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 .
Status of the Claims
Claims 1, 5, 8-10,15,19-20, 22-25, 27, 29, 31, 34 and 40-41 are pending and are subject to this office action. Claim 1 and 22 are amended. Claims 2, 4 and 7 are canceled. Claims 8-9, 29, 31, 34 and 40-41 were previously withdrawn as being directed to non-elected inventions.
Response to Amendment
The Examiner acknowledges the Applicant’s response filed on 09/02/2026 containing amendments and remarks to the claims.
Response to Arguments
Applicant’s arguments, see pg. 6, filed 09/02/2026, with respect to the rejection of claim 22 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Applicant has amended claim 22 to correct the antecedent basis issue with the limitation, “aerosol-former agent”. Therefore, the rejection of claim 22 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see pg. 6-9, filed 09/02/2026, with respect to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered and but they are not persuasive. Applicant has amended claim 1 to require the aerosol generating material comprise 6-30 wt% nicotine which was previously presented in claim 7 and a molar ratio of nicotine to acid of at least 0.5:1 which was previously presented in claim 4 and a molar ratio of nicotine to acid of less than 1.5:1 which was previously presented in claim 4. The Examiner notes that while the new limitations were separately claimed in dependent claims 2, 4, and 7 the combination of an aerosol generating material comprising 6-30 wt% nicotine and a molar ratio of nicotine to acid of 0.5:1 to 1.5:1 was not previously presented.
On pg. 7, Applicant argues that the selection of a wt% of nicotine and wt% of an acid does not inherently yield a molar ratio because the molar ratio is further dependent on the molecular weight of the chosen acid and molecular weight of nicotine. The Examiner does not find the argument persuasive. The molecular weight of nicotine and a chosen acid is known and the molar ratio of nicotine to acid can be readily derived from a particular wt % of nicotine and a wt% of acid. For example, Kabirat discloses the chosen acid may be lactic acid ([0200-0201]). Therefore, in view of the aerosol generating material comprising 1-20 wt% nicotine ([0163, 0185, 0187]) and 1-20 wt% acid ([0163, 0188]) a person having ordinary skill in the art could have reasonably arrived at an aerosol generating material having a molar ratio of nicotine to lactic acid in a range of about 0.03:1 to 11:1, which overlaps with the claimed range and therefore the claimed range is considered prima facie obvious.
On pg. 7-8, Applicant argues that Kabirat does not disclose or suggest a motivation to select the claimed range of molar ratio of nicotine to acid. The prior office action relies on Kabirat disclosing an aerosol generating material comprising ranges of nicotine wt% and acid wt%, where a person of ordinary skill in the art could have reasonably arrived at an aerosol generating material having a molar ratio of nicotine to acid in a range that overlaps with the claimed range and therefore the claimed range is considered prima facie obvious and suggestion or motivation to select a specific range of molar ratio of nicotine to acid is not required (see MPEP 2144.05(I)). Applicant has not shown that the claimed molar ratio of nicotine to acid has unexpected and superior results, and thus the rejection is maintained.
On pg. 8, Applicant argues preferred embodiments of Kabirat disclose distributing the active ingredient and acid across separate materials. The Examiner does not find the argument persuasive because the disclosure is not limited to preferred embodiments of Kabirat’s invention. Applicant points to a specific example in Kabirat’s disclosure that fall outside the claimed range of molar ratio of nicotine to acid. However, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments, and patents are relevant for all that they contain (MPEP 2123(I)-(II)).
Therefore, the rejections below are maintained and modified based on Applicant’s amendment.
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 1, 5, 10, 15, 19, 20, 22-25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Kabirat (US 20230037155 A1).
Regarding claim 1, Kabirat discloses a first aerosol generating material (“an aerosol generating composition”) comprising an amorphous solid (“an aerosol generating material”), the amorphous solid comprising:
0.5-60 wt % of a gelling agent;
0-80 wt % of an aerosol-former material; and
0-60 wt % of at least one of an active substance, a flavorant and an acid; ([0031-0036], [0040-0044], [0100]),
Where the active substance may comprise nicotine in an amount of 1-20 wt% ([0163, 0185, 0187]),
Where the acid may be included in an amount of 1-20 wt% ([0163, 0188]),
The amorphous solid may optionally comprise filler ([0210, 0213]), and;
Where the weights are all calculated on a dry weight basis ([0040-0044, 0093, 0163, 0188]).
The claimed ranges for amount of nicotine, gelling agent, aerosol former, and acid all overlap with the ranges taught by the prior art and therefore are considered prima facie obvious.
Kabirat does not explicitly disclose the molar ratio of nicotine to acid. However, Kabirat discloses the amorphous solid may comprise 1-20 wt% nicotine ([0163, 0185, 0187]), and 1-20 wt% acid ([0163, 0188]) where the acid may be lactic acid ([0200-0201]). Therefore, a person having ordinary skill in the art could have reasonably arrived at an embodiment where the range of molar ratio of nicotine to acid overlaps with the claimed range and therefore the claimed range is considered prima facie obvious.
Regarding claim 5, Kabirat discloses the acid may be at least one of lactic acid, benzoic acid, levulinic acid, and pyruvic acid ([0200]).
Regarding claim 10, Kabirat discloses the amorphous solid comprises 1-60 wt% of filler ([0210]). The claimed range overlaps with the range taught by the prior art and is therefore considered prima facie obvious.
Regarding claim 15, Kabirat discloses the gelling agent comprises alginates or carboxymethylcellulose ([0170, 0175-0176, 0179]).
Regarding claim 19, Kabirat discloses the amorphous solid comprises 0.5-60 wt % of a gelling agent ([0031-0036], [0040-0044]). The claimed range overlaps with the range taught by the prior art and is therefore considered prima facie obvious.
Regarding claim 20, Kabirat discloses the aerosol former material may comprise one or more of erythritol, propylene glycol, glycerol, and triacetin, ([0182]).
Regarding claim 22, Kabirat discloses the amorphous solid comprises 0-80 wt % of an aerosol-former material ([0031-0036], [0040-0044]). The claimed range overlaps with the range taught by the prior art and is therefore considered prima facie obvious.
Regarding claim 23, Kabirat discloses the amorphous solid comprises no tobacco ([0187]).
Regarding claim 24, Kabirat discloses the amorphous solid is in the form of a sheet (i.e. a film, [0220, 0256]).
Regarding claim 25, Kabirat discloses the amorphous solid is in the form of a shredded sheet ([0220, 0256]).
Regarding claim 27, Kabirat discloses the amorphous solid comprises up to 60 wt% flavorant ([0184]). The claimed range overlaps with the range taught by the prior art and is therefore considered prima facie obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MORGAN FAITH DEZENDORF whose telephone number is (571)272-0155. The examiner can normally be reached M-F 8am-430pm EST.
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/M.F.D./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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