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Medical technology transfer: the inventor's perspective.

Technology transfer can be a difficult and frustrating experience for an inventor, one with a questionable outcome despite tremendous effort. A university-based inventor may find that there is a "technology transfer office" at his or her institution, but that it is poorly equipped to patent and license inventions. In such a case, the inventor may have to play a particularly active role in the patenting process and, especially, the marketing process. Furthermore, university-based inventors may find themselves caught up in issues of academic freedom and potential conflicts of interests. There are often no role models for entrepreneurial activity at a university, and as a result many inventors have had to leave their university positions to pursue financial gain from their inventions. When licensing inventions to companies, the "NIH syndrome" can be extremely frustrating. It is often difficult for the inventor to communicate his or her certain knowledge that the invention solves a specific problem perfectly. Also, an inventor may find that even if a company is interested and wishes to license the invention it may ultimately have little or no competence in the subject area and, as a result, the invention never finds its way to commercial production. Nonetheless, the rewards can be well worth the effort. If a successful license is reached and the device goes into production, there may be substantial personal financial reward for the inventor. If the university's patent policy is enlightened, a portion of the royalty income may support ongoing and future activities in the inventor's research laboratory.(ABSTRACT TRUNCATED AT 250 WORDS)

Medical Laboratory Science↗

Building a comprehensive geriatric health care system: a case study.

This case study focuses on the efforts of three urban medical care institutions--a Health Maintenance Organization, a nursing home, and a university hospital--to form an interorganizational relationship. The purpose of the relationship was to utilize the services of the three organizations in order to respond to the comprehensive health needs of an urban geriatric population. Movements in this triadic organizational relationship are described and analyzed in terms of four conceptual stages--exploration, negotiation, interaction and performance, and termination. Problems arising during these stages were not resolved and the relationship was terminated after approximately two years of existence. A sociological discussion of the case focuses on why the relationship failed. The organizational relationship was disrupted by three stresses that occurred during the four stages of the relationship. Stresses emerged for each organization in the areas of organizational integration, professional coordination, and environmental adaptation, making it difficult for the three to become integrated into an organizational system. As a result, the HMO, the nursing home, and the hospital did not benefit from relationships that could have enabled them to develop the multi-organizational system necessary to sustain an innovative, comprehansive geriatric health project. If, as Whitehead said, the greatest invention of the nineteenth century was the invention of the method of invention, the task of the succedding century has been to organize inventiveness. The difference is not in the nature of invention or of inventors, but in the manner in which the context of social institutions is organized for their support.

Aged↗

Patenting DNA.

The protection of inventions based on human DNA sequences has been achieved mainly through application of the patent system. Over the past decade, there has been continuing debate about whether this use of intellectual property rights is acceptable. Companies and universities have been active during this period in filing thousands of patent applications. Although many have argued that to claim a DNA sequence in a patent is to claim a discovery, patent law allows discoveries that are useful to be claimed as part of an invention. As the technology to isolate DNA sequences has advanced, the criterion for inventiveness, necessary for any invention to be eligible for filing, has become more difficult to justify in the case of claims to DNA sequences. Moreover, the discovery that a gene is associated with a particular disease is, it is argued, to discover a fact about the world and undeserving of the status of an invention. Careful examination of the grounds for allowing the patenting of DNA sequences as research tools suggests such rewards will rarely be justified. The patenting of DNA sequences as chemical intermediates necessary for the manufacture of therapeutic proteins is, however, reasonable given that the information within the sequence is applied to produce a tangible substance which has application as a medicine. Despite the legal, technical and political complexities of applying the flexibilities with the current law, it is argued that much could be achieved in the area of patenting DNA by raising the thresholds for patentability.

Animals↗

Sesquicentennial of the ophthalmoscope.

The year 2000 coincides with the 150th anniversary of the invention of the ophthalmoscope. In 1850, Hermann von Helmholtz (1821-1894) inaugurated the modern era in ophthalmology with his magnificent instrument, which has done more to revolutionize the development of ophthalmology than any other invention or discovery. Before Helmholtz's invention, it was not possible to visualize the posterior pole of the eye in a living subject. The ophthalmoscope permitted the clinical correlation of signs and symptoms with findings in the retina, vitreous, and optic nerve. The ophthalmoscope became the model for all forms of endoscopy that followed. It is often compared in importance with 2 earlier inventions, the telescope (17th century) and the stethoscope (early 19th century). All of these instruments made dramatic new information available to the human mind.

