A Specific Antibody for Detecting Human IgG4 in Medical Tests
This patent describes a unique lab-made antibody designed to precisely find and stick to a specific part of human IgG4, a type of immune protein, which is useful for diagnosing certain diseases.
Original patent title: “Anti-human igg4 monoclonal antibody and human igg4 assay reagent using said antibody”
This patent describes a unique lab-made antibody designed to precisely find and stick to a specific part of human IgG4, a type of immune protein, which is useful for diagnosing certain diseases. Owned by Nitto Boseki Co with 24 claims and 2 forward citations, and it is expected to expire in 2038.
Coverage
What does this patent actually cover?
This patent claimsclaimsThe numbered statements at the end of a patent that legally define what the inventor owns.Read more → a monoclonal antibody that specifically binds to human IgG4. The antibody targets a very particular spot, or epitope, on the human IgG4 heavy chain constant region (specifically amino acid positions 221 to 327 of SEQ ID NO: 4), which must include glutamic acid at position 299, as stated in claimclaimA numbered sentence at the end of a patent that legally defines what the inventor owns. The most important section.Read more → 1. The patent also covers methods for using this antibody to detect human IgG4 in a sample, for example, through an immunological particle agglutination inhibition method (claim 11 and 12). This detection involves the antibody binding to IgG4 in the sample, then adding an insoluble carrier with IgG4 attached, and observing if clumping (agglutination) is inhibited, which indicates the presence of IgG4 in the original sample (claim 13). The patent further includes kits containing this antibody for such detection, which can assist in diagnosing IgG4-related diseases (claim 14 and 18).
The gap
What does this patent NOT cover?
- Does not cover antibodies that bind to other types of human immunoglobulins like IgG1, IgG2, or IgG3.
- Does not cover antibodies that bind to a different region or epitope on human IgG4, especially if it lacks glutamic acid at position 299.
- Does not cover detection methods for human IgG4 that do not use this specific monoclonal antibody or its bivalent forms.
- Does not cover detection methods that are not based on the principle of immunological particle agglutination inhibition.
- Does not cover diagnostic methods for IgG4-related diseases that do not rely on detecting human IgG4 levels.
These exclusions are unique to PatentBrief — derived from the actual claim language, not patent-office boilerplate.
Key facts
What made this novel
The cleverness lies in the extreme specificity of the monoclonal antibody. It's designed to bind to a very precise epitope on the human IgG4 heavy chain, specifically requiring glutamic acid at position 299. This targeted binding ensures that the antibody only detects IgG4, avoiding false positives from other similar proteins.
The Patent Drawing

Schematic visualization of the patent's claim structure. Hand-drawn diagrams in progress for each landmark patent.
Where you've seen this
Real-world examples
Diagnostic kits for IgG4-related autoimmune pancreatitis
Laboratory tests for IgG4-related sclerosing cholangitis
Assay reagents for measuring serum IgG4 levels in clinical settings
Research tools for studying IgG4-mediated immune responses
Why it matters
The bigger picture
Human IgG4 is a specific type of antibody in the body, and its levels can be elevated in certain autoimmune conditions known as IgG4-related diseases. Accurately detecting and measuring IgG4 is crucial for diagnosing and monitoring these conditions. This patent provides a highly specific tool, a monoclonal antibody, that can improve the reliability and precision of such diagnostic tests, helping doctors identify these diseases more effectively.
Filed
July 5, 2018
Market context
Who's building on this
Companies in this space
Nitto Boseki Co Ltd, the assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more →, is active in the field of clinical diagnostics and likely uses this technology in its own product development. Other companies specializing in in vitro diagnostics and immunoassay development, such as Roche Diagnostics, Siemens Healthineers, and Abbott Laboratories, are continually developing and refining assays for various biomarkers, including immunoglobulins, and might build on similar highly specific antibody technologies.
Market impact
This patent contributes to the market for diagnostic reagents and kits, particularly for autoimmune and inflammatory diseases. By providing a highly specific antibody for human IgG4, it enables more accurate and reliable diagnostic tests. This precision can lead to earlier and more confident diagnoses of IgG4-related diseases, potentially improving patient outcomes and influencing the development of specialized diagnostic product lines within the clinical laboratory market.
