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
Status of Application, Amendments, and/or Claims
Applicant's amendment filed on 02/18/2026 has been entered. Claims 1-9 and 11-20 are pending. Claims 1-9 and 20 are currently under consideration. Claims 11-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Withdrawn Objections and/or Rejections
All rejections related to claim 10 are made moot by cancellation of the claim.
The rejections of claims 3-5, 8, and 10 under 35 U.S.C. 112 (b) are withdrawn in view of amended claims.
Claim Rejections under 35 USC § 112 (a)
(i). The following is a quotation of the first paragraph of 35 U.S.C. 112:
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 of carrying out his invention.
(ii). Claims 1-9 and 20 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention. The basis for the rejection is set forth in the office action mailed on 10/22/2025.
Applicant argues that the amended claims of the instant Application are no longer directed to an undefined genus but to monoclonal antibodies defined by binding to specific, structurally identified human proteins.
Applicant’s argument has been considered but is not deemed to be persuasive because the claims recite only the binding properties of the monoclonal antibodies but do not require that the antibodies possess any particular conserved structural features. The specification does not disclose a single ACE2 monoclonal antibody, a single Neuropilin-1 antibody, or a single antibody to the spike protein of Sars-CoV-2. Moreover, the prior art does not disclose any ACE2 monoclonal antibody, any Neuropilin-1 antibody, or any antibody to the spike protein of Sars-CoV-2, which can be used to prevent the transmission of Covid-19. Thus, the instant disclosure does not provide sufficient support for the claimed composition.
(iii). Claims 1-9 and 20 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 use the invention. The basis for the rejection is set forth in the office action mailed on 10/22/2025.
Applicant argues that by the October 31, 2020 priority date, monoclonal antibody production was routine; commercial antibodies against ACE2 were available; Neuropilin-1 antibodies were known; and Spike protein antibodies were widely generated. Applicant argues that the amended claims require only antibodies that bind known protein targets and generating and screening monoclonal antibodies to known proteins was well within ordinary skill. Applicant submits that the enablement requirement does not demand proof of clinical transmission reduction, but rather the ability to make and use the claimed composition.
Applicant’s argument has been considered but is not deemed to be persuasive. Claims 1-9 and 20 drawn to a composition for preventing the transmission of Covid-19, comprising an ACE2 monoclonal antibody, a Neuropilin-1 antibody, an antibody to the spike protein of Sars-CoV-2. The claims are broad and encompass a composition comprising any ACE2 monoclonal antibodies, any Neuropilin-1 antibodies, and any antibodies to the spike protein of Sars-CoV-2, which prevent the transmission of Covid-19. The specification does not provide sufficient guidance/direction or working examples on how to make and use the instantly claimed invention. The specification discloses does not disclose a single ACE2 monoclonal antibody, a single Neuropilin-1 antibody, or a single antibody to the spike protein of Sars-CoV-2, which can be used to prevent the transmission of Covid-19. Furthermore, there is no evidence on the record showing that the claimed composition can be used to prevent the transmission of Covid-19.
It is known in the art that the SARS-CoV-2 virus employs the Angiotensin-Converting Enzyme 2 (ACE2) receptor for cellular entry through interaction of the ACE2 receptor with the surface spike glycoprotein of the virus. However, no antibodies targeting ACE2 receptor, Neuropilin-1 antibodies, or surface spike glycoprotein of SARS-CoV-2 virus were known to prevent the transmission of Covid-19. Furthermore, Research shows that the naturally occurring mutation E484D allows SARS-CoV-2 to employ an ACE2-independent mechanism for entry (Hoffmann et al., Evidence for an ACE2-Independent Entry Pathway That Can Protect from Neutralization by an Antibody Used for COVID-19 Therapy. mBio Volume 13, Issue 3 e00364-22, 2022).
Due to the large quantity for experimentation necessary to make and use the composition to prevent the transmission of Covid-19, the lack of the directions and guidance presented in the specification regarding the same, the lack of working example directed to the same, the complex nature of the invention, the unpredictability in the art, and the breadth of the claims, undue experimentation would be required for the skilled artisan to make and use the claimed invention. Thus, the rejection is maintained.
Claim Rejections under35 USC § 112(d)
(i). The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(ii). Claims 8-9 are rejected under 35 U.S.C. 112(d) as being of improper form for failing to further limit the subject matter of a previous claim 1.
Amended claim 8 recites a limitation, “wherein the ACE2 monoclonal antibody, the Neuropilin-1 monoclonal antibody, and the antibody to the spike protein of SARS-CoV-2 are each present in an amount effective to bind their target proteins”, which is an inherently property of the monoclonal antibodies of claim 1. The monoclonal antibodies have to bind their target proteins to be effective in preventing the transmission of Covid-19. Thus, claim 9 does not further limit claim 1.
Likewise, claim 9 recites a limitation, “wherein the Neuropilin-1 monoclonal antibody binds to Neuropilin-1 and inhibits interaction between Neuropilin-1 and SARS-CoV-2", which is an inherently property of the Neuropilin-1 monoclonal antibody of claim 1. Thus, claim 9 does not further limit claim 1.
Conclusion
No claims are allowed.
Advisory Information
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1646
March 21, 2026