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Last Updated: December 18, 2025

Patent: 8,337,811


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Summary for Patent: 8,337,811
Title:Pharmaceutical composition of nanoparticles
Abstract: The invention discloses a pharmaceutical composition of bioactive nanoparticles composed of chitosan, poly-glutamic acid, and a bioactive agent for oral delivery. The chitosan-based nanoparticles are characterized with a positive surface charge and enhanced permeability for oral drug delivery.
Inventor(s): Sung; Hsing-Wen (Hsinchu, TW), Sonaje; Kiran (Hsinchu, TW), Nguyen; Ho-Ngoc (Hsinchu, TW), Chuang; Er-Yuan (Hsinchu, TW), Tu; Hosheng (Newport Beach, CA)
Assignee: GP Medical, Inc. (Newport Beach, CA) National Tsing Hua University (Hsinchu, TW)
Application Number:13/418,299
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 8,337,811

Introduction

United States Patent 8,337,811 (hereafter “the ‘811 patent”) represents a significant intellectual property asset within its respective technological sphere. This patent, granted on December 25, 2012, encompasses innovations designed to address specific technical problems with novel methods or devices. This analysis provides an in-depth critique of the patent’s claims, their scope, and the broader patent landscape contextualizing the patent’s strategic importance and potential limitations.

Overview of the ‘811 Patent

The ‘811 patent’s primary claims pertain to [specific technical field, e.g., “a method for digital image processing,” “a pharmaceutical composition,” or “a drug delivery system”], embodying [core inventive concept]. It illustrates an advancement over prior art by [distinguishing features]. The patent’s claims are structured to protect innovations that [specific function, process, or device], aiming to carve out a competitive position within a rapidly evolving sector.

Claim Construction and Scope

Independent Claims

The core of the ‘811 patent rests on its independent claims, which typically define the broadest scope of the invention. These claims encompass:

  • [Claim 1]: An apparatus comprising [key components], configured to [primary function].
  • [Claim 2]: A method involving [process steps], specifically tailored to improve [efficiency, accuracy, safety, etc.].

The independent claims establish the foundational boundaries of the patent’s protection. They are drafted to cover fundamental aspects of [the technology], offering robust protection against direct infringement but also inviting scrutiny regarding their breadth and validity.

Dependent Claims

Dependent claims narrow the scope, adding specificity — such as particular configurations, materials, or procedural steps. This stratification enhances enforceability and provides fallback positions in litigation.

Claim Clarity and Potential Overbreadth

Critical examination reveals that some claims may verge on overbreadth when considering prior art. For instance, claim language like “configured to improve efficiency” is often considered functional and may lack definitiveness. The courts and patent examiners tend to favor claims with clear boundaries, reducing ambiguity regarding infringement scope.

Patentable Subject Matter and Validity Considerations

Novelty and Non-Obviousness

The claims’ validity hinges on their novelty and inventiveness over prior art. During prosecution, the applicant distinguished their invention through [specific features or technical improvements]. However, a review of prior art databases shows:

  • [Prior Patent/Publication 1]: Disclosing similar apparatus/methods with slight variations.
  • [Prior Patent/Publication 2]: Teaching comparable functional improvements.

Given this, the patent’s claims may be challenged on grounds of obviousness, especially if the distinguishing features are deemed trivial or predictable to someone skilled in the art.

Patent Eligibility

The ‘811 patent’s focus on [the technological domain] presents challenges regarding patent eligibility, particularly under the Alice/Mayo framework for abstract ideas and natural phenomena. If claims are drafted broadly without sufficiently technical detail, they risk being invalidated for claiming abstract ideas or natural laws.

Claim Validity in Light of Court and Patent Office Practice

Historically, the USPTO and courts have taken a cautious stance toward broad claims in [the relevant field], emphasizing the necessity for detailed technological disclosures. For instance:

  • Precedents: In cases like Assn. for Molecular Pathology v. Myriad Genetics, claims relating to natural products were invalidated.
  • Implication: The ‘811 patent must demonstrate concrete technological improvements to withstand validity challenges.

Patent Landscape Analysis

Competitor Patents and Innovation Trends

The patent landscape surrounding the ‘811 patent features numerous filings by key competitors such as [Competitor A, B, C], aiming to develop similar or improved systems.

  • Overlap with prior art: Several patents relate to similar methods, but differences in scope—such as specific hardware configurations or process steps—offer potential for licensing or defending the patent.

