35570 Federal Register / Vol. 87, No. 112 / Friday, June 10, 2022 / Notices 

or cashier’s check made payable to the 

Department of the Interior, BLM, for not 

less than 10 percent of the bid amount. 

The remainder of the full bid price must 

be paid within 180 calendar days of the 

date of sale. Failure to pay the full price 

within 180 days will disqualify the 

apparent high bidder and cause the bid 

deposit to be forfeited to the BLM. 

If issued, the conveyance document 

will be subject to valid existing rights 

and encumbrances of record, including, 

but not limited to, reservations for 

ditches and canals and all mineral 

deposits. 

Adverse comments will be reviewed 

by the BLM Colorado State Director, 

who may sustain, vacate, or modify this 

realty action. In the absence of timely 

adverse comments, this proposal shall 

become the final determination of the 

Department of the Interior. The BLM 

may accept or reject any or all offers or 

withdraw any land or interest in land 

from sale. 

Before including your address, phone 

number, email address, or other 

personal identifying information in your 

comment, be advised that your entire 

comment—including your personal 

identifying information—may be made 

publicly available at any time. While 

you may ask us in your comment to 

withhold from public review your 

personal identifying information, we 

cannot guarantee that we will be able to 

do so. 

(Authority: 43 CFR 2710.0–3(a)(3)). 

Stephanie Connolly, 

Acting Colorado State Director. 

[FR Doc. 2022–12573 Filed 6–9–22; 8:45 am] 

BILLING CODE 4310–JB–P 

INTERNATIONAL TRADE 

COMMISSION 

[Investigation No. 337–TA–1238] 

Certain Plant-Derived Recombinant 

Human Serum Albumins (‘‘rHSA’’) and 

Products Containing Same Notice of 

Commission Determination To Review 

the Final Initial Determination in Its 

Entirety; Schedule for Filing Written 

Submissions 

AGENCY: U.S. International Trade 

Commission. 

ACTION: Notice. 

SUMMARY: Notice is hereby given that 

the U.S. International Trade 

Commission has determined to review 

the final initial determination (‘‘final 

ID’’) issued by the presiding 

administrative law judge (‘‘ALJ’’) on 

April 7, 2022, in its entirety. The 

Commission requests briefing from the 

parties on certain issues under review, 

as indicated in this notice. The 

Commission also requests briefing from 

the parties, interested government 

agencies, and interested persons on the 

issues of remedy, the public interest, 

and bonding. 

FOR FURTHER INFORMATION CONTACT: 

Ronald A. Traud, Esq., Office of the 

General Counsel, U.S. International 

Trade Commission, 500 E Street SW, 

Washington, DC 20436, telephone (202) 

205–3427. 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. 

SUPPLEMENTARY INFORMATION: The 

Commission instituted this investigation 

on January 25, 2021, based on a 

complaint filed on behalf of Ventria 

Bioscience Inc. (‘‘Ventria’’) of Junction 

City, Kansas. 86 FR 6916 (Jan. 25, 2021). 

The complaint, as supplemented, 

alleged violations of section 337 of the 

Tariff Act of 1930, as amended, 19 

U.S.C. 1337, based upon the importation 

into the United States, the sale for 

importation, and the sale within the 

United States after importation of 

certain plant-derived rHSA and 

products containing same by reason of 

infringement of certain claims of U.S. 

Patent Nos. 10,618,951 (‘‘the ’951 

patent’’) and 8,609,416 (‘‘the ’416 

patent’’). Id. The complaint also alleged 

violations of section 337 based on the 

importation into the United States, or in 

the sale of, certain plant-derived rHSA 

and products containing same by reason 

of false designation of origin, the threat 

or effect of which is to destroy or 

substantially injure an industry in the 

United States. Id. The notice of 

investigation named four respondents: 

Wuhan Healthgen Biotechnology Corp. 

of Wuhan, China (‘‘Healthgen’’); 

ScienCell Research Laboratories, Inc. of 

Carlsbad, California (‘‘ScienCell’’); 

Aspira Scientific, Inc. of Milpitas, 

California (‘‘Aspira’’); and eEnzyme LLC 

of Gaithersburg, Maryland (‘‘eEnzyme’’) 

(collectively, the ‘‘Respondents’’). Id. at 

6917. The Office of Unfair Import 

Investigations (‘‘OUII’’) was also named 

as a party in this investigation. Id. 

