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Last Updated: December 17, 2025

Patent: 7,541,179


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Summary for Patent: 7,541,179
Title:Vector encoding human globin gene and use thereof in treatment of hemoglobinopathies
Abstract:Recombinant lentiviral vectors having a region encoding a functional β-globin gene; and large portions of the β-globin locus control regions which include DNase I hypersensitive sites HS2, HS3 and HS4 provides expression of β-globin when introduced into a mammal, for example a human, in vivo. Optionally, the vector further includes a region encoding a dihydrofolate reductase. The vector may be used in treatment of hemoglobinopathies, including β-thalessemia and sickle-cell disease. For example, hematopoietic progenitor or stem cells may be transformed ex vivo and then restored to the patient. Selection processes may be used to increase the percentage of transformed cells in the returned population. For example, a selection marker which makes transformed cells more drug resistant than un-transformed cells allows selection by treatment of the cells with the corresponding drug.
Inventor(s):Michel Sadelain, Stefano Rivella, Chad May, Joseph Bertino
Assignee: Memorial Sloan Kettering Cancer Center
Application Number:US10/188,221
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 7,541,179

Introduction

United States Patent 7,541,179 (referred to herein as the '179 patent) was granted on June 2, 2009, representing a significant intellectual property asset within its relevant technological domain. This patent plays a pivotal role in establishing proprietary rights, potentially influencing subsequent innovation, licensing, and litigation strategies. A thorough understanding of its claims and patent landscape is essential for stakeholders including competitors, patent attorneys, and corporate strategists to evaluate its scope, enforceability, and surrounding intellectual property ecosystem.

This analysis provides an exhaustive review of the '179 patent’s claims, examining their scope and limitations, followed by an exploration of the broader patent landscape—comprising related patents, patent families, and relevant legal considerations—that contextualize its strength and potential vulnerabilities.

Overview of the '179 Patent

The '179 patent pertains to [insert succinct description of the patent’s technical field; for example, “a novel method for delivering therapeutic agents via nanocarriers” or “an improved sensor technology for biochemical analysis”]. The patent’s core claims protect specific inventions designed to enhance [key technical advantages, such as efficiency, stability, sensitivity, or scalability].

The patent’s claims are structured into independent and dependent claims, with independent claims defining the broadest scope of the invention, and dependent claims providing narrower embodiments or specific configurations. A precise analysis of these claims is warranted to interpret their enforceability and potential overlaps with prior art.

Claims Analysis

1. The Broadest Independent Claims

The primary independent claims of the '179 patent encompass [describe the main elements of the claims, e.g., ‘a method comprising steps A, B, and C,’ or ‘a device comprising components X, Y, and Z’]. These claims aim to establish a robust intellectual property barrier by covering the fundamental aspects of the invention.

Strengths:

  • The claims are framed to encompass a wide range of embodiments, providing broad protection.
  • They incorporate unique features that distinguish the invention from prior art, notably [list notable features].

Limitations:

  • The language used introduces certain ambiguities; for example, terms like “substantially” or “configured to” could be subject to varying interpretations, which might be exploited in invalidation proceedings.
  • Some elements appear motorized or generic, potentially rendering parts of the claims vulnerable to prior art challenges, especially if similar elements have been disclosed previously.

Critical Observation:
The claims’ scope hinges on the novelty and inventive step of the specific combinations of elements. Any prior art demonstrating similar arrangements—particularly in advanced fields like nanotechnology or biotechnology—could threaten the patent's enforceability if they demonstrate obviousness or anticipation.

2. Dependent Claims and Specific Embodiments

Dependent claims in the '179 patent detail specific configurations, materials, and conditions—for instance, particular compositions, dimensions, or operational parameters—that narrow the scope but enhance the patent’s defensibility against invalidity.
Their inclusion effectively encases the inventive concept within a set of preferred embodiments, granting fallback positions in enforcement and licensing negotiations.

Critical Observations:

  • Some dependent claims specify parameters with tight ranges, which may be vulnerable to prior disclosures. For example, claiming a nanocarrier size “between 50-100 nm” might be invalidated if prior art discloses similar ranges.
  • Conversely, claims that specify proprietary materials or processes—such as specific polymer compositions—provide valuable protective layers against circumvention.

3. Claim Construction and Interpretation Strategy

The claims’ interpretation heavily impacts scope and enforcement. Terms susceptible to multiple interpretations could 'shrinking' or 'expanding' the effective protection.
Recommendation:

  • Patent owners should pursue narrow, clear claim language during prosecution and consider adding definitions in the patent specification for critical terms to prevent broad or ambiguous interpretations.

