How Medical Research Leads to New Patent Ideas

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 a successful 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. 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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Does My Invention Qualify For A Patent?

If you have invented a certain thing that is distinct from the others and you firmly stand that it will create a huge impact in the industry, provisional patent should be a huge interest for you. Without having the stamp of patent on your particular invention, there will be a huge probability that your idea will be stolen from you. With provisional patent, you will solely reap the fruit of your labor.

Do you think your invention qualify for a patent? To figure it out, you are opted to create a bunch of researches and paper works to prove the uniqueness and advantages of your own invention. Always make a reality check to make sure that it won't be disqualified for a particular line.

In America for instance, U.S. Patent and Trademark Office (USPTO) filter those with unique inventions to protect various inventors for possible counterfeit of ideas. They have the power to reject applications after further investigations and tests. When they are already fully convinced that your craft is distinct from the others, they will give credit on your invention by issuing a provisional patent for your own security.

There are also certain products that cannot be patented such as unsafe pharmaceutical products, dangerous nuclear weapons, those that are not operable and non-operable for aesthetic development, those creations that are deemed illegal in nature and "whimsical" as what the patent office labeled them which means "serving no serious purpose". More so, the legal office also dismantles ideas violating rights and principles of other people. Certainly, if USPTO discover these things, they won't think twice to disapprove your application.

The most important criteria that USPTO consider to approve applications for provisional patent are the uses and benefits that a particular invention can generate. Even though the invention is distinct and unique, but if a particular craft will have no benefits and advantages to various customers, application for patent will surely be rejected. It is the responsibility of the inventor to jot down all the uses and benefits of his invention signed by different professionals and experts that would attest to the usefulness of the creation.

At this point, inventors must be very careful not to disclose particular ideas. It would matter a lot if you publicly announce any information pertaining to your invention before the application of provisional patent. Aside from that, character and credibility of the people around whom you sought for assistance and opinions during the entire process must be given emphasis as they will be part of your secured assets to prevent unauthorized disclosure of your craft.

For the purpose of documentation, jot down anything you did. You should also know your associates or advisers well so you will not be abused in the long run. Focus well on your invention and consider the subject of applying for early rights over your unfinished products to avoid problems in the future.

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Narrower Patents for Biotech Inventions?

The European Court of Justice (ECJ) has made a controversial decision to hand down judgement on a case which had requested a preliminary ruling on the biotechnology Directive's legal protection regarding genetic material.

The case, which has been of great political and commercial interest on an international scale, centres round the company Monsanto, holders of a patent which claims a DNA sequence coding for an enzyme that protects plants from glyphosate-containing herbicides (CP4-EPSPS).

With this enzyme, Monsanto have developed a soy plant, "Roundup Ready", which is resistant to Monsanto's own non-selective herbicide, Roundup, and is widely cultivated in Argentina.

A large cargo of the plant, which had been processed into soy meal, was seized on arrival at Amsterdam in 2005 and 2006 and on testing, revealed both the presence of the enzyme CP4-EPSPS, and the DNA sequence encoding it.

The issue at hand was that the patent protection only applied to the DNA sequence coding in a form in which it could be expressed into a plant, and not when it was present in harvested goods or as isolated DNA. On a general scale, Article 9 of the Directive 98/44 does not confer patent protection when the patented product no longer performs its function but has the potential to do so again if extracted and introduced into a living organism.

Despite the fact that Monsanto's patent was applied for and granted before the Directives adoption, absolute protection would only apply under the national legislation at the time of grant.

The ECJ concluded that patent protection only extends to a situation where DNA performs the function for which it is patented, within the product within which it is incorporated.

Despite the Directive's aim, which was to clarify existing patent laws and provide more protection, the Directive may have simply narrowed the protection afforded to biotechnological inventions.

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How To Patent

Introduction and types of patent Many types of ideas can be patented. Anything that has a function or use can be patented. Also, patent protection can cover many (but not all) types of business methods, most types of computer programs, new methods and processes, new chemicals and compounds, and new materials or new uses for old materials. Where the invention is for a design feature or an ornamental cover or casing, for example, then a design patent is the best way of protecting the invention. How to get a design patent, and how to patent a design, is explained in a separate section below.

