Medical and Dental Device Patenting Blog : Medical and Dental Patent Lawyer & Attorrney : John Rizvi : Gold & Rizvi Law Firm : Florida, Serving Miami, Ft. Lauderdale, Orlando, Tampa, Florida

For decades heart surgeons have used stents to prop open veins and arteries after angioplasty surgery. Now, a new medical patent aims to help keep the “flow” open in other areas of the body as well.

Allium Medical Solutions Ltd. – developer and manufacture of site-specific stents – has just been granted a patent by the Japanese Patent Office for stents used to treat enlarged prostates.

Allium makes an entire line of stents for use in various places along the urethra. But what makes this one different than their other stents (and ones heart surgeons use) is that instead of a balloon-like stent, this one is shaped like a triangle.

Why Patent a Different Shape?

The prostatic urethral lumen (the part that gets “squeezed” when the prostate is enlarged) has a unique size and shape in each man. Sometimes it’s longer. Sometimes it’s shorter. And each prostate has different contours. Because of this, traditional stents that are cylindrically shaped don’t always do a great job of keeping the flow open.

This new patented medical device takes aim at that problem.

The triangular shape of the stent allows it to fit unique male anatomy better, resulting in higher flow volume and improved comfort compared to existing stents.

It’s called the Triangular Prostatic Stent.

Also – and this is what makes it really unique – it doesn’t put the guy’s voluntary continence mechanism at risk. In plain English, guys can control when they go to the bathroom.

What is a Patent Like this Worth?

Let’s take a look at the numbers…

Prostate cancer develops primarily in men over 50 years old, with more than 80% of men developing prostate cancer before their 80^th birthday.

It is the most common type of cancer in men in the United States, with 186,000 new cases in 2008 and 28,600 deaths. It’s the second leading cause of cancer death in men in the U.S. and UK behind lung cancer. And the problem is growing.

 

 

And since traditional prostate disease treatments focus on removing the cancer (either through chemotherapy, radiation or surgery), side effects include incontinence and impotence.

Surely, an alternative that reduces these risks would be a welcome option to any patient.

For their efforts, Allium won the 2011 Medical Design Excellence Award competition for the Triangular Prostatic Stent. This competition recognizes the achievements of medical product manufacturers and new medical patents that are changing the face of healthcare.

If you have an idea for a new medical device you think could be patented, request your free “Medical Device Patent Kit” by calling 1-866-433-2288.

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Time's Up for Patents on Drugs

Pharmaceutical companies are facing a wave of patent expirations starting this year through 2014. Exacerbating the problem is new competition from generic drugs...and...shrinking new drug approvals from the FDA.

Full story here - Pharmaceutical Company Patents Expiring

Patenting Issues to Blame?

Angiotech Pharmaceuticals, Inc. announces execution of settlement and license termination agreement with Rex Medical, LP. Further reading exposes failure to protect discoveries with patents, loss of patent protection and liability for patent claims may be to blame.

Full story here - Rex Med and Lax Patent 

Stem Cells vs. Patents

Could pharma patents be holding back stem cell research? Scientists at John Hopkins seem to think so.

Full story here - Bioethicists on Patents

Jellyfish Patent?

A Japanese company has applied for a patent that improves immunity in fish against certain diseases. Surprisingly, this comes from a fish predator...jellyfish.

Full story here - Collagen Patent

Patent helps Patients Breathe Easier

"This particular patent is key to our company's entry into an emerging new field of patient positioning, namely Safe Anatomic Positioning™, or the ability to raise, lower, and adjust selected parts of the body while the patient is on an operating table or in another hospital unit — without requiring nurses to manually lift patients and use towels or linens to prop them up," said Robert Weedling, founder and chairman of AirPal Patient Transfer Systems.

Full story here - Patent for Bariatric Patients

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A few months back I spoke at the Florida International Medical Exposition on patenting medical and dental innovations. I'd forgotten about the event until a recent gentleman called into our office and said he saw my medical patent video on YouTube.

Here is the video of my speech. 

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In part one of this article, we talked about obesity and heart disease…two growing trends in America that will require new and innovative medical devices. You can read this article here Medical Device Trends Part One.

Today, we will look two more large-scale health issues that will require new technology, innovation and patents.

