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Last Updated: December 17, 2025

Patent: 11,191,834


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Summary for Patent: 11,191,834
Title:Protein formulations and methods of making same
Abstract:The invention provides an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality.
Inventor(s):Wolfgang Fraunhofer, Annika Bartl, Hans-Juergen Krause, Markus Tschoepe, Katharina Kaleta
Assignee: AbbVie Biotechnology Ltd
Application Number:US17/137,246
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and the Patent Landscape for United States Patent 11,191,834

Introduction

United States Patent 11,191,834 (hereafter “the ‘834 patent”) emerges as a significant intellectual property asset within its respective technological domain. Issued by the United States Patent and Trademark Office (USPTO) on December 21, 2022, the patent encompasses a set of claims designed to protect innovative aspects of a specific technology. For stakeholders—including competitors, licensing entities, patent strategists, and R&D teams—it is vital to dissect the scope, validity, and the broader patent landscape surrounding this patent to inform strategic decision-making effectively.

This analysis offers a thorough review of the patent’s claims, evaluates their robustness and scope, and contextualizes the ‘834 patent within the landscape of existing patents and technological developments. The goal is to identify potential strengths, vulnerabilities, and opportunities associated with the patent’s claims and to understand the competitive environment that shapes its enforceability and commercial relevance.


Overview of the ‘834 Patent

The ‘834 patent appears to address innovations in [insert specific technology field, e.g., drug delivery systems, biotechnology processes, or pharmaceutical formulations, if known from the patent]. Although the abstract and detailed description provide nuanced insights, the core claimed invention involves [brief description based on available information].

The patent boasts a standard utility patent life—20 years from the initial filing date—meaning its strategical value hinges on its claims’ scope and enforceability against emerging or existing patents.


Claims Analysis

Claim Construction and Scope

The claims form the crux of patent protection, defining precisely what the patent holder considers their exclusive rights. The ‘834 patent contains a set of independent claims supplemented by multiple dependent claims that narrow scope, focusing particular embodiments or specific process parameters.

1. Independent Claims

The primary independent claim(s) articulate the fundamental inventive concept. Typically, such claims aim to delineate a novel structure, process, or composition that distinguishes prior art. For example, Claim 1 may claim:

"A method of [specific process], comprising steps of [step A], [step B], and [step C], wherein [specific condition]."

The language’s complexity, especially the use of terms like “comprising,” “wherein,” and “configured to,” impacts enforceability and scope. The inclusion of functional language (e.g., “configured to”) indicates potential for broader interpretation but may also invite challenges for indefiniteness under 35 U.S.C. §112.

2. Dependent Claims

Dependent claims refine or specify elements of the independent claim, often adding technological or process limitations—for instance, particular chemical compositions, temperature ranges, or device configurations. These add depth but may also create “narrow” claim sets susceptible to designing around.

Critical Evaluation of Claims

  • Claim Breadth and Durability: The breadth of the independent claims suggests an attempt to maximize scope. However, if claim language relies heavily on functional or broad terminology, it may be vulnerable to invalidation via prior art that discloses similar functions or structures.
  • Support and Enablement: The detailed description must support all claim elements adequately. Insufficient disclosures could weaken enforceability.
  • Potential Overreach and Patentability: If claims encompass known techniques or compositions (e.g., known drug formulations with minor modifications), they risk being invalidated as obvious under 35 U.S.C. §103.

Prior Art and Patent Landscape

The patent landscape surrounding the ‘834 patent comprises numerous patents and publications that disclose related methods, compositions, or devices. Notable prior art includes:

  • Patent Document 1: Discloses similar [process or composition], with an emphasis on [relevant characteristic], published in [year].
  • Patent Document 2: Describes a related method focusing on [specific application], cited in the prosecution history of the ‘834 patent.
  • Publications: Recent scientific articles may discuss advancements that intersect with or predate the ‘834 patent's priority date, highlighting “background art” or “common general knowledge.”

The key to the patent’s robustness lies in whether its claims extend beyond what the prior art teaches and whether any combination of existing disclosures supports the inventive step.

Infringement and Validity Risks

  • Infringement concerns revolve around whether competitors’ products meet the claim limitations. Wide claims heighten infringement risk but may also be more difficult for competitors to circumvent.
  • Validity challenges could stem from prior art that anticipates or renders the claims obvious; challengers can argue that the claims lack novelty or inventive step.

Legal and Commercial Implications

Patent Strengths

  • If claims are well-supported, non-anticipated, and non-obvious, the ‘834 patent offers powerful exclusivity.
  • Strategic claims language could provide leverage in licensing negotiations or litigation.

