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 .
Claims 9-10, 12-13 and 15-28 are pending.
Claims 18-28 are withdrawn from further consideration by the examiner, 37 C.F.R. 1.142(b) as being drawn to non-elected inventions.
Claims 9-10, 12-13 and 15-17, drawn to a cell having an improved engraftment fitness comprising a first chimeric antigen receptor (CAR) comprising a particular first ligand binding domain capable of specifically binding to CD19 encoded by a nucleotide sequence of SEQ ID NO: 12 as the species; a particular second CAR comprising a second ligand binding domain capable of specifically binding to a particular tumor antigen selected from L1CAM encoded by a nucleotide of SEQ ID NO: 16 as the species; and wherein the cell has an improved engraftment fitness compared to a cell lacking the first CAR, a pharmaceutical composition comprising said cell and a pharmaceutically acceptable excipient, are being acted upon in this Office Action.
Priority
Applicant’ claim priority to provisional application 62/202,698, filed August 7, 2015, is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 10, 2026 has been considered by the examiner and an initialed copy of the IDS is included with this Office Action.
Rejection withdrawn
The new matter rejection of claims 9-10, 12-13, 15-17, 29 and 30 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of the claim amendment.
The rejection of claims 9-10, 12-13, 15-17 and 30 under 35 U.S.C. 102 (a)(1)as being anticipated by Jensen et al (WO2017/027291, published February 16, 2017; PTO 892) is withdrawn in light of the claim amendment.
The rejection of claims 9 and 29 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jensen et al (WO2017/027291, published February 16, 2017; PTO 892) in view of Bitter et al (US20160362472, published December 15, 2016; PTO 892) and/or Fry et al (WO2016/149578, published September 22, 2016; PTO 892 is withdrawn in view of the claim amendment.
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 double patenting rejection is appropriate where the claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 9-10, 12-13 and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,458,167.
Although the claims at issue are not identical, they are not patentably distinct from each other because while the ‘167 patent issued from the application which served as the parent for the present case, the examined application was filed as a CON, not a DIV, and therefore no shield against double patenting that might be provided by 35 U.S.C 121 would be applicable here.
The subject matter claimed in the instant application is fully disclosed in the ‘167 patent.
Issued claim 1 recites a T cell comprising a first chimeric antigen receptor (CAR) encoded by a first polynucleotide, and a second CAR encoded by a second polynucleotide, wherein the first CAR is different from the second CAR, and the first CAR and the second CAR each comprise a 4-1BB signaling domain, a CD3-zeta signaling domain, a transmembrane domain, and an extracellular spacer comprising an IgG hinge spacer, and wherein: the first polynucleotide comprises: a first nucleic acid encoding a leader sequence, and a second nucleic acid 3′ of the first nucleic acid, wherein the second nucleic acid encodes a first ligand binding domain which specifically binds to a B cell specific cell surface molecule; and the second polynucleotide comprises: a third nucleic acid encoding a leader sequence, and a fourth nucleic acid 3′ of the third nucleic acid, wherein the nucleic acid encodes a second ligand binding domain which specifically binds to a cell surface tumor specific molecule; wherein: (i) the B cell specific cell surface molecule is selected from CD19 or CD20, and wherein the first ligand binding domain is encoded by a nucleotide sequence having at least 95% identity with any one of SEQ ID NOs: 12 or 14; and (ii) the cell surface tumor specific molecule is EGFR, and wherein the second ligand binding domain comprises the amino acid sequence of SEQ ID NO:19 (species). The issued patent also teaches chimeric antigen receptor that binds to L1CAM comprising the amino acid sequence of SEQ ID NO: 15, which is identical to instant SEQ ID NO: 15. The issued patent also teaches chimeric antigen receptor that binds to ROR1 comprising the amino acid sequence of SEQ ID NO: 17, which is identical to instant SEQ ID NO: 157.
Issued claim 2 recites the T cell of claim 1, wherein the first polynucleotide or the second polynucleotide, further comprises: an inducible promoter, wherein the inducible promoter is 5′ of the first nucleic acid or the third nucleic acid; or a suicide gene system.
Issued claim 3 recites the T cell of claim 1, wherein the T cell is selected from: a CD8+ T cytotoxic lymphocyte cell selected from a naive CD8+ T-cell, a CD8+ memory T-cell, a central memory CD8+ T-cell, a regulatory CD8+ T-cell, an IPS derived CD8+ T-cell, an effector memory CD8+ T-cell, or a bulk CD8+ T-cell; or a CD4+ T helper lymphocyte cell selected from a naive CD4+ T-cell, a CD4+ memory T-cell, a central memory CD4+ T-cell, a regulatory CD4+ T-cell, an IPS derived CD4+ T-cell, an effector memory CD4+ T-cell, or a bulk CD4+ T-cell, which corresponds to instant claim 16.
