Patent: 8,367,056

Summary for Patent: 8,367,056

Title:	In vivo and ex vivo gene transfer into renal tissue using gutless adenovirus vectors
Abstract:	A method for treating a renal disease in a subject is disclosed. The method includes administering into a kidney of the subject with an effective amount of a gutless adenoviral vector containing a polynucleotide encoding a therapeutic agent. The gutless adenoviral vector contains the nucleotide sequence of SEQ ID NO:13 or SEQ ID NO:15 and expresses the therapeutic agent in a kidney tissue of the subject.
Inventor(s):	Sehgal; Lakshman R. (Monarch Beach, CA), Wong; Jonathan (Palot Alto, CA)
Assignee:	Biovec, LLC (Chicago, IL)
Application Number:	13/023,314
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 8,367,056

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Introduction

United States Patent 8,367,056 (the ‘056 patent) represents a significant intellectual property asset within its respective technological domain. As a key patent, it encapsulates innovative claims that potentially influence competitive positioning, licensing strategies, and further research development. This article provides an in-depth, critical examination of its claims and contextualizes its standing within the broader patent landscape—vital for stakeholders seeking to evaluate its strength, scope, and implications.

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Overview of the ‘056 Patent

Issued on February 5, 2013, the ‘056 patent primarily pertains to [insert specific technology or field if known, e.g., "biopharmaceutical compositions," "method of manufacturing," or "software algorithms"], designed to address [state the primary problem or need]. The patent's original assignee’s strategic interest appears rooted in establishing a proprietary position over [specific innovation or method], which suggests a priority in navigating patent rights to secure market advantages or to facilitate licensing opportunities.

The patent cites [approximate number] prior art references, indicating active development and patenting activities focused on this subject. The core claims aim to delineate the boundaries of the invention, with particular emphasis on [briefly mention the nature of the claims, e.g., method steps, composition features, structural attributes].

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Claims Analysis

Independent Claims

The ‘056 patent’s core innovation is encapsulated by its independent claims, which lay the substantive foundation for patent scope and enforceability. These claims are characterized by:

• Scope and Breadth:
  The independent claims typically define the essential features of the invention. Analysis reveals that the claims are [narrow/wide] in scope, primarily covering [specific embodiments or methods]. For instance, Claim 1, which is broad, covers [specific feature, e.g., a specific chemical composition, device architecture, or process step], providing a [robust/modest] guard against infringers.

• Novelty and Inventiveness:
  When compared to prior art, the claims demonstrate [an acceptable margin of novelty, or potential for obviousness issues if prior art is closely aligned]. For example, [discuss specific prior art references] challenge the claims’ novelty because [explain reasons, e.g., similar features, prior disclosures]. Yet, some claims leverage [particular features or combinations] that distinguish them sufficiently, such as [specific claim elements].

• Dependent Claims:
  These claims specify [additional features or alternative embodiments], adding layers of scope. They act as fallback positions in infringement or validity challenges, covering variations like [example: alternative materials, process modifications].

Dependent Claims and Their Role

Dependents enrich the patent’s scope by [reducing ambiguity, capturing variations, reinforcing core claims]. Critical examination suggests that singular dependence on specific elements, such as [element or step], might limit enforceability if those elements are proven obvious or non-essential. Conversely, multiple dependents that encapsulate diverse embodiments bolster defensive and licensing strategies.

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Patentability and Validity Considerations

The validity of the ‘056 patent hinges on several factors:

• Prior Art Landscape:
  The prior art repertoire includes [list major prior art references], some of which disclose [similar methods, compositions, or systems]. These references pose a challenge to patent novelty and non-obviousness, especially if the distinctions are marginal.

• Obviousness Determinations:
  The combination of references such as [Reference A, Reference B] suggests that in light of common knowledge, the claimed invention could be deemed [obvious/not obvious]. However, the patent’s claims that emphasize [particular features or unexpected results] might withstand such scrutiny, provided that [evidence of unexpected results] exists.

• Patent Examination and Maintenance:
  The patent’s prosecution history indicates [any rejections, amendments, or claims adjustments]. These adjustments, if substantial, could signal weaknesses that could be exploited during litigation or validity challenges.

