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
Claims 1-9 are pending.
Claims 1-9 have been examined.
Claims 1-9 are rejected.
Priority
PCT international application number 18/782894 filed on 07/24/2024.
The instant application is a continuation (CON) of Application 19/240,575 filed 06/17/2025.
Information Disclosure Statement
The information disclosure statements submitted on 10/24/2024, 08/11/2025, and 11/19/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The present application contains no drawings.
Specification Objections
[1] The disclosure is objected to because of the following informalities:
In paragraphs [0004] and [0071], the term Aveeno® is identified as a registered trademark. The registered trademark symbol (®) should appear adjacent to the mark, consistent with notations used in the images contained in the two NPL references submitted in the IDS filed on 10/24/2024.
Claim Rejections - 35 USC § 112(b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second para.:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
[2] Claims 3, 5 and 6, are rejected as being indefinite. The claims recite the term “about” with respect to claimed parameters, which is a relative term that lacks a clear, objective boundary. The term “about” is not defined by the claims, and the specification fails to provide an objective standard or guidance for determining the permissible degree of variation encompassed by the term. As a result, a person of ordinary skill in the art would not be reasonably apprised of the scope of the claimed invention. Because the inventive concept concerns sunscreen compositions intended to provide protection, and the effectiveness of such compositions depends upon the specific composition and concentration of the active ingredients, the claimed parameters must be stated with precision. In the absence of an objective standard for the term “about,” the claims fail to set forth clear metes and bounds, rendering it unclear which compositions fall within the scope of the claims and which do not.
Claim Rejections - 35 USC § 102
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 the appropriate paragraph 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.
[3] Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fares et al. (Patent WO2023009315A1, published 02/02/2023).
In regard to claims 1-6, the reference teaches a sunscreen composition comprising titanium dioxide and zinc oxide, wherein each may be present in amount ranging from about 0.01 wt.% to about 25 wt.% (see reference claims 2-4; paragraphs [0019] and [0057], inter alia), and because the reference explicitly permits each component to be present at amounts well below 25 wt.%, it necessarily discloses embodiments in which the total combined amount of titanium dioxide and zinc oxide is less than 25 wt.%, as required by instant claim 2. The reference further teaches film forming agents, tricontanyl polyvinylpyrrolidone (PVP) and VP/hexadecene copolymer, each of which may be present in amounts ranging from about 0.01 wt.% to about 2.50 wt.% or from about 2.50 wt.% to about 5 wt.% (reference claim 16, paragraph [0073]). Because the disclosed ranges for each polymer independently overlap and extend across identical concentration intervals, the reference contemplates compositions in which the relative amounts of tricontanyl PVP and VP/hexadecene copolymer may be selected anywhere within those ranges. Accordingly, the reference necessarily teaches embodiments in which the weight ratio of less than 1, less than 0.60, or about 0.50, as recited in instant claims 1, 4, and 5. Additionally, the reference teaches glycerin in amounts ranging from about 0.01 wt.% to about 5 wt.% or from about 5 wt.% to about 10 wt.% (reference claims 9-10; paragraphs [0064]-[0065]). The reference further teaches that the sunscreen composition may be formulated as an oil-in-water emulsion (reference claim 18; paragraph [0094]) and may have an SPF 30-100 (reference paragraph [0046]). Moreover, the reference teaches that the inclusion of organic photoactive agents is optional (reference claim 3, paragraph [0042]). Accordingly, the reference explicitly contemplates embodiments in which no organic photoactive agents are present. Such embodiments correspond to the claimed limitation of being substantially free of organic photoactive agents. Accordingly, claims 1-6 are anticipated.
Claim Rejections - 35 USC § 103
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.
[4] Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Fares et al. (Patent WO2023009315A1, published 02/02/2023).
In regard to claims 1-6, the reference teaches a sunscreen composition comprising titanium dioxide and zinc oxide, wherein each may be present in amount ranging from about 0.01 wt.% to about 25 wt.% (see reference claims 2-4; paragraphs [0019] and [0057], inter alia). Because the reference explicitly allows each component to be present at amounts well below 25 wt.%, the disclosure necessarily encompasses embodiments in which the combined amount of titanium dioxide and zinc oxide is less than 25 wt.%, as required by instant claim 2. The reference further teaches film forming agents including tricontanyl polyvinylpyrrolidone (PVP) and VP/hexadecene copolymer, each of which may be present in amounts ranging from about 0.01 wt.% to about 2.50 wt.% or from about 2.50 wt.% to about 5 wt.% (reference claim 16, paragraph [0073]). Because the disclosed concentration ranges for each polymer overlap and extend across the same intervals, the reference reasonably contemplates compositions in which the relative amounts of tricontanyl PVP and VP/hexadecene copolymer may be selected anywhere within those ranges. Thus, the reference encompasses embodiments in which the weight ratio of tricontanyl PVP and VP/hexadecene copolymer is less than 1, less than 0.60, or about 0.50, as recited in instant claims 1, 4, and 5. Additionally, the reference teaches glycerin in amounts ranging from about 0.01 wt.% to about 5 wt.% or from about 5 wt.% to about 10 wt.% (reference claims 9-10; paragraphs [0064]-[0065]). The reference also teaches that the sunscreen composition may be formulated as an oil-in-water emulsion (reference claim 18; paragraph [0094]) and may have an SPF 30-100 (reference paragraph [0046]). Moreover, the reference teaches that the inclusion of organic photoactive agents is optional (reference claim 3, paragraph [0042]). Accordingly, the reference explicitly contemplates embodiments in which no organic photoactive agents are present, corresponding to the claimed limitation of being substantially free of organic photoactive agents. Accordingly, it would have been obvious to one of ordinary skill in the art at the time of the invention to arrive at the sunscreen composition recited in claims 1-6 in view of the teachings of the reference.
