DETAILED ACTION
Applicant’s amendment and remarks filed March 20, 2026 are acknowledged and entered. Claims 64-66 and 69, previously withdrawn from consideration, are under examination because they now recite elected subject matter, as amended. Claims 73-76 and 79-82 are withdrawn from consideration because they are directed to non-elected subject matter.
Any prior rejection or objection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.
Claims Summary
Claim 59, part c (elected species of a combination of DENV and ZIKV), is directed to a composition comprising an immunological adjuvant and a combination of:
A resurfaced DENV-4 glycoprotein subunit EDIII variant comprising SEQ ID NO: 3 (rsD4DIII-1), a dimer or oligomer comprising the variant, or a recombinant DENV comprising the glycoprotein, or comprising the dimer or oligomer; and
A resurfaced ZIKV glycoprotein subunit EDIII variant comprising SEQ ID NO: 24 (rsZDIII-2.39), a dimer or oligomer comprising the variant, or a recombinant ZIKV comprising the glycoprotein, or comprising the dimer or oligomer.
The combination of SEQ ID NO: 3 and 24 is also represented in new claims 71 and 72. Claim 60 is directed to an embodiment wherein the DENV and ZIKV variants are conjugated to at least one nanoparticle, and the variant(s) is engineered with a C-terminus tag comprising SEQ ID NO: 65 (a SpyTag that facilitates Aquifex aeolicus Lumazine Synthase (aaLS) nanoparticle conjugation). Claims 61 and 62 are directed to methods of eliciting an immune response in a subject by administering the composition of claim 59 and claim 60, respectively.
Claims 64, 77 and 78 are directed to a method of treating a DENV infection or a disease caused by a DENV infection, and a ZIKV infection or a disease caused by a ZIKV infection in a subject, by administering the combination outlined above, represented in part v, subsections (a), (b) and (c). The subject has one or more of DHF and DSS (claim 65). The variant, dimer, oligomer, recombinant virus, or vaccine is effective against all DENV serotypes (claim 66) and ZIKV serotypes (claim 70).
Claim Objections
Claim 64 is objected to because of the following informalities:
In claim 64, lines 1-2, there is an extra “a” before “disease caused by”.
Appropriate correction is required.
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.
Claim 66 is 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.
Claim 66 recites the limitation "vaccine" in claim 64. There is insufficient antecedent basis for this limitation in the claim.
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.
(New Rejection) Claims 64-66, 70, 77 and 78 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of eliciting an immune response against DENV and ZIKV, does not reasonably provide enablement for a method of treating an existing infection or disease as a result of a DENV and ZIKV infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The breadth of the claims encompasses a method of treating an existing DENV and ZIKV infection, or treating any disease that is a result of a DENV or ZIKV infection, in any subject, comprising three different constructs: a DENV and ZIKV glycoprotein comprising SEQ ID NO: 3 and 24, respectively; a dimer or oligomer comprising SEQ ID NO: 3 and 24; or a DENV comprising SEQ ID NO: 3 and ZIKV comprising SEQ ID NO: 24. The nature of the invention is the induction of an immune response to these constructs in patients that are already ill, such that the immune response serves to improve the symptoms of disease caused by the infection.
The specification does not provide any guidance or working examples of treating an existing DENV or ZIKV infection, nor the treatment of any disease caused by a DENV or ZIKV infection. Beyond their immunogenicity demonstrated in the examples in the specification, there is no evidence that such immunogenicity would result in an improvement in a subject has developed, for example, Dengue Shock Syndrome, or a patient that has brain swelling due to a ZIKV infection.
The state of the art concerning DENV and ZIKV treatment is that it remains in development, even four to seven years after Applicant’s earliest effective filing date in 2019. Singh et al. (Cureus, 2023 Oct 9;15(10):e46713, 10 pages) reports that there are no curative treatments for DENV, and that disease is managed supportively, with treatments still being explored (see abstract, pages 1-2). Li et al. (Nano Today, 2026, 66:102902, 17 pages) reports that there are no treatments for ZIKV infection aside from supportive care, such as fluid replacement (see page 2, left column), and that the development of antiviral strategies is complicated by the lack of a relevant animal model of human disease (see page 14, left column, second full paragraph).
The specification provides guidance for making the claimed constructs, and working examples showing that the glycoproteins are immunogenic and can protect against challenge in a DENV mice model. However, there is no evidence in the instant specification nor in the cited art to show that immunogenicity can be extrapolated to treatment of existing infections or diseases. Thus, the level of predictability regarding efficacy in humans is low.
In view of the breadth of the claims, the nature of the invention, the state of the art, the guidance in the specification and the low level of predictability, it would require undue experimentation to practice the methods of treatment.
Conclusion
Claims 59-62, 71 and 72 are objected to for reciting non-elected subject matter.
SEQ ID NO: 3 and 24 are free of the prior art of record.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 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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/STACY B CHEN/Primary Examiner, Art Unit 1672
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