v.
Itc
United States Court of Appeals
for the Federal Circuit
______________________
APPLE INC.,
Appellant
v.
INTERNATIONAL TRADE COMMISSION,
Appellee
MASIMO CORPORATION, CERCACOR
LABORATORIES, INC.,
Intervenors
______________________
2024-1285
______________________
Appeal from the United States International Trade
Commission in Investigation No. 337-TA-1276.
______________________
Decided: March 19, 2026
______________________
JOSEPH J. MUELLER, Wilmer Cutler Pickering Hale and
Dorr LLP, Boston, MA, argued for appellant. Also repre-
sented by SARAH R. FRAZIER; DEREK ANTHONY GOSMA, Los
Angeles, CA; MARK D. SELWYN, THOMAS GREGORY
SPRANKLING, Palo Alto, CA; DAVID P. YIN, Washington, DC.
RONALD TRAUD, Office of the General Counsel, United
States International Trade Commission, Washington, DC,
argued for appellee. Also represented by MICHELLE W.
Case: 24-1285 Document: 107 Page: 2 Filed: 03/19/2026
2 APPLE INC. v. ITC
KLANCNIK, MARGARET D. MACDONALD, HOUDA MORAD.
JOSEPH R. RE, Knobbe, Martens, Olson & Bear, LLP,
Irvine, CA, argued for intervenors. Also represented by
BRIAN CHRISTOPHER CLAASSEN, STEPHEN C. JENSEN,
SHEILA N. SWAROOP; JONATHAN EDWARD BACHAND, Wash-
ington, DC.
______________________
Before LOURIE, REYNA, and STARK, Circuit Judges.
STARK, Circuit Judge. In September 2020, Apple Inc. (“Apple”) launched the Apple Watch Series 6 (“Apple Watch”), which included a feature capable of estimating the wearer’s blood oxygena- tion level. Nine months later, in June 2021, Masimo Cor- poration and Cercacor Laboratories, Inc. (collectively, “Masimo”) filed a complaint with the United States Inter- national Trade Commission (“Commission”), under § 337 of the Tariff Act of 1930 as amended (“Tariff Act”), alleging that Apple’s importation and sale of the Apple Watch in- fringed several Masimo patents covering wearable blood oxygen measurement devices. In its complaint, Masimo charged that Apple was unlawfully engaged in unfair trade practices in violation of the Tariff Act. The Commission instituted an investigation and found that Masimo proved Apple did, in fact, violate § 337 by importing, selling, and offering for sale Apple Watch models that incorporated the blood oxygen functionality covered by Masimo’s patents. Accordingly, the Commission issued a limited exclusion or- der (“LEO”) barring importation of the infringing Apple Watches. Apple now appeals. Finding no error in the Com- mission’s domestic industry determination, its validity rul- ings, or its infringement findings, we affirm.
Case: 24-1285 Document: 107 Page: 3 Filed: 03/19/2026
APPLE INC. v. ITC 3 I A Masimo was founded in California in 1989 with a goal of addressing persistent problems encountered by conven- tional noninvasive pulse oximeters used to measure blood oxygenation levels, including inaccurate and false read- ings, particularly under clinical conditions. In 1995, Masimo introduced its motion- and low-perfusion-tolerant Signal Extraction Technology (“Masimo SET”), which sub- stantially reduced false alarms caused by certain condi- tions prevalent in clinical settings, such as patient movement or poor circulation. Masimo has obtained multiple patents for the Masimo SET technology and is the assignee of U.S. Pa- tent Nos. 10,912,502 (the “’502 patent”) and 10,945,648 (the “’648 patent”). Because both the ’502 and ’648 patents name Jeroen Poeze as their first named inventor, we will refer to them collectively throughout this opinion as the “Poeze Patents.” The Poeze Patents claim priority to an application filed on July 3, 2008, and they share a title, “User-Worn Device for Noninvasively Measuring a Physio- logical Parameter of a User.” J.A. 366. Generally, the Poeze Patents cover wearable technology that measures user physiological metrics by way of optical emitters and photodetection. These devices use light-emitting diodes (“LEDs”) to emit light at specific wavelengths into tissue at a measurement site, such as the fingertip. Photodetectors on the device then measure the returned intensity of these optical emissions, which is attenuated by the wearer’s tis- sue and blood. The level of attenuation is then used to de- termine the desired physiological parameter of the device wearer. On September 24, 2020, Masimo filed with the U.S. Pa- tent and Trademark Office the applications that later be- came the Poeze Patents. Their claims share substantially similar limitations, including that the covered devices Case: 24-1285 Document: 107 Page: 4 Filed: 03/19/2026 4 APPLE INC. v. ITC must be “user-worn” and utilize transmissive windows that extend across or exist within a convex protrusion of the de- vice. Claim 19 of the ’502 