Certain Dental Ceramics, Products Thereof, and Methods of Making the Same; Commission Decision To Review in Part a Final Initial Determination Finding No Violation of Section 337; Schedule for Filing Written Submissions on the Issues Under Review and on Remedy, the Public Interest, and Bonding; Extension of the Target Date, 48865-48867 [2018-21007]
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Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
[FR Doc. 2018–20990 Filed 9–26–18; 8:45 am]
investigation are or will be available for
inspection during official business
hours (8:45 a.m. to 5:15 p.m.) in the
Office of the Secretary, U.S.
International Trade Commission, 500 E
Street SW, Washington, DC 20436,
telephone (202) 205–2000. General
information concerning the Commission
may also be obtained by accessing its
internet server at https://www.usitc.gov.
The public record for this investigation
may be viewed on the Commission’s
electronic docket (EDIS) at https://
edis.usitc.gov. Hearing-impaired
persons are advised that information on
this matter can be obtained by
contacting the Commission TDD
terminal on (202) 205–1810.
BILLING CODE 7020–02–P
SUPPLEMENTARY INFORMATION:
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.
Authority: These investigations are
being conducted under authority of title
VII of the Tariff Act of 1930; this notice
is published pursuant to section 207.12
of the Commission’s rules.
By order of the Commission.
Issued: September 21, 2018.
Lisa Barton,
Secretary to the Commission.
INTERNATIONAL TRADE
COMMISSION
[Investigation No. 337–TA–1050]
Certain Dental Ceramics, Products
Thereof, and Methods of Making the
Same; Commission Decision To
Review in Part a Final Initial
Determination Finding No Violation of
Section 337; Schedule for Filing
Written Submissions on the Issues
Under Review and on Remedy, the
Public Interest, and Bonding;
Extension of the Target Date
U.S. International Trade
Commission.
ACTION: Notice.
AGENCY:
Notice is hereby given that
the U.S. International Trade
Commission has determined to review
in part the final initial determination
(‘‘final ID’’) issued by the presiding
administrative law judge (‘‘ALJ’’) on
July 23, 2018, finding no violation of
section 337 of the Tariff Act of 1930, in
the above-captioned investigation. The
Commission requests certain briefing
from the parties on the issues under
review, as indicated in this notice. The
Commission also requests briefing from
the parties, interested persons, and
interested government agencies on the
issues of remedy, the public interest,
and bonding. The Commission has
determined to extend the target date for
completion of the investigation from
November 23, 2018 to November 30,
2018.
FOR FURTHER INFORMATION CONTACT:
Sidney A. Rosenzweig, Office of the
General Counsel, U.S. International
Trade Commission, 500 E Street SW,
Washington, DC 20436, telephone (202)
708–2532. Copies of non-confidential
documents filed in connection with this
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SUMMARY:
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The
Commission instituted this investigation
on April 25, 2017, based on a complaint,
as supplemented, filed by Ivoclar
Vivadent AG of Schaan, Liechtenstein;
Ivoclar Vivadent, Inc. of Amherst, New
York; and Ardent, Inc. of Amherst, New
York (collectively ‘‘Ivoclar’’). 82 FR
19081 (Apr. 25, 2017). The complaint,
as supplemented, alleged violations of
section 337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), in the
importation into the United States, the
sale for importation, or the sale within
the United States after importation of
certain dental ceramics, products
thereof, and methods of making the
same by reason of the infringement of
certain claims of four United States
patents: U.S. Patent No. 7,452,836 (‘‘the
’836 patent’’); U.S. Patent No. 6,517,623
(‘‘the ’623 patent’’); U.S. Patent No.
6,802,894 (‘‘the ’894 patent’’); and U.S.
Patent No. 6,455,451 (‘‘the ’451 patent’’).
The notice of investigation named as
respondents GC Corporation of Tokyo,
Japan; and GC America, Inc. of Alsip,
Illinois (collectively, ‘‘GC’’). The Office
of Unfair Import Investigations was also
named as a party.
