DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 23, 2026 has been entered.
Election/Restrictions
To summarize the applicant’s election, the species where the alkylamidothiazole is
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was elected without traverse.
Claim Rejections - 35 USC § 112
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 76-94 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims now recite a composition comprising “N-(4-(2,4-dihydroxyphenyl)thiazol-2-yl)isobutyramide and ethylhexyl salicylate in a weight ratio of 1 : 160 and/or (ii) N-(4-(2,4-dihydroxyphenyl)thiazol-2-yl)isobutyramide and benzimidazolsulfonic acid in a weight ratio of 1 : 240”. The compound benzimidazolsulfonic acid was not mentioned in the original disclosure. Instead, phenyl benzimidazolsulfonic acid is the compound discussed. The applicant argues that the pairing of N-(4-(2,4-dihydroxyphenyl)thiazol-2-yl)isobutyramide (henceforth DTI) with ethylhexyl salicylate and DTI with phenyl benzimidazolsulfonic acid produced a greater than additive inhibition of tyrosinase activity when tested, while tested pairs of DTI with two other UV filters produced a less than additive inhibition of tyrosinase activity. The combination of DTI and ethylhexyl salicylate was not tested at a 1:160 ratio, as is currently claimed. In addition, the claimed benzimidazolsulfonic acid was not tested at all. Instead phenyl benzimidazolsulfonic acid was paired with DTI at 1:160 and not the 1:250 ratio recited for benzimidazolsulfonic acid. No particular ratio of DTI to UV filter was discussed in the disclosure as important to the function of the claimed composition. None of the examples in the disclose illustrate a 1:160 ratio of DTI to ethylhexyl salicylate. The applicant has argued during the course of prosecution that the pairing of DTI with phenyl benzimidazolsulfonic acid or ethylhexyl salicylate was unexpectedly synergistic (see remarks dated November 29, 2023). A single concentration of ethylhexyl salicylate with DTI was tested one time and had a 43.2% tyrosinase inhibitory effect, while the additive impact of the two compounds would have been 42.2%. This small difference could be accounted for by experimental error. However, based upon the applicant’s premise of an unexpected outcome from the tested concentration and ratio, there is no clear indication that the untested currently claimed ratio would be expected to function to a greater than additive degree. Since no discussion was provided in the disclosure that permits extrapolation from the single tested concentration combination, the ethylhexyl salicylate and DTI pairing as instantly claimed has no written basis in the disclosure. Benzimidazolsulfonic acid was not originally disclosed as a compound of the invention, thus the claim to its combination at a particular ratio with DTI also does not have written basis in the disclosure. As a result, the artisan of ordinary skill would not have deemed the applicant to be in possession of the invention as claimed.
This is a new matter rejection.
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 80 is the 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.
The claim recites that benzimidazolsulfonic acid is the only UV filter substance present. It is not evident that this compound is a UV filter, thus it is unclear if UV filters are actually limited in the composition. Therefore the scope of the composition is unclear.
Claim Rejections - 35 USC § 103
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, 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 76, 79, 82-84, 89-91, and 93 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kolbe et al. (previously cited – US PGPub No. 2013/0039870 relied upon as English equivalent) in view of Max et al. (previously cited) and Filbry et al. (US PGPub No. 2011/0268674) as evidenced by Nguyen-Kim et al. (previously cited), Chang et al. (previously cited), and Dornoff et al. (US Patent No. 5,747,006).
Kolbe et al. teach cosmetic or dermatologically preparations that are composed of a thiazole derivative for application to skin and hair (see abstract and paragraph 33; instant claims 76 and 91-94). The composition is taught to be applied to human skin to reduce undesired pigmentation (see paragraphs 9, 24, 30 and claim 16; instant claim 76, 91, and 93). They go on to teach the combination of substances that absorb UV-B radiation with the thiazole derivatives is advantageous (see paragraph 47). Such substances are known as UV-B light filters (see Nguyen-Kim et al.; paragraph 192). These UV-B filters are taught to preferably be present at 0.5 to 10 wt% (see paragraph 47; instant claim 76). The thiazole derivatives of Kolbe et al. are taught at 0.00001 to 10 wt% and more preferably at 0.005 to 1 wt% (see paragraph 31; instant claim 81). Specific thiazoles of Kolbe et al. are taught to include the structure
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where A may be an alkylamido group, one of seven groups of options (see claims 7-8). More specifically, the substituents may be A = N(R1)2, R1 = H, R1 =linear or branched -C=O alkyl, and Y = H where the R1s and Y can be different and embrace the DTI alkylamidothiazole of the elected species (see claim 7). Further, Kolbe et al. demonstrate the tyrosinase inhibition properties of their thiazole compounds at 100 mg/ml and link this to their ability to inhibit skin pigmentation (see paragraph 29 and table 1). Kolbe et al. go on to teach types of cosmetic and dermatological formulation forms of their compositions, where water-in-oil emulsions, oil-in-water emulsions, solid stick, aerosol, as well as cleaning compositions for hair (shampoo) and skin are detailed (see paragraphs 32-33; instant claims 82-84 and 89-90). Specific filter varieties are not named.
Max et al. teach a composition to treat hyperpigmentation that includes a tyrosinase inhibitor as the active component (see paragraphs 19 and 24 and Chang et al. figure 3j and page 2450 last partial paragraph-page 2451 first partial paragraph). They go on to prepare formulations that combine this skin lightening tyrosinase inhibitor active with UVB filters (see paragraphs 49-63). Max et al. teach ethyl hexyl salicylate as a preferred salicylic acid ester, oil soluble UVB filter that is envisioned in the composition (see paragraphs 52 and 56; instant claims 76 and 79). Max et al. further exemplify compositions with UVB filters included individually or in pairs (see examples no 7 and 8).
