DETAILED ACTION
Status of the Claims
Claims 1-12 are pending in the instant application and 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All rejections and/or objections not explicitly maintained in the instant office action have been withdrawn per Applicants’ claim amendments and/or persuasive arguments.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 U.S. effective filing date has been determined to be 12/18/2023, the filing date of the instant application.
Information Disclosure Statement
No Information Disclosure Statements have been filed in the instant application. Applicants are reminded of their duty to disclose patents and publications relevant to the patentability of the instant claims. Applicant is reminded of the requirements of 37 CFR 1.56 and Li Second Family Limited Partnership v. Toshiba Corp., 56 USPQ2d 1681 (Fed. Cir. 2000); accord McKesson Information Solutions, Inc. v. Bridge Medical, Inc. 487 F.3d 897, 913. (Fed.Cir.2007).
Claim Objections
Claims 17 and 18 are objected to because the claims recite “that at least one active agent” (line 1 of each claim) which should read “the at least one active agent”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a Written Description Rejection and New Matter
Scope of the Claimed Invention:
A composition comprising water, a UV absorbing system comprising bemotrizinol, and at least one active agent susceptible to degradation by UV rays, wherein water is present in the composition in an amount of at least 1% by weight based on the total weight of the composition, wherein bemotrizinol is present in the composition in an amount effective to protect the at least on active agent against UV rays, and wherein the composition has one or more of the following properties: a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher (instant claim 1). Applicant further claims the compositions of claim 1, wherein the UVAPF/SPF ratio is of at least 2/5 (instant claim 10), the UVA1/UV ratio is at least 0.75 or higher (instant claim 11), and 0.8 or higher (instant claim 12).
Claim 1 has been amend to recite “water is present in the composition in an amount of at least 1% by weight based on the total weight of the composition” and “wherein bemotrizinol is present in the composition in an amount effective to protect the at least on active agent against UV rays” (lines 2-5). The examiner finds no support in the as-filed Application for these limitations and are therefore considered to introduce new matter into the claims.
New claim 13 reciting “water is present in the composition in an amount of at least 3% by weight based on the total weight of the composition” The examiner finds no support for this limitation in the as-filed Application and is therefore considered to introduce new matter into the claims.
Disclosure of the Prior Art:
Moyal (“UVA protection labeling and in vitro testing methods,” 2010; RSC, Photochemical & Photobiological Science, Vol. 9, pp. 516–523) teaches that: “In Europe, in September 2006, the European Commission recommended a UVAPF/SPF ratio as high as at least 1/3.” (p. 516, col. 2, 3rd paragraph). And that: “The FDA defines 4 categories based on UVA1/UV ratio as shown in Table 2.” (p. 517, col. 2, 4th paragraph). And that: “The wavelength at which the summed absorbance reaches 90% of total absorbance is defined as the “critical wavelength” and is considered to be a measure of the breadth of sunscreen protection Sunscreen products are then classified as “broad spectrum” having a significant part of their absorbance in the UVA, when the critical wavelength is longer than 370 nm.” (p. 518, col. 1, 2nd paragraph).
Disclosure of the Instant Application:
The instant Specification discloses that: “[0010] The present disclosure relates to compositions comprising at least one active agent and a UV absorbing system comprising bis-ethylhexyloxypheno methoxyphenyl triazine (BEMT or bemotrizinol), wherein the compositions have UV protection properties such as a critical wavelength of at least 370 nm, a UVAPF/SPF ratio of at least 1/3 and/or a UVA1/UV ratio of 0.7 or higher.” (p. 2). And that: “[0050] The compositions and methods of the present disclosure can comprise, consist of, or consist essentially of the essential elements and limitations of the disclosure described herein, as well as any additional or optional ingredients, components, or limitations described herein or otherwise useful. For example, the UV (ultraviolet) absorbing system of the compositions of the disclosure can "consist essentially of" bis-ethylhexyloxyphenol methoxyphenyl triazine alone, or bis- ethylhexyloxyphenol methoxyphenyl triazine in combination with oxides of zinc, titanium and/or cerium, and/or one or more additional organic UV filters.” (p. 10). And further that: “[0051] For purposes of the present disclosure, the "basic and novel property" associated with compositions, components and methods which "consist essentially of" identified ingredients or actions is "UVAPF/SPF ratio of at least 1/3 and/or a UVA1/UV ratio of 0.7 or higher."” (p. 10).
