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 .
DETAILED ACTION
Application status
Claims 1-4, 6, 9, 16, 19-20, 23, 27-29, 43, 48, 51 and 80-92 are pending in this application.
Priority
The instant application is the 371 national stage entry of PCT/US2021/046382, filed on 08/17/2021, which claims benefit of 63066570 filed on 08/17/2020.
Election
Applicant's election of Group I, Claims 1-4, 6, 9, 16, 19-20, 23, 27-28, and 80-92 in the response filed on 01/21/2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 29, 43, 48 and 51 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b) as being drawn to a non-elected invention.
For the reasons provided above, this restriction requirement is deemed proper, and therefore, it is made final.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/21/2023 and 01/21/2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 10, 23, 80-84 and 91 are objected to because of the following informalities:
Claim 10 is objected to for the recitation of abbreviation “AAV” which can be substantially improved with respect to form. The Examiner suggest replacing the noted term with ---adeno-associated virus (AAV)---.
Claim 23 is objected to for the recitation of “an AAV vector of claim 16” which can be substantially improved with respect to form. The Examiner suggests replacing the article so that it reads ---the AAV vector of claim 16---.
Claims 80-83 are objected to because the recitation of “SEQ ID NO: # or consists of” can be substantially improved with respect to form. The Examiner suggest inserting a comma after the “SEQ ID NO: #”, i.e. ---SEQ ID NO: #, or consists of---.
Claim 84 is objected to for the recitation of “the vector” which can be substantially improved with respect to form. The Examiner suggests replacing the article so that it reads ---the AAV vector---. Claim 91 is objected to for the recitation of “AAV particle” which can be substantially improved with respect to form. The Examiner suggests replacing the article so that it reads ---the AAV particle---.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 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.
Claims 6, 19 and 92 are rejected under 35 U.S.C. § 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 6 recites the phrase “comprises at least 90% identity to residues 148-345 of SEQ ID NO: 6 or at least 90% identity to residues 147-313 of SEQ ID NO: 5, or comprises residues 148-345 of SEQ ID NO: 6 or residues 147-313 of SEQ ID NO: 5” which is unclear. Metes and bounds of this phrase is unclear because it recites a broader limitation followed by a narrower limitation. In the interest of advancing prosecution, the noted phrase is given the broader interpretation as “comprises at least 90% identity to residues 148-345 of SEQ ID NO: 6 or at least 90% identity to residues 147-313 of SEQ ID NO: 5”.
Claim 19 recites “the vector” in claim 16 which is unclear because claim 16 recites two different vectors, i.e. a viral vector or an AAV vector. It is unclear which one of these vectors “the vector” is referring to. In the interest of advancing prosecution, the noted phrase is interpreted as “the AAV vector”.
Claim 92 recites the phrase “said polynucleotide” in lines 2 and 5 which is unclear. It is unclear which polynucleotide of the two, i.e., “a polynucleotide flanked by AAV2 ITRs” or “the polynucleotide of claim 1”, the noted phrase is referring to.
In the interest of advancing prosecution while fixing grammar issues present in this claim, claim 92 is interpreted as:
“The AAV particle of claim 84, wherein the AAV particle further comprises (i) an AAV9 capsid protein and (ii) a polynucleotide flanked by AAV2 ITRs,
wherein said polynucleotide of claim 1 comprising a hSyn1 promoter sequence operably linked to a polynucleotide encoding a Shank3 protein,
wherein the amino acid sequence of the Shank3 protein consists of the amino acid sequence of SEQ ID NO: 18, and
wherein said polynucleotide of claim 1 encoding the Shank3 protein is operably linked to a WPRE sequence and an hGH polyA sequence.”
Claim Rejections - 35 USC § 102
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.
Claims 1, 3-4 and 80 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uchino et al. (Accession No. AB841411, publicly available since 2013, see sequence search available in SCV, which has been copied/pasted below for Applicants’ convenience: result 1 from 20251007_124819_us-18-021-693-17.rge).
The instant claims are drawn to a non-naturally occurring polynucleotide encoding a Shank3 protein, wherein the Shank3 protein comprises an SH3 domain, a PDZ domain, a Homer binding domain, a Cortactin binding domain, and a SAM domain; wherein the SH3 domain comprises at least 90% identity to residues 474-525 of SEQ ID NO: 6 or at least 90% identity to residues 473-524 of SEQ ID NO: 5;wherein the PDZ domain comprises at least 90% identity to residues 573-662 of SEQ ID NO: 6 or at least 90% identity to residues 572-661 of SEQ ID NO: 5;wherein the Homer binding domain comprises at least 90% identity to residues 1294-1323 of SEQ ID NO: 5 or 6;wherein the Cortactin binding domain comprises at least 90% identity to residues 1400-1426 of SEQ ID NO: 5 or 6 and/or wherein the SAM domain comprises at least 90% identity to residues 1664-1729 of SEQ ID NO: 6 or at least 90% identity to residues 1663-1728 of SEQ ID NO:5; wherein the amino acid sequence of the Shank3 protein encoded by the polynucleotide is at least 90% identical to the amino acid sequence of any one of SEQ ID NOs: 17-20 or consists of the amino acid sequence of any one of SEQ ID NOs: 17-20; and wherein the polynucleotide is less than 4.7 kb.
Uchino et al. teach a mouse shank3c gene having 91.9% sequence identity Applicants’ SEQ ID NO: 17 (see sequence search available in SCV, which has been copied/pasted below for Applicants’ convenience: result 1 from 20251007_124819_us-18-021-693-17.rge), which has 99.9% sequence identity to Applicants’ SEQ ID NO: 1 (see result 1 of 20251007_124708_us-18-021-693-1.rge, which is available in SCV), thereby anticipating claims 1, 4 and 80. Therefore, teachings of Uchino et al. anticipate Applicants’ claimed invention.
20251007_124819_us-18-021-693-17.rge
RESULT 1
AB841411
LOCUS AB841411 4157 bp mRNA linear ROD 01-AUG-2013
DEFINITION Mus musculus SHANK3c-3 mRNA for SH3 and multiple ankyrin repeat
domains protein 3 variant c-3, complete cds, strain: Crl:CD-1
(ICR).
ACCESSION AB841411
VERSION AB841411.1
KEYWORDS .
SOURCE Mus musculus (house mouse)
ORGANISM Mus musculus
Eukaryota; Metazoa; Chordata; Craniata; Vertebrata; Euteleostomi;
Mammalia; Eutheria; Euarchontoglires; Glires; Rodentia; Myomorpha;
Muroidea; Muridae; Murinae; Mus; Mus.
REFERENCE 1
AUTHORS Uchino,S. and Waga,C.
TITLE Identification of novel Shank3c transcripts
JOURNAL Unpublished
REFERENCE 2 (bases 1 to 4157)
AUTHORS Uchino,S. and Waga,C.