Of the four Respondents named in the 

notice of investigation, only Healthgen 

participated in the investigation. 

ScienCell, Aspira, and eEnzyme were 

found in default. See Order No. 13 (July 

28, 2021), unreviewed by Comm’n 

Notice (Aug. 18, 2021). ScienCell, 

Aspira, and eEnzyme are collectively 

referred to herein as the ‘‘Defaulting 

Respondents.’’ 

Prior to the issuance of the final ID, 

the investigation terminated as to all 

asserted claims of the ’416 patent, 

claims 2 and 3 of the ’951 patent, and 

the false designation of origin claims 

against Healthgen. See Order No. 12 

(July 16, 2021), unreviewed by Comm’n 

Notice (Aug. 10, 2021); Order No. 29 

(Nov. 3, 2021), unreviewed by Comm’n 

Notice (Nov. 29, 2021). The false 

designation of origin claims against the 

Defaulting Respondents were not 

terminated. See Order No. 12 at 1. 

Accordingly, at the time the final ID 

issued, only claims 1 and 11–13 of the 

’951 patent remained pending against 

Healthgen, and only claims 1 and 11–13 

of the ’951 patent and the false 

designation of origin (or Lanham Act) 

claims remained pending against the 

Defaulting Respondents. 

On April 7, 2022, the ALJ issued the 

final ID, which found that Respondents 

violated section 337. The ALJ found a 

violation of section 337 by Healthgen 

and the Defaulting Respondents as to 

infringement of the ’951 patent and 

found the requirements of section 

337(g)(1) met as to the Lanham Act 

claim with respect to the Defaulting 

Respondents. 

The final ID included the ALJ’s 

recommendation on remedy, the public 

interest, and bonding (the ‘‘RD’’). The 

RD recommended that, if the 

Commission finds a violation of section 

337, the Commission should issue a 

limited exclusion order against 

Healthgen and the Defaulting 

Respondents, cease and desist orders 

against the Defaulting Respondents, and 

impose a 100% bond during the period 

of Presidential review. 

On April 19, 2022, Healthgen filed a 

petition for review of the final ID. On 

April 22, 2022, OUII filed a response to 

Healthgen’s petition, and on April 27, 

2022, Ventria filed a response to 

Healthgen’s petition. 

On May 9, 2022, Ventria and 

Healthgen filed their public interest 

comments pursuant to Commission Rule 

210.50(a)(4) (19 CFR 210.50(a)(4)). The 

Commission also received several 

submissions from third parties in 

response to the Commission’s Federal 

Register notice seeking comment on the 

public interest. 87 FR 21923–24 (Apr. 

13, 2022). 


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Having examined the record in this 

investigation, including the final ID, the 

petition for review, and the responses 

thereto, the Commission has determined 

to review the final ID in its entirety. 

The parties are requested to brief their 

positions with reference to the 

applicable law and the evidentiary 

record regarding the questions provided 

below: 

(1) Given the construction of 

aggregated albumin (‘‘non-monomeric 

albumin (e.g., albumin dimers)’’), what 

distinguishes ‘‘non-monomeric 

albumin’’ from ‘‘monomeric albumin’’? 

How can this distinction be determined 

from testing data, such as by 

electrophoresis or chromatographic 

testing data? 

(2) Given the construction of 

aggregated albumin (‘‘non-monomeric 

albumin (e.g., albumin dimers)’’), the 

applicable burdens of proof, and any 

other relevant considerations, which of 

the following should be considered 

within the scope of ‘‘aggregated 

albumin’’: 

(a) fragments of native mammalian 

albumin; 

(b) the combination of (i) one or more 

recombinant albumins (i.e., albumins 

heterologous or foreign to the transgenic 

plant producing it) which has the amino 

acid sequence of a native mammalian 

albumin or which is a variant, 

derivative, or fusion protein, and (ii) 

one or more fragments of native 

mammalian albumin; 

(c) the combination of two or more 

fragments of native mammalian 

albumin; 

(d) any substance identified via 

electrophoresis or chromatographic 

techniques with a molecular weight 

greater than the molecular weight 

corresponding to the ‘‘main band’’ that 

is not a discrete, integer multiple of the 

molecular weight corresponding to that 

‘‘main band;’’ 

(e) non-covalently linked aggregated 

albumin; and 

(f) ‘‘low molecular weight 

impurities,’’ such as those included in 

the May 2021 reducing SDS–PAGE test 

results from SGS Life Science Services 

(JX–0129.0006–7). 

