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 03 September 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 17-18, 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).
Regarding claim 1, 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 oils such as olive oil (i.e. claimed plant oil as the at least one liquid lipophilic component) (0028).
Together these would provide compositions as instantly claimed. 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 1 reciting amounts of 1,2-heptanediol, it would have been obvious to one of ordinary skill in the art to have selected an amount 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). Moreover, in any case, the selection of appropriate weight percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in percent by weight. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claims 1 and 21 reciting an amount of the at least one liquid lipophilic component, although Faergemann does not explicitly disclose an amount of an oil such as olive oil, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amounts (i.e. about 0.01 to 50% by weight) through routine experimentation based on the formulation desired. 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).
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 18, Faergemann further discloses wherein the excipients include emulsifiers (i.e. claimed at least one cosmetically or pharmaceutically active substance and/or additive) ([0028]).
Regarding claim 23, Faergemann further discloses wherein excipients include solvents such as water (i.e. claimed aqueous solution) ([0028]).
Response to Arguments
Applicant mainly refers to assertions from the Declaration of 03 September 2026 (i.e. Ebbecke Declaration), and mainly asserts on pp. 6-7 regarding the experiments and data disclosed in the application in support of the addition of 1,2-heptanediol to a composition containing, e.g., a variety of different plant oils in improving the short term and long term sensory properties as claimed.
The Examiner appreciates the explanations and the amendment regarding subject matter previously in claims 16 and 19. Regarding the other assertions made by the Applicant regarding the experiments and data demonstrated by the Ebbecke Declaration, the Examiner has explained in detail below regarding the reasons Examiner does not find the assertion of patentability to be persuasive in their current scope.
Response to Declaration
The Examiner appreciates the data provided in the executed Declaration of Dr. Ebbecke of 03 September 2026. Unfortunately, the Declaration is insufficient to overcome the obviousness rejection above because the showing is not commensurate in scope with the claims.
Examiner disagrees that patentability has been demonstrated for the claims (in their current scope). To overcome a prima facie case of obviousness via submission of unexpected results, Applicant must demonstrate not only that the results would have been unexpected to one having ordinary skill in the art at the time of the invention, but also that the instant claims are commensurate in scope with the results provided. See MPEP 716.02(d).
In this instant case, while Applicant’s result does not seem to be predicted by the prior art, conversely the claims do not appear to be commensurate in scope with the results presented. For example, the data referenced in Exhibit B is limited to specific ratio ranges of the 1,2-heptanediol to the at least one liquid lipophilic component, namely from 95 : 5 to 50 : 50. Similarly, the Lange Declaration, submitted 08 January 2026, supports a range of 85 : 15 to 50 : 50 ratio (Lange: Tables 2-17 and para. [22]), which is consistent with the instant Specification (see, for example, para. [0384] of the Specification). However, the instant claims are not limited at all. Accordingly, it is not clear to the Examiner how such showing of 95 : 5 to 50 : 50 is reasonably representative of the much broader subject matter of the instant claims in its current scope, which encompasses as little as 0.001% wt. of 1,2-heptanediol and as much as 50% wt. of the at least one liquid lipophilic component.
Moreover, the claims in their current scope appear to speak to subjective properties resulting from the combination of the ingredients (e.g., “improved” spreading/absorption and “reduced” fatty/greasy feel) with no comparison point of improvement (e.g., to the same composition without alkanediol? Or to the same composition of an alternative alkanediol?), rather than highlight the objective results demonstrated by the Declarations. The Examiner further notes that the following portions of the instant Specification appear to speak to the embodiment asserted by the Applicant:
Para. [0374-0375], “… have a significantly better solubility in the liquid lipophilic component containing composition compared to 1,2-pentanediol or 1,2-hexanediol, which lead to turbid solutions, or 1,2-octanediol, which tends to precipitate or recrystallize in oily solutions. …do not precipitate in the liquid lipophilic component containing composition and, thus, do not lead to turbidity. Thus, due to their better solubility stable liquid lipophilic component containing composition can be obtained and even maintained during storage.”
Para. [0340], “…it does not contain a silicone or silicone derivative, in particular a silicone oil.”
Para. [0353], “…is suitable to partially or completely replace a silicone in a cosmetic or pharmaceutical composition, in order to achieve a superior skin sensation as usually achieved by the addition of silicone. By the complete or partial replacement of silicone with a green alkanediol in a cosmetic or pharmaceutical composition, the naturality index, which is the criteria for natural and organic cosmetic ingredients, of a cosmetic or pharmaceutical formulation, can be significantly increased.”
Para. [0342], “Surprisingly, it was found, as described in more detail in the following Example 1, that 1,2-heptanediol is easier to incorporate into a liquid lipophilic component or the cosmetic or pharmaceutical composition as described in the present invention. The solubility of the 1,2-heptanediol in a liquid lipophilic containing formulation or composition is superior compared to the solubility of 1,2-pentanediol and 1,2- hexanediol, as is demonstrated by the following examples. In contrast, 1,2-octanediol tends to precipitate or recrystallize in oily solutions. Due to their excellent solubility in a liquid lipophilic component containing composition, the 1,2-heptanediol can be advantageously provided in high concentrations in the composition according to the present invention. This in turn enhances the availability of the 1,2-heptanediol in the topical formulation or composition.
Accordingly, the Examiner suggests amending the claims to more closely reflect the results obtained in the Declaration, and consider further including claim language that would highlight the results achieved by Applicant, such as: superiority in solubility (resulting in a clear and non-turbid solution) when compared to the same composition with 1,2-pentanediol, 1,2-hexanediol, or 1,2-octanediol; and wherein the composition does not contain a silicone or silicone derivative.
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 1, 17-18, 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, and claims 1-2, 13-19, 21-22, 24, and 32-38 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 plant oils and/or octocrylene) 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, 17-18, 21, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 13, 17, 19-21, 23-24, and 26-36 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, 5, 12-15, 17-28, and 30-40 of copending Application No. 18/009,314; claims 1-2, 14, 16-22, 25-26, and 28-32 of copending Application No. 18/009,324; and claims 16-17 and 19-36 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 primarily 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.
Response to Arguments
Applicant asserts the amended claims are not obvious variants of the reference claims and requests reconsideration and withdrawal of the obviousness type double patenting rejections.
The Examiner does not find the assertions to be persuasive. The amended claims, in their current scope, share significant overlap with the conflicting claims. For example, copending Application No. 18/301,004 discloses 0.1-5% wt. of a mixture comprising 1,2-heptanediol and 1.0-40% wt. of at least one liquid lipophilic component comprising plant oils, and provides same benefit as instantly claimed. Thus it is not clear to the Examiner how the pending claims, in their current scope, highlights the distinct effect achieved by the Applicant in formulating the specific combination. As such, 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
