PTAB

IPR2015-01192

Infopia Co Ltd v. Polymer Technology Systems Inc

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: METHOD FOR DETERMINING HDL CONCENTRATION FROM WHOLE BLOOD OR PLASMA
  • Brief Description: The ’397 patent discloses a method and test strip for determining the concentration of HDL cholesterol in a whole blood sample. The test strip uses a vertically stacked structure of layers, including a dispersement layer, a red blood cell separation layer, a non-HDL separation chemistry layer, and an HDL reaction layer, to permit vertical downward fluid flow for analysis.

3. Grounds for Unpatentability

Ground 1: Obviousness over Connolly, Patel, Kozak, Kitajima, Kawaguri, and Steinhausen - Claims 19-20 are obvious over Connolly in view of Patel, Kozak, Kitajima, Kawaguri, and Steinhausen.

  • Prior Art Relied Upon: Connolly (Patent 5,597,532), Patel (Patent 5,215,886), Kozak (Patent 5,460,974), Kitajima (Patent 5,876,605), Kawaguri (Patent 5,171,689), and Steinhausen (a chapter on the principles of dry chemistry systems).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Connolly taught the foundational elements of the claimed method: a multi-layer test strip for measuring HDL cholesterol from whole blood, comprising a dispersement layer, a separating layer, and a reaction layer arranged for vertical downward fluid flow. The secondary references were alleged to supply the remaining specific limitations. Patel and Kozak were cited for explicitly teaching a non-HDL separation chemistry layer to remove VLDL and LDL while allowing HDL to pass through. For the limitation requiring a red blood cell separation layer "not containing an agglutinin or a coagulant," Petitioner pointed to Kitajima and Kawaguri, which disclosed methods of separating red blood cells without such agents. Finally, for dependent claim 20, which requires stacking the red blood cell layer above the non-HDL layer, Petitioner argued this arrangement was explicitly disclosed in Kozak. Steinhausen was used to establish that the general principles of multi-layer, vertical-flow dry chemistry systems were well known.
    • Motivation to Combine: Petitioner contended that a person of ordinary skill in the art (POSITA) would combine these references because they all belong to the same field of diagnostic blood test strips and address the same problem of improving the accuracy and reliability of cholesterol measurement. A POSITA would have been motivated to modify Connolly’s foundational test strip by incorporating the specific, known separation layers from Patel, Kozak, Kitajima, and Kawaguri to create a more comprehensive and effective device.
    • Expectation of Success: The combination was asserted to be a predictable integration of known elements, each performing its established function, which would have yielded the expected result of a more reliable HDL cholesterol test.

Ground 2: Obviousness over Carroll, Patel, Kozak, Kitajima, Kawaguri, and Steinhausen - Claims 19-20 are obvious over Carroll in view of Patel, Kozak, Kitajima, Kawaguri, and Steinhausen.

  • Prior Art Relied Upon: Carroll (Patent 6,040,195), Patel (Patent 5,215,886), Kozak (Patent 5,460,974), Kitajima (Patent 5,876,605), Kawaguri (Patent 5,171,689), and Steinhausen (a chapter on the principles of dry chemistry systems).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presented a similar argument to Ground 1 but used Carroll as the primary reference. Petitioner argued that Carroll disclosed a diagnostic test strip for analytes like HDL cholesterol with a vertically aligned spreading layer, separating layer, and preconditioned membrane that allowed a sample to pass directly downward. The same secondary references were then relied upon to supply the remaining limitations not explicitly taught by Carroll. Patel and Kozak provided the teaching of a non-HDL separation chemistry layer. Kitajima and Kawaguri taught the use of a red blood cell separation layer without an agglutinin or coagulant. Kozak further provided the specific stacked arrangement recited in claim 20. Steinhausen again provided evidence of the well-understood principles of these systems in the art.
    • Motivation to Combine: The motivation argument was parallel to that in Ground 1. Petitioner argued a POSITA would have found it obvious to modify the known Carroll test strip with the teachings of the secondary references. Since all references were directed at improving diagnostic blood testing, a POSITA would combine their respective features to achieve the predictable result of a more robust and accurate test for HDL cholesterol.
    • Expectation of Success: Petitioner asserted that because each element was known in the art and would be combined according to its known function, a POSITA would have had a high expectation of success in creating the claimed invention.

4. Key Claim Construction Positions

  • "without substantial lateral migration of fluid below said dispersement layer": Petitioner argued this term, which appears in claim 19, should not be construed to mean a complete absence of lateral flow. Citing the ’397 patent’s own specification, which acknowledged that "fluid movement, especially spreading, in all directions" occurs, Petitioner contended that a POSITA would understand this limitation to mean simply that the primary fluid path is vertically downward through the stacked layers. The proposed construction was that "some fluid movement and spreading of the fluid will take place in the vertically stacked layers below the dispersement layer." This construction was central to arguing that prior art references showing dominant vertical flow met the limitation, even if some incidental lateral spreading occurred.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 19 and 20 of the ’397 patent as unpatentable.