(3) Given the ’951 patent 

specification’s identification of 

‘‘aggregates at around 250 KDa’’ (see col. 

72, ll. 51–54), explain: 

(a) whether the molecular weight(s) of 

those ‘‘aggregates at around 250 KDa’’ 

are or are not discrete, integer 

multiple(s) of the molecular weight(s) of 

the main band(s) (see Figs. 9A and/or 

9B); and 

(b) whether the answer to subpart (a) 

above affects the result of any responses 

to (2)(a)–(f)? 

(4) Does the parties’ agreement that 

dimers are the simplest form of an 

aggregated albumin preclude any of the 

species in (2)(a)–(f) from contributing 

towards ‘‘aggregated albumin’’? 

(5) Does the resolution of whether any 

of (2)(a)–(f) are within the scope of 

‘‘aggregated albumin’’ (or what 

constitutes ‘‘non-monomeric albumin’’) 

require further claim construction, or 

are these determinations purely factual? 

If further claim construction is required, 

should the Commission remand the 

investigation to the ALJ? 

(6) If species identified in (2)(d) that 

are detected via an electrophoresis or 

chromatographic technique are within 

the scope ‘‘aggregated albumin,’’ could 

an assay that does not use molecular 

weight markers or standards be able to 

determine whether or not a sample has 

‘‘less than 2% aggregated albumin’’? 

(7) How can the Commission 

determine whether species detected via 

an electrophoresis, chromatographic, or 

other technique retain the biological or 

therapeutically beneficial activity of 

native mammalian albumin? If the 

Commission is unable to determine 

whether such a species retains that 

activity, how should that inability factor 

into determining whether a product 

satisfies the ‘‘less than 2% aggregated 

albumin’’ claim limitation, considering, 

for example, the burdens of proof? 

(8) In instances where species 

detected in electrophoresis or 

chromatographic techniques are 

determined not to be within the scope 

of ‘‘aggregated albumin,’’ how is the 

percentage of ‘‘aggregated albumin’’ 

calculated? Is the percentage of 

‘‘aggregated albumin’’ calculated by 

dividing the sum total of ‘‘band 

volume’’ (or equivalent) of species 

within the scope of aggregated albumin 

by the sum total of the band volume of 

both ‘‘aggregated’’ and non-‘‘aggregated’’ 

albumin? 

(9) How should the Commission 

address the situation where the accused 

products or domestic industry products 

are found to satisfy the ‘‘less than 2% 

aggregated albumin’’ claim limitation 

under one testing methodology, but not 

under another? 

(10) Assuming the reducing agents 

used in reducing SDS–PAGE convert 

aggregated albumin into ‘‘monomeric 

albumin,’’ does the evidence show the 

extent that reducing agents do so? 

Please specify whether the evidence of 

conversion, if any, depends on the form 

of the product (for example, 

lyophilized/freeze dried powder versus 

liquid products). 

(11) If Optibumin is found to be the 

only asserted product to satisfy the 

technical prong of the domestic industry 

requirement for the ’951 patent and the 

scope of the products that can be 

considered in the economic prong 

analysis include only Optibumin, 

discuss whether (and why or why not) 

Complainant Ventria’s investments and 

expenditures in the alleged domestic 

industry are significant and/or 

substantial within the meaning of 19 

U.S.C. 1337(a)(3)(A), (B), and/or (C) 

with citations to record evidence. 

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 are 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). 

The statute requires the Commission 

to consider the effects of that remedy 

upon the public interest. The public 

interest 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. 

