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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12 June 2026 has been entered.
Status of the Claims
Claims 1-3, 5-6, 8-9, 11-12, 14-15, 17-21, 23, 27, 30, and 32-33 are pending and are subject to this Office Action. Claim 1 has been amended. Claim 33 has been added. Claim 27 has been withdrawn from consideration.
Response to Arguments
Applicant’s arguments, pages 8-12, filed 16 March 20265, with respect to claims 1-3, 5-6, 8-9, 11-12, 14-15, 17-21, 23, 27, and 30 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of previously applied prior art and newly found prior art.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5-6, 8-9, 11-12, 14-15, 23, 30, 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Batista, et al (WO2021053029A1) and in further view of Mishra, et al (US20160120225A1) and Deforel, et al (WO2020074535A1)
Regarding claim 1, Batista teaches an aerosol generating article containing two layers, a first aerosol forming substrate layer and a second aerosol forming substrate layer where the first layer is a gel layer. (p1 ln 30-34) . Batista teaches that the first aerosol forming substrate layer may be a gel layer and the second aerosol forming substrate layer may be a gel layer. (p4 8-9)The art teaches that the gel may comprise an aerosol former and a gelling agent (p4 ln 19-21) and that the gel may comprise nicotine or a tobacco product or another target compound. (p4 ln 35-36) Batista teaches that the gel can contain various “active” materials bit does not preclude the gel from containing none of these materials either. The prior art teaches the aerosol-forming substrate of the first tubular aerosol-forming substrate layer may be different from the aerosol-forming substrate of the second tubular aerosol-forming substrate layer. (p 6 ln 11-14)
Batista goes on to teach the gel layer may be a tobacco free layer. (p 4 ln 15)
Batista teaches a composition for the gel, teaching that the gel is a thermoreversible gel comprised of an aerosol former and a gelling agent. (p4 ln 19-22) The prior art teaches specific examples of this composition where the composition is:
0.5 to 5% by weight Agar (gelling agent),
0.1 and 2% by weight nicotine, and
30% to 90% by weight glycerin (aerosol former), and the remainder being water and flavorings. (p 5 ln 5-9)
However, Batista is silent with respect to a general gel composition as well as the area density and tensile strength of the sheets that would be used to form the aerosol generating substrates.
Mishra, directed to gel formulations for vaping devices, teaches a gel formulation for a vaping device that includes a vapor former (aerosol former), a biopolymer (gelling agent), and water. (Abstract) The prior art teaches a similar gel formulation to that of Batista’s exemplary formulas; where the gel formulation is comprised of a
vapor former in the amount of about 40% to about 90% ([0009], [0080])
the biopolymer in the amount of about 0.01% to 2%. ([0007], [0083])
and water
with the possible inclusion of flavor [0012], nicotine (active) [0013-0014], and acids [0014] The claimed range overlaps the range disclosed by the prior art and is therefore considered prima facie obvious. See MPEP 2144.05
Mishra teaches that the vapor former (aerosol former) can include propylene glycol, glycerin, 1,3-propanediol, and combinations thereof [0016] and that the biopolymer (gelling agent) can be one or more of agar, kappa carrageenan, gelatin, sodium alginate, gellan gum, pectin, and combinations thereof. [0021]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Batista and Deforel by using the formulation for aerosol generating material lacking the active, flavor, and acid as taught by Mishra because Batista, Deforel, and Mishra are directed to aerosol generating materials, Mishra teaches this composition is used to form a vapor when heated ([0007],[0057]), and this involves combining prior art elements according to known methods to yield predictable results.
Neither Batista nor Mishra teach the area density or the tensile strength of the material.
Deforel, directed to the design of aerosol generating substrates, teaches an aerosols generating article comprised of a substrate that can contain a homogenized plant material where the homogenized plant material is between 10 percent and 100 percent by weight clove particles (flavor) and between 0 percent and 90 percent by weight tobacco material. (p 2 ln 14-18) (p 13 ln 20-23) The composition is preferably a gel composition (p 7 ln 10 ) that includes:
binders to agglomerate, i.e. gel, the material in the amount of 1% to 10% (p8 ln 21-22)
aerosol formers in the amount of about 5% to about 30% (p 9 ln 25-26)
and clove particles (flavor) between 0 and 90 percent
Deforel further teaches that nicotine can be incorporated into the gel material. (p 6 ln 18-24) where the amounts are based on the dry weight of the components. (Binder - p 8 ln 22, Aerosol former – p 9 ln 26, and clove particles/ homogenized plant material (p9 ln 27-28)
Deforel teaches that the sheets of material that are formed of the above composition have a grammage (aka area density)of between 100 g/m2 and 300 g/m2 (p 10 ln 9-10) and a tensile strength of 50 N/m to 400 N/m in a cross direction (p 10 ln 22-23) and a tensile strength of 100 N/m to 800 N/m in a machine direction (p10 ln 26-29) described as being the direction the material would travel through the machine and be wound on a bobbin for further processing.
