DETAILED ACTION
Notice of 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 the Claims
The amendments filed 10/27/2025 have been entered.
Response to Arguments
Applicant’s arguments, filed 10/27/2025, have been fully considered.
Applicant traverses the rejection of claims under 35 U.S.C. 103(a) as being unpatentable over Lou et al (WO 2017/194486; of record) in view of Xi et al (US 2016/0122305; of record), arguing that “there is no teaching in the cited references, either alone or in combination, of the specific weight ratio of the antioxidants in the pending claims” (Applicant Arguments, Page 6). In particular, regarding the amount of antioxidant identified by the prior art, Applicant argues that “Xi merely teaches... from about 0.0001% to about 98% by weight of the composition” which does “not teach the limitations provided in the pending claims, particularly... a weight ratio of from 0.8:4.2 [to] 4.2:0.8” (Applicant Arguments, Page 6). As such, Applicant argues that one of ordinary skill in the art would not “pursue a particular subset [from within Xi] over another as a starting point for experimentation because the general conditions and parameters were not sufficiently disclosed” (Applicant Arguments, Page 6).
The argument is not found persuasive. It is maintained that it would have been obvious in view of Lou et al and based further on Xi et al to include antioxidants such as BHT and dilauryl thiodipropionate in the composition of Lou et al as previously discussed. And, in doing so, it is further maintained that would have been prima facie obvious to determine the optimal amount by weight of each antioxidant to include therein, with an obvious starting amount of each antioxidant in the same amount (i.e., in a 1:1 ratio). As stated by MPEP 2144.05, “[g]enerally, 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” (see also In re Aller (220 F.2d 454 (CCPA): “where 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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))). As discussed by the court in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1293 (Fed. Cir. 2015), every ordinary artisan in medicine performs “merely routine optimization of drug dosage to maximize therapeutic effect.”
Applicant, however, further argues that “[a] particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before determination of the optimum or workable ranges of said variable might be characterized as routine experimentation” (Applicant Arguments, Page 7).
It is maintained that antioxidants such as BHT and dilauryl thiodipropionate would be recognized as result effective variables based on the teachings of the prior art. In particular, Lou et al identify issues associated with compositions comprising retinoic acid precursors such as retinyl propionate which arise as “the result of in situ oxidation” (Page 1, Lines 21-27) and Xi et al teach that compositions comprising retinyl propionate “will typically include an antioxidant” (Paragraph 0051), further disclosing BHT and dilauryl thiodipropionate as usable antioxidants (Paragraph 0020). It is evident that the amount of antioxidant included in a composition to minimize oxidation and the negative effects associated therewith entails a result-effective variable.
Applicant next argues that the instant compositions exhibit unexpected results, pointing to Examples 6, 7 and 8 of the instant Specification (Applicant Arguments, Pages 7-8). In particular, Applicant argues that:
“Example 6 demonstrates that compositions comprising an oil-soluble alkylresorcinol and a retinoid having further an active mixture of BHT and dilauryl thiodipropionate unexpectedly resulted in lower ΔE values over time... when compared to compositions comprising an oil-soluble alkylresorcinol and a retinoid with either BHT or dilauryl thiodipropionate alone” (Applicant Arguments, Page 7);
“Example 7 demonstrates that samples having active mixtures of BHT and dilauryl thiodipropionate specifically in a weight ratio of BHT to dilauryl thiodipropionate ranging from 0.8:4.2 and 4.2:0.8 unexpectedly resulted in lower ΔE values over time” (Applicant Arguments, Pages 7-8); and
“Example 8 [demonstrates] that the specific combination of BHT and dilauryl thiodipropionate... surprisingly performed better than other antioxidants and combinations of antioxidants” (Applicant Arguments, Page 8).
The arguments are not found persuasive. Turning to Example 6, while it is shown that the ΔE values (i.e., the perceived numerical difference between an initial color and a changed color) is improved (i.e., reduced) over time in compositions comprising 0.05% and 0.2% BHT and dilauryl thiodipropionate (1:1 ratio) compared to compositions comprising 0.05% and 0.2% BHT or dilauryl thiodipropionate alone, Example 6 did not measure ΔE values in a control composition lacking BHT and dilauryl thiodipropionate so as to evaluate whether the improvement constitutes anything more than the expected additive effect of the two antioxidants.
