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 3/9/2026.
Claims 1, 5, and 13 are amended.
Claims 1-19 are pending.
Applicant has overcome the rejection of claim 13 under 35 U.S.C. 112(b) as being indefinite by amending the claim in the reply filed 3/9/2026.
Response to Arguments
Applicant's arguments filed 3/9/2026, regarding Kannisto, have been fully considered but they are not persuasive.
Applicant argues that Example 1 of Table 1 of Kannisto is a comparative example (citing [0138]) rather than a working example (p. 6).
While the Examiner notes that Kannisto’s Example 1 is a comparative example, the mere fact that Kannisto’s comparative example is used to reject claim 1 does not make the rejection any less anticipatory. “A reference is no less anticipatory if, after disclosing the invention, the reference then disparages it.” MPEP 2131.05. “A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” MPEP 2131. Here, Kannisto discloses two compositions, the first composition containing 39% microcrystalline cellulose, 3.5% sodium chloride, 3.0% nicotine bitartrate dihydrate, 1.5% potassium hydroxide, 51% water, 1.0% rapseed oil, and 1.0% flavor (Sample 1), and the second composition containing 39% microcrystalline cellulose, 3.5% sodium chloride, 3.0% nicotine bitartrate, 1.5% potassium hydroxide, 47% water, 5% rapeseed oil, and 1.0% flavor (Sample 2). Each of Sample 1 and Sample 2 contain a filler, an active ingredient comprising a nicotine component, and about 3% to 4.5% salt as required by claim 1. Therefore, Each of Sample 1 and Sample 2 anticipate claim 1 even if the samples are comparative.
Applicant argues that while Kannisto describes a broad range of salt (citing [0108] describing 1.0-10% salt) such a range lacks sufficient specificity to anticipate the claimed range (p. 7; citing MPEP 2131.03(II)).
As noted by Applicant, MPEP 2131.03(II) describes that “[w]hen the prior art discloses a range which touches or overlaps the claimed range, but no specific examples falling within the claimed range are disclosed, a case by case determination must be made as to anticipation” (emphasis added). Here, the Examiner agrees that Kannisto describes a broader range of 1.0-10% salt than the claimed range of “about 3% to about 4.5%.” However, this is not a situation where there are no specific examples falling within the claimed range. Rather, as discussed above, Kannisto indeed discloses the use of 3.5% sodium chloride (Example 1). Moreover, Kannisto further discloses a working example in which a wet composition comprising microcrystalline cellulose, sodium chloride, nicotine bitartrate, potassium hydroxide, water, monoglyceride, and optionally triglyceride and flavor was prepared ([0164]), wherein a sample comprises 41.72% cellulose (corresponding to the microcrystalline cellulose), 3.56% taste enhancer, 6.41% nicotine and tobacco (corresponding to the nicotine bitartrate), 5.36% potassium hydroxide solution (corresponding to the potassium hydroxide and water), 35.51% water and humectants (corresponding to the water), 4.97% rapeseed oil (corresponding to the triglyceride), 0.99% monoglyceride (corresponding to the monoglyceride), and 1.49% flavor (corresponding to the flavor) (Table A). Taking the combination of [0164] and Table A, one of skill in the art would appreciate that the taste enhancer used in the example A is sodium chloride because sodium chloride is the only constituent in the list from [0164] that is missing. Moreover, Kannisto teaches wherein it is known that sodium chloride is generally used for its effect on taste ([0109]), which further supports the conclusion that sodium chloride is a taste enhancer. Thus, since Kannisto discloses multiple working examples (see also [0172] and Table 8a, showing six samples using 3.79% taste enhancer/sodium chloride) and comparative examples within the claimed range, Kannisto satisfies the “sufficient specificity” requirement.
Applicant argues that salts being in the amount of about 3% to about 4.5% is advantageous (citing pages 6-7 of the instant specification) by achieving an oral composition that is milder in flavor and neither too sweet nor too salty (p. 7-8).
The Examiner finds Applicant’s argument unpersuasive because Applicant appears to be arguing unexpected results of salt used in the claimed range in an anticipation rejection. “Evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based.” MPEP 2131.04.
Applicant's arguments, see page 8, filed 3/9/2026, with respect to the rejection of claims 1-2, 5, and 19 under 35 U.S.C. 102(a)(1) as being anticipated by Summers have been fully considered and are persuasive. Applicant has amended claim 1 to include the limitation “an active ingredient comprising a nicotine component.” Summers 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 Moldoveanu et al. (US 2015/0068545; of record). This rejection is necessitated in view of the amendment to independent claim 1, which affects the scope of the dependent claims and at least claim 19 in which Summers was used to reject.
Applicant's arguments filed 3/29/2026, regarding the double patenting rejection, have been fully considered but they are not persuasive.
Applicant argues that claim 1 of the present application recites “an active ingredient comprising a nicotine component” which is distinguished from reference application 16/707,057 (p. 9).
The Examiner finds Applicant’s argument unpersuasive because the reference application also claims that “the active ingredient is selected from the group consisting of a nicotine component” (claim 5). Therefore, such an amendment to claim 1 does not distinguish the claimed invention from the reference application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 5, the claim limitation “wherein the active ingredient is selected from the group consisting of botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutraceuticals, and combinations thereof” is indefinite because it is unclear if claim 5 requires a different active ingredient in addition to the claimed “nicotine component” in claim 1 or if the nicotine component in claim 1 is supposed to satisfy the active ingredient in claim 5. For example, claim 1 and 5 cannot be satisfied at the same time if the active ingredient is selected to be a terpene, but claim 1 and 5 can be satisfied at the same time if the active ingredient is tobacco (i.e., contains both nicotine and is a botanical). For examination purposes, the limitation can be interpreted either as (a) requiring a second active ingredient, or (b) the nicotine component in claim 1 could satisfy both claims 1 and 5.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 1-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kannisto et al. (US 2020/0297026; of record).
