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 1-3, 5-9, 12, 18-19, 21-24, and 26-30 are pending and are subject to this Office Action. This is the first Office Action on the merits of the claims.
Election/Restriction
Applicant's election with traverse of Claims 1-3, 5-9, 12, 18-19, and 21-24 in the reply filed on July 30, 2026 is acknowledged. The traversal is on the ground(s) that combined search and examination of the alleged inventions would not be a serious burden. This is not found persuasive because the invention of Group I (Claims 1-3, 5-9, 12, 18-19, and 21-24) is classified in A24B15/16, the invention of Groups II-IV (Claims 26-28) is classified in A24B 15/167, the invention of Groups V (Claim 29) is classified in A24D1/20, and the invention of Group VI (Claim 30) is classified in A24F40/20. In accordance with MPEP § 803, serious search burden on the examiner may be prima facie shown by explanation of separate classification.
The requirement is still deemed proper and is therefore made FINAL.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-9, 12, 18-19, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Aoun (WO 2020/025730 A1) in view of Saar (US 2023/0210786 A1).
Regarding Claim 1, Aoun, directed to cannabis compositions (pg 3, ln 30 – pg 4, ln 7, The first aerosol forming composition may be an amorphous solid comprising an active substance; and pg. 38, ln 17-18, the active substance may comprise one or more constituents, derivatives or extracts of cannabis), teaches a method of forming an aerosol-generating material comprising: a constituent, derivative or extract of cannabis; aerosol-former material; and gelling agent (pg 32, ln 15-18, The substrate may be manufactured by a method comprising (a)-(d) to form an amorphous solid; and pg 26, ln 29 – pg 31, ln 26, the amorphous solid may comprise a gelling agent, an aerosol generating agent, one or more active substances (cannabis constituent, derivative, or extract), water (solvent)); the method comprising:
(a) mixing the constituent, derivative or extract of cannabis with the aerosol-former material, the gelling agent, a solvent and any optional further components of the aerosol-generating material to form a slurry (pg 32, ln 15-18, The substrate may be manufactured by a method comprising (a) forming a slurry comprising components of the first aerosol-forming composition or precursors thereof; and pg 26, ln 29 – pg 31, ln 26, the amorphous solid may comprise a gelling agent, an aerosol generating agent, one or more active substances, water (solvent); and pg. 38, ln 17-18, the active substance may comprise one or more constituents, derivatives or extracts of cannabis);
(d) forming a layer of the slurry (pg 32, ln 15-18, The substrate may be manufactured by a method comprising (a) forming a slurry comprising components of the first aerosol-forming composition or precursors thereof, (b) applying the slurry to a sheet carrier, (c) setting the slurry to form a gel); and
(e) drying the slurry to form the aerosol-generating material (pg 32, ln 15-18, The substrate may be manufactured by a method comprising (a) forming a slurry comprising components of the first aerosol-forming composition or precursors thereof, (b) applying the slurry to a sheet carrier, (c) setting the slurry to form a gel, (d) drying to form an amorphous solid),
but does not teach the method wherein the aerosol generating material comprises an antioxidant, nor the method comprising (a) mixing the gelling agent, a solvent and any optional further components of the aerosol-generating material; (b) separately mixing together the constituent, derivative or extract of cannabis with the aerosol-former material and an antioxidant; (c) combining the mixtures of parts (a) and (b) to form a slurry.
Saar, directed to cannabis compositions ([0001]-[0003]), teaches a method of forming a cannabis composition ([0001], A cannabinoid is solubilized to form a pharmaceutical dosage form),
comprising mixing a constituent of cannabis with an antioxidant to prevent unfavorable changes in aspect and taste of the constituent of cannabis in a relatively short time due to oxidation processes ([0128], An antioxidant may be added to the solubilized cannabinoid to prevent its oxidation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method of Aoun wherein an antioxidant is added to the slurry at step (a) such that the aerosol-generating material comprises an antioxidant because Aoun and Saar are directed to cannabis compositions, Saar demonstrates that the inclusion of an antioxidant prevents unfavorable changes in aspect and taste of the constituent, derivative or extract of cannabis in a relatively short time due to oxidation processes (Saar, [0128]), and this involves combining prior art elements according to known method to yield predictable results.
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method comprising (a) mixing the gelling agent, a solvent and any optional further components of the aerosol-generating material; (b) separately mixing together the constituent, derivative or extract of cannabis with the aerosol-former material and an antioxidant; and (c) combining the mixtures of parts (a) and (b) to form a slurry because the selection of any order of mixing ingredients is prima facie obvious in the absence of new or unexpected results. See MPEP § 2144.04 IV C. As Aoun in view of Saar discloses a method comprising mixing an aerosol-former material, a gelling agent, a solvent, an antioxidant, and a constituent, derivative or extract of cannabis to form a slurry, separately mixing some of the components would not yield new or unexpected results.
Regarding Claim 2, Aoun in view of Saar teaches the method according to claim 1. Aoun further teaches the method wherein the slurry is set to form a gel prior to drying step (e) (pg 32, ln 15-18, The substrate may be manufactured by a method comprising (a) forming a slurry comprising components of the first aerosol-forming composition or precursors thereof, (b) applying the slurry to a sheet carrier, (c) setting the slurry to form a gel, (d) drying to form an amorphous solid).
