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 .
2. The amendments and remarks filed 05/22/2026 are acknowledged. Claims 12-14 are amended. Claims 12-18 are pending and under examination.
Withdrawn Rejections
3. The rejection of claims 12-13 and 17-18 under 35 U.S.C 102(a)(1) as being unpatentable over Amarillo Biosciences, Inc., is withdrawn in light of Applicant’s amendment thereto. See pages 3-4 of the previous Office action.
Maintained Rejection
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.
4. 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).
This rejection is maintained for reasons of record (pp. 4-5, Office action mailed 23 February 2026) and for the reasons discussed below. For convenience, the rejection is repeated herein:
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).
Applicant’s arguments
A. Applicant argues that adenoviral vector comprising a nucleic acid molecule encoding IFN-a, is distinct from the composition comprising a specific amount of IFN-a of the claimed invention.
B. Applicant argues the dosage of the composition is not described in Turner, et al.
C. Applicant argues that a person of ordinary skill in the art cannot infer the level of encoded protein in the serum directly and unambiguously. Applicant argues the dosage of IFN is disclosed in the serum and the amount of IFN-a contained in the composition is unknown.
Response to arguments
A. Applicants argue that Turner, et al. teaches the adenoviral vector and not the IFN alpha protein. However, Turner, et al. teach recombinant interferon alpha was assessed (column 36, lines 3-5, figure 10b) and teach non-viral vectors such as interferon alpha protein can be introduced in the cell (column 22).
B. Turner expressly teaches administering an amount of an interferon alpha composition to a human subject to treat a coronaviridae infection by buccal and/or sublingual routes and discloses specific interferon dosage ranges in connection with that administration, including ranges extending to values within the claimed 1 IU-1000 IU range (col 4, lines 9-12). Anticipation does not require that the reference use the same words as the claim as it requires only that the references discloses each claimed limitation.
C. Applicant arguments that the interferon level in serum with the amount of interferon in the administered composition is a distinction from the claimed invention. Turner’s approximately 1000 IU/ml value does not establish that the composition dose must exceed 1000 IU. However, Turner expressly discloses interferon ranges extended down to about 100 to 250 IU (col 4, line 9-12), which fall within or adjacent to the claimed range. As such, the rejection is maintained.
Conclusion
5. No claims are allowed
6. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SYED J ABBAS/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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