DETAILED ACTION
Applicant’s amendment and remarks filed July 6, 2026 are acknowledged and entered. Any prior objection or rejection that is not repeated or addressed below is withdrawn or moot in view of Applicant’s amendment. This action is made non-final in view of the new grounds of rejection.
The rejection of claims 1-3 and 10 under 35 U.S.C. 103 as being unpatentable over Hajitou et al. (Nature Protocols, 2007, 2(3):523-531, “Hajitou”) in view of Chen et al. (Chemistry & Biology, 2004, 11:1081-1091, “Chen”) is overcome by Applicant’s persuasive remarks filed July 6, 2026. Likewise, the rejection of claims 20 and 21 under 35 U.S.C. 103 as being unpatentable over Hajitou et al. (Nature Protocols, 2007, 2(3):523-531, “Hajitou”) in view of Chen et al. (Chemistry & Biology, 2004, 11:1081-1091, “Chen”) as applied to claim 1, and further in view of Baric et al. (US 2016/0238601, “Baric”), is also overcome.
Claims Summary
Claim 1 is directed to an immunogenic composition comprising an effective amount of a therapeutic engineered phage and a pharmaceutically acceptable carrier, wherein the phage comprises one or more fusion polypeptides comprising an antigenic polypeptide and a phage coat protein. The phage further comprises a fusion polypeptide comprising a tissue-targeting polypeptide and a phage coat protein. The tissue-targeting polypeptide targets lung tissue. The phage coat protein comprises at least one of pIII, pVI, pVII, pVIII, rpVIII and pIX (claim 3). The tissue-targeting polypeptide comprises SEQ ID NO: 4 (CAKSMGDIVC) (claim 11). The phage is an AAVP and further comprises a viral gene (claim 20), specifically a coronavirus S protein (elected species, claim 21). The S protein comprises SEQ ID NO: 85 (elected species, claim 22). The viral gene encoding the S protein comprises nucleotide sequence SEQ ID NO: 84 (elected species, claim 23). The phage further comprises a fusion polypeptide comprising an aerosol delivery polypeptide that targets lung tissue and acts as a transcytosis domain and a phage coat protein (claim 24). The aerosol delivery polypeptide comprises SEQ ID NO: 4 (claim 24). The aerosol delivery polypeptide is encoded by SEQ ID NO: 81 (claim 26).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Sartorius et al. (Pharmaceutics, September 1, 2019, 11(9):437, 22 pages, “Sartorius”) in view of McNaughton et al. (US 2014/0186265 A1, “McNaughton”).
Sartorius discloses a filamentous phage particle engineered to express an antigenic peptide as a fusion with the pVIII protein, and a targeting single-chain antibody (polypeptide) fused with the pIII protein (see abstract and Figure 1). The single-chain antibody targets dendritic cells (see abstract). Pages 3-5 outline examples of antigens that induce immune responses.
Sartorius does not explicitly disclose immunogenic compositions comprising a pharmaceutically acceptable carrier. However, it would have been obvious to have formulated Sartorius’ phage in a composition in order to administer it, with a reasonable expectation of success, as in McNaughton. McNaughton discloses pharmaceutical compositions comprising phage and a pharmaceutically acceptable carrier, as well as therapeutically effective amounts (see paragraph [0119]).
Sartorius does not disclose targeting DCs in lung tissue specifically. However, it would have been obvious to have targeted the phage to any desired tissue. McNaughton discloses multifunctional phage for delivery of therapeutic agents and imaging reagents (see abstract). The phage comprises a targeting peptide displayed on the phage surface via fusion to the pIII coat protein that mediates transduction of a disease cell, and a therapeutic agent fused to a coat protein, pVIII, displayed on the phage surface (see paragraph [0129]). The targeting peptide binds to a lung cancer cell or tissue (see paragraphs [0131] and [0151]). Given the similarity of the constructs, one would have had a reasonable expectation of success of targeting the phage of Sartorius to lung tissue. Further, Sartorius reports that, in general, administered filamentous phage are found in most organs after one hour, including the lungs (see page 13, section 5, fourth paragraph). Therefore, the claimed embodiments would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claim is allowed.
This action is made non-final in view of the new grounds of rejection. Any inconvenience is regretted.
Claims 11, 20-24 and 26 are objected to for being dependent on a rejected claim but would otherwise be allowable if rewritten in independent form. SEQ ID NO: 4, 81, 84 and 85 are free of the prior art of record.
Suwan et al. (PNAS, September 10, 2019, 116(37):18571-18577, cited in the IDS filed 7/11/2025) discloses targeted AAVP vectors for systemic transgene delivery against cancer (see abstract and Figure 1C). The construct has a targeting ligand fused to a coat protein, an antigen fused to a coat protein, and a transgene cassette for transgene expression. The antigen fused to the coat protein is for the purpose of evading pre- and post-internalization barriers to transduction of mammalian cells, thus improving gene delivery (see abstract). There is no teaching or fair suggestion to apply this gene delivery construct/method to immunogenic constructs like Sartorius (outlined above), which are directed to phage-based vaccines that display antigens.
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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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