DETAILED ACTION
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 .
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in [0042] and [0039] of the originally filed disclosure. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Applicant is advised that should claim 14 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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 paragraph:
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.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites “essentially contains” this renders the metes and bounds of the claim indefinite, as its unclear if “essentially contains” is meant to convey. Does the materially actually have to be a UV-attentuating material ir just something close to that material, or was applicant trying to say something along the lines of “consisting essentially of”? For purposes of examination, the Examiner will examine the claim as reciting “consisting essentially of” in place of “essentially contains”.
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 paragraphs 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.
Claim(s) 1, 4-5, 9, 11-12 and 14-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mintel (Vegan Facial Sunscreen, 2022). Mintel is cited on the 7/31/2025 IDS.
In view of the 112b above, Claim ---11 is interpreted as reciting “consisting essentially of”. However, absent a clear disclosure in the specification regarding what would materially change the composition, "essentially contains" is interpreted to be "comprising" language.
MPEP 2111.03: For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant’s invention.
Mintel teaches a sunscreen formulation comprising:
Zinc oxide – reading on instant claims 1a, 11-12 and 14-16;
Polysorbate 60 – reading on surfactant of instant claims 1b;
Ammonium polyacryloyldimethyl taurate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate and xanthan gum (i.e. anionic polysaccharide) – reading on thickening system of instant claims 1c and 4-5.
Regarding claim 9: Mintel teaches the sunscreen to give highly transparent UV protection, reading on non-whitening upon application to keratinous material.
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.
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.
Claim(s) 1-12 and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singleton (US 2019/0290560), Cohen (US 5,876,736) and Candau (US 2008/0019930).
In view of the 112b above, Claim ---11 is interpreted as reciting “consisting essentially of”. However, absent a clear disclosure in the specification regarding what would materially change the composition, "essentially contains" is interpreted to be "comprising" language.
MPEP 2111.03: For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant’s invention.
Regarding claim 1a: Singleton discloses a broad spectrum emulsion sunscreen having an SPF value of at least 30 and which does not contain an organic sunscreen active and only contains the physical sunscreen active, zinc oxide. The zinc oxide is visible transparent when the sunscreen is applied to the skin (Abs).
Regarding claim 1b: Singleton teaches the composition to be a W/O emulsion comprising Polyglycerol-3 sorbityl Linseedate (i.e. surfactant) [0042-0043].
Regarding claims 2 and 6: Singleton teaches the zinc oxide to be used in amounts ranging from 20-25%, which overlaps with the claimed ranges and overlapping ranges are prima facie obvious absent evidence showing the claimed range to be critical.
Regarding claim 7: Singleton teaches the sunscreen to not contain (i.e. are free) organic sunscreen active agents (Abs and [0014]).
Regarding claim 8: Singleton teaches broad spectrum sunscreens and teaches that the FDA defines broad spectrum as sunscreens having a critical wavelength of at least 370nm [0018], as such the sunscreen of Singleton would necessarily need to have a critical wavelength of 370nm or higher to be labeled as a broad spectrum sunscreen.
Regarding claim 9: Singleton teaches that the zinc oxide is visibly transparent when the sunscreen is applied to the skin, reading on non-whitening upon application to keratinous material.
Regarding claim 10: Singleton teaches the composition to be a W/O emulsion [0042].
Regarding claims 11-12 and 14-16: Single teaches the use of zinc oxide (Abs).
Regarding claim 17: Singleton teaches the zinc oxide to have an average particle size of greater than 0.1 microns (i.e. 100nm), which overlaps with the claimed 1-500nm. While Singleton does not teaches the mean primary particle size, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
However, Singleton does not teach the claimed thickening surfactant system.
Cohen teaches cosmetic compositions comprising sunscreen agents (Abs) and teaches that sufficient amounts of thickening agents can be added to the composition such that the composition does not run off the face and other skin areas when applied. The thickeners complement the function of emulsifiers in holding together the water and oil phases of the composition. A preferred thickener of the present cosmetic makeup composition includes xanthan gum. Other thickeners which may be used in place of or together with xanthan gum include, for example, sodium polyacrylate, starch and the like. The thickener generally comprises from about 0.01 to about 3 wt. % of the composition, preferably about 0.5 to about 1.2 wt. % of the composition (col. 8, lines 15-26).
Candau teaches sunscreen compositions (Abs) in the form of W/O or O/W emulsions [0182]. These sunscreens comprise hydrophilic thickening agents including Hostacerin AMPS (i.e. ammonium polyacryloyldimethyl taurate), xanthan gum (i.e. anionic polysaccharide) and copolymers of 2-acrylamido-2-methylpropanesulfonic acid and of hydroxyethyl acrylate, such as Sepinov EMT 10 (i.e. hydroxyethyl acrylate/sodium acryloyldimethyl taurate) [0155].
