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 .
Response to Amendment
This office action is in response to Applicant’s amendment filed 4/14/2026.
Claim 1 is amended.
Claims 3, 6, and 10-17 are cancelled.
Claims 1-2, 4-5, 7-9, and 18-25 are pending.
Response to Arguments
Applicant's arguments filed 4/14/2026, regarding the 103 rejection, have been fully considered but they are not persuasive.
Applicant notes that claim 1 has been amended to recite “particulate filler comprising at least microcrystalline cellulose in an amount of at least about 50% by weight based on the total weight of the pouched composition” (p. 5). Applicant further notes that Kannisto mentions that the particulate non-tobacco material may include microcrystalline cellulose (MCC) and lists MCC in a percentage of 39% in the compositions in Tables 1, 2 and 6 (p. 6). Applicant argues that these exemplary percentages are lower than the claimed “at least about 50% by weight” (p. 6).
The Examiner has noted Applicant’s argument but finds it unpersuasive. The Examiner notes and agrees with Applicant that the exemplary percentage of 39% MCC is lower than the claimed “at least about 50% by weight” as claimed. However, “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” MPEP 2123(II). Here, Kannisto more broadly discloses that the particulate non-tobacco material can be present in about 30% to about 80% by weight ([0057], [0074]), wherein the particulate non-tobacco material is microcrystalline cellulose ([0076]-[0078]). This broader range of 30-80% MCC overlaps the claimed range of “at least about 50% by weight.” In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Applicant's arguments, see page 7, filed 4/14/2026, with respect to the rejection(s) of claim(s) 1-2, 4-5, 7-9, 18-19, and 25 on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending U.S. Application No. 17/836771 in view of Moldoveanu and Stahl have been fully considered and are persuasive Applicant has amended claim 1 to include the limitation “particulate filler comprising at least microcrystalline cellulose in an amount of at least about 50% by weight based on the total weight of the pouched composition.” The copending application fails to disclose such a limitation. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly cited prior art.
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.
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 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 1-2, 4-5, 7-9, 18, 20-21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Kannisto et al. (US 2020/0297026; of record) in view of Moldoveanu et al. (US 2015/0068545; of record) and Stahl et al. (US 2021/0307375; of record).
Regarding claims 1-2, 4-5, and 25, Kannisto discloses an oral pouched nicotine product comprising a moist filling material (“pouched composition”) and a saliva-permeable pouch (“pouch”) (abstract) comprising:
about 30% to about 80% by weight of a particulate non-tobacco material ([0057], [0074]) which may comprise cellulose, such as microcrystalline cellulose (MCC) ([0076]-[0078]) (“particulate filler comprising at least microcrystalline cellulose” overlapping the claimed range of “at least about 50% by weight”),
a nicotine source ([0057]); “active ingredient,” “nicotine component” “stimulant” (see [0015])),
a non-encapsulated non-particulate flavoring agent ([0057]; “one or more flavoring agents”), and
about 1.0% to about 10% w/w of a salt ([0107]-[0108]; overlapping the claimed range of “about 3% to about 4.5%” and “about 3.5% to about 4.0%”),
wherein oral pouched nicotine product may be free from tobacco (i.e., an oral pouched nicotine non-tobacco product) ([0057]), and
wherein water is added to the moist filling material ([0023]; with no added oven volatiles such as propylene glycol) such that the moist filling material has a moisture content within the range of from about 10% to about 60% by weight, such as from about 40% to about 60% by weight ([0062]), wherein moisture content includes water ([0031]) (“water content of at least 30%”).
In a specific example, Kannisto discloses a moist filling material comprising 39% microcrystalline cellulose, 3% nicotine bitartrate dihydrate, 1.0% flavor containing limonene and linalyl acetate, 3.5% sodium chloride, and 51% water (Sample 1, Table 1; also contains no tobacco material).
