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 .
Status of the Application
Claims 1, 4-6, 8-14, 16-20, 26-30, 35-37, 40, and 44-45 are pending
Claims 1, 4-6, 8-14, 16-20, 26-30, 35-37, 40, and 44-45 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/27/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims benefit of U.S. Provisional Application No. 62/062,138 filed on 08/06/2020 and PCT Application No. PCT/US21/44897 filed on 08/06/2021.
Election/Restrictions
Applicant’s election without traverse of indomethacin and COVID-19 infection in the reply filed on 11/26/2025 is acknowledged.
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, 8-14, 16-20, 26-30, 35-37, 40, and 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over Iverson (WO 2019/046201, as disclosed in IDS) in view of Napoli et al. (A Panel of Broad-Spectrum Antivirals in Topical Ophthalmic Medications from the Drug Repurposing Approach during and after the Coronavirus Disease 2019 Era, Journal of Clinical Medicine, 2020, 9 (2241), pp. 1-16, as disclosed in IDS).
Iverson is drawn towards methods of inhibiting side effects associated with vaccination in a human subject comprising administering a composition comprising a NSAID such as indomethacin and a co-agent such as ketotifen (see abstract; claims 1-2). Iverson teaches such compositions suitable for oral administration and daily administration in one or multiples doses (paragraphs 0030, 0038; claim 7). Iverson teaches administration essentially simultaneously with vaccination (paragraph 0022). Iverson teaches examples of typical amounts of NSAIDS, including about 150mg to about 900 mg for naproxen and ibuprofen (paragraphs 0029-0032). Iverson teaches ketotifen formulated in an amount of from about 0.5 mg to about 3 mg (claim 12).
Iverson does not teach a method for treating a coronavirus infection comprising administering a NSAID and ketotifen.
Napoli et al. teaches methods of treating coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using antiviral treatments (see abstract). Napoli et al. teaches indomethacin and ketotifen as broad spectrum antivirals for such treatment (pg. 2, paragraphs 5-6; see Table 3). Regarding claims 5 and 28, Napoli et al. teaches that some patients with COVID-19 are asymptomatic or those with conjunctivitis as an early symptom may test negative for a conjunctival sac SARS-CoV-2 test (see abstract; pg. 9, 6th paragraph). Regarding claim 6, Napoli teaches COVID-19 as an infectious disease, wherein SARS-CoV-2 can be transmitted through the eye (pg. 2, lines 3-10). Regarding claims 9-11, Napoli et al. is drawn towards treatments for the SARS-CoV-2 virus in general (see abstract), which would read on the recited patient populations, variants, and attendant symptoms.
It would have been obvious to one of ordinary skill in the art to administer the composition orally or at the time of vaccination for beta coronavirus or SARS-CoV-2, as suggested by Napoli, and produce the claimed invention.
One of ordinary skill in the art would have been motivated to do so since Napoli teaches that indomethacin and ketotifen provide antiviral activity in patients with SARS-CoV-2 (pg. 2, paragraphs 5-6; see Table 3), with a reasonable expectation of success absent evidence of criticality of the particular steps.
Even though the range for dosages as taught by Iverson is not the same as the claimed dosages, Iverson does teach an overlapping range of dosages, and it has been held that 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). See MPEP § 2144.05(I). Furthermore, the determination of dosages is well within the purview of those skilled in the art through routine experimentation, and it has been held that “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). See MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art to optimize the dosages in order to obtain the desired efficacy depending on the subject being treated (paragraph 0029).
The amounts of active agents to be used, the pharmaceutical forms, e.g., tablets, etc; mode of administration, flavors, surfactant are all deemed obvious since they are all within the knowledge of the skilled pharmacologist and represent conventional formulations and modes of administration.
Furthermore, no unobviousness is seen in the ratio claimed because once the usefulness of a compound is known to treat a condition, it is within the skill of the artisan to determine the optimum ratio.
With regards to the limitation claimed in instant claim 45, which claims a dose of about 50 mg of indomethacin, Iverson does not specifically teach the exact amount claimed in instant claim 45. However, it would be within the skill of an ordinary artisan to be able to modify the dosage in order to obtain the desired efficacy depending on the subject being treated (paragraph 0029). It is noted that "[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).
Conclusion
Claims 1, 4-6, 8-14, 16-20, 26-30, 35-37, 40, and 44-45 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691