US 12013326

Here's a concise summary of US patent 12013326:

Patent Number: US12013326B2

Title: Analytical ultracentrifugation for characterization of recombinant viral particles

Assignee: Genzyme Corp

Inventors: Catherine R. O'Riordan, Brenda BURNHAM

Filing Date: 2023-11-10

Issue Date: 2024-06-18

Abstract Overview (derived from the "Definitions" section of the patent text):
The patent relates to methods for characterizing recombinant viral vectors, such as adeno-associated viral (AAV), adenoviral (rAd), lentiviral, and Herpes simplex viral (rHSV) particles, using analytical ultracentrifugation (AUC). The methods involve subjecting a viral preparation to AUC under boundary sedimentation velocity conditions, monitoring sedimentation at time intervals, plotting the differential sedimentation coefficient distribution value (C(s)) versus the sedimentation coefficient in Svedberg units (S), and integrating the area under each peak to determine the relative concentration of different viral particle species. These species can include full capsids with intact genomes, empty capsids, and particles with variant (e.g., truncated or aggregated) genomes. The invention aims to provide a generic assay for characterizing recombinant viral preparations, regardless of genome sequence or capsid serotype, for monitoring drug product quality, homogeneity, purity, and manufacturing consistency.

Plain-Language Overview of Key Inventive Concepts (derived from the "Definitions" section, as explicit claims were not provided):
Given that the specific numbered claims were not provided in the supplied patent text, the following are the primary inventive concepts as described in the "Definitions" section, which are typically found in independent claims:

1. Method for Characterizing Viral Particles: A method for characterizing a preparation of recombinant viral particles involves using analytical ultracentrifugation (AUC) under boundary sedimentation velocity conditions. The sedimentation of the viral particles is monitored over time. A plot is generated showing the differential sedimentation coefficient distribution value (C(s)) against the sedimentation coefficient (S). The area under each peak on this plot is integrated to determine the relative concentration of each viral particle species, where each peak represents a distinct species.

2. Method for Assessing Vector Genome Integrity: The invention also describes a method to assess the integrity of a vector genome within recombinant viral particles using AUC. This involves the same AUC and plotting steps as above. Species of viral particles are identified by peaks on the C(s) versus S plot, and the genome size of a particular species is calculated by comparing its S value to a standard curve established from viral particles with known genome sizes.

3. Method for Determining Heterogeneity: Another aspect of the invention provides a method to determine the heterogeneity of recombinant viral particles in a preparation. By subjecting the preparation to AUC and plotting C(s) versus S, the presence of peaks in addition to the peak representing capsids containing an intact viral genome indicates that the recombinant particle preparation is heterogeneous. These additional peaks can represent empty capsid particles or recombinant viral particles with variant genomes.

USPTO Database Information:
US12013326B2 is an active patent. The application was filed by Genzyme Corp on November 10, 2023, and granted on June 18, 2024. The anticipated expiration date is January 19, 2036. There is a pending PTAB case, IPR2026-00149, associated with this patent.

CAFC 2026 Dockets:
A search of CAFC 2026 dockets for patent number US12013326 did not yield any specific entries. Given that PTAB case IPR2026-00149 is noted as "Pending", it is unlikely to have reached the Court of Appeals for the Federal Circuit by April 26, 2026.