[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Pages 17617-17618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05935]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1279]


Certain Flocked Swabs, Products Containing Flocked Swabs, and 
Methods of Using Same; Notice of a Commission Determination To Review 
in Part a Final Initial Determination; and, on Review, To Find No 
Violation of Section 337; 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 has determined to review in part the presiding 
administrative law judge's (``ALJ'') final initial determination 
(``ID'') issued on October 28, 2022, finding no violation of section 
337, in the above-referenced investigation. On review, the Commission 
has determined to find no violation of section 337. The investigation 
is terminated in its entirety.

FOR FURTHER INFORMATION CONTACT: Cathy Chen, Esq., Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 205-2392. 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: On September 2, 2021, the Commission 
instituted this investigation under section 337 of the Tariff Act of 
1930, as amended, 19 U.S.C. 1337, based on a complaint filed by Copan 
Italia S.p.A. and Copan Industries, Inc. (``Copan,'' or 
``Complainants''). 86 FR 49343-44 (Sept. 2, 2021). The complaint 
alleged a violation of section 337 in the importation into the United 
States, the sale for importation, or the sale within the United States 
after importation of certain flocked swabs, products containing flocked 
swabs, and methods of using same by reason of infringement of claims 1, 
6-9, 11-14, 16-19, and 21-22 of U.S. Patent No. 9,011,358 (``the '358 
patent''); claims 1, 4-6, 8, 9, 11-13, 16-20, and 22-24 of U.S. Patent 
No. 9,173,779 (``the '779 patent''); and claims 1, 3, 5, 7-10, 18, and 
20 of U.S. Patent No. 10,327,741 (``the '741 patent''). The complaint 
also alleged the existence of a domestic industry.
    The notice of investigation named numerous respondents, including 
Han Chang Medic of Chungnam, Republic of Korea (``HCM''); Wuxi NEST 
Biotechnology Co., Ltd. of Wuxi, Jiangsu, China; NEST Scientific Inc. 
and NEST Scientific USA, both of Rahway, New Jersey (collectively, 
``NEST''); Miraclean Technology Co., Ltd. of Shenzhen, Guangdong, China 
(``Miraclean''); Vectornate Korea Ltd. of Jangseong, Republic of Korea 
and Vectornate USA, Inc. of Mahwah, New Jersey (collectively, 
``Vectornate''); Innovative Product Brands, Inc. of Highland, 
California (``Innovative''); Thomas Scientific, Inc. of Swedesboro, New 
Jersey (``TSI''); Thomas Scientific, LLC (``TSL'') and Stellar 
Scientific, LLC (``Stellar''), both of Owings Mills, Maryland; Cardinal 
Health, Inc. of Dublin, Ohio (``Cardinal''); KSL Biomedical, Inc. and 
KSL Diagnostics, Inc., both of Williamsville, New York (collectively, 
``KSL''); Jiangsu Changfeng Medical Industry Co., Ltd. of Yangzhou, 
Jiangsu, China (``JCM''); No Borders Dental Resources, Inc., dba 
MediDent Supplies of Queen Creek, Arizona (``MediDent''); BioTeke 
Corporation (Wuxi) Co., Ltd. of Wuxi, Jiangsu, China (``BioTeke''); 
Fosun Pharma USA Inc. of Princeton, New Jersey (``Fosun''); Hunan 
Runmei Gene Technology Co., Ltd. of Changsha, Hunan, China (``HRGT''); 
VWR International, LLC of Radnor, Pennsylvania (``VWR''); and Slmp, LLC 
dba StatLab Medical Products of McKinney, Texas (``StatLab''). Id. at 
49343-44. The Commission's Office of Unfair Import Investigations 
(``OUII'') was also named as a party in this investigation. Id. at 
49344. After institution, Huachenyang (Shenzhen) Technology Co., Ltd. 
(``HCY'') and HCY USA, LLC (``HCY USA'') were allowed to intervene as 
respondents in this investigation. Order No. 30 (Dec. 7, 2021), 
unreviewed by Notice (Jan. 6, 2021).
    On June 15, 2022, a Claim Construction Order (Order No. 51) issued 
construing claim terms from the asserted patents. Pursuant to the 
parties' request, that Order was amended with respect to the definition 
of level of a person of ordinary skill in the art in Order No. 66 (July 
1, 2022). An evidentiary hearing was held on June 27-July 1, 2022.
    During the course of the investigation, a number of respondents 
were terminated from the investigation or were found in default. See ID 
at 7 n.5 (noting termination of the investigation as to KSL, VWR, 
Cardinal, Innovative, Vectornate, TSL, TSI, Stellar, HCY USA, StatLab, 
and Fosun); ID at 7 n.6 (citing Order No. 27 (Nov. 15, 2021), 
unreviewed, Comm'n Notice (Dec. 6, 2021) (finding HRGT in default); 
Order No. 31 (Dec. 15, 2021), unreviewed, Comm'n Notice (Jan. 10, 2022) 
(finding HCM and MediDent in default)). The following respondents 
remain in the investigation: NEST, JCM, BioTeke, Miraclean, and HCY 
(collectively, ``Respondents'').