The specification discloses that: “[0056] According to the present disclosure, compositions comprising at least one active agent are provided. Such active agents are preferably those active agents which can be susceptible to degradation after prolonged exposure to light. Preferably, the at least one active agent in compositions of the present disclosure are natural compounds, obtained from natural products, are modified natural compounds (natural compound derivatives), or are synthetic versions of any of these.” (pp. 11-12). The instant Specification list broad categories of suitable active agents ([0057] through [0065] (pp. 12-13).
The instant Specification discloses two Examples pp. 33-35 including Avobenzone and Bemotrizinol as sunscreen actives ->3.00 wt.% in Example 1 for both, and 3.00 wt.% for Avobenzone and 5.0 wt.% for Bemotrizinol in Example 2.
The instant Specification discloses that: “When present, water is preferably present in an amount of from about 10% to about 80% by weight, preferably from about 20% to about 70% by weight, preferably from about 35% to about 65% by weight, including all ranges and subranges therebetween, all weights being based on the total weight of the composition.” (p. 27, [0117]).
The instant Specification discloses that: “Compositions of the present disclosure may also optionally further include at least one additive or auxiliary commonly used in cosmetic compositions and known to a person skilled in the art as being capable of being incorporated into such compositions. Such additives or auxiliaries may be chosen from film formers, colorants (e.g., pigments and dyes), waxes, active agent protection against UV rays agents such as piperidinol compounds, SPF boosters such as diethylhexyl syringylidenemalonate, ethylhexyl methoxycrylene and butyl octyl salicylate, thixotropic agents (e.g., clays), fillers, preservatives, fragrances, surfactants, antioxidants, spreading agents, dispersing agents, antifoaming agents, neutralizing agents, stabilizing agents, active agents not susceptible to degradation by UV rays, fibers, wetting agents and their mixtures.” (p. 29, [0126]).
Discussion:
In the case Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (Fed. Cir. 2010), the court found that: “Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. “[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Id. at 930 n.10 (quoting Brenner, 383 U.S. at 536). Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of “invention”—that is, conceive of the complete and final invention with all its claimed limitations—and disclose the fruits of that effort to the public.” In the instant case, the claims cover a breadth of subject matter not supported by the application as filed.
The instant claims include one specific UV screening agent, bemotrizinol, with a generic “at least one active ingredient” and three properties that are essentially defined by regulatory agencies (European Commission and FDA, per Moyal) for broad spectrum sunscreen products, and the as-filed Application provides no link between the claimed properties and the constituent ingredients. The instant claims are generic to a vast number of species compositions where Applicant has provided two Examples. Accordingly, the claims are properly rejected for lack of written description because the number of species within the scope of the claim is vast as compared to the disclosure, and no link between the structure and properties is disclosed in the as-filed Application. The claims are therefore rejected as failing to comply with the written description requirement, as the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of a representative number of species within the scope of the claimed invention (MPEP §2163(II)(A)(3)(a)(i)).
The Specification discloses that: “According to the present disclosure, compositions comprising at least one active agent are provided. Such active agents are preferably those active agents which can be susceptible to degradation after prolonged exposure to light.” but does not disclose “at least one active agent susceptible to degradation by UV rays” and the Specification discloses “active agents not susceptible to degradation by UV rays”, and while the Specification list several active agents there is no description of any link between any active agent and degradation by light or UV rays such that one of ordinary skill would have recognized that Applicants were in possession of the claimed compositions comprising “at least one active agent susceptible to degradation by UV rays”. Furthermore, instant claims 15 and 16 each recite specific actives but do not claim “active agents susceptible to degradation by UV rays” therefore claims 15 and 16 lack proper written description as that the Specification provides no link between the recited active agents and “degradation by UV rays”.
Claim 1 has been amend to recite “at least one active agent susceptible to degradation by UV rays wherein water is present in the composition in an amount of at least 1% by weight based on the total weight of the composition” and “wherein bemotrizinol is present in the composition in an amount effective to protect the at least on active agent against UV rays” (lines 2-5). The examiner finds no support in the as-filed Application for these limitations and are therefore considered to introduce new matter into the claims. Therefore claim 1 is rejected as introducing new matter into the claims.
New claim 13 reciting “water is present in the composition in an amount of at least 3% by weight based on the total weight of the composition” The examiner finds no support for this limitation in the as-filed Application and is therefore considered to introduce new matter into the claims. Therefore claim 13 is rejected as introducing new matter into the claims.
