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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/14/2026 has been entered.
Election/Restrictions
Claims 17-21, 23-24 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 09/08/2025.
Response to Arguments
Applicant’s arguments filed May 14, 2026 have been fully considered. Applicant amended independent claim 1 to include a new limitation. Accordingly, the prior rejection under 35 U.S.C. § 102 over Ghanouni is withdrawn. Upon further examination, a new rejection under 35 U.S.C. § 103 over Ghanouni in view of Spieles is set forth below.
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.
Claims 1, 2, 5–7, 9, 12–15, 26, and 27 are rejected under 35 U.S.C. § 103 as being unpatentable over Ghanouni (WO 2020/025701 A1) in view of Spieles et al. (US 2022/0386681 A1).
Spieles claims priority to EP 19209346.6, filed November 15, 2019. The foreign priority application supports the glycerol and propylene glycol mixture, the relied-upon ratio, and the viscosity, texture, and formability teachings used in the rejection.
Regarding claim 1, Ghanouni teaches an amorphous solid for use in aerosol generation (an aerosol-generating material comprising an amorphous solid) (p. 3, ll. 5–15), the amorphous solid comprising:
about 1 to about 12 wt% constituent, derivative, or extract of cannabis (about 5 wt% active substance, wherein the active substance comprises one or more constituents, derivatives, or extracts of cannabis) (p. 12, ll. 1–7; p. 35, ll. 7–15);
about 10 to about 80 wt% aerosol-former material (about 20–40 wt% aerosol-generating agent) (p. 11, ll. 7–12);
a gelling agent (a hydrocolloid gelling agent comprising cellulose or a cellulose derivative) (p. 10, ll. 16–23);
optionally filler, wherein the amount of gelling agent and optional filler taken together is from about 10 to about 60 wt% (about 15–27 wt% gelling agent, with filler being optional, such that the amount of gelling agent and optional filler taken together is about 15–27 wt% when filler is absent) (p. 10, ll. 10–14);
wherein the wt% values are calculated on a dry-weight basis (the gelling-agent, aerosol-generating-agent, and active-ingredient amounts are calculated on a dry-weight basis) (p. 3, ll. 13–20); and
wherein the gelling agent is not crosslinked (a cellulose or cellulose-derivative hydrocolloid gelling agent without a crosslinking agent) (p. 10, ll. 16–23).
Ghanouni teaches finite, identified amounts for the active substance, aerosol-generating agent, and gelling agent, and expressly identifies cannabis and cellulose derivatives as suitable active substances and gelling agents. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select the combination of about 5 wt% cannabis active substance, about 20–40 wt% aerosol-generating agent, and about 15–27 wt% cellulose-derivative gelling agent from Ghanouni’s identified alternatives to obtain an amorphous solid providing delivery of the active ingredient and sufficient flexibility to avoid brittleness, with a reasonable expectation of success (pp. 10–12 and 35).
Ghanouni further teaches that the aerosol-generating agent may comprise one or more compounds selected from propylene glycol and glycerol (propylene glycol and glycerol as suitable aerosol-generating agents) (p. 11, ll. 7–15), and that the aerosol-generating agent may act as a plasticizer providing flexibility to the amorphous solid (an aerosol-generating plasticizer that prevents brittleness and provides flexibility to the amorphous-solid sheet) (p. 11, ll. 15–20).
Ghanouni does not teach wherein the aerosol-former material is a mixture of glycerol and propylene glycol in a weight ratio of 3:1 to 1:3.
Spieles is in the same field of endeavor and teaches a solid aerosol-releasing substrate comprising an aerosol-former material that is a mixture of glycerol and propylene glycol (a combination of glycerol and propylene glycol used as the aerosol-forming agent) (¶ [0038]). Spieles teaches a propylene glycol:glycerol weight ratio of 40:60 to 60:40 (a glycerol:propylene glycol weight ratio of 60:40 to 40:60, or 1.5:1 to 0.67:1) (¶ [0039]). This range falls entirely within the claimed glycerol:propylene glycol weight ratio of 3:1 to 1:3, or 3.0:1 to 0.33:1. Spieles further teaches that the relative amounts of glycerol and propylene glycol may be adjusted and that the ratio influences the viscosity, texture, and formability of the substrate (adjusting the glycerol and propylene glycol ratio to obtain a desired viscosity and improved texture and formability) (¶ [0040]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the aerosol-generating agent of Ghanouni to comprise the glycerol and propylene glycol mixture taught by Spieles in a weight ratio within 3:1 to 1:3. Ghanouni teaches glycerol and propylene glycol as suitable aerosol-generating agents and teaches that the aerosol-generating agent acts as a plasticizer providing flexibility to the amorphous solid (Ghanouni p. 11, ll. 7–20), while Spieles teaches that combining glycerol and propylene glycol in a glycerol:propylene glycol ratio of 1.5:1 to 0.67:1 permits adjustment of viscosity and improves the texture and formability of a solid aerosol-generating substrate (Spieles ¶¶ [0038]–[0040]). One of ordinary skill in the art would have had a reasonable expectation of success because both references use the same aerosol-forming components for aerosol-forming and plasticizing functions in solid aerosol-generating compositions.
