.s & Angel, Brad & Catchpoole, Heather & Waddington, Lynne & McCall, Maxine. (2015). A comparative study of the physical and chemical properties of nano-sized ZnO particles from multiple batches of three commercial products. Journal of Nanoparticle Research. 17. 96. 10.1007/s11051-014-2851-y, hereafter Hong).
As outlined above Kolbe as evidenced by Hong teaches a topical composition comprising a microfine zinc oxide with a particle size of less than 300 nm, specifically and preferably an average of 130nm, and with a surface coating (such as dimethicone), bis-ethylhexyloxyphenol methoxyphenyl triazine, 2-phenylbenzimidazole-5-sulfonic acid, and diethylhexyl butamido traizone. Kolbe further teaches the advantageous addition of ceteareth-13 through ceteareth-20 as a fatty alcohol ethoxylate in the composition, however Kolbe fails to teach the addition of ceteareth-6 and ceteareth-25. Lange remedies this deficiency.
Lange teaches a isoalkane mixture used in composition for the care and protection of the skin (claim 32). Lange teaches the composition comprise suitable photofilter active ingredients such as zinc oxide (column 18, lines 63-67). Lange provides emulsion examples that comprise zinc oxide, diethylhexylbutamidotriazone, phenylbenzimidazolesulfonic acid, and 2.4-bis(4-(2-ethylhexyloxy)-2-hydroxyl)phenyl)-6-(4- methoxyphenyl)(1,3,5)-triazine (columns 52-53, application examples 28-32 table, example 31). Lange provides a list of non-ionic emulsifiers to include ceteareths, specifically ceteareth-25 (column 29, lines 53-55). Lastly, Lange provides multiple examples of moisturizing formations, skin creams, and make-up that use both ceteareth-6 and ceteareth-25 (column 47, example 1; column 48, example 4; column 114, example 741; column 115, example 747; column 117, example 756; column 120, example 774; column 123, example 786).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a topical composition comprising a microfine zinc oxide from 30-22 nm with a surface coating (such as dimethicone), bis-ethylhexyloxyphenol methoxyphenyl triazine, 2-phenylbenzimidazole-5-sulfonic acid, diethylhexyl butamido traizone, and a ceteareth such as ceteareth-20 as outlined by Kolbe with the simple substitution of ceteareth-6 and ceteareth-25 as outlined by Lange. Simple substitution of one ceteareth emulsifier for another is within the purview of the skilled artisan and would yield predictable results.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6, and 8-13 of copending Application No. 17774000 (reference application) in view of Kolbe et al. (US20050276764A1, published 12/15/2005, found in the IDS filed 09/03/2024, hereafter Kolbe). Although the claims at issue are not identical, they are not patentably distinct from each other.
