DETAILED ACTION
Election/Restrictions
Applicant’s election of species SEQ ID NO: 1, filed May 11, 2026, is acknowledged and entered. SEQ ID NO: 3 and 5 are withdrawn from consideration being directed to non-elected species.
Specification
The disclosure is objected to because of the following informalities:
There are sequences on at least pages 31, 32, 54, 64, and Table 2 of the specification, filed 10/21/2023, that lack sequence identifiers. Appropriate correction is required.
Claims Summary
Claim 1 is directed to an immunogenic fusion protein comprising a polypeptide with at least 90% sequence identity to a polypeptide comprising aa 26-979 of SEQ ID NO: 1. SEQ ID NO: 1 is 954-aa and represents the construct tFrSc6-HN. According to the specification, page 54, last two paragraphs, the sequence comprises the RSV F N-terminal ectodomain from GenBank accession number P03420 (with signal peptide, presumably aa 1-25 of SEQ ID NO: 1) fused with the ectodomain of human PIV3 strain JS (GenBank accession number Z11575, translated sequence aa 87-572 of the third protein identified in the 5’3’ frame 2 translation). It appears from Table 2 that SEQ ID NO: 1 contains a modified sequence of wildtype RSV F (Accession No. P0320), having the following changes:
Mutations L4P, T16A, G25S, I79M, P102A, T103A, A122T, V152I, S213R, A241V, I379V and M447V
Amino acids at positions 103-109 changed from ANNRARR to ANNQAR
Amino acids at positions 110-136 deleted and replaced with GSGSGR
Amino acids at positions 137-142 changed from FLGFLL to SLGFLL
Amino acids at positions 510-513 changed from DELL to DELLGS
Amino acids at positions 87-89 of Z11575’s translated sequence are TND
Amino acid at position 979 is PKSCS
C-terminal addition of amino acids GSGSG(H)12
Claim 2 is directed to an embodiment wherein the composition additionally comprises a pharmaceutically acceptable excipient, and an immunological adjuvant (claim 3), selected from a polyphosphazene, a CpG or poly(I:C), or a host defense peptide (claim 4). The composition is for administration to a human subject (claim 5). The adjuvant is formulated with a mucoadhesive lipidic carrier to produce a mucoadhesive lipidic carrier system (claim 6). The mucoadhesive lipidic carrier comprises a cationic liposome (claim 7), comprising, for example, DOTAP, among other choices (claim 8). Also claimed is a method of treating or preventing RSV and/or PIV3 in a subject, comprising administering the fusion protein (claims 9 and 10) with an immunological adjuvant (claims 11 and 18), selected from a polyphosphazene, a CpG or poly(I:C), or a host defense peptide (claim 12), formulated with a mucoadhesive lipidic carrier (claim 14), such as a cationic liposome (claim 15), DOTAP among other choices (claim 16). The subject is a human subject (claims 13 and 19). The composition is administered parenterally, among other choices (claims 17 and 20).
Claim Objections
Claims 15 and 16 are objected to because of the following informalities:
Claims 15 and 16 are directed to “The immunogenic composition of claim 14” and “The immunogenic composition of claim 15”. Claim 14 is directed to a method, not an immunogenic composition. Appropriate correction is required.
For purposes of compact prosecution, claims 15 and 16 will be treated as if dependent (directly or indirectly, respectively) on claim 14.
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 9-20 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 against an RSV and/or PIV3 infection, does not reasonably provide enablement for a method of treating or preventing an RSV and/or PIV3 infection in a human subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
The breadth of the claims encompasses the treatment of an existing RSV and PIV3 infection, as well as the prevention of an RSV and PIV3 infection. The nature of the invention is the induction of an immune response by a fusion protein of RSV/PIV3 that will induce serve to protect against a subsequent infection with RSV/PIV3. The nature of the invention also includes the induction of an immune response to RSV/PIV3 in a subject already experiencing disease(s) as a result of RSV/PIV3 infection, such that the subject’s symptoms will improve (treatment).
The specification shows the construction of an RSV/PIV3 fusion protein and its formulation with adjuvant TriAdj, which consists of Poly(I:C), HDP ADR-1002 peptide, and polyphosphazene (see pages 64-65), or AlOH (see page 66). RSV challenge experiments were conducted in mice and cotton rats (see pages 66-67), showing protection from RSV (see pages 69-70). There do not appear to be any experiments showing treatment of an existing RSV infection, or an existing PIV3 infection, nor prevention of a PIV3 infection.
The state of the art is that animals models for RSV infection and disease are limited, in that each model only represents one or a few of the symptoms of human RSV infection/disease (see abstract of Zhang et al., Viruses, 2024, 16:1701, 19 pages). Mice and cotton rats exhibit different clinical symptoms than humans (see Zhang et al., Table 1). With regard to PIV3, Vacher et al. (Rev Med Virol., October 9, 2025, 35(6):e70071, 20 pages) reports that the protective efficacy of many candidates, including adjuvanted subunit candidates, remains to be seen (see Vacher abstract, Table 2, section 1.3).
Given the breadth of the claims, the nature of the invention, the state of the art, the limited guidance in the specification, the limited working examples and the low level of predictability of the animal model data, it would require undue experimentation to use the method for treating or preventing RSV and/or PIV3 in a human subject.
Conclusion
The subject matter of claims 1-8, elected species of a polypeptide at least 90% identical to aa 26-979 of SEQ ID NO: 1, is free of the prior art of record. Claims 1-8 are objected to for reciting non-elected subject matter.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Garg et al. (Antiviral Research, 2018, 158:78-87), Applicant’s own work, discloses a construct similar to the instantly claimed construct, specifically a fusion protein comprising RSV F ectodomain and HPIV3 HN (see page 82, section 2.2). However, the RSV F portion is from a different source (GenBank accession number EF566942) than that used by Applicant (GenBank accession number P03420) which is represented in instant SEQ ID NO: 1, in addition to other changes outlined in instant Table 2. There is no teaching or fair suggestion to use GenBank accession number P03420 as the source for the RSV portion of the fusion protein, nor is there any teaching or fair suggestion to make additional changes as outlined in instant Table 2.
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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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