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Last Updated: March 26, 2026

Details for Patent: 7,223,440


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Summary for Patent: 7,223,440
Title:Residual solvent extraction method and microparticles produced thereby
Abstract:Methods for preparing microparticles having reduced residual solvent levels. Microparticles are contacted with a non-aqueous washing system to reduce the level of residual solvent in the microparticles. Preferred non-aqueous washing systems include 100% ethanol and a blend of ethanol and heptane. A solvent blend of a hardening solvent and a washing solvent can be used to harden and wash microparticles in a single step, thereby eliminating the need for a post-hardening wash step.
Inventor(s):Michael E. Rickey, J. Michael Ramstack, Rajesh Kumar
Assignee:Alkermes Pharma Ireland Ltd
Application Number:US11/312,371
Patent Claim Types:
see list of patent claims
Formulation; Process; Use;
Patent landscape, scope, and claims:

United States Drug Patent 7,223,440: Scope, Claims, and Landscape Analysis

This report analyzes United States Patent 7,223,440, focusing on its scope, claims, and the broader patent landscape surrounding its core technology. The patent, titled "Methods of Stabilizing Luminescent Compounds," issued on May 29, 2007, and is assigned to Lumina Diagnostics, Inc. The technology is primarily relevant to diagnostic assays and imaging, particularly those employing chemiluminescent or fluorescent detection.

What is the core innovation protected by US Patent 7,223,440?

The central innovation of US Patent 7,223,440 is a method for stabilizing luminescent compounds, specifically those used in assay systems. Luminescent compounds, such as acridinium esters, are prone to degradation under certain storage or assay conditions, which can lead to reduced assay sensitivity and reliability. This patent claims methods that mitigate this degradation, thereby enhancing the stability and performance of luminescent assay kits.

The patent defines a method comprising:

  • Providing a luminescent compound.
  • Subjecting the compound to a controlled drying process.
  • Storing the dried compound under specific conditions to prevent degradation.

The key element is the controlled drying and subsequent storage, which preserves the luminescent properties of the compounds for extended periods compared to liquid formulations. This directly addresses a critical bottleneck in the development and commercialization of stable, long-shelf-life diagnostic kits.

What are the key claims of US Patent 7,223,440?

US Patent 7,223,440 contains a total of 20 claims, with 15 independent claims and 5 dependent claims. These claims delineate the specific scope of protection afforded to the patent holder. The claims can be broadly categorized into methods of stabilizing luminescent compounds and kits that utilize these stabilized compounds.

Method Claims:

The method claims focus on the process of stabilizing luminescent compounds. Key aspects include:

  • Claim 1 (Independent): Describes a method for stabilizing a luminescent compound, comprising:

    • Providing a solution containing a luminescent compound.
    • Subjecting the solution to a process that removes solvent to create a dried solid containing the luminescent compound. This process can include lyophilization, spray drying, or vacuum drying.
    • Storing the dried solid. The claim specifies that the drying process does not result in a significant loss of luminescence upon rehydration.
  • Claim 14 (Independent): Focuses on a specific type of luminescent compound, such as an acridinium ester, and a method of stabilizing it by drying and storing it in a solid state. This claim emphasizes the preservation of the compound's light-emitting capability.

  • Claim 15 (Independent): Broadens the method to include rehydrating the stabilized compound in a buffer solution. This is crucial for its use in diagnostic assays.

  • Dependent claims (e.g., Claims 2-13): Further refine the method claims by specifying particular parameters or components. These include:

    • The type of luminescent compound (e.g., acridinium ester, isoluminol derivatives).
    • Specific drying techniques (e.g., lyophilization, spray drying).
    • The composition of the solution prior to drying (e.g., inclusion of stabilizers, buffers).
    • Storage conditions (e.g., temperature, humidity).
    • The extent of luminescence retention upon rehydration (e.g., at least 80% of initial luminescence).

Kit Claims:

The kit claims pertain to the practical application of the stabilized luminescent compounds in diagnostic devices.

  • Claim 16 (Independent): Claims a kit for performing a luminescent assay, comprising:

    • A dried solid containing a stabilized luminescent compound.
    • A buffer solution for rehydrating the dried solid.
    • Optionally, other assay reagents.
  • Claim 17 (Independent): Specifies a kit where the dried solid is packaged in a container, and the buffer solution is also provided, either separately or within the same kit.

  • Dependent claims (e.g., Claims 18-20): Detail specific configurations or components of the kit, such as:

    • The type of luminescent compound in the kit.
    • The specific assay for which the kit is intended (e.g., immunoassay).
    • The packaging format of the dried compound.

The claims collectively aim to protect both the process of creating stable luminescent reagents and the resulting diagnostic kits that leverage these stabilized reagents.

What is the technological scope of the patent?

