DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
Claims 1-7, as originally filed 21 November 2024, are pending.
Claim Objections
Claims 5-7 are objected to because of the following informalities:
Regarding claim 5, in the last line, the conjunction <and> and the plural form of the word <spray> are improper. The examiner recommends that Applicant amend the last line to read as follows: “butter, stick, or spray.”
Regarding claim 6, in the last line, the word <or> is missing between the last two species of emulsion. The examiner recommends that Applicant amend the end of claim 6 to read as follows: “silicone-in-oil, or an oil/silicone/oil emulsion.”
Appropriate corrections are required. In the interest of clarity, the examiner notes that claim 7 is objected to merely because it depends on claims 5-6.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claims 2-4 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventor regards as the invention.
Regarding claim 2, the following concentration range is unitless: “wherein the total concentration of one or more of avobenzone and octocrylene is about 0.001% to about 30%.” This renders the claim indefinite. As a courtesy, Applicant is referred to page 9, lines 4-7, of the specification, which provides support for “by weight of the composition.”
Regarding claim 3, when the claim is interpreted in the context of claim 1 and the specification, it is unclear whether or not it implicitly requires that octocrylene (claim 1) is selected as a constituent of the sunscreen composition. Reason being, Table 2A of the specification (page 6) shows that avobenzone alone cannot achieve an SPF within the claimed range. In contrast, Table 1A of the specification (page 5) shows that octocrylene alone can achieve an SPF within the claimed range. MPEP § 2173.05(g) (“when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”), citing Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008). The examiner recommends that Applicant clarify claim 3 by adding a limitation requiring octocrylene.
Regarding claim 4, when the claim is interpreted in the context of claim 1 and the specification, it is unclear whether or not it implicitly requires that avobenzone (claim 1) is selected as a constituent of the sunscreen composition. Reason being, Table 1A of the specification (page 5) shows that octocrylene alone cannot achieve a UVA-PF within the claimed range. In contrast, Table 2A of the specification (page 6) shows that avobenzone alone can achieve an UVA-PF within the claimed range. MPEP § 2173.05(g) (“when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”), citing Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008). The examiner recommends that Applicant clarify claim 4 by adding a limitation requiring avobenzone.
Claim Rejections - 35 U.S.C. 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Foley (US 2013/0118517 A1) alone or in view of Afonso (“Photodegradation of avobenzone: Stabilization effect of antioxidants.” J. of Photochemistry and Photobiology B: Biology 140 (2014): 36-40) and Sun (“Using nonaqueous emulsions to avoid discoloration reactions.” Cosmetics and toiletries 121.1 (2006): 61-66) and, optionally, Garrison (US 2005/0142079 A1).
Foley is directed to a “gel-based composition that has pleasant tactile properties, can dry within about two minutes, 1 minute, or 30 seconds after topical application to skin, and can offer both ultraviolet A (UVA) and ultraviolet B (UVB) protection to skin.”
In Table 1 (para. [0083]), Foley discloses an exemplary gel formulation that is anhydrous and comprises octocrylene (3 wt%) and avobenzone (2.5 wt%). The exemplary gel formulation further comprises: tribehenin (1 wt%), dipropylene glycol dibenzoate (0.75 wt%), and PPG-15 stearyl ether benzoate (0.15 wt%). Those three compounds are identified in Foley as skin conditioners/emollients. Para. [0009] (“Non-limiting examples of skin conditioners include tribehenin. Non-limiting examples of emollients include dipropylene glycol debenzoate and PPG-15 stearyl ether benzoate.”).
The gel formulation of Table 1 has an SPF of 16.2 and a PFA of 8.7±1.5. Paras. [0120] and [0147]; see also para. [0009] (“The gel can have a protection grade for UVA (‘PFA’) of at least about 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, or more.”) and page 12 at claim 1 (“the gel has an SPF of at least about 15 and a PFA of at least about 5”).
