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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/31/2026 has been entered.
Status of the Claims
Claims 1, 3-12, 14-16 and 18-22 are pending.
Claim 1, 3, 4, 7, and 22 have been amended.
Claim 2, 13, and 17 have been canceled.
Response to Arguments
Applicant' s arguments, filed 3/31/2026 have been fully considered and are persuasive. The Applicant has amended claim 1 to include limitations that were not previously presented, specifically that the soluble fiber including psyllium, inulin, arabinoxylans, beta-glucans, or any combination thereof. The prior art of record does not appear to disclose the new limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art, Goggin (US 20050002993), in combination with previously applied prior art.
Claim Rejections - 35 USC § 103
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.
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(s) 1, 3-12, 14-16 and 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 20130118512) in view of Goggin (US 20050002993) and further in view of Robinson (US 20080173317).
Regarding claims 1, 6, 8, 9 and 18, Jackson teaches a method of forming a dissolvable-chewable tobacco tablet ([0067]-[0068]).
Jackson teaches a molten mixture including a soluble fiber in an amount of about 10% or greater ([0038]), a sugar alcohol such as mannitol and sorbitol ([0039]) in an amount of about 20 % or more ([0041]), tobacco or a tobacco derivative ([0020]-[0021]), and water ([0055]), wherein the moisture content is about 5 to about 20 wt % ([0065]), thus the claimed range is prima facie obvious in view of the teachings of Jackson.
Jackson teaches adding the molten mixture to an extruder ([0063]-[0064]) and heating the molten mixture ([0055]) to a temperature between 160 F, or 71 C, to 251 F, or 122 C (Examples 1-6, [0077]-[0088]). Jackson expressly teaches that the extrusion equipment includes a single machine capable of achieving multiple steps of the processes described herein, such as, for example, kneader systems available from Buss AG ([0064]). Thus, the molten mixture temperature during mixing would be the same as the temperature at “an extruder” as it is the same machine.
It is interpreted that the soluble fiber, sugar alcohol and tobacco must be in powder form in order to powder mix. Jackson teaches that the tobacco material is in powder form ([0020]) and the soluble fiber, rice, is made up of fine granules, or powder ([0036]).
Jackson does not expressly teach (a) that the soluble fiber including psyllium, inulin, arabinoxylans, beta-glucans, or any combination thereof, (b) the form of the sugar alcohol, and (c) forming the molten mixture by powder mixing for a period of time the soluble fiber, the sugar alcohol and the tobacco to form a powder mixture, and then adding the powder mixture and water to the extruder.
With respect to (a), Goggin teaches a confectionary product for delivering a pharmaceutically active agent (abstract). Goggin teaches including soluble fibers in the product, wherein an example of a suitable soluble fiber is cereal beta-glucan ([0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included cereal beta-glucan, disclosed by Goggin, as the soluble fiber in the product of dissolvable-chewable tobacco tablet of Jackson, with a reasonable expectation of success and predictable results.
With respect to (b) and (c), Robinson teaches smokeless tobacco products that are non-chewable tobacco products that are placed in the mouth of a user, and dispense or disperse tobacco to the user via the mouth ([0078]). Robinson teaches powder mixing for a period of time soluble fiber (specifically rice starch), sugar alcohol (specifically mannitol), and tobacco to form a powder mixture ([0088]-[0089]). Robinson further teaches adding a powder mixture to an extruder (specifically Automatic Pasta Maker) and then an aqueous solution is added to the powder mixture which is in the extruder, and mixed again. Then that molten mixture is extruded from the extruder ([0084]).
Robinson teaches it is a powder mixture, or a dry mixture, thus the mannitol is inherently in a powder or granulated form, or in the alternative, it would have been obvious to make the mannitol into a powder or granulated form as that is a dry form that allows for dry mixing.
