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 .
Status of Application
The Amendments and Remarks filed on 04/10/26 are acknowledged.
Claims 1 and 11 were amended.
Claims 1-13 are pending and included in the prosecution.
Response to Amendments/Arguments
Claim Objection
In light of the amendment of claim 11, the objection to this claim is withdrawn.
Rejections under 35 USC §§ 102(a)(1) and 103
Applicant amended claim 1 to recite that the particle size control solution does not contain the binder. In light of this amendment, Applicant’s arguments (Pages 6-8, filed 04/10/26) regarding the following rejections have been fully considered and are persuasive.
Rejection of claims 1-2 and 5-13 under 35 U.S.C. 102(a)(1) as being anticipated by Mua et al. (US 2013/0152953 A1 – “Mua”)
Rejection of claims 3-4 under 35 U.S.C. 103 as being unpatentable over Mua in view of Cantrell et al. (US 2012/0138074 A1 – “Cantrell”)
Since Mua and Cantrell do not teach or suggest a particle size control solution which does not contain the binder, the rejections based on these references are withdrawn.
However, upon further consideration of the amended claims, a new ground(s) of rejection is made over Mua et al. (US 2013/0152953 A1 – “Mua”) in view of Kӧster et al. (Pharmaceutics. 2021; 13(2):241, pp. 1-17 – “Koster”).
Since the new grounds of rejection were necessitated by Applicant’s amendment, this action is made FINAL.
Provisional double patenting rejections
The terminal disclaimer filed on 04/10/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Numbers 18/812,401; 18/813,174; 18/817,499; and 18/818,012 has been reviewed and is accepted. The terminal disclaimer has been recorded. The provisional double patenting rejections are withdrawn.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
New Rejections Necessitated by Amendment
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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.
Claims 1-2 and 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mua et al. (US 2013/0152953 A1 – “Mua”) in view of Kӧster et al. (Pharmaceutics. 2021; 13(2):241, pp. 1-17 – “Koster”).
Instant claim 1 is drawn to a method for preparing a pouch filling material comprising:
step S1 of preparing a solid-phase filling material comprising a binder;
step S2 of preparing a particle size control solution comprising a processing aid; and
step S3 of spraying the particle size control solution onto the solid-phase filling material while stirring the solid-phase filling material, wherein the particle size control solution does not contain the binder.
Mua discloses a method of preparing a smokeless tobacco composition adapted for oral use, the composition including a tobacco material and an effervescent material (Abstract, claims 1-34). The method includes (i) mixing a tobacco material with an effervescent material capable of causing effervescence in the oral cavity, the effervescent material comprising a sugar material containing an entrapped gaseous component, such that release of the entrapped gaseous component occurs upon dissolution of the sugar material in the oral cavity, wherein the mixing step comprises (a) admixing a granulated composition comprising a tobacco material with a gasified sugar material in particulate form; or (b) forming a gasified sugar material in situ by mixing a water source with a molten composition comprising a tobacco material and a sugar alcohol; and (ii) incorporating the mixture formed in step (i) into a smokeless tobacco product (claim 23). The mixture is in a particulate form and is loaded into a pouch ([0014], FIG. 1, [0083]-[0086], Examples 1-4 – [0089]-[0096], and claim 34). The composition includes at least about 2 dry weight percent of at least one binder ([0005], [0008], [0052], [0057]-[0058], [0064]-[0071], claims 1, 7-8, 17, and 23-24), wherein the binder includes povidone (polyvinylpyrrolidone), sodium alginate, xanthan gum, and gum Arabic ([0045]). Solvents for the binder solution include water and ethanol ([0066]). The granulation material is mixed with a binder solution (e.g., by spraying the binder solution into the granulator) and granulated to a desired particle size ([0065], [0090]). In an alternative embodiment, while maintaining the composition in molten form (e.g., maintain the molten material at a temperature of at least about 100° C. or at least about 125° C.), a source of water is introduced into the molten composition, typically while vigorously stirring or agitating the molten material ([0071], [0074], [0090], [0098]).
Mua does not expressly teach that the particle size control solution does not contain the binder.