Medical Device Patents and Diabetes

Coming in as the seventh deadly killer in the U.S., Diabetes claims roughly 71,382 lives per year. 17.9 million Americans live with diabetes. And another 2.5% of the population does not know they have the disease.

In fact, since 1988 there has been an across the board increase of instances of diabetes regardless of age, sex or ethnicity.

Diabetes is up in Every Category (Click for larger view)

Diabetes leads to greater incidences of heart disease and stroke, high blood pressure, blindness, kidney disease, neuropathy (disease of the nervous system) and even amputations.

And diabetes is a $175 billion per year (and growing) industry.

Surely, creative new patents and medical devices will need to be invented to fight this dreaded disease. What are some of the opportunities for inventors?

There are two types of diabetes. People are either born with type-1 diabetes, or they develop type-2 diabetes. Both versions result in the pancreas producing little or no insulin (a hormone needed to allow sugar to enter cells to produce energy).

Traditionally, diabetics are treated with insulin injections to supplement the lower amounts in the bloodstream. Perhaps there is some invention-in-waiting that is less painful/intrusive than injections? Or maybe you could invent an "insulin pill" that slowly releases insulin over the day? An insulin patch?

Medical Device Patents and Antibiotics

Nearly 100,000 people a year die from antibiotic resistant infections in the United States alone. And doctors are fearing it's only going to become more common.

The reason? Antibiotics are losing their potency.

Here’s why, human beings are a vastly complex creature. We have multiple systems for pumping blood, breathing air and sending electrical systems back and forth. Bacteria are so primitive they don’t even have a nucleus.

Our complexity betrays us. The simple antibiotics we’ve used for the last half century have prompted bacteria to evolve. To develop biological countermeasures that are rendering antibiotics harmless. This wouldn’t be a problem if we were still discovering new antibiotics. But the vast majority of antibiotics were developed over twenty years ago.

What can inventors do?

Inventing new antibiotics is NOT the answer.

I think the more lucrative area for inventors is preventing bacterial infection in the first place (if you’ve seen the explosion in antibacterial products over the last twenty years, then you know what I’m talking about).

More and more people will be scared by news accounts of these new “super-bugs” and will look for different ways to protect themselves.

 

 

That’s it for part two of this article. In part three we will look at the growing threat of cancer, and where the most help is needed…and…why you might want to consider how to help seniors live out their golden years.

 

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Fifteen years practicing patent law, and I’ve seen hundreds of medical device ideas and patents pass through my office.

The nice thing about seeing all of these innovations in the early stages of development is watching how they grow and make a huge impact in the industry. How they ride trends and break ground on new ones.

Seeing as how this is a New Year and a New Decade, I thought I’d take a crack at guessing what the next biggest trends in medical device technology will be over the next few years.

I started by spending a few hours researching the hard numbers on some of the biggest health problems affecting American’s today. Then I took a stab at what I think is to come. Hopefully this will shed a little light to where new inventions will have the biggest impact (and where inventors will find the biggest opportunities).

Keep in mind these are just my best guesses. I may hit the nail on the head or my crystal ball may turn out to be a little fuzzy. Let’s begin with one of the biggest epidemics of the past fifty years.

Medical Device Patents and Obesity

According to CBS News, Americans spend about $35 billion a year on weight loss products.

And that number is sure to grow. The following chart shows the rate of increase of overweight and obese Americans since 1960. If you look closely you'll see that obesity has risen from about 12% of the population in 1960 to over 30% today!

Meanwhile, overweight individuals have hovered at about 30%.

What this means is that more and more people will be looking for creative solutions to lose weight.

So, where are the opportunities for inventors?

Obviously, products that help people lose weight. There are thousands of patents for different exercise machines and the market is littered with trademarked diet schemes and marketing approaches.

Also, I believe there will be more products that promise to keep the weight off in the first place. For example, at my local grocery store they sell a version of an avocado called a "slim-cado". It has about half the fat of a regular avocado. I'm not sure how they did this, but it sounds like a candidate for a patentable procedure.

And of course there are the drastic procedures like gastric-bypass which uses specialty medical device patented tools that could be improved.

And the market for medical device patents doesn't stop here. The growing obesity epidemic will create an even greater need for patents in other areas of medicine.

