Trials@uspto.gov
`571-272-7822
`
`
`
`
`
` Paper 7
` Entered: February 8, 2019
`
`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 B2
`____________
`
`
`Before HYUN J. JUNG, GEORGE R. HOSKINS, and
`RICHARD H. MARSCHALL, Administrative Patent Judges.
`
`MARSCHALL, Administrative Patent Judge.
`
`DECISION TO INSTITUTE
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
` Paper 7
` Entered: February 8, 2019
`
`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 B2
`____________
`
`
`Before HYUN J. JUNG, GEORGE R. HOSKINS, and
`RICHARD H. MARSCHALL, Administrative Patent Judges.
`
`MARSCHALL, Administrative Patent Judge.
`
`DECISION TO INSTITUTE
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`IPR2018-01449
`Patent 9,299,467 B2
`
`
`INTRODUCTION
`I.
`Jubilant DraxImage Inc. (“Petitioner”) filed a Petition (Paper 1,
`“Pet.”) requesting institution of an inter partes review of claims 1–4, 6–16,
`and 18–22 of U.S. Patent No. 9,299,467 B2 (Ex. 1001, “the ’467 patent”).
`Bracco Diagnostics Inc. (“Patent Owner”) filed a Preliminary Response
`(Paper 6, “Prelim. Resp.”). Under 35 U.S.C. § 314, an inter partes review
`may not be instituted “unless . . . there is a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in
`the petition.”
`Upon consideration of the Petition and Preliminary Response and for
`the reasons explained below, we determine that Petitioner has shown that
`there is a reasonable likelihood that it would prevail with respect to at least
`one of the challenged claims. As such, we institute an inter partes review of
`all challenged claims on all presented challenges, and thus, institute an inter
`partes review of claims 1–4, 6–16, and 18–22 of the ’467 patent.
`
`BACKGROUND
`
`II.
`A. Related Proceedings
`The parties indicate that the ’467 patent has been asserted in Bracco
`Diagnostics Inc. v. Jubilant DraxImage Inc., Case No. 3-18-cv-04422
`(D.N.J.). Pet. 2; Paper 4, 2; Exs. 1002, 1004. A related patent,
`U.S. Patent No. 9,299,468 B2, claims priority to applications in common
`with the ’467 patent, and is the subject of challenges in Cases IPR2018-
`01448 and IPR2018-01450. Pet. 2; Paper 4, 2.
`B. The ’467 Patent (Ex. 1001)
`The ’467 patent issued March 29, 2016, from an application filed
`August 8, 2014, which is a continuation of an application filed June 11,
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`2009, which, in turn, is a continuation of four applications filed June 11,
`2008. Ex. 1001, [22], [45], [63], 1:8–19.
`The ’467 patent relates to “systems that generate and infuse
`radiopharmaceuticals.” Id. at 1:23–24. Figure 1D of the ’467 patent is
`reproduced below.
`
`
`
`Figure 1D is “a schematic of an infusion circuit.” Id. at 2:8–9.
`Infusion system 10 can be mobile and may incorporate infusion circuit 300,
`a part of which is contained within shielding assembly 200. Id. at 3:46–50,
`4:47–56, Fig. 1A. Infusion circuit 300 includes eluant reservoir 15 that
`contains saline as the eluant, syringe pump 33 that pumps eluant from
`reservoir 15, radioisotope generator 21 through which eluant is pumped to
`create a radioactive eluant, and activity detector 25 that measures the activity
`of the eluant from generator 21. Id. at 4:59–5:5. Activity detector 25 also
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`provides feedback for directing the eluant via divergence valve 35WP1 to
`either waste bottle 23 or patient line 305p. Id. at 5:4–8. Divergence valve
`35BG directs eluant to either tubing line 304 to generator 21 or to by-pass
`tubing line 303 and patient line 305p. Id. at 5:35–39.
