PTAB

IPR2019-00488

QIAGEN North American Holdings Inc v. HandyLab Inc

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Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Microfluidic System for Amplifying and Detecting Polynucleotides in Parallel
  • Brief Description: The ’708 patent discloses an apparatus for conducting polymerase chain reactions (PCR) in parallel across multiple lanes of a microfluidic cartridge. The system features separately controllable heat sources for each reaction zone to maintain uniform temperature and a detector for identifying amplification products.

3. Grounds for Unpatentability

Ground 1: Obviousness over Zou I and McNeely or Pease - Claims 1-6, 9-10, 18-20, 23-25, 28, and 30-33 are obvious over Zou I in view of McNeely or Pease.

  • Prior Art Relied Upon: Zou I (Patent 6,509,186), McNeely (Application # 2004/0037739), and Pease (Application # 2004/0151629).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Zou I discloses the core inventive concept: a multi-lane microfluidic unit with a PCR reaction zone in each lane, each coupled to a separately controllable heat source that maintains a substantially uniform temperature for independent thermal cycling. However, Zou I lacks integration into a complete, automated machine. McNeely and Pease were cited as teaching the remaining conventional elements of claim 1: an integrated machine with a receiving bay for a removable microfluidic cartridge, an optical detector for real-time detection of PCR products, and a processor coupled to the detector and heat sources to control the system.
    • Motivation to Combine (for §103 grounds): A Person of Ordinary Skill in the Art (POSA) would combine Zou I with a system like McNeely or Pease for several reasons. Zou I itself suggested its microfluidic chip could be used in existing "macro thermal cycler machines," which McNeely and Pease exemplify. The combination would predictably provide the known benefits of integrating amplification with real-time detection, improving user interface and control, and enhancing safety and reproducibility by containing the reaction in a standardized cartridge.
    • Expectation of Success (for §103 grounds): A POSA would have had a high expectation of success, as the combination involved arranging old, well-known elements, each performing its known function to yield a predictable result.

Ground 2: Obviousness over Zou I, McNeely or Pease, and Hsieh - Claims 7-8 are obvious over Zou I in view of McNeely or Pease, further in view of Hsieh.

  • Prior Art Relied Upon: Zou I (Patent 6,509,186), McNeely (Application # 2004/0037739) or Pease (Application # 2004/0151629), and Hsieh (Patent 7,122,799).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground builds on the combination in Ground 1 to address the specific optical detection limitations of claims 7 and 8. These claims require an optical detector configured to independently detect a plurality of fluorescent dyes having different emission spectra (claim 7) and at a plurality of different locations (claim 8). Petitioner asserted that Hsieh explicitly teaches optical detection systems using multiple LEDs and photodetectors in a grid pattern to achieve these exact capabilities.
    • Motivation to Combine (for §103 grounds): Since Zou I discloses a system with multiple, independently controlled reaction zones, a POSA would be motivated to incorporate the advanced detection capabilities of Hsieh. This would increase the throughput and efficiency of the combined system by allowing for the simultaneous detection of different polynucleotides or a larger number of samples, a well-understood goal in the field of PCR analysis.

Ground 3: Obviousness over Zou I, McNeely or Pease, and Zou II - Claims 11-17 are obvious over Zou I in view of McNeely or Pease, further in view of Zou II.

  • Prior Art Relied Upon: Zou I (Patent 6,509,186), McNeely (Application # 2004/0037739) or Pease (Application # 2004/0151629), and Zou II (Patent 6,762,049).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground targets claims related to a "contact heat source" configured at the receiving bay to be thermally coupled to distinct locations on the cartridge. Petitioner argued that Zou II teaches this specific configuration: a reusable array of independently controlled contact heat sources (thermal blocks) located in a base unit, onto which a low-cost, disposable microfluidic chip is pressed for thermal coupling. This allows for selective heating of distinct locations on the disposable chip. Zou II also discloses the use of a compliant layer to improve thermal contact, as recited in dependent claims.
    • Motivation to Combine (for §103 grounds): A POSA would combine the teachings of Zou II with the base system of Zou I and McNeely/Pease to achieve the known, significant benefit of a low-cost, disposable cartridge system. Separating the expensive, reusable heating elements in the base from the single-use cartridge was a known design choice that reduced assay costs, eliminated cleaning steps, and enhanced biohazard safety.
  • Additional Grounds: Petitioner asserted additional obviousness challenges against claim 29 based on the primary combination further in view of Chow (Patent 5,955,028) for teaching a removable heating stage, and against claims 26-27 based on the primary combination further in view of Duong (WO 2001/54813) for teaching a handheld barcode reader as a sample identifier.

4. Key Claim Construction Positions

  • "contact heat source": Petitioner proposed this term be construed to mean "a heat source that can be configured to be in direct or indirect physical contact, where indirect physical contact is through a physical medium." This construction, supported by the patent’s specification, is broad enough to encompass various thermal coupling methods and was central to the arguments in Ground 3.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-33 of the ’708 patent as unpatentable.