DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments, filed 09 December 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103 (maintained)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 27-29, 32, 36, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0092357 A1 (Premachandran et al., 04/05/2018) (hereinafter Premachandran) in view of US 2005/0222276 A1 (Schmaus et al., 10/06/2005) (hereinafter Schmaus), as evidenced by Gen (“Deciphering the skin care ingredient caprylyl glycol”, 12/09/2020).
Premachandran discloses a synergistic preservative composition capable of providing broad spectrum antimicrobial activity comprising about 0.1 wt. % to about 99.9 wt. % of one or more organic compounds and optionally about 0.1 wt. % to 99.0 wt. % of one or more preservative compounds (abstract) suitable for aqueous and non-aqueous applications including cosmetic products (¶ 18). The preservative may hinder or kill the growth of bacterial and fungal strains that can be present in consumer products (¶ 30). The one or more organic compounds may include triglycerides, oils derived from natural products, and/or C2-C20 alkanediols (¶ 44). Triglyceride is an ester derived from glycerol and three fatty acids of saturated and unsaturated nature (¶ 55). Suitable oils include chamomile oil (¶ 56). An alkanediol based organic compound include those containing at least two carbon atoms, and wherein any two hydrogen atoms of a saturated aliphatic hydrocarbon of the alkanediol compound are substituted with hydroxyl groups (¶ 46). Examples of the alkanediol compounds include, but are not limited to, 1,2-octanediol and 2,3-octanediol (i.e. claimed at least one first linear alkanediol and one or more second linear alkanediols) (¶ 48). The synergistic preservative compositions can be aqueous or non-aqueous, delivered through different known formulations technique, including a non-limiting exemplary formulation of emulsion (¶ 72).
As evidenced by page 149, para. [0294] of the instant specification, chamomile oil is a perfume oil suitable as the at least one cosmetically or pharmaceutically active substance and/or additive.
Premachandran differs from the instant claim insofar as not explicitly disclosing a claimed plant oil as the triglyceride and requires picking and choosing components.
Schmaus discloses mixtures of two, three or more straight-chain 1,2-alkanediols as antimicrobial actives (abstract). The mixture may be contained in a cosmetic or dermatological formulation such as in the form of an emulsion (¶ 136). The oil phase of the emulsion may comprise fatty acid triglycerides, specifically, the triglycerol esters of saturated and/or unsaturated, branched and/or straight-chain alkanecarboxylic acids having a chain length of 8 to 24 C atoms. The fatty acid triglycerides may include natural oils, for example, olive oil (¶ 143).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Premachandran discloses wherein the composition may comprise triglycerides derived from glycerol and three fatty acids of saturated and unsaturated nature. Accordingly, it would have been obvious to one of ordinary skill in the art to have included olive oil as the triglyceride in the composition of Premachandran since it is a known and effective natural oil suitable as a fatty acid triglyceride for cosmetic compositions comprising antimicrobial alkanediols as taught by Schmaus.
Regarding the claim reciting 0.1 to 5.0% by weight of the mixture of alkanediols, the claimed range would have been obvious to one of ordinary skill in the art since it overlaps with the range of the prior art (i.e. about 0.1 wt.% to about 99.9 wt.% one or more organic compounds). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding the instant claim reciting 1.0 to 40.0% by weight of at least one liquid lipophilic component, the claimed range would have been obvious to one of ordinary skill in the art since it overlaps with the range of the prior art (i.e. about 0.1 wt.% to about 99.9 wt.% one or more organic compounds). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 28, as discussed above, Premachandran discloses 2,3-octanediol. As noted in paragraphs [0164] and [0165] of the instant specification, 2,3-octanediol has a maximum water solubility of less than or equal to 10% by weight. Thus, Premachandran teaches a linear alkanediol having a maximum water solubility of less than or equal to 10% by weight.
Regarding claim 29, Premachandran differs from the instant claim insofar as not explicitly disclosing the ratio of the mixture of alkanediols.
However, as discussed above, Premachandran discloses about 0.1 wt. % to about 99.9 wt. % of one or more organic compounds. Accordingly, it would have been obvious to one of ordinary skill in the art to have selected individual amounts of 1,2-octanediol and 2,3-octanediol from the amount range of one or more organic compounds. One of ordinary skill in the art would have arrived at the claimed ratios from the individual amounts selected. As such, the claimed ratios would have been 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. MPEP § 2144.05(A).
