Trials@uspto.gov
`571-272-7822
`
`
`
`
`
` Paper 28
` Entered: February 6, 2020
`
`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.
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
` Paper 28
` Entered: February 6, 2020
`
`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.
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(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). Pursuant to 35 U.S.C. § 314, we instituted an inter partes review
`of claims 1–4, 6–16, and 18–22 the ’467 patent, on all presented challenges.
`Paper 7 (“Dec. to Inst.”), 2, 21. After institution, Patent Owner filed a
`Response (Paper 13, “PO Resp.”), to which Petitioner filed a Reply (Paper
`14, “Pet. Reply”), and Patent Owner filed a Sur-Reply (Paper 15, “PO Sur-
`Reply”). An oral hearing in this proceeding was held on October 29, 2019; a
`transcript of the hearing is included in the record (Paper 24, “Tr.”).
`We have jurisdiction under 35 U.S.C. § 6. This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`For the reasons that follow, we determine that Petitioner has shown by a
`preponderance of the evidence that claims 1–4, 6–16, and 18–22 of the
`’467 patent are unpatentable.
`
`BACKGROUND
`
`II.
`A. Real Parties in Interest
`Petitioner states that the “real parties-in-interest for this Petition are
`Jubilant DraxImage Inc., Jubilant Pharma Limited, and Jubilant Life Science
`Limited.” Pet. 2. Patent Owner states that “Bracco Diagnostics Inc.
`(‘Bracco’) . . . is the real party-in-interest.” Paper 4, 2.
`B. 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
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`(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 IPR2018-01448 and
`IPR2018-01450. Pet. 2; Paper 4, 2.
`The parties also indicate that the district court litigation is stayed
`pending resolution of Investigation No. 337-TA-1110 by the U.S.
`International Trade Commission (“ITC” or “Commission”). Pet. 2 (citing
`Exs. 1002–1004); PO Resp. 2 (citing Exs. 1002–1004); Ex. 1004 (order
`from civil action no. 3:18-cv-4422 granting joint motion to stay pending
`resolution of ITC Investigation No. 337-TA-1110).
`In the ITC investigation filed March 27, 2018, Bracco Diagnostics,
`Inc. contends that Jubilant DraxImage Inc., Jubilant Pharma Limited, and
`Jubilant Life Sciences violate Section 337 of the Tariff Act of 1930 by
`importing strontium-rubidium infusion systems and components that
`infringe one or more of U.S. Patent Nos. 9,814,826; 9,750,869; and
`9,750,870. Ex. 1003, 1, 14. The ’467 patent is not part of the ITC
`investigation, but Patent Owner indicates that the investigation “involv[es]
`related patents.” PO Resp. 2 (citing Exs. 1002–1004). Patent Owner also
`states that “an ITC evidentiary hearing was held April 11–17 relative to the
`related patents, and many of the same factual issues disputed there are also
`in dispute here.” Id.
`Patent Owner subsequently filed a “Notice of Commission
`Determination to Review in Part a Final Initial Determination Finding No
`Section 337 Violation.” Paper 19; Ex. 2018 (notice from Investigation No.
`337-TA-1110 issued Sept. 30, 2019). The notice states that a Final Initial
`Determination (“FID”) was issued on August 1, 2019, “the FID finds . . . all
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`asserted claims are infringed but invalid as obvious over the prior art,” and
`the “Commission has determined to review the FID in part.” Ex. 2018, 2.
`Petitioner filed a “Notice of Commission Final Determination of No
`Violation of Section 337; Termination of the Investigation.” Paper 25, 1;
`Ex. 1039. According to Petitioner, “Ex. 1039 indicates that the Commission
`determined to affirm with modification and to supplement the prior Final
`Initial Determination’s findings with respect to the invalidity of the patent
`claims asserted in the 1110 Investigation.” Paper 25, 1 (citing Ex. 1039, 2);
`Ex. 1039, 2 (stating that “the Commission has determined to affirm with
`modification and to supplement the FID’s findings with respect to the
`invalidity of the asserted patent claims”).