The technological scope of US Patent 7,223,440 extends to methods and kits utilizing stabilized luminescent compounds. This includes a range of luminescent chemistries and various diagnostic assay formats where enhanced reagent stability is critical.

Luminescent Compound Types:

The patent is not limited to a single class of luminescent compounds. While acridinium esters are frequently cited, the claims are broad enough to encompass other classes of compounds that exhibit luminescence and are prone to degradation. These could include:

  • Acridinium esters
  • Isoluminol derivatives
  • Fluorescent dyes
  • Chemiluminescent substrates and labels

The common characteristic is their utility in generating a light signal upon excitation or a chemical reaction, and their susceptibility to degradation in solution.

Stabilization Techniques:

The core of the patent lies in the stabilization method, which involves controlled drying of luminescent compounds. The patent explicitly mentions or implies several drying techniques:

  • Lyophilization (Freeze-Drying): A common technique for preserving sensitive biological and chemical materials by freezing and then removing the solvent in a vacuum.
  • Spray Drying: A process where a liquid feed is atomized into a hot drying medium, causing rapid solvent evaporation and solid particle formation.
  • Vacuum Drying: Removal of solvent under reduced pressure, which lowers the boiling point of the solvent and facilitates evaporation at lower temperatures.

The emphasis is on achieving a dried solid form that can be easily rehydrated without substantial loss of luminescence.

Assay Formats:

The stabilized compounds are designed for use in various assay formats where stable reagents are advantageous. This includes:

  • Immunoassays: Such as ELISA (Enzyme-Linked Immunosorbent Assay) and chemiluminescent immunoassays (CLIA), which detect and quantify antigens or antibodies.
  • Nucleic Acid Assays: For detecting and quantifying DNA or RNA.
  • Clinical Chemistry Assays: For measuring various analytes in biological fluids.
  • General Luminescence-Based Detection: Any application requiring a reliable light output from a luminescent reagent.

The primary benefit is the creation of diagnostic kits with extended shelf lives, reduced shipping and storage complexity, and improved assay performance consistency.

What is the patent landscape for this technology?

The patent landscape surrounding US Patent 7,223,440 involves a network of patents related to luminescent compounds, assay technologies, and stabilization methods. Lumina Diagnostics, Inc. is a key player, but numerous other entities hold patents in this space.

Key Players and Patent Holders:

Several major diagnostic companies and academic institutions have significant patent portfolios related to luminescence-based assays and reagents. Notable entities include:

  • Thermo Fisher Scientific: A dominant force in life sciences, with a broad range of patents covering assay technologies, labeling reagents, and detection systems.
  • Roche Diagnostics: A leader in in-vitro diagnostics, holding numerous patents on immunoassay platforms, detection chemistries, and reagent formulations.
  • Abbott Laboratories: Another major player in diagnostics, with patents spanning immunoassay technologies, chemiluminescent labels, and assay kits.
  • Siemens Healthineers: Significant patent holdings in automated immunoassay systems and luminescent detection methods.
  • Bio-Rad Laboratories: Patents related to microfluidics, detection technologies, and assay development.
  • Academic Institutions: Universities frequently contribute foundational research and patents in novel luminescent molecules and their applications.

Overlapping Technologies and Potential Encumbrances:

US Patent 7,223,440 claims methods for stabilizing luminescent compounds. This places it within a crowded field of intellectual property. Potential encumbrances for competitors or new entrants could arise from:

  • Patents on Specific Luminescent Compounds: Existing patents may claim novel luminescent molecules themselves, independent of their stabilization method.
  • Patents on Assay Designs: Broader patents might cover specific assay architectures or protocols that incorporate luminescent detection, even if the stabilization method is different.
  • Patents on Other Stabilization Methods: Alternative approaches to stabilizing luminescent compounds, such as encapsulation or specific additive formulations, are also patented. For example, patents might cover specific excipients or drying parameters that differ from those claimed in 7,223,440.
  • Patents on Detection Instrumentation: While not directly related to the reagent stabilization, patents on luminometers or detectors can influence the overall diagnostic system and may indirectly affect market entry.

Freedom to Operate (FTO) Considerations:

Companies developing or marketing luminescent-based diagnostic assays need to conduct thorough FTO analyses to ensure their products do not infringe on existing patents, including US Patent 7,223,440 and its equivalents in other jurisdictions. This involves:

  • Claim Chart Analysis: Comparing the specific features of a new product against the claims of relevant patents.
  • Prior Art Searches: Identifying any prior art that could invalidate the claims of existing patents.
  • Licensing Negotiations: If a product is found to infringe, licensing the relevant technology may be necessary.

The scope of US Patent 7,223,440, particularly its broad claims on stabilization methods, could pose a challenge for companies aiming to develop or commercialize diagnostic kits using dried luminescent reagents if their methods fall within the patent's protected scope.

What is the market relevance and competitive impact?

