3DETAILED ACTION
Response to Arguments
Applicant's arguments and declaration filed 3/27/2026 have been fully considered but they are not persuasive. Applicant argues the studies cited in the declaration establish unexpected results. The Examiner disagrees. Firstly, the studies compare benzoic acid to levulinic acid and lactic acid under one very specific set of conditions (propylene glycol concentration, glycerine concentration, water concentration, nicotine concentration, temperature, humidity, duration). It is possible that under different conditions, levulinic acid and lactic acid perform just as well as benzoic acid, if not better. The data does not establish that benzoic acid yields unexpected results relative to levulinic acid and lactic acid under a variety of different conditions. Secondly, lactic acid and levulinic acid are only 2 of the 15 carboxylic acids disclosed by Rabinowitz other than benzoic acid. It is possible that other carboxylic acids disclosed by Rabinowitz perform just as well as benzoic acid, if not better. While Applicant is not required to compare benzoic acid to all 15 carboxylic acids, comparison with only 2 of the 15 carboxylic acids is not sufficient to overcome the prior art.
It is also noted that the claims 1, 17, and 19 do not recite a minimum amount of benzoic acid and due to the comprising language of the preamble, other acids are not excluded. A formulation comprising for example, 0.5 mola equivalents of an acid that is not benzoic acid, and 0.001 mole equivalents of benzoic acid, would read on the acid requirements of these claims. Therefore, any argument of unexpected results regarding benzoic acid cannot be used to overcome a 103 rejection for claims where only a negligible amount of benzoic acid, e.g. 0.001 molar equivalents, is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 11-12, and 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Anderson (US 2015/0313275).
Regarding claims 1, 17, and 19, Anderson teaches a cartomizer a nicotine solution and a heating element [0011, 0069-0070]. The cartomizer is part of an electronic vapor provision system comprising a vaporizer for vaporizing liquid for inhalation by a user [0014] and a power supply comprising a battery for supplying power to the vaporizer [0099]. The process of using the system comprises vaporizing the nicotine solution [0145].
Anderson teaches the nicotine solution comprises a carrier [0110], nicotine in an amount of 3 wt%, pyruvic acid in an amount of 0.5% wt%, lactic acid in an amount of 0.4 wt% and benzoic acid in an amount of 0.1 wt% [0119]. The molecular mass of the components are as follows: nicotine - 162.2 g/mol; pyruvic acid - 87.1 g/mol; lactic acid - 90.1 g/mol; benzoic acid - 122.1 g/mol. Thus, the above mole equivalents of the acids based on 3 wt% nicotine in the embodiment of Anderson described in [0119] are 0.3 moles pyruvic acid, 0.23 moles lactic acid, and 0.04 moles benzoic acid, i.e. a total content of acid present in the solution is 0.57 mole equivalents based on the nicotine and the nicotine is present in unprotonated form and in protonated form. This embodiment reads on the present limitations.
In another embodiment [0158], Anderson teaches 4.5 wt% nicotine and 0.375% each of benzoic acid, lactic acid, acetic acid, and pyruvic acid. Based on the above molar masses, as well as an acetic molar mass of 60.1 g/mol, the mole equivalents in this embodiment with 4.5 wt% nicotine are 0.11 benzoic acid, 0.14 lactic acid, 0.22 acetic acid and 0.15 pyruvic acid, i.e. a total content of acid present in the solution is 0.6 mole equivalents based on the nicotine and the nicotine is present in unprotonated form and in protonated form. This embodiment also reads on the present limitations.
Regarding claims 2, 18, and 20, Anderson teaches the solution comprises water [0158].
Regarding claims 11-12, Anderson teaches the carrier is glycerol and propylene glycol [0158].
Claim Rejections - 35 USC § 103
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.
Claims 4 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson.
Regarding claim 4, as cited above with respect to claim 1, Anderson teaches an embodiment [0119] wherein the total acid content present in the solution is 0.57 mole equivalents based on the nicotine. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). In the instant case, one skilled in the art would expect the solution of Anderson disclosed in [0119], having 0.57 mole equivalents of acid to have the same properties as the claimed solution, having 0.5 mol equivalents of acid. In any case, Anderson teaches an acid range having a total acid content as low 0.1% or 0.5% by weight [0153]. Such an acid concentration would overlap the claimed molar equivalents. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 7, as cited with respect to claim 1 above, Anderson teaches an embodiment [0158] comprising 0.11 mole equivalents benzoic acid based on the nicotine and 0.5 mole equivalents of other acids based on the nicotine. Claim 7 as it depends from claim 1 allows for a total acid content of up to 0.6 mole equivalents based on the nicotine. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). In the instant case, one skilled in the art would expect the solution of Anderson disclosed in [0158], having 0.11 mole equivalents benzoic acid and 0.5 mole equivalents of other acids, to have the same properties as the claimed solution having 0.2 mole equivalents of benzoic acid and 0.4 mole equivalents of other acids.
Regarding claims 8-9, Anderson teaches the nicotine can be included in range starting at 1 wt% or 2 wt% [0143]. One of ordinary skill in the art would have found it obvious to include, in embodiments with 1 wt% or 2 wt% nicotine, acid in the same ratio with nicotine as disclosed in other embodiments, such as those disclosed with respect to claim 1, to achieve the same desired effects of the acid such as reduced throat harshness [0018]. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Claims 1-2, 4, 7-9, 11-12, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rabinowitz (US 2014/0345635).
Regarding claims 1, 4, 7-9, 17, and 19, Rabinowitz teaches a cartomizer a nicotine solution and a heating element [0071]. The cartomizer is part of an electronic vapor provision system comprising a vaporizer for vaporizing liquid for inhalation by a user [00067] and a power supply comprising a battery for supplying power to the vaporizer [0068]. The process of using the system comprises vaporizing the nicotine solution [0067].
Rabinowitz teaches the nicotine solution comprises a carrier [0038], nicotine in an amount of 0.5 wt% to 4 wt% [0037], and acid in a molar ratio of 1:2 with nicotine [0051], i.e. 0.5 mole equivalents based on the nicotine and the nicotine is present in unprotonated form and in protonated form. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Rabinowitz teaches a number of different acids including benzoic acid [0048]. Rabinowitz does not explicitly teach selecting benzoic acid. However, one of ordinary skill in the art would have found it obvious to use benzoic acid for at least a portion of the 0.5 mole equivalents of acid for the effects of minimizing loss of nicotine or enhancing or controlling aerosol formation as suggested by Rabinowitz [0042]. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Regarding claims 2, 18, and 20, Rabinowitz teaches the solution comprises water [0038].
Regarding claims 11-12, Rabinowitz teaches the carrier is glycerol and propylene glycol [0038].
Conclusion
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/ERIC YAARY/Examiner, Art Unit 1755
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