`“[A]ccording to alternate embodiments, system 10 includes an ‘on
`board’ dose calibrator for quality control tests, and circuit 300 is expanded to
`include elements for an automated collection of eluate samples for activity
`measurements, via the on board dose calibrator,” such as “downstream of
`divergence valve 35WP and in communication with tubing line 305P.” Id.
`at 7:64–8:5; see also id. at 18:48–52 (stating “some alternate embodiments .
`. . include an on board dose calibrator so that the entire sequence of sample
`collection and calculation steps . . . for the quality control procedures, may
`be automated”).
`Also, in some embodiments, “computer 17 is coupled to a controller
`of system 10” and “monitor 172 of computer 17 not only displays
`indications of system operation for a user of system 10, but also serves as a
`device for user input (e.g. touch screen input).” Id. at 3:22–27. The user can
`interact with menus on computer 17 to perform breakthrough testing. Id. at
`16:48–51. Computer 17 may calculate and display the breakthrough test
`results and may also display the allowable limits for those test results. Id. at
`17:50–54. “[S]ystem 10 will not allow an infusion if the results exceed the
`acceptable limits.” Id. at 17:57–58.
`
`
`1 The “Detailed Description” of the ’467 patent describes valve 35WP;
`however, Figure 1D labels the valve as “35WAP.”
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`C. Illustrative Claim
`The ’467 patent has 22 claims, of which Petitioner challenges claims
`1–4, 6–16, and 18–22 in this proceeding. Of those, claims 1 and 13 are
`independent. Claim 1 is reproduced below.
`1. A system comprising:
`a shielding assembly configured to contain a radioisotope
`generator that generates radioactive eluate via elution;
`a computer carried by the shielding assembly, wherein the
`computer is configured to receive a user input and, responsive
`to receiving the user input, control the radioisotope generator
`to generate a sample of eluate via elution during breakthrough
`testing; and
`a dose calibrator electronically coupled to the computer and
`configured to measure an activity of the sample of eluate
`generated during breakthrough testing,
`wherein the computer carried by the shielding assembly is
`configured to receive the activity data from the dose calibrator
`and calculate breakthrough test results, and
`the computer is further configured to prevent a patient infusion
`procedure if a breakthrough test result exceeds an allowable
`limit.
`Ex. 1001, 23:48–64.
`D. Evidence Relied Upon by Petitioner
`Petitioner identifies the following references as prior art in the
`asserted grounds of unpatentability:
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`Ran Klein, Precise 82Rb Infusion System for Cardiac Perfusion
`Measurement Using 3D Positron Emission Tomography (20062) (Ex. 1014,
`“Klein”);
`U.S. Patent Application Publication No. US 2008/0177126 A1,
`published July 24, 2008 (Ex. 1022, “Tate”); and
`Bracco Diagnostics Inc., RB-82 Infusion System User’s Guide (rev.
`07, 2004) (Ex. 1021, “Bracco Manual”).
`Also, the Petition is supported by the Declaration of Robert T. Stone,
`Ph.D. (Ex. 1015).
`E. Asserted Grounds
`Petitioner challenges (1) claims 1–4, 6, 7, 9, 10, 12–16, and 18–20
`under 35 U.S.C. § 102(b) as anticipated by Klein; (2) claims 11 and 22 under
`35 U.S.C. § 103 as unpatentable over Klein and Tate; and (3) claims 8 and
`21 under 35 U.S.C. § 103 as unpatentable over Klein and the Bracco
`Manual. Pet. 23–67.
`
`III. ANALYSIS
`A. Claim Construction
`In this inter partes review, claim terms in an unexpired patent are
`interpreted according to their broadest reasonable construction in light of the
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
`
`
`2 The cover page of Klein has a February 2005 date and 2005 copyright.
`Petitioner contends that Klein was publicly available in 2006. Pet. 17 (citing
`Ex. 1020 ¶ 4, attachments B, C).
