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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
`
`______________
`Patent Owner’s Preliminary Response
`
`

`

`IPR2018-01449
`US Patent No. 9,299,467
`
`
`
`Patent Owner’s Preliminary Response
`
`C. 
`
`I. 
`II. 
`
`Table of Contents
`INTRODUCTION ....................................................................................... 1 
`PETITIONER’S ASSERTED LEVEL OF ORDINARY SKILL IN
`THE ART AND CLAIM CONSTRUCTION ........................................... 2 
`III.  FACTUAL BACKGROUND: THE CITED PRIOR ART AND
`PROSECUTION HISTORY OF THE ’467 PATENT ............................. 3 
`A. 
`Overview of Petitioner’s art and arguments ..................................... 4 
`B. 
`The art at issue in the Petition and during prosecution ................... 5 
`1.  The “Klein” references ............................................................... 6 
`2.  Petitioner’s secondary references ............................................ 16 
`3.  The “Hirschman” reference (Ex. 2001) .................................. 20 
`Overview of the art and arguments relied on by the examiner
`during prosecution ........................................................................... 21 
`1.  Prosecution of pertinent members of the ’467 patent family21 
`2.  Prosecution of the ’467 patent ................................................. 22 
`IV.  ARGUMENT ............................................................................................. 25 
`A. 
`Legal Standards ................................................................................ 26 
`B. 
`The Board should exercise its discretion and deny institution ...... 28 
`1.  Braun Factor 1: “the similarities and material differences
`between the asserted art and the prior art involved during
`examination” .................................................................................... 28 
`2.  Braun Factor 2: “the cumulative nature of the asserted art
`and the prior art evaluated during examination” ........................ 41 
`3.  Braun Factor 3: “the extent to which the asserted art was
`evaluated during examination” ...................................................... 46 
`4.  Braun Factor 4: “the extent of the overlap between the
`arguments made during examination and the manner in which a
`petitioner relies on the prior art or a patent owner distinguishes
`the prior art” .................................................................................... 48 
`5.  Braun Factor 5: “whether a petitioner has pointed out
`sufficiently how the Office erred in evaluating the asserted prior
`
`Page i of vii
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`Patent Owner’s Preliminary Response
`
`IPR2018-01449
`US Patent No. 9,299,467
`art” .................................................................................................... 59 
`6.  Braun Factor 6: “the extent to which additional evidence and
`facts presented in the petition warrant reconsideration of the
`prior art or arguments” .................................................................. 61 
`7.  Weighing the factors ................................................................. 62 
`V.  CONCLUSION .......................................................................................... 64 
`
`
`
`
`
`
`Page ii of vii
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`

`

`IPR2018-01449
`US Patent No. 9,299,467
`
`
`
`
`Patent Owner’s Preliminary Response
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Apotex Inc. v. Celgene Corp.,
`IPR2018-00685, Paper 8 (PTAB Sept. 27, 2018) ............................................... 64
`Becton Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) ............................................... 28
`Boehringer Ingelheim Int’l GMBH v. Biogen, Inc.,
`IPR2015-00418, Paper 14 (PTAB Jul. 13, 2015) ............................................... 19
`Cultec, Inc. v. StormTech LLC,
`IPR2017-00777, Paper 7 (PTAB Aug. 22, 2017) ............................................... 26
`In re Hall,
`781 F.2d 897-99 (Fed. Cir. 1986) ....................................................................... 18
`Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) .......................................................................... 26
`Hospira, Inc. v. Genentech, Inc.,
