`
`/MB/
`
`14997136 - GAU: 1633
`
`Sheet 1 of 10
`
`Form PTO-1449
`U.S. Department of Commerce
`
`Information Disclosure Statement
`
`APPLICANT:
`Carl H. June etal.
`FILING DATE:
`
` DOCKET NO.
`
`
`
`Date Considered: 04/18/2016
`
`
`
`APPLN.NO.
`
`To Be Assigned
`
`GROUP:
`Not Yet Assigned
`
`Subclass
`
`Filing Date if
`appropriate
`
`Examiner
`Initial
`
`Document Number
`
`U.S. PATENT DOCUMENTS
`Name
`Date
`
`Herewith
`
`
`
`Pf}| 5,359,046 10/25/1994|Caponetal.
`
`5,686,281
`
`5,712,149
`
`11/11/1997
`
`Roberts
`
`01/27/1998
`
`Roberts
`
`
`
`Pt 5874,240 02/23/1999|Ni etal.
`
`5,906,936
`
`6,103,521
`
`6,319,494
`
`6,355,779
`
`6,410,319
`
`05/25/1999
`
`Eshhar, et al.
`
`08/15/2000
`
`Capon etal.
`
`11/20/2001
`
`Capon etal.
`
`03/12/2002
`
`Goodwin etal.
`
`06/25/2002
`
`Raubitschek, etal.
`
`US2003/060444
`
`03/27/2003
`
`Finneyet al.
`
`US2003/0077249
`
`04/24/2003
`
`Bebbingtonetal.
`
`6,569,997
`
`05/27/2003
`
`Kwon
`
`US2003/0148982
`
`08/07/2003
`
`Brenner etal.
`
`US2004/038886
`
`02/26/2004
`
`Finneyet al.
`
`US2004/0043401
`
`03/04/2004
`
`Sadelain, et al.
`
`US2005/01 13564
`
`05/26/2005
`
`Campana, etal.
`
`US2005/012967 1
`
`06/16/2005
`
`Cooperetal.
`
`7,049,136
`
`7,052,906
`
`7,070,995
`
`7,265,209
`
`7,319,143
`
`7,320,787
`
`05/23/2006
`
`Seed etal.
`
`05/30/2006
`
`Lawson etal.
`
`07/04/2006
`
`Jensen
`
`09/04/2007
`
`Jensen
`
`01/15/2008
`
`Gross, et al.
`
`01/22/2008
`
`Seed etal.
`
`P}| US2008/0131415|06/05/2008|Riddell etal. |
`
`ExaminerSignature:
`
`/Michael Burkhart/
`
`*EXAMINER:Initial if reference considered, whether or not citation is in conformance with MPEP 609; Draw line throughcitation if not in conformance and not considered.
`UPenn Ex. 2026
`Include copy of this form with next communication to applicant(s).
`Miltenyi v. UPenn
`IPR2022-00855
`Page 1
`
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 1
`
`
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/MB/
`
`14997136 - GAU: 1633
`
`Sheet 2 of 10
`
`Form PTO-1449
`U.S. Department of Commerce
`
`Information Disclosure Statement
`
`GROUP:
`Not Yet Assigned
`
`Pf}| 7,446,190 11/04/2008|Sadelain,etal.
`Pf 7,446,191
`| 7,514,537
`Pf} US2009/0257994
`| 7,741,465
`
`
`
`PCT
` 11/04/200806/01/2013 Jensen
`
`
` Country
`
`DOCKET NO.
`046483-6001US13(01088)
`APPLICANT:
`Carl H. June etal.
`FILING DATE:
`
`APPLN.NO.
`
`To Be Assigned
`
`Herewith
`
`04/07/2009
`
`Jensen
`
`10/15/2009
`
`Jensen
`
`06/22/2010
`
`Eshhar etal.
`
`US2010/0233200
`
`09-16-2010
`
`Medin
`
`US2011/0052554
`
`03/03/2011
`
`Zakrzewskietal.
`
`7,994,298
`
`08/09/2011
`
`Zhang et al.
`
`US2012/0148552
`
`06/14/2012
`
`Jensen
`
`8,211,422
`
`8,252,914
`
`8,389,282
`
`8,399,645
`
`07/03/2012
`
`Esshar et al.
`
`08/28/2012
`
`Zhang et al.
`
`03/05/2013
`
`Sadelain et al.
`
`03/19/2013
`
`Campana etal.
`
`US2013/071414
`
`03/21/2013
`
`Dotti et al.