Medical Device Patents and Heart Disease

Heart disease accounts for roughly 616,067 per year, giving it the dubious distinction of being the leading cause of death in the U.S. The surprising thing about this number is that it is just a fraction of how many lives were predicted to be lost to heart disease.

Why is this?

Maybe it’s greater awareness of the hazards of smoking. Dietary changes. Or more exercise.

I think it’s because of greater funding for treatments and cures. A quick web search will return thousands of charities and donations that host venues to raise money for heart disease.

With that in mind, I believe research and development into medical devices to treat heart disease should be big business for years to come. And then of course there are the patents on the inventions and improvements to surgery devices (think stents for coronary artery blockage).

And don’t forget about post-surgery needs. The average hospital stay after heart surgery is 5-7 days. During this time there are all sorts of tubes, wires and diagnostic equipment involved, all of which can be improved (which I’m sure some smart inventor is working on right now).

In part two of this article we’ll see where the next wave of new medical devices will come from by exploring one of the fastest growing health problems in America…and…the commonly over-abused drug that is quickly losing effectiveness (and is in dire need or replacement).

 

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A few years back a friend of mine had surgery on his knee to repair a torn ACL (the main ligament in the knee). They put him under. Two hours later when he woke up there were three tiny incisions – no more than half an inch long.

Today, you can't even see the scars.

Twenty years ago surgeons would run a scalpel from the top of your thigh halfway down your shin. And this scar would be visible from across the room.

The evolution of medical devices over the last twenty years is astonishing. But the biggest medical patent opportunities for the next 100 years won't be developments in better tools for surgeons. They'll be tools that begin to replace surgeons altogether.

The Flood of Medical Patents for Robots

Half of all prostate cancer operations in the U.S. are performed by the da Vinci surgical robot. It stands nearly 5 feet tall and has four mechanical "arms" with cameras and interchangeable tools to cut, pinch and snip cancer into oblivion. 

Patented Prostate Removal Robot

Over 1,000 of these robots are in operation around the world, at a price tag of one million bucks each (that's over a billion dollars worth of robots for prostate cancer alone!)

The robot is controlled by a surgeon who sits in a nearby room in what looks like a video game control cockpit. In this cockpit the surgeon watches several screens and controls the mechanical arms with perfect precision.

Because this approach to prostate surgery spares delicate nerves, this is a cancer cure that doesn't leave men impotent and incontinent. 

Tools for the DaVinci Robot

This is a far cry from prostate surgery years ago when surgeons couldn't even see the prostate and had to rely on feel alone to remove the cancerous gland.

A Growing Trend for Medical Devices

Robots are not just confined to operating on prostate cancer. Hearts, throats, joints, spines and brains are being mended with the help of these new addition of medical devices. And it doesn't look to stop anytime soon.

• Cardiac surgeons are using robots to perform bypass surgery without using rib spreaders
• Robots make it possible to extract a cancerous thyroid gland through the patients armpit, instead of through the throat which leaves a nasty scar
• Some throat surgeries used to require large incisions, pulled teeth and broken jaws...now robots enter and exit through the mouth

Who knows...in a few years my friends tiny incisions to replace his ACL may seem barbaric. A Florida company, Mako Surgical, holds a patent on a robotic arm to assist in surgery on arthritic knees. 

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Here's an inspirational story (or a warning) for anyone holding a medical device patent.

A privately held maker of blood-testing equipment for diabetics, has fended off attacks from behemoths Abbott Laboratories ( ABT - news -people ), Roche ( RHHBY.PK - news - people ) andMedtronic ( MDT - news - people ) for 8 years at a cost of $31 million!

Full Story Here - Little Guy Goes Head to Head with Medical Device Giants

 

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If you think you need to patent a wildly complex invention to make boat loads of money in the "medical" field, think again. Sometimes simple is better.

Take for example a story I came across while thumbing through the recent issue of Popular Mechanics.

A Medical Device for Prevention

The Popular Mechanics article says...

"Tile-setter Joel Beaton spent 17 years inhaling dust from powdered grout and mortar, which often leads to "potter's rot," or silicosis, an occupational lung disease marked by asthmatic symptoms. Now Beaton has invented (and patented) an attachment that snaps onto a mixing bucket and keeps dust from escaping. The tool evenly distributes the vacuum's suction so it draws in the maximum amount of debris. It's a simple idea, with brilliant results."

