IP Library Granted Patent US 12,514,922
Granted Patent B2
US 12,514,922 · App. 18/163,038 · Granted Jan 6, 2026

Recombinant non-pathogenic marek's disease virus constructs encoding infectious laryngotracheitis virus and infectious bursal disease virus antigens

Inventors: Stephanie Cook (Omaha, NE); Mohamad Morsey (Omaha, NE); Ian Tarpey (St. Ives, GB); Iwan Verstegen (Boxmeer, NL); Paulus Jacobus Antonius Sondermeijer (Boxmeer, NL); Paul Vermeij (St. Anthonis, NL)
Assignee: Intervet Inc.
A61K39/245A61P31/22C12N7/00A61K2039/5256A61K2039/552A61K2039/70
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,514,922
App. No.
18/163,038
Granted
Jan 6, 2026
Kind
B2
Abstract

The present invention discloses novel recombinant multivalent non-pathogenic Marek's Disease virus constructs that encode and express both Infectious Laryngotracheitis Virus protein antigens and an Infectious Bursal Disease virus protein antigen, and methods of their use in poultry vaccines.

Claims (20)

1 . A recombinant herpesvirus of turkeys (rHVT) comprising a nucleic acid that comprises a nucleotide sequence that encodes an Infectious Laryngotracheitis Virus glycoprotein D (ILTV gD), a nucleotide sequence that encodes an Infectious Laryngotracheitis Virus glycoprotein I (ILTV gI), and a nucleotide sequence that encodes an Infectious Bursal Disease Virus viral protein 2 (IBDV VP2); wherein the nucleic acid sequence is located in a nonessential site in the rHVT genome; and wherein the nonessential insertion site is selected from the group consisting of the US2 site and the UL54.5 site; wherein the nucleic acid is configured to be transcribed in the opposite direction relative to respectively, a US2 gene or a UL54.5 gene of rHTV.

2 . The rHVT of claim 1 , wherein the nucleotide sequence encoding the ILTV gD protein is operatively under the control of a first promoter, the nucleotide sequence encoding the ILTV gI protein is operatively under the control of a second promoter, and the nucleotide sequence encoding the IBDV VP2 protein is operatively under the control of a third promoter.

3 . The rHVT of claim 2 , wherein the first promoter is the endogenous ILTV gD promoter, the second promoter is the endogenous ILTV gI promoter, and the third promoter is the murine cytomegalovirus immediate early 1 gene (mCMV-IE1) promoter.

4 . The rHVT of claim 3 , wherein the ILTV gD comprises an amino acid sequence that has greater than 90% identity with SEQ ID NO: 2, the ILTV gI comprises an amino acid sequence that has greater than 90% identity with SEQ ID NO: 4, and the IBDV VP2 comprises an amino acid sequence that has greater than 90% identity with SEQ ID NO: 6.

5 . The rHVT of claim 4 , wherein the nonessential insertion site is the US2 site.

6 . The rHVT of claim 3 , wherein the nonessential insertion site is the US2 site.

7 . An immunogenic composition comprising the rHVT of claim 6 .

8 . An immunogenic composition comprising the rHVT of claim 5 .

9 . An immunogenic composition comprising the rHVT of claim 4 .

10 . An immunogenic composition comprising the rHVT of claim 3 .

11 . An immunogenic composition comprising the rHVT of claim 2 .

12 . An immunogenic composition comprising the rHVT of claim 1 .

13 . A vaccine comprising the immunogenic composition of claim 12 .

14 . A vaccine comprising the immunogenic composition of claim 9 .

15 . A vaccine comprising the immunogenic composition of claim 8 .

16 . A vaccine comprising the immunogenic composition of claim 7 .

17 . A method for aiding in the protection of a chicken against ILTV and IBDV comprising administering the vaccine of claim 16 .

18 . A method for aiding in the protection of a chicken against ILTV and IBDV comprising administering the vaccine of claim 15 .

19 . A method for aiding in the protection of a chicken against ILTV and IBDV comprising administering the vaccine of claim 14 .

