Ge Healthcare Ltd v. Johns Hopkins University

1. Case Identification

• Case #: IPR2025-00808
• Patent #: 11,938,201
• Filed: March 28, 2025
• Petitioner(s): GE Healthcare Ltd.
• Patent Owner(s): Johns Hopkins University
• Challenged Claims: 1-3

2. Patent Overview

• Title: Low Molecular Weight Radiopharmaceuticals for FAP Targeting
• Brief Description: The ’201 patent claims low molecular weight radiopharmaceutical compounds for medical imaging and therapy. The compounds utilize a modular three-component structure (B-L-A) designed to target Fibroblast Activation Protein-alpha (FAP-α), comprising a radiolabeling moiety (B), a linker (L), and a specific genus of quinolinyl-based FAP-α targeting moieties (A).

3. Grounds for Unpatentability

Ground 1: Obviousness over US-633, Meletta, and Jansen - Claims 1-3 are obvious over US-633 in view of Meletta and Jansen.

• Prior Art Relied Upon: US-633 (Application # 2010/0098633), Meletta (a 2015 publication), and Jansen (a 2014 scientific paper).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that US-633 discloses a modular three-component FAP-targeting radiopharmaceutical platform analogous to the claimed invention. The radiolabeling moieties (“B”) and linkers (“L”) taught by US-633 fall within the broad functional definitions of the challenged claims. The sole distinction is the FAP-targeting moiety (“A”); US-633 teaches a boronic acid pyrrolidine moiety that is not within the structural genus required by the claims.
  • Motivation to Combine: Petitioner asserted that Meletta, a publication that analyzed the compounds from US-633, identified a critical flaw: the boronic acid targeting moiety was insufficiently selective for FAP, leading to non-specific tissue accumulation. Meletta explicitly stated a need for “more selective inhibitors” for future studies. This disclosure, Petitioner contended, would have directly motivated a person of ordinary skill in the art (POSITA) to replace the deficient targeting moiety in the US-633 platform. A POSITA seeking a solution would have found Jansen, which discloses “compound 60,” a potent and highly selective FAP inhibitor that meets every structural requirement of the claimed “A” moiety.
  • Expectation of Success: A POSITA would have had a high expectation of success. The modular design taught in US-633 is inherently suited for component swapping, and the superior properties of Jansen’s compound 60 (high selectivity, affinity, and favorable pharmacokinetics) directly address the specific problem of poor selectivity identified by Meletta. Petitioner illustrated this by presenting four specific, predictable radiotracer compounds (A1-A4) that would have been obvious to create.

Ground 2: Obviousness over US-121 and Jansen - Claims 1-3 are obvious over US-121 in view of Jansen.

• Prior Art Relied Upon: US-121 (Application # 2012/0009121) and Jansen (a 2014 scientific paper).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that US-121 teaches low molecular weight radiotracers with the same modular three-component architecture claimed in the ’201 patent. US-121’s compounds, however, target Prostate-Specific Membrane Antigen (PSMA), not FAP, using a small-molecule urea-based targeting moiety. The chelators and linkers disclosed in US-121 are consistent with the functional requirements for the “B” and “L” components of the challenged claims.
  • Motivation to Combine: A POSITA would have been motivated to adapt the proven and successful radiotracer platform of US-121 to target FAP, a well-known and compelling target for a wide range of cancers. Petitioner contended that a POSITA would have sought to replace the PSMA-specific targeting moiety of US-121 with an effective FAP-targeting moiety to broaden the platform’s applicability. Jansen’s compound 60 would have been the ideal candidate for this substitution due to its high selectivity for FAP and its comparable small molecular size to the PSMA-targeting moiety in US-121.
  • Expectation of Success: US-121 explicitly invites the modification of its components, stating that “other equivalent components can be employed.” The established success of the US-121 framework in tumor imaging, combined with the excellent FAP-targeting properties of compound 60, would give a POSITA a strong expectation that the resulting FAP-targeting radiotracer would be effective.

4. Key Claim Construction Positions

• “low molecular weight compound”: Petitioner argued this term does not require special construction. However, should the Board find construction necessary, Petitioner proposed it should mean “having a molecular weight at least an order of magnitude less than an antibody-based radiopharmaceutical.” This construction is based on the specification’s distinction between the claimed small molecules and large antibody-based agents. Petitioner contended that the Patent Owner’s reliance during prosecution on an arbitrary upper limit of 1500 Da was based on extrinsic evidence and is contradicted by examples in the specification itself that would exceed this limit.

5. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under 35 U.S.C. §325(d), asserting that the grounds presented are materially different from those considered during prosecution. The Examiner did not have the benefit of Meletta, which provides a specific motivation to modify the primary reference (US-633), nor the specific Jansen reference that discloses a targeting moiety (compound 60) that meets the claim limitations without modification. Petitioner contended the Examiner erroneously believed the prior art required chemical modification to arrive at the claimed invention, an error the new prior art combinations correct. The petition also argued against denial based on an unrelated Post-Grant Review (PGR), noting different grounds, prior art, and parties.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-3 of the ’201 patent as unpatentable.