Invented by Nara; Peter L., Sindelar; Daniel L., Tobin; John Knox, Wiggins; Taralyn Janette, Tobin; Gregory John, Potempa; Jan Stanislaw

Let’s dive into a breakthrough patent focused on detecting and treating diseases linked to a mouth bacteria called Porphyromonas gingivalis. This patent introduces clever ways to find and fight a special protein, gingipain, that this bacteria makes. Gingipain doesn’t just cause gum problems. It may also play a big role in other serious diseases. Here, we break down what this patent means, why it’s a big deal, and how it could help many people worldwide.

Background and Market Context

Gum disease is one of the most common health problems in the world. But it’s not just about sore gums or losing teeth. Research now shows that the root cause—bacteria like Porphyromonas gingivalis (called Pg for short)—may be linked to diseases all over the body, not just the mouth.

Pg is a tiny bug that hides in the mouth, often forming a sticky film on teeth called a biofilm. Even after careful cleaning or visits to the dentist, this bug can come back quickly. It’s sneaky and often doesn’t cause pain or swelling until it’s done a lot of harm. Many people have it living in their mouths and don’t even know it.

The real problem with Pg is not just where it lives, but what it makes. Pg produces special proteins called gingipains. These proteins can break down other proteins and help the bacteria survive. But that’s not all. Gingipains can move from the mouth into the blood and reach organs like the heart, brain, and joints. There, they may trigger inflammation. Scientists believe this can lead to diseases like heart attacks, strokes, arthritis, and even Alzheimer’s disease.

For years, doctors and dentists struggled to connect the dots. Why do people with gum disease seem to get sick in other ways? Only now, with new tools and better science, are we starting to see the full picture. The market for products that can find and stop these harmful proteins is growing quickly. People want simple, accurate tests to catch disease early and new treatments to stop it in its tracks.

This patent is aimed at tackling a huge market need—fast, reliable ways to spot gingipain, and smart treatments that target the bacteria and its dangerous proteins. If doctors can find gingipain early, they can treat the root cause before it leads to bigger problems. The idea is to use tests that look for antibodies (the body’s way of fighting germs) against gingipain. If a person has high levels of these antibodies, it may mean their body is fighting a Pg infection, even if they feel fine.

The patent also covers new treatments that work like guided missiles. These treatments use special molecules—called antigen-binding molecules or ABMs—that stick to gingipain and block its harmful effects. These ABMs can be given to people as medicine, helping their body get rid of Pg or stop it from causing damage elsewhere.

As the world learns more about how mouth health links to overall health, the demand for these tests and treatments will only grow. This invention may help millions prevent, discover, and treat diseases earlier and more effectively than ever before.

Scientific Rationale and Prior Art

To understand why this invention is groundbreaking, it helps to know what scientists already knew—and what was missing.

Pg is a special type of bacteria known as “gram-negative.” It doesn’t use sugar for energy and prefers to live where there isn’t much oxygen, such as the spaces between the gums and teeth. Pg can hide out in the mouth for a long time, forming biofilms that are hard to remove. It can also slip into the bloodstream, especially if the gums bleed.

One of the most powerful tools Pg uses are its gingipains. These are enzymes that cut up proteins. There are different kinds, like RgpA, RgpB, and Kgp. They help the bacteria get nutrients and defend themselves from the body’s immune system. But when gingipains escape into the blood, they can also harm healthy tissues. Studies have found gingipains in the brains of people with Alzheimer’s disease, in the blood of people with heart disease, and in other tissues with chronic inflammation.

Until now, most ways to find Pg involved looking for the bacteria itself—using DNA tests, growing it in a lab, or looking under a microscope. But these methods have problems. Pg doesn’t always show up in the mouth, even when it’s causing trouble somewhere else. Sometimes, the bacteria are hiding or their DNA is hard to find. Plus, by the time a doctor or dentist sees the signs, the disease can be far along.

The body does try to fight Pg. When Pg or its gingipains get into the body, the immune system makes special antibodies to attack them. These antibodies float around in the blood and other body fluids. If you have a lot of these antibodies, it can mean your body is fighting a Pg infection.

Some research tried to measure these antibodies. But there were no simple, standard tests for this. Some used “ELISA” tests—a lab method where a plate is coated with a piece of the target protein, and if the person’s blood has matching antibodies, they stick and can be measured. But the best pieces of gingipain to use in these tests were not well known. Also, treatments that could target gingipain directly were just starting to be explored.

There were also no good ways to link antibody levels to the need for treatment. Doctors couldn’t say, “If your antibodies are high, you should get this medicine.” There were no clear links between the test results and what to do next.

This invention changes all that. It describes exactly which parts of gingipain work best for these tests, how to make the tests reliable, and how to decide who needs treatment. It also covers new ABMs (antigen-binding molecules) designed to stick to gingipain and act as a treatment. These ABMs are carefully chosen and improved so they work in humans and last long enough in the body to be useful.