`
`8,465,743
`
`Document Number
`
`FOREIGN PATENT DOCUMENTS
`Date
`Chas
`
`Translation Yes/No/Abstract
`
`WO01992/015322
`
`17 Sep 1992
`
`PCT
`
`WO/1995/30014
`
`09 Nov 1995
`
`PCT
`
`WO01996/23814
`
`08 Aug 1996
`
`WO1996/24671
`
`15 Aug 1996
`
`WO/1997/015669
`
`01 May 1997
`
`WO/1997/23613
`
`03 Jul 1997
`
`WO0O1998/18809
`
`07 May 1998
`
`PCT
`
`PCT
`
`PCT
`
`PCT
`
`PCT
`
`
`
`P}| WO1999/00494 07 Jan 1999
`
`ExaminerSignature:
`
`/Michael Burkhart/
`
`Date Considered:
`
`04/78/2016
`
`*EXAMINER:Initial if reference considered, whether or not citation is in conformance with MPEP 609; Draw line throughcitation if not in conformance and not considered.
`UPenn Ex. 2026
`Include copy of this form with next communication to applicant(s).
`Miltenyi v. UPenn
`IPR2022-00855
`Page 2
`
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 2
`
`
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/MB/
`
`14997136 - GAU: 1633
`
`Sheet 3 of 10
`
`Form PTO-1449
`U.S. Department of Commerce
`
`046483-6001US13(01088)
`APPLICANT:
`Carl H. June etal.
`FILING DATE:
`
`Herewith
`
`APPLN.NO.
`
`To Be Assigned
`
`GROUP:
`Not Yet Assigned
`
`Information Disclosure Statement DOCKET NO.
`
`
`
`Date Considered:
`
`
`
`
`Document Number
`
`FOREIGN PATENT DOCUMENTS
`Date
`Country
`Class
`
`Subclass
`
`Translation Yes/No/Abstract
`
`WO01999/57268
`
`11 Nov 1999
`
`PCT
`
`WO/2000/14257
`
`16.03.2000
`
`PCT
`
`WO/2002/077029
`
`03 Oct 2002
`
`PCT
`
`WO/2002/033101
`
`25 Apr 2002
`
`PCT
`
`
`
`a WO/2002/088334 07 Nov 2002._|PCT
`
`EP 0574512B1
`
`05 Feb 2003
`
`EP1226244
`
`28 July 2004
`
`W02005/019429
`
`03 Mar 2005
`
`EP
`
`EP
`
`EP871495
`
`15 June 2005
`
`EP
`
`W0O2006/060878
`
`15 Jun 2006
`
`PCT
`
`W02008/045437
`
`17 Apr 2008
`
`PCT
`
`[wesomsor|rawamejor|
`
`neparepe|
`[Remorse[ornarareper|
`oe WO/2010/085660
`29 Jul 2010
`P
`
`CT
`
`W02011/059836
`
`19 May 2011
`
`P
`
`CT
`
`W02012/033885
`
`15 Mar 2012
`
`PCT
`
`W02012/058460
`
`03 May 2012
`
`W02012/082841
`
`21 Jun 2012
`
`W02012/127464
`
`27 Sep 2012
`
`WO2012/135854
`
`04 Oct 2012
`
`PCT
`
`PCT
`
`PCT
`
`PCT
`
`WO2012/138858
`
`11 Oct 2012
`
`PCT
`
`
`
`WO2013/033626 07 Mar 2013.|P
`
`| WO2013/040371 21 Mar 2013.‘|PCT
`
`
`P}| WO2013/059593 25 Apr 2013 PCT
`
`
`ExaminerSignature:
`
`/Micheel Burkhart!
`
`4/18/2016
`
`*EXAMINER:Initial if reference considered, whether or not citation is in conformance with MPEP 609; Draw line throughcitation if not in conformance and not considered.
`UPenn Ex. 2026
`Include copy of this form with next communication to applicant(s).
`Miltenyi v. UPenn
`IPR2022-00855
`Page 3
`
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 3
`
`
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/MB/
`
`14997136 - GAU: 1633
`
`Sheet 4 of 10
`
`APPLN.NO.
`DOCKET NO.
`Form PTO-1449
`
`U.S. Department of Commerce 046483-6001US13(01088)|To Be Assigned
`APPLICANT:
`Carl H. June et al.
