`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`Jubilant DraxImage Inc.,
`
`Petitioner
`
`v.
`
`Bracco Diagnostics Inc.
`
`Patent Owner
`
`
`
`
`
`
`U.S. Patent No. 9,299,467
`
`
`Inter Partes Review Case No.: 2018-01449
`
`PETITIONER’S REPLY BRIEF
`
`
`Mail Stop: PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`TABLE OF CONTENTS
`
`IPR2018-1449
`
`Page
`Introduction ...................................................................................................... 1
`Ground 1: Klein Anticipates the Challenged Claims. ..................................... 2
`A. Klein Discloses a Computer That Prevents Patient Elutions in
`Response to Failed Strontium Breakthrough Tests. .............................. 3
`The ITC Rejected Bracco’s Expert Witness Testimony and
`Arguments. .......................................................................................... 11
`III. Ground 3: Bracco Distributed the Bracco Manual to Its Customers with
`No Confidentiality Markings. ........................................................................ 13
`IV. Bracco’s Attacks on Dr. Murthy’s Testimony Are Unjustified
`Distractions from the Remaining Issues in Dispute. ..................................... 15
`Conclusion ..................................................................................................... 18
`
`B.
`
`I.
`II.
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`V.
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`ii
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`IPR2018-1449
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`TABLE OF AUTHORITIES
`
`Cases
`Cordis Corp. v. Boston Scientific Corp.,
`561 F.3d 1319 (Fed. Cir. 2009) ..................................................................... 14, 15
`CRFD Research, Inc. v. Matal,
`876 F.3d 1330 (Fed. Cir. 2017). ............................................................................. 7
`Garrett Corp. v. United States,
`422 F.2d 874 (Ct. Cl. 1970) ................................................................................. 13
`Gemtron Corp. v. Saint-Gobain Corp.,
`572 F.3d 1371 (Fed. Cir. 2009) ............................................................................ 14
`Icon Health & Fitness, Inc. v. Strava, Inc.,
`849 F.3d 1034 (Fed. Cir. 2017) ............................................................................ 14
`In re Bond,
`910 F.2d 831 (Fed. Cir. 1990) ................................................................................ 7
`In re Reynaud,
`331 F.2d 625 (C.C.P.A. 1964) ............................................................................. 10
`Nobel Biocare Services AG v. Instradent USA, Inc.,
`903 F.3d 1365 (Fed. Cir. 2018) ............................................................................ 15
`ParkerVision, Inc. v. Qualcomm Inc.,
`903 F.3d 1354 (Fed. Cir. 2018) ............................................................................ 10
`Purgess v. Sharrock,
`33 F.3d 134 (2d. Cir. 1994) .................................................................................. 13
`Other Authority
`Manual of Patent Examining Procedure § 2145 (9th ed. Nov. 2015) ..................... 13
`
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`iii
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`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
`
`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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`iv
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`IPR2018-1449
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`EXHIBIT
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`DESCRIPTION
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`1014
`
`1015
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`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)
`
`
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`v
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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
`
`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
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`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))
`
`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)
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`vi
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`EXHIBIT
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`DESCRIPTION
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`2006
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`2007
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`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`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
`
`Deposition testimony of Dr. Venkatesh Murthy in IPRs 2018-01448,
`-01449, and -01450
`
`2017
`
`Exhibit 1001 from Dr. Murthy’s Deposition (corrections to Ex. 1017)
`
`
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`vii
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`IPR2018-1449
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`I.
`
`INTRODUCTION
`The Petition demonstrates that Klein discloses all claimed components of the
`
`’467 Patent’s infusion system, including a shielding assembly with a generator (red),
`
`a computer (green), and a dose calibrator (blue) that perform breakthrough testing
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`on an eluate sample (pink):
`
`Ex. 1014, FIG 2-2 (annotated)
`
`
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`The Petition also shows that the prior art teaches every limitation of the Challenged
`
`Claims, that Klein anticipates certain Challenged Claims, and that the modifications
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`of Klein to practice the other Challenged Claims would have been obvious to a
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`POSITA.
`
`The issues remaining for the PTAB to decide are narrow. There are no claim
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`construction issues in dispute. POR § II.B. Although the parties define POSITA
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`differently, neither party argues that the differences between them are material to the
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`outcome of this IPR. Id. § II.C. Bracco makes no challenge specific to Ground 2.
`
`Thus, the Board need not revisit these issues.