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 modify the teachings of Singleton with those of Cohen and Candau. One of skill in the art would have been motivated to add 0.5-1.2% of a mixture of thickening agent as taught by Cohen as these agents help the composition to remain on the skin and not run off after application. One of skill in the art would have also been motivated to use a combination of thickening agents taught to be suitable for use in sunscreen composition such as Hostacerin AMPS, xanthan gum and Sepinov EMT 10, as its prima facie obvious to select known materials for incorporation into a composition based on their recognized suitability and mixtures of these agents are taught. One of skill in the art would have a reasonable expectation of success as Singleton, Cohen and Candau teaches cosmetic compositions comprising sunscreen agents and its well-known in the art to include thickening agents into these types of compositions.
Regarding claim 3: The above references make obvious the inclusion of 0.5-1.2% of the thickening agents, which overlaps with the claimed ranges and overlapping ranges are prima facie obvious absent evidence showing the claimed range to be critical.
Regarding claim 4: The above references make obvious the inclusion of Hostacerin AMPS (i.e. ammonium polyacryloyldimethyl taurate).
Regarding claim 5: The above references make obvious the inclusion of Sepinov EMT 10 (i.e. hydroxyethyl acrylate/sodium acryloyldimethyl taurate).
Claim(s) 1-7 and 9-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah (US2020/0101002), Cohen (US 5,876,736) and Candau (US2008/0019930). Shah is cited on the 7/31/2025 IDS.
In view of the 112b above, Claim ---11 is interpreted as reciting “consisting essentially of”. However, absent a clear disclosure in the specification regarding what would materially change the composition, "essentially contains" is interpreted to be "comprising" language.
MPEP 2111.03: For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant’s invention.
Shah teaches mineral sunscreen compositions comprising (a) one or more mineral UV filtering agents; (b) one or more stilbenoids; (c) ethylhexylmethoxycrylene. (d) diethylhexyl syringylidenemalonate; and (e) a cosmetically acceptable carrier (abs).
Regarding claims 1a, 2, 6 and 11-18: Shah teaches preferred mineral UV filtering agents to include titanium dioxide and/or zinc oxide [0058], thus the selection of either is prima facie obvious. Shah teaches that these filters can be surface treated with compounds such as amino acids, reading on surface treatment agent[0060], be used in amounts ranging from 5-10% [0089] and have a mean particle size ranging from 5nm to 100nm, which overlaps with the claimed 1-500nm. While Shah does not teaches the mean primary particle size, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Regarding claim 1b and 10: Shah teaches the sunscreen can comprise an emulsifier (i.e. a surfactant) and these can be chosen according to the emulsion to be obtained (W/O or O/W) [0117], thus it would be obvious to formulate sunscreen as a W/O or O/W emulsion.
Regarding claim 7: Shah teaches that organic UV filtering agents can be excluded [0052].
Regarding claim 9: The instant specification defines non-whitening to be compositions having minimal or no visually white appearance. Shah teaches that the compositions are less opaque and less white than traditional mineral sunscreens (abs) and teaches that the inclusion of stilbenoids, ethylhexylmethoxycrylene and diethylhexyl syringylidenemalonate allow for the use of reduced amounts of UV mineral filtering agents and reducing these amounts reduced the whitening of the composition, as such it would have been prima facie obvious to optimize the amounts of UV mineral filtering agents used in order to obtain ideal SPF protection while at the same time controlling the whiteness of the composition to achieve minimal whiteness.
However, Shah does not teach the claimed thickening surfactant system.
Cohen teaches cosmetic compositions comprising sunscreen agents (Abs) and teaches that sufficient amounts of thickening agents can be added to the composition such that the composition does not run off the face and other skin areas when applied. The thickeners complement the function of emulsifiers in holding together the water and oil phases of the composition. A preferred thickener of the present cosmetic makeup composition includes xanthan gum. Other thickeners which may be used in place of or together with xanthan gum include, for example, sodium polyacrylate, starch and the like. The thickener generally comprises from about 0.01 to about 3 wt. % of the composition, preferably about 0.5 to about 1.2 wt. % of the composition (col. 8, lines 15-26).
Candau teaches sunscreen compositions (Abs) in the form of W/O or O/W emulsions [0182]. These sunscreens comprise hydrophilic thickening agents including Hostacerin AMPS (i.e. ammonium polyacryloyldimethyl taurate), xanthan gum (i.e. anionic polysaccharide) and copolymers of 2-acrylamido-2-methylpropanesulfonic acid and of hydroxyethyl acrylate, such as Sepinov EMT 10 (i.e. hydroxyethyl acrylate/sodium acryloyldimethyl taurate) [0155].
