ITM Isotope Technologies Munich SE v. The Johns Hopkins University et al.

Petition

Petition summary

Invalidity analysis

Prosecution analysis

Examiner search

## 1. Case Identification
- Case Number: [PGR2025-00012](https://ai-lab.exparte.com/case/ptab/PGR2025-00012)
- Patent #: [11,938,201](https://ai-lab.exparte.com/patent/11938201)
- Filed: December 24, 2024
- Petitioner(s): [ITM Isotope Technologies Munich SE](https://ai-lab.exparte.com/party/itm-isotope-technologies-munich-se)
- Patent Owner(s): The [Johns Hopkins University](https://ai-lab.exparte.com/party/johns-hopkins-university)
- Challenged Claims: 1-3

## 2. Patent Overview
- Title: Compounds for Imaging and Treating FAP-α Related Diseases
- Brief Description: The [’201 patent](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1001) relates to low molecular weight compounds for diagnostic imaging and radiotherapy targeting fibroblast-activation protein-α (FAP-α). The compounds have a general structure B-L-A, where A is a FAP-α targeting moiety, B is an optical or radiolabeled functional group, and L is a linker connecting them.

## 3. Grounds for Unpatentability
#### Ground I: Obviousness over Jansen I/II, Zimmerman, and Pomper - Claims 1-3 are obvious over Jansen I and/or Jansen II in view of Zimmerman and Pomper.
  - **Prior Art Relied Upon:** [Jansen I](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1007) (Patent [9,346,814](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1007)), [Jansen II](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1010) (ACS Med. Chem. 2013), [Zimmerman](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1009) (Application # [2010/0098633](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1009)), and [Pomper](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1006) (Application # [2012/0009121](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1006)).
  - **Core Argument for this Ground:**
    - **Prior Art Mapping:** Petitioner argued that the core components of the claimed B-L-A structure were well-known. The FAP-α targeting moiety (A), specifically the claimed quinolinoyl ring structure, was disclosed in [Jansen I](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1007) and [Jansen II](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1010) as a potent FAP inhibitor. [Zimmerman](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1009) taught attaching such inhibitors to radiolabeled functional groups (B) via linkers (L) to create radiopharmaceuticals for imaging and therapy. [Pomper](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1006) further taught the benefits of using *low molecular weight* agents for improved tumor access and disclosed suitable linkers. The combination of these references, Petitioner asserted, disclosed every element of the challenged claims.
    - **Motivation to Combine:** A Person of Ordinary Skill in the Art (POSA) would combine the potent FAP inhibitors of [Jansen I](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1007)/[II](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1010) with the imaging/therapeutic agents and linkers of [Zimmerman](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1009) to create a clinically useful product. [Pomper](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1006) provided an explicit motivation to make these compounds have a low molecular weight to improve pharmacokinetics and achieve better imaging results.
    - **Expectation of Success:** As each component was known to perform its intended function, a POSA would have a reasonable expectation of success in combining a known FAP inhibitor with a known imaging agent via a known linker to produce a functional imaging/therapeutic compound.
    - **Key Aspects:** Petitioner contended that the Patent Owner overcame an obviousness rejection during prosecution by submitting a declaration from Dr. Pomper showing allegedly unexpected results. Petitioner argued this evidence was insufficient, as it was based on only 11 examples and was not commensurate with the vast scope of the claims.

