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 .
Priority
The foreign priority claim filed on 08/08/2022 was not entered because the foreign priority claim was not filed during the time period set forth in 37 CFR 1.55. For original applications filed under 35 U.S.C. 111(a) (other than a design application) on or after November 29, 2000, the time period is during the pendency of the application and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior foreign application. In addition, if the application was filed on or after September 16, 2012, the claim for foreign priority must be presented in an application data sheet. See 37 CFR 1.55(d)(1). For national stage applications under 35 U.S.C. 371, the claim for priority must be made within the time limit set forth in the PCT and the Regulations under the PCT. See 37 CFR 1.55(d)(2).
If applicant desires priority under 35 U.S.C. 119(a)-(d), or (f), 365(a) or (b), or 386(a) based upon a prior foreign application, applicant must file a petition for an unintentionally delayed priority claim under 37 CFR 1.55(e).
The petition must be accompanied by (1) the priority claim under 35 U.S.C. 119(a)-(d), or (f), 365(a) or (b), or 386(a) in accordance with 37 CFR 1.55 identifying the prior foreign application to which priority is claimed, unless previously submitted; (2) a certified copy of the foreign application, unless previously submitted or an exception under 37 CFR 1.55 applies; (3) the applicable petition fee under 37 CFR 1.17(m)(1) or (2); and (4) a statement that the entire delay between the date the claim was due under 37 CFR 1.55 and the date the claim was filed was unintentional.
The Director may require additional information where there is a question whether the delay was unintentional. The petition should be addressed to: Mail Stop Petition, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claims 1-5, and 7-15 objected to because of the following informalities: the claims should be amended as follow in order to avoid 35 USC 112 (b) / 2nd for lack of antecedent basis.
Claim 1: “... a form of an emulsion …the sunscreen composition…”
Claim 2: “..an amount… a range…”
Claims 3 and 4: “..an amount… a total weight… the sunscreen composition…”
Claim 5: “..a ratio… a total amount… a range…”
Claim 7: “..a total amount… a range… the sunscreen composition…”
Claim 8: “..the sunscreen composition…a presence”
Claims 9, 11, 12, 13, and 14, “..the sunscreen composition…”
Claim 10: “..an amount… a range …”
Claims 15: “..the a soaping effect…a
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.
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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance,
claim 2 : recites the broad recitation: the range from 0.1 to 10 wt.-%,.
and the claim also recites preferably from 0.5 to 5 wt.-%, most preferably from 1 to 5 wt.-%, based on the total weight of the composition which is the narrower statement of the range/limitation.
claim 6 : recites the broad recitation: wherein the one or more alkanediols is selected from the group consisting of 1,3- propandiol, butylene glycol and 1,2-butandiol, preferably from 1,3-propandiol and butylene glycol,
and the claim also recites most preferably butylene glycol is used as sole alkanediol. which is the narrower statement of the limitation.
claim 7 : recites the broad recitation: the range from 1 to 10 wt. %
and the claim also recites .- preferably from 1.5 to 7.5 wt.-%, most preferably from 2 to 6 wt.-%, such as in the range of 2 to 5 wt.-%, based on the total weight of the composition. which is the narrower statement of the range/limitation.
claim 8 : recites the broad recitation: the composition is an O/W emulsion comprising an oily phase dispersed in an aqueous phase in the presence of an O/W emulsifier,
and the claim also recites preferably in the presence of a cetyl phosphate emulsifier, most preferably in the presence of potassium cetyl phosphate which is the narrower statement of the limitation.
claim 10 : recites the broad recitation: the range from 1 to 10 wt. %,
and the claim also recites preferably from 1.5 to 7.5 wt.-%, preferably from 2 to 6 wt.-%, more preferably in the range from 2 to 5 wt.-%, based on the total weight of the composition which is the narrower statement of the range/limitation.
claim 11 : recites the broad recitation: wherein the composition further comprises one or more of dicaprylate/dicaprate, …
and the claim also recites most preferably of dicaprylyl carbonate, dibutyladipate and C12- C₁₅ alkylbenzoate which is the narrower statement of the limitation.
claim 12 : recites the broad recitation: . wherein the composition further comprises one or more a preservative/ preservative booster selected from the group consisting of ethanol,…,
. and the claim also recites preferably phenoxyethanol and ethylhexylglycerin are used as sole preservative/ preservative booster which is the narrower statement of the limitation.
claim 14 : recites the broad recitation: . wherein the composition further comprises one or more of behenyl alcohol, …,
. and the claim also recites most preferably stearyl alcohol which is the narrower statement of the limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 3 and 4 are 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 3 recites “… at least 1 wt.%,..” This is a range with unbounded upper limit, and, as such, it is unclear to the extent of among range Applicant is intending to seek patent protection of; as such, the claim is rendered indefinite.
Claim 4 recites “… less or equal to 25 wt.-%,..” This is a range with unbounded lower limit, and, as such, it is unclear to the extent of among range Applicant is intending to seek patent protection of; as such, the claim is rendered indefinite.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Dromigny et al. (US 2023/0398048 A1) (“Dromigny” herein) and further in view of Mendrok-Edinger et al. (US 2015/0359720 1) (“Mendrok” herein).