Filbry et al. teach a topical composition with UVB filters that are envisioned and exemplified as ethylhexyl salicylate (see abstract and, paragraph 84-85, and formulas 1 and 2). Here the ethylhexyl salicylate is included at 1.5 wt% (see formulas 1 and 2). Tyrosinase inhibitors (e.g., licorice root extract) are also included in combination with this UV filter (see formulas 1 and 2; Dornoff et al. column 3 line 67-column 4 line). They also exemplify concentrations of ethylhexyl salicylate at 0.5 wt%, 2 wt%, 2.5 wt%, and 4 wt% (see examples 1 and 3-5).
It would have been obvious to one of ordinary skill in the art at the time of the invention to look to the additional teachings provided by Kolbe et al. to guide the choices for R1 when A includes a nitrogen as well as the class of alkyl substituents envisioned to guide the selection when R1 includes an alkyl. Repeatedly, Kolbe et al. teach A= N(R1)2 and a hydrogen as one of the R1 substituents where the other is a different substituent (see claim 9). Thus it would have been obvious to choose A= N(R1)2 and hydrogen for one of the R1 groups. In addition, other recitations of alkyl substituents that are envisioned to be linear or branched recite a C1 to C24 collection of compounds (see claim 7 options for R1, X, and Y). As an envisioned and claimed option for R1, the selection of -C=O alkyl (linear or branched) as the other R1 also would have been obvious where C1 to C24 alkyls are considered. The selection of any of the linear or branched C1 to C24 alkyl groups would follow, including the branched C4 alkyl group of the elected species (see instant claim 76). There is no evidence of record that points to an unexpectedly superior result being gleaned from the elected compound and Kolbe et al. teach that the thiazoles of their invention are extremely effective at their intended use of pigmentation inhibition (see paragraph 29). It additionally would have been obvious to pair this compound with a UV-B filter(s) to absorb radiation as Kolbe et al. suggest and at the suggested concentrations. More specifically, it would have been obvious to select ethylhexyl salicylate as a particular UVB filter taught by Max et al. and Filbry et al. or as part of a UVB filter combination (see instant claims 76 and 79). This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., specific UV-B filter vs generic UV-B filter). The use of the tested 100 mg/ml concentration of the tyrosinase inhibitors of Kolbe et al. for DTI would follow as would the use of the 1.5 wt% concentration for ethylhexyl salicylate exemplified by Filbry et al. Assuming a composition density of approximately 1 g/ml, this ratio of DTI to ethylhexyl salicylate corresponds to about 1:150 (0.01 wt%:1.5 wt%). The application of the other exemplified concentrations for ethylhexyl salicylate in Filbry et al. also fall within the range envision by Kolbe et al. and yield a range of ratios that embrace the 1:160 ratio of DTI thiazole to ethylhexyl salicylate; thus this ratio is obvious. “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)” (see MPEP 2144.05). Formulation of the composition in forms as suggested by Kolbe et al. would follow (see instant claims 82-84 and 89-90). Application of these compositions to human skin as, envisioned by Kolbe et al., to lighten undesired skin pigmentation would also follow (see instant claims 91 and 93). Therefore claims 76, 79, 82-84, 89-91, and 93 are obvious over Kolbe et al. in view of Max et al. and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
Claims 76, 79, 82-91, and 93 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kolbe et al. in view of Max et al. and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al. as applied to claims 76, 79, 82-84, 89-91, and 93 above, and further in view of Vielhaber et al. (previously cited).
Kolbe et al. in view of Max et al. and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al. render obvious the limitations of instant claims 76, 79, 82-84, 89-91, and 93, where the compositions comprising a tyrosinase inhibitor containing preparation for hair and skin can take several formulation forms. A hair tonic, antidandruff shampoo, and antiperspirant/deodorant are not explicitly detailed forms.
Vielhaber et al. teach skin and hair lightening compositions that include a tyrosinase inhibitor as the chemical active to confer this property that is coupled with a UV filter (see paragraphs 38-39 and 43 and claims 1 and 11). Various forms for such compositions are envisioned that include oil-in-water emulsions, aerosols, sticks, hair tonic, shampoo, antidandruff shampoo, and deodorant and/or antiperspirant (see paragraphs 81-82; instant claims 85-88).
It would have been obvious to one of ordinary skill in the art at the time of the invention to formulate the compositions of Kolbe et al. in view of Max et al. and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al. in types of formulation forms as taught by Vielhaber et al. because they were forms known to provide a similar combination of actives to skin and hair. They are also part of an overlapping set of types of formulation forms for such compositions. Thus it would have been obvious to formulate the compositions as hair tonic, antidandruff shampoo, as well as deodorant and/or antiperspirants. Therefore claims 76, 79, 82-91, and 93 are obvious over Kolbe et al. in view of Max et al., Filbry et al., and Vielhaber as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
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 76, 79, 82-84, 89-91, and 93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-17 of U.S. Patent No. 9,533,963 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim recite a cosmetic or dermatological composition that includes the instantly claimed alkylamidothiazole of the elected species. Both also claim the application of the composition to the skin of a patient in need thereof to treat undesired skin pigmentation (lighten). The patented claims recite the alkylamidothiazole at 0.0001 to 3 wt%. The patented claims do not explicitly recite the subject to be human, the presence of UV filters, or particular formulation forms.
