Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Reexamination Certificate
1997-03-05
2002-04-09
Swartz, Rodney P. (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
C424S009100, C424S009200, C424S184100, C424S201100, C424S202100, C424S203100, C424S204100, C424S211100, C424S215100, C424S221100, C424S828000, C424S829000
Reexamination Certificate
active
06368603
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to Lyme Disease (
Borrelia burgdorferi
antigen) compositions, especially combination compositions, and to methods of making and using the same, especially for veterinary uses. The compositions can include, in addition to a
Borrelia burgdorferi
antigen or antigens, an antigen for an additional pathogen, such as a canine, feline or equine pathogen, for instance an antigen from at least one of: rabies virus, canine distemper virus, adenovirus, corona virus, parainfluenza, parvovirus, FeLV, feline herpesvirus, equine influenza virus, equine herpes virus, and the like. The compositions advantageously induce an immunological response against Lyme Disease (
Borrelia burgdorferi
) infections, as well as against any other antigen in the composition, when administered to a host. The compositions elicit long-term immunity (response) against Lyme Disease
Borrelia burgdorferi
in animals, including horses and dogs, and afford protection or elicit immunological response in the animals. In combination compositions, there is an absence of efficacy interference.
The invention further relates to methods for making and using such compositions.
The invention additionally relates to the antibodies elicited by the compositions, isolated from an animal or cell culture as the case may be, which are useful for preparing a diagnostic kit, test or assay for the detection of a
Borrelia burgdorferi
antigen or Lyme Disease or another antigen of another pathogen or another pathogen.
BACKGROUND OF THE INVENTION
Lyme disease is a multisystem illness, transmitted by ticks of the
Ixodes ricinus
complex. The spirochaete
Borrelia burgdorferi
sensu lato is the aetiologic agent of Lyme disease, which is now the most common arthropod borne disease in the United States, and is endemic in Central Europe (Barbour et al., 1993). Although curable by antibiotic therapy in its early stages, if Lyme disease is allowed to progress, cardiac, neurological and joint abnormalities can arise. Investigations into the development of a human vaccine for Lyme disease are under way. The outer surface lipoprotein OspA of
Borrelia burgdorferi
is the current major candidate molecule for development of such a vaccine. Recombinant OspA lipoprotein (rOspA) is known to elicit a protective immune response in mice against challenge by infectious
B. burgdorferi
(Fikrig et al., 1990; Erdile et al., 1993; U.S. Ser. No. 08/373,455). OspA is currently undergoing human field trials as a subcutaneously administered vaccine in the United States (Keller et al., 1994).
Above-cited applications WO93/08299 and PCT/US92/08697 relate to recombinant OspA (rOspA) vaccines, especially lipidated rOspA, and methods for expressing DNA encoding OspA, and isolating the lipidated rOspA. Above-cited U.S. Pat. Nos. 5,582,990 and 5,523,089 and application WO 90/04411 relate to DNA encoding OspA, the amino acid sequence of OspA including rOspA and lipidated forms thereof, synthetic OspA including rOspA and lipidated forms thereof, compositions containing OspA or synthetic OspA, and methods of using such compositions. And, the other above-cited applications relate to DNA encoding other Borrelia antigens or other Osps, or to DNA encoding useful fragments of OspA or of other Osps, amino acid sequences thereof, compositions containing such fragments or other Osps, and methods for using such compositions. DNA from documents cited herein pertaining to
Borrelia burgdorferi
can be used in the methods of U.S. Pat. Nos. 5,582,990, and 5,523,089 or PCT/US92/08697 to produce OspA, other Borrelia antigens or Osps, or fragments thereof, for use in this invention. In regard to DNA and antigens useful in this invention, reference is also made to Molecular Microbiology (1989), 3(4), 479-486.
A particular problem in the art involves the infection of domesticated animals with
Borrelia burgdorferi
from tick bites. For instance, dogs and horses are susceptible to Lyme Disease due to tick bites, and their masters are unaware of the infection until it is too late (the tell-tale circular ring around the tick bite being undetected due to fur, and the dog or horse is unable to verbalize complaints such as sore joints, etc. from the infection, or due to masters not appreciating the subtle symptoms of the disease in animals). In addition, there is a concern about possible transmission to humans.
A further problem in the art involves vaccination strategies. More specifically, when vaccinating domesticated animals it is preferred to administer multiple antigens in one, “cocktail” or multivalent composition; for instance, to reduce the number of shots and number of visits to the veterinarian.
A Lyme Disease combination or “cocktail” or multivalent vaccine or immunological or immunogenic composition (
Borrelia burgdorferi
antigen in combination with other antigens in a composition, particularly for canines), is not presently available or known.
A still further problem in the art, especially as to multivalent composition, involves “efficacy interference”, namely a failure of one or more antigens, in a combination composition to maintain or achieve efficacy. This is believed due to interference on that antigen stimulating an immunological, antigenic, antibody, or protective response in the host, e.g., dog, when administered, because of the presence of the other antigens. For instance, rabies antigens in a combination with other antigens suffer interference from or interfere with the stimulation of an immunological, antigenic, antibody or protective response by those other antigens in such a composition, especially when that composition is administered to dogs. More particularly, antigens, such as rabies antigens and Leptospira antigens, when administered with one or more other antigens can interfere with the response elicited by those antigens. Indeed, Leptospira antigens can interfere with OspA. However, for other hosts, such as cats, combination vaccines are known. Perhaps, without wishing to be bound by any one theory, the “efficacy interference” is due to some peculiarity of the canine biological system or, to the reaction with the canine biological system by presently known antigens or, by the combination thereof.
Regardless of the theory, there is heretofore to the inventor's knowledge, no known Lyme Disease combination with other antigenic composition, especially for canine use, and which does not exhibit efficacy interference. There is a need for a Lyme Disease combination, especially for canine use. It would indeed be surprising, unexpected and non-obvious to be able to formulate a Lyme Disease combination (with other antigens) composition which exhibits a lack of efficacy interference in canines, especially because as shown by the present knowledge and efficacy interference, one cannot simply combine “antigen compositions” to prepare a useful combination or “cocktail” composition.
Additionally, it would be advantageous if such a Lyme Disease antigen cocktail composition provided long term protection for canines, as well as protection for pups with maternal immunity to Lyme Disease. As the skilled artisan is aware, maternal immunity is immunity that a newborn acquires from its mother upon birth and/or from nursing, which immunity, after a period of time, lapses in the newborn, thereby leaving the newborn susceptible. Furthermore, the presence of maternal antibodies in the newborn prevents the newborn from obtaining a protective response when administered an antigen composition, e.g., a vaccine, thus meaning that the newborn must enter a period of no or little immunity, i.e., susceptibility, to the danger of the newborn before administration of an antigen or vaccine composition can be considered. In regard to maternal immunity, reference is made to U.S. Pat. No. 5,338,683, issued Aug. 16, 1994 and incorporated herein by reference.
Thus, alternative vaccination strategies are desirable.
It would even be more advantageous, surprising and unexpected if the
Borrelia burgdorferi
antigen which can be used in a combination
Frommer William S.
Frommer & Lawrence & Haug LLP
Kowalski Thomas J.
Merial Limited
Swartz Rodney P.
LandOfFree
Lyme combination compositions and uses does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Lyme combination compositions and uses, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Lyme combination compositions and uses will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2820144