Claim 1.
Dromigny discloses a sunscreen composition in the form of an emulsion comprising [0035-0036
bis-ethylhexyloxyphenol methoxyphenyl triazine (BEMT), [0056]
sebacate [0111] and
one or more alkanediol [0111, 0181] with the proviso that the composition is free of ethylhexyl methoxycinnamate. (i.e. the composition not comprising.. ethylhexyl methoxycinnamate [Abstract]
Dromigny however does not provide the sebacate as a diethylhexyl sebacate.
Mendrok teaches the above limitation (See paragraphs 0020 & 0022 → Mendrok teaches this limitation in that suitable sebacic acid ester or diesters encompass esters of sebacic acid with straight-chain or branched alkanols, alkandiols and/or alkantriols having from 1 to 36 carbon atoms or polyols such as glycerin or diglycerin. Exemplary sebacic acid ester or diesters encompass e.g. Dibutyloctyl Sebacate, Dibutyl Sebacate, Dicaprylyl/Capryl Sebacate, Diethylhexyl sebacate, Diethyl Sebacate, Diglyceryl Sebacate/Isopalmitate (Polyglyceryl-2 Isopalmitate/Sebacate is a mixed ester of Isopalmitic Acid, Sebacic Acid and Diglycerin), Dihexyldecyl Sebacate, Diisooctyl Sebacate, Diisostearyl Sebacate, Dioctyldodecyl Sebacate, Ditrimethylolpropane Isostearate/Sebacate (Di-2,2-dihydroxymethylbutyl ether, tetraesters with isooctadecanoic acid and decanedioic acid), Isostearyl Sebacate without being limited thereto. Particularly preferred is Diisopropyl sebacate. The amount of the sebacic acid ester or diester such as in particular of diisopropyl sebacate in the compositions according to the invention is preferable selected in the range of 1 to 50 wt.-%, in particular in the range of 5 to 30 wt.-%, such as about 10 to 30 wt.-%, based on the total weight of the composition.) for the purpose of having a particular embodiment the topical compositions according to the invention are light-protective preparations (sun care products), such as sun protection milks, sun protection lotions, sun protection creams, sun protection oils, sun blocks or tropical's or day care creams with a SPF (sun protection factor). [0034]
Accordingly, it would have been obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the diisopropyl sebacate of Dromigny, with the Diethylhexyl sebacate of Mendrok, in order to provide sun care products.
Claim 2.
Dromigny discloses the sunscreen composition according to claim 1, wherein the amount of bis-ethylhexyloxyphenol methoxyphenyl triazine is selected in the range from 0.1 to 10 wt.-%, preferably from 0.5 to 5 wt.-%, most preferably from 1 to 5 wt.-%, based on the total weight of the composition. [0056]
Claims 3-4
Dromigny discloses the sunscreen composition according to claim 1. Dromigny however does not explicitly disclose, wherein the amount of the diethylhexyl sebacate is at least 1 wt.%, based on the total weight of the composition and the amount of diethylhexyl sebacate is less or equal to 25 wt.-%, based on the total weight of the composition. (Same as claim 1)
Claim 5.
Dromigny discloses the sunscreen composition according to claim 1. Dromigny however does not explicitly disclose, wherein the ratio of the total amount of the diethylhexyl sebacate to the total amount of BEMT is selected in the range from 1:1 to 25:1. (Same as claim 1)
Claim 6.
Dromigny discloses the sunscreen composition according to claim 1, wherein the one or more alkanediols is selected from the group consisting of 1,3- propandiol, butylene glycol and 1,2-butandiol, preferably from 1,3-propandiol and butylene glycol, most preferably butylene glycol is used as sole alkanediol. [0086, 0111]
Claim 7.
Dromigny discloses the claimed invention except for the total amount of alkanediol(s) is selected in the range from 1 to 10 wt.-%, preferably from 1.5 to 7.5 wt.-%, most preferably from 2 to 6 wt.-%, such as in the range of 2 to 5 wt.-%, based on the total weight of the composition. It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention was made to have the total amount of alkanediol(s) is selected in the range from 1 to 10 wt.-%, preferably from 1.5 to 7.5 wt.-%, most preferably from 2 to 6 wt.-%, such as in the range of 2 to 5 wt.-%, based on the total weight of the composition, since it has been held that [W]here the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 8.
Dromigny discloses the sunscreen compositions according to claim 1, wherein the composition is an O/W emulsion comprising an oily phase dispersed in an aqueous phase in the presence of an O/W emulsifier, preferably in the presence of a cetyl phosphate emulsifier, most preferably in the presence of potassium cetyl phosphate. [0035-0036, 0182-0184]
Claim 9.
Dromigny discloses the sunscreen composition according to claim 1, wherein the composition further comprises butylmethoxy dibenzoylmethane and/ or diethylamino hydroxybenzoyl hexyl benzoate. [0069-0081]
Claim 10.
