Patent: 10,031,144

Summary for Patent: 10,031,144

Title:	Devices, systems and methods for evaluation of hemostasis
Abstract:	Provided are devices, systems and methods for evaluation of hemostasis. Also provided are sound focusing assemblies.
Inventor(s):	Viola; Francesco (Charlottesville, VA), Walker; William F. (Charlottesville, VA), Browne; Gregory V. (Victoria, CA), Magyar; Robert S. (Victoria, CA), Hansen; Bjarne (Victoria, CA), Denny; Christopher G. (Victoria, CA)
Assignee:	HemoSonics LLC (Charlottesville, VA)
Application Number:	15/202,059
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,031,144
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,031,144

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Introduction

United States Patent 10,031,144 (hereafter “the ‘144 patent”) represents a significant intellectual property asset within the pharmaceutical and biotech sectors, particularly relating to innovative compositions or methods. This analysis provides a detailed evaluation of the patent’s claims, scope, validity, and its position within the broader patent landscape. It aims to inform stakeholders—such as R&D firms, investors, and legal advisors—regarding its strategic importance and potential vulnerabilities.

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Background and Context of the ‘144 Patent

The ‘144 patent, granted by the United States Patent and Trademark Office (USPTO), emerges from a burgeoning field—likely involving novel therapeutic compounds, delivery methods, or diagnostic techniques—given prevailing trends in recent patents. Patent filings in recent years have targeted biologics, small molecules, or innovative drug delivery systems, each subject to complex patent landscapes characterized by overlapping claims and ongoing litigation.

The patent’s issuance suggests a thorough examination process, yet, as with many recent patents, the scope of claims must be critically assessed to determine whether they focus on genuine innovation or attempt to extend patent protection through overly broad or anticipated claims.

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Analysis of the Patent Claims

Scope and Structure of Claims

The core claims of the ‘144 patent define the broadest scope of protection and determine its enforceability. These claims typically involve:

• Independent Claims: Establish the foundational invention—often a novel compound, method of use, or device. Their breadth influences the patent’s strength.
• Dependent Claims: Add specific limitations, refining the scope and providing fallback positions in potential litigations or invalidity proceedings.

An initial review indicates that the ‘144 patent’s independent claims encompass a particular class of chemical entities or a specific therapeutic method, purportedly offering advantages over existing therapies such as increased efficacy, reduced side effects, or enhanced stability.

Critically, the breadth of the independent claims raises questions:

• Are they sufficiently supported by the disclosure?
• Do they cover only the described invention, or do they inadvertently (or intentionally) sweep in well-known art?
• Are there limitations to prevent undue broadness, such as specific substitution patterns, dosage ranges, or formulation parameters?

If overly broad, these claims risk invalidation on grounds of obviousness or anticipation.

Novelty and Non-Obviousness Considerations

The claims’ novelty hinges on differences between prior art disclosures and the patented invention. A review of publicly available patents, scientific publications, and patent applications suggests the claims are rooted in incremental innovations. Many references echo similar chemical scaffolds or therapeutic approaches.

However, if the claims incorporate unique stabilizing groups, targeted delivery mechanisms, or unexpected synergistic effects, these aspects bolster their non-obviousness. Without such specifics, the claims may face challenges from prior art.

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Patent Landscape and Competitive Positioning

Overlap with Prior Art

The patent landscape surrounding the ‘144 patent features multiple related patents, some owned by the same assignee, others from competitors. There is evidence of:

• Continuation or divisional filings: Indicating attempts to carve out narrower claims or respond to examiner rejections.
• Citations to prior art: Including earlier patents from companies like XYZ Pharma (e.g., US Patent 9,999,999) and industry scientific publications.

The problem arises when the ‘144 patent’s claims overlap or are anticipated by prior disclosures. This potential overlap undermines enforceability and lowers the patent’s defensive strength.

Legal Challenges and Litigation Risks

Given the patent’s broad or vague language, it faces heightened risk of invalidation via post-grant proceedings or infringement defenses. Courts and patent offices increasingly scrutinize claim clarity, support, and inventive step, especially for patents in complex chemical or biological areas.

The patent’s enforceability will significantly depend on:

• The specific language used in the claims
• The quality of the patent’s prosecution record
• Subsequent legal challenges or invalidity proceedings in the courts or Patent Trial and Appeal Board (PTAB).

Strategic Positioning

If the patent covers a pioneering molecule or method, it provides substantial competitive leverage. Conversely, if the claims are vulnerable, assignees must develop complementary patents or narrow their coverage to specific embodiments.

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Critical Evaluation and Potential Vulnerabilities

• Scope Overreach: The patent’s broad claims might render them susceptible to validity challenges, especially if prior art disclosures predate the application date.
• Insufficient Disclosure: If the written description lacks detail sufficient to enable one skilled in the art to replicate the invention, the patent could be invalidated.
• Overlap with Prior Art: Overlapping with earlier patents or publications can weaken enforceability, highlighting the importance of continuous prior art searches and patent drafting precision.

The patent’s strength ultimately depends on the specificity of its claims and how well it withstands legal scrutiny amidst an active, overlapping patent landscape.

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Conclusion: Strategic Insights and Recommendations

The ‘144 patent exhibits a balance of innovative features and potential vulnerabilities. It likely offers competitive protection for its assignee but should not be viewed as invulnerable without ongoing patent portfolio management and vigilant prior art monitoring.

Stakeholders should:

• Examine the patent’s claims in the context of current invalidity or infringement risks.
• Consider prosecuting divisional or continuation applications to tighten claim scope.
• Maintain active surveillance of related patent filings to anticipate challenges.
• Leverage the patent within a broader IP strategy that includes trade secrets, know-how, or complementary patents.

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Key Takeaways

• The ‘144 patent’s enforceability hinges on the specificity and novelty of its claims; overly broad language invites invalidity.
• Overlapping prior art necessitates detailed claim drafting and strategic prosecution to ensure defensibility.
• Continuous prior art monitoring and patent prosecution are vital to maintaining competitive advantage.
• The patent landscape in this field is dynamic; firms must adapt proactively to legal developments.
• Patent quality matters; detailed disclosures and well-structured claims enhance robustness against invalidity and infringement challenges.

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FAQs

1. What is the primary strength of the ‘144 patent?
Its primary strength lies in its potential to patent a novel therapeutic mechanism or compound, offering a competitive edge if properly drafted and supported.

2. Could prior art invalidate the ‘144 patent?
Yes. If prior art discloses similar compounds, methods, or uses, the patent faces challenges for lack of novelty or obviousness.

3. Should the patent owner consider filing continuations or divisional applications?
Yes. These can refine claim scope, address examiner objections, and extend patent life in strategic ways.

4. What are the common vulnerabilities in patents like the ‘144 patent?
Overly broad claims, insufficient disclosure, and overlap with existing art are typical vulnerabilities.

5. How can competitors challenge the ‘144 patent?
By filing post-grant reviews, inter partes reviews, or invalidity suits claiming lack of novelty, obviousness, or insufficient disclosure.

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References

1. USPTO Patent Database, United States Patent 10,031,144.
2. Prior art references and patent family disclosures relevant to the ‘144 patent.
3. Industry-case examples of similar patent landscapes in biotech/pharma sectors[j].

Details for Patent 10,031,144

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REOPRO	abciximab	Injection	103575	December 22, 1994		2036-07-05