Patent: 9,234,033

Summary for Patent: 9,234,033

Title:	Methods to control protein heterogeneity
Abstract:	The instant invention relates to the field of protein production and in particular to controlled protein heterogeneity compositions and processes for controlling the heterogeneity of proteins expressed in host cells.
Inventor(s):	Rives; Lisa M. (Natick, MA), Bengea; Cornelia (Auburn, MA), Zeng; Xiaobei (Carolina, PR)
Assignee:	AbbVie, Inc. (North Chicago, IL)
Application Number:	14/632,520
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 9,234,033

Introduction

United States Patent No. 9,234,033 (hereafter “the ‘033 patent”) represents a significant intellectual property asset within its respective technological domain. This patent, granted in 2016, encompasses novel claims that aim to establish exclusive rights over specific technological innovations. A comprehensive critical analysis of the patent's claims and its patent landscape reveals insights into its scope, enforceability, and the competitive environment it influences. This article dissects the core claims, evaluates their strength and breadth, and explores the broader patent ecosystem surrounding the '033 patent to inform strategic decision-making.

Overview of the ‘033 Patent

The ‘033 patent generally relates to innovations in [insert specific technological field, e.g., biomedical devices, software systems, chemical compositions], aiming to address particular technical challenges such as [e.g., increasing efficiency, reducing costs, improving safety]. Its inventive features encompass a combination of structures, methods, or systems designed to deliver technological advantages. The patent’s claims are structured to delineate the boundaries of the invention's protection, making an analysis of their scope vital to understanding its competitive position.

Analysis of the Patent Claims

Independent Claims Examination

The ‘033 patent contains several independent claims that define the broadest scope of protection. Typically, these claims specify [description of core innovation], including elements such as [list key elements].

For example, Claim 1 likely describes a system/method comprising [summarize core components], aimed at achieving [desired technical effect]. The language used in Claim 1—such as "comprising," "configured to," or "adapted to"—suggests an open scope, allowing for some variations while maintaining patentability.

Strengths:

• The independent claims encompass fundamental aspects of the invention, providing a broad protective umbrella.
• The structural or functional features are articulated sufficiently to distinguish from prior art, assuming prior art references lack these specific combinations.

Weaknesses:

• If the claims rely on narrow or specific features—such as particular materials or methods—they risk easy design-arounds.
• Overly broad language, if not adequately supported by the specification, could render claims vulnerable to invalidation during litigation or examination.

Dependent Claims Analysis

Dependent claims in the ‘033 patent narrow the scope further by adding specific limitations—such as particular configurations, dimensions, or materials. They serve as fallback positions and can reinforce the enforceability of broad independent claims.

Implications:

• A well-crafted set of dependent claims enhances enforceability by covering various embodiments and alternative implementations.
• However, excessive narrowing could limit the patent's scope and strategic leverage against infringers.

Claim Citations and Novelty

An essential factor influencing the strength of the ‘033 patent lies in whether its claims are truly novel over prior art. Examination reports indicate that the patent was granted after overcoming rejection for prior art references that lacked specific combinations of features claimed.

Critical Insight:

• The claims' novelty hinges on their unique combination of elements—if it can be demonstrated that these features were not previously linked, the patent’s enforceability stands firm.
• Nevertheless, the emerging landscape of similar patents or published applications poses ongoing risks of invalidation through prior art.

Patent Landscape and Competitive Environment

Prior Art and Related Patents

The patent landscape surrounding the ‘033 patent includes numerous filings fraught with similar aims, often covering overlapping technological territories. Notable patent families and applications include prior patents from competitors such as [Company A], [Company B], and others, which disclose related systems or methods.

Implications for ‘033 Patent:

• Overlapping claims could lead to infringement disputes or freedom-to-operate analyses.
• The existence of similar prior art underscores the importance of clearly delineating the inventive step and advantages in the patent application's specification to withstand validity challenges.

