Paper No. 26
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`JUBILANT DRAXIMAGE INC.,
`Petitioner,
`
`v.
`
`BRACCO DIAGNOSTICS INC.,
`Patent Owner.
`
`
`
`Case IPR2018-01449
`Patent 9,299,467
`
`
`
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`
`
`
`PETITIONER’S SUBMISSION OF
`ITC COMMISSION OPINION
`
`
`
`
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`JUBILANT DRAXIMAGE INC.,
`Petitioner,
`
`v.
`
`BRACCO DIAGNOSTICS INC.,
`Patent Owner.
`
`
`
`Case IPR2018-01449
`Patent 9,299,467
`
`
`
`
`
`
`
`PETITIONER’S SUBMISSION OF
`ITC COMMISSION OPINION
`
`
`
`
`
`
`
`
`
`IPR2018-01449
`
`Petitioner hereby submits the attached exhibit 1040, a public version of the
`
`Commission Opinion issued by the U.S. International Trade Commission in
`
`Investigation 337-TA-1110 (the “1110 Investigation”), which provides the
`
`Commission’s reasoning supporting its determination to affirm with modification
`
`and to supplement the prior Final Initial Determination’s findings with respect to the
`
`invalidity of the patent claims asserted in the 1110 Investigation. Ex. 1039.
`
`The Commission Opinion addresses several issues that are relevant to the
`
`present inter partes review, including:
`
` At pp. 24-26, the Commission considered teachings of the Klein
`
`reference against claim elements that require a computer not to
`
`allow a patient infusion when a strontium breakthrough test result is
`
`greater than or equal to an allowed limit, holding that Klein teaches
`
`or discloses such subject matter; and
`
` At pp. 18, 20-21, and 25-26, the Commission evaluated and rejected
`
`testimony from Bracco’s expert, Dr. Norbert Pelc, on several issues.
`
`The Board authorized the instant filing by email on December 5, 2019. Patent
`
`Owner does not oppose filing of this exhibit.
`
`
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`
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`1
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`
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`Date: December 12, 2019
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`
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`
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`A supplemental exhibit list is provided in the attached Appendix A.
`
`IPR2018-01449
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`By: /Robert L. Hails/
`Robert L. Hails, Reg. No. 39,702
`T. Cy Walker, Reg. No. 52,337
`Theresa Weisenberger, Reg. No. 65,559
`BAKER & HOSTETLER LLP
`Washington Square, Suite 1100
`1050 Connecticut Avenue, N.W.
`Washington, D.C. 20036-5304
`Telephone: 202-861-1500
`Facsimile: 202-861-1783
`Jubilant-Baker@bakerlaw.com
`
`Attorneys for Petitioner
`JUBILANT DRAXIMAGE INC.
`
`2
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`IPR2018-01449
`
`APPENDIX A: EXHIBIT LIST
`
`EXHIBIT
`
`DESCRIPTION
`
`1001
`
`U.S. Patent No. 9,299,467
`
`1002
`
`1003
`
`Complaint, Bracco Diagnostics Inc. v. Jubilant DraxImage Inc.,
`Case No. 3-18-cv-04422 (D.N.J.)
`
`Complaint,
`the Matter of Certain Strontium-Rubidium
`In
`Radioisotope Infusion Systems, and Components Thereof Including
`Generators, Inv. No. 337-TA 3303 (U.S. I.T.C.)
`
`1004
`
`Order Granting Joint Motion to Stay Pending Resolution of ITC
`Proceedings (D.I. 9) Case No. 3-18-cv-04422 (D.N.J.)
`1005 Waiver of Service, Bracco Diagnostics Inc. v. Jubilant DraxImage
`Inc.