Issued claim 4 recites the T cell of claim 1, wherein the B cell specific cell surface molecule is CD20, and the first ligand binding domain comprises the amino acid sequence of SEQ ID NO:13, which corresponds to instant claim 9.
Issued claim 5 recites the T cell of claim 1, wherein the B cell specific cell surface molecule is CD19, and the first ligand binding domain comprises the amino acid sequence of SEQ ID NO:11, which corresponds to instant claim 9.
Issued claim 6 recites the T cell of claim 1, wherein: the first polynucleotide comprises: a fifth nucleic acid encoding a linker, wherein the fifth nucleic acid is 3′ of the nucleic acid encoding the first CAR, and a sixth nucleic acid encoding a marker domain, wherein the sixth nucleic acid sequence is 3′ of the fifth nucleic acid; and the second polynucleotide comprises: a seventh nucleic acid encoding a linker, wherein the seventh nucleic acid is 3′ of the nucleic acid encoding the second CAR, and an eighth nucleic acid encoding a marker domain, wherein the eighth nucleic acid is 3′ of the seventh nucleic acid sequence.
Issued claim 7 recites the T cell of claim 6, wherein: the leader sequence of the first polynucleotide or the second polynucleotide comprises a granulocyte-macrophage colony-stimulating factor signal sequence; the linker of the first polynucleotide or the second polynucleotide comprises a ribosome skip sequence or an internal ribosome entry sequence (IRES); and the marker domain of the first polynucleotide or the second polynucleotide comprises a truncated HER2 polypeptide (Her2tG) or a truncated EGFR polypeptide (EGFRt).
Issued claim 8 recites the T cell of claim 7, wherein: the leader sequence of the first polynucleotide or the second polynucleotide comprises the amino acid sequence of SEQ ID NO:29 or SEQ ID NO:31; the extracellular spacer of the first CAR or the second CAR comprises the amino acid sequence selected from SEQ ID NO:01, SEQ ID NO:03, or SEQ ID NO:39; the 4-1BB signaling domain comprises the amino acid sequence of SEQ ID NO:07, and the CD3-zeta signaling domain comprises the amino acid sequence of SEQ ID NO:09; the linker of the first polynucleotide or the second polynucleotide comprises the nucleotide sequence of SEQ ID NO:34; and the marker domain of the first polynucleotide or the second polynucleotide comprises the amino acid sequence of SEQ ID NO:35 or SEQ ID NO:37.
Issued claim 9 recites a pharmaceutical composition comprising the T cell of claim 1 and a pharmaceutically acceptable excipient, which corresponds to instant claim 17.
Issued claim 10 recites a T cell comprising: a first chimeric antigen receptor (CAR) comprising a first ligand biding domain capable of specifically binding to a B cell specific cell surface molecule; and a second CAR comprising a second ligand biding domain capable of specifically binding to a cell surface tumor specific molecule, wherein the first CAR is different from the second CAR, and wherein the first CAR and the second CAR each comprise a 41-BB signaling domain, CD3-zeta signaling domain, a transmembrane domain, and an extracellular spacer comprising an IgG hinge spacer; and wherein: (i) the B cell specific cell surface molecule is selected from CD19 or CD20, and wherein the first ligand binding domain is encoded by a nucleotide sequence having at least 95% identity with any one of SEQ ID NOs: 12 or 14, which corresponds to new claim 30, and (ii) the cell surface tumor specific molecule is EGFR, and wherein the second ligand binding domain comprises the amino acid sequence of SEQ ID NO:19, which corresponds to instant claims 9 and 13.
Issued claim 11 recites the T cell of claim 10, wherein the B cell specific cell surface molecule is CD20, and the first ligand binding domain comprises the amino acid sequence of SEQ ID NO:13, which corresponds to instant claims 9 and 13.
Issued claim 12 recites T cell of claim 11, wherein the B cell specific cell surface molecule is CD19, and the first ligand binding domain comprises the amino acid sequence of SEQ ID NO:11, which corresponds to instant claims 9 and 13.
Issued claim 13 recites the T cell of claim 10, wherein the T cell is a CD4+ T cell, which corresponds to instant claims 14-16.
Issued claim 14 recites the T cell of claim 10, wherein the T cell is a CD8+ T cell, which corresponds to instant claims 14-16.