patent, from which asserted claim 22 depends, is representative for purposes of the is- sues presented in this appeal: A user-worn device configured to non-invasively measure an oxygen saturation of a user, the user- worn device comprising: a plurality of emitters configured to emit light, each of the emitters comprising at least two light emitting diodes (LEDs); four photodiodes arranged within the user- worn device and configured to receive light after at least a portion of the light has been attenuated by tissue of the user; a protrusion comprising a convex surface including separate openings extending through the protrusion and lined with opaque material, each opening positioned over a different one associated with each of the four photodiodes, the opaque material configured to reduce an amount of light reaching the photodiodes without being at- tenuated by the tissue; optically transparent material within each of the openings; and one or more processors configured to re- ceive one or more signals from at least one of the four photodiodes and output meas- urements responsive to the one or more sig- nals, the measurements indicative of the oxygen saturation of the user. J.A. 704 at 46:22-45 (emphasis added). Case: 24-1285 Document: 107 Page: 5 Filed: 03/19/2026 APPLE INC. v. ITC 5 Figure 3B of the ’502 patent, reproduced below, depicts an illustrative embodiment of a claimed pulse oximeter: J.A. 623. B Apple released the accused version of the Apple Watch on September 15, 2020. It contained a feature Apple called the “Blood Oxygen sensor,” which “employs LEDs, along with photodiodes” to measure the wearer’s “blood oxygen levels.” J.A. 70359. On June 30, 2021, Masimo filed its complaint against Apple with the Commission, which it amended on July 7, 2021. Masimo’s amended complaint alleged that the Apple Watch infringed various claims of several Masimo patents, including the Poeze Patents, and sought an exclusion order pursuant to § 337 of the Tariff Act pro- hibiting Apple from importing the Apple Watch. Section 337 makes it “unlawful to import articles that infringe a valid and enforceable United States patent if ‘an industry in the United States, relating to the articles protected by the patent . . . exists or is in the process of being estab- lished.’” Motiva LLC v. Int’l Trade Comm’n, 716 F.3d 596, Case: 24-1285 Document: 107 Page: 6 Filed: 03/19/2026 6 APPLE INC. v. ITC 597 (Fed. Cir. 2013) (quoting 19 U.S.C. § 1337(a)(2)). Upon finding a § 337 violation, the Commission is empowered to “declare[] certain activities related to importation to be un- lawful trade acts and . . . to grant prospective relief,” in- cluding prohibiting importation of infringing articles, when appropriate. ClearCorrect Operating, LLC v. Int’l Trade Comm’n, 810 F.3d 1283, 1289 (Fed. Cir. 2015) (internal quotation marks omitted). The Commission instituted an investigation to deter- mine whether Masimo was entitled to such relief. In June 2022, an administrative law judge (“ALJ”) held a five- day hearing, during which she heard testimony from 22 live witnesses, and after which she issued a 342-page opin- ion, setting out her determinations that: (i) Masimo estab- lished the existence of a domestic industry relating to the Poeze Patent claims it was asserting against Apple; (ii) the Apple Watch infringed some of those claims; (iii) some of the infringed claims had not been proven invalid for lack of adequate written description or obviousness; and (iv) Masimo was not estopped by prosecution history laches from enforcing its patents. Ultimately, the ALJ held that Apple violated § 337 because the Apple Watch infringed claims 24 and 30 of the ’648 patent, claims practiced by Masimo that Apple failed to prove were invalid. Apple and Masimo then cross-petitioned for Commis- sion review of the ALJ’s ruling, and the Commission granted such review in part. On October 26, 2023, the Commission issued its final determination, affirming the ALJ’s finding of a § 337 violation as to claims 24 and 30 of the ’648 patent and reversing her determination that claim 12 of the ’648 patent and claims 22 and 28 of the ’502 patent were invalid for lack of adequate written description. How- ever, the Commission also found that no domestic industry existed as to claim 22 of the ’502 patent. Based on these rulings, the Commission’s overall finding was that Apple violated § 337 with respect to four claims that had not been shown to be invalid: claims 12, 24, and 30 of the ’648 patent Case: 24-1285 Document: 107 Page: 7 Filed: 03/19/2026 APPLE INC. v. ITC 7 and claim 28 of the ’502 patent. [1] As relief, the Commission issued a LEO barring importation of the infringing Apple Watches. Apple timely appealed from the Commission’s judg- ment, and we granted Masimo leave to intervene in sup- port of the Commission. We have jurisdiction under 28 U.S.C. § 1295(a)(6). 