Prior art

As a technical patent analyst, here is an analysis of the prior art cited during the prosecution of U.S. Patent No. 11,938,201. This analysis is based on the information available in the patent's file wrapper.

Analysis of Cited Prior Art for U.S. Patent No. 11,938,201

The following references were cited by the examiner during the prosecution of the application that led to the issuance of US Patent 11,938,201. This information is critical for understanding the scope of the patent's claims and potential arguments regarding their validity.

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U.S. Patent Documents

• Citation: US 9,770,523 B2

  • Publication Date: September 26, 2017
  • Filing Date: March 20, 2014
  • Assignee: Johns Hopkins University
  • Brief Description: This patent discloses compounds that are inhibitors of prostate-specific membrane antigen (PSMA). The compounds are radiolabeled and used for imaging and therapy of PSMA-expressing tissues, such as prostate cancer. The core structure involves a linker connecting a PSMA-targeting moiety to a chelator for a radionuclide.
  • Potential Anticipation: This reference is highly relevant as it comes from the same assignee and deals with a similar "theranostic" concept of linking a targeting moiety to a radiolabel via a linker for imaging and therapy. While targeting a different protein (PSMA vs. FAP-alpha), the general chemical structures of the linkers and chelating agents could be seen as anticipating the general structure claimed in 11,938,201, particularly broader claims related to the overall B-L-A (Reporter-Linker-Targeting Moiety) structure. An argument for anticipation under 35 U.S.C. § 102 would depend on the breadth of the claims in 11,938,201 and whether the specific FAP-alpha targeting moiety "A" was considered novel and non-obvious over the PSMA-targeting moieties disclosed.

• Citation: US 2012/0009121 A1

  • Publication Date: January 12, 2012
  • Filing Date: December 10, 2010
  • Inventors: Pomper et al.
  • Brief Description: This patent application, also assigned to Johns Hopkins University, describes PSMA-targeting compounds and their uses. It details various linkers and chelators that can be conjugated to PSMA inhibitors for imaging and therapeutic applications. The document provides a broad disclosure of potential linker chemistries.
  • Potential Anticipation: Similar to US 9,770,523, this reference establishes a state of the art for radiolabeled small molecule inhibitors for cancer targeting. The detailed description of linkers in this application could be used to argue that the linker "L" in certain claims of 11,938,201 was already known in the art for connecting a targeting molecule to a radionuclide chelator. The text of 11,938,201 explicitly incorporates this reference by reference for its disclosure of suitable linkers, which weakens any argument of novelty for the linker component itself.

Foreign Patent Documents

• Citation: WO 2016/096795 A1

  • Publication Date: June 23, 2016
  • Filing Date: December 18, 2014
  • Applicants: University Hospital Heidelberg
  • Brief Description: This international patent application discloses quinoline-based inhibitors of Fibroblast Activation Protein (FAP). The compounds are described as being useful for diagnostics and therapeutics, and the application discloses conjugation to chelators for radiolabeling. This is a key piece of prior art as it relates directly to FAP-targeting radiopharmaceuticals.
  • Potential Anticipation: This reference is arguably the most relevant prior art. It discloses the core FAP-targeting quinoline structure that is also a central part of the claimed invention in 11,938,201. Depending on the specific substitutions claimed in 11,938,201, this reference could anticipate several of the core composition of matter claims. An anticipation argument would focus on whether the specific compounds claimed in 11,938,201 are explicitly or inherently disclosed in this application.

• Citation: WO 2017/140417 A1

  • Publication Date: August 24, 2017
  • Filing Date: February 15, 2017
  • Applicants: SOFIE BIOSCIENCES, INC.
  • Brief Description: This application describes FAP-targeting compounds for imaging and therapy. It discloses a range of FAP inhibitors, including those based on a quinoline scaffold, and their linkage to imaging or therapeutic moieties.
  • Potential Anticipation: This reference, published before the priority date of 11,938,201, also discloses FAP inhibitors for theranostic use. The breadth of its disclosures on FAP-targeting scaffolds and linkers could be used to argue that the inventions claimed in 11,938,201 were already described. A direct comparison of the claimed structures in 11,938,201 with the disclosed structures in this application is necessary to determine the extent of potential anticipation.

Non-Patent Literature

• Jansen, K. et al., "Discovery of a Potent and Selective Inhibitor of Fibroblast Activation Protein," Journal of Medicinal Chemistry, 2013, Vol. 56, pp. 7848-7861.

  • Publication Date: 2013
  • Brief Description: This article reports the discovery and optimization of potent and selective small-molecule inhibitors of FAP. It describes the structure-activity relationship of a series of compounds, laying the groundwork for the development of FAP-targeted agents.
  • Potential Anticipation: This reference provides a foundational disclosure of the FAP-inhibiting chemical scaffolds. While it may not disclose the full B-L-A structure with radiolabels for imaging and therapy, it discloses the "A" (targeting moiety) component. This reference would be crucial in an obviousness argument under 35 U.S.C. § 103, suggesting that one of ordinary skill in the art would have been motivated to combine the FAP inhibitors disclosed by Jansen with known radiolabeling techniques (as taught by the Pomper references, for example) to arrive at the claimed invention. It is less likely to anticipate claims directly under § 102 unless it discloses a specific claimed compound.

• Jansen, K. et al., "Structure-Based Design of Potent and Selective Inhibitors of Fibroblast Activation Protein," Journal of Medicinal Chemistry, 2014, Vol. 57, pp. 3053-3074.

  • Publication Date: 2014
  • Brief Description: A follow-up publication by the same group that further explores the structure-based design of FAP inhibitors, providing more detailed insights into the binding interactions and further chemical modifications.
  • Potential Anticipation: Similar to the 2013 Jansen paper, this article provides key insights into the "A" moiety of the claimed compounds. It would be a strong reference for an obviousness challenge, detailing the state of the art in FAP inhibitor design just before the priority date of the 11,938,201 patent.

In summary, the prosecution of US Patent 11,938,201 involved overcoming prior art that established the general concept of using radiolabeled small molecules for cancer theranostics (the Pomper references) and prior art that specifically disclosed FAP inhibitors with quinoline-based scaffolds for similar purposes (the WO applications and Jansen papers). The patentability of the claims in 11,938,201 likely rests on the novelty and non-obviousness of the specific chemical structures of the FAP-targeting moiety "A" and the complete B-L-A conjugate, which were not identically disclosed in this combination in the prior art.