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 Submission
Applicant’s submission filed on 2026 June 8 has been entered. Claims 1-9 and 11-15 are pending.
Claim Interpretation
Claims 2 and 4 recite a product-by-process, and claims 6 and 8 recite an intermediate product, but a product is limited only by its final structure. See MPEP 2113.
Claim Rejections - 35 USC § 103
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 1-3, 6, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Pontes (WO 2018197879 A1 cited on an IDS and with reference made to national stage US 20200187551 A1 cited on an IDS) in view of Yao (CN 105341995 A with reference made to machine translation).
Claim 1: Pontes teaches a non-combustible aerosol provision system ([105], hybrid electronic heating device) comprising a concentrated tobacco flavor composition ([100], tobacco product) comprising at least one volatile tobacco flavor compound having a boiling point of less than 200°C at atmospheric pressure ([96], multiple volatiles with boiling points < 200°C are extracted) and at least one semi-volatile tobacco flavor compound having a boiling point between 200 and 250°C at atmospheric pressure ([96], multiple semi-volatiles with 200°C < boiling points < 250°C are extracted),
wherein the concentrated tobacco flavor composition ([100], tobacco product) further comprises a tobacco extract (tobacco extract), and wherein the tobacco extract (tobacco extract) comprises nicotine ([97-98], the tobacco extract can be substantially free of alkaloids, TSNAs, and/or nicotine, so in each variation nicotine will be present in at least trace amounts).
The majority of Pontes’ disclosed volatile compounds read on the instant (semi)-volatile compounds. Compounds with atmospheric boiling points < 200°C include methyl butanol, furfural, cyclotene, dimethylpyrazines, trimethylpyrazine, tetramethylpyrazine, 2,6-nonadienal, 2-nonenal, linalool, linalool oxide, isobutyric acid, isovaleric acid, 3-methylvaleric acid, and methional. Compounds with 200°C < atmospheric boiling points < 250°C include benzyl alcohol, phenylethanol, furaneol, isophorone, ketoisophorone, safranal, solanone, hepatanoic acid, benzoic acid, para-cresol, guaiacol, vinylphenol, ethylguaicol, and vinylguaiacol, and Pontes teaches extract as mixtures thereof.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to select at least one volatile compound from each volatility group, because Pontes’ list discloses numerous volatile compounds from each volatility group, teaches extract as mixtures thereof, and thus meaningfully overlaps with the instant composition comprising at least one volatile compound from each volatility group. See MPEP 2131.03(III).
Pontes does not explicitly teach that the tobacco extract is diluted in a solvent selected from the group consisting of propylene glycol, glycerine, vegetable glycerine and triacetin.
Yao teaches a tobacco extract ([31], tobacco extract) diluted in a solvent (solvent) of propylene glycol and glycerine, such that the solvent can generate aerosol to yield more total aerosol [28].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use, as Pontes’ nonlimited solvent, Yao’s specific solvent of propylene glycol and glycerine, because doing so would enable the solvent to both extract tobacco compounds and generate aerosol in order to yield more total aerosol.
Claim 2: modified Pontes teaches a system as claimed in claim 1, wherein the concentrated tobacco flavor composition comprises the tobacco extract ([100], tobacco extract) prepared from a first tobacco material by distillation and fractionation [90], wherein the extract comprises concentrated tobacco flavor compounds [96], including a first fraction (multiple compounds can be extracted into a mixture; the first fraction forms from the first effluent stream distilled and fractionated out of the influent stream) of tobacco compounds having a boiling point of less than 200°C at atmospheric pressure ([96], multiple Tb < 200 °C volatiles are extracted), and a second fraction (multiple compounds can be extracted into a mixture; the second fraction forms from the second effluent stream distilled and fractionated out of the influent stream) of tobacco compounds having a boiling point between 200 and 250°C at atmospheric pressure (multiple 200 °C < Tb < 250 °C semi-volatiles are extracted).
