UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`In the Matter of
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS
`OF PRODUCING THE SAME
`
`Inv. N0. 337-TA-1120
`
`ORDER NO. 35:
`
`GRANTING RESPONDENT JENNEWEIN BIOTECHNOLOGIE
`GMBH’S MOTION TO ADMIT EXHIBITS INTO EVIDENCE
`
`A
`
`(May 23, 2019)
`
`On May 21, 2019, and pursuant
`
`to Ground Rule 10.1.1, respondent
`
`Jennewein
`
`Biotechnologie GmbH (“Jennewein”) moved (1120-030) to admit a collection of exhibits, listed
`
`in an Exhibit A to the motion, into evidence afier the evidentiary hearing. The motion explains
`
`“[d]ue to a technical difficulty, the Exhibits were inadvertently not served upon Ace Federal” but
`
`were successfully served upon complainant Glycosyn LLC (“Glycosyn”),
`
`the Commission
`
`Investigative Staff (“Staff”), and my attorney-advisor on the last day of the hearing, May 17,
`
`2019.
`
`(Mot. at 1.) The motion describes the exhibits as having been admitted “through the
`
`direct testimony of Dr. Gregory Stephanopoulos, the cross examination of Dr. Kristala Prather,
`
`and deposition designations, which were not objected to by the parties.”
`
`(Id.) The motion
`
`represents “Glycosyn’s counsel and the Staff do not oppose the motion.” (Id.)
`
`For good cause shown, and in the absence of any opposition, Jem1ewein’s motion (1120
`
`030) is hereby granted. The exhibits listed in Attachment A to this order are received into
`
`
`
`Washington, D.C.
`
`In the Matter of
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS
`OF PRODUCING THE SAME
`
`Inv. N0. 337-TA-1120
`
`ORDER NO. 35:
`
`GRANTING RESPONDENT JENNEWEIN BIOTECHNOLOGIE
`GMBH’S MOTION TO ADMIT EXHIBITS INTO EVIDENCE
`
`A
`
`(May 23, 2019)
`
`On May 21, 2019, and pursuant
`
`to Ground Rule 10.1.1, respondent
`
`Jennewein
`
`Biotechnologie GmbH (“Jennewein”) moved (1120-030) to admit a collection of exhibits, listed
`
`in an Exhibit A to the motion, into evidence afier the evidentiary hearing. The motion explains
`
`“[d]ue to a technical difficulty, the Exhibits were inadvertently not served upon Ace Federal” but
`
`were successfully served upon complainant Glycosyn LLC (“Glycosyn”),
`
`the Commission
`
`Investigative Staff (“Staff”), and my attorney-advisor on the last day of the hearing, May 17,
`
`2019.
`
`(Mot. at 1.) The motion describes the exhibits as having been admitted “through the
`
`direct testimony of Dr. Gregory Stephanopoulos, the cross examination of Dr. Kristala Prather,
`
`and deposition designations, which were not objected to by the parties.”
`
`(Id.) The motion
`
`represents “Glycosyn’s counsel and the Staff do not oppose the motion.” (Id.)
`
`For good cause shown, and in the absence of any opposition, Jem1ewein’s motion (1120
`
`030) is hereby granted. The exhibits listed in Attachment A to this order are received into
`
`
`
`evidence. Jennewein shall be responsible for providing the court reporter with a copy of the list
`
`of admitted exhibits.
`
`SO ORDERED.
`
`Cameron Elliot
`Administrative Law Judge
`
`-2
`
`
`
`
`ATTACHMENT A
`
`ATTACH M ENT A
`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C..
`
`Before the Honorable Cameron Elliot
`Administrative Law Judge
`
`In the Matter of:
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AN
`D METHODS
`OF PRODUCING THE SAME
`
`Inv. No. 337-TA-1120
`
`RESPONDENT’S ADMITTED EXHIBIT LIST
`DIRECT EXAMINATION OF GREGORY STEPHANOPOULOS
`
`Exhibit No.
