IP Library › Granted Patent US 12,453,813
Granted Patent B2
US 12,453,813 · App. 18/447,492 · Granted Oct 28, 2025

Radioisotope delivery system with multiple detectors to detect gamma and beta emissions

Inventors: Clif Moyers (Oak Ridge, TN); Adrian Nunn (Lambertville, NJ); Andrew Schimmoeller (Plain City, OH); Brian Cherundolo (White Marsh, MD)
Assignee: Bracco Diagnostics, Inc.
A61M5/007A61K51/121A61K51/1282A61M5/1408A61M5/142A61M5/162A61M5/16827A61M5/16881A61N5/1007G01T1/20G01T7/005G21F5/015G21G1/0005G21G4/08G21H5/02A61K2123/00A61M2205/18A61M2205/3313A61M2205/3389A61M2205/702A61N2005/1021G01T1/1603G21G2001/0031
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Quick Facts
Patent No.
US 12,453,813
App. No.
18/447,492
Granted
Oct 28, 2025
Kind
B2
Abstract

A nuclear medicine infusion system may be used to generate and infuse radioactive liquid into a patient undergoing a diagnostic imaging procedure. In some examples, the infusion system includes a frame that carries a radioisotope generator that generates radioactive eluate via elution. The frame may also carry a beta detector and a gamma detector. The beta detector can be positioned to measure beta emissions emitted from the radioactive eluate supplied by the generator. The gamma detector can be positioned to measure gamma emissions emitted from a portion of the radioactive eluate to evaluate a safety of the radioactive eluate delivered by the infusion system.

Claims (48)

1. An infusion system comprising:

a frame that carries a beta detector, a gamma detector, a strontium-rubidium radioisotope generator that generates a radioactive eluate via elution, and a controller communicatively coupled to the beta detector and the gamma detector,

the beta detector is positioned to measure beta emissions emitted from the radioactive eluate,

the gamma detector is positioned to measure gamma emissions emitted from the radioactive eluate,

the controller is configured to determine an activity of rubidium in the radioactive eluate based on the beta emissions measured by the beta detector and determine an activity of strontium in the radioactive eluate based on the gamma emissions measured by the gamma detector,

the controller is configured to determine a cumulative volume of the radioactive eluate generated by the radioisotope generator and to prevent a patient infusion procedure if the cumulative volume of the radioactive eluate exceeds an allowable limit, and

the controller is configured to determine a cumulative activity of rubidium during a patient dosing procedure, compare the cumulative activity of rubidium to a threshold stored in memory, and cease delivering eluate to a patient if the cumulative activity of rubidium exceeds the threshold.

2. The infusion system of claim 1 , wherein the controller is configured to compare the determined activity of strontium to a breakthrough threshold to generate a breakthrough test result and prohibit the patient infusion procedure if the controller determines that the determined activity of strontium exceeds the breakthrough threshold.

3. The infusion system of claim 1 , wherein the allowable limit for the cumulative volume of radioactive eluate ranges from 17 to 30 liters.

4. The infusion system of claim 1 , wherein the threshold for the cumulative activity of rubidium is between 10 mCi and 60 mCi.

5. The infusion system of claim 1 , wherein the controller is configured to control the infusion system to prevent the patient infusion procedure if the strontium-rubidium radioisotope generator was built more than 25 days ago.

6. The infusion system of claim 1 , wherein the controller is configured to determine a cumulative volume of the radioactive eluate delivered to the patient during the patient infusion procedure, and cease delivering the radioactive eluate to the patient if the cumulative volume exceeds a threshold volume.

7. The infusion system of claim 6 , wherein the threshold volume is between 1 ml and 120 ml.

8. The infusion system of claim 1 , further comprising an infusion tubing line configured to receive the radioactive eluate, either directly or indirectly, from the strontium-rubidium radioisotope generator, and an eluate-receiving container in fluid communication with the infusion tubing line to receive a portion of the radioactive eluate, thereby providing a static portion of the radioactive eluate,

wherein the beta detector is positioned to measure the beta emissions emitted from the radioactive eluate flowing through the infusion tubing line; and

the gamma detector is positioned to measure the gamma emissions emitted from the static portion of the radioactive eluate in the eluate-receiving container.

