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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/01/2026 has been entered.
Election/Restrictions
Claims 20-24 and 25 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/29/2025.
Response to Arguments
Applicant’s arguments filed June 1, 2026 have been fully considered but are not persuasive. The Declarations submitted under 37 C.F.R. § 1.132 have also been fully considered but are not persuasive.
Applicant has amended claim 1 to require that the one or more gelling agents comprise carboxymethyl cellulose and that the filler comprise wood pulp. Applicant argues that Ghanouni does not teach the presently claimed combination, including the recited component amounts. This argument is not persuasive because Ghanouni teaches carboxymethylcellulose as a suitable gelling agent ¶ [0060], wood pulp as a suitable fibrous filler ¶ [0075], filler in an amount of about 10–30 wt%, which overlaps the claimed range over about 15–30 wt% ¶ [0074], and gelling-agent amounts that, when used with filler within the overlapping range, provide a combined gelling-agent and filler amount within about 20–75 wt% ¶¶ [0059], [0074].
Applicant further argues that the amount of filler was not recognized in the prior art as a result-effective variable for improving transfer or release of an aerosol-generating agent. This argument is not persuasive because the present rejection does not rely on Ghanouni recognizing improved transfer or release as the result obtained by varying the filler amount. Ghanouni independently teaches that inclusion of fibrous filler increases the tensile strength of the amorphous solid ¶ [0076]. Thus, Ghanouni provides a reason to include wood-pulp filler and select an amount within the overlapping range regardless of whether Ghanouni recognized Applicant’s asserted transfer benefit.
Applicant also argues that Ghanouni’s teaching concerning mechanical strength is unrelated to the asserted improvement in release of aerosol-generating agents. This argument does not overcome the rejection because Ghanouni’s teaching that fibrous filler increases tensile strength provides an independent reason for using the claimed filler in the amorphous solid ¶ [0076].
Applicant’s arguments concerning Watanabe have been fully considered. However, the rejection relying on Watanabe has been withdrawn, and those arguments are therefore moot.
The Aoun Declaration is limited to comparing a 1:1 alginate/pectin blend and CMC, each at a solids content of 13%, when dispersed in deionized water or tap water containing calcium impurities. Although the results indicate that the alginate/pectin blend underwent calcium-induced crosslinking under the tested conditions and CMC did not, claim 1 does not require tap water, calcium-containing impurities, a particular solvent, or resistance to calcium-induced crosslinking. Further, Ghanouni expressly teaches CMC as a suitable gelling agent and separately identifies calcium-crosslinked alginate and pectin embodiments ¶ [0060]. Accordingly, the Aoun Declaration does not distinguish the claimed CMC composition from Ghanouni’s CMC embodiment.
The remaining declaration evidence concerning improved transfer of aerosol-generating agent is limited to particular formulations and does not establish that the asserted result occurs throughout the full scope of claim 1, including about 1–80 wt% aerosol-generating agent, about 15–35 wt% filler, and about 20–75 wt% combined gelling agent and filler. The evidence also does not establish criticality of the claimed ranges relative to the overlapping ranges taught by Ghanouni. Therefore, the declaration evidence is insufficient to overcome the prima facie case of obviousness.
Applicant additionally presented new claims 30 and 31. The limitations of claims 30 and 31 are addressed by the rejection over Ghanouni in view of Phillips set forth below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 6, 8–11, 18, 28, and 29 are rejected under 35 U.S.C. § 103 as being unpatentable over Ghanouni et al. (US 2021/0315266 A1).
Regarding claim 1, Ghanouni teaches an aerosol-generating composition comprising an amorphous solid, the amorphous solid comprising:
an aerosol-generating agent in an amount of from about 1 to 80 wt% of the amorphous solid (an aerosol-generating agent, including glycerol, in an amount of about 10–80 wt%) ¶ [0063];
one or more gelling agents comprising carboxymethyl cellulose (a gelling agent comprising carboxymethylcellulose) ¶¶ [0059]–[0060];
a filler (one or more fillers) ¶ [0074];
a flavorant (a flavorant contained in the amorphous solid) ¶ [0064]; and
wherein the filler comprises wood pulp (a fibrous organic filler comprising wood pulp) ¶ [0075].
Ghanouni does not expressly teach the claimed filler range of about 15–35 wt%. However, Ghanouni teaches filler in an amount of about 10–30 wt%, which overlaps the claimed range over about 15–30 wt% ¶ [0074]. Overlapping ranges are prima facie evidence of obviousness. MPEP § 2144.05(II).
