Digital Commons Network^™

The Case Of The Missing Device Patents, Or: Why Device Patents Matter, Erika Lietzan, Kristina M. L. Acri, Evan Weidner

Faculty Publications

A company that earns premarket approval of its medical device is entitled to an extension of one patent claiming the device, to make up for some of the time it spent doing premarket research. Yet, surprisingly, a mere thirteen percent of those eligible for this extension (also known as patent term "restoration") ask for one. In contrast, most drug companies entitled to this same patent extension ask for one.

In this Article, we attribute the imbalance largely to differences between the two regulatory frameworks. In brief, because the FDA classifies and regulates devices based on what they do and how …

The Causation Canon, Sandra F. Sperino

Faculty Publications

It is rare to witness the birth of a canon of statutory interpretation. In the past decade, the Supreme Court created a new canon-the causation canon. When a statute uses any causal language, the Court will assume that Congress meant to require the plaintiff to establish "but-for" cause.

This Article is the first to name, recognize and discuss this new canon. The Article traces the birth of the canon, showing that the canon did not exist until 2013 and was not certain until 2020. Demonstrating how the Court constructed this new canon yields several new insights about statutory interpretation.

The …

Solutions Still Searching For A Problem: A Call For Relevant Data To Support "Evergreening" Allegations, Erika Lietzan, Kristina M. L. Acri

Faculty Publications

For years pharmaceutical policymaking discussions have been revolving around allegations of supposed “evergreening” by pharmaceutical companies, and policymakers have considered a range of significant policy reforms — including to antitrust law and drug regulatory law — to address this purported problem. This paper evaluates empirical data offered to substantiate “evergreening” and explains that these data — though mostly accurate — do not support proposed policy changes.

The “evergreening” claim is that by securing additional patents and FDA-related exclusivities after approval of their new drugs, brand drug companies enjoy a period of exclusivity in the market that is longer than the …

Metamorphosis Imposes Variable Constraints On Genome Expansion Through Effects On Development, R. Lockridge Mueller,, Clayton E. Cressler, R S. Schwartz, R A. Chong, M. Butler

School of Biological Sciences: Faculty Publications

Genome size varies ∼100,000-fold across eukaryotes and has long been hypothesized to be influenced by meta- morphosis in animals. Transposable element accumulation has been identified as a major driver of increase, but the nature of constraints limiting the size of genomes has remained unclear, even as traits such as cell size and rate of development co-vary strongly with genome size. Salamanders, which possess diverse metamorphic and non-metamorphic life histories, join the lung- fish in having the largest vertebrate genomes—3 to 40 times that of humans—as well as the largest range of variation in genome size. We tested 13 biologically-inspired hypotheses …

Designing A Digital Employee Experience For Research Administration Using A Sequential Mixed-Methods Approach, Michael A. Jones

Full-Text Theses & Dissertations

This dissertation examines the concept of digital employee experience in the research administration industry. Using a digital employee experience framework, the study examined how the pandemic impacted the research administration work environment. This dissertation presents perceptions and draws insights from research administration leaders, management, and staff on digital work and digital employee experiences through the pandemic. The dissertation was motivated by three research questions: (1) What challenges did research administrators encounter during the Pandemic? (2) What were the research administrators’ perceptions of digital transformation during their employee journey? and (3) What is the future of research administration as the industry …

South Dakota State University Graduate Catalog 2023-2024, South Dakota State University

South Dakota State University Catalogs and Bulletins: 1935 to present

No abstract provided.

South Dakota State University Undergraduate Catalog 2023-2024, South Dakota State University

South Dakota State University Catalogs and Bulletins: 1935 to present

No abstract provided.

Trade Rules Of State Enterprises: A Lawmaking Perspective, Shixue Hu

Michigan Journal of International Law

State Enterprises are important actors in global trade, yet their regulation is a highly contentious issue that presently troubles the WTO and U.S.-China trade talks. This article proposes a typological framework of the multinational, regional, and bilateral trade rules concerning state enterprises. It compares their similarities and divergences from a lawmaking perspective, analyzing how lawmakers mix and match legal elements of ownership, control, purpose, authorization, function, activity, and industry of state enterprises with diverse policy ends. It reveals that some elements regulate behaviors while others pay more regulatory attention to the firm’s identity. These action-oriented and actor-focused approaches provide different …

Blacktip Shark (Carcharhinus Limbatus) Jaw, Laura D. Nicolas, David W. Kerstetter

All Scans: Kerstetter Fisheries and Avian Ecology 3D Scan Series

Jaw from blacktip shark (Carcharhinus limbatus)

Pulse, Vol. 2 Spring 2023

PULSE: A Student Publication of Literary & Artistic Works

No abstract provided.