Modified Pontes does not explicitly teach that the step of distillation is molecular distillation, and that the step of fractionation is high vacuum fractionation.
The claimed process of distilling by molecular distillation and fractionating by high-vacuum fractionation does not distinguish, absent evidence to the contrary, the instant tobacco composition over modified Pontes’ tobacco composition. Modified Pontes teaches all positively recited ingredients of the concentrated tobacco flavor composition See MPEP 2113.
Claim 3: modified Pontes teaches a system as claimed in claim 2, wherein the tobacco extract comprises a higher concentration of volatile flavor and aroma compounds compared to a tobacco extract prepared by an aqueous extraction process ([50, 63, 67], extraction conditions are optimized to increase volatiles concentrations, i.e., concentrations are higher than for a generic aqueous extraction process).
Claim 6: modified Pontes teaches a system as claimed in claim 2, wherein the extract comprises less than 15 wt-% nicotine prior to dilution [98].
Pontes’ disclosed range overlaps with the claimed range to yield prima facie obviousness. The courts have held that a prime facie case of obviousness exists where claimed ranges "overlap or lie inside ranges disclosed by the prior art". In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997. The courts have held that a prior art reference teaching a protective layer “not less than about 10 nm [i.e., 100 Angstroms]" renders obvious a claim reciting a protective layer within a range of "50 to 100 Angstroms". In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941). The courts have held that prior art renders obvious a claimed range with an overlapping endpoint, particularly when there is no showing of criticality of the claimed range.
Claim 11: modified Pontes teaches a system as claimed in claim 1, wherein the aerosol provision system ([105], hybrid electronic heating device which comprises both liquid precursor, as in “electronic device”, and solid precursor, as in “heating device”) is a tobacco heating product comprising an aerosol-generating material (tobacco extract) which is to be heated to volatilize constituents (heating device).
Claim 12: modified Pontes teaches a system as claimed in claim 1, wherein the aerosol provision system ([105], hybrid electronic heating device which comprises both liquid precursor, as in “electronic device”, and solid precursor, as in “heating device”) is a hybrid product comprising an aerosol-generating material (tobacco extract) which is to be heated to volatilize constituents (heating device), and a liquid (inhalable liquid) which is to be heated to form a vapor (inhalable).
Claim 13: modified Pontes teaches a system as claimed in claim 11, wherein the aerosol-generating material ([105], tobacco extract) comprises the tobacco flavor composition (tobacco extract).
Claim 14: modified Pontes teaches a system as claimed in claim 12, wherein the liquid ([105], inhalable liquid) comprises the tobacco flavor composition (tobacco extract).
Claims 4-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Pontes (WO 2018197879 A1 cited on an IDS and with reference made to national stage US 20200187551 A1 cited on an IDS) in view of Yao (CN 105341995 A with reference made to machine translation) as applied to claim 2 and further in view of Nie (CN 109349678 A with reference made to machine translation).
Claims 4 and 7: modified Pontes teaches a system as claimed in claim 2, wherein the extract comprises less than 15% w/w nicotine prior to dilution [98].
Modified Pontes does not explicitly teach that the extract is diluted from about 100 fold to about 1000 fold to make a 1% w/w to 0.1% w/w solution,
and that the extract diluted in the solvent comprises from about 0.1% to about 0.001% w/w nicotine.
Nie teaches a tobacco extract diluted 1000 fold in ethanol [29], such that the diluted extract imparts a rich and mellow aroma [29], increased smoke concentration ([29], concentration increases; [12], concentration is smoke concentration), and improved satisfaction to a user [29].
Each element of Nie’s cigarette – choice of 70% ethanol as a solvent, dilution by 1000x, and flavoring in 0.01-0.1% mass ratio – yields “the cigarette”, so each element of Nie’s cigarette is suggested to contribute to Nie’s benefit.
Nie’s solvent is ethanol [Nie 54], Pontes’ solvent is exemplified as ethanol [Pontes 82], and Yao’s solvent is exemplified as propylene glycol and glycerine [Yao 31]. All four compounds are aerosol-forming, non-toxic, organic solvents to yield expectation to succeed.