`
`Bracco’s limited counter-arguments are unpersuasive. On Ground 1, Bracco
`
`argues only that Klein does not disclose that its computer is “configured to prevent
`
`a patient infusion procedure if a breakthrough test result exceeds an allowable limit.”
`
`On Ground 3, Bracco disputes that its own product manual qualifies as a printed
`
`publication. As a last recourse, Bracco takes issue with clerical errors in, but not the
`
`substance of, Dr. Murthy’s declaration.1 These counter-arguments are inapt, as
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`discussed below.
`
`II. GROUND 1: KLEIN ANTICIPATES THE CHALLENGED CLAIMS.
`On Ground 1, Bracco raises a single distinction against the prior art, namely,
`
`that Klein does not disclose a computer system that prevents patient infusions when
`
`high breakthrough tests are detected. POR § IV. As discussed below, Klein’s
`
`
`1 Bracco takes issue with the Bracco Manual and Murthy Declaration in all three
`
`related IPRs, but the roles of this evidence vary among these IPRs. For example, Dr.
`
`Murthy’s testimony is relied upon only to discuss the background technology in this
`
`proceeding.
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`2
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`IPR2018-1449
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`computer disables patient elutions each night. Ex. 1014 at 19. Bracco’s expert, Dr.
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`Pelc, agrees that this operation locks out patient elutions. Ex. 2012 at 981:9-10.
`
`Klein further discloses that the computer re-enables the patient elutions only after
`
`completing a morning breakthrough test with low breakthrough levels. Ex. 1014 at
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`18, 29, 44. While Bracco’s expert disputes that Klein performs this latter operation,
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`his opinion is contradicted by clear, straightforward disclosure from Klein.
`
`Therefore, the Board should adopt Ground 1 and cancel the affected claims.
`
`A. Klein Discloses a Computer That Prevents Patient Elutions
`in Response to Failed Strontium Breakthrough Tests.
`The Board should reject Bracco’s argument that Klein does not disclose the
`
`lockout feature, recited in the claims as follows:
`
`Claim 1:
`
`the computer is further configured to prevent a patient
`infusion procedure if a breakthrough test result exceeds
`an allowable limit.
`
`Claim 13:
`
`preventing, with the computer, a patient infusion
`procedure if a breakthrough test result exceeds an
`allowable limit.
`
`Klein discloses a computer-controlled infusion system. Ex. 1014 at 19, 30-
`
`31; see Ex. 1015 § IX.B.3; Pet. at 14-17. The computer provides a touch-screen user
`
`interface through which operators control the system. Ex. 1014 at 30-31. The
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`computer “limit[s] user input to ensure validity” through the user interface by adding
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`buttons “only at relevant states” and removing them immediately thereafter. Id.; Ex.
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`1015 § IX.B.3.
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`Klein provides an exemplary user interface screen showing how the computer
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`selectively enables and disables elutions (yellow) based on operational state. This
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`example relates to test runs:
`
`Klein, FIG. 3-12(c) (annotated)
`
`
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`Ex. 1014 at 53-54 (system requires proper user ID to enable test runs). Thus, Klein’s
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`computer locks out different types of elutions—it enables and disables buttons for
`
`them on the user interface—based on the system’s operational state. Ex. 1015
`
`§ IX.B.3.
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`With respect to patient infusions, Klein’s computer disables Patient Elution
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`Runs each night:
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`IPR2018-1449
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`Klein, FIG. 2-1
`
`
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`Ex. 1014 at 19; Ex. 1015 § IX.B.5. Bracco’s expert, Dr. Pelc, agrees that this
`
`operation locks the system out until a strontium breakthrough test is performed:
`
`The Klein thesis discloses that the system is locked out until you do
`the calibration run. It's absolutely clear that Klein intends his system
`to require that that calibration run be done before patient elutions are
`done for the day, and then at midnight, that permission expires, and you
`have to redo the calibration run.
`
`Ex. 2012 at 981:9-14 (emphasis added); see also Ex. 1014 at 18 (calibration run
`
`includes strontium breakthrough test). Dr. Pelc distinguished the claims based on
`
`his incorrect inference that, in Klein, operators determine whether strontium
`
`breakthrough test results are sufficiently low to resume patient infusions, not the
`
`computer. Ex. 2012 at 1078:8-1079:12. Dr. Pelc’s opinion is contradicted by
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`overwhelming disclosure from Klein.
