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 .
Status of the Claims
Claims 1-4, 7-14, 16-17, and 19-20 are pending and are subject to this Office Action. Claims 1, 12, 16, and 20 are amended. Claims 5-6, 15, and 18 are cancelled.
Response to Amendments
The amendments to the claims filed on March 3, 2026 are acknowledged.
Response to Arguments
Applicant's arguments, see pgs 6-8, filed March 3, 2026, with respect to the rejection(s) of claims 1-4, 7-14, 16-17, and 19-20 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
On pg. 5-7, Applicant argues that the none of the references disclose, teach, or suggest a solid nicotine-containing material that is porous. Examiner respectfully disagrees with the argument because Li discloses that the solid nicotine containing material is tobacco (Li, [0071]-[0077]), and tobacco is a porous air-permeable material as would be known to one of ordinary skill in the art (see Mironov, US 2015/0342254 A1, [0033]). Additionally, Li states that the tobacco material may be volume expanded or puffed tobacco (Li, [0075]), which would increase the porosity of the tobacco material. Therefore, the invention disclosed by Li in view of Bell and Atkins reads on the new limitation of amended claims 1, 12, 16, and 20.
The following is a modified rejection based on amendments made to the claims.
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 1-4, 7-14, 16-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2018/0007966 A1, cited on the IDS dated 9/12/2022) in view of Bell (US 2016/0205992 A1, cited on the IDS dated 9/12/2022) and Atkins (US 2020/0022417 A1), as evidenced by Olsson (US 2017/0052160 A1).
Regarding Claim 1, Li, directed to non-combustible vaping devices ([0001]), teaches an aerosol generating assembly ([0004], [0040], [0042], Figs. 1A-1C; E-vaping device 60 comprises a replaceable pre-vapor formulation tank section 70, a reusable power supply section 72, and a flavor insert 80. Pre-vapor formulation tank section 70 may include a pre-vapor formulation tank 22. The e-vaping device 60 is configured to heat a pre-vapor formulation housed within pre-vapor formulation tank 22 to generate a vapor (aerosol), and therefore, e-vaping device 60 is an aerosol-generating assembly) comprising:
a solid, nicotine-containing material, wherein the solid, nicotine-containing material is porous ([0040], [0071]-[0072], [0075]-[0077], Figs. 1A-1C; E-vaping device 60 comprises a flavor insert 80. Flavor insert 80 may be a tobacco rod 80 that holds a flavor material 85 that is one or more types of tobacco. Tobacco is a porous solid, nicotine-containing material. The tobacco can be a volume expanded or puffed tobacco);
an aerosolizable liquid comprising an acid ([0040], [0042], [0047]-[0050], Figs. 1A-1C; E-vaping device 60 comprises a replaceable pre-vapor formulation tank section 70, which may include a pre-vapor formulation tank 22. Pre-vapor formulation tank 22 includes a pre-vapor formulation reservoir 23 housing a pre-vapor formulation. [0070], Heating element 34 vaporizes the pre-vapor formulation to generate a vapor/aerosol 95. [0101], Pre-vapor formulation may be a liquid. [0104], The pre-vapor formulation may include one or more acids); and
wherein the assembly is configured to heat the aerosolizable liquid to form a vapor and/or an aerosol ([0054], [0070], Figs. 1A-1C; E-vaping device 60 comprises a heating element 34. Heating element 34 heats and vaporizes the pre-vapor formulation (aerosolizable liquid) to generate a vapor/aerosol 95),
wherein the vapor/aerosol is contacted with the solid, nicotine-containing material to entrain one or more components thereof, and thus forming an inhalable medium ([0077]-[0078], Figs. 1A-1C; The generated vapor 95 is directed through channel 28 and through flavor insert/tobacco rod 80 to entrain at least one flavorant compound to form a flavored vapor 97 for inhalation by a user),
but does not teach the assembly i) wherein the solid, nicotine-containing material has a pH of at least 7, ii) wherein the aerosolizable liquid has a pH of at least 2 and less than 7 to improve the taste of an inhalable medium, wherein the acid is in an amount up to 5% by weight, wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa, and iii) wherein the difference between the pH of the solid nicotine-containing material and the pH of the aerosolizable liquid is of from 3.0 to 5.5 to provide a higher amount of nicotine delivery.