Diluting modified Pontes’ tobacco extract 1000x as taught by Nie would yield less than 0.015% w/w nicotine ([Pontes 98], less than 15% w/w nicotine * (1 / 1000x dilution) = less than 0.015% w/w nicotine).
Modified Pontes’ range overlaps with the claimed range to yield prima facie obviousness. The courts have held that a prime facie case of obviousness exists where claimed ranges "overlap or lie inside ranges disclosed by the prior art". In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997. The courts have held that a prior art reference teaching a protective layer “not less than about 10 nm [i.e., 100 Angstroms]" renders obvious a claim reciting a protective layer within a range of "50 to 100 Angstroms". In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941). The courts have held that prior art renders obvious a claimed range with an overlapping endpoint, particularly when there is no showing of criticality of the claimed range.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use, as Yao’s generic dilution factor, Nie’s specific 1000x dilution factor such that the diluted extract is 0.1% w/w and such that the diluted extract comprises less than 0.015% w/w nicotine, because doing so would help to impart a rich and mellow aroma, increase smoke concentration, and improve satisfaction of a user.
Claim 5: modified Pontes teaches a system as claimed in claim 4, wherein a volume of the diluted extract is applied to a second tobacco material to give final extract concentration in the second tobacco material of 0.01-10% by dry weight [106].
Pontes’ disclosed range overlaps with the claimed range to yield prima facie obviousness. The courts have held that a prime facie case of obviousness exists where claimed ranges "overlap or lie inside ranges disclosed by the prior art". In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997. The courts have held that a prior art reference teaching a protective layer “not less than about 10 nm [i.e., 100 Angstroms]" renders obvious a claim reciting a protective layer within a range of "50 to 100 Angstroms". In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941). The courts have held that prior art renders obvious a claimed range with an overlapping endpoint, particularly when there is no showing of criticality of the claimed range.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Pontes (WO 2018197879 A1 cited on an IDS and with reference made to national stage US 20200187551 A1 cited on an IDS) in view of Yao (CN 105341995 A with reference made to machine translation) as applied to claim 2 and further in view of Kudithipudi (US 20190300893 A1) and Albino (US 20060157072 A1).
Claim 8: modified Pontes teaches a system as claimed in claim 2, wherein the extract is substantially free of TSNAs prior to dilution [97].
Modified Pontes does not explicitly teach that the extract comprises from about 5 x 10-5 to about 5 x 10-4 % TSNAs prior to dilution.
Kudithipudi teaches a tobacco material that has been genetically modified to yield reduced TSNAs [7], exemplified along twenty-two embodiments between 5 x 10-6 % and 2 x 10-4 % TSNAs ([220], (0.05 parts TSNA / 1 million parts material) * (1 million / 106) * (100% / 1) = 5 x 10-6 % TSNAs, and (2 parts TSNA / 1 million parts material) * (1 million / 106) * (100% / 1) = 2 x 10-4 % TSNAs).
Albino teaches that TSNA concentration is a result-effective variable [285] that controls taste and flavor [281 and 285] balanced against carcinogenicity [286].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use one of Kudithipudi’s tobacco materials as a starting material for Pontes’ extraction process and to routinely optimize which of Kudithipudi’s TSNA concentrations is selected such that the tobacco extract comprises from about 5 x 10-5 to about 5 x 10-4 % TSNAs prior to dilution, because doing so would optimize taste and flavor balanced against carcinogenicity.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Pontes (WO 2018197879 A1 cited on an IDS and with reference made to national stage US 20200187551 A1 cited on an IDS) in view of Yao (CN 105341995 A with reference made to machine translation) as applied to claim 2 and further in view of Nie (CN 109349678 A with reference made to machine translation) and Kudithipudi (US 20190300893 A1) and Albino (US 20060157072 A1).
Claim 9: modified Pontes teaches a system as claimed in claim 2.
