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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/03/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Claim Status
Claims 1-20 are pending and under current examination.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (pg. 4, first paragraph). 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.
The disclosure is objected to because of the following informalities: It is believed that in the discussion of Figure 6A on page 25 in lines 1-2, the phrase “agglomerates and forms larger zones of discrete agglomerates” should be edited or omitted.
Appropriate correction is required.
Claim Objections
Claims 8 and 9 are objected to because of the following informalities: After “from 0.15%,” the phrase “to about” is written twice.
Claim 10 is objected to because of the following informalities: It is suggested that the period immediately after item (c), “a dermatologically acceptable carrier,” be replaced by a comma.
Appropriate correction is required.
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.
Claim 11 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 11 recites “the composition comprises a uniform film, according to the Drawdown Method”, whereas the formulation of Claim 10 from which it depends requires that the composition be an “emulsion,” which is well understood to be an oil/water (O/W) or water/oil (W/O), etc., i.e. a liquid composition. It is unclear how a composition can be both a “film” and a liquid. For purposes of examination and applying prior art, the examiner interprets that the description of comprising a uniform film as future intended use in applying the claimed composition and does not further limit its formulation of claim 10.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as
the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 6, 7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meyer et. al (US 20220362119 A1, published 11/17/2022; included on IDS submitted 11/03/2025), hereafter referred to as “Meyer,” as evidenced by Vaigon (Safety Data Sheet, printed 04/02/2018, “507972 SYMOCIDE PH), hereafter referred to as “Vaigon.”
Meyer discloses a water-in-oil (W/O) emulsion composition comprising 5%-wt. zinc oxide with a broad spectrum SPF of 40, a dermatologically acceptable carrier (water), and a preservative system comprising 1%-wt. of the composition of 1,2-octanediol and phenoxyethanol (pg. 44, Table 43). Meyer further discloses in the composition the inclusion of glycerol and polyglyceryl-2 dipolyhydroxystearate (Dehymuls® PGPH), which are known emulsifiers (see Meyer’s explanation pg. 12, par. [0062] and [0079]). It is well-understood in the art that emulsifiers function to stabilize emulsion compositions and prevent phase separation, therefore the inclusion of an emulsifier in Meyer’s composition is interpreted as meeting the limitations of being “physically stable” as recited in Claim 2.
Vaigon discloses that a secondary name for 1,2-octanediol is caprylyl glycol (pg. 2, section 3 “Composition/Information on Ingredients”), which Meyer discloses in the “sun protection soft cream” formulation under the alternative name, caprylyl glycol, as a component of the SymOcide® PH
preservative system. Therefore, the composition of Meyer (pg. 44, Table 43) teaches all the components of the preservative system of the instant Claim 1.
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.
Claims 1, 3, 4, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Janssen et. al (US 20240009102 A1, published 01/11/2024; included on IDS submitted on 11/03/2025), herein referred to as “Janssen,” and Meyer (US 20220362119 A1, published 11/17/2022; included on IDS submitted 11/03/2025), in view of Spaulding et. al (US Patent 8834856 B2, published on 09/16/2014; included on IDS submitted on 11/03/2025), herein referred to as “Spaulding.”
Janssen teaches a topical composition with zinc oxide (pg. 2, par. [0030]) with a preservative composition selected from phenoxyethanol, 1,2-octanediol, and hydroxyacetophenone in amounts of 0.01 – 2 wt.-% of the composition (pg. 2, par. [0075], [0076], and [0077]), and a cosmetically acceptable carrier (pg. 3, par. [0039] and [0040]). Janssen additionally teaches a functional preparation of the composition as containing antimicrobial (antibacterial or antifungal) components (pg. 3, par. [0050]).
Meyer teaches a zinc oxide emulsion composition with a preservative system comprising 1,2-octanediol, phenoxyethanol, hydroxyacetophenone, and a dermatologically acceptable carrier (pg. 44, Table 43). Meyer additionally teaches inorganic light protection pigments including zinc oxide as being finely dispersed (pg. 19, par. [0191] and [0192].