Response to Arguments:
Applicant's arguments filed 06/09/2026 have been fully considered but they are not persuasive.
Applicant argues that: “Claim 1 has been amended to identify active agents susceptible to degradation and to reflect the presence of a UV absorbing system comprising bemotrizinol as well as water” (p. 6, 2nd paragraph). And that: “The Office Action rejected claims 1-12 under 35 U.S.C. § 112 as failing to comply with the written description requirement, […]. At least in view of the above amendments, Applicant respectfully submits that these rejections have been rendered moot, and requests reconsideration and withdrawal of these rejections.” (p. 6, lines 14-18).
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Claim Rejections - 35 USC § 112(b)
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 1-18 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 pre-AIA the applicant regards as the invention.
Claim 1 is rejected as being indefinite because the claim recites “at least one active agent susceptible to degradation by UV rays” which is considered indefinite because “UV rays” is not range of different wavelengths of light, and “susceptible to degradation” is relative terminology not defined in a way that one of ordinary skill would understand the metes and bounds of the claimed “at least one active agent susceptible to degradation by UV rays”. Particularly, the instant Application does not provide any objective standard for ascertaining if an active agent should be considered to be “susceptible to degradation by UV rays”, and therefore one of ordinary skill would not be reasonably appraised of the species of active agent(s) included or excluded by the recited claim language. Appropriate clarification is required. Claims 2-18 inherit the above discussed issue and do nothing to clarify the issue and are therefore rejected for the same reasoning.
Claim 1 is further rejected as being indefinite because the claim recites “wherein bemotrizinol is present in the composition in an amount effective to protect the at least on active agent against UV rays” which unclear because “the at least one active agent” is not defined, and therefore it is unclear what exactly “an amount effective to protect the at least one active agent against UV rays” should be considered. Appropriate clarification is required. Claims 2-18 inherit the above discussed issue and do nothing to clarify the issue and are therefore rejected for the same reasoning.
Claim Rejections - 35 USC § 102
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 1-6, 8, 10-14, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Chatelain et al. (“Photostabilization of Butyl methoxydibenzoylmethane (Avobenzone) and Ethylhexyl methoxycinnamate by Bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S), a New UV Broadband Filter,” 2001; American Society of Photobiology; Photochemistry and Photobiology, Vol. 74, No. 3, pp. 401–406).
Applicant Claims
A composition comprising bemotrizinol and at least one active agent, wherein the composition has one or more of the following properties: a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher (instant claim 1).
Disclosure of the Prior Art
Chatelain et al. discloses that: “It is now well documented that chronic UVA exposure induces damage to human skin. Therefore, modern sunscreens should not only provide protection from both UVB and UVA radiation but also maintain this protection during the entire period of exposure to the sun. UVA filters, however, are rare and not sufficiently photostable. We investigated the effect of the introduction of a new UV filter, bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S), in oil in water sunscreen formulations on the photostability of butyl methoxydibenzoylmethane (Avobenzone [AVB]) after irradiation with an optically filtered Xenon arc source (UV irradiance adjusted at 1 mean effective dose [MED]/min). With spectrophotometrical methods to assess the sun protection factor (SPF) and UVA ratio and chromatographical methods to determine the amount of UV filters recovered after irradiation we showed that Tinosorb S prevented the photodegradation of AVB in a concentration-dependent way, leading to a sustained SPF and UVA ratio even after irradiation with doses of up to 30 MED. Since AVB was shown to destabilize ethylhexyl methoxycinnamate (EHM) we tested the effect of Tinosorb S in sunscreens containing this UV filter combination. Here too Tinosorb S showed photoprotective properties toward both UV filters. Thus, Tinosorb S can be used successfully to improve the photostability and efficiency of sunscreens containing AVB and EHM.” (Abstract, see whole document).
Chatelain et al. discloses that: “Formulations with varying amounts of the above mentioned UV filter in a oil in water emulsion were used during this study. The vehicle consisted of water, carbomer, trometamol, sorbitol 70%, polysorbate 20, sorbitan laurate, cetearyl alcohol, dicapryllyl maleate, dimeticone 350 PHE, C12–15 alkyl benzoate, methyl and propyl parahydroxy benzoate; the amount of water was adjusted according to the quantity of UV filters.” [emphasis added](p. 402, col. 1, §MATERIALS AND METHODS, 1st paragraph). The examiner notes that a oil-in-water emulsion would have implicitly included a greater proportion of water that oil, implying at least 51% water (instant claim 1, “wherein water is present in the composition in an amount of at least 1% by weight based on the total weight of the composition”)(MPEP §2144.01).