`
`Description
`
`Received Into Evidence
`
`CX-0014C
`
`CX-0027C
`
`CX-0029C
`
`CX-003 8C
`
`CX-0053C
`
`CX-0056C
`
`CX-0203C
`
`CX-0227C
`
`CX-0240C
`
`Samain patent applicationmsg - email from J. McCoy to G.
`Ruiz-Palacios 7/8/2008
`
`Massimo Merighi’s Lab Notebook MM02 (10/5/09
`12/10/09)
`
`Massimo Merighi’s Lab Notebook.MM04 (2/8/10 - 4/7/10)
`
`Massimo Merighi’s Lab Notebook MM25 (I2/I8/2014
`4/1/15)
`
`Glycosyn Lab Meeting lawyer data-complete slide set.pptx
`
`Glycosyn Lab Meeting l2_(]8_l6 Johnipptx
`
`Appendix C to Dr. Prather's Initial Expert Report - Germany
`Testing Data
`
`Excerpts of Lab book Sami Derya 2018 [certified translation]
`
`' Jennewein - #1540 construction and characterization
`confidential
`
`CX-025 2C
`
`E. coli BL21 (DE3) strain 1540_genome.fas
`
`
`
`CX-0253C
`
`20180323 Description of strain 1540 concerning insertion of
`genesresultidocx
`(StefanJenneweinEx. 10)
`
`CX-0260C
`
`R. Wheeler Notebook
`
`CX-0269C
`
`CX-0274C
`
`CX-0279C
`
`CX-0283C
`
`CX-0287C
`
`CX-0288C
`
`CX-0289C
`
`CX-0293C
`
`CX-0294C
`
`CX-0297C
`
`CX-0307C
`
`CX-0328
`
`CX-0334C
`
`CX-0335C
`
`CX-0336C
`
`Katja Parscbat’s Lab Book Part 1
`
`Jennewein, Stefan Deposition Exhibit No. 23
`20l809l8_KW38-18_Miller-assay_PF_24l0.xlsx [certified
`translation]
`
`Study l0Dl26352_DRAFT Final
`Report_l l 152018_reviewed.docx
`
`Mil|er_assay_lK_KW3 l+Ctrl.xlsx [certified translation]
`
`Beta Galactosidase Activity_Miller Assay_Battelle_l540 V
`derivative_vl .xlsx
`
`Raw Data_l 540
`
`Raw Data_l 540 Derivative
`
`Battelle Laboratory Record Book No 55174
`
`Beta Galactosidase Activity_Miller assay
`Battelle_l540_v2.xlsx
`
`Annex4 Discription Jennewein GMO for application
`
`Parschat, Katja Deposition Exhibit No. 2 - Detailed
`description of the construction of Jennwein's 2'-fucosyllactose
`production strain 1540
`
`Parschat, Katja Deposition Exhibit No. 21 - Drawing by Dr.
`Parschat
`
`Parchat, Katja Deposition Exhibit No. 25 - background of
`lacZ minus strains - data.xlsx
`
`Parchat, Katja Deposition Exhibit No. 26 - Background of
`lacZ minus strains - Conduction of the assays CW48.docx
`
`Parchat, Katja Deposition Exhibit No. 27 - Lab book Katja
`Parschat.pdf
`
`
`
`CX-0337C
`
`CX-(l338C
`
`CX-0339C
`
`CX-0340C
`
`CX-0342C
`
`CX-0343C
`
`CX-0344C
`
`CX-0345C
`
`CX-0346C
`
`CX-0347C
`
`CX-0389C
`
`CX-0390C
`
`CX-0391C
`
`CX-0392C
`
`CX-0393C
`
`Parchat, Katja Deposition Exhibit No. 2
`Parschat_cert.pdf
`
`8 - Lab book Katja
`
`Parchat, Katja Deposition Exhibit No. 2
`Parschat_EN.docx
`.
