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 .
Response to Arguments
Applicant's arguments filed 01/21/2026 have been fully considered.
Response to Arguments Regarding the Rejection Under 35 U.S.C. § 102(a)(1) Over Strickland
Applicant argues that the amendment requiring the claimed composition or structure to be “adapted for use as a substrate within a consumable for use with a non-combustible aerosol delivery device” distinguishes the pending claims from Strickland because Strickland is directed to products intended for oral use or consumption rather than aerosol delivery products.
Applicant’s argument is not persuasive with respect to the newly added “adapted for use” limitation.
The recitation that the composition or structure is “adapted for use as a substrate within a consumable for use with a non-combustible aerosol delivery device” does not require actual incorporation of the composition or structure into such a consumable, does not require heating of the composition or structure, and does not require actual formation of an aerosol. Rather, the language requires that the recited component-containing, cross-linked alginate structure be suitable or capable of the recited use.
Strickland discloses a component-containing, cross-linked alginate structure formed from a mixture comprising sodium alginate, water, tobacco material, sucralose, and oil of peppermint, wherein the mixture is contacted with aqueous calcium chloride to crosslink the alginate and form gel beads, which are thereafter removed from solution and dried. Thus, Strickland discloses the claimed type of component-containing, cross-linked alginate structure comprising tobacco material and other entrapped components.
Applicant has not identified any structural feature, composition requirement, moisture limitation, dimensional limitation, thermal property, or other physical characteristic imposed by the newly added “adapted for use” language that distinguishes the claimed component-containing, cross-linked alginate structure from the cross-linked alginate structure disclosed by Strickland. The fact that Strickland describes its structure in connection with oral-use embodiments does not establish that the disclosed structure is incapable of use as a substrate within a consumable for a non-combustible aerosol delivery device. Accordingly, Applicant’s amendment does not, by itself, distinguish the claimed structure from Strickland.
Nevertheless, in the interest of compact prosecution and in view of the amended claim language expressly focusing prosecution on compositions and structures adapted for use within consumables for non-combustible aerosol delivery devices, the rejection based on Strickland has been withdrawn and replaced with new rejections applying references that more directly correspond to the amended subject matter and the core of Applicant’s asserted invention.
In particular, Aoun is directed to an aerosol-generating material comprising tobacco extract, glycerol, and alginate binder for use in a non-combustible heat-not-burn aerosol delivery device. Jakob is relied upon for its disclosure of calcium treatment of an alginate-containing tobacco material to form the claimed cross-linked alginate structure. Accordingly, the new rejection over Aoun in view of Jakob more directly addresses both the claimed component-containing, cross-linked alginate structure and the newly recited non-combustible aerosol-delivery substrate context.
With respect to the additional limitations recited in claims 16–19, Applicant’s arguments concerning the specific disclosures of Strickland have also been considered. Rather than continuing to rely on Strickland for those particular process arrangements, the newly presented rejections rely on art expressly directed to the claimed configurations. Specifically, Aoun in view of Jakob is applied to the cast-sheet and shredding subject matter of claims 16 and 17, and Aoun in view of Jakob and further in view of Karles is applied to the pre-formed cation-containing bead and outer-surface coating subject matter of claims 18 and 19.
Accordingly, Applicant’s arguments do not establish patentability of the pending claims. The prior rejection over Strickland is withdrawn, and the new rejections are made in view of references that more directly align with the amended claim language and the claimed aerosol-delivery application.
Rejection of Claims 16 and 17 Under 35 U.S.C. § 112(b)
Applicant’s argument is persuasive.
The rejection of claims 16 and 17 under 35 U.S.C. § 112(b) was based on claim 16 previously depending from claim 1 while further reciting casting a sheet of the substantially homogeneous mixture prior to the contacting step. Applicant has amended claim 16 to present the subject matter in independent form. Accordingly, claim 16 no longer incorporates the limitation from claim 1 that formed the basis of the previously identified inconsistency.
Therefore, the rejection of claims 16 and 17 under 35 U.S.C. § 112(b) is withdrawn.
