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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 23, 2026 has been entered.
DETAILED ACTION
3. Claims 1, 3, 8 – 23, 26, 29, 35, and 37 – 41 are pending in this application. Applicant’s Amendment and Remarks, filed February 23, 2026, is entered, wherein claims 3 and 16 are amended, claims 2, 4 – 7, 24 – 25, 27 – 28, 30 – 34, and 36 are canceled, and claims 38 – 41 are new.
Receipt is acknowledged of Declaration of Jose R. Matos filed on February 23, 2026.
Claims 1, 3, 8 – 23, 26, 29, 35, and 37 – 41 are examined on the merits herein.
Priority
4. This application is a domestic application, filed February 12, 2024, and claims benefit as a continuation in part of PCT/US2022/038505, filed July 27, 2022, which claims benefits of domestic application 63/233,578 and 63/337,804, filed August 16, 2021 and May 3, 2022, respectively.
Withdrawn Rejections
5. The rejection of claims 1, 3, 8 – 23, 26, 29, 35, and 37 in the previous Office Action, mailed April 29, 2025, under 35 U.S.C. 103 as being unpatentable over Newman et al. in view of Payne has been considered and is withdrawn in view of the data provided in the declaration filed February 23, 2026.
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:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. 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.
Claims 1, 3, 8 – 23, 26, 29, 35, and 37 – 41 are rejected under 35 U.S.C. 103 as being unpatentable over Newman et al. (US10729735B1, August 4, 2020, first cited in the Office Action mailed October 25, 2026) in view of Kumar et al. (Pharmacognosy Reviews, 2013, Vol. 7, Issue 14, Reference included with PTO-892) and Wang et al. (PLOS ONE, 2013, Vol. 8, Issue 2, Reference included with PTO-892).
a. Regarding claims 1, 3, 8 – 23, 26, 29, 35, and 37 – 41, Newman et al. teaches a pharmaceutical composition and method for treating and/or preventing viral infection in a mammalian subject (Col. 6, lines 48 – 50). The pharmaceutical composition is an antiviral composition comprises oleandrin (Col. 6, line 67). Oleandrin may be extracted from Nerium plant biomass using subcritical liquid carbon dioxide. (Col. 12, lines 33 – 41). The extract may comprise at least one other pharmacologically active agent, obtained along with oleandrin (Col. 12, lines 54 – 56). In some embodiments, the extract comprises one or more cardiac glycosides and one or more cardiac glycoside precursors (Col. 12, lines 66 – 67; Col. 13, line 1). The extract may further comprises alkaloid (Col. 12, line 53). The composition can be administered systemically, such as orally (Col. 11, lines 36 and 39), to the mammal in one or more therapeutically effective doses (Col. 8, lines 63 – 64) for treating viral infection that is caused by Arterviridae (should be spelled as Arteriviridae) (Col. 7, lines 5 – 6). Newman et al. teaches a method of treating a subject at risk of contracting a viral infection, wherein the method comprising chronically administering to the subject one or more doses of an antiviral composition on a recurring basis over an extended treatment period prior to the subject contracting the viral infection, thereby preventing the subject from contracting the viral infection (Col. 6, lines 60 – 66). Newman et al. interprets “subject” as warm blooded animals, such as cows and pigs, and the subject at risk of viral infection may be a subject living with other subject having viral infection (Col. 18, lines 36 – 38; lines 42 – 43). The chronic administration of the antiviral composition provides relief of symptoms associated with the viral infection or amelioration of the viral infection. Administration of the composition to the subject can begin immediately after infection or any time within one day to 5 days after infection or at the earliest time after definite diagnosis of infection with virus (Col. 8, lines 53 – 59). The anticipated oleandrin plasma concentration based on human clinical data will be in the range of 0.005 to about 10 ng/mL (Col. 39, lines 14 – 26). The dose of oleandrin can be about 0.2 to about 1 microg/kg body weight/day, about 0.5 to about 1.0 microg/kg body weight/day, about 0.75 to about 1.5 microg/kg body weight/day, about 1.5 to about 2.52 microg/kg body weight/day, about 2.5 to about 3.0 microg/kg body weight/day, about 3.0 to 4.0 microg/kg body weight/day or about 3.5 to 4.5 microg oleandrin/kg body weight/day (Col. 39, lines 29 – 35). In some embodiments, the cardiac glycoside is administered in at least two dosing phases: a loading phase and a maintenance phase (Col. 11, lines 23 – 25). In some embodiments, one or more doses of oleandrin are administered per day for plural days until the viral infection is cured. In other embodiments, one or more doses of cardiac glycoside are administered per day for plural days and plural weeks until the viral infection is cured. One or more doses can be administered in a day. One, two, three, four five, six, or more doses can be administered per day (Col. 10, lines 14 – 21). The treatment period can be one or more weeks, one or more months, one or more quarters, and/or one or more years (Col. 10, lines 53 – 55). Furthermore, Newman et al. teaches that oleandrin can be used in combination with digoxin (Col. 9, line 33).
