PTAB: Protein modeling software claims are patent-eligible, arguing preemption

It has been over a year since the Federal Circuit decided McRO v. Namco Bandai. In short, McRO decided that software models can be patent-eligible. This long-awaited case sent ripples of hope to many in the patent bar, especially to those reeling from the confusion and unpredictability of Alice decided two years prior. But the McRO message has still not made its way to all examiners, especially in the life sciences. Fortunately, the PTAB sees fit to correct and overturn such examiners, as shown in a recent case Ex parte Ohrn, Appeal No. 2017-003914 (PTAB Nov. 20, 2017).

In Ex parte Ohrn, the Examiner had argued that the claims simply used a computer as a tool, i.e., “converting one form of numerical representation into another by organizing information through mathematical concepts,” and were thus an abstract idea. In addition to holding that this was an overgeneralization of the claims, the Board used three main arguments to counter this assertion.

First, the Board found that the exact manner in which the modeling was implemented was novel, and thus the Examiner failed to provide evidence that the computer was used simply as a tool for generic activity. The Board found that the “claimed method uses a combined order of specific rules that render information into a specific format that is then used and applied to create desired results.”

Second, the specific, claimed features of rules permit the improvement realized by the invention. Claim 1 focused on a specific articulated improvement in protein modeling instead of a result of an abstract idea itself.

Third, the Board found the preemption argument persuasive that the specific method recited in the claims did not improperly monopolize the basic tools of scientific and technological work. It cited fairly specific characterizations made by the appellant of what the claims do not cover.

While the preemption argument can be a strong one, the savvy patent practitioner will tell you that this argument is not without consequence. For purposes of prosecution history estoppel, characterizations made on the record as to what the claimed invention does not cover greatly weakens or even destroys such equivalence coverage in litigation. But a granted patent narrowed by such prosecution history estoppel can be better than an application where the argument was not used, leading to an abandoned application. That being said, the preemption argument can be a double-edged sword.

The PTAB Shows It Is Possible to Get “Good” Bioinformatics Claims Patent-Eligible

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.

How to overcome an abstract idea rejection? Emphasize narrowing claim amendments and lack of prior art rejections

Recently decided ex parte Blaho, Appeal No. 2016-007954, (PTAB September 28, 2017) reversed an Examiner’s abstract idea rejection. In doing so, the Board first dismissed the Examiner’s characterization of the claims. Then, the Board found that the long prosecution history with significant amendments to overcome prior art rejections was evidence that the claim elements were not routine or conventional. It is a case worth studying for practice tips.

In ex parte Blaho, the panel found that the claimed invention was more than the asserted abstract idea. Whereas Planet Bingo merely retrieved numbers and then merely performed processing of the retrieved numbers, the Board found that the claims at issue recited specific interaction among multiple devices. Thus, the claims are not merely management of human activity.

Then more interestingly, the panel rejected the Examiner’s assertion that the claim elements are routine or conventional, pointing to the long prosecution of this case (going back all the way to an abandoned parent application). Here, the Board found that the Examiner not providing a good prior art rejection was evidence that the elements are not routine or conventional. The Board lifted this argument straight from the Reply Brief, as shown below.

Your correspondent had never seen this exact argument successfully used to overcome abstract ideas. But it is a variation of a similar classic argument against abstract ideas: that the Examiner cannot reject the claims under prior art grounds is evidence that the claims are not abstract.

This prior art/preemption argument will not always win the day because of the Ariosa v. Sequenom Federal Circuit line of reasoning: “the absence of complete preemption does not demonstrate patent eligibility.” Slip op. at 14. But this prior art/preemption argument is still in line with Supreme Court and Federal Circuit precedent. The Supreme Court in Alice stressed the balancing act that should exist in the patent-eligibility analysis of judicial exceptions. The Federal Circuit in McRO further articulated this by framing the discussion on preemption: a claim is directed to an abstract idea when it improperly preempts. A big part of preemption is the specific implementation recited in the claims or whether the claim invention recites mere conventional or generic routines.

Ex parte Blaho is an interesting way of articulating this argument as it relates to prior art rejections. It reframes the debate on preemption. That is, it is a way to push back against Examiner arguments asserting that the claims recite an abstract idea with only generic or routine claim elements. If it doesn’t just recite an abstract idea with generic or routine claim elements, no improper preemption.

This case highlights three important practice tips. First, where appropriate, it is important to push against the Examiner’s characterization of the claims in Step 1.

Second, if there is no prior art rejection, or if there are a large number of references cobbled together, this may be used to further bolster the case that the claims are not really directed to an abstract idea because the claims do not improperly preempt. If they did, a good prior art rejection would be found.

Third, use cogent and persuasive advocacy in your briefs. You may find the Board using your exact arguments in its decision.

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