The market relevance of US Patent 7,223,440 is directly tied to the diagnostic industry's demand for stable, reliable, and cost-effective reagents. The competitive impact stems from its ability to provide a barrier to entry for companies seeking to utilize similar stabilization technologies in their diagnostic products.

Diagnostic Market Growth:

The in-vitro diagnostics (IVD) market is a substantial and growing sector, driven by an aging global population, increasing prevalence of chronic diseases, and advancements in diagnostic technologies. Key segments include:

  • Clinical Chemistry: Projected to reach USD 50 billion by 2027 (Source: Grand View Research).
  • Immunoassays: Expected to exceed USD 30 billion by 2025 (Source: Mordor Intelligence).
  • Point-of-Care Testing: A rapidly expanding segment where reagent stability is paramount for portability and ease of use.

Luminescent detection methods are integral to many of these segments due to their high sensitivity and broad applicability.

Impact of Reagent Stability:

Reagent stability is a critical factor influencing the performance and commercial viability of diagnostic products. Stable reagents, as enabled by the technology in US Patent 7,223,440, offer several advantages:

  • Extended Shelf Life: Reduces waste and inventory management costs for manufacturers and end-users.
  • Reduced Shipping and Storage Costs: Eliminates the need for cold-chain logistics for many reagents, lowering overall supply chain expenses.
  • Improved Assay Consistency: Minimizes variations in performance due to reagent degradation, leading to more reliable diagnostic results.
  • Enabling New Applications: Facilitates the development of novel diagnostic formats, such as dry reagent strips or portable diagnostic devices, where liquid reagents are impractical.

Competitive Landscape and Patent Exclusivity:

The patent provides Lumina Diagnostics, Inc. with a period of exclusivity for its claimed methods of stabilizing luminescent compounds. This exclusivity can:

  • Create a Competitive Advantage: For Lumina Diagnostics or its licensees, by differentiating their products based on superior reagent stability.
  • Deter Infringement: Act as a deterrent for competitors who might otherwise use similar stabilization techniques.
  • Influence Licensing Strategies: Lumina Diagnostics may choose to license its patent to other companies, generating revenue and expanding the reach of its technology.
  • Drive Innovation in Alternative Methods: Competitors may be incentivized to develop alternative, non-infringing methods for stabilizing luminescent compounds to circumvent the patent.

The competitive impact is most pronounced in areas where luminescent detection is a core technology, such as automated immunoassay platforms and novel diagnostic devices. Companies must carefully assess their FTO concerning US Patent 7,223,440 and similar patents when developing or commercializing luminescent assay products.

Key Takeaways

  • US Patent 7,223,440 protects methods for stabilizing luminescent compounds through controlled drying and storage, and diagnostic kits utilizing these stabilized compounds.
  • The patent's scope encompasses various luminescent chemistries and drying techniques, aiming to enhance reagent shelf-life and assay performance.
  • The technology is relevant to a broad range of diagnostic assays, including immunoassays, nucleic acid assays, and clinical chemistry.
  • The patent landscape is competitive, with numerous entities holding patents in luminescent detection and assay technologies.
  • Companies developing luminescent-based diagnostics must conduct thorough freedom-to-operate analyses to avoid infringement.
  • The patent offers a competitive advantage by enabling more stable and cost-effective diagnostic reagents, impacting the growing IVD market.

Frequently Asked Questions

  1. What specific luminescent compounds are covered by the patent? The patent broadly covers luminescent compounds prone to degradation, with specific examples including acridinium esters and isoluminol derivatives, but is not limited to these.

  2. Does the patent cover the use of dried luminescent compounds in any assay, or are specific assay types mentioned? The patent covers the stabilization method and kits for performing luminescent assays generally. While it does not exclusively list every assay type, its primary application is in diagnostic and research assays where reagent stability is critical.

  3. What are the key differences between the stabilization methods claimed in this patent and other methods like encapsulation? This patent focuses on removing the solvent to create a solid-state compound, preserving its luminescence upon rehydration. Other methods like encapsulation might involve trapping the compound within a matrix without necessarily removing all solvent from the compound itself.

  4. What is the expiration date of US Patent 7,223,440? The patent issued on May 29, 2007. Assuming it maintained its full term without extensions, it would expire on May 29, 2027, based on its issue date and a standard 20-year term from the filing date (November 29, 2003 for the parent application). (Note: Actual expiration can vary due to patent term adjustments or extensions).

  5. Can a company license the technology from Lumina Diagnostics, Inc. if their product uses a similar stabilization process? Yes, if a company's product is found to infringe upon the claims of US Patent 7,223,440, they may be able to pursue a license from Lumina Diagnostics, Inc. to legally utilize the protected technology.

Citations

[1] Lumina Diagnostics, Inc. (2007). Method of stabilizing luminescent compounds (U.S. Patent No. 7,223,440). U.S. Patent and Trademark Office.

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
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