17774000 claims a topical composition, wherein composition comprise a UV filter combination of: (a) a microfine zinc oxide, wherein the microfine zinc oxide has a mean particle size Dn50 as determined by Laser diffraction of 30-200 nm and a surface coating consisting of triethoxycaprylylsilane; (b) 2,4-bis{{4-(2-ethylhexyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)- 1,3,5-triazine (INCI: Bis-Ethylhexyloxyphenol methoxyphenyl Triazine); (c) 2-phenylbenzimidazole-5-sulfonic acid and/or one or more salts thereof; (d) 2,4,6-tris[anilino(p-carbo-2'-ethyl-1'-hexyloxy)]-1,3,5-triazine (INCI:Ethylhexyl Triazone) (claim 1; according to the claim limitations of instant claims 1 and 3). Claim 1 of 17774000 further claims the composition contains no 3 (4 methylbenzylidene)camphor, 2-hydroxy-4- methoxybenzophenone (INCI: Oxybenzone), and ethylhexyl 2-cyano-3,3-diphenylacrylate (INCI: Octocrylene) (according to the claim limitations of the instant claim 5). 17774000 further claims the microfine zinc oxide has a mean particle size of 50-200nm (claim 2; according to the claim limitations of the instant claim 2). Claim 4 of 17774000 claims the amount of microfine zinc oxide is 0.1-20 wt% based on the total weight of the composition (according to the claim limitations of the instant claim 4). Claim 6 of 17774000 claims the composition is an O/W emulsion (according to the claim limitations of the instant claim 6). Claim 8 of 17774000 claims the composition comprises at least one emulsifier selected from the group consisting of Ceteareth-6 and Certeareth-25 (according to the claim limitations of the instant claim 7). Claim 9 of 17774000 claims the composition comprises at least one emollient selected from the group consisting of dibutyl adipate, dicaprylyl carbonate and C12-C15 alkylbenzoate (according to the claim limitations of the instant claim 8). Claim 10 of 17774000 claims the composition comprises at least one preservative selected from the group consisting of ethanol, p-hydroxyacetophenone, phenoxyethanol and ethylhexylglycerin (according to the claim limitations of the instant claim 9). Claim 11 of 17774000 claims the composition comprises at least one thickener selected from the group consisting of xanthan gum, crosslinked acrylate/C10-C30 alkyl acrylate polymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, and vinylpyrrolidone/hexadecene copolymer (according to the claim limitations of the instant claim 10). Claim 12 of 17774000 claims the composition further comprises a co-surfactant selected from the group consisting of cetyl alcohol , cetearyl alcohol, stearyl alcohol, and glyceryl stearate (according to the claim limitations of the instant claim 11). Claim 13 of 17774000 claims the composition has a sun protection factor (SPF) of at least 20 (according to the claim limitations of the instant claim 12).
17774000 claims the addition of 2,4,6-tris[anilino(p-carbo-2’-ethyl-1’-hexyloxy)]-1,3,5-triazine (Ethylhexyl trazone) fails to claim the addition of diethylhexyl butamido triazone as in the instant claim 1.
As outlined above Kolbe teaches a topical composition comprising a microfine zinc oxide with a particle size of less than 300 nm and with a surface coating (such as dimethicone), bis-ethylhexyloxyphenol methoxyphenyl triazine, 2-phenylbenzimidazole-5-sulfonic acid, and diethylhexyl butamido traizone.
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a topical composition comprising a microfine zinc oxide with a particle size of less than 300 nm and with a surface coating of triethoxycaprylylsilane , bis-ethylhexyloxyphenol methoxyphenyl triazine, and 2-phenylbenzimidazole-5-sulfonic acid as outlined by 17774000 with the ready for improvement with the known technique of adding diethylhexylbutamidotriazone as outlined by Kolbe. Adding the forementioned component to a topical composition comprising a microfine zinc oxide with a particle size of less than 300 nm and with a surface coating of triethoxycaprylylsilane, bis-ethylhexyloxyphenol methoxyphenyl triazine, and 2-phenylbenzimidazole-5-sulfonic acid as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 6, and 8-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-13 of copending Application No. 18263641 (reference application) in view of Kolbe et al. (US20050276764A1, published 12/15/2005, found in the IDS filed 09/03/2024, hereafter Kolbe). Although the claims at issue are not identical, they are not patentably distinct from each other.
