UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
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`In the Matter of
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`CERTAIN LIGHT-BASED
`PHYSIOLOGICAL MEASUREMENT
`DEVICES AND COMPONENTS
`THEREOF
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`Inv. No. 337-TA-1276
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`NOTICE OF A COMMISSION DETERMINATION TO REVIEW IN PART A FINAL
`INITIAL DETERMINATION; REQUEST FOR WRITTEN SUBMISSIONS ON THE
`ISSUES UNDER REVIEW AND ON REMEDY, THE PUBLIC INTEREST, AND
`BONDING
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` U.S. International Trade Commission.
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`AGENCY:
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`ACTION:
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`SUMMARY: Notice is hereby given that the U.S. International Trade Commission
`(“Commission”) has determined to review in part a final initial determination (“ID”) of the
`presiding administrative law judge (“ALJ”), finding a violation of section 337. The Commission
`requests written submissions from the parties on the issues under review and submissions from
`the parties, interested government agencies, and other interested persons on the issues of remedy,
`the public interest, and bonding, under the schedule set forth below.
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`FOR FURTHER INFORMATION CONTACT: Ron Traud, Office of the General Counsel,
`U.S. International Trade Commission, 500 E Street SW, Washington, D.C. 20436, telephone
`202-205-3427. Copies of non-confidential documents filed in connection with this investigation
`may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. For help
`accessing EDIS, please email EDIS3Help@usitc.gov. General information concerning the
`Commission may also be obtained by accessing its Internet server at
`https://www.usitc.gov. Hearing-impaired persons are advised that information on this matter can
`be obtained by contacting the Commission’s TDD terminal on (202) 205-1810.
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`SUPPLEMENTARY INFORMATION: The Commission instituted this investigation on
`August 18, 2021, based on a complaint filed on behalf of Masimo Corporation and Cercacor
`Laboratories, Inc., both of Irvine, CA (collectively, “Complainants”). 86 FR 46275 (Aug. 18,
`2021). The complaint, as amended, alleged violations of section 337 of the Tariff Act of 1930,
`as amended, 19 U.S.C. 1337, based upon the importation into the United States, the sale for
`importation, and the sale within the United States after importation of certain light-based
`physiological measurement devices and components thereof by reason of infringement of certain
`claims of U.S. Patent No. 10,912,501 (“the ’501 patent”), U.S. Patent No. 10,912,502 (“the ’502
`patent”), U.S. Patent No. 10,945,648 (“the ’648 patent”), U.S. Patent No. 10,687,745 (“the ’745
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`Notice.
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`patent”), and U.S. Patent No. 7,761,127 (“the ’127 patent”). Id. The amended complaint further
`alleged that an industry in the United States exists and/or is in the process of being established as
`required by section 337. Id. The notice of investigation named Apple Inc. of Cupertino, CA
`(“Apple”) as a respondent. Id. at 46276. The Office of Unfair Import Investigations is not
`participating in this investigation. Id.
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`Complainants previously withdrew certain asserted claims pursuant to Order No. 25
`(Mar. 23, 2022), unreviewed by Comm’n Notice (Apr. 12, 2022), and Order No. 33 (May 20,
`2022), unreviewed by Comm’n Notice (June 10, 2022). Only claim 12 of the ’501 patent, claims
`22 and 28 of the ’502 patent, claims 12, 24, and 30 of the ’648 patent, claims 9 and 27 of the
`’745 patent, and claim 9 of the ’127 patent remain in the investigation. Claim 18 of the ’745
`patent is still at issue for purposes of the domestic industry.
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`On January 10, 2023, the ALJ issued the Final ID, which found that Apple violated
`section 337 as to claims 24 and 30 of the ’648 patent, but not as to claim 12 of the ’501 patent,
`claims 22 and 28 of the ’502 patent, claim 12 of the ’648 patent, claims 9 and 27 of the ’745
`patent, and claim 9 of the ’127 patent. See Final ID at 335–36. On January 24, 2023, the ALJ
`issued a Recommended Determination on remedy and bonding (“RD”) should a violation be
`found in the above-captioned investigation. The RD recommended that, if the Commission finds
`a violation, it should issue a limited exclusion order directed to certain wearable electronic
`devices with light-based pulse oximetry functionality and components thereof that are imported,
`sold for importation, and/or sold after importation by Apple; and a cease and desist order
`directed to Apple. RD at 2, 5. The RD found the record did not support Apple’s request for an
`exemption for service and repair. Id. at 2-3. The RD additionally recommended that the
`Commission set a zero percent (0%) bond (i.e., no bond) during the sixty-day period of
`Presidential review. Id. at 6.
