Trials@uspto.gov
`571-272-7822
`
`Paper 29
`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.
`
`IPR2018-01450
`Patent 9,299,468 B2
`
`
`
`
`
`
`
`
`
`Before HYUN J. JUNG, GEORGE R. HOSKINS, and
`RICHARD H. MARSCHALL, Administrative Patent Judges.
`JUNG, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`INTRODUCTION
`I.
`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
`
`
`
`
`571-272-7822
`
`Paper 29
`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.
`
`IPR2018-01450
`Patent 9,299,468 B2
`
`
`
`
`
`
`
`
`
`Before HYUN J. JUNG, GEORGE R. HOSKINS, and
`RICHARD H. MARSCHALL, Administrative Patent Judges.
`JUNG, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`INTRODUCTION
`I.
`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
`
`
`
`
`
`IPR2018-01450
`Patent 9,299,468 B2
`preponderance of the evidence that claims 21–23 of U.S. Patent No.
`9,299,468 B2 are unpatentable.
`A. Background and Summary
`Jubilant DraxImage Inc. (“Petitioner”) filed a Petition (Paper 1,
`“Pet.”) requesting institution of an inter partes review of claims 21–23 of
`U.S. Patent No. 9,299,468 B2 (Ex. 1001, “the ’468 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 the ’468
`patent. Paper 7 (“Dec. to Inst.”). In particular, we instituted review of
`claims 21–23 on all presented challenges. Dec. to Inst. 2, 14, 16, 19.
`After institution, Patent Owner filed a Response (Paper 14, “PO
`Resp.”), to which Petitioner filed a Reply (Paper 15, “Pet. Reply”). Patent
`Owner thereafter filed a Sur-Reply (Paper 16, “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 25, “Tr.”).
`B. 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. 10.1 Patent Owner states that “Bracco Diagnostics Inc.
`(‘Bracco’) is the owner of U.S. Patent No. 9,299,468” and “is the real party-
`in-interest.” Paper 4, 2.
`C. Related Matters
`The parties indicate that the ’468 patent has been asserted in Bracco
`Diagnostics Inc. v. Jubilant DraxImage Inc., Case No. 3-18-cv-04422
`
`1 The Petition does not include page numbers for each page. Thus, we, like
`Patent Owner, identify page numbers by referring to the page of the PDF
`document. See PO Resp. 12 n.3.
`
`2
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`IPR2018-01450
`Patent 9,299,468 B2
`(D.N.J.). Pet. 10; Paper 4, 2; PO Resp. 2; Ex. 1002 (complaint for patent
`infringement involving the ’468 patent and others). 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. 10 (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 of U.S. Patent Nos. 9,814,826; 9,750,869; and 9,750,870.
`Ex. 1003, 1, 14. The ’468 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[, 2019] 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 20; 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
`asserted claims are infringed but invalid as obvious over the prior art,”
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`IPR2018-01450
`Patent 9,299,468 B2
`petitions for review of the FID were filed, 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 26;
`Ex. 1047. According to Petitioner, “Ex. 1047 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 26, 1 (citing Ex. 1047, 2);
`Ex. 1047, 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 27; Ex. 1048. Petitioner states that
`the “Commission Opinion addresses several issues that are relevant to the
`present inter partes review.” Paper 27, 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” and held that “Klein teaches or discloses such subject matter.” Id.
`(citing Ex. 1048, 24–26). Patent Owner has filed an appeal of the
`Commission Opinion. Ex. 2019.
`The same patent is also challenged in IPR2018-01448, and a related
`patent that claims priority to common applications is challenged in IPR2018-
`01449. Pet. 10; Paper 4, 2; PO Resp. 1–2.
`D. The ’468 Patent
`The ’468 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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`IPR2018-01450
`Patent 9,299,468 B2
`2009, which, in turn, is a continuation of four applications filed June 11,
`2008. Ex. 1001, codes (22), (45), (63), 1:8–21; see also Pet. 9, 20 (arguing
`that June 2008 is the earliest date to which the ’468 patent claims priority),
`14–17 (describing prior applications).
`The ’468 patent relates to “systems that generate and infuse
`radiopharmaceuticals.” Ex. 1001, 1:25–26. Figure 1D of the ’468 patent is
`reproduced below.
