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
Applicants’ election without traverse of Group I, claims 1-11 in the reply filed on July 20, 2026 is acknowledged. Claims 12-13 are withdrawn. Claims
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 30, 2023 has been considered by the examiner.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 2, 5, 6, 8, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over. Kousolas et al. (WO 2020/028719 A2 in IDS on 6/30/2023) in view of Garcia-Sastre (US 10,131,695 B2).
Claims 1 and 2. Kousolas et al. teach live-attenuated engineered chimeric Herpes Simplex Virus Type-1 (HSV-1) VC2 virus comprising a nucleotide sequence encoding a heterologous polypeptide operably linked to a promoter, wherein the heterologous polypeptide replaces the glycoprotein C (gC) open-reading frame (ORF) in VC2, and wherein the nucleotide sequence encoding the heterologous polypeptide operably linked to a promoter encodes an oncolytic protein (see claims 1-25, and Examples 1-3).
Claims 5-11. Kousolas et al. teach a recombinant nucleic acid comprising a nucleotide sequence encoding a live-attenuated chimeric Herpes Simplex Virus Type-1 (HSV-1) VC2 viral vector (abstract - "The compositions comprise herpes simplex viruses comprising recombinant herpes simplex virus genomes"; pg 17, In 13-15 - "Preferably, the vaccines of the present invention comprise a live, attenuated HSV comprising a recombinant HSV genome of the present invention"; claim 4 "wherein the recombinant HSV genome is derived from the genome of VC2") and a nucleotide sequence encoding a heterologous polypeptide operably linked to a promoter (pg 16, In 8-10 "the nucleic acid construct encoding an oncolytic protein or tumor antigen will be in the form of an expression cassette comprising a promoter operably linked to a coding sequence for the oncolytic protein or tumor antigen"), wherein the heterologous polypeptide replaces the glycoprotein C (gC) open-reading frame (ORF) in VC2 (pg 6, In 31-33; pg 7, In 1 "VC2-delta-gC-NIS comprises the modifications to the UL53 and UL20 genes described above and further comprises the replacement of the HSV gene (UL44) encoding glycoprotein C (gC) with an expression cassette comprising a nucleotide sequence encoding the Mws musculus sodium iodide symporter").
Kousolas et al. does not teach the nucleotide sequence encoding the heterologous polypeptide operably linked to a promoter encodes the influenza virus hemagglutinin A.
Garcia-Sastre et al. teach flu hemagglutinin (HA) polypeptides that induce a cross -protective immune response against the conserved HA stem domain (see col 2, In 32-54 and claims 1-47), wherein the nucleotide sequence encoding the heterologous polypeptide operably linked to a promoter encodes the influenza virus hemagglutinin A or a fragment thereof (see col 201, In 10-15 "An expression vector comprises a nucleic acid encoding a flu hemagglutinin (HA) polypeptide described herein in a form suitable for expression of the nucleic acid in a host cell.
Regarding present claim 11. Garcia-Sastre et al. teach flu hemagglutinin (HA) polypeptides and an adjuvant (see Figures 42-44 and paragraph 1006).
Since Kousolas et al. teach a recombinant HSV genome derived from the genome of VC2 for use as a vaccine (abstract; claim 4), and Garcia-Sastre et al. discloses the heterologous polypeptide operably linked to a promoter encoding the influenza virus hemagglutinin A for use in a vaccine (abstract; col 201, In 10-15); it would have been obvious to one of ordinary skill in the art that the flu hemagglutinin A of Garcia-Sastre et al. could be introduced within the Kousolas et al. construct to provide a safe viral vector for immunization due to its inability to enter ganglionic axons and establish latency.
One would have thus been motivated to provide Kousolas et al. live-attenuated engineered chimeric Herpes Simplex Virus Type-1 (HSV-1) VC2 virus comprising a nucleotide sequence encoding a heterologous polypeptide operably linked to a promoter, wherein the heterologous polypeptide replaces the glycoprotein C (gC) open-reading frame (ORF) in VC2, and wherein the heterologous polypeptides is Garcia-Sastre’s influenza virus hemagglutinin.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Claims 3, 4, 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over. Kousolas et al. (WO 2020/028719 A2) in view of Garcia-Sastre (US 10,131,695 B2) as applied to claim 1 and further in view of Schickli et al., (Phil Trans, 2001, p. 1965-1973) and (Accession number AF 389118 (see sequence alignment below) and Accession number GU734771 and Szpara et al. (Journal of Virology, 2010, p. 5303-5313).
Kousolas et al. and Garcia-Sastre et al. teach the claimed invention as discussed above. They don’t teach present SEQ ID NO: 19 and SEQ ID NO: 20.