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`On January 23, 2023, Complainants and Apple each filed a petition for review. On
`January 31, 2023, Complainants and Apple each filed responses to the respective petitions. On
`February 23, 2023, the parties filed their public interest statements pursuant to 19 CFR
`210.50(a)(4). The Commission received numerous comments on the public interest from non-
`parties.
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`Having reviewed the record of the investigation, including the Final ID, the parties’
`submissions to the ALJ, and the petitions and responses thereto, the Commission has determined
`to review the Final ID in part. Specifically, the Commission has determined to review (1) the
`domestic industry with regard to the’501 patent, the ’502 patent, the ’648 patent, and the ’745
`patent; (2) obviousness with regard to the’501 patent, the ’502 patent, the ’648 patent, and the
`’745 patent; (3) written description with regard to claim 28 of the ’502 patent and claim 12 of the
`’648 patent; (4) claim construction and infringement with regard to the ’745 patent; and (5)
`subject matter jurisdiction. The Commission has determined not to review the remaining findings
`of the Final ID, including the finding of no violation as to the ’127 patent. The Commission notes
`that on pages 282-83 of the Final ID, in the section entitled “Element[9]: ‘a thermistor,’” the ALJ
`refers to claim 1 as the independent claim from which claim 9 depends. The Commission
`understands that reference to be a typographical error and notes that the reference should be to
`claim 7.
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`In connection with its review, the Commission requests responses to the following
`questions. The parties are requested to brief their positions with reference to the applicable law
`and the existing evidentiary record.
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`(1) What evidence and argument was presented to the ALJ that shows that Complainants
`were developing, as of the filing of the Complaint, the Masimo Watch and that the
`Masimo Watch would practice the Poeze and ‘745 patent claims?
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`(2) Should the Commission consider evidence post-dating the Complaint, such as the
`final design of the Masimo Watch, to establish that Complainants were developing a
`physical article that would practice the Poeze patents and the ’745 patent?
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`(3) If the Commission considers the Masimo Watch to be a domestic industry product in
`the process of being established for the Poeze patents and the ’745 patent, what
`investments and activities should the Commission consider in its analysis?
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`(4) What should be considered as a domestic industry product for purposes of an industry
`in the process of being established – the Rev Sensor products, the Masimo Watch or
`both? What activities and investments should be considered toward satisfying the
`domestic industry requirement with respect to that DI product(s)? Was it appropriate
`to consider investments related to the Circle and Wing Sensors (assuming they are not
`shown to practice the Poeze patents or the ‘745 patent prior to the filing of the
`Complaint) leading to the development of the Rev Sensor products, in finding that a
`domestic industry exists or is in the process of being established for the Poeze and
`‘745 patents? See ID at 301-24. If the Masimo Watch is a DI product for an industry
`in the process of being established, would it be appropriate to consider activities and
`investments in products (that themselves do not practice the Poeze patents prior to the
`filing of the Complaint) that contributed to the development of the Masimo
`Watch? What investments were made for the Circle sensor, Wing sensor, and
`Masimo Watch prior to the Complaint being filed and what investments were made
`after? Should the Commission consider investments made after the Complaint was
`filed?
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`(5) Should recruiting labor expenditures be considered to contribute towards the
`satisfaction of the economic prong?
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`(6) Should executive labor expenditures generally, and executive legal labor expenditures
`specifically, be considered to contribute towards the satisfaction of the economic
`prong? How closely does their work have to be connected to the domestic industry
`product to be included? With respect to the executive labor included in the Final ID’s
`analysis of a domestic industry (see ID at 311-313), what evidence shows the extent
`to which the executives’ work was connected to the domestic industry product?
