bluebird bio, Inc. et al. vs Sloan Kettering Institute for Cancer Research et al.

Petitioner's Notice of Appeal

Final Written Decision: DECISION Final Written Decision Determining No Challenged Claims Unpatentable 35 U.S.C. § 318(a)

Order: Conduct of the Proceeding 37 C.F.R. §§ 42.1, 42.5, 42.123(b)

Other: Hearing transcript

Order: Conduct of the Proceeding 37 C.F.R. sec. 42.5

SRT_Demonstratives for 1-24-2024 hearing

Petitioner's Current List of Exhibits

Exhibit 1069

LEAP Practitioner Request and Verification Form (Patent Owner)

ORDER Setting Oral Argument 37 C.R. 4270

Petitioner's Request for Oral Argument

Patent Owner Request for Oral Argument (061)

Patent Owner Sur-reply (061)

Dismissing Without Prejudice Patent Owner’s Motion for Pro Hac Vice Admission of Mary Jean Kim 37 C.F.R. § 42.10

Conduct of the Proceeding 37 C.F.R. § 42.5

Reply in Support of Petition for Inter Partes Review of U.S. Patent No. 8,058,061

Petitioner's Current List of Exhibits

Exhibit 1050

Exhibit 1051

Exhibit 1052

Exhibit 1053

Exhibit 1054

Exhibit 1055

Exhibit 1056

Exhibit 1057

Exhibit 1058

Exhibit 1059

Exhibit 1060

Exhibit 1061

Exhibit 1062

Exhibit 1064

Exhibit 1066

Exhibit 1067

Exhibit 1068

Declaration of Mary Jean Kim in Support of Motion for Pro Hac Vice (061)

Patent Owner Motion for Pro Hac Vice of Mary Jean Kim (061)

Petitioner's Notice of Deposition of Michel Sadelain

Joint Stipulation to Revise Scheduling Order

Petitioner's Notice of Deposition of Chad May

Petitioner's Notice of Deposition of James Riley, Ph.D.

Petitioner's Notice of Deposition of Stefano Rivella

Petitioner's Objections to Patent Owner's Exhibits

Ex. 2048 Printout of a Press Release from Cell Press

Ex. 2049 Printout of a Website from LOC.gov

Ex. 2050 Printout from CrossRef.org

Ex. 2051 May 2017 Declaration of Dr. Leonard J. Forys for IPR of U.S. Patent No. 7_5

Ex. 2052 Bungert

Ex. 2054 Bungert

Ex. 2055 Transcript of Dr Bungert Deposition 07.10.2023

Ex. 2057 MCINERNY

Ex. 2058 Grosveld

Ex. 2059 Fraser

Ex. 2060 Fraser

Ex. 2061 Kulozikpdf

Ex. 2062 Milotpdf

Ex. 2063 Peterson

Ex. 2064 Bungert

Ex. 2065 Tuan

Ex. 2066 Collis

Ex. 2067 Costa

Ex. 2068 Newton and Graham

Ex. 2069 C-SPAN Hearing

Ex. 2070 White House Press Briefing 08.09.2001

Ex. 2071 Newsday Report

Ex. 2072 Malilcpdf

Ex. 2073 Stamatoyannopoulos

Ex. 2074 Malech

Ex. 2075 Stoechert

Ex. 2076 Ryan

Ex. 2077 Walsh

Ex. 2078 Arcasoy

Ex. 2079 McCune

Ex. 2080 Adachi

Ex. 2081 Himanen

Ex. 2082 Wallace

Ex. 2083 Eckert

Ex. 2084 Second Amended and Supplemental Complaint No. 21-1478-RGA

Ex. 2056 August Declaration of James Riley (061)

SRT Response (061)

Notice of Deposition of Jorg Bungert_7.10.2023_IPR2023-00074_Pat8058061

Order: ORDER Granting Petitioner’s Motions for Pro Hac Vice Admission of Krystina L. Ho and Max. H. Yusem 37 C.F.R. 42.10

Notice of Deposition of Ingrid Hsieh-Yee_6.30.2023_IPR2023-00074_Patent8058061

Patent Owner Updated Mandatory Notice_061

power of attorney ipr_061

Petitioner's Motion for Pro Hac Vice Admission of Krystina L. Ho

Petitioner's Motion for Pro Hac Vice Admission of Max H. Yusem

Petitioner's Current List of Exhibits

Ex. 1048

Ex. 1049

ORDER Granting Patent Owners Unopposed Motion for Pro Hac Vice Admission of Wanda French-Brown, James H. McConnell, and Howard S. Suh 37 C.F.R. sec 42.10

Joint Stipulation to Modify Due Dates 1, 2, and 3

San Rocco Therapeutics LLC's Motion for Admission Pro Hac Vice of Wanda French-Brown

Declaration of Wanda French-Brown in Support of Motion for Admission Pro Hac Vice

San Rocco Therapeutics LLC's Motion for Admission Pro Hac Vice of James H. McConnell

Declaration of James H. McConnell in Support of Motion for Admission Pro Hac Vice

San Rocco Therapeutics LLC's Motion for Admission Pro Hac Vice of Howard S. Suh

Declaration of Howard S. Suh in Support of Motion for Admission Pro Hac Vice

Patent Owner's Exhibit List

Panel Change Order

Petitioner's Objections to Patent Owner's Exhibits

Patent Owner's Objections to Petitioner's Evidence Pursuant to 37 C.F.R. § 42.64(b)(1)

