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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/23/2025 has been entered.
Status of Claims
Claims 1-2, 6-7, 9-11, 15, 27-28, and 30-38 are pending. Claims 1 and 9 are amended. Claims 3-5, 8, 12-14, 16-26, and 29 are canceled. The amendments to claims 1 and 9 overcome each and every rejection made under 35 USC 112(b), and thus these rejections are withdrawn.
Claim Objections
Claim 38 is objected to under 37 CFR 1.75(c) as being in improper form because it depends from a cancelled claim. See MPEP § 608.01(n). Accordingly, the claim not been further treated on the merits.
Response to Arguments
Examiner would like to thank Applicant representative for discussing the possibility of canceling claim 38 by Examiner Amendment, but because additional search and consultation revealed prior art that renders the amended limitation obvious to one of ordinary skill in the art, Applicant will instead be given the opportunity to amend or cancel claim 38 as appropriate to correct the dependency issue.
Applicant’s arguments, see Remarks, pg 6 “it is submitted that Anderson US ‘275 fails to disclose or suggest the claimed molar ration between lactic acid and other organic acids”, filed 10/23/2025, with respect to the rejection(s) of claim(s) 1-2, 6-7, 9-11, 15, 27-28, and 30-38 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Anderson et al. (US 2015/0313275 A1) and Benhalima et al. (US 2022/0142227 A1), as discussed 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.
Claims 1-2, 6-7, 9-11, 15, and 27-28, 30-37 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 2015/0313275 A1) in view of Benhalima et al. (US 2022/0142227 A1).
Regarding claims 1 and 15, Anderson discloses an electronic smoking article or vaping device that is configured to provide a pleasant sensory experience for smokers that is similar to the sensory experience enjoyed while smoking a lit end cigarette, ([0009]). Anderson discloses that the vaping device is configured to include a mixture of an aerosol former, nicotine, and an acid, ([0011]). Anderson discloses compositions where the concentration of nicotine is substantially between 1.5% and 6% by wt, ([0023]). Anderson discloses that the acid is operative upon the aerosol so as to reduce the amount of nicotine content in the gas phase of the aerosol in comparison to the aerosol being formed in the absence of the acid, ([0012]), and that the acid is operative on the aerosol so as to reduce the amount of perceived throat harshness in comparison to the aerosol formed in comparison to the aerosol in the absence of the acid, ([0013]). Anderson discloses that the term aerosol former describes any suitable known compound or mixture of compound that in use facilitates the formation of an aerosol and that is substantially resistant to thermal degradation at the operating temperature of the aerosol generating article, and that suitable aerosol formers include propylene glycol and glycerol, ([0110]). Anderson discloses an embodiment where the aerosol former is a combination of glycerin (glycerol) and propylene glycol, ([0111]). Anderson discloses that the embodiment need not include water, noting that the inclusion of water is optional, ([0112] meeting Applicant’s definition of a formulation comprising no substantially water), (see present Specification ([0059]). The embodiment may comprise one or more acids from a list of acids which includes benzoic acid, lactic acid, and tartaric acid, ([0114]). The liquid aerosol formulation optionally also includes a flavorant, ([0113]). Anderson does not disclose the discrete amount by weight of each acid component in the formulation.