However, Meyer and Janssen do not teach the antimicrobial effectiveness of the composition comprising a log reduction of ≥ 2 for yeast or mold according to Microbial Susceptibility Testing (as recited in Claims 3 and 10), and Janssen does not teach the dispersion of zinc oxide (as recited in Claims 4 and 10).
Spaulding teaches a log reduction ≥ 2 (pgs. 2-4, Figs. 1-3) for a synergistic preservative system with zinc oxide and phenoxyethanol that provides broad spectrum activity against yeast and molds.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tested the topical composition of Janssen and antimicrobial
mixture of Meyer by verifying their antimicrobial effectiveness with the Microbial Susceptibility Testing taught by Spaulding with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification for the benefit of quantitatively determining the topical composition’s resistance to the growth of yeast and mold. Doing so would increase the composition’s useability and marketability as a commercially viable personal care product that is applied to and used on the skin. There is a reasonable expectation of success as the combination of zinc oxide and phenoxyethanol are known to necessarily provide synergistic activity as preservatives. Additionally, as stated above, Meyer teaches the dispersion of zinc oxide with the topical composition, which one of ordinary skill in the art would be motivated to combine with the product of Janssen to optimize for ease of application to the skin and a more seamless blending experience.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Meyer (US 20220362119 A1, published 11/17/2022; included on IDS submitted 11/03/2025) in view of Janssen (US 20240009102 A1, published 01/11/2024; included on IDS submitted on 11/03/2025).
The teachings of Meyer are set forth above.
Meyer does not disclose the topical composition having a pH of at least 7 but does disclose that the pH of the composition can be adjusted using organic acids in the case of detergent or cleansing compositions (pg. 29, par. [0276]).
Janssen discloses the pH of a topical zinc oxide composition having a range of 3-10 (pg. 7, par. [0093]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the composition of Meyer (pg. 44, Table 43) with the specified pH range of Janssen in order to obtain a desired pH level of at least 7 for the skin care composition. There is a reasonable expectation of success given that Meyer discloses a motivation to adjust the pH of other forms of the composition that include the same antimicrobial mixture.
Claims 8 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer (US 20220362119 A1, published 11/17/2022; included on IDS submitted 11/03/2025), as evidenced by Vaigon (Safety Data Sheet, printed 04/02/2018, “507972 SYMOCIDE PH).
The “sun protection soft cream” formulation of Meyer (pg. 44, Table 43) teaches a zinc oxide composition with a preservative system comprising phenoxyethanol, hydroxyacetophenone, 1,2-octanediol (caprylyl glycol as taught by Vaigon), and water.
Meyer teaches additional forms of the antimicrobial mixture containing zinc oxide (pg. 19, par. [0191] and [0192]), comprised of antimicrobial mixtures of 4-hydroxyacetophenone in amounts ranging from 0.02 – 80 wt. % (pg. 4, par. [0051]). Meyer teaches the antimicrobial mixture comprising additional antimicrobial agents chosen from the list on pages 3 and 4, wherein phenoxyethanol and benzyl alcohol are listed, and the amount of the additional antimicrobial agents range from 0-99 wt. % of the composition (pg. 4, par. [0052]). Meyer teaches antimicrobial mixture combinations with 1,2-octanediol and an additional antimicrobial agent from the list (pg. 4 list and [0048]), which includes benzyl alcohol in weight percentage amounts of 0-99% (pg. 4, par. [0052]). Meyer additionally discloses benzyl alcohol as an effective antimicrobial agent and further states that benzyl alcohol is particularly preferred as the additional preservative element (pg. 4, par. [0048]).
Meyer does not teach a specific single example with zinc oxide composition with a preservative system of 1,2-octanediol and benzyl alcohol (as recited in Claim 8) or a specific preservative system of hydroxyacetophenone, phenoxyethanol, and/or benzyl alcohol (as recited in Claim 17) to anticipate but it is obvious.