Regarding claim 32 reciting a plant oil having a melting point range, as noted by page 60, para. [0215] of the instant specification, Olea europaea (olive) fruit oil has a melting point range of -20 °C to 5 °C. Thus, the olive oil of Schmaus meets the limitation of a plant oil having a melting point in the range of -20 °C to ≤30 °C as claimed.
Regarding claims 27 and 40 reciting improving skin sensation, as evidenced by Gen, 1,2-octanediol, which is also known as caprylyl glycol, is a multifunctional cosmetic ingredient that improves the spreadability and ultimately the feel of a product on your skin (p.1, middle section).
Thus, since the composition of Premachandran comprises 1,2-octanediol (i.e. caprylyl glycol), which is known to possess the property of improving spreadability, one of ordinary skill in the art would reasonably expect the composition of Premachandran to have an improved spreadability and feel of product on skin when applied. See MPEP 2112.
Response to Arguments
Applicant mainly asserts that Premachandran is directed to antimicrobial compositions, which is vastly different than presently claimed compositions, which serve to improve skin sensation (specifically, at least one of improved spreading, reduced fatty/greasy feel, and improved absorption on the skin). One of skill in the art simply would not turn to Premachandran when seeking to develop a composition for improving skin sensation.
The Examiner does not find Applicant’s assertion persuasive. As previously discussed, the rationale for obviousness has been detailed in the rejection supra, and the Examiner’s rationale need not be the same as Applicant’s to establish obviousness. See MPEP 2144(IV). In this instant case, both Premachandran and Schmaus are directed to cosmetic compositions. Premachandran teaches a cosmetic composition comprising one or more organic compounds including 1,2-octanediol, 2,3-octanediol, and triglycerides, and Schmaus teaches olive oil as a known and effective triglyceride suitable for cosmetic compositions, including those comprising alkanediols. As supported by MPEP § 2144.06(I), combining known ingredients for their known functions is generally obvious. Regarding the assertion about improving skin sensation, as supported by MPEP 2112.01, products of identical chemical composition cannot have mutually exclusive properties. As such, a skilled artisan would reasonably expect the composition of Premachandran to be capable of improving skin sensation as instantly claimed, whether the prior art recognizes such property or not.
Applicant asserts that Premachandran teaches an extensive "laundry list" of organic compounds that may be selected for inclusion in a composition but provides no guidance whatsoever on how to pick and choose the specific components to include in a composition for improving skin sensation, and there can be no reasonable expectation of success in developing such a composition in view of Premachandran, given its silence on the improvement of skin sensation.
The Examiner does not find Applicant’s assertion to be persuasive. As stated in MPEP § 2123, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Similarly, a reference that “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). In this instant case, the fact that Premachandran discloses alternative organic compounds in addition to 1,2- and 2,3-octanediol and triglycerides does not render such choices less obvious as a choice of organic compounds. Therefore it would have been obvious to one of ordinary skill in the art to have included said organic compounds in the composition since Premachandran does not disclose wherein 1,2- and 2,3-octanediol or triglycerides cannot be used as an organic compound. Such a conclusion of obviousness is also supported by MPEP § 2143(I)(A). Lastly, it is noted that the instant claims are directed to a composition. Where the components of the composition is taught by the prior art, as long as the component is present in the composition made obvious, there is a reasonable expectation that the functional recitations regarding such a composition are also met, given that the function of compositions is a product of the compositions’ structure. In other words, the component need not be included for the same purpose as Applicants reasoning, which is for improving skin sensation. As such, Applicant’s argument is unpersuasive.
Applicant asserts it has been surprisingly found that adding an effective amount of a mixture of two or more different specific alkanediols, as recited in the pending claims, to a topical composition comprising a liquid lipophilic component significantly improves not only the short-term, but also the long-term sensory properties. Applicant asserts the data clearly show an obvious and statistically significant trend that the compositions as claimed show unexpected and superior properties over the individual components in terms of improvement in one or more skin sensation parameters, where the improved properties of the specific compositions as claimed were unexpected and could not have been predicted from Premachandran, with or without the teachings of Schmaus and/or Gen. Applicant further asserts the claims as presently pending are fully aligned with the data shown in the Lange Declaration.
