DETAILED ACTION
Applicant's amendment and remarks filed June 17, 2026 have been entered. Claims 34, 36 and 38-44 are under examination.
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:
Neutralizing antibodies that bind to a viral antigenic epitope of CBV1, wherein the neutralizing antibodies are raised by immunization with inactivated CBV1;
Neutralizing antibodies that bind to a viral antigenic epitope of CBV2, wherein the neutralizing antibodies are raised by immunization with inactivated CBV2; and
Neutralizing antibodies that bind to a viral antigenic epitope of at least one of CBV3, CBV4, CBV5 and CBV6, wherein the neutralizing antibodies are raised by immunization with one of inactivated CBV3, CBV4, CBV5 and CBV6, respectively.
The step of administering comprises administering sera comprising the antibodies (claim 36). The composition is administered to a pregnant woman (claim 38) or to a baby (claim 39). In one embodiment, the method comprises administering the neutralizing 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, 36 and 38-44 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.
Claim 36
This aspect of the rejection addresses new matter in claim 36. The limitation “administering sera” does not appear to be disclosed in the application as originally filed. While sera is disclosed in cross-neutralization studies, and administration of antibodies is disclosed in paragraphs [0017] and [0038] of the published application (US 2024/0408189 A1) there does not appear to be support for administering sera.
Claims 34, 36 and 38-44
The claims are directed to methods of administering neutralizing antibodies to CBV1, CBV2, and any one or more of CBV3-6, that have been raised by immunization with inactivated viruses. The claims encompass a large genus of neutralizing antibodies for which the specification has not adequately described a single neutralizing 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 and neutralizing CBV, no other structures have been provided. Applicant has provided a method of making neutralizing antibodies to CBV, but the structure of the antibodies themselves have not been identified. This is a reach-through situation where antibodies are theoretically made and claimed in a method of use, but no structures (i.e., amino acid sequences of the antibodies) have been identified. Applicant is identifying the antibodies by what they do, but not by what they are. Without a structure, there is no structure-function nexus. Serum antibodies raised by immunization of a subject with inactivated viruses are polyclonal antibodies, which will vary subject to subject, not to mention the immune status of such individuals. Polyclonal antibodies’ structures are not defined in terms of CDRs in this application. Even if the particular epitopes to which the antibodies bind 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 particular 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 06/17/2026 have been considered but fail to persuade. Applicant points to a precedential Federal Circuit Decision, Teva Pharms. v. Eli Lilly (April 16, 2026). Applicant notes that the decision concluded that the antibodies (used in method claims) were not the invention, rather their use in the method was the invention, and since the antibodies were well-known in the prior art as well as methods for making them, the methods were adequately described and enabled without disclosing sequences of the antibodies. In an attempt to be consistent with the decision outlined above, Applicant notes that the claims are directed to methods, not antibodies per se, and that the antibodies used in the instant claims are well known and described in the instant application (i.e., known passive immunity from mother to fetus, and monospecific polyclonal sera raised in monkeys and horses). Applicant notes that the antigens (inactivated viruses) are also known, and that there is no rule that antibodies must be defined by CDRs sequences, for example, to provide adequate written description.
In response, regarding the decision, while it is precedential, the Office has not provided guidance on how the decision will impact current examination practice with regard to antibodies and written description. At this time, the issues of record remain as before. The antibodies provided in the specification are only defined by function, with no provided structures. While there is no per se rule about antibodies needing to be identified by CDRs, the fact is that antibody structures are defined by CDRs (variable regions, etc.) and antigens/epitopes since these are the areas that determine binding specificity. 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.
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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