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
1. Claims 1-7, 16-20 are amended. Claims 8-15 are canceled.
Newly amended and submitted claims 18, 19 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: it is noted applicant elected species (spike protein polypeptide; membrane protein polypeptide; nucleocapsid protein polypeptide; deleted ORF, COP-B8R; vaccinia virus D13L gene; SEQ ID NO: 7) in the reply filed on 9/19/2024. Amended claims 18, 19 are now drawn to A41L ORF deletions.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 18, 19 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 7, 18-20 are now considered withdrawn. Claims 1-6, 16, 17 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 5/15/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
3. (previous objection, withdrawn) Claims 2-6, 8, 11, 12, 14, 16, 17 were objected to because of informalities.
Applicant contends: the claims are amended.
In view of applicant’s amendments, the objection is withdrawn.
Claim Rejections - 35 USC § 112
4. (previous rejection, withdrawn) Claim 19 was 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.
Applicant contends: claim 19 is amended.
In view of applicant’s amendments, the rejection is withdrawn.
Claim Rejections - 35 USC § 103
5. (previous rejection, withdrawn) Claims 1-6, 8, 11, 12, 14, 17, 18 were rejected under 35 U.S.C. 103 as being unpatentable over Howley et al. (WO2018032057; previously cited) in view of Burt et al. (US20060286124; previously cited) and Wu et al. (“A new coronavirus associated with human respiratory disease in China,” Nature, Vol. 579: 265-269 (2020); previously cited).
Applicant contends: the reference fails to teach or suggest the invention as claimed; there is no teaching which would have motivated to skilled person to insert nucleic acid sequences into the deleted ORFs or intergenic reasons as claimed with a reasonable expectation that the claimed insertions into the virus genome would impart advantageous characteristics such as attenuation and increased immunogenicity; the references are silent about antigens in the specifically claimed insertion sites.
In view of applicant’s amendments, the rejection is withdrawn.
6. (previous rejection, withdrawn) Claim 19 was rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US20200289633; previously cited) in view of Burt et al. (US20060286124)(cited above) and Wu et al. (“A new coronavirus associated with human respiratory disease in China,” Nature, Vol. 579: 265-269 (2020))(cited above)
Applicant contends: Robinson et al. does not cure the deficiencies.
In view of applicant’s amendments, the rejection is withdrawn.
7. In view of applicant’s amendments, embodiment drawn to elected species for COP-B8R in (i) with D13L in (ii) and (iii) is free of the prior art of record.
Thus, the prior art search is herein extended to additional embodiments within the scope of the amended claims.
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.
8. (new, necessitated by amendment) Claims 1-6, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bell et al. (WO2019134049A1)(See PTO-892: Notice of References Cited) in view of Burt et al. (US20060286124; previously cited) and Wu et al. (“A new coronavirus associated with human respiratory disease in China,” Nature, Vol. 579:265-269 (2020); previously cited).
See claims 1-6, 17 as submitted 6/11/2025.
The embodiment herein rejected reads on claim 1 (a)(i), or “a composition for raising an immune response in an animal which prevents or decreases the risk of SARS-CoV-2 coronavirus disease, the composition comprising a genetically engineered attenuated vaccinia virus, wherein the attenuated vaccinia virus genome comprises one nucleic acid sequence:
(i) a nucleic acid sequence encoding a human coronavirus SARS-CoV 2 spike (S)
protein polypeptide or an immunogenic part thereof, inserted into a deleted ORF of
a COP-B8R gene.
Bell et al. teaches: modified vaccinia vectors (title); derived from Copenhagen strain (abstract)(as recited in claim 1); with TK mutation, which attenuates the virus (p. 20)(as recited in claim 1); insertion of transgenes (p. 25); one, two or three transgenes are inserted into the locus of the deleted B8R gene (p. 25)(as recited in claim 1 (a)(i)); wherein transgene includes protein capable of eliciting an immune response for use as a vaccine (p. 4).
Bell et al. does not teach SARS-CoV-2 spike protein polypeptide; membrane protein polypeptide; nucleocapsid protein polypeptide.
Burt et al. teaches: spike protein as major antigen of coronavirus [0043](as recited in claims 1, 2, 6); antigens N protein (also [0019])(as recited in claims 4, 5, 6), M protein (eliciting immune response [0014]) [0004](as recited in claims 3, 5, 6); formation of fusion proteins [0010]; SARS coronavirus (abstract); use in vector [0061]; methods for treating or preventing coronavirus infection or eliciting immune response against coronavirus infection [0067]; combining S and N in composition as separate components, or fused [0107](as recited in claims 3, 5, 6); immunogenic polypeptides as described herein may be arranged, combined, or fused in a linear form [0042].
Wu et al. teaches: 2019-nCOV (abstract)(also known as SARS CoV-2); spike, membrane, nucleocapsid proteins (p. 266).
One of ordinary skill in the art would have been motivated to use SARS CoV-2 immunogen proteins as taught by Burt et al. and Wu et al. with the vaccinia vector as taught by Bell et al. Bell et al. teaches MVA vectors for expressing heterologous antigens, and Burt et al. and Wu et al., which also teach use of vector with antigens of coronavirus, including SARS coronavirus, and a known SARS-CoV-2 coronavirus, teach such heterologous antigens (See MPEP 2144.06: Substituting equivalents known for the same purpose).
Further as to claims 3, 5, 6, reciting virus comprising nucleic acid sequence encoding spike protein and virus encoding membrane protein and nucleocapsid protein, as Burt et al. already teaches or suggests combining S and N in immunogenic composition, as separate components ([0107]), as well as use of fusion proteins, arranged, combined, or fused in a linear form [0042], and Bell et al. teaches use of MVA encoding heterologous antigens (three transgenes), such a recitation is considered to be an obvious embodiment in view of the teachings or suggestions of Bell et al. in view of Burt et al. and Wu et al.
One of ordinary skill in the art would have had a reasonable expectation of success for using SARS CoV-2 immunogens as taught by Burt et al. and Wu et al. with the vector as taught by Bell et al. There would have been a reasonable expectation of success given the underlying materials (antigens as taught by Bell et al. and Burt et al.; SARS-CoV proteins as taught by Burt et al. and Wu et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
9. SEQ ID NOs: 1, 7 are free of the prior art of record. Thus claim 16 is still objected to for depending on a rejected claim.
10. No claims are allowed.
11. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached at 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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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1671