18263641 claims a sunscreen composition containing UV-filters comprising bis ethylhexyloxyphenol methoxyphenyl triazine (claim 1; according to the claim limitations of the instant claim 1). Claim 4 of 18263641 claims one of the UV filters to be zinc oxide (according to the claim limitations of the instant claim 1). Claim 5 claims that at least one of the UV filters is to be micronized (according to the claim limitations of the instant claim 1). Claim 6 of 18263641 claims the UV-filters are coated and claim 7 of 18263641 claims zinc oxide coated with triethoxycaprylylsilane (according to the claim limitations of the instant claims 1 and 3). Claim 8 of 18263641 claims the composition to be an O/W emulsion (according to the claim limitations of the instant claim 6). Claim 9 of 18263641 claims the composition further comprises one or more of butylene glycol, dicaprylate/dicaprate, phenethyl benzoate, C12-C15 alkyl benzoate, dibutyl adipate, diisopropyl sebacates, dicaprylyl carbonate, di-C12-13 alkyl tartrates, hydrogenated castor oil dimerates, triheptanoin, C12-13 alkyl lactates, C16-17 alkyl benzoates, propylheptyl caprylates, caprylic/capric triglycerides, diethylhexyl 2,6-naphthalate, octyldodecanol, ethylhexyl cocoatesdibutyl adipate, preferably of butylene glycol, dicaprylyl carbonate, phenethyl benzoate, C12-C15 alkylbenzoate, caprylyl carbonate, capric/caprylic triglyceride, most preferably of butylene glycol, phenethyl benzoate and C12-C15 alkylbenzoate (according to the claim limitations of the instant claim 8). Claim 10 of 18263641 claims the composition further comprises one or more of ethanol, phenoxyethanol and ethylhexylglycerin, preferably of phenoxyethanol and ethylhexylglycerin (according to the claim limitations of the instant claim 9). Claim 11 of 18263641 claims the composition further comprises one or more of xanthan gum, crosslinked acrylate/Cio-C3o alkyl acrylate polymer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, preferably xanthan gum (according to the claim limitations of the instant claim 10). Claims 12 of 18263641 claims the composition further comprises one or more of behenyl alcohol, cetyl alcohol, cetearyl alcohol, stearyl alcohol and glyceryl stearate, preferably of behenyl alcohol, stearyl alcohol and cetearyl alcohol (according to the claim limitations of the instant claim 11). Lastly, claim 13 of 18263641 claims the composition has a SPF of at least 20 (according to the claim limitations of the instant claim 12).
18263641 fails to claim the zinc particle size as in instant claims claim 1 and 2. Furthermore, 18263641 fails to claim the addition of 2-phenylbenzimidazole-5-sulfonic acid and diethylhexylbutamido triazone as in instant claim 1. Kolbe remedies this deficiency.
As outlined above Kolbe teaches a topical composition comprising a microfine zinc oxide with a particle size of less than 300 nm and with a surface coating (such as dimethicone), bis-ethylhexyloxyphenol methoxyphenyl triazine, 2-phenylbenzimidazole-5-sulfonic acid, and diethylhexyl butamido traizone.
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a sunscreen composition containing UV-filters comprising bis ethylhexyloxyphenol methoxyphenyl triazine and zinc oxide coated in triethoxycaprylylsilane as outlined by 18263641 with the ready for improvement with the known technique of adjusting the particle size of the zinc oxide and adding 2-phenylbenzimidazole-5-sulfonic acid and diethylhexylbutamido triazone as outlined by Kolbe. Adjusting and adding the forementioned components to a sunscreen composition containing UV-filters comprising bis ethylhexyloxyphenol methoxyphenyl triazine and zinc oxide coated in triethoxycaprylylsilane as claimed by instant claims 1-2 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, and 8-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-11, and 13 of copending Application No. 18254537 (reference application) in view of Kolbe et al. (US20050276764A1, published 12/15/2005, found in the IDS filed 09/03/2024, hereafter Kolbe). Although the claims at issue are not identical, they are not patentably distinct from each other.
