Legal regulation of the software "patentable subject matter" requirement in the US and in Europe: The need for certainty, predictability and uniformity

This thesis critically investigates the divergent international approaches to the legal regulation of the patentability of computer software inventions, with a view to identifying the reforms necessary for a certain, predictable and uniform inter-jurisdictional system of protection. Through a critical analysis of the traditional and contemporary US and European regulatory frameworks of protection for computer software inventions, this thesis demonstrates the confusion and legal uncertainty resulting from ill-defined patent laws and inconsistent patent practices as to the scope of the “patentable subject matter” requirement, further compounded by substantial flaws in the structural configuration of the decision-making procedures within which the patent systems operate. This damaging combination prevents the operation of an accessible and effective Intellectual Property (IP) legal framework of protection for computer software inventions, capable of securing adequate economic returns for inventors whilst preserving the necessary scope for innovation and competition in the field, to the ultimate benefit of society. In exploring the substantive and structural deficiencies in the European and US regulatory frameworks, this thesis develops to ultimately highlight that the best approach to the reform of the legal regulation of software patentability is two-tiered. It demonstrates that any reform to achieve international legal harmony first requires the legislature to individually clarify (Europe) or restate (US) the long-standing inadequate rules governing the scope of software “patentable subject matter”, together with the reorganisation of the unworkable structural configuration of the decision-making procedures. Informed by the critical analysis of the evolution of the “patentable subject matter” requirement for computer software in the US, this thesis particularly considers the potential of the reforms of the European patent system currently underway, to bring about certainty, predictability and uniformity in the legal treatment of computer software inventions.

The Ford administration, Angola and the perception of Post-Vietnam US credibility, 1974-1976

This thesis is a study of how the Gerald Ford administration struggled to address a perceived loss of US credibility after the collapse of Vietnam, with a focus on the role of Secretary of State Henry Kissinger in the formulation, implementation and subsequent defence of US Angolan policy. By examining the immediate post-Vietnam period, this thesis shows that Vietnam had a significant impact on Kissinger’s actions on Angola, which resulted in an ill conceived covert operation in another third world conflict. In 1974, Africa was a neglected region in Cold War US foreign policy, yet the effects of the Portuguese revolution led to a rapid decolonization of its African territories, of which Angola was to become the focus of superpower competition. After South Vietnam collapsed in April 1975, Kissinger became fixated on restoring the perceived loss of US prestige, Angola provided the first opportunity to address this. Despite objections from his advisors, Kissinger methodically engineered a covert program to assist two anti-Marxist guerrilla groups in Angola. As the crisis escalated, the media discovered the operation and the Congress decided to cease all funding. A period of heated tensions ensued, resulting in Kissinger creating a new African policy to outmanoeuvre his critics publicly, while privately castigating them to foreign leaders. This thesis argues that Kissinger’s dismissal of internal dissent and opposition from the Congress was influenced by what he perceived as bureaucrats being affected by the Vietnam syndrome, and his obsession with restoring US credibility. By looking at the private and public records – as expressed in government meetings and official reports, US newspaper and television coverage and diplomatic cables – this thesis addresses the question of how the lessons of Vietnam failed to influence Kissinger’s actions in Angola, but the lessons of Angola were heavily influential in the construction of a new US-African policy.