How to Patent an Idea An idea can best be protected by a utility patent application. This is also sometimes called a "regular" patent application. The idea can be explained in words and, if possible, by drawings. The drawings do not need to be like blueprints; instead, they are simplified and do not usually have to show conventional features. And, it is not necessary to have a working model.

Before getting into the details, we would like to mention that there is also something called a "provisional patent application" discussed hereunder. It gives patent pending status for one year, permitting a utility patent application to be filed at any time during that year. That is another way to get a patent. The provisional application is much less expensive than a utility patent application, and can be recommended when there is an urgent need to get a patent application on file with the US Patent Office. For example, just prior to a trade show or publication of the invention, there is an urgent need to have the idea on file with the US Patent Office. For further information, see the section below called "How to patent using a provisional patent application."

Here's a simple example showing how to patent an idea for a very simple and amusing invention. The simple idea: add a blinking light to a pencil eraser. For the moment, we aren't concerned with whether it has been done before; we could find that out using a patent search if we wished. For now, the idea would be expressed in words in the patent application, written just as above. And, since it is possible to illustrate the idea in a drawing, we would also add a sketch showing where the light should be placed on the eraser. What else should be shown? The light should have a power source, for example a small solar panel or a small battery, and connecting wires should be shown connecting the power source to the light. Then, text is added to the patent application by describing the parts shown in the drawings, explaining possible uses and advantages, and mentioning possible alternatives that are included in the invention such as various types of light sources such as LEDs, incandescent bulbs, phosphorescent lighting, and so on.

Next, a claim is added to describe the invention broadly, such as the following:

Claim 1: A pencil eraser having a light, comprising: a pencil body; an eraser member attached at one end of the pencil body; a light source mounted on the eraser; and a power source connected to supply power to the light source.

Standard text is then added including sections titled: background of the invention; summary of the invention; brief description of the drawings; and an abstract of the disclosure. These are not usually hard to do, but can take some time.

Then, a Declaration is prepared showing the name of the inventor and title of the invention. This is from a standard form provided by the US Patent Office.

Last, a cover page including a Transmittal sheet is prepared, listing what is being filed with the US Patent Office. The Transmittal page normally will include a check for the amount of the US government filing fee, and a postcard filing receipt. The check can be omitted, as can the signed Declaration, but in that case the US Patent Office will send a notice asking for those items along with a relatively small late fee.

The drawings may or may not be accepted as filed. If not accepted, the US Patent Office sends a notice, and sets a time period for submitting the formal drawings. A specially skilled draftsman normally prepares the formal drawings, since the US Patent Office has very specific and detailed requirements for the drawings. We work with such a skilled patent draftsman, to provide the formal drawings.

The application is examined by the US Patent Office. If granted, the application matures into a utility patent. A granted utility patent can be enforced in court, and it can be assigned and licensed too.

If you call or email us, we would be happy to discuss your invention or idea. There is no charge for discussing how to patent your idea or invention. Sometimes we can provide an insight into how to manufacture or market the invention, based on our experiences. We can help with negotiating with potential distributors, investors, and licensees. We can explain how to get a patent, how to patent your ideas, the costs involved, and any other issues of interest to you. We can explain what might help, and the lowest cost ways to get the needed protection. This is at no charge, and we like talking with inventors.

At this point we can provide a fixed fee estimate, based on your brief description of your idea. In some cases, we would need to see more information such as a drawing or a written description, that would help us form an accurate fixed fee estimate. That is all confidential. At that point, if you wish to proceed further, then you would provide one half the estimated amount in advance; we prepare the draft application and paperwork; then you send the other half of the fee after you have approved a final draft that you feel is ready for filing with the US Patent Office.

We would enjoy helping you get a patent! And, if you like, we can give our comments based on our own experience on how to commercialize the invention, including suggestions on manufacturing, marketing, and attracting investors.

And that is how to patent an idea!

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What Is Inequitable Conduct When Securing a Software Patent?

An applicant for a software patent has a duty to disclose information that is material or relevant to the patent application. This means that if the applicant knows about another invention that is similar to the applicants own innovation, the applicant must disclose the other invention. If the material information is not disclosed and a patent is issued, the patent may be found unenforceable for inequitable conduct.

