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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/29/2025 has been entered.
Election/Restrictions
Claims 11, 15, 12-14 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/16/2025.
Response to Arguments
Applicant’s arguments filed 12/29/2025 traversing the rejection under 35 U.S.C. §103 based on Batista (US 2017/0143041 A1) in view of Bowen (US 2014/0345631 A1) have been fully considered but are not persuasive.
Applicant argues that the applied references fail to teach the claimed subject matter because (i) the claims recite a carboxylic acid-containing alcohol solution rather than the carboxylic acid itself, (ii) the amount of carboxylic acid present in the aerosol-generating substrate is lower than the amounts disclosed in Bowen, and (iii) amended claim 1 excludes alpha-keto or 2-oxo acids taught by Batista. These arguments do not overcome the rejection.
With respect to Batista, Examiner does not rely on Batista to teach a carboxylic acid-containing alcohol solution as claimed. Rather, Batista is relied upon for teaching an aerosol-generating substrate in which acidic additives are employed to influence aerosol delivery characteristics. Batista establishes the general framework that acids may be incorporated into aerosol-generating substrates to modify aerosol behavior, but does not limit the invention to alpha-keto or 2-oxo acids.
Bowen, in contrast, expressly teaches the use of non-alpha-keto carboxylic acids, including stearic acid and decanoic (capric) acid, in nicotine formulations [0243], and further teaches that different acids possess distinct physical properties, such as melting point, which can affect aerosol behavior and release profile [0344–0345]. Thus, Bowen teaches the identity and functional interchangeability of the claimed carboxylic acids, as well as their suitability for use in aerosol-generating nicotine systems.
Applicant’s argument that Bowen discloses higher acid concentrations and therefore teaches away from the claimed amounts is not persuasive. Bowen teaches that acid type and amount influence aerosol performance, thereby identifying acid concentration as a result-effective variable. Where the prior art teaches the same components used for the same purpose, optimization of the relative amounts involves only routine experimentation (see MPEP § 2144.05(A)). Applicant has not provided evidence demonstrating that the claimed acid concentrations are critical or yield unexpected results relative to Bowen’s disclosed formulations.
Applicant further argues that Bowen teaches away from low acid concentrations because Bowen prefers protonated nicotine salts. This argument is unpersuasive. A preference for certain formulations does not constitute a teaching away from other workable formulations absent a clear discouragement or indication that such alternatives are inoperable. Bowen does not state that lower acid concentrations are unsuitable or inoperative, nor does Bowen preclude partial protonation systems. Rather, Bowen teaches that acid selection and amount may be adjusted to tune formulation performance.
Finally, Applicant’s exclusion of alpha-keto or 2-oxo acids does not render the claims nonobvious. The rejection does not depend on alpha-keto acids to meet the claimed limitations. Bowen independently teaches the claimed non-alpha-keto carboxylic acids for use in nicotine formulations, and their selection for use in an aerosol-generating substrate as taught by Batista would have been an obvious modification yielding predictable results.
Accordingly, Applicant’s arguments do not demonstrate error in the Examiner’s conclusion that the claimed subject matter represents an obvious combination and optimization of known elements, and the additional limitations fail to impart a patentable distinction over the applied prior art. The rejection under 35 U.S.C. § 103 is therefore maintained.
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.
Claim(s) 1, 5, 7-9, 17-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Batista et al. (US 2017/0143041), and further in view of Bowen et al. (US 2014/0345631).
Regarding claim 1, Batista teaches an aerosol-generating substrate for an electronic nicotine delivery device, including an aerosol-forming substrate that may be solid or semi-solid (e.g., foam, gel, sheet, or slurry) and that forms an aerosol upon heating (Batista ¶[0031]–¶[0034]; ¶[0051]).
Batista further teaches the use of volatile delivery enhancing compounds, wherein the volatile delivery enhancing compound comprises an organic acid, more preferably a carboxylic acid, to enhance aerosol delivery (Batista ¶[0048]–¶[0049]).
Batista does not teach:
dissolving the carboxylic acid in an alcohol solution to form a carboxylic acid-containing alcohol solution; nor
the specific concentration ranges of carboxylic acid in such an alcohol solution as recited in claim 1.
However, Bowen discloses nicotine salt formulations for aerosol devices, wherein carboxylic acids (e.g., benzoic acid, salicylic acid, pyruvic acid, levulinic acid, and others) are dissolved in alcohol carriers, such as propylene glycol, vegetable glycerin, or ethanol, to form carboxylic acid-containing alcohol solutions (Bowen ¶[0118]; ¶[0121]).
Bowen further teaches that such acid/alcohol formulations improve aerosol delivery by reducing harshness and improving inhalation tolerability, and exemplifies formulations including carboxylic acid concentrations of approximately 1.5 wt% (Bowen, Example 1; ¶[0140]–¶[0145]).