Modified Pontes does not explicitly teach that the extract diluted in the solvent comprises between 1 x 10-10 % and 1 x 10-8 % w/w TSNAs.
Nie teaches a tobacco extract diluted 1000 fold in ethanol [29], such that the diluted extract imparts a rich and mellow aroma [29], increased smoke concentration ([29], concentration increases; [12], concentration is smoke concentration), and improved satisfaction to a user [29].
Each element of Nie’s cigarette – choice of 70% ethanol as a solvent, dilution by 1000x, and flavoring in 0.01-0.1% mass ratio – yields “the cigarette”, so each element of Nie’s cigarette is suggested to contribute to Nie’s benefit.
Nie’s solvent is ethanol [Nie 54], Pontes’ solvent is exemplified as ethanol [Pontes 82], and Yao’s solvent is exemplified as propylene glycol and glycerine [Yao 31]. All four compounds are aerosol-forming, non-toxic, organic solvents to yield expectation to succeed.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to dilute Pontes’ extract 1000 fold as taught by Nie, because doing so would help to impart a rich and mellow aroma, to increase smoke concentration, and to improve satisfaction of a user.
Kudithipudi teaches a tobacco material that has been genetically modified to yield reduced TSNAs [7], exemplified along twenty-two embodiments between 5 x 10-6 % and 2 x 10-4 % TSNAs ([220], (0.05 parts TSNA / 1 million parts material) * (1 million / 106) * (100% / 1) = 5 x 10-6 % TSNAs, and (2 parts TSNA / 1 million parts material) * (1 million / 106) * (100% / 1) = 2 x 10-4 % TSNAs).
Albino teaches that TSNA concentration is a result-effective variable [285] that controls taste and flavor [281 and 285] balanced against carcinogenicity [286].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use one of Kudithipudi’s tobacco materials as a starting material for Pontes’ extraction process and to routinely optimize which of Kudithipudi’s TSNA concentrations is selected such that the tobacco extract comprises from about 1 x 10-7 to about 1 x 10-5 % w/w TSNAs prior to dilution and therefore from about 1 x 10-10 to about 1 x 10-10 % w/w TSNAs after Nie’s 1000x dilution, because doing so would optimize taste and flavor balanced against carcinogenicity.
Claims 2-3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Pontes (WO 2018197879 A1 cited on an IDS and with reference made to national stage US 20200187551 A1 cited on an IDS) in view of Yao (CN 105341995 A with reference made to machine translation) as applied to claim 1 and further in view of Wang (CN 108936791 A with reference made to machine translation).
Claim 2: modified Pontes teaches a system as claimed in claim 1, wherein the concentrated tobacco flavor composition ([100], tobacco extract) comprises a tobacco extract prepared from a first tobacco material by distillation and fractionation [90], wherein the extract comprises concentrated tobacco flavor compounds [96], including a first fraction (multiple compounds can be extracted into a mixture; the first fraction forms from the first effluent stream distilled and fractionated out of the influent stream) of tobacco compounds having a boiling point of less than 200°C at atmospheric pressure ([96], multiple Tb < 200 °C volatiles are extracted), and a second fraction (multiple compounds can be extracted into a mixture; the second fraction forms from the second effluent stream distilled and fractionated out of the influent stream) of tobacco compounds having a boiling point between 200 and 250°C at atmospheric pressure (multiple 200 °C < Tb < 250 °C semi-volatiles are extracted).
Pontes does not explicitly teach that the step of distillation is molecular distillation, that the step of fractionation is high vacuum fractionation, or that the extract is diluted in a solvent.
Wang teaches a tobacco extract prepared from tobacco material by molecular distillation [19] and high vacuum fractionation [13], such that the tobacco material can be processed by a purely physical mechanism which saves solvent [19], reduces needed equipment [19], and reduces pollution [19].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to operate Pontes’ distillation under Wang’s molecular, i.e. short-path vacuum, conditions and to operate Pontes’ fractionation under Wang’s high vacuum conditions, because doing so would save solvent, reduce needed equipment, and reduce pollution.
