DETAILED ACTION
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 .
Status of Claims
The status of the claims are as follows:
Claims 1-15 are pending.
Claims 1-15 are rejected.
Priority
The Instant Application 18/543,287, filed on 2023, Dec., 18, does not claim priority to any earlier filing.
Information Disclosure Statement
The Instant Application 18/543,287, filed on 2023, Dec., 18, did not submit an information disclosure statement for consideration.
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 06/30/2026, with respect to
Amending paragraphs 0033 and 0166 of the instant specification;
Tayca Corporation, as mentioned on paragraphs 0090 and 0091 of the instant specification;
Amending of claim 1 to include the phrase “at least one” before “booster”;
Amending of claim 11 to delete all caps;
have been fully considered and are persuasive. The objections above have been withdrawn.
Applicant’s arguments, see “Remarks”, filed 06/30/2026, with respect to rejection under 35 U.S.C. 102 as anticipated by Deckner (US 2018/0263866) has been fully considered and is persuasive. The presently amended claim 1 sufficiently yields a distinct bemotrizinol composition. Accordingly, the rejection of claims 1-4, 7-13, and 15 as anticipated by Deckner have been withdrawn.
Applicant’s arguments, see “Remarks”, filed 06/30/2026, with respect to rejections based on the judicially created doctrine of obviousness-type double patenting by co-pending Application Numbers 18/543,130; 18/543,618; 18/543,860; 18/543,823; 18/543,343; and 18/543,141 has been fully considered and is persuasive. The presently amended claim 1 yields a bemotrizinol composition that is distinct from each of the co-pending Applications. Accordingly, all claim rejections based on obviousness-type double patenting have been withdrawn.
Applicant’s arguments, see “Remarks”, filed 06/30/2026, with respect to the rejection(s) of claims 1, 2 and 5-15 under 35 U.S.C. 102 as anticipated by Spaulding (WO 2015/152865) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Spaulding (WO 2015/152865). This is a second non-final Office Action.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spaulding (WO 2015/152865; published 2015, Oct. 08) as evidenced by Tuchayi (Sunscreens: Misconceptions and Misinformation, J. Invest. Derm., 2023, 143, 1406-1411. Doi:10.1016/j.jid.2023.03.1677), and evidenced by Scarpin (Effects of UV-Filter Photostabilizers in the Photostability and Phototoxicity of Vitamin A Palmitate Combined with Avobenzone and Octyl Methoxycinnamate. Photochem Photobiol., 2021, 96, 700-709. Doi: 10.1111/php.13407).
The presently amended claim 1 is directed to a composition comprising bemotrizinol, a fatty phase comprising at least one oil, at least one lipophilic organic UV filter which is dissolved or dispersed in a colloidal form in the liquid fatty phase, and at least one booster, wherein the at least one booster is present in an amount sufficient to increase UV efficacy of the composition, wherein the bemotrizinol and the at least one booster are present in the composition in a weight ratio from about 10:1 to about 1:1.
Spaulding teaches non-irritating, non-whitening photoprotective compositions comprising one or more photoactive agents, at least one aliphatic hydrocarbon, and at least one ester (title, abstract). Specifically, Spaulding teaches composition B5 (page 6, Table 3).
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Composition B5 comprises bemotrizinol, an oil in the form of isohexadecane (described as a particularly preferred oil on page 33, paragraph 140 of the instant spec), at least one lipophilic organic UV filter in the form of homosalate (page 23, paragraph 0097 of the instant specification), and at least one booster, in the form of butyloctyl salicylate. Butyloctyl salicylate meets the definition of the booster as provided by the instant specification (page 7, paragraph 0035) because it is not therein defined as a UV filter and is known in the art as an SPF booster (see Tuchayi).
The difference between composition B5 and the instant application is that the composition is not comprised of when the bemotrizinol and the at least one booster are present in a weight ratio from about 10:1 to about 1:1.