[[Page 17618]]

    Also, during the course of the investigation, Complainants withdrew 
their allegations with respect to claims 7-9, 11-14, 16-19, 21, and 22 
of the '358 patent, claims 4-6, 8, 11-13, 16-20, and 22-24 of the '779 
patent, and claims 5, 7-9, and 20 of the '741 patent, and the 
investigation was terminated as to these claims. Thus, claims 1 and 6 
of the '358 patent, claims 1 and 9 of the '779 patent, and claims 1, 3, 
10, and 18 of the '741 patent remain in the investigation.
    On October 28, 2022, the ALJ issued a final ID, finding no 
violation of section 337 in this investigation. Specifically, the final 
ID terminated claim 18 of the '741 patent after Complainants did not 
proceed with this claim at the hearing. With respect to the remaining 
asserted claims of the '358, '779, and '741 patents, the final ID found 
no violation based on Complainants' failure of proof with respect to 
infringement and the technical prong of the domestic industry 
requirement. The final ID also determined that the asserted patent 
claims have not been shown to be invalid. The final ID further found 
that if the asserted domestic industry products satisfy the technical 
prong of the domestic industry requirement, Complainants have shown 
that the economic prong of the domestic industry requirement is 
satisfied with respect to all the asserted patents under section 
337(a)(3)(A). On November 14, 2022, the ALJ issued a recommended 
determination on remedy, the public interest, and bonding.
    Also on November 14, 2022, Complainants, Respondents, and OUII 
filed separate petitions for review of the final ID. On November 22, 
2022, they filed separate replies to the petitions for review.
    No submissions were received in response to the Commission's notice 
soliciting submissions from the public on the public interest issues 
raised by the recommended determination. 87 FR 70863 (Nov. 21, 2022).
    Having reviewed the record of the investigation, including the 
final ID, the Claim Construction Order, and the parties' submissions, 
the Commission has determined to review in part the final ID and, on 
review, affirm the final ID's finding of no violation of section 337 
with the supplemental reasoning discussed below. In particular, the 
Commission has determined to review and adopt the ALJ's claim 
constructions, including the term ``perpendicularly'' in the '358 and 
'779 patent claims and the term ``oriented manner'' in the '741 patent 
claims, based on the reasoning provided in the Claim Construction Order 
and the final ID. The Commission supplements the ID's construction of 
the term ``perpendicularly'' with the inventor's statements during 
prosecution at RX-0309.0270-0271, which further supports the ID's 
finding at page 50 that the fibers of prior art Griffiths were not 
flocked in an ordered arrangement normal to the surface although 
Griffiths employs electrostatic flocking. Copan does not challenge the 
final ID's findings that Respondents' accused products do not infringe 
and that the domestic industry products do not practice these 
limitations under the ALJ's claim constructions. Having failed to show 
that its alleged domestic industry products practice any of the 
asserted patents, Copan has necessarily failed to show the existence of 
a domestic industry under section 337(a)(3) for the asserted patents. 
Accordingly, the Commission has determined to review and take no 
position on the economic prong of the domestic industry requirement.
    The Commission has also determined to review and adopt the final 
ID's findings that the JCM accused products do not infringe and that 
Copan's domestic industry products do not practice the absorption ``by 
capillarity'' limitations of the '358 and '779 patents based on the 
reasoning provided in the final ID. The Commission supplements the ID's 
reasoning with the inventor's statements made during prosecution of the 
'779 patent. In particular, in an August 11, 2014 reply to an office 
action from June 11, 2014, the inventor argued that a ``brush'' 
disclosed in the prior art, Hedberg (U.S. Patent No. 5,623,941) (RX-
0141), ``does not provide an appreciable capillary action of the fiber 
layer, since the quantity of liquid collected by dipping the brush in a 
liquid (please note that a collection of liquid by dipping a device 
into the liquid does not require a capillary action, since also a spoon 
can collect liquid when dipped into a liquid container, despite the 
fact that a spoon evidently has no capillary action) was easily lost by 
the swab, thus showing the absence of a capillary effect . . . .'' JX-
0005.1555 (emphasis in original). The Commission finds the inventor's 
statements during prosecution further support the ID's finding that Dr. 
Michielsen's testing, which included collecting liquid after dipping an 
accused swab into beet juice, did not reliably show liquid absorbed 
solely by capillarity. See, e.g., ID at 103. Thus, the Commission finds 
the record evidence supports the ID's finding that Dr. Michielsen's 
testing does not show, by a preponderance of the evidence, that the 
absorption ``by capillarity'' limitation is met by the JCM accused 
products and Copan's domestic industry products. See ID at 103-106, 
111, 128-29, 131.
    Among other findings, the Commission has determined not to review 
the final ID's findings that BioTeke's redesigned products should be 
adjudicated and are not infringing and that the asserted claims have 
not been shown to be invalid.
    In addition, the Commission corrects a typographical error on page 
151 of the ID. The sentence should read as follows: ``the evidence does 
not show, clearly and convincingly, obviousness of any asserted claim . 
. . .''
    Accordingly, the Commission has determined to affirm the ID's 
finding of no violation of section 337 with the supplemental reasoning 
discussed above. The investigation is terminated in its entirety.
    The Commission vote for this determination took place on March 17, 
2023.
    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: March 17, 2023.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2023-05935 Filed 3-22-23; 8:45 am]
BILLING CODE 7020-02-P