`IPR2017-00739, Paper 16 (PTAB July 27, 2017) .............................................. 26
`Kyocera Wireless Corp. v. ITC,
`545 F.3d 1340 (Fed. Cir. 2008) .......................................................................... 18
`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .......................................................................... 18
`Microsoft Corp. v. Corel Software, LLC,
`IPR2016-01300, Paper 13 (PTAB Jan. 4, 2017) ................................................ 18
`Mylan Pharm. v. Boehringer Ingelheim GMBH,
`IPR2016-01565, Paper 23 (PTAB Aug. 1, 2017) ............................................... 19
`NHK Spring Co., Ltd. v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) ............................................... 57
`
`Page iii of vii
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`

`

`Patent Owner’s Preliminary Response
`
`IPR2018-01449
`US Patent No. 9,299,467
`Pfizer Inc. v. Giogen Inc.,
`IPR2017-01166, Paper 9 (PTAB Nov. 13, 2017) ............................................... 19
`SAS Institute v. Iancu,
`138 S.Ct. 1348 (2018) ......................................................................................... 26
`Unified Patents Inc. v. Berman,
`IPR2016-01571, Paper 10 (PTAB Dec. 14, 2016) ....................................... 58, 64
`Statutes
`35 U.S.C. § 102 .......................................................................................................... 7
`35 U.S.C. § 102(b) ................................................................................................... 18
`35 U.S.C. § 314(a) & 325(d) .................................................................................... 26
`35 U.S.C. § 325(d) ............................................................................................passim
`
`
`
`
`
`
`
`Page iv of vii
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`

`

`IPR2018-01449
`US Patent No. 9,299,467
`
`
`
`Patent Owner’s Preliminary Response
`
`EXHIBIT LIST
`
`Exhibit
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`1006
`1007
`1008
`1009
`1010
`1011
`
`1012
`
`1013
`
`1014
`1015
`
`Description
`Petitioner’s Exhibits
`U.S. Patent No. 9,299,467
`Complaint, Bracco Diagnostics Inc. v. Jubilant DraxImage Inc.,
`Case No. 3-18-cv-04422 (D.N.J.)
`Complaint, In the Matter of Certain Strontium-Rubidium
`Radioisotope Infusion Systems, and Components Thereof
`Including Generators, Inv. No. 337-TA 3303 (U.S. I.T.C.)
`Order Granting Joint Motion to Stay Pending Resolution of ITC
`Proceedings (D.I. 9) Case No. 3-18-cv-04422 (D.N.J.)
`Waiver of Service, Bracco Diagnostics Inc. v. Jubilant
`DraxImage Inc.
`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) (“Alvarez-Diez”)
`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) (“Klein-2004”)
`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) (“Klein Thesis”)
`Declaration of Robert T. Stone, Ph.D.
`
`Page v of vii
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`

`

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`
`Patent Owner’s Preliminary Response
`
`1021
`
`1022
`
`1023
`1024
`
`1025
`
`IPR2018-01449
`US Patent No. 9,299,467
`1016
`Curriculum Vitae of Robert T. Stone, Ph.D.
`1017
`Declaration of Ventakesh Murthy, M.D.
`1018
`Barker, et al., U.S. Patent 4,585,009, granted April 29, 1986
`1019
`U.S. Pharmacopeia 23 National Formulary 18 (1995)
`1020
`Declaration of Andy Adler, Ph.D.
`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 (“Tate”)
`ISO 13485:2003 – Medical Devices – Quality Management
`Systems – Requirements for Regulatory Purposes (July, 2003)
`21 CFR Part 820.1 (2005)
`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)
`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 3303 (U.S. I.T.C.)
`Declaration of Carol Wadke
`deKemp, U.S. Patent Publication No. 2007/0213848 (“deKemp-
`848”)
`deKemp, U.S. Patent Publication No. 2007/0140958 (“deKemp-
`958”)
`
`1026
`1027
`1028
`
`1029
`
`1030
`
`1031
`1032
`
`1033
`
`1034
`
`Page vi of vii
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`

`

`IPR2018-01449
`US Patent No. 9,299,467
`
`
`
`Patent Owner’s Preliminary Response
`
`Patent Owner’s Exhibits
`Hirschman, et al., U.S. Patent Publication No. 2011/0178359,
`filed December 28, 2007 (“Hirschman”)
`
`2001
`
`Page vii of vii
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`IPR2018-01449
`US Patent No. 9,299,467
`I.
