# US 12,364,744 B2 · Methods and compositions for the diagnosis, prophylaxis and treatment of Lyme disease > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,364,744 B2 - Document ID: US12364744B2 - Status: Granted - Kind: B2 - Application number: 17/534,970 - Filed: 2021-11-24 - Published: 2022-05-26 - Granted: 2025-07-22 - Earliest claimed: 2020-11-25 - Assignees: Lankenau Institute for Medical Research - Applicants: Lankenau Institute for Medical Research - Inventors: Sunil Thomas - Web page: https://patentgrep.com/patent/US12364744B2 ## CPC - A61K 39/0225: {Spirochetes, e.g. Treponema, Leptospira, Borrelia} - A61P 31/04: Antibacterial agents - G01N 33/56911: {Bacteria} - G01N 33/6893: {related to diseases not provided for elsewhere} - A61K 2039/521: {inactivated (killed)} - A61K 2039/53: {DNA (RNA) vaccination} - A61K 2039/54: {characterised by the route of administration} - A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59} - G01N 2333/20: from Spirochaetales (O), e.g. Treponema, Leptospira - G01N 2800/26: Infectious diseases, e.g. generalised sepsis - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract Reagents that include certain identified peptides derived from B. burgdorferi proteins, or nucleic acid sequences encoding same are useful in the diagnosis of Lyme borreliosis (Lyme Disease) in infected subject are disclosed herein. Such reagents can also include nucleic acid sequences encoding the peptides. Pharmaceutical compositions useful for the treatment or prophylaxis of B. burgdorferi infection include certain peptides derived from B. burgdorferi proteins, or nucleic acid sequences encoding same. Methods of treating or preventing Lyme borreliosis (Lyme Disease) include administering effective amount of such pharmaceutical compositions. An antibody independent prophylactic pharmaceutical composition comprises a sonicate of B. burgdorferi bacterium; and methods of treating or preventing Lyme borreliosis include administering effective amounts of that sonicate composition are also disclosed herein. ## Claims ### Claim 1 A reagent useful for the diagnosis of Lyme borreliosis in a subject comprising: i) a fusion protein of at least one outer surface protein consisting of: a) a peptide consisting of SEQ ID NO: 14; b) a peptide consisting of at least 90% identity to a peptide of SEQ ID NO: 14; or c) a peptide variant consisting of a sequence different in one or more conservative amino acids to a peptide of SEQ ID NO: 14; and ii) at least one additional outer surface protein of: (d) a peptide of SEQ ID NO: 10; (e) a peptide of SEQ ID NO: 11; (f) a peptide of SEQ ID NO: 12; (g) a peptide of SEQ ID NO: 13; (h) a peptide of SEQ ID NO: 14; (i) a peptide of SEQ ID NO: 15; (j) a peptide of SEQ ID NO: 16; (k) a peptide of SEQ ID NO: 17; (l) a peptide of SEQ ID NO: 18; (m) a peptide having at least 90% identity to a peptide of any of SEQ ID NO: 10 to 18; or (n) a peptide variant differing in one or more conservative amino acids to a peptide of any of SEQ ID NO: 10-18, wherein the at least one sequence of i) is not the same as the at least one sequence of ii). ### Claim 2 (depends on 1) The reagent of claim 1, wherein said fusion protein comprises a combination of at least 3, 4, 5, 6, 7, 8, 9, or 10 of said peptides (d)-(n). ### Claim 3 (depends on 1) A reagent useful for the diagnosis of Lyme borreliosis in a subject comprising at least two nucleic acid sequences that encode the fusion protein of claim 1. ### Claim 4 (depends on 3) The reagent of claim 3, wherein said fusion protein comprises at least 3, 4, 5, 6, 7, 8, 9, or 10 of said peptides (d)-(n). ### Claim 5 (depends on 1) The reagent of claim 1, wherein said peptides (a) to (n) are immobilized on an immobilization surface. ### Claim 6 (depends on 1) The reagent of claim 1, wherein said are covalently or noncovalently joined to a molecule or moiety capable alone or in combination with one or more additional molecules of generating a detectable signal. ### Claim 7 (depends on 1) The reagent of claim 1, wherein said composition comprises a fusion protein of 4 of said peptides (d)-(n). ### Claim 8 (depends on 1) A method of diagnosing Lyme borreliosis in a subject, comprising contacting in vitro a biological sample from the subject in with a reagent of claim 1; and detecting in said sample the presence of an antibody that binds one or more of said peptides. ### Claim 9 (depends on 8) The method of claim 8, wherein the biological sample is whole blood, plasma, serum, ascites fluid, peritoneal fluid or a tissue or fluid from a tissue or joint sample. ### Claim 10 (depends on 3) A pharmaceutical composition for the treatment, retardation, or prophylaxis of Lyme borreliosis comprising a pharmaceutically acceptable carrier, an excipient or adjuvant, and the reagent of claim 3. ### Claim 11 (depends on 10) The composition of claim 10, wherein said fusion protein comprises at least 3, 4, 5, 6, 7, 8, 9, or 10 of said peptides (d)-(n). ### Claim 12 (depends on 1) A pharmaceutical composition for the treatment, retardation, or prophylaxis of Lyme borreliosis comprising a pharmaceutically acceptable carrier, an excipient or adjuvant, and the reagent of claim 1. ### Claim 13 (depends on 12) The composition of claim 12, wherein said fusion protein comprises a combination of at least 3, 4, 5, 6, 7, 8, 9, or 10 of said peptides (d)-(n). ### Claim 14 (depends on 12) The composition of claim 12, wherein said peptides are covalently or noncovalently joined to a molecule or moiety capable alone or in combination with one or more additional molecules of generating a detectable signal. ### Claim 15 (depends on 12) The composition of claim 12, wherein said composition comprises a fusion protein of 4 of said peptides (d)-(n).