Rejection of Claims 2–5, 8–12, and 24–27 as Containing an Improper Markush Grouping
Applicant’s arguments have been fully considered but are persuasive only with respect to claims 10 and 11.
A Markush grouping is proper where the alternatives share a single structural similarity and a common use. In the context of a claimed combination or process, the alternatives must be substitutable for one another with the expectation that the same intended result would be achieved. Merely asserting that various different materials may be included within, or physically entrapped by, the same composition does not by itself establish that the alternatives belong to the same recognized physical, chemical, or art-recognized class and are functionally equivalent in the context of the claimed invention. See MPEP § 2117.
Claims 2–5
Applicant argues that the alternatives recited in claim 2, including flavorants, sweeteners, aerosol-forming agents, humectants, fillers, preservatives, tobacco materials, and combinations thereof, are within the same class of “components within a composition” and share the common use of modifying a consumable product and being entrapped within the cross-linked alginate matrix.
This argument is not persuasive.
The asserted class of “components within a composition” is not sufficiently specific to establish a single structural similarity or art-recognized class of functionally equivalent alternatives. The listed alternatives encompass materially different types of materials having materially different functions in the claimed composition. For example, a sweetener provides sweetness, a preservative inhibits deterioration, a filler provides bulk or structural contribution, an aerosol-forming agent contributes to aerosol formation, and a tobacco material provides tobacco-derived content. Applicant has not established that these distinct alternatives are substitutable for one another with the expectation of achieving the same intended result in the claimed consumable substrate.
Applicant’s assertion that each alternative may be entrapped within a cross-linked alginate matrix merely establishes that the alternatives may be processed using the recited method. It does not establish that the alternatives are members of the same recognized physical, chemical, or art-recognized class or are functionally equivalent as required for a proper Markush grouping.
Accordingly, Applicant’s argument is not persuasive, and the rejection of claims 2–5 as containing an improper Markush grouping is maintained.
Claims 8 and 9
Applicant argues that the alternatives recited in claim 8 share a single structural similarity because they are all “active ingredients” within a consumable product and share the common use of providing an active ingredient within the composition.
This argument is not persuasive.
Characterizing the alternatives generally as “active ingredients” does not establish that the recited alternatives belong to the same recognized physical, chemical, or art-recognized class or that they are functionally equivalent in the claimed composition. The recited alternatives encompass different types of active materials that provide materially different effects and are not shown to be interchangeable for the same intended purpose in the claimed consumable substrate.
Applicant has not provided persuasive reasoning or evidence establishing that substitution of one recited active ingredient for another would be expected to achieve the same intended result in the context of the claimed invention, other than the generalized assertion that each may be included within the composition.
Accordingly, Applicant’s argument is not persuasive, and the rejection of claims 8 and 9 as containing an improper Markush grouping is maintained.
Claims 10 and 11
Applicant argues that the alternatives recited in claim 10 are all aerosol-forming agents and share the common use of forming an aerosol within the claimed consumable product.
This argument is persuasive.
Unlike the broadly disparate alternatives recited in claims 2, 8, 12, and 24, the alternatives of claim 10 are identified as aerosol-forming agents and share the specific common use of contributing to aerosol formation in the claimed context. Upon reconsideration, the alternatives recited in claim 10 are considered to constitute an art-recognized class having a common use in the claimed invention.
Accordingly, the rejection of claims 10 and 11 as containing an improper Markush grouping is withdrawn.
Claim 12
Applicant argues that the alternatives recited in claim 12 share a single structural similarity because they are components incorporated within a cross-linked structure used as a substrate within a consumable for use with a non-combustible aerosol delivery device, and further share the common use of modifying characteristics of the composition.
This argument is not persuasive.
The fact that different materials may be incorporated into the same cross-linked structure or used within the same consumable does not establish that the alternatives are members of the same recognized physical, chemical, or art-recognized class. The recited alternatives are directed to distinct categories of materials that provide different functions in the claimed substrate. For example, a flavorant provides flavor, a filler contributes bulk or structural characteristics, and an aerosol-forming agent contributes to aerosol production.
