Between Knowledge And Technology: Patenting Methods,Rethinking Materiality

How does the law construe certain things and activities as knowledge that can become the object of intellectual property? When we look at the quantitative trends in recent patenting activities—more people patenting many more things—we tend to view that, in part, as an effect of the law's ability to construe new kinds of innovation (software, genetic sequences, etc.) in ways that conform to established legal concepts of patentable invention. The assumption is that what changes is not the shape of the box called invention, but the objects that are made to fit that box. But in fact while new technologies produce new innovations, the very concept of invention has not just expanded but undergone substantial qualitative change. The wave of inventive activity associated with the industrial revolution led to an unprecedented reliance on patenting, but as the law articulated ways to protect those inventions, it also took their emblematic form—the machine—as the template for the legal concept of invention. Analogously, the recent reinterpretations of patent law to enable the protection of living organism and biological entities have challenged and modified the traditional machine-inspired concept of invention, initiating a trend toward a more developmental one. The information-based inventions discussed here may elicit a reconceptualization of invention in yet another way.     

Patenting of hybridomas and genetically engineered microorganisms

Summary Many new technologies arrived at through basic research have practical applications. Two recent breakthroughs in microbiology, recombinant DNA techniques and hybridoma techniques, will permit designing cells for specific practical purposes resulting in new products or functions of commercial significance. The unique cell or its usefulness, or both, may satisfy the requirements of a patentable invention, i.e. an inventive act having utility and novelty. Ownership of such patents permits recovery of expenses incurred in the invention process and investment for all concerned in additional research. An integral part of the patenting process is submission of the new cell to an official repository, an outstanding example of which is The American Type Culture Collection.     

Intellectual property in natural sciences

The way from scientific finding through invention to production line and finally to the consument is long and expensive and patent should be taken into account. This is evident because the investment connected with the new application needs clear definition of intellectual property rights. Independently what we personally think about patenting in nature sciences--this is a common practice around the world. The positive and negative parameters of patenting are focus on biotechnology. The development of biotechnology is a cumulative effect of co-operation of several disciplines: biology, biochemistry, chemistry, engineering, genetics, medicines and pharmacy and many more. Between not cited here is law and consequently the needs of cooperation between researchers and lawyers. There are several barriers in this co-operation, for example: nomenclature as well as the way of thinking. These borders could be pass only with intercommunication and cross-understanding. The dialog and transfer of knowledge is a must for understanding the nomenclature, terminology of nature by lawyers and by researchers in case of law. Polish legislation concerning intellectually rights is regulated by the law "Prawo w?asno?ci przemys?owej" (30 June, 2000; Dz. U. 2003, Nr 119, pos. 1117, with later amendments). This legislation is related to European Union directives and Munich Convention. Accordingly patenting of product and process is possible in Poland. However, the procedure is time and money consuming, particularly in the case of patent submission in several countries. Amendment of the Polish law to biotechnology made possible patenting of living organism and their parts. It is worth to stress that patented inventions can be used free of charge for research and teaching.     

Genomic patenting and the utility requirement

This paper analyses the ways in which genomic knowledge is portrayed as useful knowledge in gene patenting in order to fulfil the ‘utility’/‘industrial applicability’ requirement for patentability. It gives examples of utility claims in gene patents and asks whether genomics (as opposed to genetics) changes our ideas about what is useful and what can be patented. It puts forward a provisional classification of different types of utility and argues that merely identifying the physiological function of a gene diverges radically from our commonsense understanding of what it is for an invention to be useful. Furthermore, social, political and ethical issues inevitably arise when discussing the utility requirement, because an invention cannot be useful in isolation from a social context.     

Genomic patenting and the utility requirement

This paper analyses the ways in which genomic knowledge is portrayed as useful knowledge in gene patenting in order to fulfil the 'utility'/'industrial applicability' requirement for patentability. It gives examples of utility claims in gene patents and asks whether genomics (as opposed to genetics) changes our ideas about what is useful and what can be patented. It puts forward a provisional classification of different types of utility and argues that merely identifying the physiological function of a gene diverges radically from our commonsense understanding of what it is for an invention to be useful. Furthermore, social, political and ethical issues inevitably arise when discussing the utility requirement, because an invention cannot be useful in isolation from a social context.     

Invisible genomes: the genomics revolution and patenting practice

In the mid-1990s, the company Human Genome Sciences submitted three potentially revolutionary patent applications to the US Patent and Trademark Office, each of which claimed the entire genome sequence of a microorganism. The patent examiners, however, objected to these applications, and after negotiation they were eventually re-written to resemble more traditional gene patents. In this paper, which is based on a study of the patent examination files, we examine the reasons why these patent applications were unsuccessful in their original form. We show that with respect to utility and novelty, the patent attorney's case built on an understanding of the genome as a computer-related invention. The patent examiners did not object to the patenting of complete genome sequences as computer-related inventions on moral grounds or in terms of the distinction between a discovery and an invention. Instead, their objections were based on classification, rules and procedure. Rather than patent examiners having a notion of a genome that should not be patented, the notion of a 'genome', and the ways in which it may be different from a 'gene', played no role in these debates. We discuss the consequences of our findings for patenting in the biosciences.     