20 . A method for aiding in the protection of a chicken against ILTV and IBDV comprising administering the vaccine of claim 13 .

Assignments (2)
CHANGE OF ADDRESS Recorded Sep 26, 2023
From: INTERVET INC.
To: INTERVET INC.
Reel/Frame 065028/0818 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 2, 2023
From: COOK, STEPHANIE; MORSEY, MOHAMAD; TARPEY, IAN; VERSTEGEN, IWAN; SONDERMEIJER, PAULUS JACOBUS ANTONIUS; VERMEIJ, PAUL
To: INTERVET INC.
Reel/Frame 062568/0846 →
Continuity (3)
Continuation 16309297
Provisional Application 62351471 · Jun 17, 2016
Related Publication 20240123057A1 · Apr 18, 2024
References Cited (93)
US 5187087A · Sondermeijer et al. · 1993 [cited by applicant]
US 5733554A · Audonnet et al. · 1998 [cited by applicant]
US 5830745A · Hock et al. · 1998 [cited by applicant]
US 5834305A · Cochran et al. · 1998 [cited by applicant]
US 5853733A · Cochran et al. · 1998 [cited by applicant]
US 5928648A · Cochran · 1999 [cited by applicant]
US 5961982A · Cochran · 1999 [cited by applicant]
US 5965138A · Cochran et al. · 1999 [cited by applicant]
US 5980906A · Audonnet et al. · 1999 [cited by applicant]
US 6121043A · Cochran et al. · 2000 [cited by applicant]
US 6183753B1 · Cochran et al. · 2001 [cited by applicant]
US 6299882B1 · Junker · 2001 [cited by applicant]
US 6875856B2 · Wild et al. · 2005 [cited by applicant]
US 6913751B2 · Cochran et al. · 2005 [cited by applicant]
US 8932604B2 · Cook et al. · 2015 [cited by applicant]
US 9114108B2 · Bublot et al. · 2015 [cited by applicant]
US 9409954B2 · Cook et al. · 2016 [cited by applicant]
US 9555016B2 · Makridakis · 2017 [cited by applicant]
US 9555096B2 · Bublot et al. · 2017 [cited by applicant]
US 9770502B2 · Bublot et al. · 2017 [cited by applicant]
US 10188720B2 · Esaki et al. · 2019 [cited by applicant]
US 10308956B2 · Verstegen et al. · 2019 [cited by applicant]
US 10323257B2 · Bublot et al. · 2019 [cited by applicant]
US 10655146B2 · Esaki et al. · 2020 [cited by applicant]
US 10813991B2 · Reddy et al. · 2020 [cited by applicant]
US 10822620B2 · Bublot et al. · 2020 [cited by applicant]
US 11058761B2 · Mebatsion et al. · 2021 [cited by applicant]
US 11123425B2 · Fujisawa et al. · 2021 [cited by applicant]
US 11229698B2 · Cook · 2022 [cited by examiner]
US 11596687B2 · Cook · 2023 [cited by examiner]
US 20080233146A1 · Sato · 2008 [cited by applicant]
US 20180163230A1 · Bublot et al. · 2018 [cited by applicant]
US 20210010033A1 · Bublot et al. · 2021 [cited by applicant]
US 20210386854A1 · Ameiss et al. · 2021 [cited by applicant]
CN 1472315A · 2004 [cited by applicant]
CN 103589693A · 2014 [cited by applicant]
CN 103874508A · 2014 [cited by applicant]
CN 103890183A · 2014 [cited by applicant]
EP 728842A2 · 1996 [cited by applicant]
EP 1026246A1 · 2000 [cited by applicant]
EP 1298139B1 · 2007 [cited by applicant]
EP 1801204B1 · 2011 [cited by applicant]
EP 2644702A1 · 2013 [cited by applicant]
EP 3041939B1 · 2019 [cited by applicant]
EP 3708670A1 · 2020 [cited by applicant]
JP 2015500631A · 2015 [cited by applicant]
RU 2593950C2 · 2016 [cited by applicant]
RU 2624037C2 · 2017 [cited by applicant]
WO 198704463A1 · 1987 [cited by applicant]
WO 199203554A1 · 1992 [cited by applicant]
WO 1996005291A1 · 1996 [cited by applicant]
