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 .
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Claims 17-21, 23-24 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
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 01/16/2026 have been fully considered but they are not persuasive.
Applicant’s “multiple independent selections” argument is not persuasive
Applicant argues that the presently claimed amorphous solid is not anticipated because a person of ordinary skill in the art would need to make “multiple independent selections” from Ghanouni to arrive at the claimed invention.
This argument misstates the standard for anticipation. Anticipation does not require that a reference describe the claimed invention as a single, preferred, or expressly highlighted embodiment. Rather, anticipation exists when a single reference describes the claimed subject matter such that it falls within the scope of what is disclosed, even if the reference also discloses alternative embodiments.
Ghanouni expressly discloses an aerosol-generating amorphous solid comprising:
an active ingredient,
an aerosol-generating (aerosol-former) material, and
a gelling agent,
along with explicit wt% ranges for each component calculated on a dry weight basis. The presently claimed amorphous solid merely recites one embodiment that falls squarely within the compositional framework and ranges disclosed by Ghanouni. Selecting a disclosed active ingredient and formulating it within disclosed ranges does not amount to impermissible “reconstruction,” but rather reflects the ordinary reading of a reference that teaches compositional alternatives.
Accordingly, Applicant’s “multiple selections” argument does not overcome anticipation.
Applicant’s argument that cannabis is merely “one of many actives” is not persuasive
Applicant argues that although cannabis and derivatives thereof are listed in Ghanouni, the reference does not disclose cannabis as a preferred active ingredient, and therefore anticipation is lacking.
This argument is not persuasive. A reference anticipates if it expressly discloses the claimed subject matter, regardless of whether it is described as preferred. Ghanouni explicitly lists cannabis and cannabis-derived actives among the active ingredients suitable for inclusion in the amorphous solid. The fact that Ghanouni also discloses other active substances does not negate that cannabis is expressly disclosed as an option.
Anticipation does not require exclusivity or preference. Because cannabis is expressly identified as a suitable active ingredient in Ghanouni, this limitation is met.
Applicant’s reliance on amended wt% ranges does not distinguish over Ghanouni
Applicant argues that amended claim 1 recites specific wt% ranges and that Ghanouni does not disclose these exact amounts without further selection.
However, Ghanouni explicitly discloses broad numeric ranges for:
the active ingredient,
the aerosol-generating material, and
the gelling agent,
and these disclosed ranges encompass the wt% ranges recited in amended claim 1. Where a prior art reference discloses ranges that read on the claimed ranges, the claimed subject matter is anticipated. Selecting a value within a disclosed range does not confer novelty.
Accordingly, the recited wt% limitations do not patentably distinguish the claim from Ghanouni.
Applicant’s “non-crosslinked gelling agent” argument is not persuasive
Applicant asserts that amended claim 1 requires that the gelling agent is not crosslinked, and that Ghanouni allegedly teaches only crosslinked gelling agents.
This assertion is incorrect. Ghanouni broadly discloses the use of hydrocolloid gelling agents and provides a list of suitable gelling agents. While Ghanouni describes calcium-crosslinked alginate and/or calcium-crosslinked pectin as possible embodiments, the reference does not require crosslinking for the gelling agent generally. The use of crosslinking is described as optional (“may comprise”), not mandatory.
Thus, Ghanouni expressly discloses embodiments in which the gelling agent is not crosslinked, and amended claim 1 reads on those embodiments.
Applicant’s reliance on preferred or exemplary crosslinked embodiments does not negate the broader disclosure of non-crosslinked gelling agents.
Applicant’s argument regarding the combined amount of gelling agent and filler is not persuasive
Applicant argues that Ghanouni does not explicitly disclose the combined amount of gelling agent and optional filler as recited in amended claim 1.
However, Ghanouni teaches:
explicit wt% ranges for the gelling agent, and
the inclusion of filler material in the amorphous solid.
Where a reference discloses the same components and teaches ranges that allow for the claimed combined amount, anticipation is not avoided merely because the reference does not expressly total the amounts in the same manner as the claim. The claimed composition is fully encompassed by the teachings of Ghanouni.
Applicant’s alleged “technical effect” does not overcome anticipation
Applicant argues that the claimed combination provides a technical effect, such as improved delivery, and that this effect is not disclosed in Ghanouni.