The investigation was previously
terminated as to certain asserted patent
claims, including all of the asserted
claims of the ’623 patent and the ’451
patent, based upon withdrawal of the
complaint. Order No. 18 (Nov. 21,
2017), not reviewed, Notice (Dec. 6,
2017); Order No. 24 (Dec. 19, 2017), not
reviewed, Notice (Jan. 18, 2018); Order
No. 51 (Feb. 22, 2018), not reviewed,
Notice (Mar. 23, 2018); Order No. 56
(Mar. 28, 2018), not reviewed, Notice
(Apr. 27, 2018). Remaining within the
scope of the investigation, as to
infringement, domestic industry, or
both, are claims 1, 2, 4, 5, 7, 9, 10, 13,
15–19, and 21 of the ’836 patent; and
claims 1, 2, 4, 16–21, 34, 36 and 38 of
the ’894 patent.
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48865
On July 23, 2018, the ALJ issued the
final ID. The ID finds, inter alia, that
Ivoclar failed to demonstrate
infringement of the above-referenced
claims of the ’836 patent. The ID finds,
inter alia, that claims 36 and 38 (‘‘the
’894 flexure strength claims’’) are
invalid as indefinite under 35 U.S.C.
112 ¶ 2. The ID further finds that Ivoclar
failed to demonstrate infringement and
failed to meet the technical prong of the
domestic industry requirement as to the
remaining claims of the ’894 patent
(claims 1, 2, 4, 5, 7, 9, 10, 13, 15–19, and
21) (‘‘the ’894 annealing claims’’). The
ID finds that some, but not all, of the
’894 annealing claims are invalid in
view of certain prior art.
Ivoclar, GC, and the Commission
investigative attorney filed petitions for
review and replies to the other parties’
petitions.
Having reviewed the record of the
investigation, including the final ID, as
well as the parties’ petitions for review
and responses thereto, the Commission
has determined as follows. The
Commission has determined to review
the ID’s findings as to the ’894 annealing
claims. The Commission has
determined not to review the ID’s
findings as to the ’894 flexure strength
claims because the Commission finds
that the invalidity of claims 36 and 38
has been shown clearly and
convincingly. The Commission has
determined not to review the ID’s
findings for the ’836 patent claims.
Accordingly, the Commission finds no
violation of section 337 as to the ’836
patent and as to the ’894 flexure
strength claims. The Commission has
determined not to review the remainder
of the ID.
In connection with the Commission’s
review, the Commission notes that
‘‘[a]ny issue not raised in a petition for
review will be deemed to have been
abandoned by the petitioning party and
may be disregarded by the Commission
in reviewing the initial determination.’’
19 CFR 210.43(b)(2).
The parties are asked to provide
additional briefing on the following
issues, with reference to the applicable
law and the existing evidentiary record.
For each argument presented, the
parties’ submissions should set forth
whether and/or how that argument was
presented and preserved in the
proceedings before the ALJ, in
conformity with the ALJ’s Ground Rules
(Order No. 2), with citations to the
record.
1. For purposes of invalidity of the
’894 annealing claims, if the
Commission were to find that a person
of ordinary skill is entitled to rely upon
the patentee’s representation about the
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48866
Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
disclosure of Barrett teaching lithium
disilicates, see, e.g., PharmaStem
Therapeutics, Inc. v. Viacell, Inc., 491
F.3d 1342, 1362 (Fed. Cir. 2007)
(‘‘Admissions in the specification
regarding the prior art are binding on
the patentee for purposes of a later
inquiry into obviousness.’’), what is the
role, if any, of enablement of the prior
art, see, e.g., Hoeschst Marion Roussel,
Inc., 314 F.3d 1313, 1354 (Fed. Cir.
2003) (‘‘A claimed invention cannot be
anticipated by a prior art reference if the
allegedly anticipatory disclosures cited
as prior art are not enabled.’’)? Please be
certain to identify the appropriate
burdens of production and persuasion,
and the effect of those burdens in this
investigation.
2. If the Commission finds that the
sequence of steps performed by GC can
practice the ‘‘annealing’’ limitation of
the ’894 annealing claims if annealing
were to occur:
a. Whether Ivoclar demonstrated, by a
preponderance of evidence, that GC’s
methods practice the ‘‘annealing’’
limitation of claim 1 of the ’894 patent
(including all time and temperature
limitations).
b. Whether the WO196 patent
application (RX–563) can be
invalidating prior art, as discussed in
Ivoclar’s reply to GC’s petition, at p. 94.
c. Whether, to ascertain if GC’s
products or Ivoclar’s products meet the
other limitations of claim 1, or the
limitations of any claim dependent
upon claim 1, a remand to the presiding
ALJ is warranted.
