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 .
DETAILED ACTION
This is a response to Applicant’s communication filed on June 24, 2024. Application No. 18/552,305, is a 371 of PCT/US2022/021791, filed March 24, 2022, and claims the benefit of U.S. Provisional application No. 63/165,542, filed March 24, 2021. In a preliminary amendment filed March 7, 2026, Applicant cancelled claims 8-19, 26, 28, and 30; and added new claims 33-35. Claims 1-7, 20-25, 27, 29, and 31-35 are pending.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-7, 20-25, 27, 29, and 31-35 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims of the present invention are drawn to methods of inhibiting or preventing a coronavirus infection (claim 1); a method for treating a coronavirus disease (claim 5); as well as a method for alleviating or ameliorating symptoms related to a coronavirus disease (claim 20).
The specification provides no direction or evidence demonstrating how the compounds of the present invention, specifically ANAVEX 1066 can perform any of the claimed methods. The specification merely defines what is a coronavirus and provides definitions for an invention which is not claimed. The specification does not even attempt to provide some sort of mechanism of action as to how the claimed compounds may or may not function. Moreover, the data presented in the figures appears to be irrelevant. There is no context for the data presented in figures 2 and 3. Without context it is unclear how to interpret data. Accordingly, the claimed invention does not enable the ordinary artisan to use the invention as claimed.
Claim Rejections - 35 USC § 102(a)(1)
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.
Claims 1-7, 20-25, 27, 29 and 31-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Missling, U.S. Patent No. 10,195,192. Missling discloses AV1066 as therapeutic treatment for visceral and neuropathic pain. The ‘192 patent suggests AV1066 is a mixed Sigma-1/Sigma-2 receptor ligand. Missling, ‘192 patent, Col. 1, lns. 17-49. Because the present disclosure fails to enable treating a coronavirus disease (see 35 USC 112(a), rejection above) the methods disclosed in the ‘192 patent therefore read on the claims of the present invention. See Id.; see also Id., Col. 2, lns. 3-41 for conditions/disease treated with AVAVEX1066.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625