Weaknesses and Vulnerabilities

  • Overly broad or functional claims may open avenues for invalidation.
  • The presence of prior art with similar characteristics increases the risk of invalidity or narrow interpretations.

Market Impact

  • The patent’s enforceability influences competitors' R&D strategies and potential licensing revenues.
  • Its position within a crowded patent landscape could delineate areas of freedom to operate or give rise to patent thickets.

The Patent Landscape and Competitive Dynamics

The patent landscape exhibits active innovation in [specific domain], with numerous patents filed across entities such as [notable competitors or research institutions]. The ‘834 patent’s strength depends on:

  • Its strategic claim scope and how it overlaps or diverges from existing IP.
  • Encroachment from third-party patents or publications.
  • Ongoing patent filings that might serve as prior art or challenge its claims.

Freedom to Operate (FTO) analyses are essential, especially if the patent claims are broad or if key competitors hold related patents. Litigation, licensing negotiations, or strategic partnerships could hinge on such analyses.


Conclusion

The ‘834 patent presents an inventive advance within its technological arena. Its claims, if rigorously supported by the specification and drafted with precision, can afford significant market exclusivity. Conversely, overbroad claims or claims lacking novelty may undermine its enforceability or render it vulnerable to validity challenges.

A nuanced understanding of the patent landscape reveals that the patent’s strength will ultimately depend on demonstrated novelty and non-obviousness over prior art and how the patent’s claims align with or differ from existing IP. Vigilant monitoring of related filings and potential legal challenges remains imperative for stakeholders seeking to navigate its strategic implications.


Key Takeaways

  • Scrutinize Claim Language: The strength of the “834” patent relies on precise, well-supported claims that avoid broad functional language vulnerable to invalidation.
  • Assess Prior Art Diligently: Extensive prior art exists; thorough analyses are necessary to validate the patent’s novelty and inventive step.
  • Monitor Patent Ecosystem: The technology area is active; continuous landscape mapping aids in identifying infringement risks and licensing opportunities.
  • Strategic Positioning: Broad claims can deter competitors but risk invalidation; narrower claims provide stronger enforceability but limit scope.
  • Legal Vigilance: Regular FTO assessments, combined with proactive defense strategies, are crucial in maximizing patent value.

FAQs

1. What are the key factors determining the strength of the claims in the ‘834 patent?
The strength hinges on claim clarity, scope, novelty over prior art, non-obviousness, and sufficient support in the specification. Clear, narrow claims that focus on inventive aspects tend to be more enforceable.

2. How can competitors challenge the validity of the ‘834 patent?
They might cite prior art disclosures, scientific publications, or demonstrate obviousness based on existing technology, especially if the claims are broad or lack specific structural or process limitations.

3. What strategies can be employed to maximize the patent’s commercial value?
Precise claim drafting, continuous monitoring of the patent landscape, licensing negotiations, and aggressive enforcement practices are key to maximizing value.

4. How does the patent landscape influence the enforceability of the ‘834 patent?
A crowded landscape with overlapping patents increases infringement risks but also offers opportunities for cross-licensing or strategic alliances, influencing enforcement decisions.

5. What are the future considerations for maintaining the patent’s relevance?
Regular patent portfolio updates, monitoring technological advances, and potential filings for improvements or complementary inventions help sustain the patent’s strategic relevance.


References

[1] USPTO Patent Document 11,191,834, issued December 21, 2022.
[2] Prior art references cited during prosecution.
[3] Industry publications discussing advances in the relevant technology domain.

More… ↓

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Details for Patent 11,191,834

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. HUMIRA adalimumab Injection 125057 December 31, 2002 ⤷  Get Started Free 2040-12-29
Abbvie Inc. HUMIRA adalimumab Injection 125057 February 21, 2008 ⤷  Get Started Free 2040-12-29
Abbvie Inc. HUMIRA adalimumab Injection 125057 April 24, 2013 ⤷  Get Started Free 2040-12-29
Abbvie Inc. HUMIRA adalimumab Injection 125057 September 23, 2014 ⤷  Get Started Free 2040-12-29
Abbvie Inc. HUMIRA adalimumab Injection 125057 November 23, 2015 ⤷  Get Started Free 2040-12-29
Abbvie Inc. HUMIRA adalimumab Injection 125057 March 09, 2016 ⤷  Get Started Free 2040-12-29
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 11,191,834

Country Patent Number Estimated Expiration
South Africa 201205433 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2014130064 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2009073569 ⤷  Get Started Free
United States of America 9085619 ⤷  Get Started Free
United States of America 8883146 ⤷  Get Started Free
United States of America 8420081 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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