9. The infusion system of claim 1 , further comprising:

an eluant reservoir containing an eluant;

a pump coupled to the eluant reservoir via an eluant line;

an eluate-receiving container carried by the frame;

a waste container carried by the frame; and

an infusion tubing circuit that includes an infusion tubing line, an eluate line, a waste line, and a multi-way divergence valve, wherein the infusion tubing line is in fluid communication with the eluate line via the multi-way divergence valve and the waste line is in fluid communication with the eluate line via the multi-way divergence valve,

wherein the beta detector is positioned to measure the beta emissions from the radioactive eluate flowing through the eluate line, and the gamma detector is configured to measure the gamma emissions from a static portion of the radioactive eluate in the eluate-receiving container and received from the infusion tubing line.

10. The infusion system of claim 9 , wherein

the controller is communicatively coupled to the multi-way divergence valve and configured to control flow from the eluate line to a select one of the infusion tubing line and the waste line via the multi-way divergence valve; and

the controller is further configured during a quality control process to:

control the pump to pump the eluant through the strontium-rubidium radioisotope generator and generate the radioactive eluate,

determine a radioactive activity of the radioactive eluate based on the beta emissions measured via the beta detector while the radioactive eluate is directed to the waste container,

upon the radioactive activity of the radioactive eluate reaching a threshold level of rubidium activity, control the multi-way divergence valve to place the infusion tubing line in fluid communication with the eluate line,

further control the pump to fill the eluate-receiving container with the radioactive eluate,

control the gamma detector to detect the gamma emissions from the radioactive eluate in the eluate-receiving container after a period of time sufficient for substantially all rubidium in the radioactive eluate to decay, and

determine the activity of strontium in the eluate-receiving container based on the gamma emissions measured by the gamma detector.

11. The infusion system of claim 1 , further comprising radioactive shielding surrounding the beta detector, the gamma detector, and the strontium-rubidium radioisotope generator, the radioactive shielding providing a barrier effective to reduce radiation emitted by the strontium-rubidium radioisotope generator and the radioactive eluate below a limit allowable for operating personnel.

12. The infusion system of claim 11 , wherein the radioactive shielding comprises a shielding assembly having a plurality of compartments, including a compartment containing the beta detector, a compartment containing the gamma detector, and a compartment containing the strontium-rubidium radioisotope generator.

13. The infusion system of claim 11 , wherein the frame carries the beta detector and the gamma detector and also receives the strontium-rubidium radioisotope generator by supporting the shielding assembly which, in turn, is configured to contain the beta detector, the gamma detector, and the strontium-rubidium radioisotope generator.

14. The infusion system of claim 11 , wherein the controller is carried by the frame outside of the radioactive shielding.

15. The infusion system of claim 1 , wherein the gamma detector comprises a solid state gamma detector coupled to a multi-channel analyzer and the beta detector comprises a scintillator and photomultiplier.

16. A method comprising:

pumping an eluant through a strontium-rubidium radioisotope generator and thereby generating a radioactive eluate via elution;

measuring beta emissions emitted from the radioactive eluate via a beta detector;

measuring gamma emissions emitted from the radioactive eluate via a gamma detector;

determining, via one or more controllers, an activity of rubidium in the radioactive eluate based on the beta emissions measured by the beta detector and an activity of strontium in the radioactive eluate based on the gamma emissions measured by the gamma detector;

determining, via the one or more controllers, a cumulative volume of the radioactive eluate generated by the radioisotope generator and preventing a patient infusion procedure if the cumulative volume of the radioactive eluate exceeds an allowable limit; and

determining, via the one or more controllers, a cumulative activity of rubidium during a patient dosing procedure, comparing the cumulative activity of rubidium to a threshold stored in memory, and ceasing to deliver the radioactive eluate to a patient if the cumulative activity of rubidium exceeds the threshold.

17. The method of claim 16 , comparing, via the one or more controllers, the determined activity of strontium to a breakthrough threshold to generate a breakthrough test result and prohibiting the patient infusion procedure if the determined activity of strontium exceeds the breakthrough threshold.

18. The method of claim 16 , further comprising preventing, by the one or more controllers, the patient infusion procedure if the strontium-rubidium radioisotope generator was built more than 25 days ago.

