[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Notices]
[Pages 58100-58101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22814]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1167]


Certain Laparoscopic Surgical Staplers, Reload Cartridges, and 
Components Thereof; Final Determination Finding a Violation of Section 
337 and Issuance of Remedial Orders; Suspension of Enforcement of the 
Remedial Orders Pending Final Resolution of a Final Written Decision by 
the Patent Trial and Appeal Board; and Termination of the Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission (the ``Commission'') has determined that: (i) The 
respondents have violated section 337 of the Tariff Act of 1930, as 
amended, by importing, selling for importation, or selling in the 
United States after importation certain laparoscopic surgical staplers, 
reload cartridges, and components thereof that infringe complainants' 
U.S. Patent No. 9,844,379 (``the '379 patent''); (2) the appropriate 
remedies are a limited exclusion order and cease and desist orders; and 
(3) enforcement of said remedial orders will be suspended pending final 
resolution of a Final Written Decision by the Patent Trial and Appeal 
Board (``PTAB'') that the asserted claims of the '379 patent are 
unpatentable. This investigation is terminated.

FOR FURTHER INFORMATION CONTACT: Benjamin S. Richards, 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 may 
be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email 
[email protected]. 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.

SUPPLEMENTARY INFORMATION: The Commission instituted this investigation 
on July 5, 2019, based on a complaint filed by Ethicon LLC of Guaynabo, 
PR; Ethicon Endo-surgery, Inc. of Cincinnati, OH; and Ethicon US, LLC 
of Cincinnati, OH (collectively, ``Ethicon''). 84 FR 32220 (July 5, 
2019); see also 84 FR 65174 (Nov. 26, 2019) (amending the caption). The 
complaint alleged violations of section 337 of the Tariff Act of 1930, 
as amended, 19 U.S.C. 1337, based on the importation into the United 
States, the sale for importation, and the sale within the United States 
after importation of certain laparoscopic surgical staplers, reload 
cartridges, and components thereof by reason of infringement of one or 
more claims of U.S. Patent Nos. 9,844,379; 9,844,369 (``the '369 
patent''); 7,490,749 (``the '749 patent''); 8,479,969 (``the '969 
patent''); and 9,113,874 (``the '874 patent''). 84 FR at 32220. The 
Commission's notice of investigation named the following as 
respondents: Intuitive Surgical Inc., of Sunnyvale, CA; Intuitive 
Surgical Operations, Inc., of Sunnyvale, CA; Intuitive Surgical 
Holdings, LLC, of Sunnyvale, CA; and Intuitive Surgical S. De R.L. De 
C.V. of Mexicali, Mexico (collectively, ``Intuitive''). Id. The Office 
of Unfair Import Investigations is not participating in this 
investigation. Id.
    On October 23, 2020, the Chief Administrative Law Judge (``CALJ'') 
granted Ethicon's motion for leave to amend the complaint, case 
caption, and notice of investigation to reinstate the original plain 
English statement of the category of accused products, as well as the 
original case caption, and to reincorporate Intuitive's laparoscopic 
surgical staplers and components thereof as articles to be excluded. 
Order No. 14, unreviewed by Comm'n Notice (Nov. 21, 2019). As initially 
instituted, the investigation covered reload cartridges for those 
staplers, but not the staplers themselves. See id.

[[Page 58101]]