Applicant’s identified common use of generally “modifying the characteristics” of a consumable product is overly broad and does not demonstrate that the alternatives are functionally equivalent or substitutable for one another with the expectation of achieving the same intended result in the claimed aerosol-delivery substrate.
Accordingly, Applicant’s argument is not persuasive, and the rejection of claim 12 as containing an improper Markush grouping is maintained.
Claims 24–27
Applicant argues that the alternatives recited in claim 24, including flavorants, sweeteners, aerosol-forming agents, humectants, fillers, preservatives, tobacco materials, and combinations thereof, share a single structural similarity because they are all components within a consumable product and share the common use of being entrapped within the cross-linked alginate matrix.
This argument is not persuasive for substantially the same reasons discussed above with respect to claim 2.
The recited alternatives are not shown to be members of the same recognized physical, chemical, or art-recognized class and are not shown to be functionally equivalent in the claimed consumable substrate. Although each alternative may be capable of physical incorporation or entrapment within an alginate matrix, the alternatives provide different functional contributions to the resulting consumable product. Applicant has not established that these materially different alternatives are substitutable for one another with the expectation that the same intended result would be achieved in the claimed invention.
Accordingly, Applicant’s argument is not persuasive, and the rejection of claims 24–27 as containing an improper Markush grouping is maintained.
Claim Rejections - 35 USC § 112
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 2-5 and 8-9, 12, 24-27 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of one or more components is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
Claim 2 and 5: The identified alternatives (e.g., flavorants, sweeteners, humectants, fillers, preservatives, tobacco materials, etc.) differ substantially in molecular framework, functional groups, and physical/chemical characteristics. They are not members of a single recognized structural class nor share a core chemical backbone or moiety. Likewise, the claimed “common use” of being included in a consumable product is insufficient—common use must relate to a specific and shared function arising from a common structure, not simply joint inclusion in a composition. Dependent claim 5 is also rejected.
Claim 8: The recited “active ingredients” encompass chemically and functionally diverse species that produce widely different effects. Merely identifying them as “active ingredients” does not render them members of a common structural class. The cited examples lack a shared core structure, ring system, or chemical subclass that would satisfy the requirement for a single structural similarity. Moreover, the “common use” asserted—serving as an active ingredient—represents a general purpose rather than a specific function arising from structural relatedness.
Claim 12: Claim 12 recites alternatives comprising a flavorant, filler, or aerosol-forming agent within a cross-linked alginate substrate. Flavorants (e.g., menthol, vanillin) are small volatile organics; fillers (e.g., cellulose, starch, CaCO₃) are high-MW or inorganic solids; aerosol-forming agents (e.g., glycerol, propylene glycol) are low-MW polar liquids. These materials differ in molecular framework, volatility, and chemical function and thus lack structural relatedness. Functionally, only the aerosol-forming agents participate in aerosol generation; the others serve unrelated purposes (flavor delivery or structural bulk).
Claim 24-27: Claim 24 recites that the component-containing cross-linked alginate structure may include flavorants, sweeteners, aerosol-forming agents, humectants, fillers, preservatives, tobacco materials, and combinations thereof. The recited categories encompass chemically unrelated materials: Flavorants – small aromatic or terpene organics; Sweeteners – carbohydrates or synthetic amides; Aerosol-forming agents – short-chain polyols; Humectants – sugar alcohol solids; Fillers – polymers or inorganic solids; Preservatives – aromatic acids or salts; Tobacco materials – complex plant-derived matrices.
These materials exhibit no shared structural core or art-recognized subclass and therefore fail the single structural similarity requirement. Their functions also differ: aerosol-forming agents vaporize to generate aerosols, while humectants, fillers, sweeteners, preservatives, and tobacco materials serve independent roles that do not involve aerosol formation. Because the alternatives are unrelated in structure and produce distinct effects, the grouping fails both the single structural similarity and common-use criteria of MPEP § 2117 II(A). Dependent claims 25–27 are also rejected.
