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 Arguments
Applicant’s arguments filed on 03/25/2026 have been fully considered but are moot in view of Applicant’s amendment to independent claim 1.
Applicant has amended independent claim 1 to include new limitations, including that the filling material is void of any liquid fractions or liquid extracts derived from a part of any member of a plant of the genus Nicotiana and/or one or more components isolated therefrom. The amendment materially changes the scope of the independent claim and necessitated further consideration of the prior art. Accordingly, the prior rejection based on Dube has been withdrawn and replaced with new grounds of rejection relying on different prior art that better addresses the claims as amended.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 4, 5, 9, 11, 12, 15, 16, 21, and 22 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Chapman et al. (U.S. 2016/0157515).
Regarding claim 1, Chapman teaches a filling material for use in an oral pouched smokeless product, the filling material comprising tobacco material (a pouched product containing a composition adapted for oral use, wherein the composition may comprise particulate tobacco material) (¶ [0035]).
wherein the total tobacco material content of the filling material consists of tobacco material derived from tobacco stalks, tobacco roots, tobacco flowers, or combinations thereof (the tobacco material may comprise any selected portion of a plant of the genus Nicotiana, including stalks, roots, and flowers, which may be isolated for further use) (¶ [0045]). Selection of an isolated stalk, root, or flower portion provides a filling in which the tobacco material is derived from one or more of the recited plant portions.
wherein the filling material is void of any liquid fractions or liquid extracts derived from a part of any member of a plant of the genus Nicotiana and/or one or more components isolated therefrom (the selected plant material may be physically processed into particulate, shredded, ground, granular, or powder form) (¶ [0047]). Chapman separately describes tobacco extracts only as an optional feature of certain embodiments (¶ [0048]); therefore, Chapman directly discloses particulate-tobacco embodiments that do not contain a tobacco liquid fraction or liquid extract.
Regarding claim 2, Chapman teaches the filling material of claim 1 comprising isolated stalk-, root-, or flower-derived tobacco material. Applicant’s specification acknowledges that stalks, roots, and flowers naturally have a lighter appearance than commonly used tobacco leaf and stem material. Accordingly, Chapman’s filling material comprising those naturally lighter plant portions is inherently light-coloured.
Regarding claim 4, Chapman teaches wherein the tobacco material is non-bleached because Chapman states that the tobacco material may optionally be subjected to treatments including bleaching (¶ [0046]). The disclosed embodiment in which the optional bleaching treatment is not performed comprises non-bleached tobacco material.
Regarding claim 5, Chapman teaches wherein the filling material further comprises non-tobacco plant material (the pouch composition may comprise one or more releasable components, including particulate tobacco material together with particulate non-tobacco material or fibrous plant material) (¶ [0035]).
Regarding claim 9, Chapman teaches wherein the non-tobacco plant material comprises or consists of fibres or particles from non-tobacco plants (particulate non-tobacco material and fibrous plant material may be included in the pouch composition) (¶ [0035]).
Regarding claim 11, Chapman teaches the filling material containing further ingredients, wherein the further ingredients comprise stabilizers, humectants, plasticisers, thickeners, dyes, salts, flavours, gum base, flavour additives, or any combination thereof (representative excipients and additional ingredients include fillers or carriers, thickeners, film formers and binders, buffers and pH-control agents, salts, humectants, sweeteners, and natural or artificial flavors) (¶ [0051]).
Regarding claim 12, Chapman teaches wherein the tobacco material is shredded, threshed, cut, ground, cured, fermented, processed, pasteurized, or reconstituted (the tobacco material may be provided in particulate, shredded, ground, granular, or powder form) (¶ [0047]).
Regarding claim 15, Chapman teaches an oral pouched smokeless product comprising the filling material of claim 1 (a water-permeable fabric pouch containing a composition adapted for oral use) (¶ [0037]).
Regarding claim 16, Chapman teaches wherein the total tobacco material content of the filling material consists of tobacco material derived from tobacco stalks, tobacco roots, or combinations thereof (selected portions of a Nicotiana plant, including stalks and roots, may be isolated for use in the tobacco composition) (¶ [0045]).
