DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/26/2026 has been entered. New claims 34-44 are under examination. Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.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 34 is directed to a method comprising administering to a subject at risk of developing T1D caused by infection with any of CBV1, 2, 3, 4, 5 or 6, a composition comprising:
Antibodies that bind to a viral antigenic epitope of CBV1 and CBV2, and
Antibodies that bind to a viral antigenic epitope of at least one of CBV3, CBV4, CBV5 and CBV6.
The antibodies are neutralizing antibodies (claim 35). The composition is serum comprising the antibodies (claim 36). The composition further comprises a pharmaceutically acceptable excipient (claim 37). The composition is administered to a pregnant woman (claim 38) or to a baby (claim 39). In one embodiment, the vaccine comprises antibodies against CBV1-6 (claim 40). Administration results in passive immunization of the subject against coxsackie B viruses (claim 41). The subject has an HLA-conferred susceptibility to developing T1D (claims 42-44).
Claim Rejections - 35 USC § 112
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 34-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to methods of administering antibodies to CBV1, CBV2, and any one or more of CBV3-6. The claims encompass a large genus of antibodies, for which the specification has not adequately described a single antibody.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In this case, aside from the generally known structure of antibodies and their function of binding to CBV, no other structures have been provided. Applicant has not made any antibodies to CBV that have the claimed function of binding to an antigenic epitope of CBV. Applicant has not specified which antigenic epitope. Without a structure and a binding target on CBV, there is no structure-function nexus. Even if the particular epitope were provided, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional. In this case, no antigen has been provided, nor any portions of the structure of the antibodies that bind (e.g., CDRs, variable domains, etc.). Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Applicant’s arguments filed 01/26/2026 have been considered but fail to persuade. Applicant argues that the specification, specifically Figure 3, demonstrates that maternal anti-CBV antibodies transferred to the fetus through the placenta reduce risk of T1D (page 18, line 26 through page 19, line 3, or paragraph [0096] of the published application). Applicant also notes that the specification describes anti-CBV sera generated by vaccination of mice, monkey and horse (Tables 10 and 14-15). Example 2 shows anti-CBV1 antibodies in mice protected mice against viremia and infection. Tables 14-15 show cross-neutralization data for antibodies. Applicant concludes that based on this information, the inventors had possession of the claimed antibodies. Applicant additionally presents a Chemicon brochure and a Millipore brochure showing that antibodies to CBV are known and available.
In response, regarding Figure 3, the data used in the risk assessment is based on cord blood samples and analyzing them for the presence of maternal antibodies. However, the instant claims are not directed to administration of maternal anti-CBV antibodies to a fetus. The instant claims are directed to administering antibodies against CBV 1 and 2, and one or more of CBV 3-6. Maternal antibodies, whose composition is not set forth in terms of which serotypes the antibodies were directed against, are not representative of the claimed genus of anti-CBV antibodies. As for the other antibodies and sera, these too are not representative of the claimed genus of anti-CBV antibodies. The cross-neutralization data of Tables 14-15 does not resolve the issue of the lack of structure. The antibodies of the Chemicon brochure and Millipore brochure are not disclosed in the specification as antibodies that are representative of the large genus of antibodies claimed. The functionally defined antibodies of the claims are not adequately described. Therefore, the claims remain rejected for reasons of record.
Conclusion
No claim is allowed.
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/STACY B CHEN/Primary Examiner, Art Unit 1672