PTAB

IPR2019-00490

QIAGEN North American Holdings Inc v. HandyLab Inc

Log In
Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Microfluidic System for Amplifying and Detecting Polynucleotides in Parallel
  • Brief Description: The ’900 patent discloses a multi-cartridge apparatus for performing and detecting polymerase chain reactions (PCR) in parallel. The system uses a plurality of multi-lane microfluidic cartridges that are inserted into a corresponding plurality of receiving bays within a single instrument for simultaneous or sequential processing.

3. Grounds for Unpatentability

Ground 1: Obviousness over Zou I in view of McNeely or Pourahmadi (Claims 1-8, 12, 14, 15, 17, 19-22)

  • 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 teaches the core inventive concept: a multi-lane microfluidic unit where each lane has a PCR reaction zone with a separately controllable heat source configured to maintain a substantially uniform temperature. Petitioner asserted that McNeely and Pourahmadi supply the remaining claimed elements, as both teach integrated machines with a plurality of receiving bays designed to accept multiple removable microfluidic cartridges. These references also disclose the use of standard components such as optical detectors for real-time analysis and processors for controlling system operations.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Zou I's advanced, independently-controlled PCR unit with the well-known multi-cartridge machine architecture of McNeely or Pourahmadi. The motivations were to achieve the predictable benefits of increased sample throughput, automation, and the integration of real-time detection capabilities. Petitioner noted that Zou I itself suggested its use with existing "macro thermal cycler machines," directing a POSITA toward such a combination.
    • Expectation of Success: Success would be highly expected, as the combination involves the straightforward integration of known components, each performing its established function, to create a more efficient, higher-throughput system.

Ground 2: Obviousness over Zou I and McNeely/Pourahmadi, in further view of Zou II (Claims 9-11, 13)

  • Prior Art Relied Upon: Zou I (’186 patent), McNeely (’739 application), Pourahmadi (’167 application), and Zou II (Patent 6,762,049).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground adds the teachings of Zou II, which discloses a system with a reusable thermal cycler module (containing an array of contact heat sources) that is separate from a low-cost, disposable microfluidic chip. Zou II explicitly teaches the selective heating of distinct locations on the chip and the use of a compliant layer to improve thermal contact, thereby enabling independent thermal control over different reaction zones.
    • Motivation to Combine: A POSITA would incorporate Zou II’s teachings into the base combination to gain the significant and known advantages of using inexpensive, disposable cartridges. This modification would reduce overall assay costs, minimize biohazard risks by making the sample-containing part disposable, and eliminate cleaning steps, all while keeping the complex and expensive heating elements reusable within the main instrument. This combination preserves the independent thermal control taught by Zou I while making the system more commercially practical and user-friendly.

Ground 3: Obviousness over Zou I and McNeely/Pourahmadi, in further view of Chow (Claim 18)

  • Prior Art Relied Upon: Zou I (’186 patent), McNeely (’739 application), Pourahmadi (’167 application), and Chow (Patent 5,955,028).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground adds Chow to teach a heating stage configured to be removable from the device. Chow discloses an integrated analysis system where a removable stage or "adapter" contains the heating and/or optical components and is configured to mate with a microfluidic cartridge.
    • Motivation to Combine: A POSITA would be motivated to make the heating stage of the combined apparatus removable as a simple mechanical design choice. This modification would predictably improve the serviceability of the instrument, allowing for easier replacement or upgrades of the heating module without servicing the entire machine. This was argued to be a known engineering option for improving modularity and maintenance.
  • Additional Grounds: Petitioner asserted an additional obviousness challenge (Claim 16) based on the primary combination in further view of Duong (WO 2001/54813), which taught adding a barcode reader for sample identification and tracking.

4. Key Claim Construction Positions

  • The term "contact heat source" was argued 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." Petitioner contended this construction is consistent with the patent's specification and was necessary to properly apply prior art references that teach both direct contact (e.g., a heat block) and indirect contact (e.g., heat conducted through a physical medium) heating methods.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-22 of the ’900 patent as unpatentable under 35 U.S.C. §103.