`Petitioner also filed a public version of a Commission Opinion for
`Investigation No. 337-TA-1110. Paper 26; Ex. 1040. Petitioner states that
`the “Commission Opinion addresses several issues that are relevant to the
`present inter partes review.” Paper 26, 1. According to Petitioner, “the
`Commission considered teachings of the Klein reference against claim
`elements that require a computer not to allow a patient infusion when a
`strontium breakthrough test result is greater than or equal to an allowed
`limit, holding that Klein teaches or discloses such subject matter.” Id.
`(citing Ex. 1040, 24–26). Petitioner also states that “the Commission
`evaluated and rejected testimony from Bracco’s expert, Dr. Norbert Pelc, on
`several issues.” Id. (citing Ex. 1040, 18, 20–21, 25–26). Patent Owner has
`filed an appeal of the Commission Opinion. Ex. 2019.
`C. 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, codes (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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`D. 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.
`E. Evidence Relied Upon by Petitioner and Patent Owner
`Petitioner identifies the following references as prior art in the
`asserted grounds of unpatentability:
`
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`35 U.S.C. §
`102(b)3
`
`Klein
`
`Reference(s)/Basis
`
`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”).
`Petitioner also relies upon the Declaration of Robert T. Stone, Ph.D.
`(Ex. 1015) and the Declaration of Venkatesh L. Murthy, M.D., Ph.D.
`(Ex. 1017). Patent Owner filed a Declaration of Norbert J. Pelc, Sc.D.
`(Ex. 2003) and deposition transcripts for Dr. Stone and Dr. Murthy
`(Exs. 2010, 2016).
`F. Asserted Grounds
`Petitioner challenges claims 1–4, 6–16, and 18–22 on the following
`grounds. Pet. 23–67.
`Claim(s) Challenged
`1–4, 6, 7, 9, 10, 12–
`16, 18–20
`11, 22
`
`103(a)
`
`Klein, Tate
`
`
`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).
`3 The relevant sections of the Leahy-Smith America Invents Act (“AIA”),
`Pub. L. No. 112–29, 125 Stat. 284 (Sept. 16, 2011), took effect on March 16,
`2013. The application from which the ’467 patent issued was filed in
`August 2014, but asserts continuation priority to several applications filed
`before March 2013. Because there is no argument in the record to suggest
`the AIA version of Title 35 applies to the ’467 patent, our citations to Title
`35 are to the pre-AIA version.
`
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`Claim(s) Challenged
`8, 21
`
`
`
`35 U.S.C. §
`103(a)
`
`Reference(s)/Basis
`Klein, Bracco Manual
`
`III. ANALYSIS
`
`A. Legal Standards
`To prevail in its challenges, Petitioner must prove unpatentability by a
`preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
`To anticipate a claim under 35 U.S.C. § 102, “a single prior art
`reference must expressly or inherently disclose each claim limitation.”
`Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1334 (Fed. Cir. 2008).
`That “single reference must describe the claimed invention with sufficient
`precision and detail to establish that the subject matter existed in the prior
`art.” Verve, LLC v. Crane Cams, Inc., 311 F.3d 1116, 1120 (Fed. Cir.
`2002).
`A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
`between the subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
`(3) the level of ordinary skill in the art; and (4) objective evidence of
`nonobviousness. See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
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`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
`development, including work with prototypes and finished
`commercial products.
`Pet. 10–11 (citing Ex. 1015 ¶¶ 32–42).
`Petitioner also contends that “[s]uch a person would have had a basic
`understanding, through education or experience, of general design control
`principles and processes and practices for partial or full automation of
`existing processes or test procedures.” Id. at 11 (citing Ex. 1015 ¶¶ 32–42).
`Petitioner further argues that Patent Owner’s proposed level of ordinary skill
`in the related ITC case is flawed because the claims challenged in this
`proceeding additionally recite a computer that automates procedures
`previously manually performed by medical personnel and “[m]edical
`personnel like those suggested by the Patent Owner lack the education and
`experience to develop the hardware and software controls for such
`computer-controlled systems or to design radiation shielding.” Id. at 11–12
`(citing Ex. 1014; Ex. 1015 § IV; Ex. 1021; Ex. 1031).
