US 7704721

US Patent 7704721 has the following summary:

• Title: Compositions and methods to prevent AAV vector aggregation
• Assignee: Genzyme Corp (Original Assignee); Genzyme Corporation (Current Assignee as of 2016-10-06)
• Inventors: John Fraser Wright and Guang Qu
• Filing Date: June 1, 2005
• Issue Date: April 27, 2010
• Abstract: Compositions and methods are provided for preparing and storing concentrated stock solutions of adeno-associated virus (AAV) virions without aggregation. The invention describes high ionic strength solutions (e.g., approximately 500 mM) that are also isotonic with the target tissue, achieved by using salts of high valency like sodium citrate. These formulations enable AAV stock solutions up to 6.4×10^13 vg/mL with no observed aggregation, even after ten freeze-thaw cycles. Additionally, the surfactant Pluronic® F68 (at 0.001%) can be added to prevent virion losses to surfaces, and nuclease treatment of virion preparations can eliminate surface nucleic acid strands that contribute to aggregation.

Overview of Independent Claims:

• Claim 1: This claim describes a method for preventing aggregation of recombinant adeno-associated virus (rAAV) virions in a purified preparation. The method comprises three key steps:
  1. Providing a lysate that contains rAAV virions.
  2. Purifying these rAAV virions from the lysate using either ultracentrifugation, chromatography, or a combination of both.
  3. Adding one or more salts containing multivalent ions (specifically chosen from citrate, phosphate, sulfate, and magnesium) to the purified virions. This addition must result in a preparation with an ionic strength of at least 200 mM. The preparation must have a high concentration of purified rAAV virions, ranging from greater than 1×10^13 vg/ml up to 6.4×10^13 vg/ml, and the pH of this preparation must be maintained between 7.5 and 8.0.

Legal Status and Docket Information (as of April 26, 2026):

The patent US7704721B2 is currently listed as "Expired - Lifetime" on Google Patents. While it was anticipated to expire on June 1, 2025, the "Expired - Lifetime" status indicates it has passed its expiration date.

Regarding litigation:

• A PTAB case, IPR2025-01195, was filed, but it was "Not Instituted - Procedural".
• A US case was filed in the Delaware District Court (case number 1:24-cv-00882).
• First worldwide family litigation was also filed.

As for the CAFC 2026 dockets, a direct search for "US7704721" in current CAFC dockets for 2026 was not explicitly performed by me in this response, but the information from Google Patents (which indicates "Expired - Lifetime" and notes litigation in Delaware District Court and PTAB IPR2025-01195) provides the latest available legal status information. There is no mention of an active CAFC appeal for this specific patent in the provided text.US Patent 7704721 provides compositions and methods to prevent adeno-associated virus (AAV) vector aggregation.

Here is a concise summary of US Patent 7704721:

• Title: Compositions and methods to prevent AAV vector aggregation
• Assignee: Genzyme Corp (Original Assignee); Genzyme Corporation (Current Assignee as of October 6, 2016).
• Inventors: John Fraser Wright and Guang Qu
• Filing Date: June 1, 2005
• Issue Date: April 27, 2010
• Abstract: The patent describes compositions and methods for preparing and storing concentrated stock solutions of AAV virions while preventing aggregation. The formulations are high ionic strength solutions (e.g., approximately 500 mM) that are also isotonic with the intended target tissue. This is achieved by using salts of high valency, such as sodium citrate. Using these formulations, AAV stock solutions can reach concentrations of up to 6.4×10^13 vg/mL without significant aggregation, even after ten freeze-thaw cycles. The surfactant Pluronic® F68, at a concentration of 0.001%, may be added to prevent virion losses to surfaces during handling. Additionally, nuclease treatment of virion preparations can eliminate small nucleic acid strands on virion surfaces that exacerbate aggregation.

Plain-Language Overview of Independent Claims:

• Claim 1: This claim outlines a method for preventing the aggregation of recombinant adeno-associated virus (rAAV) virions in a purified preparation. The method involves several steps:
  1. Starting with a lysate that contains rAAV virions.
  2. Purifying these rAAV virions from the lysate using methods such as ultracentrifugation, chromatography, or a combination of both.
  3. After purification, adding one or more salts containing multivalent ions, specifically chosen from citrate, phosphate, sulfate, or magnesium. The purpose of this addition is to achieve an ionic strength of at least 200 mM in the virion preparation. This method is applied to concentrated rAAV virion preparations, where the concentration exceeds 1×10^13 vg/ml and can go up to 6.4×10^13 vg/ml. Throughout this process, the pH of the purified preparation of rAAV virions is maintained between 7.5 and 8.0.

USPTO and CAFC 2026 Dockets:

As of April 26, 2026, US Patent 7704721B2 is listed as "Expired - Lifetime" on Google Patents.

Regarding litigation:

• A PTAB case, IPR2025-01195, was filed, but it was "Not Instituted - Procedural."
• A US case was filed in the Delaware District Court (case number 1:24-cv-00882).
• First worldwide family litigation was also filed.

A search for specific dockets related to US7704721 within the CAFC 2026 dockets did not return any direct results. The USPTO website provides general information about patent searches and applying for patents but does not show specific docket information for this expired patent.