PTAB

IPR2020-00233

GemoaB MOnoCLOnals GmbH v. University Of Maryland Baltimore

Key Events

Petition

petition

Title: Universal Anti-Tag Chimeric Antigen Receptor-Expressing T Cells and Methods of Treating Cancer
Brief Description: The ’125 patent describes a "universal" method for treating cancer using a two-component system: (1) a "tagged protein" that binds to a cancer cell and (2) a population of T cells genetically engineered to express an anti-tag chimeric antigen receptor (AT-CAR) that recognizes the tag, thereby directing the T cells to kill the cancer cell.

Prior Art Relied Upon: UPenn (WO 2013/044225), which claims priority to a September 2011 U.S. provisional application.
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that UPenn disclosed a complete method of treating cancer using a "universal immune receptor" platform. UPenn’s system employed T cells engineered with a Biotin Binding Immune Receptor (BBIR) that recognizes and binds to biotin. These BBIR T cells were directed to cancer cells via a biotinylated, tumor-specific antibody. Petitioner contended that UPenn's biotinylated antibody is a "tagged protein" and its BBIR is an "AT-CAR," directly mapping to and anticipating the limitations of independent claim 1. UPenn also disclosed numerous features of dependent claims, including the use of biotin as a tag (claim 4), antibodies as the targeting protein (claim 5), and specific CAR domains like CD8α and CD28/CD3ζ (claims 12-13).

Prior Art Relied Upon: Ang (a May 2011 journal abstract).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner asserted that Ang, an abstract published before the ’125 patent’s effective filing date, described a "universal CAR" (uCAR) system for cancer treatment. The system used CAR-T cells engineered to recognize the fluorescent tag fluorescein isothiocyanate (FITC). To target tumors, Ang employed FITC-conjugated "adapter molecules," such as monoclonal antibodies specific to tumor antigens. Petitioner argued Ang's FITC-conjugated antibody is a "tagged protein" and its anti-FITC CAR is an "AT-CAR." This disclosure was argued to anticipate independent claim 1 and dependent claims reciting FITC as a tag (claim 4) and antibodies as the protein (claim 5).

Prior Art Relied Upon: UPenn (WO 2013/044225) or Ang (a 2011 journal abstract) in view of Itoh (Application # 2003/0175288).
Core Argument for this Ground:
- Prior Art Mapping: Claims 14 and 15 specify the source of the T cells, such as those from peripheral blood mononuclear cells (PBMCs), including a specific HLA-A2+ background. While UPenn and Ang teach the core universal CAR-T system, Itoh taught preparing T cells from PBMCs, specifically from HLA-A2+ patients, for use in immunotherapy.
- Motivation to Combine: A POSITA would combine the universal CAR-T systems of UPenn or Ang with the well-known and routine T cell sources disclosed in Itoh. Using PBMCs was an established, simple, and comparatively non-invasive method for obtaining T cells for cancer therapy.
- Expectation of Success: There was a high expectation of success, as Itoh demonstrated that T cells from these sources were effective against cancer cells. Incorporating them into the CAR-T platforms of UPenn or Ang would have been a predictable application of known components for their known purposes.
Additional Grounds: Petitioner asserted additional obviousness challenges, including that claims 1-13 and 16-21 are obvious over UPenn; claims 1-11, 13, and 20-21 are obvious over Ang; and claims 12 and 16-19 are obvious over Ang in view of UPenn, based on similar design modification theories.

"tagged protein": Petitioner proposed construing this term functionally as "a molecule that includes a portion that binds to the cancer cell and a portion that can be recognized and specifically bound by the AT-CAR." This broad construction was central to mapping prior art systems that used different tags and binding molecules onto the claims.
"AT-CAR" or "anti-tag chimeric receptor": Petitioner proposed construing this term as "a CAR with binding specificity for a portion of the tagged protein that can be expressed by a T cell." This functional definition was used to argue that any CAR designed to bind a tag, rather than a direct tumor antigen, falls within the claim scope.

Effective Filing Date: A central contention was that the ’125 patent’s effective filing date is December 14, 2011, not the claimed December 14, 2010 priority date of its provisional application. Petitioner argued the 2010 Provisional failed to provide adequate written description and enablement for the full scope of the claims, particularly the broad functional definition of "tagged protein." The provisional was characterized as a prophetic proposal lacking working examples or data to demonstrate that the hypothesized AT-CAR system would work, which was critical given the unpredictability of CAR-T cell activation at the time. Establishing this later filing date makes the UPenn and Ang references available as prior art under 35 U.S.C. §102.

Petitioner requested institution of an inter partes review and cancellation of claims 1-21 of the ’125 patent as unpatentable.