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 response to applicant’s reply filed on June 30, 2026.
Status of Claims
Amendment of claims15 and 17-19 is acknowledged.
Claims 15-36 are currently pending and are the subject of this office action.
Claim 20-36 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 2, 2026.
Claims 15-19 are under examination.
Priority
The present application is a 371 of PCT/SG2021/050295 filed on 05/27/2021 and claims priority to foreign application No. SG10202007071Q filed on 07/23/2020.
Claim Rejections - 35 USC § 103 (New Rejection Necessitated by Amendment).
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:
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.
1) Claim(s) 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elmaleh et. al. (US 2023/0149345) in view of: Pharmafile (May 15, 2020), Hoffmann et. al. (Antimicrobial Agents and Chemotherapy (June 2020) 64:1-3) and Clinical Trial NCT04418128 (June 9, 2020).
For claims 15-18, Elmaleh teaches a method of treating a coronavirus infection like COVID-19 (caused by the SARS-CoV 2 virus) (see abstract, [0002], [0167] and [0207)] comprising the administration of a composition comprising the mast cell stabilizer ketotifen (see [0049], [0230]-[0231], see also claims 40 and 63-64), wherein the coronavirus can be: SARS-CoV, SARS-CoV-2 or MERS-CoV (see [0205]-[0206] and claims 38-39).
Elmaleh does not teach the co-administration of nafamostat. However, the prior art teaches that nafamostat is effective in treating COVID-19. For example: Pharmafile teaches that nafamostat is a potent antiviral inhibitor that is effective in treating COVID-19 in lung cells. Hoffmann teaches that Nafamostat mesylate blocks activation of SARS-CoV-2 (see title for example), and finally Clinical Trial NCT04418128 shows that nafamostat is effective in treating COVID-19.
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to treat COVID-19 combining two compositions (ketotifen and nafamostat) each of which is taught by the prior art to be useful for the same purpose (treating COVID-19), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See also: In re Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A. 1966).
All this would result in the practice of claims 15-18 with a reasonable expectation of success.
2) Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elmaleh et. al. (US 2023/0149345) in view of: Pharmafile (May 15, 2020), Hoffmann et. al. (Antimicrobial Agents and Chemotherapy (June 2020) 64:1-3) and Clinical Trial NCT04418128 (June 9, 2020) as applied to claims 15-18 above, further in view of Villoutreix et. al. (US 2023/0181556).
For claim 19, Clinical Trial NCT04418128 teaches that nafamostat can be administered by continuous intravenous infusion of 0.1-0.2 mg/kg/h (see under Arms and Interventions) which for an 80 kg human translates into: 8.0 mg/h to 16.0 mg/h, which for 24h day translates into 192 to 384 mg/day (which anticipates 20-50 mg or more). Further, 0.1-0.2 mg/kg/h, when multiplied by 24 hs. results in 2.4 mg/kg/day to 4.8 mg/kg/day which anticipates the instantly claimed range (2-20 mg/kg/day).
Villoutreix teaches a method of treating COVID-19 comprising administering a therapeutically effective amount of ketotifen (see [0007]-[0008], see also claim 1), wherein the therapeutically effective amount is 0.001 mg/kg/day to 7 mg/kg/day (see [0025]), which for a 80 kg human it translates into 0.08 mg/day to 560 mg/day which overlaps with the instantly claimed range (1 mg or more).
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,
16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower
claimed range is sufficient to establish a prima facie case of obviousness." In re
Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also
In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
All this will result in the practice of claim 19 with a reasonable expectation of success.
Response to Applicant’s arguments
Since a new rejection was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant are no longer applicable or have been considered/answered in the rejection itself.
Conclusion
No claims are allowed.
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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
July 18, 2026.
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