TITLE Direct Submission
JOURNAL Submitted (30-JUL-2013) Contact:Shigeo Uchino National Institute of
Neuroscience, Neurochemistry; 4-1-1 Ogawahigashi, Kodaira, Tokyo
187-8502, Japan URL :http://www.ncnp.go.jp/nin/index.html E-mail
:uchino\@ncnp.go.jp
FEATURES Location/Qualifiers
source 1..4157
/organism="Mus musculus"
/mol_type="mRNA"
/strain="Crl:CD-1 (ICR)"
/db_xref="taxon:10090"
gene 1..4157
/gene="SHANK3c-3"
CDS 189..4157
/gene="SHANK3c-3"
/note="alternative splicing"
/codon_start=1
/product="SH3 and multiple ankyrin repeat domains protein
3 variant c-3"
/protein_id="BAN67189.1"
/translation="MEAPGAGFACPLPPGIASVTYVFVYSPSGPGGSGPAPGPGPASP
APPAPPPRGPKRKLYSAVPGRKFIAVKAHSPQGEGEIPLHRGEAVKVLSIGEGGFWEG
TVKGRTGWFPADCVEEVQMRQYDTRHETREDRTKRLFRHYTVGSYDSLTSHSDYVIDD
KVAILQKRDHEGFGFVLRGAKAETPIEEFTPTPAFPALQYLESVDVEGVAWRAGLRTG
DFLIEVNGVNVVKVGHKQVVGLIRQGGNRLVMKVVSVTRKPEEDGARRRAPPPPKRAP
STTLTLRSKSMTAELEELASIRRRKGEKLDEILAVAAEPTLRPDIADADSRAATVKQR
PTSRRITPAEISSLFERQGLPGPEKLPGSLRKGIPRTKSVGEDEKLASLLEGRFPRST
SMQDTVREGRGIPPPPQTAPPPPPAPYYFDSGPPPTFSPPPPPGRAYDTVRSSFKPGL
EARLGAGAAGLYDPSTPLGPLPYPERQKRARSMIILQDSAPEVGDVPRPAPAATPPER
PKRRPRPSGPDSPYANLGAFSASLFAPSKPQRRKSPLVKQLQVEDAQERAALAVGSPG
PVGGSFAREPSPTHRGPRPGSLDYSSGEGLGLTFGGPSPGPVKERRLEERRRSTVFLS
VGAIEGSPPSADLPSLQPSRSIDERLLGTGATTGRDLLLPSPVSALKPLVGGPSLGPS
GSTFIHPLTGKPLDPSSPLALALAARERALASQTPSRSPTPVHSPDADRPGPLFVDVQ
TRDSERGPLASPAFSPRSPAWIPVPARREAEKPPREERKSPEDKKSMILSVLDTSLQR
PAGLIVVHATSNGQEPSRLGAEEERPGTPELAPAPMQAAAVAEPMPSPRAQPPGSIPA
DPGPGQGSSEEEPELVFAVNLPPAQLSSSDEETREELARIGLVPPPEEFANGILLTTP
PPGPGPLPTTVPSPASGKPSSELPPAPESAADSGVEEADTRSSSDPHLETTSTISTVS
SMSTLSSESGELTDTHTSFADGHTFLLEKPPVPPKPKLKSPLGKGPVTFRDPLLKQSS
DSELMAQQHHAASTGLASAAGPARPRYLFQRRSKLWGDPVESRGLPGPEDDKPTVISE
LSSRLQQLNKDTRSLGEEPVGGLGSLLDPAKKSPIAAARLFSSLGELSTISAQRSPGG
PGGGASYSVRPSGRYPVARRAPSPVKPASLERVEGLGAGVGGAGRPFGLTPPTILKSS
SLSIPHEPKEVRFVVRSVSARSRSPSPSPLPSPSPGSGPSAGPRRPFQQKPLQLWSKF
DVGDWLESIHLGEHRDRFEDHEIEGAHLPALTKEDFVELGVTRVGHRMNIERALRQLD
GS
Alignment Scores:
Length: 4157
Score: 3356.50 Matches: 705
Percent Similarity: 55.5% Conservative: 0
Best Local Similarity: 55.5% Mismatches: 0
Query Match: 91.9% Indels: 565
Gaps: 1
US-18-021-693-17 (1-706) x AB841411 (1-4157)
Qy 2 GlyProLysArgLysLeuTyrSerAlaValProGlyArgLysPheIleAlaValLysAla 21
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 345 GGCCCGAAGCGGAAACTTTACAGTGCCGTCCCCGGCCGCAAGTTCATCGCTGTGAAGGCG 404
Qy 22 HisSerProGlnGlyGluGlyGluIleProLeuHisArgGlyGluAlaValLysValLeu 41
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 405 CACAGCCCGCAGGGCGAGGGCGAGATCCCGCTGCACCGCGGCGAGGCCGTGAAGGTGCTC 464
Qy 42 SerIleGlyGluGlyGlyPheTrpGluGlyThrValLysGlyArgThrGlyTrpPhePro 61
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 465 AGCATTGGGGAGGGCGGTTTCTGGGAGGGAACCGTGAAGGGCCGAACAGGCTGGTTCCCA 524
Qy 62 AlaAspCysValGluGluValGlnMetArgGlnTyrAspThrArgHisGluThrArgGlu 81
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 525 GCTGACTGTGTGGAAGAAGTGCAGATGCGACAGTATGACACCCGGCATGAAACCAGAGAG 584
Qy 82 AspArgThrLysArgLeuPheArgHisTyrThrValGlySerTyrAspSerLeuThrSer 101
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 585 GACCGGACGAAGCGTCTCTTCCGCCACTACACTGTGGGTTCCTATGACAGCCTCACTTCA 644
Qy 102 HisSerAspTyrValIleAspAspLysValAlaIleLeuGlnLysArgAspHisGluGly 121
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 645 CACAGCGATTATGTCATCGATGATAAGGTGGCTATCCTGCAGAAAAGGGACCATGAGGGG 704
Qy 122 PheGlyPheValLeuArgGlyAlaLysAlaGluThrProIleGluGluPheThrProThr 141
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 705 TTTGGCTTTGTTCTCCGGGGAGCCAAAGCAGAGACCCCCATTGAGGAGTTTACACCCACA 764
Qy 142 ProAlaPheProAlaLeuGlnTyrLeuGluSerValAspValGluGlyValAlaTrpArg 161
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 765 CCTGCCTTCCCTGCACTCCAATACCTTGAGTCTGTAGATGTGGAAGGTGTGGCCTGGAGG 824
Qy 162 AlaGlyLeuArgThrGlyAspPheLeuIleGluValAsnGlyValAsnValValLysVal 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 825 GCTGGACTTCGAACTGGGGACTTCCTCATTGAGGTGAACGGAGTGAATGTCGTGAAGGTT 884
Qy 182 GlyHisLysGlnValValGlyLeuIleArgGlnGlyGlyAsnArgLeuValMetLysVal 201
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 885 GGACACAAGCAAGTGGTGGGTCTCATCCGTCAGGGTGGCAACCGCCTGGTCATGAAGGTT 944
Qy 202 ValSerValThrArgLysProGluGluAspGlyAlaArgArgArgAlaProProProPro 221
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 945 GTGTCTGTGACCAGGAAACCCGAGGAGGATGGTGCTCGGCGCAGAGCCCCACCACCCCCA 1004
Qy 222 LysArgAlaProSerThrThrLeuThrLeuArgSerLysSerMetThrAlaGluLeuGlu 241
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1005 AAGAGGGCTCCCAGCACCACGCTGACCCTGCGGTCCAAGTCCATGACGGCTGAGCTCGAG 1064
Qy 242 GluLeuAlaSerIleArg------------------------------------------ 247
||||||||||||||||||
Db 1065 GAACTTGCTTCCATTCGGAGAAGAAAAGGGGAGAAGTTGGATGAGATCCTGGCAGTTGCC 1124
Qy 247 ------------------------------------------------------------ 247
Db 1125 GCGGAGCCGACACTGAGGCCGGACATTGCAGATGCTGACTCGAGGGCGGCCACTGTCAAG 1184
Qy 247 ------------------------------------------------------------ 247
Db 1185 CAGCGGCCCACCAGCCGGAGGATCACCCCTGCTGAGATCAGCTCATTGTTTGAGCGCCAG 1244
Qy 247 ------------------------------------------------------------ 247
Db 1245 GGCCTCCCAGGCCCAGAGAAGCTGCCGGGCTCTCTGCGGAAGGGGATTCCACGGACCAAA 1304
Qy 247 ------------------------------------------------------------ 247
Db 1305 TCTGTAGGGGAGGATGAGAAGCTGGCATCCCTACTGGAAGGGCGCTTCCCACGCAGCACG 1364
