The bioinformatics market continues to show signs of impressive market growth. But patent eligibility laws in the US have not helped the cause of such a promising industry. But a recent PTAB decision, Ex parte Donnett, Appeal No. 2017-003694 (PTAB September 29, 2017), reversing the examiner’s abstract idea rejection may indicate a turning of the tide.
Before delving into the case, the subject matter eligibility issues associated with bioinformatics is not that it isn’t possible to get allowed claims. It is. The problem lies in getting good allowed claims. As a software invention, the novel feature (and often incredibly groundbreaking technological improvements) typically takes place before performing a medical procedure. For example, pioneering heart modeling software that is able to simulate where is a personalized optimal ablation target is inventive for the software piece–not for performing an ablation procedure based on the software.
Since Alice and Mayo, however, the USPTO has pushed for these “post-invention” medical procedures especially for inventions having clinical application because these medical procedure steps tie in the real world. This is despite real-world limitations not being required for other technologies. See McRO and Enfish. And in a recent CLE hosted by Fenwick & West, former SPE of art unit 1631 Marjorie Moran continued to talk about the need to tie in real-world steps in these claims.
The only problem is that reciting these additional steps creates a divided infringement nightmare for patentees, especially for bioinformatics inventions that have clinical applications. Since a doctor would be performing the medical procedure and since presumably another party could perform the software piece that precedes the medical procedure, patentees would have to pursue a difficult infringement argument. Plus, even proving infringement, Section 287 deprives a patentee the ability to collect damages against a doctor or healthcare entity.
So it appears that, while Europe, China and other countries have made strides in clarifying a reasonable patent-eligibility framework, the US has taken steps backward in the aftermath of Alice v. CLS Bank and Mayo. Bioinformatics technology are at the cross-roads of two Supreme Court decisions unfavorable to patent-eligibility: one from the software side and one from the life sciences side. And because of the relatively few patent applications for bioinformatics inventions, there is a dearth of guidance from Federal Circuit decisions directly on point. This is why the following PTAB decision ex parte Donnett is so interesting.
The claim at issue in ex parte Donnette is directed to predicting seizures. Claim 1 recites an apparatus configured to predict an upcoming neurologically abnormal state by comparing the indication of the set of correlations obtained during a sampling time period to each of Normal and Non-Normal templates.
In its analysis, the Board first found that the Examiner’s step 1 analysis was erroneous. Just because the claim recites correlations, this does not mean that the Examiner had sufficiently shown that the claim is directed to an abstract idea ‘of itself’. The Board instead quoted the appellant’s argument that the claims are directed to seizure prediction, with an innovation in digital EEG signal processing. The Board quoted the appellant’s argument that “the innovation reflects both an improvement in the functioning of the signal processor and an improvement in another technology, seizure prediction.”
At the conclusion of its decision, the Board seemed a bit non-committal. That is, the Board did not expressly conclude that the claimed invention was not directed to an abstract idea because of the technological improvements articulated by the appellant. It merely quoted the appellant’s arguments. Instead, the Board concluded that the Examiner did not sufficiently show that the conclusory statement met the minimum threshold for establishing that the claims are directed to an abstract idea. Even with such non-commitment, it is a big win for the appellant. These claims do not appear to suffer from the divided infringement issues noted above and will likely receive a Notice of Allowance shortly.
Is this the first of a tide of bioinformatics claims that are both good and patent-eligible? Perhaps. But too early to tell.