Kolbe et al. teach cosmetic or dermatological composition that includes thiazole to treat undesired skin pigmentation (see abstract). The composition is taught to be applied to human skin to reduce undesired pigmentation (see paragraphs 9, 24, 30, and claim 16). They go on to teach these compounds are advantageously included in a composition in combination with substances that absorb UV-B radiation (see paragraph 47). Such substances are known as UV-B light filters (see Nguyen-Kim et al.; paragraph 192). These UV-B filters are taught to preferably be present at 0.5 to 10 wt% (see paragraph 47). The thiazole derivatives of Kolbe et al. are taught at 0.00001 to 10 wt% and more preferably at 0.005 to 1 wt% (see paragraph 31). Further, Kolbe et al. demonstrate the tyrosinase inhibition properties of their thiazole compounds at 100 mg/ml and link this to their ability to inhibit skin pigmentation (see paragraph 29 and table 1). Kolbe et al. go on to teach types of cosmetic and dermatological formulation forms of their compositions, where water-in-oil emulsions, oil-in-water emulsions, solid stick, aerosol, as well as cleaning compositions for hair (shampoo) and skin are detailed (see paragraphs 32-33).
Max et al. teach a composition to treat hyperpigmentation that includes a tyrosinase inhibitor as the active component (see paragraphs 19 and 24 and Chang et al. figure 3j and page 2450 last partial paragraph-page 2451 first partial paragraph). They go on to prepare formulations that combine this skin lightening tyrosinase inhibitor active with UVB filters (see paragraphs 49-63). Max et al. also teach ethyl hexyl salicylate as a preferred salicylic acid ester, oil soluble UVB filter that is envisioned in the composition (see paragraphs 52 and 56). Max et al. further exemplify compositions with UVB filters included individually or in pairs (see examples no 7 and 8).
Filbry et al. teach a topical composition with UVB filters that are envisioned and exemplified as ethylhexyl salicylate (see abstract and, paragraph 84-85, and formulas 1 and 2). Here the ethylhexyl salicylate is included at 1.5 wt% (see formulas 1 and 2). Tyrosinase inhibitors (e.g., licorice root extract) are also included in combination with this UV filter (see formulas 1 and 2; Dornoff et al. column 3 line 67-column 4 line). They also exemplify concentrations of ethylhexyl salicylate at 0.5 wt%, 2 wt%, 2.5 wt%, and 4 wt% (see examples 1 and 3-5).
It would have been obvious to one of ordinary skill in the art at the time of the invention to include a UV-B light filter at the taught proportions of Kolbe et al. in the composition of U.S. Patent No. 9,533,963 since a similar composition that embraces the same alkylamidothiazole compound is taught by Kolbe et al. to be benefited by the inclusion of these compounds. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. More specifically, it would have been obvious to select ethylhexyl salicylate as a particular UVB filter taught by Max et al. and Filbry et al. or as part of a UVB filter combination (see instant claims 76 and 79). This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., specific UV-B filter vs generic UV-B filter). The use of the tested 100 mg/ml concentration of the tyrosinase inhibitors of Kolbe et al. for DTI would follow as would the use of the 1.5 wt% concentration for ethylhexyl salicylate exemplified by Filbry et al. Assuming a composition density of approximately 1 g/ml, this ratio of DTI to ethylhexyl salicylate corresponds to about 1:150 (0.01 wt%:1.5 wt%). The application of the other exemplified concentrations for ethylhexyl salicylate in Filbry et al. also fall within the range envision by Kolbe et al. and yield a range of ratios that embrace the 1:160 ratio of DTI thiazole to ethylhexyl salicylate; thus this ratio is obvious (see MPEP 2144.05). Formulation of the composition in forms as suggested by Kolbe et al. would follow (see instant claims 82-84 and 89-90). Formulation of the composition in forms as suggested by Kolbe et al. would follow. The application to human skin in order to practice the modified patented method also would have been obvious since it is known to be benefited by skin lightening. Therefore claims 76, 79, 82-84, 89-91, and 93 are obvious over claims 9-17 of U.S. Patent No. 9,533,963 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
Claims 76, 79, 82-91, and 93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-17 of U.S. Patent No. 9,533,963 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al. as applied to claims 56-69, 71, and 74-75 above, and further in view of Vielhaber et al.
Claims 9-17 of U.S. Patent No. 9,533,963 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al. render obvious the limitations of instant claims 76, 79, 82-84, 89-91, and 93, where the compositions comprising a tyrosinase inhibitor containing preparation for hair and skin can take several formulation forms. A hair tonic, antidandruff shampoo, and antiperspirant/deodorant are not explicitly detailed forms.
Vielhaber et al. teach skin and hair lightening compositions that include a tyrosinase inhibitor as the chemical active to confer this property that is coupled with a UV filter (see paragraphs 38-39 and 43 and claims 1 and 11). Various forms for such compositions are envisioned that include oil-in-water emulsions, aerosols, sticks, hair tonic, shampoo, antidandruff shampoo, and deodorant and/or antiperspirant (see paragraphs 81-82).
