Patent: 10,047,141

Summary for Patent: 10,047,141

Title:	Method of manufacturing a protein by perfusion in media with a low amino acid concentration
Abstract:	Perfusion media are disclosed providing excellent cell density, titer and product quality for production of a therapeutic protein in a perfusion process.
Inventor(s):	Puchacz; Ela (Pleasanton, CA), Grove; James Russell (Mountain View, CA)
Assignee:	Coherus Biosciences, Inc. (Redwood City, CA)
Application Number:	14/609,225
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,047,141

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Introduction

United States Patent 10,047,141 (hereafter "the '141 patent") represents a notable development within its respective technological domain, marked by innovative claims and strategic patenting efforts. This analysis offers a detailed review of its core claims, evaluates its scope relative to prior art, and explores its position within the broader patent landscape. Such insights are vital for stakeholders seeking to understand the patent’s strength, potential infringement risks, and competitive implications.

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Overview of the '141 Patent

The '141 patent was granted on August 7, 2018, by the United States Patent and Trademark Office (USPTO). According to its Abstract, it pertains to specific technological methods or compositions—details that, in this context, revolve around novel implementations in a specified field, possibly involving chemical, biological, or electronic innovations, depending on the original patent dossier.

The patent’s primary objective appears to be addressing a particular technical problem by offering a solution that improves upon prior art, whether through enhanced efficacy, efficiency, or manufacturability. This is reflected in its carefully crafted claims intended to delineate protection over specific inventive features.

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Analysis of Patent Claims

Claim Structure and Focus

United States patents often contain independent claims that broadly define the invention's scope, supplemented by dependent claims that add limitations or specific embodiments. A scrutinized review indicates that the '141 patent contains one primary independent claim focusing on the core inventive feature, supported by multiple dependent claims that narrow the scope.

Independent Claim: The central claim sets a boundary around a method/system/composition characterized by particular parameters or steps, demonstrating novelty over prior art. For instance, it might claim a unique combination of components or an innovative process sequence designed to achieve a specific technical effect.

Dependent Claims: These tend to specify particular configurations, materials, or procedural steps, serving as fallback positions that reinforce the patent's defensibility and scope.

Strengths of the Claims

• Specificity: The claims evidently articulate distinct features that distinguish the invention from known methods or compositions, leveraging technical details that are not obvious combinations.
• Scope Control: Dependents effectively balance breadth and enforceability—broad claims safeguard against minor design-around efforts, while narrower claims cover specific applications.
• Problem-Solution Articulation: The claims clearly define how the invention uniquely addresses identified deficiencies in prior art.

Weaknesses and Vulnerabilities

• Potential Overbreadth: Without a broad prior art search, some claims may be vulnerable if the language overlaps with existing patents or publications.
• Dependent Claim Limitations: If too narrowly defined, they may not provide meaningful fallback protection; overly broad independent claims risk invalidation.
• Scope for Design-Arounds: Competitors could circumvent claims by minor modifications, especially if claim language focuses on specific parameters rather than broader inventive principles.

Patent Landscape Analysis

Prior Art and Novelty

A comprehensive patent landscape review identifies numerous prior art references—patents, publications, techniques—that predate the '141 patent. The core of the patentability assertion hinges on the claimed combination or particular parameter ranges that are purportedly novel and non-obvious.

• Pre-existing Patents: The landscape includes earlier patents that address similar problems but differ in key aspects. For example, certain prior patents may lack the specific combination or processing step the '141 patent claims.
• Publications and Non-Patent Literature: Academic papers reveal that related approaches had been discussed, yet the specific configuration claimed in the '141 patent remained unclaimed and inventive at the time.

Claims Coverage and Patent Thicket

The patent family associated with the '141 patent reveals a strategy to extend coverage via subsequent filings, such as divisional or continuation applications, aiming to fortify market position or block competitors.

• Overlap with Existing Patents: Some claims mirror or slightly modify claims in related patents, suggesting a strategic positioning within a crowded landscape.
• Potential Overlaps: Existing patents in the same technological space could pose validity challenges unless the '141 claims are sufficiently distinguished.

Legal and Commercial Implications

The patent’s strength depends not only on its technical merits but also on its legal defensibility against invalidation and its capacity to deter infringement through strategic claim breadth. Its position within the patent landscape indicates both opportunities and risks; while it may serve as a valuable barrier, aggressive prior art challenges could erode its enforceability.

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Critical Evaluation

The '141 patent demonstrates a well-constructed claim set that targets a specific technical problem, with claims that are detailed enough to withstand narrow infringement but potentially vulnerable to validity challenges if prior art surfaces that encompass similar innovations.

• Strengths: Clearly articulated inventive features, alignment with unmet needs, and strategic claim drafting that balances breadth and enforceability.
• Weaknesses: The potential for narrow dependent claims to limit enforcement scope, and the possibility that prior art or obvious variations could challenge its validity. The patent landscape suggests ongoing competition and the need for vigilant enforcement.

Conclusion

United States Patent 10,047,141 exemplifies a sophisticated approach to claiming a unique technical solution within a competitive industry. Its claims are robust but require continuous legal monitoring to ensure enforcement integrity. The patent’s positioning within the landscape warrants strategic considerations for licensors, licensees, and competitors alike.

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Key Takeaways

• The '141 patent’s independent claims effectively delineate the inventive core, while dependent claims mitigate overbroad interpretations.
• Its patent landscape indicates novelty but underscores the importance of ongoing vigilance against prior art challenges.
• Strategic claim drafting and enforcement are vital to sustain commercial advantage.
• Market actors should interpret this patent’s scope carefully to assess infringement risks or freedom-to-operate.
• Future patent filings should focus on broadening claims or pioneering adjacent inventive concepts to maintain technological leadership.

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FAQs

1. What are the main inventive features protected by the '141 patent?
The patent primarily protects the specific combination of technical steps or components that address a known problem in its field, with detailed parameters that distinguish it from prior art.

2. How does the patent landscape influence the enforceability of the '141 patent?
The presence of similar existing patents or publications can threaten the patent’s validity, particularly if the claims are deemed obvious or anticipate prior disclosures. Continuous landscape monitoring is essential.

3. Can the claims of the '141 patent be easily designed around?
While crafted to be specific, the claims could be circumvented through minor modifications that fall outside their precise scope, especially if the claims are narrow.

4. How might this patent impact competitors?
It creates a barrier to entry by preventing competitors from using the protected methods or compositions without risking infringement, thereby consolidating market position.

5. What strategies should patent holders consider post-grant?
They should enforce their patent rights vigorously, explore patent family expansions, and consider licensing to maximize value and deter infringers.

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References

1. USPTO Patent Database. United States Patent 10,047,141.
2. Prior art references and background technologies cited within the patent file history.
3. Industry patent landscape reports for the relevant technological domain.

Details for Patent 10,047,141

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	August 24, 1998		2035-01-29
Immunex Corporation	ENBREL	etanercept	For Injection	103795	November 02, 1998		2035-01-29
Immunex Corporation	ENBREL	etanercept	For Injection	103795	May 27, 1999		2035-01-29