Detailed Office 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 .
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.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-9, 11-14, 17-18, and 20-21, drawn to a method of forming an aerosol-generating material, in the reply filed on August 31, 2026, is acknowledged. The traversal is on the ground(s) that there is allegedly no undue burden to examine all the claims in the application because the Examiner in the international PCT application (PCTEP2022070643) examined all the claims as evidenced by the International Search Report/Written Opinion dated January 12, 2024. This is found NOT PERSUASIVE. The USPTO is not bound by the decisions of a foreign patent office and, as such, has deemed there to be a search burden as detailed in the restriction requirement of August 31, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 23-25 are withdrawn.
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(s) 4 and 11 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.
Regarding claim 4, the phrase "suitably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 11, the phrase "such as" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
6. 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.
7. Claim(s) 1-9, 11-14, 17-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Aoun et al. (WO2020025730A1-from IDS) in view of Klipfel et al (WO2016050470A1-from IDS (US10321707B2))
In regard to claim 1, Aoun et all discloses a method of forming an aerosol-generating material (method of manufacture of tubular substrate; Page 32, Line 13) comprising:
a constituent, derivative or extract of cannabis (The active substance may comprise one or more constituents, derivatives or extracts of tobacco, cannabis or another botanical. Page 38, Line 9);
aerosol-former material (aerosol generating agent, refers to an agent that promotes the generation of an aerosol; Page 41, Line 20);
gelling agent (gelling agent; Page 26, Line 29);
and optionally filler (the amorphous solid in some cases, comprise no filler. Page 30, Line 23);
the method comprising:
(a) providing a slurry comprising the gelling agent, aerosol-forming agent, a solvent and any optional further components of the aerosol-generating material; (Step a: forming a slurry comprising components of the first aerosol-forming composition or precursors thereof, Page 32, Line 15; the first aerosol-forming composition described herein comprises an aerosol-forming material referred to as an “amorphous solid”. Page 3, Line 14);
(b) adding the constituent, derivative or extract of cannabis to the slurry;
(c) forming a layer of the slurry (Step b: applying the slurry to a sheet carrier, Page 32, Line 17. The step (b) of forming a layer of the slurry may comprise spraying, casting or extruding the slurry, for example. Page 32, Line 20);
and (d) drying the slurry to form the aerosol-generating material (Step d: drying to form an amorphous solid. Page 32, Line 15).
Aoun teaches the addition of all the ingredients (gelling agent, solvent, aerosol forming agent, and the active substance) to the amorphous solid. Aoun fails to teach the recited order of the addition of these ingredients.
Klipfel discloses a method of preparation of a slurry for the production of a homogenized tobacco material. Klipfel teaches a preferred method comprising a first step of introduction in a tank of the suspension of binder in aerosol-former 5 and of the cellulose pulp 6. Afterwards, the tobacco powder 7 is introduced (Page 17, Line 9-11). Klipfel further teaches the suspension 5, the pulp 6 and the tobacco powder 7 are suitably dosed to control the amount of each of them introduced in the tank (Page 17, Line 11-13). The tobacco powder is an active substance and is functionally equivalent to the claimed invention and is serving the same function to the active substance of Aoun et al.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Aoun et al to include the teachings of Klipfel by adding the active substance to the slurry (gelling agent, solvent, and aerosol forming agent) last to control the amount of active ingredients added of Aoun et al, including the constituent, derivative or extract of cannabis.
In regard to claim 2, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1, as discussed above wherein the slurry is set to form a gel prior to drying step (d) (Step C: setting the slurry to form a gel, Page 32, Line 17).
In regard to claim 3, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1, as discussed above wherein the thickness of the layer formed in step (c) is less than 4mm (the amorphous solid may have a thickness of about 0.015mm to about 1.0mm. Page 26, Line 9).
In regard to claim 4, Aoun et. al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 3, as discussed above wherein the thickness of the layer is in the range of about 1mm to about 3mm, suitably about 1.5mm to about 2.5m.
Aoun does not expressly disclose the claimed range of 1mm to about 3 mm. Aoun et al does teaches an amorphous solid having a thickness of about 0.015mm to about 1.0mm.