`
`
`
`Figure 1D is “a schematic of an infusion circuit.” Id. at 2:10–11.
`Infusion system 10 can be mobile and may incorporate infusion circuit 300,
`a part of which is contained within shielding assembly 200. Id. at 3:52–54,
`4:53–61, 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
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`IPR2018-01450
`Patent 9,299,468 B2
`of the eluant from generator 21. Id. at 4:65–67, 5:2–3, 5:6–7, 5:10–11.
`Activity detector 25 also provides feedback for directing the eluant via
`divergence valve 35WP to either waste bottle 23 or patient line 305p. Id. at
`5:10–14. 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
`5:41–45.
`“[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 8:4–12; see also id. at 18:56–60 (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 3:28–33.
`E. Illustrative Claim
`The ’468 patent has 29 claims, of which Petitioner challenges claims
`21–23 in this proceeding. Of those, claim 21, reproduced below, is the only
`independent claim.
`21. A mobile radioisotope generator system comprising:
`
`a
`shielding assembly configured
`to contain a
`strontium/rubidium
`radioisotope generator
`that generates
`radioactive eluate via elution of an eluant and an infusion tubing
`
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`IPR2018-01450
`Patent 9,299,468 B2
`circuit comprising an eluate tubing line configured to convey
`eluate from the strontium/rubidium radioisotope generator;
`
`means for measuring an activity of the eluate flowing
`through the eluate tubing line;
`
`means for receiving eluate from the eluate tubing line and
`measuring breakthrough activity of the eluate; and
`
`means for receiving activity data from the means for
`measuring the activity of the eluate and controlling the mobile
`radioisotope generator system based on the received activity data
`to deliver a dose of eluate to a patient during a patient infusion
`procedure,
`
`wherein the means for receiving activity data and
`controlling the mobile radioisotope generator system is further
`configured to receive breakthrough activity data from the means
`for receiving eluate and measuring breakthrough activity,
`determine at least an activity of strontium-82 and an activity of
`strontium-85 in the eluate from the breakthrough activity data,
`and prevent the patient infusion procedure if the activity of
`strontinum-82 or the activity of strontium-85 exceeds an
`allowable limit.
`
`Ex. 1001, 25:52–26:10.
`F. Prior Art and Asserted Grounds
`Petitioner identifies the following references as prior art in the
`asserted grounds of unpatentability:
`U.S. Patent Application Publication No. US 2008/0242915 A1,
`published October 2, 2008 (Ex. 1023, “Jackson”);
`U.S. Patent Application Publication No. US 2011/0178359 A1,
`published July 21, 2011 (Ex. 1022, “Hirschman”); and
`
`7
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`IPR2018-01450
`Patent 9,299,468 B2
`Ran Klein, Precise 82Rb Infusion System for Cardiac Perfusion
`Measurement Using 3D Positron Emission Tomography (20062) (Ex. 1014,
`“Klein”).
`Also, the Petition is supported by the Declaration of Robert T. Stone,
`Ph.D. Ex. 1015. Petitioner also filed a Declaration of Venkatesh L. Murthy,
`M.D., Ph.D. Ex. 1017. Patent Owner filed a Declaration of Norbert J. Pelc,
`Sc.D. Ex. 2003. Deposition transcripts for Dr. Stone and Dr. Murthy were
`also filed. Exs. 2010, 2016. No deposition transcript for Dr. Pelc was filed.
`Petitioner asserts that claims 21–23 would have been unpatentable on
`the following grounds:
`Claim(s) Challenged
`21, 23
`22
`
`35 U.S.C. §
`102(b)3
`103(a)
`
`Reference(s)/Basis
`
`Klein
`Klein, Hirschman, Jackson
`
`Pet. 31–53.
`
`
`
`
`2 The cover page of Klein has a February 2005 date and 2005 copyright.
`Petitioner contends that Klein was publicly available in 2006. Pet. 25 (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 ’468 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 ’468 patent, our citations to Title
`35 are to the pre-AIA version.
`
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`IPR2018-01450
`Patent 9,299,468 B2
`
`II. 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).
`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
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`IPR2018-01450
`Patent 9,299,468 B2
`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. 18 (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
`18–19 (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 19–20 (citing Ex. 1015 ¶¶ 32–42; Ex. 1021).