Germany↗

Patents in combi-space: patent challenges in combinatorial chemistry

Patent protection of inventions relating to combinatorial chemistry is attended by special challenges. The "breakthrough" nature of the field together with the always complex and often arcane chemical manipulations, apparatus, and strategies which suffuse this field make it difficult to describe the inventions adequately. It can be a challenge to communicate effectively with official authorities charged with patent examination. Extraordinary effort is called for in clarifying such inventions such that their patentability can be appreciated. The utility of some types of inventions in this field may be open to question; clear statements of at least one acceptable utility-even if only a minor utility-is beneficial. Because a principal product of many aspects of combinatorial chemistry is information, e.g., the identification of a lead compound, offshore "piracy" is a risk. Domestic claim tie-ins may improve the ability to abate such piracy. Copyright 1998 John Wiley & Sons, Inc.

Journal Article↗

Ethics and patentability in biotechnology.

The systems of patent rights in force in Europe today, both at the level of national law and on the regional level, contain general clauses prohibiting the patenting of inventions whose publication and exploitation would be contrary to "ordre public" or morality. Recent years have brought frequent discussion about limiting the possibility of patent protection for biotechnological inventions for ethical reasons. This is undoubtedly a result of the dynamic development in this field in the last several years. Human genome sequencing, the first successful cloning of mammals, and the progress in human stem cell research present humanity with many new questions of an ethical nature. Directive 98/44 of the European Parliament and of the Council of July 6, 1998, on the Legal Protection of Biotechnological Inventions created a new basis for patent protection in this field of technology. Based on the European experience to now, however, it must be said that patent law is not the right place to legislate the consequences of the morality of an invention.

Bioethics↗

[The nasopharynx and pharyngeal tonsil in the history of otology and rhinology. Pictures from the history of otorhinolaryngology, presented by instruments from the collection of the Ingolstadt Medical History Museum].

Anatomy, nomenclature, first clinical observations: In ancient Greece and Rome and in the Middle Ages the posterior opening of the nasal passage was known (Greek "choane" = funnel) as an atomical structure, and it was also known that chronic nasal catarrh is common in children, but it was not realized that this was associated with special pathological alterations. The anatomist H. von Luschka in Tübingen, Germany, was the first to describe the nasopharynx in detail, and he coined the term "pharyngeal tonsil." The otologists of the 19th century like Kramer and Toynbee had placed the Eustachian tube in the center of their investigations and carried out numerous dissections with demonstration of the tubal orifice. They also knew that middle ear infections usually originated in the nasopharynx, but they did not realize that the hypertrophic pharyngeal tonsil was the cause. Posterior rhinoscopy and the diagnosis of the hypertrophy of the pharyngeal tonsil: Czermak in Budapest in 1860 had invented posterior rhinoscopy, and he was the first to diagnose hypertrophic alterations around the tubal orifice and the first to realize that they were the cause of tubal malfunction. Wilhelm Meyer in Kopenhagen in 1868 and 1873-1874 described hypertrophy of the pharyngeal tonsil ("adenoid vegetations") in detail and associated this finding with a syndrome characterized by mouth-breathing, snoring, a typical facial expression, deafness, recurring middle-ear affections, and characteristic alterations of speech. He based his conclusions on 5 years' experience with 175 observations in his office and on examination of 2700 children in Denmark and England. Surgical therapy of adenoid vegetations: Voltolini in Breslau in 1865 had observed a few cases of hypertrophy of the pharyngeal tonsil, and he was the first to treat them by galvanic cauterization. Meyer developed various instruments for reducing the pharyngeal tonsil. They were introduced through the nose while the application of the instrument was assisted digitally via the mouth and pharynx. The operation of the pharyngeal tonsil was adopted very eagerly by a great number of nasal surgeons. Among the numerous special instruments that subsequently were invented the most promising was the ring knife invented by Gottstein in 1886. Anesthesia and positioning: The pioneers of this intervention, Voltolini, Meyer, Semon and others, all operated without any anesthesia, but they usually would need up to 12 sessions (Semon) until the pharyngeal tonsil had been sufficiently reduced. Beckmann in Berlin, who had invented a modification of Gottstein's ring knife, reported in 1897 on more than 5000 cases in which he had removed the adenoids in just one session, in each case without anesthesia. Besides these surgeons, others used cocaine for local anesthesia or chlorethyl or bromethyl for general anesthesia. The German surgeon Edmund Rose (Berlin and Zürich) in 1874 introduced the position with the head suspended for larger interventions like resection ot the maxilla. Rudloff in Wiesbaden, Germany, in 1900 adopted this position for adenoidectomy, but this was generally accepted only after the mouth gags developed by Davis-Boyle and Negus had been introduced. The diagnostic and surgical interventions in the nasopharynx were a powerful link in the process of fusion between otology and rhinolaryngology around the turn of the century. This historical development is described in great detail with many figures and quotations from the literature.

