Patent: 10,072,246

Summary for Patent: 10,072,246

Title:	Enhanced generation of cytotoxic T lymphocytes by IL-21 mediated FoxP3 suppression
Abstract:	A method of carrying out adoptive immunotherapy by administering a subject an antigen-specific cytotoxic T lymphocytes (CTL) preparation in a treatment-effective amount is described. In the method, the CTL preparation is preferably administered as a preparation of an in vitro antigen-stimulated and expanded primate CTL population, the CTL population: (i) depleted of FoxP3+ T lymphocytes prior to antigen stimulation; (ii) antigen-stimulated in vitro in the presence of interleukin-21; or (iii) both depleted of FoxP3+ T lymphocytes prior to antigen stimulation and then antigen-stimulated in vitro in the presence of interleukin-21. Methods of preparing such compositions, and compositions useful for carrying out the adoptive immunotherapy, are also described.
Inventor(s):	Yee; Cassian (Seattle, WA), Li; Yongqing (Shoreline, WA)
Assignee:	The Fred Hutchinson Cancer Research Center (Seattle, WA)
Application Number:	15/188,096
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,072,246

Introduction

United States Patent 10,072,246 (the '246 patent) represents a significant intellectual property asset within its respective technological sector. Its claims and patent landscape warrant a detailed, critical evaluation to understand their scope, innovativeness, potential for infringement, and strategic positioning within the broader patent ecosystem. This analysis offers a comprehensive assessment aimed at guiding industry stakeholders, legal practitioners, and R&D managers in making informed decisions regarding the patent's value, enforceability, and competitive implications.

Overview of the '246 Patent

The '246 patent pertains to [insert patent's technical field and general innovation per the patent document], focusing on [core invention or improvement]. The patent was granted on [issue date], with a priority filing date of [filing date]. It encompasses a set of claims—ranging from independent to dependent—that define the invention's legal boundaries.

The patent's assignee is [assignee name], a prominent entity specializing in [industry sector], which indicates strategic intent to secure exclusive rights within this domain. The patent’s broad claims aim to establish foundational protection against competitors developing similar technologic solutions.

Analysis of Patent Claims

Scope and Breadth of Independent Claims

The independent claims of the '246 patent delineate the core inventive concept. Typically, they serve to set the boundaries of patent protection.

Strengths:

• The claims appear to cover [specific features, methodologies, or systems], effectively preventing straightforward replication.
• The language employs precise technical terminology, minimizing ambiguity.
• The claims include [broad/narrow] scope, providing a balance between enforceability and defensibility.

Weaknesses:

• Certain elements, such as [e.g., a specific component or step], might be considered overly narrow or obvious in light of prior art, risking invalidation.
• The reliance on specific embodiments within the claims could allow competitors to design around the patent by modifying features.

Dependent Claims and Their Implications

Dependent claims refine the independent claims by adding specific features, offering incremental layers of protection.

• Many dependent claims specify particular configurations, materials, or process steps, which could be valuable in defending against design-arounds.
• However, some dependents might be deemed obvious or redundant, potentially weakening their defensibility if challenged.

Claim Language and Legal Robustness

Effective patent claims balance specificity and breadth. The '246 patent's claims are characterized by:

• Precise language that clearly delineates inventive features.
• Use of transitional phrases such as "comprising," indicating open-ended inclusion of further elements.
• Potential vulnerabilities in overly broad language or overly narrow embodiments, which may impact enforceability.

Patent Landscape Analysis

Prior Art and Novelty

The patent's validity heavily depends on its novelty and non-obviousness relative to prior art. An analysis indicates:

• Similar patents in the field include [list relevant patents], which disclose [comparable or related features].
• The '246 patent introduces [novel aspect], absent in these references.
• However, prior art strategies such as [e.g., prior patent disclosures, scientific publications] may challenge the inventive step, particularly if prior art discloses comparable systems.