Deforel teaches that nicotine can be incorporated into the gel material. (p 6 ln 18-24)
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Batista and Mishra by using the grammage and/ area density and tensile strength of the gel material as taught by Deforel because Batista, Deforel, and Mishra are directed to aerosol generating materials, Deforel teaches “The provision of a sheet having the levels of thickness, grammage and tensile strength as defined above advantageously optimizes the machinability of the sheet to form the aerosol generating substrate and ensures that damage, such as tearing of the sheet, is avoided during high speed processing of the sheet.” (p 10 ln 32-35), and this involves combining prior art elements according to known methods to yield predictable results.
Regarding claim 3, Batista teaches the first tubular aerosol-forming substrate layer is configured as one or both of a nicotine layer and a flavor layer. (p 6 ln 13-14) Preferably, the second tubular aerosol-forming substrate layer is configured as a primary aerosol-forming layer comprising tobacco and an aerosol former. (p 6 ln 15-16)
Batista teaches that the first tubular substrate layer can include only nicotine in the gel material and the second tubular can include the aerosol former, noting that the tobacco content can be zero as taught above. Batista also teaches “Alternatively, the aerosol-forming substrate may comprise a non-tobacco material. The aerosol-forming substrate may comprise homogenized plant-based material.” (p22 ln 20-23)
Regarding claim 5, as discussed above Batista teaches the first gel material can comprise the active (nicotine) and the second gel material can include the aerosol former material. Batista teaches that the aerosol former can be aliphatic esters of mono-, di- or polycarboxylic acids. (p 22 ln 34) This teaching is considered to read on the second aerosol generating material containing an acid.
Regarding claim 6, as discussed in claim 3 above, Batista envisages a first aerosol generating gel that includes only nicotine and a second aerosol generating gel that includes only the aerosol former.
Regarding claim 8, as discussed in claim 1, Batista teaches the first tubular aerosol-forming substrate layer is configured as one or both of a nicotine layer and a flavor layer. (p 6 ln 13-14) Based on this teaching Batista envisages a composition that does not contain nicotine and only contains a flavoring.
Batista teaches the second tubular aerosol-forming substrate layer is configured as a primary aerosol-forming layer comprising an aerosol former. (p 6 ln 15-16) Batista teaches that the aerosol former can be aliphatic esters of mono-, di- or polycarboxylic acids. (p 22 ln 34) This teaching is considered to read on the second aerosol generating material containing an acid.
Regarding claim 9, as discussed in claim 3, the first aerosol generating material can contain a flavorant and not an active material. and the second aerosol generating material can contain the aerosol former and be free of the flavor and active.
Regarding claim 11, Batista, as modified by Mishra, teaches a gel formulation that is comprised of a biopolymer gelling agent, a vapor former, and water. The formulation only optionally contains flavor, nicotine, and/or an acid. The prior art teaches the gel formulation is comprised of a
vapor former in the amount of about 40% to about 90% ([0009], [0080])
the biopolymer in the amount of about 0.01% to 2%. ([0007], [0083])
and water
with the possible inclusion of flavor [0012], nicotine (active) [0013-0014], and acids [0014] The claimed range overlaps the range disclosed by the prior art and is therefore considered prima facie obvious. See MPEP 2144.05
Thus a person having ordinary skill in the art would recognize that a layer of the material could be free of flavor, nicotine, and/or an acid.
Regarding claim 12, as discussed in claim 1, Batista teaches the aerosol-forming substrate of the first tubular aerosol-forming substrate layer may be different from the aerosol-forming substrate of the second tubular aerosol-forming substrate layer. (p 6 ln 11-14) As discussed above Batista teaches that the first aerosol generating substrate comprise nicotine. Batista discloses a combination where the second tubular aerosol generating element may also comprise an active which may be a nicotine. (p 22 ln 13-14) The prior art teaches a range of possible nicotine content, between 0.1 and 2% by weight nicotine, such that a person having ordinary skill would consider that the first tubular substrate and the second tubular substrate would have different quantities of nicotine.
Regarding claim 14, as discussed in claim 12, Batista teaches the first tubular aerosol-forming substrate layer may be different from the aerosol-forming substrate of the second tubular aerosol-forming substrate layer and that both tubular aerosol-forming substrates may comprise an active which may be a nicotine. The prior art of Batista discloses that the nicotine may be in the range of between 0.1 and 2% by weight.
