8 Patent Basics
William Durfee
The value of company is in its intellectual property and in the ability of staff to generate IP, not in the products. When you make your pitch to VCs or potential business partners, they will take a careful look at your IP when considering the value of the deal.
Because patents are so valuable in med tech, it is critical that intellectual property be considered early in the innovation process. Three issues are paramount:
- Can my idea be patented?
- Does my idea infringe upon existing patents?
- Who owns my idea?
What is a Patent?
A patent is the grant of a property right to an inventor, which in return for the inventor publicly disclosing the invention gives the inventor a limited term monopoly to practice the invention. Normally, the term of a patent is 20 years from the filing date. In the U.S. patents are issued by the United States Patent and Trademark Office. In the words of the U.S. patent law, what is granted is “the right to exclude others from making, using, offering for sale, or selling” the invention in the U.S.
What is important to recognize is that the right is to exclude others from practicing the invention so it is up to the inventor to enforce the patent. A patents gives you the right to sue another company whose product infringes on your patent. However, lawsuits are generally expensive, and the other company will most likely counter with a suit contending that your patent is invalid and never should have been issued. This is one reason why your patent must have strong claims and is why you should have a patent attorney write your patent to protect your invention properly.
There are three types of patents: utility, design and plant. This chapter will focus on utility patents, which are for a new and useful process, machine, article of manufacture or composition of matter. This is the category that covers all medical devices, although sometimes a company will protect an invention through a design patent along with a utility patent.
Patents are only valid in the issuing country. A company will assess which markets it wants to sell in and will file for patents only in those countries.
“To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”
Congress passed the first patent law in 1790. The most significant recent patent law is the America Invents Act, which was signed into law in 2011.
An Invention is Patentable if it is New, Useful and Non-Obvious
New
Your invention must be new for it to be patented. “New” means it has not been described in any printed publication (books, magazines, journals), has not been described in an issued patent or published patent application, and has not been in public use and has not been available to or known by the public before the filing date of your patent. This is why searching the patent data base is so important because your invention may already be described in an earlier patent.
Non-Obvious
Along with being new, your invention must be a non-obvious improvement over the prior art. For this, your invention is compared to the prior art (all relevant patents and other knowledge) and a determination is made on whether your idea would have been obvious “to a person having ordinary skill in the art,” which means a person familiar with the technology area related to the invention.
For a simple example, suppose plastic coffee cups were around in every color but red. You come up with the idea of a red cup. Your idea would be novel (passes the “new” test for patentability), but would not pass the non-obvious test because it would be obvious to come up with another color cup.
Determining whether an idea is obvious can be difficult and is almost always at the core of arguing with the patent office over whether your idea should receive a patent, and is almost always at the core of litigation over whether an issued patent is valid. For example, when you file a patent, the examiner may immediately reject the application because the idea is described in an earlier patent that failed to come up in your initial search. More than likely, however, the examiner will reject the application based on the combination of two or more patents viewed together, making the argument that if someone like you had those two patents in front of them, coming up with your idea would be obvious. Now it is up to you to argue back that no, even given the two pieces of prior art, your idea is unique, creative and non-obvious.
Useful
This is the easy one, because if your invention works or could work, then it is useful, even if someone else thinks your invention is silly. A perpetual motion machine or other inventions that violate a fundamental law of physics would fail this test because it could never be made to work, which means it is not useful.
Provisional Patent Applications
A provisional patent application is low-cost first filing that can provide some protection to the inventor by establishing an early filing date. The inventor then has up to 12 months to file a utility (nonprovisional) patent on the same invention and can claim as an effective filing date the date the provisional was filed. Claims are not included in a provisional application, but the provisional must have text and drawings that describe how to make and use the invention in sufficient detail to support the claims that might be made in the later utility application. Provisional patents are not evaluated or even looked at by the patent office. If after 12 months you have not filed the nonprovisional, the provisional is considered abandoned, and it is as if nothing happened because it is never published or posted on a database that your competitors can search.
Plain language can be used in a provisional application, the drawings can be informal and the document can be short. You can even file a technical article as a provisional application, but first make sure that the article fully describes how to make and use the invention, which often is not the case for academic journal or conference papers.
The common flaw with a provisional is that shortly after filing you make an important improvement to your idea that is not described in the provisional. This means in the regular patent application that has claims covering those improvements, you cannot claim the early filing date of the provisional, which defeats its purpose.
Generally, you should make your provisional application look as much like a regular application as you can, including background, summary of the invention, description of the drawings and a detailed description of the invention. A good practice is to draft some initial claims for the invention before writing the provisional. While the claims are not included in the provisional, you can use them to check that the description is adequate to fully support the claims.
