CHAIRMAN
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C. 20436
`
`May 1(cid:28), 2020
`
`The President
`The White House
`Washington, D.C. 20500
`
`Dear Mr. President:
`
`In accordance with subsection (j) of section 337 of the Tariff Act of 1930, as amended
`(19 U.S.C. § 1337) (“section 337”), and the July 21, 2005 Memorandum for the United States
`Trade Representative (70 Fed. Reg. 43251), I am transmitting to you and the United States Trade
`Representative copies of the Commission’s limited exclusion order, as described below, and the
`record upon which the Commission based its determination.
`
`On May 1(cid:28), 2020, the United States International Trade Commission issued a limited
`exclusion order pursuant to section 337 in USITC Investigation No. 337-TA-1120, Certain
`Human Milk Oligosaccharides and Methods of Producing the Same. The limited exclusion order
`prohibits the unlicensed importation of human milk oligosaccharides and methods of producing
`the same that infringe one or more of claims 1-3, 5, 8, 10, 12, 18, and 24-28 of U.S. Patent No.
`9,970,018 that are manufactured abroad by or on behalf of, or imported by or on behalf of
`respondent Jennewein Biotechnologie GmbH of Rheinbreitbach, Germany (“Respondent”).
`
`The Commission concluded that the statutory public interest factors enumerated in
`subsection (d)(1) of section 337 do not preclude the issuance of this remedy. The Commission
`also determined that during the period of Presidential review, the products described above,
`manufactured abroad or imported by, for, or on behalf of Respondent, may be imported and sold
`in the United States with the posting of a bond in the amount of five (5) percent of the entered
`value.
`
`
`
`(cid:38)(cid:82)(cid:81)(cid:73)(cid:76)(cid:71)(cid:72)(cid:81)(cid:87)(cid:76)(cid:68)(cid:79)(cid:3)(cid:53)(cid:72)(cid:80)(cid:82)(cid:89)(cid:72)(cid:71)(cid:3)(cid:54)(cid:39)(cid:37)(cid:38)(cid:82)(cid:81)(cid:73)(cid:76)(cid:71)(cid:72)(cid:81)(cid:87)(cid:76)(cid:68)(cid:79)(cid:3)(cid:53)(cid:72)(cid:80)(cid:82)(cid:89)(cid:72)(cid:71)(cid:3)(cid:54)(cid:39)(cid:37)
`
`

`

`The President
`May 1(cid:28), 2020
`Page 2
`
`Enclosures
`
`Sincerely,
`
`David S. Johanson
`Chairman
`
`

`

`CHAIRMAN
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C. 20436
`
`May 1(cid:28), 2020
`
`The Honorable Steven T. Mnuchin
`Secretary of the Treasury
`Washington, D.C. 20220
`
`Dear Mr. Secretary:
`
`In accordance with subsection (d) of section 337 of the Tariff Act of 1930, as amended
`(19 U.S.C. § 1337) (“section 337”), I am transmitting to you a copy of the Commission’s limited
`exclusion order, as described below, and the record upon which the Commission based its
`determination.
`
`On May 1(cid:28), 2020, the United States International Trade Commission issued a limited
`exclusion order pursuant to section 337 in USITC Investigation No. 337-TA-1120, Certain
`Human Milk Oligosaccharides and Methods of Producing the Same. The limited exclusion order
`prohibits the unlicensed importation of human milk oligosaccharides and methods of producing
`the same that infringe one or more of claims 1-3, 5, 8, 10, 12, 18, and 24-28 of U.S. Patent No.
`9,970,018 that are manufactured abroad by or on behalf of, or imported by or on behalf of
`respondent Jennewein Biotechnologie GmbH of Rheinbreitbach, Germany (“Respondent”).
`
`The Commission concluded that the statutory public interest factors enumerated in
`subsection (d)(1) of section 337 do not preclude the issuance of this remedy. The Commission
`also determined that, during the period of Presidential review, the products described above,
`manufactured abroad or imported by, for, or on behalf of Respondent, may be imported and sold
`in the United States with the posting of a bond in the amount of five (5) percent of the entered
`value.
`
`

`

`Secretary Mnuchin
`May 1(cid:28), 2020
`Page 2
`
`Enclosures
`
`cc:
`
`Charles Steuart, Chief
`IPR & Restricted Merchandise Branch
`Office of International Trade
`Regulation and Rulings
`U.S. Customs and Border Protection
`90 K Street, NE
`Washington, D.C. 20229-1177
`
`Sincerely,
`
`David S. Johanson
`Chairman
`
`

