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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
Claims 1, 4, 8, 16, and 19 are amended. Claims 12 and 13 are cancelled. Claims 21-23 are newly added.
Response to Arguments
Applicant's amendments and arguments filed June 12, 2026 with respect to the rejections under §102 and §103 have been fully considered and are not persuasive. Regarding Hunt paragraph [0070], Applicant argues, Remarks page 7, the amended claim 1 temperature of 10 oC to 35 oC neither overlaps with nor is close to that of Hunt and a prima facie case of obviousness is no longer established based on Hunt et al. ‘494. Applicant’s Remarks page 8, argue Hunt et al. ‘494 does not provide any suggestions to lower such drying temperature to less than 40 oC. Applicant is essentially arguing Hunt is limited to the temperatures cited in paragraph [0070]. However, Hunt paragraph [0099] discloses drying tobacco coated spheres while using an alternative binding solution consisting of 10% (w/w) PLASDONE.RTM. K29/32, 45% water, and 45% ethanol in a rotor granulator run using a fluid bed air exhaust temperature of 15.2 - 17.7 oC. These spheres are allowed to dry for 3 hours in the rotor granulator with the resulting moisture content measured at below 6% by LOD balance. This anticipates the claimed temperature ranges of amended claims 1 and 4 .
This Office action is a second non-final to address the rejection of claim 20 which was inadvertently missed by the Examiner in the non-final action dated March 24, 2026.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitation “at temperature of 10o C to 35o C.” in the last line of the claim should read “at a temperature of 10o C to 35o C.” Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-7, 10, 17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunt et al. (US 2012/0055494).
Regarding claims 1-2, 4, and 7, Hunt discloses a method for making a smokeless tobacco composition that involves first forming a granulation mixture, granulating the granulation mixture, and then blending the resultant granules with further blending components. The material can then be formed into a predetermined shape, such as by compression or extrusion, (Abstract, [0008]). The invention provides a smokeless tobacco product suitable for insertion in the oral cavity that includes a tobacco material and an effervescent material, ([0016]). The tobacco material is provided in a finely divided or powder form (reads over a tobacco raw material powder of claim 1). The tobacco material (i.e., the flavoring material) typically has an average size of about 10 to about 100 microns, which is encompassed by the claimed average size range of 100 µm or less of claim 1, ([0032]). In certain preferred embodiments, the smokeless tobacco product is in the form of a compressed or molded pellet (reads over a flavoring molded body of claim 10), wherein the pellet can have any variety of shapes, including traditional pill or tablet shapes, ([0050]). The smokeless tobacco product being suitable for insertion in the oral cavity and preferably in the form of a compressed pellet in a variety of shapes, including traditional tablet shapes, (reads over the flavoring molded body is tobacco for oral use of claim 7).
In one embodiment, the process for making the compressed pellet involves first forming a tobacco-containing granulation mixture, granulating the mixture by the addition of a binder solution to produce an intermediate granular product, then blending the granules with a second composition to form the final pellet composition, wherein the granulation mixture is typically relatively dry that is mixed with a binder solution. The granulation material is mixed with a binder solution (e.g., by spraying the binder solution into the granulator) (reads over the mixing limitation of claim 1), ([0051]). The binder solution will typically have a solids content of about 5 to about 20 percent (w/w), and preferred solvents include water and ethanol (reads over a 2-carbon alcohol of claim 1 and the listing of alcohols of claim 2), ([0052]).
Hunt additionally discloses drying tobacco coated spheres while using an alternative binding solution consisting of 10% (w/w) PLASDONE.RTM. K29/32, 45% water, and 45% ethanol in a rotor granulator run using a fluid bed air exhaust temperature of 15.2 - 17.7 oC. These spheres are allowed to dry for 3 hours in the rotor granulator with the resulting moisture content measured at below 6% by LOD balance ([0099]). This anticipates the temperature ranges of claims 1 and 4.
Regarding claims 5 and 14, Hunt discloses the hardness of the smokeless tobacco product is typically at least about 5 kp (kiloponds) (49 N) to about 20 kp (196 N) using a hardness tester such as a Varian VK 200 or equivalent, ([0072]); which anticipates the claimed range of 10 to 200 N of claims 5 and 14.