Koster teaches granulation with demineralized water (Abstract) and without binder (Page 3, section 2.2.3). Koster teaches that if the material is soluble in the granulation liquid, granulation without binder addition is possible (Page 1, 1st ¶, last 3 lines). When comparing granules with and without binder, a reduction of fines was observed when a binder was added, and granulation without a binder did not lead to a distinct reduction of large particles (Page 7, section 3.3, Figure 4a). Without a binder, no gel was formed that could have inhibited water permeation (Page 12, last ¶, lines 5-6). Absence of binder could lead to acceptable tablets (Page 14, 2nd ¶ and Figure 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of preparing a smokeless tobacco composition adapted for oral use, wherein the composition comprises a tobacco material, a sugar, and a binder, as taught by Mua, in view of the granulation with water and without binder that did not lead to a distinct reduction of large particles and no gel formation that could have inhibited water permeation, as taught by Koster, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so because of the advantages of preparing a granulation without binder including no distinct reduction of large particles (Page 7, section 3.3, Figure 4a), no gel formation that could have inhibited water permeation (Page 12, last ¶, lines 5-6), and preparation of acceptable finished products such as tablets (Page 14, 2nd ¶ and Figure 9), as taught by Koster.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 1, the limitation of a method for preparing a pouch filling material would have been obvious over the method of preparing a smokeless tobacco composition (Abstract, claims 1-34), wherein the method includes (i) mixing a tobacco material with an effervescent material capable of causing effervescence in the oral cavity, wherein the mixing step comprises (a) admixing a granulated composition comprising a tobacco material with a gasified sugar material in particulate form; or (b) forming a gasified sugar material in situ by mixing a water source with a molten composition comprising a tobacco material and a sugar alcohol; and (ii) incorporating the mixture formed in step (i) into a smokeless tobacco product (claim 23), wherein the mixture is loaded into a pouch ([0014], FIG. 1, [0083]-[0086], Examples 1-4 – [0089]-[0096], and claim 34), as taught by Mua.
Regarding instant claim 1, the limitation of step S1 of preparing a solid-phase filling material comprising a binder would have been obvious over the at least one binder ([0005], [0008], [0052], [0057]-[0058], [0064]-[0071], claims 1, 7-8, 17, and 23-24), wherein the binder includes povidone (polyvinylpyrrolidone), sodium alginate, xanthan gum, and gum Arabic ([0045]), as taught by Mua.
Regarding instant claim 1, the limitation of step S2 of preparing a particle size control solution comprising a processing aid would have been obvious over the use of solvents for the binder solution including water and ethanol ([0066]), as taught by Mua.
Regarding instant claim 1, the limitation of step S3 of spraying the particle size control solution onto the solid-phase filling material while stirring the solid-phase filling material would have been obvious over the granulation material mixed with a binder solution (e.g., by spraying the binder solution into the granulator) and granulated to a desired particle size ([0065], [0090]), and an alternative embodiment, which includes maintaining the composition in molten form and introducing a source of water into the molten composition, typically while vigorously stirring or agitating the molten material ([0071], [0074], [0090], [0098]), as taught by Mua.
Regarding instant claim 1, the newly added limitation of wherein the particle size control solution does not contain the binder would have been obvious over the granulation with water (Abstract) and without binder including no distinct reduction of large particles (Page 7, section 3.3, Figure 4a), no gel formation that could have inhibited water permeation (Page 12, last ¶, lines 5-6), and preparation of acceptable finished products such as tablets (Page 14, 2nd ¶ and Figure 9), as taught by Koster.
Regarding instant claim 2, the limitation of step S4 of performing granulizing by mixing the particle size control solution with the solid-phase filling material after step S3 would have been obvious over the granulation material mixed with a binder solution (e.g., by spraying the binder solution into the granulator) and granulated to a desired particle size ([0065], [0090]), as taught by Mua.
Regarding instant claim 5, the limitation of the binder included in an amount of 20% by weight or less with respect to a total weight of the solid-phase filling material would have been obvious over the composition including at least about 2 dry weight percent of at least one binder ([0008], [0052], claim 8), as taught by Mua. The limitation of the particle size control solution included in an amount of 5% by weight to 30% by weight with respect to the total weight of the solid-phase filling material would have been obvious over the sugar alcohol syrup which contains sugar alcohol in water and maltitol syrup which contains greater than about 90% by weight maltitol on a dry basis, which is calculated to leave about 10% by weight of water in the solution ([0027]), as taught by Mua.
Regarding instant claim 6, the limitation of the binder would have been obvious over the povidone (polyvinylpyrrolidone), sodium alginate, xanthan gum, and gum Arabic ([0045]), as taught by Mua.