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 modify the teachings of Shah with those of Cohen and Candau. One of skill in the art would have been motivated to add 0.5-1.2% of a thickening agent as taught by Cohen as these agents help the composition to remain on the skin and not run off after application. One of skill in the art would have also been motivated to use a combination of thickening agents taught to be suitable for use in sunscreen composition such as Hostacerin AMPS, xanthan gum and Sepinov EMT 10, as its prima facie obvious to select known materials for incorporation into a composition based on their recognized suitability and mixtures of these agents are taught. One of skill in the art would have a reasonable expectation of success as Shah, Cohen and Candau teaches cosmetic compositions comprising sunscreen agents and its well-known in the art to include thickening agents into these types of compositions and Shah teaches that structuring agent can be used [0177].
Regarding claim 3: The above references make obvious the inclusion of 0.5-1.2% of the thickening agents, which overlaps with the claimed ranges and overlapping ranges are prima facie obvious absent evidence showing the claimed range to be critical.
Regarding claim 4: The above references make obvious the inclusion of Hostacerin AMPS (i.e. ammonium polyacryloyldimethyl taurate).
Regarding claim 5: The above references make obvious the inclusion of Sepinov EMT 10 (i.e. hydroxyethyl acrylate/sodium acryloyldimethyl taurate).
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 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 of copending Application No. 18/906505 in view of Cohen (US 5,876,736) and Candau (US2008/0019930).
US’505 teaches an O/W or W/O emulsion (instant claim 10) comprising 5-40% zinc oxide which could be surface treated and has a primary particle size ranging from 10-40nm (instant claims 1a, 2, 11-18), a surfactant (instant claim 1b), a thickening system having an anionic polysaccharide and an amphiphilic thickening agent), wherein the composition is devoid of organic UV filters (instant claim 7), is non-whitening (instant claim 9) and has a critical wavelength of 370nm or higher (instant claim 8).
However, US’505 does not teach the thickening system as claimed comprising all three claimed components.
The teachings of Cohen and Candau are discussed above and incorporated into this rejection. The claims are obvious over these reference for the same reasons discussed above and there is a reasonable expectation of success as US’505 teaches including anionic polysaccharide and an amphiphilic thickening agent
This is a provisional nonstatutory double patenting rejection.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-18 of copending Application No. 18/906466 in view of Cohen (US 5,876,736) and Candau (US2008/0019930).
US’466 teaches an O/W or W/O emulsion (instant claim 10) comprising 5-40% zinc oxide which could be surface treated and has a primary particle size ranging from 10-40nm (instant claims 1a, 2, 11-18), a surfactant (instant claim 1b), a thickening system having an anionic polysaccharide, wherein the composition is devoid of organic UV filters (instant claim 7) and is non-whitening (instant claim 9).
However, US’466 does not teach the thickening system as claimed comprising all three claimed components.
The teachings of Cohen and Candau are discussed above and incorporated into this rejection. The claims are obvious over these reference for the same reasons discussed above and there is a reasonable expectation of success as US’466 teaches including anionic polysaccharides.
Regarding claims 8-9: The composition made obvious above contains the claimed structural and the claimed UV agent in the claimed amounts, as such it’s expected to have a critical wavelength of 370nm of higher as claimed and be non-greasy or non-whitening.
This is a provisional nonstatutory double patenting rejection.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-17 of copending Application No. 18/906303 in view of Cohen (US 5,876,736) and Candau (US2008/0019930).
US’303 teaches an O/W or W/O emulsion (instant claim 10) comprising 5-40% zinc oxide which could be surface treated and has a primary particle size ranging from 10-40nm (instant claims 1a, 2, 11-18), a surfactant (instant claim 1b), a thickening system having an anionic polysaccharide, wherein the composition is devoid of organic UV filters (instant claim 7) and is non-whitening (instant claim 9).
However, US’303 does not teach the thickening system as claimed comprising all three claimed components.
The teachings of Cohen and Candau are discussed above and incorporated into this rejection. The claims are obvious over these reference for the same reasons discussed above and there is a reasonable expectation of success as US’303 teaches including anionic polysaccharides.
US’303 does not teach inclusion of a surfactant. Candau further teaches that emulsions generally comprise at least one emulsifier (i.e. surfactant) and these are selected according to the emulsion to be obtained [0182], as such it would have been prima facie obvious to add an emulsifier to the composition of US’303 as it teaches formulating emulsions.
Regarding claims 8-9: The composition made obvious above contains the claimed structural and the claimed UV agent in the claimed amounts, as such it’s expected to have a critical wavelength of 370nm of higher as claimed and be non-greasy or non-whitening.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
Prosecution Insights