`FILING DATE:
`Herewith
`
`Information Disclosure Statement
`
`GROUP:
`
`Translation Yes/No/Abstract
`English equivalent of
`JP2003-517301
`JP2003-517301 2/ May 2003=|JP
`
`Document Number
`WO 2001/34843
`
`FOREIGN PATENT DOCUMENTS
`Date
`Country
`Class
`17 May 2001
`PCT
`
`
`
`Not Yet Assigned
`
`
`
`
`
`
`
`Baeksgaardet al., “Acute tumor lysis syndrome in solid tumors--a case report and review of the
`literature.” 2003, Cancer Chemother Pharmacol., 51:187-92
`Bondanzaetal., “Suicide gene therapy of graft-versus-host disease induced by central memory
`human T lymphocytes.” 2006, Blood 107:1828-1836
`Brentjens et al., “Eradication of systemic B-cell tumors by genetically targeted human T
`lymphocytes co-stimulated by CD80 andinterleukin-15.” 2003, Nature Medicine, 9(3): 279-286
`Brentjens et al., “Genetically targeted T cells eradicate systemic acute lymphoblastic leukemia
`xenografts.” 2007, Clin Cancer Res 13:5426-5435
`Brentjens et al., “Safety and persistence of adoptively transferred autologous CD19-targeted T
`cells in patients with relapsed or chemotherapy refractory B-cell leukemias.” 2011 Blood
`118(18):4817-4828
`Brentjens et al., “Treatment of chronic lymphocytic leukemia with genetically targeted
`autologous T cells: case report of an unforeseen adverse event in a phase| clinical trial.” 2010,
`Mol Ther, 18: 666-8
`Brentjens, et al. “A Phase| Trial for the Treatment of Chemo-refractory Chronic Lymphocytic
`Leukemia with CD19-Targeted Autologous T Cells.” Mol. Therapy, 2008, p. S15, Vol 16, Suppl
`1.
`Brocker and Karjalainen, “Signals through T cell receptor-¢ chain alone are insufficient to prime
`resting T lymphocytes.” 1995, J. Exp. Med., 181:1653-1659
`Call, et al., “The T cell receptor: critical role of the membrane environmentin receptor assembly
`and function.” 2005, Annu Rev Immunol. 2005, 23:101-125
`Campana etal., “T-Cell Immunotherapy for B-Lineage Acute Lymphoblastic Leukemia
`Using Chimeric Antigen Receptors That Deliver 4-1BB-Mediated Costimulatory Signals”
`2003 Blood 102(11); abstract #223
`Carpenito et al., “Control of large, established tumor xenografts with genetically retargeted
`humanT cells containing CD28 and CD137 domains.” 2009, Proc Natl Acad Sci USA
`106:3360-3365
`
`JP2004-529636
`|
`
`Pf JP2004-529636 30 Sep 2004|JP
`
`WO 02/077029
`
`03 Oct 2002
`
`PCT
`
`English equivalent of
`
`OTHER DOCUMENT(S) (including Author, Title, Date, Pertinent Pages, etc.)
`A NCBI Direct Submission NP 000725 dated November 21, 2010
`
`A NCBI Direct Submission NP 932170.1 dated November 21, 2010
`
`ExaminerSignature:
`
`/Michael Burkhart/
`
`Date Considered;
`04/18/2016
`
`*EXAMINER:Initial if reference considered, whether or not citation is in conformance with MPEP 609; Draw line throughcitation if not in conformance and not considered.
`Include copy of this form with next communication to applicant(s).
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 4
`
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 4
`
`
`
`
`
`Form PTO-1449
`U.S. Department of Commerce
`
`Information Disclosure Statement
`
`
`
`
`OTHER DOCUMENT(S) (cluding Author, Title, Date, Pertinent Pages, etc.)
`Davila et al., “B Cell Aplasia In a Patient with Relapsed B Cell Acute Lymphoblastic Leukemia
`Following Re-Induction and Consolidation with Autologous T Cells Genetically Targeted to the
`CD19 Antigen.” 2010 ASH Meeting Abstract No. 3268, presented December 6, 2010 (poster
`abstract
`Davila et al., “T Cells Genetically Targeted to CD19 Eradicate B-All in a Novel Syngeneic
`Mouse Disease Model.” 2010 ASH Meeting Abstract No. 171, presented December 6, 2010
`poster abstract
`Dohneretal., “p53 gene deletion predicts for poor survival and non-responseto therapy with
`purine analogs in chronic B-cell leukemias.” 1995, Blood, 85: 1580-9
`Dropulic et al., “Gene-based immunotherapy for human immunodeficiency virus infection and
`acquired immunodeficiency syndrome.” 2006, Human Gene Therapy, 17: 577-88
`Dull et al., “A third-generation lentivirus vector with a conditional packaging system.” 1998, J
`Virol, 72: 8463-71
`Eshharetal., “Specific activation and targeting of cytotoxic lymphocytes through chimeric single
`chains consisting of antibody-binding domains and the Yor ¢ subunits of the immunoglobulin
`and T-cell receptors.” 1993, Proc Natl Acad Sci USA 90:720-724
`Finneyet al., “Activation of resting human primary T cells with chimeric receptors: costimulation
`from CD28, inducible costimulator, CD134, and CD137 (4-1BB)in series with signals from the
`TCR zeta chain.” 2004, J. Immunol 172:104-113.