Qy 247 ------------------------------------------------------------ 247
Db 1365 TCAATGCAGGACACAGTGCGTGAAGGTCGAGGCATTCCACCCCCGCCGCAGACCGCCCCG 1424
Qy 247 ------------------------------------------------------------ 247
Db 1425 CCACCCCCACCCGCGCCCTACTACTTCGACTCCGGGCCACCCCCCACCTTCTCACCGCCG 1484
Qy 247 ------------------------------------------------------------ 247
Db 1485 CCACCACCGGGCCGGGCCTATGACACTGTGCGCTCCAGCTTCAAACCAGGCCTGGAGGCT 1544
Qy 247 ------------------------------------------------------------ 247
Db 1545 CGTCTGGGTGCGGGGGCCGCCGGCCTGTATGATCCGAGCACGCCTCTGGGCCCGCTGCCC 1604
Qy 247 ------------------------------------------------------------ 247
Db 1605 TACCCTGAGCGTCAGAAGCGTGCGCGCTCCATGATCATACTGCAGGACTCTGCGCCAGAA 1664
Qy 247 ------------------------------------------------------------ 247
Db 1665 GTGGGTGATGTCCCCCGGCCTGCGCCTGCCGCCACACCGCCTGAGCGCCCCAAGCGCCGG 1724
Qy 247 ------------------------------------------------------------ 247
Db 1725 CCTCGGCCGTCAGGCCCTGATAGTCCCTATGCCAACCTGGGCGCCTTCAGTGCCAGCCTC 1784
Qy 247 ------------------------------------------------------------ 247
Db 1785 TTCGCTCCGTCGAAACCACAGCGCCGCAAGAGCCCGCTGGTGAAGCAGCTTCAGGTGGAG 1844
Qy 247 ------------------------------------------------------------ 247
Db 1845 GACGCTCAGGAGCGCGCGGCCCTGGCCGTGGGTAGCCCGGGACCAGTGGGCGGAAGCTTT 1904
Qy 247 ------------------------------------------------------------ 247
Db 1905 GCACGAGAACCCTCTCCGACGCACCGCGGGCCCCGGCCAGGCAGCCTTGACTACAGCTCT 1964
Qy 247 ------------------------------------------------------------ 247
Db 1965 GGAGAAGGCCTAGGCCTTACCTTCGGCGGCCCTAGCCCTGGCCCAGTCAAGGAGCGGCGC 2024
Qy 247 ------------------------------------------------------------ 247
Db 2025 CTGGAGGAGCGACGCCGTTCCACTGTGTTCCTCTCTGTGGGTGCCATCGAGGGCAGCCCT 2084
Qy 247 ------------------------------------------------------------ 247
Db 2085 CCCAGCGCGGATCTGCCATCCCTACAACCCTCCCGCTCCATTGATGAGCGCCTCCTGGGG 2144
Qy 247 ------------------------------------------------------------ 247
Db 2145 ACAGGCGCCACCACTGGCCGCGATTTGCTACTCCCCTCCCCTGTCTCTGCTCTGAAGCCA 2204
Qy 247 ------------------------------------------------------------ 247
Db 2205 TTGGTCGGTGGTCCCAGCCTTGGGCCCTCAGGCTCCACCTTCATCCACCCTCTCACTGGC 2264
Qy 247 ------------------------------------------------------------ 247
Db 2265 AAACCCTTGGATCCTAGCTCACCCTTAGCTCTTGCTCTGGCTGCCCGGGAGCGGGCTCTG 2324
Qy 247 ------------------------------------------------------------ 247
Db 2325 GCCTCGCAAACACCTTCCCGGTCCCCCACACCTGTGCACAGCCCCGATGCTGACCGCCCT 2384
Qy 247 ------------------------------------------------------------ 247
Db 2385 GGACCCCTCTTTGTGGATGTGCAAACCCGAGACTCTGAGAGAGGACCGTTGGCTTCCCCA 2444
Qy 247 ------------------------------------------------------------ 247
Db 2445 GCCTTCTCCCCTCGGAGTCCAGCGTGGATTCCAGTGCCTGCTCGGAGAGAGGCAGAGAAG 2504
Qy 247 ------------------------------------------------------------ 247
Db 2505 CCCCCTCGGGAAGAGCGGAAGTCACCAGAGGACAAGAAGTCCATGATCCTCAGCGTCTTG 2564
Qy 247 ------------------------------------------------------------ 247
Db 2565 GACACGTCCTTGCAACGGCCAGCTGGCCTTATTGTTGTGCATGCCACCAGCAATGGGCAG 2624
Qy 247 ------------------------------------------------------------ 247
Db 2625 GAGCCCAGCAGGCTGGGGGCTGAAGAGGAGCGCCCCGGTACTCCGGAGCTGGCCCCAGCC 2684
Qy 247 ------------------------------------------------------------ 247
Db 2685 CCCATGCAGGCAGCAGCTGTGGCAGAGCCCATGCCAAGCCCCCGGGCCCAGCCCCCTGGC 2744
Qy 248 ---------------------------------SerSerGluGluGluProGluLeuVal 256
|||||||||||||||||||||||||||
Db 2745 AGCATCCCAGCAGATCCCGGGCCAGGTCAAGGCAGCTCAGAGGAGGAGCCAGAGCTGGTA 2804
Qy 257 PheAlaValAsnLeuProProAlaGlnLeuSerSerSerAspGluGluThrArgGluGlu 276
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2805 TTCGCTGTGAACCTGCCACCTGCTCAGCTGTCCTCCAGCGATGAGGAGACCAGAGAGGAG 2864
Qy 277 LeuAlaArgIleGlyLeuValProProProGluGluPheAlaAsnGlyIleLeuLeuThr 296
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2865 CTGGCCCGCATAGGGCTAGTGCCACCCCCTGAAGAGTTTGCCAATGGGATCCTGCTGACC 2924
Qy 297 ThrProProProGlyProGlyProLeuProThrThrValProSerProAlaSerGlyLys 316
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2925 ACCCCGCCCCCAGGGCCGGGCCCCTTGCCCACCACGGTACCCAGCCCGGCCTCAGGGAAG 2984
Qy 317 ProSerSerGluLeuProProAlaProGluSerAlaAlaAspSerGlyValGluGluAla 336
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2985 CCCAGCAGCGAGCTGCCCCCTGCCCCTGAGTCTGCAGCTGACTCTGGAGTAGAGGAGGCT 3044
Qy 337 AspThrArgSerSerSerAspProHisLeuGluThrThrSerThrIleSerThrValSer 356
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3045 GACACTCGAAGCTCCAGTGACCCCCACCTGGAGACCACAAGCACCATTTCCACAGTGTCC 3104
Qy 357 SerMetSerThrLeuSerSerGluSerGlyGluLeuThrAspThrHisThrSerPheAla 376
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3105 AGCATGTCCACCCTGAGCTCGGAGAGTGGGGAACTCACGGACACCCACACCTCCTTTGCC 3164
Qy 377 AspGlyHisThrPheLeuLeuGluLysProProValProProLysProLysLeuLysSer 396
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3165 GATGGACACACTTTTCTACTCGAGAAGCCACCAGTGCCTCCCAAGCCCAAGCTCAAGTCC 3224
Qy 397 ProLeuGlyLysGlyProValThrPheArgAspProLeuLeuLysGlnSerSerAspSer 416
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3225 CCGCTGGGGAAGGGGCCGGTGACCTTCAGGGACCCGCTGCTGAAGCAATCCTCGGACAGT 3284
Qy 417 GluLeuMetAlaGlnGlnHisHisAlaAlaSerThrGlyLeuAlaSerAlaAlaGlyPro 436
