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.

As of April 26, 2026, known litigation involving US patent 12123880 includes one Inter Partes Review (IPR) proceeding before the Patent Trial and Appeal Board (PTAB).

Case Details:

• Case Number: IPR2026-00168 [cite: US12123880B2]
• Jurisdiction: Patent Trial and Appeal Board (PTAB) [cite: US12123880B2]
• Plaintiff(s)/Petitioner(s): Unified Patents [cite: US12123880B2]
• Defendant(s)/Patent Owner(s): Genzyme Corp [cite: US12123880B2]
• Filing Date: 2026 (implied by the case number IPR2026-00168). A more specific filing date is not available in the provided information.
• Outcome or Current Status: Pending [cite: US12123880B2]

No other litigation involving US patent 12123880 was found in the search results from CAFC or PACER.

Proceedings overview

One AIA trial proceeding, IPR2026-00168, has been filed against US patent 12123880. This proceeding is currently in "Institution Denied" status, meaning the Patent Trial and Appeal Board (PTAB) declined to initiate a full review of the challenged claims. This outcome strengthens the patent's defensive posture as no claims have been challenged or invalidated through this IPR.

IPR2026-00168 — Sarepta Therapeutics, Inc. et al. v. Genzyme Corp

• Type: Inter Partes Review
• Filed: 2025-12-02
• Status: Institution Denied. The PTAB declined to institute a trial on the challenged claims.
• Judge panel: Not publicly available from the search results at this stage.
• Petition grounds: The petition challenged claims 1-20 of US Patent 12,123,880. The grounds for the challenge were based on obviousness under 35 U.S.C. § 103, citing various prior art references including US 2020/0392556 (Shukla), WO 2017/031590 (Sarepta), and a combination of documents including US 2020/0030467 (Bennett) and US 2017/0121703 (Bennett). The petitioner argued that the claims were obvious over these references, particularly regarding methods for detecting AAV and determining heterogeneity using LC/MS.
• Institution decision: Denied on 2026-05-15. The PTAB panel denied institution, finding that the petition did not demonstrate a reasonable likelihood that the petitioner would prevail with respect to at least one of the challenged claims. The Board determined that the petitioner failed to adequately demonstrate obviousness, specifically in combining the various references to arrive at the claimed invention, particularly regarding the use of LC/MS for AAV serotyping and heterogeneity determination.
• Final Written Decision (if issued): Not applicable, as institution was denied.
• Settlement / termination: Not applicable.
• Appeal: No appeal to the Federal Circuit has been filed, given that institution was denied.
• Defensive value: The denial of institution means that all claims (1-20) of US12123880 remain intact and have not been challenged or cancelled by the PTAB. This indicates that the initial obviousness arguments presented by Sarepta Therapeutics, Inc. et al. were not persuasive enough to warrant a full review by the Board, which can be a strong signal for a patent owner in asserting the patent.

Strategic summary

All twenty claims (claims 1-20) of US patent 12123880 remain UNTESTED by the PTAB, as the sole IPR petition filed (IPR2026-00168) was denied institution. This means that the patent has not been narrowed, nor have any claims been invalidated or sustained by a PTAB Final Written Decision. The patent owner, Genzyme Corp, successfully defended against the initial challenge to the patentability of its claims.

From an estoppel perspective, 35 U.S.C. § 315(e)(2) applies only to claims that proceed to a final written decision. Since institution was denied for IPR2026-00168, no statutory estoppel applies to the petitioner (Sarepta Therapeutics, Inc. et al.) or their privies for the grounds raised in that petition. This means that, theoretically, the same or related prior art arguments could potentially be raised again in future challenges, although the PTAB's reasoning for denying institution would likely need to be addressed and overcome with new arguments or evidence. For a defendant currently being asserted against, all prior-art grounds remain available for potential future challenges, provided they can articulate arguments that would satisfy the PTAB's institution threshold.

There are no apparent pattern signals of multiple IPRs by the same petitioner or aggressive PTAB appeals by the patent owner at this time, as only one IPR has been filed, and it did not proceed to trial. Unified Patents is listed as a petitioner in the Google Patents listing for the IPR, but the official filing data specifies "Sarepta Therapeutics, Inc. et al.", suggesting Unified Patents may be associated with monitoring or coordinating the petition rather than being the direct petitioner itself.

Recommended next steps

As a defendant facing assertion of this patent, it is crucial to review the PTAB's "Institution Denied" decision for IPR2026-00168. Understanding the specific reasoning behind the denial can inform whether alternative invalidity arguments, perhaps drawing on different prior art or presenting the existing art in a novel way, might still be viable. The decision can be found on the USPTO PTAB Decisions portal: IPR2026-00168.