Pharmacology And Toxicology Master's Degree Annual Program Outcomes Assessments, 2022-23, Boonshoft School Of Medicine, Wright State University

Annual Program Outcomes Assessments - All

This report reviews Wright State University's Pharmacology and Toxicology Master's Degree program for the 2022-2023 academic year.

Technical Study: Agriculture Associate Degree Annual Program Outcomes Assessments, 2022-23, Lake Campus, Wright State University

Annual Program Outcomes Assessments - All

This report reviews Wright State University's Technical Study: Agriculture Associate Degree program for the 2022-2023 academic year.

Experimentally Broadcasted Wind-Turbine Sound Drastically Alters Songbirds' Habitat Selection And Vocal Communication In A Natural Environment, Yael Lehnardt, Tom Klein, Jesse R. Barber, Oded Berger-Tal

Biology Faculty Publications and Presentations

The sound of wind turbines is a potential threat to songbirds, who use vocal communication to transfer information and rely on acoustic cues from the environment. Previous studies have shown decreased bird density around wind-farms, but the exact causes for this decline have not yet been fully recognized. We investigated the effects of wind-turbine sound on songbird populations by deploying a "Phantom Turbine": broadcasting wind-turbine sound (102dB) at a site without actual turbines. We conducted the experiment in cycles of three stages: 'before', 'noise-treatment', and 'after'. We monitored birds' abundance using mist-netting and recorded freely-flying birds' communication and background noise …

Breakwater: Anti-Blackness In Geoscience Lessons From Long Beach, Ca, Christina Marsh

Pomona Senior Theses

Breakwaters are more than just physical structures that protect against storm surges and in the context of Long Beach, CA, my hometown, they are actualizations of economic, social, environmental, geologic, and policy challenges. Inspired by Trace: Memory, History, Race, and the American Landscape by Lauret Savoy, and Teaching to Transgress by bell hooks, I use an extended metaphor and autoethnographic approach to connect a chronology of my educational life to the physical structure of a breakwater. Where the breakwater also acts as a signifier of my personal experiences of seeing it, questioning its purpose, and not always finding an answer. …

Theorizing The Korean Wave| K(Q)Ueer-Pop For Another World: Toward A Theorization Of Gender And Sexuality In K-Pop, Jungmin Kwon

School of Film Faculty Publications and Presentations

This article argues that the K-pop space, which on one level appears to be homogeneously cishetpatriarchal, actually encompasses multiple configurations of gender and sexual identity. Nonetheless, academic discussions about gender and sexuality in K-pop have been significantly weighted toward the idea of “soft masculinity” regarding male performers, thereby muffling other possible interpretations. I suggest a new term, K(Q)ueerness. It means the aesthetics, imaginations, practices, performances, and ideas of K-pop players sublate binaristic identifications, including masculinity and femininity and heterosexual and homosexual—as well as Butler’s distinction between performance and performativity—to embrace the multifarious expressions of gender and sexuality surrounding K-pop. This …

Operationalizing Indigenous-Led Impact Assessment, Dayna Scott, Jennifer Sankey, Laura Tanguay

Commissioned Reports, Studies and Public Policy Documents

Recent years have ushered in an explosion of interest and expertise in place-based, Indigenous-led impact assessment models. Across Canada and beyond, Indigenous communities have been developing and engaging with alternative approaches to “environmental assessment” (EA) or “impact assessment” (IA) in response to proposed developments in their homelands. These efforts are borne out of deep dissatisfaction and frustration; Indigenous peoples have repeatedly pointed to the inability of settler law on EA to protect their constitutionally recognized Aboriginal and Treaty rights, and to meaningfully engage with Indigenous laws, values, and perspectives regarding the socio-ecological risks posed by resource development projects. The inability …

Optimal Agricultural Land Use: An Efficient Neutrosophic Linear Programming Method, Maisam Jdid, Florentin Smarandache

Branch Mathematics and Statistics Faculty and Staff Publications

The increase in the size of the problems facing humans, their overlap, the division of labor, the multiplicity of departments, as well as the diversity of products and commodities, led to the complexity of business and the emergence of many administrative and production problems. It was necessary to search for appropriate methods to confront these problems. The science of operations research, with its diverse methods, provided the optimal solutions. It addresses many problems and helps in making scientific and thoughtful decisions to carry out the work in the best way within the available capabilities. Operations research is one of the …