The claims and the disclosure of ‘167 patent further teaches:
Patent No.:
Rejected over Patent claims:
First anti-CD19 CAR (SEQ NO: 11) explicitly in the claims:
First anti-CD20 CAR (SEQ NO: 13) explicitly in the claims:
Second anti-L1CAM CAR (SEQ ID NO: 15)
Second anti-ROR1 CAR (SEQ ID NO: 17)
11458167
1-14
1, 5, 9, 12
1, 4, 9, 11
Col. 7, lines 12-21
Col. 7, lines 21-27
17/931,258
9, 10, 30
9,
9
9
The reference SEQ ID NO: 11 is 100% identical to the claimed SEQ ID NO: 11, which is 100% identity to SEQ ID NO: 11, see reference claim 12, sequence alignment below:
Query Match 100.0%; Score 1285; Length 244;
Best Local Similarity 100.0%;
Matches 244; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQTTSSLSALGDRVTISCRASQDISKYLNWYQQKPDGTVKLLIYHTSRLHSGVPSR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQTTSSLSALGDRVTISCRASQDISKYLNWYQQKPDGTVKLLIYHTSRLHSGVPSR 60
Qy 61 FSGSGSGTDYSLTISNLEQEDIATYFCQQGNTLPYTFGGGTKLEITGSTSGSGKPGSGEG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 FSGSGSGTDYSLTISNLEQEDIATYFCQQGNTLPYTFGGGTKLEITGSTSGSGKPGSGEG 120
Qy 121 STKGEVKLQESGPGLVAPSQSLSVTCTVSGVSLPDYGVSWIRQPPRKGLEWLGVIWGSET 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 STKGEVKLQESGPGLVAPSQSLSVTCTVSGVSLPDYGVSWIRQPPRKGLEWLGVIWGSET 180
Qy 181 TYYNSALKSRLTIIKDNSKSQVFLKMNSLQTDDTAIYYCAKHYYYGGSYAMDYWGQGTSV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 TYYNSALKSRLTIIKDNSKSQVFLKMNSLQTDDTAIYYCAKHYYYGGSYAMDYWGQGTSV 240
Qy 241 TVSS 244
||||
Db 241 TVSS 244
and the second CAR comprising a second ligand binding domain which specifically binds to a tumor antigen LICAM comprising SEQ ID NO: 15 as per claim 9, and is encoded by a nucleic acid sequence set forth in SEQ ID NO: 16 as per claim 13, see reference SEQ ID NO: 15 and 16, respectively.
The reference SEQ ID NO: 15 is 100% identical to the claimed SEQ ID NO: 15, , which is 100% identity to SEQ ID NO: 15, see sequence alignment below:
Query Match 100.0%; Score 1294; Length 242;
Best Local Similarity 100.0%;
Matches 242; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQQPGAELVKPGASVKLSCKASGYTFTGYWMHWVKQRPGHGLEWIGEINPSNGRTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQQPGAELVKPGASVKLSCKASGYTFTGYWMHWVKQRPGHGLEWIGEINPSNGRTNY 60
Qy 61 NERFKSKATLTVDKSSTTAFMQLSGLTSEDSAVYFCARDYYGTSYNFDYWGQGTTLTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NERFKSKATLTVDKSSTTAFMQLSGLTSEDSAVYFCARDYYGTSYNFDYWGQGTTLTVSS 120
Qy 121 GGGGSGGGGSGGGGSDIQMTQSSSSFSVSLGDRVTITCKANEDINNRLAWYQQTPGNSPR 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GGGGSGGGGSGGGGSDIQMTQSSSSFSVSLGDRVTITCKANEDINNRLAWYQQTPGNSPR 180
Qy 181 LLISGATNLVTGVPSRFSGSGSGKDYTLTITSLQAEDFATYYCQQYWSTPFTFGSGTELE 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 LLISGATNLVTGVPSRFSGSGSGKDYTLTITSLQAEDFATYYCQQYWSTPFTFGSGTELE 240
Qy 241 IK 242
||
Db 241 IK 242
The ‘167 patent further teaches CD20CAR comprises the amino acid sequence set forth in SEQ ID NO: 13 as per claim 9 and is encoded by the sequence set forth in SEQ ID NO: 14 as per claim 13, see reference claims 11 and 10.
