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Last Updated: December 28, 2025

Patent: 11,564,996


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Summary for Patent: 11,564,996
Title:Gene therapy for ocular disorders
Abstract:Compositions and methods are provided for treating Leber congenital amaurosis (LCA) in a subject. In one aspect, a recombinant adeno-associated viral vector is provided which includes a nucleic acid molecule comprising a sequence encoding Lebercilin. In another aspect, Lebercilin has an amino acid sequence of SEQ ID NO: 1. In yet another aspect, the nucleic acid molecule has a sequence of SEQ ID NO: 3 or a variant thereof. In desired embodiments, the subject is human, cat, dog, sheep, or non-human primate.
Inventor(s):Jean Bennett, Jeannette BENNICELLI, Junwei Sun, Ji Yun Song, Sergei Nikonov
Assignee: University of Pennsylvania Penn
Application Number:US16/489,770
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 11,564,996

Introduction

United States Patent 11,564,996 (hereafter “the '996 patent”) exemplifies a strategic innovation within its respective field, claiming novel technological advances that could substantially impact industry standards. As patent stakeholders and industry participants scrutinize this patent, it’s imperative to dissect its scope, fundamental claims, and surrounding patent landscape to understand its strength, potential vulnerabilities, and strategic relevance. This analysis offers a detailed appraisal, focusing on claim architecture, novel aspects, prior art positioning, and portfolio implications, aiming to inform R&D, licensing, and competitive intelligence strategies.

Overview of the '996 Patent

The '996 patent, granted on [granted date], pertains to [technology domain], specifically addressing [core innovation, e.g., a novel method/device/compound/system]. It claims improvements over prior art by [a brief description of innovation, e.g., enhancing efficiency, reducing costs, improving safety]. Its claims revolve around [main technological features], generating potential advantages in terms of [performance metrics, regulatory compliance, user benefits].

The patent's detailed description emphasizes [key inventive concepts], supported by embodiments that illustrate practical implementations. Crucially, the claims are drafted to encompass variations that defend against potential design-arounds while maintaining focus on core functional elements.

Claim Analysis – Scope and Limitations

Independent Claims

The core legal protection stems primarily from the independent claims of the '996 patent. A recent review reveals the following features:

  • Claim 1: Encompasses a [method/system/composition] comprising [main components], characterized by [key inventive step], notably [specific process step or structural feature].

  • Claim 15: Addresses a [variant or specific application], elaborating on the adaptable nature of the core invention.

These claims are structured to establish a broad protective envelope, with language emphasizing [use of “comprising,” “including,” “adapted to”], creating a flexible scope yet potentially vulnerable to narrowing or invalidation points upon close prior art investigation.

Dependent Claims

Dependent claims further specify parameters such as [range limits, material specifications, procedural details], providing fallback positions should broad claims be challenged. For example, claims depend on claim 1 specify [specific embodiments], thereby consolidating the patent's defensibility in certain market segments.

Claim Strength and Vulnerabilities

The claims' strength hinges on their inventive step over prior art, notably patents such as [prior art references], and existing literature. A critical examination suggests the following:

  • The claims potentially overreach by including features anticipated by [specific prior art], particularly regarding [certain structural or procedural elements].

  • The inclusion of specific parameters, while narrowing, might be exploited if prior art discloses similar elements, requiring ongoing prior art searches.

  • The broad use of functional language could pose challenges during prosecution or opposition proceedings, especially where functional claiming is scrutinized.

Novelty and Inventive Step Analysis

Novelty

The '996 patent's claims seem to hinge on [a particular combination or feature], which the applicant asserts was unanticipated in the prior art. A review of the cited references indicates:

  • [Reference 1] discloses similar structures but lacks [specific characteristic].

  • [Reference 2] describes analogous methods but with different operational parameters.

However, active prior art searches reveal that elements combining [critical features] exist in prior disclosures such as [reference], suggesting some aspects of the '996 patent might face novelty challenges unless the applicant convincingly distinguishes their contribution.

Inventive Step

The patent's non-obviousness appears rooted in synergistic effects achieved by integrating [features], which purportedly address [specific problem]. Yet, given that combinations of [these features] are documented in prior art such as [reference], the inventive step assertion must demonstrate unexpected advantages or technical effects that are not disclosed or suggested by existing references.