Against Integrity: A Feminist Theory Of Moral Rights, Creative Agency & Attribution, Carys Craig, Anupriya Dhonchak

All Papers

This Chapter explores insights that feminist theories can bring to the study and development of moral rights protections in copyright law. It begins by explaining why certain facets of conventional moral rights theory are ill-suited to—indeed inconsistent with—a feminist approach in both concept and effect. In particular, to the extent that strong moral rights of integrity and association limit dialogic engagement with, and transformation of, protected works, they risk suppressing critical and counter-hegemonic expression, and support an individualized and romanticized conception of the (patriarchal) author-figure. Employing alternative feminist conceptions of situated selfhood, relationality and dialogic authorship, the Chapter then explores …

Eliminating Cash Bail In Washington State—Amending Criminal Rule 3.2, Simran Kaur

Seattle University Law Review

This Note discusses the following three parts. Part I provides an overview of the cash bail system, its history, and its contemporary use in Washington state. Part II presents the effects of bail on pretrial release, analyzing low-income and racial inequalities and the adverse impacts it can have on the accused. Part III focuses on solutions and alternatives to the cash bail system, using other states as case studies.

Fabrication And Characterization Of Amlodipine Besylate Based Sub-Cutaneous Implants: Fabricated With The Help Of Hot Melt Extrusion, Kshitij Chitnis

Electronic Theses and Dissertations

Hypertension (HTN) can lead to heart attack, cardiac arrest, or coronary heart disease, and eventually death without proper treatment. Amlodipine Besylate (AMB) was approved by, US Food and Drug Administration in 1987, as a monotherapy for the management of HTN. AMB is commercially available in tablet (2.5, 5, and 10 mg) and solution (1mg/mL) dosage forms. However, adherence to the properly prescribed dosage form is critical and difficult for patients with chronic diseases such as HTN to prevent illness progression and death. The objective of the study was to develop AMB-loaded subcutaneous implants to reduce the frequency of administration, thus, …

The Enduring Tradition Of Toxic Masculinity In French Literature, Hailey Caroline Kaim

Electronic Theses and Dissertations

Toxic masculinity, the modern definition has given a concise explanation to what French literature has been relaying to audiences for centuries. This thesis will explore how toxic masculinity is seen in French literature through five time periods: the Medieval era, 17th, 18th, 20th, and 21st century. Introducing toxic masculinity is provided by a modern definition, biological evidence, and evaluation with society’s definition of masculinity. The Medieval era will investigate two short stories of courtly love that provide readers with classical examples of toxic masculinity that both men and women displayed. Venturing into the 17th and 18th centuries, plays brought the …

Harness Therapeutic Potential Of Immune Responses: Molecular Characterization And Targeted Delivery, Nan Ji

Electronic Theses and Dissertations

The immune system plays a crucial role in protecting the body from harmful pathogens and cancer cells and maintaining tissue homeostasis. Immunotherapy has shown significant potential in treating various diseases by harnessing the therapeutic potential of immune responses through the targeting of different immune cells, receptors, and signaling pathways. This dissertation investigated two immune modulators for their immune-enhancing potential.In the first chapter, the components of innate immunity are introduced. In the second chapter, Immulina, a commercially available extract of Arthrospira platensis enriched with Braun-type proteins, was studied for its immunostimulatory effect in mouse bone marrow-derived dendritic cells and macrophages. The …

Effects Of Pictorial And Imagery Encoding On False Memories, Paul D. Loprinzi

Electronic Theses and Dissertations

Prior research demonstrates that viewing matched pictures is ineffective in reducing false memories for related lures that have not been previously externally presented during the experiment. However, other types of visual processing, such imagery encoding, have been shown to reduce false memories when evaluated from paradigms where the critical item is also thought to be internally activated, such as when using DRM lists. The prior work showing that imagery encoding can reduce false memories when using DRM lists may be confounded by a potential mismatch between the mentally-generated image and the visual word. Using a category associate procedure, as opposed …

Formulation And Development Of Curcumin Implants For Treatment Of Colorectal Cancer: Application Of Hme And 3d Printing, Neha Rajendra Sali

Electronic Theses and Dissertations

Targeted drug delivery for preventing colorectal cancer (CRC) reoccurrence after surgery can be one of the potent tumor reduction methods among other therapies, such as chemotherapy, ablation, embolization, and radiation therapy. Curcumin has been reported to target the growth factors in carcinoma cells and thereby reducing the proliferation and accelerating the apoptosis of the cancerous cells. Due to its poor bioavailability, it has several limitations for its use in anti-cancer therapy. Piperine has increased the solubility and bioavailability of curcumin and acts synergistically to suppress cancer cell growth. The current study intended to develop novel curcumin implants by coupling hot …