It would have been obvious to one of ordinary skill in the art at the time of the invention to formulate the compositions of the modified patented claims in types of formulation forms as taught by Vielhaber et al. because they were forms known to provide a similar combination of actives to skin and hair. They are also part of an overlapping set of types of formulation forms for such compositions. Thus it would have been obvious to formulate the compositions as hair tonic, antidandruff shampoo, as well as deodorant and/or antiperspirants. Therefore claims 76, 79, 82-91, and 93 are obvious over claims 9-17 of U.S. Patent No. 9,533,963 in view of Kolbe et al., Max et al., Filbry et al., and Vielhaber et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
Claims 76, 79, 82-84, 89-91, and 93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,245,252 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented method recites a cosmetic or dermatological composition that includes the instantly claimed alkylamidothiazole of the elected species. Both sets of claims recite the application of the composition to the skin of a human. The patented claims do not explicitly recite the presence of UV filters or particular formulation forms.
Kolbe et al. teach cosmetic or dermatological composition that includes thiazole to treat undesired skin pigmentation (see abstract). The composition is taught to be applied to human skin to reduce undesired pigmentation (see paragraphs 9, 24, 30, and claim 16). They go on to teach these compounds are advantageously included in a composition in combination with substances that absorb UV-B radiation (see paragraph 47). Such substances are known as UV-B light filters (see Nguyen-Kim et al.; paragraph 192). These UV-B filters are taught to preferably be present at 0.5 to 10 wt% (see paragraph 47; instant claim 76). The thiazole derivatives of Kolbe et al. are taught at 0.00001 to 10 wt% and more preferably at 0.005 to 1 wt% (see paragraph 31; instant claim 81). Further, Kolbe et al. demonstrate the tyrosinase inhibition properties of their thiazole compounds at 100 mg/ml and link this to their ability to inhibit skin pigmentation (see paragraph 29 and table 1). Kolbe et al. go on to teach types of cosmetic and dermatological formulation forms of their compositions, where water-in-oil emulsions, oil-in-water emulsions, solid stick, aerosol, as well as cleaning compositions for hair (shampoo) and skin are detailed (see paragraphs 32-33).
Max et al. teach a composition to treat hyperpigmentation that includes a tyrosinase inhibitor as the active component (see paragraphs 19 and 24 and Chang et al. figure 3j and page 2450 last partial paragraph-page 2451 first partial paragraph). They go on to prepare formulations that combine this skin lightening tyrosinase inhibitor active with UVB filters (see paragraphs 49-63). Max et al. also teach ethyl hexyl salicylate as a preferred salicylic acid ester, oil soluble UVB filter that is envisioned in the composition (see paragraphs 52 and 56). Max et al. further exemplify compositions with UVB filters included individually or in pairs (see examples no 7 and 8).
Filbry et al. teach a topical composition with UVB filters that are envisioned and exemplified as ethylhexyl salicylate (see abstract and, paragraph 84-85, and formulas 1 and 2). Here the ethylhexyl salicylate is included at 1.5 wt% (see formulas 1 and 2). Tyrosinase inhibitors (e.g., licorice root extract) are also included in combination with this UV filter (see formulas 1 and 2; Dornoff et al. column 3 line 67-column 4 line). They also exemplify concentrations of ethylhexyl salicylate at 0.5 wt%, 2 wt%, 2.5 wt%, and 4 wt% (see examples 1 and 3-5).
It would have been obvious to one of ordinary skill in the art at the time of the invention to include a UV-B light filter at the taught proportions in the composition of U.S. Patent No. 10,245,252 since a similar composition that embraces the same thiazole compound is taught by Kolbe et al. to be benefited by the inclusion of these compounds. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. It additionally would have been obvious to select ethylhexyl salicylate as a particular UVB filter taught by Max et al. and Filbry et al. or as part of a UVB filter combination (see instant claims 76 and 79). This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., specific UV-B filter vs generic UV-B filter). The use of the tested 100 mg/ml concentration of the tyrosinase inhibitors of Kolbe et al. for DTI would follow as would the use of the 1.5 wt% concentration for ethylhexyl salicylate exemplified by Filbry et al. Assuming a composition density of approximately 1 g/ml, this ratio of DTI to ethylhexyl salicylate corresponds to about 1:150 (0.01 wt%:1.5 wt%). The application of the other exemplified concentrations for ethylhexyl salicylate in Filbry et al. also fall within the range envision by Kolbe et al. and yield a range of ratios that embrace the 1:160 ratio of DTI thiazole to ethylhexyl salicylate; thus this ratio is obvious (see MPEP 2144.05). Formulation of the composition in forms as suggested by Kolbe et al. would follow. The application to human skin in order to practice the modified patented method also would have been obvious since it is known to be benefited by skin lightening. Therefore claims 76, 79, 82-84, 89-91, and 93 are obvious over claims 1-14 of U.S. Patent No. 10,245,252 in view of Kolbe et al. in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
Claims 76, 79, 82-91, and 93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,245,252 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al. as applied to claims 76, 79, 82-84, 89-91, and 93 above, and further in view of Vielhaber et al.
Claims 1-14 of U.S. Patent No. 10,245,252 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al. render obvious the limitations of instant claim 76, 79, 82-84, 89-91, and 93, where the compositions comprising a tyrosinase inhibitor containing preparation for hair and skin can take several formulation forms. A hair tonic, antidandruff shampoo, and antiperspirant/deodorant are not explicitly detailed forms.
Vielhaber et al. teach skin and hair lightening compositions that include a tyrosinase inhibitor as the chemical active to confer this property that is coupled with a UV filter (see paragraphs 38-39 and 43 and claims 1 and 11). Various forms for such compositions are envisioned that include oil-in-water emulsions, aerosols, sticks, hair tonic, shampoo, antidandruff shampoo, and deodorant and/or antiperspirant (see paragraphs 81-82).
