[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