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
Claims 1-13 are included in the prosecution.
Priority
This Application claims foreign priority to KR10-2023-0053479 filed on 04/24, 2023. Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119 (a)-(d), which papers have been placed of record in the file.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) an English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 04/19/24 and 09/17/24 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copies of PTO-1449.
Claim Objections
Claim 11 is objected to because of the following informalities: In claim 11, 4th line, the term “Santalum album” should be italicized. Appropriate correction is required.
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.
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 and 5-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mua et al. (US 2013/0152953 A1 – “Mua”).
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.
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]).
Regarding instant claim 1, the limitation of a method for preparing a pouch filling material is anticipated by 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 is anticipated by 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 is anticipated by 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 is anticipated by 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 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 is anticipated by 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 is anticipated by 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 is anticipated by 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 is anticipated by 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 are anticipated by 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 are anticipated by 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 are anticipated by the sodium hydroxide and potassium hydroxide ([0045]), as taught by Mua.
Regarding instant claims 7 and 11, the limitations of a flavoring material are anticipated by 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 are anticipated by 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 is anticipated by the use of solvents for the binder solution including water and ethanol ([0066]), as taught by Mua.
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 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.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Mua et al. (US 2013/0152953 A1 – “Mua”), as applied to claims 1-2 and 5-13 above, 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 teaching of Mua is discussed above.
Mua does 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 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 do this 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.
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 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5-8, and 10-12 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 12 of copending Application No. 18/812,401 (“the ‘401 Application”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are 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, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 12 of the ‘401 Application recites a nicotine pouch filler whereas instant claim 1 does not recite nicotine. However, instant claim 7 recites an activating material, and instant claim 8 recites that the activating material is selected from a group consisting of nicotine, inter alia, thereby rendering this limitation obvious.
Another difference is that claim 12 of the ‘401 Application recites granulation whereas instant claim 1 does not recite this limitation. However, instant claim 2 recites step S4 of performing granulizing, thereby rendering this limitation obvious.
Therefore, instant claims are obvious over claim 12 of the ‘401 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-2, 5-8, and 10-12 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 15 of copending Application No. 18/813,174 (“the ‘174 Application”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are 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, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 15 of the ‘174 Application recites a nicotine pouch filler whereas instant claim 1 does not recite nicotine. However, instant claim 7 recites an activating material, and instant claim 8 recites that the activating material is selected from a group consisting of nicotine, inter alia, thereby rendering this limitation obvious.
Another difference is that claim 15 of the ‘174 Application recites granulation whereas instant claim 1 does not recite this limitation. However, instant claim 2 recites step S4 of performing granulizing, thereby rendering this limitation obvious.
Yet another difference is that claim 15 of the ‘174 Application recites that the cellulose and the sugar alcohol are mixed at a weight ratio of 1:9 to 5:5 whereas instant claims do not recite this limitation. However, one of ordinary skill in the art would have found it obvious to include the cellulose based on the HPC and HPMC of instant claim 6, the MCC of instant claim 9, and the sugar alcohols of instant claim 9 at various weight ratios based on the desired filling, release rates, and stability. The recited ratio would have been an obvious variant unless there is evidence of criticality or unexpected results.
Therefore, instant claims are obvious over claim 15 of the ‘174 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-2, 5-8, and 10-13 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 17 of copending Application No. 18/817,499 (“the ‘499 Application”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are 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, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 17 of the ‘499 Application recites a nicotine pouch filler whereas instant claim 1 does not recite nicotine. However, instant claim 7 recites an activating material, and instant claim 8 recites that the activating material is selected from a group consisting of nicotine, inter alia, thereby rendering this limitation obvious.
Another difference is that claim 17 of the ‘499 Application recites granulation whereas instant claim 1 does not recite this limitation. However, instant claim 2 recites step S4 of performing granulizing, thereby rendering this limitation obvious.
Yet another difference is that claim 17 of the ‘499 Application recites that the water and alcohol are mixed at a weight ratio of 4:6 to 0:10 whereas instant claims do not recite this limitation. However, one of ordinary skill in the art would have found it obvious to include water and ethanol based on instant claim 13 at various weight ratios based on the desired filling, release rates, and stability. The recited ratio would have been an obvious variant unless there is evidence of criticality or unexpected results.
Therefore, instant claims are obvious over claim 17 of the ‘499 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-2, 5-8, and 10-13 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 14 of copending Application No. 18/818,012 (“the ‘012 Application”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are 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, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 14 of the ‘012 Application recites a nicotine pouch filler whereas instant claim 1 does not recite nicotine. However, instant claim 7 recites an activating material, and instant claim 8 recites that the activating material is selected from a group consisting of nicotine, inter alia, thereby rendering this limitation obvious.
Another difference is that claim 14 of the ‘012 Application recites granulation whereas instant claim 1 does not recite this limitation. However, instant claim 2 recites step S4 of performing granulizing, thereby rendering this limitation obvious.
Yet another difference is that claim 14 of the ‘012 Application recites that the content of the solvent is 10 to 60wt% of a content of the cellulose whereas instant claims do not recite this limitation. However, one of ordinary skill in the art would have found it obvious to include water and ethanol based on instant claim 13 and cellulose based on instant claims 6 and 9 at various weight ratios based on the desired filling, release rates, and stability. The recited ratio would have been an obvious variant unless there is evidence of criticality or unexpected results.
Therefore, instant claims are obvious over claim 14 of the ‘012 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615