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 .
Response to Arguments
Applicant’s arguments, see Remarks, filed 11/24/2025, with respect to Rejections under 35 U.S.C. 112(a) and (b) have been fully considered and are persuasive. The rejections have been withdrawn.
Applicant's arguments (excluding the persuasive arguments discussed above) have been fully considered but they are not persuasive.
Applicant’s arguments concerning claim amendments (e.g. “water-immiscible solvents that are liquid at 20C and have…” and “between about 2 percent by weight and about 15 percent by weight”) are addressed in the rejections below.
The applicant argues that because the examples of Liu use triethyl citrate in amounts of 20% or greater, it would not be obvious to combine the references. The examiner disagrees.
First, Liu expressly discloses that triethyl citrate is tied to the effect of producing thicker, more comfortable smoke. It would have been obvious to use the teaching of Liu in other electronic cigarettes.
Second, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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) 16-25 and 27-30 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 claim 16-18, 20, 23, 24, and 27, Kobal et al. disclose a liquid nicotine formulation with:
40-90% polyethylene glycol and/or glycerine (i.e. miscible solvent) [0074],
0.1-15% organic acid, including acetic acid [0079], and
1-10% nicotine [0081],
Kobal et al. do not disclose the exact same ranges as those in the claims. However, it would have been obvious to one of ordinary skill in the art at the time of invention/filing that the ranges in the prior art either anticipate or make obvious the claimed ranges because they encompass or significantly overlap the claimed range and are sufficiently specific.
Kobal et al. do not disclose the use of a water-immiscible solvent that is partially water-soluble that is liquid at 20°C.
However, Liu discloses the replacement of some of the propylene glycol solvent in an aerosol generating composition with triethyl citrate. Liu states:
Due to the effect of triethyl citrate, the electronic cigarette liquid which is prepared with the solvent for electronic cigarette liquid provided by the present invention, when atomized under heat, can generate relatively greater amount of smoke, which improves the experience of the smoker, who feels thick and full, neither too dry nor too wet, and thus has a relatively higher comfort level when smoking. [0024]
It would have been obvious to one of ordinary skill in the art at the time of filing/invention to use triethyl citrate to replace a portion of the aerosol generating compounds in the invention of Kobal et al. and produce aerosol with the desirable qualities as disclosed by Liu.
Liu et al. does not disclose the amount of triethyl citrate is between about 2-15%, however, it would have been obvious to change the amount of triethyl citrate to obtain various amounts “smoke” for smokers that want to feel, “thick and full, neither too dry nor too wet” because it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA).
The instant specification indicates that triethyl citrate and a suitable partially water-soluble solvent and therefore and meets the limitations of having a water-solubility of a water solubility at 20°C of less than or equal to about 100 mg/ml, having a partition coefficient (log P) at 20°C of between about 0.05 and about 0.5, and has a chain length of less than or equal to ten (Specification, page 19). The properties of triethyl citrate are inherent and therefore the triacetin of Liu inherently has the same properties as reported in the instant application.
Regarding claim 19, the instant specification indicates that triethyl citrate and triacetin meet the claimed limitations.
Regarding claim 25, Kobal et al. disclose adding oleic acid to compositions because:
[I]t is believed that these compounds provide sensory relief by inhibiting and/or modulating nicotinic acetylcholine receptors (nAChRs), as well as transient receptor protein (TRP) ion channels such as the TRPV1 and TRPA1 channels on nociceptive fibers that mediate pain perception. [0021]
It would have been obvious to one of ordinary skill in the art at the time of invention to use oleic acid in the liquid aerosol formulation to reduce irritation during inhalation (see also, claims 10, 12, 16, and 18).
Regarding claim 21, the instant specification indicates that oleic acid (see claim 25 above) is a “water-insoluble solvent” that is liquid at 20°C and has a partition coefficient (log P) at 20°C of greater than about 5 (specification, page 24 (all)).
Regarding claim 22, the formulation of Kobal et al. may contain water [0006].
Regarding claims 28 and 29, Kobal et al. do not disclose a cartridge that contains the liquid nicotine. However, using a cartridge to contain fluid to be aerosolized in a e-cigarette, vape, or aerosol generating device is notoriously well known in the art. It would have been obvious to one of ordinary skill in the art to include the liquid in a replaceable cartridge so users can replace the cartridge after it is consumed.
Regarding claim 30, Kobal et al. disclose the liquid nicotine is used in a aerosol-generating system with a heater (i.e. atomizer) [0006].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 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 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 on 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