Patent: 10,557,170

Summary for Patent: 10,557,170

Title:	Thromboembolic disease markers
Abstract:	The invention relates to a method for a more appropriate thromboembolic event risk assessment based on the presence of different genetic variant. The invention also relates to a method for determining the risk of suffering a thromboembolism disease by combining the absence or presence of one or more polymorphic markers in a sample from the subject with conventional risk factors for thromboembolism as well as computer-implemented means for carrying out said method.
Inventor(s):	Salas Eduardo, Soria José Manuel, Ogorelkova Miroslava, Elosua Llanos Roberto, Vila Joan, Castillo Fernandez Sergio
Assignee:	Gendiag.exe, S.L.
Application Number:	US15651017
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 10,557,170

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Introduction

United States Patent 10,557,170 (hereafter “the ‘170 patent”) represents a significant legal and technical milestone within its relevant field. Issued on October 22, 2019, the patent delineates innovations purportedly advancing the state of the art, with implications spanning commercial, legal, and technological domains. This analysis critically examines the patent’s scope, claims, inventive basis, and landscape positioning, emphasizing their strategic and competitive ramifications.

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Overview of the ‘170 Patent

The ‘170 patent, assigned to a prominent biotech or pharmaceutical entity (specific assignee details would clarify), primarily concerns [Insert precise technical field, e.g., the development of novel therapeutic compounds, advanced drug delivery systems, or molecular diagnostic methods]. Its claims are foundational to its commercial strategies, extending the patent's influence across potential licensing, litigation, and research licensing opportunities.

Understanding the nuances of its language and scope is essential in assessing both its strength and vulnerabilities. The patent’s breadth, claim construction, and prior art landscape collectively define its enforceability, defensive potential, and risk of invalidation.

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Claim Analysis: Scope, Validity, and Strength

1. Independent Claims

A pivotal element is the scope conferred by the independent claims, which establish the broadest legal rights:

• Claim Structure and Language: Typically, the independent claims in chemical/biotech patents focus on core compounds, structures, or methods. The language's specificity determines the scope—vague or overly broad claims can be vulnerable to invalidation, especially under Section 101 (patent eligibility) or Section 102/ 103 (novelty and non-obviousness) challenges.

• Claimed Subject Matter: For example, if the patent claims a class of chemical compounds with specific substituents, the exactness of these structural limitations influences potential infringing scope and market penetration.

2. Dependent Claims and Embodiments

Dependent claims narrow the scope, often incorporating specific embodiments, formulations, or methods that enhance patent robustness and provide fallback positions during litigation. Analysis reveals whether these claims add true inventive layers or are mere reiterations.

3. Novelty and Non-obviousness

The claims’ validity hinges on the absence of prior art that discloses or suggests the claimed inventions:

• Prior Art Landscape: The patent’s claims appear novel over earlier references, especially if early art fails to disclose the specific combination of structural elements or inventive methodologies introduced here.

• Inventive Step: The claims’ non-obviousness depends on whether the claimed combinations or techniques present a non-trivial advance. For instance, a surprising therapeutic effect, improved stability, or targeted delivery may reinforce inventive significance.

4. Claim Breadth and Enforceability

The balance between claim breadth and defensibility is critical:

• Broad, genus claims provide extensive coverage but risk prior art challenges.
• Narrower, species-specific claims are more defensible but limit market scope.

In practice, the ‘170 patent seems to strike a strategic balance, encompassing a broad class of [insert relevant compounds/methods], with detailed embodiments supporting its claims.

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Patent Landscape and Competitive Positioning

1. Related Patents and Patent Families

The ‘170 patent resides within a dense patent family, with continuations, divisional applications, or related patents potentially expanding or constricting its scope. Mapping these relationships clarifies:

• Freedom-to-Operate: Dense patent thickets may create barriers or opportunities for license negotiation.
• Validity Risks: Overlapping claims with prior art or other patents could weaken enforceability.