It would have been obvious to one of ordinary skill in the art at the time of the invention to formulate the compositions of the modified patented claims in types of formulation forms as taught by Vielhaber et al. because they were forms known to provide a similar combination of actives to skin and hair. They are also part of an overlapping set of types of formulation forms for such compositions. Thus it would have been obvious to formulate the compositions as hair tonic, antidandruff shampoo, as well as deodorant and/or antiperspirants. Therefore claims 76, 79, 82-91, and 93 are obvious over claims 1-14 of U.S. Patent No. 10,245,252 in view of Kolbe et al., Max et al., Filbry et al., and Vielhaber et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
Claims 76, 79, 82-84, 89-91, and 93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, 13, and 19 of U.S. Patent No. 8,920,785 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim recite a cosmetic or dermatological composition that includes an alkylamidothiazole. Both also claim the application of the composition to the skin of a patient in need thereof to treat undesired skin pigmentation (lighten). Specific thiazoles of the patented claims are taught to include the structure
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where A may be an alkylamido group, one of seven groups of options (see claims 7-8). More specifically, the substituents may be A = N(R1)2, R1 = H, R1 = linear or branched -C=O alkyl, and Y = H where the R1 and Y can be different are taught and embrace the alkylamidothiazole of the elected species (see claim 7). The patented claims recite the thiazole to be present at 0.005 to 3 wt%. The patented claims do not explicitly recite a listing of each compound embraced by their teachings, the subject to be human, particular formulation forms, or the presence of UV filters.
Kolbe et al. teach cosmetic or dermatological composition that includes thiazole to treat undesired skin pigmentation (see abstract). Kolbe et al. go on to teach types of cosmetic and dermatological formulation forms of their compositions, where water-in-oil emulsions, oil-in-water emulsions, solid stick, aerosol, as well as cleaning compositions for hair (shampoo) and skin are detailed (see paragraphs 32-33). These UV-B filters are taught to preferably be present at 0.5 to 10 wt% (see paragraph 47; instant claim 76). The thiazole derivatives of Kolbe et al. are taught at 0.00001 to 10 wt% and more preferably at 0.005 to 1 wt% (see paragraph 31; instant claim 81). Further, Kolbe et al. demonstrate the tyrosinase inhibition properties of their thiazole compounds at 100 mg/ml and link this to their ability to inhibit skin pigmentation (see paragraph 29 and table 1).
Max et al. teach a composition to treat hyperpigmentation that includes a tyrosinase inhibitor as the active component (see paragraphs 19 and 24 and Chang et al. figure 3j and page 2450 last partial paragraph-page 2451 first partial paragraph). They go on to prepare formulations that combine this skin lightening tyrosinase inhibitor active with UVB filters (see paragraphs 49-63). Max et al. also teach ethyl hexyl salicylate as a preferred salicylic acid ester, oil soluble UVB filter that is envisioned in the composition (see paragraphs 52 and 56). Max et al. further exemplify compositions with UVB filters included individually or in pairs (see example no 7 and 8).
Filbry et al. teach a topical composition with UVB filters that are envisioned and exemplified as ethylhexyl salicylate (see abstract and, paragraph 84-85, and formulas 1 and 2). Here the ethylhexyl salicylate is included at 1.5 wt% (see formulas 1 and 2). Tyrosinase inhibitors (e.g., licorice root extract) are also included in combination with this UV filter (see formulas 1 and 2; Dornoff et al. column 3 line 67-column 4 line). They also exemplify concentrations of ethylhexyl salicylate at 0.5 wt%, 2 wt%, 2.5 wt%, and 4 wt% (see examples 1 and 3-5). Kolbe et al. go on to teach types of cosmetic and dermatological formulation forms of their compositions, where water-in-oil emulsions, oil-in-water emulsions, solid stick, aerosol, as well as cleaning compositions for hair (shampoo) and skin are detailed (see paragraphs 32-33). Further, Kolbe et al. note the tyrosinase inhibition properties of their thiazole compounds and link this to their ability to inhibit skin pigmentation (see paragraph 29 and table 1).
It would have been obvious to one of ordinary skill in the art at the time of the invention to look to the additional teachings provided to guide the choices for R1 when A includes a nitrogen as well as the class of alkyl substituents envisioned to guide the selection when R1 includes an alkyl. Repeatedly, the patented claims teach A= N(R1)2 and a hydrogen as one of the R1 substituents where the other is a different substituent (see claim 9). In addition, other recitations of alkyl substituents that are envisioned to be linear or branched recite a C1 to C24 collection of compounds (see claim 1 options for R1, X, and Y). Thus it would have been obvious to choose A= N(R1)2 and hydrogen for one of the R1 groups. As an envisioned and claimed option for R1, the selection of linear or branched -C=O alkyl as the other R1 also would have been obvious where C1 to C24 alkyls are considered. The selection of any of the linear of branched C1 to C24 alkyl groups would follow, including the branched C4 alkyl group of the elected species. There is no evidence of record that points to an unexpectedly superior result being gleaned from the elected compound. It additionally would have been obvious to pair this compound with a UV-B filter(s) to absorb radiation as Kolbe et al. suggest and at the suggested concentrations. More specifically, it would have been obvious to select ethylhexyl salicylate as a particular UVB filter taught by Max et al. and Filbry et al. or as part of a UVB filter combination (see instant claims 76 and 79). This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., specific UV-B filter vs generic UV-B filter). The use of the tested 100 mg/ml concentration of the tyrosinase inhibitors of Kolbe et al. for DTI would follow as would the use of the 1.5 wt% concentration for ethylhexyl salicylate exemplified by Filbry et al. Assuming a composition density of approximately 1 g/ml, this ratio of DTI to ethylhexyl salicylate corresponds to about 1:150 (0.01 wt%:1.5 wt%). The application of the other exemplified concentrations for ethylhexyl salicylate in Filbry et al. also fall within the range envision by Kolbe et al. and yield a range of ratios that embrace the 1:160 ratio of DTI thiazole to ethylhexyl salicylate; thus this ratio is obvious (see MPEP 2144.05). Formulation of the composition in forms as suggested by Kolbe et al. also would have been obvious given the similar active compounds and utility in the compositions. The application of the composition to human skin would then follow since it was known to benefit from a lightening treatment. Therefore claims 76, 79, 82-84, 89-91, and 93 are obvious over claims 1, 8-9, 13, and 19 of U.S. Patent No. 8,920,785 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
Claims 76, 79, 82-91, and 93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, 13, and 19 of U.S. Patent No. 8,920,785 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al. as applied to claims 76, 79, 82-84, 89-91, and 93 above, and further in view of Vielhaber et al.
