Introduction

On April 28, 2016, a decision was made by PTAB in Ex parte Schulhauser, an application apparently owned by Medtronic Inc.The Appelants sought a review of the Examiner’s decision to reject claims regarding “subject matter relate[d] to ‘medical devices for monitoring physiological conditions and, in some embodiments, to a minimally invasive implantable device for monitoring a physiological conditions [sic] and detecting the onset of a critical cardiac event such as a myocardial infarction.” Claims 1-11 were rejected.

Decision

Upon review of the Examiner’s decision, PTAB (Patent Trial and Appeal Board) decided to affirm the rejections of Claims 1-10 and reverse the rejection of Claim 11.

For reader’s reference, Claim 1 is included below. The Board held that some limitations of a claimed method are not considered to have patentable weight since those steps require precursors. In other words, a condition precedent must be met in order for these steps to take place. For example, “determining the current activity level of the subject from the activity level data if the electrocardiac signal data is within the threshold electrocardiac criteria,” communicates that this step would only be executed once the condition is met. However, whether the condition is met or not, the claimed method remains unaffected. Because additional steps are conditioned, mutually exclusive, and neither inhibit nor advance the claimed method, they carry no patentable weight. Because prior art disclosed such a method, the Claim’s rejection was affirmed. 

While the method claims remained rejected, PTAB did make the decision to reverse the Examiner’s rejection of Claim 11, which was directed to a “system for monitoring cardiac conditions [including] various ‘means for’ limitations involving functions substantially similar to those recited in claim 1.” Although the limitations provided for the system are similar to those provided for the method, they are patentable in the system’s case because the system must have the capability of performing such processes if needed. As stated in the opinion, “the system claim differs from the method claim because the structure…is present in the system regardless of whether the condition is met and the function is actually performed.” In comparison to prior art, the claimed system necessitates a certain order of operations while the prior art does not disclose any such essential order. While the system may perform the same functions as prior art, it does so in a distinct way.

1.A method for monitoring of cardiac conditions incorporating an implantable medical device in a subject, the method comprising the steps of:

collecting physiological data associated with the subject from the implantable device at present time intervals, wherein the collected data includes real-time electrocardiac signal data, heart sound data, activity level data and tissue perfusion data;

comparing the electrocardiac signal data with a threshold electrocardiac criteria for indicating a strong likelihood of a cardiac event;

triggering an alarm state if the electrocardiac signal data is not within the threshold electrocardiac criteria;

determining the current activity level of the subject from the activity level data if the electrocardiac signal data is within the threshold electrocardic criteria;

determining whether the current activity level is below a threshold activity level;

comparing the tissue perfusion data with a threshold tissue perfusion criteria for indicating a strong likelihood of a cardiac event if the current activity level is determined to be below a threshold activity level;

triggering an alarm state if the threshold tissue perfusion data is not within the threshold tissue perfusion criteria; and

triggering an alarm state if the threshold tissue perfusion data is within the threshold tissue perfusion criteria and the heart sound data indicates that S3 and S4 heart sounds are detected,

wherein if an alarm state is not triggered, the physiological data associated with the subject is collected at the expiration of the preset time interval.

Conclusion

PTAB’s decision in Ex parte Schulhauser magnified in a way the difference between a method and a system patent claim. Although both include limitations, some with conditions precedent, a system’s structure is a more concrete entity that must include the capabilities of addressing all limitations in order to function properly, whereas a claimed method may be interpreted more broadly by the patent examiner, namely, independently of its limitations that include conditions precedent. It is important to consider these differences upon writing claims to create optimal patent protection.

Full Ex parte Schulhauser decision can be read here: https://www.uspto.gov/sites/default/files/documents/Ex%20parte%20Schulhauser%202016_04_

28.pdf