Regarding claim 2, modified Ghanouni teaches the amorphous solid of claim 1, wherein the constituent, derivative, or extract of cannabis is present in an amount of about 2 to about 8 wt% (about 5 wt% active substance, wherein the active substance comprises one or more constituents, derivatives, or extracts of cannabis) (Ghanouni p. 12, ll. 1–7; p. 35, ll. 7–15).
Because claim 2 recites alternatives (A), (B), and (C) using “and/or,” Ghanouni’s teaching of about 5 wt% of the cannabis active substance satisfies alternative (A).
Regarding claim 5, Ghanouni as modified by Spieles teaches the amorphous solid of claim 1, wherein the gelling agent comprises or is cellulose or a derivative thereof (a hydrocolloid gelling agent comprising cellulose or a cellulose derivative) (Ghanouni p. 10, ll. 16–23).
Regarding claim 6,Ghanouni as modified by Spieles teaches the amorphous solid of claim 5, wherein the polysaccharide gelling agent is a cellulose derivative (a cellulose-derivative hydrocolloid gelling agent) (Ghanouni p. 10, ll. 16–23).
Regarding claim 7,Ghanouni as modified by Spieles teaches the amorphous solid of claim 5, wherein the cellulose derivative is carboxymethylcellulose (CMC) (carboxymethylcellulose) (Ghanouni p. 10, ll. 20–23).
Regarding claim 9,Ghanouni as modified by Spieles teaches the amorphous solid of claim 1, wherein the gelling agent is CMC (carboxymethylcellulose as the hydrocolloid gelling agent) (Ghanouni p. 10, ll. 20–23).
Regarding claim 2, Modified Ghanouni teaches the amorphous solid of claim 1, wherein the constituent, derivative, or extract of cannabis is present in an amount of about 2 to about 8 wt% (about 5 wt% active substance comprising one or more constituents, derivatives, or extracts of cannabis) (Ghanouni p. 12, ll. 1–7; p. 35, ll. 7–15).
Because claim 2 recites alternatives (A), (B), and (C) using “and/or,” the disclosed amount of about 5 wt% satisfies alternative (A).
Regarding claims 5–7 and 9, Modified Ghanouni teaches the amorphous solid of claim 1, wherein the gelling agent comprises or is cellulose or a derivative thereof, the polysaccharide gelling agent is a cellulose derivative, the cellulose derivative is carboxymethylcellulose (CMC), and the gelling agent is CMC (carboxymethylcellulose as the hydrocolloid gelling agent) (Ghanouni p. 10, ll. 16–23).
Ghanouni identifies a finite number of suitable hydrocolloid gelling agents and expressly identifies carboxymethylcellulose. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select carboxymethylcellulose from Ghanouni’s identified gelling-agent alternatives to provide the disclosed gelling and structural function in the amorphous solid, with a reasonable expectation of success (Ghanouni p. 10, ll. 16–23).
Regarding claims 12–14, Modified Ghanouni teaches the amorphous solid of claim 1, wherein the constituent, derivative, or extract of cannabis is a cannabinoid, the cannabinoid is cannabidiol (CBD), and the cannabinoid is cannabidiol (cannabidiol as the cannabis-derived cannabinoid active substance) (Ghanouni p. 35, l. 22–p. 36, l. 2).
Ghanouni identifies a finite number of suitable cannabis-derived cannabinoids and expressly identifies cannabidiol. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select cannabidiol from Ghanouni’s identified cannabinoid alternatives for its disclosed active-substance function in the amorphous solid, with a reasonable expectation of success (Ghanouni p. 35, l. 22–p. 36, l. 2).
Regarding claim 15, Modified Ghanouni teaches an aerosol-generating material comprising the amorphous solid of claim 1, optionally comprising from about 50 to about 100 wt% of the amorphous solid (an aerosol-generating material comprising about 50 wt% of the amorphous solid) (Ghanouni p. 3, ll. 5–10).
Regarding claim 26, Modified Ghanouni teaches the amorphous solid of claim 1, wherein the filler is hemp fibre (a fibrous organic filler comprising hemp fibre) (Ghanouni p. 14, ll. 5–9).
Regarding claim 27, Modified Ghanouni teaches the amorphous solid of claim 1, wherein the amorphous solid further comprises a flavourant, wherein the flavourant is hemp (a flavourant comprising hemp) (Ghanouni p. 37, ll. 6–21).
Ghanouni identifies a finite number of suitable flavourants and expressly identifies hemp. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select hemp from Ghanouni’s identified flavourant alternatives to provide the disclosed taste or aroma to the amorphous solid, with a reasonable expectation of success (Ghanouni p. 37, ll. 6–21).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H Wilson can be reached at (571) 270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A KESSIE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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