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3285 GAGCTCATGGCCCAGCAGCACCATGCTGCCTCTACTGGGTTGGCTTCTGCTGCTGGGCCC 3344
Qy 437 AlaArgProArgTyrLeuPheGlnArgArgSerLysLeuTrpGlyAspProValGluSer 456
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3345 GCCCGCCCTCGCTACCTCTTCCAGAGAAGGTCCAAGCTGTGGGGGGACCCCGTGGAGAGT 3404
Qy 457 ArgGlyLeuProGlyProGluAspAspLysProThrValIleSerGluLeuSerSerArg 476
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3405 CGGGGGCTCCCTGGGCCTGAAGATGACAAACCAACTGTGATCAGTGAGCTCAGCTCCCGT 3464
Qy 477 LeuGlnGlnLeuAsnLysAspThrArgSerLeuGlyGluGluProValGlyGlyLeuGly 496
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3465 CTGCAGCAGCTGAATAAAGACACACGCTCCTTGGGGGAGGAACCAGTTGGTGGCCTGGGC 3524
Qy 497 SerLeuLeuAspProAlaLysLysSerProIleAlaAlaAlaArgLeuPheSerSerLeu 516
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3525 AGCCTGCTGGACCCTGCTAAGAAGTCACCCATTGCAGCAGCTCGGCTCTTCAGCAGCCTC 3584
Qy 517 GlyGluLeuSerThrIleSerAlaGlnArgSerProGlyGlyProGlyGlyGlyAlaSer 536
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3585 GGTGAGCTGAGCACCATCTCAGCGCAGCGCAGCCCGGGGGGCCCGGGCGGAGGGGCCTCC 3644
Qy 537 TyrSerValArgProSerGlyArgTyrProValAlaArgArgAlaProSerProValLys 556
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3645 TACTCGGTGCGGCCCAGCGGCCGGTACCCCGTGGCGAGACGAGCCCCGAGCCCAGTGAAA 3704
Qy 557 ProAlaSerLeuGluArgValGluGlyLeuGlyAlaGlyValGlyGlyAlaGlyArgPro 576
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3705 CCCGCATCGCTGGAGCGGGTGGAGGGGCTGGGGGCGGGCGTGGGAGGCGCGGGGCGGCCC 3764
Qy 577 PheGlyLeuThrProProThrIleLeuLysSerSerSerLeuSerIleProHisGluPro 596
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3765 TTCGGCCTCACGCCTCCCACCATCCTCAAGTCGTCCAGCCTCTCCATCCCGCACGAACCC 3824
Qy 597 LysGluValArgPheValValArgSerValSerAlaArgSerArgSerProSerProSer 616
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3825 AAGGAAGTGCGCTTCGTGGTGCGAAGTGTGAGTGCGCGCAGCCGCTCCCCCTCACCATCT 3884
Qy 617 ProLeuProSerProSerProGlySerGlyProSerAlaGlyProArgArgProPheGln 636
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3885 CCGCTGCCCTCGCCTTCTCCCGGCTCTGGCCCCAGTGCCGGCCCGCGTCGGCCATTTCAA 3944
Qy 637 GlnLysProLeuGlnLeuTrpSerLysPheAspValGlyAspTrpLeuGluSerIleHis 656
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3945 CAGAAGCCCCTGCAGCTCTGGAGCAAGTTCGATGTGGGCGACTGGCTGGAGAGCATCCAC 4004
Qy 657 LeuGlyGluHisArgAspArgPheGluAspHisGluIleGluGlyAlaHisLeuProAla 676
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4005 TTAGGCGAGCACCGAGACCGCTTCGAGGACCATGAGATCGAAGGCGCACACCTGCCTGCG 4064
Qy 677 LeuThrLysGluAspPheValGluLeuGlyValThrArgValGlyHisArgMetAsnIle 696
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4065 CTCACCAAGGAAGACTTCGTGGAGCTGGGCGTCACACGCGTTGGCCACCGCATGAACATC 4124
Qy 697 GluArgAlaLeuArgGlnLeuAspGlySer 706
||||||||||||||||||||||||||||||
Db 4125 GAGCGTGCGCTCAGGCAGCTGGATGGCAGC 4154
Claims 1, 3-4 and 81 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uchino et al. (Accession No. AB569469, publicly available since 2010, see sequence search available in SCV, which has been copied/pasted below for Applicants’ convenience: result 1 from 20251007_124819_us-18-021-693-18.rge).
The instant claims are drawn to a non-naturally occurring polynucleotide encoding a Shank3 protein, wherein the Shank3 protein comprises an SH3 domain, a PDZ domain, a Homer binding domain, a Cortactin binding domain, and a SAM domain; wherein the SH3 domain comprises at least 90% identity to residues 474-525 of SEQ ID NO: 6 or at least 90% identity to residues 473-524 of SEQ ID NO: 5;wherein the PDZ domain comprises at least 90% identity to residues 573-662 of SEQ ID NO: 6 or at least 90% identity to residues 572-661 of SEQ ID NO: 5;wherein the Homer binding domain comprises at least 90% identity to residues 1294-1323 of SEQ ID NO: 5 or 6;wherein the Cortactin binding domain comprises at least 90% identity to residues 1400-1426 of SEQ ID NO: 5 or 6 and/or wherein the SAM domain comprises at least 90% identity to residues 1664-1729 of SEQ ID NO: 6 or at least 90% identity to residues 1663-1728 of SEQ ID NO:5; wherein the amino acid sequence of the Shank3 protein encoded by the polynucleotide is at least 90% identical to the amino acid sequence of any one of SEQ ID NOs: 17-20 or consists of the amino acid sequence of any one of SEQ ID NOs: 17-20; and wherein the polynucleotide is less than 4.7 kb.
Uchino et al. teach a human shank3 gene having 91.9% sequence identity Applicants’ SEQ ID NO: 18 (see sequence search available in SCV, which has been copied/pasted below for Applicants’ convenience: result 1 from 20251007_124819_us-18-021-693-18.rge), which has 99.9% sequence identity to Applicants’ SEQ ID NO: 2 (see result 1 of 20251007_124708_us-18-021-693-2.rge, which is available in SCV), thereby anticipating claims 1, 4 and 81. Therefore, teachings of Uchino et al. anticipate Applicants’ claimed invention.
20251007_124819_us-18-021-693-18.rge
RESULT 1
AB569469
LOCUS AB569469 5196 bp mRNA linear PRI 07-JUL-2010
DEFINITION Homo sapiens SHANK3 mRNA for SH3 and multiple ankyrin repeat
domains 3, complete cds.
ACCESSION AB569469
VERSION AB569469.1
KEYWORDS .
SOURCE Homo sapiens (human)
ORGANISM Homo sapiens
Eukaryota; Metazoa; Chordata; Craniata; Vertebrata; Euteleostomi;
Mammalia; Eutheria; Euarchontoglires; Primates; Haplorrhini;
Catarrhini; Hominidae; Homo.
