UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
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`In the Matter of
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`CERTAIN FLOCKED SWABS,
`PRODUCTS CONTAINING FLOCKED
`SWABS, AND METHODS OF USING
`SAME
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`Investigation No. 337-TA-1279
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`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
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`U.S. International Trade Commission.
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`Notice.
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`AGENCY:
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`ACTION:
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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.
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`FOR FURTHER INFORMATION CONTACT: Cathy Chen, Esq., Office of the General
`Counsel, U.S. International Trade Commission, 500 E Street, S.W., Washington, D.C. 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 EDIS3Help@usitc.gov. 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.
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`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
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`No. 10,327,741 (“the ’741 patent”). The complaint also alleged the existence of a domestic
`industry.
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`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).
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`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.
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`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”).
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`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.
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`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.
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`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.
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`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).
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`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.
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`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
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`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.
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`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.
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`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 . . . .”
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`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.
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`The Commission vote for this determination took place on March 17, 2023.
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`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.
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`By order of the Commission.
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`Lisa R. Barton
`Secretary to the Commission
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` Issued: March 17, 2023
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