The reference SEQ ID NO: 13 is 100% identical to the claimed SEQ ID NO: 13, which is 100% identity to SEQ ID NO: 13, see sequence alignment below:
ALIGNMENT:
Query Match 100.0%; Score 1417; Length 266;
Best Local Similarity 100.0%;
Matches 266; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 METDTLLLWVLLLWVPGSTGDIVLTQSPAILSASPGEKVTMTCRASSSVNYMDWYQKKPG 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 METDTLLLWVLLLWVPGSTGDIVLTQSPAILSASPGEKVTMTCRASSSVNYMDWYQKKPG 60
Qy 61 SSPKPWIYATSNLASGVPARFSGSGSGTSYSLTISRVEAEDAATYYCQQWSFNPPTFGGG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SSPKPWIYATSNLASGVPARFSGSGSGTSYSLTISRVEAEDAATYYCQQWSFNPPTFGGG 120
Qy 121 TKLEIKGSTSGGGSGGGSGGGGSSEVQLQQSGAELVKPGASVKMSCKASGYTFTSYNMHW 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TKLEIKGSTSGGGSGGGSGGGGSSEVQLQQSGAELVKPGASVKMSCKASGYTFTSYNMHW 180
Qy 181 VKQTPGQGLEWIGAIYPGNGDTSYNQKFKGKATLTADKSSSTAYMQLSSLTSEDSADYYC 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VKQTPGQGLEWIGAIYPGNGDTSYNQKFKGKATLTADKSSSTAYMQLSSLTSEDSADYYC 240
Qy 241 ARSNYYGSSYWFFDVWGAGTTVTVSS 266
||||||||||||||||||||||||||
Db 241 ARSNYYGSSYWFFDVWGAGTTVTVSS 266
And the ROR1CAR comprises the amino acid sequence set forth in SEQ ID NO: 17 and is encoded by the sequence set forth in SEQ ID NO: 17 as per claim 9, and is encoded by a nucleotide sequence set forth in SEQ ID NO: 18 as per claim 13, see reference SEQ ID NO: 17 and 18, respectively.
The reference SEQ ID NO: 17 is 100% identical to the claimed SEQ ID NO: 17, which is 100% identity to SEQ ID NO: 17, see sequence alignment below:
Query Match 100.0%; Score 1326; Length 250;
Best Local Similarity 100.0%;
Matches 250; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 PQEQLVESGGRLVTPGGSLTLSCKASGFDFSAYYMSWVRQAPGKGLEWIATIYPSSGKTY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 PQEQLVESGGRLVTPGGSLTLSCKASGFDFSAYYMSWVRQAPGKGLEWIATIYPSSGKTY 60
Qy 61 YATWVNGRFTISSDNAQNTVDLQMNSLTAADRATYFCARDSYADDGALFNIWGPGTLVTI 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YATWVNGRFTISSDNAQNTVDLQMNSLTAADRATYFCARDSYADDGALFNIWGPGTLVTI 120
Qy 121 SSGGGGSGGGGSGGGGSELVLTQSPSVSAALGSPAKITCTLSSAHKTDTIDWYQQLQGEA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SSGGGGSGGGGSGGGGSELVLTQSPSVSAALGSPAKITCTLSSAHKTDTIDWYQQLQGEA 180
Qy 181 PRYLMQVQSDGSYTKRPGVPDRFSGSSSGADRYLIIPSVQADDEADYYCGADYIGGYVFG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 PRYLMQVQSDGSYTKRPGVPDRFSGSSSGADRYLIIPSVQADDEADYYCGADYIGGYVFG 240
Qy 241 GGTQLTVTGG 250
||||||||||
Db 241 GGTQLTVTGG 250
Each CAR comprises an IgG4 hinge spacer (see para. [0009], Fig. 2), a CD28 transmembrane domain (CD28tm, para. [0010], Fig. 2), an intracellular signaling domain comprising 4-1BB and a CD3 zeta domain, see Fig. 2, in particular.
PNG
media_image1.png
173
541
media_image1.png
Greyscale
Regarding claim 15, the ‘167 patent teaches that the cell is a CD4+ T cell or a CD8+ T cell, see reference claim 3.
Regarding claim 16, the ‘167 patent teaches that the CD4+ T cell is a naive CD4+ T-cells, CD4+ memory T-cells, central memory CD4+ T-cells, effector memory CD4+ T-cells and bulk CD4+ T-cells or the cell is a CD8+ T cytotoxic lymphocyte cell, a CD8+ memory T-cells, central memory CD8+ T-cells, effector memory CD8+ T-cells and bulk CD8+ T-cells, see reference claim 3.
Regarding claim 17, the ‘167 patent teaches a pharmaceutical composition comprising the reference chimeric antigen receptor and a pharmaceutical acceptable carrier, see reference claim 9.
Regarding claim 30, the ‘167 patent teaches FMC63 CD19CAR comprises the amino acid sequence set forth in SEQ ID NO: 11 and is encoded by the sequence set forth in SEQ ID NO: 12, see reference claims 5 and 10, in particular.
