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 February 2, 2026. Application No. 17/951,342, is a Continuation of 371 of PCT/US2021/024876, filed March 30, 2021, and claims the benefit of U.S. Provisional applications Nos.: 63/006,264, filed April 7, 2020; and 63/002,538, filed March 31, 2020. In a preliminary amendment, Applicant cancelled claims 1, 3-6, 9, 11-19, 22, 24, 25, 27, 31, 33, 38, 39, 42-46, 48, 49, 51, and 52. Claims 2, 7, 8, 10, 20, 21, 23, 26, 28-30, 32, 34-37, 40, 41, 47, 50, and 53 are pending.
Species Election
Applicant’s election without traverse of the species of the following compounds:
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(Compound A, caficrestat, or AT-001), in the reply filed on February 2, 2025, is acknowledged.
The elected species is allowable. The search is expanded accordingly. Claims 2, 7, 8, 10, 20, 21, 23, 26, 28-30, 32, 34-37, 40, 41, 47, 50, and 53 are examined below.
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 2, 7, 8, 10, 20, 21, 23, 26, 28-30, 32, 34-37, 40, 41, 47, and 50, are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for treating acute respiratory distress syndrome (ARDS), acute lung inflammation (ALI) or acute lung injury; treating cardiac injury related to or caused by an infection; or treating an infection, decreasing pathogen burden in a subject with an infection, or inhibiting pathogen replication in a subject with an infection, comprising administering the following aldose reductase inhibitor (ARI):
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(i.e., Compound A, caficrestat, or AT-001), the specification does not reasonably provide enablement for a method of treating said conditions comprising any other ARI. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Factors to be considered when determining whether claims in an application for patent are enabling include (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.08, citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims are drawn to treating acute respiratory distress syndrome brought on by an infection using an aldose reductase inhibitor (ARI), generally. ARIs are known to reduce inflammation in patients having an history diabetes or heart disease. There is no evidence that ARDS can be treated with any ARI as generally claimed. The specification only teaches the use of caficrestat (AT-001) in patients having a history of diabetes mellitus and heart disease hospitalized due to a COVID-19 infection. (Specification, p. 41-46; citing the NCT04365699.) There is no support for using any other ARI, other than caficrestat in treating ARDS. The prior art fails to provide compensatory guidance. There is therefore no correlation between treating ARDS with any ARI shown by the instant specification or the prior art. Accordingly, it would require undue experimentation for the artisan to practice the invention as broadly claimed.
It is suggested to amend claims 2, 8, and 10 to incorporate the ARI of claim 53; and canceling claims 50 and 53 to obviate this rejection.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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