PTAB

IPR2019-00170

Foundation Medicine Inc v. Caris MPI Inc

Log In
Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: System for Generating a Cancer Therapeutic Report
  • Brief Description: The ’193 patent describes a system for personalized cancer treatment. The system generates a report that identifies potential therapeutics for an individual by analyzing their molecular profile against a database of known molecular targets and associated therapies.

3. Grounds for Unpatentability

Ground 1: Obviousness over Lu and Illumina - Claims 1-14 are obvious over Lu in view of Illumina.

  • Prior Art Relied Upon: Lu (WO 03/017038) and Illumina (a 2005 technical bulletin).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Lu teaches a computerized decision support system for selecting optimal cancer treatments. This system analyzes a patient's molecular profile (disclosing EGFR and HER2 targets), compares it to a database of drug outcomes, and generates a report with therapy recommendations. However, Lu does not disclose the full set of molecular targets recited in claim 1. Illumina, a technical bulletin describing a commercial microarray assay (the DASL Cancer Panel), was argued to supply the missing elements by disclosing a panel of 502 cancer-related genes that explicitly includes all targets recited in claim 1 (AR, EGFR, HER2, KIT, MLH1, PTEN, and PDGFRA). Petitioner asserted that the combination of Lu’s system framework and Illumina’s comprehensive gene panel teaches every element of claim 1 and that the remaining dependent claims are directed to conventional features also disclosed or rendered obvious by the combination.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Lu and Illumina to improve Lu's system. Lu used older, lower-throughput technologies like PCR kits. A POSITA would have been motivated to incorporate Illumina’s well-known, high-throughput DASL microarray technology to assay a much larger number of relevant cancer targets more efficiently and cost-effectively, thereby creating a more comprehensive and powerful diagnostic tool.
    • Expectation of Success: A POSITA would have had a high expectation of success. Both references are directed to molecular profiling for cancer therapy, and the underlying technologies were well-established and complementary. Integrating a commercially available and validated gene panel like Illumina’s into a bioinformatic system like Lu’s was a routine and predictable task for a POSITA in 2006.

Ground 2: Obviousness over Lu, Illumina, and Muraca - Claims 2 and 3 are obvious over Lu, Illumina, and Muraca.

  • Prior Art Relied Upon: Lu (WO 03/017038), Illumina (a 2005 technical bulletin), and Muraca (Application # 2002/0150966).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground builds upon the Lu/Illumina combination from Ground 1 and adds Muraca to teach the specific limitations of claims 2 and 3. Claim 2 requires inputting molecular profile test values from a remote location, and claim 3 specifies input over an internet connection. Petitioner argued Muraca, which describes a specimen-linked database system, explicitly teaches that users at different physical locations can access and add information to the database remotely through a network, including via an "Internet browser."
    • Motivation to Combine: A POSITA would have been motivated to add the remote and internet-based access taught by Muraca to the core system of Lu and Illumina. This modification would provide the obvious and significant benefit of allowing geographically dispersed clinicians and researchers to access and utilize the powerful diagnostic system, maximizing its utility and accessibility, which was a common goal for such systems at the time.
    • Expectation of Success: Implementing remote database access over the internet was a well-known and routine practice by the patent's priority date. A POSITA would have found it straightforward to combine these conventional networking features with the Lu/Illumina system.

Ground 3: Obviousness over Lu, Illumina, and McDoniels-Silvers - Claims 7 and 11 are obvious over Lu, Illumina, and McDoniels-Silvers.

  • Prior Art Relied Upon: Lu (WO 03/017038), Illumina (a 2005 technical bulletin), and McDoniels-Silvers (a 2002 scientific paper).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground also builds on the Lu/Illumina combination, adding the McDoniels-Silvers reference to address claims 7 and 11. Claim 7 requires determining the molecular profile after the individual has received drug therapy, and claim 11 further specifies that the individual has failed to respond to at least one therapy. Petitioner contended that McDoniels-Silvers, a paper on gene expression in lung cancer, explicitly discloses analyzing clinical samples from patients who had previously been treated with cancer therapies, including chemotherapy and radiation, and had failed to respond.
    • Motivation to Combine: A POSITA would combine the teachings of McDoniels-Silvers with the Lu/Illumina system for clear clinical reasons. Monitoring a patient's molecular profile after treatment to assess efficacy and guide subsequent therapeutic decisions was a vital and standard practice in oncology. Incorporating this post-treatment analysis capability would make the Lu/Illumina system a more complete and clinically useful tool for managing ongoing cancer care.
    • Expectation of Success: The practice of monitoring biomarkers during and after cancer treatment was well-established. Applying the Lu/Illumina profiling technology in this known clinical context would have been a predictable application of the technology with a high expectation of success.

4. Key Claim Construction Positions

  • "likely benefit of the at least one therapeutic agent": Petitioner argued this term should be given its broadest reasonable interpretation to mean any therapeutic agent with potential efficacy. To support this, Petitioner cited a related patent from the same family (9,092,392) whose specification broadly defines "beneficial or desired medical results." This construction is critical because it allows prior art that identifies potential drug-target associations, without requiring proof of clinical success, to satisfy the claim limitation.

5. Relief Requested

  • Petitioner requests institution of IPR and cancellation of claims 1-14 of Patent 9,372,193 as unpatentable.