Patent Eligibility Another Diagnostic on Ramp to Highway 35 U.s.c. 101

• Jurisdiction: United States,Federal
• Citation: Vol. 45 No. 3
• Publication year: 2020
• Author: D. Benjamin Borson
• topic: Patent law,Intellectual Property,Civil Procedure

Patent Eligibility Another Diagnostic On Ramp to Highway 35 U.S.C. 101

D. Benjamin Borson

Borson Law Group P.C.

CARDIONET, LL AND BRAEMAR MANUFACTURING LLC, V. INFOBIONIC, INC.; SLIP. OP. 2019-1149, 955 F.3D 1350 (FED. CIR. 2020) AND CARDIONET, LL AND BRAEMAR MANUFACTURING LLC, V. INFOBIONIC, INC.; SLIP. OP. 2020-1018 (FED. CIR. 1 JULY 2020)

Introduction

Differential diagnosis of atrial fibrillation and atrial flutter from other disorders of cardiac conduction, such as blockage of the atrio-ventricular node, premature ventricular contractions (PVCs), and ventricular tachycardia (V-TACH) may have very serious consequences to a patient. V-TACH and the much more serious disorder, ventricular fibrillation (V-FIB) may be life threatening.

Electrical activity leading to a heartbeat in a normal condition is initiated by depolarization of a group of cardiac cells ("pacemakers" in the sinoatrial node or "SA" node). With an atrial pacemaker, electrical depolarization in the atria causes contraction of the atrial muscle, and forces blood into the ventricle. The electrical depolarization is conducted to another group of cells (atrioventricular node or "AV node") located at the junction between the atria and ventricles. The AV node transmits the electrical signal, via a group of specialized cardiac muscle cells (Purkinje fibers), which in a coordinate fashion, transmit the electrical signals to the ventricular muscle, causing the ventricles to contract in a coordinated fashion thereby forcing blood into the aorta and thereafter into the body. If atrial and ventricular contractions are properly spaced, an aliquot of blood from the atria properly fills the ventricles, and when the ventricles contract, an increased amount of blood is ejected from the heart.

Atrial fibrillation and atrial flutter are characterized by increased rates of depolarization of cells in the atrial muscle, thereby producing rapid contractions of the atria (atrial flutter). In atrial flutter, the pacemaker cells in the atria depolarize more rapidly than normal, leading to higher frequencies of atrial contraction. If the rate of depolarization is increased too much, the electrical impulses lose coordination, and the atria do not contract as a single unit (atrial fibrillation).

In certain disorders such as cardiac infarction, AV nodal cells may be damaged and fail to conduct electrical impulses to the ventricles. In such circumstances, the ventricles may not receive the electrical signals in a timely fashion, and do not contract in coordination with atrial contraction. If atria do not eject a sufficient amount of blood into the ventricles, the amount of blood ejected with ventricular contraction may be reduced, decreasing blood flow to the body.

The cases here, Cardionet, LL and Braemar Manufacturing LLC, v. InfoBionic, Inc., Slip Op. 2019-1149, 955 F.3d 1350 (precedential, Fed. Cir. 17 April 2020, CardioNet 1) and Slip. Op. 2020-1018 (non-precedential, Fed. Cir. 1 July 2020, CardioNet 2) involve related patents having claims related to diagnosis of myocardial conduction disorders.

CardioNet 1

The first case, CardioNet 1 (Slip. Op. 2019-1149) was an appeal from a Massachusetts district court decision holding that the claims of U.S. Patent No. 7,941,207 (the '207 patent), were ineligible for patenting under 35 U.S.C. § 101, being drawn to a natural phenomenon. The case was heard by Judges Dyk, Plager, and Stoll. The majority decision by Judge Stoll noted:

Atrial fibrillation and atrial flutter involve the "loss of synchrony between the atria and the ventricles of the heart." CardioNet 1, Slip. Op. at 2. These disorders may be either short in duration, and "'generally include between two and 20 [heart] beats and may or may not have clinical significance.' By contrast, sustained episodes 'generally include more than 20 beats and may have relatively greater clinical significance.' Atrial fibrillation can lead to irregular ventricular beating as well as blood stagnation and clotting in the atria.... Both atrial fibrillation and atrial flutter are 'associated with stroke, congestive heart failure, and cardiomyopathy.' Id. page 2 bridging to 3.

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Ventricular tachycardia is another form of cardiac arrhythmia, and is characterized by "a rapid succession of ventricular contractions (e.g., between 140 and 220 per minute) generally caused by an abnormal focus of electrical activity in a ventricle .... The occurrence of ventricular beats can be used to identify ventricular tachycardia (e.g., when there are three of more consecutive ventricular beats." Id. at page 3. V-TACH can "last from a few seconds to several days and can be caused by serious heart conditions such as a myocar-dial infarction." Id.

Further, Judge Stoll in describing the '207 patent stated:

The '207 patent describes cardiac monitoring systems and techniques for detecting and distinguishing atrial fibrillation and atrial flutter from other various forms of cardiac arrhythmia.... The patent teaches systems and techniques that determine the beat-to-beat variability in heart rate over a series of successive heartbeats. Specifically, they determine the variability in heart rate over a series of between 20 and 200 of the recent R to R intervals [the "R" waves representing the electrical signaling of ventricular contraction] or timing between the "R-waves." ...An 'R-wave' is the peak of what is referred to as the 'QRS complex of an electrocardiogram signal.'" Id. page 3 bridging to page 4.
The written description explains that in detecting atrial fibrillation and atrial flutter, the systems and techniques include accounting for the presence of irregular ventricular beats, which are 'negatively indicative of atrial fibrillation and atrial flutter.' ...The

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