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, 3-19 are pending in the application.
This office action is in response to the amendment filed on 4/6/2026.
All previous rejection not reiterated in this office action are withdrawn.
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, 3, 4, 7, 14-16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baric (US 2006/0240530), in view of Wrapp et al. (Science, 13 March 2020, Vol.367, pages 1260-1263). This is a new ground of rejection necessitated by amendment.
Claim 1 is drawn to an immunogenic composition comprising a Venezuelan Equine Encephalitis (VEE) alphavirus RNA replicon particles that encodes a ARS-CoV2 protein antigen, wherein said SARS-CoV-2 protein antigen is a spike protein or an immunogenic fragment thereof.
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.
Wrapp teaches CoV spike protein (S) is a key target for vaccines, therapeutic antibodies and diagnostics (abstract). Wrapp teaches biophysical structure evidence that SARS-CoV-2 S protein binds angiotensin-converting enzyme (ACE2) with higher affinity, and the structure of SARS-CoV-2 should enable the rapid development and evaluation of vaccine and antiviral therapeutics (page 4, 2nd col., last 4 lines).
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) Wrapp teaches SARS-CoV-2 is closely related to SARS-CoV, and the structural and biophysical information of the S protein supports precision vaccine and antiviral therapeutic design; 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, S protein of SARS-CoV-2 as taught by Wrapp 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 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). Wrapp teaches there are different strains of SARS-CoV-2 sequence in the databases (page 3, 3rd col., 2nd paragraph, line 5-9 from bottom up). It would have been obvious to an ordinary skilled in the art to include multiple antigens comprising S protein from different strain because vaccine needs to cover multiple strains of SARS-CoV-2.
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, 3-5, 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 Wrapp, Csiszovszki and Anonymous (IDS, refer to as Cornell study). This is a new ground of rejection necessitated by amendment.
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 S protein.
The teaching from Wrapp has been discussed above.
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 S protein of 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 Wrapp 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 5, 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). Csiszovszki teaches a SARS-CoV-2 spike protein comprises an amino acid sequence having 100% identity with SEQ ID NO: 2 (sequence alignment attached with previous office action). The ordinary skilled in the art would be motivated to use the S protein as antigen because Wrapp teaches the available information of biophysical and structure of said S protein makes it possible for vaccine design.
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 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).
Response to Arguments
Applicant argues the vaccine taught by Baric is not a VEE replicon particle based composition, but a SARS Coronavirus Replicon Particle based composition, which constitutes only the SARS S protein, but also a plurality of other viral structural protein, including SARS E, M and/or N proteins that are recombinantly produced and assembled in vitro into the SARS replicon Particle. Applicant argues that Baric mentions VEE RP as one of many in vitro expression systems that can be used to produce recombinant SARS structural proteins for various purposes, but not a vaccine. Applicant argues that Csiszovszki does not make up the deficiency. Applicant argues neither Baric nor Csiszovszki demonstrates successful construction of a VEE RP encoding a plurality of short peptides derived from different SARS protein, and a skilled artisan would not have known whether a single VEE RP construct has sufficient capacity to encode all of the peptides, whether each peptide will be sufficiently expressed from the VEE RP construct, or whether such VEE RP constructs would be feasible or effective as a vaccine composition.
The above argument has been fully considered but deemed unpersuasive. The alleged deficiency is not persuasive for reason discussed in the above rejection. Applicant is also reminded that claim 1 is directed to a product, an immunogenic composition comprising a VEE alphavirus RNA replicon particle encodes a SARS-CoV-2 S protein or a fragment thereof. Whether the product is a vaccine or for producing SARS-CoV-2 protein components does not impart a structural difference between the claimed composition and the composition rendered obvious by the combined teaching from prior art as discussed above. Regarding claims 7-17, it is directed to a vaccine comprising the immunogenic composition of claim 1 and pharmaceutically acceptable carrier. Naming the composition as a vaccine does not impart a structural difference between the claimed “vaccine” and the composition rendered obvious by combined teaching as discussed above either. Moreover, whether prior art demonstrates successful construction of a VEE RP encoding a plurality of short peptides derived from different SARS protein is irrelevant because claim 1 and 7 does not encode a plurality of short peptides, it only encodes a spike protein or fragment thereof.
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.
Conclusion
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 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
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