DETAILED ACTION
Status of the Claims
Claims 1 and 3-15 are pending in the instant application. Claim 13 has been withdrawn based upon Restriction/Election as discussed below. Claims 1, 3-12, 14 and 15 are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All rejections and/or objections not explicitly maintained in the instant office action have been withdrawn per Applicants’ claim amendments and/or persuasive arguments.
Priority
The instant Application is a 371 of PCT/EP2022/081069 filed 11/08/2022 and claims priority to EP 21208863.7 filed 11/17/2021.
The U.S. effective filing date has been determined to be 11/17/2021, the filing date of the document EP 21208863.7.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over BOAZ (US 2015/0126759; published May 2015) in view of ROBINSON (US 2010/0305169; published December, 2010) and KOHLHASE (US 2004/0228888; published November, 2004).
Applicants Claims
Applicant claims a personal cleansing composition comprising: (a) 0.1 to 10 wt% water-soluble UVA sunscreen, (b) 0.1 to 10 wt% water-soluble UVB sunscreen, (c) 0.01 to 6 wt% of an alkali selected from calcium hydroxide, magnesium hydroxide or mixtures thereof, wherein the solubility of the UVA or UVB sunscreen in water is higher than 50 g/L at 25°C; and (d) 5 to 40 wt% non-ionic surfactant (instant claim 1).
Determination of the scope
and content of the prior art (MPEP 2141.01)
BOAZ teaches personal care compositions including a hydroxytyrosol derivative (title, abstract, see whole document), the "Hydroxytyrosol is a highly active and naturally occurring antioxidant of much interest as a stabilizer and anti-aging ingredient in cosmetic formulations, but the three polar hydroxyl groups make its compatibility with typical lipophilic skin care vehicles very poor." ([0004]).
BOAZ teaches their personal care compositions include cleansing agents such as decyl glucoside in an amount of 0.001 wt. %to 20 wt.% based on the weight of the personal care composition ([0123]-[0124])(instant claim 1, item d 5-40 wt% non-ionic surfactant; instant claims 7 – Instant Specification indicates decyl glucoside has an HLB of 12.8 – [0048], as published; instant claim 15, 5 to 40 wt% non-ionic surfactant).
BOAZ teaches the inclusion of sunscreens, and particularly UV absorbers such as "disodium phenyl dibenzimidazole tetrasulfonate, phenylbenzimidazole sulfonic acid," and "The personal care compositions can have UVA and UVB absorption properties. The compositions can have an sun protection factor (SPF) of 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90 or more, or any integer or derivative therein." ([0137])(instant claim 1, items a & b). And that: "The personal care composition may contain, in addition to the liphophilic hydroxytyrosol carbonate ester compounds, from 0.001 wt. %to 20 wt.%, or at least 0.01 wt.%, or at least 0.1 wt.%, or at least 0.5 wt.%, or at least 1 wt.%, and up to 20 wt.%, or up to 15 wt.%, or up to 10 wt.%, or up to 8 wt. %, or up to 5 wt. % of a sunscreen agent, based on the weight of the personal care composition." ([0138])(instant claim 1 items a & b, amounts). "In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists." (MPEP §2144. 05).
BOAZ teaches a process of making the lipophilic hydroxytyrosol esters including neutralizing with a base, "The base used may be a mono or polyvalent metal hydroxide such as sodium hydroxide, potassium hydroxide, or calcium hydroxide; [ ... ]." ([0079], claim 10).
BOAZ teaches the inclusion of emulsifiers including “The emulsifiers can be nonionic, cationic, anionic, and zwitterionic emulsifiers.” ([0186]), and “an emulsifier present in an amount of from 0.001 wt.% to 20 wt.%, or 1 wt. % to 5 wt. %, in each case based on the weight of the personal care composition. The examiner notes that “amphoteric surfactant” and “zwitterionic emulsifier” are considered synonymous in the art to which the invention pertains (instant claim 10).