`Patent Owner asserts that a person of ordinary skill in the art “would
`generally have a graduate degree in medicine and/or in a medical related
`science, including physics, chemistry, biology, physiology, and/or
`biophysics, and would generally have at least some clinical, research and/or
`design experience with respect to PET imaging and/or PET imaging
`
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`systems.” PO Resp. 3–4. Patent Owner also asserts that “[a]n individual
`with an undergraduate degree along with significant experience could also
`be sufficiently skilled,” “the amount of experience following an
`undergraduate degree would depend on the level of formal education and
`amount of experience working with radiopharmaceuticals,” and “such a
`person may be working as part of a team.” Id. (citing Ex. 2003 ¶ 27); see
`also id. at 4–5 (citing Ex. 2003 ¶¶ 27–29).
`Patent Owner argues that Petitioner’s proposed level of ordinary skill
`“does not actually require familiarity with elution of radioactive isotopes,
`PET imaging, or even systems employing any form of radioactive
`substance.” Id. at 4. Patent Owner further contends that “Petitioner has
`failed to show that the Challenged Claims are invalid under either party’s
`proposed level of skill.” Id. at 5.
`In determining the level of ordinary skill in the art, various factors
`may be considered, including the “type of problems encountered in the art;
`prior art solutions to those problems; rapidity with which innovations are
`made; sophistication of the technology; and educational level of active
`workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)
`(citation and internal quotation marks omitted).
`Klein addresses the development of a system for eluting a constant
`rate of activity. See Ex. 1014, 1 (“The goal of this project is to develop a
`system that is capable of eluting 82Rb at a constant rate of activity from a
`82Sr/82Rb generator for use in a clinical and experimental setting.”). Tate
`states that “[i]t has long been recognized as very desirable to develop
`devices, systems, components and methods for calculating and delivering
`accurate and effective doses of radiopharmaceuticals to patients, while
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`reducing the exposure of administering or other medical personnel to such
`hazardous pharmaceuticals.” Ex. 1025 ¶ 11.
`Based on the full record before us, because the asserted references
`describe the problems and solutions of accurately delivering
`radiopharmaceuticals and reducing radiation exposure to operators, we find
`that Petitioner’s proposed level of ordinary skill in the art, which includes
`understanding of equipment control, “radioactive protection systems,” and
`equipment design, is consistent with the prior art of record. Pet. 10–11
`(citing Ex. 1015 ¶¶ 32–42). We, therefore, apply Petitioner’s proposed level
`of skill to our analysis.
`We also determine that the parties’ competing proposals regarding the
`level of ordinary skill agree in certain aspects. For example, both parties
`propose at least a graduate degree, albeit in different concentrations of study.
`See Pet. 10 (“graduate’s degree with some emphasis in equipment design,
`automation, or controls, . . . or a related field”); PO Resp. 3 (“a graduate
`degree in medicine and/or in a medical related science”). Both parties also
`alternatively propose that the ordinarily skilled artisan would have had “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 development, including work with prototypes
`and finished commercial products” (Pet. 10–11) or “an undergraduate degree
`along with significant experience,” “the amount of experience following an
`undergraduate degree would depend on the level of formal education and
`amount of experience working with radiopharmaceuticals” (PO Resp. 4).
`We further determine that Petitioner’s proposed ordinarily skilled
`artisan with “an undergraduate degree in [equipment design, automation, or
`
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`controls, or a related field] with two to three years’ work experience . . . in
`medical device product, automation, or instrumentation design and
`development” (see Pet. 10–11) would overlap, at least in part, Patent
`Owner’s proposal of a person having “a graduate degree in medicine and/or
`in a medical related science” and “at least some . . . design experience with
`respect to . . . PET imaging systems” (see PO Resp. 3–4). We, thus,
`determine that any differences between the parties’ proposed level of skill
`would not affect our analysis below. See also Pet. Reply 1–2 (“Although the
`parties define [the person of ordinary skill in the art] differently, neither
`party argues that the differences between them are material to the outcome
`of this IPR.”).
`C. Claim Construction
`In the present inter partes review, claim terms in the ’467 patent,
`which is unexpired, are interpreted according to their broadest reasonable
`construction in light of the Specification of the ’467 patent. 37 C.F.R.
`§ 42.100(b) (2017); Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 2131,
`2144–46 (2016) (upholding the use of the broadest reasonable interpretation
`standard).4
`Petitioner states that “[a]ll claim terms have been assigned their
`ordinary and customary meaning in this analysis.” Pet. 12. “Patent Owner
`
`
`4 On October 11, 2018, the Office revised its rules to harmonize the Board’s
`claim construction standard with that used in civil actions under 35 U.S.C.
