Registration involves a lot of rules and regulations. You can represent yourself. However, patenting in the life sciences is very complex, and the rules and regulations often change, so most people are represented by patent attorneys or agents who are familiar with the process. They must be registered with the USPTO. Cost for a lawyer can range from several to twenty thousand dollars depending on the technology, complexity, and supply of lawyers in your topic area. For example, lawyers who are experts in biotechnology have been in high demand recently.
Make sure you invented the entire scope of the claim. Make your claim narrow enough to avoid overlapping with some other piece of information or prior art or else your patent application will not be allowed. If it comes to light later, your patent will be invalidated.
The patent examiner protects the public interest by making sure the invention is eligible for patenting and not already out there. This can take months or a few years and is very complex. There may be communication between the inventor and the examiner. It is a nuanced and non-adversarial process that results in a written description of their findings. Talk with the examiner if you get a rejection to find out if the problem can be overcome—for example, by narrowing the scope of the application.
After you obtain your patent, you have to maintain it, so you will continue to need competent guidance. An overlap with another claim may come to light after your product goes to market, potentially because of the delay in the patent publication process. A 2013 law created a range of options for people to oppose your patent that may need a response. You can also perfect the patent or seek broader coverage.
Bananaip.com. Patentability of Biotech Inventions in USA – Patentable Subject Matter. December 27, 2018.
Darling J. NIA/NHLBI Entrepreneurship Webinar: Intellectual Property, Breakout. 2021.
Takenaka T. Inventorship Standards for Biotechnology Inventions Under the US and Japanese Patent Acts. April 20, 2021.