DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 21 July 2026, in the matter of Application N° 18/543,597. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No claims have been canceled. Claims 12-17 are newly added and are supported by the originally-filed disclosure.
Claims 1 and 4 have been amended. Claim 1 has been amended to add that bemotrizinol is present in the composition in an amount ranging from about 2.5% to about 10% by weight with respect to the total weight of the composition. Claim 4 has been amended to remove the second sentence limiting the active agent to a flavonoid.
No new matter has been added.
Thus, claims 1-17 now represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Withdrawn Rejections
Rejections under 35 USC 102
Applicants’ amendment to claim 1 adding the weight percent range of bemotrizinol is persuasive in overcoming both of the previously raise anticipation rejections over Raschke and Mintel. Said rejections are withdrawn.
Rejections under 35 USC 103
Applicants’ amendment to claim 1, while not wholly persuasive in overcoming the obviousness rejection in totality, is withdrawn in order to clarify the grounds of rejection.
New Rejections
Applicants’ amendments have necessitated the following ground(s) of rejection:
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. Applicants are 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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Raschke et al. (DE 10 321 145 A1; of record; machine translation cited) further in view of Skotarczak et al. (Eur. Rev. Med. Pharmacol. Sci.; 2015) and Mintel – Superior Anti-Wrinkle Dark Circle Eye Cream (herein referred to as “Mintel”; dated 20 November 2017; of record).
The instantly amended invention of claim 1 is directed to a composition comprising bemotrizinol (aka Tinosorb® S, Escalol S, bis-ethylhexyloxyphenol methoxyphenyl triazine, etc.) and at least one active agent. The claim, as amended, additionally recites that the effective amount required to “improve photostability” of the at least one active agent ranges from about 2.5% to about 10% by weight of the total composition.
Raschke discloses cosmetic and/or dermatological compositions that comprise UV protection substances (see e.g., claims 11 and 13). Paragraph [0081] further defines the compositions as advantageously containing substances that absorb UV-A and/or UV-B radiation and that such compounds are present, most preferably in an amount ranging from 1.0 to 15.0 wt% of the composition. Paragraphs [0072] and [0079] identify: 2,4-Bis-{[4-(2-Ethyl-hexyloxy)-2-hydroxy]-phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine (INCI: Anisotriazine; Tinosorb S) as one such UV filter compound. As discussed in the previously mailed correspondence, this compound is exemplified (see e.g., Formulation 16), and is therefore considered to be a preferred compound for providing UVA/UVB protection.
The Examiner acknowledges that Raschke does not expressly disclose the instantly recited range, or the narrowed ranges newly presented by instant claims 13 and 14, despite preferentially encompassing claimed ranges.
The teachings of Skotarczak provide added insight with respect to the amount of Tinosorb S that is contained within topical cosmetic formulations. Phenylobenzotriazole sulfonic acids (identified also as phenylbenzotriazole sulfonic acids) are disclosed as being broad spectrum filters for both UVA and UVB radiation (see pg. 104, right col.). Three products identified by the article as species of phenylbenzotriazole sulfonic acids include Tinosorb S (bemotrizinol) which is further taught as being fat-soluble and as having a maximum authorized cosmetic concentration of 10% (see pp. 104-105, bridging section).
What this added teaching conveys to the ordinarily skilled artisan is clear motivation to modify Raschke’s most preferred teachings even more so, to a range of 1-10 wt% of the composition. Further consideration of additional preferred teachings by Raschke (e.g., Form. 16) narrows that range even further to 2-10 wt% of the composition.
MPEP §2144.05(I) states that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In the instant case, the Examiner submits that Raschke establishes a prima facie showing of obviousness on its own. However, when considered in view of Skotarczak, the showing of obviousness becomes even tighter owing to the narrowed approved concentration range for Tinosorb S in topical cosmetic formulations.
Regarding newly added claims 15 and 16, the Examiner notes that octocrylene (ethylhexyl 2-cyano-3,3-diphenylacrylate) and octinoxate (aka octyl methoxycinnamate) are disclosed as UV filter substance that may be alternatively used. See ¶[0061]. As their inclusion, alternative to Tinosorb S is optional, the reference is considered to meet the limitations of claims 15 and 16.
Referencing the practiced compositions of Raschke such as Formulation 16, the Examiner submits that it provides added disclosure for the limitations recited by instant claim 6. Therein, it is disclosed that the only other compounds present in the composition that are known in the art to possess utility as UV filters are “TiO2” (aka titanium dioxide), “Titandioxid” (again, titanium dioxide), and ZnO (zinc oxide). Paragraph [0062] of the reference, however, notably defines the latter two as preferred inorganic metal oxide pigment compounds.