`INTRODUCTION
`
`
`
`Patent Owner’s Preliminary Response
`
`Patent Owner Bracco Diagnostics Inc. (“Patent Owner”) submits the
`
`following Preliminary Response to the Petition for Inter Partes Review (the
`
`“Petition”) filed by Jubilant Draximage Inc. (“Petitioner”) regarding Claims 1-4, 6-
`
`16, and 18-22 (“the Challenged Claims”) of U.S. Patent No. 9,299,467 (“the ’467
`
`Patent”). (Petition at 1; 68.) Petitioner has alleged that the Challenged Claims are
`
`unpatentable under 35 U.S.C. §§ 102 & 103, relying on a single reference for
`
`Ground 1 and two references for Grounds 2 and 3. (Id. at 22-23.) For the below
`
`reasons, the Board should deny Petitioner’s IPR request on all grounds.
`
`The ’467 patent relates to computer-facilitated systems and methods for
`
`maintaining and operating a radiopharmaceutical infusion system. (Ex. 1001 at
`
`1:23-56; Abstract.) Such systems and methods are used to generate and infuse
`
`radiopharmaceuticals, such as rubidium-82, into patients for the purpose of positron
`
`emission tomography (“PET”) imaging. (Id.) In particular, the Challenged Claims
`
`are directed to systems and methods for generating a rubidium radioactive eluate,
`
`using a computer to perform quality control tests with respect to the rubidium
`
`radioactive eluate, and infusing the rubidium radioactive eluate into the patient. (Id.
`
`at 23:48-25:9.) The claims further require quality control and safety features. (Id.)
`
`Petitioner seeks to invalidate the Challenged Claims on the basis of three
`
`invalidity grounds. (Petition at 23.) Each of these grounds is based on prior art that
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`Page 1 of 65
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`IPR2018-01449
`US Patent No. 9,299,467
`the PTO previously considered during prosecution of the ’467 patent. Although
`
`Patent Owner’s Preliminary Response
`
`
`
`Petitioner contends its invalidity grounds are “new,” they are in fact merely
`
`cumulative of the art and arguments considered by the examiner during prosecution
`
`of the ’467 patent. Inter partes review under these circumstances—i.e.,
`
`readjudicating similar issues that were raised by the examiner and overcome by
`
`Patent Owner—wastes the Board’s and Patent Owner’s resources. Accordingly, the
`
`Board should exercise its discretion under 35 U.S.C. § 325(d) and deny institution
`
`of the Petition. Ground 3 also fails because Petitioner failed to present any
`
`evidence beyond a date listed on the cover page of the manual to support its
`
`contention that the Bracco Manual (Ex. 1021) qualifies as prior art.
`
`Thus, Patent Owner requests that the Board reject the Petition in its entirety,
`
`and decline to institute review.
`
`II.
`
`PETITIONER’S ASSERTED LEVEL OF ORDINARY SKILL IN THE
`ART AND CLAIM CONSTRUCTION
`
`For purposes of this Preliminary Response only, the level of ordinary skill in
`
`the art and Petitioner’s assertion that all claim terms have their ordinary and
`
`customary meaning are not pertinent to any of Patent Owner’s arguments herein.
`
`Further, Patent Owner expressly disagrees with Petitioner’s asserted level of
`
`ordinary skill, and reserves the right to provide its own definition of the level of
`
`ordinary skill in the art, should the Board institute review. Patent Owner also
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`IPR2018-01449
`US Patent No. 9,299,467
`reserves its right to submit any pertinent claim construction(s), should the Board
`
`Patent Owner’s Preliminary Response
`
`
`
`institute review.
