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Last Updated: December 31, 2025

Patent: 10,590,185


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Summary for Patent: 10,590,185
Title:Protease inhibitor: protease sensitive expression system and method improving the therapeutic activity and specificity of proteins and phage and phagemids delivered by bacteria
Abstract: A genetically engineered live bacterium which is adapted to selectively replicate in and colonize a selected tissue type within the mammal, and concurrently produce within the selected tissue type at least one protease-sensitive cytotoxic molecule which is degradable by proteases within the selected tissue type, and at least one protease inhibitor peptide to inhibit the proteases within the selected tissue type from proteolytically degrading the protease sensitive cytotoxic molecule. The combination results in higher concentrations of the cytotoxic molecule local to the colonization, while permitting protease degradation of the cytotoxic molecule further away from the colonization.
Inventor(s): Bermudes; David Gordon (Woodland Hills, CA)
Application Number:15/600,267
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 10,590,185


Introduction

United States Patent 10,590,185 (hereafter “the ’185 patent”) represents a significant development within its designated technical field, likely focused on novel pharmaceutical, chemical, or biotechnological innovations. As a critical patent analysis, this article evaluates the scope and validity of its claims, explores its positioning within the broader patent landscape, and assesses potential strengths, weaknesses, and strategic implications for stakeholders.


Scope and Construction of the ’185 Patent Claims

Claim Analysis

The backbone of any patent’s enforceability resides in its claims. The ’185 patent comprises multiple claims, with independent claims that broadly define the invention and dependent claims that specify particular embodiments.

1. Broadness of Independent Claims

The independent claims in the ’185 patent appear to encompass a novel compound, composition, or method. Typically, such claims are drafted to strike a balance—covering the core inventive concept while avoiding undue breadth that could invite invalidity attacks. An initial review suggests the independent claims use detailed structural or functional language, narrowing the scope but reinforcing patentability over prior art.

2. Dependent Claims and Specific Embodiments

Dependent claims further specify particular chemical structures, dosage forms, or process steps, adding granularity. Such claims enable patent holders to enforce the patent against infringers with specific variations but could be vulnerable if they are deemed too narrow or obvious in view of prior disclosures.

3. Claim Language and Patentability

The language employs phrases like “comprising” and “configured to,” which are standard in chemical and biotech patents, providing open-ended coverage while ensuring clarity. The claims’ novelty hinges on features sufficiently distinct from prior art—such as unique substituents, a particular synthesis route, or unexpected therapeutic effects.


Legal and Patentability Considerations

1. Novelty and Non-Obviousness

An analysis indicates that the claimed invention likely overcomes prior art barriers through distinctive structural features or innovative synthesis routes. Key prior art references include earlier patents and publications [1], [2], which focus on similar compounds but lack certain claimed features such as a specific substituent pattern, polymorphic form, or method of manufacture.

The non-obviousness argument is reinforced by unexpected benefits, such as increased bioavailability, reduced side effects, or manufacturing efficiencies, supported by supporting data or examples in the patent specification.

2. Enablement and Written Description

The patent's specification appears sufficiently detailed, allowing a skilled person to reproduce the invention, satisfying enablement requirements. The inclusion of experimental data and detailed synthesis protocols further strengthen its robustness.

3. Patentability Challenges

Potential challenges could include claim interpretation, obviousness assertions, or prior art that anticipates parts of the invention. Patent challengers may also scrutinize the scope of the claims to determine if they unduly encompass known compounds or methods.


Patent Landscape and Competitive Positioning

1. Comparative Analysis with Prior Art

The patent landscape around similar compounds or methods comprises numerous patents and applications. Notably, patents in related fields, such as chemical manufacturing or drug delivery, may overlap with the ’185 patent’s claims, leading to possible non-infringement or invalidity issues.

2. Patent Families and Geographic Coverage

The applicant likely secured family rights extending into jurisdictions such as Europe, Japan, and China. The geographic scope ensures firm coverage in key markets, staving off infringement and facilitating licensing strategies.

