PTAB

IPR2018-00113

Thermo Fisher Scientific Inc v. Bio Rad Laboratories Inc

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Localized Temperature Control For Spatial Arrays of Reaction Media
  • Brief Description: The ’414 patent describes an apparatus for performing Polymerase Chain Reactions (PCR) that uses a plurality of thermally conductive sample blocks arranged in a fixed array. Each block is independently temperature-controlled by its own underlying thermoelectric module and is thermally isolated from adjacent blocks by a solid insulating barrier.

3. Grounds for Unpatentability

Ground 1: Obviousness of Claims 1-4, 7, and 8 over Goemann and Chu

  • Prior Art Relied Upon: Goemann (European Publication No. 1228804) and Chu (Patent 6,337,435).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Goemann disclosed a PCR apparatus with multiple sample blocks arranged in an array and separated by solid insulating barriers to allow for simultaneous optimization of different reaction parameters. However, Goemann’s heating units were placed beside the blocks and were not specified as thermoelectric modules. Chu disclosed a single-block PCR apparatus with a superior design, featuring independently controllable Peltier (thermoelectric) modules positioned underneath the sample block, along with a layer of thermally conductive material between the block and the modules to improve heat transfer. The combination of Goemann's multi-block, thermally isolated array with Chu's underlying, independently controlled thermoelectric module design allegedly rendered claim 1 obvious.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine these references to improve upon Goemann’s design. Goemann taught the advantage of a multi-block array for optimizing multiple PCR variables (e.g., time and temperature) in a single run. A POSITA would have recognized that Goemann's side-heating design was suboptimal for rapid and uniform thermal cycling. They would have been motivated to replace Goemann's heating elements with Chu’s well-known and more efficient Peltier-based design to achieve better temperature control, accuracy, and speed, thereby creating a superior multi-block optimization apparatus.
    • Expectation of Success: A POSITA would have a high expectation of success. Substituting Chu’s self-contained, modular block design into Goemann’s array framework was a predictable combination of known components from the same field, each performing its known function to yield an improved, yet predictable, result.

Ground 2: Obviousness of Claim 6 over Goemann, Chu, and Heimberg

  • Prior Art Relied Upon: Goemann, Chu, and Heimberg (International Publication No. WO 01/24930).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the combination of Goemann and Chu from Ground 1 to address claim 6, which further required the fixed horizontal array to be a "two-dimensional array." While the primary combination resulted in a one-dimensional (linear) array as shown in Goemann, Heimberg explicitly disclosed multi-block thermal cyclers arranged in two-dimensional arrays (e.g., 2x3 or 4x6 blocks).
    • Motivation to Combine: A POSITA would be motivated to modify the one-dimensional array of the Goemann/Chu combination into a two-dimensional array as taught by Heimberg. Heimberg explained that two-dimensional arrangements were advantageous because they could be configured to match the layout of standard 96-well microtiter plates, facilitating automation and high-throughput screening, which were well-known goals in the field of PCR.
    • Expectation of Success: The modification was a simple and known design choice. Heimberg demonstrated the workability of 2D arrays with thermal isolation, and a POSITA would expect that arranging Chu-style blocks in a 2D format within Goemann's isolated framework would be straightforward and yield the predictable benefits of automation compatibility.

Ground 3: Obviousness of Claims 1 and 7 over Schicke and Atwood

  • Prior Art Relied Upon: Schicke (Application # 2003/0214994) and Atwood (International Publication No. WO 98/43740).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner asserted that Schicke disclosed nearly all elements of claim 1, including a PCR device with multiple, thermally separate sample "segments" arranged in a horizontal array, connected by insulating layers, and controlled by separate Peltier modules positioned underneath. The primary element Schicke only suggested, but did not explicitly detail, was the "layer of thermally conductive material" between each block and its thermoelectric module. Atwood directly addressed this issue, teaching the importance of a compliant thermal interface, such as thermal grease, between a sample block and its Peltier devices.
    • Motivation to Combine: A POSITA would combine Schicke and Atwood to improve the performance and reliability of Schicke’s device. Schicke taught that good thermal "contact" was necessary, creating a recognized need. Atwood provided the explicit solution, explaining that thermal grease ensures uniform heat transfer, which is critical to PCR performance, and also acts as a lubricant to enhance the life-expectancy of the components. A POSITA would have thus been motivated to add Atwood’s thermal grease layer to Schicke's apparatus to solve a known problem and achieve predictable improvements in thermal uniformity and device longevity.
    • Expectation of Success: There was a high expectation of success, as this involved applying a standard, well-understood solution (thermal grease) to a common engineering problem in thermal cycler design (ensuring good thermal contact) to achieve a known and predictable benefit.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including for method claims 9-12, 15, and 16 based on Goemann, Chu, and Atwood (adding Atwood's teaching on controlling power to Peltiers), and for claims 6 and 14 based on combinations including Heimberg for its two-dimensional array teaching. These grounds relied on similar combination rationales and design modification theories.

4. Key Claim Construction Positions

  • "thermally insulating" and "thermally isolate": Petitioner argued that, under the broadest reasonable interpretation, these terms did not require the complete prevention of heat transfer. Instead, they should be construed to mean reducing heat transfer between adjacent blocks sufficiently to allow them to be maintained at different temperatures or run on different thermal protocols, consistent with the patent’s disclosure and the general understanding in the art that perfect isolation is impossible.
  • "plurality of sample blocks": Petitioner contended this term should be interpreted broadly to encompass both an assembly of physically separate and independent blocks, as well as distinct portions or segments of a single, larger block that are separated by insulating barriers.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-4, 6-12, and 14-16 of Patent 9,623,414 as unpatentable.