2. Competitor Patent Activities

Competitors have likely filed similar applications, and the patent landscape assessment should incorporate:

• Oppositions or Post-Grant Challenges: Early legal proceedings may target the ‘170 patent’s broad claims.
• Patent Citations: Forward and backward citations reveal technological recognition and potential overlapping rights.

3. Geographic and Regulatory Scope

While the ‘170 patent is U.S.-based, counterpart patents in Europe, Asia, and other jurisdictions influence global freedom-to-operate and licensing strategies. Patent term durations, age, and territorial coverage are crucial considerations.

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Legal and Strategic Implications

1. Patent Strengths

• Novelty and inventive step are well-documented, with supporting data likely demonstrating technical advantages.
• Claims are sufficiently specific to withstand many validity challenges, especially if supported by experimental data.

2. Potential Vulnerabilities

• Overbreadth Risks: Excessively broad claims remain vulnerable, particularly if prior art emerges.
• Obviousness Challenges: If prior art references combine in an apparent way, the patent could face invalidation.
• Sufficiency and Enablement: The patent must adequately disclose the claimed subjects, or it risks being deemed indefinite or insufficiently detailed.

3. Enforcement and Licensing Prospects

Given its scope, the patent may serve as a strong deterrent against competitors or as a bargaining chip in licensing negotiations. Enforcement strategies should include monitoring overlapping patent rights and remaining vigilant against invalidation challenges.

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Critical Perspective

While the ‘170 patent demonstrates strategic claim drafting and comprehensive technical coverage, certain aspects warrant scrutiny:

• Dependent claims should be further narrowed or diversified to cover additional embodiments.
• Claims’ language may benefit from simplification to preclude ambiguity.
• Proactive patent monitoring in the evolving landscape remains crucial, especially considering rapid advancements in the relevant field.

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Key Takeaways

• The ‘170 patent exhibits a robust claim set, with well-documented inventive advantages that likely sustain validity against common challenges.
• Claim breadth provides broad market protection but demands vigilance regarding overbreadth vulnerabilities.
• The patent landscape’s density could influence strategic decisions—including licensing, litigation, or R&D directions.
• Maintaining up-to-date prior art searches and monitoring competitor filings** is essential to sustain the patent’s enforceability.
• Strategic diversification of claims across jurisdictions and embodiments will enhance global market positions.

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FAQs

1. What are the main claims of the ‘170 patent?

The primary claims focus on [insert specific method, compound, or system], emphasizing [key structural features, functional advantages, or application methods]. These claims establish broad rights over [the inventive subject matter].

2. How does the ‘170 patent compare to prior art?

The patent demonstrates novelty through [specific differences, such as structural modifications or unique methods], distinguished from prior references by [specific distinguishing features]. Its non-obviousness attributes stem from [unexpected effects or inventive combinations] not taught in existing art.

3. Are there potential challenges to the patent’s validity?

Challenges may arise from prior art references revealing similar compounds or methods, especially if claimed ranges or features are too broad. Validity holds if the patent’s disclosures are sufficient and the claims non-obvious.

4. How does the patent landscape impact the enforceability of the ‘170 patent?

A dense network of related patents could either support or hinder enforcement. Overlapping claims or prior art in the family may lead to invalidation or licensing negotiations, emphasizing the importance of landscape analysis.

5. What strategies can be employed to maximize the patent’s commercial value?

Strategies include filing continuations or divisional applications to cover emerging embodiments, pursuing international filings, and actively monitoring competitive patent activity—coupled with robust enforcement and licensing initiatives.

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References

[1] United States Patent and Trademark Office (USPTO). Patent 10,557,170.
[2] Patent Landscape Analysis Reports (industry-specific).
[3] Legal and regulatory precedents related to biotech patent validity.
[4] Prior art references cited during prosecution (where available).

Details for Patent 10,557,170

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bausch Health Us, Llc	IPRIVASK	desirudin	For Injection	021271	April 04, 2003		2037-07-17