Masimo filed a complaint for declaratory and injunctive relief against U.S. Customs and Border Protection and several government officials to challenge ex parte rulings that allowed Apple to restore pulse oximetry functionality to several smartwatch models. The U.S. International Trade Commission found that Apple violated Section 337 by importing devices that infringe two Masimo patents covering user-worn devices for noninvasive physiological measurement. The USITC issued a limited exclusion order prohibiting importation of devices with the LED pulse oximetry function. Masimo questions CBP's use of administrative proceedings reserved for exceptional circumstances after Apple invested heavily to expand U.S. manufacturing and supply chains. Apple sought a CBP ruling under 19 CFR § 177 claiming alleged redesigns to Apple Watch models.
According to Masimo, the CBP 'inexplicably reversed course' from its prior rulings in finding that Apple could overcome the LEO by shipping its smartwatches separately from iPhones.
On Wednesday, Irvine, CA-based health technology company Masimo Corporation filed a complaint for declaratory and injunctive relief against U.S. Customs and Border Protection (CBP) and several U.S. government officials, challenging ex parte rulings that allow consumer tech giant Apple to restore pulse oximetry functionality to several smartwatch models. This functionality had previously been found to infringe Masimo's patents by the U.S. International Trade Commission (USITC), leading Masimo to question why the CBP utilized proceedings normally reserved for exceptional circumstances after Apple committed hundreds of billions to expand advanced manufacturing and supply chain capacity in the United States.
In October 2023, the USITC determined that Masimo established a Section 337 violation through Apple's importation for sale of light-based physiological measurement devices infringing upon claims of two Masimo patents: U.S. Patent No. 10912502 and U.S. Patent No. 10945648, both titled User-Worn Device for Noninvasively Measuring a Physiological Parameter of a User. The '502 and '648 patents claim methods and devices for measuring blood analytes, including oxygen levels, using photodiodes receiving light from light-emitting diodes (LEDs) passing through a measurement site and processors identifying light wavelengths absorbed by analytes. Following the Section 337 determination, the USITC issued a limited exclusion order (LEO) prohibiting Apple from importing wearable electronic devices with the LED pulse oximetry functionality.
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