Apple removes pulse oximetry from Watches to dodge ban; AliveCor advances patent review v. Apple (two big updates!)

January 17, 2024 | by

Apple redesigns US versions of the Watch 9 and Ultra 2 to delete pulse oximetry, gains approval from US Customs and Border Protection (CBP). The CBP enforces the International Trade Commission (ITC) ban on the original Watch 9 and Ultra 2 models that found that Apple violated Masimo’s patents on pulse oximetry (SpO2) sensors and software. The ban went into effect on 31 December but models were pulled from sale by 24 December.

While Apple’s emergency appeal of the ITC Limited Exclusion Order filed on 26 December grinds on in the US Court of Appeals for the Federal Circuit, right now the ITC ban is on a short-term stay that will be decided in the next few days. The appeals court will decide shortly whether Apple’s appeal will go forward and whether the Watch pulse oximetry version ban will be stayed until the completion of the appeal, typically another 18 months [TTA 28 Dec 2023].

Apple’s new versions of the Watch 9 and Ultra 2 without pulse oximetry skirts the ban and may be the longer term solution if the appeals court decides to uphold the ITC ban on the original models. According to HIStalk reporting Bloomberg News‘ coverage, the new versions have already been shipped to Apple Stores but not released for sale. Apple also has not disclosed whether previously sold Apple models will continue to have their pulse oximetry operative, or disabled via an update.

Masimo’s position is that Apple selling Watches without the disputed pulse oximetry is not a problem. They sent a letter to the appeals court confirming that “redesigned Watch products definitively do not contain pulse oximetry functionality” and thus are outside the scope of the import ban. In fact, “Apple’s claim that its redesigned watch does not contain pulse oximetry is a positive step toward accountability” around intellectual property rights. According to MedTechDive, Masimo’s CEO Joe Kiani is open to a settlement.

The appeals court decision on granting Apple a full appeal and stay of the ban of the watches with pulse oximetry is pending but may be decided in the next few days. It’s nice to have money to be able to redesign two flagship smartwatches, which Apple certainly does! 9to5Mac, Digital Trends

Updated 18 Jan  Federal appeals court continues import ban on Apple Watches with working pulse oximetry, Apple appeal on ITC LEO still pending

Apple’s other nemesis, ECG monitoring system AliveCor, is back with the US Patent Trial and Appeal Board (PTAB) about Apple’s patent infringements. AliveCor shared with this Editor that the PTAB is instituting an inter partes review (IPR) of two AliveCor petitions on Apple patents asserted against AliveCor: claims 11–20 of US Patent No. 10,866,619 (the ‘619 patent’) and claims 1–22 of US Patent No. 10,076,257 B2 (“the ’257 patent’). AliveCor continues to be engaged in an antitrust court action with Apple on its ECG technologies in Apple Watches in the US District Court of Northern California.

AliveCor’s statement to this Editor: 

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.

Unlike Masimo, Apple licensed AliveCor’s ECG technology in early Apple Watches, then took action when Apple introduced its own ECG in the Apple Watch 4 in 2020.

Updated 18 Jan  The US District Court of Northern California on 17 January upheld the continued stay of Apple’s patent infringement countersuit pending the outcome of the PTAB’s Inter Partes Review (IPR) of the 257 and 619 patents. In addition, the order reveals that the PTAB has a pending decision on whether to institute IPRs on US Patent Nos. 10,270,898 and 10,568,533. Both AliveCor and Apple are required to inform the District Court of any new IPRs ordered, as well as on the current IPRs at minimum every six months to update the Court on their status and any appeals. Court order PDF

AliveCor loses Patent Office ruling with Apple; three patents invalidated

December 8, 2022 | by

Apple prevails in the patent infringement suit by AliveCor–and got three AliveCor heart monitoring patents invalidated as ‘unpatentable’. In the duel of patent infringement claims dating back to May 2021 between AliveCor and Apple, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) not only ruled that Apple did not infringe on AliveCor’s patents, but also threw out the AliveCor patents that were the basis for the infringement. AliveCor had sued Apple for patent infringement on their ECG technology in three US patents: No. 10,595,731 (“the ’731 patent”); No. 10,638,941 (“the ’941 patent”); and No. 9,572,499 (“the ’499 patent”) in their Apple Watches 4, 5, and 6. [TTA 29 Apr 21, 9 July 21] 

The term ‘unpatentable’ is used when the PTAB deems the patent, even when granted in the past, too obvious or too general. When the PTAB finds that, they throw out the patent and it is no longer valid.

Apple of course crowed that they developed their own patents fully on their own, and not from the time when AliveCor’s ECG monitoring was incorporated into earlier Apple Watches. Apple is up to the Series 8. AliveCor has already announced it will appeal and await the pending ruling from the International Trade Commission (ITC) to block the import of Apple Watches. The ITC’s initial determination in June was positive [TTA 28 June] and AliveCor of course is ‘cautiously optimistic’ on the Final Determination due in a few days (12 December). With the PTAB’s finding, it is far less likely that the ITC will impose an import block when AliveCor’s patents have been invalidated.  9to5Mac, Mobihealthnews

AliveCor has moved forward with its KardiaMobile series, including a credit card-sized device (left), and has enjoyed substantial investment, with an August Series F (amount undisclosed) round led by GE Healthcare. 

Patent invalidation is a danger in any patent infringement lawsuit. In 2015, Bosch Healthcare, which had bought HealthHero, an early RPM platform marketed as Health Buddy, and ViTelNet, was a serial patent challenger. They went after Philips, Viterion (while owned by Bayer), both to a draw, and won against a slew of barely-out-of-the-cradle companies forgotten by nearly all of us such as Alere Health, MedApps, Waldo Health, and Express MD Solutions. Then they sued Cardiocom in 2012 with the same expectation. Except that a year later, Cardiocom was acquired by Medtronic. Deep-pocketed Medtronic fought back hard–and by 2015, the PTAB invalidated most of Bosch’s key patents. Bosch withdrew from the US market abruptly in 2015. TTA 19 June 2015, 7 September 2015 primarily about the ongoing Teladoc-Amwell dustups

Given their funding and device development, AliveCor will likely not face Bosch’s fate, but such invalidations have consequences yet to be determined and litigated.