The increasing presence of data-driven solutions in the healthcare and life sciences sector is apparent from the rise in numbers of patents and patent applications. The number of published bioinformatics patents and patent applications in the last decade has nearly doubled. Bioinformatics patents face an uphill battle due to subject matter eligibility challenges. Within the last five years, the majority of bioinformatics patent applications faced a Section 101 rejection. The challenges continue after prosecution, such as in In re Board of Trustees of Leland Stanford Junior University, where the Federal Circuit affirmed Patent Trial and Appeal Board (PTAB) decisions finding two Stanford patents directed to haplotype phasing ineligible as abstract ideas. And more recently, the Federal Circuit ruled yet another CardioNet heart monitor patent as invalid for not citing an inventive concept in CardioNet, LLC v. InfoBionic, Inc. 

There are drafting techniques that may be used to help preemptively address subject matter eligibility concerns, such as providing as much detail as possible about the algorithm, specifying any improvements to computer functionality achieved by the claimed invention, and phrasing the title, abstract, and claims so that the application is routed to a certain art unit. However, once a patent issues, whether it will survive subject matter eligibility challenges in court remains uncertain given the Federal Circuit's treatment of the United States Patent and Trademark Office (USPTO) Guidance as not binding.

Going forward, we should expect to see additional efforts by the USPTO to clarify subject matter eligibility and attempt to reconcile its differences with the Federal Circuit. The USPTO just announced its  Deferred Subject Matter Eligibility Response (DSMER) Pilot Program, designed to evaluate the impact of deferred responses on subject matter eligibility. The USPTO will also likely update its Guidance in the coming year, which it has historically updated every 1-2 years but has not since October 2019.

Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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