Regarding claims 1-2, 5, 16-17, Kannisto discloses an oral pouched nicotine product (abstract) comprising:
a particulate non-tobacco material ([0057]; “filler”), a nicotine source ([0057]; “active ingredient” in the form of a “nicotine component” and “stimulant” according to definition (b) in the 112(b) section), and a salt ([0107]) in the range of 1.0-10% w/w based on the total weight of the moist filling material ([0108]).
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).
Regarding claim 3-4, Kannisto discloses water in an amount of 51% and 47% (Example 1; Table 1).
Regarding claims 6-9, 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 10, Kannisto discloses the oral pouched nicotine product may comprise tobacco material ([0058]).
Regarding claim 11, Kannisto discloses the tobacco material may be a bleached tobacco material ([0059]; “whitened tobacco material”).
Regarding claim 12, Kannisto discloses the tobacco material may be provided as ground tobacco ([0061]; “particulate tobacco material”) or as a nicotine base extracted from tobacco ([0089]; “tobacco extract”).
Regarding claim 13-14, Kannisto discloses the moist filling material may comprise about 0.1% to about 10% by weight tobacco or alternatively comprise no tobacco ([0058]).
Regarding claim 15, 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”).
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.
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 1-13 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Moldoveanu et al. (US 2015/0068545; of record).
Regarding claims 1-2, Moldoveanu discloses a smokeless tobacco product (“oral composition”) configured for insertion into the mouth of a user (“configured for oral use”), comprising a filler (para. 19-20), a highly purified tobacco-derived nicotine (para. 57; “active ingredient comprising a nicotine component”), and about 0.5 to about 8 dry weight percent of a salt (para. 94; “salt”).
Moreover, Moldoveanu discloses that the moisture content of the smokeless tobacco product prior to use by a consumer may vary, and may exhibit a moisture content of about 20 weight percent to about 50 weight percent (para. 67).
In other words, Moldoveanu discloses that 20-50% water can be added to the smokeless tobacco product.
Regarding the claim limitations ”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,” and “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” one of ordinary skill in the art would appreciate that the disclosed dry weight percentage of the salt (i.e. the amount of salt without accounting for water) in combination with the added water would result in salt being present in an amount of 0.33% (.5*(100/150)) to 6.67% (8*(100/120)). The range of about 0.33% to about 6.67% overlaps the claimed ranges of “about 3% to about 4.5%” and “about 3.5% to about 4.0%. 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).
Regarding claims 3-4, Moldoveanu discloses that the moisture content of the smokeless tobacco product prior to use by a consumer may vary, and may exhibit a moisture content of about 20 weight percent to about 50 weight percent (para. 67). In other words, Moldoveanu discloses that 20-50% water can be added to the smokeless tobacco product (i.e. “water content of at least about 30% by weight” and “water content of at least about 40% by weight”).
Regarding claim 5, Moldoveanu discloses the active ingredient can be highly purified tobacco-derived nicotine (para. 57; “stimulant”), botanical material (para. 11; “botanicals”), guayusa leaves resulting in simulative effects likely due to the content of caffeine (para. 139), vitamins (para. 28), and/or nutraceuticals (para. 26; according to definition (b) in the 112(b) section).
Regarding claim 6, Moldoveanu further discloses additional components are added to the smokeless tobacco product further comprising flavorants (para. 13).
Regarding claim 7-9, Moldoveanu discloses botanical materials often include components such as cinnamaldehyde (para. 28). One of ordinary skill in the art would appreciate that cinnamaldehyde contains both a carbon-carbon double bond and a carbon-oxygen double bond as well as an aldehyde group.
Regarding claim 10, Moldoveanu discloses the smokeless tobacco product is made with a tobacco material (para. 7).
Regarding claim 11, Moldoveanu discloses that the tobacco pulp can be whitened (para. 55).
Regarding claim 12, Moldoveanu discloses the tobacco material can be in particulate form, in the form of an oil or aqueous extract (para. 11).
Regarding claim 13, Moldoveanu discloses the tobacco material is in the range of about 10 to about 99% on a dry weight basis (para. 58).
Moreover, Moldoveanu discloses that the moisture content of the smokeless tobacco product prior to use by a consumer may vary, and may exhibit a moisture content of about 20 weight percent to about 50 weight percent (para. 67).
In other words, Moldoveanu discloses that 20-50% water can be added to the smokeless tobacco product. This means that the amount of tobacco will be present in an amount of about 6.67% (10*(100/150)) to about 82.5% (99*(100/120)) total 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).
Regarding claim 15, Moldoveanu discloses the smokeless tobacco product can be contained within a water-permeable pouch (para. 8; “pouched composition enclosed in a pouch”).
Regarding claims 16-17, Moldoveanu discloses a filler in the form of microcrystalline cellulose (para. 95; “particulate filler” and “cellulose material”).
Regarding claim 18, Moldoveanu discloses the smokeless tobacco product can further comprise one or more additional components selected from the group consisting of flavorants, binders, pH adjusters, buffering agents, salts, sweeteners, colorants, disintegration aids, other antioxidants, humectants, and preservatives (para. 13).
Regarding claim 19, Moldoveanu discloses typical binders include xanthan gum and gum Arabic (para. 96; “natural gum binders”).
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 14-19 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).
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 (claim 1), wherein the active ingredient is selected from the group consisting of a nicotine component (claim 5).
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.
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 14, the copending application recites wherein the pouched composition is substantially free of a tobacco material (claim 1).
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
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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