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 .
Priority
Acknowledgment is made of Applicant's claim for priority from U.S. Provisional Application No. 63/581,784 filed on 09/11/2023 and U.S. Provisional Application No. 63/642,241 filed on 05/03/2024.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 14, 2026 has been entered.
Response to Amendment
By Applicant’s amendment filed on April 14, 2026 claims 1-6, 8, 10-14 and 21 have been amended, and 22 has been canceled. Claims 10, 12-13 and 15-20 are withdrawn. Claims 7 and 9 were previously canceled.
Claims 1-6, 8, 11, 14 and 21 are currently presented for examination.
Response to Arguments
Due to Applicant's amendments to the claims, filed on April 14, 2026, specifically requiring certain flavoring agents and/or a carrier wherein the substituted pyridine compound is adsorbed onto the carrier, the previous rejection under 35 U.S.C. 102(a)(2) over Tanakit et al. is hereby withdrawn. However, Applicant’s amendments to the claims necessitate a rejection under 35 USC 103 over Tanakit et al. as detailed below.
With respect to Applicant’s argument that Tanakit has a filing date of March 28, 2024, which is after the priority date of the present Application (the provisional patent application filed on September 11, 2023), and thus, only that which is disclosed in Tanakit's provisional application (U.S. Provisional Patent Application No. 63/455,198, filed March 28, 2023 could be properly used to support a rejection of the present claims (MPEP § 2136.03(III)), it is noted that all of the disclosure of Tanakit used to reject the instant claims have support in the provisional application of Tanakit. Furthermore, the new disclosure added from Tanakit that is detailed below necessary to reject the current claims and necessitated by Applicant’s amendments to the claims are also supported by the provisional application of Tanakit.
This action is non-final.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-6, 8, 11, 14 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Tanakit et al. U.S. Publication No. 2024/0350476 A1 (March 28, 2023) in view of Holton et al. U.S. Publication No. 2022/0295858 A1.
Claims 1-6, 8, 11, 14 and 21 of the instant application claim a product comprising a substrate; a composition in solid form disposed on or in the substrate comprising at least one substituted pyridine compound of formula (I) such as
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also known as 6-methyl nicotine or 2-methyl-5-[1-methylpyrrolidin-2-yl]pyridine; at least one organic acid or salt thereof; at least one flavoring agent such as ethyl vanillin, cinnamaldehyde, or citral; and further comprising a chemosensory irritant, at least one excipient such as a binder, a sweetener, a polymer, or a carrier wherein the pyridine compound is adsorbed onto the carrier; wherein the product is in the form of an oral pouch, and wherein the product is entirely devoid of (R) or (S) nicotine.
Tanakit et al. teaches smoking cessation products comprising 6-methylnicotine and methods of treating nicotine addiction using a smoking cessation production comprising 6-methylnicotine (abstract). Tanakit et al. teaches smoking cessation aids containing 6-methylnicotine, more particularly, a pouch containing a 6-methylnicotine salt or complex, wherein the pouch can be used to deliver 6-methylnicotine through the oral mucosa [0002]. Tanakit et al. further teaches methods of treating nicotine addiction and methods of treating symptoms of nicotine withdrawal by administering 6-methylnicotine using a smoking cessation product [0002].
Tanakit et al. further teaches that 6-methylnicotine, in its racemic form, purified to (S)-6-methylnicotine, or purified to (R)-6-methylnicotine, has been found to be a suitable substitute for (S)-nicotine and (R/S)-nicotine and 6-methylnicotine can be absorbed through the gum line in similar form factors while remaining palatable enough for consumption [0006].
Tanakit et al. further teaches one aspect of the disclosure provides an oral pouch comprising a saliva-permeable non-woven fabric and a composition contained within the oral pouch, the composition comprising a 6-methylnicotine salt or complex and a filler [0008] [0022]. Tanakit et al. teaches the advantages if using 6-methylnicotine and specifically teaches 6-methylnicotine can be present in the smoking cessation products as (R)-6-methylnicotine, (S)-6-methylnicotine, or any mixture thereof, such as the 6-methylnicotine can comprise at least 50% (S)-6-methylnicotine, based on the total amount of 6-methylnicotine, or least 60%, or at least 70%, or at least 80%, or at least 90%, or at least 95%, or 100% (S)-6-methylnicotine [0029]-[0036].