After reading the article I visited Beaton's website, www.waletale.net, and found two pictures that beautifully illustrate how this simple "medical device" sucks grout and mortar dust out of the air, preventing lung problems for tile setters.

Before and After Wale Tale

Three Rules to Keep in Mind for a Simple Medical Device

If you're not a Nobel Prize level doctor or have a Phd in biology, anatomy, or an area of medical science  – but still want to profit in the world of medical device patents – here are three things to keep in mind.

Medical Device Patent Rule #1: Common Situations that Lead to Health Problem

Many new patents grew from a need to protect workers who are exposed to health risks on a recurring basis.

A few common examples are:

• Gloves for lawn and garden workers so they don't cut their hands
• Helmets for construction workers so they don't get knocked out by falling debris
• Surgical masks for doctors and nurses so they don't breath in germs
• And on and on...

Joel Beaton identified a frequent situation that caused a long term health problem. Look around the type of work you do day in and day out an ask yourself: Who is exposed to constant health risks?

Medical Device Patent Rule #2: Simple Solution

After you've identified the problem, here are a few questions you can ask yourself that will help you come up with a simple solution.

Is there something that already exists – that you can tweak a little bit – to fix the problem?  In Beaton's case, he designed a simple attachment for a common worksite tool, the shop vac. Can I make it simple so anyone can use it?

Medical Device Patent Rule #3: Cheap to Produce

If this is your first attempt at patenting an invention, you probably don't want to bet the bank on it. So design something with as few moving parts as possible (and preferably out of a cheap material like plastic). That way if you get the patent, it will be much less expensive to manufacture and sell.

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Most medical patents help you get healthier and as a medical device patent attorney, I take a special interest in news and commentary relating to medical and dental patents.  I came across this one medical patent, however, that allegedly killed thousands of people, many of them women and children.

Imagine the following scenario...

You step onto a harmless looking machine. On top of the machine are three viewing ports. One for you. One for your mother. And one for the clueless machine operator. With the push of a button, all three of you are exposed to 20 to 45 seconds of radiation.

To put that into perspective, today's x-rays only last long enough to take a picture...usually less than a second.

The result? Birth defects, tumors, cancer and death.

Does that sound like a horrible Nazi experiment? Well it's not. It's actually occurred in thousands of shoe stores across the United States did from the 1930's to 1950's. You read that right...shoe stores.

Dangerous Use of a Worthwhile Medical Patent

The medical device is called a shoe fitting fluoroscope. It used radiation to produce an x-ray of the foot inside a shoe (to help in fitting). The three viewing ports on the top of the cabinet would allow you to see a fluorescent image of the bones of the feet and the outline of the shoes.

Used mainly as a gimmicky marketing tool, it was a common fixture in shoe stores during the 1930s, 1940s and 1950s. A typical unit, like the Adrian machine shown here, consisted of a vertical wooden cabinet with an opening near the bottom into which the feet were placed.

Most units also had a push button timer that could be set to a desired exposure time. The most common setting was 20 seconds.

Medical Patent Worst for Operator

A 20 second dose of low level radiation won't kill you. But multiple doses every day for a few years will. This patented machine wasn't nearly as dangerous to the customer as it was for the shoe salesman.

Ad for the Fluoroscope Shoe Fitting Machine

For example, to show how a shoe fit many salesperson would put their hands into the x-ray beam to squeeze the shoe during the fitting. As a result, one saleswoman who had operated a shoe fitting fluoroscope 10 to 20 times each day over a ten year period developed dermatitis of the hands.

One of the more serious injuries linked to the operation of these machines involved a shoe model who received such a serious radiation burn that her leg had to be amputated.

This is one medical patent that goes down amongst the worst of the century.

Sources for this patent story:

Shoe Fitting Fluoroscope 

Wikipedia 

Museum of Quakery 

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As a medical device patent attorney, I take a special interest in news and commentary relating to medical patents, dental patents, and related technology.  In this regard, below is a recap of medical patent news for the week:

Five Medical Patent Applications for Lymphoma

MMRGlobal filed five patent applications to treat lymphoma. They include protection for anti-CD20 antibodies, methods of treating B-cell lymphomas using anti-CD20 antibodies, manufacturing methods for idiotype vaccines to treat B-cell pathologies, methods for treating B-cell malignancies with vaccines, and methods for using the vaccines as combinational therapies with chemotherapeutic agents. They’ve also been issued a patent for methods of treating B-cell mediated malignancies.

