Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1999-07-06
2002-10-08
Priebe, Scott D. (Department: 1636)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C424S184100, C435S320100, C435S325000, C435S455000, C536S023100
Reexamination Certificate
active
06462027
ABSTRACT:
BACKGROUND OF THE INVENTION
Seafood and fishery products are currently very popular in the United States and around the world. Per capita consumption of fishery products in the United States increased 25 percent in the 1980s (Tucker and Robinson, 1990). In 1994, each American ate an average of 15.2 pounds of seafood, of which 54 percent was imported (Harvey, 1996).
Fishery products reach the table of the consumer from three major sources: commercial harvest of wild species, recreational harvest of wild species, and aquaculture. Growing public concern for the decline in commercially important wild fish stocks and steady demand for fishery food items has enabled aquaculture to become a rapidly emerging component of the United States agricultural industry. Compared with terrestrial food animal production industries, very little is known about the health management aspects of cultured aquatic food species, especially with regard to infectious disease.
Viral and bacterial diseases in fin-fish, shellfish or other aquatic lifeforms pose a serious problem for the aquaculture industry. Owing to the high density of animals in the hatchery tanks or enclosed marine farming areas, infectious diseases may eradicate a large proportion of the stock in, for example, a fin-fish, shellfish, or other aquatic lifeforms facility. Prevention of disease is a more desired remedy to these threats to fish than intervention once the disease is in progress. Vaccination of aquatic animals is the only preventative method which may offer long-term protection through immunity.
Vaccination with inactivated or attenuated organisms or their products has been shown to be an effective method for increasing host resistance to infection by various organisms. The use of vaccines is based on the stimulation of specific immune responses within a host or the transfer of preformed antibodies. Effective vaccines have been developed for relatively few of the infectious agents that cause disease in domestic and aquatic animals. This often reflects technical problems associated with the growth and attenuation of virulent strains of pathogens.
The fish immune system has many features similar to the mammalian immune system, such as the presence of B cells, T cells, lymphokines, complement, and immunoglobulins. Fish have lymphocyte subclasses with roles that appear similar in many respects to those of the B and T cells of mammals. Additionally, the efficiency of the immune response of fish can be affected by outside stresses, as is true in mammals. However, fish, unlike mammals, display a temperature-dependent development of protective immunity in response to antigens.
A. Development of DNA Vaccines
Effort recently has been placed on the development of subunit vaccines. A subunit vaccine consists of only limited components, most commonly proteins, of an infectious agent. Subunit vaccines have the potential for achieving high levels of protection in the virtual absence of side effects. Subunit vaccines also offer the opportunity for the development of vaccines that are stable and easy to administer.
A rapidly emerging variation of subunit immunization is genetic vaccination, also called DNA-mediated or plasmid vaccination. Genetic immunization uses naked DNA to immunize the recipient. The DNA is “naked” in the sense that it is free from any infectious delivery vehicle that can act to facilitate entry into the cell, such as viral particles. This approach is based on the finding that skeletal muscle cells injected with naked DNA are able to express the plasmid DNA-encoded proteins. The newly synthesized antigen can then stimulate a specific immune response composed of cytotoxic T cells, T-helper cells, and antibodies. Using such DNA vaccines, there is no longer a need to purify the pathogen or immunoprotective antigen for vaccination and no possibility of reversion to virulence because the DNA encodes a single viral protein.
DNA vaccines also overcome many of the subunit vaccine limitations, such as expensive production costs and poor immunogenicity, because they directly introduce only specific genes encoding protective proteins into the host and use the host cell protein synthesis machinery to produce the antigen in situ. Thus, immunization is accomplished by host cells taking up and expressing an inoculated polynucleotide. Moreover, genes that code for other proteins, such as regulatory molecules or hormones, can also be used to modulate the physiology of the target animal. Such proteins can also provide an anti-tumor response, or provide contraception.
The uptake of the DNA by host cells can result in the expression of a preselected antigen or antigens, thereby eliciting humoral or cell-mediated immune responses or both humoral and cell-mediated responses. The term “immune response” refers to a cytotoxic T cell response or increased serum levels of antibodies to an antigen. The term “immunizing” refers to the production of an immune response in a vertebrate which protects (partially or totally) from the manifestations of infection or disease caused by an infectious agent. That is, a vertebrate immunized with a DNA vaccine will not be infected or will be infected to a lesser extent than would occur without immunization.
The elicited humoral and/or cell-mediated immune response can provide protection or protective immunity against infection by pathogenic agents such as bacteria, viruses and eukaryotic organisms (e.g., parasites). The protective humoral and/or cell-mediated immune responses then interfere with the infectivity or activity of the pathogen, or limit its spread or growth, resulting in protection against subsequent challenge by the pathogen. The immune response may also combat diseases and disorders involving cells that produce specific proteins.
The DNA is expressed by the animal cells and appears to stimulate persistent humoral and/or cellular responses without integration of plasmid into chromosomal DNA. Direct DNA administration obviates the lengthy and costly requirement for purified antigens. Moreover, the resultant prolonged antigen production in vivo approximates the immune system response following immunization with a live, attenuated virus or live recombinant vaccine without the risk of infection or the necessity of adjuvants and boosters.
DNA immunization via intramuscular injection has been shown to be effective in various animals against many viruses. For example, the immunization of guinea pigs against herpes simplex virus (HSV) type 2 infection (Bourne et al. (1996)); the immunization of mice against influenza virus (Fu et al. (1997)); the vaccination of chickens against influenza viruses (Kodihalli et al. (1997)); and mammals and avians against rotaviruses (Herrmann et al. U.S. Pat. No. 5,620,896). Daheshia et al. (1997) disclose that a single application of naked DNA encoding IL-1 0 to the cornea of animals expressing herpetic stromal keratitis resolved the lesions affecting these animals, causing lesion remission.
Thus, DNA vaccination provides a novel method to induce both humoral and/or cell-mediated immunities. The simplicity of the technology, and its ability to induce antibody (Ab) and cytotoxic T-lymphocyte (CTL) responses in animals with different genetic backgrounds, and its preclinical efficacy in a variety of disease models suggest that DNA vaccination is a useful approach for vaccine development. Additionally, the ability of DNA vaccines to induce immune responses with non-replicating material offers an alternative to live vectors or pathogens for eliciting cell-mediated immunity for those instances where such agents may present potential safety concerns. Also, because the immune response that is generated is broad based, the immune response elicited by DNA vaccination is particularly effective to protect against pathogen infection or combat cells associated with hyperproliferative diseases or autoimmune diseases.
B. Direct DNA Immunization/Transfection Administered by Injection or Particle Bombardment
In the past, methods of transferring genes into live animals in vivo required either vi
Burnley Victoria Vaughn
Poet Steven E.
Kaushal Sumesh
Priebe Scott D.
Schwegman Lundberg Woessner & Kluth P.A.
University of Georgia Research Foundation Inc.
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