PTAB

IPR2019-00166

Foundation Medicine Inc v. Caris MPI Inc

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Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: System for Generating a Report Identifying Potential Cancer Therapeutics
  • Brief Description: The ’660 patent describes a system for personalized cancer treatment. The system analyzes a patient's molecular profile for a specific set of genetic targets, compares the results to reference values in a database, and generates a report identifying potential therapeutic agents based on detected molecular aberrations.

3. Grounds for Unpatentability

Ground 1: Claims 1-16, 18, and 22-23 are obvious over Von Hoff, Bibikova, and Illumina.

  • Prior Art Relied Upon: Von Hoff (Application # 2008/0014146), Bibikova (a 2004 journal article), and Illumina (a 2005 commercial technical bulletin).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the combination of references taught every limitation of the challenged claims. Von Hoff disclosed a general system for determining individualized cancer therapies by analyzing a patient's molecular profile, comparing it to a reference, and using a database to identify therapeutic agents. However, Von Hoff did not specifically mention lung cancer or the complete panel of gene targets required by claim 1. Illumina, a technical bulletin for a commercial microarray product (the DASL Assay), disclosed a cancer gene panel that included all the specific targets recited in claim 1 (PTEN, CTNNB1, cKIT, BRAF, and PIK3CA). Bibikova taught the specific application of the Illumina DASL Assay to profile tumor samples from various cancers, explicitly including lung cancer tissues. Therefore, Petitioner asserted that Von Hoff provided the foundational system, Illumina supplied the specific, missing gene panel, and Bibikova provided the explicit link to lung cancer, rendering the claimed invention obvious.
    • Motivation to Combine: Petitioner argued a person of ordinary skill in the art (POSITA) would combine these references to solve the well-known problem of improving personalized cancer therapy. The shared goal of all three references—identifying molecular targets to guide treatment—provided a strong motivation. A POSITA implementing Von Hoff’s general system would have looked to known, comprehensive commercial gene panels like that described in Illumina to identify relevant targets. Bibikova’s successful use of the Illumina panel on lung cancer tissue would have confirmed the suitability of this combination for the claimed subject matter, demonstrating a clear path for applying the combined teachings to lung cancer.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success because the underlying technologies, such as microarrays and bioinformatics databases, were well-established and routinely used before 2010. The Illumina DASL Assay was a commercially available product proven to work on cancer tissues, as shown in both Illumina and Bibikova. Combining these known elements—a general bioinformatics system, a specific commercial gene panel, and a known application to lung cancer—involved applying conventional techniques to achieve a predictable outcome.

4. Key Technical Contentions (Beyond Claim Construction)

  • Priority Date Challenge: A central contention of the petition was that the ’660 patent was not entitled to a priority date earlier than February 12, 2010. Petitioner argued that earlier provisional applications lacked written description support for the claimed molecular target “CTNNB1.” This contention was critical because it established that Von Hoff, published in 2008, qualified as prior art against the challenged claims. Petitioner further asserted that other limitations, such as the required targets PIK3CA and BRAF, lacked support prior to May 28, 2009.

5. Relief Requested

  • Petitioner requests the institution of an inter partes review (IPR) and the cancellation of claims 1-16, 18, and 22-23 of the ’660 patent as unpatentable under 35 U.S.C. §103.