US 12529702

US 12529702 B2 – Patent Overview

Title: Scoring methods for anti-PD therapy eligibility and compositions for performing same

Patent number: US 12529702 B2 (application US18/098,198; pre-grant publication US20230152326A1)

Assignees (per the source): Agilent Technologies Inc and Merck Sharp & Dohme LLC

Key dates (per the source): Priority date 2016-04-01; filed 2023-01-18; granted and published 2026-01-20; status active with adjusted expiration 2038-02-05.

Inventors: Karina Kulangara, Nancy Zhang, David Stanforth, Greg Angelides, Stephanie Waldroup, Kenneth Emancipator.

Purpose: The patent concerns deciding whether a patient with a malignancy is eligible for treatment with an anti-PD therapeutic agent (anti-PD-1/PD-L1 therapy) based on a Combined Positive Score (CPS) calculated from the patient's tumor tissue sample.

Plain-language scope: Per the source, the method involves counting, in a tumor tissue sample from a subject with a malignancy: viable PD-L1 positive tumor cells, viable PD-L1 negative tumor cells, and viable PD-L1 positive mononuclear inflammatory cells (MIC). Those counts are then used to calculate a CPS. The excerpt references figures illustrating control-sample evaluation rules, staining intensities on tumor cells, PD-L1 positive inflammatory cells, membrane/cytoplasmic staining, and artifacts (edge staining, cytoplasmic blush, necrotic tissue), plus worked CPS examples for head and neck squamous cell carcinoma (HNSCC) and gastric carcinoma. The specification defines terms including PD-L1, tumor tissue sample, FFPE/resin-embedded/frozen tissue sections, and staining. The source also lists PD-L1's role in immune evasion and its expression across many solid tumor types.

Source: https://patents.google.com/patent/US12529702/en

What the excerpt does not establish:

• The exact CPS formula (the text is truncated at "the formula:").
• The full text of the claims, including claim scope and dependency.
• Specific eligibility thresholds for anti-PD therapy.
• Details of the "compositions" referenced in the title.
• Any clinical validation data or regulatory status.

No litigation, ownership-transfer, validity, or prior-art analysis is offered.