PTAB

IPR2019-01494

NeuMoDx Molecular 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 ’900 patent is directed to a multi-cartridge apparatus for detecting polynucleotides in samples. The system uses a plurality of multi-lane microfluidic cartridges to carry out polymerase chain reactions (PCR) in parallel, featuring separately controllable heat sources for each reaction zone.

3. Grounds for Unpatentability

Ground 1: Obviousness over Zou I and McNeely/Pourahmadi - Claims 1-8, 12, 14, 15, 17, and 19-22 are obvious over Zou I in view of McNeely or Pourahmadi.

  • Prior Art Relied Upon: Zou I (Patent 6,509,186), McNeely (Application # 2004/0037739), and Pourahmadi (Application # 2002/0055167).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Zou I taught the core inventive concept: a multi-lane microfluidic unit capable of conducting PCR with independent thermal control and high temperature uniformity for each reaction lane. The remaining limitations of independent claims 1 and 7—such as an apparatus with a "plurality of cartridges," a "plurality of receiving bays" to hold them, optical detectors, and a coupled processor—were asserted to be conventional system-level features explicitly disclosed in McNeely and Pourahmadi. McNeely taught an integrated instrument with multiple bays for receiving removable microfluidic cartridges, optical sensors for real-time detection, and a user interface for processor control. Pourahmadi similarly taught a portable instrument that mates with and controls multiple microfluidic cartridges for PCR.
    • Motivation to Combine: A POSITA would combine Zou I's advanced, independently controllable PCR unit into the established multi-cartridge platforms of McNeely or Pourahmadi to achieve predictable benefits. The primary motivations cited were increasing sample throughput by multiplying the system's processing capacity and improving versatility by enabling asynchronous operation (i.e., starting and stopping different cartridges independently). Further motivations included integrating the real-time detection capabilities of McNeely and Pourahmadi with Zou I’s precise thermal control, and leveraging the known safety and reproducibility benefits of automated, cartridge-based systems. Petitioner noted that Zou I itself suggested incorporating its chip into existing "macro thermal cycler machines."
    • Expectation of Success: Petitioner asserted that combining these known elements was merely the application of known techniques to yield predictable results. A POSITA would have reasonably expected success because integrating a specialized microfluidic chip into a larger analytical instrument was a routine and well-understood task in the field.

Ground 2: Obviousness over Zou I, McNeely/Pourahmadi, and Zou II - Claims 9-11 and 13 are obvious over Zou I in view of McNeely or Pourahmadi, in further view of Zou II.

  • Prior Art Relied Upon: Zou I (Patent 6,509,186), McNeely (Application # 2004/0037739), Pourahmadi (Application # 2002/0055167), and Zou II (Patent 6,762,049).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the base combination of Ground 1 to address dependent claims reciting specific "contact heat source" configurations. Petitioner argued that Zou II taught the missing elements, including a reusable array of contact heat sources (heaters) thermally coupled to distinct, selectively heated locations on a separate, low-cost disposable microfluidic chip. This arrangement met the limitation of claim 9. Zou II also explicitly taught the independent heating of distinct locations to eliminate thermal cross-talk (meeting claim 11) and the use of a soft, compliant layer to ensure good thermal contact between the reusable heater array and the disposable chip (meeting claim 13).
    • Motivation to Combine: A POSITA would incorporate Zou II’s teachings into the base combination to gain the significant economic and practical advantages of a system with reusable heating components and low-cost, disposable cartridges. This design strategy was a well-known method to reduce overall assay costs, eliminate burdensome cleaning steps between runs, and enhance biohazard safety. The combination advanced the goal of high-throughput parallel processing with independent thermal control, a key objective described in both Zou I and Zou II.
    • Expectation of Success: Petitioner contended that modifying the base combination with Zou II’s features was a predictable design choice. The concept of separating expensive, reusable hardware from inexpensive, disposable consumables was a common and well-understood paradigm in the field of microfluidics and diagnostics, ensuring a high expectation of success.
  • Additional Grounds: Petitioner asserted additional obviousness challenges, arguing that claim 18 was obvious over the base combination in further view of Chow (Patent 5,955,028) for teaching a removable heating stage, and that claim 16 was obvious over the base combination in further view of Duong (WO 2001/54813) for teaching a barcode reader for sample identification.

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 was central to arguments for claims 8-13, as it encompassed prior art systems where a thermal block (the heat source) in the instrument makes contact with a cartridge, potentially through an intervening compliant layer, to heat the reaction zone.

5. Relief Requested

  • Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 1-22 of the ’900 patent as unpatentable.