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 1-19 are pending in the application and currently under examination.
Drawings
The drawings are objected to because the drawing should be labeled as “Fig” instead of “Figure.” 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.
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.
Claim 10 is 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 10 recites the limitation "the non-SARS-CoV-2 pathogen" in line 3. There is insufficient antecedent basis for this limitation in the claim because neither claim 1 nor claim 7 of which claim 10 depends on, recites this limitation.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 7, 14, 15, 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baric (US 2006/0240530), in view of Csiszovszki (US 10,973,909).
Claim 1 is drawn to an immunogenic composition comprising a Venezuelan Equine Encephalitis (VEE) alphavirus RNA replicon particles that encodes a first ARS-CoV2 protein antigen.
Baric teaches alphavirus vectored expression of recombinant SARS-CoV proteins, including the SARS S, F, N, M and group specific ORFs were cloned into VEE and packaged into VRPs (paragraph [0152], lines 1-4). Baric teaches various VRP-group specific ORFs have been inoculated into mice and cells, and data suggest VRP immunization induced significant antibodies to authentic S protein expressed from three different SARS isolates (paragraph [0152], lines 10-15).
The only difference between the claimed composition and the prior art disclosed composition is that the protein antigen is SARS-CoV instead of SARS-CoV-2.
Csiszovszki teaches polypeptides, vaccines and pharmaceutical compositions that find use in the prevention or treatment of SARS-CoV-2 infection in an individual (abstract). Csiszovszki teaches SARS-CoV-2 is similar to SARS-CoV (col.2, line 45).
It would have been obvious to an ordinary skilled in the art that the VEE RNA replicon particle may express different antigenic peptides, which is not limited to antigen from SARS-CoV. The ordinary skilled in the art designing a SARS-CoV-2 vaccine would be motivated to use said vector because 1) Csiszovszki teaches SARS-CoV-2 is closely related to SARS-CoV and 2) Baric teaches the VEE genome, when introduced into a cell, is a highly efficient machine for the production of large amounts of nucleic acid of interest substituting its own structure protein (paragraph [0151], bridging 1st and 2nd col). Substituting an immunogenic peptide from SARS-CoV with another from SARS-CoV-2 as taught by Csiszovszki would have been routine experimentation. Baric also teaches the viral particle may be in a formulation that comprises a pharmaceutically acceptable carrier (paragraph [0085]). Therefore, the claimed invention of claim 1 and 7 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claim 2, Csiszovszki teaches the immunogenic peptide comprises one or more SARS-CoV-2 antigen such as S protein, N capsid, envelope protein and membrane glycoprotein (col.8, lines 49-55).
Regarding claims 3 and 4, Baric teaches three different isolates of SARS-CoV S protein were packaged into VRP and immunization induced significant antibodies (paragraph [0152], lines 10-12).
Regarding claim 5, Csiszovszki teaches a SARS-CoV-2 spike protein comprises an amino acid sequence having 100% identity with SEQ ID NO: 2 (see attached sequence alignment).
Regarding claim 14 and 15, Baric teaches the composition can further comprise an adjuvant (paragraph [0103]) and also implies non-adjuvanted vaccine.
Regarding claims 16 and 19, Baric teaches the immunogenic composition may be administered to animal model such as mice and ferrets (paragraph [0202]).
Claim(s) 1-5, 7-13, 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tarpey (WO/2019/086646, IDS), in view of Csiszovszki and Anonymous (IDS, refer to as Cornell study).
Tarpey teaches a vaccine for feline leukemia virus and methods for using it alone or in combination with other protective agents (abstract). Tarpey teaches immunogenic composition that comprises a VEE alphavirus RNA replicon particle that encodes antigen from feline leukemia virus (page 5, lines 1-12).
The only difference between the claimed composition and the prior art disclosed composition is that the protein antigen is from FLV instead of SARS-CoV-2.
Csiszovszki teaches polypeptides, vaccines and pharmaceutical compositions that find use in the prevention or treatment of SARS-CoV-2 infection in an individual (abstract). Csiszovszki teaches SARS-CoV-2 is similar to SARS-CoV (col.2, line 45).
The Cornell study teaches that cats may can be infected with SARS-CoV-2 (see page 1, 1st paragraph).
It would have been obvious to an ordinary skilled in the art that the VEE RNA replicon particle may express different antigenic peptides, which is not limited to antigen from FLV. The ordinary skilled in the art designing a SARS-CoV-2 vaccine would be motivated to use said vector because Tarpey teaches the VEE alpha RNA replicons expressing antigens is safe and effective compared to some traditional vaccine formulations (page 4, lines 1-4), and the Cornell study indicates that cats may be infected with SARS-CoV-2. The ordinary skilled in the art would thus be motivated to make immunogenic vaccine composition that expressing SARS-CoV-2 antigen using the vector taught by Tarpey which is safe and effective in domestic cats. Substituting an immunogenic peptide from FLV with another from SARS-CoV-2 as taught by Csiszovszki would have been routine experimentation. Therefore, the claimed invention of claim 1 and 7 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claim 2, Csiszovszki teaches the immunogenic peptide comprises one or more SARS-CoV-2 antigen such as S protein, N capsid, envelope protein and membrane glycoprotein (col.8, lines 49-55).
Regarding claims 3, 8 and 10, Tarpey teaches in some embodiments, the immunogenic composition comprises two or more sets of alphavirus RNA replicon particles, encoding more than one antigen (page 6, lines 1-5). Tarpey teaches the second antigen the second set of alphavirus RNA replicon particles encode a feline calicirvirus antigen (page 6, line 6-8).
Regarding claims and 4, Tarpey teaches VRP that encodes a feline antigen of the FLV can be added together with one or more other live attenuated other strain of virus (page 19, lines 4-10).
Regarding claim 5, Csiszovszki teaches a SARS-CoV-2 spike protein comprises an amino acid sequence having 100% identity with SEQ ID NO: 2 (see attached sequence alignment).
Regarding claims 9, 11-12, Tarpey teaches multivalent vaccines that include alphavirus RNA replicon encodes an antigen originated from FLV together with one or more attenuated or killed feline pathogens, including FCV, FVR, FPL (page 9, lines 3rd paragraph, and page 10, 2nd paragraph), canine influenza virus and feline parvovirus (page 19, lines 4-16).
Regarding claim 13, Tarpey teaches a number of attenuated non-FLV antigen for multivalent vaccines including feline parvovirus and canine pneumovirus (page 19, 2nd paragraph). It would have been obvious to include canine parvovirus and/or canine distemper virus because they are prior art known viruses for causing diseases in domestic animals, and inclusion of said viruses in multivalent vaccines would have been obvious to an ordinary skilled in the art to prevent said diseases.
Regarding claim 15-18, Tarpey teaches the vaccine is non-adjuvanted and administered to domestic cats (page 30, example 3).
Allowable Subject Matter
Claim 6 is 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.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637