REFERENCE 1
AUTHORS Uchino,S., Waga,C. and Kohsaka,S.
TITLE Novel veriants of human SHANK3 gene
JOURNAL Unpublished
REFERENCE 2 (bases 1 to 5196)
AUTHORS Uchino,S., Waga,C. and Kohsaka,S.
TITLE Direct Submission
JOURNAL Submitted (23-JUN-2010) Contact:Shigeo Uchino National Institute of
Neuroscience, Department of Neurochemistry; Ogawahigashi 4-1-1,
Kodaira, Tokyo 187-8502, Japan E-mail :uchino\@ncnp.go.jp Phone
:81-42-341-2711 Fax :81-42-346-1751
FEATURES Location/Qualifiers
source 1..5196
/organism="Homo sapiens"
/mol_type="mRNA"
/db_xref="taxon:9606"
gene <1..>5196
/gene="SHANK3"
CDS 1..5196
/gene="SHANK3"
/codon_start=1
/product="SH3 and multiple ankyrin repeat domains 3"
/protein_id="BAJ09793.1"
/translation="MDGPGASAVVVRVGIPDLQQTKCLRLDPAAPVWAAKQRVLCALN
HSLQDALNYGLFQPPSRGRAGKFLDEERLLQEYPPNLDTPLPYLEFRYKRRVYAQNLI
DDKQFAKLHTKANLKKFMDYVQLHSTDKVARLLDKGLDPNFHDPDSGECPLSLAAQLD
NATDLLKVLKNGGAHLDFRTRDGLTAVHCATRQRNAAALTTLLDLGASPDYKDSRGLT
PLYHSALGGGDALCCELLLHDHAQLGITDENGWQEIHQACRFGHVQHLEHLLFYGADM
GAQNASGNTALHICALYNQESCARVLLFRGANRDVRNYNSQTAFQVAIIAGNFELAEV
IKTHKDSDVVPFRETPSYAKRRRLAGPSGLASPRPLQRSASDINLKGEAQPAASPGPS
LRSLPHQLLLQRLQEEKDRDRDADQESNISGPLAGRAGQSKISPSGPGGPGPAPGPGP
APPAPPAPPPRGPKRKLYSAVPGRKFIAVKAHSPQGEGEIPLHRGEAVKVLSIGEGGF
WEGTVKGRTGWFPADCVEEVQMRQHDTRPETREDRTKRLFRHYTVGSYDSLTSHSDYV
IDDKVAVLQKRDHEGFGFVLRGAKAETPIEEFTPTPAFPALQYLESVDVEGVAWRAGL
RTGDFLIEVNGVNVVKVGHKQVVALIRQGGNRLVMKVVSVTRKPEEDGARRRAPPPPK
RAPSTTLTLRSKSMTAELEELASIRRRKGEKLDEMLAAAAEPTLRPDIADADSRAATV
KQRPTSRRITPAEISSLFERQGLPGPEKLPGSLRKGIPRTKSVGEDEKLASLLEGRFP
RSTSMQDPVREGRGIPPPPQTAPPPPPAPYYFDSGPPPAFSPPPPPGRAYDTVRSSFK
PGLEARLGAGAAGLYEPGAALGPLPYPERQKRARSMIILQDSAPESGDAPRPPPAATP
PERPKRRPRPPGPDSPYANLGAFSASLFAPSKPQRRKSPLVKQLQVEDAQERAALAVG
SPGPGGGSFAREPSPTHRGPRPGGLDYGAGDGPGLAFGGPGPAKDRRLEERRRSTVFL
SVGAIEGSAPGADLPSLQPSRSIDERLLGTGPTAGRDLLLPSPVSALKPLVSGPSLGP
SGSTFIHPLTGKPLDPSSPLALALAARERALASQAPSRSPTPVHSPDADRPGPLFVDV
QARDPERGSLASPAFSPRSPAWIPVPARREAEKVPREERKSPEDKKSMILSVLDTSLQ
RPAGLIVVHATSNGQEPSRLGGAEEERPGTPELAPAPMQSAAVAEPLPSPRAQPPGGT
PADAGPGQGSSEEEPELVFAVNLPPAQLSSSDEETREELARIGLVPPPEEFANGVLLA
TPLAGPGPSPTTVPSPASGKPSSEPPPAPESAADSGVEEADTRSSSDPHLETTSTIST
VSSMSTLSSESGELTDTHTSFADGHTFLLEKPPVPPKPKLKSPLGKGPVTFRDPLLKQ
SSDSELMAQQHHAASAGLASAAGPARPRYLFQRRSKLWGDPVESRGLPGPEDDKPTVI
SELSSRLQQLNKDTRSLGEEPVGGLGSLLDPAKKSPIAAARLFSSLGELSSISAQRSP
GGPGGGASYSVRPSGRYPVARRAPSPVKPASLERVEGLGAGAGGAGRPFGLTPPTILK
SSSLSIPHEPKEVRFVVRSVSARSRSPSPSPLPSPASGPGPGAPGPRRPFQQKPLQLW
SKFDVGDWLESIHLGEHRDRFEDHEIEGAHLPALTKDDFVELGVTRVGHRMNIERALR
QLDGS"
exon <1..63
/gene="SHANK3"
/number=1
exon 64..267
/gene="SHANK3"
/number=2
exon 268..339
/gene="SHANK3"
/number=3
exon 340..447
/gene="SHANK3"
/number=4
exon 448..600
/gene="SHANK3"
/number=5
exon 601..768
/gene="SHANK3"
/number=6
exon 769..885
/gene="SHANK3"
/number=7
exon 886..963
/gene="SHANK3"
/number=8
exon 964..1029
/gene="SHANK3"
/number=9
exon 1030..1305
/gene="SHANK3"
/number=10
exon 1306..1497
/gene="SHANK3"
/number=11
exon 1498..1611
/gene="SHANK3"
/number=12
exon 1612..1689
/gene="SHANK3"
/number=13
exon 1690..1770
/gene="SHANK3"
/number=14
exon 1771..1896
/gene="SHANK3"
/number=15
exon 1897..2028
/gene="SHANK3"
/number=16
exon 2029..2109
/gene="SHANK3"
/number=17
exon 2110..2133
/gene="SHANK3"
/number=18
exon 2134..2265
/gene="SHANK3"
/number=19
exon 2266..2349
/gene="SHANK3"
/number=20
exon 2350..4605
/gene="SHANK3"
/number=21
exon 4606..>5196
/gene="SHANK3"
/number=2
Alignment Scores:
Length: 5196
Score: 3359.00 Matches: 706
Percent Similarity: 55.6% Conservative: 0
Best Local Similarity: 55.6% Mismatches: 0
Query Match: 91.9% Indels: 564
Gaps: 1
US-18-021-693-18 (1-707) x AB569469 (1-5196)
Qy 2 GlyProLysArgLysLeuTyrSerAlaValProGlyArgLysPheIleAlaValLysAla 21
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1384 GGCCCGAAGCGGAAACTTTACAGCGCCGTCCCCGGCCGCAAGTTCATCGCCGTGAAGGCG 1443
Qy 22 HisSerProGlnGlyGluGlyGluIleProLeuHisArgGlyGluAlaValLysValLeu 41
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1444 CACAGCCCGCAGGGTGAAGGCGAGATCCCGCTGCACCGCGGCGAGGCCGTGAAGGTGCTC 1503
Qy 42 SerIleGlyGluGlyGlyPheTrpGluGlyThrValLysGlyArgThrGlyTrpPhePro 61
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1504 AGCATTGGGGAGGGCGGTTTCTGGGAGGGAACCGTGAAAGGCCGCACGGGCTGGTTCCCG 1563
Qy 62 AlaAspCysValGluGluValGlnMetArgGlnHisAspThrArgProGluThrArgGlu 81
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1564 GCCGACTGCGTGGAGGAAGTGCAGATGAGGCAGCATGACACACGGCCTGAAACGCGGGAG 1623
Qy 82 AspArgThrLysArgLeuPheArgHisTyrThrValGlySerTyrAspSerLeuThrSer 101
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1624 GACCGGACGAAGCGGCTCTTTCGGCACTACACAGTGGGCTCCTACGACAGCCTCACCTCA 1683
Qy 102 HisSerAspTyrValIleAspAspLysValAlaValLeuGlnLysArgAspHisGluGly 121
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1684 CACAGCGATTATGTCATTGATGACAAAGTGGCTGTCCTGCAGAAACGGGACCACGAGGGC 1743
Qy 122 PheGlyPheValLeuArgGlyAlaLysAlaGluThrProIleGluGluPheThrProThr 141
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1744 TTTGGTTTTGTGCTCCGGGGAGCCAAAGCAGAGACCCCCATCGAGGAGTTCACGCCCACG 1803
Qy 142 ProAlaPheProAlaLeuGlnTyrLeuGluSerValAspValGluGlyValAlaTrpArg 161
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1804 CCAGCCTTCCCGGCGCTGCAGTATCTCGAGTCGGTGGACGTGGAGGGTGTGGCCTGGAGG 1863
Qy 162 AlaGlyLeuArgThrGlyAspPheLeuIleGluValAsnGlyValAsnValValLysVal 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1864 GCCGGGCTGCGCACGGGAGACTTCCTCATCGAGGTGAACGGGGTGAACGTGGTGAAGGTC 1923