`Finneyet al., “Chimeric receptors providing both primary and costimulatory signaling in T cells
`from a single gene product.” 1998, J Immunol 161:2791-2797
`Friedmann-Morvinski et al., “Redirected primary T cells harboring a chimeric receptor require
`costimulation for their antigen-specific activation.” 2005, Blood 105:3087-3093
`Geiger and Jyothi, “Development and application of receptor-modified T lymphocytesfor
`adoptive immunotherapy.” 2001, Transfusion Medicine Reviews, 15(1): 21-34
`Geigeret al., “Integrated src kinase and constimulatory activity enhances signal transduction
`through single-chain chimeric receptors in T lymphocytes,” 2001, Blood 98(8):2364-71
`Gilham etal., “Primary Polyclonal Human T lymphocytes targeted to carcino-embryonic
`antigens and neural cell adhesion molecule tumor antigens by CD3¢- based chimeric immune
`receptors.” 2001, J. Immunology, 25(2): 139-151
`Gonget al., “Cancer patient T cells genetically targeted to prostate-specific membrane antigen
`specifically lyse prostate cancer cells and release cytokines in response to prostate=specific
`membrane antigen.” 1999, Neoplasia, 1(2): 123-127
`Gribbenet al., “Stem cell transplantation for indolent lymphoma and chronic lymphocytic
`leukemia.” 2011, Biol Blood Marrow Transplant, 17: Suppl:S63-S70
`Griffin et al., “Development and application of surface-linked single chain antibodies against T-
`cell antigens.” 2001, J. Immunological Methods, 248: 77-90
`Gross and Eshhar, 1992, “Endowing T cells with antibody specificity using chimeric T cell
`receptors.” 1992, FASEB J. 6: 3370-3378
`Hallek et al., “Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a
`report from the InternationalWorkshop on Chronic Lymphocytic Leukemia
`updating the National Cancer Institute-Working Group 1996 guidelines.” 2008, Blood
`111(12):5446-5456
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/MB/
`
`14997136 - GAU: 1633
`
`Sheet 5 of 10
`
`DOCKET NO.
`
`APPLICANT:
`Carl H. June etal.
`FILING DATE:
`
`APPLN.NO.
`To Be Assigned
`
`GROUP:
`Not Yet Assigned
`
`ExaminerSignature:
`
`/Michael Burkhart
`
`Date Considered:
`
`04/18/2016
`
`*EXAMINER:Initial if reference considered, whether or not citation is in conformance with MPEP 609; Draw line throughcitation if not in conformance and not considered.
`Include copy of this form with next communication to applicant(s).
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 5
`
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 5
`
`
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/MB/
`
`14997136 - GAU: 1633
`
`Sheet 6 of 10
`
`
` Examiner Signature:
`
`to receptor-associated signal transduction pathways.” 1991, Cell 64:891-901.
`Jenaet al., “Redirecting T-cell specificity by introducing a tumor-specific chimeric antigen
`receptor.” 2010, Blood, 116: 1035-44
`Jensen et al., “Antitransgene Rejection Responses Contribute to Attenuated Persistence of
`Adoptively Transferred CD20/CD19-Specific Chimeric Antigen Receptor Redirected T Cells in
`Humans.” 2010 Biol Blood Marrow Transplant 16:1245-1256
`Johnsonetal., “Gene therapy with human and mouseT-cell receptors mediates cancer
`regression and targets normal tissues expressing cognate antigen.” 2009, Blood, 114: 535-46
`Juneet al., “Engineering lymphocyte subsets: tools, trials and tribulations.” 2009, Nat Rev
`Immunol, 9: 704-16
`Kalos, et al., “T Cells with Chimeric Antigen Receptors Have Potent Antitumor Effects and Can
`Establish Memory in Patients with Advanced Leukemia.” 2011, Sci Trans] Med 3(95):95ra73
`Kershaw et al., “A phase | study on adoptive immunotherapy using gene-modified T cells for
`ovarian cancer.” 2006, Clin Cancer Res 12:6106-6115
`Kim et al., “Human 4-1BB regulates CD28 co-stimulation to promote Th1 cell responses.” 1998,
`Eur J Immunol 28:881-890
`Kochenderferet al., “Construction and Pre-clinical Evaluation of an Anti-CD19 Chimeric Antigen
`Receptor.” 2009, J Immunother 32(7)689-702
`Kochenderfer, et al., “A Phase | Clinical Trial of Treatment of B-Cell Malignancies with
`Autologous Anti-CD19-CAR-Transduced T Cells.” 2010 ASH Meeting Abstract No. 2865,
`presented December5, 2010 (poster abstract)
`Kochenderfer, et al., “Adoptive transfer of syngeneic T cells transduced with a chimeric antigen
`receptor that recognizes murine CD19 can eradicate lymphoma and normal B cells.” 2010,
`Blood, 116(9)3875-3886
`
`
`
`Form PTO-1449
`U.S. Department of Commerce
`
`Information Disclosure Statement
`
`DOCKET NO.