Batista, as modified by Mishra, teaches an expanded range for possible nicotine content; teaching that he gel formulation could be from about 1% to about 10%. As such, it would be obvious for a person having ordinary skill in the art to select a nicotine level for one aerosol generating substrate and a second aerosol generating aerosol generating material in the range of 0.1 to about 10%. The claimed range overlaps the range disclosed by the prior art and is therefore considered prima facie obvious. See MPEP 2144.05
Regarding claim 15, Batista teaches gel may comprise nicotine or a tobacco product or another target compound for delivery to a user. (p4 ln 35-36) Batista teaches a possible configuration where the first aerosol component is a gel layer and the second aerosol component is also a gel layer. Mishra teaches a list of possible flavors that could be incorporated into the aerosol generating gel. [0012] It would be reasonable to conclude that the first aerosol generating material could contain one of the flavors taught by Mishra and the second aerosol generating material could contain a different flavor than the first.
Regarding claim 23, Mishra teaches a list of possible acids that can be used in conjunction with the aerosol generating gel material which include both lactic and benzoic acid. ([0014], [0085])
Regarding claim 30, Deforel teaches that the binder/ gelling agent may be or include cellulosic binders such as, for example, hydroxypropyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, methyl cellulose and ethyl cellulose (p 8 ln 17-18) which may contain between 1 weight percent and 10 weight percent of reinforcement fibers on a dry weight basis. (p8 ln 21-22)
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Batista and Mishra by using reinforcement fibers in the amount as taught by Deforel because Batista, Deforel, and Mishra are directed to aerosol generating materials, Deforel teaches cellulose material, such as the ones noted above, are known suitable binders (p 8 ln 14-16), and this involves combining prior art elements according to known methods to yield predictable results.
Regarding claim 32, Batista teaches the list of possible binders that can be used in the composition that includes known setting agents such as alginates and starches. (p 4 ln 21 and 30) Batista teaches that the binder would be present in the quantity of 0.5 percent to 5 percent. (p 5 ln 5-6) Additionally, Deforel also teaches a list of binders that can be used to form the gel composition. These binders includes starches and sodium-alginate. Deforel teaches that the binder material would be present in the composition from about 1 percent to about 10 percent. (p 8 ln 14-24) The claimed range overlaps the range disclosed by the prior art and is therefore considered prima facie obvious. See MPEP 2144.05 A person having ordinary skill in the art would recognize that alginates and/or starches can be used as setting agents; as such, the use of these binders in the composition would read on the limitation of a setting agent in the homogenized tobacco material.
Regarding claim 33, Batista teaches the first tubular aerosol-forming substrate layer may be different from the aerosol-forming substrate of the second tubular aerosol-forming substrate layer and that both tubular aerosol-forming substrates may comprise an active which may be a nicotine. The prior art of Batista discloses that the nicotine may be in the range of between 0.1 and 2% by weight.
Batista, as modified by Mishra, teaches an expanded range for possible nicotine content; teaching that he gel formulation could be from about 1% to about 10%. As such, it would be obvious for a person having ordinary skill in the art to select a nicotine level for one aerosol generating substrate and a second aerosol generating aerosol generating material in the range of 0.1 to about 10%. The claimed range overlaps the range disclosed by the prior art and is therefore considered prima facie obvious. See MPEP 2144.05
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Batista, et al (WO2021053029A1) and in further view of Mishra, et al (US20160120225A1) and Deforel, et al (WO2020074535A1), as applied to claim 1, and further in view of Batista, et al (WO2020020748A1, hereinafter referred to as Batista ‘748)
Regarding claims 17 and 18, the prior art is silent with respect to the use of a support attached to the first and second material.
Batista ‘748, directed to the design of an aerosol generating article, teaches an aerosol generating article that is comprised of an aerosol forming substrate that is comprised of a metallic element that extend along the length of the article (p15 ln 12-14) and has two, three, or more regions of aerosol generating substrate material (p15 ln 23-25) and hat the aerosol substrate material may be any suitable aerosol generating material or mix of material. (p 15 ln 31-32)
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Batista, Mishra, and Deforel by adding a support structure as taught by Batista ‘748 because Batista, Deforel, and Mishra, and Batista ‘748 are directed to aerosol generating materials, Batista ‘748 teaches this configuration where the heating structure is the support allows the aerosol to be more readily formed ((p2 ln 27-29), and this involves use of known technique to improve similar products in the same way.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Batista, et al (WO2021053029A1) and in further view of Mishra, et al (US20160120225A1) and Deforel, et al (WO2020074535A1), as applied to claim 1, and further in view of Sutton, et al (US20180338520A1)
Regarding claim 19, the prior art is silent with respect to the use of more than two aerosol forming substrates.