`
`III. FACTUAL BACKGROUND: THE CITED PRIOR ART AND
`PROSECUTION HISTORY OF THE ’467 PATENT
`
`The Petition purports to set forth a “new question of patentability.” (Petition
`
`at 9-10.) Specifically, Petitioner argues that it presents new arguments even though
`
`it relies on prior art that the examiner already considered. (Id. at 9.) This argument
`
`relies on the contention that the Klein Thesis (Ex. 1014) “disclos[es] the one
`
`independent claim limitation the Examiner could not find in the prior art, [and] was
`
`never substantively discussed during prosecution of the ’467 Patent,” as well as that
`
`the Klein Thesis “has far better disclosure than the references cited during
`
`prosecution.” (Petition at 9-10.) Petitioner never explains this contention, or
`
`supports it with evidence.
`
`Petitioner’s purportedly “new” argument is not new at all. It relies on the
`
`same or closely-related references that were previously applied by the examiner
`
`during prosecution. For example, the Klein Thesis is not “new” to the Office,
`
`because it considered by the examiner. Further, the Klein Thesis is merely a
`
`cumulative follow-on document. It builds on prior work that was described in other
`
`references,
`
`including
`
`the Alvarez-Diez publication (Ex. 1012)
`
`that was
`
`substantively considered by the examiner. It is also not “new” because the
`
`examiner considered similar publications that resulted from the underlying work
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`IPR2018-01449
`US Patent No. 9,299,467
`described in the Klein Thesis, including Klein-2004 (Ex. 1013). The Klein Thesis
`
`Patent Owner’s Preliminary Response
`
`
`
`also provides overlapping disclosures as compared to other Klein references that
`
`were analyzed by the examiner, including deKemp-848 (Ex. 1033). deKemp-848
`
`names Klein as a co-inventor in addition to Klein’s thesis adviser, deKemp. All of
`
`these references were considered during prosecution and were often discussed at
`
`length. The Petition effectively ignores them.
`
`Below, Patent Owner provides a brief Overview of the Petition, the
`
`individual references that are relied on in the Petition, and the prosecution histories
`
`of the ’467 patent family.1
`
`A. Overview of Petitioner’s art and arguments
`
`The Petition sets forth three grounds of invalidity:
`
`
`1 The descriptions in this Preliminary Response of the individual references that are
`
`relied on in the Petition are based at least in part on how those references are
`
`characterized in the Petition. Patent Owner notes, however, that it does not agree
`
`with all of the Petitioner’s characterizations of such references, and thus Petitioner
`
`specifically reserves the right to dispute such characterizations in the event the
`
`Board institutes review.
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`IPR2018-01449
`US Patent No. 9,299,467
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`Patent Owner’s Preliminary Response
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`
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`(Petition at 23.)
`
`The Petition primarily relies on the Klein Thesis for all three invalidity
`
`grounds. For Ground 2, Petitioner additionally relies on Tate with respect to claims
`
`11 and 22. (Petition at 61-64.) Petitioner’s reliance on Tate relates to dependent
`
`claim limitations requiring a shielding structure inside a cabinet and a computer
`
`carried by the cabinet. (Id.) For Ground 3, Petitioner additionally relies on the
`
`Bracco Manual with respect to claims 8 and 21. (Petition at 67.) Petitioner’s
`
`reliance on the Bracco Manual relates to dependent claim limitations directed to
`
`activity levels. (Id.)
`
`B.
`
`The art at issue in the Petition and during prosecution
`
`Petitioner admits that “the Office considered the references relied upon in
`
`this Petition during original prosecution[.]” (Petition at 9.) Nonetheless, Petitioner
`
`argues that it is presenting a new question of patentability on the basis that the Klein
`
`Thesis was not substantively discussed during prosecution. However, as shown
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`IPR2018-01449
`US Patent No. 9,299,467
`below, the art that is relied on in the Petition was analyzed during prosecution.