BOAZ teaches the solvents include water, and a solvent present in an amount of from 0.001 wt. % to 20 wt.% ([0158]-[0159]).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of BOAZ is that BOAZ does not expressly teach: (1) the amount of the mono or polyvalent metal hydroxide; (2) a specific example including both UVA and UVB sunscreen agents; the pH of the composition.
ROBINSON teaches a personal care composition comprising a cationic active (title) and particularly "A personal-care composition in the form of an oil-in-water emulsion comprises a water phase, an oil phase, an anionic pairing agent, a cationic active, and an anionic thickener. In one embodiment, the anionic pairing agent is pre-formed from the neutralization of an acid with a base. [ ... ] The personal-care composition allows for previously unattainable levels of the cationic active to locate within the oil phase of the emulsion." (abstract, see whole document). ROBINSON teaches "The composition may comprise from about 0.0001 % to about 10%, or from about 0.001 % to about 5%, or from about 0.01 % to about 1 %, by weight of the composition, of a base. "Base," as used herein, means a substance that may accept protons or otherwise neutralize an acid. Suitable bases include, but are not limited to, triethylamine, triethanoloamine, sodium hydroxide, potassium hydroxide, ammonium hydroxide, calcium hydroxide, magnesium hydroxide, and combinations thereof." [emphasis added]([0040], claim 8)(instant claim 1, item c; instant claim 5). ROBINSON teaches the inclusion of a water-soluble sunscreen including "phenylbenzimidazole sulfonic acid (PBSA), [ ... ] disodium phenyl dibenzimidazole tetrasulfonate" ([0056]). ROBINON teaches that: “In particular embodiments, the personal-care composition has a pH of from about 3 to about 9, or from about 4 to about 7.” ([0017])(instant claim 11). "In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists." (MPEP §2144. 05). ROBINSON further teaches the inclusion of a water phase (comprising water) in an amount of 25-95% ([0019]).
KOHLHASE teaches personal care compositions ([0033]) which contain the combination of e.g. 1 % disodium phenyl dibenzimidazole tetra sulphonate and 2 % phenyl benzimidazole sulphonic acid, which is a preferred combination in the right amounts, see example 7 ([0263], p. 24). Regarding the solubility of the sunscreen the examiner notes the instant Specification discloses that disodium phenyl dibenzimidazole tetra sulfonate and phenyl benzimidazole sulphonic acid (PBSA) are a water-soluble UVA and UVB sunscreen agent, respectively, where water-soluble is defined as solubility in water that is higher than 50 g/L at 25°C ([0024]-[0025] & [0028], of Published Application – MPEP §2112.01(II)).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a personal cleansing composition comprising both a UVA and UVB sunscreen agents, along with surfactants (non-ionic, cationic, anionic and/or zwitterionic) and an alkali metal hydroxide, as suggested by BOAZ, the alkali metal hydroxide being calcium or magnesium hydroxide as suggested by ROBINSON, and the combination of UVA and UVB sunscreens, e.g. 1 % disodium phenyl dibenzimidazole tetra sulphonate and 2 % phenyl benzimidazole sulphonic acid, as suggested by KOHLHASE, in order to produce a personal care composition with offering UV protection.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Response to Arguments:
Applicant's arguments filed 08/03/2026 have been fully considered but they are not persuasive.
Applicant argues that: “The present claims are directed to a personal cleansing composition comprising both a UVA sunscreen and a UVB sunscreen, an alkali metal selected from calcium hydroxide, magnesium hydroxide, or a combination thereof, and a non-ionic surfactant. All these features are present to provide a personal cleansing composition that provides an improved sun factor (SPF). It was surprisingly found that the claimed compositions comprising water soluble UVA sunscreen, water soluble UVB sunscreen, and one or more select alkali of calcium hydroxide, magnesium hydroxide or a combination thereof provides improved SPF. Calcium hydroxide, magnesium hydroxide, or a combination thereof are used to neutralize the acid forms of the sunscreen and give higher SPF than sodium or potassium hydroxide. The nonionic surfactant used also gives higher SPF as compared to the use of an anionic or amphoteric surfactant. Both Boaz et al. and Robinson et al. fail to disclose, discuss, suggest, or mention the use of calcium and/or magnesium hydroxide for neutralizing the acid form of the water soluble sunscreens. Rather, in Boaz et al., the method of preparing the lipophilic hydroxytryrosol ester is described in Paragraphs [0073] to [0079] where one of the steps in Paragraph [0079] describes how a base which may be sodium, potassium, or calcium hydroxide can be used. In Boaz et al., the base is used up in the process of making the compound of formula 6 and is in no way involved in sunscreens, which are merely taken from a long laundry list of ingredients. Stated another way, there is simply no motivation or suggestion from Boaz et al. to use calcium and/or magnesium hydroxide for superior SPF.” (paragraph bridging pp. 7-8).
