MIM Software Inc v. Progenics Pharmaceuticals Inc

1. Case Identification

• Case #: IPR2025-00726
• Patent #: 11,894,141
• Filed: March 14, 2025
• Petitioner(s): MIM Software Inc.
• Patent Owner(s): Progenics Pharmaceuticals, Inc.
• Challenged Claims: 1-3, 6-35

2. Patent Overview

• Title: Network for Medical Image Analysis, Decision Support System, and Related Graphical User Interface (GUI) Applications
• Brief Description: The ’141 patent discloses network-based systems and methods for automatically analyzing composite medical images (e.g., a CT scan overlaid with a nuclear medicine image) using a machine learning algorithm. The system is designed to generate a radiologist report or compute "risk indices" indicative of a patient's cancer state or progression.

3. Grounds for Unpatentability

Ground 1: Obviousness over Maier, Huang, and Armor - Claims 1-3, 6-9, 13-26, and 32-35

• Prior Art Relied Upon: Maier (Application # 2016/0203263), Huang (Application # 2007/0081712), and Armor (WO 2015/058151).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the combination of these references teaches every limitation of the challenged independent claims. Maier was asserted to disclose the foundational network-based, cloud-capable decision support system that uses a machine learning algorithm to analyze medical images and generate reports with risk metrics. Huang was argued to supply the teaching of using composite (or "fused") images, such as PET/CT, to improve analysis by identifying 3D boundaries of organs to provide anatomical context. Finally, Armor was asserted to teach the specific application of this technology to prostate cancer by using a Prostate Specific Membrane Antigen (PSMA) binding agent with a radionuclide for imaging. Dependent claims were argued to be obvious as they recite well-known variations, such as using PET scans or tracking values over time, which are also taught by the combination.
  • Motivation to Combine: A POSITA would combine Huang with Maier to improve physician decision-making; Huang’s fused PET/CT images provide superior anatomical context for the analysis performed by Maier's system. A POSITA would further incorporate Armor’s PSMA-binding agent as a simple substitution for the general imaging biomarkers in the Maier/Huang system to improve the diagnosis and monitoring of prostate cancer, a known application area for such imaging systems.
  • Expectation of Success: Petitioner asserted a POSITA would have a high expectation of success, as all three references operate in the same field of medical image processing, use compatible imaging modalities (PET, CT, SPECT), and address the common goal of improving cancer detection and monitoring.

Ground 2: Obviousness over Maier/Huang/Armor, further in view of Neumaier - Claims 6-11

• Prior Art Relied Upon: Maier (Application # 2016/0203263), Huang (Application # 2007/0081712), Armor (WO 2015/058151), and Neumaier (Patent 10,112,974).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground builds upon the primary combination in Ground 1 to address dependent claims reciting specific PSMA-binding agents. While Armor taught PSMA-targeted radiotracers generally, Petitioner argued that Neumaier explicitly discloses the use of specific PSMA-specific PET tracers, including [18F]DCFPyL (recited in claim 8) and its predecessor [68Ga]PSMA-11 (recited in claim 11), for imaging prostate cancer.
  • Motivation to Combine: A POSITA would be motivated to incorporate Neumaier’s teachings to use an improved, more accessible, and clinically superior radiotracer. Neumaier praises [18F]DCFPyL for its longer half-life and better biodistribution characteristics (e.g., less kidney uptake) compared to prior art agents like those suggested by Armor, leading to improved tumor lesion detection. This provides a clear motivation to use Neumaier’s specific agents within the broader framework established by Maier, Huang, and Armor.
  • Expectation of Success: Success would be expected because Neumaier’s agents are designed for the very PET/CT imaging modalities disclosed in the primary combination and for the same purpose of diagnosing prostate cancer.

Ground 3: Obviousness over Huang, Armor, and Maier - Claims 27 and 31

• Prior Art Relied Upon: Huang (Application # 2007/0081712), Armor (WO 2015/058151), and Maier (Application # 2016/0203263).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground reconfigures the primary references to target the method claims (27, 31) for tracking cancer progression over time. Petitioner asserted that Huang is the principal reference, as it explicitly teaches a method for "quantifying changes" in tumors by analyzing a series of images from the same patient taken at "different time points." Armor was argued to provide the context of applying this tracking method specifically to prostate cancer progression. Maier was added to this combination to supply the limitation of performing the method on a "cloud-based system," as disclosed in Maier.
  • Motivation to Combine: A POSITA would combine these references to implement a known and valuable clinical method (tracking tumor progression as taught by Huang) for a specific, challenging disease (prostate cancer, as addressed by Armor) on a modern, scalable, and practical architecture (the cloud-based system of Maier).
  • Expectation of Success: The combination was argued to be a predictable integration of known technologies, as Huang’s analysis methods are directly applicable to the types of images generated using Armor’s agents, and Maier’s cloud platform is a conventional way to deploy such software.
• Additional Grounds: Petitioner asserted additional obviousness challenges, including grounds adding Cardinale (Patent 10,815,200) and/or Giesel (a 2016 journal article) to disclose the specific 18F-PSMA-1007 radiotracer, and grounds adding Giesel and Weineisen (a 2016 journal article) to teach methods involving theranostics.

4. Key Claim Construction Positions

• "Risk Indices" / "Risk Index": Petitioner argued that these terms lack a plain and ordinary meaning and should be construed based on intrinsic and extrinsic evidence. Based on the patent specification, claim language, and the Patent Owner's own infringement contentions in parallel litigation, Petitioner proposed three alternative constructions, all centering on the concept of: "numeric value(s) indicative of cancer state and/or progression in the patient within one or more regions." This construction is broad enough to include metrics like uptake values (e.g., SUVpeak), tumor volumes, and Gleason scores, which are disclosed in the prior art.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under both 35 U.S.C. §325(d) and §314(a) (Fintiv) is unwarranted.
• §325(d): Petitioner contended that the primary prior art references (Maier, Huang, Armor) were not substantively considered by the Examiner during prosecution, even though some were cited. The Examiner focused on different, less relevant art, meaning the petition raises issues that are materially different from those previously before the Office.
• Fintiv Factors (§314(a)): Petitioner argued that the parallel district court litigation is in its infancy. Key factors weighing against denial include: no trial date has been set, the court’s scheduling order was issued very recently, there has been minimal investment by the parties or the court, and Petitioner intends to file a motion to stay the litigation if the IPR is instituted.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-3 and 6-35 of the ’141 patent as unpatentable under 35 U.S.C. §103.