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 1-3 and 7-10 are currently pending and are rejected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 18, 2025 and May 8, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment/Arguments
The amendment filed September 24, 2025 is compliant with the requirements of 37 CFR 1.121(c), accordingly the amendment has been entered. Applicant’s arguments have been fully considered and are addressed below:
Objection to the Claims
The objection of claims 1 and 3 for informalities has been overcome by the amendment correcting said informalities. The objection has been withdrawn.
35 USC § 102 Rejection
The anticipation rejection of claims 1-3 and 7-10 over Lin et al. has been overcome by deleting “SARS-CoV” from the coronaviruses listed in claim 1. The rejection has been withdrawn.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim 7 recites the limitation “wherein disulfiram is a sole active ingredient”. The specification does not define “active”. The specification discusses the “inhibitory activity” of disulfiram, which is depicted in Figures 1-3. According to paragraph 18 and claim 9, a pharmaceutical composition comprising disulfiram can further comprise a medicament for treating a coronavirus-related disease. In Example 1, a coronavirus inhibitor was used as a positive control for comparison with disulfiram. Additionally, claim 1 states that the function of the pharmaceutical composition is to treat coronavirus, which implies the composition has anti-coronaviral activity. In light of the above, it stands to reason that the term “active” in claim 7 refers to coronavirus activity.
Claim 9 recites the limitation “SARS-CoV-2-related disease”, which is being interpreted as meaning a disease caused by SARS-CoV-2 in light of the specification and original claim 9. The claim originally recited the embodiment “a coronavirus-related disease and/or a medicament for the treatment of another disease caused by virus.” The particular phrasing of “another disease caused by virus” implies that the coronavirus-related disease is a disease caused by coronavirus. Furthermore, paragraph 4 of the specification discusses the “genome of coronaviruses” and that “[t]he development of medicaments and vaccines for the treatment of coronaviruses-related diseases is mainly directed to” SARS-CoV and SARS-CoV-2. If the treatments are intended to target these coronaviruses directly, it would be reasonable to interpret “SARS-CoV-2-related disease” as meaning a disease caused by SARS-CoV-2.
Claim Rejections - 35 USC § 102
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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sargsyan et al. ChemRxiv 2020, 2020, 1-17 (pub. April 24, 2020).
Sargsyan teaches “combining disulfiram/ebselen with broad-spectrum antivirals/drugs [] to synergistically inhibit SARS-CoV-2 replication and reduce the emergence of drug resistance []. [The] antivirals “disulfiram/ebselen might destabilize the nsp10-nsp14/nsp16 complexes, thus restoring [] the host’s antiviral sensors to detect viral RNA.” Sargsyan 11. See, also, Figure 3, which shows “[i]nhibition of SARS-CoV-2 PLpro by disulfiram and ebselen.” Sargsyan 9.
This teaching anticipates claim 1, drawn to treating SARS-CoV-2 in a host (i.e., a subject) in need thereof, comprising administering an effective amount of a composition comprising disulfiram.
Claim 2 (drawn in part to treating mammalian disease) and claim 3 (drawn in part to treating humans) are anticipated by Sargsyan’s teaching that disulfiram was selected because it was “FDA-approved or in clinical trials” and, therefore, can “circumvent toxicity due to undesirable targeting of essential human proteins.” Sargsyan 4. This indicates that Sargsyan designed the disulfiram/ebselen treatment for human subjects.
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.
(1 of 2) Claims 1-3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sargsyan et al. ChemRxiv 2020, 2020, 1-17 (pub. April 24, 2020).
Sargsyan teaches “combining disulfiram/ebselen with broad-spectrum antivirals/drugs [] to synergistically inhibit SARS-CoV-2 replication and reduce the emergence of drug resistance []. [The] antivirals “disulfiram/ebselen might destabilize the nsp10-nsp14/nsp16 complexes, thus restoring [] the host’s antiviral sensors to detect viral RNA.” Sargsyan 11. See, also, Figure 3, which shows “[i]nhibition of SARS-CoV-2 PLpro by disulfiram and ebselen.” Sargsyan 9.
This teaching anticipates claims 1-3 as discussed in the anticipation rejection, anticipation being the epitome of obviousness.
Sargsyan does not teach the kit limitations of claim 9; however, a PHOSITA would have been motivated to prepare the disulfiram/ebselen medicament in kit form, because a kit containing the disulfiram/ebselen drug combination would be easier to administer since the drugs are packaged, stored, and transported together.
(2 of 2) Claims 1-3, 7-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lobo-Galo et al. J. Biomolec. Struct. Dynam. 2020, 39, 3419 (published as a draft manuscript, pages 1-18, on May 14, 2020) in view of Yoshimura et al. Alcohol. Clin. Exp. Res. 2014, 38, 572-578.
Lobo-Galo teaches in silico human docking studies of disulfiram (DSM) that “show that the catalytic Cys145 of SARS-CoV-2mp could be blocked and inactivated by DSF and its thiol-reactive derivatives metabolites,” which “provide[s] evidence that FDA-approved, DSF could potentially be develop [sic] into new antiviral agents for the treatment of COVID-19.” Lobo-Galo 13.
Lobo-Galo teaches disulfiram was known in the art for treating alcoholism and cites Yoshimura et al. for teaching DSM doses in human studies. See Table 2 (p. 13). (“DSF can potentially be tested for clinical therapeutic use against COVID-19 in a safer manner. It is in the list of FDA-approved drugs and is used to facilitate the treatment of chronic alcoholism [].” Lobo-Galo 12.)
Yoshimura treated alcoholism in humans using a powder comprising 200 mg disulfiram, 10 mg vitamin B1, and 990 mg lactose. Yoshimura 573 (right column).
Based on Lobo-Galo’s suggestion of using DSM for treating SARS-CoV-2/COVID-19, a PHOSITA would have been motivated to formulate DSM according to Yoshimura’s powder preparation, since Yoshimura teaches a safe formulation for human administration with minimal side effects. (See, e.g., Yoshimura 575 right column.) Therefore, claim 1, drawn to a method of treating a SARS-CoV-2 by administering a pharmaceutical composition comprising DSM, would have been obvious in view of Lobo-Galo and Yoshimura.
Regarding claims 2 and 3, because Lobo-Galo suggests using DSM for “clinical therapeutic use” based on in silico testing of human cells, a PHOSITA would have found it obvious to treat human coronavirus disease with DSM.
Claim 7 is obvious over Lobo-Galo and Yoshimura, as applied to claim 1, because Lobo-Galo teaches using DSM as the sole active treatment and Yoshimura teaches DSM as a sole active ingredient in a pharmaceutical composition comprising vitamin B1 and lactose, neither of which are active against coronaviruses.
Claim 8 further requires a pharmaceutically acceptable carrier, which encompasses the lactose powder taught by Yoshimura.
Claim 10, drawn to the method of claim 8 further requiring the pharmaceutically acceptable carrier to be a pharmaceutically acceptable auxiliary material, is obvious in view of the lactose filler material taught by Yoshimura.
Conclusion
Claims 1-3 and 7-10 are rejected.
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 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 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 date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L AGUIRRE whose telephone number is (571)272-5592. The examiner can normally be reached 10 am-6 pm MDT.
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/AMANDA L. AGUIRRE/ Primary Examiner, Art Unit 1626
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