#### Ground II: Obviousness over Dvořáková and Pomper - Claims 1-3 are obvious over Dvořáková in view of Pomper.
  - **Prior Art Relied Upon:** [Dvořáková](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1008) (J. Med. Chem. 2017) and [Pomper](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1006) (Application # [2012/0009121](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1006)).
  - **Core Argument for this Ground:**
    - **Prior Art Mapping:** Petitioner asserted that [Dvořáková](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1008) disclosed a compound meeting every limitation of claim 1 except for the "low molecular weight" requirement. [Dvořáková](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1008) taught a high molecular weight polymer conjugate comprising a FAP inhibitor with the claimed quinolinoyl ring (A), a linker (L), and an optical dye (B). [Pomper](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1006) explicitly taught the advantages of low molecular weight compounds over larger molecules for imaging applications, noting they have better tumor access and show promise in preclinical studies.
    - **Motivation to Combine:** A POSA, aware of the large polymer conjugate in [Dvořáková](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1008) and the benefits of smaller agents taught by [Pomper](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1006), would be motivated to modify [Dvořáková](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1008)'s compound to create a low molecular weight version. This modification would be aimed at improving pharmacokinetic properties for better imaging and therapeutic efficacy.
    - **Expectation of Success:** A POSA would have readily understood how to lower the molecular weight of [Dvořáková](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1008)'s polymer conjugate (e.g., by using fewer inhibitor units and a smaller linker) and would have reasonably expected the resulting low molecular weight compound to work for its intended purpose.

#### Ground III: Unpatentability under §112 - Claims 1-3 are unpatentable for lack of enablement, lack of written description, and indefiniteness.
  - **Core Argument for this Ground:** Petitioner argued that the claims fail multiple requirements of 35 U.S.C. §112.
    - **Enablement:** The claims cover a vast, functionally-defined genus of compounds. The specification, however, provided only two working examples and failed to provide guidance on how to practice the full scope of the claims without undue experimentation. Petitioner argued this is analogous to the situation in *Amgen v. Sanofi*, where broad functional claims were found not enabled by a specification with only a few examples and a "trial-and-error" roadmap.
    - **Written Description:** The specification failed to demonstrate that the inventors possessed the full scope of the claimed invention. With only two examples, the disclosure did not provide a representative number of species or common structural features to support the broad genus, particularly for the functionally claimed linker (L) and imaging/therapeutic moiety (B).
    - **Indefiniteness:** The claim phrase "low molecular weight" is a term of degree that was not defined in the specification, rendering the claim boundaries unclear. The definition Patent Owner advanced during prosecution ("about 50 to 1,500 Daltons") was based on the unrelated field of metabolomics and was contradicted by embodiments in the specification and incorporated references that would exceed this range.

## 5. Key Claim Construction Positions
- **"Low Molecular Weight":** Petitioner argued this term is indefinite under §112. It is a relative term with no objective boundaries provided in the specification. The definition offered during prosecution (about 50-1,500 Da) was improper, as it was based on an unrelated technical field (metabolomics) and would improperly exclude embodiments disclosed in the patent (e.g., compounds including large fluorescent dyes or polymer linkers). This contradiction between the prosecution history and the specification created ambiguity.
- **"C(O)Alkyl" / "Aryl":** Petitioner argued that where the patent intended to limit the length of a chemical group, it used specific nomenclature (e.g., "C1-6 alkyl"). The use of "C(O)alkyl" and "aryl" without such length limitations in the claims meant these terms should be construed to encompass groups of any length, contributing to the vast and indefinite scope of the claims.

## 6. Arguments Regarding Discretionary Denial
- Petitioner argued that discretionary denial under §325(d) is inappropriate because the Examiner made material errors during prosecution. The Examiner allegedly failed to appreciate the full scope of the §112 issues (enablement, indefiniteness) presented in the petition. Furthermore, the Examiner erroneously withdrew obviousness rejections based on a flawed showing of unexpected results that was not commensurate with the broad claim scope and failed to apply the [Pomper](https://ai-lab.exparte.com/case/ptab/PGR2025-00012/doc/1006) reference, which was of record and directly taught the "low molecular weight" feature that was key to allowance.

## 7. Relief Requested
- Petitioner requests institution of [Post Grant Review](https://ai-lab.exparte.com/docs/ptab/PGR2025-00012/1) and cancellation of claims 1-3 of Patent [11,938,201](https://ai-lab.exparte.com/patent/11938201) as unpatentable.

Johns Hopkins' FAP-α imaging patent challenged for obviousness & §112. Prior art teaches low molecular weight agents; claims 1-3 called indefinite.