Patently not obvious

Patenting a technology is an increasingly important issue for biometrics companies around the world. On the surface, the reason for obtaining a patent seems obvious: to register a unique invention and in doing so, to stop others from copying a design which may have taken years of dedicated work and investment to complete. In actual fact, patenting is a complex issue, which requires time, money and a clear idea of what the patent may achieve.     

Patentable invention in biotechnology

Biotechnology is a rapidly advancing field of technology which offers many benefits to society. It is perceived that an important part of maintaining the momentum, and stimulating further advances, is to protect inventions in biotechnology, where appropriate, with a patent. Here, from the perspective of invention in biotechnology, we examine in brief, the critical elements of proper subject-matter, novelty, utility, non-obviousness and sufficiency of disclosure, as requirements of patentable invention for both the United States and Canada. Topical issues which have arisen in respect of these elements are also canvassed briefly. As will be seen, Canadian Patent Law, while still unresolved with respect to the patenting of higher life forms, is in other respects in step with the pro-patent model of the United States.     

Smell intensity monitoring using metal oxide semiconductor odor sensors during intravenous olfaction test

The intravenous olfaction test using prosultiamine (PST) solution is simple to perform and has been used clinically in Japan. We monitored intranasal intensity of smell continuously in real time under various conditions of administration using metal oxide semiconductor odor sensors and established an optimal PST injection procedure. In this study, we found that 1) although there was fluctuation in the pattern of intensity of increase in smell in the PST original solution test, the pattern of increase in intranasal smell intensity could be stabilized by prolonging the injection time to 40 s and 2) dilution of PST with physiological saline was effective in preventing angialgia during intravenous injection. It appears that PST administration is best performed by adding 10 ml of saline to 10 mg (2 ml) of PST and injecting the resulting 12-ml solution (6x dilution) and that the best respiratory cycle for testing is once in every 2 s.     

The occupational meaning of smell

The sense of smell has its meaning for a successful performance of certain occupations. It has further a protective meaning. The acuity of smell often changes for different reasons. The prolonged or repeated smelling is combined with the process of smell adaptation, fatigue and habituation. They diminish the flavour sensations and increase the risk of work accidents. Some chemical compounds are characterized by a quick and high adaptation. The occupational changes of smell can be peripheral or central. The qualitative changes of the smell perception are numerous, but they have little sense in industrial hygiene. The hypersensibilisation can be temporal or lasting, where a change of profession is sometimes inevitable. The values of smell thresholds (detection, recognition, distinction) of 25 substances are given. The sensitivity of smell is greater at the smell threshold concentrations. The smell thresholds are put among the main basic properties of chemical compounds which decide about the values of MAC and about the possibilities of their passing over. 68 substances ranged according to their basic characteristics in three groups were studied. There was statistical dependence between the molecular weight, the boiling point, smell thresholds of detection and recognition. In two groups of matters there was a dependence between the threshold of irritation and the smell threshold of recognition and distinction. The regression was linear with the majority of dependencies.     

A self-administered odor identification test procedure using the "Sniffin' Sticks"

Assessment of smell function in clinical routine is often limited due to a lack of time and/or costs of the personnel administering the test. The aim of the present study was to validate a procedure allowing for self-administered olfactory testing in a clinical setting. Seventy-four healthy subjects (13 male, 61 female) from 18 to 30 years of age (mean 20.3 years) were tested on 2 days (interval 7-21 days, mean 8.7 days) with 16 odors of the "Sniffin' Sticks" identification test kit. On one occasion, the test was administered by an examiner. On another occasion, subjects administered the test to themselves, with the odors being identified after they had been "painted" on a sheet of paper. No significant differences were obtained between the results from both test procedures. With a maximum score of 16, assisted testing yielded a mean score of 13.7 [standard deviation (SD) 1.3] while the self-administered procedure yielded an average score of 13.8 (SD = 1.5) (P = 0.72). The mean difference between the assisted and the self-administered smell test procedures was 0.05 (SD = 1.28). The 95% confidence interval of differences ranged from -2.51 to 2.61. These results suggest that odor identification with the Sniffin' Sticks can also be administered by the subjects themselves.     