`
`9 - Lab book Katja
`
`Parchat, Katja Deposition Exhibit No. 3
`translation.docx
`
`0 - Katja Parschat
`
`Parchat, Katja Deposition Exhibit No. 3
`De1'ya.pdf
`
`1 - Lab book Sami
`
`Parchat, Katja Deposition Exhibit N0. 3
`Derya_EN.docx
`
`3 - Lab book Sami
`
`Parchat, Katja Deposition Exhibit No. 34
`translation_Labbook__Sami_P83-84.docx
`
`Parchat, Katja Deposition Exhibit No. 3
`T|'.iffers.pdf
`
`5 - Lab book Sina
`
`Parchat, Katja Deposition Exhibit No. 3
`Ti.iffers_cert.pdf
`
`6 - Lab book Sina
`
`Parchat, Katja Deposition Exhibit No. 3
`Tiiffers_EN.docx
`
`7 - Lab book Sina
`
`Parchat, Katja Deposition Exhibit No. 3
`tr-mslationdocx
`
`8 - Sina Tiiffers
`
`Howland, Carrie Deposition Exhibit No
`100126352_DRAFTFinal Report_l1l5
`
`. 4 - Study
`2018_reviewed.docx
`
`Howland, Carrie Deposition Exhibit N0
`schedule_v2.doc
`
`. 5 - Jennewein
`
`I-lowland, Carrie Deposition Exhibit No
`Record Book 10/9/2018
`
`. 6 - Howland Lab
`
`Howland, Carrie Deposition Exhibit No
`Derivative
`
`.7 - Raw Data_I 540
`
`Howland, Carrie Deposition Exhibit No
`Derivative_supplemental
`
`. 8 - Raw Data_1540
`
`
`
`CX-0394C
`
`CX-0422C
`
`CX-0431C
`
`RX-000 1
`
`RX-0002
`
`RX-0003
`
`RX-0004
`
`RX-0005
`
`RX-0006
`
`RX-0007
`
`RX-0008
`
`RX-0009
`
`RX-0010
`
`Howland, Carrie Deposition Exhibit No. 9 - Raw Data__l54O
`
`Emails regarding brief summary/suggestions - Fraunhofer
`IGB dated 6/ 15/18 [certified translation]
`
`Lab book Katja Parschat 2018.pdf [certified translation]
`
`Jennewein GRAS Notice (GRN) N04 57 I
`
`U.S. Patent N0. 7,521,212 (“Samain”)
`
`Lodish, H. et al, Molecular Cell Biology, 4th ed., W. H.
`Freeman Co. (2001)
`
`Zubay, G. Biochemistry, 2nd ed., Macmillan Pub. Co., (1988)
`
`Juers, D., et al, “LacZ [3-galactosidase: Structure and function
`of an enzyme of historical and molecular biological
`importance,” Protein Science 21: 1792-1807-2012
`
`Goehring et al., Similar to Those who are Breastfed, Infants
`Fed a Formula Containing 2’- Fucosyl lactose Have Lower
`Inflammatory Cytokines in a Randomized Controlled Trial, J.
`Nutr. 146 (12) 2559-2566 (2016)
`
`Marriage et al., Infants Fed a Lower Calorie Formula With 2'
`FL Show Growth and 2’-FL Uptake Like Breast-Fed Infants,
`JPGN 61: 649-658 (Marriage et al. -2015)
`
`Giacomini, et al., “Experimental conditions may affect
`reproducibility of the B-galactosidase assay,” FEMS
`Microbiology Letters, 100 (1992) 87-90
`
`Kalnins et al, “Sequence of the lacZ gene of Escherichia coli”
`(1983)
`
`Zell & Fritz, “DNA mismatch-repair in Escherichia coli
`counteracting the hydrolytic deamination of 5-methyl-cytosine
`residues” (1987)
`
`RX-001 l
`
`Ullman, Escherichia coli Lactose Operon, Encyclopedia of
`Life Sciences (2009)
`
`RX-0012
`
`GenBank Accession Number V00296 (Gl:41901)
`
`
`
`RX-0013
`
`RX-0014
`
`RX-0015
`
`RX-0016
`
`RX-0017
`
`RX-0018
`
`RX-0027
`
`RX-0028C
`
`RX-0029C
`
`RX-0030C
`
`RX-0031C
`
`RX-0032C
`
`RX-0036
`
`RX-0037
`
`RX-0038
`
`RX-0046
`
`RX-0047
`
`GenBank Accession Number M84410
`
`Kawano, et al., “Detection of low-level promoter activity
`within open reading frame sequences of Escherichia coli,”
`Nucleic Acids Research, 2005, 33:19, 6268-6276
`
`Drouillard, et al. “Large Scale Synthesis of H-Antigen
`Oligosaccharides by Expressing Helicobater pylori a1,2
`Fucosyltranferase in Metabolically Engineered Escherichia
`coli Cells,” Angew. Chem. 2006, 118, 1810-1812 _
`
`Geisser, et al. “Separation of lactose from human milk
`oligosaccharides with simulated moving bed chromatography
`Joumal of Chromatography A, 1092 (2005) 17-23
`
`W0 2010/ll5935
`
`EP 2845905
`
`Joint Technical Tutorial of the Parties, October 15, 2018
`
`Documents related to Jennewein and Battelle testing
`
`Documents related to Jennewein and Battelle testing
`
`Documents related to Jennewein and Battelle testing
`
`Documents related to Jennewein and Battelle testing
`
`Documents related to Jennewein and Battelle testing
`
`Glycosyn’s GRAS Notice (GRN 571)
`
`.
