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 Claim 13 has been withdrawn based upon Restriction/Election as discussed below.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 .
Restriction/Election
Applicant's election with traverse of Group I drawn to compositions of matter, currently claims 1, 3-12, 14 and 15 in the reply filed on 04/02/2026 is acknowledged. The traversal is on the ground(s) that “based on existing technical relationship between a composition and method of its use, i.e., category (2) under 1.475(b).” This is not found persuasive because the lack of unity of invention has been established in the Requirement for Restriction/Election.
The requirement is still deemed proper and is therefore made FINAL.
Claim 13 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/02/2026.
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.
Information Disclosure Statement
The information disclosure statement(s) submitted on 05/08/2024 05/14/2024 and were filed before the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
The abstract of the disclosure is objected to because the abstract is from the PCT and should be presented on page without any additional text, and should be at 50 t o150 words. Correction is required. See MPEP § 608.01(b).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claim 3-12 and 14 are objected to because of the following informalities: each claim recites “Claim 1” where “Claim” should be lower case “claim 1”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8-10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Each of claims 8-10 recite “wherein the composition further comprises from 0 to […] wt. […] surfactant. Where lower range is zero and therefore does not “further comprise” or further limit the subject matter of the parent claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 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, 3-12, 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% an alkali selected from calcium hydroxide, magnesium hydroxide or mixtures thereof, wherein the solubility of the UV-A or UV-B 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.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-12, 14 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 & 8 of U.S. Patent No. 11,883,516 (hereafter ‘516) in view of 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 ).
Instant claim 1 is discussed above.
‘516 claim 1 recites a personal cleansing composition for enhanced deposition of sunscreens on a topical surface of the body comprising:(a) 0.1 to 10 wt% of a water soluble UVA sunscreen; (b) 0.1 to 10 wt% of a water soluble UVB sunscreen; (c) 3 to 80 wt% surfactant; and (d) a cosmetically acceptable carrier, wherein the water soluble UVA sunscreen is selected from di sodium phenyl dibenzimidazole tetra sulfonate, terephthalylidene dicamphor sulfonic acid and mixtures thereof, and wherein the water soluble UVB sunscreen is selected from phenyl benzimidazole sulphonic acid, benzylidene camphor sulfonic acid, benzophenone-4 and mixtures thereof, and wherein the solubility in water of said UVA sunscreen and said UVB sunscreen is higher than 10 g/L at 25*C. ‘516 claim 3 recites “The personal cleansing composition as claimed in claim 1, further comprising 0.05 to 4 wt % neutralising agent.” which includes inorganic alkali (claim 4). ‘516 recites The personal cleansing composition as claimed in claim 1, comprising 10 to 75 wt% surfactant.”
The difference between the instantly rejected claims and the claims of ‘516 is that the claim of ‘516 do not expressly claim the alkali neutralizing agent is calcium hydroxide, or the specific surfactants (non-ionic, cationic, anionic, amphoteric).
BOAZ teaches personal care compositions including a hydroxytyrosol derivative, as discussed above and incorporated herein by reference.
ROBINSON teaches a personal care composition comprising a cationic active, as discussed above and incorporated herein by reference.
KOHLHASE teaches personal care compositions, as discussed above and incorporated herein by reference.
It would have been prima facie obvious before the effective filing date of the claimed invention that the instantly rejected claims are an obvious variant of the claims of ‘516 because the are directed to personal cleansing compositions including UV-A and UV-B sunscreens consistent with the instant claims. The skilled artisan would have been motivated to modify the claims of ‘516 and produce the instantly rejected claim because it would have been prima facie obvious to select known personal cleansing components (surfactant(s) and neutralizing agent(s)) as suggested by BOAZ, ROBINSON and KOHLHASE. Furthermore, the skilled artisan would have had a reasonable expectation of success in producing the invention of the instantly rejected claims because it would have required no more than an ordinary level of skill in the art to produce a personal cleansing composition .
Conclusion
Claims 1, 3-12, 14 and 15 are pending and have been examined on the merits. The abstract is objected to, and claim 3-12 and 14 are objected to. Claims 8-10 are rejected under 35 U.S.C. 112(d); claims 1, 3-12, 14 and 15 are rejected under 35 U.S.C. 103; and Claims are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,883,516. No claims allowed at this time.
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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