PTAB

IPR2019-01493

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 ’708 patent describes an apparatus for performing polymerase chain reactions (PCR) on multiple samples simultaneously. The system integrates a multi-lane microfluidic cartridge with an instrument containing a receiving bay, a plurality of separately controllable heat sources to maintain substantially uniform temperatures in each PCR reaction zone, a detector, and a processor to control the system.

3. Grounds for Unpatentability

Ground 1: 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 for conducting PCR on multiple samples, where each lane has independent temperature control and high temperature uniformity within each reaction zone. However, Zou I lacks integration into a complete, user-friendly machine. McNeely and Pease were argued to supply the missing conventional elements of such a machine. Specifically, both McNeely and Pease teach integrated instruments with a receiving bay for a microfluidic cartridge, an optical detector for monitoring reactions, and a processor coupled to the detector and heat sources for automated control.
    • Motivation to Combine: A POSITA would combine Zou I with the systems of McNeely or Pease for several reasons. Zou I itself suggests its microfluidic unit could be used in "current macro thermal cycler machines." The combination would provide the known benefits of integrating real-time detection with amplification, improving the interfacing needed for a practical device, and enhancing reproducibility and safety by enclosing the reaction in a self-contained cartridge within an automated instrument. Petitioner asserted this was a simple arrangement of known elements to yield predictable results.
    • Expectation of Success: A POSA would have a high expectation of success because combining a specialized PCR chip (Zou I) with a standard integrated instrument (McNeely or Pease) involved applying known techniques and components, each performing its expected function.

Ground 2: Claims 7-8 are obvious over Zou I in view of McNeely or Pease, and in further 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 Ground 1 by adding Hsieh to teach the specific optical detection features of claims 7 and 8. Petitioner contended that Hsieh discloses an optical detector specifically configured to detect a plurality of fluorescent dyes having different emission spectra and/or to detect dyes at a plurality of different locations. This was argued to meet the limitations requiring the ability to independently detect multiple fluorescent dyes.
    • Motivation to Combine: Because Zou I teaches multiple PCR reaction zones, each capable of an independent thermal protocol, a POSA would be motivated to incorporate the advanced detection capabilities of Hsieh. This combination would increase PCR throughput and efficiency by allowing the simultaneous processing and detection of different polynucleotides or a large number of samples, taking full advantage of the parallel processing architecture of Zou I.

Ground 3: Claims 11-17 are obvious over Zou I in view of McNeely or Pease, and in further 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 adds Zou II to the base combination to address the "contact heat source" limitations of claims 11-17. Petitioner argued Zou II teaches a reusable thermal cycler with an array of individually controllable contact heat sources (in the base) that are thermally coupled to distinct locations on a separate, disposable microfluidic chip. Zou II also discloses that the distinct locations are selectively and independently heated and may use a compliant layer to improve thermal contact. This maps directly to the claims' requirements for a contact heat source configured at the receiving bay to heat distinct locations on the cartridge.
    • Motivation to Combine: A POSA would be motivated to incorporate the teachings of Zou II to gain the predictable benefit of a low-cost, disposable cartridge system. Separating the expensive, reusable heat sources in the instrument base from the inexpensive, disposable cartridge was a known design choice to reduce assay costs, eliminate cleaning steps, and improve safety. This modification would retain the independent thermal control taught by Zou I while adding the cost-effectiveness taught by Zou II.
  • Additional Grounds: Petitioner asserted additional obviousness challenges, including: Ground 4 (claims 21-22 over Zou I and McNeely) for adding an optical detector to the lid; Ground 5 (claims 26-27 over the base combination plus Duong) for adding a barcode reader; and Ground 6 (claim 29 over the base combination plus Chow) for adding a removable heating stage.

4. Key Claim Construction Positions

  • "contact heat source": Petitioner argued this term should be construed to mean a heat source that can be configured to be in direct or indirect physical contact with the microfluidic cartridge, where indirect contact is through a physical medium. This construction was central to the arguments for claims 10-17, as it allowed prior art teaching heat sources in a base unit that press against a cartridge (like Zou II) to be considered "contact heat sources."

5. Relief Requested

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