Schickli et al., and Accession number AF 389118 teach a sequence identical with present SEQ ID NO: 19.
Szpara et al., and Accession number GU734771 disclose a sequence identical with present SEQ ID NO: 20.
One of ordinary skill in the art would have been motivated to provide the construct of Kousolas et al. and Garcia-Sastre et al. comprising a nucleic acid encoding influenza heterologous polypeptide of present SEQ ID NO: 19 and comprising the recombinant nucleic acid of present SEQ ID NO: 20 because the nucleic acid sequences identical with present SEQ ID NO: 19 and SEQ ID NO: 20 were known to the skilled artisan at the time of the present invention as taught by Schickli et al., and Szpara et al.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Present SEQ ID NO: 19 and Accession number AF 389118
Query 1 ATGAAGGCAAACCTACTGGTCCTGTTAAGTGCACTTGCAGCTGCAGATGCAGACACAATA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 33 ATGAAGGCAAACCTACTGGTCCTGTTAAGTGCACTTGCAGCTGCAGATGCAGACACAATA 92
Query 61 TGTATAGGCTACCATGCGAACAATTCAACCGACACTGTTGACACAGTACTCGAGAAGAAT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 93 TGTATAGGCTACCATGCGAACAATTCAACCGACACTGTTGACACAGTACTCGAGAAGAAT 152
Query 121 GTGACAGTGACACACTCTGTTAACCTGCTCGAAGACAGCCACAACGGAAAACTATGTAGA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 153 GTGACAGTGACACACTCTGTTAACCTGCTCGAAGACAGCCACAACGGAAAACTATGTAGA 212
Query 181 TTAAAAGGAATAGCCCCACTACAATTGGGGAAATGTAACATCGCCGGATGGCTCTTGGGA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 213 TTAAAAGGAATAGCCCCACTACAATTGGGGAAATGTAACATCGCCGGATGGCTCTTGGGA 272
Query 241 AACCCAGAATGCGACCCACTGCTTCCAGTGAGATCATGGTCCTACATTGTAGAAACACCA 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 273 AACCCAGAATGCGACCCACTGCTTCCAGTGAGATCATGGTCCTACATTGTAGAAACACCA 332
Query 301 AACTCTGAGAATGGAATATGTTATCCAGGAGATTTCATCGACTATGAGGAGCTGAGGGAG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 333 AACTCTGAGAATGGAATATGTTATCCAGGAGATTTCATCGACTATGAGGAGCTGAGGGAG 392
Query 361 CAATTGAGCTCAGTGTCATCATTCGAAAGATTCGAAATATTTCCCAAAGAAAGCTCATGG 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 393 CAATTGAGCTCAGTGTCATCATTCGAAAGATTCGAAATATTTCCCAAAGAAAGCTCATGG 452
Query 421 CCCAACCACAACACAAACGGAGTAACGGCAGCATGCTCCCATGAGGGGAAAAGCAGTTTT 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 453 CCCAACCACAACACAAACGGAGTAACGGCAGCATGCTCCCATGAGGGGAAAAGCAGTTTT 512
Query 481 TACAGAAATTTGCTATGGCTGACGGAGAAGGAGGGCTCATACCCAAAGCTGAAAAATTCT 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 513 TACAGAAATTTGCTATGGCTGACGGAGAAGGAGGGCTCATACCCAAAGCTGAAAAATTCT 572
Query 541 TATGTGAACAAAAAAGGGAAAGAAGTCCTTGTACTGTGGGGTATTCATCACCCGCCTAAC 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 573 TATGTGAACAAAAAAGGGAAAGAAGTCCTTGTACTGTGGGGTATTCATCACCCGCCTAAC 632
Query 601 AGTAAGGAACAACAGAATATCTATCAGAATGAAAATGCTTATGTCTCTGTAGTGACTTCA 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 633 AGTAAGGAACAACAGAATATCTATCAGAATGAAAATGCTTATGTCTCTGTAGTGACTTCA 692
Query 661 AATTATAACAGGAGATTTACCCCGGAAATAGCAGAAAGACCCAAAGTAAGAGATCAAGCT 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 693 AATTATAACAGGAGATTTACCCCGGAAATAGCAGAAAGACCCAAAGTAAGAGATCAAGCT 752
Query 721 GGGAGGATGAACTATTACTGGACCTTGCTAAAACCCGGAGACACAATAATATTTGAGGCA 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 753 GGGAGGATGAACTATTACTGGACCTTGCTAAAACCCGGAGACACAATAATATTTGAGGCA 812
