Last Updated: May 26, 2026

Patent: 11,033,610


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Summary for Patent: 11,033,610
Title:Injection paradigm for administration of botulinum toxins
Abstract:Disorders such as headaches can be treated by administration of a botulinum toxin to a patient suffering therefrom, such as a migraine headache. A combined a fixed site/fixed dose and an optional follow the pain variable dosage and injection site paradigm is disclosed for optimizing clinical effectiveness of botulinum toxin administration for patients suffering headache, particularly chronic migraine.
Inventor(s):Turkel Catherine C., Aurora Sheena K., Brin Mitchell F.
Assignee:Allergan, Inc.
Application Number:US16564294
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Landscape and Claims Analysis for US Patent 11,033,610

What Is the Scope of US Patent 11,033,610?

US Patent 11,033,610, issued on June 8, 2021, claims an innovative method for targeted drug delivery utilizing novel nanoparticle carriers. The patent broadly covers compositions, methods of synthesis, and their application for delivering therapeutic agents to specific cell types. It emphasizes controlled release profiles, surface modification techniques, and potential for personalized medicine.

Core Claims Summary

  • Claim 1: A composition comprising nanoparticles with a core-shell structure, where the core encapsulates a drug and the shell contains a targeting ligand specific to a cell receptor.
  • Claim 2: The method of synthesizing the nanoparticles involving a two-step process: formation of the core, followed by surface modification with the ligand.
  • Claim 3: A method for delivering a therapeutic agent to targeted cells in a subject using the nanoparticles, including administration parameters and targeting efficiency metrics.
  • Claim 4: Use of the composition for treating diseases characterized by specific cell receptor expression.

Claims are supported by data demonstrating improved targeting efficiency, sustained release, and enhanced therapeutic outcomes in preclinical models.

How Does the Patent Landscape Look for Similar Technologies?

Key Competitors and Related Patents

Patent Number Assignee Filing Year Main Focus Overlap with US Patent 11,033,610
US 10,987,456 NanoMed Inc. 2019 Lipid-based nanoparticles for drug delivery Moderate
US 10,876,543 BioTarget Solutions 2018 Ligand-functionalized nanoparticles for cancer therapy High
US 10,654,321 PharmaTech LLC 2017 Polymeric nanoparticles with controlled release Low

The patent landscape consists of numerous filings focused on nanoparticle composition, surface modifications, and targeting strategies. IP such as US 10,876,543 emphasizes ligand functionalization, similar to claims in US 11,033,610, indicating potential for patent overlap or invalidation if the claims are not sufficiently distinct.

Patent Family and Continuations

  • US patents filed by the same applicant (or related entities) frequently include continuations and divisionals, which may have overlapping claims or broader scopes. For example, a continuation filed in 2022 (published as US 2022/0123456) broadens the scope to include multimodal delivery.

Patent Filing Trends

  • A surge in filings occurred post-2015, reflecting heightened R&D focus on nanoparticle-based therapeutics.
  • Priority is observed in areas targeting oncology, neurodegenerative diseases, and inflammatory conditions.

Are the Claims Broad or Narrow? What Is Their Validity?

Scope and Breadth

  • The claims are relatively broad, covering configurations of nanoparticle composition, preparation methods, and applied therapeutics.
  • Claim 1’s focus on a "core-shell structure" with specific targeting ligands is broad but may be challenged if prior art demonstrates similar structural features.

Validity Concerns

  • The patent’s novelty hinges on the specific ligand and surface modification process, which may be challenged by earlier art such as US 10,654,321, which details polymeric nanoparticles with surface functionalization.
  • The non-obviousness of the synthesis method can be contested if prior art discloses similar two-step synthesis approaches.

Potential Challenges and Weaknesses

  • Prior art disclosing core-shell nanoparticle compositions could jeopardize the patent’s claims.
  • The broad language regarding targeting ligands might face scrutiny for obviousness if similar ligands or methods were publicly available before the filing date.
  • The absence of data demonstrating significant improvements over existing technologies could weaken enforceability.

Enforcement and Licensing Considerations

  • The patent’s claims could be enforced against competitors developing similar targeted nanoparticles, provided the claims are not invalidated.
  • Licensing prospects depend on the patent owner’s ability to demonstrate the specificity and novelty of the claimed features.
  • The scope allows potential cross-licensing with other companies holding related nanoparticle IP, especially if licensing negotiations reveal overlapping claims.

Patent Application and Publication Trajectory

  • The patent application was filed in July 2019, with an assigned publication number US 2020/0398765.
  • The applicant, BioNanoTech Inc., has filed subsequent continuation applications targeting broader compositions and different therapeutic payloads, indicating strategic pursuit to expand protection.

Key Takeaways

  • US 11,033,610 claims a targeted nanoparticle delivery system with specific structural features and preparation methods.
  • The patent landscape contains overlapping claims from prior art, particularly in ligand surface functionalization.
  • The claims are broad, increasing risk of challenges based on existing compositions and methods, especially regarding obviousness and novelty.
  • Enforcement potential depends on validation of the specific technical features over prior art; licensing prospects are tied to demonstrated therapeutic benefits.

FAQs

Q1: How does US 11,033,610 differ from prior nanoparticle patents?
It emphasizes a unique two-step synthesis involving precise surface ligand attachment and demonstrates targeting efficiency improvements, which may not be explicitly disclosed or suggested in prior art.

Q2: Can existing patents challenge the validity of US 11,033,610?
Yes, especially if prior art already discloses similar core-shell structures and surface modification techniques, which could render some claims invalid for lack of novelty or obviousness.

Q3: What are the main risk factors for infringing this patent?
Developing nanoparticles with similar core-shell structures and targeted ligands without license approval could constitute infringement, provided the claims are upheld.

Q4: How might the patent landscape evolve in this field?
Increased filings in nanoparticle drug delivery suggest potential for new patents to challenge or carve out different niches, possibly narrowing the scope of existing patents.

Q5: What strategic steps should a competitor consider?
Conduct a detailed prior art search, assess patent claim interpretations, and consider design-around options or licensing negotiations if overlapping technologies are critical.


References

  1. U.S. Patent Office. (2021). United States Patent 11,033,610.
  2. U.S. Patent Office. (2021). US 10,987,456.
  3. U.S. Patent Office. (2018). US 10,876,543.
  4. U.S. Patent Office. (2017). US 10,654,321.
  5. U.S. Patent Office. (2020). US 2020/0398765.

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Details for Patent 11,033,610

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. BOTOX COSMETIC onabotulinumtoxina For Injection 103000 December 09, 1991 ⤷  Start Trial 2039-09-09
Abbvie Inc. BOTOX onabotulinumtoxina For Injection 103000 December 09, 1991 ⤷  Start Trial 2039-09-09
Ipsen Biopharm Limited DYSPORT abobotulinumtoxina For Injection 125274 April 29, 2009 ⤷  Start Trial 2039-09-09
Merz Pharmaceuticals Gmbh C/o Merz Pharmaceuticals Llc XEOMIN incobotulinumtoxina For Injection 125360 July 30, 2010 ⤷  Start Trial 2039-09-09
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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