Issue 05/26 | July 06, 2005
USPTO Patent Rules Updates
 A Possible New Requirement for Establishing Enablement

In Rasmusson v. Smithkline Beecham Corp., Nos. 04-1191, -1192 (Fed. Cir. June 27, 2005) the Federal Circuit affirmed a decision of the Patent Office Board of Patent Appeals and Interferences in which the Board held that Rasmusson was entitled to the benefit of only its last-filed continuation application because the parent applications were not enabled.

The interference involved a method of treating prostate cancer comprising administering a therapeutically effective dose of a drug called finasteride. Rasmusson had pursued a claim to this method in a series of nine applications, the first filed in 1987 and the ninth in 1995. The Board held that Rasmusson was entitled to the benefit of the filing date of only the last-filed application because the first eight applications were non-enabled. Specifically, the Board and Federal Circuit found that the state of the art at the time of filing of each of Rasmusson’s first eight applications was such that one of ordinary skill in the art would have no basis for believing finasteride would be effective in treating prostate cancer. Between the filing of Rasmusson’s eighth and ninth applications data were presented at a medical association meeting demonstrating the efficacy of finasteride in treating prostate cancer. Hence, the court affirmed the Board’s finding that the ninth application was enabled.

The interesting feature of this aspect of the case is that the eighth and ninth applications presumably were identical (the ninth being a continuation of the eighth), yet the ninth application was found to be enabled while the eighth was not. Furthermore, enablement turned not on whether one of ordinary skill in the art could have made and used the claimed invention without undue experimentation (i.e., could have successfully treated prostate cancer with finasteride), but whether one of ordinary skill in the art would have believed they could have made and used the invention. The court stated,

  [W]here there is no indication that one skilled in the art would accept without question statements as to the effects of the claimed drug products and no evidence has been presented to demonstrate that the claimed products do have those effects, an applicant has failed to demonstrate sufficient utility and therefore cannot establish enablement.

Citing In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA 1962). But in Novak, as well as other cases relied upon by the court in its reasoning (e.g., In re Brana and In re Marzocchi), the issue was where the burden of proof lay with regard to examining an application for compliance with the enablement requirement. So, for example, in Novak the CCPA stated:

  In our opinion, when an applicant bases utility for a claimed invention on allegations of the sort made by appellants here, unless one with ordinary skill in the art would accept those allegations as obviously valid and correct, it is proper for the examiner to ask for evidence which substantiates them.

In Rasmusson, the court moved the inquiry of whether one of ordinary skill in the art would accept the asserted utility from a procedural matter of determining burden of proof during prosecution to one of establishing enablement per se.

The facts of the case and the court’s reasoning could have important ramifications. The case seems to add an additional factor to the enablement inquiry beyond whether one of skill in the art could make and use the claimed invention as disclosed; the specification together with knowledge in the art may have to imbue one of ordinary skill in the art with the belief at the time the application was filed that the claimed invention has the asserted utility. The fact that Rasmusson was not entitled to the priority of the eighth application because the application was non-enabled but was entitled to the benefit of the ninth application filing date may suggest that one cannot establish enablement of claims and therefore cannot satisfy the §112 requirements by submitting evidence of utility (e.g., a Rule 132 Declaration) after an application is filed where one of ordinary skill in the art would not have accepted the asserted utility at the time of filing.

To discuss these topics further, please feel free to contact the author Michael S. Greenfield, Ph.D. (greenfield@mbhb.com), at McDonnell Boehnen Hulbert & Berghoff LLP in Chicago, Illinois, USA.


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