[Federal Register Volume 84, Number 205 (Wednesday, October 23, 2019)]
[Notices]
[Pages 56835-56837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23072]


-----------------------------------------------------------------------

INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1100]


Certain Microfluidic Systems and Components Thereof and Products 
Containing Same; Commission Determination To Review in Part a Final 
Initial Determination Finding a Violation of Section 337 and To Extend 
the Target Date; Schedule for Filing Written Submissions

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has determined to review in part the Administrative Law 
Judge's (``ALJ'') final initial determination (``ID''), issued on July 
12, 2019, finding a violation of section 337 in the above-referenced 
investigation and to extend the target date for completion of the 
above-referenced investigation to December 19, 2019. The Commission 
requests briefing from the parties on certain issues under review, as 
indicated in this notice.

FOR FURTHER INFORMATION CONTACT: Benjamin S. Richards, Esq., Office of 
the General Counsel, U.S. International Trade Commission, 500 E Street 
SW, Washington, DC 20436, telephone (202) 708-5453. 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: On February 21, 2018, the Commission 
instituted this investigation based on a complaint filed by 10X 
Genomics, Inc. of Pleasanton, CA. 83 FR 7491 (Feb. 21, 2018). 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 microfluidic systems and components thereof and 
products containing same by reason of infringement of one or more 
claims of U.S. Patent Nos. 9,644,204 (``the '204 patent''); 9,689,024 
(``the '024 patent''); 9,695,468 (``the '468 patent''); and 9,856,530 
(``the '530 patent''). Id. The Commission's notice of investigation 
named as the sole respondent Bio-Rad Laboratories, Inc. of Hercules, 
CA. Id. The Office of Unfair Import Investigations (``OUII'') is 
participating in this investigation. Id.
    On July 12, 2019, the ALJ issued the final ID. The ID found a 
violation of section 337 by virtue of Bio-Rad's indirect infringement 
of the '024, the '468, and the '530 patents. The ID found that 10X had 
not established a violation with respect to the '204 patent. The ID 
also found that Bio-Rad failed to establish invalidity of any of the 
asserted claims of any patent. The ID further found that the domestic 
industry requirement was satisfied for each of the asserted patents. 
Finally, the ID found that Bio-Rad had not carried its burden with 
respect to various additional affirmative defenses, including improper 
inventorship and ownership.
    On July 25, 2019, the ALJ issued her recommended determination on 
remedy and bonding. The ALJ recommended, upon a finding of violation, 
that the Commission issue a limited exclusion order, issue a cease and 
desist order, and impose a bond in the amount of twenty-five percent of 
the entered value of any covered products imported during the period of 
Presidential review.
    On July 29, 2019, 10X, Bio-Rad, and OUII submitted petitions 
seeking review of the ID. On August 6, 2019, 10X, Bio-Rad, and OUII 
submitted responses to the others' petitions. On August 26, 2019, 10X 
and Bio-Rad submitted comments on the public interest pursuant to 
Commission Rule 210.50(a)(4).
    Having examined the record of this investigation, including the ID, 
the petitions for review, and the responses thereto, the Commission has 
determined to review the ID with respect to (1) all findings related to 
a violation based on the '024 patent; (2) all findings related to a 
violation based on the '468 patent; (3) noninfringement of the '204 
patent; (4) all findings related to a violation based on the '530 
patent; (5) Bio-Rad's inventorship and ownership defenses; and (6) a 
typographical error on page 91.

[[Page 56836]]

