Terumo BCT, Inc. v. Haemonetics Corporation - IPR2025-01374

Authorized Response to Director Review Request

Patent Owner's Request for Director Review to Vacate Institution and Terminate Inter Partes Review

Joint Disputed Claim Terms Chart, Haemonetics Corp. v. Terumo BCT, Inc. (D. Colo.) (Feb. 3, 2026), D.I. 77

Exhibit 3100

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Order: SCHEDULING ORDER

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Institution Decision: Grant

Director Discretionary Decision: Refer

Petitioner's Opposition to Patent Owner's Request for Discretionary Denial

U.S. Patent No. 10,758,652 (“’652 patent”)

PATENT OWNER’S PRELIMINARY RESPONSE

NexSys PCS® Plasma Collection System Brochure, Haemonetics (2021)

“ADMA Biologics Advances Expansion Plans and Opens New Plasma Collection Center in Conyers, GA; ADMA Implements Haemonetics’ Persona Technology for NexSys Plasma Collection System,” ADMA Biologics, Inc. (Aug. 10, 2021)

“Peer-Reviewed Results of Haemonetics’ Improving Plasma Collection (IMPACT) Trial Published in the Journal Transfusion,” Haemonetics Press Release (Apr. 29, 2021)

“The Transcript of Plasma Innovation Business Seminar on June 23, 2022,” Terumo Corporation

“Q&A Session at the Financial Results Briefing for the FY22,” Terumo Corporation (May 17, 2023)

“Fresenius Kabi Received FDA 510(k) Clearance for Adaptive Nomogram, Enhancing Plasma Collection Efficiency with the Aurora Xi Plasmapheresis System,” Fresenius Kabi (Jan. 28, 2025)

Patent Owner’s Brief Requesting Discretionary Denial

Interim Processes for PTAB Workload Management, Coke Morgan Stewart (Mar. 26, 2025)

Second Amended Complaint, Haemonetics Corp. v. Terumo BCT, Inc., No. 1:25-cv-01409-RMR-SBP, D.I. 48 (D. Colo.) (Aug. 12, 2025)

U.S. FDA Clears Terumo Blood and Cell Technologies’ New Plasma Collection Technology, Terumo Global (Mar. 10, 2022)

U.S. Patent No. 10,758,652, “System and Method for Collecting Plasma,” to Michael Ragusa (filed: May 30, 2017; issued: Sept. 1, 2020)

510(k) Summary, Rika Plasma Donation System, Terumo Blood and Cell Technologies (2021)

510(k) Summary, Rika Plasma Donation System, Terumo Blood and Cell Technologies (2024)

Persona Plasma Collection Solution Brochure, Haemonetics Corporation (2020)

Information Disclosure Statement by Applicant, Application No. 18/644,259 (filed: Apr. 24, 2024)

PCT Written Opinion of the International Searching Authority, No. PCT/US2024/026191 (Aug. 8, 2024)

Letter from E. Milch to A. Gawin re Notice of Infringement of Haemonetics’ Plasma Collection Patents (Oct. 1, 2024)

Lex Machina Motion Metrics Report for Patent Cases in the District of Colorado since Jan. 1, 2000

Scheduling Order in a Patent Case, Haemonetics Corp. v. Terumo BCT, Inc., No. 1:25-cv-01409-RMR-SBP, D.I. 54 (D. Colo.)

Lex Machina Timing for Patent Cases in the District of Colorado since Jan. 1, 2009

Guidance on USPTO’s recission of “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation,” Scott R. Boalick (Mar. 24, 2025)

U.S. Patent No. 10,758,652, File History (filed: May 30, 2017; issued: Sept. 1, 2020)_Part 1

U.S. Patent No. 10,758,652, File History (filed: May 30, 2017; issued: Sept. 1, 2020)_Part 2

U.S. Patent No. 10,758,652, File History (filed: May 30, 2017; issued: Sept. 1, 2020)_Part 3

U.S. Patent No. 10,758,652, File History (filed: May 30, 2017; issued: Sept. 1, 2020)_Part 4

Notice of Petitioner's Sotera Stipulation

U.S. Patent No. 7,072,769 (“Fletcher-Haynes”)(Clean)

Correspondence regarding exhibit 1005

Notice: Mandatory Notice

Notice: Power of Attorney

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Notice: Notice filing date accorded

EXPUNGED

Petition: as filed

U.S. Patent No. 11,738,124 (“’124 patent”)

File History of the ’124 patent

Declaration of Dr. Gary Fletcher in Support of Petition

U.S. Patent No. 4,898,675 (“Lavender”)

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U.S. Patent No. 8,075,468 (“Min”)

U.S. Patent No. 9,370,324 (“Barrett”)

U.S. Patent No. 6,296,602 (“Headley”)

U.S. Patent Publication No. 2017/0029762 (“Turgut”)

“Membrane versus centrifuge-based therapeutic plasma exchange: a randomized

“Volume Limits – Automated Collection of Source Plasma,” November 4, 1992,

Curriculum Vitae (“CV”) of Dr. Gary D. Fletcher

Bruce C. McLeod, MD, et al., “Apheresis: Principles and Practice,” 3rd Ed

Japanese Patent Publication No. JP 2002-282352 A and English translation (“

Sergent SR, Ashurst JV. Plasmapheresis. [Updated 2023 Jul 10]. In: StatPear

Notice: Power of Attorney