Instrumentation Laboratory Co v. HemoSonics LLC

1. Case Identification

• Case #: Post-Grant Review Case No. Unassigned
• Patent #: 10,031,144
• Filed: April 24, 2019
• Petitioner(s): Instrumentation Laboratory Company
• Patent Owner(s): HemoSonics LLC
• Challenged Claims: 1-4, 9, 11-14, 16-21, 30, 39, 42, 50, 58, 61, and 63

2. Patent Overview

• Title: Devices, Systems, and Methods for Evaluation of Hemostasis
• Brief Description: The ’144 patent relates to devices, systems, and methods for evaluating hemostasis in a blood sample. The disclosure focuses on a single-sample cartridge with multiple test chambers that is analyzed using a specific acoustic-echo interrogation technique to determine viscoelastic properties.

3. Grounds for Unpatentability

Ground 1: Lack of Written Description and Enablement under 35 U.S.C. §112(a)

• Prior Art Relied Upon: Not applicable (challenge based on intrinsic evidence).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the ’144 patent fails the written description and enablement requirements of §112(a) because the claims are impermissibly broad relative to the narrow disclosure. The specification exclusively describes a single "species" of invention—a hemostasis evaluation system using an acoustic-echo interrogation technique with an ultrasonic transducer. However, the independent claims functionally recite a broad "genus" covering any method of interrogation using any type of "transducer" to determine viscoelastic properties.
  • Key Aspects: Petitioner contended this overbreadth is a classic "genus-species" problem, where disclosing one species does not entitle the patent owner to claim the entire genus. The argument was supported by pointing to dependent claims (e.g., claims 16, 39, 58, 63) that recite an LED emitter as a transducer, a non-ultrasonic technique for which the specification provides no support or enabling disclosure for evaluating hemostasis. Petitioner asserted that implementing alternative interrogation methods would require undue experimentation, as the patent provides no guidance beyond the specific acoustic-echo method.

Ground 2: Anticipation over Schubert - Claims 1-4, 9, 11-14, 16-21, 30, 39, 42, 50, 58, 61, and 63 are unpatentable as anticipated under 35 U.S.C. §102.

• Prior Art Relied Upon: Schubert (Application # 2010/0154520).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Schubert disclosed every element of the challenged claims. Schubert described a multi-chamber test cartridge for viscoelastic testing to evaluate hemostasis. It taught a system for implementing thromboelastometry (TEM), a known force-response method for determining clot firmness (a viscoelastic property). Schubert's cartridge featured multiple chambers with different reagents (INTEM, EXTEM, FIBTEM) fed from a single inlet, directly corresponding to the claimed apparatus. The TEM system, with its oscillating pin, drive motor, and optical detection system (light beam, mirror, detector), was argued to constitute the claimed "one or more transducers" and the associated "processor" for interrogating the sample and determining hemostatic parameters.
  • Key Aspects: The argument relied on a broad construction of "transducer" to include the entire mechanical and optical chain in Schubert's TEM device. Petitioner asserted that a POSITA would have reasonably inferred the presence of a processor and memory in Schubert to control the measurements, perform data analysis, and generate the disclosed clot firmness curves.

Ground 3: Obviousness over Schubert in view of the State of the Art on TEG/TEM - Claims 1-4, 9, 11-14, 16-21, 30, 39, 42, 50, 58, 61, and 63 are obvious over Schubert in view of the State of the Art (SoA).

• Prior Art Relied Upon: Schubert (Application # 2010/0154520) in view of SoA references including Calatzis (Patent 5,777,215), Ganter (a 2008 journal article), and the TEG 5000 User Manual (2008).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that to the extent Schubert was found not to explicitly disclose processor-controlled interrogation or parallel data analysis, these features were well-known in the art of viscoelastic testing and would have been obvious to add. The SoA, exemplified by the TEG 5000 User Manual, explicitly taught using computer software for automated interrogation, simultaneous analysis of multiple samples, data processing, and generation of graphical results.
  • Motivation to Combine: A POSITA would combine the teachings because Schubert was directed to implementing a known viscoelastic test (TEM) in a novel cartridge system. It would have been a natural and obvious step to incorporate the standard, commercially available computer-based control and analysis systems (like those for TEG/TEM) to automate Schubert's cartridge.
  • Expectation of Success: A POSITA would have had a high expectation of success because both TEG and TEM were mature technologies that relied on computer processing. Applying known software automation to Schubert's TEM-based cartridge was a simple application of a known technique to a similar device to achieve predictable results.

• Additional Grounds: Petitioner asserted additional challenges for indefiniteness under §112(b) based on untethered functional claiming. An additional obviousness ground was asserted over Schubert in view of Viola 2009 (a journal article by the inventors of the ’144 patent), arguing it would have been obvious to replace Schubert's mechanical TEM system with the acoustic-echo technique taught in Viola.

4. Key Claim Construction Positions

• "transducer": Petitioner argued this term required no construction and its plain meaning is broad, covering any device that converts energy from one form to another or simply transmits force. This broad meaning was central to the argument that Schubert's mechanical/optical system met the limitation, while also supporting the §112 argument that the term was not structurally limited to the ultrasonic transducers disclosed in the ’144 patent.
• "instructions...cause the at least one processor to direct the one or more transducers...": Petitioner contended this functional language was overbroad and not supported by the specification. The claim language was argued to cover any type of interrogation using any unspecified transducer and data processing method, while the patent only described a specific acoustic-echo technique. Petitioner argued this language rendered the claims invalid under §112 for lack of enablement and written description.
• "processor is configured to determine...hemostatic parameters from signals...": Similar to the point above, Petitioner argued this language was purely functional and untethered to any specific algorithm or structure disclosed in the patent, rendering the claims indefinite and invalid under §112.

5. Relief Requested

• Petitioner requested institution of post-grant review and cancellation of claims 1-4, 9, 11-14, 16-21, 30, 39, 42, 50, 58, 61, and 63 of the ’144 patent as unpatentable under 35 U.S.C. §§ 102, 103, and 112.