The Office Action mailed on June 17, 2026 is herewith WITHDRAWN.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed June 23, 2026 to the office action made on filed on June 17, 2026 has been entered.
Claims 1-15, 17, 19, 21, and 24-27 are currently pending and Claims 1-12 and 21, 24-27 are examined on the merits herein.
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.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) filed.
Response to Arguments
The arguments over the rejection of claims 1-5, 8-12 and 20-25 under 35 U.S.C. 103 over Buchalova et al. (WO2018114749A1) is persuasive. The rejection is herewith withdrawn.
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 1-3, 8-9, 21, and 24-27 are rejected under 35 U.S.C. 103 as obvious over Bespalov et al. (RU2593585C1).
Bespalov et al. teaches cytisine in the solution is 40 mg / ml comprising EDTA - 10 mg, Citric Acid - 30 mg, Sodium hydrogen phosphate - 600 mg, Sodium dihydrogen phosphate - 750 mg, Methylparaben - 300 mg, Propylparaben - 75 mg, Sodium chloride - 8400 mg, Polysorbate 800 mg, and Purified water - up to 1000 ml. Bespalov teaches the Citric Acid is an antioxidant, Sodium hydrogen phosphate and Sodium dihydrogen phosphate as acidity regulators (up to pH 5.0-8.0), and Polysorbate as a cosolvent.
While the reference teaches cystine; Bespalov does not teach the pH values between 3.0 and 7.5 as 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, so the pH values between 3.0 and 7.5. The motivation to combine cystine, at least one inorganic pH regulation agent, water, and the pH values between 3.0 and 7.5, is because Bespalov et al. teaches acidity regulators (up to pH 5.0-8.0). Hence, a skilled artisan would have reasonable expectation to successfully achieve similar efficacy and results.
Claims 4-7 is rejected under 35 U.S.C. 103 as obvious over Bespalov et al. (RU2593585C1) as applied to claims 1-3, 8-9, 21, and 24-27 above, further in view of CN103960783A.
Bespalov et al. are as discussed above.
Bespalov et al. fails to specify sodium hyaluronate, a viscosity agent.
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.
Claims 10-11 is rejected under 35 U.S.C. 103 as obvious over Bespalov et al. (RU2593585C1) as applied to claims 1-3, 8-9, 21, and 24-27 above, further in view of Ivashchenko et al. (RU 2541312 C2).
Bespalov et al. are as discussed above.
Bespalov et al. discuss co-solvents, the reference fails to specify glycerol and propylene glycol or sweetners.
Ivashchenko et al. teaches examples 4-5 Propylene glycol 48.0, Cytisine: * = 1.3: 1, Glycerol 39.0, 0.1N aqueous HCl 10.5, Cytisine 2.5, Propylene glycol 48.0, Cytisine 3.5: 1, Glycerol 39.0, Water 5.5, and Lemon 5.0. (p10 table 1)
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the glycerol and propylene glycol or sweetners as recited in the claims. The motivation to incorporate glycerol and propylene glycol or sweetners is because Ivashchenko teaches cytisine formulations having polyalcohols such as glycerol, flavorings, and other additives. Therefore, a skilled artisan would have had reasonable expectation of success in incorporating a polyalcohols flavorings, and other additives in a cytisine containing formulation.
Claim 12 is rejected under 35 U.S.C. 103 as obvious over Bespalov et al. (RU2593585C1) in view of Ivashchenko et al. (RU 2541312 C2) as applied to claims 1-3, 8-11, 21, and 24-27 above, further in view of Hugerth et al. (US 20100124560 A1).
Bespalov et al. are as discussed above.
Bespalov et al. discuss viscosity modifying agents, the references fail to specify sweeteners such as sugar alcohols, such as sorbitol, xylitol.
Hugerth et al. teaches [0106] 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 leavulose), and lactose (also called milk sugar); sorbitol, mannitol, glycerol, xylitol, erythritol, maltitol syrup (or hydrogenated starch hydrolyzate), isomalt, lactitol; and mixtures of sugars.
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the mannitol, glycerol, xylitol, sucrose, maltitol syrup as recited in the claims. The motivation to incorporate mannitol, glycerol, xylitol, sucrose, maltitol syrup is because Hugerth et al. teaches they are suitable sweeteners. Therefore, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Reference of relevance:
Gonzalez (ES2141024B1).
Lukasz et al. (WO2016060576A1).
Conclusion
No claims allowed.
Contact Information
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Henry Alstrum-Acevedo can be reached on (571)272-0629. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAYLA SOROUSH/Primary Examiner, Art Unit 1622
Prosecution Insights