PTAB

IPR2017-00855

Instrumentation Laboratory Co v. HemoSonics LLC

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Petition
petition

1. Case Identification

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 hemostasis by measuring viscoelastic properties of a blood sample. The device utilizes a plurality of test chambers, each containing reagents such as a coagulation activator, with at least one chamber also containing a platelet inhibitor like abciximab or cytochalasin D to enable differential analysis.

3. Grounds for Unpatentability

Ground 1: Anticipation over Baugh - Claims 1, 2, 6, 7, 15, and 16 are anticipated by the [’672](https://ai-lab.exparte.com/case/ptab/IPR2017-00855/doc/1005) patent.

  • Prior Art Relied Upon: Baugh (Patent 6,221,672).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Baugh discloses every limitation of the challenged claims. Baugh describes a device for evaluating hemostasis that uses a disposable cartridge with a plurality of test cells (chambers) for receiving blood samples. Each chamber contains reagents, including a contact activator for coagulation, and is interrogated by a plunger assembly that measures changes in viscosity as the blood clots. Crucially, Baugh explicitly teaches using different amounts of a platelet inhibitor, specifically naming abciximab, in different test cells to measure its effect on coagulation, directly mapping to the key limitations of independent claim 1. Baugh also discloses a housing for the test chambers and configuring the device for use with a single patient sample distributed among the chambers.

Ground 2: Anticipation over Schubert - Claims 1, 2, 6, 7, 8, 15, and 16 are anticipated by the [’520](https://ai-lab.exparte.com/case/ptab/IPR2017-00855/doc/1006) publication.

  • Prior Art Relied Upon: Schubert (Application # 2010/0154520).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Schubert, which describes a cartridge-based system for measuring viscoelastic properties of blood, anticipates the claims. Schubert teaches a cartridge with multiple measurement cavities (chambers) to perform different tests in parallel from a single sample. It explicitly discloses combining various coagulation assays, including an EXTEM™ test (extrinsic activation) and a FIBTEM™ test. Petitioner argued that a POSITA would know the FIBTEM™ test uses cytochalasin D to suppress platelet function, thereby satisfying the limitation of claim 1 requiring a chamber with a coagulation activator and cytochalasin D. Schubert’s device uses a pin-and-cup mechanism with optical detection to interrogate the sample and determine hemostatic parameters.

Ground 3: Obviousness over Baugh and Viola - Claims 3 and 4 are obvious over the [’672](https://ai-lab.exparte.com/case/ptab/IPR2017-00855/doc/1005) patent in view of Viola 2009.

  • Prior Art Relied Upon: Baugh (Patent 6,221,672) and Viola 2009 (a journal article titled "A Novel Ultrasound-Based Method to Evaluate Hemostatic Funtion of Whole Blood").

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that Baugh discloses the base multi-chamber hemostasis testing device as detailed in Ground 1. Viola 2009 describes a technique called "sonorheometry," which is an interrogation method that uses acoustic radiation force, generated by an ultrasound transducer, to measure the viscoelastic properties of a blood sample. This method directly teaches the limitations of dependent claims 3 and 4, which add the requirements of using "acoustic radiation force" and a device "configured to transmit sound into one or more test chamber."
    • Motivation to Combine: A POSITA would combine the known acoustic interrogation technique from Viola 2009 with the multi-assay cartridge platform of Baugh to create an improved or alternative method for measuring hemostasis. Using a non-contact acoustic method would be a predictable and desirable modification to a mechanical system.
    • Expectation of Success: A POSITA would have a high expectation of success, as the combination involves applying a known analysis technique (sonorheometry) for blood coagulation to a known multi-chamber device designed for the same purpose. The integration was presented as a predictable design choice.

  • Additional Grounds: Petitioner asserted numerous additional obviousness challenges based on combinations of either Baugh or Schubert as the primary reference with secondary art. These combinations sought to render obvious claims related to lyophilized reagents (in view of the ’011 patent), specific fluid pathway designs and tangential flow for improved mixing (in view of the ’286 patent), thermally conductive housings (in view of the ’826 and ’051 patents), magnetic stirring structures (in view of the ’712 patent), and acoustic interrogation for the second independent claim 17 (in view of Viola 2009).

4. Key Claim Construction Positions

  • "test chamber configured to receive blood of a test sample": Petitioner argued this term should be construed under the Broadest Reasonable Interpretation (BRI) standard to mean "any constrained space or cavity structurally capable of receiving a blood sample." This construction does not require the chamber to actually contain blood, only that it is capable of doing so.
  • "configured to be interrogated": Petitioner proposed this phrase means the chamber must be "capable of being interrogated." This functional language was argued not to impose specific structural requirements beyond what is necessary to allow for interrogation by known techniques.
  • "activator of coagulation": This term was construed broadly to encompass any intrinsic activator (e.g., kaolin, celite), extrinsic activator (e.g., tissue factor), or other protein or co-factor in the clotting cascade.

5. Relief Requested

  • Petitioner requests the institution of an inter partes review and the cancellation of claims 1-20 of Patent 9,410,971 as unpatentable.