Regarding claim 21, Chapman teaches wherein the non-tobacco plant material comprises or consists of fibres or particles from non-tobacco plants, the non-tobacco material comprising or consisting of wheat fibres, oat fibres, potato fibres, bamboo fibres, buckwheat fibres, barley fibres, microcrystalline cellulose, and/or combinations thereof (the particulate non-tobacco material may comprise microcrystalline cellulose) (¶ [0035]). Because the claim recites the listed materials in the alternative, Chapman’s express disclosure of microcrystalline cellulose satisfies the limitation.
Regarding claim 22, Chapman teaches wherein the filling material contains further ingredients, wherein the further ingredients further comprise NaCl, NH₄Cl, Na₂CO₃, propylene glycol, one or more flavours, and/or combinations thereof (the composition may contain natural or artificial flavors) (¶ [0051]). Because the claim recites the identified ingredients in the alternative, the disclosure of one or more flavors satisfies the limitation.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3, 6, 10, 13, 17, and 18 are rejected under 35 U.S.C. § 103 as being unpatentable over Chapman et al. (U.S. 2016/0157515) in view of Kannisto et al. (U.S. 2020/0297026).
Regarding claim 3, Chapman, as applied to claim 1 above, teaches the claimed filling material, but does not expressly teach wherein the filling material comprises tobacco material in a concentration of 0.1 to 15 weight-%, wherein indications in weight-% are based on the dry weight of the total filling material.
Chapman and Kannisto are in the same field of endeavor because both references concern filling compositions for oral pouched nicotine or smokeless products.
Kannisto teaches a moist filling material comprising about 0.1 to about 10 weight-% tobacco material based on the total weight of the moist filling material (¶ [0058]). Kannisto teaches that the filling material may have a moisture content of about 35 to about 55 weight-% based on the total weight of the moist filling material (¶ [0062]). Kannisto defines a dry-weight percentage as the amount of an ingredient relative to the total weight of the ingredients excluding moisture (¶ [0037]).
At Kannisto’s disclosed moisture content of 35 weight-%, the dry portion constitutes 65 weight-% of the filling material. Kannisto’s disclosed tobacco range therefore corresponds to:
0.1 weight-% (tobacco, moist basis) ÷ 0.65 (dry fraction) = 0.154 weight-% tobacco based on the dry weight of the filling material; and
10 weight-% (tobacco, moist basis) ÷ 0.65 (dry fraction) = 15.38 weight-% tobacco based on the dry weight of the filling material.
Thus, Kannisto’s disclosed tobacco range, when expressed on the claimed dry-weight basis, overlaps the claimed range of 0.1 to 15 weight-%.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to use Kannisto’s disclosed low tobacco concentration in Chapman’s oral-pouch filling because Kannisto expressly identifies such concentrations as suitable for a moist oral pouched nicotine-tobacco product (¶ [0041]). Applying Kannisto’s low-tobacco proportions to Chapman’s stalk-, root-, or flower-derived tobacco material would predictably provide a moist oral-pouch filling containing a reduced amount of tobacco.
Regarding claim 6, Chapman, as applied to claims 1 and 5 above, teaches the filling material comprising non-tobacco plant material, but does not expressly teach wherein the filling material comprises non-tobacco plant material in a concentration of 70 to 99 weight-%, wherein the indications in weight-% are based on the dry weight of the total filling material.
Kannisto teaches that the moist filling material may comprise about 30 to about 80 weight-% particulate non-tobacco material, based on the total weight of the moist filling material (¶ [0074]). Kannisto also teaches that the moist filling material may have a moisture content of about 35 to about 55 weight-%, based on the total weight of the moist filling material (¶ [0062]).
Kannisto expresses the particulate non-tobacco material amount on a moist-weight basis, while claim 6 expresses the amount on a dry-weight basis. At Kannisto’s disclosed moisture content of 35 weight-%, the dry portion of the filling material is 65 weight-%, i.e., 1 − 0.35 = 0.65.
A moist-basis amount of 50 weight-% particulate non-tobacco material is selected from Kannisto’s disclosed range of about 30 to about 80 weight-%. When converted to a dry-weight basis, that selected amount corresponds to:
50 weight-% (particulate non-tobacco material, moist basis) ÷ 0.65 (dry fraction)= 76.92 weight-% particulate non-tobacco material based on the dry weight of the filling material.