With respect to i), Bell, directed to non-combustible vaping devices ([0002]-[0003], [0029], A smokeless inhalation device is a vaping device. The treated tobacco taught by Bell is for use in a heat-not-burn device, which is a non-combustible vaping device), teaches an aerosol generating assembly ([0049]-[0051], Fig. 10; The treated tobacco material is used in smokeless inhalation device 10. Device 10 is configured to heat the treated tobacco material to generate an aerosol from the volatilized components of the treated tobacco. Therefore, device 10 and the treated tobacco material form an aerosol generating assembly) comprising:
a solid, nicotine-containing material having a pH of at least 7 ([0028]-[0037], The tobacco material is treated to increase its pH to a basic pH of 8.5-12. Tobacco is a solid, nicotine-containing material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the solid, nicotine-containing material taught by Li having a pH of at least 7 as taught by Bell because Li and Bell are directed to non-combustible vaping devices, Li states that the vapor/aerosol generated by heating the aerosolizable liquid is at an elevated temperature relative to the solid, nicotine-containing material such that volatile compounds in the solid, nicotine-containing material are released into the vapor/aerosol (Li, [0077]-[0078]), Li states that the solid, nicotine-containing material is tobacco (Li, [0075]-[0076]), Bell demonstrates that providing a solid, nicotine-containing material such as tobacco with a pH of at least 7 enhances the release of nicotine and tobacco flavor compounds at lower temperatures (Bell, [0029]-[0031]), and the teaching in Bell would have motivated one of ordinary skill in the art to provide the solid, nicotine-containing material having a pH of at least 7.
Li in view of Bell does not teach the assembly ii) wherein the aerosolizable liquid has a pH of at least 2 and less than 7 to improve the taste of an inhalable medium, wherein the acid is in an amount up to 5% by weight, wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa, and iii) wherein the difference between the pH of the solid nicotine-containing material and the pH of the aerosolizable liquid is of from 3.0 to 5.5 to provide a higher amount of nicotine delivery.
With respect to ii), Atkins, directed to non-combustible vaping devices ([0002]-[0003], The vaporizer device taught by Atkins is configured to deliver a vapor for inhalation by a user within combusting tobacco or other substances), teaches an aerosol generating assembly ([0002], [0055]-[0056], Figs. 1A-1F; Vaporizer 100 (aerosol generating assembly) is configured to heat a vaporizable material to generate an inhalable aerosol. Therefore, vaporizer 100 and the vaporizable material form an aerosol generating assembly) comprising:
an aerosolizable liquid comprising an acid, and having a pH of at least 2 and less than 7 ([0002], [0055]-[0056], [0068], Figs. 1A-1F; Vaporizer 100 comprises a vaporizer cartridge 120. Vaporizer cartridge 120 includes a reservoir 140 for containing a liquid vaporizable material. Atomizer 141 supplies heat to the liquid vaporizable material to generate an aerosol. [0135], The liquid vaporizable material may be a nicotine liquid formulation comprising nicotine and an acid. [0160], The pH of the nicotine liquid formulation may be from 2.5 to 6.5); and
wherein the acid is in an amount up to 5% by weight ([0184], the concentration of organic acid in the nicotine liquid formulation is from about 0.5% to about 25%, wherein the concentration is of organic acid weight to total solution weight, i.e. (w/w)),
wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa ([0156], [0169]-[0173], The acid may be lactic acid. Lactic acid has a vapor pressure at 25 °C of 0.01499 mm Hg (1.999 Pa); see Olsson, [0056]),
wherein the assembly is configured to heat the aerosolizable liquid to form a vapor and/or an aerosol ([0002], [0055]-[0056], [0068], Figs. 1A-1F; Vaporizer 100 (assembly) is configured to heat the liquid vaporizable material (aerosolizable liquid) to form a vapor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the aerosolizable liquid taught by Li with the aerosolizable liquid taught by Atkins such that the aerosolizable liquid comprises an acid and has a pH of at least 2 and less than 7, wherein the acid is in an amount up to 5% by weight, wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa, because Li and Atkins are directed to non-combustible vaping devices, Li states that the aerosolizable liquid may comprise nicotine and organic acids such as lactic acid, formic acid, oxalic acid, glycolic acid, or acetic acid (Li, [0103]-[0104]), Atkins teaches an aerosolizable liquid similarly comprising nicotine and organic acids such as lactic acid, formic acid, oxalic acid, glycolic acid, or acetic acid (Atkins, [0168]-[0173]), Atkins demonstrates the providing an acidic aerosolizable liquid with a pH of between 2.5 and 6.5 causes an increased nicotine-related biological effect (e.g. a faster rise in heart rate) in the user relative to the absence of the acid (Atkins, [0160]), and this involves replacing one aerosolizable liquid with another to yield predictable results.