However, Newman et al. does not explicitly teach that said viral infection is porcine reproductive and respiratory syndrome virus (PRRSV).
Kumar et al. teach that oleandrin, a toxic cardiac glycoside of N. oleander L., inhibits the activity of nuclear factor kappa-light-chain-enhancer of activated B chain (NF-κB) in various cultured cell lines (Abstract).
Wang et al. teach that PRRSV is an Arterivirus that has been devastating the swine industry worldwide since the late 1980s. Wang et al. disclose that activation of NF-κB is required for PRRSV replication(Abstract).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for treating viral infection comprising administering oleandrin as taught by Newman et al. into administering oleandrin to treat PRRSV infection specifically in view of Kumar et al. and Wang et al. because Newman et al. teach that the pharmaceutical composition comprising oleandrin may be used to treat viral infection of Arteriviridae and Kumar et al. and Wang et al. teach that PRRSV replication may be suppressed by inhibiting NF-κB and oleandrin is capable of inhibiting NF-κB. One would have been motivated to administer oleandrin to treat PRRSV infection because Wang et al. disclose that PRRSV replication requires activation of NF-κB and Kumar et al. teach that oleandrin inhibits NF-κB activity. One of ordinary skill in the art would have had a reasonable expectation of success to modify the method for treating viral infection comprising administering oleandrin as taught by Newman et al. into administering oleandrin to treat PRRSV infection specifically in view of Kumar et al. and Wang et al. because it is known in the art that oleandrin is an antiviral agent used for treating viral infection of Arteriviridae and oleandrin targets to inhibit the activation of NF-κB, which is required for PRRSV replication.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed February 23, 2026, have been fully considered and are found to be not persuasive.
Regarding Newman et al. and Payne, Applicant argues that the combination fails to disclose, teach, or suggest a method of treating PRRSV with an antiviral composition comprising oleandrin because Newman et al. merely disclose viral families without identifying any specific virus in these families and Payne only generally teaches the members of Arteriviridae family. Applicant further argues that Newman et al. alone or in view of Payne demonstrate the unpredictability of the art because Newman et al. explain that the composition is unpredictable and not broadly applicable to every virus and this is supported by Yang. Yang finds that oleandrin is active against porcine TGEV but not MHV, establishing that oleandrin can be active against only selected members of a viral family. The Declaration also provides data to establish the unpredictability of antiviral activity of oleandrin against viruses within the same family. Applicant concludes that Newman et al., Yang, the present application, and the Declaration have clearly and overwhelmingly demonstrated the unpredictability in the art. However, these arguments are moot because the previous rejection has been withdrawn. The current rejection is based on the combination of Newman et al., Kumar et al., and Wang et al. As discussed above, Newman et al. teach that oleandrin is an antiviral agent for treating viral infection including Arteriviridae, Kumar et al. teach that oleandrin is able to inhibit NF-κB, and Wang et al. teach that PRRSV replication depends on the activation of NF-κB. One of ordinary skill in the art would have considered using the composition comprising oleandrin as an antiviral agent to treat PRRSV because Kumar et al. teach that oleandrin is able to inhibit NF-κB and Wang et al. disclose the disease mechanism of PRRSV regarding the activation of NF-κB. Therefore, the combination of Newman et al., Kumar et al., and Wang et al. renders the claimed invention obvious.
Conclusion
No claim is found to be allowable.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693