MIM Software Inc v. Progenics Pharmaceuticals Inc

1. Case Identification

• Case #: IPR2025-00725
• Patent #: 11,424,035
• Filed: March 14, 2025
• Petitioner(s): MIM Software Inc.
• Patent Owner(s): Progenics Pharmaceuticals, Inc.
• Challenged Claims: 1-38, 41-43

2. Patent Overview

• Title: Network for Medical Image Analysis, Decision Support System, and Related Graphical User Interface (GUI) Applications
• Brief Description: The ’035 patent discloses systems and methods for automatically analyzing medical images using a machine learning algorithm. The system combines anatomical images (e.g., CT scans) with nuclear medicine images (e.g., PET or SPECT scans) to generate a "risk map" and compute "risk indices" for cancer diagnosis and monitoring.

3. Grounds for Unpatentability

Ground 1: Obviousness over Maier, Huang, and Armor - Claims 1-7, 9-24, and 26-35 are obvious over Maier in view of Huang and Armor.

• 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 Maier disclosed the foundational network-based decision support system, including a processor and memory, that receives and stores medical images, accesses them upon user request, automatically analyzes them using a machine learning algorithm, and generates a report with risk metrics for a physician. To meet limitations not taught by Maier, Petitioner asserted that Huang teaches creating fused PET/CT "composite" images and using classifiers to automatically identify 3D boundaries of organs within the composite image. Petitioner further asserted that Armor teaches the missing element of administering a Prostate Specific Membrane Antigen (PSMA) binding agent with a radionuclide for imaging prostate cancer.
  • Motivation to Combine: A POSITA would combine Huang with Maier to improve diagnostic accuracy by incorporating fused anatomical and functional images, a known method for providing better context. A POSITA would further add Armor's PSMA-targeted radiotracer to apply the improved Maier/Huang system to the specific and challenging application of prostate cancer imaging, where PSMA agents are known to be particularly effective.
  • Expectation of Success: Petitioner contended success would be expected because the references describe compatible technologies within the same field of medical image processing, and combining them would predictably enhance the functionality of Maier's base system.

Ground 2: Obviousness over Maier, Huang, Armor, and Neumaier - Claims 5-8 and 22-25 are obvious over Maier in view of Huang and Armor, further in view of Neumaier.

• 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 on the primary combination by adding Neumaier to provide specific teachings for the PET imaging agents recited in dependent claims 5-8. While the primary combination established the use of a PET scan, Petitioner argued Neumaier explicitly discloses specific PSMA-targeted PET tracers, such as [18F]DCFPyL (a halogen radioisotope), and compares it favorably to prior art tracers like [68Ga]PSMA-11 (a gallium radioisotope), thereby teaching the specific limitations of claims 6-8.
  • Motivation to Combine: A POSITA would be motivated to incorporate Neumaier's teachings to improve tumor detection and use a more readily accessible radiotracer ([18F]DCFPyL) than the general class of agents taught by Armor.

Ground 3: Obviousness over Huang and Armor - Claims 36 and 41 are obvious over Huang in view of Armor.

• Prior Art Relied Upon: Huang (Application # 2007/0081712) and Armor (WO 2015/058151).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground targeted independent claims 36 and 41, which are directed to tracking prostate cancer progression over time. Petitioner argued that Huang discloses a method for "quantifying changes" by analyzing a series of digitized images from the same patient taken at "different time points," including using machine learning classifiers and calculating risk indices (e.g., "grading of the hot-spot"). Armor was asserted to provide the context of applying such imaging to evaluate the progress of prostate cancer periodically. The combination allegedly teaches the claimed method of repeatedly receiving, storing, and analyzing a series of images over time to track prostate cancer.
  • Motivation to Combine: A POSITA would combine Huang's general method for tracking changes over time with Armor's PSMA-based prostate cancer imaging to create a method specifically for monitoring the progression and treatment efficacy of prostate cancer, a known clinical need.

• Additional Grounds: Petitioner asserted an additional obviousness challenge against claims 37-38 and 42-43 based on Huang and Armor, further in view of Giesel (a 2016 journal article) and Weineisen (a 2015 journal article), to teach a "theragnostic" approach involving first and second radiopharmaceuticals for imaging and therapy.

4. Key Claim Construction Positions

• "Risk Map": Petitioner argued that based on the claims, specification, and Patent Owner's litigation assertions, this term should be construed as "a visual representation of tissue overlaid with graphical denotations marking one or more regions of cancer or risk of recurrence of cancer." This construction is broad enough to encompass what Petitioner alleges is disclosed in the prior art, such as displaying segmented tumors on a medical image.
• "Risk Indices" / "Risk Index": Petitioner contended this term should be construed as "numeric value(s) indicative of cancer state and/or progression in the patient within one or more regions," including values like tumor uptake, volumes, and other derived statistics (e.g., SUVpeak). This construction aligns with the Patent Owner's infringement contentions and covers quantitative metrics commonly disclosed in the cited prior art.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that institution is appropriate and discretionary denial should be avoided. It asserted that denial under 35 U.S.C. §325(d) is unwarranted because the primary prior art references (Maier, Huang, Armor) were not substantively considered during prosecution. Petitioner also argued against discretionary denial under Fintiv, contending that the parallel district court litigation is in its earliest stages, with no trial date set and minimal investment by the parties, making a stay pending the inter partes review (IPR) likely.

6. Relief Requested

• Petitioner requested institution of an IPR and cancellation of claims 1-38 and 41-43 of the ’035 patent as unpatentable.