The range for the amount of acid disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
With respect to iii), As Li has been modified in view of Bell and Atkins such that the solid, nicotine-containing material has a pH of 8.5-12 (Bell, [0028]-[0037]) and the aerosolizable liquid has a pH of 2.5 to 6.5 (Atkins, [0160]), wherein the difference between the pH of the solid nicotine containing material and the pH of the aerosolizable liquid is of from 2.0 to 9.5. The range for the pH difference between the solid, nicotine-containing material and the aerosolizable liquid disclosed by the prior art overlaps the claimed range of 3.0 to 5.5, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
The limitations: “wherein the aerosolizable liquid has a pH of at least 2 and less than 7 to improve the taste of an inhalable medium, wherein the difference between the pH of the solid nicotine-containing material and the pH of the aerosolizable liquid is of from 3.0 to 5.5 to provide a higher amount of nicotine delivery” appear to be intended results relating to the specific characteristics of the aerosolizable liquid and the pH difference between the liquid and the solid. Because Li in view of Bell and Atkins discloses all of the positively recited elements of the aerosol generating assembly of Claim 1, an improved taste of the inhalable medium would be an inherent result of the aerosolizable liquid comprising an acid having a pH of at least 2 and less than 7, and a higher amount of nicotine delivery would be an inherent result of the difference between the pH of the solid-nicotine containing material and the pH of the aerosolizable liquid being of from 3.0 to 5.5.
Regarding Claim 2, Li in view of Bell and Atkins teaches an aerosol generating assembly according to claim 1. Li further teaches the aerosol generating assembly wherein the solid, nicotine-containing material comprises a tobacco material ([0040], [0071]-[0072], [0075]-[0077], Figs. 1A-1C; E-vaping device 60 comprises a flavor insert 80. Flavor insert 80 may be a tobacco rod 80 that holds a flavor material 85 that is one or more types of tobacco).
Regarding Claim 3, Li in view of Bell and Atkins teaches an aerosol generating assembly according to claim 1. Bell further teaches the aerosol generating assembly wherein the pH of the solid, nicotine-containing material is of from 8 to 9.5 or from 8.5 to 9 ([0028]-[0037], The tobacco material is treated to increase its pH to a basic pH of 8.5-12. Tobacco is a solid, nicotine-containing material). The range for the pH of the solid, nicotine-containing material disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 4, Li in view of Bell and Atkins teaches an aerosol generating assembly according to claim 1. Atkins further teaches the aerosol generating assembly wherein the aerosolizable liquid has a pH of from 4 to 5 or from 4.3 to 4.8 ([0160], The pH of the nicotine liquid formulation (aerosolizable liquid) may be from 2.5 to 6.5). The range for the pH of the aerosolizable liquid disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 7, Li in view of Bell and Atkins teaches an aerosol generating assembly according to claim 1. Atkins further teaches the aerosol generating assembly wherein the aerosolizable liquid has an amount of acid of from 0.001 to 5 % by weight ([0184], the concentration of organic acid in the nicotine liquid formulation is from about 0.5% to about 25%, wherein the concentration is of organic acid weight to total solution weight, i.e. (w/w)). The range for the amount of acid in the aerosolizable liquid disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 8, Li in view of Bell and Atkins teaches an aerosol generating assembly according to claim 1. Li further teaches the aerosol generating assembly wherein the assembly is configured such that the solid, nicotine-containing material is heated only by the vapor/aerosol ([0077]-[0078], Figs. 1A-1C; The generated vapor 95 is directed through channel 28 and through flavor insert/tobacco rod 80 to entrain at least one flavorant compound to form a flavored vapor 97 for inhalation by a user. The generated vapor 95 is at an elevated temperature relative to the tobacco rod 80 such that the tobacco rod 80 (solid, nicotine containing material is only heated by the generated vapor 95).
Regarding Claims 9 and 10, Li in view of Bell and Atkins teaches an aerosol generating assembly according to claim 1. Atkins further teaches the aerosol generating assembly wherein the acid of the aerosolizable liquid has a pKa greater than 0.5, wherein the pKa of the acid is greater than 3, or is from 3.7 to 4.3 ([0156], [0169]-[0173], The acid may be lactic acid. Lactic acid has a pKa of 3.9; see Buyuktimkin, [0027]).
