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]

Download as PDF 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 daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 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. PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 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 E:\FR\FM\27SEN1.SGM 27SEN1 daltland on DSKBBV9HB2PROD with NOTICES 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). VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 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. PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 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. E:\FR\FM\27SEN1.SGM 27SEN1 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 VerDate Sep<11>2014 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 PO 00000 Frm 00075 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 27SEN1

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]


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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