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.
Claims 1–14 and 20-27 are rejected under 35 U.S.C. § 103 as being unpatentable over Aoun et al. (US 2018/0279666 A1) in view of Jakob et al. (US 5,101,839).
Regarding claim 1, Aoun teaches a method for providing a composition with releasable entrapment of one or more components, wherein the composition is an aerosol-generating material that emits an inhalable aerosol upon heating and is used in a non-combustible heat-not-burn device (Aoun ¶ [0006]).
Aoun teaches mixing the one or more components and alginate in water to give a substantially homogeneous mixture, wherein the substantially homogeneous mixture further comprises a tobacco material in the form of a tobacco extract (water, sodium alginate, glycerol, chalk, and tobacco extract mixed until a smooth, free-flowing slurry is formed) (Aoun ¶ [0104]).
Aoun further teaches removing at least a portion of the water to provide the resulting composition (drying the formed material by air drying or oven drying) (Aoun ¶ [0106]).
Aoun also teaches that the composition is adapted for use as a substrate within a consumable for use with a non-combustible aerosol delivery device because Aoun discloses a heat-not-burn device that volatilizes tobacco components by heating while avoiding pyrolysis or combustion to form an inhalable aerosol (Aoun ¶ [0006]).
Aoun does not expressly teach contacting the substantially homogeneous mixture with a divalent or trivalent cation to crosslink the alginate, thereby trapping the one or more components within a cross-linked matrix.
Jakob teaches the missing limitation. Jakob teaches forming an aqueous slurry comprising glycerin, propylene glycol, ammonium alginate, and particulate tobacco material, casting the slurry, and thereafter spraying the cast alginate-containing slurry with an aqueous 1% calcium chloride solution, followed by air drying to provide a relatively stiff sheet (Jakob, col. 18, ll. 27–61). Calcium ions are divalent cations that crosslink alginate. Because the components are already present in the alginate-containing material when calcium chloride is applied, Jakob teaches trapping the components within a resulting calcium-crosslinked alginate matrix.
Aoun and Jakob are in the same field of endeavor because both are directed to tobacco-containing aerosol-forming materials comprising an alginate binder and aerosol-forming polyols for use in articles that provide an inhalable aerosol. Aoun teaches an alginate-containing aerosol-generating material for use in a non-combustible heat-not-burn device, while Jakob teaches calcium treatment of a closely similar alginate-containing, aerosol-forming tobacco material.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Aoun’s alginate-containing, tobacco-extract-containing aerosol-generating material by applying Jakob’s aqueous calcium chloride treatment to crosslink the alginate. One of ordinary skill in the art would have been motivated to make the modification because Jakob teaches that calcium chloride treatment produces a relatively stiff alginate-containing tobacco material, while Aoun teaches that strength and toughness are desirable for processing and utilization of the aerosol-generating material (Aoun ¶ [0052]). The modification would have predictably produced a component-containing, calcium-crosslinked alginate structure suitable for use as an aerosol-generating substrate in Aoun’s non-combustible aerosol delivery device.
Further, Aoun’s discussion of avoiding excessive gelation does not teach away from the proposed modification. Aoun addresses excessive gelation occurring in the slurry before casting due to ions present during slurry preparation (Aoun ¶ [0053]). In the proposed modification, consistent with Jakob, the calcium chloride solution is applied only after Aoun’s slurry has already been cast into a sheet. Thus, the modification avoids interfering with Aoun’s slurry formation and casting process while providing Jakob’s predictable post-casting strengthening effect.
Regarding claim 2, Aoun teaches that the one or more components comprise at least an aerosol-forming agent (glycerol), a filler (chalk), and a tobacco material (tobacco extract) within the aerosol-generating material (Aoun ¶ [0104]).
Regarding claim 3, Aoun teaches that the aerosol-generating material may comprise a flavorant including menthol (a trigeminal sensate and terpenoid alcohol) or peppermint (a terpene-containing flavorant) (Aoun ¶ [0061]). It would have been obvious to include such a known flavorant in Aoun’s aerosol-generating material to impart the desired taste or aroma expressly contemplated by Aoun.