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`(7) Is there a statutory basis for considering only certain types of labor expenses with
`respect to articles protected by the asserted patent for purposes of satisfaction of the
`domestic industry requirement under section 337(a)(3)(B)?
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`(8) Is there a legislative history or caselaw basis for considering only certain types of
`labor expenses with respect to articles protected by the asserted patent for purposes of
`satisfaction of the domestic industry requirement under section 337(a)(3)(B)?
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`(9) Does Figure 7B in the Poeze Patents show two emitters, each labeled 104, where each
`emitter has LEDs that can emit light at or about 1610 nm, about 1640 nm, and about
`1665 nm? Was Complainants’ argument regarding 37 CFR 1.84(p)(4) raised in front
`of the ALJ, and if not, can the Commission still consider the argument? Is 37 CFR
`1.84(p)(4) binding authority on the Commission and does it require the Commission
`to presume that each emitter set 104 is identical? If so, is that disclosure in Figure 7B
`sufficient to convey with reasonable clarity to those skilled in the art that, as of the
`filing date, the inventor was in possession of two sets of LEDs each with “an LED
`configured to emit light at a first wavelength and an LED configured to emit light at a
`second wavelength?”
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`The parties are invited to brief only the discrete issues requested above. The parties are not to
`brief other issues on review, which are adequately presented in the parties’ existing filings.
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`In connection with the final disposition of this investigation, the statute authorizes
`issuance of, inter alia, (1) an exclusion order that could result in the exclusion of the subject
`articles from entry into the United States; and/or (2) cease and desist orders that could result in
`the respondents being required to cease and desist from engaging in unfair acts in the importation
`and sale of such articles. Accordingly, the Commission is interested in receiving written
`submissions that address the form of remedy, if any, that should be ordered. If a party seeks
`exclusion of an article from entry into the United States for purposes other than entry for
`consumption, the party should so indicate and provide information establishing that activities
`involving other types of entry either are adversely affecting it or likely to do so. For background,
`see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360,
`USITC Pub. No. 2843, Comm’n Op. at 7-10 (Dec. 1994).
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`The statute requires the Commission to consider the effects of that remedy upon the
`public interest. The public interest factors the Commission will consider include the effect that
`an exclusion order and cease and desist orders would have on: (1) the public health and welfare,
`(2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or
`directly competitive with those that are subject to investigation, and (4) U.S. consumers. The
`Commission is therefore interested in receiving written submissions that address the
`aforementioned public interest factors in the context of this investigation.
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`In addition, the Commission requests specific briefing to address the following questions
`relevant to the public interest considerations in this investigation, and responses are encouraged
`to include evidence in support of their statements:
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`(1) Please identify any ongoing or formally planned studies that use the blood oxygen
`features of the Apple Watches. Should the Commission allow an exemption or delay
`the effective date of any remedial relief so as to permit importation of the infringing
`Apple Watches for purposes of conducting such studies? Please explain the rationale
`and the scope of any such exemption or delay.
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`(2) How should the Commission define a reasonable substitute for the infringing Apple
`Watches?
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`(3) Please identify whether any reasonable substitutes for the infringing Apple Watches
`are available to consumers and whether they are capable of meeting any public health
`and welfare concerns raised by any remedial relief in this investigation. Is or would
`there be sufficient supply of any such reasonable substitutes for the infringing Apple
`Watches? Is the Masimo W1 watch a reasonable substitute and to what extent would
`supply of these products be available to fill the demand?
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`(4) Please explain how easily the infringing features of the Apple Watches could be
`removed and whether Apple is working on any redesigns with respect to the
`infringing features and how long implementation of any redesigns would take?
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`(5) Is there any production of like or directly competitive products in the United States and
`how would such production be impacted by any remedial relief?
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`(6) Should the Commission include an exemption for repair and/or replacement of
`broken products impacted pursuant to any potential remedy, and if so, should the
`exemption only apply under warranty? If a repair and/or replacement exemption is
`included, should the cutoff date for repair and replacement be the date of the Order or
`the date the Order becomes final within the meaning of 19 U.S.C. 1337(j)(4)? See
`Certain Fitness Devices, Streaming Components Thereof, and Systems Containing
`Same, Inv. No. 337-TA-1265, Comm’n Op. at 88-92 (Mar. 23, 2023) (Public
`Version); Certain Robotic Floor Cleaning Devices and Components Thereof, Inv. No.