The resulting concentration falls within the claimed range of 70 to 99 weight-%.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to use Kannisto’s disclosed amount of particulate non-tobacco material in Chapman’s filling because Kannisto teaches particulate non-tobacco material as a principal component of the moist oral-pouch filling (¶ [0057]). The modification would predictably provide a bulk or carrier material while retaining Chapman’s stalk-, root-, or flower-derived tobacco material.
Regarding claim 10, Chapman does not expressly teach wherein the filling material comprises a water content of 25 to 55 weight-% based on the total weight of the filling material.
Kannisto teaches that the moist filling material may have a moisture content of about 35 to about 55 weight-% based on the total weight of the moist filling material (¶ [0062]), which falls within the claimed range.
Therefore, it would have been obvious to provide Chapman’s filling material with Kannisto’s disclosed moisture content because Kannisto identifies that moisture range as suitable for the same type of moist oral-pouch filling.
Regarding claim 13, Chapman, as applied to claims 1, 5, and 11 above, teaches a filling material comprising stalk-, root-, or flower-derived tobacco material, non-tobacco plant material, and further ingredients, but does not expressly teach wherein the filling material comprises or consists of 0.1 to 15 weight-% tobacco material; 70 to 99 weight-% non-tobacco plant material; and 0 to 30 weight-% further ingredients, wherein the indications in weight-% are based on the dry weight of the total filling material; and wherein the filling material has a water content of 25 to 55 weight-% based on the total weight of the filling material.
Kannisto teaches a moist oral-pouch filling comprising particulate non-tobacco material, tobacco material, nicotine source, flavoring agent, pH-adjusting agent, and monoglyceride (¶ [0057]). Kannisto teaches about 0.1 to about 10 weight-% tobacco material (¶ [0058]), about 30 to about 80 weight-% particulate non-tobacco material (¶ [0074]) and a moisture content of about 35 to about 55 weight-% (¶ [0062]).
Kannisto expresses the tobacco and particulate non-tobacco material amounts on a moist-weight basis, while claim 13 expresses the dry ingredients on a dry-weight basis. At Kannisto’s disclosed moisture content of 35 weight-%, the dry portion of the filling material is 65 weight-%, i.e., 1 − 0.35 = 0.65.
For example, selecting mutually compatible values within Kannisto’s disclosed formulation framework, including 5 weight-% tobacco material, 50 weight-% particulate non-tobacco material, 10 weight-% further ingredients, and 35 weight-% water, results in a dry portion of 65 weight-%. The corresponding dry-basis concentrations are:
5 weight-% (tobacco material, moist basis) ÷ 0.65 (dry fraction)= 7.69 weight-% tobacco material, dry basis;
50 weight-% (particulate non-tobacco material, moist basis) ÷ 0.65 (dry fraction)= 76.92 weight-% particulate non-tobacco material, dry basis; and
10 weight-% (further ingredients, moist basis) ÷ 0.65 (dry fraction)= 15.38 weight-% further ingredients, dry basis.
The converted amounts fall within the respective claimed ranges, and the selected 35 weight-% water content falls within the claimed water range.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to formulate Chapman’s filling using amounts selected from Kannisto’s disclosed ranges because Kannisto teaches those formulation components and proportions for the same type of moist oral-pouch product. Applying those proportions to Chapman’s identified tobacco source would predictably provide a low-tobacco, high-non-tobacco-material filling containing conventional further ingredients.
Regarding claim 17, Chapman, as applied to claims 15 and 16 above, teaches the claimed oral pouched smokeless product, but does not expressly teach wherein the filling material comprises tobacco material in a concentration of 0.1 to 10 weight-%, wherein indications in weight-% are based on the dry weight of the total filling material.
Kannisto teaches a moist filling material comprising about 0.1 to about 10 weight-% tobacco material, based on the total weight of the moist filling material (¶ [0058]). Kannisto further teaches that the moist filling material may have a moisture content of about 35 to about 55 weight-%, based on the total weight of the moist filling material (¶ [0062]).
Kannisto expresses the tobacco amount on a moist-weight basis, while claim 17 expresses the tobacco amount on a dry-weight basis. At Kannisto’s disclosed moisture content of 35 weight-%, the dry portion of the filling material is 65 weight-%, i.e., 1 − 0.35 = 0.65.