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`Klein discloses that the computer does not re-enable patient infusions unless
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`a calibration run is performed that yields strontium breakthrough values lower than
`
`a predetermined limit:
`
`Only after a calibration run with low Sr breakthrough has been
`successfully completed can patient elutions be carried out. …
`Once the daily protocol has been completed successfully, patient
`elutions are enabled until the end of the day.
`
`Ex. 1014 at 18 (emphases added).
`
`The 82Rb infusion system software must ensure that the protocol is
`followed (i.e. that each run is enabled only after the prerequisites have
`been completed successfully).
`
`Id. at 44 (emphasis added).
`
`The system must ensure compliance with the daily protocol described
`in the previous chapter. A flush followed by a calibration run and
`successful breakthrough measurement must be completed in order to
`enable patient elutions for the remainder of the day.
`
`Id. at 29 (emphases added).
`
`The software ensured that the daily protocol (discussed below) is
`followed and generated a recording of each elution.
`
`Id. at 17 (emphasis added). Contrary to Dr. Pelc’s opinions, Klein assigns
`
`responsibility for re-enabling patient infusions to the computer’s software. Thus, a
`
`POSITA would recognize from this disclosure that Klein’s computer operates as
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`claimed: It “prevent[s] a patient infusion procedure if a breakthrough test result
`
`exceeds an allowable limit.” Ex. 1001 at claims 1, 13; see also Ex. 1015 §§ XI.A.7,
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`XI.J.5.
`
`Bracco’s counter-arguments are unpersuasive, and they should be rejected.
`
`First, Bracco argues that Klein’s disclosure does not “expressly state” that a lockout
`
`occurs. POR at 12-13. Anticipation, however, does not demand word-for-word
`
`correspondence between prior art and the claims. In re Bond, 910 F.2d 831, 832
`
`(Fed. Cir. 1990) (no ipsissimus verbis test). Instead, the relevant question is whether
`
`“one skilled in the art would reasonably understand or infer from the prior art
`
`reference’s teaching that every claim [limitation] was disclosed in that single
`
`reference.” CRFD Research, Inc. v. Matal, 876 F.3d 1330, 1338 (Fed. Cir. 2017).
`
`A POSITA would recognize immediately from Klein’s disclosure that the computer
`
`“prevent[s] a patient infusion procedure if a breakthrough test result exceeds an
`
`allowable limit.”
`
`Bracco’s second argument
`
`that Klein’s discussion of breakthrough
`
`experiments somehow suggests the computer does not prevent patient infusions as
`
`claimed (POR at 14), should be rejected. Klein disables Patient Elutions (orange),
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`the only type of elution that qualifies as a “patient infusion procedure” under the
`
`claims:
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`7
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`IPR2018-1449
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`Klein, FIG. 3-15 (annotated)
`
`
`
`The “experiments” to which Bracco refers involve a Calibration Run (green) not a
`
`“patient infusion procedure”:
`
`Daily calibration samples are used to test for the breakthrough of Sr
`activity; if significant Sr activity is detected, the generator cannot be
`used on humans. … We continued to use the generator on the
`development system past the specifications and experienced first
`breakthrough after approximately 40 L were eluted through the
`generator. Once breakthrough appeared, it was tracked over two
`months.
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`8
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`POR at 14-15 (quoting Ex. 1014 at 122) (emphasis added). Klein distinguishes these
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`experiments and patient procedures. Id. at 53 (test runs have no clinical application).
`
`Klein never suggests that the breakthrough experiments involve any “patient
`
`infusion procedure.” To the contrary, Klein confirms that “if significant Sr activity
`
`is detected, the generator cannot be used on humans.” Id. at 122 (emphasis added);
`
`Ex. 1015 §§ XI.A.7, XI.J.5. Bracco’s claims impose no requirement that the
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`computer must disable all operation, as Bracco suggests, only “patient infusion
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`procedure[s].” Therefore, Bracco’s argument should be rejected.
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`Bracco misreads Klein to argue that its discussion of manual entry of
`
`breakthrough readings somehow indicates that a lockout does not occur. POR at 15.
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`Klein discloses that manual readings are the exception, not the norm, and automated
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`breakthrough testing suffices in many cases:
`
`The integral activity recorded from the dose calibrator is used to
`calibrate the activity counter and verify that the calibration constant is
`within tolerance from previous records. If the dose calibrator
`sensitivity is sufficiently high, breakthrough measurements are
`conducted after 20 minutes from completion of the elution. If the dose
`calibrator is not sufficiently sensitive to measure breakthrough, the
`activity can be entered manually after measurement in a more sensitive
`device.
