The U.S. Patent Trial and Appeal Board (PTAB) will review two Apple-owned electrocardiogram technology patents in an infringement suit as AliveCor looks to reverse the board’s opinion from December 2023.
A panel of administrative patent judges granted AliveCor’s bid for a review, citing a “reasonable likelihood” that AliveCor would successfully show the unpatentability of Apple’s technology. The PTAB will formally review the validity of certain patent claims, considering AliveCor’s arguments. However, it’s important to note that this is just the beginning of the process, and no final decisions on the patentability of the claims have been made yet.
In a statement to MassDevice, AliveCor said: “AliveCor applauds the U.S. Patent Trial and Appeal Board (PTAB) decisions to institute Inter Partes Review (IPR) of two patents Apple meritlessly asserted against AliveCor. These institution decisions closely follow last week’s decision by the Court in the Northern District of California to stay the underlying district court case while the PTAB analyzes the validity of Apple’s patents. Institution decisions directed to Apple’s remaining asserted patents are expected in the coming months. Separately, our antitrust case against Apple is proceeding in the U.S. District Court, Northern District of California, where the judge will decide several pending motions before setting a trial date for later this year. Our cases are among many recent developments revealing the extent of Apple’s bullying.”
The PTAB review decision follows its ruling in December in which it dealt a setback to AliveCor in the intellectual property fight with Apple and its AFib detection technology. The board agreed with Apple that AliveCor’s claims surrounding U.S. Patent No. 10,595,731 B2 were unpatentable.
In that December ruling, the PTAB said: “Considering all the art and argument of record, and the level of ordinary skill in the art, we agree with [Apple] that ‘after an ECG is measured, it would have been obvious to confirm arrhythmia detection using a machine learning algorithm based on the PPG data, motion sensor data, and/or ECG data.’”
AliveCor requested and was granted a pause in the lawsuit in December as the presiding judge decided to wait for the PTAB decision on the challenges, despite Apple claiming the challenge would not be fair.
U.S. Patent Nos. 10,076,257 B2 and 10,866,619 B1 are at stake in this appeal. Patent ‘257 is a “Seamlessly embedded heart rate monitor” and is “directed to an electronic device having an integrated sensor for detecting a user’s cardiac activity and cardiac electrical signals,” according to the PTAB filing. Patent ‘619 is an “Electronic device having sealed button biometric sensing system” and relates to a biometric sensing system in an electronic device, the patent filing says.
Two companies are suing Apple over medtech IP
Multiple parties are challenging the validity of Apple’s patents. AliveCor’s petition to the court mentioned two cases where Masimo is challenging Apple’s U.S. Patent No. 10,076,257 B2. AliveCor filed petitions for Inter Partes Review (IPR) of patents related to the ‘257 patent as well.
In January 2020, Masimo accused Apple of poaching its employees and infringing 10 of its patents to improve the health monitoring functions of the Apple Watch. The court sought to determine whether Apple misused confidential information from Masimo related to the technology used to measure health data.
Earlier in 2023, a U.S. Administrative Law Judge in Washington, D.C. ruled in the company’s favor in a patent spat with Apple.
The judge ruled that Apple violated Section 337 of the Tariff Act of 1930 by importing and selling certain Apple Watches in the U.S. These watches featured light-based pulse oximetry functionality and components. However, the judge also ruled that Apple did not violate four other patents belonging to Masimo.
A turning point in the long-running dispute came in October when the U.S. International Trade Commission (ITC) ruled in Masimo’s favor. The ITC recommended a limited exclusion order for infringing Apple Watches with light-based pulse oximetry functionality. It found that Apple violated U.S. laws by incorporating this patented technology in its products.
Apple paused sales on the affected models beginning on its website on Dec. 21 and retail locations on Dec. 24.
What is the history between AliveCor and Apple?
The legal battles between the two companies have been ongoing for several years and are filled with ITC wins and numerous PTAB cases.
AliveCor first unveiled the ECG-equipped KardiaBand for Apple Watch in March 2016. It is a thin wristband designed specifically for the Apple Watch that returns single-lead ECG readings and diagnostics that can be viewed through its app and sent to managing physicians. The device was later cleared for use in the Apple Watch in November 2017.
AliveCor sued Apple over the IP of its ECG technology in 2020. AliveCor stopped selling its KardiaBand for use with the Apple Watch a year before the lawsuit. At the time, Apple had already launched its onboard EKG scanning and AF technology on its Apple Watch. Since, Apple has received FDA clearance for irregular heart rhythm notifications on its devices and continues to develop the technology.
The ITC initially took up this case in 2021. AliveCor alleged that Apple violated U.S. tariff law by importing certain Apple watches that infringe patents for its ECG technology. The company develops AI-powered cardiac care offerings, including an FDA-cleared wireless, patchless, six-lead ECG sensor. It also develops an FDA-cleared credit-card-sized personal ECG.
In December 2022, Apple scored the ITC win that AliveCor was appealing. PTAB agreed with Apple that AliveCor’s claims around U.S. Patent No. 10,595,731 B2 were unpatentable. The board made the determination based on the IP law concept of obviousness. A few weeks later, ITC ruled in favor of AliveCor, stating that the Apple Watch infringed its patented technology. The ITC issued a limited exclusion disorder (LEO) and a cease and desist order along with the final determination. It set a bond in the amount of $2 per unit of infringing Apple Watches imported or sold during its review period.