Regarding the claim limitation “particulate filler comprising at least microcrystalline cellulose in an amount of at least about 50% by weight based on the total weight of the pouched composition,” Kannisto’s disclosed range of about 30-80% weight MCC overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
However, Kannisto is silent as to at least one sweetener present in an amount of about 0.1% to about 5% by weight.
Moldoveanu teaches a smokeless tobacco product (abstract) which includes a tobacco formulation contained in a water permeable pouch ([0008]), wherein it is known in the art that exemplary flavorants can act to alter the bitterness, sweetness, sourness or saltiness of the smokeless tobacco product ([0094]), wherein flavorants include salts (e.g., sodium chloride), natural sweeteners or artificial sweeteners, and mixtures thereof ([0094]), wherein combinations of flavorants often sued include 0.1 to about 2 dry weight percent of an artificial sweetener, 0.5 to about 8 dry weight percent of a salt such as sodium chloride, and about 1 to about 5 dry weight percent of an additional flavoring ([0094]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added 0.1 to about 2 dry weight percent of an artificial sweetener as in Moldoveanu to Kannisto’s moist filling material in order to alter/enhance the sweetness of the oral product (Moldoveanu; [0094]).
Regarding the claim limitation “ a sweetener being present in an amount of about 0.1% to about 5% by weight based on the total weight of the pouched composition,” The Examiner notes that adding 0.1 to about 2 dry weight percent of artificial sweetener to Sample 1 would result in an oral product that has about 0.05 to 1 percent of artificial sweetener after accounting for the 51% weight of water. Thus, the added artificial sweetener would overlap the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Moreover, Kannisto further discloses that humectants are added during mixing on the components ([0168]).
However, modified Kannisto is silent as to the pouched composition comprising one or more cellulosic ether in an amount of about 1% by weight to about 5% by weight, or where the one or more cellulosic ether comprises methyl cellulose, hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), hydroxyethyl cellulose, or carboxymethylcellulose (CMC).
Stahl teaches a nicotine pouch composition (abstract), wherein the pouch composition further comprises a humectant ([0152]) selected from hydroxypropyl cellulose ([0153]; “cellulosic ether” and “HPC”), the humectant is in an amount of such as 1-3% by weight of the pouch composition ([0154]; within the claimed range of “about 1% by weight to about 5% by weight”), wherein the humectant acts to attract and retain water in the oral cavity during use and additionally moderates the release of nicotine, e.g., facilitates the sustained release of nicotine ([0155]; see also [0241]).
It would have been obvious to said skilled artisan to have modified Kannisto’s humectant to be hydroxypropyl cellulose in an amount such as 1-3% by weight of the pouch composition as in Stahl in order to obtain the predictable and beneficial result of additionally facilitating the sustained release of nicotine (Stahl; [0155]).
Regarding claims 7-9, modified Kannisto discloses the flavor contains limonene (Example 1; Table 1). One of ordinary skill in the art would appreciate that limonene has a carbon-carbon bond, and is a monoterpene.
Regarding claim 18, modified Kannisto discloses the oral pouched nicotine product further comprises a pH adjusting agent ([0057]).
Regarding claim 20, modified Kannisto discloses the artificial sweeteners include sucralose, saccharin, aspartame, acesulfame K, neotame, and the like (Moldoveanu; [0094]).
Regarding claim 21, modified Kannisto discloses 3% nicotine bitartrate dihydrate (Sample 1; Table 1).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kannisto et al. in view of Moldoveanu et al. as applied to claim 18 above, and further in view of Cheng et al. (US 2009/0022856; of record).
Regarding claim 19, modified Kannisto discloses the oral composition as discussed above with respect to claim 18, wherein the flavoring agent can include sweeteners (Moldoveanu; [0094]).
However, modified Kannisto is silent as to one or more binding agents comprising a natural gum binder.
