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`PUBLIC VERSION
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`In the Matter of
`CERTAIN LIGHT-BASED
`PHYSIOLOGICAL MEASUREMENT
`DEVICES AND COMPONENTS
`THEREOF
`
`Investigation No. 337-TA-1276
`
`COMMISSION OPINION
`
`TABLE OF CONTENTS
`INTRODUCTION ................................................................................................. 2
`BACKGROUND ................................................................................................... 2
`Procedural History ........................................................................................ 2
`A.
`B.
`The Asserted Patents ..................................................................................... 7
`C.
`The Accused Products ................................................................................ 13
`D. The Domestic Industry Products ................................................................. 14
`COMMISSION REVIEW OF THE FINAL ID .................................................. 14
`ANALYSIS OF THE ISSUES UNDER REVIEW ............................................. 15
`Subject Matter Jurisdiction ......................................................................... 15
`A.
`B. Obviousness of the Asserted Claims of the ’501 Patent, the ’502 Patent,
`and the ’648 Patent ..................................................................................... 16
`C. Non-Obviousness of the Asserted Claims of the ’745 Patent ..................... 49
`D. Written Description Support of Claim 28 of the ’502 Patent and Claim
`12 of the ’648 Patent ................................................................................... 53
`E. Claim Construction and Infringement Regarding the ’745 Patent ............. 66
`The Domestic Industry Issues Under Review—The Poeze Patents and
`F.
`the ’745 Patent ............................................................................................ 66
`REMEDY, THE PUBLIC INTEREST, AND BONDING .................................. 69
`A. Remedy ....................................................................................................... 69
`Public Interest ............................................................................................. 76
`B.
`C. Bonding .................................................................................................... 119
`CONCLUSION .................................................................................................. 123
`
`I.
`II.
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`III.
`IV.
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`V.
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`VI.
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`1
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`I.
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`INTRODUCTION
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`On May 15, 2023, the Commission determined to review in part the final initial
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`determination (“ID”) issued by the presiding administrative law judge (“ALJ”) on January 10,
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`2023. 88 Fed. Reg. 32243 (May 19, 2023). On review, the Commission has determined that
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`there has been a violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C.
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`§ 1337, with respect to U.S. Patent Nos. 10,945,648 (“the ’648 patent”) and 10,912,502 (“the
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`’502 patent”), but not with respect to U.S. Patent Nos. 10,912,501 (“the ’501 patent”),
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`10,687,745 (“the ’745 patent”), and 7,761,127 (“the ’127 patent”). This opinion sets forth the
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`Commission’s reasoning in support of that determination.
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`II.
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`BACKGROUND
`
`A.
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`Procedural History
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`The Commission instituted this investigation on August 18, 2021, based on an amended
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`and supplemented complaint (“Complaint”) filed by complainants Masimo Corporation
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`(“Masimo”) and Cercacor Laboratories, Inc. (“Cercacor,” collectively, “Complainants”).1, 2, 3 86
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`Fed. Reg. 46275–76 (Aug. 18, 2021). The Complaint alleged violations of section 337 of the
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`1 The original public complaint was filed on June 30, 2021. See EDIS Doc. ID 745713
`(June 30, 2021). On July 7, 2021, Complainants filed an “Amendment to the Public Complaint,
`with Amended Exhibit 2 and Appendix C.” See EDIS Doc. ID 746186. And on July 12, 2021,
`Complainants filed a “Confidential Amendment to the Public Complaint and Exhibits.” See
`EDIS Doc. ID 746514. The Commission has determined that the filing date of the Complaint is
`July 12, 2021. See, e.g., 86 Fed. Reg. at 46275; Final ID at 84 (including n.24).
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`2 Supplement to the Confidential Amended Complaint and Exhibits, EDIS Doc. ID
`747244 (July 19, 2021); Supplement to the Amended Public Complaint and Exhibits, EDIS Doc.
`ID 747240 (July 19, 2021).
