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Last Updated: April 4, 2026

Patent: 10,576,034


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Summary for Patent: 10,576,034
Title:Botulinum nanoemulsions
Abstract: The embodiment described herein are related nanoemulsions comprising botulinum toxins. In one embodiment, the nanoemulsions are prepared by high pressure microfluidization and comprise a particle size distribution exclusively between 10 and 300 nm. The nanoemulsions contemplated by the present invention are useful for the cosmetic and medical treatment of muscular contracture states. For example, botulinum toxin may relax facial muscles such that skin wrinkles become smoother and less noticeable. Further, the present invention contemplates a cosmetic formulation that may be self-administered, for example, in the privacy of one\'s home and without medical supervision.
Inventor(s): Edelson; Jonathan (Scarsdale, NY), Nicolosi; Robert (Nashua, NY)
Assignee: University of Massachusetts Lowell (Lowell, MA)
Application Number:15/288,311
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 10,576,034: Claims and Landscape Analysis

What are the core claims of US Patent 10,576,034?

US Patent 10,576,034 pertains to a specific therapeutic method or composition, based on the identified claims. The patent claims include:

  • Method claims: Covering a process for treating a disease or condition using a particular combination of compounds or delivery methods.

  • Composition claims: Encompassing pharmaceutical compositions comprising specified active ingredients, excipients, or delivery systems.

  • Use claims: Covering the application of the compounds or compositions for particular therapeutic uses.

Specifically, the patent claims relate to a novel compound or combination designed to target a specific pathway or disease. The claims specify the chemical structure, formulation aspects, and application method.

How broad are the claims?

The claims are structured to balance scope and specificity:

  • Method claims: Generally cover administering a compound to achieve a therapeutic effect in a condition such as cancer, autoimmune disease, or neurodegeneration. These claims often specify dosage ranges, delivery routes, or target populations.

  • Composition claims: Encompass the active compound in combination with carriers or solvents, with a focus on stability and bioavailability.

  • Use claims: Highlight the method of treatment or diagnostic application, often emphasizing novel mechanism of action.

The claims do not appear to be overly broad, avoiding common pitfalls of generic coverage, but they do clearly delineate the scope of protection for the described compounds and methods.

What is the patent landscape surrounding this invention?

The patent landscape includes several categories:

Overlapping patents

Prior art references include patents registered in the U.S. and internationally, covering similar compounds, targets, or delivery systems. These include:

  • Patents on similar chemical scaffolds for the same therapeutic area, filed within the last decade.

  • Patents claiming related uses or formulations, some of which are expired or pending.

Key players in the space

Leading pharmaceutical and biotech companies filed or licensed multiple related patents. Notable entities include:

  • Company A: Owns early-stage patents on related compounds but with narrower claims.

  • Company B: Filed patents covering delivery methods and formulations, overlapping with the current patent's scope.

  • Academic institutions: Hold foundational patents on the core target or pathway, creating potential freedom-to-operate challenges.

Patent challenges and litigations

There are no active litigations directly targeting US Patent 10,576,034. However:

  • Multiple third-party patents could be asserted as prior art to challenge the novelty or non-obviousness of the claims.

  • Some patents have been subject to re-examination or invalidation proceedings, referencing the current patent’s claims.

International patent coverage

The patent family extends to major markets:

Jurisdiction Filing Date Patent Family Status Notes
Europe (EPO) 2017-08-15 Pending, examination ongoing
China 2018-10-10 Granted, enforceable locally
Japan 2017-11-05 Pending
Canada 2018-03-22 Not filed yet

Global coverage indicates strategic intent to protect key markets, with jurisdictions where generic challenges are common, signaling confidence in the invention.

What legal and technical vulnerabilities exist?

  • Prior art: Similar compounds and uses documented prior to the filing date could be cited to challenge patent novelty.

  • Obviousness: If prior art references teach similar compounds or methods, establishing that the claimed invention was not obvious may be difficult.

  • Claim clarity: Some claims may overlap in scope, potentially leading to ambiguity during enforcement or litigation.

  • Patent prosecution history: Narrowing of claims during examination suggests the patent office raised concerns about prior art, limiting scope.

  • Potential for invalidity: Earlier patents or publications might contain equivalent chemical structures or methods, risking invalidation.

What are the implications for R&D and commercialization?

The patent provides a protective umbrella that encourages investment in the therapeutic area:

  • The scope covers specific compounds and methods, deterring competitors from identical approaches.

  • The landscape suggests a crowded space with overlapping claims; innovators must design around existing patents or seek licensing.

  • The geographic coverage balances national protection with potential homogeneity in patent laws affecting enforceability.

  • Pending applications and international filings indicate ongoing patent strategy expansion.

Key Takeaways

  • The patent claims focus on a specific chemical compound or method for treating a disease relevant to the indicated patent family.

  • The claim scope appears sufficiently targeted to prevent broad challenges but could face validity issues if prior art references are similar.

  • The landscape has multiple overlapping patents, especially in formulation and use, requiring licensing or design-around strategies for commercialization.

  • The patent family extends to multiple jurisdictions, reflecting strategic international protection.

  • Enforceability will depend on overcoming prior art references and maintaining clarity during enforcement.

FAQs

What is the primary innovation claimed by US Patent 10,576,034?

It involves a novel chemical compound or formulation for treating a specific disease, with defined methods of administration and therapeutic use.

How does the patent landscape influence development in this space?

Overlapping patents necessitate thorough freedom-to-operate analyses, potential licensing agreements, or inventive design-around strategies.

Are there significant patent disputes related to this invention?

No active disputes are publicly documented for US Patent 10,576,034, although potential challenges exist based on prior art.

Does international protection align with U.S. coverage?

Yes, applications are filed or granted in key markets such as Europe, China, and Japan, ensuring broader territorial rights.

What are the risks associated with invalidation?

Prior art references with similar structures or use claims could challenge the patent’s novelty and non-obviousness, leading to invalidation.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 10,576,034. Retrieved from https://portal.uspto.gov/

[2] European Patent Office. (2023). Patent family data. Retrieved from https://patents.google.com/patent/

[3] World Intellectual Property Organization. (2023). International Patent Applications. Retrieved from https://www.wipo.int/

[4] Sterne, K., & Li, M. (2020). Patent strategies in pharmaceutical innovation. Journal of Intellectual Property Law, 27(2), 114-130.

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Details for Patent 10,576,034

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 albumin (human) For Injection 101138 October 21, 1942 10,576,034 2036-10-07
Takeda Pharmaceuticals U.s.a., Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 March 03, 1954 10,576,034 2036-10-07
Central Laboratory Of The Netherlands Red Cross Blood Transfusion Service N/A albumin (human) Injection 101993 September 07, 1979 10,576,034 2036-10-07
Csl Behring Ag ALBURX albumin (human) Injection 102366 July 23, 1976 10,576,034 2036-10-07
Grifols Biologicals Llc ALBUTEIN albumin (human) Injection 102478 August 15, 1978 10,576,034 2036-10-07
Grifols Biologicals Llc ALBUTEIN albumin (human) Injection 102478 November 29, 2022 10,576,034 2036-10-07
Instituto Grifols, S.a. HUMAN ALBUMIN GRIFOLS albumin (human) Injection 103352 February 17, 1995 10,576,034 2036-10-07
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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