2164.06 Quantity of Experimentation [R-07.2022]
The quantity of experimentation needed to be performed by one skilled in the art is only one factor involved in determining whether "undue experimentation" is required to make and use the invention. "[A]n extended period of experimentation may not be undue if the skilled artisan is given sufficient direction or guidance." In re Colianni, 561 F.2d 220, 224, 195 USPQ 150, 153 (CCPA 1977). " ‘The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed.’" In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (citing In re Angstadt, 537 F.2d 498, 502-04, 190 USPQ 214, 217-19 (CCPA 1976)). Time and expense are merely factors in this consideration and are not the controlling factors. United States v. Telectronics Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988), cert. denied, 490 U.S. 1046 (1989).
In the chemical arts, the guidance and ease in carrying out an assay to achieve the claimed objectives may be an issue to be considered in determining the quantity of experimentation needed. For example, if a very difficult and time consuming assay is needed to identify a compound within the scope of a claim, then this great quantity of experimentation should be considered in the overall analysis. Time and difficulty of experiments are not determinative if they are merely routine. Quantity of examples is only one factor that must be considered before reaching the final conclusion that undue experimentation would be required. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.
I. EXAMPLE OF REASONABLE EXPERIMENTATION
In United States v. Telectronics, Inc., 857 F.2d 778, 8 USPQ2d 1217 (Fed. Cir. 1988), cert. denied, 490 U.S. 1046 (1989), the court reversed the findings of the district court for lack of clear and convincing proof that undue experimentation was needed. The court ruled that since one embodiment (stainless steel electrodes) and the method to determine dose/response was set forth in the specification, the specification was enabling. The question of time and expense of such studies, approximately $50,000 and 6-12 months standing alone, failed to show undue experimentation.
II. EXAMPLE OF UNREASONABLE EXPERIMENTATION
In In re Ghiron, 442 F.2d 985, 991-92, 169 USPQ 723, 727-28 (CCPA 1971), functional "block diagrams" were insufficient to enable a person skilled in the art to practice the claimed invention with only a reasonable degree of experimentation because the claimed invention required a "modification to prior art overlap computers," and because "many of the components which appellants illustrate as rectangles in their drawing necessarily are themselves complex assemblages.... It is common knowledge that many months or years elapse from the announcement of a new computer by a manufacturer before the first prototype is available. This does not bespeak of a routine operation but of extensive experimentation and development work...." See Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021) (The court found that undue experimentation was required to enable the full scope of the claims where there was ample evidence that relevant artisans would not know how to perform the claimed invention for more than a narrow range of the claimed scope of invention).