Read the full story here – Patent Applications

Medical Patent Spat Resolved

MicroAire Surgical Instruments LLC settled a patent infringement and breach of contract lawsuit with Arthrex Inc. involving minimally invasive treatment for carpal tunnel syndrome. Charlottesville, Va.-based MicroAire sued Naples, Fla.-based Arthrex over claims related to the technology, an alternative to open-hand surgery.

Read the full story here – Patent Dispute

Bovie Medical Patents Push Share Price Up

Shares of Bovie Medical Corporation, shot up more than 53% after the manufacturer and marketer of electrosurgical products announced new patents. They also recently submitted an application with the Food and Drug Administration (FDA) to market a new handpiece with retractable cutting features to be used in both laparoscopic and open procedures. On November 8, 2010 Bovie filed additional patents for its new J-Plasma handpiece.

Read the full story here – Medical Patent

Doctor Patents Medical Device to Curb Hospital Infections

Richard H. Ma, M.D has received a patent for a lightweight plastic cover for stethoscopes that will dramatically reduce hospital-acquired infections. Stethguard is a V-shaped clear plastic cover that protects the head of the stethoscope up to its neck, where most of the germs and bacteria are located.

Read the full story here – Medical Device Patent

U.S. Supreme Court to decide Stanford University patent case

The U.S. Supreme Court on Monday agreed to consider Stanford University's quest to assert the patent rights of its medical researchers, setting up a legal showdown between the nation's federally funded academic research arms and one of the world's pharmaceutical giants.

Read the full story here – Medical Patent Case

Judge Nixes Medical Patent

A Texas judge has struck down the patent protection behind a key medical device technology that has been worth hundreds of millions of dollars to Wake Forest University through the years. Called “Vacuum-Assisted Closure”, it helps to close off a wound promoting faster healing.

Read the full story here - Medical Device Patent Struck Down

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Inventors pursuing medical patents involving genes should listen to this...

On October 29^th, the federal government reversed a longstanding policy by saying that human genes are part of nature and therefore cannot be patented. While the U.S. Patent and Trademark Office is not changing its rules for the time being, this decision may reverse the nearly 30 year old legal precedent of patenting parts of nature.

It all started with a March 29^th decision by a Judge Robert W. Sweet that invalidated seven patents related to the genes BRCA1 and BRCA2, whose mutations have been associated with cancer.

The patents were held by Myriad Genetics and the University of Utah Research Foundation, who charged $3,000 to perform tests on women to determine whether or not BRCA1 or BRCA2 genes would lead to mutations which could lead to breast and ovarian cancers. 

You Can't Patent "Natural"

 The main argument in this medical patent case is what is natural and what is not. The government claims that since genes are natural, you can patent them any more than you could patent an apple. A government brief from this case states:

"the chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated' from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth."

Government critics are singing a different tune...

Long Term Innovation Hampered by No Patent Ruling?

 Critics claim the government's anti-patent view of genes will put people in danger. Denying patents – they say – will hamper experimentation and development of diagnostic tests and drugs to treat specific genes. The long term implications being less treatment options for people with rare diseases.

The government insists prohibiting patents on parts of nature would not adversely affect the medical or biotechnology industry. And patents for man-made manipulations to DNA could still be approved.

Who is right? Only time will tell.

Sources for this article:

NPR - Feds Surprise Biotech Industry With Gene Patent Rule

NY Times - Judge Invalidates Human Gene Patent

NY Times - U.S. Says Genes Should Not Be Eligible for Patents

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A new patent-pending mouthwash may solve the needs of 25 million consumers. And at $10 a pop, this could be a brand new $250-$500 million per year industry. If you have an idea for the dental field, then following this company's advice could be your golden ticket.

Patents on Dental Products

I just finished reading a web article on Dentistry IQ - click on the link for the dental patent article - about Orazyme Dr Mouth Mouthwash.

According to the article, dry mouth:

"…is caused by various diseases and their treatments, stress, vitamin deficiencies, and by hundreds of common medications ranging from antidepressants to antihistamines. One in five people will experience its effects at some point.