WO 1998037216A1 · 1998 [cited by applicant]
WO 2000061736A2 · 2000 [cited by applicant]
WO WO2012052384A1 · 2012 [cited by applicant]
WO 2013057235A1 · 2013 [cited by applicant]
WO 2013057236A1 · 2013 [cited by applicant]
WO 2013082327A1 · 2013 [cited by applicant]
WO 2016102647A1 · 2016 [cited by applicant]
WO 2017216287A1 · 2017 [cited by applicant]
WO 2018112051A1 · 2018 [cited by applicant]
WO 2020127964A1 · 2020 [cited by applicant]
WO 2021257706A1 · 2021 [cited by applicant]
Afonso, et al., The Genome of Turkey Herpesvirus, Journal of Virology, 2001, 971-978, 75-2. [cited by applicant]
Bobrovskaya, Irina Vladimirovna, Antigenic Properties of Infectious and Thermoinactivated Vaccine Preparations of Marek's Disease Virus Strains, Shchyolkovo, Jan. 28, 2000 (Machine Translation), N/A. [cited by applicant]
Bobrovskaya, Irina Vladimirovna, Antigenic Properties of Infectious and Thermoinactivated Vaccine Preparations of Marek's Disease Virus Strains, Shchyolkovo, Jan. 31, 2000, N/A. [cited by applicant]
Dartiel, et al., Herpesvirus of Turkey Recombinant Viruses Expressing Infectious Bursal Disease Virus (IBDV) VP2 Immunogen Induce Protection Against an IBDV Virulent Challenge in Chickens, Virology, 1995, 481-490, 211. [cited by applicant]
Fuchs, et al., Molecular Biology of Avian Infectious Laryngotracheitis Virus, Veterinary Research, 2007, 261-279, 38. [cited by applicant]
Hao, X. et al., Research Progress in Herpesvirus of Turkey Vectored Avian Influenza Vaccines, China Poultry, 2015, 48-52, 37(21). [cited by applicant]
Hao, Xiaoli et al., Research Progress in Herpesvirus of Turkey Vectored Avian influenza Vaccines, China Poultry, 2015, 48-52 (Machine Translation), 37(21). [cited by applicant]
Johnson, et al., Protection Against Infectious Laryngotracheitis by i Ovo Vaccination with Commercially Available Viral Vector Recombinant Vaccines, Avian Diseases, 2010, 1251-1259, 54. [cited by applicant]
Kingham, et al., The Genome of Herpesvirus of Turkeys: Comparative Analysis with Marek's Disease Viruses, Journal of General Virology, 2001, 1123-1135, 82. [cited by applicant]
Murthy, et al., Pathogenesis of Marek's Disease: Effect of Immunization with Inactivated Viral and Tumor-Associated Antigens, Infection and Immunity, 1979, pp. 547-533, 26-2. [cited by applicant]
Petherbridge, et al., Cloning of Gallid Herpesvirus 3 (Marek's Disease Virus Serotype-2), Journal of Virological Methods, Nov. 17, 2009, 158. [cited by applicant]
Sondermeijer, et al., Avian Herpesvirus as a Live Viral Vector for the Expression of Heterologous Antigens, Vaccine, 1993, 349-358, 11. [cited by applicant]
Sun, et al., Protection of Chickens from Newcastle Disease and Infectious Laryngotracheitis with a Recombinant Fowlpox Virus Co-Expressing the F, HN Genes of Newcastle Disease Virus and GB Gene of Infectious Laryngotrac… [cited by applicant]
Tsukamoto, et al., Complete, Long-Lasting Protection Against Lethal Infectious Bursal Disease Virus Challenge by a Single Vaccination with an Avian Herepesvirus Vector Expressing VP2 Antigens, Journal of Virology, 2002,… [cited by applicant]
Van Zijl, et al., Regeneration of Herpesviruses from Molecularly Cloned Subgenomic Fragments, Journal of Virology, 1988, 2191-2195, 62-6. [cited by applicant]
