PTAB

IPR2018-01207

10X Genomics Inc v. Bio Rad Laboratories Inc

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Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: System and Method for Forming and Concentrating an Emulsion
  • Brief Description: The ’635 patent discloses a system for generating and concentrating emulsions, comprising a microfluidic chip and an instrument. The instrument applies pressure to wells on the chip to drive fluids through a network of channels, forming droplets at a junction, and then applies a second pressure differential to remove a portion of the continuous-phase fluid, thereby concentrating the collected emulsion.

3. Grounds for Unpatentability

Ground 1: Claims 1-8, 12-14, 16-21, and 23-27 are obvious over Kumacheva, Modlin, and Mason.

  • Prior Art Relied Upon: Kumacheva (Application # 2010/0184928), Modlin (Application # 2005/0266582), and Mason (WO 2010/124068).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Kumacheva taught a device with an array of parallel flow-focusing devices (FFDs) for generating droplets (emulsion production units). Modlin taught a microfluidic system with a well plate assembly in a standard microplate format and an instrument that uses a pressure manifold to drive fluids through parallel microfluidic circuits. The combination of Kumacheva's FFDs with Modlin's standardized, pressure-driven, parallel well plate system allegedly met the limitations for a system that forms an emulsion.
    • Prior Art Mapping (Incremental Contribution): To meet the claim limitation of concentrating the emulsion, Petitioner relied on Mason. Mason taught that it is advantageous to remove surfactant-containing continuous phase from an emulsion to reduce cost and recycle the surfactant. Petitioner asserted that Modlin’s instrument, which can apply positive or negative pressure, was capable of performing the reverse flow described by Mason to drain the continuous phase from the output well, thereby concentrating the droplets.
    • Motivation to Combine: A POSITA would combine Kumacheva and Modlin to substantially increase the parallelization and throughput of droplet generation (from four in Kumacheva to 96 or more with Modlin's format), automate the process, and increase compatibility with standard laboratory robotics. A POSITA would further incorporate Mason's teaching to reduce the significant cost of producing microemulsions by recycling expensive surfactants, a known practice in the field. Draining the excess continuous phase also allowed for more compact storage of the droplets.
    • Expectation of Success: Petitioner contended a POSITA would have a high expectation of success because the combination involved well-known microfabrication techniques and predictable fluidic principles. Modlin provided extensive detail on the design, fabrication, and operation of a pressure-driven system, and Mason's method of draining a heavier continuous phase via reverse flow was a straightforward fluidic operation that Modlin's instrument was configured to perform.

Ground 2: Claims 9-10, 15, and 22 are obvious over Kumacheva, Modlin, Mason, and Banerjee.

  • Prior Art Relied Upon: Kumacheva (Application # 2010/0184928), Modlin (Application # 2005/0266582), Mason (WO 2010/124068), and Banerjee (WO 2007/123744).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground builds on the combination in Ground 1 to address claims requiring a pressure sensor. Petitioner argued that Modlin itself rendered a pressure sensor obvious by disclosing integrated sensors for monitoring parameters including pressure, and a controller that could operate in a closed-loop manner using feedback signals. However, if Modlin were found insufficient, Banerjee explicitly taught a fluidic system equipped with pressure sensors to automatically detect and report system performance issues such as leaks, blockages, and flow volumes.
    • Motivation to Combine: A POSITA would be motivated to add Banerjee's pressure sensors to the combined Kumacheva/Modlin/Mason system to improve reliability and safety. The sensors would allow the instrument to detect pressure anomalies caused by clogged channels, leaks, or instrument malfunction. This would prevent device failure (e.g., delamination from excessive pressure), ensure consistent and precise droplet production, and facilitate rapid troubleshooting, all of which were known benefits of using pressure sensors in microfluidic systems.
    • Expectation of Success: Petitioner argued success was expected because integrating pressure sensors into fluidic control systems was a standard and well-understood practice for improving system monitoring and control.

4. Relief Requested

  • Petitioner requests institution of an IPR and cancellation of claims 1-10 and 12-27 of the ’635 patent as unpatentable under 35 U.S.C. §103.