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.
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, 5-7, 10, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunt et al. (US 2012/0055494).
Regarding claims 1-2 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 (anticipates 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, anticipating 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 (anticipates a flavoring molded body of claim 1), 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 anticipates 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) (anticipates 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 (anticipates a 2-carbon alcohol of claim 1 and the listing of alcohols of claim 2), ([0052]).
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 and 17, 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 and 17.
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 4, 12, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt et al. (US 2012/0055494).
Regarding claims 4 and 12, Hunt discloses the tobacco formulation may be oven-dried, in warmed air at temperatures of about 40o C to about 95o C which overlaps the claimed range of 10o C to 40o C. 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 4 and 12.
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, 13, 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 include Hunt the ethanol in a ratio of 2.1 parts to 30.7 parts (i.e., 1 part alcohol to 14.6 parts tobacco power material) tobacco material 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 13, Hunt discloses the tobacco formulation may be oven-dried, in warmed air at temperatures of about 40o C to about 95o C which overlaps the claimed range of 10o C to 40o C. 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 claim 13.
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 and 9 are 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 following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 8, the prior art of record, Hunt (US 2012/0055494 A1), discloses the flavoring molded body of claim 1. However, Hut does not explicitly disclose or at least reasonably suggest adding the flavoring molded body to a dispersion medium to prepare a tobacco material including the dispersion medium and the tobacco raw material powder dispersed in the dispersion medium.
Chida (EP 2957183 A1, cited on 11/28/2023 IDS) teaches uniformly imparting a smoking flavor to tobacco products such as smoking articles using a tobacco material containing leaf tobacco particles having an average particle size of 30 µm or less and a liquid dispersion medium for dispersing the particles, ([0011]-[0012]). Because the tobacco material of the invention is obtained by dispersing the tobacco leaf particles in a liquid dispersion medium, the tobacco material can take the form of a slurry which is obtained by the liquid dispersion medium and the leaf tobacco particles are typically mixed in a weight ratio of generally 1 part of leaf tobacco per 1.5 to 99 parts by weight of tobacco material. The tobacco material is evenly and uniformly added to the smoking article by, for example, using a spray or the like to apply the inventive tobacco material to the smoking article which uniformly imparts the tobacco material to the tobacco product, ([0042]-[0044]). Chida does not teach nor reasonably suggest preparing a flavoring molded body by the method of claim 1 and adding the flavoring molded body to a dispersion medium in order to prepare a tobacco material that includes the dispersion medium and the tobacco raw material powder material dispersed in the dispersion medium.
Considering the above prior art, it is unclear how one of ordinary skill in the art would arrive at the claimed invention without the use of hindsight.
Claim 9 is objected to due to dependency on an objected base claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONNIE KIRBY JORDAN whose telephone number is 571-272-5214. The examiner can normally be reached M-F 8AM - 4PM (EST).
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/RONNIE KIRBY JORDAN/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747