`
`Ex. 1014 at 43 (emphasis added); see also id. at 64 (The computer “read[s]
`
`breakthrough from the dose calibrator” at the conclusion of the “Wait for
`
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`Breakthrough Reading” state). Klein’s computer operates as claimed when it
`
`performs automated breakthrough readings, which suffices for present analysis.2 A
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`prior art reference may meet a limitation if the reference discloses subject matter that
`
`is reasonably capable of operating so as to meet the limitation, even if it does not
`
`meet the limitations in all modes of operation. ParkerVision, Inc. v. Qualcomm Inc.,
`
`903 F.3d 1354, 1361 (Fed. Cir. 2018) ); In re Reynaud, 331 F.2d 625, 628 (C.C.P.A.
`
`1964) (prior art may be relied upon for all that it teaches).
`
`Bracco’s argument that responsibility for preventing patient elutions falls on
`
`the operator, not the computer, (POR at 16-18) is inconsistent with a plain reading
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`of Klein. This argument relies on a tortured interpretation of FIG. 3-15 (above), in
`
`which Dr. Pelc concluded a calibration run is “successful” when it completes, even
`
`if high strontium breakthrough levels were detected. Ex. 2012 at 981:22-983:9 (“I
`
`interpret this to say that a successful calibration run in Klein means you went through
`
`these steps.”). Dr. Pelc’s opinion is not credible.
`
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`2 Manual entry is also consistent with Klein’s disclosure that the computer performs
`
`lockout. No matter whether the computer receives breakthrough measurements
`
`electronically from the dose calibrator or manually via human data entry, the
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`software ensures that the daily protocol is followed. Ex. 1014 at 17, 33 (supra).
`
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`10
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`Klein’s system does not deem strontium breakthrough tests to be “successful”
`
`merely when a calibration run completes. They are successful only when test results
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`show low strontium breakthrough:
`
`Only after a calibration run with low Sr breakthrough has been
`successfully completed can patient elutions be carried out.
`
`Ex. 1014 at 18. Moreover, it is the computer’s “software”—not its operator—that
`
`causes Patient Elution runs to be “enabled only after the prerequisites [e.g., the low
`
`Sr breakthrough] have been completed successfully.” Id. at 44. The computer
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`disables patient elutions each night and re-enables them only after the system
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`confirms that breakthrough activity falls within Health Canada limits. Id. at 29, 33.
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`Dr. Pelc’s opinion contradicts this clear disclosure, and it should be rejected.
`
`B.
`
`The ITC Rejected Bracco’s Expert Witness Testimony and
`Arguments.3
`Bracco relies heavily on Dr. Pelc’s ITC testimony involving patents with the
`
`same disclosure that recite the lockout function. POR at 2-3, 15-18. For example,
`
`U.S. Patent No. 9,814,826, which is at issue at the ITC, recites an analogous claim
`
`element:
`
`
`3 Petitioner cites the ALJ’s reasoning as persuasive authority, recognizing that the
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`Board will assess the evidence for itself.
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`IPR2018-1449
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`configuring a computer…to not allow a patient infusion if the strontium
`breakthrough test result is greater than or equal to an allowed limit.
`
`Ex. 1036, claim 1; Ex. 1035 at 2, 39-40.
`
`In the ITC, the ALJ heard the parties’ arguments regarding the lockout
`
`function, observed both experts testify, and ultimately rejected Bracco’s arguments.
`
`Ex. 1035 at 49-53. Overall, and on the lockout feature specifically, the ALJ found
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`Petitioner’s expert, Dr. Stone, to be more credible than Dr. Pelc. See id. at 52-53
`
`(declining to adopt Pelc’s opinions regarding lockout), 48, 57, 79, 85, 96 (crediting
`
`Stone’s testimony).
`
`On the lockout feature, the ALJ recognized a basic fallacy in Bracco’s
`
`interpretation of Klein:
`
`Klein expressly states the system will only “enable patient elutions”
`with a successful breakthrough measurement. Klein at .000039
`(emphasis added); see also id. at .000028. If there were no system
`lock-out, as Bracco contends, then there would be no need to
`“enable” patient elutions. See also id. at .000029 (system disables
`patient elusion [sic] runs each night at midnight, when the validation
`from the calibration run expires).