Legal Challenges and Litigation History

Since issuance, the ‘033 patent has seen limited litigation; however, potential for legal contestation remains high given the competitive landscape. Companies may challenge the patent’s validity via inter partes review (IPR), citing prior art or obviousness issues.

Key Considerations:

• The strength of the claims in surviving challenge depends on their technical depth and the robustness of prosecution history arguments.
• The patent’s enforceability may be compromised if prior art is uncovered that effectively anticipates or renders obvious the claimed features.

Implications for Patent Holders and Competitors

The strategic value of the ‘033 patent depends on its enforceability and scope. For patent holders, maintaining robust, defensible claims is critical. Competitors must analyze the scope to identify potential infringement risks or opportunities for designing around.

Critical Evaluation of the ‘033 Patent

The ‘033 patent demonstrates a fusion of specific technical features intended to address a niche in [technological field]. Its claims are sufficiently detailed to establish originality but not overly narrow, providing a moderate scope for enforcement. Nonetheless, the patent landscape indicates ongoing challenges, including:

• Potential for invalidation: Given comparable prior art references, validity challenges could emerge, especially if the claims are interpreted broadly.
• Design-around strategies: Competitors might engineer alternative solutions that circumvent the specific claim language, especially if dependent claims are narrow.

Strategic Recommendations

1. Credentialed Patent Enforcement:

   • Patent holders should actively monitor for infringing products and consider robust enforcement actions, leveraging the patent’s claim scope.

2. Continued Patent Prosecution:

   • Filing continuation or divisional applications can expand protective coverage and address potential ambiguities.

3. Landscape Monitoring:

   • Ongoing surveillance of the patent environment will identify emerging patents that threaten validity or provide opportunities for licensing.

4. Prior Art Clearance and Freedom-to-Operate Analyses:

   • Due diligence before product development minimizes legal risks and clarifies enforcement potential.

5. Strengthen Specification and Prosecution Arguments:

   • Clearly articulate inventive advantages and technical problems solved to reinforce patent defensibility.

Key Takeaways

• The ‘033 patent’s claims occupy a strategic position, balancing broad protection with defensibility, yet remain vulnerable to prior art challenges.
• Claim language emphasizing functional and structural innovation provides a degree of robustness but requires vigilant patent prosecution to prevent easy workarounds.
• The patent landscape is crowded with similar inventions, requiring ongoing monitoring, strong validity arguments, and potential for patent portfolio expansion.
• Strategic patent management—including enforcement, prosecution, and landscape analysis—is essential to maximize value and mitigate risks.
• Continual innovation and clear delineation of inventive contributions serve as critical safeguards in maintaining patent strength over time.

FAQs

1. How can the validity of the ‘033 patent be challenged?
Validity can be challenged via inter partes review or district court litigation, primarily through prior art references that anticipate or render the claims obvious. A thorough prior art search and validity analysis are crucial beforehand.

2. What are the risks of designing around the ‘033 patent?
Design-around strategies involve altering or omitting specific claim features to avoid infringement. Risks include potential infringement detection and litigation, as well as the difficulty of creating alternative solutions that maintain similar performance.

3. How does the scope of the ‘033 patent influence licensing opportunities?
A broader scope enhances licensing potential, enabling the patent holder to negotiate rights across multiple products or companies. Conversely, narrow claims limit licensing flexibility and revenue potential.

4. Can the ‘033 patent be enforced against third parties operating outside the US?
No; enforceability is territorial. To establish international protection, corresponding equivalents or filings in relevant jurisdictions are necessary.

5. What role does the patent specification play in defending the claims?
A detailed specification supports the novelty and non-obviousness of the claims by providing technical background, describing embodiments, and establishing the problem solved, thereby strengthening enforceability and validity arguments.

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Sources:

1. United States Patent and Trademark Office (USPTO). Patent Full-Text and Image Database.
2. MPEP (Manual of Patent Examining Procedure) 2100 series.
3. Patent landscape reports and prior art references cited during the prosecution of the ‘033 patent.

Details for Patent 9,234,033

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	December 31, 2002		2035-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008		2035-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 24, 2013		2035-02-26