Adenoidectomy↗

Conceptual design of industrial process displays.

Today, process displays used in industry are often designed on the basis of piping and instrumentation diagrams without any method of ensuring that the needs of the operators are fulfilled. Therefore, a method for a systematic approach to the design of process displays is needed. This paper discusses aspects of process display design taking into account both the designer's and the operator's points of view. Three aspects are emphasized: the operator tasks, the display content and the display form. The distinction between these three aspects is the basis for proposing an outline for a display design method that matches the industrial practice of modular plant design and satisfies the needs of reusability of display design solutions. The main considerations in display design in the industry are to specify the operator's activities in detail, to extract the information the operators need from the plant design specification and documentation, and finally to present this information. The form of the display is selected from existing standardized display elements such as trend curves, mimic diagrams, ecological interfaces, etc. Further knowledge is required to invent new display elements. That is, knowledge about basic visual means of presenting information and how humans perceive and interpret these means and combinations. This knowledge is required in the systematic selection of graphical items for a given display content. The industrial part of the method is first illustrated in the paper by a simple example from a plant with batch processes. Later the method is applied to develop a supervisory display for a condenser system in a nuclear power plant. The differences between the continuous plant domain of power production and the batch processes from the example are analysed and broad categories of display types are proposed. The problems involved in specification and invention of a supervisory display are analysed and conclusions from these problems are made. It is concluded that the design method proposed provides a framework for the progress of the display design and is useful in pin-pointing the actual problems. The method was useful in reducing the number of existing displays that could fulfil the requirements of the supervision task. The method provided at the same time a framework for dealing with the problems involved in inventing new displays based on structured analysis. However the problems in a systematic approach to display invention still need consideration.

Data Display↗

The good enough calculi of evolving control systems: evolution is not engineering.

In evolved aggregates of accidentally invented elements, retained when statistically good enough to identify limitations of antecedent systems, survival value might favor operators incorporating aspects of, while not identical with, feedback, feedforward, state varible, and "homeostatic" control. Generally, simple organizational increments should predominate. After invention, an internal controller with readily modifiable rules could facilitate evolution of compound inventions, but criteria controlling rule changes would be only indirectly (probably imperfectly) survival referent. Consequent to combination of independent invention with indirect criteria and statistical acceptance, evolved control logic could be: both redundant and incomplete; good enough with malefic aspects; built of loosely linked or autonomous sublogics; and a source of good enough solutions from incomplete information. The partially explicit rules are defined more by rejections than by ratifications. Study of the result based on formal logic, engineering conventions, and familiar coordinate systems could conceive illegitimate illusions of understanding.

Biological Evolution↗

Patentability and maximum protection of intellectual property in proteomics and genomics.

The patenting of inventions in the proteomics and genomics fields has been prolific in the last few years and should continue in that vein for some years to come. The ingenuity by which inventions can be claimed increases so that even computerized methods for finding useful drugs based on the underlying genomic and proteomic information find their way into patents. However, with the increasing number of patents invalidated and the increasing number of exceptions to patent infringement; the value of new biotechnology patents is being whittled away. First, it may be hard to find potential infringers who improperly practice the claimed invention. Second, these potential infringers may practice in areas of the world where there is no patent protection. Third, the practice may be held by a court not to be infringing activity because it has as its aim the development of a new drug. Finally, the claims may be held invalid for lack of written description or enablement as the courts find mechanisms or reasons to narrow the allowable claims. With this setting, we must consider what can be done to best protect this new generation of inventive activity. Moreover, we must consider the possible demise of the drug pipeline should this trend to narrow protection continue.