It would have been obvious for one of ordinary skill in the art at the time of filing to have powder mixed the soluble fiber, the sugar alcohol and the tobacco together to form a powder mixture, and then added the powder mixture and water to the extruder, as taught by Robinson, in the invention of Jackson with a reasonable expectation of success and predictable results. The courts have held that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (see MPEP 2144.04 IV C).
Regarding the limitations, “the molten mixture being free of cross-linking between the sugar alcohol and cross-linking between the sugar alcohol and the soluble fiber” and “a glass transition temperature of the molten mixture being in a range of -40 °C and 30 °C”, these limitations are a result of the method (see paragraph [0061] of the published application). Thus, since the claimed method steps and claimed components of the tablet are taught by Jackson, these limitations are inherently met. Case law holds that a material and its properties are inseparable. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01 II.
Regarding claims 3 and 19, modified Jackson teaches that the method further comprises contacting a plasticizer, specifically glycerin, to the molten mixture (Jackson, [0046]) which is added to the extruder.
Regarding claim 4, modified Jackson teaches that the method further comprises: dividing the molten mixture to form a plurality of individual tablets, each tablet of the plurality of individual tables sized to be at least partially received in an oral cavity of an adult tobacco consumer (Jackson, [0070]).
Regarding claims 5 and 20, modified Jackson teaches that the method further comprises at least partially coating one or more of the plurality of individual tablets, the coating including methylcellulose and a sweetener (Jackson, [0071]-[0072]), wherein example sweeteners are sorbitol and xylitol (Jackson, [0008]).
Regarding claim 7, modified Jackson teaches that one or more soluble fibers can be included (Jackson, [0027]) and that the soluble fiber also includes maltodextrin (Jackson, TABLE 1).
Regarding claim 10, modified Jackson teaches that the tobacco or the tobacco derivative is present in the molten mixture in an amount ranging from about 5 weight percent to about 70 weight percent tobacco (Jackson, [0024]).
The teaching in Jackson of “about 5 weight percent tobacco” ([0024]) meets the claim limitation, “an amount of the tobacco ranging from 1 weight percent to 4 weight percent of the tablet.” The courts have held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) See also Ortho-McNeil Pharm, Inc. v. Caraco Pharm Labs, Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007) wherein the court construed the term "about 1:5" to mean "approximately 1:5, encompassing a range of ratios no greater than 1:3.6 to 1:7.1".
Regarding claims 11 and 12, modified Jackson teaches that the tobacco or the tobacco derivative has an average fiber size of about 50 microns (Jackson, [0020]).
Regarding claims 14 and 15, modified Jackson teaches that the method further comprises cooling the molten mixture to ambient temperature to form a cooled mixture, the cool mixture including a matrix defined by the soluble fiber and the sugar alcohol (Jackson, [0060]-[0062]).
Regarding claim 16, modified Jackson teaches that the method further comprises: portioning the cooled mixture into the plurality of individual tablets, by placing the mixture into a tablet shaped mold (Jackson, [0070]).
Regarding claim 21, modified Jackson does not explicitly teach rounding edges of at least a portion of the plurality of individual tablets, however, it would have been obvious for one of ordinary skill in the art at the time of the invention to have rounded the edges of the tablet so that the edges don’t cause the user discomfort when the tablet is placed into the user’s mouth and because Jackson teaches that the product may be provided in any suitable shape or form including a coin or bead. Therefore, if the product is to be provided in a shape that has rounded edges, it would be obvious for one of ordinary skill to reasonably modify the method disclosed by modified Jackson to include a step of rounding edges.
Regarding claim 22, modified Jackson teaches including the soluble fiber in an amount of about 10% or greater (Jackson, [0038]), and, a sugar alcohol such as mannitol and sorbitol (Jackson, [0039]) in an amount of about 20% or more (Jackson, [0041]). The claimed ranges are prima facie obvious in view of these teachings of modified Jackson.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YANA B KRINKER whose telephone number is (571)270-7662. The examiner can normally be reached Monday, Wednesday, Thursday and Friday.
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YANA B. KRINKER
Examiner
Art Unit 1755
/YANA B KRINKER/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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