Ghanouni also does not expressly state that the gelling agent and filler taken together are present in an amount of about 20–75 wt%. However, Ghanouni teaches about 15–27 wt% gelling agent ¶ [0059]. Selection of a filler amount within the overlapping range of about 15–30 wt% provides a combined gelling-agent and filler amount of about 30–57 wt%, within the claimed range.
Ghanouni further teaches that fibrous filler increases the tensile strength of the amorphous solid ¶ [0076].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select carboxymethylcellulose as Ghanouni’s gelling agent, wood pulp as Ghanouni’s fibrous filler, and a filler amount within the overlapping range of about 15–30 wt%, thereby providing a combined gelling-agent and filler amount within about 20–75 wt%, to obtain the increased tensile strength attributed to the fibrous filler.
Regarding claim 4, Ghanouni teaches wherein the filler is present in an amount of at least about 10 wt% of the amorphous solid (filler present in an amount of about 10–30 wt%) ¶ [0074].
Regarding claim 6, Ghanouni teaches wherein the flavorant comprises menthol (the amorphous solid comprising menthol as a flavorant) ¶ [0161].
Regarding claim 8, Ghanouni teaches filler in an amount of about 10–30 wt%, which overlaps the claimed range of about 20–35 wt% over about 20–30 wt% ¶ [0074]. Overlapping ranges are prima facie evidence of obviousness. MPEP § 2144.05(II).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select a filler amount within the overlapping range of about 20–30 wt% because Ghanouni identifies that amount as suitable for the amorphous solid and teaches that fibrous filler increases tensile strength ¶ [0076].
Regarding claim 9, Ghanouni teaches wherein the aerosol-generating agent is comprised in the amorphous solid in an amount of from about 30 to about 60 wt% of the amorphous solid (aerosol-generating agent present in an amount of about 30–60 wt%) ¶ [0063].
Regarding claim 10, Ghanouni teaches wherein the gelling agent is comprised in the amorphous solid in an amount of from about 20 to about 40 wt% of the amorphous solid (gelling agent present in an amount of about 20–40 wt%) ¶ [0059].
Regarding claim 11, Ghanouni teaches wherein the composition comprises from about 1 to about 50 wt% flavorant (flavorant present in an amount of about 1–30 wt%) ¶ [0064].
Regarding claim 18, Ghanouni teaches wherein the aerosol-generating agent comprises glycerol, optionally in combination with propylene glycol (the aerosol-generating agent comprising glycerol or propylene glycol) ¶ [0063].
Regarding claim 28, Ghanouni teaches wherein the gelling agent is not crosslinked (carboxymethylcellulose as the gelling agent without the setting agent or crosslinking treatment taught for alginate and pectin embodiments) ¶ [0060].
Regarding claim 29, Ghanouni teaches wherein the gelling agent is not calcium-crosslinked (carboxymethylcellulose as the gelling agent, while calcium crosslinking is taught for alginate and pectin embodiments) ¶ [0060].
Claims 30 and 31 are rejected under 35 U.S.C. § 103 as being unpatentable over Ghanouni et al. (US 2021/0315266 A1) in view of Phillips et al. (US 2019/0200667 A1).
Regarding claims 30–31, Ghanouni teaches the aerosol-generating composition of claim 1 for the reasons set forth above. Ghanouni further teaches that the amorphous solid may comprise tobacco material ¶¶ [0065]–[0066].
Ghanouni does not expressly teach wherein the amorphous solid further comprises a colorant and wherein the aerosol-generating composition further comprises tobacco material, wherein the colorant renders the amorphous solid visually indistinguishable from the tobacco material, or wherein the colorant is caramel.
Phillips teaches a product comprising tobacco material and a tobacco-alternative plant material ¶ [0007], wherein the tobacco-alternative plant material has an appearance similar to a tobacco-containing product ¶¶ [0004], [0012]. Phillips further teaches adding caramel color to the tobacco-alternative plant material ¶¶ [0010], [0056] and teaches that its treatment techniques produce tobacco-alternative materials having an appearance similar to tobacco-based products ¶ [0013].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to add caramel color to Ghanouni’s amorphous solid in a composition further comprising tobacco material, as taught by Phillips, so that the amorphous solid has an appearance similar to and visually blends with the tobacco material, thereby providing a tobacco-containing product having the tobacco-like appearance expressly sought by Phillips.
Conclusion
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/JENNIFER A KESSIE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747