Cheng teaches an oral pouch product including an immobilized flavorant (abstract) comprising one or more natural or modified starches or polysaccharides, such as gum Arabic and other ingredients, such as sweeteners present in an range of preferably about 4 wt% to about 6 wt% in order to contribute to the overall solubility of the immobilizing matrix thereby helping to regulate and the rate of degradation of the immobilizing matrix and thus the release of flavorant from the oral pouch product (para. 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of modified Kannisto to include gum Arabic as in Cheng in order to obtain the predictable result of forming an immobilizing matrix to desirably control the degradation rate of the immobilizing matrix and thus the rate of release of flavorant from the oral pouch product (Cheng; para. 33).
Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Kannisto et al. in view of Moldoveanu et al. as applied to claim 21 above, and further in view of Duignan et al. (US 2021/0195937; of record).
Regarding claims 22-24, modified Kannisto discloses the oral composition as discussed above with respect to claim 21, including a pH adjusting agent ([0057]) including sodium carbonate or sodium bicarbonate ([0101]).
However modified Kannisto is silent as to further comprising an aryl or carboxylic acid in the amount of up to about 10% by weight; wherein the aryl or carboxylic acid is benzoic acid.
Duignan teaches a smokeless product containing or more non-tobacco plant material (abstract) wherein a pH stabilizer or pH adjuster (22, 24) may be acetic acid, benzoic acid, sodium carbonate, sodium bicarbonate, and mixture thereof (para. 59), wherein the pH stabilizer or pH adjuster includes about 0.5-4 % of the total weight (para. 59).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted modified Kannisto’s pH adjusting agent (e.g., sodium carbonate or sodium bicarbonate) for Duignan’s pH stabilizer or pH adjuster in the form of acetic acid or benzoic acid because (a) substituting equivalents known for the same purpose is obvious (see MPEP 2144.06(I), and (b) such a modification would allow the pH of the solution to be maintained over a shelf life along with changing the pH to better suit the product (Duigan; para. 59).
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, 4-5, 7-9, 18-19, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/836771 in view of Moldoveanu et al. (US 2015/0068545; of record), Stahl et al. (US 2021/0307375; of record), and Axelsson et al. (US 2011/0214681).
Regarding claims 1 and 25, the copending application recites an oral composition configured for oral use (claim 1), wherein the composition is enclosed in a pouch to form a pouched composition (claim 15) comprising a filler (claim 1), wherein the filler is in the form of a particulate filler (claim 16), wherein the particulate filler comprises a cellulose material, a cellulose derivative, and combinations thereof (claim 17), an active ingredient (claim 1), one or more flavoring agents (claim 6), one or more sweeteners (claim 18), and a salt, the salt being present in an amount of about 3% to about 4.5% by weight based on the total weight of the composition (claim 1), wherein the composition is substantially free of a tobacco material (claim 14), and wherein the composition has a water content of at least about 30% by weight based on the total weight of the composition (claim 3).
While the copending application recites the genus of cellulose derivatives, the copending application does not recite the species cellulosic ether in an amount of about 1% by weight to about 5% by weight or that the one or more cellulosic ether comprises methyl cellulose, hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), hydroxyethyl cellulose, or carboxymethylcellulose (CMC).
Stahl teaches a nicotine pouch composition (abstract), wherein the pouch composition further comprises a humectant ([0152]) selected from hydroxypropyl cellulose ([0153]; “cellulosic ether” and “HPC”), the humectant is in an amount of such as 1-3% by weight of the pouch composition ([0154]; within the claimed range of “about 1% by weight to about 5% by weight”), wherein the humectant acts to attract and retain water in the oral cavity during use and additionally moderates the release of nicotine, e.g., facilitates the sustained release of nicotine ([0155]; see also [0241]).
It would have been obvious to said skilled artisan to have modified the copending application’s composition to be hydroxypropyl cellulose in an amount such as 1-3% by weight of the pouch composition as in Stahl in order to obtain the predictable and beneficial result of additionally facilitating the sustained release of nicotine (Stahl; [0155]).