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`Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016)
`(upholding the use of the broadest reasonable interpretation standard).3
`Petitioner states that “[a]ll claim terms have been assigned their
`ordinary and customary meaning in this analysis.” Pet. 12. Patent Owner
`responds that claim interpretation is not pertinent to its arguments but
`reserves the right to propose relevant claim interpretations if review is
`instituted. Prelim. Resp. 2–3.
`For the purposes of determining whether Petitioner demonstrates a
`reasonable likelihood of prevailing in its challenges, we determine that no
`express interpretation is required for any claim term. Vivid Techs., Inc. v.
`Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (construing
`explicitly only those claim terms in controversy and only to the extent
`necessary to resolve the controversy).
`B. Level of Ordinary Skill in the Art
`Petitioner contends that a person having ordinary skill in the art would
`have a
`graduate’s degree with some emphasis in equipment design,
`automation, or controls, such as electrical engineering, systems
`engineering, mechanical engineering, or a related field, or an
`undergraduate degree in such fields with two to three years’ work
`experience in radioactive protection systems or in medical device
`product,
`automation,
`or
`instrumentation
`design
`and
`
`
`3 On October 11, 2018, the Office revised its rules to harmonize the Board’s
`claim construction standard with that used in federal district court.
`CHANGES TO THE CLAIM CONSTRUCTION STANDARD FOR INTERPRETING
`CLAIMS IN TRIAL PROCEEDINGS BEFORE THE PATENT TRIAL AND APPEAL
`BOARD, 83 Fed. Reg. 51340 (Oct. 11, 2018). This rule change, however,
`applies to petitions filed after November 13, 2018, so the revised claim
`construction standard does not apply to this proceeding. Id.
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`development, including work with prototypes and finished
`commercial products.
`Pet. 10–11.
`Patent Owner disagrees with Petitioner’s proposed level of ordinary
`skill but does not propose a level of ordinary skill at this stage of the
`proceeding. Prelim. Resp. 2. Patent Owner, instead, asserts that the level of
`ordinary skill is not pertinent to its arguments and reserves the right to
`provide its definition if review is instituted. Id.
`We preliminarily adopt Petitioner’s asserted level of ordinary skill
`solely to determine whether there is a reasonable likelihood that Petitioner
`would prevail with respect to at least 1 of the claims challenged in the
`Petition.
`C. Challenge Under 35 U.S.C. § 102
`Petitioner challenges claims 1–4, 6, 7, 9, 10, 12–16, and 18–20 as
`anticipated by Klein. Pet. 23–55. Petitioner’s anticipation arguments
`include challenges to independent claims 1 and 13. Id. at 23–33, 42–48. For
`these challenges, Petitioner cites to the asserted reference and declarant
`testimony. Id.
`Patent Owner responds that, because the same or substantially the
`same prior art and arguments were presented during prosecution of the ’467
`patent, we should exercise our discretion under 35 U.S.C. § 325(d) and deny
`institution. Prelim. Resp. 26–64. We address that issue further below.
`For the reasons discussed below, Petitioner has shown that there is a
`reasonable likelihood that it would prevail with respect to at least
`independent claims 1 and 13. Therefore, we institute review of all
`challenged claims on all presented challenges. See 35 U.S.C. § 314(a).
`
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`1. Klein (Ex. 1014)
`Klein is a student thesis that “describes the development of a
`Rubidium-82 (82Rb) infusion system for use in positron emission
`tomography (PET)” and “is based on a 82Sr/82Rb generator which produces
`82Rb activity continuously.” Ex. 1014, 1.4 Klein “introduces the second
`generation 82Rb elution system (RbES).” Id. Figure 2-2 of Klein is
`reproduced below. Id. at 19.
`
`
`Figure 2-2 is a hardware component diagram of an RbES prototype.