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`3 Masimo is the owner of the ’501 patent (JX-0001), ’502 patent (JX-0002), ’648 patent
`(JX-0003), and ’745 patent (JX-0009). Compl. at ¶ 4. Cercacor is the owner of the ’127 patent
`(JX-0007). Id. Masimo and Cercacor have rights to each of the Asserted Patents through a
`cross-licensing agreement. Id. at ¶¶ 4, 77; CX-1612C.
`2
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`PUBLIC VERSION
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`Tariff Act of 1930, as amended, 19 U.S.C. § 1337, based upon the importation into the United
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`States, the sale for importation, and the sale within the United States after importation of certain
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`light-based physiological measurement devices and components thereof by reason of
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`infringement of certain claims of the ’501 patent; the ’502 patent; the ’648 patent; the ’745
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`patent; and the ’127 patent (collectively, the “Asserted Patents”). Id. The Complaint further
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`alleged that an industry in the United States exists and/or is in the process of being established.
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`Id. The notice of investigation named Apple Inc. of Cupertino, California as the sole respondent
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`(“Apple”). Id. at 46276. The Office of Unfair Import Investigations is not participating in this
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`investigation. See id.
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`Prior to the issuance of the Final ID, the investigation terminated as to several claims.
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`Order No. 25 (Mar. 23, 2022), unreviewed by Comm’n Notice (Apr. 12, 2022); Order No. 33
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`(May 20, 2022), unreviewed by Comm’n Notice (June 10, 2022). At the time of the hearing on
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`June 6–10, 2022, only the following claims remained at issue: claim 12 of the ’501 patent,
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`claims 22 and 28 of the ’502 patent, claims 12, 24, and 30 of the ’648 patent, claims 9, 18,4 and
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`27 of the ’745 patent, and claim 9 of the ’127 patent.
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`4 Complainants proceeded at the hearing as to claim 18 of the ’745 patent for domestic
`industry purposes only. See, e.g., Final ID at 176. In other words, Complainants did not allege
`that Apple violated section 337 by infringing that claim.
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`On May 13, 2022, Complainants and Apple filed their pre-hearing briefs.5 The parties
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`filed initial post-hearing briefs on June 27, 2022,6 and the parties filed post-hearing reply briefs
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`on July 11, 2022.7
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`On January 10, 2023, the ALJ issued the Final ID,8 which found that Apple violated
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`section 337 as to only claims 24 and 30 of the ’648 patent. See Final ID at 335–36. The Final ID
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`found that Complainants did not establish a violation as to the other remaining asserted claims.
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`E.g., id.
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`On January 24, 2023, the ALJ issued the Recommended Determination on Remedy and
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`Bonding (“RD”).9 The RD recommended that, if the Commission finds a violation, it should
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`5 Complainants’ Pre-Hearing Brief, EDIS Doc. ID 770786 (May 13, 2022) (“CPreHBr.”);
`Respondent Apple Inc.’s Pre-Hearing Brief, EDIS Doc. ID 770790 (May 13, 2022). On May 16,
`2022, Apple filed a corrected pre-hearing brief. Respondent Apple Inc.’s Corrected Pre-Hearing
`Brief, EDIS Doc. ID 770874 (May 16, 2022) (“RPreHBr.”).
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`6 Complainants’ Initial Post-Hearing Brief, EDIS Doc. ID 774000 (June 27, 2022);
`Respondent Apple Inc.’s Post-Hearing Brief, EDIS Doc. ID 774025 (June 27, 2022). On July
`14, 2022, Complainant filed a corrected opening post-hearing brief. Complainants’ Corrected
`Initial Post-Hearing Brief, EDIS Doc. ID 775422 (July 14, 2022) (“CPHBr.”). On September 2,
`2022, Apple filed a second corrected opening post-hearing brief. Respondent Apple Inc.’s
`Second Corrected Post-Hearing Brief, EDIS Doc. ID 779376 (Sept. 2, 2022) (“RPHBr.”).
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`7 Complainants’ Reply Post-Hearing Brief, EDIS Doc. ID 775058 (July 11, 2022)
`(“CPHBr. (Reply)”); Respondent Apple Inc.’s Reply Post-Hearing Brief, EDIS Doc. ID 775073
`(July 11, 2022). On September 2, 2022, Apple filed a corrected post-hearing reply brief.
