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 .
DETAILED ACTION
This office action is in reply to Applicant’s Remarks/Arguments filed on 17 June 2026 for application 18/512,088 filed on 17 November 2023. Claims 2, 4-8, 12-13, 15, 18-20, 22-34, 37-40, 42-43, 45, 47, 49, 51, 53, 55-56, 58-61 and 63 are canceled. Claims 3 and 48 is amended. Currently, claims 1, 3, 9-11, 14, 16-17, 21, 35-36, 41, 44, 46, 48, 50, 52, 54, 57, and 62 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 17 June 2026 was filed after the mailing date of the application on 17 November 2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection the previous office action is set out below.
35 U.S.C. 102, 103, and Double Patenting
Applicant’s arguments to claims 1, 3, 21 and 35-36 were found persuasive and the rejection has been withdrawn.
REJECTIONS – MAINTAINED & NEW
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(New/Maintained) Claims 1, 3, 9-11, 14, 16, 21, 35-36, 57 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over T. Cihlar (Remdesivir treatment methods, US 11,975,012 B2, filed 28 May 2021, published 23 December 2021; entered in IDS on 17 September 2024) in view of Huang et al. (Pharmaceutical formulation containing active metabolites of remdesivir for inhalation, WO 2021/231361 A1, published 18 November 2021).
Cihlar discloses the use of the drug Remdesivir (pg. 19 – methods of use) as a means of preventing or treating viral infections in a patient including Arenaviridae viruses (pg. 26, col. 20, lines 20-46), Coronaviridae viruses (pg. 26-27, col. 20, line 47 to col. 21, line 19), Filoviridae viruses (pg. 27, col. 21, line 20-31) but teaches that any suitable viral infection can be treated by the method of the disclosure (pg. 26, col. 20, line 15-16).
Cihlar does not, however teach the use of Remdesivir in the treatment of poxviruses.
Huang rectifies this deficiency by teaching the use of Remdesivir active metabolites, naturally formed after administration of Remdesivir to the human body, to other viruses including the Vaccinia virus including poxviridae, chordopoxvirinae, and orthopoxvirus (pg. 7, para. 37).
As such, it would have been prima facie obvious, to a person of ordinary skill in the art, to consider the use of Remdesivir in the treatment of a patient with a viral infection as disclosed by Cihlar, including poxvirus as taught by Huang, who teaches using the active metabolites instead of the parent drug due to difficulties in administering as an injectable solution (para. 0006). However, as Cihliar teaches, the parent drug is a reasonable therapeutic for viral infections.
(New/Maintained) Regarding the limitations of claim 3, wherein the compound of formula I, formula Ia, or formula Ib is administered, are met as Cihlar discloses the use of Remdesivir to treat viral infections including poxviruses as taught by Huang.
(New/Maintained) Concerning the limitations of claim 21, a method of treating a poxvirus infection in a patient in need thereof, wherein the method comprises administering to the patient a pharmaceutical composition comprising a compound of formula I, formula Ia, or formula Ib, or pharmaceutically acceptable salt or deuterated analogs and one or more pharmaceutically acceptable carriers, are met as Cihlar discloses the use of Remdesivir to treat viral infections including poxviruses as taught by Huang, utilizing pharmaceutically acceptable excipients as taught by Cihlar (pg. 19, col. 5, lines 23-30).
(New/Maintained) With respect to the limitations of claim 35, wherein the poxvirus infection is an orthopox virus infection, are met as Huang teaches treating orthopoxvirus (pg. 7, para. 0037).
(New/Maintained) With regards to the limitations of claim 36, wherein the poxvirus infection is listed, are met as Huang teaches treating Vaccinia virus (pg. 7, para. 0037).
(Maintained) With concern to the limitations of claim 9, wherein the compound or pharmaceutically acceptable salt or deuterated analog thereof is administered orally, are met as Cihlar teaches that Remdesivir can be administered in any route appropriate to the condition to be treated including oral, rectal, nasal, pulmonary, topical vaginal and parenteral (including subcutaneous, intramuscular, intravenous, intradermal, intrathecal, and epidural) and implants (pg. 25, col. 17, lines 3-10).