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`Id. at 51 (emphasis added). The ALJ rejected Bracco’s arguments—and Dr. Pelc’s
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`opinions —because they drew illogical inferences from the evidence. Id. at 49-53.
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`The Board should do the same here.
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`III. GROUND 3: BRACCO DISTRIBUTED THE BRACCO MANUAL TO
`ITS CUSTOMERS WITH NO CONFIDENTIALITY MARKINGS.
`The Bracco Manual (Ex. 1021) qualifies as a printed publication. Bracco
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`admits that it distributed the printed manual to an interested segment of the public—
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`users of its commercially-available CardioGen system. POR at 6, 19. These users
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`are the very people that Bracco identifies as having ordinary skill in the art. POR at
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`3-4 (clinical experience with PET imaging).
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`Bracco’s admissions demonstrate the manual is a printed publication.
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`Comcast Cable Comm’ns. v. Promptu Sys. Corp., IPR2018-00343, Paper 56, at 73
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`(P.T.A.B. 2019) (“A court can appropriately treat statements in briefs as binding
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`judicial admissions of fact.”) (quoting Purgess v. Sharrock, 33 F.3d 134, 144 (2d.
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`Cir. 1994)); Manual of Patent Examining Procedure § 2145 (9th ed. Nov. 2015)
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`(“Attorney argument is not evidence unless it is an admission, in which case, an
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`examiner may use the admission in making a rejection.”); see Fed. R. Evid.
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`801(d)(2). Bracco admits that it distributed Bracco Manuals to an interested segment
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`of the public (i.e., users of Bracco’s CardioGen system). Bracco did so for a product
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`that has been commercially available since 1989, roughly two decades before the
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`earliest priority date claimed by the ’467 Patent. See Ex. 1002 ¶¶ 30-33; Garrett
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`Corp. v. United States, 422 F.2d 874, 878 (Ct. Cl. 1970) (“distribution to commercial
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`companies without restriction on use does [constitute publication]”). Moreover, the
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`manual (Ex. 1021) contains no confidentiality markings or other language restricting
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`its use.
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`Bracco argues that the manual does not qualify as a printed publication solely
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`because “all such customers were under an obligation of confidentiality during the
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`relevant time period.” POR at 19. Bracco, however, provided no evidence to
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`substantiate this allegation.4 Its contention is mere attorney argument and should be
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`disregarded. Icon Health & Fitness, Inc. v. Strava, Inc., 849 F.3d 1034, 1043 (Fed.
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`Cir. 2017) (vacating PTAB decision relying on attorney argument that was
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`unsupported by evidence) (citing Gemtron Corp. v. Saint-Gobain Corp., 572 F.3d
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`1371, 1380 (Fed. Cir. 2009) (“[U]nsworn attorney argument...is not evidence and
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`cannot rebut...other admitted evidence....”)).
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`Bracco’s reliance on Cordis (POR at 58) is misplaced. There, evidence
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`demonstrated that an inventor requested—and the receiving parties maintained—
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`confidentiality of a disputed monograph. Cordis Corp. v. Boston Scientific Corp.,
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`561 F.3d 1319, 1334 (Fed. Cir. 2009). Here, Bracco “points to no evidence that [it]
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`4In its Institution Decision, the Board recognized that Bracco “likely possess[es]
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`information relevant to public availability of the Bracco manual” which might
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`support its contention. Paper 7 (Dec. to Inst.) at 17. Significantly, Bracco does not
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`dispute this point in its Patent Owner Response.
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`IPR2018-1449
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`ever distributed the [Bracco Manual] with an expectation that it would be kept
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`confidential or not disseminated.” Nobel Biocare Services AG v. Instradent USA,
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`Inc., 903 F.3d 1365, 1377 (Fed. Cir. 2018) (citing Cordis, 561 F.3d at 1333-34)
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`(disregarding attorney arguments of confidentiality). Furthermore, the Bracco
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`Manual (Ex. 1021) “bears no designations, such as ‘draft’ or ‘confidential,’ that
`
`might suggest that it was not intended for public distribution.” 903 F.3d at 1377.
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`Having admitted to distributing the manual, Bracco confirms the Bracco Manual
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`qualifies as a printed publication.
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`IV. BRACCO’S ATTACKS ON DR. MURTHY’S TESTIMONY ARE
`UNJUSTIFIED DISTRACTIONS FROM THE REMAINING ISSUES
`IN DISPUTE.