`
`Patent Owner’s Preliminary Response
`
`
`
`Indeed, the Office considered and substantively analyzed several references that are
`
`directly related to the work described in the Klein Thesis.
`
`As further shown below, the secondary references that Petitioner relies on
`
`were also analyzed by the examiner, or are cumulative of the Hirschman reference.
`
`Hirschman was heavily cited during prosecution, so Petitioner’s secondary
`
`references are merely cumulative of the art analyzed by the examiner.
`
`1.
`
`The “Klein” references
`
`The Klein Thesis is the primary reference cited by Petitioner. (Petition at 9-
`
`10.) In this section, Patent Owner provides a brief summary of the Klein Thesis
`
`and several closely-related publications that either name Ran Klein as an author or
`
`inventor, or provided the foundation for his thesis work.
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`Page 6 of 65
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`IPR2018-01449
`US Patent No. 9,299,467
`a)
`
`
`
`Patent Owner’s Preliminary Response
`
`Klein Thesis (Ex. 1014)2
`
`The Klein Thesis is a graduate thesis submitted based on Ran Klein’s work
`
`with the University of Ottawa Heart Institute (“UOHI”). Dr. Klein is the author
`
`identified on the cover page of the thesis, and Dr. Klein credits his advisors Robert
`
`deKemp and Andy Adler for their support with the project. (Ex. 1014-Klein at ii.)
`
`As Dr. Klein explains, his thesis describes the development of a Rubidium-
`
`82 infusion system for use in positron emission tomography (“PET”). (Id. at 1.)
`
`The infusion system described in the Klein Thesis built upon a system that was
`
`previously developed at UOHI:
`
`
`2 The Klein Thesis includes a February, 2005 date on its face. Petitioner attempts to
`
`show that the Klein Thesis was published and publicly accessible to those of
`
`ordinary skill in the art by at least January 26, 2007. (Petition at 17.) In support of
`
`this assertion, Petitioner references a declaration of Andy Adler, one of Dr. Klein’s
`
`thesis advisors, and the Wayback Machine. (Id.) For purposes of this Preliminary
`
`Response only, and without waiving its right to challenge the prior art status of the
`
`Klein Thesis in the future, Patent Owner does not currently address whether the
`
`Klein Thesis is prior art under 35 U.S.C. § 102. Patent Owner, however, reserves
`
`the right to do so in the future.
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`Page 7 of 65
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`IPR2018-01449
`US Patent No. 9,299,467
`“The first generation 82Rb elution system developed at the UOHI
`was described by Alvarez-Diez et al., 1999 [30].” (Ex. 1014-Klein
`at 16 (emphasis added).)
`
`Patent Owner’s Preliminary Response
`
`The Alvarez-Diez publication (Ex. 1012) referenced in the quote above is described
`
`in §III.B.1.c.
`
`The Klein Thesis explains:
`
`“[The Alvarez-Diez system] was based on an industrial PC running
`MS-DOS coupled to a LCD touch-screen. The software ensured
`that the daily protocol (discussed below) is followed and generated a
`recording of each elution. In addition, some rudimentary error
`detection was included. The system contained all the necessary
`components in a single cart, but had to be calibrated manually at a
`single flow rate … by monitoring an external dose calibrator during
`the calibration run.” (Id. at 17.)
`
`The Klein Thesis describes a system that has the same functionality and is based on
`
`the same hardware design as the Alvarez-Diez system:
`
`“The RbES had to ensure the same functionality as the first
`generation system, while adding constant-activity elution capability,
`improved user interface, and additional automation to reduce
`radiation exposure to the operator and patients. The system was
`based on the hardware design of the first generation system but had
`an updated computer system, user interface, and operating system
`which enabled more advanced developments.” (Id.)
`
`Page 8 of 65
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`IPR2018-01449
`US Patent No. 9,299,467
`Thus, the Klein Thesis describes a system that is closely-related to the first-
`
`Patent Owner’s Preliminary Response
`
`
`
`generation Alvarez-Diez system.
