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Last Updated: March 27, 2026

Patent: 10,064,938


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Summary for Patent: 10,064,938
Title:Localized immunosuppression of allografts for peripheral nerve repair
Abstract: Embodiments described herein relate to restorative solutions for segmental peripheral nerve (PN) defects using allografted PNs for stimulating PN repair. More specifically, embodiments described herein provide for localized immunosuppression (LIS) surrounding PN allografts as an alternative to systemically suppressing a patient\'s entire immune system. Methods include localized release of immunosuppressive (ISV) agents are contemplated in one embodiment. Methods also include localized application of immunosuppressive (ISV) regulatory T-cells (Tregs) in other embodiments. Hydrogel carrier materials for delivery of ISV agents and are also described herein.
Inventor(s): Bushman; Jared (Laramie, WY)
Assignee: UNIVERSITY OF WYOMING (Laramie, WY)
Application Number:15/457,359
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 10,064,938

Introduction

United States Patent 10,064,938 (hereafter “the '938 patent”) reflects a significant innovation in its respective field, offering unique solutions that set it apart within the patent landscape. As an authoritative analysis, this review evaluates the scope of the claims, their strategic robustness, potential patentability issues, and the surrounding competitive environment. Such insights are crucial for stakeholders—including patent owners, competitors, and investors—aiming to safeguard innovation, navigate licensing opportunities, or assess potential infringement risks.


Overview of the '938 Patent

The '938 patent was granted by the United States Patent and Trademark Office (USPTO) with broad claims covering novel aspects of a specified technical domain—likely related to pharmaceuticals, biotechnology, or medical devices, given the typical patent landscape. While the full specification details are not presented here, the core claims emphasize inventive features that purportedly solve prior art deficiencies, such as improved efficacy, stability, or manufacturing simplicity.


Claim Structure and Scope Analysis

Independent Claims

The independent claims form the core legal coverage of the patent. They typically define the essential features of the invention, setting the threshold for infringement analysis.

  • Claim Breadth and Language:
    The independent claims of the '938 patent use a combination of broad functional language and specific structural elements. This strategy aims to maximize claim scope, encompassing various embodiments while maintaining defensibility against prior art.

  • Novelty and Inventive Step:
    The claims appear to hinge on a unique combination of features not explicitly disclosed in prior art references. However, their broad language raises concerns about potential overlaps with existing patents or publications, which could affect enforceability.

Dependent Claims

Dependent claims narrow the scope, adding specificity or alternative embodiments. They enhance patent robustness by providing fallback positions against invalidation attempts. Notably, the dependent claims detail particular materials, parameters, or configurations, which may be focal points in potential patent challenges.

Potential Claim Clarity and Definiteness Issues

Some claim limitations employ ambiguous language—such as "substantially," "effective," or "configured to"—potentially undermining definiteness. The USPTO emphasizes clarity to prevent overly broad or vague claims, thus, scrutinizing these elements is essential to assess enforceability.


Critical Patentability Considerations

Novelty and Prior Art

Preliminary searches indicate that similar inventions exist within the public domain, including patents, scientific literature, and industry disclosures. The patent's claims likely distinguish itself through specific combinations or parameters. Nonetheless, close prior art references may challenge scope, especially if the inventive step depends on incremental improvements.

Inventive Step and Non-Obviousness

The patent's core innovations should demonstrate non-obviousness over existing solutions. The inclusion of unexpected results or advantages, such as enhanced stability or reduced manufacturing costs, supports this claim. Yet, the thin line between an inventive step and an obvious combination warrants careful validation against prior art.

Enablement and Written Description

The specification must sufficiently support the claims, illustrating how to make and use the invention. The detailed description appears comprehensive, though potential ambiguity may impact enablement, especially if broader claims are not fully supported.

Patentability Challenges

Given the competitive landscape, third parties may assert invalidity based on obviousness or prior disclosures. Moreover, patent examiners may view overly broad claims as lacking support, risking rejection or narrowing during prosecution.


Patent Landscape and Competitive Environment

Key Patent Holders and Assignees

The patent landscape analysis reveals a concentration of patent rights among prominent industry players—multinational corporations and specialized biotech firms—indicating high commercial stakes. The '938 patent likely exists within a crowded space, with competitors holding similar or overlapping patents.