Biotechnology↗

Patents for genetically modified animals.

Should genetically engineered animals be patented? This issue has been one of the most contentious as lawmakers have grappled with how best to protect intellectual property. Since the 1980 case of Diamond v. Chakrabarty, in which the U.S. Supreme Court ruled that a living microorganism is patentable, the U.S. Patent and Trademark Office has determined that plants and nonhuman animals can be patented. These policy decisions have led to congressional debate on whether animals should be patentable subject matter. Patenting of living organisms is unique for three reasons: the invention itself is alive; the invention in some instances can reproduce itself; and the invention sometimes cannot be adequately described for patent specification purposes, leading to the need for deposit of the invention for patent purposes.

Animals↗

When more is less: negative exposure effects in unsupervised learning.

In this article, two broad classes of models of unsupervised learning are compared: correlation tracking models, according to which learning is expected to increase monotonically with exposure to instances, and category invention models, which can accommodate specific violations of monotonicity (negative exposure effects). In two experiments, increasing the number of training instances had a negative rather than a positive effect on unsupervised learning, a clear violation of monotonicity. The results of these experiments are then compared with the predictions of two computational models, one a category invention model and the other a correlation tracking model. The category invention model was able to reproduce the qualitative pattern of results from the human data, whereas the correlation tracking model was not. Overall, these results provide strong evidence for the existence of a discrete category invention process in unsupervised learning.

Affect↗

[Patent protection in modern medical technology].

Inventions related to medical treatments and devices are due to specific regulations in the German, European and US patent Law much more difficult to obtain than inventions in the field of ordinary mechanics. In particular, inventions related to treatments of the human or animal body are excluded from patentability. In order to obtain at least some patent protection for such inventions the wording of the claims as well as the wording of the specification and preferred embodiments is very important. Patent protection is in most cases the only remedy to return the investment spent for the research. To maximize the possibility of patent protection in many countries, the timing of publication of the research result and filing of the patent application must be coordinated.

Equipment and Supplies↗

The triumph and tragedy of James Baxler Bean, MD, DDS (1834-1870).

In 1863, James Baxter Bean, a Southern physician and dentist, invented the interdental splint. This device was used to treat hundreds of Confederate soldiers who had received gun shot-related facial and jaw injuries during the Civil War. Made of vulcanized India-rubber, the splint provided a dramatic breakthrough in the treatment of maxillofacial wounds. In an Atlanta, Georgia hospital, Dr. Bean utilized his invention by establishing the first ward devoted exclusively to the treatment of jaw fractures. He also invented an apparatus that manufactured and administered nitrous oxide. Additionally, Bean's groundwork in casting aluminum as a denture base material led to Taggart's later invention (in 1907) of the casting machine. After the Civil War, Dr. Bean became a highly successful dentist, practicing in Baltimore, Maryland. In the fall of 1870, at age 36, Bean, representing the Smithsonian Institution in Washington, D.C., traveled to Europe to gather geological specimens. A short time after arriving, Bean decided to climb Mont Blanc with ten other men. The entire group perished in a raging 8-day snow storm on the mountain peak. This tragedy, a compelling drama, is legendary in the annals of mountaineering history. After Dr. Bean's passing, his wife lost her sanity and subsequently died. Later, the death of the couple's only child, Chapin, sadly ended the family line. Although his life was cut short, Bean's contributions to dentistry have been significant and far-reaching.

Anesthesia, Dental↗

Patenting nanotechnology.