`
`The Klein Thesis also is not a standalone publication. In addition to its close
`
`relationship to the Alvarez-Diez system, the Klein Thesis resulted in additional
`
`publications authored by Ran Klein and others at UOHI, including deKemp and
`
`Adler. As of the February 2005 date listed on the Klein Thesis, the underlying
`
`work had already resulted in at least three additional publications:
`
`
`
`(Ex. 1014-Klein at 3.) The first bullet references the Klein-2004 publication that is
`
`in the IPR record as Ex. 1013.
`
`The Petition relies on the Klein Thesis for the vast majority of the claim
`
`limitations at issue in each of the three grounds. The Klein Thesis was in the
`
`prosecution record for the priority applications (see, e.g., Exs. 1007 at 394, 411;
`
`1009 at 708, 818; and 1010 at 582, 847). It was also considered by the examiner
`
`during the prosecution of the ’467 patent itself (Ex. 1011 at 202, 320). Although
`
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`IPR2018-01449
`US Patent No. 9,299,467
`the thesis itself was not directly discussed at length during prosecution, the
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`Patent Owner’s Preliminary Response
`
`
`
`prosecution histories reveal a repeated reliance on related Klein publications,
`
`including Klein-2004, Alvarez-Diez, and deKemp-848.
`
`b)
`
`Klein-2004 (Ex. 1013)
`
`One of the references that manifested from Dr. Klein’s thesis work is the
`
`Klein-2004 reference entitled “Precision Control of Eluted Activity from a Sr/Rb
`
`Generator for Cardiac Positron Emission Tomography.” (Ex. 1013-Klein at 1.)
`
`The Klein-2004 reference lists Dr. Klein as the lead author, followed by Dr. Klein’s
`
`two thesis advisers (Adler and deKemp) and R.S. Beanlands.
`
`The Klein-2004 reference was considered during prosecution of the ’467
`
`patent’s parent applications (see, e.g., Ex. 1007 at 138, 252; Ex. 1009 at 494, 559;
`
`Ex. 1010 at 578, 723), and was also substantively analyzed during prosecution of
`
`the ’467 patent. (Ex. 1011 at 84-88 and 110-24.)
`
`Klein-2004 includes a Rubidium-82 elution system diagram:
`
`The figure above depicts a system diagram that is nearly identical to the hardware
`
`design illustrated in Figure 2-2 of the Klein Thesis:
`
`
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`Page 10 of 65
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`IPR2018-01449
`US Patent No. 9,299,467
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`
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`Patent Owner’s Preliminary Response
`
`
`
`(Ex. 1014-Klein at 19.)
`
`Petitioner argues that the Klein Thesis presents a “new question of
`
`patentability” (Petition at 9-10), yet Petitioner’s only statement regarding
`
`differences between the Klein Thesis and Klein-2004 is the following:
`
`“Although Klein-2, deKemp ’848 and deKemp ’958 refer to
`undesirable effects of strontium breakthrough, none discloses a
`computer to test for such issues or to implement safety protocols
`when detected. (Ex. 1013, 1033, 1034).” (Petition at 10.)
`
`Significantly, Petitioner does not present any specific citations to Klein-2004 to
`
`support this statement. Indeed, the statement appears to be inconsistent with Klein-
`
`2004, which presents similar disclosures to those relied on in the Klein Thesis.
`
`(Compare Ex. 1014-Klein at 3 & FIG. 2-2 with Ex. 1013-Klein at FIG. 1 (including
`
`a “Computer” and reference to “control signals”).)