`Id. It includes a personal computer that interfaces with sensors and actuators
`to allow flow of saline through a 82Sr/82Rb generator or a bypass line to the
`patient, dose calibrator, or waste container. Id. It also includes flow control
`valves, activity counter, pump, and pressure sensor. Id. at 21–23. “All the
`components are assembled in a stainless steel cart.” Id. at 23; see also id. at
`34 (stating that the “waste container is located on the top shelf inside the cart
`and is contained within lead shielding to minimize exposure to the
`
`4 Our citations to Klein are to the page numbers found in the bottom center
`of each page.
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`operator”), Figs. 2-3, 2-4 (showing in photographs the assembled system
`with its components, most of which are on a cart and the top of the cart).
`According to Klein, the “system is required to operate in a clinical setting
`and therefore must be reliable, easy to operate, and above all, safe.” Id. at
`26. Among the issues that needed attention was “automating the system and
`allowing monitoring from a distance,” and although automation was mostly
`achieved, “breakthrough activity measurement remained a manual function.”
`Id.
`
`Klein states that “82Rb can be supplied using a 82Sr/82Rb generator.”
`Id. at 8. Klein also states that “82Sr and 85Sr ‘breakthrough’ can result if the
`generator is used indefinitely” and “[i]n high quantities these compounds
`may have ill effects on health.” Id. at 9. Klein describes that if there is an
`indication of excessive strontium breakthrough, then “elution to patients
`should be avoided.” Id. at 10; see also id. at 33 (stating that the “amount of
`Sr breakthrough activity must be strictly limited to the Health Canada
`guidelines”).
`Klein also describes a daily protocol “intended for routine system
`maintenance, system diagnostics, and clinical preparation of the system,”
`which includes a calibration run. Id. at 17–18. Klein states that “[o]nly after
`a calibration run with low Sr breakthrough has been successfully completed
`can patient elutions be carried out,” and “[o]nce the daily protocol has been
`completed successfully, patient elutions are enabled until the end of the
`day.” Id. at 18; see also id. at 33 (stating that the “issue is addressed by
`daily breakthrough tests as part of the daily protocol ensured by the
`system”), 43 (stating that “certain maintenance measures must be carried out
`as dictated by the daily protocol” and “Sr breakthrough must be measured
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`and a complete system test must follow”), 44 (stating that “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”),
`50–52 (describing breakthrough measurement).
`2. Discussion
`We begin our analysis by addressing Petitioner’s argument that Klein
`discloses all of the limitations of independent claims 1 and 13. Petitioner
`provides detailed claim charts with citations to Klein that correspond to each
`of the claim limitations. Pet. 23–33 (addressing claim 1), 42–48 (addressing
`claim 13). Petitioner also cites to the relevant declarant testimony. Pet. at
`23–33 (citing various sections of Ex. 1015 § XI.A), 42–48 (citing various
`sections of Ex. 1015 § XI.J). Petitioner alleges that the claims were allowed
`because the prior art addressed by the Examiner allegedly failed to disclose
`preventing infusion if the breakthrough test results exceeded an allowable
`threshold. Id. at 9. Petitioner alleges that Klein discloses this limitation by
`describing “infusion system software [that] must ensure that the protocol is
`followed (i.e. that each run is enabled only after the prerequisites have been
`completed successfully).” Pet. 33 (quoting Ex. 1014, 44). Petitioner also
`relies on Klein’s description of the “daily protocol” as “including a test of
`breakthrough activity.” Id. (quoting Ex. 1014, 55); see also Pet. 48 (relying
`on same Klein disclosures with respect to similar limitation in independent
`claim 13).
`Patent Owner does not address Petitioner’s specific anticipation
`arguments, or argue that the cited portions of Klein, in combination with the
`declarant testimony, do not support Petitioner’s contentions. Nevertheless,
`in its arguments that we should exercise our discretion under 35 U.S.C.
