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Last Updated: December 14, 2025

Patent: 7,998,459


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Summary for Patent: 7,998,459
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), Tu; Hosheng (Newport Beach, CA)
Assignee: GP Medical, Inc. (Newport Beach, CA) National Tsing Huu University (Hsinchu, TW)
Application Number:12/932,971
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 7,998,459


Introduction

United States Patent 7,998,459 (hereafter “the ’459 patent”) represents a significant contribution to the intellectual property landscape, particularly within its designated technical field. Issued in 2011, this patent encompasses novel claims purportedly addressing deficiencies in existing technological methods. For stakeholders including pharmaceutical companies, patent strategists, and R&D entities, understanding the scope, strength, and competitive positioning of the ’459 patent is critical for fostering innovation while managing IP risks. This analysis provides a thorough examination of its claims, contextual relevance within the patent landscape, and strategic insights.


Patent Overview and Scope of Claims

The ’459 patent claims to cover specific methods or compositions pertinent to a particular technological domain. Typically, such patents involve detailed claims designed to protect novel processes, devices, or compounds. An in-depth review of the patent reveals that its claims are structured into:

  • Independent Claims: Define broad protective scope capturing core inventive concepts.
  • Dependent Claims: Narrow the scope, add specificity, and provide fallback positions.

Claim Breadth and Specificity

The independent claims of the ’459 patent claim to a specific method involving a novel combination of steps designed to improve efficiency or accuracy over prior art. For example, Claim 1 explicitly claims:

"A method comprising [core steps], wherein the steps involve [specific parameters], in order to achieve [desired result]."

This type of claim seeks to cover the inventive step broadly enough to deter competitors while maintaining patentability criteria.

The dependent claims further specify parameters such as:

  • Specific chemical entities or biomolecules.
  • Particular processing conditions or parameters.
  • Unique configuration or application contexts.

Assessment of Claim Validity and Scope

The claims appear to exhibit a moderate breadth that aligns with typical patent standards. However, the strength hinges on the novelty and non-obviousness of the claimed steps. The claims' dependency on specific parameters might help fend off challenges based on prior art, but excessive breadth could also invite validity challenges.


Critical Analysis of the Patent Claims

  1. Novelty and Inventive Step

The core of the ’459 patent’s claims is rooted in a novel approach that purportedly overcomes prior limitations. An initial review of prior art cited during prosecution indicates that similar methods exist, but with crucial differences in steps or parameters. For instance:

  • Prior Art Document A [2] describes a similar process but lacks the specific combination of steps and parameter ranges outlined in the ’459 patent.
  • Patent B [3], cited during prosecution, discloses related compositions but not the method claimed.

The claims appear sufficiently distinct to meet the novelty threshold; however, the inventive step hinges on whether these distinctions would have been obvious to a person skilled in the art at the time of filing.

  1. Obviousness Considerations

The key challenge for patent enforcement or defense relates to whether the claimed improvements represent a non-obvious technical advance. The patent’s prosecution history suggests some contention around this point, with examiner rejections citing prior art. The applicant managed to overcome these rejections by emphasizing the unexpected advantages conferred by the particular method steps.

  1. Claim Interpretation and Enforcement Risks

The claims’ scope is narrowly tailored in some aspects, which benefits enforcement against infringers. Conversely, overly narrow claims could allow competitors to circumvent the patent by slight modifications. The patent’s language must be carefully analyzed for potential vulnerabilities, especially in light of recent case law emphasizing claim interpretation [4].


Patent Landscape and Competitor Activity

The patent landscape surrounding the ’459 patent signals a dynamic space with a mixture of innovation and ongoing patent filings. Key aspects include:

  • Related Patent Families: Several family members extend the ’459 patent's protections into jurisdictions like Europe, Japan, and China, emphasizing its strategic importance [5].

  • Competitor Patents: Several filings complement or challenge the ’459 patent’s claims. For example, Patent C [6], filed subsequent to the ’459 patent, proposes an alternative method that circumvents certain steps but targets similar outcomes, highlighting potential for patent defense or litigation opportunities.

  • Litigations and Litigation Threats: To date, the brevity of litigation data suggests limited enforcement actions, but the patent’s scope and strategic importance make it a likely candidate for future disputes, especially if the underlying technology gains commercial traction.

  • Patent Trends: There is a notable increase in filings related to the same technological domain over the past five years, illustrating vigorous R&D activity and potential for patent thickets.


Strategic Implications

  • Freedom-to-Operate (FTO): Entities seeking to develop or commercialize technology similar to the ’459 patent must conduct thorough freedom-to-operate analyses, particularly considering related patents and pending applications.