19. The method of claim 16 , wherein the threshold for the cumulative activity of rubidium is between 10 mCi and 60 mCi.

20. The method of claim 16 , wherein the allowable limit for the cumulative volume of radioactive eluate ranges from 17 to 30 liters.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2024
From: MOYERS, CLIF; NUNN, ADRIAN; CHERUNDOLO, BRIAN
To: BRACCO DIAGNOSTICS INC.
Reel/Frame 066509/0141 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2024
From: SCHIMMOELLER, ANDREW
To: BATTELLE MEMORIAL INSTITUTE
Reel/Frame 066509/0148 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2024
From: BATTELLE MEMORIAL INSTITUTE
To: BRACCO DIAGNOSTICS INC.
Reel/Frame 066509/0152 →
Continuity (5)
Continuation 16334882
Provisional Application 62397022 · Sep 20, 2016
Provisional Application 62397026 · Sep 20, 2016
Provisional Application 62397025 · Sep 20, 2016
Related Publication 20240148961A1 · May 9, 2024
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WO 2018057635A1 · 2018 [cited by applicant]
WO 2018057636A1 · 2018 [cited by applicant]
WO 2020191384A1 · 2020 [cited by applicant]
WO 2020191386A1 · 2020 [cited by applicant]
337-1110_ 662084: Complainant Bracco Diagnostics Inc.'s Response to Jubilant's Motion for Summary Determination of Noninfringement of U.S. Pat. Nos. 9,750,869, 9,750,870, and 9,814,826 by Jubilant's Version 3.1 and Vers… [cited by applicant]
337-1110_ 662084: Complainant Bracco Diagnostics Inc.'s Response to Jubilant's Motion for Summary Determination of Noninfringement of U.S. Pat. Nos. 9,750,869, 9,750,870, and 9,814,826 by Jubilant's Version 3.1 and Vers… [cited by applicant]
337-1110_662795: Staff's Response to Respondents' Motion for Summary Determination of Noninfringement of U.S. Pat. Nos. 9,750,869; 9,750,870; and 9,814,826 by Respondents' Version 3.1 and 4 Designs (Motion Response/Repl… [cited by applicant]
337-1110_662796: Staff's Response to Complainant's Motion for Summary Determination of Infringement and Satisfaction of the Economic & Technical Prongs of the Domestic Industry Requirement (Motion Response/Reply); 1-138… [cited by applicant]
Attachment D: Respondents' Obviousness Contentions, Exchanged in ITC Investigation No. 337-TA-1110, Aug. 8, 2018, 38 pages. (Confidential Business Information Redacted). [cited by applicant]
Exhibit D.1: U.S. Pat. No. 9,814,826 Claim Char—Obviousness Over Klein, Exchanged in ITC Investigation No. 337-TA-1110, Aug. 8, 2018, 207 pages. (Confidential Business Information Redacted). [cited by applicant]
Exhibit D.2: U.S. Pat. No. 9,750,869 Claim Chart—Obviousness Over Klein, Exchanged in ITC Investigation No. 337-TA-1110, Aug. 8, 2018, 244 pages. (Confidential Business Information Redacted). [cited by applicant]
Exhibit D.3: U.S. Pat. No. 9,750,870 Claim Chart—Obviousness Over Klein, Exchanged in ITC Investigation No. 337-TA-1110, Aug. 8, 2018, 172 pages. (Confidential Business Information Redacted). [cited by applicant]
Exhibit D.4: U.S. Pat. No. 9,814,826 Claim Chart—Obviousness Over Cardiogen-82, Exchanged in ITC Investigation No. 337-TA-1110, Aug. 8, 2018, 224 pages. (Confidential Business Information Redacted). [cited by applicant]
Exhibit D.5: U.S. Pat. No. 9,750,869 Claim Chart—Obviousness Over Cardiogen-82, Exchanged in ITC Investigation No. 337-TA-1110, Aug. 8, 2018, 255 pages. (Confidential Business Information Redacted). [cited by applicant]
Exhibit D.6: U.S. Pat. No. 9,750,870 Claim Chart—Obviousness Over Cardiogen-82, Exchanged in ITC Investigation No. 337-TA-1110, Aug. 8, 2018, 199 pages. (Confidential Business Information Redacted). [cited by applicant]
Bracco Diagnostics Inc.'s Rebuttal Contentions in Response to Respondents' Aug. 8, 2018 Contentions (Including Responses to OUII Staff ROG Nos. 13, 18, 19, 20-22, 32 and Respondents' ROG Nos. 5, 9-11, 18, 33), Investiga… [cited by applicant]