[5] Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Fares et al. (Patent WO2023009315A1, published 02/02/2023) as applied to claim 1-6 above, and further in view of LaRosa et al. (Patent US20210093529A1, published 04/01/2021).
As discussed supra, Fares et al. teaches the sunscreen composition recited in claims 1-6.
Fares et al. further teaches certain limitations recited in instant claims 7 and 9, including steareth-21 and phenoxyethanol (reference claims 8 and 11 ),- but does not fully teach all of the additional components required by these claims.
LaRosa et al., however, teaches a comparable sunscreen composition and further discloses steareth-21 (paragraph [0059]), cetearyl olivate (paragraph [0059]), sorbitan olivate (paragraph [0591]), phenoxyethanol (paragraph [0080]), chlorphenesin (paragraph [0591]), ethylhexylglycerin (paragraph [0591]), and caprylyl glycol (paragraph [0591]).
In view of the substantial overlap between the sunscreen compositions disclosed by Fares et al. and LaRosa et al., and because LaRosa et al. explicitly teaches the additional emulsifiers and preservatives recited in claims 7 and 9 for use in similar oil-in-water sunscreen formulations containing titanium dioxide and zinc oxide, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Fares et al. to include the additional components taught by LaRosa et al. in order to achieve a formulation with suitable emulsification and preservative characteristics.
[6] Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Fares et al. (Patent WO2023009315A1, published 02/02/2023) as applied to claim 1-6 above, and further in view of Won-jin et al. (KR20180055501A, published 05/25/2018).
As discussed supra, Fares et al. teaches the sunscreen composition recited in claims 1-6.
Fraes et al. does not explicitly disclose a shear viscosity of less than 32 Pa·s at 1 s−1 at 25° C.
Won-jin et al., however, teach a low viscosity sunscreen composition comprising 5-25 wt.% of titanium dioxide and zinc oxide and additional ingredient such as emulsifiers, wherein the composition has a viscosity of 5,000 cPs or less (i.e., 5 Pa.s; 1 cPs = 0.001 Pa.s) (reference claims 2-3 and 5). Accordingly, Won-jin et al. teach a viscosity below the presently claimed limitation of less than 32 Pa.s. It would have been obvious to one of ordinary skill in the art to modify the composition of Fares et al. to achieve a low viscosity formulation as taught by Won-jin et al. , as viscosity is a result effective variable that may be adjusted through routine optimization of known formulation parameters. Therefore claim 8 is obvious over Fares et al. in view of Won-jin et al.
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.
[6] Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-13 of copending Application 19/240,575 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending application 19/240,575 teaches sunscreen composition comprising about 8 wt% TiO2 and about 15 wt% ZnO (corresponding to instant claims 1 and 3), wherein the total amount of titanium dioxide and zinc oxide is less than 25 wt% (i.e., 24 wt%) (corresponding to instant claim 2). The reference application further teaches about 1 wt% triacontanyl PVP and about 2 wt% VP/hexadecene copolymer (corresponding to instant claim 1), wherein the weight ratio of triacontanyl PVP to VP/hexadecene copolymer (i.e., 1/2) is less than 1, less than about 0.6, and less than about 0.5 (corresponding to instant claims 1, 2, 4, and 5), and about 5 wt% glycerin (corresponding to instant claim 6). The sunscreen composition is an oil-in-water emulsion substantially free of low molecular weight, organic UV absorbers (corresponding to instant claim 1). The composition further comprises steareth-21, cetearyl olivate, and sorbitan olivate (corresponding to instant claim 7), and further comprises phenoxyethanol, chlorphenesin, ethylhexylglycerin, and caprylyl glycol (correspond to instant claim 9). Additionally, the composition provides an in vitro SPF of at least 25 as measured by the In Vitro SPF Test Method and has a shear viscosity of less than 32 Pa·s at 1 s−1 at 25° C (corresponding to instant claims 1 and 8). Accordingly, claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting over claims 10-13 of Application No. 19/240,575.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALI M ALAOUIE whose telephone number is 571-272-0844. The examiner can normally be reached Flextime: (M-TH) 7:30 am 6:30 pm.
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/ALI M. ALAOUIE/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614