If a rejection is made, the applicant should be prepared to show that the cloned nucleic acid can be put to such use. The applicant should further expect to have to appeal the rejection, perhaps to the Federal Circuit. Of course, to the degree that a particular chromosome can be stated as the target for the probe, or an allele frequency can be given for a particular band identified by a claimed nucleic acid, so much the better. U.S. patent 5,817,479 suggests that association of expression level with a disease state is an acceptable utility. Examiners are instructed to conduct their own analysis.
Examiners are to accept results from high homology over the entire length of an open reading frame.
However, finding additional proteins having the same, or higher, sequence identity but known to have a different biological function will provide a basis for challenging the applicant's asserted utility. For example, a GTPase domain and a sequence susceptible to myristoylation can be identified, but there is no high degree of sequence identity overall to any known protein and therefore it is not possible to assign the protein to any particular signal transduction pathway. Yes, but the applicant should expect to be challenged by the Examiner. The challenge can be overcome by evidence that in fact the proliferation rate of a cell is affected by the activity of the protein encoded by the claimed nucleic acid. The Final Guidelines continue to require that a utility for the claimed invention be either asserted in the specification or readily apparent to the skilled artisan.