And that: “SPF, in vitro, was measured for all sunscreens before irradiation. For sunscreens containing only AVB (2.5 or 5%) the SPF was very low ranging between 2.5 and 4. As expected, addition of either EHM or Tinosorb S or both boosted the SPF values to 20–50 on an average (data not shown).” (p. 402, col. 2, §RESULTS, 1st paragraph). And that: “When Tinosorb S (5 or 10%) was included in the formulations no differences between the control SPF values and SPF values after irradiation of the sunscreens were observed (data not shown). The SPF remained stable even after 30 MED irradiation.” (paragraph bridging pp. 402-403). And further that: “Tinosorb S prevents photodegradation of Avobenzone.” (Figure 3)(instant claims 17-18).
Chatelain et al. discloses that: “The prevention of the photodegradation of AVB, in formulations containing only AVB, was already maximal at a concentration of 5% Tinosorb S in the formulation. An increase to 10% Tinosorb S in the sunscreen induced only a marginal increase of the photoprotection of AVB (Fig. 4). With regard to the AVB concentration the photodegradation prevention by Tinosorb S was similar in formulations containing either 2.5 or 5% AVB (Fig. 3).” (p. 403, col. 2, §Recovery of the UV filters after irradiation, 1st paragraph).
The examiner notes that Tinosorb S is synonymous with bemotrizinol (instant claim 1, line 1), and the amounts of Tinosorb S and Avobenzone are consistent with Applicants own Example 2 “EMULSION SPF30” including Avobenzone 3.00 wt.%, and Bemotrizinol 5.00 wt.%, therefore the properties of instant claims 1-3 and 10-12 would have also been present (MPEP §2112.01-II – “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”). The compositions are free of mineral UV filters (instant claim 4), and include “10% or less by weight relative to the total weight composition of additional organic UV filters” (AVB = 2.5% or 5% + bemotrizinol = 5% or 10%)(instant claim 5), the compositions are free of oxybenzone and/or octinoxate (instant claim 6), the compositions are an emulsion (instant claim 8).
Response to Arguments:
Applicant's arguments filed 06/09/2026 have been fully considered but they are not persuasive.
Applicant argues that: “Given the above amendments to claim 1, Applicant respectfully submits that the anticipation rejections based on Chatelain and Moyal as well as the obviousness rejection in which Chatelain is the primary reference and Moyal is the secondary reference have been rendered moot -- the asserted references cannot teach or suggest all elements of the pending claims as amended or newly added, in particular the at least one active agent. Accordingly, Applicant respectfully requests that these rejections should be reconsidered and withdrawn” (p. 6, last paragraph).
In response the examiner argues that Chatelain et al. clearly includes a “sunscreen active agent” (instant Specification, p. [0025]) which is susceptible to degradation by UV rays, and particularly Avobenzone. Therefore Applicants argument is not convincing as the argument does not distinguish the claim(s) over the cited reference.
Claims 1-6, 8 and 10-18 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by BECK (US 2013/0315848 A1; published November, 2013).
Applicant Claims
A composition comprising water, a UV absorbing system comprising bemotrizinol, and at least one active agent susceptible to degradation by UV rays, wherein water is present in the composition in an amount of at least 1% by weight based on the total weight of the composition, wherein bemotrizinol is present in the composition in an amount effective to protect the at least one active agent against UV rays, and wherein the composition has one or more of the following properties: a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher (instant claim 1).
Disclosure of the Prior Art
BECK discloses “Use of UV-filters, if desired in combination with polyols, to enhance dermal penetration of resveratrol in topical cosmetic compositions.” (abstract).
BECK discloses that “Resveratrol was formulated in cosmetic compositions
depicted in Tables 1 […]” including Avobenzone (PARSOL® 1798) – 4.5% w/w, Bis-ethylhexyloxyphenol Methoxyphenyl triazine (Tinosorb S) – 2.00% w/w, dl-alpha Tocopherol acetate – 0.50% w/w, Resveratrol 0.05% w/w, and water – 55.05% w/w, among other ingredients. The species Tocopherol acetate (Vitamin E) and Resveratrol, as well as, Avobenzone, constitute the at least one active agent (instant claims 1,13-18).