Claim 3: modified Pontes teaches a system as claimed in claim 2, wherein the tobacco extract comprises a higher concentration of volatile flavor and aroma compounds compared to a tobacco extract prepared by an aqueous extraction process ([50, 63, 67], extraction conditions are optimized to increase volatiles concentrations, i.e., concentrations are higher than for a generic aqueous extraction process).
Claim 6: modified Pontes teaches a system as claimed in claim 2, wherein the extract comprises less than 15% w/w nicotine prior to dilution [98].
Pontes’ disclosed range overlaps with the claimed range to yield prima facie obviousness. The courts have held that a prime facie case of obviousness exists where claimed ranges "overlap or lie inside ranges disclosed by the prior art". In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997. The courts have held that a prior art reference teaching a protective layer “not less than about 10 nm [i.e., 100 Angstroms]" renders obvious a claim reciting a protective layer within a range of "50 to 100 Angstroms". In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941). The courts have held that prior art renders obvious a claimed range with an overlapping endpoint, particularly when there is no showing of criticality of the claimed range.
Claims 4-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Pontes (WO 2018197879 A1 cited on an IDS and with reference made to national stage US 20200187551 A1 cited on an IDS) in view of Yao (CN 105341995 A with reference made to machine translation) and Wang (CN 108936791 A with reference made to machine translation) as applied to claim 2 and further in view of Nie (CN 109349678 A with reference made to machine translation).
Claims 4 and 7: modified Pontes teaches a system as claimed in claim 2, wherein the extract comprises less than 15% w/w nicotine prior to dilution [98].
Modified Pontes does not explicitly teach that the extract is diluted from about 100 fold to about 1000 fold to make a 1% w/w to 0.1% w/w solution,
and that the extract diluted in the solvent comprises from about 0.1% to about 0.001% w/w nicotine.
Nie teaches a tobacco extract diluted 1000 fold in ethanol [29], such that the diluted extract imparts a rich and mellow aroma [29], increased smoke concentration ([29], concentration increases; [12], concentration is smoke concentration), and improved satisfaction to a user [29].
Each element of Nie’s cigarette – choice of 70% ethanol as a solvent, dilution by 1000x, and flavoring in 0.01-0.1% mass ratio – yields “the cigarette”, so each element of Nie’s cigarette is suggested to contribute to Nie’s benefit.
Nie’s solvent is ethanol [Nie 54], Pontes’ solvent is exemplified as ethanol [Pontes 82], and Yao’s solvent is exemplified as propylene glycol and glycerine [Yao 31]. All four compounds are aerosol-forming, non-toxic, organic solvents to yield expectation to succeed.
Diluting modified Pontes’ tobacco extract 1000x as taught by Nie would yield less than 0.015% w/w nicotine ([Pontes 98], less than 15% w/w nicotine * (1 / 1000x dilution) = less than 0.015% w/w nicotine).
Modified Pontes’ range overlaps with the claimed range to yield prima facie obviousness. The courts have held that a prime facie case of obviousness exists where claimed ranges "overlap or lie inside ranges disclosed by the prior art". In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997. The courts have held that a prior art reference teaching a protective layer “not less than about 10 nm [i.e., 100 Angstroms]" renders obvious a claim reciting a protective layer within a range of "50 to 100 Angstroms". In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941). The courts have held that prior art renders obvious a claimed range with an overlapping endpoint, particularly when there is no showing of criticality of the claimed range.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use, as Yao’s generic dilution factor, Nie’s specific 1000x dilution factor such that the diluted extract is 0.1% w/w and such that the diluted extract comprises less than 0.015% w/w nicotine, because doing so would help to impart a rich and mellow aroma, increase smoke concentration, and improve satisfaction of a user.
Claim 5: modified Pontes teaches a system as claimed in claim 4, wherein a volume of the diluted extract is applied to a second tobacco material to give final extract concentration in the second tobacco material of 0.01-10% by dry weight [106].