Moreover, the copending application does not recite the at least one sweetener being present in an amount of about 0.1% to about 5% by weight.
Moldoveanu teaches a smokeless tobacco product (abstract) which includes a tobacco formulation contained in a water permeable pouch ([0008]), wherein it is known in the art that exemplary flavorants can act to alter the bitterness, sweetness, sourness or saltiness of the smokeless tobacco product ([0094]), wherein flavorants include salts (e.g., sodium chloride), natural sweeteners or artificial sweeteners, and mixtures thereof ([0094]), wherein combinations of flavorants often sued include 0.1 to about 2 dry weight percent of an artificial sweetener, 0.5 to about 8 dry weight percent of a salt such as sodium chloride, and about 1 to about 5 dry weight percent of an additional flavoring ([0094]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added 0.1 to about 2 dry weight percent of an artificial sweetener as in Moldoveanu to the copending application’s composition in order to alter/enhance the sweetness of the oral product (Moldoveanu; [0094]).
Lastly, while the copending application recites the genus of cellulose particulate cellulose, the copending application does not recite the species cellulosic filler being microcrystalline cellulose and in an amount of at least about 50% by weight based on the total weight of the pouched composition.
Axelsson teaches a snuff composition (title, abstract) comprising a nicotine-cellulose combination present in a bag or pouch suitable for buccal administration ([0013]), the cellulose being microcrystalline cellulose ([0024]-[0025]) such that nicotine is sorbed on the microcrystalline cellulose to form a nicotine-microcrystalline cellulose carrier complex ([0028], [0036]-[0037]) present in the composition at a concentration of from 7.5% to about 65% ([0039]) and nicotine is present in the composition in the range of from about 0.1% to about 10% ([0045]). This means Axelsson teaches the microcrystalline cellulose may be present in an amount of 0-64.9% (7.5-10 rounding up to 0%, and 65-0.1 respectively).
It would have been obvious to said skilled artisan to have used microcystralline cellulose in an amount of 0-64.9% as in Axelsson for the particulate cellulose in the copending application to achieve a fast onset of nicotine release in the oral cavity (Axelsson; [0001], [0012]), achieve a higher total release of nicotine through the complete or almost complete release of nicotine in the oral cavity (Axelsson; [0005], [0012])
Regarding claim 2, the copending application recites wherein the salt is present in an amount of about 3.5% to about 4.0% by weight based on the total weight of the composition (claim 2).
Regarding claim 4, the copending application recites wherein the composition has a water content of at least about 40% by weight based on the total weight of the composition (claim 4).
Regarding claim 5, the copending application recites wherein the active ingredient is selected from the group consisting of a nicotine component, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutraceuticals, and combinations thereof (claim 5).
Regarding claim 7, the copending application recites wherein the one or more flavoring agents comprises a compound having a carbon-carbon double bond, a carbon-oxygen double bond, or both (claim 7).
Regarding claim 8, the copending application recites wherein the one or more flavoring agents comprises one or more aldehydes, ketones, esters, terpenes, terpenoids, trigeminal sensates, or combinations thereof (claim 8).
Regarding claim 9, the copending application recites wherein the one or more flavoring agents comprises one or more of ethyl vanillan, cinnamaldehyde, sabinene, limonene, gamma- terpinene, beta-farnesene, and citral (claim 9).
Regarding claim 18, the copending application recites wherein the composition further comprises one or more sweeteners, one or more binding agents, one or more humectants, one or more organic acids, one or more gums, one or more buffering agents and/or pH adjusters, and combinations thereof (claim 18).
Regarding claim 19, the copending application recites wherein the one or more binding agents comprises a natural gum binder (claim 19).
This is a provisional nonstatutory double patenting rejection.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SONNY V NGUYEN whose telephone number is (571)272-8294. The examiner can normally be reached Monday - Friday; 7:00 AM - 3:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Y Louie can be reached at (571) 270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SONNY V NGUYEN/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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