DETAILED ACTION
Election/Restrictions
Applicant’s election of Group II, claims 14, 20-22 and 27-30, in the reply filed on January 5, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of species (i.e., the first protein outlined in claim 14) with traverse is acknowledged. The traversal is on the grounds that the generic claim contains sufficiently few species that a search and examination of all the species at one time would not impose a serious burden on the examiner. This is not found persuasive because burden of search is not a consideration in a finding of lack of unity in a national stage application. The requirement is still deemed proper and is therefore made FINAL.
Specification
The disclosure is objected to because of the following informalities:
In the “Brief Description of the Figures”, Figures 7A and 7B are not delineated. A description for each is required. See MPEP 608.01(f). Appropriate correction is required.
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
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 similar routes (claims 30 and 66), wherein the first and second doses are the same composition (claim 67), or different compositions (claim 68). A first dose is administered and a second dose is administered at least one week later (claim 69), wherein the first and second dose are the same composition (claim 70), or different compositions (claim 71). 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) with a vaccine comprising an mRNA or a DNA (claim 74). Administration is topical or intramuscular (claim 75).
Applicant is advised that should claim 30 be found allowable, claim 66 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Priority
The subject matter of claims 14, 20-22, 27-30 and 66-75 is 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 Objections
Claim 14 is objected to because of the following informalities:
In claim 14, line 5, there should be a comma between “SEQ ID NO: 6” and “a third domain”. Claims 20-22, 27-30 and 66-76 are objected to because they are dependent on claim 14. Appropriate correction is required.
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.
Claims 27-30 and 66-77 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 27 recites the limitation "the polynucleotide" in claim 21. There is insufficient antecedent basis for this limitation in the claim. Claims 28-30 and 66-77 are also rejected because they depend from claim 27.
The term “similar routes” in claims 30 and 66 is a relative term which renders the claims indefinite. The term “similar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 67 and 68 are also rejected because they depend from claim 66.
Claims 68 and 71 are directed to an embodiment wherein the first dose and the second dose are different compositions. With regard to claim 68, claim 68 is dependent on claim 66. In claim 66, a first dose and a second dose are administered. In claim 66, the first and second doses are the same composition referenced in claim 27. If Applicant intends that the doses are different compositions, then the first and second dose in claim 66 should be set forth as such. Thus, the limitation in claim 68 does not properly depend from claim 66. The same applies to claim 71 and dependent claims 72-74, wherein the first dose and second dose are different compositions.
Claim 76 is dependent on canceled claim 43, rendering the metes and bounds of claim 76 unclear.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 67 and 70 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 67 and 70 are directed to embodiments wherein the first dose and the second dose are the same composition. Such is already the case in claims 66 and 69, respectively. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 66, 67, 69, 70, 75 and 77 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.
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 paragraph [0209] and [0232]) (claims 27-29, 69, 70 and 77). Administration is via a variety or routes including intramuscular, topical, nasal mucosal, among others (see paragraph [0211]) (claim 75). Simultaneous administration at the same or different sites is contemplated (see paragraph [0128]) (claims 30, 66 and 67). Therefore, the claims are anticipated by the prior art.
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