When a patent holder sues to enforce a patent, the defendant will often look for evidence of inequitable conduct in order to invalidate the patent and end the patent enforcement action. Typically this will involve combing through mountains of documents that the inventors or their attorneys had knowledge of in order to find information that could have been disclosed during examination of the patent. If the defendants can find evidence of inequitable conduct, they can escape paying damages for their infringement.

The information that must be disclosed is defined by 37 C.F.R. 1.56(a) which states that the information is material if: "(1) It establishes, either by itself or in combination with other information, a prima facie case of unpatentability of a claim; or (2) It refutes, or is inconsistent with, a position the applicant takes in (i) Opposing an argument of unpatentability relied on by the Office, or (ii) Asserting an argument of patentability."

The danger to patent holders is that disclosure requirements provide a way for an infringer to invalidate an otherwise valid patent. The infringer doesn't have to show that he didn't infringe the patent. Instead he need only show that the patentee engaged in inequitable conduct while obtaining the patent. This is a real danger because inventors in their professional activities are exposed to mountains of potentially relevant information. In addition, the patent examination process, particularly when multiple applications are filed in many different jurisdictions, also brings forward much potentially relevant material.

The test for inequitable conduct is whether a patent would not have issued "but for" the alleged inequitable conduct. Thus if a patent examiner would have allowed patent claims anyway had he known of information that was known to the inventors, there is no inequitable conduct. This is significant because it is almost impossible for an inventor to disclose everything she knows in her area of expertise with a remote chance of being material. If the test were whether everything the inventor knew remotely bearing on the subject of the patent was disclosed, most patents could be invalidated for inequitable conduct.

Patents can still be invalidated for egregious misconduct, such a filing a false affidavit. And patent applicants must disclose all material information. However, software patentees need not be concerned if they do not disclose the many documents that mentions a common software operation or structure used in their invention, but that is not an inventive element or relevant to the patentability of their invention. This is also a great benefit to the United States Patent and Trademark Office, as examiners are spared from reviewing thousands of pages of immaterial information disclosed out of fear that during an infringement action the patent holders will be accused of inequitable conduct if the information is not disclosed.

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File a Patent to Protect Your Intellectual Property

You may have heard the old adage, "the proof is in the pudding." While the origin of this cryptic verse is lost in the mists of time, one modern application for the phrase concerns filing a patent in order to protect your intellectual property.

Before a product, device, invention, gadget, widget, gizmo, machine or doo-hickey is ever released onto the unsuspecting public, there's usually been some brainstorming, planning, logistics work, research, and trial and error that has gone into the design and creation of the physical creation. Oftentimes these inventions appeal to a limited group of consumers and don't end up making much money for the producer or the inventor, since their appeal is limited to the narrow band of society that enjoys or needs what they have created.

Sometimes, however, an invention or creation is generated that has amazing, mass appeal. Currently, "crazy bands" (the rubber bands that hold a physical shape such as an apple, a cowboy, a monster, a surfer girl) are all the rage - everyone from 6-year olds to university professors are enjoying their strange fascination. Who'd have thought THAT was possible? Answer - the man, woman or group of people who filed the patent, guaranteeing that they owned the intellectual property - and thus the financial rights - to developing, selling and profiting from the sales of crazy bands. Filing a patent for the idea or design for the product, BEFORE it was even produced, helped to ensure that the generators of the initial idea for crazy bands were the ones to benefit from their creation.

Filing a patent can be a complicated, often arduous process, and wise inventors know that a good portion of filing a patent is to ensure that someone else, somewhere else, has not already had the same idea and patented it previously. Imagine the incredible discouragement that comes from researching, investing in and inventing a new device or process, only to see it reach fruition and receive a legal notice to 'cease and desist' because someone else has already staked their claim to a similar invention or device?!

Investigating similar patent claims, researching the best method to present your patent filing, and filing the actual patent are wise ways to ensure the successful development of your new process, idea or invention. Patent lawyers exist for just such purposes, and fledgling as well as experienced inventors and entrepreneurs are encouraged to seek the help of these knowledgeable men and women while pursuing their goal of creating a new item or process for use by others in the world.

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