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 .
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.
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.
Claim 1-2, 4, 6, 8, 10, 12-13, 16, 19-21, 23, 27, 29-31, 33, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Crooks et al. (US 2005/0066980) in view of Dittrich et al. (US 2005/0034739) and Scott et al. (US 2013/0048000).
Regarding claim 1, Crooks discloses a delivery system (Figure 1, cigarette 10, [0028]) comprising:
an aerosol-generating material comprising:
tobacco material (Figure 10, tobacco rod 12, [0028]), comprising leaf tobacco (Oriental tobacco leaf in an exemplary tobacco blend, [0042]); and
an aerosolizable material comprising:
an inorganic material (filler material incorporates inorganic components, [0036]),
a binder (binder included with aerosol forming material, [0051]); and
an aerosol-former material (tobacco blend contains aerosol forming
material, [0047]);
and an aerosol-modifying agent release component comprising an aerosol modifying agent (Figure 10, breakable capsule 54 carries a payload that changes the nature or character of the smoke (e.g., a flavoring agent), [0070]).
Crooks fails to disclose that the aerosolizable material is in the form of a shredded sheet and that the inorganic material is in an amount of 50% to 90% by weight of the aerosolizable material. Dittrich teaches a similar smoking article including a smokable (i.e. aerosolizable) filler material in the form of a shredded sheet (smoking material is produced in a sheet then shredded, [0036]) and the aerosolizable material comprises an inorganic material in an amount of 50% to 90% by weight of the aerosolizable material (smoking material contains chalk (an inorganic material in an amount of 74%, [0036]). Dittrich also teaches that it is desired to reduce the amount of tobacco material in smoking articles in order to reduce the potential health problems associated with tobacco [0002] and that the formulation using chalk increased the static burn rate of the smoking article [0037]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Crooks to incorporate the teachings of Dittrich to provide the smokable filler material in the form of a shredded sheet and chalk in the shredded sheet at an amount of 74% because doing so would reduce the amount of tobacco material in smoking articles in order to reduce the potential health problems associated with tobacco and using chalk increases the static burn rate of the smoking article, as recognized by Dittrich [0002] and [0037].
Crooks also fails to disclose wherein the leaf tobacco comprises total sugars and nicotine in a weight ratio of between about 8:1 and about 20:1; however, Scott et al teaches harvested and cured leaf tobacco characterized by specific chemical profiles ([0026],[0092],[0094], Table 4). Specifically, Scott et al discloses leaf nicotine levels ranging from 0.2% to 5.0% by weight ([0015],[0028]), and further discloses reducing sugar levels from below detectable levels to 20% and total sugar levels spanning up to 20% or higher ([0018],[[0089]). Combining Scott et al’s disclosed total sugar range with Scott’s disclosed leaf nicotine range yields a calculated total sugar to nicotine weight ratio spanning from 5.5:1 to 20:1 which directly overlaps and encompasses the claimed range of 8:1 to 20:1 (Note: Under MPEP 2144.05, where a claimed numerical range overlaps or falls within a range disclosed or suggested in the prior art, a prima facie case of obviousness exists. Applicant has provided no comparative data showing that the claimed range of 8:1 to 20:1 produces unexpected or critical results compared to adjacent ratios). Hence, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to have combined the inorganic-filler aerosol-generating sheet/tobacco blend of the modified Crooks invention with the specific sugar-to-nicotine ratio leaf tobacco of Scott et al merely in order to balance mildness, combustion rate and overall organoleptic properties for an optimal user smoking-experience.
Regarding claim 2, modified Crooks teaches a delivery system as claimed in claim 1, wherein the delivery system comprises a filter material comprising the aerosol- modifying agent release component (Crooks, Figure 10, filter 36 comprises at least one breakable capsule 54, [0070])
and optionally the filler material comprises a filamentary tow or a cellulose based material (Crooks, Figure 10, walls of compartment 60 may be made of plasticized cellulose acetate, [0074]).
Regarding claim 4, modified Crooks teaches a delivery system as claimed in claim 1, wherein the aerosol-modifying agent release component comprises a breakable capsule containing the aerosol modifying agent (Crooks, Figure 10, breakable capsule 54 contains for example a flavoring agent, [0070]), and optionally the capsule comprises a shell and the aerosol modifying agent is enclosed within the shell (Crooks, Figure 10, capsule 54 possesses a rigid outer shell that encapsulates mixtures of medium chain triglycerides and flavor agents, [0075]).
Regarding claim 6, modified Crooks teaches a delivery system as claimed in claim 4, wherein the capsule is substantially spherical in shape (Crooks, Figure 10, capsule 54 is generally spherical in shape (there is no definition in the instant application for how spherical "substantially spherical" is), [0075]) and optionally has a diameter in the range of 2 mm to 4 mm (Crooks, Figure 10, capsule 54 have a diameter of about 3mm to 4mm, [0074]).