`
`APPLICANT:
`Carl H. June etal.
`FILING DATE:
`Herewith
`
`APPLN. NO.
`To Be Assigned
`
`GROUP:
`Not Yet Assigned
`
`aaHollymanetal., “Manufacturing Validation ofBiologically Functional TCellsTargetedtoCD19
`
`OTHER DOCUMENT(S) (cluding Author, Title, Date, Pertinent Pages, etc.)
`Hekele et al., “Growth retardation of tumors by adoptive transfer of cytotoxic T lymphocytes
`reprogrammed by CD44v6-specific scFv:zeta-chimera.” 1996, Int J Cancer 68:232-238
`Ho et al., “Adoptive Immunotherapy: Engineering T cell responses as biological weaponsfor
`tumor massdestruction.” 2003, Cancer Cell 3:431-437
`Antigen for Autologous Adoptive Cell Therapy.” J. Immunother., 2009, pp. 169-180, Vol 32, No.
`Homback et al., “The Recombinant T Cell Receptor Strategy:
`Insights into Structure and
`Function of Recombinant Immunoreceptors on the Way Towards an Optimal Receptor Design
`for Cellular Immunotherapy,” 2002 Current Gene Therapy 2:211-226
`P|| Imai et al., “Chimeric receptors with 4-1BB signaling capacity provoke potentcytotoxicity
`against acute lymphoblastic leukemia.” 2004, Leukemia 18(4):676-684
`|| Imai et al., 2005, Genetic modification of primary naturalkiller cells overcomesinhibitory signals
`
`and inducesspecific killing of leukemic cells, Blood, 106:376-383
`International Search Report for PCT/US2011/064191 dated 05/01/2012.
`
`P|| Irving & Weiss, “The cytoplasmic domain of the T cell receptor zeta chain is sufficient to couple
`
`bey
`mat
`/Michael Burkhart/
`
`Date Considered:
`
`Aaste)
`04/78/2016
`
`*EXAMINER:Initial if reference considered, whether or not citation is in conformance with MPEP 609; Draw line throughcitation if not in conformance and not considered.
`Include copy of this form with next communication to applicant(s).
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 6
`
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 6
`
`
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/MB/
`
`14997136 - GAL: 4833
`
`Sheet 7 of 10
`
` Examiner Signature:
`
`
`Krauseetal., “Antigen-dependent CD28 signaling selectively enhances survival and
`proliferation in genetically modified activated human primary T lymphocytes.” 1998, J. Exp.
`Med., 188(4): 619-626
`Lamannaet al., “Pentostatin, cyclophosphamide, andrituximabis an active, well-tolerated
`regimen for patients with previously treated chronic lymphocytic leukemia.” 2006, J Clin Oncol,
`24: 1575-81
`Lamerset al., “Treatment of metastatic renal cell carcinoma with autologous T-lymphocytes
`genetically retargeted against carbonic anhydraseIX:first clinical experience.” 2006, J Clin
`Oncol 24:e20-e22
`Laport et al., “Adoptive transfer of costimulated T cells induces lymphocytosis in patients with
`relapsed/refractory non-Hodgkin lymphoma following CD34+-selected hematopoietic cell
`transplantation.” 2003, Blood 102: 2004-2013
`Lee et al., “In vivo inhibition of human CD19-targeted effector T cells by natural T regulatory
`cells in a xenotransplant murine model of B cell malignancy.” 2011, Cancer Res 71:2871-2881
`Letourneur & Klausner, “T-cell and basophil activation through the cytoplasmic tail of T-cell-
`receptor zeta family proteins.” 1991, Proc Natl Acad Sci U S A 88:8905-8909.