In connection with the final
disposition of this investigation, the
Commission may (1) issue an order that
could result in the exclusion of the
subject articles from entry into the
United States, and/or (2) issue one or
more cease and desist orders that could
result in the respondent(s) 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. (December
1994).
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17:20 Sep 26, 2018
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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 or
disapprove the Commission’s action.
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. 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
combined written submissions on the
issues under review and remedy, the
public interest and bonding. 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.
The parties’ submissions on the issues
under review and on remedy, the public
interest, and bonding should not exceed
40 pages. Reply submissions on the
issues under review should not exceed
25 pages per side. Parties are
encouraged to incorporate by reference
any arguments adequately presented in
their petitions for review and responses
thereto, rather than repeating
arguments. The page limits above are
exclusive of exhibits, but parties are not
to circumvent the page limits by
incorporating material by reference from
the exhibits or from the record.
The complainants’ opening
submission is to include proposed
remedial orders for the Commission’s
consideration; the date that the ’894
patent expires; the HTSUS numbers
under which the accused products are
imported; and the names of known
importers of the products at issue in this
investigation.
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Written submissions by the parties
and the public must be filed no later
than close of business on Friday,
October 5, 2018. Reply submissions by
the parties and the public must be filed
no later than the close of business on
Friday, October 12, 2018. No further
submissions 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 and submit 8 true paper
copies to the Office of the Secretary by
noon the next day pursuant to section
210.4(f) of the Commission’s Rules of
Practice and Procedure (19 CFR
210.4(f)). Submissions should refer to
the investigation number (‘‘Inv. No.
337–TA–1050’’) in a prominent place on
the cover page and/or the first page. (See
Handbook for Electronic Filing
Procedures, https://www.usitc.gov/
secretary/fed_reg_notices/rules/
handbook_on_electronic_filing.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. All such requests should be
directed to the Secretary to the
Commission and must include a full
statement of the reasons why the
Commission should grant such
treatment. See 19 CFR 201.6. Documents
for which confidential treatment by the
Commission is properly sought will be
treated accordingly. 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,1 solely for cybersecurity
purposes. All nonconfidential written
submissions will be available for public
inspection at the Office of the Secretary
and on EDIS.
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
1 All contract personnel will sign appropriate
nondisclosure agreements.
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Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: September 21, 2018.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2018–21007 Filed 9–26–18; 8:45 am]
BILLING CODE 7020–02–P
JOINT BOARD FOR THE
ENROLLMENT OF ACTUARIES
Invitation for Membership on Advisory
Committee
Joint Board for the Enrollment
of Actuaries.
ACTION: Request for applications.
AGENCY:
The Joint Board for the
Enrollment of Actuaries (Joint Board),
established under the Employee
Retirement Income Security Act of 1974
(ERISA), is responsible for the
enrollment of individuals who wish to
perform actuarial services under ERISA.
To assist in its examination duties
mandated by ERISA, the Joint Board
established the Advisory Committee on
Actuarial Examinations (Advisory
Committee) in accordance with the
provisions of the Federal Advisory
Committee Act (FACA). The current
Advisory Committee members’ terms
expire on February 28, 2019. This notice
describes the Advisory Committee and
invites applications from those
interested in serving on the Advisory
Committee for the March 1, 2019–
February 28, 2021 term.
DATES: Applications for membership on
the Advisory Committee must be
received no later than December 7,
2018.
SUMMARY:
You may mail or deliver
applications to: Internal Revenue
Service; Joint Board for the Enrollment
of Actuaries; SE:RPO, Room 3422/IR,
Attn: Ms. Elizabeth Van Osten; 1111
Constitution Avenue NW, Washington,
DC 20224. Applications may also be
sent electronically to: nhqjbea@irs.gov.
See SUPPLEMENTARY INFORMATION for
application requirements.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Van Osten, Designated Federal
Officer, at 202–317–3648.
SUPPLEMENTARY INFORMATION:
daltland on DSKBBV9HB2PROD with NOTICES
ADDRESSES:
1. Background
To qualify for enrollment to perform
actuarial services under ERISA, an
applicant must satisfy certain
experience and knowledge
requirements, which are set forth in the
Joint Board’s regulations. An applicant
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17:20 Sep 26, 2018
Jkt 244001
48867
may satisfy the knowledge requirement
through the successful completion of
Joint Board examinations in basic
actuarial mathematics and methodology
and in actuarial mathematics and
methodology relating to pension plans
qualifying under ERISA.