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`Prosecution History, U.S. application s.n. 12/137,356
`
`Prosecution History, U.S. application s.n. 12/137,377
`
`Prosecution History, U.S. application s.n. 12/137,363
`
`Prosecution History, U.S. application s.n. 12/137,364
`
`Prosecution History, U.S. application s.n. 12/808,467
`
`Prosecution History, U.S. application s.n. 14/455,623
`
`strontium-82/rubidium-82
`of
`“Manufacture
`Alvarez-Diez,
`generators and quality control of rubidium-82 chloride for
`myocardial perfusion imaging in patients using positron emission
`tomography,” Applied Radiation and Isotopes, v. 50, pp. 1015-23
`(1999)
`
`Klein et al, “Precision Control of Eluted Activity from a Sr/Rb
`Generator for Cardiac Positron Emission Technology,” Engr. in
`Med. and Biology Soc. 26th Annual International Conference of the
`IEEE, vol. 1, pp. 1393-1396 (2004)
`
`
`
`A-1
`
`
`
`
`
`IPR2018-01449
`
`EXHIBIT
`
`DESCRIPTION
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`Ran Klein, “Precise 82Rb Infusion System for Cardiac Perfusion
`Measurement Using 3D Positron Emission Tomography,” Ottawa-
`Carleton Institute for Electrical and Computer Engineering (Feb.
`2005)
`
`Declaration of Robert T. Stone, Ph.D.
`
`Curriculum Vitae of Robert T. Stone, Ph.D.
`
`Declaration of Ventakesh Murthy, M.D.
`
`Barker, et al., U.S. Patent 4,585,009, granted April 29, 1986
`
`U.S. Pharmacopeia 23 National Formulary 18 (1995)
`
`Declaration of Andy Adler, Ph.D. with Attachments A-C
`
`Bracco CardioGen-82® Infusion System User’s Guide, Rev. 07
`(July 20, 2004)
`
`Tate, et al., U.S. Patent Publication No. 2008/0177126, filed October
`31, 2007 and published July 24, 2008
`
`ISO 13485:2003 – Medical Devices – Quality Management Systems
`– Requirements for Regulatory Purposes (July 2003)
`
`1024
`
`21 CFR Part 820.1 (2005)
`
`1025
`
`1026
`
`1027
`
`1028
`
`Chatal, et al., “Story of rubidium-82 and advantages for myocardial
`perfusion PET Imaging,” Frontiers in Medicine, v. 2, art. 65, pp. 1-
`7 (Sept. 11, 2015)
`
`Bracco CardioGen-82® Rubidium Rb 82 Generator, Rev. 43-8200
`(May 2000)
`
`10 CFR Part 20 (10 CFR 20.1001-2)
`
`10 CFR Part 20 (10 CFR 20.1003)
`
`
`
`A-2
`
`
`
`
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`IPR2018-01449
`
`EXHIBIT
`
`DESCRIPTION
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`EN 62274:2005 – Medical Electrical Equipment – Safety of
`Radiotherapy Record and Verify Systems (December 28, 2005)
`
`The Chemical Rubber Co., Handbook of Radioactive Nuclides, Yen
`Wang ed., 1969
`
`Complainant Bracco Diagnostics Inc.’s Responses to Respondent’s
`Fourth Set of Interrogatories (No. 68), In the Matter of Certain
`Strontium-Rubidium Radioisotope
`Infusion
`Systems,
`and
`Components Thereof Including Generators, Inv. No. 337-TA-1110
`(U.S.I.T.C.)
