Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Priority
This Application is a national phase application filed under 35 U.S.C. § 371 claiming priority to International Application No. PCT/AU2022/050880, filed on August 11, 2022, which is a continuation of PCT/AU2022/050429, filed May 6, 2022, which claims priority to foreign Application No. AU2021902530, filed on August 13, 2021, which claims priority to foreign Application No. AU2021902500, filed on August 11, 20201 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 09/04/2024 is acknowledged. Claims 1, 5, 10, -13, 16, 18, 20, 22, 25, 28, 30, 32, 34, 37-38, 43, 52, 54 and 57 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
MPEP 15.59 AMEND TITLE
For the instant application, the title is not clear as it pertains to the article in which the design is embodied, the title should be amended throughout the application, original oath or declaration excepted, to read: (Example) Coronavirus Antigens and Methods of Use.
Drawings Objections
The drawings are objected to because Figures 1B, 3 and 40 are illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 73). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Appropriate correction is required.
Claim Objections
Claims 12, 16, 18 and 20 are objected to for the following informalities:
Claim 12 parts (iii) and (viii) recite “more or more of the mutations”. The limitations should recite “one or more”.
Claim 20 recites “e) utralising antibodies”. The term should be “e) neutralising”.
Claims 16 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Claim 57 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 57 requires performing a method of producing a soluble S protein trimer, but does not appear to recite any steps to actually perform the method without delineating how to perform the method. Thus, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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.
(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 1, 5, 10, 12, 13, 20, 22, 25, 28, 30, 32, 34, 37-38, 43, 52, 54 and 57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rauch et al. “Rauch” (WO2021156267, IDS of record dated 10/10/2024).
The claims are directed to a coronavirus (CoV) vaccine antigen comprising a CoV S protein trimer wherein the S protein trimer is modified to comprise a structural modification which reduces the size of the alanine cavity in the coiled-coil region of the S protein trimer and wherein the S protein trimer elicits neutralizing antibody responses, wherein the structural modification comprises substitution of A1016 and/or A1020 with a more hydrophobic amino acid.
Regarding claims 1, 5, 10, 12, 13, 20, 22, 25, 28, 30, 32, 34, 37-38, 43, 52, 54 and 57, Rauch discloses “a nucleic acid suitable for use in treatment or prophylaxis of an infection with a coronavirus, preferably with a Coronavirus SARS-CoV-2, or a disorder related to such an infection, preferably COVID-19. The present invention is also directed to compositions, polypeptides, and vaccines. The compositions and vaccines preferably comprise at least one of said nucleic acid sequences, preferably nucleic acid sequences in association a lipid nanoparticle (LNP). The invention is also directed to first and second medical uses of the nucleic acid, the composition, the polypeptide, the combination, the vaccine, and the kit, and to methods of treating or preventing a coronavirus infection, preferably a Coronavirus infection” (Abstract). Rauch discloses a pre-fusion stabilizing mutation such as K986P (P is more hydrophobic than K) and V987P, also called as 2P mutation or S-2P (it has RBD down conformation, see D2: Figure 4B), and additional cavity filling mutations such as single mutations T887W, A1020W, P1069F or a double mutation T887W and A1020W (page 26, lines 25-41; page 27, lines 1-32; page 37, lines 1-6; SEQ ID NO: 408; Table 4 at page 178, RNA ID R9641; claims 12-15, Note: mutations indicated have a higher hydrophobicity than alanine). DNA sequences encoding different SARS-Co V-2 S proteins were cloned in plasmids to obtain plasmid constructs, which were then used for in vitro RNA transcription (Example l; Table 4). The mRNA was used to formulate compositions comprising lipid nanoparticles by using cationic lipids, structural lipids, PEG-lipids, and cholesterol (page 188, section 1.4; Table A). For protein expression, HeLa cells were also transiently transfected with mRNA encoding SARS-Co V-2 pre-fusion stabilized proteins (Examples 2b-c; Tables 6-7; Figures 2-3). Mice (Examples 3, 5-7, 11, 16-18; Tables 8, 10-12, 16, 22-24; Figures 5-10, 14, 22-24), rats (Examples 8, 12, 14; Tables 13, 17, 20; Figures 11, 15-16), hamsters (Example 9; Tables 14-15; Figure 12), and nonhuman primates (Example 15; Table 21; Figures 17-22) were immunized intramuscularly with different mRNA compositions and immune responses were detected via ELISA, ICS and VNTs (Example 10, Figure 13). Rauch also discloses in human trials that vaccination was sufficient to result in virus-neutralizing antibody titers (page 57, para 2; Examples; Figures). The ratios of the level of spike protein or RBD binding antibodies to the level of neutralizing antibodies is also shown (Figure 13H). Future Phase 1 human clinical trials to assess the neutralizing activity of the vaccines against emerging SARS-Co V-2 variants Mink Cluster 5 variant, B.1.1.7, B1.351, P.1, CAL.20C are also suggested (Example 19; Table 25). Additional mutations such as disulfide bonds in addition to the proline stabilization, as well as mutated protonation sites are also disclosed (page 28; claims 16-18). Multiple mutations of the prefusion spike protein from current claim 12 that are derived from variants of interest/concern are also disclosed (page 84, lines 30-36; claims 79-80, 186). Rauch discloses the spike protein having additional tri/multimerization domains, self-cleaving peptides, linkers etc. (page 30-36; claims 22-28), and also truncation of the C-terminal transmembrane domain is disclosed (page 22, lines 23-41; SEQ ID NO: 31 having 94.6% identity to SEQ ID NO: 1 of instant application; Table 1). It is considered that protein expression of S protein trimer with the 2P mutation and additional mutations such as A1020W would inevitably lead to increase in the melting temperature. The use of TLR agonist and aluminium adjuvants amongst others is also disclosed (page 107, 113; Figures 8-10, 12). Polyvalent and multivalent vaccines are also disclosed (page 115, lines 18-26; pages 120-121; claims 76-82). Rauch also discloses kits comprising the vaccines and treatment of a subject previously infected with SARS-CoV-2 is also disclosed (Abstract; pages 118-120; page 135, para 3; page 202, last para; claims 167, 194,232).
Therefore, the cited prior art anticipates the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
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.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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