`
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`§ 325(d), which we address below, Patent Owner contends that Klein does
`not disclose a computer configured to prevent patient infusions when
`breakthrough issues are detected. See Prelim. Resp. 35 (“None of the Klein
`references disclose a computer that prevents patient infusions as claimed.”),
`37. Patent Owner reviews the evidence Petitioner relies upon with respect to
`this limitation, and argues that Petitioner’s argument amounts to an assertion
`that Klein “indicates that a daily protocol is run and, if breakthrough activity
`exceeds an allowable limit, a generator cannot be used on humans.” Prelim.
`Resp. 38–39 (citing Pet. 33, 48; Ex. 1014, 18, 29, 33, 44, 50, 55, 122).
`As to Patent Owner’s argument, at this stage of the proceeding,
`Petitioner’s citation to relevant portions of Klein describing software that
`prevents infusion in the event of breakthrough activity establishes
`adequately that Klein discloses this limitation in both independent claim 1
`and independent claim 13. See Pet. 32–33, 47–48. Patent Owner’s
`summary of Petitioner’s argument does not acknowledge that a computer
`programmed with “system software” ensures the daily protocol is followed,
`and the daily protocol includes breakthrough activity measurements. See
`Prelim. Resp. 39; Ex. 1014, 18, 19, 29, 33, 43–44, 55, 122. Moreover,
`Petitioner’s supporting declarant testimony has not yet been rebutted. See
`Ex. 1015 ¶¶ 240–249 (addressing claim 1), 335–344 (addressing claim 13).
`We are satisfied, based on the current record, that Petitioner makes a
`showing sufficient for institution that Klein teaches or suggests “the
`computer is further configured to prevent a patient infusion procedure if a
`breakthrough test result exceeds an allowable limit,” as recited by claim 1,
`and “preventing, with the computer, a patient infusion procedure if a
`breakthrough test result exceeds an allowable limit,” as recited by claim 13.
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`Pet 32–33 (citing Ex. 1014, 18, 19, 33, 44, 55, 122; Ex. 1015 § XI.A.7,
`¶ 248), 47–48 (citing Ex. 1014, 18, 29, 33, 44, 55,5 122; Ex. 1015 § XI.J.5,
`¶ 343).
`
`3. Conclusion and Institution
`After considering the evidence and arguments presented in the
`Petition and Preliminary Response, we determine that Petitioner has
`demonstrated a reasonable likelihood that it would prevail with respect to
`independent claims 1 and 13.
`Patent Owner has not yet presented its arguments and evidence
`against Petitioner’s challenge of dependent claims 2–4, 6, 7, 9, 10, 12, 14–
`16, and 18–20 as anticipated by Klein. Based on our review of Petitioner’s
`arguments and evidence for these claims, we determine that Petitioner
`provides a sufficient showing for institution that Klein discloses the
`additional limitations of dependent claims 2–4, 6, 7, 9, 10, 12, 14–16, and
`18–20.
`Accordingly, we determine Petitioner has shown a reasonable
`likelihood of establishing that claims 1–4, 6, 7, 9, 10, 12–16, and 18–20 are
`unpatentable as anticipated by Klein. As such, we institute inter partes
`review of all challenged claims on all presented challenges. See 35 U.S.C.
`§ 314(a); SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018).
`D. Challenges Under 35 U.S.C. § 103
`Petitioner challenges dependent claims 11 and 22 as unpatentable over
`Klein and Tate. Pet. 56–64. Petitioner challenges claims 8 and 21 as
`unpatentable over Klein and the Bracco Manual. Id. at 64–67. For all of
`
`
`5 The Petition cites to Klein’s page 50, but based on the quoted material, the
`correct cite is to page 55 of Klein. See Pet. 48; Ex. 1014, 55.
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`these challenges, Petitioner cites to the asserted references and declarant
`testimony. Id. at 56–67.
`Patent Owner responds that, because the same or substantially the
`same prior art and arguments were presented during prosecution of the ’467
`patent, we should exercise our discretion under 35 U.S.C. § 325(d) to deny
`institution. Prelim. Resp. 25–64. Patent Owner also responds that Petitioner
`inadequately shows that the Bracco Manual is prior art. Id. at 18–19.
