DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08 January 2026 has been entered.
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 08 January 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 1, 16-19, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Faergemann et al. (US 2009/0221716 A1, 09/03/2009) (hereinafter Faergemann).
Faergemann discloses cosmetic or pharmaceutical compositions comprising at least 3 different diols with the general structure (CH2)nH2O2, wherein n is the number of CH2 and being between 3 to 10 (i.e. alkanediols) in a total amount of from about 0.1 to about 50% (v/v) (abstract). Exemplary diols include heptane-1,2-diol, heptane-2,3-diol, octane-1,2-diol, and octane-2,3-diol (0018). Each of the diols may form a 1:1:1 v/v combination (0041). The compositions may be administered topically as solutions or emulsions, which may contain excipients including emulsifiers (i.e. claimed at least one cosmetically or pharmaceutically active substance and/or additive of claim 18) such as water (i.e. claimed aqueous solution of claim 23) and oils such as olive oil (i.e. claimed plant oil as the at least one liquid lipophilic component) (0028).
The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claim 17, as noted by paragraph [0215] of the instant Specification, olive oil is characterized by a melting point range of -20 °C to +5 °C. Therefore, the olive oil disclosed by Faergemann meets the melting point range as claimed.
Regarding claim 19, although Faergemann does not explicitly disclose amounts by weight, it would have been obvious to one of ordinary skill in the art to have selected the amounts by volume of diols within the disclosed range of about 0.1 to about 50% v/v. Such amounts selected would have equated to a % by weight amount that overlaps with the claimed % by weight amount (i.e. 0.001 to 15.0% by weight), thus making the claimed range 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. See MPEP § 2144.05(I).
Regarding claim 21, as discussed above, Faergemann discloses wherein the total amount of diols may be up to about 50% v/v, and that it may also comprise oils such as olive oil (i.e. liquid lipophilic component).
Faergemann does not explicitly disclose the total amount of oils.
However, the claimed amount would have been obvious to one of ordinary skill in the art since Faergemann discloses up to about 50% v/v of diols, therefore deriving the claimed amount of the olive oil as the oils would have also been obvious. 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. See MPEP § 2144.05(II)(A).
Response to Arguments
Applicant asserts Faergemann 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 Faergemann, given its silence on the improvement of skin sensation. Applicant further asserts Faergemann encourages away from the presently claimed compositions in encouraging the use of 3 different diols. Antimicrobial properties would be expected in view of Faergemann, but not improvement of skin sensation.
The Examiner does not find Applicant’s argument 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, Faergemann teaches a cosmetic or pharmaceutical compositions comprising about 0.1-50% v/v of at least three different diols including heptane-1,2-diol; olive oil; and emulsifiers. 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 Faergemann to be capable of provide an improvement of skin sensation as instantly claimed, whether the prior art recognizes such property or not. Lastly, Faergemann does not teach away because the instant claims employ the open-ended transitional term “comprising,” which would not exclude additional diols.
Applicant asserts it is surprisingly found that adding 1,2-heptanediol to a topical composition comprising a plant oil or another liquid lipophilic component significantly improves the short term, but also the long term sensory properties. Applicant further asserts the claims have been amended to recite specific liquid lipophilic components: plant oils, fatty acid esters cetearyl nonanoate and propanediol dicaprylate caprate, and UV filters octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicylate, and isoamyl p-methoxycinnamatethe, all of which have been specifically exemplified within the working examples, or are appropriately generalized from the working examples.
The Examiner is not persuaded by these assertions. 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. Accordingly, although Faergemann does not explicitly disclose the claimed alkanediols with the functional property of improving skin sensation, and instead for their antimicrobial properties, it is not necessary for Faergemann to disclose the same properties. As Faergemann discloses the same alkanediols, one would reasonably expect such properties to flow from its structural presence.
Regarding allegations of unexpected results, assuming purely arguendo that the unexpectedness of 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. The examples in the Declaration employ specific ratios of the lipophilic components and 1,2-heptanediol, and any alleged unexpected results would have been obtained, for example, not with any amounts of 1,2-heptanediol and “lipophilic component” generally, but instead with specific ratio and amounts of each component. Note for example, in para. 21 of the Declaration, Tables 22a-22g all employ a specific ratio of 85:15 (lipophilic component : 1,2-heptanediol). Therefore, it is not clear how results obtained with such complex mixtures of ingredients would be reasonably representative of a broadly claimed composition within the scope of the instant claims, for example a composition simply containing “at least one liquid lipophilic component” of any amounts and ratios to the 1,2-heptanediol as recited in applicant’s claim 1.
Response to Declaration
The Declaration under 37 CFR 1.132 filed 08 January 2026 is insufficient to overcome the rejection of claims 1, 16-19, 21, and 23 based upon Faergemann et al. (US 2009/0221716 A1, 09/03/2009) (hereinafter Faergemann) 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 employ specific ratios of the lipophilic components to 1,2-heptanediol, as well as specific amounts of 1,2-heptanediol, and any alleged unexpected results would have been obtained, for example, not with any amounts of 1,2-heptanediol and “lipophilic component” generally, but instead with specific ratio and amounts of each component. Note for example, in para. 21 of the Declaration, Tables 22a-22g all employ a specific ratio of 85:15 (lipophilic component : 1,2-heptanediol). Therefore, it is not clear how results obtained with a more complex mixtures of ingredients would be reasonably representative of a broadly claimed composition within the scope of the instant claims, for example a composition simply containing “at least one liquid lipophilic component” of any amounts and ratios to the 1,2-heptanediol as recited in applicant’s claim 1.
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 § 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 1, 16-19, 21, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-29, 32, 36, and 40 of copending Application No. 18/301,004, 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 1, 16-19, 21, and 23 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; claims 1, 17-19, 21-23, and 27-28 of copending Application No. 18/009,295; claims 1, 3-5, 12-15, and 17-26 of copending Application No. 18/009,314; claims 1-2, 13-22, and 25-26 of copending Application No. 18/009,324; and claims 16-31 of copending Application No. 18/301,090 in view of Faergemann et al. (US 2009/0221716 A1, 09/03/2009) (hereinafter Faergemann). The pending claims differ from the copending claims insofar as reciting at least one liquid lipophilic component. However, Faergemann discloses cosmetic or pharmaceutical compositions comprising at least 3 different diols with the general structure (CH2)nH2O2, wherein n is the number of CH2 and being between 3 to 10 (i.e. alkanediols), useful in inactivating microorganisms or preventing their growth (abstract). Exemplary diols include heptane-1,2-diol and heptane-2,3-diol (0018). The compositions may be administered topically as solutions or emulsions, which containing excipients including oils such as olive oil (i.e. claimed plant oil as the at least one liquid lipophilic component) (0028). Accordingly, it would have been obvious to one of ordinary skill in the art to have included olive oil in the composition of the copending claims since it is a known and effective excipient oil suitable for cosmetic compositions as taught by Faergemann. 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612