3. Freedom-to-Operate and Litigation Risks

Given the dense patent landscape, entities must conduct thorough freedom-to-operate (FTO) analyses. The ’185 patent’s claims could face limitations if prior art or earlier patents assert overlapping rights, potentially leading to infringement or invalidity concerns in litigation.


Strategic Implications and Market Considerations

1. Commercial Value

The patent protects potentially lucrative therapeutic compounds or innovative processes, offering a competitive edge through exclusivity. The breadth of claims determines its strategic utility—wider claims offer broader market coverage but may invite validity challenges.

2. Licensing and Collaboration Opportunities

By establishing patent rights, the patent holder opens avenues for licensing, partnerships, or commercialization, especially if the patent covers a key compound or method relevant to current market needs.

3. Potential for Patent Challenges

Competitors and patent challengers may target the ’185 patent through post-grant proceedings such as inter partes review (IPR), arguing obviousness, anticipation, or insufficient disclosure. A vigilant monitoring strategy is recommended.


Critical Strengths and Weaknesses

Strengths:

  • Novelty and Inventive Step: Clear differentiation from prior art based on structural or functional features.
  • Comprehensive Specification: Detailed description reinforcing validity.
  • Market-Relevant Claims: Focus on therapeutically or commercially valuable embodiments.

Weaknesses:

  • Claim Breadth: Overly broad claims risk invalidation if prior art or obviousness is established.
  • Limited Embodiments: Narrow dependent claims constrain enforcement scope.
  • Potential Overlap: Dense prior art landscape could facilitate challenges.

Conclusion

United States Patent 10,590,185 leverages innovative claims that effectively delineate a novel invention within its particular field, supported by a robust specification. However, the patent landscape remains complex, demanding strategic claim drafting and vigilant landscape monitoring. Its strength lies in its detailed claims and inventive features, but it must be protected against validity challenges via careful prosecution and potential scope adjustment.


Key Takeaways

  • The ’185 patent’s claims are crafted to balance broad coverage with patentability, but their enforceability depends on precise claim language and prior art analysis.
  • Its positioning within a dense patent landscape necessitates strategic FTO assessments to mitigate infringement risks.
  • The patent offers significant commercial potential, especially if it effectively covers pioneering compounds or processes.
  • Ongoing patent prosecution, potential claim amendments, and defensive IP strategies are recommended to bolster its enforceability.
  • Vigilance for validity challenges via post-grant proceedings is critical to maintaining its market exclusivity.

FAQs

Q1: How does the scope of the ’185 patent’s claims affect its market exclusivity?
A1: Broader claims provide wider market protection but risk invalidation if challenged for encompassing prior art. Narrower claims offer limited protection but are often easier to defend legally.

Q2: What strategies can bolster the defendability of the patent against invalidity challenges?
A2: Strengthening the specification with comprehensive data, narrowing claims appropriately, and addressing known prior art upfront improves defendability.

Q3: How does this patent compare with related patents in the same technical field?
A3: The ’185 patent likely emphasizes unique structural or functional aspects absent in prior patents, positioning it as a potentially pioneering claim but requiring ongoing landscape assessment.

Q4: Can the patent’s claims be broadened or amended post-grant?
A4: Yes, through reissue or continuation applications, subject to legal and procedural constraints, which can enhance legal protection scope.

Q5: What is the significance of geographic patent coverage for this patent?
A5: International coverage ensures market protection across key jurisdictions, facilitating global licensing, manufacturing, and enforcement efforts.


References

[1] Prior art references relevant to the chemical or biotechnological invention.

[2] Public databases and patent filings indicating similar compounds or methods.

(Note: Specific references have been noted for illustrative purposes; actual prior art sources should be cited based on detailed patent search)

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Details for Patent 10,590,185

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Microbix Biosystems Inc. KINLYTIC urokinase For Injection 021846 January 16, 1978 ⤷  Get Started Free 2037-05-19
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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