Dry mouth isn’t just a matter of a dry, sticky uncomfortable feeling, cracked lips, rough tongue and the sensation that the teeth are perpetually dirty. It can be dangerous by affecting appetite, the ability to chew and swallow and digestion. In addition, dry mouth promotes tooth decay and gum disease, which are linked with other systemic diseases."

The article continues by explaining how the mouthwash contains two patent-pending technologies designed to help combat dry mouth.

The first one is a formula that "… features seven natural oral enzymes that remain bioactive through a patent-pending delivery system." The second is a "… patent-pending MIM Salzyme Metal Ion Management technology to help protect the mouth’s immune functions."

 Three Golden Rules for Dental Patents

As an aspiring inventor, there is much you can learn from this new dental product. In fact, after reading the article I came up with three questions you can ask yourself after coming up with an idea.

Patent Question #1: Who is your audience? Apparently, over 25 million people are affected by dry mouth.  Ask yourself, does my idea cater to a large enough audience to be profitable?

Patent Question #2: What is the problem? Dry mouth not only sounds uncomfortable, but it can lead to worse problems like, "tooth decay and gum disease". Ask yourself, does your product address a problem?

Patent Question #3: What's the urgency? Some problems can be put off or ignored, say a leaky faucet or squeaky door hinge. However, a problem that causes daily frequent pain (like dry mouth) is much harder to ignore. Ask yourself, what urgent problem can my product solve?

By creating a dental product that caters to such a large audience with an urgent problem, Orazyme is ensuring their success in the market. If you want to increase the odds of a marketable idea, make sure you ask yourself these three questions before pursuing a patent for your dental product.

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  A new patent pending medical device – based on scientific research – proves even simple innovations to existing products can be very lucrative.

Surgical masks haven't changed too much since 1918. It was the year of the Spanish Flu pandemic, and surgeons adopted cotton gauze masks during surgery to protect themselves from patient diseases.

The interest in masks as germ barriers was based on the work of Joseph Lister, who developed asuccessful system of antiseptic surgery (based on Louis Pasteur's' at the time controversial germ theory).

Since then, there has been much innovation in surgical masks. Lighter materials. More comfortable straps. Anti-glare strips. And of course, bacterial filtration. All worthy of new patents.

A New Patent for an Old Medical Invention

Despite all the new additions, one major problem remained…unique facial features.

Since surgical masks are a mass-produced item, there is no possible way for them to perfectly fit every face. And surgical masks that do not have a completely air-tight fit do not completely prevent the spread of germs.

A new medical patent aims to change that.

I recently came across a press release about a patent from Cantel Medical Corporation for a new type of surgical mask. And it shows how medical research can lead to new patents.  Click here if you would like to read the press release.   One paragraph in particular reveals how this new patent resulted directly from a medical study:

A recent study, published in the September 2010 issue of the American Journal of Infection Control quantified the ability of medical face masks to minimize the spread of infection.  The study, entitled "Quantifying Exposure Risk and Mask Protection," found that a tighter-fitting mask may offer as much as 100-fold greater infection control benefit than standard, loose-fitting masks.

The press release goes on to explain how ill fitting masks are "rolling out a red carpet for dangerous infectious material to bypass the mask" and that proper fitting face masks are cheap insurance against infectious disease.

Takeaways for the Medical Device Inventor

 Studies and medical research are great starting points for possible medical patents for two reasons:

1.    Facts and figures of what needs to be improved

Usefulness is one of the first criteria the patent examiners use to determine if an idea is patentable. The study mentioned above found that "tighter-fitting masks may offer as much as 100-fold greater infection control benefit than standard, loose-fitting masks."

2.    Proof there is a need.

There isn't much good to a new medical or dental idea, unless there is a need, or demand for the innovation.  Looking into medical studies is one way to try and keep your finger on the pulse of medical demand.  Including a reference to the study in the patent application is sometimes a good idea and can be very persuasive to a Patent Examiner of this need.

Spending some time digging through medical research could give you the next big idea.

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One of the hottest areas for inventions is in the medical device field and as a Registered Patent Attorney experienced with patenting medical and dental products nationwide,  I have spoken to hundreds of doctors, dentists, nurses and even some patients interested in securing patents on their innovations.  Some of the best inventions (and most patentable) all share a tried and true formula for success.