Turning to Example 7, while the ΔE values in the composition comprising 0.1% BHT and 0.1% dilauryl thiodipropionate in a 1:1 ratio increased by 0%, 47% and 98% over 2, 6 and 10 weeks, the ΔE values in the compositions comprising BHT and dilauryl thiodipropionate in a 4:1 ratio (0.2% total) or in a 1:4 ratio (0.2% total) were significantly increased, by 44%, 156% and 241% over 2, 6 and 10 weeks (in the 4:1 ratio) and 19%, 141% and 211% over 2, 6 and 10 weeks (in the 1:4 ratio). Significantly, the increase in ΔE values in the 0.2% total 4:1 and 1:4 combinations was higher than that in compositions comprising 0.2% BHT alone (i.e., 20%, 100% and 165% over 2, 6 and 10 weeks (see Example 6)) or 0.2% dilauryl thiodipropionate alone (i.e., 0%, 36% and 68% over 2, 6 and 10 weeks (see Example 6)).
Lastly, turning to Example 8, only three of the comparative examples begin at 2 weeks, rendering it impossible to determine the increase in ΔE values relative to that baseline in the other examples. And, regarding those three comparative examples, ΔE values were increased by 4%, 51% and 90% over 2, 6 and 10 weeks (0.1% Tinogard DA + 0.01% Tinogard TT), 6%, 54% and 94% over 2, 6 and 10 weeks (0.1% Tinogard DA + 0.05% Tinogard TT), and 3%, 49% and 88% over 2, 6 and 10 weeks (0.1% Tinogard DA + 0.2% Tinogard TT), which are improved compared to the inventive compositions of Example 7.
Collectively, the available data does not evidence unexpected results.
For all the foregoing reasons, Applicant’s arguments are not found persuasive.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11 and 15-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lou et al (WO 2017/194486; of record) in view of Xi et al (US 2016/0122305; of record).
Claim 1 is drawn to a cosmetic composition comprising:
(a) an oil-soluble alkyresorcinol (more specifically, 4-hexyl resorcinol (claim 16), in an amount ranging from 0.001 to 10% by weight (claim 3), even more specifically, in an amount ranging from 0.01 to 5.0% by weight (claim 15));
(b) a retinoid (more specifically, retinyl propionate (claim 18) in an amount ranging from 0.001 to 10% by weight (claim 4), more specifically 0.01 to 1% by weight (claim 17));
(c) an oil having a Hansen total solubility parameter from 16 to 22 (more specifically, caprylic/capric triglycerides (claim 10));
(d) an active mixture of BHT and dilauryl thiopropionate wherein the weight ratio of BHT to dilauryl thipropionate is from 0.8:4.2 and 4.2:0.8 (more specifically, from 0.8:2.2 to 2.2:8 (claim 5), even more specifically from 0.8:1.2 to 1.2:0.8 (claim 6)).
As taught by Lou et al, “compositions with retinoic acid precursors… can provide benefits to skin”, however the “instability of such precursors, typically the result of in situ oxidation, results in premature formation of retinoic acid as well as other oxidized compounds in packaged compositions and prior to application” which “results in a product that may irritate a consumer’s skin… possesses a malodor and/or is tainted with discoloration” (Page 1, Lines 21-27). To overcome these problems, Lou et al teach “a skin benefit composition” comprising “a retinoic acid precursor and a resorcinol to impede oxidation of the precursor in situ in the composition” (Abstract) which “surprisingly can be topically applied without causing skin irritation [and is] free of malodor and discoloration” (Page 2, Lines 3-5), specifically disclosing at Page 16, Example 2, a composition comprising:
(a) 4-hexyl resorcinol, 0.35% by weight;
(b) retinyl propionate 0.37% by weight; and
(c) caprylic capric triglyceride “added to balance, 100%”
As such, Example 2 of Lou et al differs from the instantly claimed composition in that it does not comprise an active mixture of BHT and dilauryl thiodipropionate wherein the weight ratio of BHT to dilauryl thipropionate is from 0.8:4.2 and 4.2:0.8 and, more specifically, 0.8:1.2 to 1.2:0.8.
Xi et al disclose “compositions useful for improving the aesthetic appearance of human skin” (Abstract) which, “[i]n one embodiment… may include additional skin actives, including but not limited to retinoids” (Paragraph 0049) wherein “[e]xamples of retinoids include… retinyl palmitate” (Paragraph 0051). Significantly, as further taught by Xi et al, “[c]ompositions according to this embodiment will typically include an antioxidant such as ascorbic acid and/or BHT and/or a chelating agent such as EDTA or a salt thereof” (Paragraph 0051), although elsewhere, Xi et al further disclose as useable antioxidants, “BHT… [and] dilauryl thiodipropionate” (Paragraph 0020).