Qy 182 GlyHisLysGlnValValAlaLeuIleArgGlnGlyGlyAsnArgLeuValMetLysVal 201
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1924 GGACACAAGCAGGTGGTGGCTCTGATTCGCCAGGGTGGCAACCGCCTCGTCATGAAGGTT 1983
Qy 202 ValSerValThrArgLysProGluGluAspGlyAlaArgArgArgAlaProProProPro 221
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1984 GTGTCTGTGACAAGGAAGCCAGAAGAGGACGGGGCTCGGCGCAGAGCCCCACCGCCCCCC 2043
Qy 222 LysArgAlaProSerThrThrLeuThrLeuArgSerLysSerMetThrAlaGluLeuGlu 241
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2044 AAGAGGGCCCCCAGCACCACACTGACCCTGCGCTCCAAGTCCATGACAGCTGAGCTCGAG 2103
Qy 242 GluLeuAlaSerIleArg------------------------------------------ 247
||||||||||||||||||
Db 2104 GAACTTGCCTCCATTCGGAGAAGAAAAGGGGAGAAGCTGGACGAGATGCTGGCAGCCGCC 2163
Qy 247 ------------------------------------------------------------ 247
Db 2164 GCAGAGCCAACGCTGCGGCCAGACATCGCAGACGCAGACTCCAGAGCCGCCACCGTCAAA 2223
Qy 247 ------------------------------------------------------------ 247
Db 2224 CAGAGGCCCACCAGTCGGAGGATCACACCCGCCGAGATTAGCTCATTGTTTGAACGCCAG 2283
Qy 247 ------------------------------------------------------------ 247
Db 2284 GGCCTCCCAGGCCCAGAGAAGCTGCCGGGCTCCTTGCGGAAGGGGATTCCACGGACCAAG 2343
Qy 247 ------------------------------------------------------------ 247
Db 2344 TCTGTAGGGGAGGACGAGAAGCTGGCGTCCCTGCTGGAAGGGCGCTTCCCGCGGAGCACC 2403
Qy 247 ------------------------------------------------------------ 247
Db 2404 TCGATGCAAGACCCGGTGCGCGAGGGTCGCGGCATCCCGCCCCCGCCGCAGACCGCGCCG 2463
Qy 247 ------------------------------------------------------------ 247
Db 2464 CCTCCCCCGCCCGCGCCCTACTACTTCGACTCGGGGCCGCCCCCGGCCTTCTCGCCGCCG 2523
Qy 247 ------------------------------------------------------------ 247
Db 2524 CCCCCGCCGGGCCGCGCCTACGACACGGTGCGCTCCAGCTTCAAGCCCGGCCTGGAGGCG 2583
Qy 247 ------------------------------------------------------------ 247
Db 2584 CGCCTGGGCGCGGGCGCTGCCGGCCTGTACGAGCCGGGCGCGGCCCTCGGCCCGCTGCCG 2643
Qy 247 ------------------------------------------------------------ 247
Db 2644 TATCCCGAGCGGCAGAAGCGCGCGCGCTCCATGATCATCCTGCAGGACTCGGCGCCCGAG 2703
Qy 247 ------------------------------------------------------------ 247
Db 2704 TCGGGCGACGCCCCTCGACCCCCGCCCGCGGCCACCCCGCCCGAGCGACCCAAGCGCCGG 2763
Qy 247 ------------------------------------------------------------ 247
Db 2764 CCGCGGCCGCCCGGCCCCGACAGCCCCTACGCCAACCTGGGCGCCTTCAGCGCCAGCCTC 2823
Qy 247 ------------------------------------------------------------ 247
Db 2824 TTCGCTCCGTCCAAGCCGCAGCGCCGCAAGAGCCCCCTGGTGAAGCAGCTGCAGGTGGAG 2883
Qy 247 ------------------------------------------------------------ 247
Db 2884 GACGCGCAGGAGCGCGCGGCCCTGGCCGTGGGCAGCCCCGGTCCCGGCGGCGGCAGCTTC 2943
Qy 247 ------------------------------------------------------------ 247
Db 2944 GCCCGCGAGCCCTCCCCGACCCACCGCGGTCCGCGCCCGGGTGGCCTCGACTACGGCGCG 3003
Qy 247 ------------------------------------------------------------ 247
Db 3004 GGCGATGGCCCGGGGCTCGCGTTCGGCGGCCCGGGCCCGGCCAAGGACCGGCGGCTGGAG 3063
Qy 247 ------------------------------------------------------------ 247
Db 3064 GAGCGGCGCCGCTCCACTGTGTTCCTGTCCGTGGGGGCCATCGAGGGCAGCGCCCCCGGC 3123
Qy 247 ------------------------------------------------------------ 247
Db 3124 GCGGATCTGCCATCCCTACAGCCCTCCCGCTCCATCGACGAGCGCCTCCTGGGGACCGGC 3183
Qy 247 ------------------------------------------------------------ 247
Db 3184 CCCACCGCCGGCCGCGACCTGCTGCTGCCCTCCCCGGTGTCTGCCCTGAAGCCGTTGGTC 3243
Qy 247 ------------------------------------------------------------ 247
Db 3244 AGCGGCCCGAGCCTGGGGCCCTCGGGTTCCACCTTCATCCACCCACTCACCGGCAAACCC 3303
Qy 247 ------------------------------------------------------------ 247
Db 3304 CTGGACCCCAGCTCACCCCTGGCCCTTGCCCTGGCTGCCCGAGAGCGAGCTCTGGCCTCC 3363
Qy 247 ------------------------------------------------------------ 247
Db 3364 CAGGCGCCCTCCCGGTCCCCCACACCCGTGCACAGTCCCGACGCCGACCGCCCCGGACCC 3423
Qy 247 ------------------------------------------------------------ 247
Db 3424 CTGTTTGTGGATGTACAGGCCCGGGACCCAGAGCGAGGGTCCCTGGCTTCCCCGGCTTTC 3483
Qy 247 ------------------------------------------------------------ 247
Db 3484 TCCCCACGGAGCCCAGCCTGGATTCCTGTGCCTGCTCGCAGGGAGGCAGAGAAGGTCCCC 3543
Qy 247 ------------------------------------------------------------ 247
Db 3544 CGGGAGGAGCGGAAGTCACCCGAGGACAAGAAGTCCATGATCCTCAGCGTCCTGGACACA 3603
Qy 247 ------------------------------------------------------------ 247
Db 3604 TCCCTGCAGCGGCCAGCTGGCCTCATCGTTGTGCACGCCACCAGCAACGGGCAGGAGCCC 3663
Qy 247 ------------------------------------------------------------ 247
Db 3664 AGCAGGCTGGGGGGGGCCGAAGAGGAGCGCCCGGGCACCCCGGAGTTGGCCCCGGCCCCC 3723
Qy 247 ------------------------------------------------------------ 247
Db 3724 ATGCAGTCAGCGGCTGTGGCAGAGCCCCTGCCCAGCCCCCGGGCCCAGCCCCCTGGTGGC 3783
Qy 248 ------------------------------SerSerGluGluGluProGluLeuValPhe 257
||||||||||||||||||||||||||||||
Db 3784 ACCCCGGCAGACGCCGGGCCAGGCCAGGGCAGCTCAGAGGAAGAGCCAGAGCTGGTGTTT 3843
Qy 258 AlaValAsnLeuProProAlaGlnLeuSerSerSerAspGluGluThrArgGluGluLeu 277
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3844 GCTGTGAACCTGCCACCTGCCCAGCTGTCGTCCAGCGATGAGGAGACCAGGGAGGAGCTG 3903
Qy 278 AlaArgIleGlyLeuValProProProGluGluPheAlaAsnGlyValLeuLeuAlaThr 297
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3904 GCCCGAATTGGGTTGGTGCCACCCCCTGAAGAGTTTGCCAACGGGGTCCTGCTGGCCACC 3963
Qy 298 ProLeuAlaGlyProGlyProSerProThrThrValProSerProAlaSerGlyLysPro 317
