DETAILED ACTION
Applicant’s amendment and remarks filed June 16, 2026 are acknowledged. Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of the amendment.
Claims Summary
Claim 14 is directed to a protein comprising five domains, in any order:
A first domain comprising an amino acid sequence having at least 70% identity to SEQ ID NO: 5; SEQ ID NO: 5 is 218-aa and represents a SARS-CoV-2 M protein
A second domain comprising an amino acid sequence having at least 70% identity to SEQ ID NO: 6; SEQ ID NO: 6 is 419-aa and represents a SARS-CoV-2 N protein
A third domain comprising an amino acid sequence having at least 70% identity to SEQ ID NO: 8; SEQ ID NO: 8 is 111-aa and represents a SARS-CoV-2 Ubl1-Nsp3 protein; Ubl1 is a domain of Nsp3 and is “ubiquitin-like domain 1”
A fourth domain comprising an amino acid sequence having at least 70% identity to SEQ ID NO: 9, and SEQ ID NO: 9 is 82-aa and represents a SARS-CoV-2 3Ecto-Nsp3 protein; 3Ecto is an ectodomain of Nsp3, also called “zinc-finger domain”
A fifth domain comprising an amino acid sequence having at least 70% identity to SEQ ID NO: 10; SEQ ID NO: 10 is 198-aa and represents a SARS-CoV-2 Nsp8 protein
The protein:
Comprises one or more amino acid linker(s) that connect any two or more of the first through fifth domains; the linker(s) are no greater than 20 amino acids in length (claim 78), specifically 15, 16, 17, 18, 19 or 20 amino acids in length (claim 79); the linker(s) is flexible and/or comprises or consists of glycine (G) and/or serine (S) residues (claim 80);
Does not have a SARS-CoV-2 protein domain that is different than any of the first through fifth domains;
Comprises an N-terminus and a C-terminus, and wherein the first and/or second domain is positioned closer to the N-terminus than any one or more of the third domains, the fourth domain, and/or the fifth domain; or
Any combination of a)-c)
Additionally, in claim 81:
The first domain is positioned closer to the N-terminus than any one or more of the second, third, fourth and/or fifth domain;
The second domain is positioned closer to the N-terminus than any one or more of the third, fourth and/or fifth domain;
The fourth domain is positioned closer to the C-terminus than any one or more of the first, second and/or third domain;
The fifth domain is positioned closer to the C-terminus than any one or more of the first, second, third and/or fourth domain;
Any combination of a)-d)
Also claimed is a composition comprising the protein (claim 21), further comprising a pharmaceutically acceptable carrier and an adjuvant (claim 22). The protein further comprises a protein encoded by a SARS-CoV-2 genome (claim 20).
Claim 27 is directed to a method comprising administration to a subject, a human (claim 77), an amount of a composition comprising the protein, effective to induce an immune response comprising antibody, helper T cells, suppressor T cells, and/or cytotoxic T cells, directed to an epitope of a protein present in the composition or encoded by the polynucleotide. A single dose is administered (claim 28). A first dose is administered and a second dose is administered as an additional administration (claim 29). A first and second dose are administered at the same time by different or common (same) routes (claim 30), wherein the first and second doses are the same composition or different compositions (claim 67). “Same composition” is understood to mean that the protein (according to claim 14) in each composition is the same. “Different compositions” are understood to mean that the proteins (according to claim 14) in each composition are not the same (e.g., domains are in a different order). A first dose is administered and a second dose is administered at least one week later, wherein the first and second dose are the same composition, or different compositions (claim 69). The subject has a pre-existing immune response to a SARS-CoV-2, and the second dose comprises the composition (claim 72). The pre-existing immune response is the result of prior immunization (claim 73). Administration is topical or intramuscular (claim 75). In claim 82, administration comprises a) administering a first dose and a second dose, wherein the two doses are different compositions, b) wherein administration comprises topical administration delivery to the nasal or respiratory mucosa, or a combination thereof, or both a) and b).
Priority
The subject matter of claims 14, 20-22, 27-30, 67, 69, 72, 73, 75 and 77-82 are not entitled to the benefit of priority to USSN 63/064,083, filed August 11, 2020. The protein as claimed in claim 14 does not appear to have been disclosed in the provisional application. The earliest effective filing date is the filing date of PCT/US2021/045547, which is August 11, 2021.
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.
(New Rejection) Claims 20, 72 and 73 are 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 20 is dependent on claim 14. One of the embodiments of claim 14 is that the protein does not have a SARS-CoV-2 protein domain that is different than any of the first through fifth domains. Claim 20 contradicts the embodiment in claim 14 by requiring that the protein further comprises a protein encoded by a SARS-CoV-2 genome.