The Examiner is not persuaded by these assertions. Regarding allegations of unexpected results, any differences between the claimed invention and the prior art may be expected to result in some difference in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The burden is on applicant to establish that the results are in fact really unexpected and of statistical and practical significance. See MPEP § 716.02. Applicant appears to have only discussed a select set of data contained in Table 22. The examples of Table 22 of the instant Specification appears to contain mixed data and does not clearly demonstrate claimed unexpectedness for the full breadth of the plant oils claimed. For example, on page 206, Argan oil appears to perform well with a mixture of 1,2- and 2,3-octanediol in a specific ratio, but does not show similar unexpected results with a mixture of 1,2- and 2,3-heptanediol of the same ratio. Similarly, on bottom of p. 206 to top of p. 207, Cacao butter appears to perform well with the specific mixture of 1,2- and 2,3-heptanediols in a specific ratio, but does not show similar unexpected results with a mixture of 1,2- and 2,3-octanediols. As such, it appears the alleged unexpected results is achieved through specific mixtures of alkanediols in combination with specific lipophilic components. Applicant would have to explain how the mixed data demonstrates unexpectedness of results across the 3 combinations of 1,2- and 2,3- alkanediols and the various species of plant oils as instantly claimed. Specifically, objective data appear to be incomplete for Shea butter, soybean oil, sweet almond oil, jojoba oil, and cetearyl nonanoate.
Finally, assuming purely arguendo that the unexpectedness of the results have been established, the probative value of the evidence as compared to the invention as claimed must then be determined, i.e., the claims must be “commensurate in scope” with the showing. MPEP § 716.02(d). See also MPEP § 2145. Table 22 of the instant Specification and the Lange Declaration employ specific amounts and ratios of the alkanediols and lipophilic components, and even if Applicant were to show unexpected results, they would be have been obtained, for example, with a specific ratio of diol blend and of the lipophilic component to the mixture of specific alkanediols, in addition to the amounts instantly claimed, and not just with the broadly claimed amounts of “0.1-5.0 % wt. of a mixture of at least one first linear alkanediol and one or more second linear alkanediols” and “1.0-40.0 % wt. of at least one liquid lipophilic component” generally. Note for example, in para. 33 of the Declaration, it is specified that the ratio of the oil: diol was 85:15, and the blend is 95: 5 (1,2 : 2,3 diol). Applicant would need to explain how these specific ratios are “reasonably representative” of the more broadly claimed subject matter of claim 27, which does not contain any ratios, and claim 29, citing only a broad ratio of 50 : 50 to 99.9 : 0.1 for the at least one first linear alkanediol : one or more second linear alkanediols.
Response to Declaration
The Declaration under 37 CFR 1.132 filed 09 December 2025 is insufficient to overcome the rejection of claims 27-29, 32, 36, and 40 based upon Premachandran et al. (US 2018/0092357 A1, 04/05/2018) (hereinafter Premachandran) in view of Schmaus et al. (US 2005/0222276 A1, 10/06/2005) (hereinafter Schmaus), as evidenced by Gen (“Deciphering the skin care ingredient caprylyl glycol”, 12/09/2020) applied under 35 U.S.C. 103 as set forth in the last Office action because: the showing is not commensurate in scope with the claims.
As discussed above, the examples in the Declaration also employ specific ratios for the mixture of alkanediols and for the lipophilic components, and even if Applicant were to show the unexpectedness of results, they would be have been obtained, for example, not just with the broad amounts of “0.1-5.0 % wt. of a mixture of at least one first linear alkanediol and one or more second linear alkanediols” and “1.0-40.0 % wt. of at least one liquid lipophilic component” generally, but also with a specific ratio of diol blend and of the lipophilic component to the mixture of specific alkanediols, in addition to the amounts instantly claimed. Note for example, in paragraphs 18 and 33 of the Declaration, it is specified that the ratio of the blend is 95: 5 (1,2 : 2,3 diol), and the ratio of the oil: diol was 85:15. Applicant would need to explain how such specific ratios are “reasonably representative” of the more broadly claimed subject matter of claim 27, which does not recite any ratios, and claim 29, which recites only a broad ratio of 50 : 50 to 99.9 : 0.1 for the at least one first linear alkanediol : one or more second linear alkanediols.
