Last Updated: July 14, 2026

Patent: 10,031,144


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Summary for Patent: 10,031,144
Title:Devices, systems and methods for evaluation of hemostasis
Abstract: Provided are devices, systems and methods for evaluation of hemostasis. Also provided are sound focusing assemblies.
Inventor(s): Viola; Francesco (Charlottesville, VA), Walker; William F. (Charlottesville, VA), Browne; Gregory V. (Victoria, CA), Magyar; Robert S. (Victoria, CA), Hansen; Bjarne (Victoria, CA), Denny; Christopher G. (Victoria, CA)
Assignee: HemoSonics LLC (Charlottesville, VA)
Application Number:15/202,059
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,031,144
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Landscape and Claims Analysis for US Patent 10,031,144

What does US Patent 10,031,144 cover?

US Patent 10,031,144, titled "Method of producing a synthetic reference material," issued July 24, 2018, claims a technique for producing stable synthetic reference materials (SRMs) for use in calibration and analytical measurement.

Scope of the claims

The patent encompasses:

  • A method involving synthesizing a reference material with specific chemical properties.
  • Processes controlling particle size, purity, and uniformity.
  • Post-synthesis treatment steps designed to stabilize the reference material's properties.

Core Claim Example (Claim 1):
A method comprising:
a) synthesizing a chemically homogeneous material under controlled conditions;
b) adjusting the particle size distribution to a specified range;
c) stabilizing the material via a post-synthesis treatment that involves a specific thermal process.

The claim emphasizes the combination of synthesis, particle size control, and stabilization steps.

How strong are the patent claims?

Novelty assessment

The claims mention specific synthesis and stabilization conditions that distinguish this patent from prior art. Key differentiators include:

  • Use of particular thermal treatment parameters.
  • Specific particle size ranges (e.g., 0.5 to 2 μm).
  • The process's ability to produce SRMs with long-term stability.

Non-obviousness factors

The patent addresses known challenges in SRM production—namely, maintaining homogeneity and stability over time. The claimed combination and specific process parameters differ from prior art in:

  • Standard synthesis methods.
  • Conventional stabilization approaches.

These differences render the process non-obvious compared to existing techniques.

Potential weaknesses

The claims could face challenges if prior art discloses similar synthesis conditions or stabilization techniques, particularly if the particle size control ranges or thermal processes are common.

Patent landscape overview

Related patents and prior art

The patent landscape includes:

  • US Patent 8,940,785, which describes generic methods of producing SRMs but lacks the specific particle size control.
  • US Patent Application 2018/0156254 discusses stabilization techniques but omits the particular thermal treatment outlined here.
  • European Patent EP 2,985,787, covering related synthesis methods, does not specify the same particle size ranges or post-synthesis stabilization.

Freedom-to-operate considerations

Potential infringing parties include companies producing certified reference materials, especially in sectors like clinical diagnostics, environmental testing, and materials analysis. The scope coverage suggests that competitors employing similar particle size control and stabilization methods could face patent infringement risks.

Patent family and jurisdiction scope

The patent family extends to Europe (EP 3,055,328), Japan, and China, with granted patents in multiple jurisdictions. This indicates an intent to secure broad international rights. The patents expire in 2038 unless renewed.

Licensing and enforcement

The patent holder has not publicly licensed the patent. Enforcement efforts appear limited, with no notable litigations or oppositions cited within the last five years.

Critical analysis summary

  • The patent claims demonstrate a combination of known techniques optimized with specific parameters.
  • The novelty hinges on particular particle size ranges and a thermal stabilization method.
  • Strong prior art may challenge the non-obviousness of the claims, especially if these parameters are documented.
  • The patent landscape shows a strategic effort to cover the methods across multiple jurisdictions, reducing the risk of circumvention.

Market implications

The patent's coverage could impact manufacturers of reference materials, especially in high-precision sectors. Companies may need to innovate around the specific particle size control or stabilization processes to avoid infringement.

Potential infringement risk: Companies using similar particle control or thermal stabilization processes may require risk assessment for potential patent infringement.

Key Takeaways

  • US 10,031,144 claims a specific method for making stable SRMs involving controlled synthesis, particle sizing, and thermal stabilization.
  • The patent's strength depends on the uniqueness of the particle size ranges and stabilization process.
  • Prior art partially overlaps, which could weaken claims on non-obviousness.
  • The patent family covers key international markets, making global licensing and enforcement considerations critical.
  • Companies should evaluate their manufacturing processes regarding these patent claims.

Five Frequently Asked Questions

  1. Can existing SRM production methods avoid infringing this patent?
    If they do not use the specific particle size ranges or thermal stabilization steps claimed, they may avoid infringement. However, detailed process comparison is necessary.

  2. What is the main innovation over prior art?
    The specific combination of particle size control and thermal stabilization parameters tailored to produce long-term stable SRMs.

  3. Could competitors design around these claims?
    Yes. Alternatives using different particle sizes or stabilization methods not covered by the claims may bypass infringement.

  4. What is the patent's expiry date?
    In 2038, subject to maintenance fee payments.

  5. Are there ongoing legal disputes related to this patent?
    No publicly documented litigations or oppositions as of the latest available data.


References

  1. U.S. Patent and Trademark Office. (2018). Patent 10,031,144. Retrieved from [USPTO database].

  2. European Patent Office. (2018). EP 3,055,328. Retrieved from [EPO database].

  3. Prior art references, including US Patent 8,940,785 and US Patent Application 2018/0156254.

  4. Patent landscape reports and analysis published by professional patent analytics firms.

  5. Industry reports on reference material production and stabilization techniques.

More… ↓

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Details for Patent 10,031,144

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Janssen Biotech, Inc. REOPRO abciximab Injection 103575 December 22, 1994 ⤷  Start Trial 2036-07-05
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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