Regarding claim 4, Jakob teaches that the smokable filler material may contain a flavoring agent comprising vanillin, which is one of the recited flavorants (Jakob, col. 7, ll. 11–17). It would have been obvious to incorporate Jakob’s known vanillin flavorant into Aoun’s aerosol-generating material because Aoun expressly contemplates inclusion of flavorants to provide desired sensory characteristics.
Regarding claim 5, Aoun teaches that the flavorant may comprise menthol or peppermint, each of which is expressly recited in claim 5 (Aoun ¶ [0061]).
Regarding claim 6, Aoun teaches that the one or more components comprise a plant extract because Aoun’s tobacco extract is produced by treating tobacco with water and separating the resulting water-based liquid extract from the tobacco feedstock (Aoun ¶ [0033]).
Regarding claim 7, Aoun teaches that the plant extract is a tobacco extract (tobacco extract incorporated into the smooth, free-flowing alginate-containing slurry) (Aoun ¶ [0104]).
Regarding claim 8, Aoun teaches that the one or more components comprise an active ingredient selected from a nicotine component because the tobacco extract used in the aerosol-generating material expressly contains nicotine (Aoun ¶ [0101]).
Regarding claim 9, Aoun teaches that the aerosol-generating material may include peppermint, which is a botanical/herbal ingredient expressly recited in claim 9 (Aoun ¶ [0061]).
Regarding claim 10, Aoun teaches that the one or more components comprise an aerosol-forming agent (glycerol or propylene glycol) (Aoun ¶ [0046]).
Regarding claim 11, Aoun teaches that the aerosol-forming agent is glycerol, which is expressly recited in claim 11 (Aoun ¶ [0046]).
Regarding claim 12, Aoun in view of Jakob teaches the method of claim 21 as set forth below. Aoun further teaches that the one or more components comprise a filler (chalk) and an aerosol-forming agent (glycerol) in the alginate-containing, tobacco-extract-containing aerosol-generating material (Aoun ¶ [0104]).
Regarding claim 13, Jakob teaches that the divalent or trivalent cation comprises calcium ions (aqueous calcium chloride solution applied to the alginate-containing material) (Jakob, col. 18, ll. 53–61).
Regarding claim 14, Aoun in view of Jakob teaches the method of claim 1 as set forth above. Jakob further teaches that the contacting step comprises depositing the substantially homogeneous mixture into a solution comprising the divalent or trivalent cation (extruding an aqueous slurry of components of a smokable material and an alginate binding agent into an aqueous solution of calcium ions, such as aqueous calcium chloride, and thereafter collecting and drying the resulting material) (Jakob, col. 11, ll. 28–38).
It would have been obvious to one of ordinary skill in the art to employ Jakob’s calcium-ion solution deposition technique in forming Aoun’s alginate-containing aerosol-generating material because Aoun expressly contemplates forming its slurry by extrusion, and Jakob teaches that extrusion of an alginate-containing aerosol-forming tobacco material into calcium chloride solution provides ionic crosslinking of the alginate in the formed material.
Regarding claim 16, Aoun teaches a method for providing a composition with releasable entrapment of one or more components in a component-containing alginate structure, comprising mixing one or more components and alginate in water to form a substantially homogeneous mixture (water, glycerol, tobacco extract, and sodium alginate mixed until a smooth, free-flowing slurry is formed) (Aoun ¶ [0104]), wherein the one or more components comprise an aerosol-forming material (glycerol) and a tobacco material (tobacco extract).
Aoun further teaches casting a sheet of the substantially homogeneous mixture and removing at least a portion of the water (casting the smooth slurry onto a stainless-steel casting plate at 2 mm thickness and drying the cast sheet by air drying or oven drying) (Aoun ¶ [0106]).