The Joint Board, the Society of
Actuaries, and the American Society of
Pension Professionals & Actuaries
jointly offer examinations acceptable to
the Joint Board for enrollment purposes
and which are acceptable to the other
two actuarial organizations as part of
their respective examination programs
members affiliated with any one
actuarial organization or employed with
any one firm.
Membership normally will be limited
to actuaries currently enrolled by the
Joint Board. However, individuals
having academic or other special
qualifications of particular value for the
Advisory Committee’s work will also be
considered for membership. Federallyregistered lobbyists and individuals
affiliated with Joint Board enrollment
examination preparation courses are not
eligible to serve on the Advisory
Committee.
2. Scope of Advisory Committee Duties
The Advisory Committee plays an
integral role in the examination program
by assisting the Joint Board in offering
examinations that enable examination
candidates to demonstrate the
knowledge necessary to qualify for
enrollment. The Advisory Committee’s
duties, which are strictly advisory,
include (1) recommending topics for
inclusion on the Joint Board
examinations, (2) reviewing and drafting
examination questions, (3)
recommending examinations, (4)
reviewing examination results and
recommending passing scores, and (5)
providing other recommendations and
advice relative to the examinations, as
requested by the Joint Board.
5. Member Designation
3. Member Terms and Responsibilities
Members are appointed for a 2-year
term. The upcoming term will begin on
March 1, 2019, and end on February 28,
2021. Members may seek reappointment
for additional consecutive terms.
Members are expected to attend
approximately 4 meetings each calendar
year and are reimbursed for travel
expenses in accordance with applicable
government regulations. In general,
members are expected to devote 125 to
175 hours, including meeting time, to
the work of the Advisory Committee
over the course of a year.
4. Member Selection
The Joint Board seeks to appoint an
Advisory Committee that is fairly
balanced in terms of points of view
represented and functions to be
performed. Every effort is made to
ensure that most points of view extant
in the enrolled actuary profession are
represented on the Advisory Committee.
To that end, the Joint Board seeks to
appoint several members from each of
the main practice areas of the enrolled
actuary profession, including small
employer plans, large employer plans,
and multiemployer plans. In addition,
to ensure diversity of points of view, the
Joint Board limits the number of
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Fmt 4703
Sfmt 4703
Advisory Committee members are
appointed as Special Government
Employees (SGEs). As such, members
are subject to certain ethical standards
applicable to SGEs. Upon appointment,
each member will be required to
provide written confirmation that he/
she does not have a financial interest in
a Joint Board examination preparation
course. In addition, each member will
be required to attend annual ethics
training.
6. Application Requirements
To receive consideration, an
individual interested in serving on the
Advisory Committee must submit (1) a
signed, cover letter expressing interest
in serving on the Advisory Committee
and describing his/her professional
qualifications, and (2) a resume and/or
curriculum vitae. Applications may be
submitted by regular mail, overnight
and express delivery services, and
email. In all cases, the cover letter must
contain an original signature.
Applications must be received by
December 7, 2018.
Dated: September 19, 2018.
Thomas V. Curtin, Jr.,
Executive Director, Joint Board for the
Enrollment of Actuaries.
[FR Doc. 2018–21001 Filed 9–26–18; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Nanosyn, Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
DATES:
E:\FR\FM\27SEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Pages 48865-48867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21007]
-----------------------------------------------------------------------
INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1050]
Certain Dental Ceramics, Products Thereof, and Methods of Making
the Same; Commission Decision To Review in Part a Final Initial
Determination Finding No Violation of Section 337; Schedule for Filing
Written Submissions on the Issues Under Review and on Remedy, the
Public Interest, and Bonding; Extension of the Target Date
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that the U.S. International Trade
Commission has determined to review in part the final initial
determination (``final ID'') issued by the presiding administrative law
judge (``ALJ'') on July 23, 2018, finding no violation of section 337
of the Tariff Act of 1930, in the above-captioned investigation. The
Commission requests certain briefing from the parties on the issues
under review, as indicated in this notice. The Commission also requests
briefing from the parties, interested persons, and interested
government agencies on the issues of remedy, the public interest, and
bonding. The Commission has determined to extend the target date for
completion of the investigation from November 23, 2018 to November 30,
2018.
