PTAB

IPR2018-00950

HemoSonics LLC v. Ca Casyso GmbH

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Cartridge Device for a Measuring System for Measuring Viscoelastic Characteristics of a Sample Liquid
  • Brief Description: The ’671 patent discloses a disposable cartridge for use with a measuring system to assess the blood coagulation process. The cartridge contains multiple cavities pre-loaded with different reagents to perform parallel differential tests on a single blood sample.

3. Grounds for Unpatentability

Ground 1: Obviousness over Braun and Lang 2006 - Claims 1-4, 6, 8-15, 18-23, and 25-40 are obvious over Braun in view of Lang 2006.

  • Prior Art Relied Upon: Braun (Patent 5,629,209) and Lang 2006 (a 2006 journal article on thromboelastometry).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Braun taught the core structural elements of independent claim 1, including a disposable, multi-chamber cartridge for analyzing coagulating blood. Braun disclosed an inlet port, ductwork connecting to multiple fluid-receiving chambers (cavities), and the use of preloaded reagents to affect blood clotting, including extrinsic activators (tissue thromboplastin), intrinsic activators (kaolin), and suppressors of thrombocyte function (aspirin). Petitioner asserted that Lang 2006, which described the well-known ROTEM thromboelastometry test device, supplied the specific reagent combinations recited in claim 1. Lang 2006 explicitly taught using reagents for an extrinsic pathway test (EXTEM), an intrinsic pathway test (INTEM), and a test with a platelet inhibitor (FIBTEM), directly corresponding to the reagents required in the first, third, and second cavities of claim 1, respectively. Dependent claims were allegedly addressed by this combination, as Lang 2006 taught the specific viscoelastic measurement techniques (e.g., measuring clot firmness, clotting time) and ROTEM system features, while Braun taught the physical cartridge features (e.g., housing, solid-form reagents).
    • Motivation to Combine: A POSITA would combine Braun and Lang 2006 because they address the same field of technology. A POSITA would naturally look to incorporate the well-known and standardized reagent sets and analytical methods from Lang 2006 (ROTEM) into the versatile multi-chamber cartridge system taught by Braun to create an improved, self-contained testing device.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because combining a known cartridge with known reagents and testing methods involved applying predictable technologies to achieve a known goal.

Ground 2: Obviousness over Braun, Lang 2006, and Hillman - Claim 5 is obvious over Braun in view of Lang 2006 and Hillman.

  • Prior Art Relied Upon: Braun (Patent 5,629,209), Lang 2006, and Hillman (Patent 5,204,525).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon Ground 1 to address claim 5, which required the intrinsic activation reagent to be Hagemann factor (Factor XII). While Braun and Lang 2006 taught using intrinsic activators generally (e.g., kaolin), Petitioner argued that Hillman explicitly taught the use of Hagemann factor as a reagent in a clotting assay to assess blood coagulation.
    • Motivation to Combine: A POSITA, seeking to implement an intrinsic pathway test as taught by Braun and Lang 2006, would be motivated to consult references like Hillman for known and suitable intrinsic activators. Using Hagemann factor, a known component of the intrinsic pathway, would have been an obvious choice.

Ground 3: Obviousness over Farnam and Lang 2006 - Claims 1-4, 6, 8-15, 18-23, and 25-40 are obvious over Farnam in view of Lang 2006.

  • Prior Art Relied Upon: Farnam (Patent 7,674,616) and Lang 2006.
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner presented Farnam as an alternative primary reference to Braun, arguing it provided the same fundamental teachings. Farnam taught a multi-chamber, point-of-care cartridge with an inlet, ductwork, separate reaction chambers, and pre-loaded reagents (including extrinsic and intrinsic activators) for the simultaneous analysis of blood coagulation. As in Ground 1, Lang 2006 was relied upon to teach the specific reagent combinations (EXTEM, INTEM, FIBTEM) and the viscoelastic measurement techniques required by the claims.
    • Motivation to Combine: The motivation was identical to that in Ground 1: a POSITA would combine Farnam’s point-of-care cartridge with the standard ROTEM testing protocols and reagents described in Lang 2006 to create a comprehensive and efficient coagulation analysis system.
  • Additional Grounds: Petitioner asserted additional obviousness challenges for specific claims by combining the Braun/Lang 2006 or Farnam/Lang 2006 combinations with further references. These included adding Warden (Patent 6,016,712) for platelet aggregometry testing (claims 7, 24) and Lang 2005 (a 2005 journal article) for details of a light beam detector (claims 16, 17).

4. Key Claim Construction Positions

  • "Cavity" or "Cavities": Petitioner proposed this term be construed as "a space(s) within an object." This construction was argued to be consistent with the specification's use of the term to describe various spaces within the cartridge (e.g., receiving cavity, reagent cavity, measurement cavity).
  • "one or more reagents configured for suppressing thrombocyte function": Petitioner proposed the construction "any reagent or reagents selected to inhibit platelet functionality." This was based on the specification's reference to using known compositions like FIBTEM for this purpose.
  • "one or more reagents configured for testing platelet aggregometry": Petitioner proposed this be construed as "selection of reagents that cause platelets to aggregate," asserting the specification provided little detail beyond a passing reference to the device's suitability for such tests.

5. Relief Requested

  • Petitioner requested institution of an inter partes review of claims 1-40 of the ’671 patent and cancellation of those claims as unpatentable under 35 U.S.C. §103.