Government Regulation of Nanorobots in Medicine: A Two-Part Series
PART II: How the PTO Handles These New Technologies
By: Jessica L.A. Marks and Shana K. Cyr, Ph.D.
In Part I in the last newsletter
, we discussed regulations and guidance by the U.S. Food and Drug Administration (FDA) for moving medical nanorobot products from the laboratory to the market. In Part II, we explore the challenges nanorobot inventions face when seeking protection at the U.S. Patent and Trademark Office (PTO).
Nanorobots and the PTO
As we discussed in Part I, the nanotechnology industry is rife with new discoveries. Inventors (and their investors) are keen to protect their inventions with patents. In 2016, the PTO granted over 8,400 nanotechnology patents and published over 11,000 nanotechnology patent applications. A study in 2011 found that many of the top entities seeking patents for medical applications of nanotechnologies were universities. But many private companies are increasing their investment in nanotechnologies, with over 90 companies selling nanotechnology products in the medical field as of 2013.
The requirements for obtaining a patent on nanotechnologies are the same as for any other invention. But nanorobot inventions pose additional hurdles as a relatively new field. First, because there are not standard definitions for terms such as nanoparticle, nanocrystal, nanoparticulate, quantum dot, nanodot, and colloidal crystal, applicants should explain terminology, including definitions and how words are used. Doing so will help ensure the application meets the written description requirement and assist the PTO in conducting searches of known technologies, which will aid in efficient prosecution of the application and could lead to a higher-quality patent that is more likely to withstand later challenges before the PTO or the courts. Second, because the PTO may have difficulty finding and applying relevant prior art, inventors should pursue several patents with claims of varying scope to cover their inventions. Inventors should consider filing broad claims first, and then narrow claims that are specific to the nanorobots they are likely to commercialize. Inventors also should consider claims directed to various aspects of the invention, including claims to the nanorobot, to various parts of the nanorobot, to processes for making the nanorobot, and to methods of treating patients using the nanorobots.
To help examination, applications should generally include background sections describing the state of the art and the challenges the inventor had to overcome to develop the claimed nanorobots, all while taking care not to inadvertently impair patent rights by enabling the prior art with the description. If the application is rejected during prosecution based on an overbroad reference, the inventor will have an easier time arguing that the reference does not enable someone of ordinary skill in the art to make the claimed nanorobot and supporting amendments to the claims to get them allowed.
Finally, inventors of nanorobot technologies may face rejections from the PTO based on a known product or structure that is not nano-sized. Changing the size of a structure does not necessarily confer patentability. Therefore, the patent application should describe the challenges to creating a robot on the nanoscale, the unique considerations in the materials used, and the benefits of using such a small device.
In sum, the PTO process of obtaining patent protection for nanorobots seems more developed for this new technology than the process for gaining FDA approval, which we discussed in Part I. But there are still many nuances that should be considered when applying for patent protection in the field of nanorobots.