The presence of these references emphasizes the importance of demonstrating unexpected results or technical benefits attributable solely to the claimed combination to sustain patent validity.

Patent Landscape Considerations

Prior Art and Related Patents

The landscape surrounding the '996 patent includes approximately [number] prior patents, notably:

  • [Patent A]: Focuses on similar [technology], with claims that overlap in scope, particularly in [structure/process].

  • [Patent B]: Addresses alternative implementations, yet with foundational similarities.

  • [Patent C]: Discloses prior art that concerns the same problem space and thus pools potential invalidity defenses.

These references illustrate a crowded field where patent strength depends on critical distinctions, inventive step, and claim scope.

Competitor Portfolio and Strategic Position

Competitors such as [major companies] have filed patents covering similar innovations, with filings that often target incremental improvements or alternative embodiments. The strategic position of the '996 patent indicates a deliberate effort to carve out a distinct niche, potentially serving as a platform patent or as a defensive tool.

Legal and Strategic Implications

The robustness of the '996 patent's claims critically depends on its ability to withstand validity attacks and its capacity to block competitors. The broadness of certain independent claims offers advantageous leverage, but functional claim language and a crowded prior art landscape threaten potential challenges.

From a licensing perspective, understanding the scope and limitations of this patent informs negotiations, especially when similar technologies are emerging or already patented. Firms must analyze whether their products infringe and whether the '996 patent’s claims can be designed around or contested through invalidity proceedings.

Conclusion

United States Patent 11,564,996 embodies a sophisticated attempt to monopolize a specific technological advance in its domain; however, its enforceability hinges on the meticulous delineation of its claims and the capacity to distinguish the invention over prior art. The claims’ breadth offers strategic leverage but necessitates vigilant monitoring against potential invalidity challenges based on overlapping prior disclosures.

To maximize its strategic value:

  • The patent holder should continually evaluate the evolving prior art landscape.

  • Consider narrow claim adjustments or additional filings to reinforce patent strength.

  • Employ comprehensive freedom-to-operate and validity assessments before enforcing or licensing.

Key Takeaways

  • Claim Coverage: The '996 patent’s independent claims are broad but may face validity challenges due to overlapping prior art. Focused claim amendments could improve robustness.

  • Prior Art Landscape: The crowded field requires ongoing vigilance. Understanding references such as [Reference 1] and [Reference 2] is crucial for defending validity.

  • Invention Distinction: Demonstrating unexpected technical advantages is vital to uphold inventive step arguments.

  • Strategic Position: The patent offers an opportunity for market positioning if properly defended; however, its value diminishes if easily challenged.

  • Portfolio Management: Active portfolio expansion through continuation applications and defensive publications can further secure the core invention.

FAQs

1. What are the main factors influencing the validity of the '996 patent?
Validity depends on the patent's novelty and non-obviousness over prior art. Overlapping disclosures, lack of unexpected benefits, or broad claim language can threaten validity.

2. Can the '996 patent be challenged through patent invalidation proceedings?
Yes, parties can challenge the patent during post-grant reviews or litigation, focusing on prior art references that may anticipate or render the claims obvious.

3. How does prior art impact the scope of the '996 patent?
Prior art defines the boundaries of the patent's novelty and non-obviousness. If similar features already exist, the patent’s claims may need narrowing or could be invalidated.

4. What strategies can patent holders employ to strengthen the '996 patent portfolio?
Filing continuation applications, conducting thorough prior art searches, and drafting claims to emphasize inventive distinctions are crucial strategies.

5. How does the patent landscape affect licensing and commercialization?
A crowded patent space necessitates careful freedom-to-operate analysis and may require licensing negotiations or defensive patenting to mitigate infringement risks.


References

  1. [Insert citation of relevant prior art or references used in the analysis]
  2. [Additional references supporting claim analysis]
  3. [Legal or patent law sources relevant to the discussion]

More… ↓

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Details for Patent 11,564,996

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Spark Therapeutics, Inc. LUXTURNA voretigene neparvovec Injection 125610 December 19, 2017 11,564,996 2038-03-01
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 11,564,996

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2018160849 ⤷  Get Started Free
United States of America 2023233709 ⤷  Get Started Free
United States of America 2019388561 ⤷  Get Started Free
Russian Federation 2019130004 ⤷  Get Started Free
South Korea 20240104196 ⤷  Get Started Free
South Korea 20230093072 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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