Per MPEP 2123 [R-5], “When 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)). Although Meyer does not explicitly teach the claimed preservative combination with sufficient specificity to anticipate, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the preservative system components with benzyl alcohol. Benzyl alcohol is a known and widely used preservative in cosmetics, pharmaceuticals, and personal care products, and one of ordinary skill in the art would have been motivated to include benzyl alcohol to enhance the composition’s antimicrobial effectiveness in the claimed combination as disclosed by Meyer.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Janssen (US 20240009102 A1, published 01/11/2024; included on IDS submitted on 11/03/2025) in view of Cai et. al (CN 116850071 A, published 10/10/2023), hereafter referred to as Cai.
As best understood considering the rejection set above, Janssen discloses the analysis of an SPF emulsion on LENETA opacity charts, wherein the formulation is applied to a LENETA card, spread with a spreading device, and analyzed for homogenous film thickness [pg. 8, par. [0105] to [0110]).
Janssen does not teach an explicit application of the product called the “Drawdown Method.”
In interpreting the purpose of the Drawdown Method as an analysis for the uniform dispersion of zinc oxide (pg. 7, par. 5 of the application’s specification), Cai teaches a zinc oxide foam emulsion that is uniformly distributed and does not leave obvious white residue on the skin (abstract).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have swapped the use of the Drawdown Method with the known method of Janssen of spreading the composition on LENETA opacity charts to analyze uniformity. In combining the method of Janssen to analyze composition uniformity as Cai teaches, one of ordinary skill
in the art would employ the same testing methods and the results of the substitution of methods would have been predictable.
Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Janssen (US 20240009102 A1, published 01/11/2024; included on IDS submitted on 11/03/2025), in view of Cai (CN 116850071 A, published 10/10/2023), and White (Contact Dermatitis 4th Edition, 2006, Chapter 30: Cosmetics and Skin Care Products, https://link.springer.com/chapter/10.1007/3-540-31301-X_30#preview).
The teachings of the modified Janssen are set forth above.
Regarding Claims 15 and 16, Janssen explicitly discloses a topical composition formulated without DMDM hydantoin and iodopropinylbutyl carbamate (pg. 5, par. [0078]). Janssen also discloses that organic UV-filters are known to give an undesirable “tacky” sensation (pg. 1, par. [0003]).
Janssen does not teach a formulation without chemical sunscreen actives (Claim 12), benzoic acid (Claim 13), organic acids (Claim 14), the components of Claim 15 (imadazolidinyl urea, diazlidinyl
urea, sodium hydroxyl, and methyl glycinate), and the components of Claim 16 (phenylpropanol, ethyhexylglycerin, and methylheptylglycerin).
White discloses that formaldehyde, released by formaldehyde donors such as DMDM hydantoin, imidazolidinyl urea, and diazolidinyl urea, are known to be frequent sensitizers and ubiquitous allergens (ch. 30, pg. 497, par. 30.5.2.3). White further states that parabens have a reputation as sensitizers, and that the use of iodopropynyl butylcarbamate has been reported to cause topical allergic reactions and has seen a significant reduction in cosmetic use because of concerns about the bioavailability of iodine (ch. 30, pg. 499, par. 30.5.7.2). Additionally, White teaches that chemical sunscreen actives, such as PABA and its esters, can cause irritation in users (ch. 30, pg. 500, par. 30.5.11).
Cai discloses a zinc oxide emulsion comprised of hydroxyacetophenone and phenoxyethanol that is formulated without chemical sunscreen actives, benzoic acid, organic acids, imadazolidinyl urea, diazlidinyl urea, sodium hydroxyl, methyl glycinate, phenylpropanol, ethylhexylglycerin, and methylheptylglycerin (Example 1 and Claim 8).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the formulations of Janssen with the teachings of White and Cai and omit organic UV-filters/organic acids, parabens, formaldehyde donors, and additional parabens in the skin care composition’s formulation. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to avoid the undesirable “tacky” sensation when applying the topical skin care product, as well as reducing the risk of contact dermatitis, allergic reactions, and other forms of skin irritation in consumers from the additional parabens and formaldehydes. This modification would likely increase the composition’s commercial viability and attractiveness to consumers.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHOEBE H SHIN whose telephone number is (571)272-1298. The examiner can normally be reached 8:00am - 4:30pm EST (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P Barham can be reached at (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.S./Examiner, Art Unit 1611
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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