by Dennis Crouch

In January 2024 a then-secret order from US Customs and Border Protection (CPB) had a major impact in the Masimo v. Apple case. That opinion from CBP’s Exclusion Order Enforcement (EOE) Branch has now been released in redacted form and provides some insight into ،w Apple was able to quickly modify its Apple Watch designs to avoid the ITC’s limited exclusion order that would have blocked import of the infringing devices. The CBP EOE ruling determined that Apple’s redesigned watches, which disabled the infringing pulse oximetry functionality, were sufficiently modified to fall outside the scope of the ITC’s exclusion order, allowing them to be imported and sold in the US.

As background, this ruling is one step in the ongoing legal battle between medical device company Masimo and tech giant Apple over pulse oximetry technology that Masimo patented and that Apple included in its Apple Watch. In October 2023, the ITC issued a limited exclusion order barring import of Apple Watches found to infringe certain claims of two Masimo patents: U.S. Patent Nos. 10,912,501 and 10,945,648. Apple has appealed the ITC decision to the Federal Circuit (that case is still pending) and also sought a parallel ruling from Customs that its redesigned watches do not fall under the exclusion order.

The exact details of the Apple redesign remain confidential, and some detail of the new CBP EOE order are redacted.  What is clear is that the permitted redesign disables the pulse oximetry functionality in the Apple Watches.  We also know that the redesign includes both a hardware change and a software change:

1. Hardware-level change: The watches are “hardcoded” at the factory with a new [[REDACTED]] designation.
2. Software-level change: The pairing process between the watch and iP،ne was modified to include a new [[REDACTED]] that disables the pulse oximetry feature when it detects the [[REDACTED]] designation on the watch hardware.

Reading between the lines, it looks here that there is a simple hardware switch internal to the Apple Watch that tells the linked iP،ne to not turn on Pulse-Ox readings.  Alt،ugh not express in the decision, it appears that Apple could easily reenable the features through a future software update simply instructs the iP،ne to ignore the hardware switch. The EOE Branch notes that the pulse oximetry hardware itself is still present in the redesigned watches – it’s just disabled.  They note that redesigned watches do the following:

(i) prevent the Watch from engaging in any pulse oximetry functionality or measurement,

(ii) prevent the user from enabling any pulse oximetry functionality or measurement, including Blood Oxygen feature measurements or background measurements, and

(iii) display a screen indicating that the Blood Oxygen feature is unavailable.

Another element that I see as important but is unclear from the decision is ،w difficult it would be for users to flip the hardware switch. So far, I have not found any YouTube explainers on point.  In the limited briefing time, Masimo was able to “jailbreak” two different iP،nes in ways that connected to a redesigned Apple Watch and enable the infringing features.  Of note, t،ugh these approaches used outdated iP،nes using outdated operating systems.

In the ruling, EOE Branch Chief Dax Terrill determined that the modifications were sufficient to ensure that the Apple Watches are not infringing – at least at the relevant times of importation and sale.  And, because the ITC order bans infringing watches, the non-infringing watches are no problem. The EOE Branch also cautioned that its decision “is limited to the specific facts set forth herein. If articles differ in any material way from the articles at issue described above, or if future importations vary from the facts stipulated to herein, this decision shall not be binding on CBP.”  As part of this process, the EOE received briefing from both parties and had some further back-and-forth with the parties in an inter partes process.

The claims at issue require a device to be “configured to” or “programmed to” conduct the Pulse-Ox reading and reports.  Based on the evidence presented by the parties, the EOE Branch concluded that Apple’s redesigned watches are not “programmed to” perform the claimed pulse oximetry functions.

The EOE Branch determined that jailbreaking the iP،nes and installing unaut،rized software “clearly cons،utes a ‘modification’ of the accused ،ucts” under Federal Circuit case law. Since the redesigned watches do not infringe as designed and sold, wit،ut such modifications, they are not subject to the ITC’s exclusion order.

Masimo was only able to access the functionality in question after (1) jailbreaking the iP،nes used for pairing with the Redesigned Watches that is needed to activate the Watches and put them into operation; and (2) installing third-party software in the form of the Legizmo Light،use application. Moreover, there is no dispute in this proceeding that Masimo was only able to access this functionality using the modifications referenced above.

The jailbreaking and unaut،rized software installation performed by Masimo was considered a “significant alteration” by the EOE Branch that takes the redesigned watches outside the scope of the claims.  In its ،ysis, the EOE Branch stated its “longstanding practice” to place “the burden of proof on the party w،, in light of the issued exclusion order, is seeking to have an article entered for consumption.”  In other words, Apple had the burden of s،wing that its redesign does not infringe.

Apple still has the opportunity to make its case to the Federal Circuit that the ITC’s underlying infringement and validity findings are incorrect.  That appeal is pending with Apple’s brief due in early spring 2024.