Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
The Applicant’s reply filed on 4/20/26 is acknowledged. Claims 16-19, 21, 25, and 29-36 are pending. Claims 35 and 36 are new. Claims 16, 25, and 29-34 have been amended. Claims 16-19, 21, 25, and 29-36 are under consideration.
Objections Withdrawn
The objections to claims 16 and 29 are withdrawn in view of the amended claims.
Rejections Withdrawn
The rejection of Claims 16-19, 21, 25, and 29-34 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the amended claim(s).
The rejection of Claims 25 and 29-34 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is withdrawn in view of the amended claim(s).
Rejections Maintained and New Grounds of Rejections
Claim Objections
Claims 16 and 29 are objected to because of the following informalities:
In claims 16 and 29, the Markush group of (d) appears to be missing a comma between “peg-100 stearate” and “peg-40”, and also between “hydrogenated castor oil” and “titanium dioxide”.
In claims 16 and 29, the Markush group of (d) includes numerous repeated ingredients including phenoxyethanol, several of the parabens, homosalate, dimethicone, zinc stearate, dicaprylyl ether, ethylhexyl, and 1-2 hexanediol. The list should be checked carefully for all repeated compounds.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-19, 21, 25, and 29-36 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 16 and 29, the Markush group of (d) includes “ethylhexyl”. This is not a full chemical name and it appears that the rest of the term is missing. In addition, “ethylhexyl” alone does not appear in the instant specification. The metes and bounds of the claims are unclear because it is unclear what compound is permitted to be part of the claims. Dependent claims 17-19, 21, 25, and 30-36 are rejected as depending from and no clarifying indefinite claims 16 and 29.
Claim Rejections - 35 USC § 103
The following The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 16-19, 21, 25 and 29-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stada (EP 1591105 A1; cited in IDS, translation provided in parent) in view of Stein et al. (US 5,705,169; 1998).
Stada teaches the use of antioxidants and compositions thereof for the protection of skin against infrared radiation (e.g. abstract). Stada teaches the compositions comprising antioxidants, including D-carnosine and/or L-carnosine and derivatives thereof (i.e. compound of Formula (I)), UV filters and a carrier (e.g. paragraphs 0010, 0020). Stada exemplifies a composition comprising one of more antioxidants, one or more UV filters, a carrier, and titanium dioxide (e.g. Example 5). While the example does not comprise carnosine as the antioxidant it would have been obvious to one of ordinary skill in the art at the time of the instant invention to replace the exemplified antioxidant (α-tocopherol acetate, α-bisabolol, and green tea extract) with carnosine. Stada teaches these antioxidants to be appropriate for the composition and one of ordinary skill in the art would have predicted success in selecting any of those recited in paragraph 0010 including carnosine.
Stada teaches a method consisting of a step of applying the composition onto human skin for damage caused by the activation of the formation of matrix metalloproteinase 1 (e.g. paragraph 0013-0020; Claims 1 and 2). Stada teaches the compositions can preferably be used during the irradiation of the skin with sun rays to protect against damage from IR and UV rays (e.g. paragraph 0021). Stada teaches that the composition protects the skin against IR radiation and that the “…use of antioxidants according to the invention presumably leads to a reduction of the content of reactive oxygen species. This will cause IR radiation activated and mediated via the MAPKinase signaling pathway formation of Matrix metalloproteinase-1 counteracted” (emphasis added. e.g. paragraphs 0004, 0012; Claim 11). Stada exemplifies the total antioxidant (a) and total UV filters (b) as 2.1 % and 15 % by weight respectively (e.g. Example 5). This results in a ratio of about 12:88, which is slightly below that of Claim 16. Stada also teaches the ranges of total antioxidant (a) and total UV filters (b) as 0.001-25 % and 0.1-15 % by weight respectively (e.g. paragraphs 0016 and 0025). This results ratios which overlap the ranges of claims 16 and 24. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I). In addition, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the concentrations of (a) and (b) through routine experimentation to arrive at the claimed ratios in order to optimize the resulting drug. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding the limitation “for the inhibition of MMP-1 expression induced by UV radiation” in addition to the teachings already described, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case Stada teach a drug comprising the claimed ingredients which is applied to human skin, therefore the claims have been met.
Regarding the limitation “in an amount effective to inhibit at least one of…”, the instant Specification indicates that the preferred concentration of (a) is 0.05-19.5 wt% and (b) is 0.05-19 wt% (i.e. effective amounts) (e.g. paragraph 0036). Stada exemplifies the total antioxidant (a) and total UV filters (b) as 2.1 % and 15 % by weight respectively, which are within the range (e.g. Example 5). Stada also more broadly teaches the ranges of total antioxidant (a) and total UV filters (b) as 0.001-25 % and 0.1-15 % by weight respectively (e.g. paragraphs 0016 and 0025).
Stada does not teach that the UV protection factor is the elected species of ketotricyclo(5.2.1.0) decane derivatives. This is made up for by the teachings of Stein et al.
