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 .
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.
This office action is a response to applicant’s communication submitted November 3, 2023, wherein claims 8, 11-12, 14, 37-38, 40-41, 45-46, were preliminarily amended, claims 1-5, 15-36, and 47-51 were canceled, and claim 52 was cancelled. This application is a 371 of PCT/US2022/027784 filed 05/05/2022 and claims benefit of US provisional application 63/184,609 filed 05/05/2021
Claims 6-14, 37-46, and 52 are pending in this application.
Response to Amendment
The amendment filed August 5, 2026 has been entered. Claims 6-14, 39-40, 42, 46, and 52 were amended and claims 1-5, 15-36, and 47-51 are canceled. Applicant’s amendments to the claims have overcome the objections to the drawings, specification and claims, the 112(b), 102, and 103 rejections previously set forth in the Non-Final Office Action mailed March 5, 2026. As such, these rejections and objections are hereby withdrawn.
Applicant’s arguments filed August 5, 2026 were fully considered but they were not persuasive. Modified/New rejections necessitated by Applicant’s amendment are addressed below.
Claims 6-14, 37-46, and 52 are pending in this application.
Priority
This application is a 371 of PCT/US2022/027784 filed 05/05/2022 and claims benefit of US provisional application 63/184,609 filed 05/05/2021
Claim Interpretation
Claim 45 recites, “wherein the host is immune suppressed”. The phrase is interpreted to mean “a subject in whom any part of the immune system is not working normally, or is working sub-normally, in other words in whom any part of the immune response, or an immune activity is reduced or impaired, whether due to disease or clinical intervention or other treatment, or in any way)” as defined on page 214 of the instant specification (lines 11-15).
Modified/New 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.
Claims 6-14, 37-40, 45-46, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Liotta (WO 2016145142, IDS filed May 27, 2025) view of Neyts (WO 2011/160191, IDS filed May 27, 2025) as evidenced by Lanko (Antiviral Research, 2021, cited in previous action).
Regarding claims 6-14, 37-40, 45-46, and 52: Liotta teaches nucleotide and nucleoside therapeutic compositions and uses in treating infectious diseases, viral infections, and cancer, where the base of the nucleotide or nucleoside contains at least one thiol, thione or thioether (abstract). Liotta teaches the method can be used to treat viral infections from RNA virus, DNA virus, or retrovirus (pg. 5, lines 1-10). Liotta teaches compounds of the invention can be administered in combination with a second antiviral agent such as pleconaril (pg. 194, lines 8-16). Liotta teaches compositions of one of the following compounds:
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is administered together with a second antiviral agent described above (pg. 194, lines 20-23). Compound 2023 meets the structural limitations as recited by instant claims 6-14. Liotta teaches in certain embodiments a method of treating a subject diagnosed with hepatitis B virus (HBV), wherein the subject is immunocompromised (i.e. immune suppressed, pg. 193, lines 21-28, 29-31). Liotta teaches liposomal suspensions (including liposomes targeted to viral antigens) may also be prepared by conventional methods to produce pharmaceutically acceptable carriers, this may be appropriate for the delivery of free nucleosides, acyl nucleosides or phosphate ester prodrug forms of the nucleoside compounds according to the present invention (pg. 213, lines 4-7). Liotta teaches compounds of the invention can be administered in combination with a second antiviral agent such as pleconaril (pg. 194, lines 8-16). Liotta teaches compositions of one of the following compounds:
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is administered together with a second antiviral agent described above (pg. 194, lines 20-23).
Liotta does not specifically teach a combination of the claimed compound with a second antiviral agent that is vapendavir.
However, Neyts teaches the treatment of enteroviruses with the following compound:
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(abstract). Neyts teaches the compound can be used in combination with a second anti-enteroviral agent for the treatment of an enteroviral infection (pg. 7, lines 1-5). According to Lanko, this compound is known as vapendavir (pg. 5, figure 3).
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to modify the composition such that it includes vapendavir as the second anti-viral agent. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as both the claimed compound and vapendavir are known antiviral agents effective against enteroviruses, and the art teaches generally the use of combination therapies against viral infections.
