US 11566277

Analysis of U.S. Patent 11,566,277

Report Date: May 12, 2026

This report provides a concise summary of United States Patent 11,566,277, including details of its prosecution history, an overview of its independent claims, and its current legal status.

I. Patent Overview

Title	Compositions and methods for analyte detection
Assignee	Harvard University
Inventors	George M. Church, Jehyuk Lee, Daniel Levner, Michael Super
Filing Date	February 15, 2022
Issue Date	January 31, 2023
Application No.	17/671,803

Abstract:
The patent describes methods and compositions for detecting multiple analytes in a sample. The core of the invention lies in using "detection reagents" which consist of a probe (like an antibody or nucleic acid) that binds to a specific target analyte, and a nucleic acid "label." This nucleic acid label contains a unique sequence of "subsequences" that acts as a barcode or identifier for the probe. By detecting these subsequences in a specific time-ordered sequence (temporally-sequential manner), the system can identify which probe has bound to its target, and thus identify the analyte present in the sample. The detection can be performed through methods like hybridization with fluorescently labeled "decoder probes" or by sequencing. This allows for multiplexed analysis, meaning many different analytes can be detected simultaneously in the same sample, such as a tissue section.

II. Independent Claims in Plain Language

U.S. Patent 11,566,277 has three independent claims: Claim 1, Claim 14, and Claim 21. Below is a plain-language explanation of each.

Independent Claim 1: This claim describes a method for identifying multiple different substances (analytes) within a sample. The process involves:

1. Contacting the sample with a collection of specialized "detection reagents." Each type of reagent is designed to stick to a specific substance you want to find.
2. Each detection reagent has a unique "barcode" made of a nucleic acid (like DNA). This barcode is composed of several pre-determined segments, or "subsequences."
3. Detecting these barcode segments one after another over time. Each segment, when detected, produces a specific signal (e.g., a color).
4. The specific order of signals you detect over time identifies the barcode, which in turn tells you which detection reagent is present, and therefore what substance has been found in the sample.

Independent Claim 14: This claim focuses on the "detection reagent" itself as a product. The reagent is a composite molecule that includes:

1. At least one "probe," which is the part that recognizes and binds to a specific substance (analyte) of interest. This probe could be an antibody, a nucleic acid, or other types of molecules.
2. At least one nucleic acid "label" attached to the probe. This label functions as a barcode.
3. This nucleic acid barcode is made up of at least one pre-determined segment ("subsequence") that is designed to be detected in a time-ordered fashion.
4. The sequence of these segments serves as a unique identifier for the probe it's attached to.

Independent Claim 21: This claim describes a kit for performing the detection method. The kit contains:

1. A collection of the detection reagents described in Claim 14 (or at least the nucleic acid label part of them).
2. At least one other reagent needed for the detection process, such as a set of "decoder probes." These decoder probes are complementary to the barcode segments and carry a detectable label (like a fluorescent dye), producing a unique signal when they bind.

III. Legal Status and Litigation

As of May 12, 2026, U.S. Patent 11,566,277 is active.

A search of court dockets and legal news indicates that this patent is the subject of recent litigation. In early May 2026, 10x Genomics Inc. and Harvard College filed a lawsuit against Element Biosciences Inc. in the U.S. District Court for the District of Delaware. The complaint alleges that Element Biosciences' AVITI24 platform and Teton chemistry infringe on U.S. Patent 11,566,277, along with three other patents. This case is in its early stages in district court, and there are no proceedings before the Court of Appeals for the Federal Circuit (CAFC) at this time.