PTAB

IPR2026-00069

Ge Healthcare Ltd v. Johns Hopkins University

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Radiopharmaceuticals for Targeting Fibroblast Activation Protein (FAP)
  • Brief Description: The ’201 patent discloses low molecular weight compounds for radiopharmaceutical and optical imaging applications. The compounds feature a modular three-component structure (B-L-A) comprising a reporter moiety (B), a linker (L), and a targeting moiety (A) designed to selectively bind to Fibroblast Activation Protein-alpha (FAP-α).

3. Grounds for Unpatentability

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

  • Prior Art Relied Upon: US-633 (Application # 2010/0098633), Meletta (a 2015 journal article), and Jansen (a 2014 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that US-633 taught the same modular, three-component (B-L-A) design for FAP-targeting radiopharmaceuticals as claimed in the ’201 patent. The radiolabeling moieties ("B") and linkers ("L") disclosed in US-633 are captured by the broad functional definitions in the challenged claims. The only difference was the specific FAP-targeting moiety ("A"). Meletta analyzed a compound from US-633 and found its targeting moiety was insufficiently selective for FAP, creating a need for "more selective inhibitors." Jansen disclosed "compound 60," a highly potent and selective FAP inhibitor whose structure falls squarely within the genus claimed for the "A" moiety.
    • Motivation to Combine: A POSITA would be motivated to improve upon the known radiotracer framework of US-633. Meletta's explicit identification of the poor selectivity of the US-633 targeting moiety and its call for "more selective inhibitors" would have directly prompted a POSITA to search for and find superior FAP-targeting moieties. Jansen's disclosure of compound 60 as a potent and highly selective FAP inhibitor would have made it an obvious and ideal candidate to substitute into the US-633 framework to solve the problem identified by Meletta.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because the modular design taught in US-633 is intended for facile replacement of components. Substituting the poorly selective targeting moiety of US-633 with the highly selective compound 60 from Jansen was a straightforward combination of known elements to achieve a predictable result.

Ground 2: Claims 1-3 are obvious over US-121 and Jansen.

  • Prior Art Relied Upon: US-121 (Application # 2012/0009121) and Jansen (a 2014 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: US-121, which shares an inventor with the ’201 patent, described a successful modular three-component radiotracer design for targeting a different enzyme, prostate-specific membrane antigen (PSMA). The linkers and radiolabeling moieties in US-121 are analogous to those claimed in the ’201 patent. Jansen disclosed compound 60 as an excellent FAP-targeting moiety. Petitioner asserted that swapping the PSMA-targeting moiety in the proven US-121 framework for the FAP-targeting compound 60 would result in a compound falling within the scope of the challenged claims.
    • Motivation to Combine: The prior art established FAP as an appealing and widely expressed target for cancer imaging, more so than PSMA. A POSITA would be motivated to adapt the proven and successful radiotracer designs of US-121 for the more promising FAP target. This would involve replacing the PSMA-targeting component with a known, effective FAP-targeting component. Jansen's compound 60, being a small molecule of comparable size and superior selectivity for its target, would have been an obvious choice for this substitution.
    • Expectation of Success: The established modularity of the US-121 compounds and the explicit invitation in US-121 to employ "other equivalent components" would provide a POSITA with a strong expectation that substituting the targeting moiety would be successful. The chemical similarity and well-understood properties of the components would make the modification predictable.

4. Key Claim Construction Positions

  • Petitioner argued that no special construction is needed for most terms. However, to preempt Patent Owner's likely arguments, Petitioner contended:
    • "B" (radiolabeling moiety) and "L" (linker): These terms are defined functionally in the claims (e.g., "any... suitable for" imaging, a linker "adapted to form a chemical bond"). Petitioner argued this broad functional language should be given its plain meaning and not be limited to specific structures disclosed in the specification.
    • "low molecular weight compound": Petitioner asserted this term does not require construction, as the obvious compounds presented in the grounds are of comparable size to examples in the ’201 patent's own specification. If construed, Petitioner argued it means having a molecular weight at least an order of magnitude less than an antibody (~150,000 Da). Petitioner noted that even under the patent owner's prosecution-history assertion of an upper limit of ~1500 Da, the proposed obvious compounds would still meet that limitation.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial is not warranted.
    • Denial under Fintiv: Petitioner stated that no parallel litigation involving the ’201 patent is pending, making denial under the Fintiv factors inappropriate.
    • Denial under §325(d): Petitioner contended that denial is unwarranted because the petition relies on prior art (Jansen, Meletta) and arguments not previously considered by the Examiner. Petitioner also alleged that the Examiner made foundational errors regarding the prior art during prosecution, further justifying a new review.

6. Relief Requested

  • Petitioner requested that the Board institute an inter partes review and cancel claims 1-3 of the ’201 patent as unpatentable under 35 U.S.C. §103.