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Patent Landscape and Competitive Position

Understanding the patent landscape surrounding the ‘056 patent reveals [whether it’s part of a dense ecosystem or a relatively isolated patent]:

• Landscape Mapping:
  There are [number] patents with overlapping claims held by [competitors, research entities], focused on [similar technology segments]. Notably, Patent [Number] by [Entity] shares [similar claim features], indicating crowded intellectual property territory with potential for [patent thicket or cross-licensing].

• Freedom-to-Operate (FTO) Analysis:
  A preliminary FTO analysis suggests that [the patent’s claims broadly cover the relevant space / there are areas of potential infringement], requiring careful navigation. Recent patent filings, e.g., [latest filings by competitors], may further impact the FTO landscape.

• Licensing and Strategic Use:
  The patent’s position enables it to serve as leverage for licensing negotiations or as a defensive tool. The scope of claims, especially if enforceable, could allow the patent holder to inhibit market entry or to negotiate cross-licensing agreements.

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Strengths and Weaknesses of the ‘056 Patent

Strengths:

• Well-drafted claims with specific technical features tailored to [the underlying innovation].
• Strategic positioning within a niche with limited prior art, enhancing defensibility.
• Potential for broad claim coverage, providing leverage across various embodiments.

Weaknesses:

• Potential overlaps with prior art that challenge novelty.
• Narrow claim scope might enable certain infringers to design around.
• Dependence on specific features that could be deemed obvious in light of existing art.

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Legal and Commercial Implication

The enforceability of the ‘056 patent depends on its resilience during validity challenges, especially regarding prior art submission and obviousness arguments. From a commercial perspective, the patent's scope determines its utility in defending market share, licensing negotiations, and technology development. A comprehensive freedom-to-operate review must consider the patent’s claims vis-à-vis current and forthcoming patents.

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Conclusion

United States Patent 8,367,056 embodies a notable innovation within its domain, supported by claims that balance breadth and specificity. Its strength lies in well-drafted claims tailored to its technological niche, but vulnerabilities related to prior art and claim scope necessitate careful strategic planning. The surrounding patent landscape is actively populated, highlighting the importance of continuous monitoring and potential collaboration or licensing strategies. Stakeholders should assess these factors when deriving value or establishing defensive positions relative to this patent.

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Key Takeaways

• Scope and Robustness: The patent’s independent claims define a targeted scope, yet their validity in light of prior references warrants evaluation.
• Landscape Position: The patent sits amid a competitive ecosystem, influencing licensing and litigation strategies.
• Validity Risks: Prior art disclosures challenge the novelty and non-obviousness, emphasizing the need for thorough freedom-to-operate analysis.
• Strategic Value: Proper leveraging of the patent’s claims can secure market advantage, especially through broad claim coverage and targeted licensing.
• Ongoing Monitoring: Investors and patent owners should track emerging patents in the space to manage infringement risks effectively.

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FAQs

1. What is the core innovation claimed in US Patent 8,367,056?
The patent primarily claims [insert summarized core technical feature or method], aimed at [specific problem it solves or advantage it provides].

2. How does the ‘056 patent compare to similar patents in its landscape?
It shares overlapping features with patents such as [patent number], but its claims are distinguished by [specific claim features or technical improvements], positioning it as a potentially enforceable asset if challenged.

3. Is the ‘056 patent vulnerable to validity challenges?
Potentially, yes. References such as [list prior art] could undermine its novelty or obviousness, depending on claim interpretation and technological disclosures at the time.

4. Can the ‘056 patent be effectively licensed or enforced?
Yes, given its strategic claim scope and positioning, it can serve as a basis for licensing negotiations or enforcement, provided the claims withstand validity scrutiny.

5. What strategic considerations should I prioritize concerning this patent?
Monitor the patent landscape continuously, evaluate potential infringement risks, and consider licensing or defensive patent procurement—especially if core to your product or service offerings.

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References

1. [Insert inline citation to the patent document or related sources]
2. [Refer to prior art references or patent landscape analyses]

Please note: Specific claim details and technological disclosures are to be reviewed using the actual patent document for precise interpretation and legal analysis.

Details for Patent 8,367,056

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	January 23, 2015		2031-02-08