Tanakit et al. specifically teaches an oral pouch comprising a saliva-permeable non-woven fabric including, but is not limited to, viscose, rayon, polyurethanes, or a combination thereof, and further comprising a binder such as a thermoplastic binder ([0037]-[0042] [0058]). Tanakit et al. further teaches that composition comprises other components such as a filler to provide bulkiness to the pouch including, but not limited to, cellulose, microcrystalline cellulose, maltitol, mannitol, erythritol, allulose, and combinations thereof [0054]. The composition can further include one more additional components including, but not limited to, a binder, a humectant, a flavoring agent, a sweetening agent, and a capsule comprising an inner payload [0055]. The humectant is not particularly limited; propylene glycol, glycerin, and combinations thereof are particularly contemplated [0059]. The sweetening agent is not particularly limited and can comprise one or more natural sweetening agents, one or more artificial sweetening agents, or a combination thereof such as monosaccharides, disaccharides, trisaccharides, polysaccharides, sugar alcohols, sucrose, glucose, dextrose, maltose, fructose, saccharin, aspartame, acesulfame, neotame sucralose, cyclamates, and combinations thereof [0060]. The flavoring agent can include apple, cinnamon, orange, mango, citrus, lemon, peppermint, mint, menthol, wintergreen, tobacco, coffee, vanilla, lime, and peach flavoring agents, and combinations thereof [0061]. A suitable oral pouch comprising 6-methyl nicotine is described in table 1 [0067].
Tanakit et al. further teaches other suitable forms comprising 6-methyl nicotine including an oral dissolvable film, a chewing gum, and an oral or nasal spray [0068]-[0093].
Tanakit et al. teaches that when administered directly, 6-methylnicotine may be unpalatable to some consumers, introducing the risk of the consumer refusing to use the smoking cessation product and returning to tobacco use as a result. Therefore, in order to increase the palatability of the oral or nasal spray, flavoring, cooling agents, and natural analgesics may be used [0090]. Natural analgesics suitable for soothing the application of 6-methylnicotine include methyl salicylate [0092]. Tanakit et al. specifically teaches in TABLE 4 a composition comprising 0.5-5% of 6-methylnicotine; 0.1-1% of a pH Adjuster comprising the organic acids Citric acid, levulinic acid, malic acid, salicylic acid; and 0-1% of the Aroma Methyl salicylate, menthol, L-carvone [0093].
Thus Tanakit et al. specifically teaches a tobacco harm reduction (THR) product comprising at least one substituted pyridine compound of formula (I) such as
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also known as 6-methyl nicotine or 2-methyl-5-[1-methylpyrrolidin-2-yl]pyridine and further comprising at least one excipient, at least one organic acid, at least one chemosensory irritant, at least one flavoring agent, a substrate and combinations thereof, wherein the product is in the form of an oral pouch, a chewing gum, a dissolving oral film, as well as an oral or nasal spray.
With respect to claims 4 and 14 of the instant application which claim the product further comprises a carrier wherein at least one substituted pyridine compound is adsorbed onto the carrier, Tanakit et al. teaches that 6-methylnicotine can be present in the smoking cessation products as 6-methylnicotine (i.e., the “free form” of the molecule), a 6-methylnicotine salt, or a 6-methylnicotine complex [0032]. Tanakit et al. teaches that the 6-methylnicotine complex can be a complex of 6-methylnicotine with a cyclodextrin (i.e., a 6-methylnicotine cyclodextrin complex) or a complex of 6-methylnicotine with an ion exchange resin (i.e., 6-methylnicotine polacrilex) [0034]. For example, the 6-methylnicotine cyclodextrin complex can be a complex with β-cyclodextrin (beta-cyclodextrin) [0034]. Tanakit et al. teaches that it is believed that 6-methylnicotine complexed with a cyclodextrin or with an ion exchange resin is generally more stable with respect to degradation and oxidation than 6-methylnicotine [0034].
Tanakit et al. also teaches to include excipients such as fillers, binders and humectants which are carriers that will adsorb onto the 6-methylnicotine compound, for example, the filler can include, cellulose, microcrystalline cellulose; the binder can include, modified celluloses, hydroxypropyl cellulose, methyl cellulose, hydroxypropyl methylcellulose (i.e., hypromellose), polyvinyl pyrrolidone, copovidone, gum arabic, pectin, and combinations thereof; and the humectant includes propylene glycol, glycerin, and combinations thereof ([0054]-[0059]). Tanakit et al. teaches the composition comprises a blend of dry ingredients and optionally one or more liquid ingredients [0066]. The composition can comprise one or more powdered solids, one or more granulated solids, or a combination thereof [0066]. The composition can be dry or substantially dry [0066].
