DETAILED ACTION
This office action is in response to applicant’s filing dated April 23, 2026.
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 of Claims
Claims 1-25 are pending in the instant application. Acknowledgement is made of Applicant's remarks filed December 28, 2023.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a composition comprising the compound endosidin 2, or a pharmaceutically acceptable salt thereof, for use in inhibiting exocytosis in an immune cell, wherein inhibiting exocytosis in the cell reduces translocation of ACE2 to the cell membrane of an immune cell, which reduces SARS-CoV-2 infection susceptibility of the immune cell in the reply filed on April 23, 2026 is acknowledged. Applicant did not indicate any additional components elected. Thus, in the interest of compact prosecution, the formulation species election has been construed as a composition requiring no additional components since no components were indicated as set forth in the species election.
Claims 12-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 4, 5, 10, and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 April 23, 2026.
Claims 1-3 and 6-9 are presently under examination.
Priority
The present application is a 371 of PCT/US2022/073403 filed on July 2, 2022, which claims benefit of US Provisional Application No. 63/217,976 filed on July 2, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 28, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where marked with a strikethrough.
Drawings
Acknowledgement is made of the drawings received on December 28, 2023. These drawings are accepted.
Claim Rejections - 35 USC § 102
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 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 1-3 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang (US 2020/0196599 A1, cited in the IDS filed December 28, 2023).
Regarding claims 1, 2, 7, and 8, Zhang teaches a composition comprising ES2 together with one or more diluents, excipients, or carriers (claim 19). Zhang teaches ES2 is endosidin 2 [0003].
Regarding the limitations “for use in inhibiting exocytosis in an immune cell, wherein inhibiting exocytosis in the cell reduces translocation of ACE2 to the cell membrane of an immune cell, which reduces SARS-CoV-2 infection susceptibility of the immune cell” (instant claim 1), “wherein the immune cell is a macrophage or a monocyte” (instant claim 6), “for use in inhibiting endocytosis recycling, wherein inhibiting endocytosis recycling reduces translocation of ACE2 to the cell membrane of an immune cell, which reduces SARS-CoV-2 infection susceptibility of the immune cell” (instant claim 7), the wherein limitations of these claims are directed to an intended use of the composition, for use in inhibiting exocytosis in an immune cell, wherein inhibiting exocytosis in the cell reduces translocation of ACE2 to the cell membrane of an immune cell, which reduces SARS-CoV-2 infection susceptibility of the immune cell, a macrophage or a monocyte (instant claims 1 and 6) and for inhibiting endocytosis recycling reduces translocation of ACE2 to the cell membrane of an immune cell, which reduces SARS-CoV-2 infection susceptibility of the immune cell (instant claim 7). Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the intended use for inhibiting exocytosis in an immune cell or inhibiting endocytosis recycling does not limit the claim to a particular structure.
Regarding claims 3 and 9, Zhang teaches the composition matters may be formulated in various dosage forms, including dry formulation, liquid formulation, granular or pellet formulation; the practice and information are known in the arts; and in some other embodiments, the final product of the composition disclosed herein may be formulated as a nanoparticle together with one or more adjuvants, excipients or carriers [0039]. A composition comprising the disclosed ES2 formulated as a nanoparticle together with one or more adjuvants, excipients or carriers reads on a composition is carried in a drug delivery particle.
Thus, the teachings of Zhang anticipate the composition of claims 1-3 and 6-9.
Conclusion
Claims 1-3 and 6-9 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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