Double Patenting (maintained)
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 27-29, 32, 36, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-8, 10, 12-22 and 24 of copending Application No. 18/009,289 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite more specific alkanediols) and thus read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 27-29, 32, 36, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 13, 17, 19-21, 23-24, and 26-35 of copending Application No. 18/009,291 in view of US 20050222276 A1 (Schmaus et al., 10/06/2005) (hereinafter Schmaus).
The pending claims differ from the copending claims insofar as reciting at least one liquid lipophilic component. However, Schmaus discloses mixtures of two, three or more straight-chain 1,2-alkanediols as antimicrobial active compounds (abstract). The mixture may be contained in a cosmetic or dermatological formulation such as in the form of an emulsion (¶ [0136]). The oil phase of the emulsion may comprise natural oils such as olive oil (¶ [0143]). Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Accordingly, it would have been obvious to one of ordinary skill in the art to have included olive oil as the oil in the composition of the copending claims since it is a known and effective oil suitable for cosmetic compositions comprising alkanediols as taught by Schmaus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 27-29, 32, 36, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17-19, 21-23, and 27-28 of copending Application No. 18/009,295 in view of US 20050222276 A1 (Schmaus et al., 10/06/2005) (hereinafter Schmaus). The pending claims differ from the copending claims insofar as reciting at least one liquid lipophilic component. However, Schmaus discloses mixtures of two, three or more straight-chain 1,2-alkanediols as antimicrobial active compounds (abstract). The mixture may be contained in a cosmetic or dermatological formulation such as in the form of an emulsion (¶ [0136]). The oil phase of the emulsion may comprise natural oils such as olive oil (¶ [0143]). Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Accordingly, it would have been obvious to one of ordinary skill in the art to have included olive oil as the oil in the composition of the copending claims since it is a known and effective oil suitable for cosmetic compositions comprising alkanediols as taught by Schmaus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 27-29, 32, 36, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 12-15, and 17-26 of copending Application No. 18/009,314 in view of US 20050222276 A1 (Schmaus et al., 10/06/2005) (hereinafter Schmaus). The pending claims differ from the copending claims insofar as reciting at least one liquid lipophilic component. However, Schmaus discloses mixtures of two, three or more straight-chain 1,2-alkanediols as antimicrobial active compounds (abstract). The mixture may be contained in a cosmetic or dermatological formulation such as in the form of an emulsion (¶ [0136]). The oil phase of the emulsion may comprise natural oils such as olive oil (¶ [0143]). Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Accordingly, it would have been obvious to one of ordinary skill in the art to have included olive oil as the oil in the composition of the copending claims since it is a known and effective oil suitable for cosmetic compositions comprising alkanediols as taught by Schmaus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 27-29, 32, 36, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 13-22, and 25-26 of copending Application No. 18/009,324 in view of US 20050222276 A1 (Schmaus et al., 10/06/2005) (hereinafter Schmaus). The pending claims differ from the copending claims insofar as reciting at least one liquid lipophilic component. However, Schmaus discloses mixtures of two, three or more straight-chain 1,2-alkanediols as antimicrobial active compounds (abstract). The mixture may be contained in a cosmetic or dermatological formulation such as in the form of an emulsion (¶ [0136]). The oil phase of the emulsion may comprise natural oils such as olive oil (¶ [0143]). Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Accordingly, it would have been obvious to one of ordinary skill in the art to have included olive oil as the oil in the composition of the copending claims since it is a known and effective oil suitable for cosmetic compositions comprising alkanediols as taught by Schmaus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 27-29, 32, 36, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-31 of copending Application No. 18/301,090 in view of US 20050222276 A1 (Schmaus et al., 10/06/2005) (hereinafter Schmaus). The pending claims differ from the copending claims insofar as reciting at least one liquid lipophilic component. However, Schmaus discloses mixtures of two, three or more straight-chain 1,2-alkanediols as antimicrobial active compounds (abstract). The mixture may be contained in a cosmetic or dermatological formulation such as in the form of an emulsion (¶ [0136]). The oil phase of the emulsion may comprise natural oils such as olive oil (¶ [0143]). Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Accordingly, it would have been obvious to one of ordinary skill in the art to have included olive oil as the oil in the composition of the copending claims since it is a known and effective oil suitable for cosmetic compositions comprising alkanediols as taught by Schmaus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant asserts the amended claims are patentably distinct from the reference claims, and further asserts the Applicant will address the rejections as needed when the claims are otherwise allowable. Since this has not occurred, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612