`Levine et al., “Gene transfer in humansusing a conditionally replicating lentiviral vector.” 2006,
`Proc Natl Acad Sci U S A 103:17372-17377
`Macallan et al., “Measurement and modeling of human T cell kinetics.” 2003, Eur J Immunol,
`33: 2316-26
`Maheret al., “Human T-lymphocyte cytotoxicity and proliferation directed by a single chimeric
`TCRzeta /CD28 receptor.” 2002, Nat Biotechnol 20(1):70-5
`McGuinness, etal., “Anti-tumor activity of human T cells expressing the CC49-zeta chimeric
`immune receptor.” 1999, Hum.Gene Ther 10:165-173.
`Milone et al., “Chimeric receptors containing CD137 signal transduction domains mediate
`enhancedsurvival of T cells and increased antileukemic efficacy in vivo.” 2009, Mol Ther
`17(8):1453-64
`Molina, “A decade ofrituximab: improving survival outcomes in non-Hodgkin's lymphoma.”
`2008, Ann Rev Med, 59: 237-50
`Morganetal., “Case report of a serious adverse eventfollowing the administration of T cells
`transduced with a chimeric antigen receptor recognizing ERBB2.” 2010, Mol Ther, 18: 843-51
`Moritz & Groner, “A spacer region between the single chain antibody- and the CD3 zeta-chain
`domain of chimeric T cell receptor components is required for efficient ligand binding and
`signaling activity,” 1995, Gene Therapy, 2:539-546
`
`
`
`Form PTO-1449
`U.S. Department of Commerce
`
`Information Disclosure Statement
`
`DOCKET NO.
`
`APPLICANT:
`Carl H. June etal.
`FILING DATE:
`
`APPLN. NO.
`To Be Assigned
`
`GROUP:
`Not Yet Assigned
`
`OTHER DOCUMENT(S) (cluding Author, Title, Date, Pertinent Pages, etc.)
`Kochenderfer, et al., “Eradication of B-lineage cells and regression of lymphoma in a patient
`treated with autologousT cells genetically-engineered to recognize CD19.” 2010, Blood
`116:4099-4102
`
`Kochenderfer, et al., “Novel Antigen-Specific Expansion of T Cells Transduced with a CD19
`Chimeric Antigen Receptor.” 2010 ASH Meeting Abstract No. 3262, presented December 6,
`2010 (poster abstract)
`Kohn, et al., “CARs on track in the clinic.” 2011, Molecular Ther 19(3):432-438
`
`7
`ants
`/Michael Burkhart/
`
`Date Considered:
`
`RGE
`RC
`04/18/2016
`
`*EXAMINER:Initial if reference considered, whether or not citation is in conformance with MPEP 609; Draw line throughcitation if not in conformance and not considered.
`Include copy of this form with next communication to applicant(s).
`UPenn Ex.2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 7
`
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 7
`
`
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/MB/
`
`14997136 - GAU: 1633
`
`Sheet 8 of 10
`
`
`
`Form PTO-1449
`U.S. Department of Commerce
`
`Information Disclosure Statement
`
`DOCKET NO.
`
`APPLICANT:
`Carl H. June etal.
`FILING DATE:
`
`APPLN. NO.
`To Be Assigned
`
`GROUP:
`Not Yet Assigned
`
`| Moritz et al., “Cytotoxic T lymphocytes with a grafted recognition specificity for ERBB2-
`
`OTHER DOCUMENT(S) (cluding Author, Title, Date, Pertinent Pages, etc.)
`
`expressing tumorcells” 1994, Proc. Natl. Acad. Sci. 91:4318-4322
`Naldini et al., “In vivo gene delivery and stable transduction of nondividing cells by a lentiviral
`vector.” 1996, Science, 272: 263-7
`Nicholson, et al., “Constructions and Characterization of a Functional CD19 Specific Single
`Chain Fv Fragmentfor Immunotherapy of B Lineage Leukemia and Lymphoma.” Mol. Immunol.,
`1997, pp. 1157-1165, Vol 34, No. 16-17.
`
`ai Ochoaetal.,ImmuneDefectsInTCellsFromCancerPatients,ParallelsInInfectious
`
`Diseases, from: Cancer Immunotherapy at the Crossroads: how tumors evade immunity and
`what can be done (currentclinical oncology), edited by James H. Finke, Ronald M. Bukowski,
`2004 edition.