In response to Applicants allegation of unexpected results, the examiner notes that any allegation of unexpected results must be commensurate in scope with any data shown (MPEP §716.02(d)), and the burden is on Applicant to explain their supplied data, and particularly to establish that: “The evidence relied upon should establish ‘that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.’” (MPEP §716.02(b)). In the instant case Applicants point to no data nor provide any explanation as to why the result(s) should be considered unexpected. The data in Tables 1 & 2 of the instant Specification do not include data showing the full range of the alkali (0.01 to 6 wt. %). Therefore, the argument directed at unexpected results is not convincing. Additionally, “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” (MPEP §2145(II)).
In response to Applicants argument regarding the utility of the alkali (e.g. calcium hydroxide) in the prior art, “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” (MPEP §2144(IV)).
Applicant further argues that: “Furthermore, it is noted that Boaz et al. discloses that the amount of peroxide compound ranges from 0.9 to 4 equivalents per equivalent of the lipophilic formyltyrosol ester. OA 05/26 relies upon the amounts disclosed in Robinson et al. of base because the amounts presented in Boaz et al. are not comparable. However, there is no indication from Boaz et al. or Robinson et al. that the amounts disclosed in Robinson et al. will be compatible with the formulation of Boaz et al. especially given that the hydroxide is used up in the process of making the compound has no interaction with sunscreen. Robinson defines that the base is used for reacting with an acid either preformed or in situ to prepare an anionic pairing agent. Robinson et al. makes very clear that acids such as stearic acid or salicylic acid or oleic acid are reacted with a base such as triethanolamine to form an anionic pairing agent. There is no motivation or suggestion to use sunscreens. Kohlhase et al. fails to cure these deficiencies. As such, the present claims are non obvious over the art of record.” (p. 8, 2nd paragraph).
In response the examiner argues that it would have been within the ordinary level of skill to include an amount of calcium and/or magnesium hydroxide in a personal care product as taught by both BOAZ and ROBINSON, to neutralize acid compound(s) and provide an appropriate pH for a topical composition (e.g. a neutral pH of ~7.0). And ROBINSON particularly teaches neutralizing acids with the disclosed “Base” ([0039], [0040]) which acids include “Suitable acids include carboxylic acids, alkyl or aryl sulfonic acids, and salts, derivatives, and mixtures thereof.” ([0041]). And particularly that: “One suitable alkyl or aryl sulfonic acid is phenylbenzimidazole sulfonic acid (PBSA).” ([0044]). Therefore, the amount is clearly to neutralize acid compound(s) such as PBSA, as suggested by ROBINSON, and including “disodium phenyl dibenzimidazole tetrasulfonate, phenylbenzimidazole sulfonic acid,” as suggested by BOAZ ([0137]).
The terminal disclaimer filed on 08/03/2016 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of USPN 11,883,516 has been reviewed and is accepted. The terminal disclaimer has been recorded. And the non-statutory double patenting rejection is therefore withdrawn.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. BUDDE (US 2019/0380927 A1) is cited as teaching calcium containing sunscreen compositions with calcium included as an SPF booster (see whole document).
Conclusion
Claims 1, 3-12, 14 and 15 are pending and have been examined on the merits. Claims 1, 3-12, 14 and 15 are rejected under 35 U.S.C. 103. No claims allowed at this time.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IVAN A GREENE whose telephone number is (571)270-5868. The examiner can normally be reached M-F, 8-5 PM PST.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
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