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 .
Status of the Claims
Claims 16-35 are pending in the instant application and subject to examination herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/EP2021/059355, filed on 04/09/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/27/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112(b) – Withdrawn
The prior rejection of claim 18 under 35 U.S.C. 112(b) is withdrawn in response to Applicant’s amendment of claim 18.
Claim Rejections - 35 USC § 112(d) – Withdrawn
The prior rejection of claim 18 under 35 U.S.C. 112(d) is withdrawn in response to Applicant’s amendment of claim 18.
Claim Rejections - 35 USC § 102 – Withdrawn
The prior rejection of claims 16-17, 19, 22-26 and 31-35 under 35 U.S.C. 102(a)(1) as being anticipated by AB Science_2020 (AB Science, EU Clinical Trial, EudraCT number 2020-001635-27)1 is withdrawn in response to Applicant’s argument establishing that AB Science_2020 is not valid prior art under 35 U.S.C. 102(a)(1) because the effective publication/posting date of AB Science_2020 is 05/04/2020 and therefore not before Applicant’s Effective Filing Date of 04/10/2020.
Claim Rejections - 35 USC § 103 - Withdrawn
The prior rejection of claims 16-17, 19 and 22-35 under 35 U.S.C. 103 as being unpatentable over AB Science_2020 (AB Science, EU Clinical Trial, EudraCT number 2020-001635-27)2 is withdrawn in response to Applicant’s argument establishing that AB Science_2020 is not valid prior art under 35 U.S.C. 102(a)(1) because the effective publication/posting date of AB Science_2020 is 05/04/2020 and therefore not before Applicant’s Effective Filing Date of 04/10/2020.
The prior rejection of claims 16-17, 19-20 and 23-35 under 35 U.S.C. 103 as being unpatentable over Gros (WO 2014/079709 A1) in view of Huang (Huang, et al.; The Lancet, v395, pp497-506; 2020), Kim (Kim, et al.; Antiviral Research, v88, pp227-235; 2010), Buonerba (Buonerba, et al.; Frontiers in Pharmacology, v9, Article 189, pp1-10; 2018) and Nguyen (Nguyen, et al.; Biotechnology Letters, v34, pp831-838; 2012) is withdrawn in response to Applicant’s argument in traverse of the rejection. As Applicant has noted, Gros is directed to methods for treating cancer or viral disease by administering a small molecule inhibitor/activator in combination with deoxynucleotide or deoxynucleoside analog agents (page 10, lines 1-10), and oseltamivir, the anti-viral treatment reported by Huang as being administered to SARS-CoV-2, is a neuraminidase inhibitor, not a (deoxy)nucleotide or (deoxy)nucleoside drug, and is therefore not within scope of the invention of Gros.
The prior rejection of claims 16, 19-21 and 23-35 under 35 U.S.C. 103 as being unpatentable over Gros in view of Huang, Kim, Buonerba and Nguyen and further in view of AB Science_2018 (AB Science, “Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels,” ClinicalTrials.gov, Identifier NCT037771040, version 2: 2018-12-07)3 is withdrawn in response to Applicant’s argument in traverse of the rejection. As Applicant has noted, Gros is directed to methods for treating cancer or viral disease by administering a small molecule inhibitor/activator in combination with deoxynucleotide or deoxynucleoside analog agents (page 10, lines 1-10), and oseltamivir, the anti-viral treatment reported by Huang as being administered to SARS-CoV-2, is a neuraminidase inhibitor, not a (deoxy)nucleotide or (deoxy)nucleoside drug, and is therefore not within scope of the invention of Gros.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The prior rejection of claims 16 and 22-34 are rejected under 35 U.S.C. 103 as being unpatentable over Umetsu (U.S. PG Pub 2015/0297593 A1) is maintained.
Applicant has traversed the rejection on the grounds that a person of ordinary skill in the art would not have a reasonable expectation of treating a SARS-CoV-2 infection using Umetsu’s invention, because Umetsu’s invention regards an ability of Masitinib to inhibit airway hyperactivity and inflammation, demonstrated with the exemplary virus H3N1 (Influenza A) of the Orthomyxoviridae virus family, whereas the instant invention regards the suppression of viral replication of SARS-CoV-2 virus, from the virus family Coronaviridae, that is accomplished by Masitinib’s enzymatic inhibition of the 3CLpro protease.
Applicant’s argument has been considered, but is not found reasonable, because claim 16 and its dependent claims do not specifically limit to the suppression of viral replication of SARS-CoV-2, but rather are drawn to “method for treating a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection4 causing coronavirus disease 2019 (COVID-19) in a subject in need thereof, comprising administering to the subject masitinib, or a pharmaceutically acceptable salt or solvate thereof.” Treating a viral infection, taken in its broadest reasonable interpretation, can include treating some or all of the effects of the infection in addition to, or alternative to, inhibiting viral replication in the patient.