The reference SEQ ID NO: 12 is 100% identical to the claimed SEQ ID NO: 12, which is at least 95% identity to SEQ ID NO: 12, see sequence alignment below:
ALIGNMENT:
Query Match 100.0%; Score 735; Length 735;
Best Local Similarity 100.0%;
Matches 735; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GACATCCAGATGACCCAGACCACCTCCAGCCTGAGCGCCAGCCTGGGCGACCGGGTGACC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 GACATCCAGATGACCCAGACCACCTCCAGCCTGAGCGCCAGCCTGGGCGACCGGGTGACC 60
Qy 61 ATCAGCTGCCGGGCCAGCCAGGACATCAGCAAGTACCTGAACTGGTATCAGCAGAAGCCC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ATCAGCTGCCGGGCCAGCCAGGACATCAGCAAGTACCTGAACTGGTATCAGCAGAAGCCC 120
Qy 121 GACGGCACCGTCAAGCTGCTGATCTACCACACCAGCCGGCTGCACAGCGGCGTGCCCAGC 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GACGGCACCGTCAAGCTGCTGATCTACCACACCAGCCGGCTGCACAGCGGCGTGCCCAGC 180
Qy 181 CGGTTTAGCGGCAGCGGCTCCGGCACCGACTACAGCCTGACCATCTCCAACCTGGAACAG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 CGGTTTAGCGGCAGCGGCTCCGGCACCGACTACAGCCTGACCATCTCCAACCTGGAACAG 240
Qy 241 GAAGATATCGCCACCTACTTTTGCCAGCAGGGCAACACACTGCCCTACACCTTTGGCGGC 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GAAGATATCGCCACCTACTTTTGCCAGCAGGGCAACACACTGCCCTACACCTTTGGCGGC 300
Qy 301 GGAACAAAGCTGGAAATCACCGGCAGCACCTCCGGCAGCGGCAAGCCTGGCAGCGGCGAG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 GGAACAAAGCTGGAAATCACCGGCAGCACCTCCGGCAGCGGCAAGCCTGGCAGCGGCGAG 360
Qy 361 GGCAGCACCAAGGGCGAGGTGAAGCTGCAGGAAAGCGGCCCTGGCCTGGTGGCCCCCAGC 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 GGCAGCACCAAGGGCGAGGTGAAGCTGCAGGAAAGCGGCCCTGGCCTGGTGGCCCCCAGC 420
Qy 421 CAGAGCCTGAGCGTGACCTGCACCGTGAGCGGCGTGAGCCTGCCCGACTACGGCGTGAGC 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 CAGAGCCTGAGCGTGACCTGCACCGTGAGCGGCGTGAGCCTGCCCGACTACGGCGTGAGC 480
Qy 481 TGGATCCGGCAGCCCCCCAGGAAGGGCCTGGAATGGCTGGGCGTGATCTGGGGCAGCGAG 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 TGGATCCGGCAGCCCCCCAGGAAGGGCCTGGAATGGCTGGGCGTGATCTGGGGCAGCGAG 540
Qy 541 ACCACCTACTACAACAGCGCCCTGAAGAGCCGGCTGACCATCATCAAGGACAACAGCAAG 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 ACCACCTACTACAACAGCGCCCTGAAGAGCCGGCTGACCATCATCAAGGACAACAGCAAG 600
Qy 601 AGCCAGGTGTTCCTGAAGATGAACAGCCTGCAGACCGACGACACCGCCATCTACTACTGC 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 AGCCAGGTGTTCCTGAAGATGAACAGCCTGCAGACCGACGACACCGCCATCTACTACTGC 660
Qy 661 GCCAAGCACTACTACTACGGCGGCAGCTACGCCATGGACTACTGGGGCCAGGGCACCAGC 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 GCCAAGCACTACTACTACGGCGGCAGCTACGCCATGGACTACTGGGGCCAGGGCACCAGC 720
Qy 721 GTGACCGTGAGCAGC 735
|||||||||||||||
Db 721 GTGACCGTGAGCAGC 735
The ‘167 patent teaches CD20CAR comprises the amino acid sequence set forth in SEQ ID NO: 13 (reference claim 11) and is encoded by the sequence set forth in SEQ ID NO: 14.
