US 12123880

Here's a concise summary of US Patent 12123880:

US Patent 12123880

• Title: Methods for detecting AAV
• Assignee: Genzyme Corp.
• Inventors: Xiaoying Jin, Catherine O'Riordan, Lin Liu, Kate ZHANG
• Filing Date: May 22, 2023
• Issue Date: October 22, 2024
• Abstract: The patent describes methods for determining the serotype and/or heterogeneity of a viral particle, specifically adeno-associated virus (AAV) particles, using mass determination techniques such as liquid chromatography/mass spectrometry (LC/MS) or liquid chromatography/mass spectrometry-mass spectrometry (LC/MS/MS). The invention also includes recombinant AAV particles with amino acid substitutions that alter N-terminal acetylation or deamidation, aiming to improve stability, assembly, and/or transduction efficiency.

Plain-Language Overview of Independent Claims:

• Independent Claim 1: This claim describes a method to determine the serotype of an AAV particle. It involves three main steps:

  1. Denaturing the AAV particle.
  2. Subjecting the denatured AAV particle to liquid chromatography/mass spectrometry (LC/MS).
  3. Determining the masses of the three main capsid proteins (VP1, VP2, and VP3) of the AAV particle.
     The specific combination of these determined masses then indicates the AAV serotype.

• Independent Claim 2: This claim outlines a method for determining the heterogeneity of an AAV particle. It follows a similar process to Claim 1, but with an additional comparison step:

  1. Denaturing the AAV particle.
  2. Subjecting the denatured AAV particle to liquid chromatography/mass spectrometry (LC/MS).
  3. Determining the masses of VP1, VP2, and VP3 of the AAV particle.
  4. Comparing these determined masses with the known theoretical masses for VP1, VP2, and VP3 of that specific AAV serotype.
     Any deviation in one or more of these masses indicates heterogeneity within the AAV capsid.

• Independent Claim 3: This claim details a method for determining the serotype of an AAV particle that involves digestion into smaller fragments before mass spectrometry:

  1. Denaturing the AAV particle.
  2. Subjecting the denatured AAV particle to reduction and/or alkylation.
  3. Subjecting the denatured viral particle to digestion to create fragments of VP1, VP2, and/or VP3.
  4. Subjecting these protein fragments to liquid chromatography/mass spectrometry-mass spectrometry (LC/MS/MS).
  5. Determining the masses of these fragments.
     The unique combination of fragment masses identifies the AAV serotype.

• Independent Claim 4: This claim describes a method for determining the heterogeneity of an AAV particle using the digestion-based approach of Claim 3, with an added comparison step:

  1. Denaturing the AAV particle.
  2. Subjecting the denatured AAV particle to reduction and/or alkylation.
  3. Subjecting the denatured viral particle to digestion to create fragments of VP1, VP2, and/or VP3.
  4. Subjecting these protein fragments to liquid chromatography/mass spectrometry-mass spectrometry (LC/MS/MS).
  5. Determining the masses of these fragments.
  6. Comparing these determined fragment masses with the theoretical masses of fragments for the specific AAV serotype.
     Any deviation in the fragment masses indicates heterogeneity within the AAV capsid.

• Independent Claim 13: This claim describes a recombinant AAV (rAAV) particle itself. The key feature is an amino acid substitution at position 2 of either the VP1 and/or VP3 capsid protein. This substitution is specifically designed to alter the N-terminal acetylation of that protein compared to the parent (unmodified) AAV particle.

• Independent Claim 14: This claim describes a recombinant AAV (rAAV) particle with one or more amino acid substitutions at specific residues (A35, N57, G58, N382, G383, N511, G512, N715, or G716) of VP1 or VP3, with numbering based on AAV2 VP1. These substitutions are designed to alter the deamidation of the capsid compared to the parent AAV particle.

CAFC 2026 Dockets:
As of April 26, 2026, there is no mention of US12123880 in the CAFC 2026 dockets. However, the patent information notes a PTAB case IPR2026-00168 has been filed and is pending, which is an inter partes review at the Patent Trial and Appeal Board, not the Court of Appeals for the Federal Circuit (CAFC). There is also a mention of "First worldwide family litigation filed" but no specific court or docket information is provided.