The Commission has determined not to review the remainder of the ID.
    The Commission has further determined to extend the target date in 
this investigation to December 19, 2019.
    The parties are requested to brief their positions on only the 
following issues under review with reference to the applicable law and 
the evidentiary record:
    1. With respect to Bio-Rad's ownership defense, would Drs. Hindson 
and Saxanov be considered inventors of the asserted patents based only 
on the ``ideas'' they developed at QuantaLife/Bio-Rad? Your response 
should address how, if at all, those ``ideas'' correspond to the 
particular inventions claimed in the asserted patents.
    2. Was the ALJ correct to focus on the ``inventive concept'' of the 
asserted patents in determining whether Bio-Rad has ownership rights in 
the asserted patents? If not, what is the correct focus?
    3. The ID construed the term ``amplification'' in the '024 and '468 
patent claims to mean ``increasing the number of copies of the target 
sequence to be detected, including by reverse transcription.'' Explain 
whether the ID's construction is supported by the Application No. PCT/
US 99/01705 (``the '705 application''), U.S. Patent Application 
Publication No. 2011/0053798 (``the '798 application''), or the 
specifications of the '024 and '468 patents. Please cite and explain 
each section that supports or detracts from this construction as well 
as any expert testimony that interprets those sections.
    4. If the Commission determined to construe ``amplification'' to 
exclude reverse transcription, consistent with OUII's petition, what 
effect, if any, would that have on the ID's finding of infringement of 
the asserted claims of the '024 and '468 patents?
    5. In its response to OUII's petition on the construction of 
``amplification,'' Bio-Rad argues that, if the ID's construction of 
``amplification'' is modified to exclude reverse transcription, then 
the ID's infringement findings with respect to the '024 patent should 
be reversed. Bio-Rad's argument focuses particularly on whether 
amplification occurs in a droplet. Explain how, if at all, modifying 
the ID's construction of ``amplification'' to exclude reverse 
transcription could give rise to a noninfringement finding based on the 
location where amplification occurs.
    6. Has Bio-Rad waived its noninfringement argument for the '024 
patent based on the location where amplification occurs, as described 
in question 5, by failing to raise the argument in its petition for 
review? If you contend that the argument is not waived, provide 
citations to where this issue was raised in Bio-Rad's prehearing brief, 
posthearing brief, and petition for review.
    7. Does the evidence of record support the conclusion that [[ ]] in 
the context of the products accused of infringing the '204 patent?
    8. Claim 1 of the '530 patent includes the clause ``wherein said 
barcode molecules become detached from said gel bead.'' Is this clause 
part of step (c) of the claimed method such that barcode molecules must 
become detached from the gel bead during that step, or does the clause 
modify the entire method such that the barcode molecules may become 
detached during any step of the method? Address the significance of the 
separate indentation of the ``wherein'' clause and the punctuation 
setting it off from the rest of the claim.
    9. If claim 1 of the '530 patent is construed such that the barcode 
molecules must become detached from the gel bead during step (c) of the 
claimed method, does a preponderance of the evidence show that Bio-
Rad's accused products and/or 10X's domestic industry products practice 
step (c) of claim 1? Please identify all evidence supporting your 
position.
    10. Did any party argue in its pre- or post-hearing briefing that 
the ALJ's construction of claim 1 of the '530 patent, as laid out in 
orders 22 and 35, was indefinite? If they did, identify where in the 
briefing those arguments were made.
    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 issue: (1) An exclusion order that could result in the 
exclusion of the subject articles from entry into the United States, 
and/or (2) a cease-and-desist order that could result in the respondent 
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).
    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 this investigation are 
requested to file written submissions on the issues identified in this 
Notice and on the issues of remedy, the public interest, and bonding. 
Complainant and OUII are requested to submit proposed remedial orders 
for the Commission's consideration. Complainant is also requested to 
state the date that the 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 Respondent's 
products at issue in this investigation.
    The parties' written submissions and proposed remedial orders must 
be filed no later than the close of business on October 31, 2019. Reply 
submissions must be filed no later than the close of business on 
November 7, 2019. Opening submissions are limited to 75 pages. Reply 
submissions are limited to 60 pages. Such submissions should address 
the ALJ's recommended determination on remedy and bonding. Interested 
government agencies and any other interested parties are also 
encouraged to file written submissions on the issues of remedy, the 
public interest, and bonding. Third-party submissions should be filed 
no later than the close

[[Page 56837]]

of business on October 31, 2019, 2019. 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 pursuant to Section 
210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 
210.4(f)). Submissions should refer to the investigation number (``Inv. 
No. 337-TA-1100'') in a prominent place on the cover page and/or the 
first page. (See Handbook on Filing Procedures, https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf). Persons with questions 
regarding filing should contact the Secretary at (202) 205-2000.
    Any person desiring to submit a document to the Commission in 
confidence must request confidential treatment unless the information 
has already been granted such treatment during the proceedings. All 
such requests should be directed to the Secretary of the Commission and 
must include a full statement of the reasons why the Commission should 
grant such treatment. See 19 CFR 210.6. Documents for which 
confidential treatment by the Commission is 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,\1\ solely for 
cybersecurity purposes. All non-confidential written submissions will 
be available for public inspection at the Office of the Secretary and 
on EDIS
---------------------------------------------------------------------------

    \1\ All contract personnel will sign appropriate nondisclosure 
agreements.
---------------------------------------------------------------------------

    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 
210).

    By order of the Commission.

    Issued: October 17, 2019.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2019-23072 Filed 10-22-19; 8:45 am]
 BILLING CODE 7020-02-P