Office of the Secretary
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C. 20436
`
`October 2, 2024
`
`Dax Terrill, Chief
`Exclusion Order Enforcement Branch
`U.S. Customs and Border Protection
`Regulations and Rulings – Office of Trade
`90 K Street NE – 10th Floor
`Washington, DC 20229-1177
`
`Re:
`
`Certain Light-Based Physiological Measurement Devices and Components
`Thereof, Investigation No. 337-TA-1276.
`
`Dear Mr. Terrill:
`
`Thank you for your letter of September 13, 2024, seeking clarification as to the
`proceedings in the above-referenced investigation, Certain Light-Based Physiological
`Measurement Devices and Components Thereof, Inv. No. 337-TA-1276. Specifically, you seek
`confirmation or clarification regarding whether and to what extent the Commission found or
`determined that the preamble is limiting in claim 19 of U.S. Patent No. 10,912,502 (“the ’502
`patent”). In sum, the Commission considered the entirety of the preamble of claim 19 of the
`’502 patent to be limiting.
`
`In the above-referenced investigation, the Commission found a violation of section 337
`of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337, based on infringement of claims 22 and
`28 of the ’502 patent, among others, by Respondent Apple Inc. (“Apple”). See 88 Fed. Reg.
`74032-33 (Nov. 1, 2023). Complainants Masimo Corporation and Cercacor Laboratories, Inc.
`(collectively “Masimo”) asserted several other patents in the investigation, including U.S. Patent
`No. 10,912,501 (“the ’501 patent”), which is relevant to this issue and is in the same patent
`family as the ’502 patent. Id.
`
`In the ’502 patent, claim 22 depends from claim 19, which includes preamble language
`describing “[a] user-worn device configured to non-invasively measure an oxygen saturation of a
`user.” See Light-Based Physiological Measurement Devices, Commission Opinion (“Comm’n
`Op.”) at 8-10, EDIS Doc. ID 808521 (Public Version) (Nov. 14, 2023).
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`PUBLIC VERSION
`
`

`

`Chief Terrill
`October 2, 2024
`Page 2
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`As you have recognized, the parties filed a joint stipulation wherein Masimo stipulated
`that “[f]or purposes of this Investigation only, Masimo does not contest that the preambles of the
`claims of the ’501 patent, the ’502 patent, [among others,] are limiting on the claims.” Light-
`Based Physiological Measurement Devices, Joint Stipulation of Facts ¶ 9, EDIS Doc. ID 770692
`(Confidential) (May 13, 2022). This stipulation was cited in the Final Initial Determination in
`the context of infringement for claim 1 of the ’501 patent, which contains similar language to
`claim 19 of the ’502 patent. Light-Based Physiological Measurement Devices, Final Initial
`Determination (“Final ID”) at 34 n.8, EDIS Doc. ID 789795 (Public Version) (Jan. 10, 2023).
`
`When addressing infringement of claims 19 and 22 of the ’502 patent, the Final ID
`recognized that “[t]here is no dispute that the Accused Products meet the limitations of the
`preamble of ’502 patent claim 19.” Id. at 40. The Final ID cited evidence, first discussed in the
`context of the ’501 patent, showing that “the Accused Products are watches configured to
`measure blood oxygen saturation.” Id. at 34. The Commission determined not to review the
`Final ID’s findings with respect to infringement regarding the ’501 patent and the ’502 patent.
`See 88 Fed. Reg. 32243-46 (May 19, 2023).1
`
`In the context of the technical prong of the domestic industry requirement, the Final ID
`found that certain prototype devices met the limitations of claim 28 of the ’502 patent, which has
`the same preamble language as claim 19. Final ID at 68-69. The Final ID referenced an earlier
`discussion of similar preamble language in the ’501 patent, finding that the prototype devices
`measured blood oxygen saturation and met the “user-worn” limitation. Id. (citing id. at 60-63).
`The Commission determined to review the Final ID’s domestic industry findings and affirmed
`the existence of a domestic industry with respect to the ’502 patent without modifying the Final
`ID’s technical prong analysis. Comm’n Op. at 66-68.
`
`In the context of invalidity, the Final ID found that a prior art reference, U.S. Patent No.
`7,620,212 (RX-0411, “Lumidigm”), did not meet the preamble limitations of claim 19 of the
`’502 patent, because Lumidigm did not enable the measurement of oxygen saturation in its only
`user-worn embodiment, which was a wristwatch. Final ID at 113-118. The Final ID further
`found that claim 22 of the ’502 patent was not shown to be obvious in view of Lumidigm based
`on the failure to meet these preamble limitations and other limitations in the claims. Id. at 113-
`27. The Commission determined to review the Final ID’s obviousness findings and affirmed the
`Final ID’s analysis of the preamble language of claim 19 of the ’502 patent. Comm’n Op. at 22-
`23. The Commission also affirmed, with modified reasoning, the Final ID’s determination that
`claim 22 of the ’502 patent was not shown to be obvious in view of Lumidigm. Id. at 21-49.
`
`1 In the context of claim construction, Apple argued before the Administrative Law Judge that
`the “configured to” language in the preamble of claim 19 should be read in conjunction with the
`“positioned over” language in the body of claim 19 to require that certain elements be oriented
`vertically, but the Administrative Law Judge adopted a construction of “over” that made this
`argument irrelevant. Final ID at 26-30; id. at 30 n.5. The Commission did not review this claim
`construction. See 88 Fed. Reg. 32243-46 (May 19, 2023).
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`PUBLIC VERSION
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`

`

`Chief Terrill
`October 2, 2024
`Page 3
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`In accordance with the foregoing, we confirm that the Commission found the preamble of
`claim 19 of the ’502 patent to be limiting. The Commission explicitly discussed the preamble
`language of claim 19 in the context of infringement and invalidity. See Final ID at 34, 40, 115-
`118; Comm’n Op. at 22-23. With respect to the specific preamble phrases identified in your
`letter, the Commission’s infringement and invalidity analysis explicitly considered “a user-worn
`device,” “configured to,” and “non-invasively measure an oxygen saturation of a user” as claim
`limitations. See Final ID at 34, 40, 115-118; Comm’n Op. at 22-23. The Commission also relied
`on identical preamble language in claim 28 of the ’502 patent with respect to the technical prong
`of the domestic industry requirement. See Final ID at 60-63, 68-69. Accordingly, the
`Commission considered the entirety of the preamble of claim 19 of the ’502 patent to be limiting.
`
`Sincerely,
`
`Lisa R. Barton
`Secretary to the Commission
`
`PUBLIC VERSION
`
`