The reference SEQ ID NO: 14 is 100% identical to the claimed SEQ ID NO: 14, see para. [0221], sequence alignment below:
ALIGNMENT:
Query Match 100.0%; Score 798; Length 798;
Best Local Similarity 100.0%;
Matches 798; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATGGAGACAGACACACTCCTGCTATGGGTGCTGCTGCTCTGGGTTCCAGGTTCCACAGGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ATGGAGACAGACACACTCCTGCTATGGGTGCTGCTGCTCTGGGTTCCAGGTTCCACAGGT 60
Qy 61 GACATTGTGCTGACCCAATCTCCAGCTATCCTGTCTGCATCTCCAGGGGAGAAGGTCACA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GACATTGTGCTGACCCAATCTCCAGCTATCCTGTCTGCATCTCCAGGGGAGAAGGTCACA 120
Qy 121 ATGACTTGCAGGGCCAGCTCAAGTGTAAATTACATGGACTGGTACCAGAAGAAGCCAGGA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ATGACTTGCAGGGCCAGCTCAAGTGTAAATTACATGGACTGGTACCAGAAGAAGCCAGGA 180
Qy 181 TCCTCCCCCAAACCCTGGATTTATGCCACATCCAACCTGGCTTCTGGAGTCCCTGCTCGC 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 TCCTCCCCCAAACCCTGGATTTATGCCACATCCAACCTGGCTTCTGGAGTCCCTGCTCGC 240
Qy 241 TTCAGTGGCAGTGGGTCTGGGACCTCTTACTCTCTCACAATCAGCAGAGTGGAGGCTGAA 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 TTCAGTGGCAGTGGGTCTGGGACCTCTTACTCTCTCACAATCAGCAGAGTGGAGGCTGAA 300
Qy 301 GATGCTGCCACTTATTACTGCCAGCAGTGGAGTTTTAATCCACCCACGTTCGGAGGGGGG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 GATGCTGCCACTTATTACTGCCAGCAGTGGAGTTTTAATCCACCCACGTTCGGAGGGGGG 360
Qy 361 ACCAAGCTGGAAATAAAAGGCAGTACTAGCGGTGGTGGCTCCGGGGGCGGTTCCGGTGGG 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 ACCAAGCTGGAAATAAAAGGCAGTACTAGCGGTGGTGGCTCCGGGGGCGGTTCCGGTGGG 420
Qy 421 GGCGGCAGCAGCGAGGTGCAGCTGCAGCAGTCTGGGGCTGAGCTGGTGAAGCCTGGGGCC 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 GGCGGCAGCAGCGAGGTGCAGCTGCAGCAGTCTGGGGCTGAGCTGGTGAAGCCTGGGGCC 480
Qy 481 TCAGTGAAGATGTCCTGCAAGGCTTCTGGCTACACATTTACCAGTTACAATATGCACTGG 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 TCAGTGAAGATGTCCTGCAAGGCTTCTGGCTACACATTTACCAGTTACAATATGCACTGG 540
Qy 541 GTAAAGCAGACACCTGGACAGGGCCTGGAATGGATTGGAGCTATTTATCCAGGAAATGGT 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 GTAAAGCAGACACCTGGACAGGGCCTGGAATGGATTGGAGCTATTTATCCAGGAAATGGT 600
Qy 601 GATACTTCCTACAATCAGAAGTTCAAAGGCAAGGCCACATTGACTGCAGACAAATCCTCC 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 GATACTTCCTACAATCAGAAGTTCAAAGGCAAGGCCACATTGACTGCAGACAAATCCTCC 660
Qy 661 AGCACAGCCTACATGCAGCTCAGCAGCCTGACATCTGAGGACTCTGCGGACTATTACTGT 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 AGCACAGCCTACATGCAGCTCAGCAGCCTGACATCTGAGGACTCTGCGGACTATTACTGT 720
Qy 721 GCAAGATCTAATTATTACGGTAGTAGCTACTGGTTCTTCGATGTCTGGGGCGCAGGGACC 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 GCAAGATCTAATTATTACGGTAGTAGCTACTGGTTCTTCGATGTCTGGGGCGCAGGGACC 780
Qy 781 ACGGTCACCGTCTCCTCA 798
||||||||||||||||||
Db 781 ACGGTCACCGTCTCCTCA 798
The ‘167 patent teaches that the second ligand binding domain of L1CAM CAR comprises the amino acid sequence set forth in SEQ ID NO: 15 and is encoded by the sequence set forth in SEQ ID NO: 16.