`
`Page 11 of 65
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`IPR2018-01449
`US Patent No. 9,299,467
`c)
`
`
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`Patent Owner’s Preliminary Response
`
`Alvarez-Diez (Ex. 1012)
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`The Alvarez-Diez reference names Teresa Alvarez-Diez as the lead author
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`and also lists deKemp as a co-author. (Ex. 1012-Alvarez-Diez at 1015.) As noted
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`above, the Klein Thesis explains that this reference describes a predecessor system
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`at UOHI. (Ex. 1014-Klein at 16-17.) Further, the Klein Thesis system was based
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`on the same hardware described in Alvarez-Diez. (Id.)
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`Alvarez-Diez is analyzed at length in the prosecution history of the ’467
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`patent. (See, e.g., Ex. 1011 at 52-59, 76-80, 83-88, 110-24.) Alvarez-Diez depicts
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`an automated patient delivery system (D) that is connected to a controlling
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`computer with a touch screen (C) on a stainless steel cart (G):
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`IPR2018-01449
`US Patent No. 9,299,467
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`Patent Owner’s Preliminary Response
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`(Ex. 1012-Alvarez-Diez at 1020.)
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`In Petitioner’s argument
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`regarding a purported “new question of
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`patentability” (Petition at 9-10), Petitioner’s only statement regarding differences
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`between the Klein Thesis and Alvarez-Diez is the following:
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`“Alvarez-Diez describes that a generator is connected to a delivery
`system only after initial quality control is finalized. Ex [sic] 1012,
`at 1020.” (Petition at 10 (emphasis in Petition).)
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`Petitioner’s citation to 1020 appears to refer to the following statement in Alvarez-
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`Diez:
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`US Patent No. 9,299,467
`“When the initial quality control of the 82Sr/82Rb generator is
`finalized, the generator is connected to an automated delivery
`system (Fig. 5).” (Ex. 1012-Alvarez-Diez at 1020.)
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`Patent Owner’s Preliminary Response
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`Petitioner does not explain this excerpt in any way. Petitioner also does not explain
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`how such a distinction is material in view of the Challenged Claims, given that it
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`appears to refer to connecting a patient to a generator (see caption text for Figure 5,
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`reproduced above). Petitioner further ignores that these passages relate to initial
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`quality control. (See, e.g., Ex. 1012-Alvarez-Diez at §2.4.) Accordingly, Petitioner
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`has provided no explanation for what additional disclosure in the Klein Thesis
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`renders its argument “new,” in view of the lengthy discussion of Alvarez-Diez
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`during prosecution.
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`d)
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`deKemp-848 (Ex. 1033)
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`deKemp-848 is a published patent application that lists Robert deKemp and
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`Ran Klein as inventors. This reference was analyzed at length during prosecution
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`of the ’467 patent. (See, e.g., Ex. 1011 at 83-88, 144-53, 170-81.) deKemp-848
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`was also analyzed in detail during prosecution of the parent applications. (See, e.g.,
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`Ex. 1010 at 176-83, 193, 197-217, 250-57, 271-89, 309-17, 330-47, 386-89, 401-
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`18, 483-89, 551-67, 838-45, 857-69, 907-15, 929-47.)
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`deKemp-848 depicts a similar elution system diagram to those shown above:
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`Patent Owner’s Preliminary Response
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`(Ex. 1033-deKemp-848 at FIG. 3.)
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`In Petitioner’s argument
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`regarding a purported “new question of
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`patentability” (Petition at 9-10), Petitioner’s only statement regarding differences
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`between the Klein Thesis and the deKemp references is the following:
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`“Although Klein-2, deKemp ’848 and deKemp ’958 refer to
`undesirable effects of strontium breakthrough, none discloses a
`computer to test for such issues or to implement safety protocols
`when detected. (Ex. 1013, 1033, 1034).” (Petition at 10.)
