DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election without traverse of invention Group II (claims 12-18, drawn to a composition for treatment and/or prevention of an infection of Coronavirus comprises a therapeutically effective amount of interferon alpha (INF-a), wherein the composition is in a dosage form of sublingual administration and/or buccal administration) in the reply filed on 01/07/2026 is acknowledged.
Status of Claims
3. Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/07/2026. The amendment filed 01/07/2026 are acknowledged. Claims 12-18 are pending and under examination.
Priority
4. The instant application was effectively filed on 04/27/2023, which claims benefit of Provisional Application No. 63/375,962 filed 09/16/2022, which further claims benefit of Provisional Application No. 63/336,052 filed 04/28/2022.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted 25 July 2024 and the references cited therein have been considered, unless indicated otherwise.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claims 12-13 and 17-18 are rejected under 35 U.S.C 102(a)(1) as being unpatentable over Amarillo Biosciences, Inc. (Amarillo Biosciences to Reaffirm Low-Dose Interferon Research Leadership Position and Global Commitment to Support Related Therapeutics. https://www.ainos.com/news_view/7, publicly available 08/13/2020).
The instant claims direct toward a composition for treatment and/or prevention of an infection of Coronavirus comprises a therapeutically effective amount of interferon alpha (INF-a), wherein the composition is in a dosage form of sublingual administration and/or buccal administration
Amarillo Bioscience, Inc. teach low-dose non- injectable interferon (IFN) delivered through nasal, oral mucosal, topical and transdermal pathways, either in liquid, ointment or lozenge form for treatment or prevent of COVID through their VLEDONA drug program. Instant claims 12 and 18 teach a composition for treatment and/or prevention of an infection of Coronavirus comprises a therapeutically effective amount of interferon alpha (INF-a), wherein the composition is in a dosage form of sublingual administration and/or buccal administration which is in the dosage form of lozenge, tablet, film or spray. This recites the limitations of instant claim 12 and 18.
Amarillo Bioscience, Inc. further teach positive data from laboratory research and clinical trials using recombinant IFN, either alone or in combination with other antivirals, indicate IFN as an attractive therapeutic option. Instant claims 13 and 17 recite the INF-a is a recombinant INF-a and comprises an antiviral and/or anti-inflammatory agent. This recites the limitations of instant claim 13 and 17. Amarillo Bioscience, Inc. anticipate the claimed invention.
8. Claims 12-18 are rejected under 35 U.S.C 102(a)(1) and 102(a)(2) as being unpatentable over Turner, et al (U.S. Patent 8,309,531 B2, issued November 13, 2012).
The instant claims direct toward a composition for treatment and/or prevention of an infection of Coronavirus comprises a therapeutically effective amount of interferon alpha (INF-a), wherein the composition is in a dosage form of sublingual administration and/or buccal administration.
Turner, et al. teach a method for treating or reducing the effects of an infections in a human subject (claim 1), wherein said infection is caused by a pathogen selected from a member of the Coronaviridae family (claim 7-8), by administering an amount of a composition of interferon-alpha (claim 1), and the dosage can be administered by a route from buccal and/ or sublingual means (paragraph 42). Turner, et al. anticipate instant claim 12.
Instant claim 13 limit the interferon alpha to a recombinant interferon alpha. Turner, et al. teach suitable interferon alphas include recombinant interferon alpha-2a and recombinant interferon alpha-2b (paragraph 47). Turner, et al. anticipates instant claim 13.
Instant claim 14 limit the interferon alpha to 1 IU-1000 IU. Turner, et al. teach the dosage of interferon alpha can range from 200 to 10,000 IU. Turner, et al. anticipate instant claim 14.
Instant claim 15 recite the composition further comprises a buffer, a carrier and/or an excipient. Turner, et al. teach the composition further comprises a pharmaceutically acceptable excipient (claim 26). Turner, et al. anticipate instant claim 15.
Instant claim 16 recite the composition further comprises interferon beta and/or interferon gamma. Turner, et al. further teach interferon refers to a peptide or protein having amino acid sequence of an interferon such as interferon alpha, beta and/or gamma (paragraph 44). Turner, et al. anticipate instant claim 16.
Instant claim 17 recite the composition further comprises an antiviral agent and/or anti-inflammatory agent. Turner, et al. teach interferon alpha composition further comprises administering an additional therapeutic agent selected from an anti-viral agent (claim 15). Turner, et al. anticipate instant claim 17.
Instant claim 18 recite the dosage is in a form of lozenge, tablet, film or spray. Turner, et al. teach the dosage can be in the form of a tablet (paragraph 98). Turner, et al. anticipate instant claim 18. Turner, et al. anticipate the claimed invention (claims 12-18).
Conclusion
9. No claims are allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Syed J Abbas whose telephone number is (571)272-0015. The examiner can normally be reached M-Th, 9:00AM-4:00PM.
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/SYED J ABBAS/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674