How to Patent a Medical Device

What is a smarter way to patent a medical device?

Medical device patents can make a direct impact on sales as well as create licensing opportunities. Even pending patent applications may help startups raise capital. Manufacturers and designers should pay particular attention to independent claims and the strategy of filing child applications. Let’s look at some smart ways to patent a medical device.

Need to patent a medical device? Contact US patent attorney Vic Lin at 949-223-9623 or email vlin@icaplaw.com to explore how we can patent your medical device.

Should you search prior art patents on medical devices?

The medical device prior art tends to be quite crowded, meaning that broad patent claims will be challenging to obtain. With that in mind, a patentability search can help give you a sense of which features to focus on. Knowledge of the prior art can provide a helpful roadmap for claiming more unique features.

However, you will need to disclose to the USPTO any relevant prior art references found in your search.

Design or utility patent?

In most cases, you will want to get utility patents to protect the unique functional features of your medical device. It may help to pursue design patents on any nonfunctional ornamental features of your medical device.

For example, does your medical device have a cool-looking component where its appearance does not serve a functional purpose? Explore filing design patent applications on such visual features. To speed up the examination of your design patent, submit a Rocket Docket request.

Start with a provisional or nonprovisional patent application?

Understand the differences between a provisional and nonprovisional patent application. Both are aimed at obtaining a utility patent, but only the nonprovisional application can get you to that goal. A provisional patent application is merely a temporary placeholder that must be converted to a nonprovisional application within one year.

If your goal is to get a utility patent granted sooner, then file a utility nonprovisional patent application as soon as possible. You can speed up your nonprovisional application by submitting a Track One request with the initial filing.

What kinds of claims should your utility patent application focus on?

Generally, the claims in a utility patent application will consist of either apparatus or method claims. Apparatus claims, or device claims, focus on the structure of your medical device. Method claims are written with verbs, i.e., doing this, moving that, pushing this piece, pulling that part, etc.

While apparatus claims are great, they also tend to have a higher risk of rejection due to medical device prior art being rather crowded. Sometimes, it can be easier to get method claims allowed because the examiner may find it more challenging to find prior art patents that your claimed processes.

What should you expect after your utility nonprovisional patent application is filed?

After filing your utility nonprovisional patent application, expect a long wait for the initial examination by the patent examiner. We’re talking anywhere from 18 to 36 months unless a Track One request is submitted with the initial filing.

When you finally receive that initial review, expect a letter from the patent examiner called an Office Action. It is common for a medical device patent application to receive multiple Office Action rejections. For your mental health, expect the back-and-forth process with the examiner to be a slog.

Why file child patent applications for your medical device?

Do you want the broadest possible patent coverage for your device? If so, then one granted utility patent might not be enough. Competitors will always look for ways to design around your patent. By filing a continuing application, you get a second shot at covering your competitors’ medical devices.

Even if you do not know where the competition is headed, a pending child application gives you time to scope the market. The goal is to strike the right balance with your claims. You want claims that cover competing medical devices. At the same time, those claims need to be adequately supported by your specification.

Should you apply for foreign medical device patents?

A US patent gives the owner rights only in the United States. Competitors can still skirt your US patent by, for example, making products in China and selling them in Europe. To pursue foreign patents, consider filing an international PCT application.

To pursue foreign patents, keep in mind that your invention must not have been publicly disclosed before your earliest patent filing date. To reserve the right to file foreign patents, therefore, always keep your invention confidential until after your first patent application is filed.

If you care about pursuing only US patents, then you have a 1-year grace period from your earliest date of public disclosure.

Need to patent your medical device?

Contact US patent attorney Vic Lin at (949) 223-9623 or email vlin@icaplaw.com to explore how we can help you get your medical device patented.

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