Regarding claim 8, modified Crooks teaches a delivery system as claimed in claim 1, wherein the aerosol-modifying release component comprises a plurality of breakable capsules containing the aerosol modifying agent (Crooks, Figure 10, at least one breakable capsule 54, [0070]).
Regarding claim 10, modified Crooks teaches a delivery system as claimed in claim 8, wherein the aerosol modifying agent in each capsule of the plurality of capsules is different to the aerosol modifying agent in each of the other capsules of the plurality of capsules or the aerosol modifying agent in each capsule of the plurality of breakable capsules is identical to the aerosol modifying agent in each of the other capsules of the plurality of breakable capsules (Crooks, list of possible flavors in the capsules are listed in [0075], and different flavors may be components of multiple capsules [0078]).
Regarding claim 12, modified Crooks teaches a delivery system as claimed in claim 1, wherein the aerosol modifying agent is a liquid (Crooks, capsule payload can be liquid, [0077]).
Regarding claim 13, modified Crooks teaches a delivery system as claimed in claim 2, wherein the filamentary tow comprises a denier per filament in the range 5 to 12 (Crooks, filter material (may be cellulose acetate tow [0009]) have a denier per filament of about 1.8 to about 10, [0084]).
Regarding claim 16, modified Crooks teaches a delivery system as claimed in claim 1, wherein the aerosolizable material comprises the aerosol-former material in an amount of between about 10% and about 20% by weight of the aerosolizable material (Crooks, aerosol forming material present at least 10% of the combined weight of the aerosol forming material and tobacco material, [0049]).
Regarding claim 19, modified Crooks teaches a delivery system as claimed in claim 1, wherein the aerosolizable material comprises the binder in an amount of at least about 1% by weight of the aerosolizable material (Dittrich, 8% sodium alginate (a binder), [0036]).
Regarding claim 20, modified Crooks teaches a delivery system as claimed in claim 1, wherein the aerosol-former material is selected from the group consisting of: glycerol, sorbitol, propylene glycol, triethylene glycol, lactic acid, diacetin, triacetin, triethylene glycol diacetate, triethyl citrate, ethyl myristate, isopropyl myristate, methyl stearate, dimethyl dodecanedioate, dimethyl tetradecanedioate, and mixtures thereof (Crooks, polyol and glycerin (same as glycerol) specifically listed in [0048] as preferred aerosol-forming material).
Regarding claim 21, modified Crooks teaches a delivery system as claimed in claim 1, wherein the tobacco material comprises dry ice expanded tobacco material (Crooks, dry ice expanded tobacco is listed in [0039]).
Regarding claim 23, modified Crooks teaches a delivery system as claimed in claim 21, leaf tobacco comprising sugars and nicotine in a weight ratio of between about 8:1 and about 20:1 or between about 8:1 and about 15:1 is present in the tobacco material in an amount of at least 5% by weight of the tobacco material (Scott, nicotine levels in cured leaf material from below detectable levels to about 5%, which overlaps with the claimed range (about 5% can be "at least 5%"), [0015]). Also see MPEP 2144.05 I. In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018) (the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality).
Regarding claim 27, modified Crooks teaches a delivery system as claimed in claim 21, as set forth above. Modified Crooks does not explicitly teach wherein the tobacco material comprises the leaf tobacco in an amount of between about 30% and about 50% by weight of the tobacco material. However, Crooks does teach wherein the tobacco material comprises the leaf tobacco in an amount of up to about 30% by weight of the tobacco material (up to about 30% Oriental tobacco leaf in an exemplary tobacco blend, [0042]). According to MPEP 2144.05.1. In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim as limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.), it would be obvious to use greater than 30% leaf tobacco due to the ranges overlapping. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used about 30% of the leaf tobacco in the tobacco material because the range taught in Crooks ([0042]) overlaps with the claimed range (see MPEP 2144.05.I. In re Woodruff).
Regarding claim 29, modified Crooks teaches a delivery system as claimed in claim 1, wherein the aerosol- generating material comprises the tobacco material in an amount of between about 20% and about 90% of the aerosol-generating material (Crooks, in [0049], aerosol forming material listed as between about 5% and 60%, making the tobacco amount between about 40% and 95%).
Regarding claim 30, modified Crooks discloses a delivery system as claimed in claim 1, wherein the tobacco material and/or the aerosolizable material is shredded and has a width of between about 0.01 and 1.5 mm (Dittrich, sheet shredded at 31 cpi ("cuts per inch"), which translates to 0.0323 inches or 0.82 mm, which is in the claimed range, [0036]).
Regarding claim 31, modified Crooks teaches a delivery system as claimed in claim 1, wherein the aerosolizable material does not comprise additional colorants and/or wherein the aerosol-generating material comprises a flavorant (colorants not mentioned in Crooks, and tobacco rod may contain flavoring materials, [0041]).
