[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46713-46715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16723]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1144]


Certain Dental and Orthodontic Scanners and Software; Commission 
Determination To Review in Part a Final Initial Determination Finding a 
Violation of Section 337; Request for Written Submissions on the Issues 
Under Review and on Remedy, the Public Interest, and Bonding; Extension 
of the Target Date

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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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''). The Commission requests written submissions from the 
parties on the issues under review and submissions from the parties, 
interested government agencies, and interested persons on the issues of 
remedy, the public interest, and bonding, under the schedule set forth 
below. The target date is extended to September 28, 2020.

FOR FURTHER INFORMATION CONTACT: Robert Needham, Esq., Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 708-5468. 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 
[email protected]. General

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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.

SUPPLEMENTARY INFORMATION: The Commission instituted this investigation 
on March 5, 2019. 84 FR 7933-34 (March 5, 2019) based on a complaint 
filed on behalf of Align Technology, Inc. of San Jose, California 
(``Align''). The complaint alleges violations of section 337 of the 
Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into 
the United States, the sale for importation, or the sale within the 
United States after importation of certain dental and orthodontic 
scanners and software by reason of infringement of one or more claims 
of U.S. Patent Nos. 9,299,192 (``the '192 patent''); 7,077,647 (``the 
'647 patent''); 7,156,661 (``the '661 patent''); 9,848,958 (``the '958 
patent''); and 8,102,538 (``the '538 patent''). Id. The complaint 
further alleges that a domestic industry exists. Id. The Commission's 
notice of investigation named as respondents 3Shape A/S of Copenhagen, 
Denmark; 3Shape, Inc. of Warren, New Jersey; and 3Shape Trios A/S of 
Copenhagen, Denmark (together, ``3Shape''). Id. The Office of Unfair 
Import Investigations (``OUII'') is not participating in the 
investigation. Id.
    The Commission subsequently terminated the investigation with 
respect to the '958 patent based on Align's withdrawal of those 
allegations. Order No. 17 (Jul. 2, 2019), not reviewed Notice (Jul. 23, 
2019). On October 8, 2019, Align stated that it would no longer pursue 
a violation with respect to claims 4 and 20 of the '647 patent, claims 
1 and 19 of the '661 patent, and claims 1, 3-5, and 22 of the '192 
patent. On October 21, 2019, Align stated that it would no longer 
pursue a violation with respect to claim 2 of the '647 patent. 
Accordingly, at the time of the Final ID, Align asserted claims 1 and 
18 of the '647 patent, claims 2 and 20 of the '661 patent, claims 1 and 
2 of the '538 patent, and claims 2, 28, and 29 of the '192 patent.
    On April 30, 2020, the ALJ issued the Final ID finding a violation 
of section 337 with respect to the '647 and '661 patents, and no 
violation with respect to the '538 and '192 patents. Specifically, the 
ALJ found that claims 1 and 18 of the '538 patent are not infringed and 
that claims 2, 28, and 29 of the '192 patent are invalid. The ALJ found 
that Align satisfied the remaining requirements for a violation with 
respect to the '538 and '192 patents.
    On May 12, 2020, 3Shape and Align each filed a petition for review 
of the Final ID. On May 20, 2020, the parties responded to each other's 
petitions. The Commission also received four comments on the public 
interest.
    Having reviewed the record of the investigation, including the 
final ID and the parties' petitions and responses, the Commission has 
determined to review the ID in part. Specifically, the Commission has 
determined to review: (1) The findings regarding importation and 
induced infringement; (2) the construction of limitation 1.5/18.5 of 
the `647 patent (``individually matching [match] each of the dental 
objects in the subsequent digital model with a dental object in the 
initial digital model to determine corresponding dental objects, the 
matching comprising [including instructions to]'') in the asserted 
claims of the '647 patent, and the application of that construction 
regarding infringement, invalidity, and the technical prong of the 
domestic industry; (3) the findings regarding whether the asserted 
claims of the '647 and '661 patents are directed to patentable subject 
matter; (4) the construction of the limitation ``wherein the device is 
configured for maintaining a spatial disposition with respect to the 
portion that is substantially fixed during operation of the optical 
scanner and imaging means'' in the asserted claims of the '538 patent, 
and the application of that construction regarding infringement, 
invalidity, and the technical prong of the domestic industry 
requirement; (5) the findings regarding whether Okamato anticipates the 
asserted claims of the '538 patent; (6) the findings regarding whether 
Paley-Kriveshko anticipates or renders obvious the asserted claims of 
the '192 patent; and (7) the findings regarding the satisfaction of the 
economic prong of the domestic industry requirement.
    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.

    (1) Please explain whether it is proper to construe the 
limitation ``wherein the device is configured for maintaining a 
spatial disposition with respect to the portion that is 
substantially fixed during operation of the optical scanner and 
imaging means'' to mean ``the operation of the optical scanner and 
imaging means is substantially or effectively simultaneous.'' Please 
note that this proposed construction removes the following 
requirement of the ALJ's construction: ``such that movement (i.e., a 
change in spatial disposition) can be ignored and depth data and 
color data correspond to the same reference array.'' Additionally, 
please explain how the above construction would impact findings on 
infringement, invalidity, and the domestic industry requirement.
    (2) Please explain, with citations to the record, whether there 
is a motivation to modify Paley-Kriveshko in a way that renders 
invalid as obvious the asserted claims of the '192 patent.
    (3) What information, if any, is contained in the record 
concerning Align's employee headcount and salary and compensation 
expenditures outside the United States pertaining to Align's DI 
Products? What information, if any, is contained in the record 
concerning the value added in the United States to Align's DI 
Products?
    (4) Please explain, with citations to the record, whether 
Align's investments in plant and equipment under a sales-based 
allocation are significant.

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.
    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).
    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 
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

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interest factors in the context of this investigation.
    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.
    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 recommended determination by the ALJ on 
remedy and bonding.
    In its initial submission, Complainant is also requested to 
identify the remedy sought and to submit proposed remedial orders for 
the Commission's consideration. Complainant is further requested to 
state the dates that the Asserted Patents expire, 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 August 11, 2020. Reply submissions must be filed no later than the 
close of business on August 18, 2020. No further submissions on these 
issues will be permitted unless otherwise ordered by the Commission. 
Initial submissions are limited to 40 pages. Reply submissions are 
limited to 20 pages. No further submissions on any of these issues will 
be permitted unless otherwise ordered by the Commission.
    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-1144) 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.
    Any person desiring to submit a document to the Commission in 
confidence must request confidential treatment. All such requests 
should be directed to the Secretary to the Commission and must include 
a full statement of the reasons why the Commission should grant such 
treatment. See 19 CFR 201.6. Documents for which confidential treatment 
by the Commission is properly sought will be treated accordingly. A 
redacted non-confidential version of the document must also be filed 
simultaneously with 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.
    The target date is extended to September 28, 2020.
    The Commission vote for this determination took place on July 28, 
2020.
    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).

    By order of the Commission.

    Issued: July 28, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020-16723 Filed 7-31-20; 8:45 am]
BILLING CODE 7020-02-P