Claims 41-44 are rejected under 35 U.S.C. 103 as being unpatentable over Liotta (WO 2016145142, IDS filed May 27, 2025), Neyts (WO 2011/160191, IDS filed May 27, 2025) and Lanko (Antiviral Research, 2021, cited in previous action). as applied to claims 6-14, 37-40, 45-46, and 52 above in view of Liotta (ACS Med. Chem. Lett., 2018, cited in previous action, hereinafter referred to as Liotta (ACS Med. Chem. Lett.)),
Regarding claims 41-44: As discussed above, Liotta and Neyts render obvious the composition of claim 6 and the method of claim 38. Liotta suggests generally that the method is applicable to enterovirus and rhinovirus (pg. 184, lines 3-15). Liotta includes the enteroviruses human coxsackieviruses A1-A22 and A24 (i.e. coxsackievirus A16 falls within this grouping, pg. 5, lines 11-16, pg. 184, lines 3-15).
Liotta does not specifically demonstrate a method of treating enterovirus and rhinovirus, such as Coxsackie A16.
However, Liotta (ACS Med. Chem. Lett.) teaches that EID-2023 is an orally available treatment for rhino- and enteroviruses with extensive and positive safety data (pg. 406, col. 2, para. 2, last bullet point).
Taken together, it would have been prima facie obvious to apply the method to enterovirus, such as coxsackies virus and rhinovirus specifically as suggested by Liotta and supported by Liotta (ACS Med. Chem. Lett.). A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as compound 2023 is an established antiviral in the art of treating these viruses specifically and coxsackie is a known virus in this category of virus that is in need of treatment.
Response to Arguments
Applicant’s arguments filed August 5, 2026 with respect to the claims have been fully considered but they are not persuasive.
On pages 15-16 of Applicant’s response, Applicant argues the newly amended claims that specify that the second antiviral agent is vapendavir are novel and nonobvious over Liotta and Liotta ACS Med Chem Lett.
See Modified rejections above.
On pages 16-17 of Applicants response, Applicant argues that Liotta describes that the compounds therein can be used in combination with other antiviral agents and lists 75 specific antiviral agents that could be used in combination (bridging para). On page 18 of Applicants response, Applicant argues the skilled person would have to trial these 75 agents to arrive at the specific combination with vapendavir as is instantly claimed (para. 2). Applicant argues that Liotta Med Chem discloses EIDD-2023 for the treatment of enterovirus, does not provide any guidance on any additional compound that could be used in combination, and does not even disclose using EIDD-2023 in combination with another agent (pg. 18, paras. 3-4). Applicant argues Neyts and Lanko describe the use of vapendavir in the treatment of enteroviruses, they do not paint a picture of the totality of the art available when considering this compound for use in combination with the claimed compound (EIDD-2023, pg. 18, para. 5).
However, as Liotta specifically states other antiviral agents can be used alongside the claimed compounds, as recognized by Applicant, Liotta recognizes combination therapies generally. Wherein the art recognizes both the compounds of Liotta and vapendavir for the treatment of enteroviruses, 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. The idea of combining them flows logically from their having been individually taught in the prior art (See MPEP 2144.06 (I)).
On pages 18-19 of Applicant’s response, Applicant cites articles Tammaro and Sun (bridging para.). Applicant argues Tammaro demonstrates vapendavir is specifically noted as having failed clinical trials due to its low efficacy Applicant argues Sun teaches 3C-protease inhibitors were considered more effective than vapendavir. Applicant argues a person of ordinary skill in the art would choose another compound before choosing vapendavir based on other references in the art.
However, although Tammaro teaches vapendavir as having low efficacy and side effects, Tammaro supports the notion that vapendavir as a known anti-enteroviral compound a person of ordinary skill in the art would be motivated to use in the treatment of this type of infection (pg. 3, section 2.1.1). Similarly, although a nonpreferred embodiment, Sun demonstrates that vapendavir possesses antiviral activity against enteroviruses (pg. 7783, table 1). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use (See MPEP 2123 (II)).
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 103 rejection is maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
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 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 SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
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