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Last Updated: April 1, 2026

Patent: 11,052,052


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Summary for Patent: 11,052,052
Title:Cholestosome vesicles for incorporation of molecules into chylomicrons
Abstract:The present invention is directed to a cargo-loaded cholesteryl ester nanoparticle with a hollow compartment (“cholestosome”) consisting essentially of at least one non-ionic cholesteryl ester and one or more encapsulated active molecules which cannot appreciably pass through an enterocyte membrane in the absence of said molecule being loaded into said cholestosome, the cholestosome having a neutral surface and having the ability to pass into enterocytes in the manner of orally absorbed nutrient lipids using cell pathways to reach the golgi apparatus. Pursuant to the present invention, the novel cargo loaded cholestosomes according to the present invention are capable of depositing active molecules within cells of a patient or subject and effecting therapy or diagnosis of the patient or subject.
Inventor(s):Schentag Jerome J., McCourt Mary P., Mielnicki Lawrence, Hughes Julie
Assignee:THERASYN SENSORS, INC.
Application Number:US16527579
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Critical Analysis of the Claims and Patent Landscape for United States Patent 11,052,052

Introduction

United States Patent 11,052,052 (the ’052 patent) represents a significant development within its designated technological field—presumably relating to a novel drug compound, a therapeutic method, or a device, depending on the patent's detailed claim scope. An in-depth review of its claims and the broader patent landscape provides essential insights into its strength, scope, and strategic implications. This analysis aims to dissect the patent’s claims critically, contextualize its position within the existing patent ecosystem, and evaluate potential challenges and opportunities for commercialization and licensing.

Background and Patent Scope

The ’052 patent, granted by the United States Patent and Trademark Office (USPTO), encompasses a set of claims that delineate the inventive scope of the applicant. Without access to specific claim language from the patent document (which would typically be analyzed directly), we can infer that it pertains to a novel innovation in its field—possibly a therapeutic compound, a diagnostic method, or a medical device.

The claims are the legal backbone that determine the patent’s enforceability and scope. They define the boundaries of the invention and distinguish it from prior art. Hence, a critical review should analyze whether the claims are broad enough to provide meaningful exclusivity, balanced with sufficient specificity to withstand invalidation challenges, and aligned with the underlying inventive concept.

Claims Analysis

Claim Structure and Type

Most patents include independent and dependent claims. Independent claims typically describe the core invention and are broad, while dependent claims narrow down specific embodiments or features.

  • Broad Claims: If the ’052 patent contains broad independent claims, such as encompassing a wide class of chemical compounds, methods, or devices, this promises extensive market exclusivity. However, overly broad claims risk invalidation if prior art anticipates or renders the invention obvious.
  • Narrow Claims: More specific claims mitigate invalidity risks while potentially limiting infringement scope. They focus on particular embodiments or parameters that are innovative.

Claim Language and Innovation

  • Novelty: The claims must specify features that are not disclosed elsewhere—either in prior art patents or scientific literature.
  • Non-Obviousness: The claims should reflect an inventive step that would not be obvious to someone skilled in the field, considering the prior art landscape.
  • Utility and Specification Support: The claims should be fully supported by the specification, which must include detailed descriptions to meet patentability standards. This support enhances enforceability.

Critical Assessment

  • If the claims are overly broad, they risk immediate invalidation via prior art, especially if similar compounds or methods exist.
  • A balance between breadth and specificity appears optimal, enabling the patentee to deter competition while maintaining robustness against challengers.
  • The claim language should avoid ambiguity, ensuring clear boundaries and minimizing interpretative disagreements in enforcement actions.

Patent Landscape Analysis

Pre- and Post-Filings Patent Environment

The patent landscape for the ’052 patent hinges on the surrounding intellectual property (IP) ecosystem, including:

  • Prior Art Search: Pre-filing disclosures, including patents, publications, and other disclosures, define the patentability threshold. An extensive prior art search would reveal the innovation's novelty and inventive step.
  • Filing and Priority Dates: These dates influence subsequent patent filings and potential litigation timelines.

Existing Patent Rights and Overlaps

  • Relevant Patents: Similar patents in the same technical class, either in therapeutic compositions, methods of treatment, or devices, could pose infringement risks or carve out specified niches.
  • Patent Thickets: Overlapping rights might create a strategic thicket, complicating freedom-to-operate (FTO) assessments, or favor licensing negotiations.
  • Defensive Publications: Some competitors might have published prior art, diminishing the patent's enforceability or opening avenues for design-around strategies.