`
`Schaefer, J.-et al., “A data comparison between a traditional
`and the single-step B
`galactosidase assay,” Data in Brief 8, 350-352 (2016)
`
`NCBI Reference Sequence: NZ_CP032667.l, “Escherichia
`coli str. K-12 substr. MGl655
`chromosome, complete genome.”
`
`Davanloo et al., 1984
`
`Studier_Moffat 1996
`
`t
`
`
`
`RX-0056
`
`RX-0089C
`
`RX-0228
`
`RX-0235
`
`RX-0320C
`
`RX-0321C
`
`RX-03 26
`
`RX-0327
`
`RX-0328C
`
`RX-0329C
`
`RX-0358C
`
`RX-03 82
`
`RX-03 84C
`
`RX-0394C
`
`RX-0396
`
`RX-0397
`
`John McCoy Deposition, Ex. 5: Document entitled "GRAS
`Notification of Purified 2‘-Fucosyllactose, Food Usage
`Conditions for General Recognition of Safety on Behalf of
`Glycosyn LLC of the Wobum, Massachusetts and
`FrieslandCampina Domo B.B., Amersfoort, The Netherlands"
`
`Massimo Merighi Deposition, Ex. 27: Document entitled,
`"Strain and Plasmid Descriptions, Growth and Production
`Protocols,"
`
`Robert Wheeler Deposition, Ex. 7: Photograph
`
`CV of Gregory Stephanopoulos (Gregory Stephanopoulos
`Deposition, Ex. 4)
`
`Article written by Dr. Stefan Iennewein, et. al. regarding
`TTFL12 strain
`
`Email from Matthew Karambelas to Michael Bott, Jurlich
`regarding receipt of strains
`
`IBIS World Industry Report on Infant Nutrition
`
`Frost & Sullivan Report on HMO Opportunity Assessment
`
`Annex to Tech Transfer Agreement
`
`Annex to Tech Transfer Agreement
`
`Annex to Tech Transfer Agreement
`
`European Application No. 14 162 869.3
`
`Witness Statement of Gregory Stephanopoulos
`
`Drafl Battelle Report (Gregory Stephanopoulos, Ex.. 16)
`
`Declaration of John McCoy (Gregory Stephanopoulos, Ex..
`21)
`
`Declaration of John McCoy (Gregory Stephanopoulos, Ex..
`22)
`
`
`
`
`RX-0400
`
`RX-0401
`
`RX-0402C
`
`J.H. Miller, “Experiment 48 Assay of B-Galactosidase,”
`Experiments in Molecular Genetics, Cold Spring Harbor, NY
`(1972) 352-355
`
`Puccio et a]., Effects of Infant Formula With Human Milk
`Oligosaccharides on Growth and Morbidity: A Randomized
`Multicenter Trial, JPGN 64 (4) 624- 631-2017
`
`Complainant Glycosyn LLC’s Disclosure of Priority Dates
`and Dates of Conception/Reduction to Practice Under Ground
`Rule 7.1
`
`RX-0409C
`
`Rebuttal Witness Statement of Gregory Stephanopoulos
`
`RX-0431C
`
`RDX-0013
`
`Jennewein activity testing results
`
`Absorbance Diagram
`
`Demonstrative purposes
`only
`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`
`Before the Honorable Cameron Elliot
`Administrative Law Judge
`
`In the Matter of:
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS
`OF PRODUCING THE SAME
`
`Inv. N0. 337-TA-1120
`
`RESPONDENT’S ADMITTED EXHIBIT LIST
`CROSS EXAMINATION OF KRISTALA PRATHER (Infringement)
`
`Exhibit No.