`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
`systems.” PO Resp. 6 (citing Ex. 2003 ¶ 27). 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 7 (citing Ex. 2003 ¶¶ 28–29).
`
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`IPR2018-01450
`Patent 9,299,468 B2
`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 6. 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 7.
`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.”). Jackson
`similarly describes “a need to improve the quality control of the
`administration of radiopharmaceuticals to patients” and “a need to reduce
`the exposure of people, such as PET technicians, to radioactivity during the
`manual steps of administering a radiopharmaceutical to patients.” Ex. 1023
`¶ 11. According to Hirschman, “a need exists for integrated systems and
`methods capable of the generation, preparation, and administration of
`pharmaceutical substances . . . such as radioactive pharmaceutical
`substances.” Ex. 1022 ¶ 18.
`Based on the full record before us, because the asserted references
`describe the problems and solutions of accurately delivering
`radiopharmaceuticals, reducing radiation exposure to operators, and
`
`11
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`IPR2018-01450
`Patent 9,299,468 B2
`integrating systems related to radiopharmaceuticals, 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. 18 (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. 18 (“graduate’s degree with some emphasis in equipment design,
`automation, or controls, . . . or a related field”); PO Resp. 6 (“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. 18) 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. 6).
`We further determine that Petitioner’s proposed ordinary skilled
`artisan with “an undergraduate degree in [equipment design,
`automation, or controls, or a related field] with two to three years’
`work experience . . . in medical device product, automation, or
`instrumentation design and development” (see Pet. 18) 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
`
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`IPR2018-01450
`Patent 9,299,468 B2
`systems” (see PO Resp. 6). We, thus, determine that any differences
`between the parties’ proposed level of skill would not affect our
`analysis below. See also Pet. Reply 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 ’468 patent,
`which is unexpired, are interpreted according to their broadest reasonable
`construction in light of the Specification of the ’468 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. 20. In the Decision
`to Institute, we preliminarily interpreted means-plus-function terms of
`independent claim 21. Dec. to Inst. 9–10. Patent Owner responds that
`“construction of these means-plus-function terms is not critical to the
`outcome of this proceeding” because Patent Owner “agrees that the primary
`
`
`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
`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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`IPR2018-01450
`Patent 9,299,468 B2
`reference of Klein includes items that meet all of the above means-plus-
`function elements.” PO Resp. 3. Patent Owner also provides comments on
`the means-plus-function terms. Id. at 3–6.
`For “means for measuring an activity of the eluate flowing through
`the eluate tubing line,” we preliminarily determined that the function is
`“measuring an activity of the eluate flowing through the eluate tubing line”
`and the corresponding structure for performing the function is activity
`detector 25. Dec. to Inst. 9 (citing Ex. 1001, 5:10–15). “Patent Owner
`agrees that an activity detector is one structure in the [S]pecification that can
`perform the specified function.” PO Resp. 4 (citing Ex. 2003 ¶ 32).
`For “means for receiving eluate from the eluate tubing line and
`measuring breakthrough activity of the eluate,” we preliminarily determined
`that the function is “receiving eluate from the eluate tubing line and
`measuring breakthrough activity of the eluate” and the corresponding
`structure for performing the function is a dose calibrator. Dec. to Inst. 9
`(citing Ex. 1001, 18:56–60). “Patent Owner agrees that a dose calibrator is
`one structure in the [S]pecification that can perform the specified function.”
`PO Resp. 4 (citing Ex. 2003 ¶ 33).
`For “means for receiving activity data from the means for measuring
`the activity of the eluate and controlling the mobile radioisotope generator
`system based on the received activity data to deliver a dose of eluate to a
`patient during a patient infusion procedure,” we preliminarily determined
`that the function is “receiving activity data from the means for measuring the
`activity of the eluate and controlling the mobile radioisotope generator
`system based on the received activity data to deliver a dose of eluate to a
`patient during a patient infusion procedure” and the corresponding structure
`
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`IPR2018-01450
`Patent 9,299,468 B2
`that performs the function is a controller of system 10. Dec. to Inst. 9–10
`(citing Ex. 1001, 5:50–51).