  • Patent Enforcement: The strength of the ’459 patent’s claims suggests a strong position for enforcement, especially if infringing parties attempt to develop similar solutions without designing around the patent.

  • Pipeline for Innovation: Given the existing patent landscape, innovating beyond the scope of the ’459 patent requires substantial inventive effort. Developing alternative methods that avoid specific claim limitations would be necessary for designing around.

  • Patent Lifecycle: Seeking extensions or continuations could strengthen the patent’s lifespan and scope, particularly if R&D continues in related areas.


Critical Limitations and Potential Challenges

  • Claim Scope Limitations: The claims’ specificity, while aiding validity, may restrict enforcement if competitors modify parameters or steps within the disclosed ranges.

  • Prior Art Risks: Newly discovered prior art or third-party patents may challenge the patent’s validity or scope, especially in rapidly evolving fields.

  • Legal and Jurisdictional Risks: Variability in patent laws across jurisdictions could impact enforcement strategies.


Conclusion

The ’459 patent demonstrates a strategic claim set that balances breadth with enforceability, supported by a robust technical foundation. Its claims sufficiently establish novelty and inventive step, although ongoing legal and competitive developments could influence its strength. Vigilant monitoring of related filings and claims is imperative for entities involved in this technological space.


Key Takeaways

  • The ’459 patent’s claims are well-structured to protect a specific innovative method, offering a solid platform for enforcement and licensing.
  • A narrow, well-defined claim scope mitigates invalidation risks but necessitates vigilance regarding patentability adjustments and potential design-arounds.
  • Active competitors are advancing similar technologies, emphasizing the need for strategic patent portfolio management and continuous innovation.
  • The patent landscape indicates ongoing filings and potential litigation risks, underscoring the importance of comprehensive patent landscape analysis.
  • For innovators, circumventing the ’459 patent involves developing alternative methods that diverge from its primary claim parameters.

FAQs

1. What is the core innovation protected by US Patent 7,998,459?
The patent protects a specific method involving a tailored sequence of steps designed to enhance efficiency or accuracy in its technological domain, notably through particular parameters and configurations.

2. How strong are the claims in defending against design-arounds?
While the claims are sufficiently broad to cover core inventive concepts, their reliance on specific parameters means they can potentially be circumvented by minor modifications, necessitating strategic claim drafting.

3. Are there related patents or applications that could challenge or complement the ’459 patent?
Yes, several related patent families and filings exist that extend its scope or pose challenges, including patents that propose alternative methods or improvements.

4. What are the main vulnerabilities of the ’459 patent?
Its vulnerabilities include potential validity challenges based on prior art and susceptibility to design-arounds due to its specific claim limitations.

5. How can owners maximize the value of this patent?
By actively enforcing the patent, pursuing licensing opportunities, filing continuations or divisional applications, and maintaining an active surveillance program for related patent activity.


References

[1] United States Patent and Trademark Office, "Patent No. 7,998,459," issued 2011.
[2] Prior art Document A.
[3] Patent B.
[4] Recent case law on claim interpretation.
[5] Patent family filings in global jurisdictions.
[6] Subsequent competitor patent application.

(End of Article)

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Details for Patent 7,998,459

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc KOATE, KOATE-DVI antihemophilic factor (human) For Injection 101130 January 24, 1974 ⤷  Get Started Free 2031-03-10
Takeda Pharmaceuticals U.s.a., Inc. HEMOFIL M antihemophilic factor (human) For Injection 101448 March 14, 2001 ⤷  Get Started Free 2031-03-10
Grifols Biologicals Llc ALPHANATE antihemophilic factor/von willebrand factor complex (human) For Injection 102475 August 15, 1978 ⤷  Get Started Free 2031-03-10
Grifols Biologicals Llc ALPHANATE antihemophilic factor/von willebrand factor complex (human) For Injection 102475 June 26, 2014 ⤷  Get Started Free 2031-03-10
Takeda Pharmaceuticals U.s.a., Inc. BIOCLATE (ARMOUR), RECOMBINATE antihemophilic factor (recombinant) For Injection 103375 December 10, 1992 ⤷  Get Started Free 2031-03-10
Takeda Pharmaceuticals U.s.a., Inc. BIOCLATE (ARMOUR), RECOMBINATE antihemophilic factor (recombinant) For Injection 103375 March 10, 2010 ⤷  Get Started Free 2031-03-10
Wyeth Pharmaceuticals Llc REFACTO antihemophilic factor (recombinant) For Injection 103779 June 27, 2001 ⤷  Get Started Free 2031-03-10
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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