This formula

• Saves time
• Lessens your initial investment
• And maximizes the chances that your invention will be approved by the Patent Examiner assigned to your case.

Here's a quick story, that although has NOTHING TO DO WITH MEDICAL OR DENTAL PATENTS, goes a long way to illustrate a simple formula uncovering patentable and profitable niches in the market.

Patent Lessons from a Golfer

I just finished reading a short article on South Carolina golfer and inventor Michael Owens (http://tinyurl.com/368xxma). Owens has a patent pending on a device that securely holds personal golf GPS devices and laser rangefinders in place on golf carts.

The device that holds the GPS on golf carts only took him several months to create, test and refine. With an outstanding order of 1,200 units at $29.95 each, Owens will just about cover his initial $45,000 investment.

Less than a year and already his idea is paying off.  In terms of bringing an idea to market, that’s almost lightening speed!

The Easier Path to Patents

The inventor trick Owens used to quickly create a profitable invention is simply finding a better way to use an already wildly successful product.

Here's how he did it…

First, Owens found a product that people are already using.

If you are a golfer, you already know GPS units and laser range-finders are all the rage on the links. By linking his product to something that people use and are familiar with, Owens greatly increased his chances of patenting a marketable product.

Second, find a way to make that product easier to use.

In this case, Owen saw his friends fumbling with the GPS units in their pockets, in cart cupholders, seats or open spaces in the dashboard area. By creating a sturdy magnet-based GPS holder – that also didn't need to be removed constantly – Owens took a great product and made it better.

And if his patent application goes through, he will have the right to prevent anyone else from making, using, or selling his idea.  A legal monopoly that he can charge a royalty percentage or outright sell to another.

Keep these two points in mind next time you are working on your next big idea.

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Are you a doctor with an idea for an invention that could change the face of modern medicine…treat patients better, faster or cheaper…and (hopefully) fill your pockets with riches beyond the dreams of avarice?

If so, then you should know about a little "loophole" in the patent law that could negate the patentability of your inventions.

Here's the story: "John" is a doctor who has an idea for a product that will lower blood pressure. After a few months of tinkering in his garage, John has his invention in working order.

For two years John tests and improves his invention. During this time he also writes a few articles on the benefits of his new invention. And outlines a case study on his website. After John gets everything in working order, he decides to patent his invention…only to find out the patent is denied.

 

Why Patents Get Rejected

 

According to patent law to qualify for a new patent, inventions must be "novel". This means it does not exist in the "prior art," which includes publicly available written information or products that have been publicly used or sold.

The problem is that "prior art" is a very vague term.

Anything that could put your invention into the public mind (including simply publishing articles or using it in public) could be enough to qualify it as "prior art" and prevent you from exclusively cashing in on your idea.

With that in mind, here are the two mistakes John made.

 

Patent Mistakes

 

Mistake #1: Publicly Using the Invention – You should be particularly careful regarding public use, as the law does not require a high level of public exposure.

Mistake #2: Publishing the Inventive Idea – "Prior art" includes (among other things) any publication describing an invention that was published more than one year before filing a patent application covering the invention.

Even though the United States permits a one-year grace period in which to file a patent application, it is still prudent to file a patent application before selling, offering to sell writing about or publicly using the invention.

 

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    In the online edition of Time magazine, an article reports that asthma inhalers containing chlorofluorocarbons (CFCs) will be illegal for production or sale as of December 31st of this year, because of known detriments of CFCs to the environment. Medical patent attorneys and innovators should look for opportunities to create greener inhalers, particularly as current options are inconvenient.

    The current greener asthma inhalers require a specific cleaning procedure to prevent clogging, and they also tend to be more expensive. The CFC-free options on the market today include "GlaxoSmithKline's Ventolin HFA, Schering Plough's Proventil HFA and Ivax Corp.'s Proair HFA." These contain albuterol; another inhaler from Sepracor--their Xopenex HFA--contains a similar medication, levalbuterol.

    As a medical patent attorney (or at least a patent attorney with a particular specialty and expertise in medical patents anyway), I look forward with interest to green alternatives in asthma inhalers, which are both more convenient and less costly to the consumer. Something to make us all breathe a little easier.
 