`“Patent Owner agrees that a controller is one structure in the
`[S]pecification that can perform the specified function” but “notes that the
`controller may be coupled to a computer, and some activities described in
`the [S]pecification may require the computer.” PO Resp. 5 (citing Ex. 1001,
`3:28–29, 5:41–6:5, 6:43–46, 7:14–28, 13:13–24, 13:44–14:15, 21:45–50;
`Ex. 2003 ¶ 34). Patent Owner also argues that “Klein’s computer does not
`‘prevent the patient infusion procedure if the activity of strontium-82 or the
`activity of strontium-85 exceeds an allowable limit.’” Id. (citing Ex. 2003
`¶ 35). We address the latter argument below in our analysis of Petitioner’s
`anticipation challenge.
`Petitioner’s Reply does not present any additional arguments
`regarding any express interpretations. See Pet. Reply 3–4. Petitioner instead
`asserts that Patent Owner made admissions and that the issue about Klein’s
`computer preventing the patient infusion procedure if the activity of
`strontium-82 or strontium-85 exceeds an allowable limit would resolve the
`parties’ dispute. See id.
`In view of the full record before us, because the parties do not dispute
`our preliminary interpretations of claim 21’s means-plus-function terms, we
`apply those interpretations to our analysis below. In particular, for “means
`for measuring an activity of the eluate flowing through the eluate tubing
`line,” we determine that the function is “measuring an activity of the eluate
`flowing through the eluate tubing line” and that the corresponding structure
`for performing the function is, at least, activity detector 25. Ex. 1001, 5:10–
`15 (describing “activity detector 25, for measuring the activity of the eluate
`discharged from generator 21”).
`
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`IPR2018-01450
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`For “means for receiving eluate from the eluate tubing line and
`measuring breakthrough activity of the eluate,” we determine that the
`function is “receiving eluate from the eluate tubing line and measuring
`breakthrough activity of the eluate” and that the corresponding structure for
`performing the function is, at least, a dose calibrator. Ex. 1001, 18:56–60
`(stating that “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”).
`For “means for receiving activity data from the means for measuring
`the activity of the eluate and controlling the mobile radioisotope generator
`system based on the received activity data to deliver a dose of eluate to a
`patient during a patient infusion procedure,” we determine that the function
`is “receiving activity data from the means for measuring the activity of the
`eluate and controlling the mobile radioisotope generator system based on the
`received activity data to deliver a dose of eluate to a patient during a patient
`infusion procedure” and that the corresponding structure that performs the
`function is, at least, a controller of system 10 that may be coupled to a
`computer. Ex. 1001, 5:50–51 (describing a “controller . . . of system 10,
`which controller receives feedback from activity detector 25”), 5:53–61
`(describing the operation of the controller and valves 35BG and 35WP based
`on feedback from activity detector 25).
`Patent Owner further states that it “believes that no additional specific
`constructions are required at this time” but “reserves the right to put forth
`any additional specific constructions in these proceedings, should the need
`arise.” PO Resp. 5–6. Petitioner also agrees that, other than the means plus
`function terms, no other claim term need express interpretation. Tr. 8:14–
`19.
`
`16
`
`
`
`IPR2018-01450
`Patent 9,299,468 B2
`We agree with the parties that no other express interpretation is
`required for any claim term to resolve the parties’ dispute regarding
`patentability. 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(b)
`As discussed below, the parties’ disputes are related to whether Klein
`discloses all the limitations of independent claim 21. Patent Owner does not
`present any arguments specifically for dependent claim 23. See generally
`PO Resp.; PO Sur-Reply.
`After reviewing the complete record, we conclude that Petitioner has
`shown by a preponderance of the evidence that Klein discloses all the
`limitations of independent claim 21 and dependent claim 23.
`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
`
`
`5 Our citations to Klein are to the page numbers found in the bottom center
`of each page.
`
`17
`
`
`
`IPR2018-01450
`Patent 9,299,468 B2
`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
`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”).
`
`18
`
`
`
`IPR2018-01450
`Patent 9,299,468 B2
`“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
`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
`
`19
`
`
`
`IPR2018-01450
`Patent 9,299,468 B2
`breakthrough from dose calibrator” (id. at 64). The “dose calibrator is used
`to detect the breakthrough activity . . . through m
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