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`Petitioner does not present any specific citations to deKemp-848 to support this
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`statement. Indeed, Petitioner’s characterization again appears to be inconsistent
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`with the reference:
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`Patent Owner’s Preliminary Response
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`IPR2018-01449
`US Patent No. 9,299,467
`“[E]ach of the operating modes of the elution system is controlled
`by the controller unit 28 operating under software control. As a
`result, it is possible to implement a wide variety of automated
`processes, as required. Thus, for example, elution runs can be fully
`automated, based on user-entered target parameters, which allows
`the user to avoid unnecessary radiation exposure. Similarly, it is
`possible to automate desired system calibration and 82Sr break-
`through detection protocols, which ensures consistency as well as
`limiting radiation exposure of users.” (Ex. 1033-deKemp-848 at
`¶34; see also id. at FIG. 3; Ex. 1034-deKemp-958 at FIG. 1.)
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`Likewise, Petitioner’s assertion
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`that deKemp-848 does not disclose
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`“implement[ing] safety protocols” is wrong, as demonstrated by the following
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`description in deKemp-848:
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`“In the embodiment of FIG. 7, the controller 28 implements a
`threshold-based control algorithm, in which the generator valve 16
`is controlled by comparison of measured activity concentration to a
`desired activity concentration. If the measured concentration is
`higher than the desired concentration, the generator valve 16 directs
`saline flow to the bypass line 18 rather than the generator 8, and vice
`versa.” (Ex. 1034-deKemp at ¶36.)
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`2.
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`Petitioner’s secondary references
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`Petitioner’s invalidity grounds rely on the Klein Thesis alone (Ground 1) or
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`in combination with Tate (Ground 2) or the Bracco Manual (Ground 3). (Petition at
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`23.) Petitioner relies on Tate in an effort to show that “[m]oving Klein’s off-cart
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`dose calibrator and its shielding to an on-board location, as disclosed in Tate, is an
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`Patent Owner’s Preliminary Response
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`obvious alternative.” (Petition at 60.) Petitioner relies on the Bracco Manual for its
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`disclosure of a specific activity level of 1.0 millicurie per second. (Petition at 64.)
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`Petitioner’s reliance on both of these secondary references appears unrelated to its
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`“new question of patentability” argument. (Petition at 9-10.)
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`a)
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`Tate (Ex. 1022)
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`The Tate reference is Patent App. Pub. No. 2008/0177126 to Tate et al. (Ex.
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`1022-Tate at (76).) Tate was relied on during prosecution of the ’467 patent (Ex.
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`1011 at 83-88, 110-24) and was repeatedly relied on during prosecution of the ’467
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`patent’s parent applications. (See, e.g., Ex. 1010-FH at 196-217, 269-90, 329-47,
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`399-418, 549-66, 838-45, 855-69, 907-15, 927-48.)
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`Thus, Petitioner does not rely on anything in Tate that was not previously
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`evaluated during prosecution.
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`b)
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`The Bracco Manual (Ex. 1021)
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`Petitioner’s third invalidity ground requires the Bracco Manual in addition to
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`the Klein Thesis. (Petition at 23.) The Bracco Manual is entitled “RB-82 Infusion
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`System User’s Guide,” and the cover page includes a reference to “July 20, 2004”
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`and “Rev 07.” (Ex. 1021-Bracco at 1.)
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`Patent Owner’s Preliminary Response
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`(1)
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`Petitioner has not shown that the Bracco Manual is
`available as prior art
`Petitioner presents no evidence that the Bracco Manual qualifies as prior art
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`to the ’467 patent. Instead, Petitioner merely states in the Petition that the Bracco
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`Manual “issued at least as early as 2004” and that it is “prior art to the ’467 Patent
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`under 35 U.S.C. § 102(b).” (Petition at 19 & 22-23.)
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`A petitioner bears the burden of demonstrating that a reference is a printed
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`publication. See In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir.
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`2016). The touchstone of this inquiry is “public accessibility.” In re Hall, 781 F.2d
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`897-99 (Fed. Cir. 1986). A reference is shown to be publicly accessible if there is a
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`satisfactory showing that a reference has been “disseminated or otherwise made
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`available to the extent that persons interested and ordinarily skilled in the subject
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`matte