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
Applicant’s election without traverse of claims 1-12 in the reply filed on 09/03/2025 is acknowledged.
Claims 13-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/03/2025.
Response to Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive. Applicant argues that Mua does not anticipate claim 1 because the claim allegedly requires a double selection from a narrow list of additives and a narrow list of nonionic surfactants. This argument is not persuasive. Claim 1 broadly recites an additive comprising a cannabinoid, terpene, essential oil, plant extract, or mixtures thereof, and a surfactant comprising a polysorbate, an ethoxylated oil, or mixtures thereof. Mua discloses an aerosol-generating component comprising a substrate impregnated with aerosol-forming or aerosol-modifying materials, including additives and nonionic surfactants. Mua further identifies cannabinoids, terpenes, and plant-derived oils/extracts as suitable additives, and identifies polysorbate 80 and related polyoxyethylene sorbitan surfactants as suitable nonionic surfactants. Thus, the relied-upon additive and surfactant are disclosed in the same aerosol-forming composition context, not in unrelated embodiments.
Applicant further argues that Mua discloses broad and undifferentiated lists that would require a person of ordinary skill to make numerous selections. This argument is not persuasive because claim 1 itself is broad and does not require a particular additive species, a particular surfactant species, or a particular pairing of those species. Mua’s disclosure of at least one additive falling within the claimed additive class and at least one surfactant falling within the claimed surfactant class in an aerosol-modifying composition for impregnation into the disclosed substrate is sufficient to meet the broad language of claim 1.
Applicant’s reliance on the “at once envisage” standard is also not persuasive. The rejection does not rely on combining distinct and unrelated teachings merely because they appear somewhere in Mua. Rather, Mua teaches the claimed components in the same field and same disclosed use, namely an aerosol-forming or aerosol-modifying composition incorporated into a substrate for an aerosol-generating product. Therefore, the claimed arrangement is disclosed by Mua as applied in the rejection.
Applicant also argues that the claimed selection provides improved aerosol formation, improved stability, improved additive dispersion, controlled delivery, improved taste and smell, and high additive loading. These arguments are not persuasive because these alleged advantages are not recited in claim 1. Claim 1 does not require any particular degree of stability, uniformity, controlled delivery, sensory improvement, or loading precision. Limitations not appearing in the claims are not persuasive to distinguish over the prior art.
Applicant’s reliance on Examples 2 and 3 is likewise not persuasive. The examples allegedly show incorporation of cannabidiol at certain concentrations, but claim 1 is not limited to cannabidiol, to those concentrations, or to any specific loading accuracy. Further, the examples do not provide a comparison against Mua demonstrating that the claimed product has unexpected properties over the closest prior art. The asserted results therefore are not commensurate in scope with claim 1.
Applicant additionally argues that the surfactant is combined with the additive before impregnation and solubilizes the additive or creates a stable emulsion with the additive. This argument is not persuasive with respect to claim 1 because claim 1 has not been amended to include this limitation. The cited limitation appears in amended claim 2 and is not part of claim 1. Accordingly, this argument does not overcome the rejection of claim 1 or the dependent claims that do not include the amended limitation.
Applicant further argues that the dependent claims are patentable for at least the reasons argued with respect to claim 1. This argument is not persuasive because the arguments directed to claim 1 are not persuasive for the reasons discussed above. Further, Mua discloses the additional limitations of the dependent claims as set forth in the rejection, including cannabaceae/cannabis-derived substrates, ethoxylated sorbitan or polysorbate surfactants, cannabidiol, tetrahydrocannabinol, additive concentrations greater than the claimed amounts, and reconstituted material in strip, shred, sheet, or similar form.
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) 1-5, 7-8 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mua et al. (US 2021/0315255).
Regarding Claim 1:
Mua teaches an aerosol generating product, comprising:
“a plant-containing substrate impregnated with an aerosol-modifying composition”
Mua teaches an aerosol-generating component comprising a substrate impregnated with one or more aerosol-forming or modifying materials (¶ [0061]).
The substrate portion 110 is described as being loaded or impregnated with aerosol-forming materials such as glycerol, glycols, and other additives (¶¶ [0049],[0087] [0105] ).
“wherein the aerosol-modifying composition comprises an additive and a surfactant mixture”
Mua describes the aerosol-forming composition as including an additive (e.g., active compound or flavorant) and a surfactant mixture containing polyhydric alcohols and non-ionic surfactants (¶¶ [0087] – [0089], [0098]).