Benhalima teaches vaping compositions comprising a vaping base composition, nicotine, at least one acid, and optionally at least one flavoring, ([0021]-[0025]), and is thus within the Applicant’s field of endeavor. Benhalima teaches the use of acids that have a neutral taste, recognized by a taste expert, in the vaping composition, such as lactic acid and tartaric acid, ([0036]-[0037]). The vaping base may comprise propylene glycol, ([0118])and glycerol, ([0019]), and may comprise substantially no water, ([0120] describing using 1% or less, and a range that includes 0%). Benhalima teaches that the composition may comprise at least one, two, or three acids, ([0052]). Benhalima teaches that the composition may comprise tartaric acid in an amount between 0.1% - 1% by weight, ([0075]). Benhalima teaches that the composition may comprise lactic acid in an amount between 0.1% - 1% by weight, ([0076]). Benhalima teaches that the composition may comprise benzoic acid but the amount of benzoic acid should be kept within limits defined by health authorities, such as less than 0.1%, ([0046]). Benhalima teaches that prior art compositions comprised nicotine in an amount between 0 mg/ml to 20 mg/ml, ([0016]), reasonably suggesting to one of ordinary skill in the art that no or low wt% of nicotine is compatible with the composition).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the composition of Anderson according to the teachings of Benhalima. One of ordinary skill in the art would have recognized that modifying the range of nicotine wt% from Anderson to a lower percentage would be desirable, because some customers may reasonably want a lower dose of nicotine (such as customers looking to reduce their nicotine consumption). Generally, one of ordinary skill in the art would have recognized that the selection of the acids to use, their respective amounts, and the total amounts would have both an effect on the amount of nicotine in the vapor, but also the sensory and taste experienced when vaping the liquid composition. Altering the amounts and selection of acids within the ranges taught by the prior art is considered obvious, to achieve differences in these parameters. Benhalima recognizes that while the liquid composition may comprise benzoic acid, (Benhalima explicitly reciting that the invention does not exclude the presence of benzoic acid), it should be kept at a wt% of less than 0.1%, ([0046]). Benhalima teaches that while the overall acid wt % of the acids should be between 0.1% and 1% by wt, when using lactic acid and tartaric acid should be between 0.1% and 1% by weight, ([0075]-[0076]), reasonably suggesting that the composition of each acid may be used within a range of 0.1% and 1% by weight, such that the cumulative total of all the acid is still within 0.1% and 1% by weight. Thus, it would be obvious to modify the liquid composition of Anderson as taught by Benhalima to arrive at a liquid composition of: Nicotine at 0.5% by wt, Benzoic Acid at 0.09% by wt, lactic acid at 0.175 by wt, and tartaric acid at 0.09% by wt, with a vaping base of propylene glycol and glycerol, where the composition comprises substantially no water.
The molecular weight of nicotine is known to be 162.236, the molecular weight of benzoic acid is known to be 122.123, the molecular weight of lactic acid is known to be 90.078, and the molecular weight of tartaric acid is known to be 150.087. To convert a composition where percentages are given in wt% to mol%, it is known to divide the wt% of each material by its corresponding molecular weight.
The following table converts the composition, from wt% to mole wt%.
Component
Wt%
Molecular Wt
Mole %
Nicotine
0.5
162.236
0.0031
Benzoic Acid
0.09
122.123
0.00074
Lactic Acid
0.175
90.078
0.0019
Tartaric Acid
0.09
150.087
0.00060
The mole ratio of nicotine to the sum of lactic acid and other acids is: 1 to 0.825, which falls within the claimed range of 1:0.9 to 1:0.3.
The mole ratio of lactic acid to tartaric acid (an other acid) is 3.24 to 1, which falls within the claimed range of 4:1 to 2:1.
Regarding claims 2 and 30, modified Anderson discloses the liquid composition according to claim 1. The mole ratio of the nicotine to the total mole of benzoic acid, lactic acid, and tartaric acid in the liquid composition of modified Anderson above is 1:1.064, which meets the claimed range of 1:0.85 to 1:1.15.
Regarding claims 6 and 31, modified Anderson discloses the liquid composition according to claim 1. The modified composition comprises tartaric acid as one of the organic acids selected in the liquid composition of claim 1.
Regarding claims 7 and 32, modified Anderson discloses the liquid composition according to claim 1. The mole ratio of the nicotine to benzoic acid in the liquid composition of modified Anderson above is 1:0.24, which meets the claimed range of 1:07 to 1:0.15.
Regarding claims 9 and 33, modified Anderson discloses the liquid composition according to claim 1. The modified composition uses tartaric acid, see the rejection of claim 1 above. This acid inherently has a solubility in glycerol of 0.32 mol/kg or more in molality, (show for instance in Applicant’s Specification ([0134]-[0137] Tables 27-28).
Regarding claims 10, 27-28, 34 and 36-37, modified Anderson discloses the liquid composition according to claim 1.
Anderson discloses that the embodiment need not include water, noting that the inclusion of water is optional, ([0112] meeting Applicant’s definition of a formulation comprising no substantially water), (see present Specification ([0059]).
Benhalima teaches that the liquid composition may comprise no water, by disclosing a range of water that includes 0%, ([0120]).
Regarding claims 11 and 35, modified Anderson discloses the liquid composition according to claim 1. Anderson discloses that the liquid aerosol formulation optionally also includes a flavorant, ([0113]). Benhalima teaches that the composition may comprise a flavoring, ([0044]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL E VAKILI whose telephone number is (571)272-5171. The examiner can normally be reached Monday - Friday 7:30 am - 4:30 pm.
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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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/D.E.V./Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747