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
This Application filed on 08/02/2022 is a 371 of PCT/EP2020/084783 filed on 12/06/2020, and claims priority to POLAND 432155 and EP 19461613.2 filed on 12/10/2019.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed November 12, 2025 to the office action made on August 12, 2025.
Claims 1-15, 17, 19 and 21-25 are currently pending and Claims 1-12 and 21-25 are examined on the merits herein.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 2/23/26 is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Response to Arguments
The arguments over the rejection of claims 1-3 and 20 under 35 U.S.C. 102(a)(1) over Su (CN102219786A) is persuasive in view of amendments made to the claims. The rejection is herewith withdrawn.
The arguments over the rejection of claims 1-3 and 20 under 35 U.S.C. 102(a)(1) over Liu et al. (HPLC method for simultaneous determination of 8 kinds of alkaloids in total alkaloids of Sophora alopecuroides. Zhongguo Shiyan Fangjixue Zazhi. Volume: 19. Issue: 8. Pages: 142-145 Journal. 2013. DOI: 10.11653/syfj2013080142) is persuasive in view of amendments made to the claims. The rejection is herewith withdrawn.
The arguments over the rejection of claims 1-3 and 20 under 35 U.S.C. 102(a)(1) over Wang et al. (HPLC simultaneous determination of cytisine and sophoridine in Sophora alopecuroides L. Yaowu Fenxi Zazhi. Volume: 31. Issue: 1. Pages: 148-150. Journal. 2011) is persuasive in view of amendments made to the claims. The rejection is herewith withdrawn.
The arguments over the rejection of claims 1-6, 8-12 and 20 under 35 U.S.C. 103 over Docherty (WO2019202396A1) in view of Lindell et al. (WO 03055486 A1) is persuasive in view of amendments made to the claims. The rejection is herewith withdrawn.
The arguments over the rejection of claim 7 under 35 U.S.C. 103 over Docherty (WO2019202396A1) in view of Lindell et al. (WO 03055486 A1) as applied to claims 1-6, 8-12 and 20 above, further in view of CN103960783A is persuasive in view of amendments made to the claims. The rejection is herewith withdrawn. Applicant’s argument over claims 1-6, 8-12 and 20 rejections depends on the validity of the previous arguments which were not found persuasive. The rejection is herewith maintained.
The rejections are as below:
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 1-5, 8-12 and 20-25 are rejected under 35 U.S.C. 103 as obvious over Lindell et al. (WO2010044736).
Lindell et al. teaches a multi portion intra-oral dosage form comprising a component for treating tobacco dependence being selected from one or more of varenicline, bupropion, nortriptyline, doxepin, fluoxetine, imipramine, moclobemide, and/or cytisine. (see claim 26). The formulation comprises a buffer and/or a pH -adjusting agent, which upon administration of a rapidly disintegrating portion to a subject transiently elevates the pH of the saliva of the subject by 0.2 - 3.5 pH units, preferably by 0.5-2.0 pH units. (The Examiner’s contention is that based on saliva pH typically in the range of 6.2 to 7.6, the range is ~6.4-8.6). (see claims 4-6). A pH-buffer component and/or a pH adjusting component selected from a carbonate including bicarbonate or sesquicarbonate, glycinate, phosphate, glycerophosphate or citrate of an alkali metal, such as potassium or sodium, or ammonium, including trisodium phosphate, disodium hydrogen phosphate; tri potassium phosphate, dipotassium hydrogen phosphate, and calcium hydroxide, sodium glycinate, tromctamol or an amino acid; and mixtures thereof. (see claim 39) Tables G1 and G2, show formulations comprising water, buffering agents, maltitol, lemon flavor, and/or menthol. The reference generally teaches incorporation of water-swellable excipient may be selected from superdisintegrants such as crospovidone, croscarmellose, sodium starch glycolate, cellulose compounds such as microcrystalline cellulose, starches, alginic acid and inorganic clays. Suitable sweeteners may be selected from the group consisting of sugar alcohols, such as sorbitol, xylitol, single sugars including sugars extracted from sugar cane and sugar beet (sucrose), dextrose (also called glucose), fructose (also called ieavulose), and lactose (also called milk sugar); sorbitol, mannitol, glycerol, xylitol, erythritol, maltitol syrup (or hydrogenated starch hydrolyzate), isomalt, lactitol; and mixtures of sugars including glucose syrup, e g starch hydroiysates, containing a mixture of dextrose, maltose and a range of complex sugars, invert sugar syrup, e g sucrose inverted by invertase (also called sucrase or sacchrase) containing a mixture of dextrose and fructose, high sugar content syrups such as treacle and honey containing a mixture of particular Ieavulose, dextrose, maltose, laclitole, sucrose, resins, dextrin and higher sugars; and malt or malt extracts. Specifically , the reference teaches Other additives may be added optionally to the oral formulation. Optional additives comprise at least one or more additives selected from the group consisting of solvents, such as ethanol and water; co-solvents, such as propylene glycol; stabilisers, such as preservatives, eg antioxidants; softeners, such as sorbitol and glycerine. The complexes thereof in any form to a subject through for example, but not limiting to, mouth sprays.
While the reference teaches cystine, at least one inorganic pH regulation agent, water, and the pH values between 3.0 and 7.5, as a spray; Lindell does not teach an example of a formulation.
It would have been obvious to one of ordinary skill in the art at the time of filing to combine cystine, at least one inorganic pH regulation agent, water, and the pH values between 3.0 and 7.5, as a spray. The motivation to combine cystine, at least one inorganic pH regulation agent, water, and the pH values between 3.0 and 7.5, as a spray is because Lindell et al. teaches a dosage form comprising a component for treating tobacco dependence being selected from cytisine, buffer and/or a pH -adjusting agent to elevate the pH of the saliva of the subject by 0.2 - 3.5 pH units, preferably by 0.5-2.0 pH units, water as a solvent, in an oral spray formulation. Hence, a skilled artisan would have reasonable expectation to successfully treat tobacco dependence.
Furthermore, while Lindell teaches the use of both inorganic and organic pH-buffer component and/or a pH adjusting component, it would be obvious to choose an inorganic pH-buffer component and/or a pH adjusting components, as Lindell teaches the claimed disodium hydrogen phosphate. Absent evidence to the contrary, either buffering and adjusting agents is obvious as both are taught.
Claims 6-7 is rejected under 35 U.S.C. 103 as obvious over Lindell et al. (WO2010044736)., as applied to claims 1-5, 8-12 and 20-25 above, further in view of CN103960783A.
Lindell et al. are as discussed above.
Lindell et al. discuss viscosity modifying agents, the references fail to specify sodium hyaluronate.
CN103960783A teaches gel matrix is poloxamer, carbomer, polyvinyl alcohol, povidone, sodium carboxymethylcellulose, methylcellulose, hydroxyethylcellulose, sodium hyaluronate, polyethylene glycol Glycols, a mixture of one or more of hypromellose.
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the sodium hyaluronate as recited in the claims. The motivation to incorporate sodium hyaluronate is because CN103960783A teaches sodium hyaluronate as a matrix. Therefore, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Reference of relevance:
Gonzalez (ES2141024B1).
Conclusion
No claims allowed.
Contact Information
The arguments are not persuasive and the rejection is made FINAL. 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 fled 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 extension fee 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 LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
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/LAYLA SOROUSH/Primary Examiner, Art Unit 1622