This argument is not persuasive. Anticipation is determined by whether the structural and compositional limitations of the claim are disclosed, not by whether the reference recognizes or describes the same advantages or results. Intended use, benefits, or discovered properties do not impart patentability to an otherwise anticipated composition.
Additionally, arguments regarding “teaching away” are inapplicable to anticipation and do not negate the express disclosure in Ghanouni.
For the reasons discussed above, Ghanouni expressly discloses all of the limitations of amended claim 1. Applicant’s arguments rely on preference, selection, and alleged advantages rather than on a lack of disclosure, and therefore do not overcome the rejection.
Accordingly, the rejection of claim 1 under 35 U.S.C. § 102 is maintained.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1–2, 5–6 and 9-10, and 12–15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ghanouni et al. (WO 2020/025701).
Regarding Claim 1:
Ghanouni teaches an amorphous solid suitable for use in aerosol generation (p. 3, l. 5–15).
the amorphous solid comprises at least about 5 wt% of an active substance (p. 12, l. 30), wherein the active substance may be a constituent, derivative, or extract of cannabis and includes specific cannabinoids such as CBD, CBG, THC, CBN, and CBC (p. 35, l. 25 – p. 36, l. 10).
the amorphous solid comprises 20–40 wt% aerosol-forming material such as glycerol, propylene glycol, and triacetin (p. 11, l. 5–15).
5–40 wt% of a gelling agent (p. 10, l. 5–10), wherein the gelling agent may be selected from alginate, pectin, starch, cellulose derivatives, gums, PDMS, clay, and polyvinyl alcohol (p. 10, l. 15–25).
Ghanouni teaches optionally filler in an amount of up to 60wt% (p. 32, l. 22).
All weight percentages are disclosed as being on a dry-weight basis (p. 10, l. 10).
Ghanouni describes both crosslinked and non-crosslinked gelling systems, indicating the presence of non-crosslinked embodiments (p. 10, l. 25–30). Ghanouni further teaches that crosslinking is optional, explaining that the gelling agent may be combined with a setting agent, such as calcium source during formation of the amorphous solid but is not required (p. 10, l. 25–30).
Regarding Claim 2:
Ghanouni teaches that the amorphous solid comprises an active substance in the amount of at least about 5 wt% (p. 12, l. 30), and further teaches the active substance may be derivative, or extract of cannabis which are expressly listed as suitable active substances (p. 35, l. 25 – p. 36, l. 10).
Accordingly, Ghanouni teaches an amorphous solid comprising a cannabis derivative present in an amount of at least 5 wt%, which falls within and anticipates the recited range of about 2 to about 8 wt% of a constituent, derivative, or extract of cannabis as recited in claim 2.
Regarding Claim 5:
Ghanouni teaches gelling agents selected from cellulose derivatives (p. 10, l. 15–25).
Regarding Claim 6:
Ghanouni teaches gelling agents comprising cellulose derivatives (p. 10, l. 18–20; p. 11, l. 1–5).
Regarding Claim 7:
Ghanouni discloses hydroxypropyl cellulose, hydroxyethyl cellulose, and carboxymethyl cellulose as examples of cellulose derivatives (p. 10, l. 18–20).
Regarding Claim 9:
Ghanouni expressly discloses carboxymethylcellulose (CMC) as a gelling agent (p. 10, l. 18).
Regarding Claim 10:
Ghanouni teaches aerosol-forming materials including glycerol, propylene glycol, and triacetin (p. 11, l. 10–15).
Regarding Claim 12:
Ghanouni discloses the active ingredient as a cannabinoid (p. 35, l. 25 – p. 36, l. 10).
Regarding Claim 13:
Ghanouni lists CBG, CBC, CBD, THC, CBN, CBL, CBV, THCV, THCA, and related cannabinoids (p. 35–36).
Regarding Claim 14:
Ghanouni specifically identifies cannabidiol (CBD) as a cannabinoid (p. 35, l. 25).
Regarding Claim 15:
Ghanouni discloses an aerosol-generating material comprising 50–100 wt% amorphous solid, or consisting entirely of the amorphous solid composition (p. 3, l. 8–12; p. 14, l. 30–33).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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