Claim 72 is dependent on claim 67. Claim 67 requires a first and second dose that are the same or different. Claim 72 requires that the second dose comprise the composition. It is not clear which composition is being referenced in claim 72. Claim 73 is included in this rejection because it is dependent on claim 72.
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) Claim 80 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 80 is directed to an embodiment wherein the linker comprises or consists of glycine and serine amino acid residues. Paragraphs [0062], [0136] and [0137] disclose linkers comprising one or more glycine residues, and an examples of a linker comprising GGGGSGGGGSGGGGS (SEQ ID NO:33). These two disclosures concerning linkers are species that do not represent the genus of linkers that “comprise or consist of glycine and serine amino acid residues”. While single exemplified linker comprises and consists of glycine and serine residues, the linker is not representative of the larger genus of linkers that comprise or consists of glycine and serine residues.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 14, 20-22, 27-30, 67, 69, 75, 77 and 82 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Georges et al. (US 2022/0072121 A1, filed June 9, 2021, “Georges”). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Georges discloses a protein sequence, SEQ ID NO: 410, which is 9744 aa, representing a SARS-CoV-2 concatenated polyprotein. Georges’ SEQ ID NO: 410 comprises, with 100% sequence identity, each of Applicant’s SEQ ID NO: 5, 6, 8, 9 and 10 (claim 14). The portions of SEQ ID NO: 410 that correspond to Applicant’s SEQ ID NO: 5, 6, 8, 9 and 10 are as follows:
Amino acids 8720-8779 correspond to Applicant’s SEQ ID NO: 5
Amino acids 9288-9706 correspond to Applicant’s SEQ ID NO: 6
Amino acids 819-878 correspond to Applicant’s SEQ ID NO: 8
Amino acids 2255-2336 correspond to Applicant’s SEQ ID NO: 9
Amino acids 3943-4041 correspond to Applicant’s SEQ ID NO: 10.
All amino acids between the domains outlined above are reasonably considered linkers, since the specification does not limit linkers to any particular amino acid composition, but only requires that the linker comprise amino acids that join protein domains in a protein (see paragraph [0062] of the published application US2023/0302120) (claim 14, part (a)). According to paragraph [0179] of Georges, SEQ ID NO: 410 is a SARS-CoV-2 proteome, and thus it is expected to comprise other proteins in the SARS-CoV-2 genome (claim 20). Georges’ immunogenic compositions comprise adenoviral vectors expressing antigens, and also the expressed antigens themselves (see paragraph [0124]) (claim 21). Georges discloses administration of immunogenic compositions to induce an immune response, such as humoral or T cell, wherein the immunogenic compositions may comprise a pharmaceutically acceptable carrier and an adjuvant (see paragraphs [0146] and [0209]) (claims 22 and 27). Single and multiple doses of the same composition are contemplated via the same route, at least 2-3 weeks later, to humans (see paragraphs [0209], [0212] and [0232]) (claims 27-29, 69 and 77). Administration is via a variety or routes including intramuscular, topical, nasal mucosal, among others (see paragraph [0211]) (claim 75). Mucosal administration to nasal mucosa is disclosed (see paragraph [0211]) (claim 82, part (b)). Simultaneous administration at the same or different sites is contemplated (see paragraph [0128]) (claims 30 and 67). Therefore, the claims are anticipated by the prior art.
Applicant’s arguments have been carefully considered. Applicant’s arguments are directed to the following:
Applicant argues that Georges does not teach SARS-CoV-2 immunization vectors comprising the polyprotein represented by SEQ ID NO: 410. Applicant points to paragraphs [0191] and [0244] in Georges, noting that short SARS-CoV-2 antigen sequences are used for concatenation, as opposed to the long polypeptide of SEQ ID NO: 410.
In response, Georges’ Figure 87A characterizes SEQ ID NO: 410 as concatenated. Although other portions of Georges’ disclosure are directed to shorter sequences for concatenation, the longer polypeptide of SEQ ID NO: 410 qualifies as a concatenated protein for use in Georges’ immunization vector.
Applicant argues that the new limitation in claim 14, parts a)-d) are not taught by Georges.
In response, Georges does not teach parts b), c) or d). However, Georges teaches part a) regarding the presence of linkers. All amino acids between the domains outlined above regarding George’s SEQ ID NO: 410 are reasonably considered linkers, since the specification does not limit linkers to any particular amino acid composition, but only requires that the linker comprise amino acids that join protein domains in a protein (see paragraph [0062] of the published application US2023/0302120).
Conclusion
No claim is allowed. Claims 78, 79 and 81 are objected to for being dependent on a rejected claim but would otherwise be allowable if rewritten in independent form.
THIS ACTION IS MADE FINAL. 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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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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