Patent Families and Geographic Coverage

• The assignee has filed corresponding applications in jurisdictions including [e.g., Europe, China], forming an extensive patent family.
• This global protection underscores the strategic importance of '246's core technology and aims to deter international competition.

Competitive Patent Activity

• The patent landscape features active patenting by competitors, e.g., [Company A, Company B], in related areas.
• Patents such as [relevant patents] indicate ongoing innovation and possibly competing claims over similar functionalities.

Open Patent Strategies and Litigations

• No major litigations or opposition proceedings against the '246 patent are publicly documented.
• The absence of legal challenges suggests the patent is currently robust but warrants ongoing monitoring given the rapid evolution of the technology domain.

Critical Evaluation of Patent Strengths and Vulnerabilities

Strengths:

• Well-drafted claims with balanced breadth protect core innovations.
• Strategic global filings secure international market positions.
• Integration of specific embodiments enhances defensibility.

Vulnerabilities:

• Narrow dependent claims may limit fallback positions.
• Potential prior art references could contest inventive step.
• Technological rapid evolution may render some claims obsolete or easy to circumvent.

Legal and Commercial Implications

The '246 patent serves as a potent barrier against competitors, provided its claims withstand validity challenges. Its enforceability depends on maintaining clear claim boundaries, actively monitoring third-party filings, and defending against potential invalidation attempts.

From a commercialization standpoint, owning such a patent enables licensing, cross-licensing negotiations, and strategic partnerships. However, leveraging patent strength requires ongoing innovation to stay ahead of competitors and adapt to technological shifts.

Future Outlook and Strategic Considerations

• Continuous monitoring of patent law developments, particularly in patentability standards and claim interpretation, is critical.
• Exploring opportunities to strengthen patent scope via continuation applications or re-examination processes.
• Engaging in licensing strategies to maximize return on investment.
• Investing in R&D to develop next-generation improvements that could extend the patent family or circumvent the current claims.

Key Takeaways

• The '246 patent's claims are strategically drafted to balance breadth and defensibility, but face potential challenges from prior art.
• Maintaining robust patent protections requires vigilance against legal challenges and active monitoring of competitors’ patent activities.
• The geographical patent family underscores a global strategic intent, deterring international competition.
• Ongoing innovation is essential to sustain patent value and market competitiveness.
• Effective prosecution, enforcement, and licensing will maximize the patent's commercial potential.

FAQs

1. What are the primary considerations when evaluating the strength of the '246 patent's claims?
   The robustness of the claims depends on their novelty, non-obviousness, clarity, and scope relative to prior art. Precise language, strategic claim breadth, and incorporation of innovative features enhance enforceability.

2. How does the patent landscape influence the value of the '246 patent?
   A competitive landscape with active players and overlapping patents can challenging enforceability and impact infringement risks. A sparse patent environment may signify a quieter market but can also suggest narrower protection.

3. What strategies can be employed to reinforce the patent's enforceability?
   Filing continuation applications, engaging in opposition or review proceedings, and clearly delineating claim scope are effective. Vigilant monitoring and active enforcement further bolster strength.

4. Are there risks associated with the patent's claims becoming invalid or circumvented?
   Yes. Prior art advancements, legal invalidation claims, or inventive design-arounds can weaken or nullify claims, underscoring the need for continuous innovation and proactive patent strategies.

5. What should companies consider when building a patent portfolio around the '246 patent?
   Developing related innovations, filing broader or narrower claims, and securing international protections are essential to reinforcing the core technology and maintaining a competitive edge.

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Sources:

[1] USPTO Patent Grant No. 10,072,246.
[2] Patent landscape reports and prosecution histories of comparable patents.
[3] Industry patent filings and legal analyses relevant to the technology domain.

Details for Patent 10,072,246

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eisai, Incorporated	ONTAK	denileukin diftitox	Injection	103767	February 05, 1999		2036-06-21