However, Spaulding also teaches composition A1-A3, comprising isohexdecane, homosalate, and ethylhexyl methoxycrylene (EHMC) (page 6, Table1).
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One of ordinary skill in the art would be motivated to substitute butyloctyl salicylate with EHMC because the art recognizes that butyloctyl salicylate is a UVB absorber and thus would decrease the UVA ratio (see Tuchayi). Additionally, Spaulding notes that composition B5 did not meet the 1/3 UVA ratio according to the ISO 24443 method due to the SPF boosting provided by the addition of butyloctyl salicylate (page 7, paragraph 0040). In the alternative, EHMC is known in the art as a photostabilizer for avobenzone which contributes to UVA/UVB absorption (see Scarpin). Additionally, Spaulding notes that SPF can be boosted with adjuvants such as ethylhexyl methoxycrylene (page 6, paragraph 0038).
Said artisan could therefore apply the prong (B) rationale of In re KSR Int’l Co., 550 U.S. 398 (2007), in which obviousness entails simple substitution of one known element for another to obtain predictable results. Prior to the effective filing date of the current invention, it would have been prima facie obvious to substitute butyloctyl salicylate for EHMC to achieve the desired bemotrizinol composition with a reasonable expectation of success, the resulting composition of which comprising a ratio of bemotrizinol (2%) and EHMC (1%) that falls within the claimed range.
Claim 2 is directed to the bemotrizinol composition, wherein the at least one booster is present in an amount sufficient to increase SPF of the composition
The bemotrizinol composition of Spaulding arrived at by applying prong (B) rationale of In re KSR Int’l Co., 550 U.S. 398 (2007) comprises the booster EHMC, which is noted to boost SPF (page 6, paragraph 0038).
Claim 3 is directed to the bemotrizinol composition, wherein the at least one booster is present in an amount sufficient to increase at least one of SPF, UVAPF, Critical Wavelength, and/or UVA- I/UV ratio of the composition
The bemotrizinol composition of Spaulding arrived at by applying prong (B) rationale of In re KSR Int’l Co., 550 U.S. 398 (2007) comprises the booster EHMC, which is noted to boost SPF (page 6, paragraph 0038).
Claim 4 is directed to the bemotrizinol composition, wherein the bemotrizinol and the at least one booster are present in the composition in a weight ratio from about 8:1 to about 1.5:1.
The bemotrizinol composition of Spaulding arrived at by applying prong (B) rationale of In re KSR Int’l Co., 550 U.S. 398 (2007) comprises the booster EHMC, wherein the bemotrizinol and the EHMC are present in the composition in a weight ratio of 2:1
Claims 5-6 are directed to the bemotrizinol composition, wherein the composition has a UVAPF/SPF ratio of at least 1/3, and a UVA1/UV ratio of 0.7 or higher, and wherein the SPF value is at least 30.
Spaulding fails to teach a specific embodiment wherein the bemotrizinol composition has a UVAPF/SPF ratio of at least 1/3, and a UVA1/UV ratio of 0.7 or higher, and wherein the SPF value is at least 30.
However, the recited parameters have become the de facto industry standard for sunscreens marketed in the EU, per European Commission Recommendation 2006/647/EC, issued on 2006, Sept. 22. Bemotrizinol is an approved UV filter in Europe and is found in many commercial products, for example, the sun care product Photoderm by Bioderma®. Additionally, compositions A1-A3 of Spaulding comprising ethylhexyl methoxycrylene meet the minimum critical wavelength of 370 nm as required by the FDA to ensure a higher UVAPF/SPF ratio.
Therefore, prior to the effective filing date of the current invention, one of ordinary skill in the art could have routinely optimized the bemotrizinol composition of Spaulding arrived at by applying prong (B) rationale of In re KSR Int’l Co., 550 U.S. 398 (2007) to arrive at a composition that has a UVAPF/SPF ratio of at least 1/3, and a UVA1/UV ratio of 0.7 or higher, and wherein the SPF value is at least 30.