`
`Description
`
`Received Into Evidence
`
`CX-0047C
`
`CX-0048C
`
`CX—0200
`
`CX-0203C
`
`CX-0240C
`
`CX-0243C
`
`CX-0253C
`
`Miller assay protocol_McCoy index cards.pdf
`
`Beta galactosidase assay.pdf
`
`Exhibit 4 to Dr. Prather's Expert Report - Declaration of K.
`Prather ISO Glycosyn‘s Initial Claim Construction Brief
`
`Appendix C to Dr. Prather's Initial Expert Report - Germany
`Testing Data
`
`Jennewein - #1540 construction and characterization
`confidential
`
`Annex 9 - Fermentation_pr0cess_3.2.pdf
`
`I
`
`20180323 Description of strain I540 conceming insertion of
`genes result_.d0cx (Stefan JenneweinEx. 10)
`
`CX-0260C
`
`R. Wheeler Notebook
`
`CX-0334C
`
`Parchat, Katja Deposition Exhibit No. 25 - background of
`lacZ minus strains - data.xlsx
`
`
`
`RX-U002
`
`RX-U008
`
`RX-0009
`
`RX-0014
`
`U.S. Patent No. 7,521,212 (“Samain”)
`
`Giacomini, et al., “Experimental conditions may affect
`reproducibility of the B-galactosidase assay,” FEMS
`Microbiology Letters, 100 (I992) 87-90
`
`Kalnins et al, “Sequence of the lacZ gene of Escherichia coli”
`(1983)
`
`Kawano, et al., “Detection of low-level promoter activity
`within open reading frame sequences of Escherichia coli,”
`Nucleic Acids Research, 2005, 33:19, 6268-6276
`
`RX-0027
`
`Joint Technical Tutorial of the Parties, October 15, 2018
`
`RX-0228
`
`RX-0321C
`
`Robert Wheeler Deposition, Ex. 7.:Photograph
`
`Email from Matthew Karambelas to Michael Bolt, Jurlich
`regarding receipt of strains
`
`
`
`
`$2
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`CERTAIN HUMAN MILK OLIGOSACCHARIDES AND
`METHODS OF PRODUCING THE SAME
`4
`
`INV. NO. 337-TA-1120
`
`-::~//.:
`
`PUBLIC CERTIFICATE OF SERVICE
`
`I, Lisa R. Barton, hereby certify that the attached Order No. 35 has been served by hand upon
`the Commission Investigative Attorney, Lisa Murray, Esq. and the following parties as
`indicated, on
`2 3 Zmg
`_____
`.
`_
`'~»=-»-~*',;‘*“~
`
`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`500 E Street SW, Room 112A
`Washington, DC 20436
`
`FOR COMPLAINANT GLYCOSYN LLC
`
`Michael C. Newman, Esq.
`MINTZ LEVIN COHN FERRIS GLOVSKY
`AND POPEO PC
`One Financial Center
`Boston, MA 02111
`
`) Via Hand Delivery
`(
`) Express Delivery
`(
`(,/f Via First ClassMail
`(
`) Other:
`~
`l
`
`FOR RESPONDENTJENNEWEIN BIOTECHNOLOGIE GmbH
`
`Gary M. Hnath, Esq.
`MAYER BROWN, LLP
`1999 K Street, NW
`Washington, DC 20006
`
`\
`
`) Via Hand Delivery
`(
`)
`xpress Delivery
`(
`( Q/\£/ia First Class Mail
`(
`) Other:
`
`.
`
`
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