(Maintained) Regarding the limitations of claim 10, wherein the compound or the pharmaceutically acceptable salt or deuterated analog thereof is administered parenterally, are met as Cihlar teaches that Remdesivir can be administered in any route appropriate to the condition to be treated including oral, rectal, nasal, pulmonary, topical vaginal and parenteral (including subcutaneous, intramuscular, intravenous, intradermal, intrathecal, and epidural) and implants (pg. 25, col. 17, lines 3-10).
(Maintained) Concerning the limitations of claim 11, wherein the compound or the pharmaceutically acceptable salt or deuterated analog thereof is administered once daily, are met as Cihlar teaches that Remdesivir can be administered once daily or twice daily (pg. 25, col. 17, line 22).
(Maintained) With respect to the limitations of claim 14, wherein the compound or the pharmaceutically acceptable salt or deuterated analog thereof is administered at a dosage of 5 mg to 300 mg, are met as Cihlar teaches administering 150 mg to 250 mg on day one and 50 mg to 150 on subsequent days (pg. 25, col. 17, lines 28-31). A prima facie case of obviousness exists where claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP § 2144.05.
(Maintained) With regards to the limitations of claim 16, wherein the compound or the pharmaceutically acceptable salt or deuterated analog thereof is administered at a dosage of 0.1 mg/kg to 15 mg/kg, are met as Cihlar teaches administering a dose of 2.5 mg/kg to 10 mg/kg on day one and 1 mg/kg to 5 mg/kg on subsequent days (pg. 25, col. 18, lines 55-58). A prima facie case of obviousness exists where claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP § 2144.05.
(Maintained) With regards to the limitations of claim 57, wherein the patient is a human, are met as Cihlar teaches administration doses as described in paragraph 19 for human patients presumed to weighing between 3.5 kg to less than 40 kg (pg. 25, col. 18, lines 52-53).
(Maintained) With concern to the limitations of claim 62, a kit comprising a compound of formula I or a pharmaceutically acceptable salt or deuterated analog thereof, and directions for their use in treating a poxvirus infection, are met as Cihlar teaches the use of a kit, comprising a compound or composition disclosed, including Remdesivir, a label and/or instructions for using (pg. 32, col. 32 – section IV. Kits).
(New) Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Cihlar and Huang as applied to claims 1, 3, 9-11, 14, 16, 21, 35-36, 57 and 62 above, and further in view of Harness et al. (Arylamide compounds for treatment and prevention of viral infections, WO 2021/248008 A1, 2021), U.S. Food & Drug Administration (Emergency use authorization 092, 27 October 2022), and Akazawa et al. (Potential anti-monkeypox virus activity of atovaquone, mefloquine, and molnupiravir, and their potential use as treatments, bioRxiv preprint, 2 August 2022, doi.org/10.1101/2022.08.02.502485).
Cihlar discloses the use of Remdesivir to treat viral infections including poxviruses as taught by Huang.
They do not, however, disclose administering to the patient a therapeutically effective amount of an additional therapeutic agent.
Harness overcomes this by teaching the use of Brilacidin, a non-peptidic host defense peptide/protein mimetic, to treat SARS-CoV-2, in conjunction with Remdesivir. In a Calu-3 cell line assay, Harness assesses the synergistic effects of Brilacidin in combination with Remdesivir and Favipiravir. Brilacidin and Favipiravir independently exerted up to 90% and 80% inhibition of viral titers, respectively, which did not increase over time. In an Brilacidin/Remdesivir combination, the viral infectious titer was inhibited by >99% (pg. 36, example 4). This therapeutic combination was so effective that the FDA agreed to Eli Lilly and Company’s issuance request for an emergency use authorization for the treatment of suspected or laboratory confirmed COVID-19 in certain hospitalized patients, demonstrating Remdesivir’s potential application in other combinatorial therapies. In the case of monkeypox virus, a subset of orthopox virus, Akazawa identifies three approved-drugs including Atovaquone, Mefloquine, and Molnupiravir that exhibit anti-monkeypox virus activity, with 50% inhibitory concentrations at 0.5 µM (abstract).
