Enablement

How to Make and Use an Invention Without "Undue" Experimentation

A patent must do more than describe an invention. It must also teach, or enable, a person in the same field to make or use the invention without them having to engage in an “undue” amount of guesswork or experimentation. If a patent does not enable the full scope that it claims, it can become invalid.

Under 35 U.S.C. §112(a), based on the 1988 court ruling In re Wands, 858 F.2d 731, courts use the “Wands factors” to help determine whether the disclosure meets the enablement standard. These factors include:

• The quantity of experimentation necessary
• The amount of direction or guidance presented
• The presence or absence of working examples
• The nature of the invention
• The state of the prior art
• The relative skill of those in the art
• The predictability or unpredictability of the art
• The breadth of the claims

Whether a patent application is enabled is also dependent upon the subject matter of the invention. A line of cases related to "predictable" inventions suggests that a single example of making and using the claimed invention is sufficient for enabling a person to practice the scope of patent application without undue experimentation. In a second line of cases related to "unpredictable" inventions such as biotechnology, pharmaceutical, and to a lesser degree medical device inventions, courts have held that a range of examples is desired to meet the enablement requirement.

Thus, it is our practice at Torrey Pines Law Group to describe as many alternative embodiments of an unpredictable invention as possible. If a variety of homologous polynucleotide or polypeptide sequences are effective in the invention, we ask our clients to descbibe them in examples. Examples are likewise requested with respect to alternative vectors, cell lines, salts, indications, analogs, algorithms, and the like. This provides the best opportunity to fully enable a patent application and issued patent.