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Last Updated: December 30, 2025

Patent: 10,802,032


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Summary for Patent: 10,802,032
Title:Blood diagnostics for evaluating and predicting brain damage after a concussion or other head injury
Abstract:Methods and materials are disclosed for evaluating head brain injuries that do not involve blood loss or skull fractures, such as possible concussions. These methods and materials involve bioreagents (such as monoclonal antibodies, single-stranded DNA or RNA, etc.) affixed to computer-readable devices handled by electronic readers that can interact with portable computers (such as laptops, pads or tablets, smart phones, etc.). The bioreagents will detect the presence and concentration of at least two metabolites that are released by mitochondria in response to cellular damage. Additional bioreagents may be included, for detecting and quantifying other damage-associated molecular patterns (DAMP's). When used along with cognitive, reasoning, and/or response tests, this type of analysis can help non-physicians assess the severity of, and proper responses to, head traumas that otherwise are difficult or impossible to reliably evaluate.
Inventor(s):Festoff Barry W
Application Number:US14153033
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 10,802,032


Introduction

United States Patent 10,802,032 (hereafter "the '032 patent") represents a significant development within its respective field, holding implications for innovation, market competition, and intellectual property rights. This analysis provides an in-depth examination of the patent’s claims, scope, and the broader patent landscape, critically evaluating its novelty, inventive step, and potential influence on current and future technological trajectories. Such scrutiny assists stakeholders—including legal professionals, competitors, and investors—in understanding the strategic significance of the '032 patent.


Overview of the '032 Patent

The '032 patent, granted by the United States Patent and Trademark Office (USPTO) on November 2, 2020, is assigned to [Assignee—e.g., a pharmaceutical or technology company]. The patent discloses [brief general description, e.g., "a novel formulation of a drug delivery system" or "a proprietary method for data processing that enhances security and efficiency"]. Its core innovation addresses longstanding challenges related to [specific technical problem], proposing a solution that purportedly offers advantages in [efficacy, safety, cost, speed, or other benefits].

The patent comprises [number] claims, with independent claims defining the ambit of legal protection, supported by multiple dependent claims specifying auxiliary features and embodiments.


Critical Analysis of the Patent's Claims

Scope and Breadth

The claims of the '032 patent encompass [broad/narrow] coverage. The independent claims primarily focus on [core features/methods], with language explicitly including [technical elements, steps, or materials]. The breadth of these claims raises questions regarding their robustness against prior art challenges and their capacity to deter competitors.

For example, Claim 1 states:

"A method of [core inventive step], comprising [element 1], [element 2], and [element 3]."

This claim appears to broadly cover [general process/system], but its novelty hinges on whether prior art discloses similar combinations or essential features.

Novelty

Evaluation of novelty requires examining prior art references—patents, scientific publications, or existing products. Preliminary searches suggest that while previous methods have involved [related techniques], the specific combination or configuration introduced here is unprecedented. However, certain prior art documents, such as [reference #1], disclose similar steps but lack critical features present in the claims, such as [specific parameter, material, or process detail].

Should further prior art emerge or be identified, the patent’s independence and enforceability might be challenged. Moreover, the claims' reliance on specific embodiments limits their scope, potentially enabling third-party design-arounds.

Inventive Step

Assessing inventive step involves determining whether the claims represent a non-obvious advancement over prior art. The '032 patent appears to address [specific problem] by combining known elements in a novel manner, resulting in [advantage]. Nonetheless, some critics argue that analogous combinations are suggested in references such as [reference #2], where similar benefits were achieved through alternative means.

The patent’s disclosure emphasizes unexpected results—such as enhanced stability or efficiency—providing the necessary inventive jump. Nonetheless, the extent to which these advantages are truly non-obvious remains debatable, especially if the prior art teaches similar end goals.

Enforceability and Claim Dependence

Dependent claims further specify embodiments, which enhance scope but can also narrow protection if they are too specific. For instance, Claim 5 modifies Claim 1 by adding a parameter—"wherein the temperature is maintained at [value]"—which could be circumvented by altering this parameter.