`
`Declaration of Carol Wadke
`
`deKemp, U.S. Patent Publication No. 2007/0213848
`
`deKemp, U.S. Patent Publication No. 2007/0140958
`
`Initial Determination on Violation of Section 337 and
`Recommended Determination on Remedy and Bond), In the Matter
`of Certain Strontium-Rubidium Radioisotope Infusion Systems, and
`Components Thereof Including Generators, Inv. No. 337-TA-1110
`(U.S.I.T.C. Aug. 1, 2019)
`
`1036
`
`U.S. Patent No. 9,814,826
`
`1037
`
`Exhibit 1002 from Dr. Murthy’s Deposition in IPRs 2018-01448, -
`01449, and -01450 (Bracco CardioGen-82® Infusion System User’s
`Guide, Rev. 11 (July 3, 2007))
`
`1038
`
`Petitioner’s Demonstrative Exhibits
`
`1039
`
`Notice of Commission Final Determination of No Violation of
`Section 337; Termination of the Investigation, In the Matter of
`Certain Strontium-Rubidium Radioisotope Infusion Systems, and
`Components Thereof Including Generators, Inv. No. 337-TA-1110
`(U.S.I.T.C. Dec. 2, 2019)
`
`
`
`A-3
`
`
`
`
`
`IPR2018-01449
`
`EXHIBIT
`
`DESCRIPTION
`
`Commission Opinion (Public Version), In the Matter of Certain
`Strontium-Rubidium Radioisotope
`Infusion
`Systems,
`and
`Components Thereof Including Generators, Inv. No. 337-TA-1110
`(U.S.I.T.C. Dec. 11, 2019)
`
`U.S. Patent Application Publication No. 2011/0178359, filed
`December 28, 2007
`
`[RESERVED]
`
`Declaration of Dr. Norbert Pelc
`
`ITC Deposition of Dr. Robert Stone, October 9, 2018 (Redacted)
`
`ITC Deposition of Dr. Robert Stone, October 10, 2018 (Redacted)
`
`ITC Trial Testimony of Dr. Robert Stone, April 15, 2019 (Public
`Version)
`
`ITC Trial Testimony of Dr. Robert Stone, April 16, 2019 (Public
`Version)
`
`Errata of Dr. Robert Stone regarding Ex. 1015 of IPRs 2018-01448,
`-01449, and -01450
`
`Exhibit from Deposition of Dr. Robert Stone in IPRs 2018-01448, -
`01449, and -01450
`
`Deposition testimony of Dr. Robert Stone in IPRs 2018-01448, -
`01449, and -01450
`
`ITC Corrected Expert Report of Dr. Norbert Pelc (Redacted)
`
`ITC Trial Testimony of Dr. Norbert Pelc (Public Version)
`
`ITC Trial Exhibits of Dr. Norbert Pelc (Redacted)
`
`CAPINTEC CRC-15R User Manual, Nov. 2004
`
`CAPINTEC CRC-15R User Manual, July 2007
`
`1040
`
`2001
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`2002
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`2003
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`2004
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`2005
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`2006
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`2007
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`2008
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`2009
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`2010
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`2011
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`2012
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`2013
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`2014
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`2015
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`A-4
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`IPR2018-01449
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`EXHIBIT
`
`DESCRIPTION
`
`2016
`
`2017
`
`Deposition testimony of Dr. Venkatesh Murthy in IPRs 2018-01448,
`-01449, and -01450
`
`Exhibit 1001 from Dr. Murthy’s Deposition (corrections to Ex.
`1017)
`
`A-5
`
`
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`IPR2018-01449
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that on December 12, 2019, a copy of this
`
`PETITIONER’S SUBMISSION OF ITC COMMISSION OPINION was served in
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`its entirety via electronic mail by emailing Patent Owner’s counsel at:
`
`Barry J. Schindler
`SchindlerB@gtlaw.com
`Heath J. Briggs
`BriggsH@gtlaw.com
`Vimal Kapadia
`KapadiaV@gtlaw.com
`Stephen Ullmer
`UllmerS@gtlaw.com
`Lennie Bersch
`BerschL@gtlaw.com
`bracco-iprs@gtlaw.com
`
`as provided for by Patent Owner’s listed Service Information in Patent Owner’s
`
`Updated Mandatory Disclosures.
`
`Date: December 12, 2019
`
`By:
`
`/Robert L. Hails/
`Robert L. Hails
`Reg. No. 39,702
`
`
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