`
`Park and Brentjens, “Adoptive Immunotherapyfor B-cell Malignancies with Autologous
`chimeric Antigen Receptor Modified Tumor Targeted T Cells.” 2010, Discov Med
`9(47):27 7-288
`
`clones in patients with neuroblastoma.” 2007, Mol Ther 15:825-833
`
`function.” 1998, Gene Therapy, 6: 412-419
`
`CD3/CD28 costimulation.” 2006, Blood, 107:1325-31
`
`Cancer 2:331-332
`
`England J Med 365(8):725-733
`
`and antitumor activity in individuals with neuroblastoma.” 2008, Nat Med 14:1264-1270
`
`and adoptive T-cell transfer.” 2005, Nat Med 11:1230-1237
`Roederer, “T-cell dynamics of immunodeficiency.” 1995, Nat Med, 1: 621-7
`
`P|| Romeo & Seed, “Cellular immunity to HIV activated by CD4 fused to T cell or Fc receptor
`| Sabbaghet al., “TNF family ligands define niches for T cell memory.” 2007, Trends Immunol
`| Sadelainet al., “Targeting tumours with genetically enhanced T lymphocytes.” 2003,Nat Rev
`| Sadelainet al., “The promise and potential pitfalls of chimeric antigen receptors.” 2009, Curr
`| Savoldoet al., “CD28 costimulation improves expansion and persistence of chimeric antigen
`
`polypeptides.” 1991 ,Cell 64:1037-1046
`
`28:333-339
`
`Cancer 3(1):35-45
`
`Opin Immunol, 21: 215-23
`
`
`
`
`P|| Parket al., “Adoptive transfer of chimeric antigen receptorre-directed cytolytic T lymphocyte
`P|| Patelet al., “Impact of chimeric immune receptor extracellular protein domains on T cell
`| Porter et al, “A phase 1 trial of donor lymphocyte infusions expanded and activated ex vivo via
`a Porteret al., “Chimeric Antigen Receptor Therapy for B-cell Malignancies. 2011, J
`|| Porter, “Chimeric antigen receptor-modified T cells in chronic lymphoid leukemia.” 2011 New
`P|| Puleet al., “Virus-specific T cells engineered to coexpress tumor-specific receptors: persistence
`| Rapoport et al., “Restoration of immunity in lymphopenicindividuals with cancer by vaccination
`
`receptor-modified T cells in lymphoma patients.” 2011, J Clin Invest 121(5):1822-6
`Sebestyen, et al., “Human TCR that incorporate CD3zeta induce highly preferred pairing
`between TCRalpha and beta chains following gene transfer.” 2008, J Immunol. 2008,
`180(11):7736-46
`Examiner Signature:
`fichae| Burkhart
`
`Pate Considered 04/48/2016
`
`*EXAMINER:Initial if reference considered, whether or not citation is in conformance with MPEP 609; Draw line throughcitation if not in conformance and not considered.
`Include copy of this form with next communication to applicant(s).
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 8
`
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 8
`
`
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/MB/
`
`14997136 - GAU: 1633
`
`Sheet 9 of 10
`
`OTHER DOCUMENT(S) (cluding Author, Title, Date, Pertinent Pages, etc.)
`Song, et al. “CD27 costimulation augments the survival and antitumoractivity of redirected
`humanT cells in vivo.” 2011 Blood 119:696-706
`Sorror et al., “Outcomes after allogeneic hematopoietic cell transplantation with
`nonmyeloablative or myeloablative conditioning regimens for treatment of lymphoma and
`chronic lymphocytic leukemia.” 2008, Blood, 111: 446-52
`Tammana Syamet al., “4-1BB and CD28 signaling plays a synergistic role in redirecting
`umbilical cord blood T cells against B-cell malignancies.” 2010 Human Gene Therapy 21:75-86
`Till et al., “Adoptive immunotherapyfor indolent non-Hodgkin lymphoma and mantle cell
`lymphoma using genetically modified autologous CD20-specific T cells.” 2008, Blood, 112,
`2261-2271
`Uckun, et al., “Detailed studies on expression and function of CD19 surface determinant by
`using B43 monoclonal antibody and theclinical potential of anti-CD19 immunotoxins.” 1988,
`Blood, 71:13-29
`Vinay and Kwon, “Role of 4-1BB in immune responses.” 1998, Seminars in Immunology,
`10:481-489
`Willemsen etal., “Genetic Engineering of T Cell Specificity for Immunotherapy of Cancer.”
`2003, Human Immunology, 64: 56-68
`Zufferey et al., “Multiply attenuated lentiviral vector achievesefficient gene delivery in vivo.”