As such, it would have been prima facie obvious, to a person of ordinary skill in the art, at the time of filing, that Remdesivir could be used synergistically as a combination therapy as had been previously demonstrated, and to consider approved drugs that had already shown efficacy to other poxviruses, i.e. monkeypox.
Allowable Subject Matter
Claims 41, 44, 46, 48, 50, 52 and 54 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.
The following is a statement of reasons for the indication of allowable subject matter: a method of using Remdesivir to treat infections caused by Parapoxvirus, Molluscipoxvirus, Yatapoxvirus, Capripoxvirus, Suipoxvirus, Leproipoxvirus, and Avipoxvirus were not taught in the prior art in a 100% embodiment. The closest matches are taught by T. Cihlar (Remdesivir treatment methods, US 11,975,012 B2, filed 28 May 2021, published 23 December 2021; entered in IDS on 17 September 2024) in view of Huang et al. (Pharmaceutical formulation containing active metabolites of remdesivir for inhalation, WO 2021/231361 A1, published 18 November 2021) with the use of Remdesivir to treat an infection caused by Poxviridae, Chordopoxvirinae, and Orthopoxvirus.
Response to Arguments
The office kindly thanks the Applicant for their consideration and arguments to the previous office action. Responses are detailed below.
Applicant’s arguments, see pg. 8 – Claim Objections, filed 17 June 2026, with respect to claim 3 have been fully considered and are persuasive. The objection of claim 3 has been withdrawn.
Applicant’s arguments, see pg. 8 – Claim Rejections – 35 U.S.C. § 102, filed 17 June 2026, with respect to the rejections of claims 1, 3, 21 and 35-36 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of T. Cihlar (Remdesivir treatment methods, US 11,975,012 B2, filed 28 May 2021, published 23 December 2021; entered in IDS on 17 September 2024) and Huang et al. (Pharmaceutical formulation containing active metabolites of remdesivir for inhalation, WO 2021/231361 A1, published 18 November 2021) as a reworked interpretation of the previously applied 35 U.S.C. 103 rejection.
On pg. 9 – Claim Rejections – 35 U.S.C. § 103, claims 1, 3, 9-11, 14, 16, 21, 35, 36, 57 and 62, filed 17 June 2026, the Applicant argues:
… Huang is directed to inhalation formulations containing active metabolites of remdesivir – not remdesivir itself… moreover one of ordinary skill would not have sought to modify the inhalation formulations of Huang based on the oral and parenteral dosages described by Cihlar…
The Examiner acknowledges the initial point, referencing paragraph 31 of the instant office action. The reworked interpretation expands upon the viral targets that Cihlar discloses that Remdesivir is appropriate for with the teachings from Huang that expand upon the possible targets. Though Huang’s formulation may certainly be more efficacious, the fact that Remdesivir is proscribed in non-inhalation form as taught by Cihlar and the FDA above, demonstrates that other routes of administration are reasonable.
On pg. 10 – Claim Rejections - 35 U.S.C. § 103, claim 17, filed 17 June 2026, the Applicant argues:
… however, as noted above, Huang is directed to formulations containing active metabolites of Remdesivir, and accordingly does not disclose treatment of a poxvirus infection with formula I, formula Ia, and formula Ib…
The response in paragraph 33 is restated here for the purpose of response.
Conclusion
Claims 1, 3, 9-11, 14, 16-17, 21, 35-36, 57 and 62 are rejected. Claims 41, 44, 46, 48, 50, 52 and 54 are objected to.
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 Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300.
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 H Alstrum-Acevedo can be reached at 571-272-5548. 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.
/ALLEN CHAO/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Prosecution Insights