2 II “Our review of the Commission’s final determination of a Section 337 violation is governed by the standards of the Administrative Procedure Act” (“APA”). May- born Grp., Ltd. v. Int’l Trade Comm’n, 965 F.3d 1350, 1353 (Fed. Cir. 2020). “The Commission’s factual findings are reviewed for substantial evidence, and legal determina- tions are reviewed de novo.” Broadcom Corp. v. Int’l Trade Comm’n, 28 F.4th 240, 249 (Fed. Cir. 2022); see also 5 U.S.C. § 706. Substantial evidence “means such relevant evidence as a reasonable mind might accept as adequate to a In order to satisfy the technical prong of the domestic industry requirement, “an actual article protected by the patent is needed.” Broadcom Corp., 28 F.4th at 250. For purposes of § 337, “Congress’s unambiguously expressed intent was for ‘articles’ to mean ‘material things.’” ClearCorrect, 810 F.3d at 1294. In a § 337 proceeding, then, the complainant must show there is a domestic in- dustry article that actually practices at least one claim of an asserted patent. See Microsoft, 731 F.3d at 1361; Osram GmbH v. Int’l Trade Comm’n, 505 F.3d 1351, 1359 (Fed. Cir. 2007) (“The domestic product, to meet the tech- nical prong test, Section 337(a)(2), must be covered by the asserted claims.”). Hence, “[f]or the technical prong, the question is essentially [the] same as that for infringement, i.e., a comparison of domestic products to the asserted claims.” Lashify, 130 F.4th at 954 (internal quotation marks omitted). In its governing amended complaint filed on July 7, 2021, 3 Masimo “identif[ied] a ‘Masimo Watch’ . . . as We turn now to the economic prong of the domestic in- dustry requirement. The economic prong “requires that there be in existence or in the process of being established an industry in the United States pertaining to the pa- tent[(s)].” Lashify, 130 F.4th at 954 (internal quotation marks and alterations omitted). Section 337(a)(3) “identi- fies three potentially overlapping but independently suffi- cient bases” for finding the economic prong satisfied. Id. They are: (A) significant investment in plant and equipment; (B) significant employment of labor or capital; or (C) substantial investment in its exploitations, in- cluding engineering, research and development, and licensing. 19 U.S.C. § 1337(a)(3). In her initial determination, the ALJ found Masimo had satisfied subsection (B) above, by showing “significant employment of labor or capital” by way of Masimo’s “invest- ments in research and development for the Masimo Watch.” J.A. 322. The ALJ based this finding on evidence of the number of employees working on the Masimo Watch, Masimo’s monetary investments in the Masimo Watch, and the fact that “all of the research and development (‘R&D’) for the Masimo Watch has occurred in the United States.” Id. While the ALJ found that Masimo demonstrated a do- mestic industry both “in existence” and “in the process of being established,” the Commission affirmed only the find- ing of a domestic industry “in existence,” choosing not to reach the question of whether Masimo additionally proved an industry “in the process of being established.” The Com- mission reasoned that the qualitative significance of Masimo’s R&D in the Masimo Watch, and particularly the percentage of Masimo’s R&D engineers working on the ar- ticle and that their work was predominantly, if not
[*1][*2]Case: 24-1285 Document: 107 Page: 20 Filed: 03/19/2026 The claim terms “over” and “above” relate to certain in- ternal components of the claimed devices and their orien- tation. For example, claim 28 of the ’502 patent requires “a protrusion arranged above the interior surface” of the device. J.A. 705 at 47:31 (emphasis added). The parties dispute whether, for instance in this example, the claim re- quires the protrusion be “above” the interior surface such that the protrusion is higher (i.e., closer to the sky) than the interior surface when the device is in operation or whether, instead, it requires simply that the protrusion cover the interior surface, without consideration of whether during operation the protrusion happens to be higher (closer to the sky) or lower (closer to the ground) than the interior surface. The ALJ construed “above,” as used in claim 28 of the ’502 patent, and “over,” as used in claims 20 and 34 of the ’648 patent, to mean “arrangement[s] where one feature co- vers another – not the relative arrangement of the[] fea- tures