Medical devices are increasingly incorporating software and other computer elements, but software and computer patents are in the middle of a multi-year battle between different worldviews. This battle is destined to trap more and more medical device patents in a strange procedural limbo.
Ever since the Alice v. CLS Bank supreme court case in 2014 (and even a little before), the USPTO has been more reticent to grant software patents. USPTO officials likely felt burned by some high profile cases where they got bad press for issuing patents that were arguably too broad. The Alice case focused on the threshold question of whether some categories could be “eligible” for patenting in the first place, and it emphasized that wholly abstract ideas aren’t patentable.
The Alice case didn’t resolve whether software as a broad category could be deemed ineligible for patents as a threshold matter, but it left enough wiggle room for many examiners (and judges) to treat it that way. This effect was intensified by the attitude of the Director of the USPTO under President Obama, who was formerly a lawyer for Google and did not appear to favor patent eligibility for new software patents. This was consistent with the general worldview of large companies, which do not need patents to break into the market.
Now the pendulum is swinging back in the other direction for various reasons:
- Software patent examiners are feeling more confident about where to draw the line between eligible and not-eligible subject matter because many cases have been decided since Alice and they have more experience under the changed law.
- The new USPTO director appears to be generally more favorable to granting patents, including software patents. Under his direction, the PTO has drafted guidance for its examiners that provides easy categories designed to help examiners quickly get past the threshold patent eligibility question and move on to the more substantive analysis of whether inventions are novel and non-obvious in view of the “prior art.” This guidance will be issued in the next few weeks (after a long delay and revisions made by the DOJ, analysis by the OMB, etc.)
There will be some residual bias among many software patent examiners and their supervisors at the PTO against eligibility for software patents, but the above factors will likely tend to overcome that bias over time.
So what about the examiners specifically tasked with examining medical device patent applications? They are a year or two behind the curve, and they are currently rejecting medical device applications that have any software or computer component at an unreasonable rate. They are where the pure software examiners were several years ago. Many of them seem to be treating the software elements of any claim as a poison pill, even though many other clearly non-abstract elements are present and should easily make the claim patent eligible.
So a very interesting question over the next several months will be how these medical device examiners will react to the new guidance from the PTO Director. Will they catch up to their software examiner counterparts, or will they continue to lag and disproportionately reject smart devices, even though these devices are arguably the most novel and nonobvious medical devices being developed (in large part due to their software or computer aspects)?
Patent filers should seek to maintain patent strength and not seek overly broad patent scope, even if the PTO guidance seems to swing hard toward eligibility. The Courts will not necessarily agree with the PTO guidance, so the eligibility lessons learned in the software groups over the last several years should continue to be applied, no matter what happens in the near term on the PTO allowance rates for software and medical device patents.