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 Claims 1-11, 19-23 are withdrawn. Claims 12, 17 are amended. Claims 13-16, 18 are canceled. Claims 12, 17 are under consideration.
2. Due to the new rejection below, this Action is a Non-Final Action.
Drawings
3. (previous objection, maintained) The instant specification refers to drawings in colors green, red and blue (p. 4).
Applicant contends: the drawings filed are not required to be in color for an understanding of the claimed invention; applicant request that the drawings as submitted be maintained.
See the objection as recited in the previous Office Action.
The objection is maintained.
Specification
4. (previous objection, withdrawn) The disclosure was objected to because of informalities.
Applicant contends: applicant disagrees that the trademarks in the specification need to include trademark identifying symbols; use of symbols is not compulsory.
The objection is withdrawn.
Claim Objections
5. (previous objection, withdrawn) Claim 12 was objected to because of informalities:
Applicant contends: the claim is amended.
The objection is withdrawn.
Claim Rejections - 35 USC § 112
6. (previous rejection, withdrawn) Claims 12-18 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and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: the claim is amended.
The rejection is withdrawn.
Claim Rejections - 35 USC § 103
7. (previous rejection, withdrawn) Claim 12 was rejected under 35 U.S.C. 103 as being unpatentable over Rappuoli et al. (US20060257852)(cited in applicant's IDS submitted 12/5/2022) in view of Wu et al. ("A new coronavirus associated with human respiratory disease in China," Nature, Vol. 579: 265-269 (2020); previously cited).
Applicant contends: claim 12 is amended.
In view of applicant’s amendments, the rejection is withdrawn.
8. (previous rejection, withdrawn) Claims 13-18 were rejected under 35 U.S.C. 103 as being unpatentable over Rappuoli et al. as applied to claim 12 above, and further in view of Scherwitzl et al. ("Sindbis Virus with Anti-OX40 Overcomes the Immunosuppressive Tumor Microenvironment of Low-Immunogenic Tumors," Molecular Therapy Oncolytics, Vol. 17: 431-447 (2020)) (cited in applicant's IDS submitted 12/5/2022).
Applicant contends: Scherwitzl et al. teaches that reprogrammed T cells demonstrate enhanced tumor infiltration capacity as well as anti-tumor activity capable of overcoming the repressive tumor environment; activation of T cells has no relationship to treating or preventing a SARS-CoV-2 infection; combination of Sindbis vector encoding SARS-CoV-2 spike protein and anti-OX40 antibody promotes robust tissue specific Th1-type T cell immune response in lungs.
Upon further consideration, the rejection is withdrawn.
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.
9. (new rejection) Claims 12, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Rappuoli et al. (US20060257852)(cited in applicant's IDS submitted 12/5/2022) in view of Wu et al. ("A new coronavirus associated with human respiratory disease in China," Nature, Vol. 579: 265-269 (2020); previously cited) and further in view of Fotin-Mleczek et al. (WO2015135558A1)(See PTO-892: Notice of References Cited).
See claims 12, 17 as submitted 5/24/2026.
Rappuoli et al. teaches: nucleic acids and proteins from the SARS coronavirus (abstract);
used in the preparation and manufacture of vaccine formulations and methods for treating SARS
(abstract); preparing SARS spike protein subunit vaccine [0660]; including use of DNA
expression cassette encoding SARS virus S protein [0661]; including gene-delivery based systems including viral vectors and non-viral nucleic acid vectors (DNA, RNA) encoding one or more SARS virus antigens [0762]; using including replication incompetent virus-based expression vector (alphavirus vector) encoding SARS virus S protein [0661](as recited in claim 12); alphavirus particle [0772](as recited in claim 12); wherein Sindbis virus is prototype virus for studying alphavirus [0763](as recited in claim 12); using gene based delivery systems derived from alphaviruses for in vivo administration of heterologous genes including one or more SARS genes having therapeutic or prophylactic applications [0762]; pharmaceutical composition [0957].
Rappuoli et al. does not teach SARS-CoV-2.
Wu et al. teaches: RNA virus strain 2019-nCoV (also known in the art as SARS-CoV-
2)(abstract); spike protein for the virus genome (p. 270).
Rappuoli et al. in view of Wu et al. does not teach administering anti-OX40 antibody or OX40 binding fragment thereof, or Interleukin-12.
Fotin-Mleczek et al. teaches: vaccine/agonist combination comprising RNA vaccine comprising ORF coding for at least one antigen and composition comprising at least one OX40 agonist, for treatment of infectious diseases (abstract); including RNA replicons developed from Sindbis virus (p. 20); including coronavirus antigens (p. 60); as well as wherein OX40 agonist is a binding molecule that binds to OX40, such as antibody (p. 74)(as recited in claim 12); as well as IL-12 (p. 79)(as recited in claim 12).
One of ordinary skill in the art would have been motivated to combine agonists and components as taught by Fotin-Mleczek et al. with the composition as taught by Rappuoli et al. in view of Wu et al. Rappuoli et al. in view of Wu et al. teaches particles encoding coronavirus antigens for therapeutic and prophylactic applications, and Fotin-Mleczek et al., which also teaches particles encoding coronavirus antigens for therapeutic and prophylactic applications, teaches as well as the benefit of including OX40 agonists and IL-12 for increased effectiveness (See MPEP 2144.06: Substituting equivalents known for the same purpose; … See MPEP 2144.06: Art Recognized Equivalence for the Same Purpose: I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)).
One of ordinary skill in the art would have had a reasonable expectation of success for combining agonists and components as taught by Fotin-Mleczek et al. with the composition as taught by Rappuoli et al. in view of Wu et al. There would have been a reasonable expectation of success given the underlying materials (coronavirus antigens as taught by Rappuoli et al. in view of Wu et al. and Fotin-Mleczek 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
10. No claims are allowed.
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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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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