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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/16/2025 has been entered.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive.
The applicant argues that oleic acid can only be added in the invention of Kobal as an active ingredient and not the at least one acid. Although the applicant is correct that oleic is disclosed as being added as an active ingredient and not the at least one acid, the active ingredient is disclosed as being added 0.01-10%, making the claimed range of equal or greater than 0.5 percent by weight obvious. Therefore, although the applicant is technically correct that oleic acid was misidentified, the rejection remains applicable and would have been obvious to one of ordinary skill.
The applicant argues that the Goldman et al. teaches away from using 10% triethyl citrate because Goldman et al. disclose that in some embodiments, less than 0.05% or less of triethyl citrate should be used. Although Goldman et al. cautions about the effect of triethyl citrate, Goldman et al. explicitly state in example 5 [0069], a mixture with 10.0% triethyl citrate, and that, “This liquid composition was suitable for use in a personal vaporizer”. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)(MPEP 2123 (II)). In the instant case, one of ordinary skill may expect the solution to have the effect warned about in the other portion of Goldman et al., but that pointing out non-optimal results does not indicate that a particular amount is not operable. In particular, Goldman et al. teaches that a much larger amount of triethyl citrate can be used to stabilize certain compounds. For instance, in example 5, Goldman et al. disclose forming an emulsion of Oleamide and state that, “Oleamide is very waxy and much more difficult of a substance to emulsify in propylene glycol than cannabis extract.” [0069]. Therefore, instead of teaching away from the use of large amounts of triethyl citrate, Goldman et al. indicates that it is essential in large amounts to solubilize more difficult to emulsify substances.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 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.
Claim(s) 16, 18-27, and 31, is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobal et al. (US 20140271946) in view of Goldman et al. (US 20150083146)t.
Regarding claims 16, 18-27, and 31, Kobal et al. disclose a liquid nicotine formulation that contains 40-90% glycerin and/or propylene glycol (water miscible solvent) and water, 2-10% nicotine, and 0.01-10% of at a nicotinic acetylcholine receptor inhibiting or modulating compounds, which includes oleic acid [0021, 0027]. Kobal et al. further disclose that acidic flavorants can be added including citric acid (i.e. soluble organic acids [0028). Soluble organic acids such as acetic acid are also added at between 0.1 and 15% to reduce pH [0078-0079].
Although Kobal et al. do not disclose the state at 20 C, solubility, or miscibility in water of the ingredients, the ingredients are the same compounds as claimed and therefore must inherently have the same properties.
Kobal et al. do not expressly disclose adding polysorbate 80, triacetin, or triethyl citrate (partially water-soluble, water immiscible solvents). However, Goldman et al. disclose adding up to 10% triethyl citrate as lipid solubilizers so that water insoluble materials, such as menthol, cannabis extracts, and fatty acids (e.g. oleic acid derivatives) can be emulsified in propylene glycol [0069].
It would have been obvious to one of ordinary skill in the art at the time of invention to use up to 10% triethyl citrate as disclosed by Goldman et al. to ensure stable emulsions of water-insoluble or water immiscible additives in propylene glycol based liquids to be atomized such as the mixture disclosed by Kobal et al.
Regarding claim 32, the range of the ratio as claimed in the disclosure of Kobal et al. is greater than or equal to 4, which significantly overlaps and makes obvious the claimed range of less than or equal to 15.
Claim(s) 16, 18-27, and 31, is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobal et al. (US 20140271946) in view of Liu (US 20160366927).
Regarding claims 16, 18-27, and 31, Kobal et al. disclose a liquid nicotine formulation that contains 40-90% glycerin and/or propylene glycol (water miscible solvent) and water, 2-10% nicotine, and 0.01-10% of at a nicotinic acetylcholine receptor inhibiting or modulating compounds, which includes oleic acid [0021, 0027]. Kobal et al. further disclose that acidic flavorants can be added including citric acid (i.e. soluble organic acids [0028). Soluble organic acids such as acetic acid are also added at between 0.1 and 15% to reduce pH [0078-0079].
Although Kobal et al. do not disclose the state at 20 C, solubility, or miscibility in water of the ingredients, the ingredients are the same compounds as claimed and therefore must inherently have the same properties.
Kobal et al. do not expressly disclose adding polysorbate 80, triacetin, or triethyl citrate (partially water-soluble, water immiscible solvents). However, Liu discloses using 20% to 60% or more triethyl citrate in combination with propylene glycol and glycerol (see claims 5-9). Liu discloses that the liquid formulation, “Due to the effect of triethyl citrate, the electronic cigarette liquid which is prepared…generates relatively greater amount of smoke while be atomized, improves the experience of the smoker, who feels thick and full, neither too dry nor too wet, and has relatively higher comfort level.” (Abstract). It would have been obvious to one of ordinary skill in the art at the time of invention to use the triethyl citrate of Liu to make the liquid of Kobal et al. improved for the reasons provided by Liu. The results would have been predictable (i.e. improved experience for the smoker).
Regarding claim 32, the range of the ratio as claimed in the disclosure of Kobal et al. is greater than or equal to 4, which significantly overlaps and makes obvious the claimed range of less than or equal to 15.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J FELTON whose telephone number is (571)272-4805. The examiner can normally be reached Monday, Thursday-Friday 7:00-4:30, Wednesday 7:00-1:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H Wilson can be reached at 571-270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael J Felton/Primary Examiner, Art Unit 1747
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