`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________
`
`
`BLUEBIRD BIO, INC.
`Petitioner
`
`v.
`
`SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH,
`Patent Owner
`
`_________________
`
`Case No. IPR2023-00074
`Patent No. 8,058,061
`_________________
`
`PETITIONER’S CURRENT LIST OF EXHIBITS
`(as of June 8, 2023)
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`
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`
`
`
`
`Case No. IPR2023-00074
`
`
`LIST OF EXHIBITS
`
`Document
`Exhibit
`1001 U.S. Patent No. 8,058,061 to Sadelain et al. (“the ’061
`patent”)
`
`Filed
`X
`
`1002 Declaration of Jörg Bungert, Ph.D.
`
`1003
`
`Curriculum Vitae of Jörg Bungert, Ph.D.
`
`1004 May, “Therapeutic Hemoglobin Synthesis in
`Beta-Thalassemic Mice Expressing Lentivirus-Encoded
`Human Beta-Globin,” Cornell University (2001) (“the
`May Thesis”)
`
`1005 May, et al., “Therapeutic Haemoglobin Synthesis in β-
`Thalassaemic Mice Expressing Lentivirus-Encoded
`Human β-globin,” Nature, 406:82-86 (2000) (“the May
`Article”)
`
`1006 May, et al., “Lentiviral-Mediated Transfer of the Human
`β-Globin Gene and Large Locus Control Region Elements
`Permit Sustained Production of Therapeutic Levels of β-
`Globin in Long-Term Bone Marrow Chimeras,” Mol.
`Therapy, 1(5):S248-49 (2000) (“the May Abstract”)
`
`1007
`
`1008
`
`Perutz, et al., “Hemoglobin Structure and Respiratory
`Transport,” Sci. Am., 239(6): 92-125 (1978)
`
`Thein & Rochette, “Disorders of Hemoglobin Structure
`and Synthesis,” in Principles of Mol. Med. 179 (Jameson,
`ed., 1998)
`
`1009
`
`Bank, et. al, “Disorders of Human Hemoglobin,” Science,
`207:486-93 (1980)
`
`X
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`X
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`X
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`X
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`X
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`X
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`X
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`X
`
`1
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`
`
`Case No. IPR2023-00074
`
`
`Document
`Exhibit
`1010 He & Russell, “Expression, Purification, and
`Characterization of Human Hemoglobins Gower-I (ζ2ε2),
`Gower-2 (α2ε2), and Portland-2 (ζ2β2) Assembled in
`Complex Transgenic-Knockout Mice, Blood, 97(4):1099-
`1105 (2001)
`
`Filed
`X
`
`1011
`
`Bunn, “Pathogenesis and Treatment of Sickle Cell
`Disease,” N. Engl. J. Med., 337(11):762-69 (1997)
`
`1012 Hardison, et al., “Locus Control Regions of Mammalian
`β-globin Gene Clusters: Combining Phylogenetic
`Analyses and Experimental Results to Gain Function
`Insights, Gene, 205:73-94 (1997)
`
`1013
`
`Civin, et al., “Sustained, Retransplantable, Multilineage
`Engraftment of Highly Purified Adult Human Bone
`Marrow Stem Cells In Vivo,” Blood, 88(11):4102-09
`(1996)
`
`1014 High, “Gene Therapy in Haematology and Oncology,”
`Lancet, 356:S8 (2000)
`
`1015
`
`1016
`
`Ellis, et al., “Evaluation of β-globin Gene Therapy
`Constructs in Single Copy Transgenic Mice,” Nucleic
`Acids Res., 25(6):1296-1302 (1997)
`
`Li, et al., “Nucleotide Sequence of 16-Kilobase Pairs of
`DNA 5’ to the Human ε-Globin Gene,” J. Biol. Chem.,
`260(28):14901-10 (1985)
`
`1017 Mishima, et al., “The DNA Deletion in an Indian δβ-
`thalassaemia Begins One Kilobase From the Aγ Globin
`Gene and Ends in an L1 Repetitive Sequence,” Br. J.
`Haemotol., 73:375-79 (1989)
`
`1018 Vosberg, “Molecular Cloning of DNA: An Introduction
`Into Techniques and Problems,” Hum. Genet. 40(1):1-72
`(1977)
`
`X
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`X
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`X
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`X
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`X
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`X
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`X
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`X
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`2
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`
`
`Case No. IPR2023-00074
`
`
`Exhibit
`1019
`
`Document
`Roberts, “Restriction Enzymes and Their Isoschizomers,”
`Nucleic Acids Res., 15(Suppl.):r189-r217 (1987)
`
`Filed
`X
`
`1020
`
`Zufferey, et al., “Multiply Attenuated Lentiviral Vector
`Achieves Efficient Gene Delivery in Vivo,” Nature
`Biotech., 15:871-75 (1997)
`
`1021 Miyoshi, et al., “Transduction of Human CD34+ Cells that
`Mediate Long-Term Engraftment of NOD/SCID Mice by
`HIV Vectors,” Science, 283:682-86 (1999)
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`Sadelain, et. al., “Generation of a High-titer Retroviral
`Vector Capable of Expressing High Levels of the Human
`β-Globin Gene,” Proc. Natl. Acad. Sci. USA, 92:6728-32
`(1995)
`
`Bouhassira, et al., “Transcriptional Behavior of LCR
`Enhancer Elements Integrated at the Same Chromosomal
`Locus by Recombinase-Mediated Cassette Exchange,”
`Blood 90(9):3332-44 (1997)
`
`Fraser, et al., “Each Hypersensitive Site of the Human
`β-Globin Locus Control Regions Confers a Different
`Developmental Pattern of Expression on the Globin
`Genes,” Genes Dev., 7:106-113 (1993)
`
`Engel, “Developmental Regulation of Human β-Globin
`Gene Transcription: A Switch of Loyalties?,” Trend.