植物腺体的萜类代谢工程

植物所产生的气味都是从其表皮细胞特化形成的特定结构中即毛状体释放出来的。这些气味一般都是属于次生代谢过程中的单萜类化合物。产生这些气味目前认为是通过细胞质和细胞质体两种途径来合成的。而关于合成这些气味的基因调控以及基因转化工程都有了初步的研究及探索,并取得了一定的进展。     

Development of a smell identification test using a novel stick-type odor presentation kit

The odor identification is strongly influenced by the social and cultural factors; therefore, the odorants used in a smell identification test should be familiar to the test population. In addition, the device used in the test is desired to be simply handled and retain odor quality over time. We developed a novel stick-type odor presentation kit that consists of microcapsules of odorant incorporated into stable cream and the smell identification test using it. Thirteen odorants were selected to be familiar to the test population. In the test, we used two identification methods: one was a modified forced-choice paradigm with "detectable but not recognizable" and "no smell detected" added as choices and the other was a two-step identification paradigm where the participant first selected one of eight odor categories and then chose the specific odor name from the selected category. We verified the performance of the odor stick and the test by stability, using a test-retest paradigm, comparing this test with another smell test, and testing Japanese people from a range of age groups. We conclude that this kit is a useful odor presentation device, and the test using it works effectively as a smell identification test.     

无腥味大豆种质创新与利用

大豆是植物油和植物蛋白的主要来源,但大豆蛋白中含有3种结构不同的脂肪氧化酶同功酶,是产生豆腥味的根源,使大豆利用及加工受到限制。从1994年开始我们进行大豆脂氧酶缺失基因的转育与种质创新研究,目前获得了一批综合农艺性状优良的低腥味材料,其中绥无腥豆1号已于2002年3月通过黑龙江省农作物品种审定委员会审定,并开始应用于生产和加工领域。     

A polymorphism of the ability to smell urinary metabolites of asparagus.

The urinary excretion of (an) odorous substance(s) after eating asparagus is not an inborn error of metabolism as has been supposed. The detection of the odour constitutes a specific smell hypersensitivity. Those who could smell the odour in their own urine could all smell it in the urine of anyone who had eaten asparagus, whether or not that person was able to smell it himself. Thresholds for detecting the odour appeared to be bimodal in distribution, with 10% of 307 subjects tested able to smell it at high dilutions, suggesting a genetically determined specific hypersensitivity.     

Patenting in biotechnology: a review of the 20th Symposium of ECB8

The patenting of biotechnological inventions is practically in harmony with the general requirements of patent protection. It stands still in the foreground of interests since this is the only technical field where the living material itself may be the subject matter of patents. In consequence ethical problems have arisen first of all in the patenting of human cells and genes in which there is no agreement between R&D firms, patent offices and green movements. This has called for the elaboration of special Directives. On the other hand, patent systems are instrumental in safeguarding biodiversity. This review gives a picture of the patenting situation in biotechnology in the European Patent Office and in Hungary, the host country of the Congress. It also gives practical advice to biotechnological researchers on how to draft the applications and to observe the time limits, as well as on the necessity and possibilities of the deposit of microorganisms.     

The influence of the molecular basis of resistance on insecticide discovery

This paper focuses on the process of invention and development of new insecticides and the impact of current research in resistance mechanisms on that process. The topic is introduced in the context of (i) the critical need to develop new insect-control agents to ensure a continued supply of high-quality food and fibre; (ii) how resistance development will continue to influence the potential to ensure the supply of these essentials; and (iii) why new insect-control technology is welcomed by growers. The main section of the paper describes a generic agrochemical invention process and discusses the impact that an understanding of the molecular basis of resistance will have on the various stages of this process, using specific examples to illustrate these points. By focusing on insecticide invention, this paper provides a context in which other information more specific to insecticide resistance from this issue can be understood.     

Led by the nose: Olfaction in primate feeding ecology

Olfaction, the sense of smell, was a latecomer to the systematic investigation of primate sensory ecology after long years in which it was considered to be of minor importance. 1 This view shifted with the growing understanding of its role in social behavior 2 and the accumulation of physiological studies demonstrating that the olfactory abilities of some primates are on a par with those of olfactory‐dependent mammals such as dogs and rodents. 3 , 4 Recent years have seen a proliferation of physiological, behavioral, anatomical, and genetic investigations of primate olfaction. These investigations have begun to shed light on the importance of olfaction in the process of food acquisition. However, integration of these works has been limited. It is therefore still difficult to pinpoint large‐scale evolutionary scenarios, namely the functions that the sense of smell fulfills in primates’ feeding ecology and the ecological niches that favor heavier reliance on olfaction. Here, we review available behavioral and physiological studies of primates in the field or captivity and try to elucidate how and when the sense of smell can help them acquire food.     

George N. Papanicolaou (1883-1962): Fifty years after the death of a great doctor, scientist and humanitarian

Fifty years have passed since the death of Dr George Nicholas Papanicolaou, who was born in Kyme at the island of Euboea in Greece in 1883 and became known for his innovative revolutionary invention of the Pap smear test performed at the Cornell University Medical College in the USA. To date, even after the introduction of HPV vaccination into the clinical practice, Dr George Papanicolaou's method remains an essential component of the prevention strategy against cancer and has resulted in a 70% decrease in cervical cancer mortality over the last 60 years. This article, which presents briefly his biography, is dedicated to him on the occasion of the 50th anniversary of his death.