`337-TA-1252, Comm’n Op. at 76-82 (Apr. 13, 2023) (Public Version). Should the
`exemption apply to products imported prior to the cutoff date or only to products sold
`to an end user as of the cutoff date? Should the exemption cover only parts for repair,
`or should it permit replacement of entire units? Please cite and discuss the evidence
`of record relevant to whether the Commission should include a repair and/or
`replacement exemption.
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`If the Commission orders some form of remedy, the U.S. Trade Representative, as
`delegated by the President, has 60 days to approve, disapprove, or take no action on the
`Commission’s determination. See Presidential Memorandum of July 21, 2005, 70 FR 43251
`(July 26, 2005). During this period, the subject articles would be entitled to enter the United
`States under bond, in an amount determined by the Commission and prescribed by the Secretary
`of the Treasury. The Commission is therefore interested in receiving submissions concerning the
`amount of the bond that should be imposed if a remedy is ordered.
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`WRITTEN SUBMISSIONS: The parties to the investigation are requested to file
`written submissions on the issues identified in this notice. Parties to the investigation, interested
`government agencies, and any other interested parties are encouraged to file written submissions
`on the issues of remedy, the public interest, and bonding. Such submissions should address the
`RD by the ALJ on remedy and bonding.
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`In its initial submission, Complainants are also requested to identify the remedy sought
`and are requested to submit proposed remedial orders for the Commission’s consideration.
`Complainants are also requested to identify and explain, from the record, articles that it contends
`are “components thereof” of the subject products, and thus potentially covered by the proposed
`remedial orders, if imported separately from the subject products. See 86 FR 46275-76. Failure
`to provide this information may result in waiver of any remedy directed to “components thereof”
`the subject products, in the event any violation may be found. Complainants are further
`requested to provide the HTSUS subheadings under which the accused products are imported,
`and to supply the identification information for all known importers of the products at issue in
`this investigation. The initial written submissions and proposed remedial orders must be filed no
`later than close of business on June 5, 2023. Reply submissions must be filed no later than the
`close of business on June 12, 2023. No further submissions on these issues will be permitted
`unless otherwise ordered by the Commission. Opening submissions are limited to 100 pages.
`Reply submissions are limited to 50 pages. No further submissions on any of these issues will be
`permitted unless otherwise ordered by the Commission.
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`Persons filing written submissions must file the original document electronically on or
`before the deadlines stated above. The Commission’s paper filing requirements in 19 CFR
`210.4(f) are currently waived. 85 FR 15798 (March 19, 2020). Submissions should refer to the
`investigation number (Inv. No. 337-TA-1276) in a prominent place on the cover page and/or the
`first page. (See Handbook for Electronic Filing Procedures,
`https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf). Persons with questions
`regarding filing should contact the Secretary, (202) 205-2000.
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`Any person desiring to submit a document to the Commission in confidence must request
`confidential treatment by marking each document with a header indicating that the document
`contains confidential information. This marking will be deemed to satisfy the request procedure
`set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) & 210.5(e)(2)). Documents for
`which confidential treatment by the Commission is properly sought will be treated accordingly.
`Any non-party wishing to submit comments containing confidential information must serve
`those comments on the parties to the investigation pursuant to the applicable Administrative
`Protective Order. A redacted non-confidential version of the document must also be filed with
`the Commission and served on any parties to the investigation within two business days of any
`confidential filing. All information, including confidential business information and documents
`for which confidential treatment is properly sought, submitted to the Commission for purposes of
`this investigation may be disclosed to and used: (i) by the Commission, its employees and
`Offices, and contract personnel (a) for developing or maintaining the records of this or a related
`proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the
`programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or
`(ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes.
`All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential
`written submissions will be available for public inspection on EDIS.
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`The Commission vote for this determination took place on May 15, 2023.
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`The authority for the Commission’s determination is contained in section 337 of the
`Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in Part 210 of the Commission’s Rules of
`Practice and Procedure, 19 CFR Part 210.
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`By order of the Commission.
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`Issued: May 15, 2023
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`Lisa R. Barton
`Secretary to the Commission
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