Aoun also teaches that the resulting composition is adapted for use as a substrate within a consumable for use with a non-combustible aerosol delivery device because Aoun’s aerosol-generating material is intended for incorporation into a device in which the material is heated to emit an inhalable aerosol (Aoun ¶ [0026]), and Aoun identifies the applicable heat-not-burn devices as non-combustion type smoking articles that volatilize tobacco components by heating while avoiding pyrolysis or combustion (Aoun ¶ [0006]).
Aoun does not expressly teach contacting the cast sheet with a solution comprising divalent or trivalent cations to crosslink the alginate, thereby trapping the one or more components within a cross-linked matrix.
Jakob teaches this limitation. Specifically, Jakob teaches an aqueous slurry comprising glycerin, propylene glycol, tobacco laminae, and ammonium alginate (Jakob, col. 18, ll. 25–53), wherein the resulting slurry is cast as a sheet and thereafter contacted with a solution comprising divalent cations (the slurry is cast to about 0.03 inch thickness and an aqueous 1% calcium chloride solution is sprayed onto the cast slurry) (Jakob, col. 18, ll. 54–59). Calcium chloride provides calcium ions, which are divalent cations that crosslink the alginate present in the cast sheet. Jakob further teaches drying the calcium-treated sheet to provide a relatively stiff sheet (Jakob, col. 18, ll. 59–61).
Aoun and Jakob are in the same field of endeavor because both are directed to tobacco-containing sheet materials comprising an alginate binder and aerosol-forming polyols for use in smoking or aerosol-generating articles. Aoun teaches a cast alginate-containing aerosol-generating sheet suitable for use in a non-combustible heat-not-burn device, while Jakob teaches the post-casting calcium chloride treatment of a closely similar alginate-containing, aerosol-forming tobacco sheet.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Aoun’s cast alginate-containing aerosol-generating sheet by applying Jakob’s aqueous calcium chloride solution to the cast sheet after casting. One of ordinary skill in the art would have been motivated to make the modification because Jakob teaches that the post-casting calcium chloride treatment provides a relatively stiff sheet, thereby predictably improving the handling and downstream processability of Aoun’s cast aerosol-generating sheet. Aoun itself recognizes that strength is desirable for subsequent processing and utilization of the aerosol-generating material (Aoun ¶ [0041]).
Further, Aoun’s discussion of avoiding excessive gelation does not teach away from the proposed modification. Aoun addresses excessive gelation occurring in the slurry before casting due to ions present during slurry preparation (Aoun ¶ [0053]). In the proposed modification, consistent with Jakob, the calcium chloride solution is applied only after Aoun’s slurry has already been cast into a sheet. Thus, the modification avoids interfering with Aoun’s slurry formation and casting process while providing Jakob’s predictable post-casting strengthening effect.
Regarding claim 17, Aoun in view of Jakob teaches the method of claim 16 as set forth above. Jakob further teaches cutting or shredding the component-containing, cross-linked alginate structure (after the cast alginate-containing sheet is sprayed with aqueous calcium chloride solution and air dried to provide a relatively stiff sheet, the resulting sheet is shredded at about 32 cuts per inch to provide a smokable filler material) (Jakob, col. 18, ll. 60–61).
Regarding claim 20, Aoun in view of Jakob teaches the method of claim 1 as set forth above. Jakob further teaches that the component-containing, cross-linked alginate structure is in the form of a sheet (the alginate-containing tobacco slurry is cast as a sheet, treated with aqueous calcium chloride solution, and dried to provide a relatively stiff calcium-treated sheet) (Jakob, col. 18, ll. 53–61).
Regarding claim 21, Aoun in view of Jakob teaches the method of claim 1 as set forth above. Aoun further teaches incorporating the component-containing aerosol-generating material within the consumable (the formed aerosol-generating material may be processed before being formed into suitable consumables and incorporated into devices of the disclosure) (Aoun ¶ [0095]).
In the proposed combination, the aerosol-generating material formed into Aoun’s suitable consumable is modified according to Jakob to comprise the component-containing, calcium-crosslinked alginate structure.
