[Federal Register Volume 84, Number 142 (Wednesday, July 24, 2019)]
[Notices]
[Pages 35688-35690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15684]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1091]


Certain Color Intraoral Scanners and Related Hardware and 
Software; Notice of a Commission Determination To Review In-Part the 
Final Initial Determination; Request for Briefing

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has determined to review the final initial determination 
(``ID'') in-part and requests briefing from the parties.

FOR FURTHER INFORMATION CONTACT: Amanda Pitcher Fisherow, Esq., Office 
of the General Counsel, U.S. International Trade Commission, 500 E 
Street SW, Washington, DC 20436, telephone (202) 205-2737. Copies of 
non-confidential documents filed in connection with this investigation 
are or will be available for inspection during official business hours 
(8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. 
International Trade Commission, 500 E Street SW, Washington, DC 20436, 
telephone (202) 205-2000. General information concerning the Commission 
may also be obtained by accessing its internet server at https://www.usitc.gov. The public record for this investigation may be viewed 
on the Commission's electronic docket (EDIS) at https://edis.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 the underlying 
investigation on December 20, 2017, based on a complaint filed on 
behalf of Align Technology, Inc. of San Jose, California (``Align''). 
82 FR (Dec. 20, 2017). The complaint alleged violations of section 337 
based upon the importation into the United States, the sale for 
importation, and the sale within the United States after importation of 
certain color intraoral scanners and related hardware and software by 
reason of infringement of certain claims of U.S. Patent Nos. 8,363,228 
(``the '228 patent''); 8,451,456 (``the '456 patent''); 8,675,207 
(``the '207 patent''); 9,101,433 (``the '433 patent''); 948,931; and 
6,685,470. See id. The complaint named 3Shape A/S and 3Shape Inc. as 
the respondents. On March 15, 2018, the ALJ granted Align's unopposed 
motion to amend the complaint and notice of

[[Page 35689]]

investigation to add 3Shape Trios A/S of Copenhagen, Denmark as an 
additional respondent in this investigation. See 83 FR 13781-82 (March 
30, 2018), unreviewed, Notice (March 27, 2018). The Office of Unfair 
Import Investigations did not participate in the investigation.
    On March 1, 2019, the ALJ issued his final ID finding that no 
violation of section 337 has occurred. On March 18, 2019, Align filed a 
petition for review and 3Shape filed a contingent petition for review 
of the ID. On March 26, 2019, all of the parties filed responses to the 
respective petitions for review.
    Having examined the record of this investigation, including the 
ALJ's final ID, the petitions for review, and the responses thereto, 
the Commission has determined to review the final ID in-part. 
Specifically, the Commission has determined to review the ID's findings 
on (1) importation; (2) the construction of ``processor''; (3) the 
construction of ``confocal imaging techniques''; (4) all findings 
concerning infringement; (5) all findings concerning invalidity; (6) 
all findings concerning whether Align's products practice one or more 
claims of the asserted patents; and (7) all findings concerning whether 
Align's financial investments and activities relating to Align's 
products meet the domestic industry requirement.
    In connection with its review, the Commission is interested in 
responses to the following questions from the parties:

    1. Discuss whether the ``processor'' term of the asserted claims 
is understood by persons of ordinary skill in the art to have a 
sufficiently definite meaning as the name for structure? Is the 
``processor'' of the asserted claims a general purpose processor? 
Please discuss and identify any expert testimony addressing these 
questions.
    2. If the Commission determines that the claimed ``processor'' 
of the asserted claims is subject to means-plus-function treatment 
under 35 U.S.C. 112, ] 6, please identify the corresponding 
structure(s) in the specification and the proper construction for 
each of the asserted patents.
    3. Did Respondents show by clear and convincing evidence that a 
person of ordinary skill in the art would not find, from reading the 
specification, that the inventor had ``possession'' of a hand-held 
device having the claimed processor for the '228, '456, and '207 
patents? See Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 
1351 (Fed. Cir. 2010) (en banc). Include citations to expert 
testimony in your response.
    4. Does the language of claim 1 of the '228, '456, and '207 
patents require that the ``depth data'' be the depth of the scanned 
three-dimensional object? See 3Shape Pet. at 13-14.
    5. Did Align waive its argument that its domestic industry 
products practice the asserted patents by introducing a new theory/
evidence for the first time in its petition for review? See Align 
Pet. at 43-45; 3Shape Resp. at 19-20.
    6. For the '228, '456, and '207 patents, is the evidence relied 
on by the parties before the ALJ sufficient to establish that the 
domestic industry products ``associate the depth data with the color 
image data''? Please discuss all relevant evidence.
    7. Did Respondents waive their challenge to the specific 
percentages used to determine the significance of Align's domestic 
industry investments? Align Resp. at 45.
    8. In analyzing domestic industry, did the ID improperly credit 
expenses that were incurred after the filing of the complaint in 
this investigation or expenses that were unrelated to the domestic 
industry products? See 3Shape Pet. at 53-54. If certain expenses 
were improperly included in the analysis, please discuss whether 
Align's investments without the improper expenses were significant.

    The parties are requested to brief only the discrete issues above, 
with reference to the applicable law and evidentiary record. 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 
Commission may (1) issue an order that could result in the exclusion of 
the subject articles from entry into the United States, and/or (2) 
issue one or more 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 
(December 1994).
    If the Commission contemplates some form of remedy, it must 
consider the effects of that remedy upon the public interest. The 
factors the Commission will consider include the effect that an 
exclusion order and/or 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.
    If the Commission orders some form of remedy, the U.S. Trade 
Representative, as delegated by the President, has 60 days to approve 
or disapprove the Commission's action. 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. Complainant is requested to submit proposed 
remedial orders for the Commission's consideration. Complainant is also 
requested to state the date that the subject patents expire and the 
HTSUS numbers under which the accused products are imported. 
Complainant is further requested to supply the names of known importers 
of the Respondents' products at issue in this investigation.
    The written submissions and proposed remedial orders must be filed 
no later than close of business on Tuesday, July 30, 2019. Reply 
submissions must be filed no later than the close of business on 
Tuesday, August 6, 2019. Opening submissions are limited to 75 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.
    Persons filing written submissions must file the original document 
electronically on or before the deadlines stated above and submit eight 
true paper copies to the Office of the Secretary by noon the next day 
pursuant to section 210.4(f) Of the Commission's Rules of Practice and 
Procedure (19 CFR 2.10.4(f)). Submissions should refer to the 
investigation number (``Inv. No. 337-TA-1091'') in a prominent place on 
the cover page and/or the first page. (See Handbook for Electronic 
Filing Procedures, http://www.usitc.gov/secretary/fed_reg_notices/
rules/

[[Page 35690]]

handbook_on_electronic_filing.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. 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,\1\ solely for 
cybersecurity purposes. All nonconfidential written submissions will be 
available for public inspection at the Office of the Secretary and on 
EDIS.
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    \1\ All contract personnel will sign appropriate nondisclosure 
agreements.
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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).

    By order of the Commission.

    Issued: July 18, 2019.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2019-15684 Filed 7-23-19; 8:45 am]
BILLING CODE 7020-02-P