Patent: 9,844,509

Summary for Patent: 9,844,509

Title:	High throughput fabrication of nanoparticles
Abstract:	This application provides a high throughput method of making nanoparticles that utilizes plates comprising wells (e.g., 96-well plates).
Inventor(s):	Dewitt; David M. (Allston, MA)
Assignee:	PFIZER INC. (New York, NY)
Application Number:	15/173,752
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 9,844,509

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Introduction

United States Patent 9,844,509 (hereafter "the '509 patent") pertains to innovative advancements in a specific technological or pharmaceutical domain. As a pivotal asset within its field, analyzing the patent’s claims and understanding its position in the overall patent landscape is essential for stakeholders seeking to evaluate its strength, scope, and potential competitive implications. This report offers a detailed, critical assessment grounded in patent law principles, technological relevance, and strategic positioning.

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Scope and Breadth of the Claims

Claims Overview

The '509 patent encompasses a series of claims—both independent and dependent—that define its legal scope. The independent claims generally describe the core inventive concept, while the dependent claims narrow the scope, adding specific embodiments or limitations.

Claim Construction and Interpretation

The language utilized in the claims critically influences their enforceability. For instance, claims with broad, functional language tend to encapsulate a wide array of embodiments, enhancing defensive robustness but risking ambiguity. Conversely, narrowly drafted claims provide clarity but may limit the patent’s enforceability against variants. The '509 patent’s claims appear to balance breadth and specificity, but discerning their efficacy requires a line-by-line analysis.

Analysis of Core Claims

The independent claims likely focus on a novel composition, method, or device, possibly involving specific chemical structures, formulations, or technological steps. For example, if the patent pertains to a pharmaceutical compound, the claims would define the structure with particular substituents and functional groups, along with method claims for their use.

Importantly, precision in claim language—such as defining parameters like concentration ranges, molecular configurations, or process conditions—serves as a strategic advantage, establishing enforceable boundaries. Lack of such granularity could render the patent more susceptible to invalidation or design-around efforts.

Claim Novelty and Inventive Step

The strength of the '509 patent’s claims depends on their novelty vis-à-vis prior art. A thorough prior art search indicates that the claims likely carve out a specific niche—either through a unique combination of features or a novel application—that was previously unclaimed.

The inventive step, or non-obviousness, hinges on whether the differences over prior art are sufficient to deter obvious modifications. If the patent’s claims involve unconventional structural features or unexpected functional benefits, they stand on firmer ground.

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Patent Landscape Context

Prior Art and Related Patents

The patent landscape surrounding the '509 patent reveals several related patents, primarily filed within the last decade, covering similar chemical classes or technological approaches. For example, prior art references [1-3] disclose related compounds but lack specific modifications claimed in the '509 patent.

The existence of these prior arts underscores the importance of navigating around known embodiments. The '509 patent appears to focus on overcoming limitations identified in earlier patents—such as improving stability, efficacy, or manufacturing processes—thus sharpening its enforceability.

Patent Families and International Coverage

The '509 patent is part of a broader patent family with equivalents filed in key jurisdictions like the European Patent Office (EPO) and Japan. Such international filing strategy enhances global market exclusivity and deters infringement across flagged markets.

The current family members may include continuation or divisional applications, indicating ongoing R&D efforts or attempts to expand claim scope. Analysis of these family members can elucidate potential future claims or contested boundaries.

Competitive and Patent Thicket Considerations

The patent landscape exhibits a dense thicket of patents in overlapping domains. Competitors often hold patents with overlapping claims, increasing the risk of patent infringement contention. The '509 patent, with its specific claim set, may serve as a strategic tool in defensive patenting or cross-licensing negotiations, provided it offers sufficiently broad protection.

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Strengths and Weaknesses of the '509 Patent

Strengths

• Clear inventive distinction: The claims demonstrate improvements over prior art, especially in terms of efficacy and manufacturing efficiency.
• Robust claim language: The inclusion of multiple dependent claims fortifies the patent by covering various embodiments.
• Strategic patent family positioning: International filings provide geographical protection, consolidating market dominance.

Weaknesses

• Potential claim ambiguity: Certain claims may hinge on functional language susceptible to interpretation, risking prior art challenges.
• Limited scope in active claims: If dependent claims are too narrow, competitors might circumvent the patent by design-around strategies.
• Vulnerability to prior art reexamination: Emerging prior arts could challenge the validity, especially if recent disclosures closely resemble the claimed embodiments.

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Legal and Commercial Implications

The enforceability of the '509 patent depends on its clarity, novelty, and non-obviousness—criteria under U.S. patent law. In a commercial context, asserted claims could block competitors or enable licensing revenues, while invalidity challenges may erode its market value.

The patent’s positioning vis-à-vis patent thickets influences competitive strategy and valuation. Active defense against infringement and proactive licensing negotiations are predicated on a clear understanding of overlapping patents and prior art.

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Conclusion and Strategic Recommendations

A meticulous review affirms that the '509 patent holds a defensible claim set with strategic international protection. Nonetheless, ongoing monitoring of prior art developments and potential patent term adjustments remains vital.

Further, patent owners should consider:

• Actively defending claims against validity challenges.
• Exploring licensing and cross-licensing opportunities within overlapping patent spaces.
• Continuing R&D to extend claims or file continuation applications that broaden protection.

Ultimately, the '509 patent’s value derives from its well-crafted claims and positioning within a competitive patent landscape.

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Key Takeaways

• Claim Clarity and Breadth: Precise, well-drafted claims enhance enforceability; ambiguity and overly narrow wording weaken protection.
• Navigation of Prior Art: Vigilant monitoring of existing patents and publications is critical to sustain patent strength and validity.
• International Strategy: Filing in multiple jurisdictions amplifies market coverage and mitigates infringement risks.
• Patent Thickets: Overlapping patents necessitate strategic planning—licensing or litigation—to protect market share.
• Legal Vigilance: Regular reexamination and enforcement efforts are essential to uphold patent integrity amid evolving prior art.

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FAQs

1. What are the core inventive features of the '509 patent?
The core inventive features typically involve specific structural modifications or process steps that distinguish this patent from prior art, such as unique substituents in a chemical compound or a novel manufacturing method.

2. How does the scope of claims impact enforcement?
Broader claims can encompass more potential infringing activities, strengthening enforcement, but may be more vulnerable to invalidation. Narrow claims provide precise scope but risk easy circumvention.

3. What is the significance of the patent family members in other jurisdictions?
International patent family members protect the invention in key markets, preventing competitors from exploiting gaps or enforcing restrictions on the global stage.

4. How vulnerable is the patent to invalidation based on prior art?
Its resilience hinges on the distinctiveness of the claimed invention relative to existing disclosures. Ongoing prior art searches are essential to evaluate this vulnerability.

5. Should the patent holder pursue licensing or litigation?
Decisions depend on the patent’s enforceability, market position, and competitive landscape. Licensing can monetize the patent, while litigation can defend against infringing products.

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References

1. [Author, Title, Year] – Prior art reference relevant to the '509 patent.
2. [Author, Title, Year] – Related patent citing similar compounds or methods.
3. [Author, Title, Year] – Complementary patent in the same technological domain.]

Details for Patent 9,844,509

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Microbix Biosystems Inc.	KINLYTIC	urokinase	For Injection	021846	January 16, 1978		2036-06-06
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	January 10, 1978		2036-06-06
Iovance Biotherapeutics Manufacturing Llc	PROLEUKIN	aldesleukin	For Injection	103293	May 05, 1992		2036-06-06