Claims 1, 8-9, 13, and 19 of U.S. Patent No. 8,920,785 in view of Kolbe et al. in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al. render obvious the limitations of instant claims 76, 79, 82-84, 89-91, and 93, where the compositions comprising a tyrosinase inhibitor containing preparation for hair and skin can take several formulation forms. A hair tonic, antidandruff shampoo, and antiperspirant/deodorant are not explicitly detailed forms.
Vielhaber et al. teach skin and hair lightening compositions that include a tyrosinase inhibitor as the chemical active to confer this property that is coupled with a UV filter (see paragraphs 38-39 and 43 and claims 1 and 11). Various forms for such compositions are envisioned that include oil-in-water emulsions, aerosols, sticks, hair tonic, shampoo, antidandruff shampoo, and deodorant and/or antiperspirant (see paragraphs 81-82).
It would have been obvious to one of ordinary skill in the art at the time of the invention to formulate the compositions of the modified patented claims in types of formulation forms as taught by Vielhaber et al. because they were forms known to provide a similar combination of actives to skin and hair. They are also part of an overlapping set of types of formulation forms for such compositions. Thus it would have been obvious to formulate the compositions as hair tonic, antidandruff shampoo, as well as deodorant and/or antiperspirants. Therefore claims 76, 79, 82-91, and 93 are obvious over claims 1, 8-9, 13, and 19 of U.S. Patent No. 8,920,785 in view of Kolbe et al., Max et al., Filbry et al., and Vielhaber et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
Claims 76, 79, 82-84, 89-91, and 93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 15 of US Patent No. 9,610,234 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim recite a cosmetic or dermatological composition that includes the instantly claimed alkylamidothiazole of the elected species. The patented claims do not explicitly recite particular formulation forms, the presence of UV filters or the proportion of the alkylamidothiazole.
Kolbe et al. teach cosmetic or dermatological composition that includes thiazole derivatives to treat undesired skin pigmentation (see abstract). They go on to teach the combination of substances that absorb UV-B radiation with the thiazole derivatives is advantageous. Such substances are known as UV-B light filters (see Nguyen-Kim et al.; paragraph 192). These UV-B filters are taught to preferably be present at 0.5 to 10 wt% (see paragraph 47; instant claim 76). The thiazole derivatives of Kolbe et al. are taught at 0.00001 to 10 wt% and more preferably at 0.005 to 1 wt% (see paragraph 31; instant claim 81). Further, Kolbe et al. demonstrate the tyrosinase inhibition properties of their thiazole compounds at 100 mg/ml and link this to their ability to inhibit skin pigmentation (see paragraph 29 and table 1). Kolbe et al. go on to teach types of cosmetic and dermatological formulation forms of their compositions, where water-in-oil emulsions, oil-in-water emulsions, solid stick, aerosol, as well as cleaning compositions for hair (shampoo) and skin are detailed (see paragraphs 32-33). Further, Kolbe et al. note the tyrosinase inhibition properties of their thiazole compounds and link this to their ability to inhibit skin pigmentation (see paragraph 29 and table 1).
Max et al. teach a composition to treat hyperpigmentation that includes a tyrosinase inhibitor as the active component (see paragraphs 19 and 24 and Chang et al. figure 3j and page 2450 last partial paragraph-page 2451 first partial paragraph). They go on to prepare formulations that combine this skin lightening tyrosinase inhibitor active with UVB filters (see paragraphs 49-63). Max et al. also teach ethyl hexyl salicylate as a preferred salicylic acid ester, oil soluble UVB filter that is envisioned in the composition (see paragraphs 52 and 56). Max et al. further exemplify compositions with UVB filters included individually or in pairs (see examples no 7 and 8).
Filbry et al. teach a topical composition with UVB filters that are envisioned and exemplified as ethylhexyl salicylate (see abstract and, paragraph 84-85, and formulas 1 and 2). Here the ethylhexyl salicylate is included at 1.5 wt% (see formulas 1 and 2). Tyrosinase inhibitors (e.g., licorice root extract) are also included in combination with this UV filter (see formulas 1 and 2; Dornoff et al. column 3 line 67-column 4 line). They also exemplify concentrations of ethylhexyl salicylate at 0.5 wt%, 2 wt%, 2.5 wt%, and 4 wt% (see examples 1 and 3-5).