Supplemental Exhibit 1, Response to Supplemental Exhibit D.1: U.S. Pat. No. 9,814,826 Invalidity Contentions, Exchanged in ITC Investigation No. 337-TA-1110, Aug. 15, 2018, 22 pages. (Confidential Business Information R… [cited by applicant]
Supplemental Exhibit 2, Response to Supplemental Exhibit D.2: U.S. Pat. No. 9,750,869 Invalidity Contentions, Exchanged in ITC Investigation No. 337-TA-1110, Aug. 15, 2018, 23 pages. (Confidential Business Information R… [cited by applicant]
Supplemental Exhibit 3, Complainant's Supplemental Response to Respondents' Supplemental Exhibit D.3: U.S. Pat. No. 9,750,870 Invalidity Contentions, Exchanged in ITC Investigation No. 337-TA-1110, Aug. 15, 2018, 19 pag… [cited by applicant]
Bracco Diagnostics Inc.'s Supplemental Rebuttal Contentions in Response to Respondents' Aug. 8, 2018 Contentions Pursuant to Order No. 16, Investigation No. 337-TA-1110, Aug. 23, 2018, 18 pages. (Confidential Business I… [cited by applicant]
Supplemental Exhibit 1, Response to Supplemental Exhibit D.1: U.S. Pat. No. 9,814,826 Invalidity Contentions, Exchanged in ITC Investigation No. 337-TA-1110, Aug. 23, 2018, 22 pages. (Confidential Business Information R… [cited by applicant]
Supplemental Exhibit 2, Response to Supplemental Exhibit D.2: U.S. Pat. No. 9,750,869 Invalidity Contentions, Exchanged in ITC Investigation No. 337-TA-1110, Aug. 23, 2018, 25 pages. (Confidential Business Information R… [cited by applicant]
Supplemental Exhibit 3, Complainant's Supplemental Response to Respondents' Supplemental Exhibit D.3: U.S. Pat. No. 9,750,870 Invalidity Contentions, Aug. 23, 2018, 26 pages. (Confidential Business Information Redacted). [cited by applicant]
Exhibit 4, Response to Exhibit D.4: U.S. Pat. No. 9,814,826 Invalidity Contentions, Aug. 23, 2018, 37 pages. (Confidential Business Information Redacted). [cited by applicant]
Exhibit 5, Response to Exhibit D.5: U.S. Pat. No. 9,814,826 Invalidity Contentions, Aug. 23, 2018, 39 pages. (Confidential Business Information Redacted). [cited by applicant]
Supplemental Exhibit 6, Complainant's Supplemental Response to Respondents' Supplemental Exhibit D.6: U.S. Pat. No. 9,750,870 Invalidity Contentions, Aug. 23, 2018, 44 pages. (Confidential Business Information Redacted). [cited by applicant]
337-1110_652068: Respondents' Jubilant DraxImage Inc., Jubilant Pharma Limited, and Jubilant Life Sciences Limited Notice of Prior Art (Notice of Prior Art); 1-1311880: “Respondents First Supplemental Notice of Prior Ar… [cited by applicant]
Respondents' Pre-Hearing Brief, Public Version, Investigation No. 337-TA-1110, Dec. 12, 2018, 550 pages. [cited by applicant]
Complainant Bracco Diagnostics Inc.'s Pre-Hearing Brief, Public Version, Inv. No. 337-TA-1110, Dec. 13, 2018, 568 pages. [cited by applicant]
Report of Robert T. Stone, Ph.D on Invalidity of U.S. Pat. Nos. 9,750,869, 9,750,870 and 9,814,826, Sep. 17, 2018, 1051 pages. (Confidential Business Information Redacted). [cited by applicant]
Corrected Expert Report of Norbert J. Pelc, Sc.D, Investigation No. 337-TA-1110, Oct. 1, 2018, 289 pages. (Confidential Business Information Redacted). [cited by applicant]
Declaration of Robert T. Stone, Ph.D., [cited by applicant]
Curriculum Vitae of Robert T. Stone, Ph.D., [cited by applicant]
Declaration of Venkatesh L. Murthy, M.D., Ph.D., [cited by applicant]
US Pharmacopeia 23 National Formulary 18, 1995, 5 pages (cited as Exhibit 1019 in IPR2018-01448, [cited by applicant]
Declaration of Andy Adler, Ph.D., [cited by applicant]
Bracco CardioGen-82 Infusion System User's Guide, Rev. 07, Jul. 20, 2004, 49 pages (cited as Exhibit 1021 in IPR2018-01448, [cited by applicant]
