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.
Response to Amendment
Applicant’s amendment filed on September 10, 2025 amending claims 1, 2, 5, 6, 14, and adding new claims 21 and 22 has been entered. Claims 10, 12-13 and 15-20 are withdrawn. Claims 7 and 9 are canceled.
Claims 1-6, 8, 11, 14 and 21-22 are being examined as they read on the elected species.
Response to Arguments
The terminal disclaimers filed on September 10, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent Nos. 11,964,958 B1 and U.S. Patent No. 12,358,889 (Application No. 18/799,650) and U.S. Patent No. 12,358,888 (U.S. Application No. 18/593,597) has been reviewed and is accepted. The terminal disclaimer has been recorded.
Accordingly, the previous double patenting rejections over U.S. Patent No. 11,964,958 B1 and U.S. Patent No. 12,358,889 (Application No. 18/799,650) and U.S. Patent No. 12,358,888 (U.S. Application No. 18/593,597) are hereby withdrawn.
The terminal disclaimers filed on September 10, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on copending Application No. 18/807,086; copending Application No. 18/498,854; copending Application No. 18/926,671; and copending Application No. 19/222,752 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Accordingly, the previous double patenting rejections over copending Application No. 18/807,086; copending Application No. 18/498,854; copending Application No. 18/926,671; and copending Application No. 19/222,752 are hereby withdrawn.
Due to Applicant’s amendments to the claims the previous rejection of claims 1, 8 and 11 under 35 U.S.C. 102(a)(1) over Seeman et al. is hereby withdrawn.
Due to Applicant’s amendments to the claims the previous rejection of claims 1-4, 6, 8, 11 and 14 under 35 U.S.C. 102(a)(1) over Pan et al. is hereby withdrawn.
Due to Applicant’s amendments to the claims the previous rejection of claims 1-4, 6, 8, 11 and 14 under 35 U.S.C. 102(a)(2) over Ye is hereby withdrawn.
Applicant's arguments filed September 10, 2025 with respect to the rejection of claims 1-6, 8, 11 and 14 under 35 U.S.C. 102(a)(2) over Tanakit et al. have been fully considered but they are not persuasive.
Applicant argues that Tanakit, either alone or in combination, disclose a tobacco harm reduction product that is “entirely devoid of (R) or (S) nicotine,” as required by the instant claims and none of the other cited references of record cure these deficiencies at least because they were not cited for such purposes.
These arguments are found not persuasive since there is no teaching or suggestion found in Tanakit for the inclusion of R) or (S) nicotine. 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. 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]. Thus the product of Tanakit is entirely devoid of (R) or (S) nicotine as required by the instant claims.
Thus the previous rejection under 35 U.S.C. 102(a)(2) over Tanakit et al. is hereby maintained and reproduced below.
Due to Applicant’s amendment to claim 2, specifically removing at least one organic acid, the previous rejection of claim 2 under 35 USC 103 over Tanakit et al. is hereby withdrawn. However, said claim is now only being rejected under 35 U.S.C. 102(a)(2) over Tanakit et al. in view of Applicant’s amendments to claim 2.
New claim 21 which claims specific organic acids is being rejected under 35 USC 103 over Tanakit et al. with regard to the elected species of tartaric acid. Claim 22 is being rejected on the same ground of 35 U.S.C. 102(a)(2) over Tanakit et al.
This action is FINAL.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-6, 8, 11, 14 and 21-22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tanakit et al. U.S. Publication No. 2024/0350476 A1 (March 28, 2023).
Claims 1-6, 8, 11, 14 and 21-22 of the instant application claim a tobacco harm reduction (THR) product (i.e. any product designed to help an individual cease tobacco smoking [0031] of specification) 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, and wherein the THR 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].
The cited claims of the instant application are anticipated since 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.
Thus the cited claims of the instant application are rejected in view of the cited prior art teachings.
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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tanakit et al. U.S. Publication No. 2024/0350476 A1 (March 28, 2023) as set forth above.
Claim 21 of the instant invention as it reads on the elected species claims the composition further comprises tartaric acid as an organic acid.
Tanakit is as detailed above.
Tanakit does not specifically exemplify a composition comprising 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.
Conclusion
Claims 10, 12-13 and 15-20 are withdrawn. Claims 7 and 9 are canceled. Claims 1-6, 8, 11, 14 and 21-22 are rejected. No claims are allowed.
THIS ACTION IS MADE FINAL. 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM