ESTs under Canadian Patent Law: Useful or Not?

The following discussion will examine the utility requirement for patentability in the context of EST patents. Part I will provide background information regarding the utility requirement under patent law and will explain why it has been difficult to apply to ESTs. Part II will briefly examine how other jurisdictions, in particular the United States, have addressed the difficul- ties associated with applying the current utility require- ment to biological materials, in particular ESTs. Part III will look at how Canadian courts have interpreted and applied the utility requirement for patentability, and will suggest that ESTs have sufficient value to the scientific community to satisfy this requirement. In addition, it will examine how the doctrine of sound prediction may allow patent protection to be extended beyond the simple EST nucleotide sequence. This article will conclude by suggesting two reasons why the utility criterion for patentability has proven difficult to apply to human genetic materials. The patenting of human genetic materials, including ESTs, raises a number of concerns apart from the question of whether they meet the utility requirement under patent legislation. Not only are there legal concerns in terms of whether such ‘‘inventions’’ are patentable subject-matter and whether they satisfy the requirements of novelty and non-obviousness, but there are also important moral concerns. While all of these issues are clearly related and not completely separable, an examination of their intersection is beyond the scope of this article

Cultural Adaptation of the Evaluation in Ayres Sensory Integration® (EASI) for Spanish-Speaking Populations

[Abstract] Importance: Spanish-speaking populations represent a significant percentage of occupational therapy clientele globally. Culturally appropriate Spanish translations of assessments are therefore imperative. This study describes the process of a culturally adapted translation of a set of tests for use with Spanish-speaking pediatric populations. Objective: To produce a culturally adapted Spanish translation of the Evaluation in Ayres Sensory Integration® (EASI) for international use. Method: We used cultural adaptation methodology that included direct and back translations of the EASI by bilingual translators and interviews with pediatric occupational therapists and children ages 3–6 yr from Spain. Linguistic experts helped revise the translations, and pediatric occupational therapy leaders in five Spanish-speaking North and South American countries reviewed the translations for comprehensibility and cultural appropriateness. Results: Back translations demonstrated equivalence with the original EASI tests except for a few test instructions and scoring criteria. Interviews with occupational therapists and children in Spain revealed some comprehension difficulties for several tests, which were revised in consultation with a linguistic expert. Additional adaptations were made on the basis of recommendations to address cultural differences by occupational therapy leaders from five North and South American countries. Most changes in wording were made in one EASI test (Praxis: Following Directions) that is heavily dependent on language comprehension. Conclusions and Relevance: We used currently recommended methodologies to develop and adapt a Spanish translation of the EASI for use across diverse cultures. What This Article Adds: A Spanish translation of the EASI has been developed for use in culturally diverse Spanish-speaking countries around the world

The pedagogy and principles of teaching therapeutic practice with children and young people.

Technical approaches suggesting that systematically produced, generalized, and scientific knowledge are the most solid foundations for practice present significant challenges for the social work profession, in which the decisions faced often are not technical but rather moral, requiring the application of ethically based and intuitive skills. Meanwhile, the command, control, and measurement of outcomes in social work practice also present significant conundrums for the delivery of relational person-centered social work and social care. With a focus too often on efficiency rather than on effectiveness, this managerialistic approach frequently fails to acknowledge the complexity inherent in the act of caring. In this context and framework, teaching therapeutic practice with children draws a balance between traditional systematic teaching methods and use of creative media including art, play, and music. This article outlines the positive contribution to professional social work practice that the teaching of therapeutic approaches to child care can make

Determinants of abstract acceptance for the Digestive Diseases Week – a cross sectional study

BACKGROUND: The Digestive Diseases Week (DDW) is the major meeting for presentation of research in gastroenterology. The acceptance of an abstract for presentation at this meeting is the most important determinant of subsequent full publication. We wished to examine the determinants of abstract acceptance for this meeting. METHODS: A cross-sectional study was performed, based on abstracts submitted to the DDW. All 17,205 abstracts submitted from 1992 to 1995 were reviewed for acceptance, country of origin and research type (controlled clinical trials (CCT), other clinical research (OCR), basic science (BSS)). A random sub-sample (n = 1,000) was further evaluated for formal abstract quality, statistical significance of study results and sample size. RESULTS: 326 CCT, 455 OCR and 219 BSS abstracts were evaluated in detail. Abstracts from N/W Europe (OR 0.4, 95% CI 0.3–0.6), S/E Europe (OR 0.4, 95% CI 0.2–0.6) and non-Western countries (OR 0.3, 95% CI 0.2–0.5) were less likely to be accepted than North-American contributions when controlling for research type. In addition, the OR for the acceptance for studies with negative results as compared to those with positive results was 0.4 (95% CI 0.3–0.7). A high abstract quality score was also weakly associated with acceptance rates (OR 1.4, 95% CI 1.0–2.0). CONCLUSIONS: North-American contributions and reports with statistically positive results have higher acceptance rates at the AGA. Formal abstract quality was also predictive for acceptance