Wild, et al., A Genomic map of Infectious Laryngotracheitis Virus and the Sequence and Organization of Genes Present in the Unique Short and Flanking Regions, Virus Genes, 1996, 107-116, 12-2. [cited by applicant]
Wu, et al., Molecular Detection and Differentiation of Infectious Bursal Disease Virus, Avian Diseases, 2007, 515-526, 51. [cited by applicant]
U.S. Appl. No. 16/309,297, filed Dec. 12, 2018. [cited by applicant]
United States Department of Agriculture, U.S. Veterinary Biological Product License No. 165A, issued Jan. 31, 2024 cited in Opposition Proceeding of European Patent No. 3471766 B1 (1 page). [cited by applicant]
United States Department of Agriculture, Summary of Studies Supporting USDA Product Licensure completed on Jan. 23, 2024 for U.S. Veterinary Biological Product License No. 165A cited in Opposition Proceeding of European… [cited by applicant]
Merck& Co., Inc., 2024, “Merck U.S. Patent Rights for Products” [retrieved on Aug. 14, 2024]. Retrieved from the Internet:<URL: https://www.merck.com/products/patent/> cited in Opposition Proceeding of European Patent N… [cited by applicant]
Genbank Accession No. AF291866.1, “Meleagrid herpesvirus 1 strain FC126, complete genome,” Jan. 25, 2001 (51 pages). [cited by applicant]
Gimeno et al., 2011, “Replication of recombinant herpesvirus of turkey expressing genes of infectious laryngotracheitis virus in specific pathogen free and broiler chickens following in ovo and subcutaneous vaccination,… [cited by applicant]
European Patent Office, Preliminary Opinion of the Board of Appeal dated May 13, 2022 issued in the Opposition-Appeal of European Patent Patent No. 3185899 B1 (10 pages). [cited by applicant]
Cook et al., 2024, “Innovax®-ILT-IBD: A Double Recombinant HVT-Based Vaccine for Protection Against IBDV and ILTV Plus Marek's Disease Virus,” Annual Meeting of the American Association of Avian Pathologists (AAAP), St.… [cited by applicant]
Summary of Product Characteristics, from the European Marketing Authorization for Innovax® ILT-IBD filed by the proprietor, Intervet International B.V. on Jan. 26, 2024 in Opposition Proceeding of European Patent No. 34… [cited by applicant]
European Pharmacopoeia 9.0, “Marek's Disease Vaccine (Live), ” Apr. 2013:0589, pp. 1073-1075, filed by the proprietor, Intervet International B.V. on Jan. 26, 2024 in Opposition Proceeding of European Patent No. 3471766… [cited by applicant]
European Pharmacopoeia 11.1, “Avian Infectious Laryngotracheitis Vaccine (Live),” Apr. 2023:1068, pp. 4601-4602, filed by the proprietor, Intervet International B.V. on Jan. 26, 2024 in Opposition Proceeding against Eur… [cited by applicant]
European Pharmacopoeia 11.1, “Avian Infectious Bursal Disease Vaccine (Live),” Apr. 2023:0587, pp. 4598-4600, filed by the proprietor, Intervet International B. V. on Jan. 26, 2024 in Opposition Proceeding against Europ… [cited by applicant]
European Medicines Agency, Summary of Opinion (initial authorisation) on Innovax® ILT-IBD dated Feb. 17, 2023 (2 pages). [cited by applicant]
Phenotypic and Genotypic Stability of HVT-IBD-ILT 134 Master Seed Virus following Successive Passage in Chicken Embryo Fibroblast Cells (APHIS Product Code No. 1J81.R0) abstract on stability test-results filed by the pr… [cited by applicant]