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 1-20 are pending and under examination.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Figure 6a (Figure 6 does not have part a). 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. 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.
Claims 15, 18-20 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.
Regarding claim 15, the recitation of “the immunogenic composition of any one of claim 1” renders the claim indefinite because it is unclear which immunogenic composition the claim is referring.
Dependent claims 18 and 19 are rejected for same reason because it depends on claim 15 and does not remedy the indefiniteness of the claim.
Claim 20 is a “use” claim that fails to recite any steps. It is unclear what the claim encompasses for the “use.” Moreover, the recitation of “any one of claim 1” also renders the claim indefinite because it is unclear what “any one” in claim 1 it is referring to.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because “use of the immunogenic composition” without any steps does not fall within any of the statutory category: process, machine, manufacture or composition of matter.
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, 5, 7-10, 12, 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horwitz (WO2018026729), in view of He et al. (CN111303297).
Horwitz teaches vaccines that is a recombinant live vaccine strain (LVS) comprising a recombinant attenuated Francisella tularensis subspecies holarctica having a deleted capB gene, and expressing an antigen presented in F. tularensis, B. anthracis, Y. pestis, as well as those identified by diseases/pathogens and/or those identified by the center for disease control as USDA Federal select agents and toxins (page 22, lines 3-8, page 3, 5-11). Horwitz teaches the vaccine can elicit an immune response in a mammalian host when the immunogenic composition is administered orally, intradermally (i.d.), subcutaneously (s.q.), intramuscularly (i.m.) or intranasally (i.n.) (page 22, lines 16-20). Horwitz teaches the multiantigen vectors are introduced into recombinant F. tularensis holarctica (page 64 and 68, Table 2 and 3).
However, Horwitz does not teach the antigenic polypeptide epitope is from SARS-CoV-2.
He et al. teach SARS-CoV-2 belongs to coronaviruses family and causes viral pneumonia/pulmonary infection (page 1, 3rd paragraph). He et al. teaches a double antigen sandwich method for detecting recombinant protein of viral antibody, wherein the recombinant protein is a fusion protein of multiple dominant epitopes of SARS-CoV-2 (page 1, last paragraph). He et al. teaches the predominant epitopes of the new coronavirus SARS-CoV-2 N protein, S protein and M protein are screened by calculation and prediction, and they are connected together by flexible polypeptides (GGGS) to form the SARS-CoV-2 virus multi-dominant epitope fusion protein as shown in SEQ ID NO: 1 (page 7, lines 2-6).
It would have been obvious to an ordinary skilled in the art that the LVS vaccine platform taught by Horwitz may be used to generate immunogenic compositions expressing a wide variety of antigenic epitopes based on the teaching from Horwitz. The ordinary skilled in the art would be motivated to express multiple dominant epitopes from SARS-CoV-2 because this infectious virus causes life threatening conditions at the time of filing. The ordinary skilled in the art would be motivated to use the multiple dominant epitopes fusion from SARS-CoV-2 encoded by SEQ ID NO: 1 to generate immunogenic response responding to multiple antigens from S, N and M, which are known at the time to have antibody response as demonstrated by He et al. Substituting one antigenic polypeptide from the teaching of Horwitz with another prior art known antigenic polypeptide taught by He et al. would have been within the capability of an ordinary skilled in the art. Therefore, the claimed invention of claim 1, 8 and 15 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claims 2-3, 9 and 10, He et al. teaches a peptide epitope fusion present in SARS-CoV-2 S, M and N, SEQ ID NO:1. Claim 3 and claim 10 recite “LVS expresses a fusion protein comprising at least one peptide epitope present in SARS-CoV-2 M and at least one peptide epitope present in SARS-CoV-2 N phosphoprotein,” which does not exclude additional epitopes. Therefore, SEQ ID NO: 1 from He also meets this claim limitation.
Regarding claim 4 and claim 12, SEQ ID NO: 1 taught by He et al. is at least 50, 100, 200 nucleotides in length (page 7, 3rd paragraph).
Regarding claims 7 and 14, since the claim does not specify what excipient is adapted for either oral and intranasal administration, it would have been obvious to an ordinary skilled in the art that any prior art known excipient routinely used for oral or intranasal administration as taught by Horwitz meets this claim limitation.
Regarding claims 16 and 17, Horwitz teaches administering the immunogenic composition in a primary and a subsequent homologous booster vaccination (page 24, lines 22-25).
Regarding claims 18 and 19, Horwitz teaches the immunogenic composition may be administered orally or intranasally (page 3, line 18).
Regarding claim 20, since the claim does not set forth any steps of how to use the immunogenic composition, the use of immunogenic composition taught by Horwitz (such as generating immunogenic response) meets the claim limitation.
Claim(s) 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horwitz and He, as applied to claims 1, 2 and 8 above, and further in view of Vilalta (US 2007/0105193, IDS).
The teaching from Horwitz and He has been discussed above.
However, neither reference teaches codon optimization of the antigenic polypeptide.
Vilatlta teaches an immunogenic composition that raises immune response in a vertebrate comprising polynucleotide that encodes a coding region from SARS-CoV, or a fragment of codon optimized coding region (paragraph [0015]). Vilatlta teaches codon optimization is for the purpose of confer optimal expression and safety in the subject it is intended to deliver to (paragraph [0082]).
It would have been obvious to an ordinary skilled in the art that the immunogenic composition expressing antigenic polypeptide encoding the SARS-CoV-2 antigen rendered obvious by combined teaching from Horwitz and He may be codon optimized for safety and optimal expression based on teaching from Vilatlta. As demonstrated by Vilatlta, codon optimization to a specific organism for optimal expression was routinely practiced at the time the application was filed. Therefore, the claimed invention of claims 6 and 13 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Allowable Subject Matter
Claims 4 and 11 are 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.
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