`Genet., 9(9):304-09 (1993)
`
`Roberts & Macelis, “REBASE – Restriction Enzymes and
`Methylases,” Nucleic Acids Res., 26(1):338-350 (1998)
`
`Roberts & Macelis, “REBASE – Restriction Enzymes and
`Methylases,” Nucleic Acids Res., 27(1):312-13 (1999)
`
`Roberts & Macelis, “REBASE – Restriction Enzymes and
`Methylases,” Nucleic Acids Res., 28(1):306-07 (2000)
`
`X
`
`X
`
`X
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`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`3
`
`
`
`Case No. IPR2023-00074
`
`
`Exhibit
`1029
`
`Document
`Roberts & Macelis, “REBASE – Restriction Enzymes and
`Methylases,” Nucleic Acids Res., 29(1):268-69 (2001)
`
`Filed
`X
`
`1030
`
`1031
`
`1032
`
`1033
`
`Sequence Manipulation Suite (last visited October 11,
`2022) (Website)
`
`Restriction Mapper, April 20, 2001 Wayback Machine
`Capture (last visited October 11, 2022) (Website)
`
`Prosecution History of U.S. Patent No. 7,541,179
`(U.S. Patent Application No. 10/188,221)
`
`Prosecution History of the ’061 Patent
`(U.S. Patent Application No. 12/433,412)
`
`1034 U.S. Provisional Application 60/301,861 to Sadelain
`
`1035 U.S. Provisional Application 60/302,852 to Sadelain
`
`1036 Declaration by Ingrid Hsieh-Yee, Ph.D.
`
`1037
`
`1038
`
`1039
`
`SciMago, Nature (last visited October 11, 2022) (Website)
`
`SciMago, Molecular Therapy (last visited October 11,
`2022 (Website)
`
`SciMago, Journal of Biological Chemistry (last visited
`October 11, 2022) (Website)
`
`1040
`
`Steele, “Editorial,” Mol. Therapy, 1(5):S1 (2000)
`
`1041 Glorioso, “Highlights from the Third Annual ASGT
`Meeting,” Mol. Therapy, 2(2):96-100 (2000)
`
`1042
`
`1043
`
`“Author Index,” Mol. Therapy, 1(5):S345-61 (2000)
`
`San Rocco Therapeutics, LLC v. bluebird bio, Inc., et al.,
`C.A. No. 21-1478-RGA, D.I. 75 (D. Del. July 26, 2022)
`
`X
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`X
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`X
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`X
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`X
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`X
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`X
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`X
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`X
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`X
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`X
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`X
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`X
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`X
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`4
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`
`
`Case No. IPR2023-00074
`
`
`Exhibit
`1044
`
`Document
`San Rocco Therapeutics, LLC v. bluebird bio, Inc., et al.,
`C.A. No. 21-1478-RGA, D.I. 76 (D. Del. July 26, 2022)
`
`Filed
`X
`
`1045
`
`San Rocco Therapeutics, LLC v. bluebird bio, Inc., et al.,
`C.A. No. 21-1478-RGA, D.I. 78 (D. Del. July 28, 2022)
`
`1046 Vidal, “Interim Procedures for Discretionary Denials in
`AIA Post-Grant Proceedings with Parallel District Court
`Litigation (June 21, 2022)
`
`1047 Himanen, et al., “A Recombinant Sickle Hemoglobin
`Triple Mutant With Independent Inhibitory Effects on
`Polymerization,” J. Biol. Chem., 271(41):25152-56 (1996)
`(“Himanen”)
`
`1048 Declaration of Krystina L. Ho
`
`X
`
`X
`
`X
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`
`
`1049 Declaration of Max H. Yusem
`
`Respectfully submitted,
`
`By: /Naveen Modi/
` Naveen Modi (Reg. No. 46,224)
` Counsel for Petitioner
`
`
`
`Dated: June 8, 2023
`
`5
`
`
`
`
`
`CERTIFICATE OF SERVICE
`I certify that I caused to be served on the counsel identified below a true and
`
`correct copy of the foregoing Petitioner’s Current List of Exhibits by electronic
`
`means on June 8, 2023:
`
`FOR THE PATENT OWNER:
`Luke Toft (Reg. No. 75,311)
`ltoft@foxrothschild.com
`Fox Rothschild LLP
`33 South Sixth Street, Suite 3600
`Minneapolis, MN 55402
`Telephone: (612) 607-7000
`Facscimile: (612) 607-7100
`
`Joe Chen (Reg. No. 70,066)
`joechen@foxrothschild.com
`Fox Rothschild LLP
`997 Lenox Drive
`Lawrenceville, NJ 08648
`Telephone: (609) 844-3024
`Facsimile: (609) 896-1469
`
`Michael W. Glynn, Ph.D.
`mglynn@foxrothschild.com
`Fox Rothschild LLP
`101 Park Avenue, 17th Floor
`New York, NY 10178
`Telephone: (212) 878-7900
`Facsimile: (212) 692-0940
`
`By: /Naveen Modi/
` Naveen Modi (Reg. No. 46,224)
` Counsel for Petitioner
`
`
`
`
`
`
`
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