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 1-2,4-5,7-10,15,19-20,22-25,27,29,31,34 and 40-41 are pending and are subject to this office action. This is the first Office Action on the merits of the claims.
Election/Restrictions
Applicant’s election without traverse of Group I claims 1, 2, 4, 5, 7, 10, 15, 19, 20, 22-25, and 27 in the reply filed on 05/14/2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation "the aerosol former agent.” There is insufficient antecedent basis for this limitation in the claim because it is the first mention of an aerosol former agent. Claim 1 recites an aerosol former material. It is unclear if the aerosol former material in claim 1 and aerosol former agent in claim 22 are the same material. The specification does not appear to disclose separate aerosol former materials and aerosol former agents. For the purposes of examination, the aerosol former agent in claim 22 will be interpreted as the aerosol former material is present in an amount of about 15-50 wt%.
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, 2, 4, 5, 7, 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 molar ratio of nicotine to acid overlaps with the claimed range and is therefore considered prima facie obvious.
Regarding claims 2 and 4, Kabirat does not 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 molar ratio of nicotine to acid overlaps with the claimed ranges and is therefore 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 7, Kabirat discloses the amorphous solid may comprise nicotine in an amount of 1-20 wt% ([0163, 0185, 0187]). The claimed range for amount of nicotine overlaps with the range taught by the prior art and is therefore considered prima facie obvious.
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
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Louie can be reached at (571) 270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.F.D./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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