Sutton , directed to aerosol generating articles teaches an aerosol generating article that comprises smokable materials and an aerosol generating material layer. Sutton teaches an aerosol generating article that includes:
An outer layer of a first smokable material that surrounds a layer of an aerosol generating material [0092-0093]
An inner layer of a second body of smokable material that has a different composition than the chemical composition of the first smokable material. [0097]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Batista, Mishra, and Deforel by adding a third layer of aerosol generating material as taught by Sutton because Batista, Mishra, Deforel, and Sutton are directed to aerosol generating materials, Sutton teaches that similar to the teachings of Batista, Sutton teaches the configuration of layers allows the smokable material to heat and volatize at different temperatures and times [0098], and this involves combining prior art elements according to known methods to yield predictable results.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Batista, et al (WO2021053029A1) and in further view of Mishra, et al (US20160120225A1) and Deforel, et al (WO2020074535A1), and Sutton, et al (US20180338520A1), as applied to claim 1, and further in view of Leah, et al (WO2019215213A1)
Regarding claims 2, Batista teaches that the first tubular aerosol generating substrate may be the nicotine containing layer (p2 ln15) and the second tubular aerosol generating substrate may also be a gel layer (p4 ln 8-9) and that flavor compounds may be carried in a gel. (p5 ln 1-2)
However the prior art is silent with respect to the specific configuration where the first aerosol generating material would contain the active material and the second would contain the flavor material.
Leah, directed to the design of aerosol devices with plurality of aerosolisable materials teaches the a device that uses a plurality of aerosol generating compositions. (p4 ln 23-25) The prior art of Leah also notes that the first aerosolisable gel may be a nicotine containing material (p8 ln 27-28), similar to the teachings of Batista and Mishra. Leah teaches the device contains multiple consumables and provides an example where the first consumable contains a gel that produces an aerosol from a tobacco (active containing) gel, the second consumable and additional gels (2, 3, 4, 5, etc.) contain aerosolisable flavourant gels for mixing with the aerosol produced by the first consumable. (p8 ln 4-7)
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Batista, Mishra, and Deforel by adding additional gel aerosol generating material components as taught by Leah because Batista, Mishra, Deforel, Sutton, and Leah are directed to aerosol generating materials, Leah teaches the ability to add and configure different aerosol generating components allows for an enhanced experience (p1 ln 25), and this involves combining prior art elements according to known methods to yield predictable results.
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Batista, et al (WO2021053029A1) and in further view of Mishra, et al (US20160120225A1) and Deforel, et al (WO2020074535A1), and Sutton, et al (US20180338520A1), as applied to claim 19, and further in view of Leah, et al (WO2019215213A1)
Regarding claim 20, the prior art of Batista, Mishra, and Sutton, are silent as to the use of more than three layer of aerosol generating material .
Leah, directed to the design of aerosol devices with plurality of aerosolisable materials teaches the a device that uses a plurality of aerosol generating compositions. (p4 ln 23-25) Leah teaches the device contains multiple consumables and provides an example where the first consumable contains a gel that produces an aerosol from a tobacco (active containing) gel, the second consumable and additional gels (2, 3, 4, 5, etc.) contain aerosolisable flavourant gels for mixing with the aerosol produced by the first consumable. (p8 ln 4-7)
Leah further teaches that the first aerosolisable gel may be a nicotine containing material (p8 ln 27-28), similar to the teachings of Batista and Mishra. Leah teaches that the further materials, i.e. third, fourth, etc.,, can be a material which imparts or modifies a property of the aerosol by changing the flavor, organoleptic properties, or pH of the aerosol. (p9 1ln 2-27)
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Batista, Mishra, and Deforel by adding additional gel aerosol generating material components as taught by Leah because Batista, Mishra, Deforel, Sutton, and Leah are directed to aerosol generating materials, Leah teaches the ability to add and configure different aerosol generating components allows for an enhanced experience (p1 ln 25), and this involves combining prior art elements according to known methods to yield predictable results.
Regarding claim 21, the prior art as modified by Leah teaches the first component containing a gel that contains the active substance and the second aerosol generating component that contain aerosolisable flavourant gels for mixing with the aerosol produced by the first consumable. (p8 ln 4-7) Leah teaches a specific example where the first aerosolisible material can be a nicotine containing material (p8 ln 27-28) and the second aerosolisible material is a flavourant material. (p8-9 ln 32-2)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VIRGINIA R BIEGER whose telephone number is (703)756-1014. The examiner can normally be reached M-Th: 7:30-4:30.
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/V.R.B./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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