Promoting Corporate Diversity: The Uncertain Role Of Institutional Investors, Jill Fisch

Seattle University Law Review

Two developments are having an impact on corporate decisions. One is the increased engagement by institutional intermediaries and a shift in the focus of that engagement from corporate governance to environmental and social issues. The other is a heightened societal awareness of diversity, equity, and inclusion (DEI) issues, particularly the importance of diversity in corporate leadership. This Article considers the intersection between the two. It describes how institutional investors have focused their attention on increasing diversity in corporate leadership, the potential motivations for that focus, and the impact of that focus, to date. It highlights the tensions that result from …

America’S Hidden Citizens: The Untold Stories Of The Unconscionable Deportations Of Its International Adoptees, Halley Cody

Seattle University Law Review

This Note addresses how the U.S. should rectify the harms it has perpetrated on non-citizen adoptees by amending the current deportation statutes to prevent their deportation. Part I addresses the history of adoption in the U.S. and related effects on immigration law. Part II highlights the stories of Adam Crapser and Philip Clay, who were adopted by American families who failed to naturalize them as minors, and who were subsequently deported after they sustained criminal records. Part III examines the policy goals behind deportation as a consequence of criminal convictions, as well as remedies instituted to prevent unwarranted deportation and …

Inadequate Privacy: The Necessity Of Hipaa Reform In A Post-Dobbs World, Katherine Robertson

Seattle University Law Review

Part I of this Comment will provide an overview of HIPAA and the legal impacts of Dobbs. Part II will discuss the anticipatory response to the impacts of Dobbs on PHI by addressing the response from (1) the states, (2) the Biden Administration, and (3) the medical field. Part III will discuss the loopholes that exist in HIPAA and further address the potential impacts on individuals and the medical field if reform does not occur. Finally, Part IV will argue that the reform of HIPAA is the best avenue for protecting PHI related to reproductive healthcare.

Comparing Biofilm Forming Potential Of Listeria Species On Non-Food And Food-Contact Surfaces Of Importance To The Dairy Industry, Hannah Cooper

The Journal of Undergraduate Research

Listeria monocytogenes (Lm) is a foodborne pathogen of major safety concerns. This bacterium can resist/adapt to environmental stressors and persist through forming robust biofilms despite dairy plants following stringent surface cleaning protocols. Surface roughness is considered a major factor controlling bacterial attachment and biofilm formation. Food contact surfaces like stainless steel (SS) have low surface roughness for easy cleaning. On the other hand, non-contact surfaces like floors need a rougher surface to ensure employee safety. Hence, we hypothesized that Listeria biofilm formation would be lower on stainless steel compared to clay brick (CB; common flooring material in dairy plants). …

Exercise Training, Cardiac Biomarkers, And Cardiorespiratory Fitness In Type 2 Diabetes: The Hart-D Study, Kershaw V. Patel, Amit Saha, Colby R. Ayers, Anand Rohatgi, Jarett D. Berry, Jaime P. Almandoz, Neil M. Johannsen, Christopher Defilippi, Timothy S. Church, James A. De Lemos, Ambarish Pandey

Clinical Research Faculty Publications

Background: High-sensitivity cardiac troponin T (hs-cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) are cardiac biomarkers commonly detected in adults with type 2 diabetes (T2D) and are associated with heart failure risk. Objectives: The purpose of this study was to evaluate the effects of exercise training (ET) on hs-cTnT and NT-proBNP and evaluate the associations of these biomarkers with cardiorespiratory fitness among adults with T2D. Methods: Participants of the HART-D (Health Benefits of Aerobic and Resistance Training in Individuals with Type 2 Diabetes) trial who were randomly assigned to one of 3 ET groups or a non-exercise control group were included. …

The Role Of Fmri In Drug Development: An Update, Owen Carmichael

Clinical Research Faculty Publications

Functional magnetic resonance imaging (fMRI) of the brain is a technology that holds great potential for increasing the efficiency of drug development for the central nervous system (CNS). In preclinical studies and both early- and late-phase human trials, fMRI has the potential to improve cross-species translation of drug effects, help to de-risk compounds early in development, and contribute to the portfolio of evidence for a compound’s efficacy and mechanism of action. However, to date, the utilization of fMRI in the CNS drug development process has been limited. The purpose of this chapter is to explore this mismatch between potential and …