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 1-7, 9, 11, 13-14 and 33-36) and species position 28 in the reply filed on 9/2/2025 is acknowledged.
Status of the Claims
Claims 37-40 and 42 have been withdraw as being directed to a non-elected invention. Claims 5, 6, 9 and 11 have been withdrawn as being directed to a non-elected species. Claims 1-4, 7, 13-14 and 33-36 are under examination at this time.
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, 13-14 and 33-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wimmer et al. (EP 2954049; published 12/16/2015).
The instant claims are directed to a polynucleotide encoding a recombinant respiratory syncytial virus (RSV) variant having an attenuated phenotype comprising a modified RSV genome or antigenome that encodes a mutant RSV protein P that differs from a parental RSV protein P at one or more amino acid residues.
Wimmer et al. teaches a recombinant attenuated human subgroup A RSV genome comprising the recombinant polynucleotide of the invention, wherein the nucleotide sequence is SEQ ID NO: 4 optionally modified to encode one or more of the following mutations: K136R in the N protein, E114V in the P protein and N88K in the M2-1 protein (see paragraph [0010] and claim 9).
For claim 13, Wimmer et al. teaches that in one embodiment the mutation in the codon encoding amino acid residue 114 of the P protein that causes an amino acid other than glutamic acid to be encoded at position 114 of the P protein may occur in a virus having a codon deoptimized L protein, such as RSV Min L (see paragraph [0036]).
For claim 14, Wimmer et al. teaches that the codon pair deoptimized recombinant polynucleotides encoding a respiratory syncytial virus (RSV) amino acid sequence of a parent RSV, where the nucleotide sequence differs from the corresponding nucleotide sequence of the parent virus , resulting in a nucleotide identity of about 77% to about 93% (see paragraph [0025].
For claim 33, Wimmer et al. teaches that a single mutation can occur in the nucleotide sequence encoding, for example, the N protein with or without causing an amino acid change (see paragraph [0036]; where Wimmer et al. discusses mutations at position 136 of the N protein). The N protein is from nucleotides 1141-2316 of SEQ ID NO: 51 (see paragraph [0028]). A single mutation that does not result in an amino acid change will produce an N protein that is 100% identical to the parental amino acid sequence. A single mutation that does result in an amino acid change at position 136 will produce an N protein that is 99.7% identical (391/392 * 100) to the parental amino acid sequence.
For claim 34, Wimmer et al. teaches a recombinant attenuated human subgroup A RSV comprising the disclosed recombinant attenuated human subgroup A RSV genome (see paragraph [0011] and claim 11).
For claim 35, Wimmer et al. teaches that the biologically derived or recombinantly modified virus may be introduced into a host with a physiologically acceptable carrier and/or adjuvant. Useful carriers are well known in the art, and include, e.g., water, buffered water, 0.4% saline, 0.3% glycine, hyaluronic acid and the like. The resulting aqueous solutions may be packaged for use as is, or lyophilized, the lyophilized preparation being combined with a sterile solution prior to administration (see paragraphs [0053] and [0054]).
For claim 36, Wimmer et al. teaches that vaccines can be combined with viruses of the other subgroup or strains of RSV to achieve protection against multiple RSV subgroups or strains, or selected gene segments encoding, e.g., protective epitopes of these strains can be engineered into one RSV clone as described herein (see paragraph [0059]). The different viruses can be in admixture and administered simultaneously or present in separate preparations and administered separately (see paragraph [0060]).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wimmer et al. (EP 2954049; published 12/16/2015) as applied to claims 1, 13-14 and 33-36 above, and further in view of Lutz et al. (WO 2019/202035; filed 4/17/2019).
The instant claim is directed to the polynucleotide of claim 1 where the mutant RSV P protein differs from SEQ ID NO: 6 at one or more positions selected from 19-34, 107, 229, 234 or 235.
The teachings of Wimmer et al. are outline above and incorporated herein. Wimmer et al. does not teach a P protein sequence with a mutation at one or more positions selected from 19-34, 107, 229, 234 or 235.
Lutz et al. teaches the sequence of a RSV P protein that is 98.2% identical to instant SEQ ID NO: 6 and contains a mutation at position 29.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use known P protein sequences, including the sequence taught by Lutz et al., as the base sequence to mutate as taught by Wimmer et al. and the result would be predictable [a polynucleotide encoding a mutant RSV P protein].
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
The following subject matter is allowable: A polynucleotide encoding a recombinant respiratory syncytial virus (RSV) variant having an attenuated phenotype comprising a modified RSV genome or antigenome that encodes a mutant RSV protein P that differs from a parental RSV protein P at one or more amino acid residues, wherein the mutant RSV protein comprises an amino acid sequence that differs from the amino acid sequence set forth in SEQ ID NO: 6 at position 28, where the residue at position 28 of the amino acid sequence is valine, isoleucine, proline, leucine, or serine.
Accordingly, claims 3, 4 and 7 are objected to as being dependent upon a rejected base claim, but would be allowable, to the extent they read on the elected species, 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
1 Using these nucleotide positions, the N protein is 392 amino acids long.