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 .
Priority
This Application is a 371 of PCT/US2021/047935, filed Aug. 27, 2021 and claims priority benefit of U.S. Provisional Application No. 63/071,564, filed Aug. 28, 2020.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 9, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 9, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claim 1 is currently pending and subject to examination.
Claim Rejections – 35 USC § 103 – Previously Presented
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.
The rejection of claim(s) 1 under 35 U.S.C. 103 as being unpatentable over Ludwig et al. (US 2022/0152080 A1; Published May 19, 2022; PCT filed Mar. 19, 2020) and further in view of Smith et al. (Bioorganic & Medicinal Chemistry, Volume 15, Issue 14, 15 July 2007, Pages 5018-5034) is maintained.
Response to Arguments
Applicant’s arguments filed June 9, 2026 have been fully considered but they are not persuasive.
Applicant argues that the cited combination does not provide a sufficient reason to modify Ludwig to arrive at the presently claimed method (Remarks, p. 7). This argument is not persuasive because “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities.” (MPEP 2144.09). The cited documents establish that the claimed compound (the compound of formula VIII) has a very close structural relationship and the same biological properties as the prior art compound (the compound of formula VII/ SL0101).
Ludwig teaches that the RSK inhibitor SL0101 (SL0101-1) has antiviral activity, including against SARS-CoV-2 (Ludwig, Specification, ¶ [0011], ¶ [0058]) (Final Action dated March 9, 2026 at 3-5). One of ordinary skill in the art would have a reasonable expectation of success to inhibit a viral infection (SARS-CoV-2 infection) with a compound of formula VIII because the compound of formula VIII is structurally analogous to the compound of formula VII/ SL0101 and is known to have similar properties. For example, Smith teaches that SL0101 (compound (1)) and the compound of formula VIII (compound (32)) are both RSK inhibitors with similar properties:
PNG
media_image1.png
199
236
media_image1.png
Greyscale
Smith, Fig. 2, p. 5022 (Final Action dated March 9, 2026 at 9);
We have shown that the ability of RSK to interact with SL0101 depends on the sugar moiety because RSK has a 40-fold greater affinity for SL0101 (1) compared to kaempferol (31) (Fig. 2).2 During the isolation of SL0101 we also identified compounds that differ from SL0101 (1) only in the number and position of the acetyl groups on the rhamnose moiety ((32) and (33)) and we found that RSK was able to bind these compounds with similar in vitro affinities as SL0101 (1) (Fig. 2).18 Furthermore, acylation of all the hydroxy groups on the rhamnose to generate tri-O-Ac-SL0101 (29) did not substantially alter the inhibitory potency or specificity for inhibiting RSK activity in vitro (Fig. 2).18
Smith, col. 2, p. 5024 (Final Action dated March 9, 2026 at 9).
The Applicant argues that they have amended the claimed method to inhibiting a SARS-CoV-2 infection and the “cited portions of Ludwig relief upon in the Office Action do not disclose the presently claimed combinations of limitations after amendment.” (Remarks, p. 7). These arguments are not persuasive because Ludwig specifically teaches that RSK inhibitors such as the compound of formula VII/ SL0101 are useful for treating SARS-CoV-2 infections and this evidence was shown in the prior office action:
In another aspect, the method of the invention is for the prophylaxis and/or treatment of a viral disease which is an infection caused by positive strand RNA virus such as, for example, Coronaviruses such as SARS-CoV, MERS-CoV or SARS-CoV-2 that cause respiratory tract infections such as SARS, MERS or Covid19.
Ludwig, Specification, ¶ [0058] (cited on page 5 of the Final Office Action dated March 9, 2026).
Reiterated Rejection
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ludwig et al. (US 2022/0152080 A1; Published May 19, 2022; PCT filed Mar. 19, 2020) and further in view of Smith et al. (Bioorganic & Medicinal Chemistry, Volume 15, Issue 14, 15 July 2007, Pages 5018-5034).
Claim 1 is directed towards a method for inhibiting a virus infection comprising administering to the subject in need thereof a pharmaceutical composition comprising a therapeutically effective amount of a compound, in which the compound is a compound having the structure of formula VIII:
PNG
media_image2.png
205
246
media_image2.png
Greyscale
.
Ludwig teaches a method for inhibiting viral infections, including SARS-CoV-2 infections comprising administering to the subject in need thereof a pharmaceutical composition comprising a therapeutically effective amount of the RSK inhibitor SL0101 (SL0101-1):
The present invention relates to an RSK inhibitor for use in a method for the prophylaxis and/or treatment of a viral disease. Specifically, the RSK inhibitor can be selected from the group consisting of BI-D1870, SL0101-1, LJH685, LJ1308, BIX 02565, FMK and a selective RSK1 inhibitor or a derivative, metabolite or pharmaceutically acceptable salt thereof.
Ludwig, Specification, ¶ [0011];
[I]nhibitors of Rsk have antiviral activity against viruses by preventing export of viral genomes from the nucleus. Surprisingly, it has been found that this object can be achieved by an RSK inhibitor according to the invention, in particular by pharmaceutical compositions comprising a RSK1 inhibitor compound.
Ludwig, Specification, ¶ [0045];
In another aspect, the method of the invention is for the prophylaxis and/or treatment of a viral disease which is an infection caused by positive strand RNA virus such as, for example, Coronaviruses such as SARS-CoV, MERS-CoV or SARS-CoV-2 that cause respiratory tract infections such as SARS, MERS or Covid19.
Ludwig, Specification, ¶ [0058] (emphasis added);
FIG. 4(A-H) show decreased M1-NP binding upon RSK-inhibition and nuclear retention of progeny vRNPs upon RSK-inhibition or RSK1 knockdown, as demonstrated in Example 2. (I-P) show that the specific RSK-inhibitors BI-D1870 and SL0101-1 inhibit viral propagation as described in Example 2
Ludwig, Specification, ¶ [0075];
PNG
media_image3.png
213
783
media_image3.png
Greyscale
Ludwig, Fig. 4N-P.
While Ludwig does not teach a method of treating a viral infection comprising administering to the subject in need thereof a compound of formula VIII, one of ordinary skill in the art would have a reasonable expectation of success to inhibit a viral infection with a compound of formula VIII because the compound of formula VIII is structurally analogous to the compound of formula VII/ SL0101 and is known to have similar properties.
For example, Smith teaches that SL0101 (compound (1)) and the compound of formula VIII (compound (32)) are both RSK inhibitors with similar properties:
PNG
media_image1.png
199
236
media_image1.png
Greyscale
Smith, Fig. 2, p. 5022.
We have shown that the ability of RSK to interact with SL0101 depends on the sugar moiety because RSK has a 40-fold greater affinity for SL0101 (1) compared to kaempferol (31) (Fig. 2).2 During the isolation of SL0101 we also identified compounds that differ from SL0101 (1) only in the number and position of the acetyl groups on the rhamnose moiety ((32) and (33)) and we found that RSK was able to bind these compounds with similar in vitro affinities as SL0101 (1) (Fig. 2).18 Furthermore, acylation of all the hydroxy groups on the rhamnose to generate tri-O-Ac-SL0101 (29) did not substantially alter the inhibitory potency or specificity for inhibiting RSK activity in vitro (Fig. 2).18
Smith, col. 2, p. 5024.
Therefore, claim 1 was prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Conclusion
No claim is found to be allowable.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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, Jeffrey Lundgren can be reached on (571) 272-5541. 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 86-217-9197 (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.
/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