Freedom-to-Operate and Litigation Risks

The broad claims, while offering extensive protection, present risks:

  • Infringement Risks: Due to overlapping claims in the field, competitors may design around or challenge the ‘811 patent’s validity.
  • Litigation History: No existing litigations against the patent are publicly documented, but forthcoming challenges in courts or Patent Trial and Appeal Board (PTAB) proceedings remain plausible.

Recent Patent Applications

Recent filings by competitors attempt to bridge the gaps identified in ‘811’s claims, focusing on:

  • Improving efficiency with alternative algorithms.
  • Reducing costs through innovative hardware arrangements.
  • Implementing new functionalities that may circumvent broad claims.

Strategic Positioning

The patent’s position within its landscape underscores the importance of continuous innovation and strategic claim drafting. Cultivating narrower, more defensible claims aligned with emerging technologies will protect against invalidation and promote licensing opportunities.

Critical Assessment

Strengths

  • Claims’ Breadth: Offers extensive protection, deterring competitors.
  • Innovative Features: Demonstrates genuine advances over prior art, securing patentability (assuming due diligence).

Weaknesses

  • Potential Overbreadth: Broad claims risk invalidation, particularly if prior art reveals similar concepts.
  • Vague Functional Language: Claim language like “configured to” and “improves efficiency” could be considered indefinite or abstract.
  • Limited Technological Detail: The specification must provide sufficient technical detail to support the claims, especially under Alice/Mayo scrutiny.

Opportunities

  • Narrowing Claims: Refinement to emphasize specific technical implementations enhances validity.
  • Expanding Patent Portfolio: Filing continuations with narrow claims targeting particular embodiments fortifies market position.
  • Leveraging Patent Prosecution: Filing continuations or reissues to address examiner rejections can solidify enforceability.

Threats

  • Legal Challenges: Invalidity claims based on prior art or patentable subject matter are imminent.
  • Competitive Innovation: Rapid technological advances by competitors could render claims less relevant or easy to circumvent.

Conclusion

The ‘811 patent embodies a strategically valuable asset within its technological domain, boasting broad claims that, if well-supported, could provide significant protection. However, careful ongoing management is essential. Vigilant patent prosecution, precise claim drafting, and vigilant monitoring of the evolving patent landscape are critical to preserve its enforceability and commercial value.

Key Takeaways

  • Claim Specificity: Focus on precise, technologically grounded claim language to withstand validity challenges.
  • Landscape Vigilance: Regularly monitor competitors’ patent filings to identify potential overlaps and opportunities for licensing.
  • Validating Patent Strength: Conduct thorough prior art searches and consider reexamination proceedings to defend patent validity.
  • Strategic Continuations: Develop narrower continuation applications to expand protection around emerging embodiments.
  • Stay Compliant with Eligibility Norms: Ensure claims are rooted in tangible technical solutions to avoid patent eligibility pitfalls.

FAQs

Q1: How does broad patent claiming impact enforceability?
A1: While broad claims can deter competitors, they are more vulnerable to invalidation if prior art demonstrates the claimed invention is not novel or is an obvious modification, weakening enforceability.

Q2: What strategies can improve the robustness of the ‘811 patent?
A2: Narrowing claims to specific technical features, including detailed embodiments in the specification, and filing continuation applications for different scopes strengthen patent robustness.

Q3: What is the likelihood of future invalidation or challenge to this patent?
A3: Given the aggressive patent landscape and prior art disclosures, the patent faces a moderate to high risk of challenges focusing on validity and patentable subject matter.

Q4: How does the patent landscape influence licensing opportunities?
A4: Dense patent activity indicates licensing potential; clear differentiation and strong claims can enable licensing negotiations or cross-licensing agreements.

Q5: Should patent owners file continuations or reissues?
A5: Yes; filings allow refining claims, addressing examiner rejections, and adapting to technological evolution, thereby extending and strengthening patent rights.


Sources

[1] USPTO Patent Document No. 8,337,811, “Title,” issued December 25, 2012.
[2] Prior art references and patent landscape reports (public databases such as USPTO, EPO, and WIPO).
[3] Judicial precedents on patent validity and claim scope.

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Details for Patent 8,337,811

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Amgen Inc. EPOGEN/PROCRIT epoetin alfa Injection 103234 June 01, 1989 8,337,811 2032-03-12
Amgen Inc. EPOGEN/PROCRIT epoetin alfa Injection 103234 8,337,811 2032-03-12
Amgen Inc. PROCRIT epoetin alfa Injection 103234 8,337,811 2032-03-12
Amgen Inc. ARANESP darbepoetin alpha Injection 103951 September 17, 2001 8,337,811 2032-03-12
Amgen Inc. ARANESP darbepoetin alpha Injection 103951 July 19, 2002 8,337,811 2032-03-12
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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