Regarding Claim 11, Li in view of Bell and Atkins teaches an aerosol generating assembly according to claim 9. Bell further teaches the aerosol generating assembly wherein the pH of the solid, nicotine-containing material is of from 8 to 9.5 or from 8.5 to 9 ([0028]-[0037], The tobacco material is treated to increase its pH to a basic pH of 8.5-12. Tobacco is a solid, nicotine-containing material). The range for the pH of the solid, nicotine-containing material disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 12, Li, directed to non-combustible vaping devices ([0001]), teaches a cartridge for use in an assembly for generating an inhalable medium ([0004], [0040], [0042], Figs. 1A-1C; E-vaping device 60 comprises a replaceable pre-vapor formulation tank section 70, a reusable power supply section 72, and a flavor insert 80. Pre-vapor formulation tank section 70 may include a pre-vapor formulation tank 22. The e-vaping device 60 is configured to heat a pre-vapor formulation housed within pre-vapor formulation tank 22 to generate a vapor (aerosol) for inhalation by a user, and therefore, e-vaping device 60 is an aerosol-generating assembly for generating an inhalable medium. Pre-vapor formulation tank section 70 and flavor insert 80 cooperate as shown in Figs. 1A-1C to form a cartridge), the cartridge comprising
an aerosolizable liquid comprising an acid in a first chamber ([0040], [0042], [0047]-[0050], Figs. 1A-1C; E-vaping device 60 comprises a replaceable pre-vapor formulation tank section 70, which may include a pre-vapor formulation tank 22. Pre-vapor formulation tank 22 includes a pre-vapor formulation reservoir 23 (first chamber) housing a pre-vapor formulation. [0070], Heating element 34 vaporizes the pre-vapor formulation to generate a vapor/aerosol 95. [0101], Pre-vapor formulation may be a liquid. [0104], The pre-vapor formulation may include one or more acids), and
a solid, nicotine-containing material in a second chamber, wherein the solid, nicotine-containing material is porous ([0040], [0071]-[0072], [0075]-[0077], Figs. 1A-1C; E-vaping device 60 comprises a flavor insert 80. Flavor insert 80 may be a tobacco rod 80 that holds a flavor material 85 that is one or more types of tobacco. Tobacco is a porous solid, nicotine-containing material. The tobacco can be a volume expanded or puffed tobacco. [0072], Flavor insert 80 may include a containment structure 82 (second chamber) enclosing an interior of the flavor insert 80),
but does not teach the cartridge i) wherein the solid, nicotine-containing material has a pH of at least 7, ii) wherein the aerosolizable liquid has a pH of at least 2 and less than 7 to improve the taste of an inhalable medium, wherein the acid is in an amount up to 5% by weight, wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa, and iii) wherein the difference between the pH of the solid nicotine-containing material and the pH of the aerosolizable liquid is of from 3.0 to 5.5 to provide a higher amount of nicotine delivery.
With respect to i), Bell, directed to non-combustible vaping devices ([0002]-[0003], [0029], A smokeless inhalation device is a vaping device. The treated tobacco taught by Bell is for use in a heat-not-burn device, which is a non-combustible vaping device), teaches an aerosol generating assembly ([0049]-[0051], Fig. 10; The treated tobacco material is used in smokeless inhalation device 10. Device 10 is configured to heat the treated tobacco material to generate an aerosol from the volatilized components of the treated tobacco. Therefore, device 10 and the treated tobacco material form an aerosol generating assembly) comprising:
a solid, nicotine-containing material having a pH of at least 7 ([0028]-[0037], The tobacco material is treated to increase its pH to a basic pH of 8.5-12. Tobacco is a solid, nicotine-containing material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the solid, nicotine-containing material taught by Li having a pH of at least 7 as taught by Bell because Li and Bell are directed to non-combustible vaping devices, Li states that the vapor/aerosol generated by heating the aerosolizable liquid is at an elevated temperature relative to the solid, nicotine-containing material such that volatile compounds in the solid, nicotine-containing material are released into the vapor/aerosol (Li, [0077]-[0078]), Li states that the solid, nicotine-containing material is tobacco (Li, [0075]-[0076]), Bell demonstrates that providing a solid, nicotine-containing material such as tobacco with a pH of at least 7 enhances the release of nicotine and tobacco flavor compounds at lower temperatures (Bell, [0029]-[0031]), and the teaching in Bell would have motivated one of ordinary skill in the art to provide the solid, nicotine-containing material having a pH of at least 7.
