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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/14/2026 has been entered.
Response to Amendment
This office action is in response to Applicant’s amendment filed 8/14/2026.
Claims 1, 5, and 18 are amended.
Claims 10-14 are cancelled.
Claims 1-9 and 15-19 are pending.
Applicant has overcome the rejection of claim 5 under 35 U.S.C. 112(b) as being indefinite by amending the claims in the reply filed 8/14/2026.
Response to Arguments
Applicant' s arguments, see pages 7-10, filed 8/14/2026, with respect to the rejections of claims 1-18 under 35 U.S.C. 102(a)(2) as being anticipated by Kannisto, claims 1-13 and 15-19 under 35 U.S.C. 103 as being unpatentable over Moldoveanu, and claims 1-9 and 14-19 under the doctrine of obviousness-type double patenting have been fully considered and are persuasive. Applicant has amended claim 1 to include the limitations “a filler comprising at least one cellulosic ether in an amount of about 1% to about 5% by weight, citric acid in an amount of about 0.1 to about 10% by weight, at least one humectant in an amount of about 1% to about 5% by weight” and “wherein the composition is substantially free of a tobacco material.” The prior art of record fails to disclose such limitations. Therefore, the rejection has been withdrawn.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 Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, the claim limitation “about 0.1 to about 10%” should be changed to “about 0.1% to about 10%” to remain consistent with the rest of the claim (reciting two % signs in the range).
Appropriate correction is required.
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 1-9 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kannisto et al. (US 2020/0297026; of record) in view of Cheng et al. (US 2009/0022856) and Moldoveanu et al. (US 2015/00685545; of record).
Regarding claim 1-2 and 16-17 Kannisto discloses an oral pouched nicotine product (abstract) comprising:
a particulate non-tobacco material ([0057]; “filler”), which may comprise cellulose such as microcrystalline cellulose ([0076]), humectant ([0168]), a nicotine source ([0057]; “active ingredient” in the form of a “nicotine component”), and a salt ([0107]) in the range of 1.0-10% w/w based on the total weight of the moist filling material ([0108]; overlapping the claimed range of “about 3% to about 4.5%,” and “about 3.5% to about 4.0%”),
wherein the product may be free from tobacco ([0057]; “substantially free of a tobacco material”).
In a specific example, the nicotine product uses 39% microcrystalline cellulose (“particulate filler” in the form of a “cellulose material”), 3.5% sodium chloride, and 3% nicotine bitartrate dehydrate (see Example 1; Table 1).
However, Kannisto is silent as to a filler comprising at least one cellulosic ether in an amount of about 1% to about 5% by weight.
Cheng teaches an oral pouch product including an immobilized flavorant (abstract) comprising microcrystalline cellulose (MCC), which helps to provide physical encapsulation of the flavorant in the matrix and helps to adjust the degradation and release rate of the flavorant ([0032]), and in addition or alternatively carboxymethyl cellulose (CMC) (“at least one cellulosic ether”) in an amount of up to about 2 wt%, which help to regulate and control the degradation rate of the immobilizing matrix and thus the rate of release of the flavorant from the oral pouch product ([0033]).
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 Kannisto to include CMC in the amount of up to 2% as in Cheng in order to obtain the predictable result of forming an immobilizing matrix to desirably control the degradation rate of the matrix and thus the rate of release of flavorant form the oral pouch (Cheng; [0033]).
Regarding the claim limitation “at least one cellulosic ether in an amount of about 1% to about 5% by weight,” Kannisto discloses up to 2% CMC, which 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).
Moreover, modified Kannisto discloses the moist filling has a pH above 7.0, such as a range of 7.0 to about 10.0 ([0099]).
Moreover, Kannisto is silent as to citric acid in an amount of about 0.1% to about 10% by weight. Lastly, Kannisto is silent as to at least one humectant in an amount of about 1% to about 5% by weight. Specifically, while Kannisto discloses adding a humectant to the composition (see [0168]), Kannisto does not disclose the specific amount to be added.
Moldoveanu teaches a smokeless tobacco product (abstract) which can use pharmaceutical grade nicotine as having a purity of greater than 98% or greater than 99% in the present invention ([0057]) comprising a pH buffering agent that provide and/or buffer within the pH range of about 5 to about 10 and include citric acid, wherein the buffering material is typically used up to about 5 dry weight percent ([0097], see also [0057]). Moreover, Moldoveanu teaches that organic acids, such as citric acid function as a throat irritation mitigant that is capable of mitigating of soothing irritation caused by smokeless tobacco products, wherein the throat irritation mitigant is in an amount of at least 1 weight percent (e.g., about 1 to about 10 weight percent) ([0101]). Lastly, Moldoveanu teaches the formulation includes a humectant which typically ranges up to about 5 dry weight percent, such as about 2 to about 5 dry weight percent ([0099]).