Regarding claims 6, 17, and 20, Hunt discloses at least a portion of the plant of the Nicotiana species (e.g., at least a portion of the tobacco portion) can be employed in a mature form, for example, Virginia tobacco leaves can be harvested or primed by stalk position, ([0030]). The tobacco material is typically used in a form that can be described as shredded, ground, granulated, fine particulate, or powder form (anticipates fine leaf tobacco powder), ([0032]). This anticipates claims 6, 17, and 20.
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.
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt et al. (US 2012/0055494).
Regarding claim 16, Hunt discloses the hardness of the smokeless tobacco product is typically at least about 5 kp (kiloponds) (49 N) to about 20 kp (196 N) using a hardness tester such as a Varian VK 200 or equivalent, ([0072]), which reads over the claimed range of 10 to 200 N of claim 16.
Regarding claim 19, Hunt discloses at least a portion of the plant of the Nicotiana species (e.g., at least a portion of the tobacco portion) can be employed in a mature form, for example, Virginia tobacco leaves can be harvested or primed by stalk position, ([0030]). The tobacco material is typically used in a form that can be described as shredded, ground, granulated, fine particulate, or powder form (reads over fine leaf tobacco powder), ([0032]). This reads over claim 19.
Claims 3, 11, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt et al. (US 2012/0055494) as applied to claims 1 and 2 above, and further in view of Cantrell et al. (US 2012/0138073, cited on 11/28/2023 IDS).
Regarding claims 3 and 11, Hunt discloses all the claim limitations as set forth above. As discussed in the rejection of claim 1, Hunt [0052] discloses ethanol as a preferred solvent for the binder solution. However, Hunt does not explicitly disclose the claimed parts by mass ratio of alcohol to tobacco raw material powder.
Cantrell teaches a smokeless tobacco composition suitable for use as a smokeless tobacco product for oral use is prepared in the following manner, ([0054]. A tobacco material having an average particle size of less than about 100 microns is mixed with a salt, sucralose and a binder material and is mixed with a 70% sugar solution comprising an emulsifier, corn syrup, glycerin (reads over an alcohol), and a flavorant to form a liquid blend. The liquid blend is added to the Hobart mixing bowl containing tobacco and binder material for admixing in the mixing bowl. The smokeless tobacco composition is extruded through a grinder apparatus and placed into a Hobart mixer to form a powder granulation. The mixture composition is about 28 parts binder material, 30.7 parts tobacco material, 0.5 parts emulsifier, 32.1 parts sugar solution, 3.5 parts corn syrup, 2.1 parts glycerin, 1.8 parts salt, 0.2 parts sucralose, and 1 part flavorant, ([0060]).
Therefore, the ratio of parts glycerin to parts tobacco material is 2.1 glycerin parts to 30.7 parts tobacco material (1 part alcohol to 14.6 parts tobacco material) is encompassed by the claimed ratio of 1 to 20 parts by mass of alcohol to 100 parts by mass of tobacco raw material powder (e.g., 1:100 parts of alcohol to parts of tobacco raw material powder to 1:5 parts of alcohol to parts of tobacco raw material powder).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice Hunt with ethanol in a ratio of 2.1 parts to 30.7 parts tobacco material (i.e., 1 part alcohol to 14.6 parts tobacco power material) for the benefit of a smokeless tobacco composition suitable for use as a smokeless tobacco oral product for oral use as taught by Cantrell. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). This reads over claims 3 and 11.
Regarding claim 15, Hunt discloses the hardness of the smokeless tobacco product is typically at least about 5 kp (kiloponds) (49 N) to about 20 kp (196 N) using a hardness tester such as a Varian VK 200 or equivalent, ([0072]), which reads over the claimed range of 10 to 200 N of claim 15.
Regarding claim 18, Hunt discloses at least a portion of the plant of the Nicotiana species (e.g., at least a portion of the tobacco portion) can be employed in a mature form, for example, Virginia tobacco leaves can be harvested or primed by stalk position, ([0030]). The tobacco material is typically used in a form that can be described as shredded, ground, granulated, fine particulate, or powder form (reads over fine leaf tobacco powder), ([0032]). This reads over claim 18.
Allowable Subject Matter
Claims 8-9 and 21-23 are allowed. The following is a statement of reasons for allowance: claim 8 is allowed for the reasons put forth in the non-final Office Action dated March 24, 2024, pages 7-8.
Claims 9 and 21-23 are allowed due to dependency.
Conclusion
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/RONNIE KIRBY JORDAN/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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