`

`CHAIRMAN
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C. 20436
`
`May 1(cid:28), 2020
`
`The Honorable Robert Lighthizer
`United States Trade Representative
`Washington, D.C. 20508
`
`Dear Ambassador Lighthizer:
`
`In accordance with subsection (j) of section 337 of the Tariff Act of 1930, as amended
`(19 U.S.C. § 1337) (“section 337”), and the July 21, 2005 Memorandum for the United States
`Trade Representative (70 Fed. Reg. 43251), I am transmitting to you and the President copies of
`the Commission’s limited exclusion order, as described below, and the record upon which the
`Commission based its determination.
`
`On May 1(cid:28), 2020, the United States International Trade Commission issued a limited
`exclusion order pursuant to section 337 in USITC Investigation No. 337-TA-1120, Certain
`Human Milk Oligosaccharides and Methods of Producing the Same.
`
`The limited exclusion order prohibits the unlicensed importation of human milk
`oligosaccharides and methods of producing the same that infringe one or more of claims 1-3, 5,
`8, 10, 12, 18, and 24-28 of U.S. Patent No. 9,970,018 that are manufactured abroad by or on
`behalf of, or imported by or on behalf of respondent Jennewein Biotechnologie GmbH of
`Rheinbreitbach, Germany (“Respondent”).
`
`The Commission concluded that the statutory public interest factors enumerated in
`subsection (d)(1) of section 337 do not preclude the issuance of this remedy. The Commission
`also determined that during the period of Presidential review, the products described above,
`manufactured abroad or imported by, for, or on behalf of Respondent, may be imported and sold
`in the United States with the posting of a bond in the amount of five (5) percent of the entered
`value.
`
`

`

`Ambassador Lighthizer
`May 1(cid:28), 2020
`Page 2
`
`Sincerely,
`
`David S. Johanson
`Chairman
`
`Enclosures
`
`cc:
`
`Shannon M. Nestor, Esq.
`Juli C. Schwartz, Esq.
`Office of the General Counsel
`Office of the United States Trade Representative
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`In the Matter of
`
`
`
`
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND
`METHODS OF PRODUCING
`THE SAME
`
`
`Investigation No. 337-TA-1120
`
`
`
`
`
`
`
`
`NOTICE OF COMMISSION FINAL DETERMINATION FINDING
`A VIOLATION OF SECTION 337; ISSUANCE OF A LIMITED EXCLUSION
`ORDER; TERMINATION OF THE INVESTIGATION
`
` U.S. International Trade Commission.
`
`Notice.
`
`
`AGENCY:
`
`ACTION:
`
`SUMMARY: Notice is hereby given that the U.S. International Trade Commission has found a
`violation of section 337 of the Tariff Act of 1930 (“section 337”), as amended, in this
`investigation. The Commission has issued a limited exclusion order (“LEO”) prohibiting the
`importation by respondent Jennewein Biotechnologie GmbH (“Jennewein”) of Rheinbreitbach,
`Germany of certain human milk oligosaccharides that infringe complainant’s asserted claims.
`The investigation is terminated.
`
`FOR FURTHER INFORMATION CONTACT: Houda Morad, Office of the General
`Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436,
`telephone (202) 708-4716. 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, D.C. 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’s TDD terminal on (202) 205-1810.
`
`SUPPLEMENTARY INFORMATION: The Commission instituted this investigation on June
`21, 2018, based on a complaint, as amended and supplemented, filed on behalf of Glycosyn LLC
`of Waltham, Massachusetts (“Glycosyn”). See 83 Fed. Reg. 28865 (June 21, 2018). The
`complaint, as amended and supplemented, alleges violations of section 337 of the Tariff Act of
`1930, as amended, 19 U.S.C. 1337 (“section 337”), based upon the importation into the United
`States, the sale for importation, and the sale within the United States after importation of certain
`human milk oligosaccharides by reason of infringement of claims 1-40 of U.S. Patent No.
`9,453,230 (“the ’230 patent”) and claims 1-28 of U.S. Patent No. 9,970,018 (“the ’018 patent”).
`
`1
`
`

