What issues can arise when determining enablement for biotechnological inventions?

When determining enablement for biotechnological inventions, a key issue that can arise is the availability of starting materials or apparatus necessary to make the invention. MPEP 2164.01(b) states: “In the biotechnical area, this is often true when the product or process requires a particular strain of microorganism and when the microorganism is available only after extensive screening.” This means that if a specific microorganism strain is crucial for the invention and is not readily available, the patent application may need to provide more detailed information on how to obtain or produce this strain to satisfy the enablement requirement.

To learn more:

• biotechnology
• enablement
• microorganisms
• patent application