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 Claims 5, 6, 9 and 11 have been withdrawn as being directed to a non-elected species.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, 3-4, 7, 13-14 and 33-36 are under examination at this time.
Withdrawn Rejections
The rejection of claims 1, 13-14 and 33-36 under 35 U.S.C. 102(a)(1) as being anticipated by Wimmer et al. (EP 2954049; published 12/16/2015) has been withdrawn in view of applicant’s amendments to claim 1 to recite specific positions for the mutations.
The rejection of claim 2 under 35 U.S.C. 103 as being unpatentable over Wimmer et al. (EP 2954049; published 12/16/2015) and Lutz et al. (WO 2019/202035; filed 4/17/2019) has been withdrawn in view of the cancelation of claim 2.
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 Lenouen et al. (WO/2018/057950; published 3/29/2018).
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,
wherein the mutant RSV protein P comprises an amino acid sequence that differs from the amino acid sequence set forth in SEQ ID NO: 6 at one or more positions selected from the group consisting of 19-34, 107, 229, 234, and 235.
Lenouen et al. teaches recombinant RSV strains suitable for use as attenuated, live vaccines in humans. The RSV strains may be produced by introducing one or more mutations in the RSV genome or antigenome sequence selected from the positions listed in tables S1, S2 and S3 (see page 6, lines 1-5). Table S1 shows mutations that were detected in 10 lineages of Min_L at the end of six passages. Min_L sequences from Linage #1 contain the mutation S30P in the P protein (see page 6, lines 1-5 and Table S1 at page 61; see the alignment below where Qy is instant SEQ ID NO: 6 and Db is the prior art sequence) [claim 1 and 34]. Thus, the Min_L sequences from Linage #1 encode a mutant RSV P protein that differs from the parental (Min_L) RSV P protein at one more amino acid residues.
Query Match 99.6%; Score 1220; Length 241;
Best Local Similarity 99.6%;
Matches 240; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MEKFAPEFHGEDANNRATKFLESIKGKFTSPKDPKKKDSIISVNSIDIEVTKESPITSNS 60
||||||||||||||||||||||||||||| ||||||||||||||||||||||||||||||
Db 1 MEKFAPEFHGEDANNRATKFLESIKGKFTPPKDPKKKDSIISVNSIDIEVTKESPITSNS 60
Qy 61 TIINPTNETDDTAGNKPNYQRKPLVSFKEDPTPSDNPFSKLYKETIETFDNNEEESSYSY 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TIINPTNETDDTAGNKPNYQRKPLVSFKEDPTPSDNPFSKLYKETIETFDNNEEESSYSY 120
Qy 121 EEINDQTNDNITARLDRIDEKLSEILGMLHTLVVASAGPTSARDGIRDAMVGLREEMIEK 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 EEINDQTNDNITARLDRIDEKLSEILGMLHTLVVASAGPTSARDGIRDAMVGLREEMIEK 180
Qy 181 IRTEALMTNDRLEAMARLRNEESEKMAKDTSDEVSLNPTSEKLNNLLEGNDSDNDLSLED 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 IRTEALMTNDRLEAMARLRNEESEKMAKDTSDEVSLNPTSEKLNNLLEGNDSDNDLSLED 240
Qy 241 F 241
|
Db 241 F 241
For claim 13, Lenouen et al. teaches that the RSV genome or antigenome is codon-pair deoptimized. In some embodiments, the L-ORF of the RSV genome or antigenome is codon-pair deoptimized (see page 6, lines 25-28 and page 15, line 29 to page 16, line 3 and page 16, lines 12-28).
For claim 14, Lenouen et al. teaches lineage #1 after six passages of Min_L has the mutation S30P in the P protein (see Table S1). Min_L has a genome length of 15111 nucleotides (see the sequence listing for Lenouen et al.). The single amino acid change of S30P (3 nucleotides ) will result in a variant genome that is 99.98% identical to the parental genome (15108/15111 x 100 = 99.98%), which is “about” 95%. The specification defines “about” as: if “X” is the value, “about X” or “around X” indicates a value of from 0.9X to 1.1X (see paragraph [0269] of the instant specification).
For claim 33, Lenouen et al. teaches lineage #1 after six passages of Min_L has the mutation S30P in the P protein (see Table S1). The P protein is 241 amino acids long (see Figure 13). Thus, the Min_L variant with the S30P mutation has 99.6% identity with the wild-type sequence (240/241 x 100 = 99.6%).
For claim 34, Lenouen et al. teaches an isolated polynucleotide molecule encoding a recombinant respiratory syncytial virus (RSV) variant having an attenuated phenotype comprising a RSV genome or antigenome sequence, wherein the RSV genome or antigenome is modified by one or more mutations selected from the positions recited in Table S1 (see page 13, lines 18-25).
For claim 35, Lenouen et al. teaches that RSV vaccines of the invention contain as an active ingredient an immunogenically effective amount of RSV produced as described herein. 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 (see page 34, lines 27-32).
For claim 36, Lenouen et al. teaches that vaccines produced in accordance with the present invention 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. The different viruses can be in admixture and administered simultaneously or present in separate preparations and administered separately (see page 37 line 32 to page 38, line 4).
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.
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 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
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