To correspond to the upper end of claim 17’s dry-basis range, a moist-basis tobacco amount of 6.5 weight-% is selected from Kannisto’s disclosed tobacco range:
10 weight-% (claimed tobacco, dry basis) × 0.65 (dry fraction)= 6.5 weight-% tobacco, moist basis.
The selected moist-basis tobacco amount of 6.5 weight-% falls within Kannisto’s disclosed range of about 0.1 to about 10 weight-% tobacco material. When converted back to a dry-weight basis, that selected value provides the upper end of the claimed range:
6.5 weight-% (tobacco, moist basis) ÷ 0.65 (dry fraction)= 10 weight-% tobacco, dry basis.
Kannisto’s disclosed lower endpoint of 0.1 weight-% tobacco on a moist basis also converts to:
0.1 weight-% (tobacco, moist basis) ÷ 0.65 (dry fraction)= 0.154 weight-% tobacco, dry basis.
Thus, Kannisto’s disclosed tobacco range, when converted using Kannisto’s disclosed 35 weight-% moisture content, overlaps the claimed dry-basis range of 0.1 to 10 weight-%.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select tobacco and moisture amounts within Kannisto’s disclosed ranges that provide the claimed dry-basis tobacco concentration because Kannisto teaches low tobacco amounts as suitable for the same type of oral pouched nicotine-tobacco product (¶ [0041]).
Regarding claim 18, Chapman, as applied to claims 15 and 16 above, teaches the claimed oral pouched smokeless product, but does not expressly teach wherein the filling material comprises tobacco material in a concentration of 2 to 8 weight-%, wherein indications in weight-% are based on the dry weight of the total filling material.
Kannisto teaches a moist filling material comprising about 0.1 to about 10 weight-% tobacco material, based on the total weight of the moist filling material (¶ [0058]). Kannisto further teaches that the moist filling material may have a moisture content of about 35 to about 55 weight-%, based on the total weight of the moist filling material (¶ [0062]).
Kannisto expresses the tobacco amount on a moist-weight basis, while claim 18 expresses the tobacco amount on a dry-weight basis. At Kannisto’s disclosed moisture content of 35 weight-%, the dry portion of the filling material is 65 weight-%, i.e., 1 − 0.35 = 0.65.
To correspond to the lower end of claim 18’s dry-basis range, a moist-basis tobacco amount of 1.3 weight-% is selected from Kannisto’s disclosed tobacco range:
2 weight-% (claimed tobacco, dry basis) × 0.65 (dry fraction)= 1.3 weight-% tobacco, moist basis.
To correspond to the upper end of claim 18’s dry-basis range, a moist-basis tobacco amount of 5.2 weight-% is selected from Kannisto’s disclosed tobacco range:
8 weight-% (claimed tobacco, dry basis) × 0.65 (dry fraction)= 5.2 weight-% tobacco, moist basis.
Both selected moist-basis tobacco amounts, 1.3 weight-% and 5.2 weight-%, fall within Kannisto’s disclosed range of about 0.1 to about 10 weight-% tobacco material. When converted back to a dry-weight basis, those selected values provide the claimed range:
1.3 weight-% (tobacco, moist basis) ÷ 0.65 (dry fraction)= 2 weight-% tobacco, dry basis; and
5.2 weight-% (tobacco, moist basis) ÷ 0.65 (dry fraction)= 8 weight-% tobacco, dry basis.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select tobacco and moisture amounts within Kannisto’s disclosed ranges that provide the claimed dry-basis tobacco concentration because Kannisto teaches low tobacco amounts as suitable for the same type of oral pouched nicotine-tobacco product (¶ [0041]).
Claims 7, 8, 19, and 20 are rejected under 35 U.S.C. § 103 as being unpatentable over Chapman et al. (U.S. 2016/0157515) in view of Kindvall (U.S. 2022/0248748).
Regarding claim 7, Chapman, as applied to claims 1 and 5 above, teaches particulate non-tobacco material, such as microcrystalline cellulose, treated to contain nicotine (¶ [0035]), but does not expressly teach wherein the non-tobacco plant material is coated with nicotine.
Chapman and Kindvall are in the same field of endeavor because both references concern nicotine-containing particulate filling materials for oral pouched products.
Kindvall teaches nicotine-containing particles having a core comprising cellulose and a first coating comprising a binder and a nicotine source applied on at least part of the outer surface of the core (¶ [0061]). Kindvall teaches that the core material may comprise microcrystalline cellulose (¶ [0080]). Kindvall teaches applying the coating to the particle cores using coating fluid-bed spraying (¶ [0145]).
