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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`JUBILANT DRAXIMAGE INC.,
`Petitioner,
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`v.
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`BRACCO DIAGNOSTICS INC.,
`Patent Owner.
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`
`
`Case IPR2018-01449
`Patent 9,299,467
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`PETITIONER’S SUBMISSION OF ITC NOTICE
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`IPR2018-01449
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`Petitioner hereby submits the attached exhibit 1039, a “Notice of Commission
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`Final Determination of No Violation of Section 337; Termination of the
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`Investigation” issued by the U.S. International Trade Commission in Investigation
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`337-TA-1110 (the “1110 Investigation”). In relevant part, Ex. 1039 indicates that
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`the Commission determined to affirm with modification and to supplement the prior
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`Final Initial Determination’s findings with respect to the invalidity of the patent
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`claims asserted in the 1110 Investigation. Id. at 2.
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`The Board authorized the instant filing by e-mail on December 5, 2019.
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`A supplemental exhibit list is provided in the attached Appendix A.
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`Respectfully submitted,
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`Date: December 6, 2019 By: /Robert L. Hails/
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`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
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`Attorneys for Petitioner
`JUBILANT DRAXIMAGE INC.
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`1
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`IPR2018-01449
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`APPENDIX A: EXHIBIT LIST
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`EXHIBIT
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`DESCRIPTION
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`1001
`
`U.S. Patent No. 9,299,467
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`1002
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`1003
`
`Complaint, Bracco Diagnostics Inc. v. Jubilant DraxImage Inc., Case
`No. 3-18-cv-04422 (D.N.J.)
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`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.)
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`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.
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`Prosecution History, U.S. application s.n. 12/137,356
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`Prosecution History, U.S. application s.n. 12/137,377
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`Prosecution History, U.S. application s.n. 12/137,363
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`Prosecution History, U.S. application s.n. 12/137,364
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`Prosecution History, U.S. application s.n. 12/808,467
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`Prosecution History, U.S. application s.n. 14/455,623
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`Alvarez-Diez, “Manufacture of strontium-82/rubidium-82 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)
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`A-1
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`IPR2018-01449
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`EXHIBIT
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`DESCRIPTION
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`1014
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`1015
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`1016
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`1017
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`1018
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`1019
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`1020
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`1021
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`1022
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`1023
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`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)
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`Declaration of Robert T. Stone, Ph.D.
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`Curriculum Vitae of Robert T. Stone, Ph.D.
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`Declaration of Ventakesh Murthy, M.D.
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`Barker, et al., U.S. Patent 4,585,009, granted April 29, 1986
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`U.S. Pharmacopeia 23 National Formulary 18 (1995)
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`Declaration of Andy Adler, Ph.D. with Attachments A-C
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`Bracco CardioGen-82® Infusion System User’s Guide, Rev. 07 (July
`20, 2004)
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`Tate, et al., U.S. Patent Publication No. 2008/0177126, filed October
`31, 2007 and published July 24, 2008
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`ISO 13485:2003 – Medical Devices – Quality Management Systems
`– Requirements for Regulatory Purposes (July 2003)
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`1024
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`21 CFR Part 820.1 (2005)
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`1025
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`1026
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`1027
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`1028
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`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)
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`Bracco CardioGen-82® Rubidium Rb 82 Generator, Rev. 43-8200
`(May 2000)
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`10 CFR Part 20 (10 CFR 20.1001-2)
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`10 CFR Part 20 (10 CFR 20.1003)
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`A-2
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`IPR2018-01449
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`EXHIBIT
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`DESCRIPTION
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`1029
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`1030
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`1031
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`1032
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`1033
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`1034
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`1035
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`EN 62274:2005 – Medical Electrical Equipment – Safety of
`Radiotherapy Record and Verify Systems (December 28, 2005)
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`The Chemical Rubber Co., Handbook of Radioactive Nuclides, Yen
`Wang ed., 1969
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`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.)
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`Declaration of Carol Wadke
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`deKemp, U.S. Patent Publication No. 2007/0213848
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`deKemp, U.S. Patent Publication No. 2007/0140958
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`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)
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`1036
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`U.S. Patent No. 9,814,826
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`1037
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`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))
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`1038
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`Petitioner’s Demonstrative Exhibits
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`1039
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`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)
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`2001
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`U.S. Patent Application Publication No. 2011/0178359, filed
`December 28, 2007
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`A-3
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`IPR2018-01449
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`EXHIBIT
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`DESCRIPTION
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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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`2016
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`[RESERVED]
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`Declaration of Dr. Norbert Pelc
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`ITC Deposition of Dr. Robert Stone, October 9, 2018 (Redacted)
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`ITC Deposition of Dr. Robert Stone, October 10, 2018 (Redacted)
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`ITC Trial Testimony of Dr. Robert Stone, April 15, 2019 (Public
`Version)
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`ITC Trial Testimony of Dr. Robert Stone, April 16, 2019 (Public
`Version)
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`Errata of Dr. Robert Stone regarding Ex. 1015 of IPRs 2018-01448,
`-01449, and -01450
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`Exhibit from Deposition of Dr. Robert Stone in IPRs 2018-01448, -
`01449, and -01450
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`Deposition testimony of Dr. Robert Stone in IPRs 2018-01448, -
`01449, and -01450
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`ITC Corrected Expert Report of Dr. Norbert Pelc (Redacted)
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`ITC Trial Testimony of Dr. Norbert Pelc (Public Version)
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`ITC Trial Exhibits of Dr. Norbert Pelc (Redacted)
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`CAPINTEC CRC-15R User Manual, Nov. 2004
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`CAPINTEC CRC-15R User Manual, July 2007
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`Deposition testimony of Dr. Venkatesh Murthy in IPRs 2018-01448,
`-01449, and -01450
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`2017
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`Exhibit 1001 from Dr. Murthy’s Deposition (corrections to Ex. 1017)
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`A-4
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`IPR2018-01449
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that on December 6, 2019, a copy of this
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`PETITIONER’S SUBMISSION OF ITC NOTICE was served in its entirety via
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`electronic mail by emailing Patent Owner’s counsel at:
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`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
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`as provided for by Patent Owner’s listed Service Information in Patent Owner’s
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`Updated Mandatory Disclosures.
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`Date: December 6, 2019
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`By:
`
`/Robert L. Hails/
`Robert L. Hails
`Reg. No. 39,702
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`