`§ 282(b) 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. 51,340 (Oct. 11, 2018) (amending 37
`C.F.R. § 42.100(b) effective November 13, 2018). This rule change does
`not apply here. See Paper 3, 1 (according filing date of August 22, 2018 to
`
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`believes that no specific constructions are required at this time” (PO
`Resp. 3), and Petitioner replies that “[t]here are no claim construction issues
`in dispute” (Pet. Reply 1). See also Tr. 8:14–19 (Petitioner’s counsel
`agreeing that no claim term in this proceeding needs express interpretation).
`We agree with the parties 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); see
`also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d
`1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter
`partes review).
`D. Challenge Under 35 U.S.C. § 102 Based on Klein
`Petitioner challenges claims 1–4, 6, 7, 9, 10, 12–16, and 18–20 as
`anticipated by Klein. Pet. 23–55. For these challenges, Petitioner cites to
`the asserted reference and Petitioner’s declarant testimony. Id. As discussed
`further below, Patent Owner argues that Klein fails to anticipate any of the
`claims because it fails to disclose a computer that prevents patient infusion
`procedures if a strontium breakthrough test result exceeds an allowable limit,
`as required by independent claims 1 and 13, but otherwise does not contest
`Petitioner’s contentions as to claims 1 and 13. PO Resp. 8–19.
`After reviewing the complete record, we conclude that Petitioner has
`shown by a preponderance of the evidence that Klein discloses all the
`limitations of claims 1–4, 6, 7, 9, 10, 12–16, and 18–20.
`
`
`
`the Petition); PO Resp. 3 (stating that the “present IPR was filed before the
`new IPR rules regarding claim construction were implemented”).
`
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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, 15; see also id. at 8 (“82Rb can be
`supplied using a 82Sr/82Rb generator.”)
`“The goal of this project is to develop a system that is capable of
`eluting 82Rb at a constant rate of activity from a 82Sr/82Rb generator for use
`in a clinical and experimental setting.” Id. at 1. 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.
`Ex. 1014, 19. Klein 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. Klein
`
`5 Our citations to Klein are to the page numbers found in the bottom center
`of each page.
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`states that “using a PC to control the system” allows for a “wide range of
`applications and devices that are readily supported” including “off-the-shelf
`user interface devices, as well as machine interfaces and data acquisition
`devices” Id. at 20.
`“All the components are assembled in a stainless steel cart.” Id. at 23.
`The “generator was placed in the cart and surrounded by lead rings to
`provide maximum radiation shielding” from which “82Rb is eluted in the
`form of 82RbCl (eluate).” Id. at 8, 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 operator”).
`“All the saline lines were mounted on a modified top cover” (id. at
`23), and “[a]lthough the generator and waste container are shielded by lead,
`the saline lines are a source of radiation during elutions” (id. at 36).
`Klein also includes flow control valves, an activity counter, pumps,
`and a pressure sensor. Id. at 21–23. Klein states that “real-time software
`controls the pumps and valves” to “affect the flow of saline through the
`generator or its bypass line to the patient, dose calibrator, or waste
`container.” Id. at 19. The system acquires data from the activity counter
`and dose calibrator. Id. The “activity counter was included in the design to
`allow data collection and monitoring of the elution of activity” so as to
`“develop[] a controller capable of directing saline through the generator or
`its bypass line by actuating the generator valve in order to achieve a constant
`rate of activity using feedback from the activity counter.” Id. at 71.
`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. Klein also states that “82Sr and 85Sr ‘breakthrough’ can result if the
`
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`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”).
`The dose calibrator “is utilized in the system for both calibration and
`testing” and “is used to detect the breakthrough activity as part of the
`calibration test through measurement of 82Rb activity.” Id. at 19, 23, 50.
`Klein’s system is calibrated “by monitoring an external dose calibrator
`during the calibration run” (id. at 17) and “[w]ait[s] for decay to read
`breakthrough from dose calibrator” (id. at 64). The “dose calibrator is used
`to detect the breakthrough activity . . . through measurement of 82Rb
`activity” and the “breakthrough of each isotope, A82Sr/A82Rb and A85Sr/A82Rb,
`is calculated as a relative activity ratio of Sr activity to 82Rb activity
`delivered.” Id. at 50–51.