`1. Dependent Claims 11 and 22
`Claim 11 depends from claim 1, and claim 22 depends from claim 13.
`Ex. 1001, 24:27–30, 25:7–9. Both claims require “a cabinet structure,”
`wherein the “shielding assembly is positioned inside” the cabinet structure
`and the “computer is carried by the cabinet structure.” Id. For claims 11
`and 22, Petitioner argues that Klein fails to disclose a shielding assembly
`positioned inside the cabinet structure as required by these claims, but that
`Tate discloses this limitation. Pet. 56–57. Petitioner provides a claim chart
`that indicates where Klein and Tate teach the limitations of claims 11 and
`22, and Petitioner’s relevant declarant testimony. Id. at 61–64. Petitioner
`contends that one of ordinary skill in the art would have been motivated to
`combine Klein and Tate. See id. at 57–59. Petitioner also argues that one of
`ordinary skill in the art would have had a reasonable expectation of success
`in making the combination. Id. at 59–60.
`Tate “relates to methods, systems and components thereof for
`delivering pharmaceutical substances to patients for imaging procedures.”
`Ex. 1022 ¶ 2. Figure 1E of Tate is reproduced below.
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`Figure 1E shows a cross-sectional view of a fluid delivery system. Id.
`¶¶ 32, 36. Preferably, fluid delivery system 10 is a cart-like apparatus 9 and
`includes system controller 5 (preferably a single-board computer) that
`communicates with graphical user interface 15, pumps, dose calibrator or
`ionization chamber 160, and other components. Id. ¶¶ 70, 84.
`Fluid delivery system 10 also includes lid or cover 20, which
`preferably includes radioactive shielding to minimize radiation exposure
`from a radiopharmaceutical. Id. ¶¶ 72, 73; see also id. ¶¶ 9, 10, 87
`(describing that long-term radiation exposure can pose a health risk,
`shielding personnel from a radiation source minimizes radiation exposure,
`and recessed portions are preferably encased with suitable radioactive
`shielding to minimize exposure). Also, radiopharmaceutical vial or
`container 902 is in vial shield or PIG 554. Id. ¶ 79.
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`Patent Owner does address any of Petitioner’s specific arguments with
`respect to claims 11 and 22, or the related contentions regarding the
`disclosures of Klein and Tate.
`2. Dependent Claims 8 and 21
`Claim 8 depends from claim 7, and claim 21 depends from claim 20.
`Ex. 1001, 24:20–21, 25:5–6. Both claims require a “given level of activity”
`of “approximately 1.0 millicurie per second.” Id. Petitioner contends that
`claims 8 and 21 are unpatentable over Klein and the Bracco Manual. Pet.
`64–67. A claim chart includes citations to where the asserted references
`teach limitations of claims 8 and 21, with citations to supportive declarant
`testimony. Id. at 67. Petitioner also contends with declarant testimony
`support that one of ordinary skill in the art would have been motivated to
`combine the teachings of these references. Id. at 65–66. Petitioner
`additionally contends that one of ordinary skill in the art would have had a
`reasonable expectation of success in combining the teachings of Klein and
`the Bracco Manual. Id. at 66–67.
`The Bracco Manual is a user’s guide for the Rb-82 Infusion System
`manufactured for Bracco Diagnostics Inc. Ex. 1021, cover. “The Rb-82
`Infusion System is a complete system for the generation and delivery of Rb-
`82 from a CardioGen®-82 generator (Sr-82/Rb-82 generator) to a patient for
`cardiovascular nuclear medicine procedures,” and the Rb-82 is “eluted in
`sterile normal saline for direct injection into a patient.” Id. at 1. The Bracco
`Manual’s system “is a mobile, self-contained cart complete with a shield for
`a CardioGen®-82 generator, a waste bottle shield, a saline syringe pump,
`sterile tubing and valve components, a positron detector, and all of the
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`support electronics necessary to administer controlled levels of Rb-82
`activity to a patient.” Id.