Stein et al. teach ketotricyclo[5.2.1.0]decane derivatives and their preparation and use as UV filters, in particular in cosmetic or pharmaceutical preparations (e.g. abstract). Stein et al. teach that the sunscreen filters customary today in cosmetics are divided into UVA and UVB filters, and it has been found that ketotricyclo[5.2.1.0]decane derivatives of the formula I, have outstanding UVA filter properties (e.g. column 1, lines 50-55 and column 2, lines 7-36). Stein et al. teach that the extremely high extinction coefficients make possible the formulation of sunscreen compositions having a high sun protection factor combined with a low use concentration, and furthermore, the compounds of the formula I can also be used for the prophylactic treatment of inflammations and allergies of the skin and for the prevention of certain types of cancer, are distinguished by a good thermal and photochemical stability, have the advantage of being non-toxic or -irritant and completely harmless to the skin, and they disperse uniformly in the conventional cosmetic carriers and can in particular form a continuous film in fatty carriers; they can be applied to the skin in this way in order to form an effective protective film (e.g. column 1, lines 50-55 and column 2, lines 7-36). Stein et al. teach that the ketotricyclo[5.2.1.0]decane derivatives have improved performance compared to dibenzoylmethanes and benzylidenecamphor derivatives (e.g. column 1, lines 56-end).
Regarding Claims 16-19 and 29, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to include the ketotricyclo[5.2.1.0]decane derivatives of Stein et al. for use in the method of Stada. Stada teaches the inclusion of UV filters, including dibenzoylmethanes and benzylidenecamphor derivatives, and Stein teaches that ketotricyclo[5.2.1.0]decane derivatives have improved properties compared to the same UV filters. It would have been obvious to one of ordinary skill in the art at the time of the instant invention to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. Both of the compositions are useful as topical cosmetic compositions comprising UV filters, and one of ordinary skill would have been motivated in order to provide the benefits of the extremely high extinction coefficients, a high sun protection factor, low use concentration, the prophylactic treatment of inflammations and allergies of the skin and for the prevention of certain types of cancer, good thermal and photochemical stability, are non-toxic or -irritant and completely harmless to the skin, they disperse uniformly in the conventional cosmetic carriers and can in particular form a continuous film in fatty carriers (e.g. column 1, lines 50-55 and column 2, lines 7-36).
Regarding Claim 21, Stada exemplify a carrier of alcohol and water (e.g. Example 5).
Regarding Claims 25 and 30-34, Stada exemplifies the total antioxidant (a) and total UV filters (b) as 2.1 % and 15 % by weight respectively, which are within the range (e.g. Example 5). Stada also broadly teaches the ranges of total antioxidant (a) and total UV filters (b) as 0.001-25 % and 0.1-15 % by weight respectively (e.g. paragraphs 0016 and 0025). This results in values which overlap with the claimed ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding Claims 35 and 36, Stada teaches that the compositions can comprise emulsifiers (e.g. paragraph 0029 and Claim 10) and exemplify a water-in-oil composition comprising polyglyceryl-2 dipolyhydroxystearate e.g. Example 5).
Response to Arguments
Applicant's arguments filed 4/20/26 have been fully considered but they are not persuasive. Arguments relevant to the references used in this office action will be addressed below.
Applicant argues that Neither Stada nor Stein teach or suggest any of the compounds listed in (d), thus rendering the claims patentable of Stada in view of Stein.
This is not found persuasive. Stada exemplifies the inclusion of titanium dioxide, which is recited in the third line of the Markush group of (d).
Applicant argues that Stada recites a voluminous group of antioxidants and there is nothing in Stada that would prompt a skilled person in the art to select carnosine from that list
This is not found persuasive. In the Board decisions on 11/2/22 and 10/17/25 the Examiner was affirmed. Specifically, on page 5 of the Patent Board Decision 11/2/22, “[w]e agree with the Examiner that it would have been obvious to a skilled artisan to have selected any of the antioxidants disclosed by Stada, including carnosine”.
Applicant further argues that the preamble "for the inhibition of MMP-1 expression induced by UV radiation" is not a mere intended use and is not inherently satisfied by the prior art.
This is not found persuasive. As described supra, Stada teaches a method consisting of a step of applying the composition onto human skin for damage caused by the activation of the formation of matrix metalloproteinase 1 (e.g. paragraph 0013-0020; Claims 1 and 2). Stada teaches the compositions can preferably be used during the irradiation of the skin with sun rays to protect against damage from IR and UV rays (e.g. paragraph 0021). Stada teaches that the composition protects the skin against IR radiation and that the “…use of antioxidants according to the invention presumably leads to a reduction of the content of reactive oxygen species. This will cause IR radiation activated and mediated via the MAPKinase signaling pathway formation of Matrix metalloproteinase-1 counteracted” (emphasis added. e.g. paragraphs 0004, 0012; Claim 11). Regarding the limitation “in an amount effective to inhibit at least one of…”, the instant Specification indicates that the preferred concentration of (a) is 0.05-19.5 wt% and (b) is 0.05-19 wt% (i.e. effective amounts) (e.g. paragraph 0036). Stada exemplifies the total antioxidant (a) and total UV filters (b) as 2.1 % and 15 % by weight respectively, which are within the range (e.g. Example 5). Stada also more broadly teaches the ranges of total antioxidant (a) and total UV filters (b) as 0.001-25 % and 0.1-15 % by weight respectively (e.g. paragraphs 0016 and 0025). In addition, in the Board decisions on 11/2/22 and 10/17/25 the Examiner was affirmed. Specifically, on page 7-8 of the Patent Board Decision 10/17/25, “the evidence of record suggests that all human skin is susceptible to MMP-1 expression when exposed to sunlight. Thus, the limitations in the appealed claims relating to inhibition of, e.g., MMP-1 activation, is met by Stada's teaching of topical application of its composition to skin, or at least topical application of its composition to skin during irradiation of the skin with sun rays”
Conclusion
No claim is allowed.
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 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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