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337-TA-1110: Complainant Bracco Diagnostics Inc.'s Responses to Respondents Jubilant DraxImage, Inc.'s, Jubilant Pharma Limited's, and Jubilant Life Sciences' Fourth Set of Interrogatories (No. 68), Aug. 6, 2018, 11 pag… [cited by applicant]
Declaration of Carol Wadke, [cited by applicant]
Petition for Inter Partes Review of U.S. Pat. No. 9,299,468, [cited by applicant]
Patent Owner's Submission of Mandatory Notice Information Under 37 CFR 42.8(a)(2), [cited by applicant]
Patent Owner's Preliminary Response, [cited by applicant]
Redline comparison between US Patent Publication No. 2004/0260143 A1 (Reilly et al.), published Dec. 23, 2004 and U.S. Pat. No. 6,767,319 B2 (Reilly et al.), issued Jul. 27, 2004, filed Nov. 29, 2018 as Exhibit 2002 in … [cited by applicant]
Declaration of Robert T. Stone, Ph.D., [cited by applicant]
Petition for Inter Partes Review of U.S. Pat. No. 9,299,467, [cited by applicant]
Patent Owner's Submission of Mandatory Notice Information Under 37 CFR 42.8(a)(2), [cited by applicant]
Patent Owner's Preliminary Response, [cited by applicant]
Petition for Inter Partes Review of U.S. Pat. No. 9,299,468, [cited by applicant]
Patent Owner's Submission of Mandatory Notice Information Under 37 CFR 42.8(a)(2), [cited by applicant]
Patent Owner's Preliminary Response, [cited by applicant]
Decision to Institute in IPR2018-01448, U.S. Pat. No. 9,299,468 B2, [cited by applicant]
Decision to Institute in IPR2018-01449, U.S. Pat. No. 9,299,467 B2, [cited by applicant]
Decision to Institute in IPR2018-01450, U.S. Pat. No. 9,299,468 B2, [cited by applicant]
Commission Opinion, Inv. No. 337-TA-1110, Public Version, Dec. 11, 2019, 43 pages. [cited by applicant]
Bracco Diagnostics Inc.'s Petition for Review with Exhibits 1, 2 and 3, Inv. No. 337-TA-1110, Dec. 23, 2019, 240 pages. [cited by applicant]
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“Alaris GH Syringe Pump Directions For Use,” Cardinal Health, Oct. 2005, 34 pages. [cited by applicant]
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BRACCO Brochure, “Rubidium 82 Infusion System, Easy to Operate . . . Automated . . . Complete”, © Bracco Diagnostics, Inc., 0605-002NA, Jun. 2001, (2 pages). [cited by applicant]
“CardioGen-82 Infusion System User's Guide,” Medical Product Service GmbH, Jul. 3, 2007, 53 pages. [cited by applicant]
“CardioGen-82 Rubidium Rb 82 Generator For Elution of Rubidium Chloride Rb 82 Injection,” Bracco Diagnostics, May 2000, 13 pages. [cited by applicant]
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R. Klein, “Precise 82RB infusion system for cardiac perfusion measurement using 3D positron emission tomography”, Ottawa-Carleton Institute for Electrical and Computer Engineering School of Information Technology and En… [cited by applicant]
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337-1110_640015: Public Version of Complaint and Exhibits 1-28 (Complaint); 1-1283977: “640015 Public Complaint: GreenbergTraurig's letter dated Mar. 27, 2018 re Complainant's filing of documents to support Bracco's req… [cited by applicant]
337-1110_643191: Notice of Institution of Investigation (Notice); 1-1285952: “1285952: Notice of Institution of Investigation Inv. No. 337-TA-1110”, create date Apr. 25, 2018, www.edis.usitc.gov. [cited by applicant]
337-1110_647318: Joint List of Disputed and Undisputed Claim Terms (Other); 1-1298795: “1298795: Joint List of Disputed and Undisputed Claim Terms”, create date Jun. 8, 2018, www.edis.usitc.gov. [cited by applicant]
337-1110_648102: Proposed Construction of Disputed Claim Terms (Response/Submission to ALJ Order); 1-1301950: “Proposed Constructions”, create date Jun. 18, 2018, www.edis.usitc.gov. [cited by applicant]