`

`See id. The notice of investigation named Jennewein as a respondent in this investigation. See
`id. The Office of Unfair Import Investigations (“OUII”) is also named as a party to the
`investigation. See id.
`
`
`The ALJ conducted an evidentiary hearing on May 14-17, 2019, and on September 9,
`2019, issued the FID finding a violation of section 337 based on the infringement of claims 1-3,
`5, 8, 10, 12, 18, and 24-28 of the ’018 patent (hereinafter, the “Asserted Claims”). In addition,
`the FID finds that the Asserted Claims are neither invalid under 35 U.S.C. §§ 103 and 112, nor
`unenforceable for inequitable conduct. Furthermore, the FID finds that the domestic industry
`requirement is satisfied. All asserted claims in the ’230 patent were withdrawn during the
`investigation. The FID also contains a recommended determination (“RD”) recommending that
`the Commission issue an LEO barring entry of articles that infringe the ’018 patent. The RD
`also recommends that the Commission impose a 5 percent bond during the period of Presidential
`review. Furthermore, as directed by the Commission, the RD provides findings with respect to
`the public interest and recommends that the Commission determine that the public interest
`factors do not preclude entry of the proposed LEO. Glycosyn does not seek and the RD does not
`recommend issuance of a cease and desist order.
`
`On October 9 and 10, 2019, respectively, Glycosyn and Jennewein filed statements on the
`public interest pursuant to Commission Rule 210.50. On October 23, 2019, non-party DuPont
`Nutrition & Health filed a public interest submission pursuant to the Commission’s notice
`requesting public interest comments. See 84 Fed. Reg. 49335 (Sept. 19, 2019).
`
`On January 30, 2020, the Commission issued a notice determining to review the FID in
`part. See 85 Fed. Reg. 6573 (Feb. 5, 2020). The Commission’s notice requested written
`submissions in response to certain questions relating to issues under review and on issues of
`remedy, the public interest, and bonding. On February 18, 2020, the parties, including OUII,
`filed written submissions in response to the notice, and on February 25, 2020, the parties filed
`responses to each other’s submissions. On February 18, 2020, non-party Abbott Laboratories
`filed a written submission concerning the public interest.
`
`Having examined the record of this investigation, including the FID, the RD, and the
`parties’ and non-parties’ submissions, the Commission has determined to affirm with
`modification the FID’s determination of a violation of section 337 with respect to claims 1-3, 5,
`8, 10, 12, 18, and 24-28 of the ’018 patent. Specifically, as explained in the Commission
`Opinion filed concurrently herewith, the Commission has determined to affirm with modification
`the FID’s findings with respect to infringement by the accused Jennewein bacterial strains and to
`reverse the FID’s decision not to adjudicate infringement with respect to Jennewein’s TTFL12
`bacterial strain. As to the TTFL12 strain, the Commission has determined that it does not
`infringe the Asserted Claims. All findings in the FID that are not inconsistent with the
`Commission’s determination are affirmed.
`
`The Commission has determined that the appropriate remedy is an LEO against
`Jennewein’s infringing products. The Commission has also determined that the public interest
`factors enumerated in subsection 337(d)(1) (19 U.S.C. 1337(d)(1)) do not preclude the issuance
`of the LEO. The Commission has further determined to set a bond during the period of
`
`2
`
`

`

`Presidential review at five (5) percent of the entered value of Jennewein’s infringing products
`(19 U.S.C. 1337(j)).
`
`The Commission’s order and opinion were delivered to the President and to the United
`States Trade Representative on the day of their issuance.
`
`The Commission’s vote for these determinations took place on May 19, 2020.
`
`The authority for the Commission’s determination is contained in section 337 of the
`Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission’s Rules of
`Practice and Procedure (19 CFR part 210).
`
`
`By order of the Commission.
`
`Issued: May 19, 2020
`
`
`Lisa R. Barton
`Secretary to the Commission
`
`
`
`3
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`Investigation No. 337-TA-1120
`
`
`In the Matter of
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS
`OF PRODUCING THE SAME
`
`
`
`
`
`
`LIMITED EXCLUSION ORDER
`
`
`The United States International Trade Commission (“Commission”) has determined that
`
`there is a violation of Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. § 1337), in
`
`the unlawful importation, sale for importation, or sale within the United States after importation
`
`by Jennewein Biotechnologie GmbH (“Jennewein” or “Respondent”) of certain 2’-fucosyllactose
`
`oligosaccharides that infringe one or more of claims 1-3, 5, 8, 10, 12, 18, and 24-28 (“the
`
`Asserted Claims”) of U.S. Patent No. 9,970,018 (“the ’018 patent”).
`
`Having reviewed the record of this investigation, including the written submissions of the
`
`parties, the Commission has made its determination on the issues of remedy, public interest, and
`
`bonding. The Commission has determined that the appropriate form of relief includes a limited
`
`exclusion order prohibiting the unlicensed entry into the United States of 2’-fucosyllactose
`
`oligosaccharides manufactured abroad by or on behalf of, or imported by or on behalf of, Respondent
`
`or any of its affiliated companies, parents, subsidiaries, or other related business entities, or its
`
`successors or assigns. The exclusion order does not apply to Respondent’s TTFL12 bacterial
`
`strain and 2’-fucosyllactose oligosaccharides produced by that strain, which, as the Commission
`
`determined, do not infringe the Asserted Claims.
`
`The Commission has also determined that the public interest factors enumerated in 19
`
`U.S.C. § 1337(d) do not preclude the issuance of the limited exclusion order, and that the bond
`
`1
`
`