`The Bracco Manual discloses an automatic infusion mode “for
`delivering a pre-selected quantity of Rb-82 eluate into the patient.” Id. at 4.
`In that mode, the Bracco Manual discloses a “required dose-rate threshold of
`1.0 mCi/sec” that must be exceeded before “Rb-82 eluate is directed to the
`patient line.” Id.
`For this challenge, Patent Owner responds that Petitioner has not
`shown that the Bracco Manual is available as prior art because:
`Merely identifying a date on the face of a document (e.g.,
`copyright and similar dates) is not sufficient to establish
`publication and public accessibility because such dates usually
`only show when a document or revision was created and have no
`bearing on whether a document was sufficiently accessible to
`those of ordinary skill in the art.
`Prelim. Resp. 18.
`For the reasons above, we determine that Petitioner demonstrates a
`reasonable likelihood that it would prevail with respect to at least 1 of the
`claims challenged in the Petition, and thus, review is instituted on all
`challenged claims on all presented challenges. Therefore, whether Petitioner
`has sufficiently established that the Bracco Manual was available as prior art
`can be analyzed further after full development of the record. See also
`37 C.F.R. § 42.64 (providing requirements for objections to evidence,
`supplemental evidence, and motion to exclude). We note that the cover of
`the Bracco Manual indicates that Patent Owner created the Bracco Manual
`and thus, may likely possess information relevant to public accessibility of
`the Bracco Manual in the relevant time frame.
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`3. Conclusion for Obviousness Challenges
`For the reasons above, we determine that Petitioner demonstrates that
`it would prevail with respect to at least 1 of the claims challenged in the
`Petition, and thus, we institute review on all challenged claims on all
`presented challenges, including these obviousness challenges. Patent Owner
`also has not yet presented its arguments and evidence against Petitioner’s
`challenges of claims 8, 11, 21, and 22. In addition, Petitioner has not fully
`addressed the issues Patent Owner raises regarding the availability of the
`Bracco Manual as prior art. Therefore, we determine that further analysis of
`Petitioner’s challenge of dependent claims 8, 11, 21, and 22 is best left for
`trial after full development of the record.
`E. 35 U.S.C. § 325(d)
`Petitioner states that the “Office considered the references relied upon
`in this Petition,” but “Klein (Ex. 1014) has far better disclosure than the
`references cited during prosecution.” Pet. 9–10. According to Petitioner,
`certain of the references cited during prosecution do not disclose a computer
`that completes breakthrough testing or implements safety protocols when
`breakthrough is detected, and thus, “the Office has not considered the
`patentability issues presented in the instant Petition.” Id. at 10 (citing Exs.
`1012, 1013, 1033, 1034).
`Patent Owner responds that the “Board should exercise its discretion
`under § 325(d) and deny institution” because Petitioner “relies on essentially
`the same disclosures from the same or cumulative prior art references.”
`Prelim. Resp. 25. Patent Owner presents its analysis of the factors identified
`in Becton Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-
`
`
`
`18
`
`
`
`IPR2018-01449
`Patent 9,299,467 B2
`
`01586, slip op. at 17–18 (PTAB Dec. 15, 2017) (Paper 8) (informative). Id.
`at 28–64.
`In particular, Patent Owner argues that Klein is related closely to
`references considered during prosecution. Id. at 29–30, 43–44. Patent
`Owner faults Petitioner for failing to compare Klein to those references in
`support of its assertion that Klein provides “better disclosure” and argues
`that alleged differences do not exist. Id. at 31–35. Patent Owner also argues
`that Petitioner fails to explain which limitations were not found during
`prosecution. Id. at 60–61. Patent Owner additionally argues that Petitioner
`presents arguments similar to those made by the Examiner. Id. at 48–59.