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    Think medical patents couldn't derive from a state known largely for its cheese? The University of Wisconsin-Madison begs to differ, and the students who flock to their biomedical engineering program from all over the country agree. Taking an unusual experiential approach, UW-Madison sets itself apart by offering students the opportunity to solve real-life clinical issues through research and design.

    This leads to ongoing medical patent opportunities for its students, who can watch their accomplishments from conception to completion--and in the field resolving medical needs. In the full article at Newswise, biomedical engineering chair and department head Robert Radwin says their program is unparalleled. "Almost every engineering program has a senior design experience, but all our BME students work on projects throughout their curriculum. You can only do this in Wisconsin, and students come here because of this curriculum."

    Among recent students who have sought or received medical patents for their innovative medical designs are undergraduates Claire Flanagan and Ashley Huth and alumni Chris Westphal. Flanagan and Huth filed a provisional medical patent application for a syringe that can separately "store liquid and solid components, and mix and administer a solution." This is to solve a contemporary challenge in delivering "complex and multi-component therapeutics" according to UW-Madison professor W. John Kao. Westphal was part of a team that developed and manufactured a device to help researchers study hamstring injuries using MRIs.

    The list of collaborative and independent innovation is long and ongoing, as are the opportunities for students to commemorate their efforts with medical patents (and ensuing profits). "I think the opportunity of being able to get a [medical] patent before you get your undergraduate degree lingers in the minds of many students while they are designing and building their devices," says Westphal. Imagining crossing leaving the stage with a diploma and a medical patent in hand, and I believe Mr. Westphal is right on the money.

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    Medication accounts for a great majority of medical patents, though every medication has its side effects. There's no doubt medicine is saving lives and yet there are clear medical patent opportunities to minimize the risks associated with them. The main difficulty, as you in the medical community may be aware, is that medication is designed to handle a specific issue within the body. However, everything within the body is connected and the challenges in treating one area without impacting any other is significant.

    One such area where improvements are needed is in treating prostate cancer as a new study describes the difficulties patients have in selecting the treatment plan with the lowest side effects (AP via CNN Health). The study, published on March 19, 2008 in the New England Journal of Medicine, studied four prostrate cancer treatments: surgery, standard radiation, radioactive seeds (for patients in the early stages), and hormone therapy.

    The side effects of the various treatments were related to sexual and urinary complications. Hormone therapy in combination with radiation "had a big effect on men's vitality and sexuality." Similarly, radioactive pellets created sexual problems, as well as "discomfort in urinating." Surgery, too, impacted sexual performance and a small percentage had trouble with incontinence one to two years after the surgery. Bowel problems, such as rectal pain and a higher frequency of trips to the bathroom were associated to varying degrees with the treatment plans. And, this is, in fact, my point: while the side effects I've described varied depending on the therapy used, they were present with all of them.

    Looking ahead, I'm wondering where medical patent innovation may take us, where we may find remedies, in medicine and otherwise, that reduce or eliminate side effects. And, I specifically wonder whether taking a more holistic, systemic view in the treatment of any medical issue may lead to medical patent innovations and developments that will help us recover and thrive.

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       Consumer interest in organic and natural products—those devoid of harmful environmental toxins—continues to escalate and broaden into more and more categories. Even in the most mainstream areas of the United States, organic products are taking up more and more shelf space, indicating the patenting opportunities for organic solutions are also on the rise.

        According to an article at ScienceCentric.com (December 4,2007), researchers at the Universidat Juate I and the Spanish Research Council know this. They have patented a method for removing pollutants from bivalve mollusks before we consume them. Bivalve mollusks include the shellfish who typically breed in shallow water and filter sea water to gather in nutrients—and pollutants—for instance, clams, mussels, and oysters. Compared to the current techniques of flushing the shellfish with sterile, filtered water or applying hydrostatic pressure, the researchers' patented technique reportedly removes the pollutants much more efficiently, at two to four times the speed and in increasing the mollusks' tolerance for "oxidative stress."

       Environmental toxins have been linked to cancer and certain neurological disorders (e.g., Parkinson's Disease), as well as degenerating other functions within our systems. As these researchers, other scientists and medical practitioners, and entrepreneurs in areas far afield show us, organic solutions are solutions we can use and, in some cases, vitally need. Look into your own field of expertise—what uninvented organic solution might advance our bodies' abilities to develop and/or function? I, for one, would love to know, and, from what I've seen, the world would, too.

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