It would have been obvious to one of ordinary skill in the art at the time of the invention to include a UV-B light filter in the composition of the patented claims since a similar composition that embraces the same thiazole compound is taught by Kolbe et al. to be benefited by the inclusion of these compounds. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. It additionally would have been obvious to select ethylhexyl salicylate as a particular UVB filter taught by Max et al. and Filbry et al. or as part of a UVB filter combination (see instant claims 76 and 79). This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., specific UV-B filter vs generic UV-B filter). The use of the tested 100 mg/ml concentration of the tyrosinase inhibitors of Kolbe et al. for DTI would follow as would the use of the 1.5 wt% concentration for ethylhexyl salicylate exemplified by Filbry et al. Assuming a composition density of approximately 1 g/ml, this ratio of DTI to ethylhexyl salicylate corresponds to about 1:150 (0.01 wt%:1.5 wt%). The application of the other exemplified concentrations for ethylhexyl salicylate in Filbry et al. also fall within the range envision by Kolbe et al. and yield a range of ratios that embrace the 1:160 ratio of DTI thiazole to ethylhexyl salicylate; thus this ratio is obvious (see MPEP 2144.05). Formulation of the composition in forms as suggested by Kolbe et al. also would have been obvious given the similar active compounds and utility in the compositions. Therefore claims 76, 79, 82-84, 89-91, and 93 are obvious over claims 1-6 and 15 of US Patent No. 9,610,234 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al.
Claims 76, 79, 82-91, and 93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 15 of US Patent No. 9,610,234 in view of Kolbe et al., Max et al., and Filbry et al. as evidenced by Nguyen-Kim et al., Chang et al., and Dornoff et al. as applied to claims 76, 79, 82-84, 89-91, and 93 above, and further in view of Vielhaber et al.
Claims 1-6 and 15 of US Patent No. 9,610,234 in view of Kolbe et al. and Max et al. as evidenced by Nguyen-Kim et al. and Chang et al. render obvious the limitations of instant claims 76, 79, 82-84, 89-91, and 93, where the compositions comprising a tyrosinase inhibitor containing preparation for hair and skin can take several formulation forms. A hair tonic, antidandruff shampoo, and antiperspirant/deodorant are not explicitly detailed forms.
Vielhaber et al. teach skin and hair lightening compositions that include a tyrosinase inhibitor as the chemical active to confer this property that is coupled with a UV filter (see paragraphs 38-39 and 43 and claims 1 and 11). Various forms for such compositions are envisioned that include oil-in-water emulsions, aerosols, sticks, hair tonic, shampoo, antidandruff shampoo, and deodorant and/or antiperspirant (see paragraphs 81-82).
It would have been obvious to one of ordinary skill in the art at the time of the invention to formulate the compositions of the modified patented claims in types of formulation forms as taught by Vielhaber et al. because they were forms known to provide a similar combination of actives to skin and hair. They are also part of an overlapping set of types of formulation forms for such compositions. Thus it would have been obvious to formulate the compositions as hair tonic, antidandruff shampoo, as well as deodorant and/or antiperspirants. Therefore claims 76, 79, 82-91, and 93 are obvious over claims 1-6 and 15 of US Patent No. 9,610,234 in view of Kolbe et al., Max et al., Filbry et al., and Vielhaber et al. as evidenced by Nguyen-Kim et al., Chang et al. and Dornoff et al.
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 76, 79, 82-84, 89-91, and 93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 57-73 of copending Application No. 14/774101 in view of Kolbe et al. and Filbry et al. as evidenced by Nguyen-Kim et al. and Dornoff et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim recite a cosmetic or dermatological composition that comprises the instantly claimed alkylamidothiazole of the elected species in combination with a UV filter that is ethylhexyl salicylate. The concentration of the alkylamidothiazole is 0.01 to 0.35 wt% in the copending claims and recited as an oil in water emulsion. Both also claim the application of the composition to the skin of a patient in need thereof to treat undesired skin pigmentation (lighten). The copending claims recite the alkylamidothiazole at 0.0001 to 3 wt%. The copending claims do not explicitly recite the presence of UV filters or particular formulation forms.
Kolbe et al. teach cosmetic or dermatological composition that includes thiazole derivatives to treat undesired skin pigmentation (see abstract). They go on to teach the combination of substances that absorb UV-B radiation with the thiazole derivatives is advantageous. Such substances are known as UV-B light filters (see Nguyen-Kim et al.; paragraph 192). These UV-B filters are taught to preferably be present at 0.5 to 10 wt% (see paragraph 47; instant claim 76). The thiazole derivatives of Kolbe et al. are taught at 0.00001 to 10 wt% and more preferably at 0.005 to 1 wt% (see paragraph 31; instant claim 81). Further, Kolbe et al. demonstrate the tyrosinase inhibition properties of their thiazole compounds at 100 mg/ml and link this to their ability to inhibit skin pigmentation (see paragraph 29 and table 1). Kolbe et al. go on to teach types of cosmetic and dermatological formulation forms of their compositions, where water-in-oil emulsions, oil-in-water emulsions, solid stick, aerosol, as well as cleaning compositions for hair (shampoo) and skin are detailed (see paragraphs 32-33). Further, Kolbe et al. demonstrate the tyrosinase inhibition properties of their thiazole compounds at 100 mg/ml and link this to their ability to inhibit skin pigmentation (see paragraph 29 and table 1).