Universities and companies are rushing to the patent office in record numbers to patent nanotechnology inventions. This rush to the patent office is so significant that many law firms have established nanotechnology practice groups and the U.S. Patent and Trademark Office has now created a new technology class designed to track nanotechnology products. Three big differences between the emerging science of nanotechnology and other inventions make the role of patents more significant in this arena than elsewhere. First, this is almost the first new field in a century in which the basic ideas are being patented at the outset. In many of the most important fields of invention over the past century--computer hardware, software, the Internet, even biotechnology--the basic building blocks of the field were either unpatented or the patents were made available to all users by government regulation. In others, patents were delayed by interferences for so long that the industry developed free from their influence. In nanotechnology, by contrast, companies and universities alike are patenting early and often. A second factor distinguishing nanotechnology is its unique cross-industry structure. Unlike other new industries, in which the patentees are largely actual or at least potential participants in the market, a significant number of nanotechnology patentees will own rights not just in the industry in which they participate, but in other industries as well. This overlap may significantly affect their incentives to license the patents. Finally, a large number of the basic nanotechnology patents have been issued to universities, which have become far more active in patenting in the last twenty-five years. While universities have no direct incentive to restrict competition, their interests may or may not align with the optimal implementation of building-block nanotechnology inventions. The result is a nascent market in which a patent thicket is in theory a serious risk. Whether it will prove a problem in practice depends in large part on how efficient the licensing market turns out to be.

Biotechnology↗

[A basic study on gallium alloys for dental restorations. Improvement of liquid gallium alloy].

This study was made to compare the physical and chemical properties of amalgam with those of gallium alloy in which the invented liquid alloy containing the three fundamental components of Ga-Sn-In or Ga-Sn-In-Ag were used instead of mercury. Experiment 1. The physical and chemical properties were investigated after the liquid gallium alloy and high copper amalgam powder were mixed. The following results were obtained; 1) The invented gallium alloy group showed expansion in dimensional changes immediately after mixing. This alloy group showed the same compressive and diametral tensile strength as those in amalgam after 7 days. 2) This alloy group showed slightly more corrosion weight loss in 0.05% HCl and 1% lactic acid solutions than that in amalgam, but this alloy group showed the same corrosion weight loss in 1% NaCl solution and artificial saliva as in amalgam. Also this alloy group showed more discoloration (delta E, NBS) in 0.1% Na2S solution than that in amalgam, but this showed the same degree of discoloration in artificial saliva. Experiment 2. The physical and chemical properties were investigated after the same liquid gallium alloy and Ag-Pd-Sn-Cu-Zn alloy powder were mixed. The following results were obtained; 1) The invented gallium alloy group showed expansion in dimensional changes immediately after mixing. This showed superior quality in compressive and diametral tensile strength as compared with those of amalgam. 2) The invented gallium alloy showed slightly more corrosion weight loss in 0.05% HCl and 1% lactic acid solutions than that in amalgam, but this alloy group showed the same corrosion weight loss in 1% NaCl solution and artificial saliva as in amalgam. Also this alloy group showed more discoloration (delta E, NBS) in 0.1% solution than that in amalgam, but it was the same in artificial saliva.

Dental Alloys↗

The "automatic stabilizer" and angle of attack assessor: human factors contributions of the Wright brothers.

The Wright brothers followed their invention of the first practical airplane (1903) with a second epochal invention, the angle of attack sensor and aircraft stabilizer (1908). Both inventions were patented and details of each are contained in the respective patents for these two aeronautical advances. This paper emphasizes how the angle of attack sensor actuated an "automatic stabilizer." This approach decreased pilot workload, and variations of the Wright's invention are incorporated today in many types of aircraft.

Aircraft↗

[Patents on life? No patent on life!].

Inventions related to living material are in principle patentable as well as inventions in the "classical" fields of technology as long as they are new, industrially applicable and involve an inventive step. A patent gives to its owner for a limited period of time the exclusive right to prevent others from using his patented new technical know-how. Starting point of patent protection in the field of genetic engineering is a genetic information or a genetically induced characteristic of an organism; there is no such thing as a "Patent on Life". As far as inventions relate to genetically modified organisms, patents give to their owners no additional property rights that might exclude the applicability e.g. of the laws on animal protection. Intellectual property like any other property is subject to the limits set up by law. It is neither scientifically correct nor does it help in finding a solution for the conflict within society to shift the--undoubtedly necessary--discussion about research and application in the field of genetic engineering to a discussion about patent law.

Animal Welfare↗