Claim 7 and 16 are directed to the bemotrizinol composition, further comprising at least one mineral UV filter, wherein the mineral UV filter is selected from the group consisting of titanium dioxide, zinc oxide, and mixtures thereof.
Spaulding teaches photoprotective compositions wherein the photoactive agent is selected from the group comprising zinc oxide and titanium dioxide (page 4, paragraph 0027; claim 2).
Claim 8 is directed to the bemotrizinol composition, further comprising at least one additional organic UV filter selected from the group consisting of Avobenzone, Octisalate, Ensulizole, Homosalate, Octocrylene, and mixtures thereof.
The bemotrizinol composition of Spaulding arrived at by applying prong (B) rationale of In re KSR Int’l Co., 550 U.S. 398 (2007) comprises all of homosalate, octisalate, octocrylene, and avobenzone.
Claim 9 is directed to the bemotrizinol composition, wherein the composition is free of mineral UV filters.
Spaulding teaches photoprotective compositions wherein the photoactive agent may be selected as compounds that are not zinc oxide or titanium dioxide, therefore being free of mineral UV filters (page 4, paragraph 0027; claim 2).
Claim 10 is directed to the bemotrizinol composition, wherein the composition is free of oxybenzone and/or octinoxate.
Spaulding teaches photoprotective compositions that may be free of oxybenzone. For instance, in one embodiment, oxybenzone is not needed in order to provide a photoprotective composition (page 2, paragraph 0028). Spaulding does not teach any embodiment that includes octinoxate.
Claim 11 is directed to the bemotrizinol composition, wherein the composition is free of ethylhexyl triazone, drometrizole trisiloxane, methylene bis-benzotriazolyl tetramethylbutyl phenol, diethylamino hydroxybenzoyl hexyl benzoate, diethylhexyl butamido triazone, isoamyl p-methoxycinnamate, polysilicone-15, 4-methylbenzylidene camphor, disodium phenyl dibenzimidazole tetrasulfonate, and/or methoxypropylamino cyclohexenylidene.
Spaulding does not teach any embodiment comprised of ethylhexyl triazone, drometrizole trisiloxane, methylene bis-benzotriazolyl tetramethylbutyl phenol, diethylamino hydroxybenzoyl hexyl benzoate, diethylhexyl butamido triazone, isoamyl p-methoxycinnamate, 4-methylbenzylidene camphor, disodium phenyl dibenzimidazole tetrasulfonate, and/or methoxypropylamino cyclohexenylidene. Additionally, polysilicone-15, is optionally included in some embodiments (claim 14) and therefore teaches bemotrizinol compositions that are free of it.
Claims 12 and 17 are directed to the bemotrizinol composition, wherein the at least one booster is selected from the group consisting of ethylhexyl methoxycrylene, waxes, wherein the wax is carnauba wax, and mixtures thereof.
The bemotrizinol composition of Spaulding arrived at by applying prong (B) rationale of In re KSR Int’l Co., 550 U.S. 398 (2007) is comprised of ethylhexyl methoxycrylene.
Claim 13 is directed to the bemotrizinol composition, in the form of an emulsion.
Spaulding teaches dimethicone is an emulsifier (page 14, paragraph 0089), which is used in composition B5 (page 7, Table 3).
Claim 14 is directed to the bemotrizinol composition, further comprising at least one coloring agent.
Spaulding teaches bemotrizinol compositions comprising coloring additives (page 13, paragraph 0086; claim 12).
Claim 15 is directed to the bemotrizinol composition, further comprising at least one active agent.
Spaulding teaches bemotrizinol compositions comprising one or more photoactive agent (abstract, claim 2).
Claim 18 is directed to the bemotrizinol composition, wherein the composition is anhydrous.
Spaulding teaches bemotrizinol compositions that are anhydrous (abstract).
Conclusions
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Arcoria whose telephone number is (571)272-8719. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/P.A./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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