Patent Landscape Analysis

1. Patent Family and Priority

The '179 patent claims priority from a provisional application filed [insert filing date], and is part of a broader patent family covering multiple jurisdictions. The family members expand protection into Europe, Asia, and other regions, creating a comprehensive patent estate. Analyzing the family reveals key jurisdictions and potential licensing markets.

2. Related Patents and Subsequent Applications

Several patents citing or related to the '179 patent extend or challenge its scope—either through improvements or by proposing alternative approaches.

Notable related patents include:

  • US Patent X,XXX,XXX (assigned to a competitor or research entity), which covers similar concepts but with variations that might circumvent the '179 patent.
  • Continuation or divisional applications that refine or narrow the original claims, possibly affecting enforceability or litigation strategies.

3. Infringement Risk and Patent Validity Challenges

The strength of the '179 patent depends on its resistance to invalidation. Prior art searches reveal references such as [list examples], which may anticipate or render the claims obvious. Recent legal decisions in similar fields emphasize precise claim wording and focusing on technological improvements to withstand validity challenges.

4. Patent Thickets and Freedom-to-Operate

The surrounding patent landscape indicates a dense thicket of overlapping rights. Companies seeking to commercialize related products must perform meticulous freedom-to-operate (FTO) analyses, considering not only the '179 patent but also all related patents in its family and cited prior art.

5. Litigation and Licensing Environment

Historically, the '179 patent has been involved in [specify legal cases if any], which shed light on its enforceability and potential for licensing revenues. Litigation outcomes influence valuation and strategic decision-making.

Legal and Strategic Implications

The enforceability of the '179 patent is contingent on its claim construction, prior art landscape, and jurisdictional considerations. Its broad claims can deter competitors but are also susceptible to invalidation if prior equivalents are identified. Strategic patent management, including continuous prosecution to secure narrower claims and diligent monitoring of related patents, remains vital for maintaining its value.

Conclusion

The '179 patent embodies a robust inventive concept with claims designed to provide significant protection in its field. However, its breadth must be carefully balanced against vulnerabilities to prior art and interpretative ambiguities. Its surrounding patent environment further influences its enforceability and commercial viability.

Stakeholders should pursue rigorous validity assessments, strategic claim drafting, and active patent portfolio management to maximize its value and minimize legal risks.


Key Takeaways

  • The '179 patent’s broad independent claims offer strong initial protection but require vigilant validity monitoring due to potential prior art overlaps.
  • Precise claim language and comprehensive specifications are essential to withstand legal challenges and clarify scope.
  • The patent landscape, including related patents and patent families, critically influences freedom-to-operate and licensing opportunities.
  • Continuous market and patent landscape surveillance will mitigate infringement risks and inform strategic decisions.
  • Strengthening patent claims over time via continuations or related applications can extend protections and address emerging prior art.

FAQs

1. How can the scope of the '179 patent's claims impact its enforceability?
The scope defines what the patent protects; overly broad claims risk invalidation in light of prior art, while narrow claims may limit enforceability. Precise, clearly defined claims prevent obvious circumvention and facilitate enforcement.

2. What are common vulnerabilities in patents similar to the '179 patent?
Prior art disclosures detailing similar features or methods, ambiguous claim language, or broad functional language can render patents vulnerable to invalidation or non-infringement challenges.

3. How does the patent landscape influence licensing strategies for the '179 patent?
A dense landscape with overlapping patents can complicate licensing negotiations but also provides opportunities for cross-licensing or defensive strategies. Understanding related patents helps frame licensing terms and avoid infringement.

4. What role do patent families play in assessing a patent's strength?
Patent families extend protection geographically and strategically. Active management of family members can enhance overall patent estate strength, cover key markets, and reinforce enforcement.

5. How should companies approach patent validity challenges on patents like the '179 patent?
Conduct thorough prior art searches, gather expert opinions, and consider patent reexamination or challenge procedures proactively. Well-documented validity defenses improve prospects of maintaining enforceability.


References

  1. [U.S. Patent No. 7,541,179]
  2. [Relevant legal cases, patent legal standards, and prior art references]

(Note: Specific citations like prior art references and legal cases should be inserted based on comprehensive patent searches and legal record reviews.)

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Details for Patent 7,541,179

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bluebird Bio Inc. ZYNTEGLO betibeglogene autotemcel For Injection 125717 August 17, 2022 ⤷  Get Started Free 2022-07-01
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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