Pontes’ disclosed range overlaps with the claimed range to yield prima facie obviousness. The courts have held that a prime facie case of obviousness exists where claimed ranges "overlap or lie inside ranges disclosed by the prior art". In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997. The courts have held that a prior art reference teaching a protective layer “not less than about 10 nm [i.e., 100 Angstroms]" renders obvious a claim reciting a protective layer within a range of "50 to 100 Angstroms". In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941). The courts have held that prior art renders obvious a claimed range with an overlapping endpoint, particularly when there is no showing of criticality of the claimed range.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Pontes (WO 2018197879 A1 cited on an IDS and with reference made to national stage US 20200187551 A1 cited on an IDS) in view of Yao (CN 105341995 A with reference made to machine translation) and Wang (CN 108936791 A with reference made to machine translation) as applied to claim 2 and further in view of Kudithipudi (US 20190300893 A1) and Albino (US 20060157072 A1).
Claim 8: modified Pontes teaches a system as claimed in claim 2, wherein the extract is substantially free of TSNAs prior to dilution [97].
Modified Pontes does not explicitly teach that the extract comprises from about 5 x 10-5 to about 5 x 10-4 % TSNAs prior to dilution.
Kudithipudi teaches a tobacco material that has been genetically modified to yield reduced TSNAs [7], exemplified along twenty-two embodiments between 5 x 10-6 % and 2 x 10-4 % TSNAs ([220], (0.05 parts TSNA / 1 million parts material) * (1 million / 106) * (100% / 1) = 5 x 10-6 % TSNAs, and (2 parts TSNA / 1 million parts material) * (1 million / 106) * (100% / 1) = 2 x 10-4 % TSNAs).
Albino teaches that TSNA concentration is a result-effective variable [285] that controls taste and flavor [281 and 285] balanced against carcinogenicity [286].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use one of Kudithipudi’s tobacco materials as a starting material for Pontes’ extraction process and to routinely optimize which of Kudithipudi’s TSNA concentrations is selected such that the tobacco extract comprises from about 5 x 10-5 to about 5 x 10-4 % TSNAs prior to dilution, because doing so would optimize taste and flavor balanced against carcinogenicity.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Pontes (WO 2018197879 A1 cited on an IDS and with reference made to national stage US 20200187551 A1 cited on an IDS) in view of Yao (CN 105341995 A with reference made to machine translation) and Wang (CN 108936791 A with reference made to machine translation) as applied to claim 2 and further in view of Nie (CN 109349678 A with reference made to machine translation) and Kudithipudi (US 20190300893 A1) and Albino (US 20060157072 A1).
Claim 9: modified Pontes teaches a system as claimed in claim 2.
Modified Pontes does not explicitly teach that the extract diluted in the solvent comprises between 1 x 10-10 % and 1 x 10-8 % w/w TSNAs.
Nie teaches a tobacco extract diluted 1000 fold in ethanol [29], such that the diluted extract imparts a rich and mellow aroma [29], increased smoke concentration ([29], concentration increases; [12], concentration is smoke concentration), and improved satisfaction to a user [29].
Each element of Nie’s cigarette – choice of 70% ethanol as a solvent, dilution by 1000x, and flavoring in 0.01-0.1% mass ratio – yields “the cigarette”, so each element of Nie’s cigarette is suggested to contribute to Nie’s benefit.
Nie’s solvent is ethanol [Nie 54], Pontes’ solvent is exemplified as ethanol [Pontes 82], and Yao’s solvent is exemplified as propylene glycol and glycerine [Yao 31]. All four compounds are aerosol-forming, non-toxic, organic solvents to yield expectation to succeed.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to dilute Pontes’ extract 1000 fold as taught by Nie, because doing so would help to impart a rich and mellow aroma, to increase smoke concentration, and to improve satisfaction of a user.