Thus, Chapman expressly identifies nicotine-treated microcrystalline cellulose as a suitable component of an oral-pouch filling, while Kindvall teaches providing that same type of nicotine-containing cellulose material as particles having a nicotine-containing coating on their outer surfaces. Kindvall further teaches that distributing the nicotine source over the larger surface of the coated particles may increase initial nicotine release during oral use (¶ [0083]).
Therefore, it would have been obvious to provide Chapman’s nicotine-treated microcrystalline cellulose with Kindvall’s nicotine-containing surface coating in order to distribute the nicotine over a larger surface and thereby increase the initial release of nicotine. The resulting filling material would comprise non-tobacco plant material coated with nicotine.
Regarding claims 8, 19, and 20, Chapman in view of Kindvall, as applied to claim 7 above, teaches the nicotine-coated non-tobacco plant material, but does not expressly teach a nicotine content within the range of 0.1 to 10 weight-% as recited in claim 8, within the range of 1 to 5 weight-% as recited in claim 19, or within the range of 2.5 to 4.5 weight-% as recited in claim 20, wherein the indications in weight-% are based on the dry weight of the nicotine-coated non-tobacco plant material.
Kindvall teaches nicotine amounts including about 14 mg nicotine base per pouched product (¶ [0088]). Kindvall teaches filling each pouch with about 0.5 to 0.6 g of coated microcrystalline-cellulose particles (¶ [0181]). Kindvall teaches that the coated particles have a moisture content of 2.6 weight-% (¶ [0178]).
Selecting Kindvall’s disclosed 14 mg nicotine dose and 0.5 g coated-particle loading, the dry weight of the nicotine-coated microcrystalline-cellulose particles is:
0.5 g (nicotine-coated MCC particles) × [1 − 0.026 (moisture fraction)]= 0.487 g (dry nicotine-coated MCC particles).
The corresponding nicotine concentration is:
0.014 g (nicotine base) ÷ 0.487 g (dry nicotine-coated MCC particles) × 100= 2.87 weight-% nicotine based on the dry weight of the nicotine-coated MCC particles.
The resulting nicotine concentration of 2.87 weight-% falls within the range of 0.1 to 10 weight-% recited in claim 8, the range of 1 to 5 weight-% recited in claim 19, and the range of 2.5 to 4.5 weight-% recited in claim 20.
Therefore, it would have been obvious to employ Kindvall’s disclosed 14 mg nicotine dose in a pouch containing Kindvall’s disclosed 0.5 g quantity of nicotine-coated microcrystalline-cellulose particles because Kindvall identifies those amounts as suitable parameters for its oral pouched nicotine product and teaches that distributing the nicotine source over the coated-particle surface may increase initial nicotine release (¶ [0083]).
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art does not teach or reasonably suggest a filling material comprising the claimed combination of:
2 to 6 weight-% tobacco material derived from tobacco stalks, tobacco roots, tobacco flowers, or combinations thereof; 75 to 85 weight-% non-tobacco plant material; 3 to 9 weight-% NaCl; 4 to 10 weight-% ammonium chloride solution having an ammonium chloride concentration of 20 weight-%; 0.3 to 1.2 weight-% sodium carbonate; 2 to 5 weight-% propylene glycol; optionally one or more flavours; and a water content of 25 to 55 weight-%, with the dry constituents calculated on the dry weight of the total filling material.
Although the prior art individually teaches oral-pouch fillings containing tobacco material, non-tobacco plant material, water, salts, pH-adjusting agents, humectants, and flavors, the prior art does not disclose or provide sufficient reason to select the particular combination of ingredients and narrow quantitative ranges recited in claim 14. In particular, the prior art does not teach the claimed amount of a 20 weight-% ammonium chloride solution together with the claimed sodium-carbonate, sodium-chloride, propylene-glycol, tobacco, non-tobacco-material, and water ranges. Arriving at the claimed formulation would require selecting and combining narrowly defined values without a sufficient teaching or reason in the prior art.
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 JENNIFER KESSIE whose telephone number is (571)272-7739. The examiner can normally be reached Monday - Thursday 7:00am - 5:00pm.
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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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/JENNIFER A KESSIE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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