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3964 CCACTCGCTGGCCCGGGCCCCTCGCCCACCACGGTGCCCAGCCCGGCCTCAGGGAAGCCC 4023
Qy 318 SerSerGluProProProAlaProGluSerAlaAlaAspSerGlyValGluGluAlaAsp 337
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4024 AGCAGTGAGCCACCCCCTGCCCCTGAGTCTGCAGCCGACTCTGGGGTGGAGGAGGCTGAC 4083
Qy 338 ThrArgSerSerSerAspProHisLeuGluThrThrSerThrIleSerThrValSerSer 357
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4084 ACACGCAGCTCCAGCGACCCCCACCTGGAGACCACAAGCACCATCTCCACGGTGTCCAGC 4143
Qy 358 MetSerThrLeuSerSerGluSerGlyGluLeuThrAspThrHisThrSerPheAlaAsp 377
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4144 ATGTCCACCTTGAGCTCGGAGAGCGGGGAACTCACTGACACCCACACCTCCTTCGCTGAC 4203
Qy 378 GlyHisThrPheLeuLeuGluLysProProValProProLysProLysLeuLysSerPro 397
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4204 GGACACACTTTTCTACTCGAGAAGCCACCAGTGCCTCCCAAGCCCAAGCTCAAGTCCCCG 4263
Qy 398 LeuGlyLysGlyProValThrPheArgAspProLeuLeuLysGlnSerSerAspSerGlu 417
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4264 CTGGGGAAGGGGCCGGTGACCTTCAGGGACCCGCTGCTGAAGCAGTCCTCGGACAGCGAG 4323
Qy 418 LeuMetAlaGlnGlnHisHisAlaAlaSerAlaGlyLeuAlaSerAlaAlaGlyProAla 437
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4324 CTCATGGCCCAGCAGCACCACGCCGCCTCTGCCGGGCTGGCCTCTGCCGCCGGGCCTGCC 4383
Qy 438 ArgProArgTyrLeuPheGlnArgArgSerLysLeuTrpGlyAspProValGluSerArg 457
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4384 CGCCCTCGCTACCTCTTCCAGAGAAGGTCCAAGCTATGGGGGGACCCCGTGGAGAGCCGG 4443
Qy 458 GlyLeuProGlyProGluAspAspLysProThrValIleSerGluLeuSerSerArgLeu 477
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4444 GGGCTCCCTGGGCCTGAAGACGACAAACCAACTGTGATCAGTGAGCTCAGCTCCCGCCTG 4503
Qy 478 GlnGlnLeuAsnLysAspThrArgSerLeuGlyGluGluProValGlyGlyLeuGlySer 497
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4504 CAGCAGCTGAACAAGGACACGCGTTCCCTGGGGGAGGAACCAGTTGGTGGCCTGGGCAGC 4563
Qy 498 LeuLeuAspProAlaLysLysSerProIleAlaAlaAlaArgLeuPheSerSerLeuGly 517
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4564 CTGCTGGACCCTGCCAAGAAGTCGCCCATCGCAGCAGCTCGGCTCTTCAGCAGCCTCGGT 4623
Qy 518 GluLeuSerSerIleSerAlaGlnArgSerProGlyGlyProGlyGlyGlyAlaSerTyr 537
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4624 GAGCTGAGCTCCATTTCAGCGCAGCGCAGCCCCGGGGGCCCGGGCGGCGGGGCCTCGTAC 4683
Qy 538 SerValArgProSerGlyArgTyrProValAlaArgArgAlaProSerProValLysPro 557
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4684 TCGGTGAGGCCCAGTGGCCGCTACCCCGTGGCGAGACGCGCCCCGAGCCCGGTGAAGCCC 4743
Qy 558 AlaSerLeuGluArgValGluGlyLeuGlyAlaGlyAlaGlyGlyAlaGlyArgProPhe 577
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4744 GCGTCGCTGGAGCGGGTGGAGGGGCTGGGGGCGGGCGCGGGGGGCGCAGGGCGGCCCTTC 4803
Qy 578 GlyLeuThrProProThrIleLeuLysSerSerSerLeuSerIleProHisGluProLys 597
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4804 GGCCTCACGCCCCCCACCATCCTCAAGTCGTCCAGCCTCTCCATCCCGCACGAGCCCAAG 4863
Qy 598 GluValArgPheValValArgSerValSerAlaArgSerArgSerProSerProSerPro 617
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4864 GAGGTGCGCTTCGTGGTGCGCAGCGTGAGCGCGCGCAGTCGCTCCCCCTCGCCGTCGCCG 4923
Qy 618 LeuProSerProAlaSerGlyProGlyProGlyAlaProGlyProArgArgProPheGln 637
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4924 CTGCCCTCGCCCGCGTCCGGCCCCGGCCCCGGCGCCCCCGGCCCACGCCGACCCTTCCAG 4983
Qy 638 GlnLysProLeuGlnLeuTrpSerLysPheAspValGlyAspTrpLeuGluSerIleHis 657
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4984 CAGAAGCCGCTGCAGCTCTGGAGCAAGTTCGACGTGGGCGACTGGCTGGAGAGCATCCAC 5043
Qy 658 LeuGlyGluHisArgAspArgPheGluAspHisGluIleGluGlyAlaHisLeuProAla 677
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 5044 CTAGGCGAGCACCGCGACCGCTTCGAGGACCATGAGATAGAAGGCGCGCACCTACCCGCG 5103
Qy 678 LeuThrLysAspAspPheValGluLeuGlyValThrArgValGlyHisArgMetAsnIle 697
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 5104 CTTACCAAGGACGACTTCGTGGAGCTGGGCGTCACGCGCGTGGGCCACCGCATGAACATC 5163
Qy 698 GluArgAlaLeuArgGlnLeuAspGlySer 707
||||||||||||||||||||||||||||||
Db 5164 GAGCGCGCGCTCAGGCAGCTGGACGGCAGC 5193
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-4, 6, 9, 16, 19-20, 23, 27-28, and 80-92 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-58 of copending Application No. 19158554.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claim 1 of the instant application:
A non-naturally occurring polynucleotide encoding a Shank3 protein, wherein the Shank3 protein comprises an SH3 domain, a PDZ domain, a Homer binding domain, a Cortactin binding domain, and a SAM domain; wherein the SH3 domain comprises at least 90% identity to residues 474-525 of SEQ ID NO: 6 or at least 90% identity to residues 473-524 of SEQ ID NO: 5;wherein the PDZ domain comprises at least 90% identity to residues 573-662 of SEQ ID NO: 6 or at least 90% identity to residues 572-661 of SEQ ID NO: 5;wherein the Homer binding domain comprises at least 90% identity to residues 1294-1323 of SEQ ID NO: 5 or 6;wherein the Cortactin binding domain comprises at least 90% identity to residues 1400-1426 of SEQ ID NO: 5 or 6 and/or wherein the SAM domain comprises at least 90% identity to residues 1664-1729 of SEQ ID NO: 6 or at least 90% identity to residues 1663-1728 of SEQ ID NO:5; wherein the amino acid sequence of the Shank3 protein encoded by the polynucleotide is at least 90% identical to the amino acid sequence of any one of SEQ ID NOs: 17-20 or consists of the amino acid sequence of any one of SEQ ID NOs: 17-20; and wherein the polynucleotide is less than 4.7 kb.