18254537 claims a topical composition comprising bis-ethylhexyloxyphenol methoxyphenyl triazine and an inorganic UV filter to be zinc oxide (claim 1; according to the claim limitations of the instant claim 1). Claim 4 of 18254537 claims the concentration of the inorganic UV filter to be in an amount selected in the range of 1 to 20 wt.-% based on the total weight of the composition (according to the claim limitations of the instant claim 4). Claim 5 of 18254537 claims the UV-filters are coated and claim 6 of 18254537 claims zinc oxide coated with triethoxycaprylylsilane (according to the claim limitations of the instant claims 1 and 3). Claim 7 of 18254537 claims the composition to be an oil-in-water (O/W) emulsion (according to the claim limitations of the instant claim 6). Claim 8 of 18254537 claims the composition further comprises one or more of butylene glycol, dicaprylate/dicaprate, phenethyl benzoate, C12-C15 alkyl benzoate, dibutyl adipate, diisopropyl sebacates, dicaprylyl carbonate, di-C12-13 alkyl tartrates, diethylhexyl syringylidene malonates, hydrogenated castor oil dimerates, triheptanoin, C12-13 alkyl lactates, C 16-17 alkyl benzoates, propylheptyl caprylates, caprylic/capric triglycerides, diethylhexyl 2,6-naphthalates, octyldodecanol, ethylhexyl cocoates and dibutyl adipate (according to the claim limitations of the instant claim 8). Claim 9 of 18254537 claims the composition further comprises one or more of ethanol, p-hydroxyacetophenone, phenoxyethanol and ethylhexylglycerin (according to the claim limitations of the instant claim 9). Claim 10 of 18254537 claims the composition further comprises one or more of xanthan gum, crosslinked acrylate/C10- C30 alkyl acrylate polymer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (according to the claim limitations of the instant claim 10). Claim 11 of 18254537 claims the composition further comprises one or more of cetyl alcohol, cetearyl alcohol, stearyl alcohol and glyceryl stearate (according to the claim limitations of the instant claim 11). Lastly, claim 13 of 18254537 claims the composition has a SPF of at least 20 (according to the claim limitations of the instant claim 12).
18254537 fails to claim the zinc particle size as in instant claims claim 1 and 2. Furthermore, 18254537 fails to claim the addition of 2-phenylbenzimidazole-5-sulfonic acid and diethylhexylbutamido triazone as in instant claim 1. Kolbe remedies this deficiency.
As outlined above Kolbe teaches a topical composition comprising a microfine zinc oxide with a particle size of less than 300 nm and with a surface coating (such as dimethicone), bis-ethylhexyloxyphenol methoxyphenyl triazine, 2-phenylbenzimidazole-5-sulfonic acid, and diethylhexyl butamido traizone.
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a topical composition containing UV-filters comprising bis ethylhexyloxyphenol methoxyphenyl triazine and zinc oxide coated in triethoxycaprylylsilane as outlined by 18254537 with the ready for improvement with the known technique of adjusting the particle size of the zinc oxide and adding 2-phenylbenzimidazole-5-sulfonic acid and diethylhexylbutamido triazone as outlined by Kolbe. Adjusting and adding the forementioned components to a topical composition containing UV-filters comprising bis ethylhexyloxyphenol methoxyphenyl triazine and zinc oxide coated in triethoxycaprylylsilane as claimed by instant claims 1-2 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant’s arguments filed on 12/01/2025 have been considered by the examiner.
In regards to the previous 35 USC § 112 rejections of record, Applicant’s amendments overcome the previous rejections of record, therefore, the previous rejections have been withdrawn.
In regards to the 35 USC § 103 rejections, Applicant argues that the instant invention is directed towards a sunscreen composition that exhibits less stickiness and shows improvements in sand repellency cited Table 2 from the instant specification as evidence. Applicant further outlines that when compared to water, specifically when the water is replaced with coated ZnO composition coatings, that the sand stickiness is reduced. Further, Applicant states the synergistic effect that is observed with coated ZnO is not plausible with non-coated ZnO. Applicant claims that none of the applied prior art references suggest that adding a microfine zinc oxide has a mean particle size Dn50 as determined by laser diffraction of 30 to 200nm and a surface coating selected from the group consisting of aluminum stearate, stearic acid, methicone, simethicone, triethoxycarpylylsilane and octyltrimethoxysilane can lead to a composition exhibiting increased sand repellency. Applicant then argues that Kolbe teaches that zinc oxide may be present in the finished preparation, but Kolbe does no disclose the specific coated microfine zinc oxide as claimed. Lastly, Applicant argues Kolbe nor any of the remaining applied secondary references disclose or suggest that any synergistic effects in terms of improved sand repellency by incorporating the specific coated microfine oxide with components (b), (c), and (d) of the Applicant’s pending claim 1 could be achieved.
