[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 46714]]
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
[[Page 46715]]
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