DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of species SARS-CoV-2, filed July 10, 2026, is acknowledged and entered. Claims 18, 19, 69 and 70 are withdrawn from consideration being directed to non-elected species.
Claims Summary
Claim 1 is directed to a method of inducing an immune response to a virus in a subject in need thereof, comprising administering a viral antigen and an adjuvantation system comprising a fungal polysaccharide. Claim 52 is directed to an immunogenic composition comprising a viral antigen and an adjuvantation system comprising a fungal polysaccharide. The fungal polysaccharide is soluble (claims 2 and 53), is a mannan (claims 3 and 54), or is isolated from C. albicans (claims 4 and 55). The adjuvantation system further comprises alum (claims 5 and 56). The virus is SARS-CoV-2 (claims 7 and 58, elected species). The viral antigen comprises a Betacoronavirus protein or polypeptide (claims 8 and 59). The subject is a human (claim 27). Administration is intramuscular, among other choices (claim 33).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5, 27, 33, 52-54 and 56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marciani (US 7,196,073 B2, cited in the IDS filed August 29, 2024). The claims are summarized above and correlated with the teachings of the prior art below in bold font.
Marciani discloses vaccine compositions comprising one or more antigens, such as viral protein antigens, and a polysaccharide conjugate as an immunopotentiator, and methods of administering the composition to humans to enhance an immune response to the antigen (see col. 3, lines 29-33 and 44-46, and col. 35, lines 31-44) (claims 1, 27 and 52). Fungal polysaccharides are disclosed, as well as soluble forms of the polysaccharides such as mannans (see col. 5, lines 18-20 and 41-44) (claims 1-3 and 52-54). Additional adjuvants to be administered with the composition include alum (see col. 34, lines 61-67) (claims 5 and 56). Administration is via a variety of routes including intramuscular (see col. 34, lines 7-10) (claim 33). Therefore, the claimed embodiments are anticipated by the prior art.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Marciani (US 7,196,073 B2, cited in the IDS filed August 29, 2024) as applied to claim 1 above, and further in view of Ray et al. (Journal of Investigative Dermatology, 1979, 73(4):269-274, “Ray”). Claims 4 and 55 are directed to embodiments wherein the fungal polysaccharide is from C. albicans.
The teachings of Marciani are outlined above. Marciana does not disclose fungal polysaccharide from C. albicans, but does not limit the source to any particular fungus. It would have been obvious to have selected a source, such as C. albicans, with a reasonable expectation of success as taught by Ray (see abstract). Ray purifies mannan from C. albicans and observes that it activates serum complement. 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.
Claims 8 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Marciani (US 7,196,073 B2, cited in the IDS filed August 29, 2024) as applied to claim 1 above, and further in view of Hotez et al. (US 2016/0376321 A1, “Hotez”).
Claims 8 and 59 are directed to embodiments wherein the viral antigen comprises a Betacoronavirus protein or polypeptide.
The teachings of Marciani are outlined above and do not include the specific suggestion to employ a Betacoronavirus protein or polypeptide. However, it would have been obvious to have selected any viral antigen for Marciani’s generic construct, with a reasonable expectation of success. Hotez discloses the S protein and the RBD from SARS-CoV for immunogenic compositions and methods of inducing an immune response (see abstract). 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.
Claims 7 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Marciani (US 7,196,073 B2, cited in the IDS filed August 29, 2024) in view of Hotez et al. (US 2016/0376321 A1, “Hotez”) as applied to claims 8 and 59 above, and further in view of Wu et al. (Nature, 2020, 579:265-269, “Wu”).
Claims 7 and 58 are directed to embodiments wherein the virus to which the immune response is directed is SARS-CoV-2.
The teachings of Marciani and Hotez are outlined above, neither of which disclose SARS-CoV-2, as it was not known at that time. However, it would have been obvious to have used the S protein disclosed by Wu in Marciani’s construct to induce an immune response, given the emerging pathogen status of SARS-CoV-2 disclosed by Wu (see abstract). One would have had a reasonable expectation of success given that SARS-CoV compositions comprising the S protein are immunogenic, as taught by Hotez. 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.
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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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