in a vertical direction.” J.A. 34. That is, the terms “refer[] to a position relative to the device’s features and not to its orientation relative to Earth.” Id. at n.4. In ar- riving at those constructions, the ALJ rejected Apple’s po- sition that the terms “require a vertical arrangement of features in a particular orientation.” J.A. 35; see also Open. Br. at 60 (“[E]ach claim requires a protrusion, open- ings, or holes situated over or above the photodiodes or in- terior surface of the device, when the device is configured to measure blood oxygen saturation”) (internal emphasis and quotation marks omitted). As the ALJ correctly determined, the plain and ordi- nary meaning of “over” and “above,” as used in the field of Apple’s challenge to the ALJ’s construction of “open- ings”/“through holes,” as used in all asserted claims, also lacks merit. The claims require that “each through hole [be] . . . arranged over a different one of the . . . photodi- odes.” J.A. 815 at 46:43-45 (emphasis added). The ALJ correctly construed these terms as encompassing “openings and holes that include material.” J.A. 36. She was right to reject Apple’s proposed construction, which would have re- quired the claimed “openings” and “through holes” to be de- void of material, including even transparent material. Nothing in the claim language precludes the “open- ings” and “through holes” from including material. To the contrary, certain of the claims actually require such mate- rial. For example, claim 19 of the ’502 patent requires “an
Case: 24-1285 Document: 107 Page: 28 Filed: 03/19/2026 A patent’s specification must contain an adequate writ- ten description of the invention. See 35 U.S.C. § 112(a). “A specification adequately describes an invention when it reasonably conveys to those skilled in the art that the in- ventor had possession of the claimed subject matter as of the filing date.” Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1335 (Fed. Cir. 2021) (internal quota- tion marks omitted). “Whether a claim satisfies the writ- ten description requirement is a question of fact.” Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 1016 (Fed. Cir. 2022) (internal quotation marks omitted). Each of the claims at issue here requires: (i) sets of LEDs, each set having multiple LEDs; (ii) four photodiodes; and (iii) an opaque protrusion with a plurality of “openings” or “holes” positioned or arranged over the photodiodes. J.A. 704 at 46:51-54; J.A. 705 at 47:13-48:23; J.A. 815 at 46:15-16, 46:59-61; J.A. 816 at 47:6-7; see also J.A. 161-62. Claim 28 of the ’502 patent and claim 12 of the ’648 patent additionally require “separate sets of LEDs emitting at a First Wavelength and a Second Wavelength” (the “matching wavelength” limitation). J.A. 167. Apple argues that neither the required combination of specific LEDs and photodiodes, nor the matching wavelength limi- tations, are supported by adequate written description. However, the ALJ’s contrary findings, adopted by the Com- mission, are supported by substantial evidence. Apple contends that the ALJ improperly relied “on ele- ments taken from four separate embodiments” in the spec- ification to find the asserted claims’ combination of required elements supported by adequate written descrip- tion. Open. Br. at 55. Specifically, Apple claims the ALJ relied on the 301A sensor embodiment (shown in Figure 3C) to disclose the required four photodiodes over which a protrusion rests with openings arranged over the photodi- odes; on the 101 sensor embodiment (shown in Figure 1) for
Case: 24-1285 Document: 107 Page: 30 Filed: 03/19/2026 Apple additionally argues that the asserted claims are invalid as obvious in view of U.S. Patent No. 7,620,212 (“Lumidigm”), which generally discloses devices containing “electro-optical sensors” that, in some embodiments, can be used for “biometric identification.” The Commission re- jected Apple’s obviousness case after finding Lumidigm does not disclose (i) measuring blood oxygen level at the wrist, or (ii) transmissive windows extending across open- ings and within openings. “The ultimate question of obvi- ousness is a legal question that we review de novo with underlying factual findings that we review for substantial evidence.” Roku, Inc. v. Universal Elecs., Inc., 63 F.4th 1319, 1324 (Fed. Cir. 2023). Here the ALJ, whose determi- nations were adopted by the Commission, committed no le- gal error and her factual findings were supported by substantial evidence. One premise of the ALJ’s rejection of Apple’s obvious- ness defense was her determination that Lumidigm failed
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