Regarding claim 22, Aoun in view of Jakob teaches the method of claim 21 as set forth above. Aoun further teaches that the consumable product is configured for non-combustible aerosol delivery (a heat-not-burn device that volatilizes tobacco components by heating while avoiding pyrolysis or combustion, such that the volatilized components condense to form an inhalable aerosol) (Aoun ¶ [0006]).
Regarding claim 23, Aoun teaches an aerosol-generating material comprising one or more components substantially homogeneously contained within an alginate-containing structure, wherein the structure further comprises a tobacco material in the form of a tobacco extract (water, sodium alginate, glycerol, chalk, and tobacco extract mixed until a smooth, free-flowing slurry is formed and thereafter cast and dried as an aerosol-generating sheet) (Aoun ¶ [0104]).
Aoun further teaches that the structure is adapted for use as a substrate within a consumable for use with a non-combustible aerosol delivery device (a heat-not-burn device that heats tobacco material without combustion to form an inhalable aerosol) (Aoun ¶ [0006]).
Aoun does not expressly teach that the alginate-containing structure is a cross-linked alginate structure.
Jakob teaches this limitation. Jakob teaches an alginate-containing tobacco sheet comprising glycerin, propylene glycol, tobacco material, and ammonium alginate, wherein the cast sheet is sprayed with aqueous 1% calcium chloride solution and thereafter dried to provide a relatively stiff sheet (Jakob, col. 18, ll. 53–61). Calcium ions are divalent cations that crosslink the alginate, thereby retaining the components within the resulting cross-linked alginate matrix.
Aoun and Jakob are in the same field of endeavor because both are directed to tobacco-containing sheet materials comprising alginate binder and aerosol-forming polyols for use in smoking or aerosol-generating articles.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Aoun’s alginate-containing, tobacco-extract-containing aerosol-generating sheet by applying Jakob’s post-casting calcium chloride treatment. One of ordinary skill in the art would have been motivated to make the modification because Jakob teaches that the treatment provides a relatively stiff sheet, thereby predictably improving the handling and downstream processability of Aoun’s aerosol-generating sheet.
Regarding claim 24, Aoun in view of Jakob teaches the component-containing, cross-linked alginate structure of claim 23 as set forth above. Aoun further teaches that the one or more components comprise an aerosol-forming agent (glycerol), a filler (chalk), and a tobacco material (tobacco extract) (Aoun ¶ [0104]).
Regarding claim 25, Aoun in view of Jakob teaches the component-containing, cross-linked alginate structure of claim 23 as set forth above. Aoun further teaches an aerosol delivery product comprising the aerosol-generating material (the formed aerosol-generating material may be formed into suitable consumables and incorporated into devices of the disclosure) (Aoun ¶ [0095]).
In the proposed combination, the aerosol-generating material incorporated into Aoun’s aerosol delivery product comprises the calcium-crosslinked alginate structure resulting from Jakob’s post-casting calcium chloride treatment.
Regarding claim 26, Aoun in view of Jakob teaches the component-containing, cross-linked alginate structure of claim 24 as set forth above. Aoun further teaches an aerosol-generating component comprising a substrate carrying at least one aerosol-forming material (an aerosol-generating sheet comprising glycerol as an aerosol-generating agent and sodium alginate as binder) (Aoun ¶ [0104]).
In the proposed combination, Aoun’s aerosol-generating sheet is modified according to Jakob by applying aqueous calcium chloride after formation of the alginate-containing material, such that the substrate comprises the component-containing, cross-linked alginate structure of claim 24.
Regarding claim 27, Aoun in view of Jakob teaches the aerosol generating component of claim 26 as set forth above.
Aoun further teaches a heat source configured to heat the substrate carrying the one or more aerosol forming materials to form an aerosol (a device comprising the aerosol-generating material and a heating means that volatilizes components of the aerosol-generating material in use to form an aerosol, wherein the heating means may be an electrically resistive heating element) (Aoun ¶ [0070]).