Preclinical atherosclerosis in rheumatoid arthritis

Introduction: There is accumulating evidence of an increased risk of cardiovascular morbidity and mortality in rheumatoid arthritis patients. A combination of both traditional cardiovascular risks and rheumatoid specific factors appear to be responsible for driving this phenomenon. Rheumatoid arthritis has been an orphan of cardiologists in the past and rheumatologists themselves are not good at CVD screening. Identifying the extent of preclinical atherosclerosis in RA patients will help us to appreciate the magnitude of this serious problem in an Irish population. Methods: We undertook a cross-sectional study of 63 RA patients and 48 OA controls and compared the 2 groups with respect to 1) traditional CV risks factors, 2) serum biomarkers of inflammation, including CRP, TNFα, IL6 and PAI-1, 3) carotid intima-media thickness (cIMT), carotid plaque and ankle-brachial index (ABI) as markers of pre-clinical atherosclerosis, 4) biochemical and ultrasonic measures of endothelial dysfunction and 5) serum and echocardiographic measures of diastolic dysfunction. Within the RA group, we also investigated for associations between markers of inflammation, subclinical atherosclerosis and diastolic dysfunction. Results: Prevalence of traditional CV risks was similar in the RA and OA groups. A number of biomarkers of inflammation were significantly higher in the RA group: CRP, fibrinogen, IL- 2, -4, -6, TNFα. PAI-1, a marker of thrombosis, correlated with disease activity and subclinical atherosclerosis in RA patients. With regard to subclinical atherosclerosis measures, RA patients had a significantly lower ABI than OA patients. Carotid plaque and cIMT readings were similar in RA and OA patients. Assessment of endothelial function revealed that RA patients had significantly higher concentrations of adhesion molecules, in particular sero-positive RA patients and RA smokers. Adhesion molecule concentrations were associated with markers of diastolic dysfunction in RA. Urine PCR, another marker of endothelial dysfunction also correlated with diastolic dysfunction in RA. Assessment of endothelial function with flow mediated dilatation (FMD) found no difference between the RA and OA groups. Disease activity scores in RA patients were associated with endothelial dysfunction, as assessed by FMD. Conclusions: We did not find significant differences in measures of subclinical atherosclerosis, flow mediated dilatation or diastolic function between RA and OA patients. This is most likely in part due to the fact that there is increasing evidence that OA has an inflammatory component to its pathogenesis and is associated with metabolic syndrome and increased CV risk. We reported a significant association between urinary PCR and measures of diastolic dysfunction. Urinary PCR may be a useful screening tool for diastolic dysfunction in RA. The association between RA disease activity and measures of vascular function supports the theory that the excess cardiovascular burden in RA is linked to uncontrolled inflammation.

Justifying jihad: US politics, propaganda and the Afghan mujahedeen

Hard-line anti-communists in the United States recognised the potential for the Soviet invasion of Afghanistan in 1979 to embroil their super-power rival in a ‘Vietnam-like quagmire.’ Their covert operation to arm the mujahedeen is well documented. This dissertation argues that propaganda and public diplomacy were powerful and essential instruments of this campaign. It examines the protagonists of this strategy, their policies, initiatives and programmes offering a comprehensive analysis heretofore absent. It stretches from the dying days of the Carter administration when Zbigniew Brzezinski saw the ‘opportunity’ presented by the invasion to the Soviet’s withdrawal in 1989. The aim of these information strategies was to damage Soviet credibility and enhance that of the US, considered under threat from growing ‘moral equivalence’ amongst international publics. The conflict could help the US regain strategic advantage in South Asia undermined by the ‘loss’ of Iran. The Reagan administration used it to justify the projection of US military might that it believed was eviscerated under Carter and emasculated by the lingering legacy of Vietnam. The research engages with source material from the Reagan Presidential Library, the United States Information Agency archives and the Library of Congress as well as a number of online archives. The material is multi-archival and multi-media including documentaries, booklets, press conferences, summit programmes and news-clips as well as national security policy documents and contemporaneous media commentary. It concludes that propaganda and public diplomacy were integral to the Reagan administration and other mujahedeen supporters’ determination to challenge the USSR. It finds that the conflict was used to justify military rearmament, further strategic aims and reassert US power. These Cold War machinations had a considerable impact on the course of the conflict and undermined efforts at resolution and reconciliation with profound implications for the future stability of Afghanistan and the world.