Regarding Claim 3, Aoun in view of Saar teaches the method according to claim 1. Aoun further teaches the method wherein the dried slurry at step (e) forms an aerosol generating material having a thickness between 0.05 mm and 0.20 mm (pg 34, ln 22-30; The amorphous solid of these embodiments may be included in an aerosol generating article/assembly as a sheet. Suitably, in any of these embodiments, the amorphous solid has a thickness of from about 50 µm to about 200 µm, or about 50 µm to about 100 µm, or about 60 µm to about 90 µm, suitably about 77 µm),
but does not teach the method wherein the thickness of the layer formed in step (d) is less than 4mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to for the layer in step (d) having a thickness less than 4mm because the slurry comprises 50wt%-90wt% of water as a solvent (WWB) and is dried to a water content of from about 5wt% to about 15wt% (Aoun, pg 31, ln 7-9; and pg 34, ln 19-20). One of ordinary skill in the art would have understood that removal of 35% - 85% of water by weight from the slurry would correspond to a 35% - 85% reduction in the thickness of the layer of in step (d) to form the aerosol generating material at step (e); and a slurry layer having a thickness of <4mm can be reduced by 35%-85% to yield an aerosol generating material having a thickness between 0.05 mm and 0.20 mm (Aoun, pg 34, ln 22-30).
Regarding Claim 5, Aoun in view of Saar teaches the method according to claim 1. Aoun further teaches the method wherein the aerosol-generating material comprises 1-60wt% gelling agent (pg 10, ln 7-8, the amorphous solid may comprise l-60wt% of a gelling agent wherein these weights are calculated on a dry weight basis).
Regarding Claim 6, Aoun in view of Saar teaches the method according to claim 1. Aoun further teaches the method wherein the aerosol-generating material comprises 5-80wt% aerosol-former material (pg 11, ln 7-9, the amorphous solid may comprise from about 5wt%, l0wt%, l5wt%, or 20wt% to about 80wt%, 70wt%, 60wt%, 55wt%, 50wt%, 45wt% 40wt%, or 35wt% of an aerosol generating agent (all calculated on a dry weight basis)).
Regarding Claim 7, Aoun in view of Saar teaches the method according to claim 1. Aoun further teaches the method wherein the aerosol-generating material comprises 1-50wt% constituent(s), derivative(s) or extract(s) of cannabis (pg 12, ln 4-6, the amorphous solid may comprise from about lwt%, 5wt%, l0wt%, l5wt%, 20wt% or 25wt% to about 70wt%, 50wt%, 45wt% or 40wt% (calculated on a dry weight basis) of active substance).
Regarding Claim 8, Aoun in view of Saar teaches the method according to claim 1 but does not explicitly teach the method wherein the aerosol-generating material comprises about 0.01 to about 0.25 wt% antioxidant.
Saar teaches a composition comprising a cannabinoid and an antioxidant ([0001], A cannabinoid is solubilized to form a pharmaceutical dosage form; and [0128], An antioxidant may be added to the solubilized cannabinoid to prevent its oxidation),
wherein the antioxidant is added to the composition in the range of 0.1% to 1% per weight and most preferred 0.2% per weight ([0131]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method of Aoun wherein the aerosol-generating material comprises about 0.01 to about 0.25 wt% antioxidant because Saar demonstrates that the inclusion of an antioxidant 0.2% per weight is most preferable for preventing unfavorable changes in aspect and taste of the constituent, derivative or extract of cannabis in a relatively short time due to oxidation processes (Saar, [0128]).
Regarding Claim 9, Aoun in view of Saar teaches the method according to claim 1. Aoun further teaches the method wherein the aerosol-generating material further comprises a setting agent (pg 10, ln 25-27, the gelling agent comprises alginate and/or pectin, and may be combined with a setting agent (such as a calcium source) during formation of the amorphous solid).
Regarding Claim 12, Aoun in view of Saar teaches the method according to claim 1. Aoun further teaches the method wherein the gelling agent comprises or is one or more compounds selected from polysaccharide gelling agents, such as alginate, pectin, starch or a derivative thereof, cellulose or a derivative thereof, pullulan, carrageenan, agar and agarose; gelatin; gums, such as xanthan gum, guar gum and acacia gum; silica or silicone compounds, such as PDMS and sodium silicate; clays, such as kaolin; and polyvinyl alcohol (pg 10, ln 17-18, the gelling agent comprises one or more compounds selected from the group comprising alginates, pectins, starches (and derivatives)).
Regarding Claims 18-19, Aoun in view of Saar teaches the method according to claim 1. Aoun further teaches the method wherein the constituent, derivative or extract of cannabis is a cannabinoid, wherein the cannabinoid is selected from cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A) (pg 35, ln 22 – pg 36, ln 7, the active substance may comprise one or more constituents, derivatives or extracts of cannabis, such as one or more cannabinoids or terpenes. Cannabinoids found in cannabis include, without limitation: cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), Cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A)).
Regarding Claim 21-22, Aoun in view of Saar teaches the method according to claim 1. Saar further teaches the method wherein the antioxidant is an enediol, wherein the antioxidant is selected from ascorbic acid, sodium ascorbate, retinol, cholecalciferol and combinations thereof ([0129], Suitable antioxidants can be selected from the group comprising lactic acid, ascorbic acid, sodium ascorbate. Ascorbic acid is an enediol; see instant specification, pg 9, ln 20-21).
Regarding Claims 23-24, Aoun in view of Saar teaches the method according to claim 1. Aoun further teaches the method wherein the layer of slurry is formed on a carrier (pg 32, ln 15-18, The substrate may be manufactured by a method comprising (a) forming a slurry comprising components of the first aerosol-forming composition or precursors thereof, (b) applying the slurry to a sheet carrier, (c) setting the slurry to form a gel, (d) drying to form an amorphous solid),
wherein the aerosol-generating material contains no filler (pg 13, ln 28-29, In some cases, the amorphous solid comprises less than lwt% of a filler, and in some cases, comprises no filler).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN M. MARTIN whose telephone number is (703)756-1270. The examiner can normally be reached M-F 8:00-5:00.
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/J.M.M./
Examiner, Art Unit 1755
/PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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