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 filed 10/16/2025 have been fully considered but they are not persuasive.
The arguments concern claim amendments that are addressed in the rejections below.
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, 31, 33, and 34, 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].
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 liquids for personal vaporizers including an embodiment where oleamide, an active ingredient that is very waxy, is emulsified in a propylene glycol base (87.85%) using 2.0 % monolaurin (a lipid stabilizer) and 10% triethyl citrate [0069]. It would have been obvious to one of ordinary skill in the art at the time of invention/filing to use the lipid stabilizers of Goldman et al. to add a desired ingredient such as oleamide to a fluid to be inhaled to treat sleep and mood disorders (as disclosed by Goldman et al.).
Goldman et al. disclose using monolaurin as a lipid stabilizer (water insoluble, water-immiscible). Monolaurin has a melting point above 20C. However, Goldman et al. disclose other lipid stabilizers including 1-oleoylglycerol, 1-arachidonoylglycerol, 2-arachidonoylglycerol (which is also a ligand for cannabinoid receptors in the brain), 1-linoleoylglycerol, 2-linoleoylglycerol, 1-caproylglycerol, 2-caproylglycerol, that are liquid at 20 C [0022]. It would have been obvious to one of ordinary skill in the art at the time of invention to use these alternatives disclosed by Goldman et al., especially 2-arachidonoylglycerol, which has effects on cannabinoid receptors that are also the target of the active ingredient (oleamide).
The resulting ratio of 10% triethyl citrate to the other lipid solubilizer (water-insoluble, water-immiscible) 2%, results in a ratio of 5, which meets the claim limitation of less than or equal to 15.
Regarding claim 34, example 5 [0069] of Goldman et al. discloses using triethyl citrate and does not disclose triacetin or polysorbate 80 in this example. However, Goldman et al. disclose triacetin as a lipid stabilizer and solubilizers, indicating that they are closely related and interchangeable [0061]. Although this disclosure is concerning different amounts for a different embodiment, one of ordinary skill in the art at the time of invention would expect triacetin to replace triethyl citrate with predictable results.
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 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