Claim 1 — Plain English
What this patent covers
This patent claims a monoclonal antibody that specifically binds to human IgG4. The antibody targets a very particular spot, or epitope, on the human IgG4 heavy chain constant region (specifically amino acid positions 221 to 327 of SEQ ID NO: 4), which must include glutamic acid at position 299, as stated in claim 1. The patent also covers methods for using this antibody to detect human IgG4 in a sample, for example, through an immunological particle agglutination inhibition method (claim 11 and 12). This detection involves the antibody binding to IgG4 in the sample, then adding an insoluble carrier with IgG4 attached, and observing if clumping (agglutination) is inhibited, which indicates the presence of IgG4 in the original sample (claim 13). The patent further includes kits containing this antibody for such detection, which can assist in diagnosing IgG4-related diseases (claim 14 and 18).
The clever bit
The cleverness lies in the extreme specificity of the monoclonal antibody. It's designed to bind to a very precise epitope on the human IgG4 heavy chain, specifically requiring glutamic acid at position 299. This targeted binding ensures that the antibody only detects IgG4, avoiding false positives from other similar proteins.
What it does not cover
- Does not cover antibodies that bind to other types of human immunoglobulins like IgG1, IgG2, or IgG3.
- Does not cover antibodies that bind to a different region or epitope on human IgG4, especially if it lacks glutamic acid at position 299.
- Does not cover detection methods for human IgG4 that do not use this specific monoclonal antibody or its bivalent forms.
- Does not cover detection methods that are not based on the principle of immunological particle agglutination inhibition.
- Does not cover diagnostic methods for IgG4-related diseases that do not rely on detecting human IgG4 levels.
Patent timeline
Application submitted to the patent office
Patent enters public domain
PatentBrief Score
Impact Score
Early stage
Citation count
10/40
Early citations
Claim breadth
16/20
Broad claimsclaimsThe numbered statements at the end of a patent that legally define what the inventor owns.Read more →
Recency
0/20
Older than 20 years
Assignee scale
0/20
Independent or smaller assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more →
PatentBrief Impact Score — based on citation count, claim breadth, recency, and assignee scale. Not a legal assessment.
Heuristic Value Estimate
What this patent might be worth
$49K – $156K
Midpoint $98K · 11.7 yr remaining · industry ×1.5
Heuristic only — blends forward/backward citation counts, claim scope, time remaining, litigation history, and CPC-derived industry baseline. Real valuations need a professional appraisal.
Claim text not yet imported for this patent
The original legal language
Original claims
24 claims as filed with the patent office.
Concepts involved
Citations
Patent lineage
Cite this patent
KASHIWAGURA, H., TERUUCHI, Y., INAGAKI, K., MATSUKI, Y., & Sasaki, D. A Specific Antibody for Detecting Human IgG4 in Medical Tests (U.S. Patent No. 20,210,140,973). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/20210140973/anti-human-igg4-monoclonal-antibody-and-human-igg4-assay-reagent-using-said-anti
Auto-generated from the patent record. Double-check author order and the issue date against the official USPTO document before submitting.
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Common Questions
Frequently Asked Questions
What does A Specific Antibody for Detecting Human IgG4 in Medical Tests cover?
This patent describes a unique lab-made antibody designed to precisely find and stick to a specific part of human IgG4, a type of immune protein, which is useful for diagnosing certain diseases.
Who owns patent US 20210140973?
This patent is owned by Nitto Boseki Co.
When does this patent expire?
This patent is expected to expire on July 5, 2038, when the invention enters the public domain.
What is patent US 20210140973 cited by?
This patent has been cited by 2 later patents that build on its ideas.
What problem does this patent solve?
Human IgG4 is a specific type of antibody in the body, and its levels can be elevated in certain autoimmune conditions known as IgG4-related diseases. Accurately detecting and measuring IgG4 is crucial for diagnosing and monitoring these conditions. This patent provides a highly specific tool, a monoclonal antibody, that can improve the reliability and precision of such diagnostic tests, helping doctors identify these diseases more effectively.
What does this patent NOT cover?
Does not cover antibodies that bind to other types of human immunoglobulins like IgG1, IgG2, or IgG3.
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