Therefore, it would have been obvious to one of ordinary skill in the art to use Aoun et al’s thickness of 1 mm because the modification would have involved a predictable thickness already taught as suitable in Aoun et al.
In regard to claim 5, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1, as discussed above wherein the aerosol-generating material comprises 1-60wt% gelling agent (the amorphous solid may comprise l-60wt% of a gelling agent wherein these weights are calculated on a dry weight basis Page 26, Line 29).
In regard to claim 6, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1, as discussed above wherein the aerosol-generating material comprises 5-80wt% aerosol-former material (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, Page 28, Line 1).
In regard to claim 7, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1 as discussed above, wherein the aerosol-generating material comprises 1-50wt% constituent(s), derivative(s) or extract(s) of cannabis (the amorphous solid may comprise from about 1wt%, 5wt%, l0wt%, l5wt%, 20wt% or 25wt% to about 70wt%, 50wt%, 45wt% or 40wt% (calculated on a dry weight basis) of active substance. Page 28, Line 30-32).
In regard to claim 8, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1 as discussed above, wherein the aerosol-generating material further comprises a setting agent (The step (c) of setting the gel may comprise the addition of a setting agent to the slurry. (See Page 32, Line 31-32).
In regard to claim 9, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1 as discussed above, wherein the aerosol-former material comprises or is one or more of glycerol, propylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, 1,3-butylene glycol, erythritol, meso- Erythritol, ethyl vanillate, ethyl laurate, a diethyl suberate, triethyl citrate, triacetin, a diacetin mixture, benzyl benzoate, benzyl phenyl acetate, tributyrin, lauryl acetate, lauric acid, myristic acid, and propylene carbonate (See Page 41, Line 25-31).
In regard to claim 11, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1 as discussed above, 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 (See Page 27, Line 12-23).
In regard to claim 12, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1 as discussed above, wherein the gelling agent is selected from the group consisting of alginate and a cellulose derivative (See Page 27, Line 14).
In regard to claim 13, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1 as discussed above, wherein the gelling agent is selected from hydroxyl methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose (CMC), hydroxypropyl methylcellulose (HPMC, methyl cellulose, ethyl cellulose, cellulose acetate (CA), cellulose acetate butyrate (CAB), and cellulose acetate propionate (CAP) (See Page 27, Line 16).
In regard to claim 14, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1 as discussed above, wherein the gelling agent is not crosslinked.
Aoun teaches that the gelling agent may comprise various gelling agents and further teaches that a setting agent, such as a calcium source, may be used to crosslink certain gelling agents (alginate or pectin) (Page 27, Line 13-23).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to use the gelling agent without crosslinking because Aoun et al. teaches crosslinking as an optional means of setting the gelling agent rather than a requirement and the omission of the optional crosslinking treatment would have resulted in a non-crosslinked gelling agent.
In regard to claim 17, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1 as discussed above, wherein the constituent, derivative or extract of cannabis is a cannabinoid (the active substance may comprise one or more constituents, derivatives or extracts of cannabis, such as one or more cannabinoids or terpenes See Page 38, Line 17).
In regard to claim 18, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 17 as discussed above, 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) (See Page 38, Line 20 – Page 39, Line 2).
In regard to claim 20, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1 as discussed above, wherein the layer of slurry is formed on a carrier (Step b: applying the slurry to a sheet carrier. The step (b) of forming a layer of the slurry may comprise spraying, casting or extruding the slurry, for example. Page 32, Line 17-21).
In regard to claim 21, Aoun et al in view of Klipfer discloses a method of forming an aerosol-generating material of claim 1 as discussed above, wherein the aerosol-generating material contains no filler (In some cases, the amorphous solid comprises less than 1 wt% of a filler, and in some cases, comprises no filler. See Page 30, Line 22-24).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNAH C NNABUGWU whose telephone number is (571)272-8791. The examiner can normally be reached Mon-Thurs. 8:30am-5:00pm.
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/HANNAH CHINWE NNABUGWU/ Examiner, Art Unit 1747
/Christopher M Rodd/ Primary Examiner, Art Unit 1766
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