One of the factors in determining patentability is whether undue experimentation would be required. What is that? In order for a patent disclosure to be deemed “enabling,” and satisfying the requirements of Section 112 of the patent law, the written description and drawings, in combination with information known in the art, must be detailed enough to enable another person of ordinary skill in the art to make and use a perfected, commercially viable product that contains the features claimed as novel and nonobvious. The disclosure should be in the written description and drawings, not merely in the claims. Some experimentation is permissible but it cannot be undue or unreasonable.
The courts typically apply the “Wands factors” to perform an undue experimentation analysis (In re Wands, 858 F.2d 731 (Fed. Cir. 1988). These factors include (but, of course, are not limited to):
- 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, and
- the breadth of the claims.
All of the factors must be considered in making this determination. It is improper to perform an undue analysis on only one factor, but they need not be given equal weight and not all must be included in the analysis. The issue with the PTO is generally over the interpretation of the data and the conclusions to be drawn from the facts. MPEP 2164 can provide guidance to inventors and practioners facing this rejection.
MPEP 2164 provides that experimentation that is complex does not necessarily make it undue if the art typically engages in similar experimentation. MPEP 2164 expressly explains that it is not necessary to enable one of ordinary skill in the art to make and use a perfected, commercially viable embodiment. Unless the claim recites a particular use, any use would be sufficient. The MPEP contains some examples that are instructive and may help you craft a defensive argument to establish patentability. It also details procedural requirements necessary to make a succeful argument. It is well worth spending a few minutes reading this section.