Li in view of Bell does not teach the assembly ii) wherein the aerosolizable liquid has a pH of at least 2 and less than 7 to improve the taste of an inhalable medium, wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa, and iii) wherein the difference between the pH of the solid nicotine-containing material and the pH of the aerosolizable liquid is of from 3.0 to 5.5 to provide a higher amount of nicotine delivery.
With respect to ii), Atkins, directed to non-combustible vaping devices ([0002]-[0003], The vaporizer device taught by Atkins is configured to deliver a vapor for inhalation by a user within combusting tobacco or other substances), teaches an aerosol generating assembly ([0002], [0055]-[0056], Figs. 1A-1F; Vaporizer 100 is configured to heat a vaporizable material to generate an inhalable aerosol. Therefore, vaporizer 100 and the vaporizable material form an aerosol generating assembly) comprising:
an aerosolizable liquid comprising an acid, and having a pH of at least 2 and less than 7 ([0002], [0055]-[0056], [0068], Figs. 1A-1F; Vaporizer 100 comprises a vaporizer cartridge 120. Vaporizer cartridge 120 includes a reservoir 140 for containing a liquid vaporizable material. Atomizer 141 supplies heat to the liquid vaporizable material to generate an aerosol. [0135], The liquid vaporizable material may be a nicotine liquid formulation comprising nicotine and an acid. [0160], The pH of the nicotine liquid formulation may be from 2.5 to 6.5),
wherein the acid is in an amount up to 5% by weight ([0184], the concentration of organic acid in the nicotine liquid formulation is from about 0.5% to about 25%, wherein the concentration is of organic acid weight to total solution weight, i.e. (w/w)),
wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa ([0156], [0169]-[0173], The acid may be lactic acid. Lactic acid has a vapor pressure at 25 °C of 0.01499 mm Hg (1.999 Pa); see Olsson, [0056]); and
wherein the assembly is configured to heat the aerosolizable liquid to form a vapor and/or an aerosol ([0002], [0055]-[0056], [0068], Figs. 1A-1F; Vaporizer 100 (assembly) is configured to heat the liquid vaporizable material (aerosolizable liquid) to form a vapor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the aerosolizable liquid taught by Li with the aerosolizable liquid taught by Atkins such that the aerosolizable liquid comprises an acid and has a pH of at least 2 and less than 7 wherein the acid is in an amount up to 5% by weight, wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa, because Li and Atkins are directed to non-combustible vaping devices, Li states that the aerosolizable liquid may comprise nicotine and organic acids such as pyruvic acid, formic acid, oxalic acid, glycolic acid, or acetic acid (Li, [0103]-[0104]), Atkins teaches an aerosolizable liquid similarly comprising nicotine and organic acids such as pyruvic acid, formic acid, oxalic acid, glycolic acid, or acetic acid (Atkins, [0168]-[0173]), Atkins demonstrates the providing an acidic aerosolizable liquid with a pH of between 2.5 and 6.5 causes an increased nicotine-related biological effect (e.g. a faster rise in heart rate) in the user relative to the absence of the acid (Atkins, [0160]), and this involves replacing one aerosolizable liquid with another to yield predictable results.
The range for the amount of acid disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
With respect to iii), As Li has been modified in view of Bell and Atkins such that the solid, nicotine-containing material has a pH of 8.5-12 (Bell, [0028]-[0037]) and the aerosolizable liquid has a pH of 2.5 to 6.5 (Atkins, [0160]), wherein the difference between the pH of the solid nicotine containing material and the pH of the aerosolizable liquid is of from 2.0 to 9.5. The range for the pH difference between the solid, nicotine-containing material and the aerosolizable liquid disclosed by the prior art overlaps the claimed range of 3.0 to 5.5, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
The limitations: “wherein the aerosolizable liquid has a pH of at least 2 and less than 7 to improve the taste of an inhalable medium, wherein the difference between the pH of the solid nicotine-containing material and the pH of the aerosolizable liquid is of from 3.0 to 5.5 to provide a higher amount of nicotine delivery” appear to be intended results relating to the specific characteristics of the aerosolizable liquid and the pH difference between the liquid and the solid. Because Li in view of Bell and Atkins discloses all of the positively recited elements of the cartridge of Claim 12, an improved taste of the inhalable medium would be an inherent result of the aerosolizable liquid comprising an acid having a pH of at least 2 and less than 7, and a higher amount of nicotine delivery would be an inherent result of the difference between the pH of the solid-nicotine containing material and the pH of the aerosolizable liquid being of from 3.0 to 5.5.