Ford, Carter and Cambodia: US foreign policy and the Khmer Rouge

This thesis is an investigation into the US response to the Khmer Rouge regime in Cambodia between 1974 and 1981. It argues that the US experience in the Vietnam War acted as a causal factor in the formulation of its Cambodian policy during the presidencies of Gerald Ford and Jimmy Carter. From taking power in April 1975 to their removal by the Vietnamese in January 1979, the Khmer Rouge initiated a revolution unrivalled in the 20th Century for its brutality and for the total eradication of modern society. This thesis demonstrates that the Ford administration viewed Cambodia only as it pertained to their strategy in Vietnam and, following US disengagement from Indochina all but ignored the atrocities occurring there as they instead pursued informal relations with the Khmer Rouge as a means of punishing the Vietnamese. The Carter administration formulated a foreign policy based on human rights yet failed to adequately address the genocide that occurred in Cambodia due to its temporal and regional proximity to Vietnam. Instead, this collective reluctance to reengage with the region and the resulting anti-Vietnamese attitude reinforced Brzezinski’s broader global strategy that allied the US with China in support of an independent Cambodia to further isolate Hanoi. Thus this thesis argues that the distorting impact of the Vietnam War, as well as global Cold War calculations, undermined any appreciation of the Cambodian conflict and caused both administrations to pursue policies in Cambodia that ultimately supported the Khmer Rouge regime. This project incorporates declassified material from the Ford and Carter Presidential Libraries, supplemented by the material from the National Archives and Library of Congress, and relevant newspapers and periodicals. It demonstrates that the limitations placed upon US foreign policy by their experience in the Vietnam War may be used to reveal unexplored elements in US-Cambodian relations.

Un reçu de loyer d'époque tardive (P. Cair. Inv. 10401)

Édition d'un papyrus grec du 7e siècle portant le texte d'un reçu de loyer pour un bien, sans doute une maison, appartenant à une église à Arsinoé (Fayoum)

Analyses on Gold and US Dollar in Vietnam's Transitional Economy

This paper looks into economic insights offerred by considerations of two important financial markets in Vietnam, gold and USD. In general, the paper focuses on time series properties, mainly returns at different frequencies, and test the weak-form efficient market hypothesis. All the test rejects the efficiency of both gold and foreign exchange markets. All time series exhibit strong serial correlations. ARMA-GARCH specifications appear to have performed well with different time series. In all cases the changing volatility phenomenon is strongly supported through empirical data. An additional test is performed on the daily USD return to try to capture the impacts of Asian financial crisis and daily price limits applicable. No substantial impacts of the Asian crisis and the central bank-devised limits are found to influence the risk level of daily USD return.

A feasibility study evaluating docetaxel-based sequential and combination regimens in the adjuvant therapy of node-positive breast cancer

BACKGROUND AND PURPOSE: Docetaxel is an active agent in the treatment of metastatic breast cancer. We evaluated the feasibility of docetaxel-based sequential and combination regimens as adjuvant therapies for patients with node-positive breast cancer. PATIENTS AND METHODS: Three consecutive groups of patients with node-positive breast cancer or locally-advanced disease, aged < or = 70 years, received one of the following regimens: a) sequential A-->T-->CMF: doxorubicin 75 mg/m2 q 3 weeks x 3, followed by docetaxel 100 mg/m2 q 3 weeks x 3, followed by i.v. CMF days 1 + 8 q 4 weeks x 3; b) sequential accelerated A-->T-->CMF: A and T were administered at the same doses q 2 weeks; c) combination therapy: doxorubicin 50 mg/m2 + docetaxel 75 mg/m2 q 3 weeks x 4, followed by CMF x 4. When indicated, radiotherapy was administered during or after CMF, and tamoxifen started after the end of CMF. RESULTS: Seventy-nine patients have been treated. Median age was 48 years. A 30% rate of early treatment discontinuation was observed in patients receiving the sequential accelerated therapy (23% during A-->T), due principally to severe skin toxicity. Median relative dose-intensity was 100% in the three treatment arms. The incidence of G3-G4 major toxicities by treated patients, was as follows: skin toxicity a: 5%; b: 27%; c: 0%; stomatitis a: 20%; b: 20%; c: 3%. The incidence of neutropenic fever was a: 30%; b: 13%; c: 48%. After a median follow-up of 18 months, no late toxicity has been reported. CONCLUSIONS: The accelerated sequential A-->T-->CMF treatment is not feasible due to an excess of skin toxicity. The sequential non accelerated and the combination regimens are feasible and under evaluation in a phase III trial of adjuvant therapy.

3-year results of docetaxel-based sequential and combination regimens in the adjuvant therapy of node-positive breast cancer: a pilot study.