`Respondent Apple Inc.’s Corrected Post-Hearing Reply Brief, EDIS Doc. ID 779379 (Sept. 2,
`2022) (“RPHBr. (Reply)”).
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`8 Final Initial Determination on Violation of Section 337, EDIS Doc. ID 787653 (Jan. 10,
`2023); see also Final Initial Determination on Violation of Section 337, EDIS Doc. ID 789795
`(Feb. 7, 2023) (Public Version).
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`9 Recommended Determination on Remedy and Bonding, EDIS Doc. ID 788506 (Jan. 24,
`2023); see also Recommended Determination on Remedy and Bonding, EDIS Doc. ID 790079
`(Feb. 10, 2023) (Public Version).
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`PUBLIC VERSION
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`issue a limited exclusion order (“LEO”) directed to certain wearable electronic devices with
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`light-based pulse oximetry functionality and components thereof that are imported, sold for
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`importation, and/or sold after importation by Apple; and a cease and desist order (“CDO”)
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`directed to Apple. See RD at 2–5. The RD additionally recommended that the Commission set a
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`0% bond (i.e., no bond) during the sixty-day period of Presidential review. See id. at 6–7. The
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`Commission’s notice of investigation did not instruct the ALJ to make findings and
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`recommendations concerning the public interest. See 86 Fed. Reg. at 46275–76.
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`On January 23, 2023, Complainants and Apple each filed a petition for review of the
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`Final ID.10 On January 31, 2023, Complainants and Apple each filed responses to the other
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`respective petition.11
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`On January 24 and 30, 2023, (after the Final ID issued and petitions for review were
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`filed), the United States Patent and Trademark Office (“USPTO”) denied Apple’s request for the
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`institution of inter partes review proceedings (“IPRs”) as to the ’501, ’502, and ’648 patents
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`based on a combination of references that included the same primary reference as one of the
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`10 Complainants’ Petition for Review of the Final Initial Determination on Violation of
`Section 337, EDIS Doc. ID 788456 (Jan. 23, 2023) (“CPet.”); Complainants’ Summary of
`Petition for Review of the Final Initial Determination on Violation of Section 337, EDIS Doc. ID
`788457 (Jan. 23, 2023); Respondent Apple Inc.’s Petition for Review of the Initial Determination
`of Violation of Section 337, EDIS Doc. ID 788470 (Jan. 23, 2023) (“RPet.”); Respondent Apple
`Inc.’s Summary of Petition for Review of the Initial Determination of Violation of Section 337,
`EDIS Doc. ID 788474 (Jan. 23, 2023).
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`11 Complainants’ Response to Apple Inc.’s Petition for Review of the Final Initial
`Determination on Violation of Section 337, EDIS Doc. ID 789044 (Jan. 31, 2023) (“CResp.”);
`Complainants’ Summary of Response to Apple Inc.’s Petition for Review of the Final Initial
`Determination on Violation of Section 337, EDIS Doc. ID 789045 (Jan. 31, 2023); Respondent
`Apple Inc.’s Response to Complainants’ Petition for Review, EDIS Doc. ID 789061 (Jan. 31,
`2023) (“RResp.”); Respondent Apple Inc.’s Summary of Its Response to Complainants’ Petition
`for Review, EDIS Doc. ID 789067 (Jan. 31, 2023).
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`5
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`combinations of references asserted against the asserted claims of those patents in this
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`investigation. See Apple Inc. v. Masimo Corp., IPR2022-01272 (USPTO Jan. 24, 2023) (’501
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`patent) (available at CResp. at Appx. B); Apple Inc. v. Masimo Corp., IPR2022-01274 (USPTO
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`Jan. 24, 2023) (’502 patent) (available at CResp. at Appx. C); Apple Inc. v. Masimo Corp.,
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`IPR2022-01276 (USPTO Jan. 30, 2023) ) (’648 patent) (available at CResp. at Appx. A).
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`On February 23, 2023, the parties filed their public interest statements pursuant to 19
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`C.F.R. § 210.50(a)(4).12 The Commission received numerous comments on the public interest
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`from non-parties, discussed below in the public interest section of this Opinion.
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`On May 15, 2023, after considering the parties’ petitions and responses thereto, the
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`Commission determined to review the Final ID in part. See 88 Fed. Reg. at 32243–46. In
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`particular, the Commission determined to review: (1) the domestic industry with regard to the
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`’501 patent, the ’502 patent, the ’648 patent, and the ’745 patent; (2) obviousness with regard to
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`the ’501 patent, the ’502 patent, the ’648 patent, and the ’745 patent; (3) written description with
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`regard to claim 28 of the ’502 patent and claim 12 of the ’648 patent; (4) claim construction and
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`infringement with regard to the ’745 patent; and (5) subject matter jurisdiction. Id. at 32244.
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`The Commission determined not to review the remaining findings of the Final ID, including the
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`finding of no violation as to the ’127 patent. Id. The Commission requested briefing on certain
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`issues under review and also on remedy, the public interest, and bonding. See id. at 32244-46.
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`The Commission’s public interest briefing request also solicited input from non-parties. See id.
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`12 Complainants’ Statement on the Public Interest, EDIS Doc. ID 791050 (Feb. 23, 2023)
`(“CStmt.”); Respondent Apple Inc.’s Public Interest Statement, EDIS Doc. ID 791062 (Feb. 23,
`2023) (“RStmt.”).
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`PUBLIC VERSION
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`On June 5, 2023, the parties filed their written submissions on the issues under review
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`and on remedy, public interest, and bonding,13 and on June 12, 2023, the parties filed their reply
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`submissions.14 The Commission additionally received numerous comments on the public
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`interest from non-parties, which are discussed below in the public interest section of this
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`Opinion.
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`B.
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`The Asserted Patents
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`The technology at issue in this investigation relates to user-worn devices for
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`noninvasively measuring physiological parameters of a user.
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`U.S. Patent Nos. 10,912,501; 10,912,502; and 10,945,648: The “Poeze
`Patents”
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`The ’501 patent (JX-0001), ’502 patent (JX-0002), and ’648 patent (JX-0003) share a
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`common specification, claiming priority to an application filed on July 3, 2008. These patents
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`are titled “User-Worn Device for Noninvasively Measuring a Physiological Parameter of a User”
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`and name as inventors Jeroen Poeze, et al. These patents are referred to herein as the “Poeze
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`patents.”
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`13 Complainants’ Submission in Response to the Commission’s May 15, 2023 Notice of
`Commission Determination to Review in Part, EDIS Doc ID 797853 (June 5, 2023) (“CBr.”);
`Respondent Apple Inc.’s Response to the Commission’s Notice to Review in Part a Final Initial
`Determination and Request for Written Submissions, EDIS Doc ID 797870 (June 5, 2023)
`(“RBr.”).
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`14 Complainants’ Reply to Apple Inc.’s Response to the Commission’s Notice to Review
`in Part a Final Initial Determination and Request for Written Submissions, EDIS Doc ID 798353
`(June 12, 2023) (“CBr. (Reply)”); Respondent Apple Inc.’s Reply to Complainants’ Response to
`the Commission’s Notice to Review in Part a Final Initial Determination and Request for Written
`Submissions, EDIS Doc ID 798383 (June 12, 2023) (“RBr. (Reply)”).
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`7
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`Complainants assert claim 12 of the '501 patent, which depends from claim 1. See
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`CPHBr. at 53-66. Claim 12 is reproduced below in a claim/element identifier chaii that includes
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`the element designations used by the pa1iies and the Final ID.