337-1110_650007: Respondent Jubilant DraxImage Inc., Jubilant Pharma Limited, and Jubilant Life Sciences Limited's Notice of Prior Art (Notice of Prior Art); 1-1306444: “Notice of Prior Art”, create date Jul. 10, 2018, … [cited by applicant]
337-1110_652080: Joint Unopposed Motion for Leave to File Joint Submission of Identification of Claim Terms and Proposed Constructions Thereof out of Time (Motion); 2-1311910: “Identification of Claim Terms”, create dat… [cited by applicant]
337-1110_652479: Granting Joint Motion to File Identification of Claim Terms and Constructions out of Time (Order); 1-1313857: “652479: Order No. 14”, create date Aug. 8, 2018, www.edis.usitc.gov. [cited by applicant]
337-1110_661785: Complainant Bracco Diagnostics Inc.'s Motion for Summary Determination of Infringement and Satisfaction of the Economic and Technical Prongs of the Domestic Industry Requirement (Motion); 1-1385894: “Le… [cited by applicant]
337-1110_661785: Complainant Bracco Diagnostics Inc.'s Motion for Summary Determination of Infringement and Satisfaction of the Economic and Technical Prongs of the Domestic Industry Requirement (Motion); 2-1385895: “Mo… [cited by applicant]
337-1110_661785: Complainant Bracco Diagnostics Inc.'s Motion for Summary Determination of Infringement and Satisfaction of the Economic and Technical Prongs of the Domestic Industry Requirement (Motion); 3-1385896: “Ch… [cited by applicant]
337-1110_661851: Errata to Staff's Response to Complainant's Motion for Summary Determination of Infringement and Satisfaction of the Economic and Technical Prongs of the Domestic Industry Requirement (Motion Response/R… [cited by applicant]
337-1110_660985: Respondents' Motion for Summary Determination of Noninfringement of U.S. Pat. Nos. 9,750,869, 9,750,870, and 9,814,826 by Respondents' Version 3.1 and Version 4 Designs (Motion); 1-1383714: “Respondents… [cited by applicant]
337-1110_660985: Respondents' Motion for Summary Determination of Noninfringement of U.S. Pat. Nos. 9,750,869, 9,750,870, and 9,814,826 by Respondents' Version 3.1 and Version 4 Designs (Motion); 2-1383715: “Memorandum … [cited by applicant]
337-1110_660985: Respondents' Motion for Summary Determination of Noninfringement of U.S. Pat. Nos. 9,750,869, 9,750,870, and 9,814,826 by Respondents' Version 3.1 and Version 4 Designs (Motion); 17-1383730: “Chart of M… [cited by applicant]
337-1110_661010: Complainant Bracco Diagnostics Inc.'s Motion for Summary Determination of Infringement and Satisfaction of the Economic and Technical Prongs of the Domestic Industry Requirement (Motion); 1-1383879: “Br… [cited by applicant]
337-1110_661010: Complainant Bracco Diagnostics Inc.'s Motion for Summary Determination of Infringement and Satisfaction of the Economic and Technical Prongs of the Domestic Industry Requirement (Motion); 2-1383880: “Br… [cited by applicant]
337-1110_661038: Respondents' Unopposed Motion to Replace Respondents' Chart of Material Facts in Support of Motion for Summary Determination (Motion); 1-1383923: “Respondents' Unopposed Motion to Replace Respondents' C… [cited by applicant]
337-1110_662007: Respondents' Memorandum in Opposition of Complainant's Motion for Summary Determination of Infringement and Satisfaction of the Economic and Technical Prongs of the Domestic Industry Requirement (Motion… [cited by applicant]
Ruby Rubidium Elution System User Manual, Jubilant DraxImage, Version 7, Created Jun. 3, 2014, Modified Jan. 9, 2015, 58 pages. [cited by applicant]
Intego PET Infusion System Operation Manual, Medrad, Rev. G, Jun. 2013, 142 pages. [cited by applicant]
Commission Investigative Staff's Prehearing Brief, Inv. No. 337-TA-1110, Dec. 20, 2018, 129 pages. (Confidential Business Information Redacted). [cited by applicant]