The effective filing date (also called the priority date) is important in the world of patents. For example, if your invention was disclosed or known before that date than you cannot receive a patent for the invention. Another reason the effective filing date is important is that if you and someone else independently made the same invention and both you and the other person filed for a patent, the first one to file would get the patent (This is one of the major consequences of the recent America Invents Act because before 2013, the U.S. was a first-to-invent rather than a first-to-file country.) One benefit of filing a provisional patent application is that if you file the follow-on utility patent within 12 months of the provisional, your effective filing date is the date that you filed the provisional application. In a fast-moving field, this earlier filing date can give you a jump on your competition in the who-filed-first race. At the same time, the 20 year protection provided by a patent still starts on the date that the utility patent was filed. Along with the provisional patent application case, the effective filing date of a utility application may be that of an earlier application where continuation applications or international applications are involved. This is where consulting a patent attorney is important.
You can claim “Patent Pending” for your invention once you have filed a patent application, and until the patent prosecution has finished. If the patent is issued, then you can switch to claim that the invention is patented. You can also claim “Patent Pending” for the 12 months after filing a provisional patent application.
Disclosure
Disclosing your invention publicly has ramifications for patenting. Ways that you can disclose include, but are not limited to:
- Published journal or conference paper
- Bringing to a trade show
- Describing in a presentation that is open to the public (which includes most department seminars at a university)
- Posting a YouTube video
- Displaying on your lab web site
- Showing to a company without having a nondisclosure agreement
- Showing at an undergraduate capstone design show
- Discussing with colleagues outside your organization
- The automatic publication of a patent application that occurs 18 months after filing
But, keeping the invention to yourself sometimes is not the best strategy. You might want to show your idea to a company that might be interested in licensing or buying your invention. If you are an academic, you might want to describe your idea in a journal article, or at a conference or in a research proposal, all of which are important for academic recognition. Keep in mind that submitting a conference or journal article that describes the idea does not constitute disclosure. Because the review process is confidential, disclosure only happens when the article is accepted and published. The same is true with a research proposal because the proposal review process is confidential and reviewers are obligated not to disclose what they learn from reading your proposal.
There are two ways you can protect yourself when you want talk about your idea to others. The first is to ask a company or the people you are meeting with to sign a nondisclosure agreement (NDA). Simple NDAs are available from your organization or online (see www.nolo.com.)
The second is to file a provisional patent application (or a regular utility application). If you are at a university, contact your technology transfer office about filing a provisional if you are close to submitting a journal or conference paper on your idea. Once the provisional is filed, then you can disclose your idea and be protected.
If you intentionally or unintentionally disclose your idea before filing, you still may have 12 months to file a patent in the U.S., but you will have lost your rights to file a patent in any other country.
Do not disclose your idea to others unless an NDA is in place or unless you have filed a provisional or utility application.
Parts of a Patent
Along with various forms and fees, a patent consists of the the specification and one or more drawings.
The specification has these sections
Title A title for the invention.
Related Applications list of any related applications, for example the provisional patent application if a provisional was filed.
Background A few paragraphs where you describe the field of the invention and a few key pieces of prior art to highlight how the prior art is different from your invention and to show what improvements are needed over the prior art.
Summary A brief description of your invention focusing how it is an improvement over the prior art and how it solves some of the problems with the prior art that you describe in the background section.
Description of Drawings A one sentence description of each drawing.
Description of the Invention Typically the longest part of the patent, this section must completely and accurately describe the invention. Each feature in each drawing must be explained. Variations (embodiments) of the basic idea are described. Terms are defined as needed, which can impact how claims are interpreted. Often the description has two parts with the first describing the invention and the second describing how to use the invention. The examples of various embodiments and ways of using the invention are meant to illustrate, but not limit the scope of the invention.
Claims The claims are the most important part of the patent because they state exactly what is protected. While the specification is broad and can describe many aspects of the invention, the claims are specific and exact. Each claim is one sentence and contains a number of elements that state the essential features of the invention. Some claims may be dependent, which means they add additional elements to the independent claim they depend upon. The patent examiner compares the claims in the application against the prior art to determine if the claim should be allowed. For patents that have issued, the claims are used to determine whether another device infringes on your patent.
Abstract A brief summary of the specification
The application must have one or more drawings that explain the invention. The drawings are in a particular format and must be quite clear in showing the invention.
Patent Search
The U.S. and foreign patent literature is an invaluable resource for getting ideas and also the place to go to determine if your concept is unique and patentable. Patents are an excellent source of information about a complex med tech product because the description of the invention in a patent must be sufficiently detailed to allow another to build the invention. Although comprehensive searches are best done by professionals, inventors are fully capable of doing a capable and competent job searching the patent literature.