The reference SEQ ID NO: 16 is 100% identical to the claimed SEQ ID NO: 16, see sequence alignment below:
Query Match 100.0%; Score 726; Length 726;
Best Local Similarity 100.0%;
Matches 726; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CAGGTGCAGCTGCAGCAGCCTGGCGCCGAGCTGGTGAAGCCAGGCGCCAGCGTGAAGCTG 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 CAGGTGCAGCTGCAGCAGCCTGGCGCCGAGCTGGTGAAGCCAGGCGCCAGCGTGAAGCTG 60
Qy 61 TCCTGCAAGGCCAGCGGCTACACCTTCACCGGCTACTGGATGCACTGGGTGAAGCAGAGA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TCCTGCAAGGCCAGCGGCTACACCTTCACCGGCTACTGGATGCACTGGGTGAAGCAGAGA 120
Qy 121 CCCGGCCACGGCCTGGAATGGATCGGCGAGATCAACCCCAGCAACGGCCGGACCAACTAC 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 CCCGGCCACGGCCTGGAATGGATCGGCGAGATCAACCCCAGCAACGGCCGGACCAACTAC 180
Qy 181 AACGAGCGGTTCAAGAGCAAGGCCACCCTGACCGTGGACAAGAGCAGCACCACCGCCTTC 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 AACGAGCGGTTCAAGAGCAAGGCCACCCTGACCGTGGACAAGAGCAGCACCACCGCCTTC 240
Qy 241 ATGCAGCTGTCCGGCCTGACCAGCGAGGACAGCGCCGTGTACTTCTGCGCCAGGGACTAC 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ATGCAGCTGTCCGGCCTGACCAGCGAGGACAGCGCCGTGTACTTCTGCGCCAGGGACTAC 300
Qy 301 TACGGCACCAGCTACAACTTCGACTACTGGGGCCAGGGCACCACACTGACCGTGAGCAGC 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 TACGGCACCAGCTACAACTTCGACTACTGGGGCCAGGGCACCACACTGACCGTGAGCAGC 360
Qy 361 GGCGGAGGGGGCTCTGGCGGCGGAGGATCTGGGGGAGGGGGCAGCGACATCCAGATGACC 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 GGCGGAGGGGGCTCTGGCGGCGGAGGATCTGGGGGAGGGGGCAGCGACATCCAGATGACC 420
Qy 421 CAGAGCAGCAGCAGCTTCAGCGTGAGCCTGGGCGACCGGGTGACCATCACCTGTAAGGCC 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 CAGAGCAGCAGCAGCTTCAGCGTGAGCCTGGGCGACCGGGTGACCATCACCTGTAAGGCC 480
Qy 481 AACGAGGACATCAACAACCGGCTGGCCTGGTATCAGCAGACCCCCGGCAACAGCCCCAGG 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 AACGAGGACATCAACAACCGGCTGGCCTGGTATCAGCAGACCCCCGGCAACAGCCCCAGG 540
Qy 541 CTGCTGATCAGCGGCGCCACCAACCTGGTGACCGGCGTGCCCAGCCGGTTTAGCGGCAGC 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 CTGCTGATCAGCGGCGCCACCAACCTGGTGACCGGCGTGCCCAGCCGGTTTAGCGGCAGC 600
Qy 601 GGCTCCGGCAAGGACTACACCCTGACCATCACAAGCCTGCAGGCCGAGGACTTCGCCACC 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 GGCTCCGGCAAGGACTACACCCTGACCATCACAAGCCTGCAGGCCGAGGACTTCGCCACC 660
Qy 661 TACTACTGCCAGCAGTACTGGTCCACCCCCTTCACCTTCGGCAGCGGCACCGAGCTGGAA 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 TACTACTGCCAGCAGTACTGGTCCACCCCCTTCACCTTCGGCAGCGGCACCGAGCTGGAA 720
Qy 721 ATCAAA 726
||||||
Db 721 ATCAAA 726
The ‘167 patent teaches that the second ligand binding domain of ROR1 CAR comprises the amino acid sequence set forth in SEQ ID NO: 17 and is encoded by the sequence set forth in SEQ ID NO: 18.
