UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.
`Petitioners,
`
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner.
`
`_________________________________________________
`
`IPR 2022-00853
`
`U.S. Patent No. 9,464,140
`
`_________________________________________________
`
`DECLARATION OF DR. ADAM BAGG
`
`UPenn Ex. 2044
`Miltenyi v. UPenn
`IPR2022-00853
`
`
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.
`Petitioners,
`
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner.
`
`_________________________________________________
`
`IPR 2022-00853
`
`U.S. Patent No. 9,464,140
`
`_________________________________________________
`
`DECLARATION OF DR. ADAM BAGG
`
`UPenn Ex. 2044
`Miltenyi v. UPenn
`IPR2022-00853
`
`
`
`Case IPR2022-00853
`Patent 9,464,140
`
`I, Dr. Adam Bagg, declare as follows:
`
`1.
`
`I am submitting this declaration to provide information about the
`
`drafting of a publication regarding a clinical trial for the therapy now known as
`
`Kymriah®. I have reviewed Exhibit 1012, titled “Chimeric Antigen Receptor-
`
`Modified T Cells in Chronic Lymphoid Leukemia,” and Exhibit 1013, its
`
`accompanying protocol, which I understand the Petitioners collectively refer to as
`
`“Porter.” Exhibit 1012 is a copy of that publication and Exhibit 1013 is its
`
`supplementary material.
`
`2.
`
`I have personal knowledge of the facts set forth in this Declaration.
`
`All statements made in this Declaration are true to the best of my knowledge.
`
`3.
`
`If called on to testify, I could and would testify competently as to the
`
`topics addressed in this declaration.
`
`4.
`
`I am currently employed as a Professor of Pathology and Laboratory
`
`Medicine at the Hospital of the University of Pennsylvania. I am a
`
`hematopathologist and my research interests include the molecular pathology of
`
`hematologic neoplasms, including leukemia.
`
`5.
`
`I am not being compensated for my participation in this case or my
`
`time spent preparing this declaration. Other than my employment at the University
`
`of Pennsylvania, which commenced in July 1999, and for which I am compensated
`
`1
`
`
`UPenn Ex. 2044
`Miltenyi v. UPenn
`IPR2022-00853
`
`
`
`Case IPR2022-00853
`Patent 9,464,140
`for my role as an employee and not in exchange for my completion of this
`
`Declaration, I do not have any financial interest in the outcome of this matter.
`
`6.
`
`I participated in the research reflected in Porter as a
`
`hematopathologist. I am listed in the protocol, Ex. 1013, as a Co-Investigator and
`
`as part of the Laboratory Team. I assisted in analyzing samples collected in the
`
`course of the patients’ treatment at the request and at the direction of my co-
`
`authors. But I did not come up with the idea for the treatment described in Porter.
`
`Also, I was not involved in creating the chimeric antigen receptor modified T cells
`
`used in the study or in formulating them for administration, nor was I involved in
`
`developing the dosing schedules or treatment regimens used in the study or in
`
`directing the care for any of the patients in the study.
`
`7. More specifically, I have been asked by counsel to describe the extent
`
`of my contribution to various portions of Porter and in particular, to the portions
`
`that I understand are being cited by the Petitioners in support of their arguments.
`
`As set forth in detail below, all of the portions of Porter cited by the Petitioners
`
`reflect the work of my co-authors and not me.
`
`8.
`
`I understand that Petitioners contend that, “Porter reports that a
`
`leukemia patient who received autologous T cells transduced with an anti-CD19
`
`CAR, i.e., ‘CART19’ cells, was in remission ten months after treatment” and
`
`“Porter also discloses that the patient in the clinical trial experienced remission.” I
`
`2
`
`
`UPenn Ex. 2044
`Miltenyi v. UPenn
`IPR2022-00853
`
`
`
`Case IPR2022-00853
`Patent 9,464,140
`did not personally treat the patient. As a laboratory-based hematopathologist, I
`
`was responsible for analyzing samples collected for this experimental research
`
`patient, at the request and direction of my co-authors. From these analyses, I
`
`determined the laboratory result indicating remission and Dr. Porter made the
`
`clinical determination of remission, based on the reported results and the patient’s
`
`overall clinical/health status.
`
`9.
`
`I understand that Petitioners contend that, “Porter discloses a
`
`pharmaceutical formulation using . . . CAR T cells at a dose of 1.46×105 cells per
`
`kg,” that “[t]he patient received a total of 3×108 T cells, of which 5% were
`
`transduced,” and that “Porter discloses treating the patient with ‘a total of 1.42×107
`
`transduced cells (1.46×105 cells per kilogram).’” I did not contribute to developing
`
`the pharmaceutical formulation, the dosage, or the transduction percentage used in
`
`this treatment.
`
`10.
`
`I understand that Petitioners contend that, “Porter discloses
`
`transducing its CART-19 construct into T cells derived from a leukemia patient”
`
`and “Porter discloses transducing its CART-19 construct with a lentiviral vector
`
`comprising a nucleic acid sequence wherein the sequence includes EF-1α
`
`promoter.” I did not participate in transducing the CART-19 construct into T cells
`
`or designing the vector used to transduce the cells.
`
`3
`
`
`UPenn Ex. 2044
`Miltenyi v. UPenn
`IPR2022-00853
`
`
`
`Case IPR2022-00853
`Patent 9,464,140
`I understand that Petitioners contend that, “Porter discloses that the
`
`11.
`
`infusion bag of CART-19 cells contains ‘the following infusible grade reagents
`
`(%v/v): 31.25 plasmalyte-A, 31.25 dextrose (5%), 0.45 NaCl, up to 7.50 DMSO,
`
`1.00 dextran 40, 5.00 human serum albumin.’” I did not participate in developing
`
`the CART-19 infusion bag or selecting these reagents.
`
`12.
`
`I understand that Petitioners contend that, “Porter teaches
`
`administering a single dose of T cells over three days” with escalating dose
`
`percentages, that Porter discloses a dosing regimen “split into three consecutive
`
`daily intravenous infusions (10% on day 1, 30% on day 2, and 60% on day 3),” and
`
`that “Porter also discloses administering a second dose of T cells on the eleventh
`
`day.” I did not participate in developing the dosing regimen for the CART-19
`
`cells.
`
`13.
`
`In short, it was my co-authors, and not me, who developed this study
`
`and the idea for this study. They created the CART-19 cells and used them to treat
`
`patients in the manner described in Porter. Any descriptions in Porter of the
`
`manufacture of CART-19 cells, the pharmaceutical composition used in that study,
`
`or the administration to patients of that composition reflects the work of the other
`
`authors, and not mine.
`
` [Remainder of this page intentionally left blank]
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`4
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`UPenn Ex. 2044
`Miltenyi v. UPenn
`IPR2022-00853
`
`
`
`Case IPR2022-00853
`Patent 9,464,140
`I declare under penalty of perjury under the laws of the United States
`
`14.
`
`of America that all statements made herein of my own knowledge are true, and that
`
`all statements made on information and belief are believed to be true. I further
`
`declare that these statements are made with the full knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both,
`
`under Section 1001 of Title 18 of the United States Code and that such statements
`
`may jeopardize the validity of U.S. Patent No. 9,464,140.
`
`
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`
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`Executed on ___July 19, 2022___
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`_/Adam Bagg/_______
`
`Dr. Adam Bagg
`
`5
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`
`UPenn Ex. 2044
`Miltenyi v. UPenn
`IPR2022-00853
`
`
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