The examiner notes that Tinosorb S is synonymous with bemotrizinol (instant claim 1, line 2), and the amounts of Tinosorb S and Avobenzone are consistent with Applicants own Example 2 “EMULSION SPF30” including Avobenzone 3.00 wt.%, and Bemotrizinol 3.00 wt.%, therefore the properties of instant claims 1-3 and 10-12 would have more likely than not also been present (MPEP §2112.01-II – “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”). The compositions are free of mineral UV filters (instant claim 4), and include “10% or less by weight relative to the total weight composition of additional organic UV filters” (instant claim 5), the compositions are free of oxybenzone and/or octinoxate (instant claim 6), the compositions are an emulsion (instant claim 8).
Claims 1-3, 5-6, 8 and 10-18 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by CHEVALIER (US 2015/0359715 A1; published December, 2015).
Applicant Claims
A composition comprising water, a UV absorbing system comprising bemotrizinol, and at least one active agent susceptible to degradation by UV rays, wherein water is present in the composition in an amount of at least 1% by weight based on the total weight of the composition, wherein bemotrizinol is present in the composition in an amount effective to protect the at least one active agent against UV rays, and wherein the composition has one or more of the following properties: a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher (instant claim 1).
Disclosure of the Prior Art
CHEVALIER discloses “a cosmetic or dermatological composition which includes, in a physiologically acceptable medium, at least trans-resveratrol and/or at least one transresveratrol derivative, and an organic filtering system including at least one UVA filter and at least one UVB filter and/or at least one mixed UVA-UVB filter, said composition having an SPF no lower than 15 and a PPD no lower than 5. The invention also relates to a use of a filtering system which includes at least one UVA filter and at least one UVB filter and/or at least one mixed UVA-UVB filter for stabilising, in particular photostabilising, a composition including transresveratrol and/or at least one trans-resveratrol derivative.” (abstract).
CHEVALIER discloses Example 1 including Compositions 2 & 4 each including Tocopherol (Vitamin E), Resveratrol and Bis-ethylhexyloxyphenol methoxyhenyl triazine (bemotrizinol). Composition 2 includes Tocopherol (0.5% w/w), Resveratrol (0.25% w/w), Butyl methoxydibenzoyl methan (Avobenzone – 3% w/w), and Bis-ethylhexyloxyphenol methoxyhenyl triazine (bemotrizinol – 1% w/w). And Composition 4 includes Tocopherol (0.5% w/w), Resveratrol (0.25% w/w), and Bis-ethylhexyloxyphenol methoxyhenyl triazine (bemotrizinol – 3% w/w). Each Example is qs’ed to 100 with water and therefore include about 10% to about 80% water (instant claims 1, 14-14). CHEVALIER discloses in Example 3 that composition 2 has a SPF of 30 and a PPD (UVA-PF) of 20 and therefore a SPF/UVA-PF of 1.5, and a UVA-PF/SPF of 0.666, or at least 1/3. And composition 4 has an SPF of 50, a PPD (UVA-PF) of 30, and therefore a SPF/UVA-PF of 1.67, and a UVA-PF/SPF of 0.6, or at least 1/3 (instant claims 1 & 10). The species Tocopherol (Vitamin E) and Resveratrol, as well as, Avobenzone, constitute the at least one active agent (instant claims 1, 13-18).
The examiner notes that the amount bemotrizinol and the amount of Avobenzone are consistent with Applicants own Example 2 “EMULSION SPF30” including Avobenzone 3.00 wt.%, and Bemotrizinol 3.00 wt.%, therefore the properties of instant claims 1-3 and 11-12 would have more likely than not also been present (MPEP §2112.01-II – “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”). The compositions include “10% or less by weight relative to the total weight composition of additional organic UV filters” (instant claim 5), the compositions are free of oxybenzone and/or octinoxate (instant claim 6), and the compositions are an emulsion (instant claim 8).
Claims 1-6, 8, 10-14, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by PERIER (US 2015/0056150 A1; published February, 2015).
Applicant Claims
A composition comprising bemotrizinol and at least one active agent, wherein the composition has one or more of the following properties: a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher (instant claim 1).
