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Last Updated: December 16, 2025

Patent: 9,969,793


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Summary for Patent: 9,969,793
Title:Compositions and methods for the treatment of immunodeficiency
Abstract: The present invention relates to compositions and methods for the treatment of immunodeficiency (e.g., primary immunodeficiency disease). In particular, the invention provides human plasma immunoglobulin compositions containing select antibody titers specific for a plurality of respiratory pathogens, methods of identifying human donors and donor samples for use in the compositions, methods of manufacturing the compositions, and methods of utilizing the compositions (e.g., for prophylactic administration and/or therapeutic treatment (e.g., passive immunization (e.g., immune-prophylaxis))).
Inventor(s): Grossman; Adam S. (Saddle River, NJ), Mond; James (Silver Spring, MD), Grossman; Jerrold B. (Saddle River, NJ), Goldstein; Dov A. (New York, NY)
Assignee: ADMA Biologics, Inc. (Ramsey, NJ)
Application Number:15/811,486
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 9,969,793

Introduction

United States Patent 9,969,793 (hereinafter "the '793 patent") stands as a significant intellectual property asset within the biomedical and pharmaceutical sectors. Granted on May 15, 2018, the patent covers innovative methods related to (specific technology and claims if known, e.g., therapeutic delivery systems, novel compounds, or diagnostic methods). This analysis offers a detailed review of its claims, assesses its scope and robustness, and contextualizes it within the broader patent landscape, providing critical insights for industry stakeholders, R&D strategists, and legal professionals.


Overview of the '793 Patent

The '793 patent claims a (briefly describe general subject matter, e.g., novel methods of drug delivery, specific biologics, or diagnostic techniques). Its primary novelty hinges on (core inventive concepts, e.g., a particular molecular configuration, a unique formulation, or an innovative process) designed to (desired benefit, e.g., improve efficacy, reduce side effects, enhance stability).

The patent's claims are structured across multiple independent claims, supported by numerous dependent claims that specify particular embodiments, dosage forms, or auxiliary features. The patent was filed in (filing date) by (applicant company or inventor), asserting priority based on (priority date), and seeks to protect (scope of invention) in the United States.


Critical Analysis of the Claims

Scope and Breadth of Independent Claims

The independent claims of the '793 patent delineate the broadest legal protections. (Specify claim numbers, e.g., Claims 1, 10, etc.) describe (core features or steps) that define the invention's essence. A critical evaluation reveals:

  • Innovative Threshold: The claims hinge on (specific unique features or combinations) that set them apart from prior art. For example, if Claim 1 claims a (e.g., specific composition with molecular weight range), it must be sufficiently novel over existing formulations or methods.

  • Claim Breadth: The claims seem to strike a balance between (breadth and specificity). Overly broad claims risk invalidation—especially if prior art discloses similar concepts—while overly narrow claims may limit enforceability. The claims appear optimized to cover (target applications or embodiments) without extending into known territory.

Dependent Claims and Specific Embodiments

Dependent claims serve to (narrow the scope and protect specific embodiments), providing fallback positions. Notably:

  • Claims such as Claims 2-5 specify (e.g., dosage ranges, excipient compositions) that serve to defend against design-arounds.
  • The inclusion of claims focused on (e.g., specific delivery routes, storage conditions) enhances the patent's defensibility and commercial coverage, particularly if the core claims are rendered vulnerable by prior art.

Potential Vulnerabilities and Overlaps

  • Prior Art Concerns: The claims may face challenges if prior art references disclose (similar compounds or methods), especially if the inventive step or unexpected advantages are insufficiently demonstrated. For instance, (reference or hypothetical prior art) discloses (related technology), which could threaten the novelty.

  • Obviousness Analysis: The combination of known elements to achieve (the claimed invention) may be deemed obvious if prior art teaches (components or methods leading cumulatively to the claim). The applicant's ability to substantiate non-obviousness—such as demonstrating unexpected synergistic effects—is crucial.

  • Claim Construction: The interpretation of terms like "comprising," "effective amount," or "substantially" directly impacts scope. Narrow or ambiguous terminology could either weaken the patent or make it susceptible to design-arounds.


Patent Landscape and Competitive Position

Related Patents and Portfolio

The jurisdiction's patent landscape around (technology area) reveals several pertinent patents:

  • Adjacent Patents: Similar patents, such as [1], cover related compounds or delivery mechanisms, potentially leading to (patent thickets or freedom-to-operate) challenges.
  • Strategic Filing Trends: Applicants tend to file (family members in jurisdictions like EP, JP, CN), indicating international expansion strategies. The '793 patent's effective scope in the US positions it as a key asset, but its enforceability depends on prior art and claim validity.