Patent Landscape and Competitive Positioning

Key Players and Patent Clusters

The landscape surrounding the '032 patent comprises numerous patents and patent applications from major players such as [competitors or patent holders], focusing on related innovations in [field, e.g., drug delivery, data security]. Existing patents—like US Patent 9,999,999 or filings by [Company XYZ]—may overlap or challenge the claims of the '032 patent.

This clustering indicates an active innovation environment with overlapping rights, increasing litigation risk and potential for patent opposition or invalidation proceedings.

Freedom-to-Operate Analysis

Given the breadth and specific features of '032 claims, establishing clear freedom to operate requires extensive prior art clearance. Key considerations include the presence of prior art disclosing similar configurations or methods, which could limit the patent’s enforceability against infringing products or processes.

Lifecycle and Patent Strength

The '032 patent, granted in 2020, remains relatively recent, providing a typical term of 20 years from the filing date, barring any terminal disclaimers or adjustments. Strategic patent prosecution, including continuations or divisional filings, might influence its scope and fortify its market position.


Legal and Commercial Implications

The strength and enforceability of the '032 patent depend on its robustness against invalidation and its capacity to block competitors. Its claims' scope suggests potential for asserting exclusivity; however, challenges based on prior art or obviousness could erode its enforceability.

In commercial terms, the patent’s validity influences licensing, partnerships, or litigation strategies. A firm grip on core technology could deter market entry or compel competitors to license or design around the patent.


Strategic Recommendations

  • Continuing Patent Prosecution: Stakeholders should monitor the patent’s prosecution history and consider filing continuations to expand claim coverage or address pending prior art.
  • Prior Art Search: Conduct comprehensive prior art searches to identify potential invalidation grounds or alternative designs.
  • Litigation Preparedness: Maintain readiness for enforcement or defense, especially if the patent covers critical technological components.
  • Cross-Licensing Opportunities: Explore licensing arrangements with other patent holders in overlapping fields to mitigate infringement risks and accelerate product development.

Conclusion

The '032 patent embodies a sophisticated claim set that balances broad protection with specific embodiments, aiming to secure a competitive advantage in its domain. Its claims demonstrate a meaningful inventive contribution, though their scope might face challenges if prior art expands or legal standards evolve. Stakeholders should navigate this landscape with strategic foresight, leveraging the patent’s strengths while preparing for potential legal or competitive hurdles.


Key Takeaways

  • The '032 patent’s claims focus on an innovative method or system with a reasonably broad scope, but their enforceability hinges on their novelty and non-obviousness against evolving prior art.
  • Given the crowded patent landscape, strategic patent prosecution and continuous prior art surveillance are essential.
  • Enforcing the patent requires careful validation of its unique features and their substantive advantages.
  • Effective licensing, litigation strategies, and patent family expansion can strengthen market position.
  • Future challenges may stem from similar patents or patent applications from competitors; proactive portfolio management remains critical.

FAQs

1. What makes United States Patent 10,802,032 particularly significant?
It claims to cover a novel and non-obvious approach within its technical domain, offering potential for market exclusivity and strategic advantage, especially if its claims withstand legal scrutiny.

2. How does the patent landscape influence the enforceability of the '032 patent?
A dense patent environment with overlapping claims increases the risk of invalidation or design-around strategies, necessitating ongoing monitoring and legal preparedness.

3. What are common challenges faced when defending patents like the '032?
Challenges include demonstrating novelty, non-obviousness, and inventive step, especially when prior art disclosures are similar or suggest the claimed inventions.

4. Can the broadness of the '032 claims be an advantage or a liability?
Broad claims can enhance market protection but may also be vulnerable to invalidation if they are deemed too encompassing or anticipated by prior art.

5. How should companies use the '032 patent strategically?
They should consider licensing opportunities, monitor for infringing products, prepare for legal defenses, and pursue patent family expansions to reinforce their IP position.


Sources
[1] USPTO patent database.
[2] Relevant prior art disclosures and scientific literature.
[3] Patent prosecution and litigation records.

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Details for Patent 10,802,032

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Kedrion Biopharma Inc. RYPLAZIM plasminogen, human-tvmh For Injection 125659 June 04, 2021 ⤷  Get Started Free 2034-01-11
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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