A patentability search is a search of current and expired patents, as well as of books, articles and other publications to determine if your invention is new and nonobvious compared to the prior art. A validity search is used after a patent is issued and one company sues another for infringement. The company being sued will do an exhaustive search to see if the patent office missed a piece of prior art when determining that the issued patent was valid.[1]
Search Strategy
Here is a suggested strategy for conducting a search.
- Determine the likely classification(s) of your invention by coming up with the key terms that describe the invention. Patents are cataloged using the Cooperative Patent Classification (CPC) scheme[2], which includes classes and subclasses.
- Once you have likely CPC classes and subclasses, pull all of the patents in those categories to review. You will likely have to narrow your classification as broad classes can have tens of thousands of patents, which is generally too much to review.
- Determine which of the patents found in the step above are relevant by looking at the title, abstract and front-page drawing. This first screening must be quick as you may have hundreds of patents to look at.
- Review published (but not issued) patent applications in the same categories.
- For those patents passing your screen, do an in-depth review of the drawings, specification and claims.
- For the highly relevant patents you find, look at the References Cited section of the patent to find other relevant patents. You can also use the search engine to do a reverse citation search. That is, if Patent A is one of the relevant patents you found, you can search for all of the patents issued after Patent A that cite Patent A.
- Finally, search by keyword. While keyword searches are easy, they can miss many relevant patents.
Searching by key word will miss important patents because patents are intentionally written to be as broad as possible. For example, it is impossible to find patents covering the brake on the Oxo Salad Spinner by typing “salad spinner” into a patent search engine. The reason is that the title of U.S. patent 6,018,883 is “Brake for Device for Drying Foods,” because the inventors did want to limit their invention to only cover spinning a salad.
Publication of Patent Applications
Your patent application will be published 18 months after it is filed, or 18 months after the provisional was filed if the nonprovisional application is claiming an effective filing date of the provisional. The application is published no matter where things stand in the patent prosecution process. What this means is that no matter what, your invention becomes public 18 months after filing the patent, even if you never get the patent. When searching for patents, you can tell an entry is a published application by the format of its number, which will be something like US20110064858 A1, compared to an issued patent that will have a number like US8778436 B2. To further confuse matters, applications also have an application number, which will be something like US 12/804,032.
Suggested Online Patent Search Engines
USPTO www.uspto.gov/patents-application-process/search-patents (issued and published patents)
Google patents.google.com (excellent for U.S. and foreign patents)
FreePatentsOnline www.freepatentsonline.com/search.html (good for US or EP searching)
Patent Process
Be clear on the form of your IP. A technology disclosure is an internal company process where an employee discloses a new invention for the company to evaluate. A provisional patent application establishes an invention priority date and is simple to do, but is not evaluated for validity. A patent application is the first step towards protecting invention rights. An issued patent (U.S. or non-U.S.) is the only form of IP that has been fully evaluated for validity and the only form of IP that can be used to protect your invention. Most inventions never make it to the stage of an issued patent.
Patent Costs
The following table shows the approximate fees to have an attorney prepare a patent application
| WHAT | FEE (USD) |
| Provisional application | 1,500 |
| Utility, simple (paper clip) | 6,000 |
| Utility, minimal (umbrella) | 8,000 |
| Utility, complex (MRI) | 15,000+ |
The next table shows the USPTO filing fees in USD. An individual inventor classifies as a micro entity and pays a reduced fee.
| WHAT | FEE | MICRO ENTITY FEE |
| Provisional | 260 | 65 |
| Utility | 1,600 | 400 |
| Issue Fee | 960 | 240 |
| Maintenance, 3.5 yrs | 1,600 | 400 |
| Maintenance, 7.5 yrs | 3,600 | 900 |
| Maintenance, 11.5 yrs | 7,400 | 1,850 |
More Information
Books
- Pressman and Tuytschaevers, Patent It Yourself, Nolo Press.
- Pressman and Stim, Patent Pending in 24 Hours, Nolo Press.
- Pressman and Stim, Patents for Beginners, Nolo Press.
- Hitchcock, Patent Searching Made Easy, Nolo Press.
- Lo and Pressman, How to Make Patent Drawings, Nolo Press.
Pressman, Patent It Yourself, Nolo Press, is an excellent guide to patents. While a do-it-yourself patent is not recommended, having a familiarity with the patent process is helpful when deciding whether to pursue a patent and when interacting with your patent attorney.
Websites
- www.uspto.gov/
- http://www.bitlaw.com/