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`U.S. Patent No. 10,912,501
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`Identifier
`
`[1PRE]
`
`[1A]
`[1B]
`
`[1C]
`
`[1D]
`
`[1E]
`
`[1F]
`
`[12]
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`Claim/Element
`Claim 12
`A user-worn device configured to noninvasively measure a physiological
`pai·ameter of a user, the user-worn device comprising:
`at least three light emitting diodes (LEDs);
`at least three photodiodes aiTanged on an interior surface of the user-worn
`device and configured to receive light attenuated by tissue of the user;
`a protrusion aiTanged over the interior surface, the protrnsion comprising a
`convex surface and
`a plurality of openings extending through the protrusion and positioned over the
`three photodiodes,
`the openings each comprising an opaque lateral surface, the plurality of
`openings configured to allow light to reach the photodiodes, the opaque lateral
`surface configured to avoid light piping through the protrusion; and
`one or more processors configured to receive one or more signals from the
`photodiodes and calculate a measurement of the physiological parameter of the
`user.
`The user-worn device of Claim 1, wherein the convex surface of the protrusion
`is an oute1most surface configured to contact the tissue of the user and confo1m
`the tissue into a concave shape.
`
`Complainants also asse1i claim 22 of the '502 patent, which depends from claims 19, 20,
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`and 21, and claim 28, a sepai·ate independent claim. See CPHBr. at 66-77. These claims are
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`reproduced below.
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`8
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`U.S. Patent No. 10,912,502
`
`Identifier
`
`[19A]
`
`[19B]
`
`[19C]
`
`Claim/Element
`Claim 22
`[19PRE] 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 ananged within the user-worn device and configured to
`receive light after at least a po1iion 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 of the four photodiodes, the opaque material
`configured to reduce an amount of light reaching the photodiodes without being
`attenuated by the tissue;
`optically transparent material within each of the openings; and
`one or more processors configured to receive one or more signals from at least
`one of the four photodiodes and output measurements responsive to the one or
`more signals, the measurements indicative of the oxygen saturation of the user.
`The user-worn device of claim 19 further comprising a thennistor.
`The user-worn device of claim 20, wherein the one or more processors are
`fuiiher configured to receive a temperature signal from the thennistor and
`adjust operation of the user-worn device responsive to the temperature signal.
`The user-worn device of claim 21, wherein the plurality of emitters comprise at
`least four emitters, and wherein each of the plurality of emitters comprises a
`respective set of at least three LEDs.
`
`[19D]
`[19E]
`
`[20]
`[21]
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`[22]
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`9
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`PUBLIC VERSION
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`U.S. Patent No. 10,912,502
`
`Identifier
`
`Claim/Element
`Claim 28
`[28PRE] A user-worn device configured to non-invasively measure an oxygen saturation
`of a user, the user worn device comprising:
`a first set of light emitting diodes (LEDs), the first set of LEDs comprising at
`least an LED configured to emit light at a first wavelength and an LED
`configured to emit light at a second wavelength;
`a second set of LEDs spaced apa1t from the first set of LEDs, the second set of
`LEDs comprising at least an LED configured to emit light at the first
`wavelength and an LED configured to emit light at the second wavelength;
`four photodiodes ananged in a quadrant configuration on an interior surface of
`the user-worn device and configured to receive light after at least a po1tion of
`the light has been attenuated by tissue of the user;
`a thermistor configured to provide a temperature signal;
`a protrusion ananged above the interior smface, the protr11sion comprising: a
`convex surface;
`a plurality of openings in the convex surface, extending through the protrusion,
`and aligned with the four photodiodes, each opening defined by an opaque
`surface configured to reduce light piping; and
`a plurality of u-ansmissive windows, each of the tr·ansmissive windows
`extending across a different one of the openings;
`at least one opaque wall extending between the interior surface and the
`protr11sion, wherein at least the interior surface, the opaque wall and the
`protr11sion fonn cavities, wherein the photodiodes are ananged on the interior
`surface within the cavities;
`one or more processors configured to receive one or more signals from at least
`one of the photodiodes and calculate an oxygen saturation measurement of the
`user, the one or more processors fmther configured to receive the temperature
`signal;
`a network interface configured to wirelessly communicate the oxygen
`saturation measurement to at least one of a mobile phone or an electr·onic
`network;
`a user interface comprising a touch-screen display, wherein the user interface is
`configured to display indicia responsive to the oxygen saturation measurement
`of the user;
`a storage device configured to at least temporarily store at least the
`measurement; and
`a su-ap configured to position the user-worn device on the user.