`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”), 50–52 (describing breakthrough
`measurement), 122 (stating “[d]aily 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”). Klein also states that 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.
`2. Independent Claim 1
`a. “A system comprising: a shielding assembly configured to
`contain a radioisotope generator that generates radioactive
`eluate via elution”
`Petitioner argues that Klein discloses a “system” and “a shielding
`assembly configured to contain a radioisotope generator that generates
`radioactive eluate via elution.” Pet. 23–25 (citing Ex. 1014, 1, 8, 19, 23–24;
`Ex. 1015 ¶¶ 199–210). Petitioner relies in part on annotated versions of
`Klein’s Figures 2-2 and 2-3, and points to a schematic of Klein’s elution
`system, as well as the shielded generator and shielded waste container
`carried on a cart. Id. at 24 (citing Ex. 1014, 19 (Fig. 2-2), 24 (Fig. 2-3)).
`We find that Klein describes an “infusion system . . . based on a
`82Sr/82Rb generator, which produces 82Rb activity continuously.” Ex. 1014,
`1. We also find that Klein shows a “Shielded Activity Counter” (Fig. 2-4),
`“Shielded Waste Container” (Fig. 2-3), and “Shielded Generator” (Fig. 2-3)
`on a stainless steel cart, and that “82Rb is eluted in the form of 82RbCl
`(eluate)” from the generator (id. at 8). See also id. at 23 (“All the
`components are assembled in a stainless steel cart shown in Figure 2-3.”), 24
`(Figs. 2-3, 2-4), 36. We further credit Petitioner’s declarant testimony
`because Klein supports that testimony. Ex. 1015 ¶¶ 199–210 (citing
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`Ex. 1014, 1, 8, 19 (Fig. 2-2), 23–24 (Figs. 2-3, 2-4), 36, 46 (Fig. 3-6)).
`Patent Owner does not address these limitations or Petitioner’s related
`arguments and evidence, or argue that Klein fails to disclose any of these
`limitations. See PO Resp. 8–19.
`Based on the full record, because Klein discloses an infusion system
`that includes a shielded 82Sr/82Rb generator on a stainless steel cart that
`generates eluate, Petitioner persuades us by a preponderance of the evidence
`that Klein discloses a “system comprising: a shielding assembly configured
`to contain a radioisotope generator that generates radioactive eluate via
`elution.”
`b. “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”
`Petitioner argues that Klein discloses a “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.” Pet. 25–28 (citing Ex. 1014, 19, 20, 23–25, 30, 53–55; Ex. 1015
`¶¶ 211–221). Petitioner relies in part on annotated versions of Klein’s
`Figures 2-2 and 2-3, and points to Klein’s personal computer and LCD touch
`screen, as well as one of the input screens shown to the operator during
`operation of the system. Id. at 27 (citing Ex. 1014, 24 (Fig. 2-3), 54 (Fig. 3-
`12)).
`We find that the relied-upon portions of Klein disclose a computer
`carried on a stainless steel cart, with the computer configured to receive user
`input via an LCD touch screen. Ex. 1014, 23, 25, 54. We also find that
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`Klein describes “allow[ing] the operator to control all the features of the
`elution system,” including operation of the generator to generate eluate via
`elution. Id. at 30, 53 (referring to steps taken by user to initiate the elution),
`54 (showing screen prompts for use by operator in Fig. 3-12, including
`“Choose Run Type” in Fig. 3-12(c)), 55 (referring to “calibration (including
`a test of breakthrough activity) at the start of each day”). We further credit
`Petitioner’s declarant testimony because Klein supports that testimony.
`Ex. 1015 ¶¶ 211–221 (citing Ex. 1014, 19, 20, 23–25, 30, 53–55). Patent
`Owner does not address these limitations or Petitioner’s related arguments
`and evidence, or argue that Klein fails to disclose any of these limitations.
`See PO Resp. 8–19.
`Based on the full record, because Klein discloses a computer and user
`input device carried on a cart containing shielding, as well as a series of
`operator inputs for controlling the elution system, Petitioner persuades us
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