Regarding claim 33, modified Crooks teaches a delivery system as claimed in claim 1, wherein the aerosol provision system is a combustible aerosol-provision system (Crooks, [0036] mentions altering the combustion properties meaning the device must be combustible),
optionally wherein the combustible aerosol provision system is substantially cylindrical in shape (Crooks, see Figure 1), optionally wherein the combustible aerosol-provision system has a circumference in the range 15 mm to 23 mm (Crooks, Figure 1, cigarette 10 has a circumference of about 17mm to 27mm, [0032]).
Regarding claim 36, modified Crooks discloses an aerosol delivery system as claimed in claim 1, as set forth above. Modified Crooks does not explicitly disclose that the cigarette is contained in a packet (or package).
However, it is reasonably suggested to one of ordinary skill in the art that cigarettes are to be sold commercially and therefore, it logically follows that the cigarettes need to be packaged for appropriate sale.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the cigarette of Crooks in a package in order to appropriately sell the cigarettes for the above reason.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Crooks et al. (US 2005/0066980; including Lawson et al. (US 4,836,224), which is incorporated by reference) in view of Dittrich et al. (US 2005/0034739) and Scott et al. (US 2013/0048000).
Regarding claim 26, modified Crooks teaches a delivery system as claimed in claim 1, as set forth above. Lawson (US 4,836,224, which is incorporated in Crooks by reference, see [0045] of Crooks), teaches wherein the tobacco material comprises nicotine in an amount of between about 1% and about 2.5% by weight of the tobacco material (majority of tobacco blends have a nicotine content from about 1.2% to 2.25%, col. 1 lines 17-22).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Crooks et al. (US 2005/0066980) in view of Dittrich et al. (US 2005/0034739).
Regarding claim 37, Crooks discloses a delivery system (Figure 1, cigarette 10, [0028]) comprising:
an aerosol-generating material comprising:
tobacco material (Figure 10, tobacco rod 12, [0028]), comprising leaf tobacco (Oriental tobacco leaf in an exemplary tobacco blend, [0042]); and
an aerosolizable material comprising:
an inorganic material (filler material incorporates inorganic components, [0036]),
a binder (binder included with aerosol forming material, [0051]); and
an aerosol-former material (tobacco blend contains aerosol forming
material, [0047]);
and an aerosol-modifying agent release component comprising an aerosol modifying agent (Figure 10, breakable capsule 54 carries a payload that changes the nature or character of the smoke (e.g., a flavoring agent), [0070]).
Crooks fails to disclose that the aerosolizable material is in the form of a shredded sheet and that the inorganic material is in an amount of 50% to 90% by weight of the aerosolizable material. Dittrich teaches a similar smoking article including a smokable (i.e. aerosolizable) filler material in the form of a shredded sheet (smoking material is produced in a sheet then shredded, [0036]) and the aerosolizable material comprises an inorganic material in an amount of 50% to 90% by weight of the aerosolizable material (smoking material contains chalk (an inorganic material in an amount of 74%, [0036]). Dittrich also teaches that it is desired to reduce the amount of tobacco material in smoking articles in order to reduce the potential health problems associated with tobacco [0002] and that the formulation using chalk increased the static burn rate of the smoking article [0037]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Crooks to incorporate the teachings of Dittrich to provide the smokable filler material in the form of a shredded sheet and chalk in the shredded sheet at an amount of 74% because doing so would reduce the amount of tobacco material in smoking articles in order to reduce the potential health problems associated with tobacco and using chalk increases the static burn rate of the smoking article, as recognized by Dittrich [0002] and [0037].
Response to Arguments
Applicant's arguments filed October 9, 2025 have been fully considered but they are not persuasive.
-Applicant argues that Scott et al discloses reducing sugar to total alkaloid ratios (10:1 to 25:1) rather than total sugar to nicotine ratios, and that the batch data in Tables 6 and 7 of Scott et al reflect total sugar total alkaloid ratios of 38:1 to 77:1, which fall outside the claimed 8:1 to 20:1 range. The Examiner disagrees. While Applicant correctly distinguishes between reducing sugars and total sugars, Applicant’s narrow focus on the specific data in Tables 6 and 7 overlooks the broader disclosure in Scott et al, as well as the standard chemical range of leaf tobaccos taught across the combined references. A reference must be evaluated for all that is reasonably teaches to one of ordinary skill in the art, not merely its specific working examples (MPEP 2144.05). Scott explicitly discloses broad parameter ranges for both total alkaloids (nicotine) and sugars in leaf tobacco. Combining Scott et al’s disclosed total sugar range with Scott et al’s disclosed leaf nicotine range yields a calculated total sugar to nicotine weight ratio which directly overlaps and encompasses the clamed range of 8:1 to 20:1. As such, the claims remain obvious under 35 USC 103 over the prior art of record.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIONNE WALLS MAYES whose telephone number is (571)272-5836. The examiner can normally be reached Mondays and Thursdays, 8:00AM - 4:00PM (EST).
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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.
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/DIONNE W. MAYES/ Primary Examiner, Art Unit 1747
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