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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2026 February 18 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 Objections
Claim 2 is objected to because of the following informalities:
Claim 2: the term “a tobacco extract” should be “the tobacco extract” to point to the same term recited earlier in claim 1, and the limitation “wherein the extract is diluted in a solvent” should be omitted because claim 1 recites the same limitation.
Appropriate correction is required.
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 a 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 February 18 have been carefully considered. Upon further search and consideration necessitated by applicant’s amendments, a new ground of rejection is made for claim 1 over Pontes in view of Yao.
Applicant argues (p. 7, [3]) that Pontes does not teach diluting tobacco extract in a solvent. However, Yao teaches diluting tobacco extract in a solvent for the benefit of generating more aerosol [Yao 28].
Applicant argues (p. 7, [final paragraph] – p. 8, [1]) limitations which are not claimed, e.g., reducing less desirable components. However, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Diluting the extract in a solvent reduces less desirable components [applicant 53], so diluting Pontes’ composition in Yao’s solvent would achieve the same reduction, absent evidence to the contrary. If applicant intends to argue improved properties, “the fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). See MPEP 2145(II).
Applicant argues (p. 8, [2]) that Pontes discloses solvents which “may” be non-polar and or immiscible with water. However, [Pontes 57-59] upon which applicant relies is non-limiting. For example, the solvent can be both polar and non-polar [Pontes 56]. Moreover, Pontes’ solvents extract tobacco, rather than dilute tobacco extract, so Pontes’ extracting solvents do not bear on the instant diluting solvent. Yao teaches a diluting extract for the benefit of generating more aerosol.
Conclusion
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