Inventing a simple medical device and getting a patent before talking with a medical device builder

My wife is a surgical nurse and noticed a particular difficulty that surgeons have been having with a specific procedure. She has a beautifully simple idea for a relatively simple device that makes this procedure so much easier to perform for the surgeon and just by her professional knowledge she is unaware of such a device being in existence currently.

She didn't tell the guy what the idea was, but in talking with a sales rep for a company that manufactures similar devices, he told her to design it, patent it, and then he can hook her up with a meeting at his company where they can possibly manufacture, market and distribute the product and she can get royalties.

Right now the desing consists of crude drawings on bar napkins but I can visualize what she is explaining, she just has a hard time putting it in detail to paper. I know that before one files a patent you need the schematics to be professionally illustrated. Other than that, neither of us have done this before so we are unsure what the steps are to patent a novel yet simple device. Perhaps we should consult a patent attorney?

Furthermore I am afraid that if we go through the trouble of patenting this device, that one of the engineers at this company will simply improve upon or change a few mechanical components enough to where a patent can be filed for an improved design, essentially stealing her original idea and cutting her out of the royalties. Is this fear substantial?

I am asking this on her behalf because I want to protect her and make sure she doesn't get taken advantage of.

As far as I know, you do not need the "schematics to be professionally illustrated" in order to file a provisional application. You can do it yourself. It's also not that expensive. Note that it isn't a replacement for later filing a "real" (-nonprovisional) one. But it can protect you for a year from others "stealing" it.

For more details see: http://www.uspto.gov/patents/resources/types/provapp.jsp

I'd recommend for one of you to learn a professional tool such as AutoCAD, and write up all the schematics.

Then apply for your patent.

An alternative would be to hire one of these engineers to satisfy all the patent submission guidelines himself. To prevent leaks and patent troubles, just have him fill in an NDA.

ATTENTION:* * IMPORTANT MESSAGE
I patented a medical device. you can draw it up yourself, no professionals needed. leave the description broad but to the point
very simple no cad needed, no attorney needed, go directly to us patent site

I believe you have answered your own question. Yes, perhaps you should consult a patent attorney.

As for the drawings of this "simple" device, how hard would it be for you to make either a working or non-working prototype? If you can do so at relatively low cost then taking it with you when you see the patent attorney would be extremely helpful and perhaps save you money.

As to the concern that someone will improve the design after you patent it, don't worry. If the improvement relies on your patent they can not sell it without your permission. If they wanted to sell something without your permission they would have to invent an alternate device that did not infringe on your patent. As a concrete example, supposed you invented the wood screw and then they improved it by using a phillips head. They still could not sell their screw without your permission. If on the other hand they invented nails, they could sell nails because nails are different than screws.

A good patent attorney specializing in medical devices will be able to help you craft your patent application in such a way as to minimize the chances of an alternate device being developed that would not infringe on your patent.

EDIT:

Since you say you could probably make a prototype I recommend you do so. Keeping your eye on the prize, which is to make money, this will be the best thing to both advance your patent claim as well as move you closer to revenue. At this point properly documenting your invention and establishing a "first to invent " claim for a United States patent is critical. Note that in other countries "first to file" is generally the rule.

By making the prototype you are doing what is termed reduction to practice.

In United States patent law, the reduction to practice is a concept
meaning the embodiment of the concept of an invention. The date of
this embodiment is critical to the determination of priority between
inventors in an interference proceeding.

Conception is the "formation in the mind of the inventor, of a
definite and permanent idea of the complete and operative invention,
as it is hereafter to be applied in practice." Hybritech Inc. v.
Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986)
(quoting 1 Robinson On Patents 532 (1890))

The embodiment of an invention can either be:

Actual reduction to practice: "[R]equires that the claimed invention work for its intended purpose." Brunswick Corp. v. U.S., 34

 

Fed. Cl. 532, 584 (1995).
Constructive reduction to practice: "[O]ccurs upon the filing of a patent application on the claimed invention." Brunswick Corp. v. U.S.,
34 Fed. Cl. 532, 584 (1995).
"Simultaneous conception and reduction to practice": "In some instances, such as the discovery of genes or chemicals, an inventor is
unable to establish a conception until he has reduced the invention to
practice through a successful experiment." The Regents of the
University of California v. Synbiotics Co., 849 F.Supp. 740, 742
(S.D.Cal., 1994) (citing Amgen, Inc. v. Chugai Pharmaceutical Co.,
Ltd., 927 F.2d 1200, 1206 (Fed. Cir. 1991)). The court will apply this
doctrine in so-called "unpredictable arts" such as biology and
chemistry where the invention is a "biologically active composition of
matter," also called a "bio-chemical substance."

Do you know a surgeon you can trust not to steal your idea? If so, show him the prototype and get his opinion, preferably in writing, as to it's utility and value. This will also help you with your patent claim.

Remember the goal is not simply to get a patent but rather to make money. You also want a good patent that will stand up and offer the best protection.

The patent office is full of thousands of patents for devices that were never made or profitable. There are many, many patent attorneys who will gladly take your money to get a patent that will ultimately be worthless.

Make the job as easy as possible for your attorney; you will get a better patent and save yourself a lot of possible litigation down the road if you should need to defend your patent.