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 .
Response to Amendment
Claims 1, 18-19, 21, 26, 29 and 31-32 are amended. Claims 17, 20-21, 23, 27, 30 and 33-34 are cancelled. Claims 22, 24-26, 28-29 and 31-32 are withdrawn. Claims 1-16 and 18-19 are presently examined.
Applicant’s arguments regarding the rejections under 35 USC 112(d) have been fully considered and are persuasive. The rejections of 11/3/2025 are overcome.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/29/2026 has been entered.
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.
Claims 1-7, 9-16 and 18-19 are rejected under 35 U.S.C. 103 as being obvious over Warchol (NZ 536863) in view of Kuntawala (US 2016/0198759) and Bowen (US 9,215,895) and Fuisz (US 2018/0199618) and Mishra (US 11,311,048) and Perrier (US 6,524,595).
Regarding claims 1-7 and 9-16, Warchol discloses an aqueous based formulation containing 5000 mg nicotine, at least 60 g of water, and a pH that is adjusted to 5.0 using citric acid (page 17, lines 4-9). The formulation comprises at least 90 percent water by weight (page 18, lines 20-23) and at least 90 percent of the nicotine is in the monoprotonated form at a pH of 5.0 (page 7, lines 20-28). It is evident that citric acid is water soluble since it would otherwise be unable to reduce the pH of the water-based formulation. It is evident that water makes up at least 90% of the weight of the solution since the solution is 100 mL at room temperature and contains only water, about 1 g of solid components, and citric acid (page 17, lines 4-9), which is evidently primarily made of water as well and would not be added in a significant amount. Warchol does not explicitly disclose (a) adding a cyclodextrin to the formulation, (b) a specific nicotine weight, (c) a specific ratio of nicotine and acid, (d) one or more flavors, and (e) the cyclodextrin being substituted β-cyclodextrin.
Regarding (a), Kuntawala teaches an e-fluid [0015] having a cyclodextrin added to it to increase the absorbability of active ingredients while suppressing any irritating tendency of the aerosol [0016]. The cyclodextrin is α, β, or γ-cyclodextrin [0017].
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the formulation of Warchol with the cyclodextrin of Kuntawala. One would have been motivated to do so since Kuntawala teaches that adding a cyclodextrin to an e-fluid increases the absorbability of active ingredients while suppressing any irritating tendency of the aerosol.
Regarding (b), Fuisz teaches an aerosolizable tobacco wax (abstract) having a nicotine concentration of less than 0.5% for users seeking lower nicotine delivery [0079]. One of ordinary skill in the art would recognize that Fuisz refers to a weight percentage since Fuisz measures other compositions by weight ([0197], [0198]) and nowhere refers to volumetric or molar percentages.
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to lower the nicotine concentration of modified Warchol to values within the range of Fuisz. One would have been motivated to do so since Fuisz teaches a nicotine concentration that allows a user to seek lower nicotine delivery.
Regarding (c), Bowen teaches a nicotine salt liquid formulation for generating an inhalable aerosol (abstract) having a 1:1 molar ratio of nicotine to acid (column 12, lines 20-39) to produce a greater satisfaction than free base nicotine (column 7, lines 51-67, column 8, lines 1-14). The acid can be either benzoic acid (column 16, lines 6-13), or citric acid (column 10, lines 15-48).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the acid of modified Warchol at the ratio of Bowen. One would have been motivated to do so since Bowen teaches a nicotine salt formulation that produces a greater satisfaction than free base nicotine.
In combination with the teaching of Fuisz that the nicotine is present at up to 0.5 wt%, it is evident that, when the acid is benzoic acid, the acid is present at about 0.38 wt%, when the acid is citric acid, the acid is present at about 0.59 wt %, and, when the acid is phosphoric acid, the acid is present at about 0.30 wt %.
Regarding (d), Mishra teaches a device having a reservoir containing a first pre-vapor formulation that is vaporized (abstract) in liquid form including a flavoring (column 10, lines 19-24). The flavoring is present at about 1% to about 12% by weight (column 10, lines 64-67, column 11, lines 1-14).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the formulation of modified Warchol with the flavorant of Mishra. One would have been motivated to do so since Mishra teaches a suitable flavorant amount for a vaporized material.
Regarding (e), Perrier teaches cyclodextrins that are used as a vector for an active ingredient (abstract) that uses substituted alpha, beta, and gamma cyclodextrin (column 3, lines 48-67) to avoid the poor solubility in an aqueous phase (column 1, lines 12-18) that unsubstituted alpha, beta, and gamma cyclodextrin have (column 1, lines 7-11).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the substituted cyclodextrin of Perrier instead of the α, β, or γ-cyclodextrin of modified Warchol. One would have been motivated to do so since Perrier teaches substituted cyclodextrins that serve as a vector for an ingredient in aqueous solutions by dissolving in the solution.
Regarding claims 18 and 19, Mishra teaches that the flavorant is menthol (column 8, lines 63-67, column 9, lines 1-20).
Claim 8 is rejected under 35 U.S.C. 103 as being obvious over Warchol (NZ 536863) in view of Kuntawala (US 2016/0198759) and Bowen (US 9,215,895) and Fuisz (US 2018/0199618) and Mishra (US 11,311,048) and Perrier (US 6,524,595) as applied to claim 1 above, as further evidenced by PubChem (already of record).
Regarding claim 8, modified Warchol teaches all the claim limitations as set forth above. Warchol additionally discloses that the acid can be phosphoric acid (page 8, lines 23-25). Modified Warchol does not explicitly teach the solubility of phosphoric acid in water.
PubChem teaches that the solubility of citric acid in water is 548 g/100 g at 20 °C (section 3.2.7, Solubility), which exceeds the claim limitation.
Response to Arguments
Regarding the rejections under 35 USC 103, applicant’s arguments have been fully considered and are persuasive. However, upon further consideration, new grounds of rejection relying on Perrier are entered as set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL E SPARKS whose telephone number is (571)270-1426. The examiner can normally be reached Monday-Friday, 9:00 am-5 pm.
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/RUSSELL E SPARKS/ Primary Examiner, Art Unit 1755
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