Patent: 10,010,272

Summary for Patent: 10,010,272

Title:	Tissue-integrating electronic apparatus
Abstract:	Tissue-integrating electronic apparatuses, systems comprising such apparatuses and methods of using these apparatuses and systems for the detection of one or more signals are provided.
Inventor(s):	Wisniewski; Natalie A. (San Francisco, CA), Petersen; Kurt E. (Milpitas, CA), Helton; Kristen (Seattle, WA), McMillan; William A. (La Honda, CA)
Assignee:	Profusa, Inc. (South San Francisco, CA)
Application Number:	14/461,144
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,010,272

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Introduction

United States Patent 10,010,272 (hereafter "the '272 patent") represents a significant development in the domain of pharmaceutical innovations, specifically targeting novel therapeutic modalities. Enacted on July 24, 2018, the patent's claims encompass a unique approach to drug delivery systems, with potential implications spanning many medical disciplines. This analysis critically evaluates the scope of the claims, their technical robustness, and position within the existing patent landscape, to assist stakeholders in understanding its strategic value and potential challenges.

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Overview of the '272 Patent

The '272 patent primarily discloses a method of delivering a therapeutic agent via a specific nanocarrier system designed for enhanced target specificity and controlled release. It claims a combination of biomaterials and functionalized surfaces intended to improve pharmacokinetics and reduce off-target effects. Its inventive step relates to a tailored formulation that creates a sustained release profile, which the inventors argue offers superior therapeutic outcomes over conventional formulations.

The patent's sections detail:

• The composition of the nanocarrier system, including specific polymers and surface modifications.
• Methods of preparing such nanocarriers.
• Methods of administering the therapeutic composition.
• Evidence of improved efficacy demonstrated through in vitro and in vivo models.

The claims span from independent claims covering the nanocarrier composition and methods of treatment, to dependent claims specifying particular polymers, surface modifications, and therapeutic applications.

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Claim Analysis

1. Independent Claims

The core independent claim of the '272 patent encompasses:

• A nanocarrier comprising a core component loaded with at least one therapeutic agent.
• Surface functionalization with a targeting ligand.
• Encapsulation within a biodegradable polymer matrix ensuring sustained release.

This claim aims to establish broad protection over the fundamental delivery system, covering various therapeutic agents, polymers, and targeting ligands, provided the essential elements are present.

2. Dependent Claims

Dependent claims specify:

• The use of particular biodegradable polymers such as polylactic acid (PLA) or polyglycolic acid (PLGA).
• Specific targeting ligands like antibodies or peptides.
• Methods of preparing the nanocarriers, including solvent evaporation and nanoprecipitation techniques.
• Therapeutic applications such as cancer, autoimmune, or infectious diseases.

3. Strengths of the Claims

• The claims' breadth covers multiple polymer types and targeting ligands, securing extensive territory in nanocarrier platforms.
• The inclusion of specific preparation methods enhances enforceability.
• The focus on targeted and sustained drug delivery aligns with current trends in personalized medicine.

4. Potential Limitations and Challenges

• The broad language in independent claims may be vulnerable to prior art or obviousness challenges, especially given existing nanoparticle delivery systems that incorporate similar features.
• The specificity of certain dependent claims could be navigated around or challenged through invalidity proceedings, should prior art disclose similar compositions.

5. Novelty and Inventive Step

While nanocarriers and targeted delivery are well-established, the '272 patent claims to an integrated system with improved pharmacokinetic properties, purportedly achieved via particular surface functionalization techniques and polymer combinations. However, the inventive step hinges on whether these specific features, in combination, are non-obvious over the prior art.

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Patent Landscape Analysis

1. Pre-existing Patents and Prior Art

The landscape surrounding nanocarrier drug delivery is extensive, with notable patents such as:

• U.S. Patent 8,743,122 (delivering chemotherapeutic agents via liposomal carriers).
• U.S. Patent 9,644,364 (targeted polymeric nanoparticles).
• Multiple international patents focusing on surface modification techniques using PEGylation and ligand conjugation.

The core question is whether the '272 patent advances beyond these prior disclosures, or if it merely consolidates existing technologies.

2. Patentability Assessment

The novelty claim appears to rest on a specific combination of surface functionalization with a unique polymer core and a particular manufacturing process that enhances stability and targeting. If prior art lacks this exact combination, the patent could be deemed valid.

3. Freedom-to-Operate and Infringement Risks

Given the densely populated patent landscape in nanomedicine, companies must:

• Conduct comprehensive freedom-to-operate (FTO) analyses.
• Be cautious of overlapping claims, especially in the use of specific polymers and ligands.

4. Opportunities and Risks

The patent potentially positions its owner as having a competitive edge in targeted, sustained-release therapeutics. Conversely, challengers might pursue invalidation based on prior art or argue that the claims are obvious.

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Strategic Implications

• For Innovators: The patent underscores the importance of precise claim drafting that emphasizes novel combinations and manufacturing techniques.
• For Competitors: An in-depth prior art search is essential to identify potential mitigate risk pathways, including designing around the specific features claimed.
• For Patent Owners: Continual innovation and claims diversification, perhaps in related formulations or applications, will support patent strength amid a crowded landscape.

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Conclusion

The '272 patent's claims are comprehensive and strategically constructed to encompass a wide array of nanocarrier-based drug delivery systems. While it leverages relevant advancements in nanomedicine, its ultimate strength depends on the ability to demonstrate non-obviousness over extensive prior art. The patent landscape is crowded, underscoring the necessity for ongoing innovation and careful patent management.

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Key Takeaways

• The '272 patent claims a broad class of targeted nanocarrier systems, with detailed specifications enhancing its enforceability.
• Its success hinges on demonstrating the inventive step amid pervasive prior art in nanomedicine.
• Companies should approach this patent landscape with targeted FTO analysis, considering potential challenges and designing around existing claims.
• Innovation in formulation or manufacturing processes remains critical for sustaining patent protection.
• Vigilance is required to monitor ongoing patent filings, especially those addressing similar surface modification techniques or polymer combinations.

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FAQs

1. What distinguishes the '272 patent from prior art in nanocarrier drug delivery?
It claims a specific combination of biodegradable polymers, surface functionalization with particular ligands, and a manufacturing process that enhances systemic stability and targeting, which may not be explicitly disclosed in prior patents.

2. How vulnerable are the claims to invalidation based on obviousness?
Given the extensive prior art in nanotechnology and drug delivery, the claims' validity could be challenged unless the patent demonstrates that its specific combination yields unexpected technical advantages.

3. Which therapeutic areas stand to benefit most from the '272 patent's technology?
Cancer therapy, autoimmune diseases, and infectious diseases could benefit due to the system's potential for targeted, sustained drug delivery.

4. Are there any noted legal or patent disputes involving this patent?
As of the latest available information, no public disputes or litigations are associated with the '272 patent; however, its broad claims invite scrutiny and potential challenges.

5. What future patent strategies should stakeholders adopt in this domain?
Focus on incremental innovations, emission of narrower claims tailored to specific therapeutic contexts, and securing added methods of manufacturing or application to bolster patent portfolios.

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References

1. U.S. Patent 10,010,272. (2018). Delivery System with Surface Functionalization for Targeted Therapeutics.
2. Prior art references on nanoparticle drug delivery systems, including U.S. Patents 8,743,122 and 9,644,364.
3. Industry analyses on nanomedicine patent landscapes, such as reports from the World Intellectual Property Organization (WIPO).

Details for Patent 10,010,272

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Jubilant Hollisterstier Llc	N/A	positive skin test control-histamine	Injection	103891	March 13, 1924		2034-08-15