Chemistry: molecular biology and microbiology – Apparatus – Including measuring or testing
Reexamination Certificate
2001-11-05
2003-02-25
Redding, David A. (Department: 1744)
Chemistry: molecular biology and microbiology
Apparatus
Including measuring or testing
C435S288700, C435S287700, C436S111000, C422S086000
Reexamination Certificate
active
06524846
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to anti-terrorism, more particularly to anti-terrorism measures for safeguarding the mail, and most specifically to safeguarding the mail from transmission of bacterial biological agents including
Bacillus antracis,
i.e. anthrax.
2. General Background
The specific problem addressed herein first came to the attention of the public in early October 2001 when the first case of mail transferred anthrax infection became known which was only several weeks after the terrorist destruction of the world trade center in New York City on Sep. 11, 2001. In the second month following this it became publicly apparent that anthrax bacteria was being sent through the U.S. Mail as confirmed by the deaths of several U.S. Postal Service (U.S.P.S.) employees from anthrax infection. Anthrax is contracted by cutaneous contact or inhalation of spores.
Clostridium botulinum
is primarily contracted by ingestion. Bubonic plague is caused by a bacterium of the genus Pasteurella and is contracted by both cutaneous contact and inhalation as is
Mycobacterium tuberculosis.
All of these bacterial biological agents have been recognized as current or potential terrorist weapons readily deployed through the mail.
Smallpox has also been recognized as a potential terrorist weapon that could also be deployed through the mail but is a virus and although it has been decades since smallpox vaccinations were administered on a large scale the vaccine is known to be quite good, i.e. relatively benign and easily administered in a single step. Smallpox vaccine was administered to six and a half million people, virtually the entire population of New York City, in the last public outbreak of smallpox in the United States in 1947 with only a handful of deaths resulting from the vaccination and fewer deaths from the outbreak. The only known vaccine for anthrax, in contrast, is considered problematic. The vaccine has been known for several decades but was only approved by the Federal Drug and Food Administration during the time discussed above in which mail borne anthrax infection became publicly known.
The anthrax vaccination currently available is publicly known to contain impurities from which side effects result. The vaccination, moreover, is not accomplished in a single step but requires four different inoculations months apart from each other and hence cannot be readily administered to anyone in a relatively brief amount of time. It is considered that vaccinations, which in principle rely upon the development of antibodies by the human body in reaction to a very small amount of the biological agent addressed, are inherently better suited to guard against viral rather than bacterial infections. Bacterial infections are typically combated with antibiotics, which are ineffective against viruses, and viruses are typically combated with vaccination. Every late fall or early winter there is typically a new strain of influenza virus for which a vaccine is developed and administered to people requesting the same.
STATEMENT OF NEED
Anthrax is particularly virulent and lethal because by the time that infection is manifest antibiotics are relatively ineffective. Without either a vaccine which can be safely and readily administered to large numbers of people or diagnosis early enough to enable effective treatment with antibiotics it is considered that anthrax, and other similar biological agents which can be contracted by contact or inhalation, presents a very serious terrorist weapon readily deployed through the mail and therefore a poignant need exists for an effective means of preventing such infection by means of this vector.
SUMMARY OF THE INVENTION
Objects of the Invention
A primary object of the present invention is the prevention of transmitting bacterial biological agents including
Bacillus antracis,
i.e. anthrax, through the mail.
A first ancillary objective of the present invention is a system for ensuring that mail does not contain biological agents including
Bacillus antracis,
i.e. anthrax.
A first auxiliary objective of the present invention is a means of recognizing mail as containing biological agents including
Bacillus antracis,
i.e. anthrax, without opening that mail.
A second ancillary objective of the present invention is means of recognizing mail containing biological agents including
Bacillus antracis,
i.e. anthrax, before handling that mail.
A second auxiliary objective of the present invention is a quarantine means for placing mail in quarantine during transportation.
A third auxiliary objective of the present invention is a quarantine means for placing mail in quarantine during storage.
Principles Relating to the Present Invention
In achievement of the above stated objectives it is considered that packaging and containers for mail be equipped with means of indicating the presence of bacterial biological agents including
Bacillus antracis,
i.e. anthrax, within that mail. It is suggested that an acidic acid-base indicator compound which changes color, when neutralized by volatile bases including gaseous amines produced by live bacteria, be utilized for visual indication. The indicator compound must be in communication with the interior of the package or container but must be read from the outside without opening the package or container which must further provide an effective seal against leakage of any bacteria therein. Paper is sufficient to provide this seal if a full enclosure is obtained and plastic, metal, and other materials are perfectly satisfactory in providing a sufficient seal if a full physical enclosure is effected.
An otherwise conventional paper envelope with a substantially transparent clear panel with an indicator disposed interiorly thereupon is suggested for primary public use. The indicator preferably is made from acidic acid-base indicator solution having a pH of 2-5 disposed upon an appropriately porous substrate. A polymeric matrix, particularly including alkoxysilanes, is specifically recommended which is readily manufactured in thin sheets and readily adheres to paper and other plastics including glassine, Cellophane™, and polyethylene which are specifically suggested for the clear panel. But the substrate can be paper, cotton, string, or any moderately porous material of essentially neutral color which will not obscure the change in color of the indicator solution therein caused by pH neutralization resulting from exposure to gaseous amines produced by live bacteria. The change in color is substantially irreversible, reversal requires weeks in an amine free environment, and will occur in moderate ambient temperatures down to below freezing if an appropriate indicator solution is utilized.
The rate of response and detection sensitivity of the indicator solution is improved by use of non-volatile acids and other components including concentrated sulfuric acid,sulfamic acid, phosphoric acid, zeolites, alumina, polyacrylic acid and suphonated perfluoroethylene. Preferred acidic acid-base indicators include: halogenated xanthene dyes, e.g. Phloxine B, Rose Bengal; Erythorsins; sulphonated azo dyes, e.g. Congo Red, Metanil Yellow; and sulphonated hydroxy-functional triphenylmethane dyes, e.g. Bromophenol Blue, Bromocresol Green, Phenol Red. Satisfactory operation below freezing is considered to be highly desirable and substantial irreversibility of the color change is considered necessary.
With further regard to an envelope providing a visual indication of live bacteria therein it is considered that such envelopes, and all other mail packaging including boxes which are intended for use by the public in enclosing material to be mailed, further preferably possess a means of verifying authenticity which is preferably invisible to humans but machine readable. A thin film plastic with magnetically stored information is suggested as are other authenticity means commonly deployed upon currency. Electronic fingerprints or ‘watermarks’ read by scanning devices embedded in a plastic window t
Gibson Peter
Redding David A.
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