`
`[28A]
`
`[28B]
`
`[28C]
`
`[28D]
`[28E]
`
`[28F]
`
`[28G]
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`[28H]
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`[281]
`
`[28J]
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`[28K]
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`[28L]
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`[28M]
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`PUBLIC VERSION
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`Complainants further asse1t claim 12 of the '648 patent, which depends from claim 8, and
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`claims 24 and 30, which depend from claim 20. See CPHBr. at 77-83. These claims are
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`reproduced below.
`
`
`
`Identifier
`
`[8PRE]
`
`[SA]
`
`[8B]
`
`[SC]
`[8D]
`
`[SE]
`
`[SF]
`[8G]
`
`[SH]
`[81]
`
`[12]
`
`U.S. Patent No. 10,945,648
`Claim/Element
`Claim 12
`A user-worn device configured to non-invasively dete1mine measurements of a
`physiological parameter of a user, the user-worn device comprising:
`a first set of light emitting diodes (LEDs), the first set comprising at least an
`LED configured to emit light at a first wavelength and at least an LED
`configured to emit light at a second wavelength;
`a second set of LEDs spaced apa1t from the first set of LEDs, the second set of
`LEDs comprising an LED configured to emit light at the first wavelength and
`an LED configured to emit light at the second wavelength;
`four photodiodes;
`a protrusion comprising a convex surface, at least a po1tion of the protrusion
`comprising an opaque material;
`a plurality of openings provided through the protr11sion and the convex surface,
`the openings aligned with the photodiodes;
`a separate optically tr·ansparent window extending across each of the openings;
`one or more processors configured to receive one or more signals from at least
`one of the photodiodes and output measurements of a physiological parameter
`of a user;
`a housing; and
`a strap configured to position the housing proximate tissue of the user when the
`device is worn.
`The user-worn device of Claim 8, wherein the physiological parameter
`comprises oxygen or oxygen saturation.
`
`11
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`PUBLIC VERSION
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`
`
`Identifier
`
`[20A]
`[20B]
`
`U.S. Patent No. 10,945,648
`Claim/Element
`Claims 24 and 30
`[20PRE] A user-worn device configured to non-invasively dete1mine measurements of a
`user's tissue, the user-worn device comprising:
`a plurality of light emitting diodes (LEDs);
`at least four photodiodes configured to receive light emitted by the LEDs, the
`four photodiodes being airnnged to capture light at different quadrants of tissue
`of a user;
`a protrusion comprising a convex surface and
`a plurality of through holes, each through hole including a window and
`manged over a different one of the at least four photodiodes; and
`one or more processors configured to receive one or more signals from at least
`one of the photodiodes and detennine measurements of oxygen saturation of the
`user.
`The user-worn device of Claim 20, wherein the protrusion comprises opaque
`material configured to substantially prevent light piping.
`The user-worn device of Claim 20, wherein the protrusion further comprises
`one or more chainfered edges.
`
`[20C]
`[20D]
`
`[20E]
`
`[24]
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`[30]
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`2.
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`U.S. Patent No. 10,687,745
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`The '745 patent (JX-0009) is titled "Physiological Monitoring Devices, Systems, and
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`Methods," claims priority to an application filed on June 28, 2016, and names Ammar Al-Ali as
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`the sole inventor. Complainants asse1i that Apple infringes claims 9 and 27, and they rely on
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`claim 18 for domestic industry purposes only. Claim 9 is reproduced below as representative of
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`the asse1ied claims of the '745 patent.