Reiterated Rejection:
Claims 16 and 22-35 are rejected under 35 U.S.C. 103 as being unpatentable over Umetsu.
Claims 16 and 22-35 are rejected under 35 U.S.C. 103 as being unpatentable over Umetsu (U.S. PG Pub 2015/0297593 A1).
Claim 16 is drawn to a method for treating a SARS-CoV-2 infection causing COVID-19 in a subject in need thereof, comprising administering to the subject masitinib, or a pharmaceutically acceptable salt or solvate thereof.
Umetsu discloses the treatment of virus-induced respiratory disease (e.g., virus-induced asthma), comprising administering a c-Kit inhibitor to a subject at risk of viral infection or having a virus-induced respiratory pathology (paragraph [0006]). Umetsu further discloses that coronavirus is in scope of the types of asthma-inducing virus to be treated by the invention (paragraphs [0022]-[0023]). Additionally, Umetsu discloses a Markush group of c-Kit inhibitors to be used that includes masitinib, with the Markush group further narrowed to just two inhibitors, of which one is masitinib (paragraph [0033]).
Umetsu does not explicitly list SARS-CoV-2 as a virus to be treated. However, a person of ordinary skill in the art would at once recognize that SARS-CoV-2 is inherently a coronavirus and is therefore within the scope of the invention disclosed by Umetsu.
Applicant’s invention is unpatentable over the disclosure of Umetsu because a person of ordinary skill in the art, at the effective time of filing, would have a reasonable expectation of applying the invention of Umetsu to the treatment of a subject having a SARS-CoV-2 infection, because Umetsu teaches the treatment of patients having virus-induced asthma, including asthma induced by a coronavirus, comprising administering a c-Kit inhibitor selected from a narrowed Markush group of just two inhibitors, one of which is masitinib.
Thus, the invention was prima facie obvious at the time of filing.
Claim 22 further limits claim 16 to wherein the subject presents at least one risk factor relevant to developing COVID-19, which per the instant Specification is a group of factors that includes “reactive airway disease” and “severe respiratory conditions” (paragraph [0097]). Umetsu discloses that asthma is characterized by airway inflammation, airway hyperreactivity (AHR), reversible air way obstruction and symptoms of wheezing and shortness of breath (paragraph [0004]). Thus, the limitations of claim 22 are met by the disclosure of Umetsu.
Regarding claims 23-33 that further limit the method of claim 16 to treatment of patients having COVID-19 of varying severity according to WHO 10-point and 7-point severity scales, Umetsu does not disclose the treatment of viral-induced asthma according to the severity of the infection; however, a person of ordinary skill in the art would have a reasonable expectation of success in treating coronavirus-induced asthma, including from a SARS-CoV-2 infection wherein the patient has COVID-19 at severity within scope of claims 23-33, because the invention of Umetsu is broadly relevant to symptomatic (e.g., asthmatic) patients, which corresponds to score ranges of 3-9 on the WHO 10-point scale or 2-6 on the WHO 7-point scale, per Tables 1 and 2, respectively, of the instant Specification – pages 14 and 16, respectively.
Umetsu discloses that c-Kit is a tyrosine-protein kinase that acts as a cell surface receptor for stem cell factor. c-Kit is known to be involved in regulation of cell survival and proliferation; hematopoiesis, stem cell maintenance, gametogenesis, mast cell development, migration and function, and melanogenesis (paragraph [0160]). Umetsu further discloses that c-Kit is also involved in virus-induced respiratory disease and pathology (e.g., virus-induced acute asthma and its associated pathologies, e.g., airway inflammation and airway hyperreactivity. Inhibition of c-Kit reduces and/or prevents virus-induced airway hyperreactivity and inflammation (paragraph [0163]). Based on this disclosure of Umetsu, the method disclosed therein is relevant to patients who are asthmatic and therefore are symptomatic (e.g., 3-9 on the WHO 10-point scale or 2-6 on the WHO 7-point scale, per Tables 1 and 2, respectively, of the instant Specification – pages 14 and 16, respectively). Thus, the limitations of claims 23-33 are met by the disclosure of Umetsu.
Claim 34 further limits claim 16 to wherein an additional pharmaceutically active agent is administered. Claim 35 further limits claim 34 to wherein the additional pharmaceutically active agent is selected from a Markush group that includes methylprednisolone, a well-known corticosteroid. Umetsu provides for “combination therapy” comprising the administration of a c-Kit inhibitor and at least one additional therapeutic agent, such as a corticosteroid (paragraph [0091]).