The reference SEQ ID NO: 18 is 100% identical to the claimed SEQ ID NO: 18, see sequence alignment below:
Query Match 100.0%; Score 745; Length 745;
Best Local Similarity 100.0%;
Matches 745; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CCAGGAACAGCTCGTCGAAAGCGGCGGCAGACTGGTGACACCTGGCGGCAGCCTGACCCT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 CCAGGAACAGCTCGTCGAAAGCGGCGGCAGACTGGTGACACCTGGCGGCAGCCTGACCCT 60
Qy 61 GAGCTGCAAGGCCAGCGGCTTCGACTTCAGCGCCTACTACATGAGCTGGGTCCGCCAGGC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GAGCTGCAAGGCCAGCGGCTTCGACTTCAGCGCCTACTACATGAGCTGGGTCCGCCAGGC 120
Qy 121 CCCTGGCAAGGGACTGGAATGGATCGCCACCATCTACCCCAGCAGCGGCAAGACCTACTA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 CCCTGGCAAGGGACTGGAATGGATCGCCACCATCTACCCCAGCAGCGGCAAGACCTACTA 180
Qy 181 CGCCACCTGGGTGAACGGACGGTTCACCATCTCCAGCGACAACGCCCAGAACACCGTGGA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 CGCCACCTGGGTGAACGGACGGTTCACCATCTCCAGCGACAACGCCCAGAACACCGTGGA 240
Qy 241 CCTGCAGATGAACAGCCTGACAGCCGCCGACCGGGCCACCTACTTTTGCGCCAGAGACAG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 CCTGCAGATGAACAGCCTGACAGCCGCCGACCGGGCCACCTACTTTTGCGCCAGAGACAG 300
Qy 301 CTACGCCGACGACGGCGCCCTGTTCAACATCTGGGGCCCTGGCACCCTGGTGACAATCTC 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 CTACGCCGACGACGGCGCCCTGTTCAACATCTGGGGCCCTGGCACCCTGGTGACAATCTC 360
Qy 361 TAGCGGCGGAGGCGGATCTGGTGGCGGAGGAAGTGGCGGCGGAGGATCTGAGCTGGTGCT 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 TAGCGGCGGAGGCGGATCTGGTGGCGGAGGAAGTGGCGGCGGAGGATCTGAGCTGGTGCT 420
Qy 421 GACCCAGAGCCCCTCTGTGTCTGCTGCCCTGGGAAGCCCTGCCAAGATCACCTGTACCCT 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 GACCCAGAGCCCCTCTGTGTCTGCTGCCCTGGGAAGCCCTGCCAAGATCACCTGTACCCT 480
Qy 481 GAGCAGCGCCCACAAGACCGACACCATCGACTGGTATCAGCAGCTGCAGGGCGAGGCCCC 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 GAGCAGCGCCCACAAGACCGACACCATCGACTGGTATCAGCAGCTGCAGGGCGAGGCCCC 540
Qy 541 CAGATACCTGATGCAGGTGCAGAGCGACGGCAGCTACACCAAGAGGCCAGGCGTGCCCGA 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 CAGATACCTGATGCAGGTGCAGAGCGACGGCAGCTACACCAAGAGGCCAGGCGTGCCCGA 600
Qy 601 CCGGTTCAGCGGATCTAGCTCTGGCGCCGACCGCTACCTGATCATCCCCAGCGTGCAGGC 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 CCGGTTCAGCGGATCTAGCTCTGGCGCCGACCGCTACCTGATCATCCCCAGCGTGCAGGC 660
Qy 661 CGATGACGAGGCCGATTACTACTGTGGCGCCGACTACATCGGCGGCTACGTGTTCGGCGG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 CGATGACGAGGCCGATTACTACTGTGGCGCCGACTACATCGGCGGCTACGTGTTCGGCGG 720
Qy 721 AGGCACCCAGCTGACCGTGACCGGC 745
|||||||||||||||||||||||||
Db 721 AGGCACCCAGCTGACCGTGACCGGC 745
The ‘167 patent also teaches that the human T cell wherein each CAR comprises an IgG4 hinge, a transmembrane domain, a 4-1BB domain, and a CD3 zeta domain, see reference claims 1, 9, Fig. 2.
Applicant's arguments filed November 18, 2025 have been fully considered but they are not persuasive.
Applicant submits that the amended claims are patentably distinct from the claims of the reference patent, as none of the claims of the patent recite the features recited in the amended claims. Accordingly, withdrawal of the rejection is respectfully requested.
In response, this application is a continuation of the parent application 15/750,708 (now 11,458,167), NOT a divisional application. A continuation application filed under Section 120, is not entitled to the benefit of the safe harbor provision protections afforded by § 121’s safe harbor.” Amgen v. Roche, 580 F.3d 1340, 1354 (Fed. Cir. 2009). Thus, a continuation application drawn to subject matter that is separately patentable from the subject matter of the parent patent is vulnerable to an obviousness-type double patenting rejection from the USPTO and later patent challenge.
Further, the subject matter claimed in the instant application is fully disclosed in the ‘167 patent as set forth above and incorporates here by reference. The amended claims would have been obvious variation of the reference claims. 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 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).
For these reasons, the rejection is maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 PHUONG HUYNH whose telephone number is (571)272-0846. The examiner can normally be reached on 9:00 a.m. to 6:30 p.m. The examiner can also be reached on alternate alternative Friday from 9:00 a.m. to 5:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Misook Yu, can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-272-0839.
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/PHUONG HUYNH/ Primary Examiner, Art Unit 1641
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