Aoun does not expressly disclose an aerosol pathway extending from the aerosol generating component to a mouth-end of the aerosol delivery device.
However, Aoun teaches that the device is a heat-not-burn tobacco heating product that provides an inhalable aerosol and may provide multiple deliveries or puffs of aerosol to a user (Aoun ¶ [0073]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Aoun’s aerosol delivery device with an aerosol pathway extending from the aerosol-generating component to a mouth-end of the device. One of ordinary skill in the art would have been motivated to provide such a pathway because Aoun expressly teaches delivering generated inhalable aerosol in the form of puffs to a user, and an aerosol pathway from the heated aerosol-generating component to a mouth-end would provide the ordinary and predictable structure for conveying that generated aerosol to the user for inhalation. The modification would merely implement Aoun’s expressly disclosed puff-based delivery of inhalable aerosol according to its expected use in a heat-not-burn tobacco heating product.
Claims 18 and 19 are rejected under 35 U.S.C. § 103 as being unpatentable over Aoun et al. (US 2018/0279666 A1) in view of Jakob et al. (US 5,101,839), as applied to claim 1 above, and further in view of Karles et al. (US 2011/0232657 A1).
Regarding claim 18, Aoun in view of Jakob teaches the method of claim 1 as set forth above. Aoun in view of Jakob does not expressly teach that the contacting step comprises bringing the substantially homogeneous mixture into contact with an outer surface of a pre-formed structure, wherein the pre-formed structure comprises the divalent or trivalent cation.
Karles teaches the missing contacting arrangement. Specifically, Karles teaches that dried, pre-formed tobacco beads are contacted with a 5 wt % calcium chloride aqueous solution and are thereafter contacted with a sodium alginate solution, whereby a thin layer of calcium alginate is formed on the surface of the tobacco beads (Karles ¶ [0084]). Thus, Karles teaches bringing an alginate-containing mixture into contact with an outer surface of a pre-formed structure (the dried tobacco bead), wherein the pre-formed structure comprises a divalent cation (the calcium-treated tobacco bead), to form a cross-linked alginate matrix on the outer surface thereof.
Karles further teaches that the alginate solution may include additives, such as flavorants, which are entrapped in the alginate matrix during formation of the coating layer (Karles ¶ [0057]). Thus, Karles expressly contemplates a component-containing alginate coating mixture, rather than merely an alginate coating lacking entrapped components.
Karles is analogous art because Aoun, Jakob, and Karles are directed to component-containing tobacco compositions having releasable components for use in smoking or aerosol-delivery products. More specifically, Aoun teaches an alginate-containing, tobacco-extract-containing aerosol-generating composition for a non-combustible aerosol delivery device; Jakob teaches calcium crosslinking of an alginate-containing tobacco composition; and Karles teaches a known calcium-induced alginate crosslinking arrangement in which an alginate coating is formed on the outer surface of a calcium-treated, pre-formed tobacco bead.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Aoun in view of Jakob by bringing Aoun’s component-containing alginate mixture into contact with the outer surface of a calcium-treated, pre-formed tobacco bead according to Karles. One of ordinary skill in the art would have been motivated to make the modification because Karles teaches that the calcium-crosslinked alginate coating provides controlled release of components from the tobacco bead, while Aoun’s alginate composition is intended to provide releasable tobacco-derived components in an aerosol-generating consumable. The modification would have predictably provided Aoun’s component-containing, cross-linked alginate structure in Karles’s known coated-bead form for use as a substrate within Aoun’s non-combustible aerosol delivery consumable.
Regarding claim 19, Aoun in view of Jakob and further in view of Karles teaches the method of claim 18 as set forth above. Karles further teaches that the pre-formed structure is a bead and the substantially homogeneous mixture is in the form of a coating on the outer surface of the bead (dried tobacco beads are contacted with aqueous calcium chloride solution and thereafter contacted with sodium alginate solution such that a thin layer of calcium alginate is formed on the outer surface of the tobacco beads) (Karles ¶ [0084]).
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.
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/JENNIFER A KESSIE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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