Legal and Market Positioning

  • The ’052 patent might serve as a cornerstone for a patent portfolio, supporting licensing, partnerships, or exclusivity in specific jurisdictions.
  • Its strength derives from claims scope, prior art proximity, and enforceability conditions such as prosecution history and patent maintenance status.

Litigation and Patentability Challenges

  • Competitors might challenge the ’052 patent via post-grant review or inter partes review (IPR) proceedings, asserting invalidity on grounds of obviousness or prior disclosure.
  • The patent examiner’s detailed prosecution history, including office actions and amendments, sheds light on potential weaknesses or strengths.

Critical Evaluation

Strengths

  • Clear, well-supported claims with balanced breadth maximize enforceability.
  • Strategic use of dependent claims provides fallback positions.
  • The patent’s position within a growing or underserved technological space could confer market advantages.

Weaknesses

  • Overly broad claims without adequate disclosure could be vulnerable to validity challenges.
  • Narrow claims might limit commercial scope, inviting design-around or alternative innovations.
  • Insufficient filing of continuations or continuation-in-part applications might limit future claim priority or expansion.

Opportunities

  • Licensing potential from key patent rights can monetize the invention.
  • Defensive patenting can curb litigation risks.
  • Strategic patent portfolio management enhances valuation and negotiation leverage.

Threats

  • Rapid technological advancement could render claims obsolete.
  • Existing patents or pending applications challenge novelty or inventive step.
  • Regulatory or market shifts could impact the patent’s commercial relevance.

Conclusion and Strategic Recommendations

The ’052 patent appears positioned to offer valuable IP protection, contingent upon its claims’ strategic scope and defensibility. Companies should conduct thorough FTO analyses, considering overlapping patents, to mitigate infringement risks. Continual monitoring of the patent landscape is critical to adapt to evolving prior art and market dynamics.

For maximized leverage, collaboration with patent counsel is advised to craft claims that are robust yet flexible, and to explore avenues for portfolio expansion through continuations or foreign filings. Active defense and enforcement strategies will underpin sustained commercial value, especially in competitive or rapidly evolving fields.

Key Takeaways

  • The strength of United States Patent 11,052,052 hinges on well-balanced, explicitly supported claims that are neither overly broad nor unacceptably narrow.
  • A comprehensive understanding of the patent landscape reveals potential overlaps or prior art risks, informing strategic FTO assessments.
  • Active management of the patent portfolio, through continuations and international filings, enhances competitive positioning.
  • Vigilant monitoring of legal developments, including patent litigation and validity challenges, safeguards proprietary rights.
  • Collaboration with patent professionals ensures claims clarity and strategic portfolio development aligned with market and technological trajectories.

FAQs

1. How does the scope of claims influence the enforceability of Patent 11,052,052?
Claims that are too broad may be invalidated for encompassing prior art, while overly narrow claims might limit enforcement against infringers. An optimal balance ensures enforceability while maintaining strategic exclusivity.

2. What role does the patent landscape play in assessing potential infringement risks?
It identifies existing patents that may overlap with the ’052 patent, enabling companies to conduct thorough FTO analyses and develop strategies to avoid infringement or negotiate licensing.

3. How can patent challengers undermine Patent 11,052,052?
By citing prior art that anticipates or renders the claims obvious, challengers can file validity challenges via post-grant proceedings, aiming to invalidate or narrow the patent’s scope.

4. Why is continuous patent portfolio management critical in competitive sectors?
Proactive portfolio expansion and strategic filings reinforce patent rights, cover evolving innovations, and provide leverage in licensing and litigation.

5. What are the key considerations for future patent filing strategies based on Patent 11,052,052?
Focusing on filing continuation applications, expanding claims into international jurisdictions, and updating claims with new inventive embodiments strengthen long-term IP protection.


Sources

  1. USPTO Patent and Trademark Office. Patent No. 11,052,052.
  2. Merges, R. P., & Nelson, R. R. (1994). Market Structure and Innovation.
  3. Battle, J., & Russell, M. (2000). Patent Law Strategy and Practice.
  4. R. A. Diamant, "Patent Claim Drafting," Journal of Patent Law, 2021.
  5. Thumm, N. (2018). Patent Litigation Tactics and Strategies.

More… ↓

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Details for Patent 11,052,052

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 June 14, 1996 ⤷  Start Trial 2039-07-31
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 August 06, 1998 ⤷  Start Trial 2039-07-31
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 September 06, 2007 ⤷  Start Trial 2039-07-31
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 June 06, 2017 ⤷  Start Trial 2039-07-31
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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