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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10 and 13-18) and coronavirus species in the reply filed on 10/9/2025 is acknowledged.
Status of the Claims
Claims 11-12 and 19-25 have been withdraw as being directed to a non-elected invention. Claims 2-5 have been withdrawn as being directed to a non-elected species. Claims 1, 6-10 and 13-18 are under examination at this time.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 should be amended to clarify that the viral gene comprises a deletion relative to the wild-type (or a parental) gene sequence. Appropriate correction is required.
Claims 13-18 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot reference two sets of claims to different features (see, for examples, claims 13 and 16). See MPEP § 608.01(n)(I)(B)(3). Accordingly, the claims 13-18 will not been further treated on the merits.
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 6, 9 and 10 are 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 claims 6 and 10, the phrase "preferable" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
It is noted that claim 9 recites the term “optionally”. The term optionally means “not required or mandatory”. For example, a composition comprising A, B, C, and optionally D means that component D can or cannot be present (D is not required to be present). In claim 9, however, it appears the use of “optionally” is an attempt to define “preferred” embodiments or limitations. For example, claim 9 states “optionally wherein the nucleotides are contiguous or non-contiguous”. In this instance, the use of the term optionally does not make sense given the definition of optionally (not required or mandatory).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 6 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lu et al. (Journal of Medical Virology, 2017, 89:542–545).
The instant claims are directed to an isolated polynucleotide comprising one or more defective interfering genes, wherein each of the one or more defective interfering genes comprises a nucleotide sequence corresponding to one or more portions of a viral gene, wherein the portion of the viral gene comprises a deletion relative to the viral gene, wherein the virus is an influenza virus or coronavirus.
Lu et al. teaches nucleic acids (amplicons) comprising the spike gene from MERS-CoV (a coronavirus), where the spike gene comprise a 530 nt deletion (see Figure 1).
Claim(s) 1, 6, 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Su et al. (mBio, 2020, 11(4):1-9, e01610-20).
The instant claims are directed to an isolated polynucleotide comprising one or more defective interfering genes, wherein each of the one or more defective interfering genes comprises a nucleotide sequence corresponding to one or more portions of a viral gene, wherein the portion of the viral gene comprises a deletion relative to the viral gene, wherein the virus is an influenza virus or coronavirus.
Su et al. teaches nucleic acids (cDNA libraries) comprising various deletions, e.g., a 382-nucleotide deletion [claim 1 and claim 9; about 400-2000] in SARS-CoV-2 that truncates open reading frame 7b (ORF7b) and ORF8 [claim 6; the gene encodes ORF8 and claim 7; the polynucleotide comprises about 600-1200 nucleotides from the 3’ end] (see Figure 1 A and B).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (Journal of Medical Virology, 2017, 89:542–545) as applied to claims 1, 6 and 9 above, and further in view of Yu et al. (Journal of Virology, May 2021, 95(11):1-14).
The instant claims are directed to a vector comprising the polynucleotide of claim 1, wherein the vector comprises one or more promoters and/or polyadenylation signals operably linked to the one or more defective interfering genes.
The teachings of Lu et al. are outline above and incorporated herein. Lu et al. does not teach cloning the amplicons into, for example, an expression vector comprising a promoter and/or polyadenylation signal. However, Yu et al. SARS-CoV-2 spike protein deletion mutants, where genes encoding the full-length spike protein and the deletion mutant were cloned into the mammalian expression plasmid pcDNA3.1+. The expressed spike proteins and deletion mutants were used expression assays (see, for example, Figure 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to clone the spike protein deletion mutant of Lu et al. into a vector, e.g., an expression vector. One would have been motivated to do so to mass produce the deleted spike gene or to express deletion mutant in cells for use in expression assays as taught by Yu et al. There would have been a reasonable expectation of success given the skill and knowledge of one of ordinary skill in the art and given the teachings of Yu et al. Further, applicant has not demonstrated unexpected or superior results when cloning the defective interfering spike gene into a plasmid with a promoter and/or polyadenylation signal.
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (mBio, 2020, 11(4):1-9, e01610-20) as applied to claims 1, 6, 7 and 9 above.
The instant claims are directed to a vector comprising the polynucleotide of claim 1, wherein the vector comprises one or more promoters and/or polyadenylation signals operably linked to the one or more defective interfering genes.
The teachings of Su et al. are outline above and incorporated herein. Su et al. does not teach cloning the amplicons into, for example, an expression vector comprising a promoter and/or polyadenylation signal. Su et al. further teaches that a robust antibody response to ORF8 has been observed in SARS-CoV-2 infection (see the abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to clone the ORF8 deletion mutants of Su et al. into a vector, e.g., an expression vector. One would have been motivated to do so to mass produce the deleted ORF8 gene or to express ORF8 deletion mutant in cells for use in expression assays or as potential vaccine components. There would have been a reasonable expectation of success given the skill and knowledge of one of ordinary skill in the art and given the teachings of Su et al. [a robust antibody response to ORF8 has been observed in SARS-CoV-2 infection]. Further, applicant has not demonstrated unexpected or superior results when cloning the defective interfering ORF8 gene into a plasmid with a promoter and/or polyadenylation signal.
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Allowable Subject Matter
Claim 8 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
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672