Query 781 AATGGAAATCTAATAGCACCAATGTATGCTTTCGCACTGAGTAGAGGCTTTGGGTCCGGC 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 813 AATGGAAATCTAATAGCACCAATGTATGCTTTCGCACTGAGTAGAGGCTTTGGGTCCGGC 872
Query 841 ATCATCACCTCAAACGCATCAATGCATGAGTGTAACACGAAGTGTCAAACACCCCTGGGA 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 873 ATCATCACCTCAAACGCATCAATGCATGAGTGTAACACGAAGTGTCAAACACCCCTGGGA 932
Query 901 GCTATAAACAGCAGTCTCCCTTACCAGAATATACACCCAGTCACAATAGGAGAGTGCCCA 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 933 GCTATAAACAGCAGTCTCCCTTACCAGAATATACACCCAGTCACAATAGGAGAGTGCCCA 992
Query 961 AAATACGTCAGGAGTGCCAAATTGAGGATGGTTACAGGACTAAGGAACACTCCGTCCATT 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 993 AAATACGTCAGGAGTGCCAAATTGAGGATGGTTACAGGACTAAGGAACACTCCGTCCATT 1052
Query 1021 CAATCCAGAGGTCTATTTGGAGCCATTGCCGGTTTTATTGAAGGGGGATGGACTGGAATG 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1053 CAATCCAGAGGTCTATTTGGAGCCATTGCCGGTTTTATTGAAGGGGGATGGACTGGAATG 1112
Query 1081 ATAGATGGATGGTATGGTTATCATCATCAGAATGAACAGGGATCAGGCTATGCAGCGGAT 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1113 ATAGATGGATGGTATGGTTATCATCATCAGAATGAACAGGGATCAGGCTATGCAGCGGAT 1172
Query 1141 CAAAAAAGCACACAAAATGCCATTAACGGGATTACAAACAAGGTGAACACTGTTATCGAG 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1173 CAAAAAAGCACACAAAATGCCATTAACGGGATTACAAACAAGGTGAACACTGTTATCGAG 1232
Query 1201 AAAATGAACATTCAATTCACAGCTGTGGGTAAAGAATTCAACaaattagaaaaaaggatg 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1233 AAAATGAACATTCAATTCACAGCTGTGGGTAAAGAATTCAACAAATTAGAAAAAAGGATG 1292
Query 1261 gaaaatttaaataaaaaaGTTGATGATGGATTTCTGGACATTTGGACATATAATGCAGAA 1320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1293 GAAAATTTAAATAAAAAAGTTGATGATGGATTTCTGGACATTTGGACATATAATGCAGAA 1352
Query 1321 TTGTTAGTTCTACTGGAAAATGAAAGGACTCTGGATTTCCATGACTCAAATGTGAAGAAT 1380
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1353 TTGTTAGTTCTACTGGAAAATGAAAGGACTCTGGATTTCCATGACTCAAATGTGAAGAAT 1412
Query 1381 CTGTATGAGAAAGTAAAAAGCCAATTAAAGAATAATGCCAAAGAAATCGGAAATGGATGT 1440
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1413 CTGTATGAGAAAGTAAAAAGCCAATTAAAGAATAATGCCAAAGAAATCGGAAATGGATGT 1472
Query 1441 TTTGAGTTCTACCACAAGTGTGACAATGAATGCATGGAAAGTGTAAGAAATGGGACTTAT 1500
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1473 TTTGAGTTCTACCACAAGTGTGACAATGAATGCATGGAAAGTGTAAGAAATGGGACTTAT 1532
Query 1501 GATTATCCCAAATATTCAGAAGAGTCAAAGTTGAACAGGGAAAAGGTAGATGGAGTGAAA 1560
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1533 GATTATCCCAAATATTCAGAAGAGTCAAAGTTGAACAGGGAAAAGGTAGATGGAGTGAAA 1592
Query 1561 TTGGAATCAATGGGGATCTATCAGATTCTGGCGATCTACTCAACTGTCGCCAGTTCACTG 1620
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1593 TTGGAATCAATGGGGATCTATCAGATTCTGGCGATCTACTCAACTGTCGCCAGTTCACTG 1652
Query 1621 GTGCTTTTGGTCTCCCTGGGGGCAATCAGTTTCTGGATGTGTTCTAATGGATCTTTGCAG 1680
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1653 GTGCTTTTGGTCTCCCTGGGGGCAATCAGTTTCTGGATGTGTTCTAATGGATCTTTGCAG 1712
Query 1681 TGCAGAATATGCATCTGA 1698
||||||||||||||||||
Sbjct 1713 TGCAGAATATGCATCTGA 1730
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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