`

`during the period of Presidential review shall be in the amount of five (5) percent of the entered
`
`value of the covered articles.
`
`Accordingly, the Commission hereby ORDERS that:
`
`1.
`
`2’-fucosyllactose oligosaccharides that infringe one or more of the Asserted
`
`Claims that are manufactured abroad by or on behalf of, or imported by or on behalf of,
`
`Respondent, or its affiliated companies, parents, subsidiaries, or other related business entities, or
`
`its successors or assigns (“covered articles”), are excluded from entry for consumption into the
`
`United States, entry for consumption from a foreign-trade zone, or withdrawal from a warehouse
`
`for consumption, for the remaining term of the ’018 patent, except under license of the patent
`
`owner or as provided by law.
`
`2.
`
`This Order does not apply to Respondent’s TTFL12 bacterial strain and
`
`2’-fucosyllactose oligosaccharides produced by that strain, which, as the Commission
`
`determined, do not infringe the Asserted Claims.
`
`3.
`
`Notwithstanding paragraph 1 of this Order, covered articles are entitled to entry
`
`into the United States for consumption, entry for consumption from a foreign trade zone, or
`
`withdrawal from a warehouse for consumption, under bond in the amount of five (5) percent of
`
`the entered value of the infringing products pursuant to subsection (j) of section 337 of the Tariff
`
`Act of 1930, as amended (19 U.S.C. § 1337(j)), and the Presidential Memorandum for the United
`
`States Trade Representative of July 21, 2005, (70 FR 43251), from the day after this Order is
`
`received by the United States Trade Representative, and until such time as the United States
`
`Trade representative notifies the Commission that this Order is approved or disapproved but, in
`
`any event, not later than sixty (60) days after the date of receipt of this Order. All entries of
`
`2
`
`

`

`covered articles made pursuant to this paragraph are to be reported to U.S. Customs and Border
`
`Protection (“CBP”), in advance of the date of the entry, pursuant to procedures CBP establishes.
`
`4.
`
`At the discretion of CBP and pursuant to the procedures it establishes, persons
`
`seeking to import 2’-fucosyllactose oligosaccharides, that are potentially subject to this Order may
`
`be required to certify that they are familiar with the terms of this Order, that they have made
`
`appropriate inquiry, and thereupon state that, to the best of their knowledge and belief, the
`
`products being imported are not excluded from entry under paragraph 1 of this Order. At its
`
`discretion, CBP may require persons who have provided the certification described in this
`
`paragraph to furnish such records or analyses as are necessary to substantiate this certification.
`
`5.
`
`In accordance with 19 U.S.C. § 1337(l), the provisions of this Order shall not
`
`apply to 2’-fucosyllactose oligosaccharides that are imported by or for the use of the United
`
`States, or imported for and to be used for, the United States with the authorization or consent of
`
`the Government.
`
`6.
`
`The Commission may modify this Order in accordance with the procedures
`
`described in Rule 210.76 of the Commission’s Rules of Practice and Procedure (19 C.F.R.
`
`§ 210.76).
`
`7.
`
`The Secretary shall serve copies of this Order upon each party of record in this
`
`Investigation and upon CBP.
`
`8.
`
`Notice of this Order shall be published in the Federal Register.
`
`
`
`
`
`
`
`
`3
`
`

`

`By order of the Commission.
`
`Issued: May 19, 2020
`
`Lisa R. Barton
`Secretary to the Commission
`
`4
`
`