Disclosure of the Prior Art
PERIER discloses “a composition containing a photostabilized combination of Butyl Methoxydibenzoyl methane methane (BMDBM), Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (BEMT), and Methylene Bis-Benzotriazolyl Tetramethyl butylphenol (MBBT) wherein: (i) the BEMT/BMDBM mass ratio is greater than or equal to 1 and preferably greater than or equal to 1.5; (ii) the content of BMDBM is comprised between 1 % and 5% by weight with regard to the total weight of the composition; (iii) the quantity of MBBT is comprised between 3% and 7% by weight with regard to the total weight of the composition, said combination containing no octocrylene, PABA or ethylhexyl meth oxycinnamate, and a pharmaceutically or cosmetically acceptable excipient.” (abstract).
PERIER discloses BMDBM is avobenzone ([0004]) and BEMT is Bemotrizinol ([0005]). PERIER discloses Example Composition 1 including BMDBM 1-5%, BEMT 2-6% and water (QSP 100). The species Avobenzone, constitutes the at least one active agent (instant claims 1, 13-14, 17-18).
The examiner notes that the amounts of bemotrizinol (instant claim 1, line 2), and Avobenzone are consistent with Applicants own Examples 1 & 2 “EMULSION SPF30” including Avobenzone 3.00 wt.%, and Bemotrizinol 3.00 wt.%, therefore the properties of instant claims 1-3 and 10-12 would have more likely than not also been present (MPEP §2112.01-II – “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”). The compositions are free of mineral UV filters (instant claim 4), and include “10% or less by weight relative to the total weight composition of additional organic UV filters” (instant claim 5), the compositions are free of oxybenzone and/or octinoxate (instant claim 6), the compositions are an emulsion (instant claim 8).
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Chatelain et al. (“Photostabilization of Butyl methoxydibenzoylmethane (Avobenzone) and Ethylhexyl methoxycinnamate by Bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S), a New UV Broadband Filter,” 2001; American Society of Photobiology; Photochemistry and Photobiology, Vol. 74, No. 3, pp. 401–406) in view of by Moyal (“UVA protection labeling and in vitro testing methods,” 2010; RSC, Photochemical & Photobiological Science, Vol. 9, pp. 516–523); SPAULDING (US 2017/0189293; published July 2017) and MAKAROVSKY (US 2018/0168970 A1; published June, 2018).
Applicants Claims
A composition comprising bemotrizinol and at least one active agent, wherein the composition has one or more of the following properties: a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher (instant claim 1).
Determination of the scope
and content of the prior art (MPEP 2141.01)
Chatelain et al. discloses UV screening agents including avobenzone and bemotrizinol, where the latter is suggested to photoprotect the former, as discussed above and incorporated herein by reference.
Moyal discloses sunscreens including Tinosorb S (2 wt.% or 3 wt.%) in combination Avobenzone (3 wt.%), and discussed the critical wavelength, the UVA-PF/SPF ratio, and the UVA1/UV ratio, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of Chatelain et al. is that Chatelain et al. does not expressly teach the composition is anhydrous or the or includes a coloring agent.
SPAULDING teaches photoprotective compositions including avobenzone, and additional UV screening agents such as bis-ethylhexylphenol methoxy triazine (Bemotrizinol)(see whole document, particularly claims 1-2), and further claims “The photoprotective composition of claim 1, wherein said photoprotective composition provides an FDA method critical wavelength of greater than or equal to 370 nm.” And “The photoprotective composition of claim 1, wherein said photoprotective composition meets the 1/3 UVA ratio requirement of ISO 24443.”
SPAULDING teaches the inclusion of color additives, water, bio-active, antioxidant, vitamin, and any combination thereof (claim 13), and that their composition can be emulsions ([0095]), or a cosmetic gel ([0049]).
MAKAROVSKY teaches “This application relates to a topical composition, and more particularly, to a photo protective composition comprising (i) at least one functional active; and (ii) at least one solubilizing compound, wherein, the composition is visibly transparent, free of odor and freeze-thaw stable.” ([0001], see whole document). MAKAROVSKY teaches that: “Non-limiting examples of suitable vitamins include: ascorbic acid (vitamin C), […]. Non-limiting ranges of vitamins include 0.1% to 10% by weight of the total composition. Other non-limiting ranges include 0.1 % to 2%, 2% to 4%, 4% to 6%, 6% to 8% or 8% to 10% by weight of the total composition.” ([0077])(instant claims 15-18).