Regarding Claim 13, Li in view of Bell and Atkins teaches a cartridge according to claim 12. Atkins further teaches the cartridge wherein the aerosolizable liquid has a pH of from 4 to 5 or from 4.3 to 4.8 ([0160], The pH of the nicotine liquid formulation (aerosolizable liquid) may be from 2.5 to 6.5). The range for the pH of the aerosolizable liquid disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 14, Li in view of Bell and Atkins teaches a cartridge according to claim 12. Bell further teaches the cartridge wherein the pH of the solid, nicotine-containing material is of from 8 to 9.5 or from 8.5 to 9 ([0028]-[0037], The tobacco material is treated to increase its pH to a basic pH of 8.5-12. Tobacco is a solid, nicotine-containing material). The range for the pH of the solid, nicotine-containing material disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 16, Li, directed to non-combustible vaping devices ([0001]), teaches a method of generating an inhalable medium using an assembly ([0004], [0040], [0042], Figs. 1A-1C; E-vaping device 60 comprises a replaceable pre-vapor formulation tank section 70, a reusable power supply section 72, and a flavor insert 80. Pre-vapor formulation tank section 70 may include a pre-vapor formulation tank 22. The e-vaping device 60 is configured to heat a pre-vapor formulation housed within pre-vapor formulation tank 22 to generate a vapor (inhalable medium), and therefore, e-vaping device 60 is an aerosol-generating assembly. The process of using e-vaping device 60 to vaporize the pre-vapor formulation constitutes a method of generating an inhalable medium using the assembly) comprising
an aerosolizable liquid comprising an acid ([0040], [0042], [0047]-[0050], Figs. 1A-1C; E-vaping device 60 comprises a replaceable pre-vapor formulation tank section 70, which may include a pre-vapor formulation tank 22. Pre-vapor formulation tank 22 includes a pre-vapor formulation reservoir 23 housing a pre-vapor formulation. [0070], Heating element 34 vaporizes the pre-vapor formulation to generate a vapor/aerosol 95. [0101], Pre-vapor formulation may be a liquid. [0104], The pre-vapor formulation may include one or more acids), and
a solid, nicotine-containing material, wherein the solid, nicotine-containing material is porous ([0040], [0071]-[0072], [0075]-[0077], Figs. 1A-1C; E-vaping device 60 comprises a flavor insert 80. Flavor insert 80 may be a tobacco rod 80 that holds a flavor material 85 that is one or more types of tobacco. Tobacco is a porous solid, nicotine-containing material. The tobacco can be a volume expanded or puffed tobacco);
the method comprising: heating the aerosolizable liquid to form a vapor and/or an aerosol ([0054], [0070], Figs. 1A-1C; E-vaping device 60 comprises a heating element 34. Heating element 34 heats and vaporizes the pre-vapor formulation (aerosolizable liquid) to generate a vapor/aerosol 95);
forming an inhalable medium, by contacting the aerosolizable liquid in the form of a vapor and/or an aerosol with the solid, nicotine-containing material to entrain one or more components thereof ([0077]-[0078], Figs. 1A-1C; The generated vapor 95 is directed through channel 28 and through flavor insert/tobacco rod 80 to entrain at least one flavorant compound to form a flavored vapor 97 for inhalation by a user),
but does not teach the method i) wherein the solid, nicotine-containing material has a pH of at least 7, ii) wherein the aerosolizable liquid has a pH of at least 2 and less than 7 to improve the taste of an inhalable medium, wherein the acid is in an amount up to 5% by weight, wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa, and iii) wherein the difference between the pH of the solid nicotine-containing material and the pH of the aerosolizable liquid is of from 3.0 to 5.5 to provide a higher amount of nicotine delivery.