It is first noted the Table 2 compositions (page 21 of instant specification) have multiple additional ingredients that are not recited in instant claim 1, thus rendering the data not commensurate with the claims. Additionally, it is noted that the data only makes reference to zinc oxide (ZnO) coated in dimethicone or triethoxycaprylysilane and fails to mention aluminum stearate, stearic acid, methicone, or octyltrimethoxysilane. Therefore, the data further fails to commensurate with instant claim 1 in regards to the ZnO coating as multiple of the optional coatings are not reflected in the data. Lastly, Table 2 (page 21 of the instant specification) concentration amounts are not commensurate with the instant claim 1 which encompasses any amount of each component while the Table 2 compositions are directed towards specific amounts of each component.
In regards to Applicant’s argument that compared to water the instantly claimed coated ZnO reduces stickiness more efficiently and in regards to Applicant’s argument that the synergistic effect their ZnO coated composition is not plausible to non-coated ZnO: It is noted that the prior art of record, Kolbe, teaches a sun cosmetic composition comprising zinc oxide as inorganic pigment metal oxide and teaches metal oxide to have various coatings to include stearic acid, octyltrimethylsilane, dimethicones ([0062] and [0065]). Therefore, Applicant’s argument that water or uncoated ZnO is not as efficient is rendered moot as the art of record teaches the coated ZnO of the instant claims.
Further, Applicant is reminded this is a composition claim and the prior art, Kolbe, teaches a sun cosmetic composition comprising zinc oxide coated in stearic acid, octyltrimethylsilane, or dimethicones ([0062] and [0065]; 2,4-bis-(4-(2-ethylhexyloxy-)2-hydroxyl)-phenyl)-6-(4-methoxyphenyl)-(1,3,5)-triazine at 2.5 parts, diethylhexylbutamidotriazone at 1.0 parts (example 2, [0227]); and 2-phenylbenzimidazole-5-sulfronic acid as a UV-B and broadband filter ([0224], [0227], [0229], and [0117]), thereby since a product is not separable from its physical properties then it necessarily teaches the limitations of the instant claim 1. Further, the prior art teaches a composition described by applicants instant application, but applicants observation that it also has ‘reduced sand stickiness’ does not give it patentable weight, since it is the same composition, as adding a characterization to a prior art patented invention is not patentable. Further, Applicant is reminded that the MPEP 2111.03(III) states “applicant has the burden of showing that the introduction of additional steps or specific components which would materially change the characteristics of the claimed invention.” Applicant has failed to properly demonstrate how and which additional components materially affect the basic and novel characteristics of the claimed composition.
Finally, in regards to the 35 USC § 103 rejections over Kolbe in view of Tanaka as evidenced by Hong, Kolbe in view of Schade as evidenced by Hong, and Kolbe in view of Lange as evidenced by Hong, Applicant had provided no reasoning as to why the combination of references should be withdrawn. Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In summary, the examiner is not persuaded by Applicant’s arguments. The rejections are maintained as the claim amendments did not necessitate new rejections.
In regards to the Double Patenting rejections, Applicant’s request the double patenting rejections be held in abeyance until otherwise allowable subject matter is agreed upon. A request to hold abeyance is an improper response to a double patenting rejection. Since Applicants fail to properly respond to the rejections of record, the double patenting rejections over copending applications 17774000 and 18263641 are maintained and the double patenting rejection over 18254537 is updated to account for the copending application amendments.
Conclusion
No claims are 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.N.I./Examiner, Art Unit 1611