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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/25/2026 has been entered.
Claims 1-2, 5-6, 8-9, 11-12, 14, 17-18, 20, 24 and 26 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 6/25/2026 is acknowledged and has been considered except where lined through.
Rejections Withdrawn in view of Applicants Amendment
All previous rejections are withdrawn in view of Applicants amendment to amend claims 1 and 14 to remove the tyrosine kinase inhibitor Ibrutinib.
New Rejections Necessitated by Amendment
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.
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.
Claim(s) 1-2, 5-6, 14, 17-18, 20, 24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fuchs, Ephraim (US20230172941A1, 2023-06-08, cited in previous action) in view of Venkataraman and Frieman (Antiviral Research 2017; 143: 142-150).
Fuchs teach a method of treating SARS coronavirus infection in a subject in need thereof comprising administering to the subject an effective amount of a tyrosine kinase inhibitor to the subject thereby treating the SARS infection (claim 3 of Fuchs). With regards to the SARS coronavirus infection, Fuchs teach that the SARS coronavirus infection is SARS-CoV-2 (claim 4 of Fuchs). With regards to the tyrosine kinase inhibitor, Fuchs teach that the tyrosine kinase inhibitor include, but are not limited to, approved tyrosine kinase inhibitors such as gefitinib and vandetanib which target EGFR (see paragraph 0030, Table 1). Regarding the effective amount, Fuchs teaches that the dose of the compositions of the present invention can be about 0.001 to 1000 mg/kg body weight of the subject treated, but an attending physician will decide the dosage taking into account a variety of factors such as age, body weight, general health… route of administration and severity of the condition being treated (paragraph 0069). Lastly, Fuchs teach that the tyrosine kinase inhibitors can be combined with another biologically active agent (paragraph 0063).
Fuchs does not specifically select gefitinib or vandetanib or a combination thereof as the tyrosine kinase inhibitor. Nor does the Fuchs teach the amounts of the tyrosine kinase inhibitors as claimed.
Venkataraman and Frieman reviews the role of epidermal growth factor receptor (EGFR) signaling in SARS coronavirus-induced pulmonary fibrosis (Title). Specifically, Venkataraman and Frieman teach that pulmonary fibrosis is caused by hyperactive host response to lung injury mediated by epidermal growth fact receptor signaling, wherein inhibition of EGFR signaling prevents excessive fibrotic response to SARS-CoV and other respiratory viral infections (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Fuchs to specifically select gefitinib or vandetanib which target EGFR for the treatment of coronavirus in view of the teachings Venkataraman and Frieman. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Venkataraman and Frieman teach that pulmonary fibrosis is caused by hyperactive host response to lung injury mediated by epidermal growth fact receptor signaling, wherein inhibition of EGFR signaling prevents excessive fibrotic response to SARS-CoV and other respiratory viral infections.
Moreover, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to optimize the amounts of the agents in view of the teachings of the combination of Fuchs.. One of ordinary skill in the art would have been motivated to make such an optimization, with a reasonable expectation of success, because:
- Fuchs teaches that the dose of the compositions of the present invention can be about 0.001 to 1000 mg/kg body weight of the subject treated, but an attending physician will decide the dosage taking into account a variety of factors such as age, body weight, general health… route of administration and severity of the condition being treated.
Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Lastly, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to combine gefitinib and vandetanib for the treatment of pulmonary fibrosis in a patient suffering from SARS-CoV. One of ordinary skill in the art would have been motivated to make such a combination, with a reasonable expectation of success, because:
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claim(s) 8-9 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fuchs, Ephraim (US20230172941A1, 2023-06-08, cited in previous action) in view of Venkataraman and Frieman (Antiviral Research 2017; 143: 142-150), as applied above to claims 1-2, 5-6, 14, 17-18, 20 , 24 and 26, in further view of Sarguro (WO2017/141137A1, IDS) and Abdoli, Amir (ACS Pharmacology & Translational Science 2020; 3: 1039-1041)..
The combination of Fuchs and Venkataraman and Frieman have been described above and incorporated herein. In short, the combination teaches a method of treating SARS coronavirus infection in a subject in need thereof comprising administering to the subject an effective amount of a tyrosine kinase inhibitor to the subject thereby treating the SARS infection, wherein the tyrosine kinase inhibitor is gefitinib.
The combination does not specifically teach that gefitinib is administered in combination with mebendazole or the claimed amounts of each agent in combination.
Sarguro teach a composition and a dosage form comprising mebendazole for use in a method of reducing HIV viral load in a subject infected with HIV, wherein the dosage form contains about 350 mg or about 450 mg of mebendazole (Abstract). Specifically, Sarguro teach that mebendazole is a known antihelminthic, wherein helminthic infections are believed to significantly suppress the immune mechanisms of the human body thereby further compromising the immune system of subjects with already compromised immune systems (page 3, lines 14-25).
Abdoli teach that helminth co-infection may suppress the efficient immune response against SARS-CoV-2 in the early state of the infection, wherein treatment and prevention of helminth infections in endemic regions might decrease the morbidity and mortality of COVID-19 (see page 1040, Conclusions).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the combination of Fuchs and Venkataraman and Frieman to include mebendazole in view of the teachings of Sarguro and Abdoli. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Sarguro teaches the use of the antihelminth, mebendazole , in patients with HIV and
-Abdoli teaches that helminth co-infection may suppress the efficient immune response against SARS-CoV-2 in the early state of the infection, wherein treatment and prevention of helminth infections in endemic regions might decrease the morbidity and mortality of COVID-19.
Moreover, It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to optimize the amounts of the agents in view of the teachings of the combination of the references. One of ordinary skill in the art would have been motivated to make such an optimization, with a reasonable expectation of success, because:
- Fuchs teaches that the dose of the compositions of the present invention can be about 0.001 to 1000 mg/kg body weight of the subject treated, but an attending physician will decide the dosage taking into account a variety of factors such as age, body weight, general health… route of administration and severity of the condition being treated; and
- Sarguro teach a composition and a dosage form comprising mebendazole for use in a method reducing HIV viral load in a subject infected with HIV, wherein the dosage form contains about 350 mg or about 450 mg of mebendazole.
Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Hondermarck et al. (FASEB BioAdvances. 2020; 2: 296-303)
-Sisk et al. (Journal of General Virology 2018: 99 (5))
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 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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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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