With respect to i), Bell, directed to non-combustible vaping devices ([0002]-[0003], [0029], A smokeless inhalation device is a vaping device. The treated tobacco taught by Bell is for use in a heat-not-burn device, which is a non-combustible vaping device), teaches an aerosol generating assembly ([0049]-[0051], Fig. 10; The treated tobacco material is used in smokeless inhalation device 10. Device 10 is configured to heat the treated tobacco material to generate an aerosol from the volatilized components of the treated tobacco. Therefore, device 10 and the treated tobacco material form an aerosol generating assembly) comprising:
a solid, nicotine-containing material having a pH of at least 7 ([0028]-[0037], The tobacco material is treated to increase its pH to a basic pH of 8.5-12. Tobacco is a solid, nicotine-containing material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the solid, nicotine-containing material taught by Li having a pH of at least 7 as taught by Bell because Li and Bell are directed to non-combustible vaping devices, Li states that the vapor/aerosol generated by heating the aerosolizable liquid is at an elevated temperature relative to the solid, nicotine-containing material such that volatile compounds in the solid, nicotine-containing material are released into the vapor/aerosol (Li, [0077]-[0078]), Li states that the solid, nicotine-containing material is tobacco (Li, [0075]-[0076]), Bell demonstrates that providing a solid, nicotine-containing material such as tobacco with a pH of at least 7 enhances the release of nicotine and tobacco flavor compounds at lower temperatures (Bell, [0029]-[0031]), and the teaching in Bell would have motivated one of ordinary skill in the art to provide the solid, nicotine-containing material having a pH of at least 7.
Li in view of Bell does not teach the assembly ii) wherein the aerosolizable liquid has a pH of at least 2 and less than 7 to improve the taste of an inhalable medium, wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa, and iii) wherein the difference between the pH of the solid nicotine-containing material and the pH of the aerosolizable liquid is of from 3.0 to 5.5 to provide a higher amount of nicotine delivery.
With respect to ii), Atkins, directed to non-combustible vaping devices ([0002]-[0003], The vaporizer device taught by Atkins is configured to deliver a vapor for inhalation by a user within combusting tobacco or other substances), teaches an aerosol generating assembly ([0002], [0055]-[0056], Figs. 1A-1F; Vaporizer 100 is configured to heat a vaporizable material to generate an inhalable aerosol. Therefore, vaporizer 100 and the vaporizable material form an aerosol generating assembly) comprising:
an aerosolizable liquid comprising an acid, and having a pH of at least 2 and less than 7 ([0002], [0055]-[0056], [0068], Figs. 1A-1F; Vaporizer 100 comprises a vaporizer cartridge 120. Vaporizer cartridge 120 includes a reservoir 140 for containing a liquid vaporizable material. Atomizer 141 supplies heat to the liquid vaporizable material to generate an aerosol. [0135], The liquid vaporizable material may be a nicotine liquid formulation comprising nicotine and an acid. [0160], The pH of the nicotine liquid formulation may be from 2.5 to 6.5),
wherein the acid is in an amount up to 5% by weight ([0184], the concentration of organic acid in the nicotine liquid formulation is from about 0.5% to about 25%, wherein the concentration is of organic acid weight to total solution weight, i.e. (w/w)),
wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa ([0156], [0169]-[0173], The acid may be lactic acid. Lactic acid has a vapor pressure at 25 °C of 0.01499 mm Hg (1.999 Pa); see Olsson, [0056]); and
wherein the assembly is configured to heat the aerosolizable liquid to form a vapor and/or an aerosol ([0002], [0055]-[0056], [0068], Figs. 1A-1F; Vaporizer 100 (assembly) is configured to heat the liquid vaporizable material (aerosolizable liquid) to form a vapor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the aerosolizable liquid taught by Li with the aerosolizable liquid taught by Atkins such that the aerosolizable liquid comprises an acid and has a pH of at least 2 and less than 7, wherein the acid is in an amount up to 5% by weight, wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa, because Li and Atkins are directed to non-combustible vaping devices, Li states that the aerosolizable liquid may comprise nicotine and organic acids such as pyruvic acid, formic acid, oxalic acid, glycolic acid, or acetic acid (Li, [0103]-[0104]), Atkins teaches an aerosolizable liquid similarly comprising nicotine and organic acids such as pyruvic acid, formic acid, oxalic acid, glycolic acid, or acetic acid (Atkins, [0168]-[0173]), Atkins demonstrates the providing an acidic aerosolizable liquid with a pH of between 2.5 and 6.5 causes an increased nicotine-related biological effect (e.g. a faster rise in heart rate) in the user relative to the absence of the acid (Atkins, [0160]), and this involves replacing one aerosolizable liquid with another to yield predictable results.