BACKGROUND: Docetaxel has proven efficacy in metastatic breast cancer. In this pilot study, we explored the efficacy/feasibility of docetaxel-based sequential and combination regimens as adjuvant therapy of node-positive breast cancer. PATIENTS AND METHODS: From March 1996 till March 1998, four consecutive groups of patients with stages II and III breast cancer, aged < or = 70 years, received one of the following regimens: a) sequential Doxorubicin (A) --> Docetaxel (T) --> CMF (Cyclophosphamide+Methotrexate+5-Fluorouracil): A 75 mg/m q 3 wks x 3, followed by T100 mg/m2 q 3 wks x 3, followed by i.v. CMF Days 1+8 q 4 wks x 3; b) sequential accelerated A --> T --> CMF: A and T administered at the same doses q 2 wks with Lenograstin support; c) combination therapy: A 50 mg/m2 + T 75 mg/m2 q 3 wks x 4, followed by CMF x 4; d) sequential T --> A --> CMF: T and A, administered as in group a), with the reverse sequence. When indicated, radiotherapy was administered during or after CMF, and Tamoxifen after CMF. RESULTS: Ninety-three patients were treated. The median age was 48 years (29-66) and the median number of positive axillary nodes was 6 (1-25). Tumors were operable in 94% and locally advanced in 6% of cases. Pathological tumor size was >2 cm in 72% of cases. There were 21 relapses, (18 systemic, 3 locoregional) and 11 patients (12%) have died from disease progression. At median follow-up of 39 months (6-57), overall survival (OS) was 87% (95% CI, 79-94%) and disease-free survival (DFS) was 76% (95% CI, 67%-85%). CONCLUSION: The efficacy of these docetaxel-based regimens, in terms of OS and DFS, appears to be at least as good as standard anthracycline-based adjuvant chemotherapy (CT), in similar high-risk patient populations.

Aging African American Women and the Impact of Positive Psychological Factors on Quality of Life

Aging African-American women are disproportionately affected by negative health outcomes and mortality. Life stress has strong associations with these health outcomes. The purpose of this research was to understand how aging African American women manage stress. Specifically, the effects of coping, optimism, resilience, and religiousness as it relates to quality of life were examined. This cross-sectional exploratory study used a self-administered questionnaire and examined quality of life in 182 African-American women who were 65 years of age or older living in senior residential centers in Baltimore using convenience sampling. The age range for these women was 65 to 94 years with a mean of 71.8 years (SD = 5.6). The majority (53.1%) of participants completed high school, with 23 percent (N = 42) obtaining college degrees and 19 percent (N = 35) holding advanced degrees. Nearly 58 percent of participants were widowed and 81 percent were retired. In addition to demographics, the questionnaire included the following reliable and valid survey instruments: The Brief Cope Scale (Carver, Scheier, & Weintraub, 1989), Optimism Questionnaire (Scheier, Carver, & Bridges, 1994), Resilience Survey (Wagnild & Young, 1987), Religiousness Assessment (Koenig, 1997), and Quality of Life Questionnaire (Cummins, 1996). Results revealed that the positive psychological factors examined were positively associated with and significant predictors of quality of life. The bivariate correlations indicated that of the six coping dimensions measured in this study, planning (r=.68) was the most positively associated with quality of life. Optimism (r=.33), resilience (=.48), and religiousness (r=.30) were also significantly correlated with quality of life. In the linear regression model, again the coping dimension of planning was the best predictor of quality of life (beta = .75, p <.001). Optimism (beta = .31, p <.001), resilience (beta = .34, p, .001) and religiousness (beta = .17, p <.01) were also significant predictors of quality of life. It appears as if positive psychology plays an important role in improving quality of life among aging African-American women.

