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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 03/02/2026 has been entered.
Election/Restrictions
Claims 28-30 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/21/2024.
Claim Rejections - 35 USC § 103
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 16–20 and 25–27 are rejected under 35 U.S.C. § 103 as being unpatentable over Rabinowitz et al. (US 2014/0345635 A1) in view of Narasimhan et al. (WO 2020/084024 A1).
Regarding claim 16, Rabinowitz teaches a liquid nicotine formulation for an aerosol-generating system (the NJOY-AB liquid formulation loaded into an electronic cigarette and vaporized to generate an aerosol) (¶ [0126]), comprising:
at least one of water and one or more water-miscible solvents (10 wt.% water, 40 wt.% glycerol, and 40 wt.% propylene glycol) (¶ [0125], Table 7);
a nicotine salt comprising lactic acid (nicotine ion-paired with lactic acid at a lactic-acid-to-nicotine molar ratio of 5:6) (¶ [0125], Table 7);
wherein the carbonated liquid nicotine formulation has an ethanol content of less than 1 percent by weight (the NJOY-AB formulation contains no ethanol) (¶ [0125], Table 7);
a nicotine content greater than or equal to 0.25 percent by weight (6.4 wt.% nicotine) (¶ [0125], Table 7);
wherein the carbonated liquid nicotine formulation has a total water and water-miscible-solvent content greater than or equal to about 70 percent by weight (10 wt.% water, 40 wt.% glycerol, and 40 wt.% propylene glycol, totaling 90 wt.%) (¶ [0125], Table 7);
wherein the one or more water-miscible solvents are one or more water-miscible polyhydric alcohols selected from the group consisting of glycerine and propylene glycol (glycerol and propylene glycol) (¶ [0125], Table 7); and
wherein a ratio of the weight-percent glycerine content to the weight-percent propylene-glycol content of the carbonated liquid nicotine formulation is less than or equal to 1.25 (40 wt.% glycerol divided by 40 wt.% propylene glycol, providing a ratio of 1.0) (¶ [0125], Table 7).
Rabinowitz does not teach that the liquid nicotine formulation is carbonated and has a carbon dioxide content greater than or equal to 0.5 percent by weight.
Narasimhan teaches incorporating carbon dioxide under pressure into an inhalable nicotine formulation comprising glycerol, propylene glycol, water, or mixtures thereof (¶ [0039]), and reports carbon dioxide contents of at least 5.8 g/kg, corresponding to at least 0.58 wt.% (¶ [0091], Table 3), as well as 11–18 g/kg, corresponding to 1.1–1.8 wt.% (¶ [0100], Table 4).
Rabinowitz teaches using an ion-pairing agent with nicotine to reduce throat impact and provide a desirable amount of throat hit without irritation (¶ [0041]). Rabinowitz further teaches that lactic acid in the NJOY-AB formulation permits adjustment of the nicotine concentration while maintaining a selected level of throat impact (¶ [0125]). Narasimhan addresses the same nicotine-associated sensory concern by teaching that incorporating carbon dioxide into an inhalable nicotine formulation reduces rough or astringent sensations and provides a smoother inhalation experience while maintaining throat hit (¶ [0021]). Narasimhan further teaches incorporating carbon dioxide into nicotine formulations containing glycerol, propylene glycol, water, or mixtures thereof (¶ [0039]), which are the same solvent components used in Rabinowitz’s NJOY-AB formulation (Rabinowitz ¶ [0125], Table 7). Accordingly, Narasimhan’s carbonation technique would have been directly applicable to Rabinowitz’s formulation as a compatible means of further reducing nicotine-associated harshness while maintaining the desired throat sensation.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to carbonate the nicotine-lactic-acid formulation of Rabinowitz according to Narasimhan to provide a carbon dioxide content greater than or equal to 0.5 percent by weight, thereby further reducing nicotine-associated roughness or astringency and providing a smoother inhalation experience while maintaining the desired throat sensation.
Regarding claim 17, modified Rabinowitz teaches wherein the carbonated liquid nicotine formulation has an ethanol content of less than or equal to about 0.5 percent by weight (the NJOY-AB formulation contains no ethanol) (Rabinowitz ¶ [0125], Table 7).
Regarding claim 18, modified Rabinowitz teaches wherein the carbonated liquid nicotine formulation has a carbon dioxide content of less than or equal to about 5 percent by weight (1.1–1.8 wt.% carbon dioxide) (Narasimhan ¶ [0100], Table 4).
Regarding claim 19, modified Rabinowitz teaches wherein the carbonated liquid nicotine formulation has a carbon dioxide content between 1 percent by weight and 3 percent by weight (1.1–1.8 wt.% carbon dioxide) (Narasimhan ¶ [0100], Table 4).
Regarding claim 20, modified Rabinowitz does not teach that the carbonated liquid nicotine formulation has a nicotine content between 0.5 percent by weight and 5 percent by weight because the embodiment relied upon from Example 4 contains 6.4 wt.% nicotine (Rabinowitz ¶ [0125], Table 7).
However, Rabinowitz teaches a limited number of nicotine concentrations suitable for substantially similar nicotine-lactic-acid formulations, including the LC3 formulation containing 4.4 wt.% nicotine, which falls within the claimed range (Rabinowitz ¶ [0108], Table 2).
One of ordinary skill in the art would have had reason to select the 4.4 wt.% nicotine concentration taught by Rabinowitz for the modified Rabinowitz formulation because Rabinowitz identifies that concentration as suitable for a nicotine-lactic-acid formulation employing the same glycerol and propylene-glycol solvent system. Selecting among Rabinowitz’s identified nicotine concentrations would have involved choosing from a finite number of identified, predictable formulation alternatives with a reasonable expectation of success. MPEP § 2143(E).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to use the 4.4 wt.% nicotine concentration taught by Rabinowitz in the modified Rabinowitz formulation, thereby predictably providing a nicotine content between 0.5 percent by weight and 5 percent by weight.
Regarding claim 25, modified Rabinowitz teaches wherein the carbonated liquid nicotine formulation has a combined glycerine and propylene glycol content of between 25 percent by weight and 85 percent by weight (40 wt.% glycerol and 40 wt.% propylene glycol, totaling 80 wt.%) (Rabinowitz ¶ [0125], Table 7).
Regarding claim 26, modified Rabinowitz teaches further comprising one or more flavorants (0.5 wt.% flavor mixture) (Rabinowitz ¶ [0125], Table 7).
Regarding claim 27, modified Rabinowitz teaches further comprising one or more flavorants, wherein the carbonated liquid nicotine formulation has a flavorant content greater than 0 percent by weight to less than or equal to about 4 percent by weight (0.5 wt.% flavor mixture) (Rabinowitz ¶ [0125], Table 7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER KESSIE whose telephone number is (571)272-7739. The examiner can normally be reached Monday - Thursday 7:00am - 5:00pm.
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/JENNIFER A KESSIE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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