The range for the amount of acid disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
With respect to iii), As Li has been modified in view of Bell and Atkins such that the solid, nicotine-containing material has a pH of 8.5-12 (Bell, [0028]-[0037]) and the aerosolizable liquid has a pH of 2.5 to 6.5 (Atkins, [0160]), wherein the difference between the pH of the solid nicotine containing material and the pH of the aerosolizable liquid is of from 2.0 to 9.5. The range for the pH difference between the solid, nicotine-containing material and the aerosolizable liquid disclosed by the prior art overlaps the claimed range of 3.0 to 5.5, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
The limitations: “wherein the aerosolizable liquid has a pH of at least 2 and less than 7 to improve the taste of an inhalable medium, wherein the difference between the pH of the solid nicotine-containing material and the pH of the aerosolizable liquid is of from 3.0 to 5.5 to provide a higher amount of nicotine delivery” appear to be intended results relating to the specific characteristics of the aerosolizable liquid and the pH difference between the liquid and the solid. Because Li in view of Bell and Atkins discloses all of the positively recited elements of the method of Claim 16, an improved taste of the inhalable medium would be an inherent result of the aerosolizable liquid comprising an acid having a pH of at least 2 and less than 7, and a higher amount of nicotine delivery would be an inherent result of the difference between the pH of the solid-nicotine containing material and the pH of the aerosolizable liquid being of from 3.0 to 5.5.
Regarding Claim 17, Li in view of Bell and Atkins teaches a method according to claim 16. Atkins further teaches the cartridge method the aerosolizable liquid has a pH of from 4 to 5 or from 4.3 to 4.8 ([0160], The pH of the nicotine liquid formulation (aerosolizable liquid) may be from 2.5 to 6.5). The range for the pH of the aerosolizable liquid disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 19, Because Atkins teaches the method wherein the aerosolizable liquid has a pH of at least 2 and less than 7 ([0160], The pH of the nicotine liquid formulation may be from 2.5 to 6.5), one of ordinary skill would reasonably expect the rate of nicotine extraction to exceed the rate of nicotine-salt formation in the solid, thereby providing an increased nicotine content in the vapor and/or aerosol as compared to using a neutral vapor and/or aerosol because the aerosolizable liquid taught by Atkins is equivalent to the claimed aerosolizable liquid.
Regarding Claim 20, Li in view of Bell and Atkins teaches the aerosol generating assembly according to claim 1. Li further teaches the assembly comprising: (i) a liquid pod containing an aerosolizable liquid comprising an acid ([0040], [0042], [0047]-[0050], Figs. 1A-1C; E-vaping device 60 comprises a replaceable pre-vapor formulation tank section 70, which may include a pre-vapor formulation tank 22. Pre-vapor formulation tank 22 includes a pre-vapor formulation reservoir 23 (liquid pod) housing a pre-vapor formulation); and
(ii) a nicotine-containing pod, containing a solid, nicotine-containing material, wherein the solid, nicotine-containing material is porous ([0040], [0071]-[0072], [0075]-[0077], Figs. 1A-1C; E-vaping device 60 comprises a flavor insert 80. Flavor insert 80 may be a tobacco rod 80 that holds a flavor material 85 that is one or more types of tobacco. Tobacco is a porous solid, nicotine-containing material. The tobacco can be a volume expanded or puffed tobacco [0072], Flavor insert 80 may include a containment structure 82 (nicotine-containing pod) enclosing an interior of the flavor insert 80);
wherein the liquid and nicotine-containing pod are configured for use in the assembly ([0040], [0042], [0047]-[0050], [0072], Figs. 1A-1C; E-vaping device 60 (aerosol-generating assembly) comprises a replaceable pre-vapor formulation tank section 70 and a flavor insert 80. Pre-vapor formulation tank section 70 comprises the pre-vapor formulation tank 22 include pre-vapor formulation reservoir 23 (liquid pod). Flavor insert 80 includes the containment structure 82 (nicotine-containing pod)).
Atkins further teaches the assembly wherein the aerosolizable liquid has a pH of from at least 2 and less than 7 ([0160], The pH of the nicotine liquid formulation (aerosolizable liquid) may be from 2.5 to 6.5),
wherein the acid has a vapor pressure at 25 °C of from 0.05 Pa to 11 Pa ([0156], [0169]-[0173], The acid may be lactic acid. Lactic acid has a vapor pressure at 25 °C of 0.01499 mm Hg (1.999 Pa); see Olsson, [0056]).
Bell further teaches the assembly wherein the solid, nicotine-containing material has a pH of at least 7 ([0028]-[0037], The tobacco material is treated to increase its pH to a basic pH of 8.5-12. Tobacco is a solid, nicotine-containing material).
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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/J.M.M./
Examiner, Art Unit 1755
/PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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