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 citric acid as in Moldoveanu to Kannisto’s composition in order to function as a pH buffering agent and/or a throat irritation mitigant. One of ordinary skill in the art would be motivated to add citric acid in a range of up to about 5 dry weight percent as taught by Moldoveanu in order to obtain the predictable result of providing a pH range of about 5 to about 10, as suggested by Kannisto (Moldoveanu; [0097]). Alternatively, one of ordinary skill would be motivated to add citric acid in an amount of about 1 to about 10 weight percent as taught by Moldoveanu to soothe the irritation caused by the oral product (Moldoveanu; [0101]). Lastly, it would have been obvious to said skill artisan to have modified the amount of humectant in Kannisto to be about 2 to about 5 percent as in Moldoveanu because such a modification involves optimization within prior art conditions. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II)(A).
Regarding claim 3-4, modified Kannisto discloses water in an amount of 51% and 47% (Example 1; Table 1).
Regarding claims 5-9, modified Kannisto discloses the flavor contains limonene (Example 1; Table 1; “flavoring agent”). One of ordinary skill in the art would appreciate that limonene has a carbon-carbon bond, and is a monoterpene (i.e., “terpenes”).
Regarding claim 15, modified Kannisto discloses the nicotine product is pouched ([0057] see also [0002]).
Regarding claim 18, Kannisto discloses the oral pouched nicotine product further comprises a pH adjusting agent ([0057]; “pH adjusters”), and citric acid (see Moldoveanu [0059]; “one or more buffering agents”).
Regarding claim 19, 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).
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 1-9 and 15-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-9, and 18-19 of copending Application No. 16/707057 (reference application) in view of Moldoveanu et al. (US 2015/00685545; of record).
Regarding claim 1, the copending application recites: an oral composition configured for oral use, comprising one or more cellulosic ether (i.e., a filler in the form of a cellulose derivative) in an amount of about 1% by weight to about 5% by weight, an active ingredient, 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 pouched composition, wherein the pouched composition is substantially free of a tobacco material (claim 1), wherein the active ingredient is selected from the group consisting of a nicotine component (claim 5), wherein the pouched composition is substantially free of a tobacco material (claim 1), and wherein the pouched product further comprises one or more humectants (claim 18).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claim recites a species of the claimed “filler,” and other chemical constituents of the composition with specific range amounts.
Moreover, the copending application is silent as to at citric acid in an amount of about 0.1% to about 10% by weight, and at least one humectant in an amount of about 1% to about 5% by weight.
Moldoveanu teaches a smokeless tobacco product (abstract) which can use pharmaceutical grade nicotine as having a purity of greater than 98% or greater than 99% in the present invention ([0057]) comprising a pH buffering agent that provide and/or buffer within the pH range of about 5 to about 10 and include citric acid, wherein the buffering material is typically used up to about 5 dry weight percent ([0097], see also [0057]). Moreover, Moldoveanu teaches that organic acids, such as citric acid function as a throat irritation mitigant that is capable of mitigating of soothing irritation caused by smokeless tobacco products, wherein the throat irritation mitigant is in an amount of at least 1 weight percent (e.g., about 1 to about 10 weight percent) ([0101]). Lastly, Moldoveanu teaches the formulation includes a humectant which typically ranges up to about 5 dry weight percent, such as about 2 to about 5 dry weight percent ([0099]).
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 citric acid as in Moldoveanu to the copending application’s composition in order to function as a pH buffering agent and/or a throat irritation mitigant. One of ordinary skill in the art would be motivated to add citric acid in a range of up to about 5 dry weight percent as taught by Moldoveanu in order to obtain the predictable result of providing a pH range from about 5 to about 10 (Moldoveanu; [0097]). Alternatively, one of ordinary skill would be motivated to add citric acid in an amount of about 1 to about 10 weight percent as taught by Moldoveanu to soothe the irritation caused by the oral product (Moldoveanu; [0101]). Lastly, it would have been obvious to said skill artisan to have modified the amount of humectant in the copending application to be about 2 to about 5 percent as in Moldoveanu because such a modification involves optimization within prior art conditions. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II)(A).
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 pouched composition (claim 2).
Regarding claim 3, the copending application recites wherein the pouched composition has a water content of at least 30% by weight based on the total weight of the pouched composition (claim 1).
Regarding claim 4, the copending application recites wherein the pouched composition has a water content of at least about 40% by weight based on the total weight of the pouched composition (claim 4).
Regarding claim 5, the copending application recites wherein the active ingredient is selected from the group consisting of botanicals, stimulants, amino acids, vitamins, cannabinoids, nutraceuticals, and combinations thereof (claim 5).
Regarding claim 6, the copending application recites the oral composition comprising one or more flavoring agents (claim 1).
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 15, the copending application recites the oral composition configured for oral use in the form of a pouched composition enclosed in a pouch (claim 1).
Regarding claim 16-17, the copending application recites one or more cellulosic ether (claim 1; “particulate filler” and “cellulose derivative”).
Regarding claim 18, the copending application recites wherein the pouched 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 because the patentably indistinct claims have not in fact been patented.
Conclusion
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/SONNY V NGUYEN/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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