Non-ionic surfactants such as polysorbate 80 and glyceryl esters are exemplified (¶ [0089]).
“wherein the additive comprises a cannabinoid, a terpene, an essential oil, a plant extract, or mixtures thereof”
Mua expressly lists cannabinoids (CBD, THC) (¶[0098]), terpenes (pinene, limonene) (¶[0093]), and plant-derived oils/extracts as exemplary additives (¶[0086], ¶ [0098] – [0100]).
“wherein the plant-containing substrate comprises cannabaceae fibers, tobacco fibers, botanical fibers, bast pulp fibers, wood pulp fibers, or mixtures thereof”
Mua discloses that the substrate may include botanical, tobacco, cellulose, and wood-pulp fibers (¶¶ [0080] – [0082] and [0061]).
“wherein the surfactant comprises a non-ionic surfactant, the surfactant comprising a polysorbate, an ethoxylated oil, or mixtures thereof”
Mua identifies suitable non-ionic surfactants including polysorbate 80, polyoxyethylene sorbitan mono- and monolaurate esters, (¶ [0089]).
“wherein the additive is incorporated into the plant-containing substrate in an amount greater than about 1 % by weight”
Mua describes the additive or aerosol-forming material being incorporated at loadings greater than 1 wt %, e.g., from about 5 wt % to 30 wt % of the substrate (¶¶ [0097] – [0099]).
Regarding claim 2, Mua teaches the aerosol-generating product of claim 1 as set forth above and further teaches wherein the plant-containing substrate comprises a reconstituted material (reconstituted material used as the substrate of the aerosol-generating product) (Mua, ¶ [0081]).
Mua further teaches that the aerosol-generating product includes the additive (a cannabinoid additive, such as cannabidiol or tetrahydrocannabinol) (Mua, ¶ [0098]) and the surfactant (a nonionic surfactant, such as polysorbate 80) (Mua, ¶ [0089]) in the aerosol-forming composition impregnated into the substrate (Mua, ¶ [0061]).
Claim 2 further recites wherein the surfactant is combined with the additive before the impregnation of the plant-containing substrate with the aerosol-modifying composition. This limitation defines the claimed product by the process through which the product is made. The patentability of a product-by-process claim is based on the product itself, and the product is not patentably distinguished from the prior art merely by the process by which it is made. MPEP § 2113. Mua discloses the same or substantially identical final aerosol-generating product, namely a reconstituted plant-containing substrate impregnated with an aerosol-forming composition comprising the claimed additive and nonionic surfactant. Therefore, the recited order of combining the surfactant and additive does not distinguish the claimed product from Mua absent evidence that the recited process imparts a structural or compositional difference to the final product.
Claim 2 further recites the surfactant solubilizing the additive or creating a stable emulsion with the additive. Mua discloses the same or substantially identical composition comprising the claimed cannabinoid additive and nonionic polysorbate surfactant in the aerosol-forming composition impregnated into the substrate (Mua, ¶¶ [0061], [0089], [0098]). Because Mua discloses the same or substantially identical product composition, there is a reasonable basis to conclude that Mua’s product possesses the same solubilized or emulsified condition. Where the claimed and prior-art products are identical or substantially identical, the burden shifts to Applicant to establish that the prior-art product does not necessarily possess the claimed characteristic. MPEP §§ 2112 and 2112.01.
Applicant has not provided evidence that combining the surfactant and additive before impregnation imparts a structural or compositional difference to the final aerosol-generating product over Mua.
Regarding Claim 3 the limitation recites:
“wherein the plant-containing substrate contains cannabaceae fibers.”
Mua discloses substrates derived from cannabis or hemp plant materials when cannabinoids are incorporated (¶ [0084]).
Regarding Claim 4 the limitation recites:
“wherein the surfactant comprises an ethoxylated sorbitan of a fatty acid or a biosurfactant.”
Mua teaches ethoxylated sorbitan surfactants (e.g., polysorbate 80, an ethoxylated sorbitan of oleic acid) and bio-derived surfactants (¶ [0089]).
Regarding Claim 5, the limitation recites:
“wherein the surfactant comprises a polyoxyethylene sorbitan monolaurate, a polyoxyethylene sorbitan monooleate, a polyoxyethylene sorbitan monostearate, or mixtures thereof.”
Mua expressly identifies polysorbate 80 and related polyoxyethylene sorbitan mono- and monostearate surfactants (¶ [0089]--[0091]).