FOR FURTHER INFORMATION CONTACT: Sidney A. Rosenzweig, Office of the
General Counsel, U.S. International Trade Commission, 500 E Street SW,
Washington, DC 20436, telephone (202) 708-2532. Copies of non-
confidential documents filed in connection with this investigation are
or will be available for inspection during official business hours
(8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S.
International Trade Commission, 500 E Street SW, Washington, DC 20436,
telephone (202) 205-2000. General information concerning the Commission
may also be obtained by accessing its internet server at https://www.usitc.gov. The public record for this investigation may be viewed
on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.
Hearing-impaired persons are advised that information on this matter
can be obtained by contacting the Commission TDD terminal on (202) 205-
1810.
SUPPLEMENTARY INFORMATION: The Commission instituted this investigation
on April 25, 2017, based on a complaint, as supplemented, filed by
Ivoclar Vivadent AG of Schaan, Liechtenstein; Ivoclar Vivadent, Inc. of
Amherst, New York; and Ardent, Inc. of Amherst, New York (collectively
``Ivoclar''). 82 FR 19081 (Apr. 25, 2017). The complaint, as
supplemented, alleged violations of section 337 of the Tariff Act of
1930, as amended (19 U.S.C. 1337), in the importation into the United
States, the sale for importation, or the sale within the United States
after importation of certain dental ceramics, products thereof, and
methods of making the same by reason of the infringement of certain
claims of four United States patents: U.S. Patent No. 7,452,836 (``the
'836 patent''); U.S. Patent No. 6,517,623 (``the '623 patent''); U.S.
Patent No. 6,802,894 (``the '894 patent''); and U.S. Patent No.
6,455,451 (``the '451 patent''). The notice of investigation named as
respondents GC Corporation of Tokyo, Japan; and GC America, Inc. of
Alsip, Illinois (collectively, ``GC''). The Office of Unfair Import
Investigations was also named as a party.
The investigation was previously terminated as to certain asserted
patent claims, including all of the asserted claims of the '623 patent
and the '451 patent, based upon withdrawal of the complaint. Order No.
18 (Nov. 21, 2017), not reviewed, Notice (Dec. 6, 2017); Order No. 24
(Dec. 19, 2017), not reviewed, Notice (Jan. 18, 2018); Order No. 51
(Feb. 22, 2018), not reviewed, Notice (Mar. 23, 2018); Order No. 56
(Mar. 28, 2018), not reviewed, Notice (Apr. 27, 2018). Remaining within
the scope of the investigation, as to infringement, domestic industry,
or both, are claims 1, 2, 4, 5, 7, 9, 10, 13, 15-19, and 21 of the '836
patent; and claims 1, 2, 4, 16-21, 34, 36 and 38 of the '894 patent.
On July 23, 2018, the ALJ issued the final ID. The ID finds, inter
alia, that Ivoclar failed to demonstrate infringement of the above-
referenced claims of the '836 patent. The ID finds, inter alia, that
claims 36 and 38 (``the '894 flexure strength claims'') are invalid as
indefinite under 35 U.S.C. 112 ] 2. The ID further finds that Ivoclar
failed to demonstrate infringement and failed to meet the technical
prong of the domestic industry requirement as to the remaining claims
of the '894 patent (claims 1, 2, 4, 5, 7, 9, 10, 13, 15-19, and 21)
(``the '894 annealing claims''). The ID finds that some, but not all,
of the '894 annealing claims are invalid in view of certain prior art.
Ivoclar, GC, and the Commission investigative attorney filed
petitions for review and replies to the other parties' petitions.
Having reviewed the record of the investigation, including the
final ID, as well as the parties' petitions for review and responses
thereto, the Commission has determined as follows. The Commission has
determined to review the ID's findings as to the '894 annealing claims.
The Commission has determined not to review the ID's findings as to the
'894 flexure strength claims because the Commission finds that the
invalidity of claims 36 and 38 has been shown clearly and convincingly.
The Commission has determined not to review the ID's findings for the
'836 patent claims. Accordingly, the Commission finds no violation of
section 337 as to the '836 patent and as to the '894 flexure strength
claims. The Commission has determined not to review the remainder of
the ID.