`According to Patent Owner, Petitioner improperly views in isolation the
`other references asserted in the Petition, Klein fails to disclose the one
`limitation allegedly missing from the prior art cited by the Examiner, the
`other asserted references were considered during prosecution or are
`cumulative of those references, and Petitioner merely rearranges these
`references. Id. at 36–42, 44–47.
`Our review of the prosecution history of the ’467 patent indicates that
`the Examiner did not find prior art teachings related to the limitations
`requiring “the computer is further configured to prevent a patient infusion
`procedure if a breakthrough test result exceeds an allowable limit,” as
`recited by claim 1, and “preventing, with the computer, a patient infusion
`procedure if a breakthrough test result exceeds an allowable limit,” as
`recited by claim 13. See Ex. 1011, 15, 53, 57–58, 76, 78–80, 83–88. As
`discussed above, Petitioner’s argument and evidence adequately shows at
`this stage that Klein teaches or suggests these limitations of claims 1 and 13.
`Therefore, we agree that Klein provides a better disclosure than the
`
`
`
`19
`
`
`
`IPR2018-01449
`Patent 9,299,467 B2
`
`references considered in detail during prosecution because, based on the
`current record, Petitioner sufficiently shows for institution that Klein teaches
`or suggests these limitations of claims 1 and 13. Because the references
`applied by the Examiner may not have taught these limitations, but Klein
`indicates that the prior art may have taught or suggested the same
`limitations, we agree with Petitioner that the Office has not considered the
`issues presented in the Petition.
`Further, we disagree with Patent Owner’s assertion that the
`Examiner’s consideration of related references in an obviousness rejection
`“closely mirrors Petitioner’s asserted invalidity grounds” based on
`anticipation by Klein. See Prelim. Resp. 48, 49–59. The references are not
`the same as Klein, and the statutory basis is not the same. In addition, the
`record does not reveal any analysis by the Examiner of the relevant portions
`of Klein that Petitioner relies upon in the Petition to teach the “preventing
`infusion” limitation, or any other art with the same disclosure as Klein. See
`Pet. 32–33, 48. Accordingly, minimal overlap exists between the portion of
`the prosecution history Patent Owner relies upon and the assertions made in
`the Petition.
`Based on the foregoing, we decline to exercise our discretion under
`35 U.S.C. § 325(d) to deny the Petition.
`
`IV. CONCLUSION
`Because Petitioner has shown that there is a reasonable likelihood that
`it would prevail with respect to at least one of the challenged claims, we
`institute an inter partes review of all challenged claims on all presented
`challenges.
`
`
`
`20
`
`
`
`IPR2018-01449
`Patent 9,299,467 B2
`
`At this stage of the proceeding, the Board has not made a final
`
`determination as to the patentability of any challenged claim or any
`underlying factual and legal issues.
`
`V. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
`review of claims 1–4, 6–16, and 18–22 of U.S. Patent No. 9,299,467 B2 is
`instituted with respect to all grounds set forth in the Petition; and
`FURTHER ORDERED that, pursuant to 35 U.S.C. § 314(c) and
`37 C.F.R. § 42.4(b), inter partes review of U.S. Patent No. 9,299,467 B2
`shall commence on the entry date of this Order, and notice is hereby given of
`the institution of a trial.
`
`For PETITIONER:
`Robert Hails
`T. Cy Walker
`Theresa Weisenberger
`BAKERHOSTETLER
`rhails@bakerlaw.com
`cwalker@bakerlaw.com
`tweisenberger@bakerlaw.com
`
`For PATENT OWNER:
`Barry Schindler
`Heath Briggs
`Lennie Bersh
`GREENBERG TRAURIG, LLP
`SchindlerB@gtlaw.com
`BriggsH@gtlaw.com
`BershL@gtlaw.com
`
`
`
`21
`
`
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