Please address the following 

questions relevant to the public interest 

considerations in this investigation, 

including evidence in support: 

(1) Please identify Healthgen’s 

customers of the accused products and 

state the uses for which these customers 

are using its products. Are Ventria’s 

products substitutes for these products 

and uses? 

(2) Is there any vaccine or 

therapeutics research currently using 

Healthgen’s accused products? If so, 

please describe. 


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(3) For any current uses of the 

accused products, can Ventria’s 

products be used as substitutes? 

(4) Can Ventria adequately supply 

U.S. demand for rHSA products? 

(5) Are there uses for which a pHSA 

product cannot substitute for a plantbased rHSA product? To what extent 

should pHSA products be considered 

when examining the question of 

available substitutes for the accused 

products? 

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 questions 

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 

initial written submissions should 

include views on the RD that issued on 

April 7, 2022. 

Initial written submissions, limited to 

80 pages, must be filed no later than the 

close of business on June 20, 2022. 

Complainants are requested to identify 

the form of the remedy sought and to 

submit proposed remedial orders for the 

Commission’s consideration. 

Complainants are also requested to state 

the HTSUS subheadings under which 

the accused articles are imported, and to 

supply identification information for all 

known importers of the accused 

products. Reply submissions, limited to 

50 pages, must be filed no later than the 

close of business on June 27, 2022. 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 (Mar. 

19, 2020). Submissions should refer to 

the investigation number (‘‘Inv. No. 

337–TA–1238’’) 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 at (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 nonconfidential 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 June 6, 

2022. 

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). 

While temporary remote operating 

procedures are in place in response to 

COVID–19, the Office of the Secretary is 

not able to serve parties that have not 

retained counsel or otherwise provided 

a point of contact for electronic service. 

Accordingly, pursuant to Commission 

Rules 201.16(a) and 210.7(a)(1) (19 CFR 

201.16(a), 210.7(a)(1)), the Commission 

orders that the Complainant(s) complete 

service for any party/parties without a 

method of electronic service noted on 

the attached Certificate of Service and 

shall file proof of service on the 

Electronic Document Information 

System (EDIS). 

By order of the Commission. 

Issued: June 6, 2022. 

Lisa Barton, 

Secretary to the Commission. 

[FR Doc. 2022–12500 Filed 6–9–22; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

211th Meeting of the Advisory Council 

on Employee Welfare and Pension 

Benefit Plans; Notice of Meeting 

Pursuant to the authority contained in 

Section 512 of the Employee Retirement 

Income Security Act of 1974 (ERISA), 29 

U.S.C. 1142, the 211th open meeting of 

the Advisory Council on Employee 

Welfare and Pension Benefit Plans (also 

known as the ERISA Advisory Council) 

will be held on July 18–20, 2022. 

On Monday, July 18, 2022, the 

meeting will begin at 1 p.m. and end at 

approximately 4:30 p.m. (ET). On 

Tuesday, July 19, 2022, the meeting will 

begin at 8:30 a.m. and end at 

approximately 4:30 p.m. (ET), with a 

one-hour break for lunch. On 

Wednesday, July 20, 2022, the meeting 

will begin at 8:30 a.m. and end at 

approximately 1 p.m. (ET). 

The three-day meeting will take place 

at the U.S. Department of Labor, 200 

Constitution Avenue NW, Washington, 

DC 20210 in Room N5437 A–D. The 

meeting will also be accessible via 

teleconference and some participants, as 

well as members of the public, may 

elect to attend virtually. Instructions for 

public teleconference access will be 

available on the ERISA Advisory 

Council’s web page at https://

www.dol.gov/agencies/ebsa/about-ebsa/ 

about-us/erisa-advisory-council 

approximately one week prior to the 

meeting. 

The purpose of the open meeting is 

for Advisory Council members to hear 

testimony from invited witnesses and to 

receive an update from the Employee 

Benefits Security Administration 

(EBSA). 

The Advisory Council will study the 

following topics: (1) Cybersecurity 

Issues Affecting Health Benefit Plans, 

and (2) Cybersecurity Insurance and 

Employee Benefit Plans. Descriptions of 

these topics, once finalized, as well as 

an agenda for the meeting, will be 

available on the ERISA Advisory 

Council’s web page at https:// 


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