Organic nitrogen in PM2.5 aerosol at a forest site in the Southeast US

There is growing evidence that organo-nitrogen compounds may constitute a significant fraction of the aerosol nitrogen (N) budget. However, very little is known about the abundance and origin of this aerosol fraction. In this study, the concentration of organic nitrogen (ON) and major inorganic ions in PM2.5 aerosol were measured at the Duke Forest Research Facility near Chapel Hill, NC, during January and June of 2007. A novel on-line instrument was used, which is based on the Steam Jet Aerosol Collector (SJAC) coupled to an on-line total carbon/total nitrogen analyzer and two on-line ion chromatographs. The concentration of ON was determined by tracking the difference in concentrations of total nitrogen and of inorganic nitrogen (determined as the sum of N-ammonium and N-nitrate). The time resolution of the instrument was 30 min with a detection limit for major aerosol components of ∼0.1 mu;gm-3. Nitrogen in organic compounds contributed ∼33% on average to the total nitrogen concentration in PM2.5, illustrating the importance of this aerosol component. Absolute concentrations of ON, however, were relatively low (lt;1.0 mu;gm-3) with an average of 0.16 mu;gm-3. The absolute and relative contribution of ON to the total aerosol nitrogen budget was practically the same in January and June. In January, the concentration of ON tended to be higher during the night and early morning, while in June it tended to be higher during the late afternoon and evening. Back-trajectories and correlation with wind direction indicate that higher concentrations of ON occur in air masses originating over the continental US, while marine air masses are characterized by lower ON concentrations. The data presented in this study suggests that ON has a variety of sources, which are very difficult to quantify without information on chemical composition of this important aerosol fraction.

Scientific writing: a randomized controlled trial comparing standard and on-line instruction.

BACKGROUND: Writing plays a central role in the communication of scientific ideas and is therefore a key aspect in researcher education, ultimately determining the success and long-term sustainability of their careers. Despite the growing popularity of e-learning, we are not aware of any existing study comparing on-line vs. traditional classroom-based methods for teaching scientific writing. METHODS: Forty eight participants from a medical, nursing and physiotherapy background from US and Brazil were randomly assigned to two groups (n = 24 per group): An on-line writing workshop group (on-line group), in which participants used virtual communication, google docs and standard writing templates, and a standard writing guidance training (standard group) where participants received standard instruction without the aid of virtual communication and writing templates. Two outcomes, manuscript quality was assessed using the scores obtained in Six subgroup analysis scale as the primary outcome measure, and satisfaction scores with Likert scale were evaluated. To control for observer variability, inter-observer reliability was assessed using Fleiss's kappa. A post-hoc analysis comparing rates of communication between mentors and participants was performed. Nonparametric tests were used to assess intervention efficacy. RESULTS: Excellent inter-observer reliability among three reviewers was found, with an Intraclass Correlation Coefficient (ICC) agreement = 0.931882 and ICC consistency = 0.932485. On-line group had better overall manuscript quality (p = 0.0017, SSQSavg score 75.3 +/- 14.21, ranging from 37 to 94) compared to the standard group (47.27 +/- 14.64, ranging from 20 to 72). Participant satisfaction was higher in the on-line group (4.3 +/- 0.73) compared to the standard group (3.09 +/- 1.11) (p = 0.001). The standard group also had fewer communication events compared to the on-line group (0.91 +/- 0.81 vs. 2.05 +/- 1.23; p = 0.0219). CONCLUSION: Our protocol for on-line scientific writing instruction is better than standard face-to-face instruction in terms of writing quality and student satisfaction. Future studies should evaluate the protocol efficacy in larger longitudinal cohorts involving participants from different languages.

Physical activity in US Blacks: a systematic review and critical examination of self-report instruments.

BACKGROUND: Physical activity self-report instruments in the US have largely been developed for and validated in White samples. Despite calls to validate existing instruments in more diverse samples, relatively few instruments have been validated in US Blacks. Emerging evidence suggests that these instruments may have differential validity in Black populations. PURPOSE: This report reviews and evaluates the validity and reliability of self-reported measures of physical activity in Blacks and makes recommendations for future directions. METHODS: A systematic literature review was conducted to identify published reports with construct or criterion validity evaluated in samples that included Blacks. Studies that reported results separately for Blacks were examined. RESULTS: The review identified 10 instruments validated in nine manuscripts. Criterion validity correlations tended to be low to moderate. No study has compared the validity of multiple instruments in a single sample of Blacks. CONCLUSION: There is a need for efforts validating self-report physical activity instruments in Blacks, particularly those evaluating the relative validity of instruments in a single sample.