`Bracco’s attacks on Dr. Murthy’s declaration are immaterial to the issues
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`remaining in this IPR. Bracco disputes only that Klein discloses a computer lockout
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`function and that the Bracco Manual is a printed publication. POR §§ IV, V. Bracco
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`waived any other patentability argument. Paper 8 (Sched. Order) at 6. Neither the
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`Petition nor Dr. Stone’s declaration rely on Dr. Murthy’s declaration for these issues.
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`With respect to the lockout function, the Petition and Dr. Stone’s declaration
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`both refer to Klein—not to Dr. Murthy’s declaration—to demonstrate how Klein’s
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`disclosure matches claims 1 and 13. See Pet. at 32-33, 47-48 (discussing Ex. 1014);
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`Ex. 1015 §§ IX.B.5, XI.A.7, XI.J.5 (same). The Petition and Dr. Stone’s declaration
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`15
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`IPR2018-1449
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`do not rely on Dr. Murthy’s declaration to analyze the Bracco Manual. See Pet. at
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`64-67; Ex. 1015 §§ IX.D, XIII. Thus, no matter whether the Board affords Dr.
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`Murthy’s declaration substantial weight, it does not affect the issues that the Board
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`must decide.
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`Dr. Murthy’s declaration provides context for Dr. Stone’s declaration.
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`Although Dr. Stone is an engineer with substantial experience both working with
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`radioactive control systems and designing medical devices (Ex. 1015 ¶¶ 2-10), he is
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`not a medical doctor. He is not an expert on topics involving medical uses of
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`rubidium-82. Thus, Dr. Stone looks to Dr. Murthy, a board-certified physician with
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`a decade of experience working with rubidium infusion systems (Ex. 1017 ¶¶ 2-6),
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`for an explanation of these topics. Id. ¶¶ 79-95, 122-125. There is nothing improper
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`in doing so.
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`Bracco criticizes Dr. Murthy’s declaration for two reasons: 1) a clerical error,
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`his declaration refers to a 2007 version of Bracco’s Manual (Ex. 1037) rather than
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`the 2004 version that became Ex. 1021; and 2) the timing of his experience with
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`Bracco’s CardioGen system. As discussed, neither challenge is material to the
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`Grounds in the Petition.
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`On the first issue, the 2004 and the 2007 versions of the Bracco Manual are
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`identical in all material respects. See Exs. 1021, 1037. Bracco offers no evidence
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`otherwise.
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`16
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`IPR2018-1449
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`On the second issue, Dr. Murthy testified that he trained on the CardioGen
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`system in July 2008, a mere month after the June 2008 date to which Bracco’s patent
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`claims priority. Ex. 1017 ¶ 5. As part of that training, Dr. Murthy reviewed journal
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`articles and product documentation describing rubidium infusions systems. Id.; see
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`also Ex. 2016 at 30:13-31:12 (testifying that his review of literature relating to the
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`CardioGen system also included review of images, clinical records, and infusion
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`records on many scans dating back to 2004). This experience provides a solid basis
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`on which to describe prevailing practices in 2008 for rubidium-82 elution systems.
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`Bracco does not challenge the substance of Dr. Murthy’s declaration. Bracco
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`provides no evidence to suggest that his declaration is unreliable in any way. Most
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`importantly, Bracco identified no issue remaining in dispute to which Dr. Murthy’s
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`declaration is material. Bracco’s criticism of Dr. Murthy’s declaration is a red
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`herring.
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`17
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`V. CONCLUSION
`Claims 1-4, 6-16, and 18-22 from the ’467 Patent should be canceled.
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`IPR2018-1449
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`Date: August 22, 2019
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`Respectfully submitted,
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`
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`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.
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`IPR2018-1449
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`CERTIFICATION
`The undersigned certifies that the foregoing Petitioner’s Reply Brief,
`
`exclusive of the Table of Contents, Table of Authorities, and Mandatory Notices,
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`has a word count of less than 5,600 words as computed by Microsoft Word.
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`By:
`
`/Robert L. Hails/
`Robert L. Hails, Reg. No. 39,702
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`19
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`IPR2018-1449
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that on August 22, 2019, a copy of this
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`Petitioner’s Reply Brief and all supporting exhibits have been served in their entirety
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`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
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`as provided for by Patent Owner’s Service Information in Patent Owner’s
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`Mandatory Disclosures.
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`By:
`
`/Robert L. Hails/
`Robert L. Hails, Reg. No. 39,702
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`20
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