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 .
Priority
The instant application is a 371 National Stage Entry of PCT/US2021/046965 filed on August 20, 2021 which claims priority to domestic application Nos. 63/138,151 filed on January 15, 2021, 63/089,976 filed on October 9, 2020, and 62/706,512 filed on August 21, 2020.
Status of Claims
Acknowledgement is made of previously presented (11, 13-14), amended (8-10, 12), and cancelled (1-7) claims filed January 27, 2026. Claims 8-14 are currently pending.
Response to Arguments
Applicant’s amendments filed January 27, 2026 are acknowledged.
Regarding the 35 U.S.C. 112(b) rejection of claims 11-14, 16-18, the Examiner apologizes for the incomplete/improper 35 U.S.C. 112(b) rejection of claims 11-14, 16-18 in the previous 8/28/25 Office Action. Upon further consideration, the rejection is withdrawn as the term “about” is deemed broad and not indefinite.
The 35 U.S.C. 102(a)(1) rejection of claims 1 and 19 over Hwang is withdrawn in light of cancelled claims.
The 35 U.S.C. 102(a)(1) rejection of claims 1, 4, 6-7, 19 over Keller is withdrawn in light of cancelled claims.
The 35 U.S.C. 103 rejection of claim 5 over Keller in view of Vlekkert is withdrawn in light of cancelled claims.
Applicant's arguments filed January 27, 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art. See also MPEP § 2145.
The remaining rejections are maintained/modified to account for cancelled claims.
Maintained/Modified Rejections
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 8-10 are rejected under 35 U.S.C. 103 as being obvious over WO 2010/019210 A2 to Keller1 in view of George et. al.2
Regarding claim 8 and halofuginone for treating a viral infection, Keller teaches halofuginone and halofuginone analogs inhibit pro-fibrotic behavior of fibroblasts, modify effector T-cell differentiation, and inhibit angiogenesis and thus are useful for treating disorders associated with fibrosis, inflammatory or autoimmune diseases, tumor neovascularization, and ocular diseases (see Keller at p. 2 ¶[005]). Keller teaches halofuginone can be administered to animals including humans (compare with instant claim 19) (see Keller at p. 168 ¶[00495]). Keller teaches the antifibrotic compound halofuginone and its analogs for treating viral infections by inhibiting viral gene expression, replication, and maturation (see Keller at p. 159 ¶[00463] and at p. 35 ¶[00126),
Regarding claims 9, 10 and 2R,3S-(+) halofuginone, Keller teaches 2R,3S-(+) halofuginone (see Keller at p. 142 ¶[00433]).
The prior art differs from the instant claims as follows: While Keller teaches the antifibrotic compound halofuginone, and optionally 2R,3S-(+) halofuginone, for treating viral infections by inhibiting viral gene expression, replication, and maturation, Keller does not specify a coronavirus or COVID-19.
Regarding claims 2-3, 8-10, and COVID-19, George teaches severe acute respiratory syndrome coronavirus 2 SARS-CoV-2, also known as COVID-19, is a coronavirus that infects humans with adverse side effects (see George at Abstract).
Regarding treating COVID-19, George also teaches antifibrotic therapies that are available or in development could have value in preventing severe COVID-19 in patients with idiopathic pulmonary fibrosis (IPF), have the potential to treat severe COVID-19 in patients without IPF, and might have a role in preventing fibrosis after SARS-CoV-2 infection (see George at Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. It would have been obvious to administer halofuginone to a COVID-19 patient because halofuginone is known in the art to be antifibrotic and antiviral (as taught by Keller) and antifibrotic treatments are known to be therapeutic for COVID-19 patients (as taught by George).
Furthermore, it is well-within the ordinary skill in art to administer a known antifibrotic for use in treating a known condition associated with fibrosis for the same purpose as taught by the prior art (treating a viral infection).
Accordingly claims 3, 8-10 are obvious over Keller in view of George.
Claims 11-14 are rejected under 35 U.S.C. 103 as being obvious over to Keller in view of George as applied to claims 8-10 above and in further view of WO 2013/149148 A2 to Bush3.
The prior art differs from the instant claims as follows: While Keller and George teach administering halofuginone for treating COVID-19, the prior art does not specify dosaging.
However,
Regarding claims 11, 12, and dosaging (1 – 20 μg/kg), Bush teaches parenteral administration of halofuginone at 0.01 mg/kg to 0.5 mg/kg (10 to 500 μg/kg) (see Bush at p.5 ¶4). Bush also teaches an oral dosage of at least 0.05 mg/kg (50 mg) (see Bush at p. 4 ¶2).
Regarding claims 13, 14, and therapeutic effective amounts (about 0.01 to about 0.5 mg), Bush teaches oral dosaging comprising 0.01 to 10 mg of halofuginone (see Bush claim 2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.05(I), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Bush teaches overlapping ranges with instant application, and discusses various administration routes. In addition per MPEP § 2144.05(II), differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, it is well-within the ordinary skill in art to optimize a known dosage range of a known compound for the same purpose as taught by the prior art (administering halofuginone).
Accordingly claims 11-14 are obvious over Keller and George in view of Bush.
Conclusion
Claims 8-14 are rejected.
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 SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/S.R./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
1 Published February 18, 2010. Cited in IDS filed 2/20/23. Hereinafter Keller. Cited in previous Office Action.
2 George et. al. "Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy" Lancet Respir Med 2020, 8, 807–815. DOI: 10.1016/S2213-2600(20)30225-3 Published online May 15, 2020. Hereinafter George. Cited in previous Office Action.
3 Published October 3, 2013. Hereinafter Bush. Cited in previous Office Action.