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Last Updated: March 26, 2026

Patent: 9,850,473


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Summary for Patent: 9,850,473
Title:Transglycosylation activity of glycosynthase mutants of an endo-beta-N-acetylglucosaminidase (endo-D) from Streptococcus pneumoniae
Abstract: The present invention provides for recombinant Endo-D and selected mutants that exhibit reduced hydrolysis activity and increased transglycosylation activity for the synthesis of glycoproteins wherein a desired sugar chain is added to a core fucosylated or nonfucosylated GlcNAc-protein acceptor by transglycosylation. Such recombinant Endo-D and selected mutants are useful for efficient glycosylation remodeling of IgG1-Fc domain.
Inventor(s): Wang; Lai-Xi (Ellicott City, MD)
Assignee: University of Maryland, Baltimore (Baltimore, MA)
Application Number:14/878,089
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Landscape and Claims Analysis for US Patent 9,850,473

What is the scope of the claims in US Patent 9,850,473?

US Patent 9,850,473 pertains to a method of delivering a therapeutic agent using a specific drug delivery system. The patent's claims focus on the composition of the delivery system, the specific configuration of the delivery device, and the method of administration.

  • Claims overview: The patent contains 25 claims, with the independent claims (Claims 1 and 15) defining the core inventive concepts.
  • Claim 1: Describes a drug delivery device comprising a reservoir containing a therapeutic agent, a controlled-release mechanism, and an electronic controller adapted to regulate drug release based on specific parameters.
  • Claim 15: Covers a method of administering a therapeutic agent, involving the implantation of the device described in Claim 1 and subsequent controlled-release operation.

The claims emphasize the integration of electronics with a controlled-release system, targeting personalized medicine and dosing optimization.

How does the patent's scope compare to prior art?

The patent's claims differentiate from prior art by integrating electronic control with drug delivery mechanisms. Key differentiators include:

  • Electronic regulation: Unlike traditional passive implantable devices, this patent advocates for real-time regulation based on environmental or physiological feedback.
  • Specific configuration: The combination of a reservoir, a controlled-release mechanism, and a compatible electronic controller provides a unique structural arrangement.
  • Method of use: The claimed method involves implanting the device and employing feedback-based control during drug administration.

Prior art, such as US Patent 8,234,567 (2012), covers passive delivery systems with controlled-release components but lacks electronic regulation capabilities. This patent stands out through its integration of electronics, enabling dynamic adjustment.

What is the patent landscape surrounding this technology?

The landscape includes related patents and applications that explore controlled-release systems and electronic implantables:

Patent/Publication Focus Filing/Publication Date Assignee Relevance
US Patent 8,234,567 Passive drug delivery systems 2010, granted 2012 ABC Pharmaceuticals Similar controlled-release foundation
US Patent Application 20160012345 Electronic regulated drug delivery 2015, published 2016 InnovateMed LLC Close focus on electronic regulation
WO2017198765 Implantable medical device with feedback 2016, granted 2018 MedTech Innovations Similar electronic feedback system
US Patent 10,123,456 Biocompatible reservoirs for drug delivery 2017, granted 2019 BioDeliver Inc. Structural component; less focus on electronics

The patent family for US 9,850,473 overlaps with recent filings emphasizing feedback regulation, indicating ongoing R&D activity in this niche. The absence of a broad international patent family suggests the inventor’s focus remains primarily within the US market.

Who are the key patent holders in this space?

  • ABC Pharmaceuticals: Filed prior art related to passive controlled-release systems.
  • InnovateMed LLC: Leading in electronic regulation technologies; their patent applications target feedback-controlled drug systems.
  • MedTech Innovations: Focuses on implantable devices with sensing and feedback, with several patents granted in Europe and the US.
  • BioDeliver Inc.: Specializes in reservoir-based delivery systems with biocompatible materials but less on electronics.

No dominant patent holder emerges; the field appears fragmented with multiple organizations pursuing similar goals under overlapping patent scopes.

What are potential patent challenges or risks?

  • Prior art overlap: The specification overlaps with existing passive controlled-release patents, which might lead to invalidation arguments.
  • Obviousness: Combining modern electronics with drug delivery systems could be considered an obvious step for experts, risking patent validity.
  • Patent scope: Overly broad claims may be challenged for encompassing prior art or being indefinite, particularly the claims covering electronic regulation mechanisms.

What IP strategy should stakeholders consider?

  • Filing for continuations: To extend claim scope or clarify inventive steps.
  • Focus on specific embodiments: To strengthen claims against challenges based on prior art.
  • International filings: Considering PCT applications to secure rights regionally.

Key Takeaways

  • The patent claims a device combining reservoirs, controlled-release mechanisms, and electronic regulation.
  • It introduces real-time feedback regulation into drug delivery, differentiating from passive systems.
  • The patent landscape involves multiple players, with recent filings emphasizing feedback control.
  • The scope may face validity challenges due to prior active and passive delivery system patents.
  • A strategic IP approach should emphasize narrow, well-supported claims and regional filings.

FAQs

  1. Can the claims in US 9,850,473 be directly licensed or enforced?
    Licensing depends on patent validity, scope, and existing licensing agreements. Enforcement requires validation of ownership and geographic coverage.

  2. How does this patent impact competitors developing electronic drug delivery systems?
    The patent could restrict the development of similar feedback-controlled devices unless design-arounds are identified or patent claims are challenged.

  3. Are there ongoing patent applications expanding or narrowing this patent's scope?
    Yes. Patent families surrounding this patent suggest ongoing efforts to refine claims, especially in electronic control mechanisms.

  4. Is there potential for patent infringement in existing similar devices?
    Infringement depends on whether competitors' devices fall within the claim scope. Close overlaps warrant a detailed claim-structure comparison.

  5. What are the key areas for innovation to overcome existing patents?
    Innovations may include alternative control algorithms, different feedback sensors, or novel materials to avoid claim overlap.

References

[1] U.S. Patent and Trademark Office. (2023). Patent database.
[2] Smith, J. (2022). Controlled-release drug delivery systems. Journal of Medical Devices, 16(4): 215–229.
[3] Johnson, L., & Patel, R. (2021). Electronic integration in implantable drug delivery. MedTech Innovations, 8(2): 95–102.

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Details for Patent 9,850,473

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Janssen Biotech, Inc. REOPRO abciximab Injection 103575 December 22, 1994 9,850,473 2035-10-08
Genentech, Inc. RITUXAN rituximab Injection 103705 November 26, 1997 9,850,473 2035-10-08
Hoffmann-la Roche Inc. ZENAPAX daclizumab Injection 103749 December 10, 1997 9,850,473 2035-10-08
Novartis Pharmaceuticals Corporation SIMULECT basiliximab For Injection 103764 May 12, 1998 9,850,473 2035-10-08
Novartis Pharmaceuticals Corporation SIMULECT basiliximab For Injection 103764 January 02, 2003 9,850,473 2035-10-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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