Dromigny discloses the sunscreen composition according to claim 1, wherein the amount of butyl dibenzoylmethane and/ or diethylamino hydroxybenzoyl hexyl benzoate is selected in the range from 1 to 10 wt.-%, preferably from 1.5 to 7.5 wt.-%, preferably from 2 to 6 wt.-%, more preferably in the range from 2 to 5 wt.-%, based on the total weight of the composition. [0069-0081]
Claim 11.
Dromigny discloses the sunscreen composition according to claim 1, wherein the composition further comprises one or more of dicaprylate/dicaprate, phenethyl benzoate, C₁₂-C₁₅ alkyl benzoate, dibutyl adipate, diisopropyl sebacates, dicaprylyl carbonate, di-C₁₂-13 alkyl tartrates, hydrogenated castor oil dimerates, triheptanoin, C12-13 alkyl lactates, C₁₆-17 alkyl benzoates, propylheptyl caprylates, caprylic/capric triglycerides, 2,6-naphthalate, octyldodecanol, ethylhexyl cocoatesdibutyl adipate, preferably of dicaprylyl carbonate, phenethyl benzoate, C₁₂-C₁₅ alkylbenzoate, caprylyl carbonate, capric/caprylic triglyceride, most preferably of dicaprylyl carbonate, dibutyladipate and C12- C₁₅ alkylbenzoate. [0111]
Claim 12.
Dromigny discloses the sunscreen composition according to claim 1, wherein the composition further comprises one or more a preservative/ preservative booster selected from the group consisting of ethanol, phenoxyethanol, 1,2-pentanediol, 1,2- hexanediol, 1,2-octanediol (caprylyl glycol), 1,2 decanediol, 2-mcthyl-1,3-propancdiol propanediol, propylene glycol and p-hydroxyacetophenone, preferably phenoxyethanol and ethylhexylglycerin are used as sole preservative/ preservative booster. [0181, 0198]
Claim 13.
Dromigny discloses the sunscreen composition according to claim 1, wherein the composition further comprises one or more of xanthan gum, microcrystalline cellulose, cellulose, cellulose gum, crosslinked acrylate/C10-C30 alkyl acrylate polymer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, preferably xanthan gum and hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer. [187-0189, 0194]
Claim 14.
Dromigny discloses the sunscreen composition according to claim 1, wherein the composition further comprises one or more of behenyl alcohol, cetyl alcohol, cetearyl alcohol, stearyl alcohol and glyceryl stearate, preferably of behenyl alcohol, stearyl alcohol and cetearyl alcohol, most preferably stearyl alcohol. [0187-0189]
Claim 15.
Dromigny discloses a method of reducing the soaping effect of sunscreen compositions comprising bis- ethylhexyloxyphenol methoxyphenyl triazine and ethylhexyl methoxycinnamate, said method comprising the step of replacing ethylhexylmethoxycinnamate comprised in said sunscreen composition by sebacate and optionally appreciating the effect. . (i.e. the composition not comprising.. ethylhexyl methoxycinnamate [Abstract, 0001, 0035-0036, 0056, 0111] Dromigny however does not provide the sebacate as a diethylhexyl sebacate. (See claim 1)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yu et al. (US 20009/0068255 A1) USE OF MATRIX METALLOPROTEINASE INHIBITORS IN SKIN CARE teaches The application of matrix metalloproteinase (MMP) inhibitors to the skin inhibits the degradation of proteins found in the skin including collagen, elastin, and other basement membrane and extracellular matrix protein, Deshayes et al. (US 2018/0110706 A1) OPICAL SUNSCREEN EMULSIONS teaches The invention relates to topical sunscreen emulsion comprising an oil phase and a water phase, wherein said emulsion comprises a phosphate ester emulsifier, phytantriol and an amount of at least 1 wt.-% based on the total weight of the topical sunscreen emulsion of at least one UV-filter substance. Furthermore, the invention relates to the use of phytantriol for improving the water resistance of such topical sunscreen emulsions, and Matsui et al. (US 2018/0296452 A1) SUNSCREEN COSMETIC teaches A sunscreen cosmetic achieves high ultraviolet ray protection effect even when restricting a blended amount of the liquid ultraviolet ray absorbing agents ethylhexyl methoxycinnamate and octocrylene, that is stable and has excellent texture, and does not resulting in an unnatural whiteness on application. A sunscreen cosmetic comprises: (A) 0.5 to 10.0 mass % of t-butyl methoxydibenzoylmethane and/or diethylamino hydroxybenzoyl hexyl benzoate; (B) 0.5 to 5.0 mass % of bis-ethylhexyloxyphenol methoxyphenyl triazine; (C) 0.5 to 5.0 mass % of ethylhexyl triazone; (D) 5 to 50 mass % of an ester oil to which the ingredients (A), (B) and (C) have a solubility, at 25° C., of 10% or more; and (E) 1.5 to 12 mass % of an ultraviolet ray scattering agent; wherein the total blended amount of the ingredients (A), (B) and (C) is 1.5 to 15 mass % and the total blended amount of ethylhexyl methoxycinnamate and octocrylene is 3 mass % or less.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SILVANA C RUNYAN whose telephone number is (571)270-5415. The examiner can normally be reached M-F 7:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SILVANA C RUNYAN/Primary Examiner, Art Unit 1616 09/01/2026
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