Table 1 of Tanakit et al. lists typical suitable components of the composition, for example, for inclusion in an oral pouch, including 5-100 mg of the active ingredient per 300-600 mg (0.8%- 33%) of the total product 6-methylnicotine salt, 6-methylnicotine β-cyclodextrin complex, or 6-methylnicotine polacrilex; Filler Microcrystalline cellulose, maltitol, mannitol, erythritol, allulose; Sweetener Acesulfame potassium, sucralose, saccharin, stevia; Flavoring agent or blend of flavoring agents; Humectant Propylene glycol, glycerin; Binder Hydroxypropyl cellulose, polyvinyl pyrrolidone, copovidone, methyl cellulose, hypromellose [0067].
Tanakit does not specifically teach a flavoring agent as claimed in claim 1. Tanakit does not specifically exemplify a composition comprising the organic acid tartaric acid.
However, Tanakit et al. teaches that the 6-methylnicotine can be present as 6-methylnicotine (i.e., the “free form” of the molecule), a 6-methylnicotine salt, or a 6-methylnicotine complex [0032]. Tanakit et al. further teaches that the 6-methylnicotine salt is not particularly limited and it is believed that 6-methylnicotine salts are generally more stable with respect to degradation and oxidation compared to 6-methylnicotine [0033]. Tanakit et al. teaches that suitable 6-methylnicotine salts include, but are not limited to, salts of 6-methylnicotine with benzoic acid, malic acid, salicylic acid, citric acid, levulinic acid, or tartaric acid [0084]. Thus tartaric acid is a suitable acid for including in the composition for salt formation.
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to include tartaric acid as an organic acid in the composition of Tanakit et al. as a suitable selection for an organic acid with a reasonable expectation of forming a suitable salt of 6-methyl nicotine. Thus claim 21 of the instant application as it reads on the elected species of tartaric acid as a species of an organic acid is rendered obvious in view of the teachings of Tanakit et al.
Although Tanakit does not specifically teach a flavoring agent as claimed in claim 1, prior to the effective filing date of the claimed invention, the flavoring agents as claimed in claim 1 of the instant application were well-known in the art to be used as flavoring agents in nicotine replacement pouches. Holton et al. teaches an oral pouch for controlled release of active agents including nicotine [0008]-[0010]. Holton et al. teaches that suitable flavoring agents include a compound having a carbon-carbon double bond, a carbon-oxygen double bond, or both, such as one or more aldehydes, ketones, esters, terpenes, terpenoids, trigeminal sensates, or a combination thereof [0017]-[0019]. Examples of the flavoring agents are ethyl vanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene, beta-farnesene, citral, methyl salicylate, ethyl salicylate, menthol, peppermint, spearmint, other mint plant species, and combinations thereof [0019] and [0080].
Accordingly, prior to the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to include any suitable flavoring agent known in the art such as those taught in Holton et al. including ethyl vanillin, cinnamaldehyde or citral, for the oral pouch product of Tanakit et al. with a reasonable expectation of predictable results since Tanakit et al. specifically teaches including a flavoring agent. Thus selecting one or more flavoring agents as claimed in claim 1 of the instant application for the product of Tanakit et al. is rendered obvious in view of the teachings of Holton et al.
Furthermore, with respect to claim 2 which claims the composition further comprises a chemosensory irritant, as defined in paragraph [00399] of the instant specification, a chemosensory irritant can be selected as cinnamaldehyde, vanillin, linalool, camphor, eugenol, or thymol, and as detailed above, Holton renders obvious adding cinnamaldehyde or vanillin to the formulation. Furthermore, Tanakit et al. specifically teaches suitable additives for the product include natural analgesics suitable for soothing the application of 6-methylnicotine, including linalool, eugenol, thymol and camphor [0092]-[0093]. Accordingly, a person of ordinary skill in the art would have been motivated to add a soothing agent such as a natural analgesic including linalool, eugenol, thymol or camphor, to the oral pouch comprising 6-methylnicotine with a reasonable expectation of improving the properties of the product by making it more palatable to the user. Thus claim 2 of the instant application is rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 10, 12-13 and 15-20 are withdrawn. Claims 7, 9 and 22 are canceled. Claims 1-6, 8, 11, 14 and 21 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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