Publication bias in gastroenterological research – a retrospective cohort study based on abstracts submitted to a scientific meeting

BACKGROUND: The aim of this study was to examine the determinants of publication and whether publication bias occurred in gastroenterological research. METHODS: A random sample of abstracts submitted to DDW, the major GI meeting (1992–1995) was evaluated. The publication status was determined by database searches, complemented by a mailed survey to abstract authors. Determinants of publication were examined by Cox proportional hazards model and multiple logistic regression. RESULTS: The sample included abstracts on 326 controlled clinical trials (CCT), 336 other clinical research reports (OCR), and 174 basic science studies (BSS). 392 abstracts (47%) were published as full papers. Acceptance for presentation at the meeting was a strong predictor of subsequent publication for all research types (overall, 54% vs. 34%, OR 2.3, 95% CI 1.7 to 3.1). In the multivariate analysis, multi-center status was found to predict publication (OR 2.8, 95% CI 1.6–4.9). There was no significant association between direction of study results and subsequent publication. Studies were less likely to be published in high impact journals if the results were not statistically significant (OR 0.5, 95 CI 95% 0.3–0.6). The author survey identified lack of time or interest as the main reason for failure to publish. CONCLUSIONS: Abstracts which were selected for presentation at the DDW are more likely to be followed by full publications. The statistical significance of the study results was not found to be a predictor of publication but influences the chances for high impact publication

A Full Suite of Histone and Histone Modifying Genes Are Transcribed in the Dinoflagellate Lingulodinium

BACKGROUND: Dinoflagellates typically lack histones and nucleosomes are not observed in DNA spreads. However, recent studies have shown the presence of core histone mRNA sequences scattered among different dinoflagellate species. To date, the presence of all components required for manufacturing and modifying nucleosomes in a single dinoflagellate species has not been confirmed. METHODOLOGY AND RESULTS: Analysis of a Lingulodinium transcriptome obtained by Illumina sequencing of mRNA shows several different copies of each of the four core histones as well as a suite of histone modifying enzymes and histone chaperone proteins. Phylogenetic analysis shows one of each Lingulodinium histone copies belongs to the dinoflagellate clade while the second is more divergent and does not share a common ancestor. All histone mRNAs are in low abundance (roughly 25 times lower than higher plants) and transcript levels do not vary over the cell cycle. We also tested Lingulodinium extracts for histone proteins using immunoblotting and LC-MS/MS, but were unable to confirm histone expression at the protein level. CONCLUSION: We show that all core histone sequences are present in the Lingulodinium transcriptome. The conservation of these sequences, even though histone protein accumulation remains below currently detectable levels, strongly suggests dinoflagellates possess histones

ESTs under Canadian Patent Law: Useful or Not?

The following discussion will examine the utility requirement for patentability in the context of EST patents. Part I will provide background information regarding the utility requirement under patent law and will explain why it has been difficult to apply to ESTs. Part II will briefly examine how other jurisdictions, in particular the United States, have addressed the difficul- ties associated with applying the current utility require- ment to biological materials, in particular ESTs. Part III will look at how Canadian courts have interpreted and applied the utility requirement for patentability, and will suggest that ESTs have sufficient value to the scientific community to satisfy this requirement. In addition, it will examine how the doctrine of sound prediction may allow patent protection to be extended beyond the simple EST nucleotide sequence. This article will conclude by suggesting two reasons why the utility criterion for patentability has proven difficult to apply to human genetic materials. The patenting of human genetic materials, including ESTs, raises a number of concerns apart from the question of whether they meet the utility requirement under patent legislation. Not only are there legal concerns in terms of whether such ‘‘inventions’’ are patentable subject-matter and whether they satisfy the requirements of novelty and non-obviousness, but there are also important moral concerns. While all of these issues are clearly related and not completely separable, an examination of their intersection is beyond the scope of this article