Filbry et al. teach a topical composition with UVB filters that are envisioned and exemplified as ethylhexyl salicylate (see abstract and, paragraph 84-85, and formulas 1 and 2). Here the ethylhexyl salicylate is included at 1.5 wt% (see formulas 1 and 2). Tyrosinase inhibitors (e.g., licorice root extract) are also included in combination with this UV filter (see formulas 1 and 2; Dornoff et al. column 3 line 67-column 4 line). They also exemplify concentrations of ethylhexyl salicylate at 0.5 wt%, 2 wt%, 2.5 wt%, and 4 wt% (see examples 1 and 3-5).
It would have been obvious to one of ordinary skill in the art at the time of the invention to include ethylhexyl salicylate at the tested 100 mg/ml concentration of the tyrosinase inhibitors of Kolbe et al. for this compound because it was known to be effective. It also would have been obvious to use of the 1.5 wt% concentration for ethylhexyl salicylate exemplified by Filbry et al. because they teach of its utility in combination with a tyrosinase inhibitor and Kolbe et al. identify the elected DTI compound as a tyrosinase inhibitor. Assuming a composition density of approximately 1 g/ml, this ratio of DTI to ethylhexyl salicylate corresponds to about 1:150 (0.01 wt%:1.5 wt%). The application of the other exemplified concentrations for ethylhexyl salicylate in Filbry et al. also fall within the range envision by Kolbe et al. and yield a range of ratios that embrace the 1:160 ratio of DTI thiazole to ethylhexyl salicylate; thus this ratio is obvious (see MPEP 2144.05). Formulation of the composition in forms as suggested by Kolbe et al. would follow (see instant claims 82-84 and 89-90). Formulation of the composition in forms as suggested by Kolbe et al. also would have been obvious given the similar active compounds and utility in the compositions. The application of the composition to human skin would then follow since it was known to benefit from a lightening treatment. The application of the composition to human skin would then follow since it was known to benefit from a lightening treatment. Therefore claims 76, 79, 82-84, 89-91, and 93 are obvious over claims 57-73 of copending Application No. 14/774101 in view of Kolbe et al. and Filbry et al. as evidenced by Nguyen-Kim et al. and Dornoff et al.
Claims 76, 79, 82-91, and 93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 57-73 copending Application No. 14/774101 in view of Kolbe et al. and Filbry et al. as evidenced by Nguyen-Kim et al. and Dornoff et al. as applied to claims 76, 79, 82-84, 89-91, and 93 above, and further in view of Vielhaber et al.
Claims 57-73 of copending Application No. 14/774101 in view of Kolbe et al. and Filbry et al. as evidenced by Nguyen-Kim et al. and Dornoff et al. render obvious the limitations of instant claims 76, 79, 82-84, 89-91, and 93, where the compositions comprising a tyrosinase inhibitor containing preparation for hair and skin can take several formulation forms. A hair tonic, antidandruff shampoo, and antiperspirant/deodorant are not explicitly detailed forms.
Vielhaber et al. teach skin and hair lightening compositions that include a tyrosinase inhibitor as the chemical active to confer this property that is coupled with a UV filter (see paragraphs 38-39 and 43 and claims 1 and 11). Various forms for such compositions are envisioned that include oil-in-water emulsions, aerosols, sticks, hair tonic, shampoo, antidandruff shampoo, and deodorant and/or antiperspirant (see paragraphs 81-82).
It would have been obvious to one of ordinary skill in the art at the time of the invention to formulate the compositions of the modified copending claims in types of formulation forms as taught by Vielhaber et al. because they were forms known to provide a similar combination of actives to skin and hair. They are also part of an overlapping set of types of formulation forms for such compositions. Thus it would have been obvious to formulate the compositions as hair tonic, antidandruff shampoo, as well as deodorant and/or antiperspirants. Therefore claims 76, 79, 82-91, and 93 are obvious over claims 57-73 of copending Application No. 14/774101 in view of Kolbe et al., Filbry et al., and Vielhaber et al. as evidenced by Nguyen-Kim et al. and Dornoff et al.
Response to Arguments
Applicant's arguments filed January 23, 2026 have been fully considered and are unpersuasive.
The applicant argues that the combination of DTI and ethylhexyl salicylate and DTI with phenylbenzimidazolesulfonic acid have a greater than additive effect on tyrosinase inhibition. The claims do not recite phenylbenzimidazolesulfonic acid, but instead recite benzimidazolsulfonic acid. The only tested combination relevant to the current claims is a single embodiment of DTI and ethylhexyl salicylate in the table on page 19 of the instant specification. The tested ratio is not the ratio that is claimed. In addition, the result of the tested combination of concentrations of DTI and ethylhexyl salicylate achieved a 43.2% tyrosinase inhibitory effect, while the additive impact of the two compounds would have been 42.2%. This difference could be experimental error and is not clearly indicative of synergy. Even if the pairing were deemed synergistic, the applicant has argued that the occurrence of synergy was unexpected. Synergistic combinations are concentration and ratio dependent. So there is no clear reason why synergy would then be expected at a different weight ratio, as is currently claimed, and at the different concentrations which are also embraced by the current claims. The disclosure does not indicate that the applicant deemed the tested ratio of DTI and ethylhexyl salicylate to be critical, given that none of the examples that are detailed employ the ratio. None of the other pairings of DTI with ethylhexyl salicylate were tested for their tyrosinase inhibitory effort, thus extrapolation of any potential synergy beyond the tested embodiment is not possible based on the disclosure. Therefor the claims are not commensurate in scope with the showing in the disclosure.
The applicant is encouraged to schedule an interview with the examiner to facilitate any future amendments in effort to more efficiently furth prosecution of the application.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615