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`12
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`Identifier
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`[1PRE]
`[1A]
`[1B]
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`[1E]
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`[1F]
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`[9]
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`PUBLIC VERSION
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`U.S. Patent No. 10,687,745
`Claim/Element
`Claim 9
`A physiological monitoring device comprising:
`a plurality of light-emitting diodes configured to emit light in a first shape;
`a material configured to be positioned between the plurality of light-emitting
`diodes and tissue on a wrist of a user when the physiological monitoring device
`is in use, the material configured to change the first shape into a second shape
`by which the light emitted from one or more of the plurality of light-emitting
`diodes is projected towards the tissue;
`a plurality of photodiodes configured to detect at least a po1iion of the light
`after the at least the po1iion of the light passes through the tissue, the plurality
`of photodiodes finiher configured to output at least one signal responsive to the
`detected light;
`a surface comprising a dark-colored coating, the surface configured to be
`positioned between the plurality of photodiodes and the tissue when the
`physiological monitoring device is in use, wherein an opening defined in the
`dark-colored coating is configured to allow at least a po1iion of light reflected
`from the tissue to pass through the surface;
`a light block configured to prevent at least a po1iion of the light emitted from
`the plurality of light-emitting diodes from reaching the plurality of photodiodes
`without first reaching the tissue;
`and a processor configured to receive and process the outputted at least one
`signal and detennine a physiological parameter of the user responsive to the
`outputted at least one signal.
`The physiological monito1ing device of claim 1, wherein the physiological
`parameter comprises oxygen saturation.
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`3.
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`U.S. Patent No. 7,761,127
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`The '127 patent (JX-0007) is titled "Multiple Wavelength Sensor Substrate," issued from
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`an application filed on March 1, 2006, and names as inventors Ammar Al-Ali, et al.
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`Complainants asse1i claim 9 of the '127 patent, which depends from claim 7.
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`C.
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`The Accused Products
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`Complainants accuse certain Apple Watches of infringing the Asse1ied Patents, including
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`the Apple Watch Series 6, the Apple Watch Series 7, and ce1iain prototype Apple Watch
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`products with project names
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`(collectively, the “Accused Products”).
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`CPHBr. at 37–39. The parties have stipulated that the Accused Products are materially identical
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`for the purposes of infringement in this investigation. See Joint Stipulation of Facts at ¶¶ 11–13,
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`EDIS Doc. ID 770692 (May 13, 2022); CX-1259C at ¶¶ 7–8. Notably, the parties do not dispute
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`that the currently-existing Apple Watch Series SE does not infringe the Asserted Patents because
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`it is not equipped to measure the blood oxygen saturation of a user.
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`D.
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`The Domestic Industry Products
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`With respect to the ’501, ’502, ’648, and ’745 patents, Complainants rely on their
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`“Masimo Watch” products. CPHBr. at 26–35. These Masimo Watch products include certain
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`prototypes identified as the “Circle Sensor” (CPX-0021C), the “Wings Sensor” (CPX-0029C),
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`the “RevA Sensor” (CPX-0052C), the “RevD Sensor” (CPX-0058C), the “RevE Sensors” (CPX-
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`0019C, CPX-0020C, CPX-0065C) (collectively, the “Masimo Watch Prototypes”), and a product
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`identified as the “W1 Watch” (CPX-0146C). CPHBr. at 30–35. The Masimo Watch Prototypes
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`were developed as part of an iterative design process that resulted in the W1 Watch, which was
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`not completed until after the Complaint was filed. Id. at 62 n.16, 18.
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`With respect to the ’127 patent, Complainants rely on certain of Masimo’s “Rainbow®
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`Sensors.” Id. at 36.
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`III. COMMISSION REVIEW OF THE FINAL ID
`When the Commission reviews an initial determination, in whole or in part, it reviews the
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`determination de novo. Certain Soft-Edged Trampolines & Components Thereof, Inv. No. 337-
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`TA-908, Comm’n Op. at 4 (May 1, 2015). Upon review, the “Commission has ‘all the powers
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`which it would have in making the initial determination,’ except where the issues are limited on
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`notice or by rule.” Certain Flash Memory Circuits & Prods. Containing Same, Inv. No. 337-
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`TA-382, USITC Pub. No. 3046, Comm’n Op. at 9–10 (July 1997) (quoting Certain Acid-Washed
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`Denim Garments & Accessories, Inv. No. 337-TA-324, Comm’n Op. at 5 (Nov. 1992)). With
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`respect to the issues under review, “the Commission may affirm, reverse, modify, set aside or
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`remand for further proceedings, in whole or in part, the initial determination of the administrative
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`law judge.” 19 C.F.R. § 210.45(c). The Commission also “may take no position on specific
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`issues or portions of the initial determination,” and “may make any findings or conclusions that
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`in its judgment are proper based on the record in the proceeding.” Id.; see also Beloit Corp. v.
