PATENTABILITY OF MEDICAL DIAGNOSTIC AND TESTING RESULTS
So much of the medical advances today involve a diagnostic test and interpreting the test results. But is the technological advance patentable?
In a recent case by the Federal Circuit - In re Gale - the patent application was for a method of ensuring that the reporting of diagnostic test results was continual and consistent. The Federal Circuit explained that the method used a computer to essentially (1) receive test result messages with timing-related metadata, (2) read the meta-data, (3) calculate a usage pattern from the metadata, and (4) determine whether the calculated usage pattern complied with a usage pattern requirement.
In other words, according to the Federal Circuit, the method was an abstract idea of (1) collecting information, (2) analyzing the information, and (3) reporting the results. The Federal Circuit reiterated that selecting information, analyzing it according to mathematical techniques, and reporting the results are non-patentable abstract ideas.
The Federal Circuit rejected the patent applicant's argument that the method was narrowly focused on metadata associated with timing and, thus, not abstract. The method did not involve a "technological improvement" according to the Court.
Notably, the Court explained that even if the patent application had NOT been rejected as obvious in view of the prior art, the patent application can still be ineligible for a patent.
In the medical device field, the mere gathering, interpreting, and reporting of test results will be challenging to patent. But the addition of using the test results to achieve a further result (e.g., treating a patient) may provide a stronger basis from which to convince the patent office of patentability.