In our April 1995 Newsletter, we reported that the United States Patent and Trademark Office issued on January 3, 1995 proposed Examiner's guidelines for utility examination of biotechnological applications. These utility examination guidelines and accompanying legal analysis were finalized on July 14, 1995 and are applicable to all inventions. The guidelines include provisions concerning inventions for biotechnology and human therapy.

The final version of the guidelines provide that the Examiner is to review the application to determine if the applicant has asserted any credible utility for the claimed invention. The Examiners are advised that if the applicant has asserted that the claimed invention is useful for any particular purpose and this assertion would be considered credible by a person of ordinary skill in the art, in view of all the evidence of record, or if the invention has a well established utility wherein a person of ordinary skill in the art would immediately appreciate why the invention is useful then a rejection based on lack of utility is not to be made. If the applicant asserts that the claimed process is useful for treating a human or animal and this utility is credible, the Examiner should not require that the applicant demonstrate that the therapeutic agent is safe or fully effective. The applicant has to provide a "reasonable correlation between the activity and the asserted use." Data from in vitro or animal testing even if not in an art recognized model is generally sufficient to support the asserted utility and the Examiner should not require the submission of clinical data.

If the applicant, however, has not asserted any specific utility for the claimed invention and the invention does not have a well-established utility, a lack of utility rejection under 35 USC 101 is to be made. A separate rejection under 35 USC 112, first paragraph, is also to be made, "on the basis that the applicant has not shown how to use the invention due to lack of disclosure of a specific utility."

In order to support the utility rejection, the Examiner must establish a prima facie showing that it is more likely than not that a person skilled in the art would not consider credible any specific utility asserted by the applicant for the claimed invention. A prima facie showing must contain:


The guidelines provide that the Examiner whenever possible must provide documentary evidence to support the factual basis needed to establish a prima facie showing of no utility.

Once the Examiner has made a prima facie showing, the burden shifts to the applicant to rebut the prima facie showing. This can be done, inter alia, by amending the claims, providing reasoning or arguments, or by providing evidence in the form of a declaration under 37 CFR 1.132 or printed publications.

The Examiner is then to review the original disclosure, the evidence of record and the applicant's submission and "only where the totality of the record continues to show that the asserted utility is not credible, should a rejection based on lack of utility be maintained."