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 UV screening composition comprising bemotrizinol and at least one active ingredient, and a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher, as suggested by Chatelain et al., Moyal and SPAULDING, to produce a UV screening composition such as emulsion composition or an anhydrous composition, and to include an active such as vitamin C (ascorbic acid), as suggested by MAKAROVSKY.
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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over BECK (US 2013/0315848 A1; published November, 2013) in view of by Moyal (“UVA protection labeling and in vitro testing methods,” 2010; RSC, Photochemical & Photobiological Science, Vol. 9, pp. 516–523).
Applicants Claims
A composition comprising bemotrizinol and at least one active agent, wherein the composition has one or more of the following properties: a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher (instant claim 1).
Determination of the scope
and content of the prior art (MPEP 2141.01)
BECK discloses topical cosmetic compositions including resveratrol and UV screening agents including 2,4-bis((4-(ethyl-hexyloxy)-2-hydroxy)-
phenyl)-6-(4-methoxyphenyl)-1,3,5-triazine (bemotrizinol), as discussed above and incorporated herein by reference.
Moyal discloses sunscreens including Tinosorb S (2 wt.% or 3 wt.%) in combination Avobenzone (3 wt.%), and discussed the critical wavelength, the UVA-PF/SPF ratio, and the UVA1/UV ratio, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of BECK is that BECK does not expressly teach the composition is a gel or the or includes a coloring agent.
BECK teaches the inclusion of color additives and/or water ([0018]), and that their composition can be emulsions ([0020]), or a cosmetic gel ([0025]).
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 UV screening composition comprising bemotrizinol and at least one active ingredient including resveratrol, and a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher, as suggested by BECK and Moyal, to produce a UV screening composition such as emulsion composition or an gel composition.
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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over CHEVALIER (US 2015/0359715 A1; published December, 2015) in view of by Moyal (“UVA protection labeling and in vitro testing methods,” 2010; RSC, Photochemical & Photobiological Science, Vol. 9, pp. 516–523).
Applicants Claims
A composition comprising bemotrizinol and at least one active agent, wherein the composition has one or more of the following properties: a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher (instant claim 1).
Determination of the scope
and content of the prior art (MPEP 2141.01)
CHEVALIER discloses cosmetic or dermatological composition which includes, in a physiologically acceptable medium, at least trans-resveratrol and/or at least one transresveratrol derivative, and an organic filtering system including at least one UVA filter and at least one UVB filter and/or at least one mixed UVA-UVB filter, said composition having an SPF no lower than 15 and a PPD no lower than 5, as discussed above and incorporated herein by reference.
Moyal discloses sunscreens including Tinosorb S (2 wt.% or 3 wt.%) in combination Avobenzone (3 wt.%), and discussed the critical wavelength, the UVA-PF/SPF ratio, and the UVA1/UV ratio, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of CHEVALIER is that CHEVALIER does not expressly teach the composition is a gel or the or includes a coloring agent.
CHEVALIER teaches an example free of TiO2 which is the mineral sunscreen included in Example 2, Compositions 2 & 4 (Example 4), and therefore it would have been prima facie obvious to composition free of mineral UV filters (instant claim 4).
CHEVALIER teaches the inclusion of color additives ([0037] – “skin coloring product”), and that their composition can be emulsions ([0162]), or a cosmetic gel ([0038])(instant claims 7-9).
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 UV screening composition comprising bemotrizinol and at least one active ingredient including resveratrol, and a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher, as suggested by CHEVALIER and Moyal, to produce a UV screening composition such as emulsion composition or an gel composition.
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 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application Nos. 18/543,130 (claims 1-12; hereafter ‘130), 18/543,141 (claims 1-10; hereafter ‘141), 18/543,157 (claims 1-13; hereafter ‘157), 18/543,309 (claims 1-13; hereafter ‘309), 18/543,343 (claims 1-13; hereafter ‘343), 18/543,375 (claims 1-13; hereafter ‘375), 18/543,618 (claims 1-13; hereafter ‘618), 18/543,702 (claims 1-12; hereafter ‘702), 18/543,823 (claims 1-11; hereafter ‘823), and 18/985,642 (claims 1-13; hereafter ‘642) in view of Chatelain et al. (“Photostabilization of Butyl methoxydibenzoylmethane (Avobenzone) and Ethylhexyl methoxycinnamate by Bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S), a New UV Broadband Filter,” 2001; American Society of Photobiology; Photochemistry and Photobiology, Vol. 74, No. 3, pp. 401–406) in view of by Moyal (“UVA protection labeling and in vitro testing methods,” 2010; RSC, Photochemical & Photobiological Science, Vol. 9, pp. 516–523), SPAULDING (US 2017/018293; published July 2017) and MAKAROVSKY (US 2018/0168970 A1; published June, 2018).
