DETAILED ACTION
Applicant’s amendment and remarks filed February 17, 2026 are acknowledged and entered. The elected species is Compound I-17. Claims 1, 2, 4, 40, 43, 45, 47, 76, 78-81 are under examination with regard to the elected species. All other claims are withdrawn being directed to embodiments that do not encompass the elected species of Compound I-17.
Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.
Claims Summary
Claim 1 is directed to an agent or a pharmaceutically acceptable salt thereof. The elected species of agent will be described in the next paragraphs. Also claimed is a pharmaceutical composition comprising the agent of claim 1, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier (claim 76). Claim 78 is directed to a method for treating a condition, disorder or disease associated with SARS-CoV-2 infection, comprising administering an effective amount of an agent or a composition of claim 1 comprising an antibody binding moiety (in the structure outlined below), wherein the effective amount is sufficient to induce or generate ADCC or ADCP toward SARS-CoV-2, induce or generate immunity toward SARS-CoV-2 that lasts for at least 12 months, or provide memory T and/or B cells against SARS-CoV-2 (claim 80). The method further comprises administering a population of immune cells comprising NK cells selected from allogeneic NK cells, peripheral blood-derived NK cells, MG4101 NK cells, CB-NK NK cells, and cord blood-derived NK cells (claim 81). Claim 79 is directed to a method for inducing, promoting, encouraging, enhancing, triggering, or generating an immune response toward SARS-CoV-2, comprising administering an effective amount of an agent or a composition of claim 1 comprising an antibody binding moiety (in the structure outlined below).
The elected species of agent of claim 1 is Compound I-17 (fully represented in claim 47). A portion of Compound I-17, SEQ ID NO: 91, is represented in claims 1 and 4. The agent has the following structure, or a pharmaceutically acceptable salt thereof:
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A is an antibody binding moiety (“ABT”) comprising SEQ ID NO: 16 (DCAWHLGELVWCT) wherein the two cysteine amino acids are linked by a disulfide bond (also recited in claims 43 and 45, respectively)
Little a=1
L is a linker moiety comprising a bivalent linear or branched C1-100 group
SEQ ID NO: 91 represents:
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Little b=1
In claim 2, the linker moiety comprises any of a variety of choices, such as:
-C(O)-[CH2CH2O]m-CH2CH2NH-C(O)-[CH2CH2O]m-CH2CH2NH, wherein m is independently 1-10. In claim 40, the linker moiety comprises one or more -[CH2CH2O]m- groups, wherein m is an integer from 7-12.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 4, 40, 43, 45, 47, 76 and 78-81 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, in the formula:
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RCN, (Xaa)y and RCC are not delineated and defined. While SEQ ID NO: 91 represents the formula as a whole, it is not clear which portions of SEQ ID NO: 91 represent RCN, (Xaa)y and RCC. The metes and bounds of the claims cannot be determined without further clarification. If claim 1 is amended to remove the formula in favor of reciting SEQ ID NO: 91, this rejection would be overcome.
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.
The following is a quotation of the first paragraph of pre-AIA 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.
Claims 78-81 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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.
All references to the specification are with reference to the published application US 20230330240.
The breadth of the claims encompasses methods of treating a condition, disorder or disease associated with SARS-CoV-2 in humans, as well as inducing, promoting, encouraging, enhancing, triggering or generating an immune response, such as ADCC and ADCP, toward SARS-CoV-2, and including immunity that lasts for at least 12 months, and memory T and B cells against SARS-CoV-2, by administering the agent described above in the Claims Summary section. Briefly, the agent comprises an antibody binding moiety (ABT) (SEQ ID NO: 16) linked to an amino acid sequence that is a target binding moiety (TBT) (SEQ ID NO: 91 or SEQ ID NO: 127 (Compound I-17)). In paragraph [0812], an ELISA binding assay is described where wells are coated with Compound I-17 and exposed to SARS-CoV-2 spike protein. The results of the assay are in the Table of paragraph [0809], showing that Compound I-17 has an IC50 value of 118 nM in an ELISA using a spike trimer, and a IC50 value of 1.26 µM in a SARS-CoV-2 (live) neutralization (plaque) assay. While this data shows that Compound I-17 can bind a spike trimer and bind SARS-CoV-2, the extrapolation to in vivo efficacy in humans (hosts of SARS-CoV-2) is not predictable. No correlation between the results of the ELISA and plaque assay, and efficacy in humans is provided.
The nature of the invention, as far as it can be deduced, is an agent that binds a cell and binds SARS-CoV-2, resulting in inhibiting an infected cell, killing an infected cell, or moving an infected cell to another location, thus having therapeutic effects. This understanding is based on the teachings of the specification according to paragraphs [0003], [0254] and [0812]. The specification does not appear to provide guidance or working examples (aside from the ELISA and plaque assay in paragraphs [0809] and [0812]) that speak to the methods of inducing immunity or methods of therapy in subjects with SARS-CoV-2 infection.
Given the breadth of the claims, the nature of the invention, the limited guidance in the specification, the lack of working examples demonstrating immunogenic and therapeutic efficacy without a relevant animal model, and the lack of predictability (also lack of data in a relevant animal model), it would require undue experimentation to practice the invention as claimed.
Applicant’s remarks filed February 17, 2026 have been carefully considered but fail to persuade. Applicant points to Example 10, which describes the binding capacity of certain target binding moieties (RCN-(Xaa)y-RCC) of the claimed agents for SARS-CoV-2 spike protein. Specifically, the target binding moiety of compound I-17 was shown to bind spike protein and effectively neutralize SARS-CoV-2. In response, the Office has considered the data in paragraph [0809] and has addressed it above.
Applicant also notes that other agents are shown to effectively bind SARS-CoV-2 spike protein and that linkers of over 70 atoms can be utilized in the claimed agents. Applicant notes that the claims have been amended to reflect the exemplary compounds in Example 10. In response, only the elected species is under examination at this point in prosecution.
Conclusion
No claim is allowed.
SEQ ID NO: 91 and SEQ ID NO: 127 are free of the prior art of record.
THIS ACTION IS MADE FINAL. 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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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