Accordingly, in view of Lou et al and based further on Xi et al, it would have been prima facie obvious to include antioxidants such as BHT and dilauryl thiodipropionate in the composition of Lou et al. In particular, it would have been obvious to include an antioxidant in view of Lou et al which identify issues associated with compositions comprising retinoic acid precursors such as retinyl propionate which arise as “the result of in situ oxidation” (Page 1, Lines 21-27). It would have been obvious to do so to further address the concerns of oxidation. Additionally, it would have been obvious to include an antioxidant based further on Xi et al which teach that compositions comprising retinyl propionate “will typically include an antioxidant” (Paragraph 0051). Notably, Xi et al specifically mention BHT and dilauryl thiodipropionate as useable antioxidants in such compositions. And, as indicated by the Court in KSR v. Teleflex (127 S,Ct. 1727 (2007)), “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”.
Finally, in including the antioxidants BHT and dilauryl thiodipropionate in the composition of Lou et al, it would have been prima facie obvious to determine the optimal amount of each antioxidant to include therein, with an obvious starting amount of each antioxidant in the same amount (i.e., in a 1:1 ratio). As stated by MPEP 2144.05, “[g]enerally, 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” (see also In re Aller (220 F.2d 454 (CCPA): “where 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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In view of all of the foregoing, claims 1, 3-6, 10 and 15-18 are rejected as prima facie obvious.
Claims 2 and 19 are drawn to the composition of claim 1, wherein active mixture of BHT and dilauryl thiopropionate is at least 0.15% by weight of the cosmetic composition (more specifically, in a total amount ranging from 0.15 to 4.0% by weight of the cosmetic composition (claim 19)).
As taught by Xi et al, regarding the inclusion of “adjuvants such as… antioxidants”, “[t]he adjuvants may comprise, individually or collectively, from about 0.00001% to about 98% by weight of the composition (more typically from about… 0.001-20%)” (Paragraph 0020).
At the outset, as discussed by MPEP 2144.05, “[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” (citing In re Wertheim, 541 F.2d 257 (CCPA 1976); In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465 (Fed. Cir. 1997)).
Additionally, as discussed above, as stated by MPEP 2144.05, “[g]enerally, 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” (see also In re Aller (220 F.2d 454 (CCPA): “where 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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))). As discussed by the court in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1293 (Fed. Cir. 2015), every ordinary artisan in medicine performs “merely routine optimization of drug dosage to maximize therapeutic effect.”
As such, claims 2 and 19 are also rejected as prima facie obvious.
Claim 7 is drawn to the composition of claim 1, wherein the oil comprises a Hansen total solubility parameter from 17 to 19.
It is asserted, absent evidence to the contrary, that caprylic capric triglyceride has a Hansen total solubility parameter from 17 to 19.
As such, claim 7 is also rejected as prima facie obvious.
Claims 8-9 are drawn to the composition of claim 1, wherein the composition comprising 14 to 28% by weight oil (claim 8), more specifically 15 to 25% by weight oil (claim 9).
Lou et al, noting that “oils such as caprylic capric triglyceride are preferred as carriers” (Page 8, Line 32), teach that “cosmetically acceptable carriers for use…in this invention… may collectively range from 0.1 to 99%... and most preferably, from 1 to 20% by weight” (Page 7, Lines 26-30).
As such, claims 8-9 are also rejected as prima facie obvious.
Claim 11 is drawn to the composition of claim 1, wherein the composition further comprises niacinamide.
As taught by Lou et al, “[c]ompositions of the present invention may optionally include… niacinamide” (Page 12, Lines 15-17).
As such, claim 11 is also rejected as prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-11 and 15-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/561,318.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘318 claims are similarly drawn to a cosmetic composition comprising an alkylresorcinol (e.g., 4-hexyl resorcinol (claim 3)), a retinoic acid precursor (e.g., retinyl propionate (claim 19)), an oil (e.g., caprylic/capric triglycerides (claim 9)), an antioxidant (e.g., BHT (claim 5)) and niacinamide (claim 20) all in the instantly claimed amounts, wherein it would have been prima facie obvious to include a second antioxidant such as dilauryl thiopropionate.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any new ground(s) of rejection presented in this Office action are necessitated by Applicant’s amendments to the claims. 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 CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611