Applicant’s invention is unpatentable over the disclosure of Umetsu, because a person of ordinary skill in the art, at the effective time of filing, would have a reasonable expectation of success in applying the invention of Umetsu to the treatment of a patient having a SARS-CoV-2 infection and has at least one risk factor for developing COVID-19, or having COVID-19 at any rating from 3-9 on the WHO 10-point scale or 2-6 on the WHO 7-point scale, or including a second pharmaceutical agent in a combination therapy, for the following reasons:
Umetsu teaches the method disclosed therein for the treatment of asthma, a condition that includes symptoms relevant to “reactive airway disease” and “severe respiratory conditions” that are included in the instant Specification as risk factors for COVID-19;
Umetsu’s method requires that the patient is symptomatic for asthma but is otherwise not dependent on the severity of the viral infection to be treated;
Umetsu provides for combination therapy wherein the c-Kit inhibitor (e.g., masitinib) is co-administered with at least one other therapeutic agent, such as a corticosteroid.
Thus, the invention was prima facie obvious at the time of filing.
The prior rejection of claims 16, 20-21 and 23-35 under 35 U.S.C. 103 as being unpatentable over Umetsu in view of AB Science_2018 (AB Science, “Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels,” ClinicalTrials.gov, Identifier NCT037771040, version 2: 2018-12-07)5 is maintained.
Applicant has traversed the rejection on the grounds that a person of ordinary skill in the art would not have a reasonable expectation of treating a SARS-CoV-2 infection using Umetsu’s invention, because Umetsu’s invention regards an ability of Masitinib to inhibit airway hyperactivity and inflammation, demonstrated with the exemplary virus H3N1 (Influenza A) of the Orthomyxoviridae virus family, whereas the instant invention regards the suppression of viral replication of SARS-CoV-2 virus, from the virus family Coronaviridae, that is accomplished by Masitinib’s enzymatic inhibition of the 3CLpro protease.
Applicant’s argument has been considered, but is not found reasonable, because claim 16 and its dependent claims do not specifically limit to the suppression of viral replication of SARS-CoV-2, but rather are drawn to “method for treating a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection6 causing coronavirus disease 2019 (COVID-19) in a subject in need thereof, comprising administering to the subject masitinib, or a pharmaceutically acceptable salt or solvate thereof.” Treating a viral infection, taken in its broadest reasonable interpretation, can include treating some or all of the effects of the infection in addition to, or alternative to, inhibiting viral replication in the patient.
Reiterated Rejection:
Claims 16, 20-21 and 23-35 are unpatentable over Umetsu in view of AB Science_2018.
Claims 16, 20-21 and 23-35 are rejected under 35 U.S.C. 103 as being unpatentable over Umetsu in view of AB Science_2018.
The limitations of claims 16 and 23-35 and the disclosure of Umetsu are discussed in the rejection above and hereby incorporated into the instant rejection.
Claim 20 further limits claim 16 to wherein masitinib is dosed at 1-12 mg/kg/day.
Claim 21 further limits claim 16 to wherein masitinib is dosed at 3 mg/kg/day for 2 days, and then 4.5 mg/kg/day afterward, with each dose escalation subject to toxicity controls.
While Umetsu does not provide a specific treatment regimen as disclosed in the instant claim 21, a person of ordinary skill in the art would have a reasonable expectation of arriving at the instantly claimed dosing regimen, because determining a safe and effective dosing regimen is a result-effective variable, and the determination of a safe and effective dosing regimen for masitinib was known in the art, including for treatment of patients in respiratory distress, as taught by AB Science_2018.
AB Science_2018 teaches a clinical trial of the treatment of patients with severe asthma and elevated eosinophil levels, with the purpose of the study to assess the safety and efficacy of masitinib (6 mg/kg/day) in severe persistent asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels (Study Description section). AB Science_2018 teaches a dose-finding regimen wherein participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment, followed by dose escalation to 6.0 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control (Arms and Interventions section). Efficacy outcomes of the study are measured by an asthma control questionnaire (Outcome Measures section). While the protocol taught by AB Science_2018 waits longer to escalate dosage than the 2-day initial dosing period of the instant claim, and ultimately surpasses 4.5 mg/kg/day dosage, a person of ordinary skill in the art would have a reasonable expectation of success in determining when to dose escalate and to determine whether 4.5 mg/kg/day is the safe and effective terminal dose.
Applicant’s invention is unpatentable over the disclosure of Umetsu in view of the teaching of AB Science_2018 because a person of ordinary skill in the art, at the effective time of filing, would have a reasonable expectation of success in arriving at the dosing regimen of starting patients on 3 mg/kg/day of masitinib and elevating to 4.5 mg/kg/day thereafter, because the determination of a safe and effective dose is a result-effective variable, and was known in the art, as taught by AB Science_2018, who teaches starting patients on a masitinib dose of 3 mg/kg/day and escalating to 4.5 mg/kg/day with a safety control after the escalation.
Thus, the invention was prima facie obvious at the time of filing.
Allowable Subject Matter
Claims 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Cited in Applicant’s Information Disclosure Statement dated 10/27/2025.
2 Cited in Applicant’s Information Disclosure Statement dated 10/27/2025.
3 https://clinicaltrials.gov/study/NCT03771040
4 Emphasis added by Examiner.
5 https://clinicaltrials.gov/study/NCT03771040
6 Emphasis added by Examiner.