Terumo BCT, Inc. v. Haemonetics Corporation - PGR2025-00078

Director Discretionary Decision: Deny

Petitioner's Authorized Preliminary Sur-Reply

Patent Owner's Preliminary Reply

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

Email Correspondence

Director Discretionary Decision: Refer

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)

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

Persona, Plasma Collection Solution Brochure

U.S. Patent No. 12,186,474

Full File History of U.S. Patent No. 10,758,652

Full File History of U.S. Patent No. 12,377,204

U.S. Patent No. 10,980,926 (“Ragusa”)

PTAB Notice of Decisions on Institution, Dec. 11, 2025

Opposition to Motion to Correct Clerical Error Under 37 C.F.R. § 42.104(c) and to Seek Leave for Dr. Fletcher to Serve an Amended Declaration

Motion to Correct Clerical Error Under 37 C.F.R. § 42.104(c) and to Seek Leave for Dr. Fletcher to Serve an Amended Declaration

E-mail authorizing motion to submit corrected petition

Petitioner's Motion to Seal, Request for In Camera Review, and for Entry of Stipulated Protective Order

Search Disclosure Declaration (Filing Party and Board Only)

Redacted Search Disclosure Declaration

Petitioner's Updated Exhibit List

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)

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)

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

Persona Plasma Collection Solution Brochure, Haemonetics Corporation (2020)

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

U.S. Patent No. 11,738,124, “System and Method for Collecting Plasma,” to Michael Ragusa (filed: Sep. 13, 2022; issued: Aug. 29, 2023)

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. Aug. 19, 2025)

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)

Notice: Notice filing date accorded

Notice: Mandatory Notice

Notice: Power of Attorney

Petition: as filed

U.S. Patent No. 12,171,916 (“’916 Patent”)

File History of the ’916 Patent

Declaration of Dr. Gary Fletcher in Support of Petition

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

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

U.S. Publication No. 2002/0033370 (“Bainbridge”)

U.S. Patent No. 10,195,319 (“Kimura”)

U.S. Patent No. 6,743,192 (“Sakota”)

“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 certified Japanese to

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

Notice: Power of Attorney