Institution Decision: Grant

Order: Scheduling Order

Patent Owner's Sur-Reply to Petitioner's Reply to Preliminary Response

Petitioner's Reply to Patent Owner's Preliminary Response

Exhibit 3001

Exhibit 3002

Patent Owner's Preliminary Response

Exclusive Licensee Agreement Between Sloan Kettering Institute for Cancer Research and San Rocco Therapeutics, LLC

Declaration of Dr. James Riley

October 2020 Declaration of Dr. Michel Sadelain

Petitioner’s October 2020 Letter Submitting Dr. Sadelain’s October 2020 Declaration in New York State Court

Joint Defense Agreement

January 2023 Declaration of Michel Sadelain

Declaration of Chad May

Declaration of Stefano Rivella

Declaration of Lucio Luzzatto

Sorrentino, “One step closer to gene therapy for hemoglobinopathies”

Caterina et al., “Human beta-globin locus control region: analysis of the 5’ DNase I hypersensitive site HS2 in transgenic mice.” Proc Natl Acad Sci U S A. 1991 Mar 1;88(5):1626-30. doi: 10.1073/pnas.88.5.1626. PMID: 2000371; PMCID: PMC51077

Judson, “Glimmering Promise of Gene Therapy”

Jackson, et al., (1996), “Role of D N A sequences outside the cores of DNase hypersensitive sites (HSs) in functions of the p-globin locus control region.” Domain opening and synergism between HS2 and HS3. J Biol Chem. 271:11871-8

Philipsen, et al. “The β-globin dominant control region: hypersensitive site 2.” EMBO J. (1990) 9:2159-67

Hardison, et. al., “Locus control regions of mammalian β-globin gene clusters: combining phylogenetic analyses and experimental results to gain functional insights.” (1997) Gene. 205:73-94.

Persons, D. A., A. W. Nienhuis. 2000. “Gene therapy for the hemoglobin disorders: past, present, and future.” Proc Natl Acad Sci U S APNAS. 97:5022-4

Kafri, “Lentiviral Vectors: Regulated Gene Expression”

Amado, “Lentiviral Vectors — the Promise of Gene Therapy within Reach?”

Chada, et al., “Specific expression of a foreign β-globin gene in erythroid cells of transgenic mice.” Nature. (1985) 314:377-80

Townes, et al., “Expression of human β-globin genes in transgenic mice: effects of a flanking metallothionein-human growth hormone fusion gene.” (1985) Mol Cell Biol. 5:1977-83

Dzierzak, et al., “Lineage-specific expression of a human β-globin gene in murine bone marrow transplant recipients reconstituted with retrovirus-transduced stem cells.” (1988) Nature. 331:35-41

Bodine, et. al., “Combination of interleukins 3 and 6 preserves stem cell function in culture and enhances retrovirus-mediated gene transfer into hematopoietic stem cells.” (1989) Proc Natl Acad Sci USA. 86: 8897-901

Bender, et al., “A majority of mice show long-term expression of a human β-globin gene after retrovirus transfer into hematopoietic stem cells.” (1989) Mol Cell Biol. 9:1426-34

Sadelain et al., Proc. Nat’l Acad. Sci. (USA) 92:6728-6732 (1995)

GenBank Accession No. Z84721 (March 19, 1997)

GenBank Accession No. NM_ 000517 (October 31, 2000)

Hardison et al., J. Mol. Biol. (1991) 222(2):233-249

A Syllabus of Human Hemoglobin Variants (1996), by Titus et al., published by The Sickle Cell Anemia Foundation in Augusta, Georgia (available online at http://globin.cse.psu.edu)

GenBank Accession No. JOO179 (August 26, 1993)

Tagle et al., Genomics (1992) 13(3):741-760

Li et al., Blood (1999) 93(7):2208-2216

Slightom et al., Cell (1980) 21(3):627-638

Excerpts from Inventor Notebooks

Excerpts from Inventor Notebooks

October 2020 Declaration of Dr. Isabelle Rivière

Verma et al., “Gene Therapy: Twenty-First Century Medicine,” Annu Rev. BioChem (2005). 74:711-38

Blau, et al., “Moleular Medicine, Gene Therapy – A Novel Form of Drug Delivery,” The New England Journal of Medicine (1995).

Morris et al., “MHC class II gene silencing in trophoblast cells is caused by inhibition of CIITA expression,” American Journal of Reproductive Immunology (1998)

Physical mapping of the globin gene deletion in β-thalassemia, Benards (1979)

Ryan, T. M., R. R. Behringer, N. C. Martin, T. M. Townes, R. D. Palmiter, R. L. Brinster. 1989. A single erythroid-specific DNase I super-hypersensitive site activates high levels of human beta-globin gene expression in transgenic mice. Genes Dev. 3: 314-23

Pasceri, P., D. Pannell, X. W u, J. Ellis. 1998. Full activity from human beta-globin locus control region transgenes requires 5'HSl, distal beta-globin promoter, and 3’ beta-globin sequences. Blood. 92:653-63

Hardison, R., J. L. Slightom , D. L. Gumucio, M. Goodman, N . Stojanovic, W. Miller. 1997. Locus control regions of mammalian beta-globin gene clusters: combining phylogenetic analyses and experimental results to gain functional insights. Gene. 205: 73-94

Hacein-Bey-Abina, et. al., “Vector mediated transformation,” (2003) N. Engl. J. Med. 348:255-256. [PubMed])

Pfeifer, Gene Therapy: Promises and Problems

Notice : Mandatory Notice

Notice: NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

Petition for Inter Partes Review of U.S. Patent No. 8,058,061

Notice : Power of Attorney

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