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
Applicant’s response dated 02 December 2025 to the previous Office action dated 03 June 2025 is acknowledged. Pursuant to amendments therein, claims 1-7, 12-14, 42-47, and 52-55 are pending in the application.
The claim objection made in the previous Office action is withdrawn in view of applicant’s amendments.
The rejection under 35 U.S.C. 112 made in the previous Office action is withdrawn in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 102 made in the previous Office action is withdrawn in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 103 made in the previous Office action is withdrawn in view of applicant’s claim amendments, but a new rejection under 35 U.S.C. 103 is made herein in view of applicant’s claim amendments.
Election/Restrictions
Claim 55 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 May 2025.
Claims 1-7, 12-14, 42-47, and 52-54 are under current consideration.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 12-14, 42-47, and 52-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scaduto et al. (US 2023/0113011 A1; published 13 April 2023; priority to 13 March 2020; of record) in view of Coe (WO 2021/188575 A1; published 23 September 2021; priority to 26 March 2020).
Scaduto et al. discloses a method of treating an illness caused by a coronavirus, in a subject in need thereof, the method comprising administering systemically to the subject an antibacterial tetracycline compound in an amount that is effective to treat an illness caused by a coronavirus, but has substantially no antibacterial activity (claim 1) wherein the illness is COVID-19, and wherein treatment is begun before the onset of COVID-19 (claim 2) wherein the antibacterial tetracycline compound is administered in an amount that results in a plasma concentration which is less than approximately 80% of MIC of the tetracycline compound for commonly-occurring bacteria (claim 3) wherein the antibacterial tetracycline compound is doxycycline (i.e., a CMT derivative comprising a phenol ring and a chemical structure sufficient to chelate and/or bind a divalent cation such as Zn2+ and a chemical structure comprising the structure in instant claims 5 and 46, a CMT derivative that can have antimicrobial activity due to a dosing at or above a MIC, a CMT derivative configured to bind a divalent cation such as Zn2+ and transport the divalent cation intracellularly) administered twice a day in a dose of about 20 mg, or minocycline (i.e., a CMT derivative comprising a phenol ring and a chemical structure sufficient to chelate and/or bind a divalent cation such as Zn2+, and comprising a phenol ring with diethylamino group to enhance scavenging of ROS) (claims 5-7); or a method of treating an illness caused by a coronavirus, in a subject in need thereof, the method comprising administering systemically to the subject a non-antibacterial tetracycline compound in an amount that is effective to treat an illness caused by a coronavirus, but has substantially no antibacterial activity (claim 10) wherein the illness is COVID-19, and wherein treatment is begun before the onset of COVID-19 (claim 11) wherein the non-antibacterial tetracycline compound is: 4-de(dimethylamino)tetracycline (i.e., CMT derivative lacks antimicrobial activity due to deletion of a C4 dimethylamino) (claim 12); wherein the subject is human (abstract); wherein the tetracycline compounds can be formulated with carriers/excipients such as magnesium stearate or calcium stearate (paragraphs [0076]-[0077]).
Scaduto et al. does not disclose a dose of a divalent zinc cation Zn2+ as claimed.
Coe discloses treatment of coronavirus infections such as COVID-19 (abstract) wherein zinc has demonstrated anti-viral activity (paragraph [0124]) wherein zinc in ionic form is provided as zinc gluconate (paragraph [0014]) wherein a daily dosage of ionic zinc may be about 20 mg (paragraph [0143]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Scaduto et al. and Coe by adding the about 20 mg of ionic zinc as zinc gluconate (i.e., contains Zn2+) daily dose of Coe to the method and composition of Scaduto et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to increase anti-viral activity and thus effectiveness of the method and composition of Scaduto et al. as suggested by Coe, and given that it is prima facie obvious to combine equivalents known for the same purpose (i.e., compositions known for use in treatment of COVID-19) per MPEP 2144.06(I).
Response to Arguments
Applicant’s arguments, see remarks pages 7-8, filed 02 December 2025, with respect to the prior art rejection(s) have been fully considered and are persuasive in that Scaduto et al. does not disclose a dose of Zn2+ as claimed. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the teachings of Coe as discussed above.
Conclusion
No claims are allowed.
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 MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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