Claim 1 of ‘554 application:
A method of delivering a human miniShank3 protein to the central nervous system (CNS) of a subject in need thereof, said method comprising administering to the CNS of the subject a pharmaceutical composition comprising a recombinant AAV virion comprising: (1) a recombinant AAV vector comprising an expression cassette flanked by inverted terminal repeats (ITRs), wherein the expression cassette comprises a polynucleotide encoding a human miniShank3 protein comprising an amino acid sequence that is at least 90% identical to SEQ ID NO: 18 or SEQ ID NO: 20, operably linked to a human Syn promoter and a polyA signal sequence; and (2) an AAV9 capsid or a capsid having an amino acid sequence that is at least 90% identical or at least 95% identical to SEQ ID NO: 29.
Claims of the instant application differ in that they are drawn to a polynucleotide encoding a human Shank3 protein (SEQ ID NO: 18) and the 554’ application is drawn to a method of delivering a human shank3 protein using a AAV vector comprising a polynucleotide encoding human shank3 protein comprising the amino acid sequence of SEQ ID NO: 18. The Examiner notes that the SEQ ID NO: 18 from the instant application and the ‘554 application is 100% identical. The instant application further claims an AAV vector comprising said polynucleotide, and methods of administering said AAV vector to a subject with neurodevelopmental disorder, all of which significantly overlap in scope with the claims of ‘554 application. All of the limitations of the dependent claims are also disclosed in the specification of ‘554 application. Taken together, it would have been obvious for a person of ordinary skill in the art (POSITA) to practice the methods of ‘554 application using said polynucleotide/AAV vectors/methods of the instant claims. A POSITA would have been motivated to practice such because both applications are drawn to virtually identical subject matter for the use of human shank3 protein for methods of treating neurodevelopmental disorders. A POSITA would have had a reasonable expectation of success based on the teachings of instant application and the ‘554 application since all of the required biochemical reagents and techniques are disclosed therein.
Claims 1-4, 6, 9, 16, 19-20, 23, 27-28, and 80-92 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-29 of copending Application No. 19378942.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claim 1 of the instant application:
A non-naturally occurring polynucleotide encoding a Shank3 protein, wherein the Shank3 protein comprises an SH3 domain, a PDZ domain, a Homer binding domain, a Cortactin binding domain, and a SAM domain; wherein the SH3 domain comprises at least 90% identity to residues 474-525 of SEQ ID NO: 6 or at least 90% identity to residues 473-524 of SEQ ID NO: 5;wherein the PDZ domain comprises at least 90% identity to residues 573-662 of SEQ ID NO: 6 or at least 90% identity to residues 572-661 of SEQ ID NO: 5;wherein the Homer binding domain comprises at least 90% identity to residues 1294-1323 of SEQ ID NO: 5 or 6;wherein the Cortactin binding domain comprises at least 90% identity to residues 1400-1426 of SEQ ID NO: 5 or 6 and/or wherein the SAM domain comprises at least 90% identity to residues 1664-1729 of SEQ ID NO: 6 or at least 90% identity to residues 1663-1728 of SEQ ID NO:5; wherein the amino acid sequence of the Shank3 protein encoded by the polynucleotide is at least 90% identical to the amino acid sequence of any one of SEQ ID NOs: 17-20 or consists of the amino acid sequence of any one of SEQ ID NOs: 17-20; and wherein the polynucleotide is less than 4.7 kb.
Claim 1 of ‘942 application:
A method of treating an autism spectrum disorder (ASD) or Phelan-McDermid syndrome in a primate subject in need thereof, the method comprising administering to the primate subject a therapeutically effective amount of a composition comprising an AAV vector, wherein the AAV vector comprises a polynucleotide encoding a Shank3 protein.
Claims of the instant application differ in that they are drawn to a polynucleotide encoding a human Shank3 protein (SEQ ID NO: 18) and the 942’ application is drawn to a method of treating an autism by administering a human shank3 protein using a AAV vector comprising a polynucleotide encoding human shank3 protein comprising the amino acid sequence of SEQ ID NO: 18. The Examiner notes that the SEQ ID NO: 18 from the instant application and the ‘942 application is 100% identical. The instant application further claims an AAV vector comprising said polynucleotide, and methods of administering said AAV vector to a subject with neurodevelopmental disorder including autism (see claim 29 of the instant application), all of which significantly overlap in scope with the claims of ‘942 application. All of the limitations of the dependent claims are also disclosed in the specification of ‘942 application. Taken together, it would have been obvious for a person of ordinary skill in the art (POSITA) to practice the methods of ‘942 application using said polynucleotide/AAV vectors/methods of the instant claims. A POSITA would have been motivated to practice such because both applications are drawn to virtually identical subject matter for the use of human shank3 protein for methods of treating neurodevelopmental disorders including autism. A POSITA would have had a reasonable expectation of success based on the teachings of instant application and the ‘942 application since all of the required biochemical reagents and techniques are disclosed therein.
Conclusion
Claims 1-4, 6, 9, 16, 19-20, 23, 27-28, and 80-92 are rejected for the reasons as stated above. Applicants must respond to the objections/rejections in this Office action to be fully responsive in prosecution.
The instant Office action is non-final.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE W LEE whose telephone number is (571)272-9949. The examiner can normally be reached on M-F between 9:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571)272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAE W LEE/
Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Prosecution Insights