[Federal Register Volume 86, Number 159 (Friday, August 20, 2021)]
[Notices]
[Pages 46882-46884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17843]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1178]


Certain Laparoscopic Surgical Staplers, Reload Cartridges, and 
Components Thereof; Commission Determination To Review in Part a Final 
Initial Determination Finding a Violation of Section 337; Schedule for 
Filing Written Submissions on the Issues Under Review and on Remedy, 
Public Interest, and Bonding

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 in part the Administrative Law 
Judge's (``ALJ'') final initial determination (``ID''), issued on June 
8, 2021, finding a violation of section 337 in the above-referenced 
investigation as to two of the four asserted patents. The Commission 
requests briefing from the parties on certain issues under review, as 
indicated in this notice.

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

[[Page 46883]]

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 (``the '379 patent'') ; 
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 ALJ 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 actual 
staplers themselves. See id.
    On October 29, 2019, the ALJ conducted a Markman hearing. 
Thereafter, on January 7, 2020, the ALJ issued Order No. 15, which 
construed various terms in the asserted patents.
    On March 5, 2020, the ALJ 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 ALJ 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 ALJ issued the subject ID on violation, which 
found a violation of section 337 based on infringement 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 ALJ issued his 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 zero percent 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. On June 29, 2021, Ethicon and Intuitive 
submitted responses to the others' petitions.
    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) 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 has determined not to review the remainder of the ID.
    In connection with its review, 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. Claim 24 of the '969 patent includes the terms ``elongated shaft 
assembly'' and ``transmission assembly.'' Concerning these terms, 
identify where in the record, if anywhere:
    a. The parties proposed constructions for these terms;
    b. The parties argued in support of any constructions proposed; and
    c. The ALJ construed these terms.
    2. Concerning the terms ``elongated shaft assembly'' and 
``transmission assembly,'' indicate whether these terms should be 
construed according to their plain and ordinary meaning. If these terms 
should be construed according to their plain and ordinary meaning, what 
is the plain and ordinary meaning of each term? If these terms should 
be construed otherwise, identify the correct mode of construction and 
the corresponding construction for each term. Identify with specificity 
the evidence of record that supports your contentions with particular 
emphasis on evidence intrinsic to the '969 patent.
    a. Explain whether the SureForm products meet these limitations 
under the parties' proposed constructions.
    3. Does the evidence of record support the conclusion that persons 
of ordinary skill in the art with respect to the '969 patent were 
responsible for the decision to create a joint venture between PMI and 
Intuitive for the purpose of modifying the PMI i60 stapler to work with 
the da Vinci Si surgical system? Provide any citations to the record 
that support your contention.
    4. Does the record indicate whether the Si EndoWrist 45 stapler is 
the subject of one or more patents? Identify any such patents.
    5. Claim 22 of the '369 patent includes the term ``elongate 
channel.'' Concerning that term, identify where in the record, if 
anywhere:
    a. The parties proposed constructions for that term;
    b. The parties argued in support of any constructions proposed; and
    c. The ALJ construed that term.
    6. Concerning the term ``elongate channel,'' indicate whether these 
terms should be construed according to its plain and ordinary meaning? 
If this term should be construed according to its plain and ordinary 
meaning, what is the plain and ordinary meaning of the term? If the 
term should be construed otherwise, identify the correct mode of 
construction and the corresponding construction. Identify with 
specificity the evidence of record that supports your contentions with 
particular emphasis on evidence intrinsic to the '369 patent.
    a. Explain whether the SureForm products meet this limitation under 
the parties' proposed constructions.
    7. Claim 22 of the '369 patent includes the limitation: ``means for 
guiding the at least one lower foot on the firing element out of the 
proximal channel opening into the internal passage upon initial 
application of a firing motion to the firing element.'' If the 
Commission determines that the corresponding structure for that 
limitation is limited to flat, as opposed to curved, chamfers and 
slopes, would

[[Page 46884]]

the accused products practice this limitation?
    8. Concerning claims 22 and 23 of the '369 patent, Intuitive states 
in its petition for review that its proposed obviousness combination 
``includes each limitation of the asserted claims under Ethicon's 
theory of infringement.'' Identify what aspect of Intuitive's 
obviousness theory is dependent on Ethicon's theory of infringement and 
explain how it is dependent.
    9. If the Commission finds that Intuitive does not infringe claims 
22 and 23 of the '369 patent, explain whether Intuitive's obviousness 
theories necessarily fail by virtue of their dependence on Ethicon's 
infringement theory.
    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).
    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, 
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, to provide 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 23, 2021. Reply submissions must be filed 
no later than the close of business on August 30, 2021. Opening 
submissions are limited to 100 pages. Reply submissions are limited to 
75 pages. No further submissions on 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-1167) 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 by marking each document 
with a header indicating that the document contains confidential 
information. This marking will be deemed to satisfy the request 
procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) 
& 210.5(e)(2)). 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 Commission vote for this determination took place on August 16, 
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: August 16, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021-17843 Filed 8-19-21; 8:45 am]
BILLING CODE 7020-02-P