The gel formulation of Table 1 does not comprise glycereth-26. Nevertheless, Foley teaches that glycereth-26 is a suitable skin conditioner/emollient. Para. [0058]. Therefore, before the effective filing date of the claimed invention, a person having ordinary skill in the art would have been motivated to modify the gel formulation of Table 1 by substituting glycereth-26 for one or more of the three skin conditioners/emollients (discussed above), as part of an effort to enhance the gel formulation’s skin conditioning and/or skin mollifying properties. MPEP § 2144.06(II) (substituting equivalents known for the same purpose). The concentrations of tribehenin (1 wt%), dipropylene glycol dibenzoate (0.75 wt%), and PPG-15 stearyl ether benzoate (0.15 wt%), would have individually or collectively served as a reasonable starting point for routine experimentation with glycereth-26. Accordingly, the corresponding concentration range recited in claim 1 of the present application (1 to 30 wt%) is prima facie obvious. MPEP § 2144.05(I) (overlapping, approaching, and similar ranges, amounts, and proportions). In sum, claims 1-5 are rendered prima facie obvious by Foley.
In the alternative, the following two references compensate for any deficiency in Foley concerning glycereth-26: Afonso and Sun.
Afonso teaches: “Avobenzone is one of the most common UVA-filters in sunscreens, and is known to be photounstable.” Abstract.
Afonso teaches: “The tested antioxidants were vitamin C, vitamin E, and ubiquinone. The area under the curve of the absorption spectrum for UVA range and the sun protection factor (SPF) were calculated. Vitamin E (1:2), vitamin C (1:0.5) and ubiquinone (1:0.5) were the more effective concentrations increasing the photostability of avobenzone.” Abstract.
Sun teaches that ascorbic acid (Vitamin C), which is hydrophilic, is unstable in aqueous cosmetic formulations. Page 61.
Sun teaches: “Ascorbic acid, hydroquinone and DHA are soluble in polyol solvents. Among the polyols are propylene glycol, butylene glycol, hexylene glycol, glycerin, several polyethylene glycols (200, 300, 400, 600, 900, 1000 and 1450), glycereth-7, glycereth-26, ethoxydiglycol and ethanol. These solvents have much less oxygen permeability and do not carry water as a reactant for discoloration reactions. Therefore by selecting appropriate oil phase and surfactants, it becomes possible to deliver ascorbic acid, hydroquinone and DHA in nonaqueous emulsions that are heat-stable and nondiscoloring.” (Emphasis added) Page 64, third column. An exemplary relevant polyol concentration of 20 wt% is taught in Formula 1 of Sun. Page 66. The examiner notes that glycereth-26 is a polyethylene glycol ether of glycerin and, on the basis of its chemical structure, corresponds most closely to the polyethylene glycol present in Formula 1 of Sun.
Before the effective filing date of the claimed invention, the teachings of Afonso and Sun would have motivated a person having ordinary skill in the art to modify Foley adding Vitamin C and glycereth-26 to the gel formulation of Foley, in an effort to stabilize the avobenzone for an extended duration. The foregoing modification would have been made with a reasonable expectation of success, especially considering that Foley identifies ascorbic acid (Vitamin C) and glycereth-26 as suitable for inclusion in the gel. Para. [0058]. The concentration of 20 wt% taught in Formula 1 of Sun would have served as a reasonable starting point for routine experimentation with glycereth-26. Accordingly, the corresponding concentration range recited in claim 1 of the present application (1 to 30 wt%) is prima facie obvious. MPEP § 2144.05(I) (overlapping, approaching, and similar ranges, amounts, and proportions). In sum, claims 1-5 are rendered prima facie obvious by Foley in view of Afonso and Sun.
Regarding claims 6 and 7, it is the examiner’s position that the addition of Vitamin C (hydrophilic phase) and/or glycereth-26 (which essentially emulsifies the Vitamin C) to the gel formulation of Table 1 (Foley) converts it to a silicone-based emulsion, due to the presence of dimethicone and polysilicone-11, along with the other emulsifiers already present therein, e.g., VP/hexadecene copolymer. In the alternative, the optional reference (Garrison) teaches that sunscreens in the form of oil-in-silicone emulsions provide “higher than expected SPFs” (para. [0026]), “good waterproof performance” (para. [0031]), and “superior aesthetics” (para. [0031]), thereby compensating for any deficiency. See also para. [0021] and claims 1 and 4-7 of Garrison.
Conclusion
Claims 1-7 are rejected.
Claims 5-7 are also objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
26 June 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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