Instrumentation Laboratory Company v. HemoSonics LLC

1. Case Identification

• Case #: Unassigned
• Patent #: 9,410,971
• Filed: February 3, 2017
• Petitioner(s): Instrumentation Laboratory Company
• Patent Owner(s): HemoSonics LLC
• Challenged Claims: 1-20

2. Patent Overview

• Title: Device, System and Methods for Evaluation of Hemostasis
• Brief Description: The ’971 patent describes a multi-chamber device and system for evaluating the hemostatic properties of a blood sample. The system uses an interrogation device to measure viscoelastic changes in the sample after it is mixed with various reagents, including an activator of coagulation and, in specific chambers, platelet inhibitors like abciximab or cytochalasin D.

3. Grounds for Unpatentability

Ground 1: Anticipation over the ‘672 Patent - Claims 1, 2, 6, 7, 15, and 16 are anticipated by the ‘672 Patent.

• Prior Art Relied Upon: Baugh (Patent 6,221,672) (“the ‘672 patent”).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the ’672 patent discloses every element of the challenged claims. The ’672 patent teaches a multi-chamber cartridge device for evaluating hemostasis by measuring the effectiveness of antiplatelet reagents. It explicitly discloses a plurality of test cells (chambers), each configured to receive a blood sample and containing reagents. The ’672 patent discloses using a coagulation activator in each chamber and adding different amounts of a platelet inhibitor, specifically naming the class of IIa/IIb inhibitors to which abciximab belongs, in subsequent chambers. An interrogation device measures changes in the sample's viscosity via a reciprocating plunger assembly, thereby determining a hemostatic parameter.
  • Key Aspects: The argument centered on the ’672 patent’s disclosure of a complete system that performs differential analysis between a baseline coagulation test and tests including platelet inhibitors, directly corresponding to the architecture of the ’971 patent's independent claim 1.

Ground 2: Anticipation over the ‘520 Publication - Claims 1, 2, 6, 7, 8, 15, and 16 are anticipated by the ‘520 Publication.

• Prior Art Relied Upon: Schubert (Application # 2010/0154520) (“the ‘520 publication”).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that the ’520 publication, which describes a cartridge for measuring viscoelastic characteristics of blood, also discloses all limitations of the challenged claims. The ’520 publication teaches a cartridge with multiple measurement cavities that can be combined to run different tests on a single sample. It explicitly discloses combining tests for intrinsic/extrinsic activation (e.g., INTEM™, EXTEM™) with a test where thrombocyte function is suppressed by cytochalasin D (FIBTEM™). This combination inherently requires a first chamber with a coagulation activator and a second chamber with an activator plus cytochalasin D. The publication also discloses an interrogation device (a pin and cup mechanism with optical detection) to measure viscoelastic properties.

Ground 3: Obviousness over ‘672 Patent and Viola 2009 - Claims 3, 4, and 17-20 are obvious over the ‘672 patent in view of Viola 2009.

• Prior Art Relied Upon: Baugh (’672 patent) and Viola 2009 (a 2009 journal article on an ultrasound-based hemostasis evaluation method).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground addressed claims requiring acoustic interrogation. Petitioner argued the ’672 patent teaches the foundational multi-chamber hemostasis device, as established in Ground 1. Viola 2009 teaches a method called sonorheometry, which uses acoustic radiation force and ultrasound transducers to measure the viscoelastic properties of a blood sample during coagulation. Viola describes the necessary components, including a transducer to transmit sound into a cuvette (test chamber) and a processor to analyze the returned signals to determine hemostatic parameters.
  • Motivation to Combine: A person of ordinary skill in the art (POSA) would have been motivated to replace the mechanical interrogation system of the ’672 patent with the known acoustic interrogation system of Viola 2009. This modification would be a predictable substitution of one known measurement technique for another to achieve the same goal of assessing hemostasis, potentially with benefits like improved sensitivity or the ability to use smaller sample volumes.
  • Expectation of Success: A POSA would have had a reasonable expectation of success because both references operate on the same fundamental principle of measuring changes in a blood sample's physical properties during clotting. Integrating a known acoustic sensor (Viola) with a known multi-well testing cartridge (’672) was presented as a straightforward application of existing technologies.

• Additional Grounds: Petitioner asserted numerous additional obviousness challenges, including combinations to render claims obvious by:

  • Adding lyophilized reagents (from the ’011 patent) to the devices of the ’672 patent or ’520 publication.
  • Incorporating specific fluid pathways for improved mixing (from the ’286 patent).
  • Adding a thermally conductive housing for temperature control (from the ’826, ’051, and ’082 references).
  • Adding a magnetic stirring structure (from the ’712 patent).

4. Key Claim Construction Positions

• "test chamber configured to receive blood of a test sample": Petitioner argued this phrase should be construed broadly under the broadest reasonable interpretation (BRI) standard to mean "any constrained space or cavity structurally capable of receiving a blood sample." Petitioner contended the term imposes no unique structural constraints beyond the ability to hold a liquid and that "configured to" merely refers to this capability, not a specific design optimization.
• "activator of coagulation": Petitioner proposed a broad construction covering any substance that initiates or accelerates the clotting cascade, including intrinsic activators (e.g., kaolin), extrinsic activators (e.g., tissue factor), and various proteins or enzymes from the coagulation pathway.
• "...chamber ... comprising a ... combination of reagents": Petitioner argued this limitation carries no temporal or structural constraints on when or how reagents are loaded. It could cover pre-loaded, lyophilized reagents or reagents added simultaneously with or after the blood sample. This broad interpretation was crucial for mapping prior art that used different reagent loading methods.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-20 of the ’971 patent as unpatentable.