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 .
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).
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
In the instant case the Abstract is only 31 words and is therefore objected to.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 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.
Scope of the Claimed Invention:
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). 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).
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.
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)).
Claim Rejections - 35 USC § 112(b)
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.
Claim 2 is 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.
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 “preferably all three of the properties”, and the claim also recites “has two or more of the properties” which is the narrower statement of the range/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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 8 and 10-12 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.” (p. 402, col. 1, §MATERIALS AND METHODS, 1st paragraph). 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).
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).
Claims 1-6 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Moyal (“UVA protection labeling and in vitro testing methods,” 2010; RSC, Photochemical & Photobiological Science, Vol. 9, pp. 516–523).
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
Moyal discloses sunscreens including Tinosorb S (2 wt.% or 3 wt.%) in combination Avobenzone (3 wt.%)(p. 521, Table 7, Product 3.A and 3.D). Moyal discloses that: “filter when photostabilized. In addition, some products contained from 2% to 4% avobenzone, which is the most efficient long UVA All products contained […] Tinosorb® S […] able to improve UVA broadness and UVA protection and level.” (p. 521, col. 2, last paragraph). Moyal discloses the critical wavelength λc as being at least 370 nm (Table 7), the UVA1/UV ratio of 0.91 or 0.92 (3.A) and 0.78 or 0.82 (3.D). The examiner notes that the UVA-PF and UVA1/UVA ratio vary based on the method used to determine the same (method #2 or #4)(instant claims 1-2 and 10-12).
Additionally, regarding the claimed properties of instant claims 1-3 and 10-12, the amounts of Tinosorb S and Avobenzone are consistent with Applicants own Example 1 including Avobenzone 3.00 wt.%, and Bemotrizinol 3.00 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 = 3% + bemotrizinol = 2% or 3%)(instant claim 5), the composition 3.A is free of oxybenzone and/or octinoxate (instant claim 6).
Claims 1-4, 6-7 and 9-12 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by CHEVALIER (US 2010/0310481; published December, 2010).
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
CHEVALIER discloses Example 4 including Butyl methoxydibenzoylmethan (Avobenzone) and Bis-ethylhexyloxyphenol methoxyphenyl triazine (bemotrizinol) in an amount of 4 wt. % and 3 wt.%, respectively (p. 9, Table at bottom of Col. 2). The compositions are directed to Anhydrous products (title, abstract, see whole document)(instant claim 7). The compositions included at least one coloring agent (Dye - p. 9, Table at bottom of Col. 2)(instant claim 9).
The amounts of bemotrizinol and Avobenzone are consistent with Applicants own Example 1 including Avobenzone 3.00 wt.%, and Bemotrizinol 3.00 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 the compositions are free of oxybenzone and/or octinoxate (instant claim 6), the compositions are anhydrous (instant claim 7).
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 1-12 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) and SPAULDING (US 2017/0189293; published July 2017).
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 and/or water (claim 13), and that their composition can be anhydrous (claim 23).
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.
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 1-12 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) and SPAULDING (US 2017/018293; published July 2017).
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.
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.
Conclusion
Claims 1-12 are pending and have been examined on the merits. Claims 1-12 are rejected under 35 U.S.C. 112(a); claim 2 is rejected under 35 U.S.C. 112(b); claims 1-12 are rejected under 35 U.S.C. 102(a)(1); claims 1-12 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.
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