Beckman Coulter Inc v. Sysmex Corp

1. Case Identification

• Case #: IPR2020-01503
• Patent #: 10,401,351
• Filed: August 20, 2020
• Petitioner(s): Beckman Coulter, Inc.
• Patent Owner(s): Sysmex Corporation and Sysmex America, Inc.
• Challenged Claims: 7-15

2. Patent Overview

• Title: Sample Analyzer and Computer Program Product
• Brief Description: The ’351 patent describes a hematology analyzer capable of analyzing both blood and body fluid samples. The system uses different measurement modes and detectors to determine cellular information from these distinct sample types.

3. Grounds for Unpatentability

Ground 1: Claims 7-15 are obvious over Nagai in view of Jagtiani.

• Prior Art Relied Upon: Nagai (Patent 8,440,140) and Jagtiani (WO 2019/236682).
• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner’s argument first established that the challenged claims were not entitled to their asserted priority date. The claims recite using an electrical detector to classify white blood cells (WBCs) in a body fluid sample. However, Petitioner asserted the ’351 patent’s specification and its entire priority chain fail to provide written description support for this feature, instead consistently disclosing an optical detector for all WBC analysis. As a result, the effective filing date for claims 7-15 is March 25, 2019, making Nagai and Jagtiani valid prior art under §102.

  • Nagai, which shares an identical specification with the ’351 patent, disclosed a hematology analyzer with both blood and body fluid modes, a controller, and an optical detector for analyzing WBCs. The claims of the ’351 patent differ by reciting an electrical detector for counting mono-nucleated and poly-nucleated cells in body fluid. Jagtiani disclosed devices and methods for analyzing biological samples, including body fluids, using an electrical impedance sensor to differentiate and count various types of cells, including WBCs (lymphocytes, monocytes, etc.). Petitioner asserted it would have been obvious to a Person of Ordinary Skill in the Art (POSA) to modify the analyzer in Nagai by substituting its optical detector (for the body fluid mode) with the known electrical impedance detector from Jagtiani to perform its known function of classifying WBCs. This combination allegedly taught all limitations of the challenged claims.

  • Motivation to Combine (for §103 grounds): A POSA would combine Nagai and Jagtiani because it represented a simple substitution of one known type of sensor for another to achieve a predictable result. This modification would allow for the additional, known capability of performing electrical impedance-based cell analysis on body fluids. Petitioner also pointed to its own DxH analyzer system, which uses an electrical detector for both blood and body fluid modes, as evidence that such a combination was a known and logical design choice to simplify the number of sensors required.

  • Expectation of Success (for §103 grounds): A POSA would have had a high expectation of success because the combination required no more than applying a known technique (Jagtiani's electrical cell differentiation) with a known device (Nagai's analyzer) in a predictable way.

4. Key Claim Construction Positions

• Petitioner argued that several key terms required construction based on the patent’s specification to highlight the lack of written description for the challenged claims.
• “optical detector” vs. “electrical detector”: Petitioner contended that based on the specification, an "optical detector" must be construed as a device measuring optical properties (e.g., via flow cytometry and scattered light), while an "electrical detector" measures electrical properties (e.g., resistance/impedance). The specification consistently described the WBC detection unit as optical. The only electrical detector described (the RBC/PLT detection unit) was for counting red blood cells and platelets, not for classifying WBCs as claimed.
• “mono-nucleated cells” and “poly-nucleated cells”: Petitioner asserted a POSA would understand these terms to refer to "mononuclear" (lymphocytes and monocytes) and "polymorphonuclear" (neutrophils, eosinophils, and basophils) cells, respectively, as defined in the specification’s description of optical analysis. The petition stressed that the specification provides no basis for how an electrical detector would classify cells into these specific groups.

5. Key Technical Contentions (Beyond Claim Construction)

• The petition’s central technical contention was that the ’351 patent and its priority applications lack adequate written description under §112 for the invention recited in claims 7-15.
• Petitioner asserted that the specification failed to demonstrate that the inventors were in possession of an invention where an electrical detector is used to count and classify mono-nucleated and poly-nucleated WBCs in body fluid. The disclosure consistently described using an optical system (the WBC detection unit) for this function, generating scattergrams from optical signals.
• The petition argued that the specification also lacked any description of a "controller" programmed to perform the claimed functions with an electrical detector. The only analysis algorithms described were for processing optical data from scattergrams. Petitioner contended that these fundamental disclosure failures meant claims 7-15 were untethered from the patent’s actual teachings and not entitled to an earlier priority date.

6. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not exercise its discretion to deny institution under §314(a) based on the Fintiv factors related to a parallel district court litigation.
• Petitioner asserted that: (1) it intended to seek a stay of the district court case upon institution; (2) the trial date was scheduled near the statutory deadline for a final written decision (FWD), minimizing concerns of inefficiency; (3) the court case had not progressed significantly, with discovery still open; and (4) the IPR raises different invalidity arguments and relies on different expert testimony than in the district court action, reducing overlap.
• Furthermore, Petitioner argued that institution should be granted under §325(d) because the primary prior art references, Nagai and Jagtiani, were not before the USPTO during the original prosecution, meaning the grounds are substantially different from those previously considered.

7. Relief Requested

• Petitioner requested the institution of an inter partes review and the cancellation of claims 7-15 of Patent 10,401,351 as unpatentable under §103.