In connection with the Commission's review, the Commission notes
that ``[a]ny issue not raised in a petition for review will be deemed
to have been abandoned by the petitioning party and may be disregarded
by the Commission in reviewing the initial determination.'' 19 CFR
210.43(b)(2).
The parties are asked to provide additional briefing on the
following issues, with reference to the applicable law and the existing
evidentiary record. For each argument presented, the parties'
submissions should set forth whether and/or how that argument was
presented and preserved in the proceedings before the ALJ, in
conformity with the ALJ's Ground Rules (Order No. 2), with citations to
the record.
1. For purposes of invalidity of the '894 annealing claims, if the
Commission were to find that a person of ordinary skill is entitled to
rely upon the patentee's representation about the
[[Page 48866]]
disclosure of Barrett teaching lithium disilicates, see, e.g.,
PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342, 1362
(Fed. Cir. 2007) (``Admissions in the specification regarding the prior
art are binding on the patentee for purposes of a later inquiry into
obviousness.''), what is the role, if any, of enablement of the prior
art, see, e.g., Hoeschst Marion Roussel, Inc., 314 F.3d 1313, 1354
(Fed. Cir. 2003) (``A claimed invention cannot be anticipated by a
prior art reference if the allegedly anticipatory disclosures cited as
prior art are not enabled.'')? Please be certain to identify the
appropriate burdens of production and persuasion, and the effect of
those burdens in this investigation.
2. If the Commission finds that the sequence of steps performed by
GC can practice the ``annealing'' limitation of the '894 annealing
claims if annealing were to occur:
a. Whether Ivoclar demonstrated, by a preponderance of evidence,
that GC's methods practice the ``annealing'' limitation of claim 1 of
the '894 patent (including all time and temperature limitations).
b. Whether the WO196 patent application (RX-563) can be
invalidating prior art, as discussed in Ivoclar's reply to GC's
petition, at p. 94.
c. Whether, to ascertain if GC's products or Ivoclar's products
meet the other limitations of claim 1, or the limitations of any claim
dependent upon claim 1, a remand to the presiding ALJ is warranted.
In connection with the final disposition of this investigation, the
Commission may (1) issue an order that could result in the exclusion of
the subject articles from entry into the United States, and/or (2)
issue one or more cease and desist orders that could result in the
respondent(s) 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.
(December 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
or disapprove the Commission's action. 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. 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 combined written submissions on the issues under review and
remedy, the public interest and bonding. 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.
The parties' submissions on the issues under review and on remedy,
the public interest, and bonding should not exceed 40 pages. Reply
submissions on the issues under review should not exceed 25 pages per
side. Parties are encouraged to incorporate by reference any arguments
adequately presented in their petitions for review and responses
thereto, rather than repeating arguments. The page limits above are
exclusive of exhibits, but parties are not to circumvent the page
limits by incorporating material by reference from the exhibits or from
the record.
The complainants' opening submission is to include proposed
remedial orders for the Commission's consideration; the date that the
'894 patent expires; the HTSUS numbers under which the accused products
are imported; and the names of known importers of the products at issue
in this investigation.
Written submissions by the parties and the public must be filed no
later than close of business on Friday, October 5, 2018. Reply
submissions by the parties and the public must be filed no later than
the close of business on Friday, October 12, 2018. No further
submissions 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 and submit 8
true paper copies to the Office of the Secretary by noon the next day
pursuant to section 210.4(f) of the Commission's Rules of Practice and
Procedure (19 CFR 210.4(f)). Submissions should refer to the
investigation number (``Inv. No. 337-TA-1050'') in a prominent place on
the cover page and/or the first page. (See Handbook for Electronic
Filing Procedures, https://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.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. All such requests
should be directed to the Secretary to the Commission and must include
a full statement of the reasons why the Commission should grant such
treatment. See 19 CFR 201.6. Documents for which confidential treatment
by the Commission is properly sought will be treated accordingly. 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,\1\ solely for
cybersecurity purposes. All nonconfidential written submissions will be
available for public inspection at the Office of the Secretary and on
EDIS.
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\1\ All contract personnel will sign appropriate nondisclosure
agreements.
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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
[[Page 48867]]
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Practice and Procedure (19 CFR part 210).
By order of the Commission.
Issued: September 21, 2018.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2018-21007 Filed 9-26-18; 8:45 am]
BILLING CODE 7020-02-P