`1997, Nature Biotechnology 15:871-875
`Chinese Patent Application No. 201180067173.X — Office Action dated October 22, 2014
`
`
`
`
`
`
`Form PTO-1449
`U.S. Department of Commerce
`
`Information Disclosure Statement
`
`DOCKET NO.
`
`APPLICANT:
`Carl H. June etal.
`FILING DATE:
`
`APPLN.NO.
`To Be Assigned
`
`GROUP:
`Not Yet Assigned
`
`Chinese Patent Application No. 201180067173.X — Second Office Action dated July 10, 2015
`
`Colombia Patent Application No. 13-137636 — Colombian resolution no. 8176 dated February
`27, 2015
`Colombia Patent Application No. 13-137636 — English translation of Office Action of September
`5, 2014
`
`Pf Cuba Patent Application No. 2013/0079 Office Action of April 1, 2014
`ae Cuba Patent Application No. 2013/0079 Office Action of October 28, 2014
`P| Eurasian Region Patent Application No. 201390847/28 Office Action dated March 11, 2015
`| European Patent App! 11846757.0 European Search Report of December 2, 2014
`
`European Patent Application No. 11846757.0 — Office Action dated August 17, 2015
`
`Guatemala Patent Application No. A-2013-150 — English translation of Observer's commentsof
`September 17, 2014.
`
`P| Japanese Patent Application No. 2013-543380 — Office Action dated October 15, 2015
`| Mexican Patent Application No. MX/a/2013/006570 — Office Action dated October 9, 2015
`
`New Zealand Patent Application No. 612512 - First Exam Report of November 20, 2013
`
`| Thailand Patent Application No. 1301003120 — Office Action of July 2014
`
`ExaminerSignature:
`
`/Michael Burkhart/
`
`Date Considered:
`
`04/18/2018
`
`*EXAMINER:Initial if reference considered, whether or not citation is in conformance with MPEP 609; Draw line throughcitation if not in conformance and not considered.
`Include copy of this form with next communication to applicant(s).
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 9
`
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 9
`
`
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/MB/
`
`14997136 - GAU: 1633
`
`Sheet 10 of 10
`
`Form PTO-1449
`U.S. Department of Commerce
`
`DOCKET NO.
`
`APPLICANT:
`Carl H. June etal.
`FILING DATE:
`
`Herewith
`
`APPLN.NO.
`
`To Be Assigned
`
`GROUP:
`Not Yet Assigned
`
`Information Disclosure Statement
`
`
`
`
`OTHER DOCUMENT(S) (cluding Author, Title, Date, Pertinent Pages, etc.)
`14/107 ,302 — Final Office Action of March 31, 2015
`Patent Application No.
`
`. Patent Application No.
`
`14/107,302 - non-final Office Action of September 30, 2014
`
`. Patent Application No.
`
`14/567,426 - non-final Office Action of January 16, 2015
`
`. Patent Application No.
`
`14/568, 195 - non-final Office Action of January 30, 2015
`
`. Patent Application No.
`
`14/568, 569 - non-final Office Action of January 15, 2015
`
`. Patent Application No.
`
`13/992,622 - non-final Office Action of June 19, 2015
`
`. Patent Application No.
`
`13/992,622 — Final Office Action of January 5, 2016
`
`. Patent Application No.
`
`14/465,952 — non-final Office Action of November 20, 2014
`
`. Patent Application No.
`
`13/938,923 — Final Office Action mailed March 28, 2014
`
`. Patent Application No.
`
`13/938,923 — Final Office Action mailed October 8, 2014
`
`. Patent Application No.
`
`13/938,923 - non-final Office Action of September 19, 2013
`
`. Patent Application No.
`
`13/938,947 - Final Office Action of September 11, 2014
`
`. Patent Application No.
`
`13/938,947 - non-final Office Action of December 16, 2013
`
`. Patent Application No.
`
`14/466 ,096 — non-final Office Action of October 8, 2014
`
`ExaminerSignature:
`
`‘Michael Burkhart/
`
`Date Considered:
`
`04/18/2016
`
`*EXAMINER:Initial if reference considered, whether or not citation is in conformance with MPEP 609; Draw line throughcitation if not in conformance and not considered.
`UPenn Ex. 2026
`Include copy of this form with next communication to applicant(s).
`Miltenyi v. UPenn
`IPR2022-00855
`Page 10
`
`UPenn Ex. 2026
`Miltenyi v. UPenn
`IPR2022-00855
`Page 10
`
`