Batista and Bowen are in the same field of endeavor, namely electronic nicotine delivery systems, and both address improving aerosol quality and delivery. A person of ordinary skill in the art would have been motivated to modify the aerosol-forming substrate of Batista to include the carboxylic acid-containing alcohol solutions taught by Bowen, in order to enhance aerosol delivery and reduce harshness, as explicitly taught by Bowen.
Claim 1 further recites that the aerosol-generating substrate comprises between about 0.2 wt% and about 1.0 wt% of the carboxylic acid-containing alcohol solution. Although Bowen exemplifies a formulation including approximately 1.5 wt% acid, adjusting the acid concentration to a lower amount within the claimed range would have been obvious as a matter of routine optimization, because acid concentration is a result-effective variable that directly affects aerosol harshness and tolerability.
Bowen teaches that carboxylic acids reduce harshness and improve inhalation experience, thereby providing motivation to optimize acid concentration for user comfort. Discovering workable or optimum ranges by routine experimentation is considered within the ordinary skill in the art when the general conditions are disclosed (see MPEP § 2144.05(A)). Applicant has not demonstrated that the claimed concentration range is critical, nor that it yields unexpected results relative to the concentrations taught by Bowen.
To the extent claim 1 recites concentration in v/v%, one of ordinary skill in the art would have been familiar with converting wt% to v/v% using known material densities, which are well-established physical properties. Bowen provides sufficient disclosure of formulation components to enable such routine conversions, and precise numerical correspondence is not required where the claimed parameter is optimized through routine experimentation.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the aerosol-forming substrate of Batista in view of Bowen to arrive at the subject matter of claim 1, including the claimed carboxylic acid-containing alcohol solution and concentration range, as a predictable result of combining known elements according to their established functions.
Claim 1 is therefore rejected under 35 U.S.C. § 103.
Regarding claim Claims 17 and 19, the limitations are rejected under 35 U.S.C. § 103 for the same reasons as claim 1, as claims 17 and 19 merely further limit the carboxylic acid species and/or concentration range recited in claim 1, which represent obvious selections from known carboxylic acids and routine optimization of result-effective variables taught by Bowen. Applicant has not demonstrated that the additional limitations of claims 17 and 19 are critical or yield unexpected results.
Regarding Claims 5, 7, and 8, the limitations depend from claim 1 and further limit the carboxylic acid to specific carboxylic acid species, including stearic acid, decanoic acid (also known as capric acid), or combinations thereof.
As discussed with respect to claim 1, Batista teaches an aerosol-generating substrate for use in an electronic nicotine delivery system, including the use of organic acids, such as carboxylic acids, to enhance aerosol formation and delivery. Bowen teaches nicotine salt and acid-containing formulations for aerosol devices and explicitly lists stearic acid and capric acid (decanoic acid) as suitable carboxylic acids for forming aerosol formulations dissolved in alcohol-based carriers (see Bowen, e.g., ¶[0123]–¶[0124], ¶[0139]).
Accordingly, the limitation of claim 7, which recites stearic acid or decanoic acid, is expressly taught by Bowen.
Further, the limitation of claim 8, which recites a combination of stearic acid and decanoic acid, would have been obvious in view of Bowen, which teaches the use of multiple carboxylic acids in aerosol formulations. Combining known carboxylic acids that are each individually taught by Bowen for the same purpose, namely, improving aerosol delivery and inhalation characteristics, would have been a predictable variation and an obvious design choice to one of ordinary skill in the art.
With respect to claim 5, which recites a broader list of carboxylic acids, Bowen teaches numerous carboxylic acids suitable for use in aerosol formulations, and the selection of one or more acids from this known list represents an obvious selection from a finite number of predictable options performing the same function.
Applicant has not demonstrated that the selection of stearic acid, decanoic acid, or combinations thereof is critical, nor that such selection yields unexpected results relative to Bowen’s teachings. Absent such a showing, narrowing the claims to these specific acids or combinations thereof does not overcome the obviousness of the claim subject matter.
Regarding claim 9, Batista teaches wherein the aerosol-generating substrate further comprises at least one or more components selected from the group consisting of propylene glycol, 1, 3 propanediol, glycerol, water, gum, flavourant, additives, nicotine, and or binder [0032].
Regarding claim 21, Bowen discloses a carboxylic acid-containing alcohol solution comprising decanoic acid and stearic acid [0243].
While Bowen does not expressly disclose a 10/90 ratio of stearic acid to decanoic acid, Bowen teaches that multiple acids may be used to form nicotine salts [0342] and further establishes that different acids exhibit distinct physical properties, such as melting point [0345], which can influence aerosol behavior and release profile [0344].
Thus, Bowen recognizes that the relative amounts of acids used in combination affect the performance characteristics of the aerosol-generating substrate. Where, as here, the general conditions of the claim are disclosed in the prior art, the selection of a particular ratio constitutes an optimization of a result-effective variable, which involves only routine skill in the art (see MPEP § 2144.05(A)).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to select the claimed 10/90 ratio of stearic acid to decanoic acid in order to optimize aerosol performance characteristics taught by Bowen. Applicant has not demonstrated that the claimed ratio exhibits criticality or produces unexpected results.
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