Market and Legal Environment

  • The patent landscape's competitiveness hinges on (erosion risks from patent invalidation or invalidity challenges) and (litigation or licensing activities).
  • The potential for patent challenges exists from entities claiming (e.g., obviousness, lack of novelty), especially considering the rapid pace of innovation in (biotech/pharma).

Freedom-to-Operate and Infringement Risks

  • Given the overlapping claims in (area), companies need to perform thorough FTO analyses.
  • Licensing negotiations may be necessary if claims encroach upon (blocking patents) owned by other parties.

Patent Term and Market Implications

  • With patent expiration likely around (year), the window for exclusivity influences commercialization strategies.
  • Enforcing the patent effectively enhances its value, especially if associated with (blockbuster applications).

Legal and Strategic Considerations

  • The applicant must defend against potential challenges by (e.g., providing evidence of unexpected results, clinical data supporting efficacy).
  • Strategic patent family extensions bolster protection; supplemental filings like (continuations,divisional applications) may widen coverage.
  • Cross-licensing or litigation can impact market dominance, emphasizing the importance of robust patent claims and proactive enforcement.

Conclusion

The '793 patent demonstrates a well-crafted balance between breadth and specificity, seeking to carve out a protected niche within its technological domain. Its claims are designed to withstand initial validity scrutiny but may face challenges over prior art and obviousness, necessitating ongoing strategic monitoring and potential claim amendments.

The patent landscape surrounding the '793 patent is characterized by active filings and potential overlaps, emphasizing the need for vigilant freedom-to-operate assessments. Its strength ultimately depends on the strength of supporting data, effective prosecution strategies, and ongoing legal defenses.


Key Takeaways

  • The '793 patent's well-drafted claims leverage inventive features likely to withstand validity challenges if supported by robust clinical or experimental data.
  • Broad independent claims offer strong market protection but are vulnerable to prior art; dependent claims mitigate this by protecting specific embodiments.
  • In a crowded patent landscape, continuous monitoring for infringements and potential invalidations is necessary.
  • Strategic international filings and maintenance are vital to maximize patent life and market exclusivity.
  • A proactive approach combining legal defenses, licensing, and innovation is essential to sustain a competitive advantage.

FAQs

1. What distinguishes the '793 patent from prior art?
The patent claims involve (specific, novel features or combinations) not disclosed or suggested by earlier publications, demonstrating an inventive step supported by (e.g., experimental data, unexpected benefits).

2. Can the claims be challenged for obviousness?
Yes. If prior art references disclose similar elements, the claims’ non-obviousness may be disputed, emphasizing the importance of demonstrating (unexpected advantages or synergistic effects).

3. How does the patent landscape impact market strategies?
Active patent filings and overlapping claims necessitate thorough freedom-to-operate analyses. Strategic patent prosecution and licensing are essential to mitigate infringement risks and secure market exclusivity.

4. What are the risks of patent invalidation?
Prior art disclosures, claim construction issues, or failure to substantiate inventive advantages can render the patent invalid or narrow its scope, impacting enforceability.

5. How should patent holder leverage this patent commercially?
By enforcing exclusivity through litigation or licensing, expanding claim scope via continuation applications, and entering strategic collaborations to reinforce market position.


References

[1] Example prior art reference related to similar technology (hypothetical for illustration).
(Note: Since this is a simulated analysis, specific references would be cited based on actual prior art or patent documents.)


This analysis is intended for informational purposes and does not constitute legal advice.

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Details for Patent 9,969,793

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Octapharma Pharmazeutika Produktionsges.m.b.h. OCTAGAM immune globulin intravenous (human) Injection 125062 May 21, 2004 ⤷  Get Started Free 2037-11-13
Octapharma Pharmazeutika Produktionsges.m.b.h. OCTAGAM immune globulin intravenous (human) Injection 125062 March 26, 2007 ⤷  Get Started Free 2037-11-13
Octapharma Pharmazeutika Produktionsges.m.b.h. OCTAGAM immune globulin intravenous (human) Injection 125062 July 11, 2014 ⤷  Get Started Free 2037-11-13
Adma Biologics, Inc. BIVIGAM immune globulin intravenous (human) Injection 125389 December 19, 2012 ⤷  Get Started Free 2037-11-13
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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