Chemistry: molecular biology and microbiology – Apparatus – Including measuring or testing
Reexamination Certificate
2001-01-09
2002-07-30
Beisner, William H. (Department: 1744)
Chemistry: molecular biology and microbiology
Apparatus
Including measuring or testing
C435S288100, C435S808000, C422S105000, C356S440000, C356S442000, C356S246000, C073S864110
Reexamination Certificate
active
06426213
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates in general to devices and methods for quickly and inexpensively analyzing the impregnation potential, or fertility, of a sperm sample in a non-laboratory setting, and in particular to such devices and methods in which a user performs only a few simple mechanical steps to provide sperm input to a computerized module which automatically performs an analysis and provides a resultant figure of merit.
Over the past few decades, animals in general-from fish to humans-have demonstrated a substantial reduction in general fertility. In most species, the problem appears about equally in the male and the female partner. The decline has been attributed to pollution of the world's environment, global warming, contra-Darwinian medical practices, selection of desirable traits without regard for fertility, and many other factors. The reality of that decline is certain and has been measured worldwide, but its causes are unclear.
In species that are important to humans the decline is often our fault. Some food animals have been carefully bred to meet specific tastes of humans, but at the expense of fertility of that species. As examples, turkeys and chickens bred to maximize white-meat production do so at the demonstrable expense of fertility. Even pets and work animals, selected over many generations for appearance or performance characteristics, have seen significant deterioration of fertility. Subfertility in poultry, cattle, pigs, and other food animals creates at least a billion dollar annual loss worldwide.
Regardless of the species, there are several techniques by which a female partner can be checked for fertility, including physical examination, hormonal workups, egg harvests, and other testing, but there are only two measurement sets by which a male partner can be checked: “sperm count” and chemistry. By far the majority of subfertile males can be identified by characterizing their sperm count. It is extremely rare to discover a male with a chemical defect that is not accompanied by another problem identifiable by a sperm count. To determine “sperm count,” some form of magnification is used to increase the apparent size of the spermatozoa, or sperm cells, and then they are “counted” by a human or a computer. In some species there are more than one billion cells per milliliter. The fast-moving cells, therefore, are very small and difficult to quantify even with a microscope. Often, an optical grid is used to divide the sample into segments to facilitate accuracy. Whether by a human observer or a computer, the cells are counted to determine (1) the total number per unit volume, (2) the degree of motility, and sometimes (3) the general shape of the cells, or “morphology.” The result of a sperm count is usually a report that includes these factors plus others, such as volume, color, pH, etc., that may reflect the general health of the male. But the overwhelmingly important single measurement, in virtually all species, is the number of motile cells available to penetrate the egg. For the purpose of this document, “sperm count” refers to “healthy sperm count”: the concentration of cells capable of impregnating an egg.
As for treatment of subfertility, there are proven treatments by which the fertility of a female can be enhanced, including a spectrum of hormones; among food animals, certain veterinary drugs are available that work upon the female to increase the average litter size. But male fertility is another matter entirely. Regardless of species and despite the efforts of medical and veterinary sciences, only a very small percentage (<1-2%) of subfertile males have conditions which can be treated to increase sperm count. In almost all cases, and in all species, there is no successful therapeutic approach to male subfertility.
In typical food animals, there is competition among the males to mate with multiple females. A subfertile male that is otherwise dominant may seek to impregnate many females, driving away less dominant but potentially more fertile competitors. This results in poor reproductive performance of multiple females and becomes very expensive. In veterinary fertility medicine, particularly as it applies to food animals, subfertility has a direct and calculable impact. It is therefore most advantageous to be able to quickly and inexpensively measure the impregnation potential of the males in a food stock so that the subfertile males can be culled from the stock, leaving only the fertile males to compete for the females.
The prior art for determining the impregnation potential or fertility of a semen sample basically includes only computer assisted semen analysis (“CASA”), microscopy, a device called the Sperm Quality Analyzer (“SQA”) and biochemical assays performed in a laboratory and therefore inappropriate for real-time analysis in the field. CASA is achieved with a microscope, one or more video cameras, video image conversion hardware, a computer, and one or more displays. CASA systems have been developed by three companies, at prices ranging from $30,000 to more than $50,000. They are generally considered too expensive for even hospital clinical laboratories, and are certainly too costly for food animal breeders, e.g. chicken breeders. As for microscopy, a conventional laboratory microscope is used, usually in conjunction with a device that presses the sample into a very thin film against a finely etched grid to facilitate counting. This method is time consuming, expensive especially in terms of labor, and the results are subjective—based on a person's ability to count the density of spermatozoa in a unit volume.
The SQA is a computerized device that has been used by sperm banks, fertility clinics, and laboratories to measure certain characteristics of sperm. A sperm sample is drawn into a transparent capillary with precise internal dimensions. After a sample rises into the capillary, the carrier is inserted into an elongated slot wherein a calibrated light is directed by a fiberoptic conduit to illuminate a small segment of the capillary. At a side of the capillary opposite the light is a photosensors which senses the occurrence and frequency of very small perturbations in the light passing through the capillary. These perturbations, which are caused by movement of the sperm cells within the capillary, are converted to digital data and communicated to a computer. The computer applies a known algorithm to the data and produces a numerically expressed Sperm Motility Index (SMI) which is on an arbitrary scale which reflects overall sperm quality or relative fertility of the sperm samples. SMI values for humans range from 0 in complete asthenzoospermic azoospermic patients to over 160 SMI units in good quality sperm. It is essentially a measurement of the number of motile cells and the nature of their motility.
This invention uses some of the principles of the SQA (optically sensing motion of sperm within a certain amount of semen) to produce a fertility figure of merit, e.g. an SMI or similar datum, but overcomes many of the problems encountered by the SQA. Moreover it includes processes which are novel and unique over those used in the SQA. It also provides features not seen or known in connection with the SQA, for example, features which make this invention adaptable to unclean animal environments. In this regard, the SQA was designed for a laboratory environment and has serious problems with contamination of the slot into which the carrier is inserted to make a reading. Minute specks of dirt can easily get into the slot and cause erroneous readings, and the device has to be significantly disassembled to clean the slot. This invention is much less likely to be contaminated, and if so, it is quickly and easily cleanable. This invention also provides a plurality of portable measurement modules each pluggable into a case for charging and interfacing with at least a printer and display. Also, the SQA takes forty seconds to provide an SMI value because it performs its basic test four times for accuracy. This
Beisner William H.
Procopio Cory Hargreaves & Savitch LLP
Progeny Systems, LLC
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