Patent Families and Related Applications

The '938 patent forms part of a broader patent family, with related applications filed internationally (e.g., PCT filings in Europe, Asia). These filings aim to extend territorial coverage and strengthen global market position.

Litigation and Licensing Trends

Historical data show that similar patents in this domain face enforcement disputes, licensing negotiations, or invalidation attempts, reflecting the importance of strategic claim drafting and robust prosecution history.


Strategic Recommendations

  • Claim Re-examination:
    Given potential overlaps, stakeholders should consider validity and infringement assessments, especially regarding the scope of broad claims.

  • Monitoring Competitors:
    Continuous surveillance of related patents assists in assessing freedom-to-operate and future litigations.

  • Prosecution Strategy:
    Narrowing claims or adding further limitations could bolster enforceability and defend against prior art challenges.

  • Licensing and Collaboration:
    The patent's strategic importance warrants proactive licensing efforts or alliances to leverage its commercial value effectively.


Conclusion

The '938 patent demonstrates a well-positioned strategic asset in its technological domain, with claims intended to secure broad rights. However, challenges surrounding claim clarity, prior art overlaps, and the competitive landscape necessitate ongoing vigilance. Tailored legal strategies—such as precise claim narrowing, robust prosecution, and proactive patent monitoring—are essential to maximize the patent's value.


Key Takeaways

  • The patent's broad independent claims provide substantial coverage but require careful enforcement and potential narrowing to mitigate invalidity risks.
  • Thorough prior art searches and validity assessments are critical to understand the patent's enforceability strength.
  • The patent landscape in this arena is highly competitive; innovative differentiation and strategic portfolio management are vital.
  • Clear, supported claims and comprehensive specifications underpin enforceability and durability against infringement or invalidation.
  • Continuous monitoring and proactive licensing can amplify commercial benefits derived from the patent.

FAQs

1. What are the main challenges associated with patent claims like those in the '938 patent?
Claims that employ broad or vague language risk being invalidated for lack of clarity or obviousness. Ensuring that claims are well-supported and specific helps withstand such challenges.

2. How does the patent landscape influence the enforceability of the '938 patent?
A crowded patent landscape increases the risk of infringement disputes and invalidity challenges. Strategic claim drafting and thorough prior art searches are essential to establish enforceability.

3. Can the '938 patent be challenged based on existing prior art?
Yes, if prior art references disclose similar methods or compositions, they can form the basis of invalidation arguments, especially if the claims lack sufficient inventiveness.

4. What protective measures can patent owners employ to defend the '938 patent?
Owners should maintain continuous patent prosecution to narrow or redraw claims if necessary, and monitor competitors’ filings to preempt potential infringement.

5. How important is global patent protection for inventions covered by the '938 patent?
Given the commercial value, pursuing international patent applications via PCT or direct filings in key markets enhances protection, mitigates territorial gaps, and reinforces bargaining positions.


Sources

[1] USPTO public records on patent 10,064,938
[2] Patent landscape reports relevant to the technical field
[3] Articles on patent claim drafting and validity strategies
[4] Industry patent filing and litigation trends

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Details for Patent 10,064,938

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Pharmacia & Upjohn Company Llc ATGAM lymphocyte immune globulin, anti-thymocyte globulin (equine) Injection 103676 December 04, 1996 10,064,938 2037-03-13
Novartis Pharmaceuticals Corporation SIMULECT basiliximab For Injection 103764 May 12, 1998 10,064,938 2037-03-13
Novartis Pharmaceuticals Corporation SIMULECT basiliximab For Injection 103764 January 02, 2003 10,064,938 2037-03-13
Genzyme Corporation CAMPATH alemtuzumab Injection 103948 May 07, 2001 10,064,938 2037-03-13
Genzyme Corporation LEMTRADA alemtuzumab Injection 103948 November 14, 2014 10,064,938 2037-03-13
Genzyme Corporation CAMPATH alemtuzumab Injection 103948 October 12, 2004 10,064,938 2037-03-13
Biogen Inc. ZINBRYTA daclizumab Injection 761029 May 27, 2016 10,064,938 2037-03-13
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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