Regarding instant claims 7 and 8, the limitations of an activating material would have been obvious over the tobacco material (Abstract, [0005], TABLES 1-3 - claims 1, 21, and 22), as taught by Mua, since tobacco inherently contains nicotine.
Regarding instant claims 7 and 9, the limitations of a bulking agent would have been obvious over the microcrystalline cellulose ([0008], [0051], Example 2 – [0091], claim 9), erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, dulcitol, iditol, isomalt, maltitol, lactitol ([0008], [0023]), as taught by Mua.
Regarding instant claims 7 and 10, the limitations of a pH control agent would have been obvious over the sodium hydroxide and potassium hydroxide ([0045]), as taught by Mua.
Regarding instant claims 7 and 11, the limitations of a flavoring material would have been obvious over the flavors including vanilla, coffee, chocolate, cream, mint, spearmint, menthol, peppermint, wintergreen, lavender, cardamon, nutmeg, cinnamon, clove, cascarilla, sandalwood (Santalum album), honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, and strawberry ([0048]), as taught by Mua.
Regarding instant claims 7 and 12, the limitations of a sweetener would have been obvious over the glucose, fructose, galactose, sucrose, lactose, maltose ([0022]), stevia, aspartame, saccharin, sucralose ([0049]), and maltodextrin ([0008], [0051], TABLES 1-4, claim 9), as taught by Mua.
Regarding instant claim 13, the limitation of the processing aid would have been obvious over the use of solvents for the binder solution including water and ethanol ([0066]), as taught by Mua, and the use of water as the granulating liquid (Abstract), as taught by Koster.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Mua et al. (US 2013/0152953 A1 – “Mua”) in view of Kӧster et al. (Pharmaceutics. 2021; 13(2):241, pp. 1-17 – “Koster”), as applied to claims 1-2 and 5-13 above, further in view of Cantrell et al. (US 2012/0138074 A1 – “Cantrell”).
Instant claim 3 is drawn to the method of claim 2, further comprising: step S5 of performing drying at a temperature of room temperature to 80°C for 2 to 5 hours after step S4.
The teachings of Mua and Koster are discussed above.
Mua and Koster do not expressly teach drying at a temperature of room temperature to 80°C for 2 to 5 hours after step S4.
Cantrell teaches a process for forming a smokeless tobacco composition configured for insertion into the mouth of a user, wherein the composition includes a tobacco material, a sugar alcohol, and a natural gum binder component (Abstract). The slurry containing the recovered solids fraction may be dried at a temperature of about 60°C to about 70°C ([0016]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of preparing a smokeless tobacco composition adapted for oral use, wherein the composition comprises a tobacco material, a sugar, and a binder, as taught by Mua, in view of the granulation with water and without binder that did not lead to a distinct reduction of large particles and no gel formation that could have inhibited water permeation, as taught by Koster, and the method of forming a smokeless tobacco composition configured for insertion into the mouth of a user, wherein the composition includes a tobacco material, a sugar alcohol, and a natural gum binder component, and wherein a slurry containing the recovered solids fraction may be dried at a temperature of about 60°C to about 70°C, as taught by Cantrell, and produce the instant invention.
One of ordinary skill in the art would have been motivated to combine the teachings of Mua and Cantrell because both references teach methods of preparing compositions comprising tobacco material, sugar(s) and binder(s), and are configured to be orally administered. It is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have had a reasonable expectation of success in drying the granules prepared by Mua at a temperature range of about 60°C to about 70°C as taught by Cantrell.
One of ordinary skill in the art would have been motivated to combine the teachings of Koster with those of Mua and Cantrell because of the advantages of preparing a granulation without binder including no distinct reduction of large particles (Page 7, section 3.3, Figure 4a), no gel formation that could have inhibited water permeation (Page 12, last ¶, lines 5-6), and preparation of acceptable finished products such as tablets (Page 14, 2nd ¶ and Figure 9), as taught by Koster.
Regarding instant claim 3, the limitation of drying at a temperature of room temperature to 80°C for 2 to 5 hours after step S4 would have been obvious over the step of drying at an overlapping temperature range of about 60°C to about 70°C ([0016]), as taught by Cantrell. Please see MPEP 2144.05. One of ordinary skill in the art would have found the claimed time period of 2 to 5 hours an obvious variant to achieve the desired level of drying in the resultant particles/granules unless there is evidence of criticality or unexpected results.
Regarding instant claim 4, the limitation of step c of sieving the dried material after step S5 would have been obvious over the step of sieving ([0090]), as taught by Mua.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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