Formulation 16 additionally discloses including Grüner Tee Extrakt (green tea extract; aka Camellia sinensis), which is considered to read on the natural extract, polyphenols, and flavonoids limitations of claims 2 and 4 (the incorporated typographical limitation of the claim) and the Chamomile extract limitation of claim 4 (pg. 18, tenth entry). As defined in the stated of the art (see e.g., Khan et al.; pg. 2, first full paragraph), “[g]reen tea contains characteristic polyphenolic compounds” and “[f]lavonols, including quercetin, kaempferol, myricitin, and their glycosides are also present in tea.”
Also as previously discussed, Formulation 16 also contains oxides of iron, titanium, and zinc as inorganic, metallic pigments (see pg. 18, entries 15, 16, and 18). This disclosure meets the limitations of claim 10.
The limitations of instant claim 11 are directed to a method of improving active agent photostability in a composition comprising adding bis-ethylhexyloxyphenol methoxyphenyl triazine to the composition during the formation of the composition in an amount sufficient to improve photostability of the at least one active agent.
The disclosure of Formulation 16 and its discussion above are considered to expressly meet the positively recited step of the claim. Regarding the improvement upon photostability, the Examiner additionally submits that the reference defines bis-ethylhexyloxyphenol methoxyphenyl triazine (aka 2,4-bis-{[4-(2-ethylhexyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine) as a species of light protection filter substance. Paragraphs [0071] and [0072] identify the compound (aka INCI: Aniso triazin) as an advantageous broadband filter of UV-A and UV-B radiation. As such, its disclosure within the practiced formulation is considered to be an amount that conveys the requisite photostability.
The Examiner concedes that the relied upon formulation of Raschke is specifically directed to a foundation formulation. However, with respect to the limitations of claims 7-9 and 17, the reference is also noted as teaching and suggesting that the practiced compositions may be formulated as a solid (i.e., anhydrous) stick or as an emulsion. See ¶[0048] and ¶[0082].
The reference also is noted as specifically disclosing the use of green tea extract, and more generically, aqueous plant extracts. See e.g., ¶[0014]. Raschke does not expressly teach other examples of plant extracts such as Polygonum Cuspidatum Root Extract.
Mintel is considered to remedy this deficiency.
The listed ingredients of the Mintel composition disclose comprising: Bis-ethylhexyloxyphenol Methoxyphenyl triazine (aka bemotrizinol) and resveratrol, thereby meeting the limitations of claims 1-3 and 11.
Additional ingredients within the cream include an aging herbal extract OB containing apigenin, quercetin, luteolin, and rutin, all of which are both flavone/flavonoid and polyphenol compounds, thereby meeting claims 2 and 4.
The cream formulation also contains Polygonum Cuspidatum Root Extract, which according to the state of the art is a source for polydatin (aka piceid), resveratrol, flavonoids, amino acids, and vitamins (see e.g., Park et al.; pg 2 of 15, first full paragraph). Disclosure of Polygonum Cuspidatum Root Extract is thus considered to meet the limitations recited by instant claims 2-5.
Lastly, the use of CI 40800 in the practiced composition is the designation for a synthetically made form of beta-carotene, which operates as an orange-yellow colorant compound as is recognized by the state of the art (see e.g., www.skincarelab.org/ingredient/ci-40800-beta-carotene/).
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition and arriving at the recited method of using said composition to improve photostability of other agents with which it is co-formulated.
As discussed by Raschke and further defined by Skotarczak, bemotrizinol is a compound that is recognized in the art as providing protection against both UV-A and UV-B radiation and as being topically, cosmetically formulated at a concentration of no more than 10% of the composition. Where Raschke could be considered deficient is with respect to its failure to explicitly disclose other natural extracts such as Polygonum Cuspidatum Root Extract. Mintel is considered to alleviate this deficiency by demonstrating that the extract is known to be used in cosmetic compositions. According to the foregoing discussion pertaining to the constituents of Polygonum Cuspidatum Root Extract, this extract contains several compounds that are also disclosed by Raschke (i.e., flavonols, flavonoids, etc.). MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.”
Following on the disclosures of the references, the Examiner respectfully advances that a person of ordinary skill in the art would have had a reasonable expectation of successfully producing the instantly claimed composition by modifying the composition of Raschke to include Polygonum Cuspidatum Root Extract.
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, and absent a clear showing of evidence to the contrary.
All claims have been rejected; no claims are allowed.
Conclusion
Applicants’ amendments 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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