DETAILED ACTION
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 . 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 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.
Election/Restrictions
Applicant’s election of Group I (claims 45-65) and the species of methylene blue (therapeutic agent), oral route (route of administration), and SARS-CoV-2 (virus treated) in the reply filed on 04 August 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 66-67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 48, 50-55, 59-60, 62, and 66-67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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 45-47, 49, 56-58, 61, and 63-65 are rejected under 35 U.S.C. 103 as being unpatentable over Golwalkar (“Treatment for COVID-19 using Methylene Blue," https://Medium.com/@dr.deepak.golwalkar/reatment-for-covid-19-using-methylene-blue-d23fc5a31a4d, 6 pages, Apr 2020).
Golwalkar discloses the sublingual use of methylene blue to treat Covid-19 (first page). Golwalkar does not state the specific does in terms of mg/kg (relative to the body weight of the patient), whereas instant claim 45 further limits the dosage in such a manner.
However, generally differences in concentration and tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II)(A). Thus, the dosage of the active agent is generally disclosed, and the determination of the optimal or workable range is routine experimentation.
Instant claim 64 further limits the length of time for the dosage to be administered, and likewise, the time for dosing is generally disclosed, and the determination of the optimal or workable range is routine experimentation.
Additional Reference Cited
The following patent publication is cited, but not relied upon for rejections at this time/ US Patent Application Publication 2006/0264423 is cited to show the state of the art for the administration of methylene blue to treat viral infections.
Conclusion
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/Brian Gulledge/Primary Examiner, Art Unit 1699