DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I, claims 1, 25, 29-32 and 34, in the reply filed on September 2, 2026 is acknowledged. The species election without traverse of SEQ ID NO: 1 is acknowledged.
The traversal is on the grounds that a search for the subject matter of Group I will include a search for the subject matter of Group II, since the same flavivirus is being searched in claims 25 and 26, except that the particle of claim 26 includes a chimeric prM, and that Groups I and II are not distinct. This is not found persuasive because search burden and distinctness is not a criteria for determining lack of unity in national stage applications, such as this one. The requirement is still deemed proper and is therefore made FINAL.
Claims Summary
Claim 1 is directed to a chimeric dengue virus E glycoprotein comprising the amino acid sequence of SEQ ID NO: 1. SEQ ID NO: 1 is 495-aa and represents a dengue 1/3 EDII “small” 438-2 E chimera. Claim 25 is directed to a flavivirus particle or VLP comprising the E glycoprotein comprising SEQ ID NO: 1. Claim 29 is directed to a population of flavivirus particles comprising the flavivirus particle of claim 25. Also claimed is a composition comprising the E glycoprotein in a pharmaceutically acceptable carrier (claim 30). Claims 31 and 32 are directed to a method of producing an immune response to, or treating, a dengue virus in a subject comprising administering an effective amount of the E glycoprotein, respectively. Claim 34 is directed to a method of protecting a subject from the effects of dengue virus infection comprising administering an effective amount of the E glycoprotein.
Claim Objection
Claims 25, 29 and 30 are objected to because of the following informalities:
Claim 25 recites, “the E glycoprotein of any of claims 1”, which should be “the E glycoprotein of claim 1”. Claims 29 and 30 are included in this objection because they are dependent on claim 25. Appropriate correction is required.
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 31, 32 and 34 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 inducing an immune response to a dengue-3 infection, and a method of administering an E glycoprotein comprising SEQ ID NO: 1 to a subject having a dengue-3 virus infection, does not reasonably provide enablement for inducing an immune response against any other serotype of dengue, nor treating an existing infection of any serotype, nor protecting a subject from the effects of a dengue virus infection of any serotype. 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 inducing an immune response to any or all of serotypes 1-4 (claim 31), treatment of an already-infected subject such that a symptom or symptoms are improved (claim 32), and the protection of a subject from developing disease due to an infection (claim 34). The nature of the invention is the induction of an immune response against any serotype of dengue virus (claim 31). The nature of the invention is the induction of an immune response in an infected subject, wherein the immune response will improve a disease symptom(s) in the subject (claim 32). The nature of the invention is the induction of an immune response with the glycoprotein such that upon subsequent infection, the subject does not develop disease (claim 34).
Regarding vaccination against dengue, Estofolete et al. (npj Vaccines, 2026, 11:68, 14 pages) discloses obstacles that researchers have faced and continue to encounter regarding dengue vaccination, including durable protection against each serotype, ADE, other immunological issues and the lack of an animal model of protection (see page 1, right column and page 2, “Immunological Challenges in Dengue Vaccine Development”). Regarding treatment, the CDC (CDC, Dengue, website www.cdc.gov/dengue/treatment/index.html, published May 15, 2024, updated May 15, 2025, accessed October 13, 2026, 2 pages) reports that no treatments are available for those that are already experiencing disease symptoms.
The specification discloses the construction of the chimeric dengue virus E glycoprotein comprising SEQ ID NO: 1. It appears that this construct has antigenic sites targeted by neutralizing antibodies in individuals exposed to primary DENV3 infection (see paragraph [0220] of the published application US 2025/0127871). As for treatment of an existing infection or protection from disease, the specification does not provide any working examples of such. Given the teaching in the art, there is low level of predictability in the absence of working examples.
Given the breadth of the claims, the nature of the invention, the teachings in the specification, the lack of working examples and the low level of predictability, it would require undue experimentation to practice the claimed methods. The following amendments would overcome this rejection: amendment of claim 31 to be limited to an immune response to dengue-3, and amendment of claims 32 and 34 to methods of administration without therapeutic or protective outcomes, would overcome this rejection.
Conclusion
No claim is allowed. Claim 1 is objected to only because it recites non-elected subject matter, but would otherwise be allowable. SEQ ID NO: 1 is free of the prior art of record.
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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
