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 is a response to Applicant’s communication filed on January 28, 2026. Application No. 17/801,219, is a 371 of PCT/CN2021/099650, filed June 11, 2021, and claims foreign priority to Chinese application No. CHINA 202010547186.8, filed June 16, 2020. In amendment filed August 7, 2025, Applicant added new claims 11-19. In an amendment filed January 28, 2026, Applicant cancelled claims 2, 3, 7, 8, 11, 12, and 15-17; and added new claims 20-23. Claims 1, 4-6, 9, 10, 13, 14, and 18-23 are pending.
Rejections Withdrawn
The rejection of claims 1-19 under 35 U.S.C. 103 as being unpatentable over Liao, X., WO2021/0276994 A1 (citing the U.S. equivalent: Liao, X., US2021/0276994 A1), in view of Balan et al., US2020/0171020 A1, is withdrawn in view of Applicant’s January 28, 2026, Amendment & Remarks.
The rejection of claims 1-19 under 35 U.S.C. 112(a), for enablement, is withdrawn in view of Applicant’s January 28, 2026, Amendment & Remarks.
New Rejection Necessitated by Applicant’s January 28, 2026, Amendment
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.
Claims 1, 4-6, 9, 10, 13, 14, and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Liao, X., WO2021/0276994 A1 (citing the U.S. equivalent: Liao, X., US2021/0276994 A1), in view of Jimenez-Guardeño et al., The PDZ-Binding Motif of Severe Acute Respiratory Syndrome Coronavirus Envelope Protein is a Determinant of Viral Pathogenesis, 10(8) Plos Pathos. E1004320 (2014). Liao discloses the HPK-1/MAP4K1 inhibitor of Formula 1 of claim 1. See Liao et al., US ‘994 publc’n, p. 33, para. [0294]; see also Id., Abstract for use as a HPK-1 inhibitor. The difference between the prior art and present invention is the use of a HPK-1/MAP4K1 inhibitor to treat diseases or conditions caused by or associated with a pathogen, wherein the pathogen is a coronavirus.
Jimenez-Guardeño teaches that the p38 MAPK pathway is activated by Sars-CoV-1. In the MAPK cascading pathway. The HPK-1/MAP4K1 receptor is upstream from p38 MAPK. Inhibition of the p38 MAPK pathway led to a decrease expression of inflammatory cytokines and to virus attenuation. Jimenez-Guardeño et al., Abstract. Inhibition of the MAPK pathway led to an increase in mice survival after infection with SARS-CoV-1, confirming the relevance of this pathway in SARS-CoV virulence. Id. Accordingly, all the elements of the present invention were known in the art at the time of the invention.
It would have been obvious to the ordinary artisan at the time of the invention to use the known HPK-1/MAP4K1 inhibitor of formula (I) of claim 1 as disclosed in Liao to treat diseases or conditions caused by or associated with a pathogen, wherein the pathogen is a coronavirus as taught by Jimenez-Guardeño with a reasonable expectation of success. The present invention combines the known prior art elements according to known methods to yield predictable results.
Rejection Maintained
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
The provisional rejection of claims 1, 4-6, 9, 10, 13, 14, and 18-23 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/009,954 (reference application), is maintained for reasons made of record. Applicant has requested that this rejection be held in abeyance until allowable subject matter has been found in the present invention. No claims are allowed at this time. Accordingly, the rejection is maintained. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘954 application claim the same subject matter claimed by the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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/TIMOTHY R ROZOF/ Primary Examiner, Art Unit 1625