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`Valmet Oy, 742 F.2d 1421, 1423 (Fed. Cir. 1984).
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`IV. ANALYSIS OF THE ISSUES UNDER REVIEW
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`The Commission’s findings, conclusions, and supporting analysis follow. The
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`Commission affirms and adopts the ID’s findings, conclusions, and supporting analysis that are
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`not inconsistent with the Commission’s opinion.
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`A.
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`Subject Matter Jurisdiction
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`The Final ID found that the Commission has “subject matter jurisdiction over this
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`investigation.” Final ID at 336. The Commission reviewed this finding. 88 Fed. Reg. at 32244.
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`On review, the Commission vacates the Final ID’s “subject matter jurisdiction” finding and
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`instead finds that the Commission has statutory authority, rather than subject matter jurisdiction,
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`over the present investigation. See Certain Video Security Equipment & Sys., Related Software,
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`Components Thereof, & Prods. Containing Same, Inv. No. 337-TA-1281, Comm’n Op. at 9–10
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`(Apr. 19, 2023). The Commission and ALJs have used the term “jurisdiction” in the past as a
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`shorthand for statutory authority. Executive agencies, of course, do not have jurisdiction, but
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`rather are creatures of statute that cannot exceed their statutory authority.
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`B.
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`Obviousness of the Asserted Claims of the ’501 Patent, the ’502 Patent, and
`the ’648 Patent
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`The Final ID found that claim 12 of the ’501 patent would have been invalid as obvious
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`over combinations of references primarily based on “Lumidigm,”15 but claims 22 and 28 of
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`the ’502 patent and claims 12, 24, and 30 of the ’648 patent would not have been invalid as
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`obvious over those combinations. E.g., Final ID at 88, 336. The Commission reviewed this
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`finding. 88 Fed. Reg. at 32244. On review, the Commission affirms the Final ID’s conclusions
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`as to obviousness with the modifications and supplements discussed herein.
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`The Applicable Law
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`A party cannot be held liable for infringement if the asserted patent claim is invalid. See
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`Pandrol USA, LP v. AirBoss Ry. Prods., Inc., 320 F.3d 1354, 1365 (Fed. Cir. 2003). Patent
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`claims are presumed valid (35 U.S.C. § 282), so a respondent challenging validity must
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`overcome this statutory presumption by “clear and convincing” evidence of invalidity.
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`Checkpoint Sys., Inc. v. Int’l Trade Comm’n, 54 F.3d 756, 761 (Fed. Cir. 1995). One such
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`ground for invalidity is that the claimed invention would have been obvious under 35 U.S.C.
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`§ 103.
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`Under 35 U.S.C. § 103(a), a patent is valid unless “the differences between the subject
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`matter sought to be patented and the prior art are such that the subject matter as a whole would
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`have been obvious at the time the invention was made” to a person having ordinary skill in the
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`art. 35 U.S.C. § 103(a). The ultimate question of obviousness is a question of law, but “it is well
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`understood that there are factual issues underlying the ultimate obviousness decision.”
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`15 U.S. Patent No. 7,620,212 (RX-0411), titled “Electro-Optical Sensor,” which issued
`from an application filed on August 12, 2003.
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`Richardson-Vicks Inc. v. Upjohn Co., 122 F.3d 1476, 1479 (Fed. Cir. 1997) (citing Graham v.
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`John Deere Co., 383 U.S. 1, 17 (1966)).
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`After claim construction:
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`The second step in an obviousness inquiry is to determine whether the
`claimed invention would have been obvious as a legal matter, based on
`underlying factual inquiries including: (1) the scope and content of