Instant claim 1 recites composition comprising bemotrizinol and at least one active agent, wherein the composition has one or more of the following properties: a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher (instant claim 1).
The claims of copending Application Nos. ‘130, ‘141, ‘157, ‘309, ‘343, ‘375, ‘618, ‘702, ‘823, and ‘642 each claim bemotrizinol in combination with one or more of the following properties: a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher.
The difference between the instantly rejected claims and the claims of copending Applications is that the claim of copending Applications do not expressly claim bemotrizinol in combination with avobenzone.
Chatelain et al. discloses UV screening agents including avobenzone and bemotrizinol, where the latter is suggested to photoprotect the former, as discussed above and incorporated herein by reference.
Moyal discloses sunscreens including Tinosorb S (2 wt.% or 3 wt.%) in combination Avobenzone (3 wt.%), and discussed the critical wavelength, the UVA-PF/SPF ratio, and the UVA1/UV ratio, as discussed above and incorporated herein by reference.
SPAULDING teaches photoprotective compositions including avobenzone, and additional UV screening agents such as bis-ethylhexylphenol methoxy triazine (Bemotrizinol), as discussed above and incorporated herein by reference.
MAKAROVSKY teaches topical compositions, and more particularly, to a photo protective composition comprising at least one functional active, and further comprising Vitamin C (ascorbic acid), 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 copending Applications because the each include bemotrizinol in combination with one or more of the following properties: a critical wavelength of at least 370 nm; a UVA-PF/SPF ratio of at least 1/3; and a UVA1/UV ratio of 0.7 or higher. The skilled artisan would have been motivated to modify the claims of copending Applications and produce the instantly rejected claim because avobenzone benefits from bemotrizinol as a photostabilizer. 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 to produce the combination sunscreen of avobenzone and bemotrizinol.
This is a provisional obviousness-type double patenting rejection.
Response to Arguments:
Applicant's arguments filed 06/09/2026 have been fully considered but they are not persuasive.
Applicant argues that: “The Office Action also rejected pending claims under the judicially created doctrine of obviousness-type double patenting over claims in Applications 18/543,130, 18/543,141, 18/543,157, 18/543,309, 18/543,343, 18/543,375, 18/543,618, 18/543,702, 18/543,823, and 18/985,642 in view of Chatelain, Moyal and Spaulding. In view of the above amendments and arguments distinguishing asserted art such as Chatelain and Moyal, Applicant respectfully submits that the asserted claims in the double patenting rejections do not render the claimed subject matter obvious in this case given that the double patenting rejections are based in part of references like Chatelain and Moyal and Spaulding which, as explained above, do not result in the claimed subject matter. As such, Applicant respectfully requests reconsideration and withdrawal of all pending double patenting rejections.” (p. 7, last paragraph).
In response the examiner argues that Chatelain et al. clearly includes a “sunscreen active agent” (instant Specification, p. [0025]) which is susceptible to degradation by UV rays, and particularly Avobenzone. Therefore Applicants argument is not convincing as the argument does not distinguish the claim(s) over the cited reference. Additionally, SPAULDING teaches inclusion of vitamins ([0108], claim 13), and MAKAROVSKY (newly cited) teaches the inclusion of vitamin C (ascorbic acid)([0077]). Accordingly, Applicants arguments are not convincing and the rejection are maintained.
Conclusion
Claims 1-18 are pending and have been examined on the merits. Claims 1-18 are rejected under 35 U.S.C. 112(a); claims 1-18 are rejected under 35 U.S.C. 112(b); claims 1-6, 8 and 10-18 are rejected under 35 U.S.C. 102(a)(1); claims 1-18 are rejected under 35 U.S.C. 103; and claims are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application Nos. 18/543,130; 18/543,141; 18/543,157; 18/543,309; 18/543,343; 18/543,375; 18/543,618; 18/543,702; 18/543,823 and 18/985,642. No claims allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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
Prosecution Insights