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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/07/2026 has been entered.
Election/Restrictions
Claims 15, 16, 18 and 20 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 09/11/2025.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Response to Arguments
Applicant’s arguments filed May 07, 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 Accordingly, the prior rejection under 35 U.S.C. § 102 over Ghanouni is withdrawn.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 Capelli is set forth below.
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.
Claims 2, 3 and 10 are 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.
Claims 2 and 3 recite respective concentration ranges followed by narrower ranges introduced by the phrase “such as.” It is unclear whether the narrower ranges are required limitations or merely nonlimiting examples of the broader ranges.
For purposes of continued examination, claims 2 and 3 are interpreted as requiring the broader recited concentration ranges, with the language following “such as” treated as exemplary and nonlimiting.
Claim 10 recites that “the gelling agent is a cellulosic derivative such as CMC.” The phrase “such as CMC” renders the scope of the claim unclear because it is uncertain whether the gelling agent is required to be CMC or may be any cellulosic derivative.
For purposes of continued examination, claim 10 is interpreted as requiring a cellulosic derivative, with the language “such as CMC” treated as exemplary and nonlimiting.
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 1–5, 7–8, 10–14, and 21–22 are rejected under 35 U.S.C. § 103 as being unpatentable over Ghanouni (WO 2020/025701) in view of Capelli et al. (US 2022/0202063 A1).
Capelli claims priority to EP 19167969 filed April 8, 2019. The foreign priority application supports the aerosol-generating film and discrete-region teachings relied-upon in the rejection.
Regarding claim 1, Ghanouni teaches an aerosol-generating material for use in aerosol generation (an aerosol-generating material comprising an amorphous solid) (p. 3, ll. 5–15), the amorphous solid comprising:
about 10 to about 50 wt% caffeine (about 20 wt% active substance, wherein the active substance comprises caffeine) (p. 12, ll. 1–9; p. 35, ll. 8–20);
about 15 to about 60 wt% gelling agent (about 15–27 wt% gelling agent) (p. 10, ll. 10–14);
about 10 to about 50 wt% aerosol-former material (about 15–50 wt% aerosol-generating agent) (p. 11, ll. 7–12);
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 caffeine 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 20 wt% caffeine active substance, about 15–50 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 wherein the aerosol-generating material is in the form of an aerosol-generating film (the amorphous solid formed as a sheet, including a planar, bunched, gathered, crimped, or rolled sheet) (p. 9, ll. 5–10).
Ghanouni does not teach wherein the aerosol-generating film comprises one or more discrete portions or regions of aerosol-generating material.
Capelli is in the same field of endeavor and teaches gathering more than one aerosol-generating film together to form a rod of aerosol-generating substrate (¶ [0129]). Capelli further teaches that the shape and size of the films may be finely tuned and controlled to provide films tailored to specific uses and needs (¶ [0127]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to provide Ghanouni’s aerosol-generating material as multiple discrete films gathered to form the aerosol-generating substrate, as taught by Capelli. Capelli teaches that the shape and size of the films may be finely tuned and controlled to tailor the films to specific uses and needs (¶ [0127]). The modification would have combined known aerosol-generating films according to a known arrangement and predictably produced a substrate comprising discrete film portions. See MPEP § 2143(I)(A).
Regarding claim 2, modified Ghanouni further teaches comprising about 20 to about 40 wt% caffeine (about 20 wt% active substance, wherein the active substance comprises caffeine) (Ghanouni p. 12, ll. 1–9; Ghanouni p. 35, ll. 8–20).
Regarding claim 3, modified Ghanouni further teaches comprising about 20 to about 40 wt% aerosol-former material (about 20–40 wt% aerosol-generating agent) (Ghanouni p. 11, ll. 7–12).
Regarding claim 4, modified Ghanouni teaches about 30 to about 50 wt% gelling agent (about 1 to about 60 wt% gelling agent, encompassing the claimed range) (Ghanouni p. 10, ll. 7–14). Where the claimed range overlaps or lies within a prior-art range, a prima facie case of obviousness exists. See 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 gelling-agent amount within the claimed range absent a showing of criticality or unexpected results.
Regarding claims 5, 7-8 and 10, 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 claim 11, modified Ghanouni further teaches wherein the aerosol-former material comprises glycerol (glycerol as the aerosol-generating agent) (Ghanouni p. 11, ll. 7–15).
Regarding claim 12, modified Ghanouni further teaches wherein the aerosol-former material comprises or is glycerol optionally in combination with propylene glycol (glycerol as the aerosol-generating agent) (Ghanouni p. 11, ll. 7–15).
Regarding claim 13, modified Ghanouni further teaches an aerosol-generating composition comprising the aerosol-generating material of claim 1 (an aerosol-generating substrate comprising the aerosol-generating material) (Ghanouni p. 3, ll. 13–20).
Regarding claim 14, modified Ghanouni further teaches comprising from about 50–100 wt% of the aerosol-generating material (about 50 wt% to about 100 wt% amorphous solid) (Ghanouni p. 3, ll. 5–10).
Regarding claim 21, 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).
Regarding claim 22, modified Ghanouni further teaches wherein the aerosol-generating material further comprises a filler, wherein the filler is hemp fibres (a fibrous organic filler material comprising hemp fibre) (Ghanouni p. 14, ll. 5–9).
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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