`

`JX0003
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`
`May 16 2018
`
`THIS IS TO CERTIFY THAT ANNEXED HERETO IS A TRUE COPY FROM
`THE RECORDS OF THIS OFFICE OF
`
`US PATENT 9,970,018
`ISSUE DATE May 15 2018
`
`By Authority of the
`
`Under Secretary of Commerce for Intellectual Property
`
`and Director of the United States Patent and Trademark OfficeIM TARVER
`
`Certifying Officer
`
`GLYITC1120 0006195
`JX0003.0001
`
`

`

`JX0003
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`
`May 16 2018
`
`THIS IS TO CERTIFY THAT ANNEXED HERETO IS A TRUE COPY FROM
`THE RECORDS OF THIS OFFICE OF
`
`US PATENT
`9,970,018
`ISSUE DATE May 15 2018
`
`By Authority of the
`Under Secretary of Commerce for Intellectual Property
`and Director of the United States Patent and Trademark Office
`
`fl
`M TARVER
`
`Certifying Officer
`
`GLYITC1120 0006196
`JX0003 0002
`
`

`

`JX0003
`
`i
`
`I 1111111111111111
`
`11111 1111111111 1111111111
`11111 1111111111 111111111111111111
`US0099700 l 8B2
`
`02 United States Patent
`Merighi et al
`
`10 Patent No
`45 Date of Patent
`
`US 9,970,018 B2
`May 15 2018
`
`54
`
`BIOSYNTHESIS OF HUMAN MILK
`OLIGOSACCHARIDES IN ENGINEERED
`BACTERIA
`71 Applicant Glycosyn LLC Woburn MA US
`72 Inventors Massimo Merighi Somerville MA
`US John M McCoy Reading MA
`US Matthew Ian Heidtman
`Brighton MA US
`73 Assignee Glycosyn LLC Woburn MA US
`Notice
`to any disclaimer the term of this
`is extended or adjusted under 35
`US C 154b by O days days
`disclaimer
`
`Subject
`
`patent
`
`This patent
`
`is subject
`
`to a tenninal
`
`21 Appl No 151712,074
`Sep 21 2017
`22 Filed
`65
`
`Prior Publication Data
`
`US 2018 0080034 Al
`
`Mar 22 2018
`
`Related US Application Data
`60 Continuation of application No 15 442,131 filed on
`Feb 24 2017 which is a continuation of application
`No 14 033,664 filed on Sep 23 2013 now Pat No
`9,587,241 which is a division of application No
`filed on Feb 16 2012 now Pat No
`13 398,526
`9,453,230
`
`60
`
`Provisional application No 61 443,470 filed on Feb
`16 2011
`
`51
`
`Int Cl
`C12P 19118
`C12N 15170
`C12P 19126
`C12P 19100
`C07H 13104
`C07H 3106
`C12N 9138
`C12N 9110
`Cl2N 9100
`52 U S Cl
`CPC
`
`2006.01
`2006.01
`2006.01
`2006.01
`2006.01
`2006.01
`2006.01
`2006.01
`2006.01
`
`C12N 15170 2013.01 C07H 3 06
`2013.01 C07H 13104 2013.01 C12N 9100
`2013.01 C12N 911051 2013.01 C12N
`912471 2013.01 C12P 19100 2013.01
`CJ2P 19118 2013.01 C12P 19126
`2013.01
`Y02P 20 52 2015.11
`
`58
`
`56
`
`Field of Classification Search
`Cl2P 19 18
`CPC
`See application file for complete search history
`
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`US PATENT DOCUMENTS
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`Glycoconjugate Journal 18 465474 2001
`
`Continued
`
`Rebecca E Prouty
`Primary Examiner
`74 Attorney Agent or Firm Mintz Levin Cohn Ferris
`Glovsky and Popeo PC Ingrid A Beattie
`engineering
`57
`ABSTRACT
`infection
`The invention provides compositions and methods for
`bacteria to produce
`oligosaccharides
`focosylated
`and the use thereof in the prevention or treatment of
`
`28 Claims 24 Drawing Sheets
`
`Copy provided by US PTO from the PIRS Image Database on 05 15 2018
`
`GLYITC1120 0006197
`JX0003.0003
`
`

`

`JX0003
`
`US 9,970,018 B2
`Page 2
`
`56
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`Copy provided by USPTO from the
`
`IRS Image Database on 05 15 2018
`
`GLY ITC1120 0006198
`JX0003.0004
`
`

`

`JX0003
`
`US 9,970,018 B2
`Page 3
`
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