Trilateral Project 24.1-Biotechnology 066

Factors to be taken into account in determining whether a disclosure would require undue experimentation are:

• 1) the quantity of experimentation necessary,
  
• 2) the amount of direction or guidance presented,
  
• 3) the presence or absence of working examples,
  
• 4) the nature of the invention,
  
• 5) the state of the prior art,
  
• 6) the relative skill of those in the art,
  
• 7) the predictability or unpredictability of the art, and
  
• 8) the breadth of the claims.

See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (citing Ex parte Forman, 230 USPQ at 547).