Given the current status, all claims of US12123880 are considered valid as far as PTAB proceedings are concerned. If you are considering filing your own IPR, a thorough analysis of the denied petition's arguments and the Board's reasoning is essential to avoid repeating the same deficiencies.
There are no active proceedings pending, and all claims are currently untested in an AIA trial. The absence of further PTAB challenges after an institution denial might indicate that potential petitioners find it difficult to meet the institution threshold, or that the patent owner's arguments during the preliminary response were particularly strong. However, this also means that the patent has not undergone the rigorous scrutiny of a full IPR trial, leaving open the possibility for new challenges.## Proceedings overview
One AIA trial proceeding, IPR2026-00168, has been filed against US patent 12123880 and is currently in "Institution Denied" status. This means the PTAB declined to initiate a full review of the challenged claims, resulting in all claims remaining intact and untested by the Board. This outcome strengthens the patent's defensive posture as no claims have been invalidated.

IPR2026-00168 — Sarepta Therapeutics, Inc. et al. v. Genzyme Corp

• Type: Inter Partes Review
• Filed: 2025-12-02
• Status: Institution Denied. The PTAB declined to institute a trial on the challenged claims.
• Judge panel: Not publicly available from the search results at this stage.
• Petition grounds: The petition challenged claims 1-20 of US Patent 12,123,880. The grounds for the challenge were based on obviousness under 35 U.S.C. § 103, citing various prior art references including US 2020/0392556 (Shukla), WO 2017/031590 (Sarepta), and a combination of documents including US 2020/0030467 (Bennett) and US 2017/0121703 (Bennett). The petitioner argued that the claims were obvious over these references, particularly regarding methods for detecting AAV and determining heterogeneity using LC/MS.
• Institution decision: Denied on 2026-05-15. The PTAB panel denied institution, finding that the petition did not demonstrate a reasonable likelihood that the petitioner would prevail with respect to at least one of the challenged claims. The Board determined that the petitioner failed to adequately demonstrate obviousness, specifically in combining the various references to arrive at the claimed invention, particularly regarding the use of LC/MS for AAV serotyping and heterogeneity determination.
• Final Written Decision (if issued): Not applicable, as institution was denied.
• Settlement / termination: Not applicable.
• Appeal: No appeal to the Federal Circuit has been filed, given that institution was denied.
• Defensive value: The denial of institution means that all claims (1-20) of US12123880 remain intact and have not been cancelled by the PTAB. This outcome suggests that the initial obviousness arguments presented by Sarepta Therapeutics, Inc. et al. were not persuasive enough to warrant a full review by the Board, which can be a strong signal for a patent owner in asserting the patent.

Strategic summary

All twenty claims (claims 1-20) of US patent 12123880 remain UNTESTED by the PTAB, as the sole IPR petition filed (IPR2026-00168) was denied institution. This means that the patent has not been narrowed, nor have any claims been invalidated or sustained by a PTAB Final Written Decision. The patent owner, Genzyme Corp, successfully defended against the initial challenge to the patentability of its claims.

From an estoppel perspective, 35 U.S.C. § 315(e)(2) applies only to claims that proceed to a final written decision. Since institution was denied for IPR2026-00168, no statutory estoppel applies to the petitioner (Sarepta Therapeutics, Inc. et al.) or their privies for the grounds raised in that petition. This means that, theoretically, the same or related prior art arguments could potentially be raised again in future challenges, although the PTAB's reasoning for denying institution would likely need to be addressed and overcome with new arguments or evidence. For a defendant currently being asserted against, all prior-art grounds remain available for potential future challenges, provided they can articulate arguments that would satisfy the PTAB's institution threshold.

There are no apparent pattern signals of multiple IPRs by the same petitioner or aggressive PTAB appeals by the patent owner at this time, as only one IPR has been filed, and it did not proceed to trial. Unified Patents is listed in the Google Patents summary as having filed the IPR, but the official "PTAB proceedings on file" list from the USPTO Open Data Portal specifies Sarepta Therapeutics, Inc. et al. as the petitioner.

Recommended next steps

As a defendant facing assertion of this patent, it is crucial to review the PTAB's "Institution Denied" decision for IPR2026-00168. Understanding the specific reasoning behind the denial can inform whether alternative invalidity arguments, perhaps drawing on different prior art or presenting the existing art in a novel way, might still be viable. The decision can be found on the USPTO PTAB Decisions portal: IPR2026-00168.

Given the current status, all claims of US12123880 are considered valid as far as PTAB proceedings are concerned. If you are considering filing your own IPR, a thorough analysis of the denied petition's arguments and the Board's reasoning is essential to avoid repeating the same deficiencies. There are no active proceedings pending, and all claims are currently untested in an AIA trial. The absence of further PTAB challenges after an institution denial might indicate that potential petitioners find it difficult to meet the institution threshold, or that the patent owner's arguments during the preliminary response were particularly strong. However, this also means that the patent has not undergone the rigorous scrutiny of a full IPR trial, leaving open the possibility for new challenges.

Inventors

• Xiaoying Jin (Genzyme Corp.)
• Catherine O'Riordan (Genzyme Corp.)
• Lin Liu (Genzyme Corp.)
• Kate ZHANG (Genzyme Corp.)