Regarding Claim 7, Mua explicitly lists cannabidiol (CBD) as an additive (¶ [0098]).
Regarding Claim 8 and 10, Mua explicitly lists cannabidiol (CBD), tetrahydrocannabinol (THC) as exemplary cannabinoids (¶ [0100]).
Regarding Claim 11 the limitation recites:
“wherein the additive is present in the plant-containing substrate in an amount greater than about 2 wt %, such as greater than about 5 wt %, … less than about 25 wt %.”
Mua teaches additive concentrations ranging from about 5 wt % to about 20 wt % (¶¶ 0099]), explicitly anticipating the claimed range.
Regarding claim 12, Mua teaches an aerosol-generating product comprising a plant-containing substrate impregnated with an aerosol-modifying composition (see rejection of claim 1) and further comprising a filler or reconstituted fibrous material (¶¶[0078], [0079]).
Mua teaches that the substrate is formed by paper-making or cast-sheet technology and may be reduced into cut rag, strips, or sheets (¶[0107]) or may be provided in particulate, shredded, or sheet form (¶[0110]).
Accordingly, Mua expressly discloses that the filler material comprises a reconstituted material in the form of a strip, sheet, or shreds, thereby meeting all limitations of claim 12.
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.
Claim 6 is rejected under 35 U.S.C. §103 as being unpatentable over Mua (US 2021/0315255) in view of Alsayar (US 2021/0361568).
Regarding Claim 6, Mua teaches an aerosol-generating product comprising an additive and surfactant mixture including a nonionic surfactant, wherein the surfactant may comprise a polysorbate, an ethoxylated oil, or mixtures thereof (see Mua ¶¶[0088]–[0091]). Mua therefore teaches the use of nonionic ethoxylated surfactants suitable for aerosol-generating compositions.
However, Mua does not specifically disclose that the surfactant comprises an ethoxylate of a hydrogenated castor oil or a biosurfactant as recited in claim 6.
Alsayar discloses similar nonionic surfactants for use in cannabinoid-containing aerosol and vapor delivery formulations.
Alsayar further discloses that hydrophobic active ingredients such as cannabinoids are dispersed or solubilized using carrier oils and surfactants to maintain homogeneity and stability (¶¶[0262]–[0264]).
Alsayar further identifies suitable surfactants and emulsifiers, including polyoxyethylene (40) hydrogenated castor oil (Cremophor RH-40), Tween 20, Tween 40, Tween 60, and Tween 80 (¶¶[0278]–[0281]), and explains that these materials function to solubilize and emulsify hydrophobic components within the vapor or aerosol-forming composition.
Mua and Alsayar are directed to the same field of endeavor, namely aerosol-generating or vapor delivery compositions that incorporate nonionic ethoxylated surfactants to aid dispersion or emulsification of hydrophobic active ingredients. Both references address compositions that are heated or vaporized to produce an inhalable aerosol and rely on similar nonionic surfactant chemistry to stabilize such formulations.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to substitute or include the ethoxylated hydrogenated castor oil surfactant of Alsayar in the aerosol-modifying composition of Mua, since both are recognized as nonionic ethoxylated surfactants performing the same emulsification and stabilization functions in aerosol-forming systems.
Such substitution would have constituted the predictable use of a known equivalent surfactant to achieve the same result, namely improved miscibility and stability of hydrophobic active materials (MPEP §2143; KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)).
Claim 9 is rejected under 35 U.S.C. § 103 as being unpatentable over Mua (US 2021/0315255 A1) in view of Rousseau et al. (US 2020/0253268 A1).
Regarding Claim 9, Mua teaches an aerosol-generating product comprising a substrate impregnated with an aerosol-forming composition including terpenes such as limonene and pinene (¶ [0093]). Mua does not expressly disclose the claim-specific isomeric/derivative list
However, Rousseau discloses that suitable terpene additives for smoking or aerosol compositions include α-pinene, β-pinene, D-limonene, terpineol, linalool, geraniol, β-caryophyllene, α-humulene, caryophyllene oxide, nerolidol, guaiol, and α-bisabolol (¶ [0092]).
Therefore, it would have been obvious to one of ordinary skill in the art to employ the specific isomeric forms of the terpenes taught by Rousseau in the aerosol substrate of Mua to obtain known and predictable aroma and vaporization characteristics, as these are routine selections within the terpene class for such applications (see MPEP § 2144.05).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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
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