Hodgkin lymphoma treatment with ABVD in the US and the EU: neutropenia occurrence and impaired chemotherapy delivery.

BACKGROUND: In newly diagnosed patients with Hodgkin lymphoma (HL) the effect of doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD)-related neutropenia on chemotherapy delivery is poorly documented. The aim of this analysis was to assess the impact of chemotherapy-induced neutropenia (CIN) on ABVD chemotherapy delivery in HL patients. STUDY DESIGN: Data from two similarly designed, prospective, observational studies conducted in the US and the EU were analysed. One hundred and fifteen HL patients who started a new course of ABVD during 2002-2005 were included. The primary objective was to document the effect of neutropenic complications on delivery of ABVD chemotherapy in HL patients. Secondary objectives were to investigate the incidence of CIN and febrile neutropenia (FN) and to compare US and EU practice with ABVD therapy in HL. Pooled data were analysed to explore univariate associations with neutropenic events. RESULTS: Chemotherapy delivery was suboptimal (with a relative dose intensity < or = 85%) in 18-22% of patients. The incidence of grade 4 CIN in cycles 1-4 was lower in US patients (US 24% vs. EU 32%). Patients in both the US and the EU experienced similar rates of FN across cycles 1-4 (US 12% vs. EU 11%). Use of primary colony-stimulating factor (CSF) prophylaxis and of any CSF was more common in the US than the EU (37% vs. 4% and 78% vs. 38%, respectively). The relative risk (RR) of dose delays was 1.54 (95% confidence interval [CI] 1.08-2.23, p = 0.036) for patients with vs. without grade 4 CIN and the RR of grade 4 CIN was 0.35 (95% CI 0.12-1.06, p = 0.046) for patients with vs. without primary CSF prophylaxis. CONCLUSIONS: In this population of HL patients, CIN was frequent and FN occurrence clinically relevant. Chemotherapy delivery was suboptimal. CSF prophylaxis appeared to reduce CIN rates.

Integrated vector management for malaria control in Uganda: knowledge, perceptions and policy development.

BACKGROUND: Integrated vector management (IVM) is increasingly being recommended as an option for sustainable malaria control. However, many malaria-endemic countries lack a policy framework to guide and promote the approach. The objective of the study was to assess knowledge and perceptions in relation to current malaria vector control policy and IVM in Uganda, and to make recommendations for consideration during future development of a specific IVM policy. METHODS: The study used a structured questionnaire to interview 34 individuals working at technical or policy-making levels in health, environment, agriculture and fisheries sectors. Specific questions on IVM focused on the following key elements of the approach: integration of chemical and non-chemical interventions of vector control; evidence-based decision making; inter-sectoral collaboration; capacity building; legislation; advocacy and community mobilization. RESULTS: All participants were familiar with the term IVM and knew various conventional malaria vector control (MVC) methods. Only 75% thought that Uganda had a MVC policy. Eighty percent (80%) felt there was inter-sectoral collaboration towards IVM, but that it was poor due to financial constraints, difficulties in involving all possible sectors and political differences. The health, environment and agricultural sectors were cited as key areas requiring cooperation in order for IVM to succeed. Sixty-seven percent (67%) of participants responded that communities were actively being involved in MVC, while 48% felt that the use of research results for evidence-based decision making was inadequate or poor. A majority of the participants felt that malaria research in Uganda was rarely used to facilitate policy changes. Suggestions by participants for formulation of specific and effective IVM policy included: revising the MVC policy and IVM-related policies in other sectors into a single, unified IVM policy and, using legislation to enforce IVM in development projects. CONCLUSION: Integrated management of malaria vectors in Uganda remains an underdeveloped component of malaria control policy. Cooperation between the health and other sectors needs strengthening and funding for MVC increased in order to develop and effectively implement an appropriate IVM policy. Continuous engagement of communities by government as well as monitoring and evaluation of vector control programmes will be crucial for sustaining IVM in the country.