DETAILED ACTION
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 .
Claims 1-3, 5, 7, 9, 11, 13-15, 17, 18, 20, 21, 23, 28, 29, 31, 35, 38,, 39, 51, 68 and 69 are pending in the application.
Election/Restrictions
Applicant's election with traverse of Group I, and species SEQ ID NO: 8, SEQ ID NO: 176, SEQ ID NO: 68, SEQ ID NO: 70 in the reply filed on 2/2/2026 is acknowledged. The traversal is on the ground(s) that the prior art He merely describes immunization of mice with full length spike protein from SARS-CoV. He does not teach administering a nucleic acid encoding a Coronaviridae antigen might successfully elicit an immunogenic response to the Cornaviridae antigen itself, or a nucleic acid construct would be suitable for such as purpose. Applicant concludes that since He does not disclose all the elements of any one of the pending claims, thus the restriction is improper.
This is not found persuasive because PCT Rule 13.2 requires the inventions must share a special technical feature that makes a contribution over prior art so that they are related to a single general inventive concept under PCT Rule 13.1. This requirement is not a prior art rejection under 102 and/or 103. As discussed in the previous office action, the technical feature shared by group I-IV is a nucleic acid encoding a viral antigen from the family of Coronaviridae. He teaches FL-S and EC-S, which are spike proteins of SARS-CoV, expressed in insect cells by nucleic acid encoding said antigen. Therefore, this technical feature cannot link the inventions as a whole to form a single general inventive concept under PCT Rule 13.1.
Therefore, this requirement is still deemed proper and is therefore made FINAL.
Applicant indicates that claim 23 is amended to depend on claim 1 so that it should be examined with Group I. This is found persuasive.
Accordingly, claims 13-18, 20, 21, 28, 29, 31, 35, 38,, 39, 51, 68 and 69 are withdrawn from consideration for being directed to nonelected subject matter. Claims 1-3, 5, 7, 9, 11 and 23 are currently under examination.
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 5, 11 and 23 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.
Regarding claim 5, the term “functional fragment or variant” renders the claim indefinite because it is unclear what function the SARS-CoV-2 antigen the claim is referring to. Does it mean it can elicit an immune response to a Coronaviridae family member, specifically to SARS-CoV-2, encodes a SARS-CoV-2 viral protein…etc? Since it is unclear what the function claim is limited to, the metes and bounds of the “variant” is also unclear.
Regarding claims 11 and 23, the term “functional fragment or variant” renders the claims indefinite because it is referring to an expressible nucleic acid that comprises a nucleic acid encoding a viral antigen from Coronaviridae family and a scaffold domain, and it is unclear what function the claim is referring to. It is unclear if the function is for the nucleic acid to be expressed, a viral antigenic response, a self-assembling polypeptide. As such, the metes and bounds of the “variant” is also unclear.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-3, 5, 7, 9, 11 and 23 is/are rejected under 35 U.S.C. 102(a1)(a2) as being anticipated by Graham (WO2016/138160).
Claim 1 is drawn to a composition comprising a) a first nucleic acid encoding a scaffold domain comprising a self-assembling polypeptide, and b) a second nucleic acid sequence encoding a viral antigen from family of Coronaviridae.
Graham teaches nucleic acid sequences encoding the RBD domains from MERS-CoV linked to a ferritin nanoparticle subunit (page 9, line 20-21, SEQ ID NO: 26 and 27). MERS-CoV is from family of Coronaviridae, and ferritin nanoparticle subunit is a scaffold domain self-assembling polypeptide that can assemble into a nanoparticle. Therefore, the teaching from Graham anticipates the claimed invention of claim 1.
Regarding claim 2, Graham teaches the self-assembling polypeptide ferritin my be from Helicobacter pylori (page 78, line 29).
Regarding claim 3, SEQ ID NO: 8 has 100% sequence identity with Lumazine synthase multimerization domain (BFR65490, see attached alignment). Graham teaches that the RBD domain can also be linked to Lumazine synthase subunit (page 79, line 36-40).
Regarding claims 5, 11 and 23, the claim recites “functional fragment or variant thereof.” Since it is unclear what function the claimed expressible nucleic acid must have (see 112 2b rejection above), the RBD domain linked to self-assemble scaffold taught by Graham meets the claim limitation of being a functional fragment or variant because it has the function of elicit an immune response to MERS-CoV (a variant of SARS-CoV-2), and forms a nanoparticle.
Regarding claim 7, Graham teaches the RBD domain linked to the nanoparticle subunit can include a signal peptide, a leader sequence, that is cleaved during cellular processing (page 79, line 23-25).
Regarding claim 9, Graham teaches that the RBD domain and the ferritin subunit may be linked together by a linker such as Ser-Gly linker (page 81, line 37-39).
Claim(s) 1 and 11 is/are rejected under 35 U.S.C. 102 (a1) as being anticipated by KX527857 (Chen, 2016).
Claim 11 is drawn to an expressible nucleic acid comprises at least 70% sequence identity to SEQ ID NO: 68 (elected sequence), and functional fragments or variant.
The sequence having accession number KX527857 has 71.7% identity to SEQ ID NO: 68, and is known as synthetic construct encoding eOD-GT8, fused to the C terminus of lumazine synthase with a linker in between; self-assembles into 60mer nanoparticle; used as a germline engaging immunogen (see attached alignment). Since the sequence has at least 70% identity with SEQ ID NO: 68, and is an immunogen linked to a scaffold domain (at least a functional variant), it meets the limitation of claim 11.
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637