    On October 29, 2019, the CALJ conducted a Markman hearing. 
Thereafter, on January 7, 2020, the CALJ issued Order No. 15, which 
construed various terms in the asserted patents.
    On March 5, 2020, the CALJ granted Ethicon's motion to terminate 
claim 1 of the '379 patent and all claims of the '749 patent from the 
investigation. See Order No. 21, unreviewed by Comm'n Notice (Mar. 25, 
2020).
    On April 21, 2020, Ethicon moved for leave to file a second amended 
complaint to include the Certificate of Correction for the '379 patent. 
The CALJ granted Ethicon's motion on May 6, 2020, and Ethicon filed its 
second amended complaint on May 7, 2020. See Order No. 36; Doc. ID 
709878.
    On June 8, 2021, the CALJ issued the subject ID on violation, which 
found a violation of section 337 based on infringement of the asserted 
claims of the '369 and '379 patents by Intuitive. The ID found no 
violation based on the '969 and '874 patents. Also, on June 8, 2021, 
the CALJ issued his recommended determination on remedy and bonding. 
The CALJ recommended, upon a finding of violation, that the Commission 
issue a limited exclusion order, issue cease and desist orders, and 
impose a bond in the amount of zero percent (0%) of the entered value 
of any covered products imported during the period of Presidential 
review.
    On June 21, 2021, Ethicon and Intuitive submitted petitions seeking 
review of the subject ID. Intuitive's petition included a request for 
suspension of enforcement of any remedial orders directed to the '379 
patent based on a Final Written Decision by the PTAB, in which the PTAB 
found all claims of the '379 patent unpatentable. See Intuitive 
Surgical, Inc. v. Ethicon LLC, IPR2020-00050, IPR2020-00051, Patent 
9,844,379, Final Written Decision Determining All Challenged Claims 
Unpatentable (Mar. 26, 2021). On June 29, 2021, Ethicon and Intuitive 
submitted responses to the other's petitions.
    On June 9, 2021, the Commission issued a notice soliciting public 
comments on the public interest factors, if any, that may be implicated 
if a remedy were to be issued in this investigation. 85 FR 30735 (May 
20, 2020). The Commission received twelve submissions from the public 
in response to its notice.
    On August 16, 2021, issued notice of its determination to review 
the ID in part with respect to (1) the ID's findings on claim 
construction, infringement, anticipation, obviousness, and 
enforceability for the '969 patent; and (2) the ID's findings on claim 
construction, infringement, and obviousness for the '369 patent. The 
Commission determined not to review the remainder of the ID, including 
the ID's determination that a violation of section 337 had occurred 
with respect to the '379 patent and that no violation occurred with 
respect to the '874 patent. In connection with its review of the ID, 
the Commission sought briefing from the parties on several questions 
germane to the issues on review and on remedy, bonding, and the public 
interest.
    The parties filed their initial response to the Commission's review 
questions on August 23, 2021, and their respective reply briefs on 
August 30, 2021.
    Having considered the parties' submissions, the ID, and the record 
in this investigation, the Commission has determined that Intuitive has 
violated section 337 by importing into the United States, selling for 
importation, or selling in the United States after importation certain 
laparoscopic surgical staplers, reload cartridges, and components 
thereof that infringe claims 2 and 3 of the '379 patent. The Commission 
has further determined to affirm, reverse, and take no position on 
certain portions of the ID, as explained in the Commission's opinion 
issued concurrently herewith.
    The Commission has determined that the appropriate remedy is: (a) A 
limited exclusion order prohibiting the importation of certain 
laparoscopic surgical staplers, reload cartridges, and components 
thereof that infringe claims 2 and 3 of the '379 patent; and (b) cease 
and desist orders against Intuitive. The Commission has determined that 
the public interest factors enumerated in section 337(d)(1) and (f)(1) 
do not preclude issuance of the limited exclusion order or cease and 
desist orders. The Commission has also determined to set a bond in the 
amount of zero percent (0%) (i.e., no bond) of the entered value of the 
excluded products imported during the period of Presidential review (19 
U.S.C. 1337(j)).
    The Commission has also determined to suspend enforcement of its 
remedial orders, including the bond provision, pending final resolution 
of a Final Written Decision issued by the PTAB on March 26, 2021, 
finding all claims of the '379 patent to be unpatentable. See 35 U.S.C. 
318(b); Intuitive Surgical, Inc. v. Ethicon LLC, IPR2020-00050, 
IPR2020-00051, Patent 9,844,379, Final Written Decision Determining All 
Challenged Claims Unpatentable (Mar. 26, 2021).
    The Commission's orders and opinion were delivered to the President 
and United States Trade Representative on the day of their issuance.
    The Commission vote for this determination took place on October 
14, 2021.
    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 14, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021-22814 Filed 10-19-21; 8:45 am]
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