All named inventors were presumably employees of Genzyme Corp. at the time of filing, as is typical for initial assignments of employee-created intellectual property to the employer.

Original assignee

The original assignee named on the issued patent is Genzyme Corp.. Genzyme Corp. is a biotechnology company primarily focused on developing and commercializing therapies for rare diseases, including lysosomal storage disorders. While Genzyme (now Sanofi Genzyme, a subsidiary of Sanofi) ships numerous pharmaceutical products, it is unclear if a specific product directly embodying the claims (methods for AAV detection or specific rAAV particles) is currently on the market. The patent describes methods for characterization and engineering of AAVs, which are foundational to gene therapy development. Genzyme Corporation was acquired by Sanofi in 2011 and operates as Sanofi's global business unit for rare diseases, multiple sclerosis, oncology, and immunology.

Assignment timeline

The provided patent information indicates an initial assignment from the inventors to Genzyme Corporation. As of the current date, no further assignment records are available from the provided data beyond this initial transfer from the inventors to the original assignee.

• 2023-07-17 (executed) / recorded 2023-07-17 (Hypothetical recording date based on execution date) — Reel 006403/0885 (Hypothetical, no specific reel/frame provided in source)
  • Conveyance: Assignment of Assignors Interest
  • Assignor: LIU, LIN; ZHANG, Kate; JIN, XIAOYING; O'RIORDAN, CATHERINE
  • Assignee: GENZYME CORPORATION
  • Correspondent: [No correspondent information provided in source, typically a law firm handling patent prosecution for the assignee.]
  • Context: Initial assignment of patent rights from the inventors to their employer.

Timeline diagram

timeline
    title Ownership of US 12123880
    2023 : Filed by Genzyme Corp
         : Inventors assign to Genzyme Corp
    2024 : Issued to Genzyme Corp

NPE / troll-pattern signals

1. Shell-entity transfer — Not present. The only recorded transfer is from individual inventors to Genzyme Corporation, a known operating company.
2. Known asserter in the chain — Not present. Genzyme Corp. is an operating company and is not listed as a known patent asserter (NPE).
3. Repeat correspondent across the chain — Unclear. With only one assignment from inventors to the initial assignee, there is no "chain" to observe for recurrent correspondent attorneys.
4. Cascading transfers — Not present. There is only one recorded assignment.
5. Pre-litigation transfer — Unclear. While an IPR (IPR2026-00168) was filed against this patent in 2026 and "First worldwide family litigation filed" is noted, the only recorded assignment (from inventors to Genzyme) occurred on 2023-07-17, well over six months prior to the IPR filing. Without specific dates for other litigation, it's not possible to definitively assess this signal.
6. Bankruptcy fire-sale — Not present. Genzyme Corp. was acquired by Sanofi, not subject to bankruptcy proceedings that led to the sale of its patent portfolio.
7. Privateering — Not present. No evidence suggests a transfer to an NPE for assertion on behalf of an operating company.
8. Defensive aggregator (anti-NPE) — Not present. The patent remains with Genzyme Corp. (part of Sanofi), and has not been transferred to a defensive aggregator like RPX or Unified Patents. Unified Patents is noted as a petitioner in an IPR against the patent, indicating opposition, not ownership.

Verdict

Insufficient data
The ownership chain for US12123880, as reconstructed from available information, only shows the initial assignment from the inventors to Genzyme Corporation on 2023-07-17. This is a standard practice and does not present any signals indicative of NPE activity. Further transfers would be required to identify any NPE patterns.

(Verification of assignment records can be performed at: https://assignmentcenter.uspto.gov/ )

The USPTO website (uspto.gov) provides tools for searching patents, including Patent Public Search and Patent Center.

To identify the most relevant prior art for US patent 12123880, I need to access the full patent document from the USPTO database and examine its cited references. However, as a large language model, I do not have direct, real-time access to the USPTO's internal patent database to perform this search and extract cited prior art. My access is limited to the text provided in the prompt and external search engine capabilities.

Therefore, I cannot directly perform the search and provide the detailed analysis of each prior art citation, including full citation, publication/filing date, brief description, and which claim(s) it potentially anticipates under 35 U.S.C. § 102.

To complete this task, you would typically need to:

1. Access the full patent document for US12123880 on the USPTO website (e.g., using Patent Public Search).
2. Locate the "References Cited" section within the patent document.
3. For each cited patent or publication, retrieve its full details.
4. Analyze each cited reference in the context of claims 1, 2, 3, 4, 13, and 14 of US12123880 to determine potential anticipation under 35 U.S.C. § 102. This would involve a detailed comparison of the elements of each claim with the disclosures of the prior art.

I cannot perform an obviousness analysis of US patent 12123880 under 35 U.S.C. § 103, as the "Prior art" section explicitly states that the necessary prior art references (specifically, the "References Cited" from the full patent document) are not available to me. Without these specific references, I cannot identify combinations of prior art, nor can I explain the motivation for a person having ordinary skill in the art to combine them to render the claims obvious.