In short, the patent fills major gaps left by earlier research:

• It gives a clear way to test for gingipain antibodies in many types of samples (blood, saliva, urine, etc.).
• It explains how to compare results to a healthy “negative control” to decide if a person is at risk.
• It connects the test to action—if antibody levels are high, start therapy.
• It introduces new treatment molecules that can block or remove gingipain from the body.

Before this, no one had brought together all these steps into a single, logical system that can be used in clinics and labs. Now, doctors have a roadmap for finding and fighting these hidden infections before they cause bigger health issues.

Invention Description and Key Innovations

Let’s take a closer look at what this patent covers and why it matters.

At its heart, the invention is about two big things:

1. Testing for gingipain antibodies to find out who may have a Pg infection or related disease.
2. Giving a targeted therapy if the test is positive, to treat the problem at its source.

Here’s how it works in simple steps:

Step 1: Testing for Gingipain Antibodies

A sample is taken from the person. This can be blood, plasma, serum, saliva, tears, urine, sweat, or even feces. The sample is then tested in the lab using an ELISA or Western blot. The test uses a piece of the gingipain protein (the patent details exactly which pieces work best) stuck to a plate. If the person’s sample has antibodies that stick to this protein, it means their body is fighting Pg or has seen it before.

The scientist or doctor compares the amount of antibody found in the sample to a “negative control.” This control could be a sample from the person before they got sick, or from a healthy person. If the antibody level is higher than the control, it suggests a Pg infection or related disease may be present.

What makes this step unique is the careful choice of the protein sequences used for the test. The patent picks out certain gingipain sequences (like those with at least 80% identity to SEQ ID NOs:162, 191, 194) that are very good at catching the right antibodies and giving clear results. The test is designed to be sensitive (picking up even small amounts) and specific (only reacting to Pg gingipain).

Step 2: Deciding Who Needs Treatment

If the test shows high levels of gingipain-binding antibodies, that’s a red flag. The person may be at risk for not just gum disease, but also for a wide range of other problems—heart disease, diabetes, cancers, arthritis, brain diseases like Alzheimer’s, and more. The patent lists many diseases that may be linked to gingipain.

This is a big leap. Instead of waiting for disease to show up, doctors can now spot risk early, with a simple test. And because the test works with many types of samples, it’s easy to use in different settings—from dental offices to hospitals.

Step 3: Treating the Problem at its Source

The next part of the invention is about what to do if the test is positive. The answer: use a therapy that targets gingipain directly. The therapy is an antigen-binding molecule (ABM) that is designed to bind to gingipain and block its harmful actions. These ABMs are “humanized” or “chimeric”—meaning they are made to work well in humans and don’t get broken down quickly by the body.

The ABMs are built based on certain genetic sequences (for example, a heavy chain variable region with sequences from SEQ ID NO:9 or 37, and a light chain variable region from SEQ ID NO:10 or 38). These regions are the best at sticking to gingipain. When given as a treatment, these ABMs can:

• Stick to and block gingipain enzymes, stopping them from harming tissues.
• Help the immune system find and clear out Pg bacteria and their harmful proteins.
• Lower inflammation and slow or stop the progress of related diseases.

The therapy can be given in many ways—by injection, by mouth, or even as a rinse or gel in the mouth. This flexibility makes it easy to use in many patients, from those with early gum disease to those with more serious health problems.

Other Innovations

The patent also covers:

• New proteins and genetic materials for making the tests and treatments. This includes special recombinant proteins (rGP-1, rGP-2) that are easier to produce and use in labs.
• Kits that contain everything needed for testing—a coated plate, the right antigens, and detection antibodies—so labs and clinics can run tests quickly and accurately.
• Ways to monitor disease over time. Doctors can test patients before and after treatment to see if antibody levels drop, showing the therapy is working.
• Use of mass spectrometry and other methods to find and measure different forms of gingipain, for even more detailed analysis.
• Strategies to keep ABMs stable in the mouth, so they aren’t broken down by enzymes and can work longer.

Why These Innovations Matter

In the past, doctors and dentists could only guess at the link between gum disease and other illnesses. They had no easy way to catch Pg infections early, or to know if someone was at risk for bigger problems. Treatments were often general—just antibiotics or cleaning the teeth—and didn’t target the real cause.

With this invention, everything changes. Now, a doctor can test for gingipain antibodies in a simple sample. If levels are high, they can give a treatment that goes straight to the problem. This approach is more precise, more effective, and can be tailored to each person. It turns old ideas about gum disease and health upside down, making prevention and early action possible.

This patent doesn’t just help scientists—it helps real people. Anyone at risk for gum disease, heart problems, diabetes, arthritis, or memory loss could benefit. The invention opens the door to a future where diseases linked to hidden infections can be caught and treated before they steal years from someone’s life.

Conclusion

This patent is a true step forward in health care. By focusing on the harmful proteins made by Porphyromonas gingivalis, it offers new ways to find disease risk early and stop it before it spreads. With smart tests and targeted treatments, doctors can help people stay healthier, longer. As science learns more about the links between the mouth and the rest of the body, inventions like this will be at the center of a new era in medicine—one where early detection and precision treatment make a real difference for everyone.

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