Kudithipudi teaches a tobacco material that has been genetically modified to yield reduced TSNAs [7], exemplified along twenty-two embodiments between 5 x 10-6 % and 2 x 10-4 % TSNAs ([220], (0.05 parts TSNA / 1 million parts material) * (1 million / 106) * (100% / 1) = 5 x 10-6 % TSNAs, and (2 parts TSNA / 1 million parts material) * (1 million / 106) * (100% / 1) = 2 x 10-4 % TSNAs).
Albino teaches that TSNA concentration is a result-effective variable [285] that controls taste and flavor [281 and 285] balanced against carcinogenicity [286].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use Kudithipudi’s tobacco material as a starting material for Pontes’ extraction process and routinely optimize which of Kudithipudi’s TSNA concentrations is selected such that the tobacco extract comprises from about 1 x 10-7 to about 1 x 10-5 % w/w TSNAs prior to dilution and therefore from about 1 x 10-10 to about 1 x 10-10 % w/w TSNAs after Nie’s 1000x dilution, because doing so would optimize taste and flavor balanced against carcinogenicity.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Pontes (WO 2018197879 A1 cited on an IDS and with reference made to national stage US 20200187551 A1 cited on an IDS) in view of Yao (CN 105341995 A with reference made to machine translation) as applied to claim 12 and further in view of Jones (WO 2019211329 A1).
Claim 15: modified Pontes teaches a system as claimed in claim 12.
Pontes does not explicitly teach that the liquid is a nicotine-free liquid.
Jones teaches an aerosol provision system comprising a liquid (p. 7, lines 16-24, liquid base) comprising a tobacco-derived extract (tobacco-derived material), wherein the liquid is nicotine-free (lines 21-24), such that nicotine extract is not needed (lines 16-20), thereby simplifying the aerosol provision system.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute Jones’ nicotine-free liquid for Pontes’ generic liquid, because doing so would make nicotine extract not needed, thereby simplifying the aerosol provision system.
Response to Arguments
Applicant’s arguments of 2026 June 8 have been carefully considered but are not persuasive.
Applicant argues (p. 7, [final paragraph] – p. 8, [1]) that Pontes teaches an extracting solvent which may be nonpolar and/or immiscible with water, rather than a diluting solvent selected from the group consisting of propylene glycol, glycerine, vegetable glycerine, and triacetin. However, [Pontes 57-59] cited by applicant disclose nonlimiting embodiments and do not disparage propylene glycol, glycerine, vegetable glycerine, and triacetin. With respect to polarity, [Pontes 56] discloses that the solvent can be polar or nonpolar. With respect to miscibility with water, [Pontes 60] discloses that the solvent can be n-butanol, cyclohexane, dichloromethane, ethyl acetate, heptane, hexane, methyl-t-butyl ether, diisopropyl ether, or diethyl ether, all of which are miscible in water (“Solvent Miscibility Chart”, Millipore Sigma). Pontes’ solvent can be both polar and nonpolar and both miscible and immiscible with water, and examples of such solvents do not constrain one of ordinary skill.
Applicant argues (p. 8, [final paragraph]) that [applicant 55] exemplifies solvents that are nonpolar and volatile, rather than solvents like Yao’s propylene glycol and glycerine that are polar and nonvolatile. However, similar to the above analysis, [applicant 55] merely exemplifies petroleum ether and hexane and does not disparage propylene glycol, glycerine, vegetable glycerine, and triacetin.
Applicant argues (p. 9, [2]) that Pontes does not teach a diluting solvent. However, Pontes does teach extracting volatiles into a solvent [88], which would dilute the volatiles, and an option of replacing the extracting solvent with a second solvent, e.g., ethanol [82]. One of ordinary skill would be motivated to use, as Pontes’ solvent having generic properties and contained in a tobacco extract, Yao’s specific solvent of propylene glycol and glycerine for Yao’s benefit of generating more aerosol.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tobey C. Le whose telephone number is (703)756-5516. The examiner can normally be reached Mon-Thu 8:30-18:30 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H. Wilson can be reached at 571-270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TOBEY C LE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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