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How likely is it that the average American will become an inventor? With a novel idea and hard work, it should be a possibility for all Americans. The data suggests otherwise. Most patents are obtained by inventors that work for large corporations. Small businesses, solo inventors, women, and minorities lag behind their counterparts in patenting. A common explanation for this phenomenon is that it is a “pipeline” issue. However, evidence suggests that the patent system is not accessible to underrepresented innovators for more problematic reasons. At almost the same time as information about the concentration of patenting activity has garnered attention, the U.S. Patent and Trademark Office (“USPTO”) has become more vocal about its interest in Artificial Intelligence (“AI”). AI will transform how the USPTO examines patent applications. It may also transform how people invent. What has been absent from the conversation about AI and patenting is the negative effect AI has had when introduced in other social systems. For example, AI models can exhibit bias that concentrates power around incumbents. In addition, leaders overestimate the ability of AI models to solve human issues. This article refers to these problems collectively as “AI enthusiasm.” This Article argues that AI enthusiasm threatens to make the patent system less accessible for underrepresented innovators. In response, this article presents a framework for improving access to the patent system given the emergence of AU. First, limits must be placed on AI-assisted examination informed by best practices that combat AI bias. Second, the USPTO should grant patents to inventions that are created with the assistance of AI only if the AI involved adheres to a set of best practices that reduce the chance of biased outcomes. Finally, true access involves removing obstacles to the innovation culture that has historically been closed to underrepresented inventors. Thus, AI tools should be deployed to assist underrepresented innovators in the patenting process. Collectively, these measures may provide U.S. innovators from all walks of life the opportunity to call themselves an inventor.

Interactive inventions are systems and processes that can be used by multiple actors at the same time. Many interactive inventions are the product of emerging technologies such as the Internet of Things that allow billions of everyday devices to communicate with each other via the Internet. Other interactive inventions are prevalent in the emerging fields of personalized medicine and FinTech (new financial technologies). Unfortunately, the law concerning how to determine liability when a patent directed to an interactive invention is infringed is dissonant across classes of inventions. Specifically, what it means to “use” an interactive system is different from what it means to “use” an interactive method. Why does the law treat these acts differently? Should it? This Article attempts to answer these important questions. Specifically, this Article contends that the current framework for what it means to “use” an interactive system is problematic. Interactive inventions are different than traditional method and system inventions. Unfortunately, courts have too often applied, especially in recent cases involving interactive systems, an outmoded framework to interactive inventions. When interactive inventions are analyzed under the proper framework, it allows for the application of sound legal principles to solve multi-actor liability problems. Specifically, this Article argues that a direct infringer “uses” an interactive system when it controls the system and obtains a benefit from it. This approach is also more consistent with the recently broadened standard for infringement of interactive methods.

A court may award attorney fees to a prevailing party in a patent trial under exceptional circumstances. Since 2005, courts had applied a rigid formula to determine whether a case was exceptional. In the summer of 2014, the Supreme Court rejected this rigid test. Instead, the Court held that an exceptional case is “simply one that stands out from others.” Finding a case exceptional, the Court said, was at the discretion of the district court and only reviewable on appeal for an abuse of discretion. A little over a year later, one interesting question is: how do district courts now determine what cases are exceptional in the absence of a more formulaic approach? The analysis of several recent cases reveal that district courts primarily analyze a party’s (1) litigation position and (2) litigation conduct to determine whether — in its discretion — to award attorney fees. To a lesser degree, district courts have also awarded attorney fees to deter infringement and unsavory litigation practices. However, the deterrence rationale has the potential to be problematic: its purpose is to deter litigation practices, but given the current legal climate it could be used to unfairly penalize litigants that might be classified as “patent trolls.” The existing literature on the award of attorney fees in patent cases sheds very little light on the problems district courts’ reliance on the deterrence rationale could present. This essay addresses these problems and offers practical insights as to when courts should rely on the deterrence rationale to award attorney fees. The essay points out that what makes a case exceptional should have little to do with the identity of the parties. In addition, this essay prescribes that district courts should not take into account the business model of the parties to justify deterrence as a rationale for awarding attorney fees.

Purpose: This experiment was designed to assess the feasibility of radio frequency energy delivered by a prototype radio frequency generator inductive heating device (REVAX) positioned external to the body, for transient heating of stents after arterial implant. Methods and Materials: Twenty-one New Zealand White rabbits underwent stenting of their infrarenal aorta. Nine rabbits were stented and immediately placed in the REVAX for external stent heating with internal temperature probes in place. Twelve rabbits were stented and 3 days later either heated or placed in the generator as a sham for 20 min. The animals were terminated 28 days later. Results: The REVAX was able to heat the aortic stents in a controlled fashion; in Phase II experiments, the stent temperature was raised to 42 °C for 20 min. In Phase I mild necrosis was noted at the stent struts. In Phase II, necrosis and mineralization of the media was seen at the stent struts, and evidence of neointimal suppression was observed. Conclusion: This study demonstrated that external heating of stents in a blood vessel in a live animal via radio frequency energy is feasible. Further studies will be needed to assess whether any specific heating regimen might inhibit fibrocellular neointimal hyperplasia.

Purpose: Endovascular brachytherapy for the prevention of intimal hyperplasia (IH) and restenosis after balloon/stent angioplasty has proven effective both in animal preparations and clinical trials. A variety of β-emitting isotopes and catheter-based devices have been developed for the delivery of low-dose radiation in clinical coronary and peripheral trials. No platform, however, has yet been developed for brachytherapy in concert with vascular surgical operations. The purpose of this study was to evaluate the vascular histopathologic response following balloon injury to rabbit carotid arteries with and without topically applied low-dose β-radiation. Methods: The β-emitting isotope strontium-90 (Sr-90) was conjugated onto the matrix of polypropylene (PLYP) mesh. Rabbit carotid arteries were balloon-injured with a #2 embolectomy catheter. Six carotid arteries were wrapped with nonradioactive PLYP mesh (controls) and Sr-90 (∼90 μCi) PLYP mesh in order to deliver low-dose radiation to the vessel wall from the external (adventitial) surface. Tissue was harvested at 6 weeks and processed for histologic examination. Results: There was consistent blockade of fibrocellular neointima formation with virtually no neointima present in all treated segments, compared to moderate neointima formation in controls. Medial thinning and smooth muscle cell (SMC) necrosis were also associated with topical brachytherapy. Conclusion: β-Radiation applied by an externally wrapped PLYP mesh labeled with Sr-90 markedly suppressed neointima formation in an animal vascular surgical injury model. Further studies, however, are necessary to determine a suitable isotope and dosage for clinical application.

Juvenile toxicology studies for pharmaceutical and biotechnology products are becoming more commonly conducted. Regulatory guidance indicates a case-by-case approach to program and study design. Routine toxicology assessments can be applied to these studies, in addition the functional development of a series of organ systems, including nervous (behavior/cognition), cardiovascular, gastro-intestinal, pulmonary, renal, immune, skeletal (growth) and reproductive, have been identified for potential evaluation. Typically these tests can be added to both rodent and non-rodent studies, however there are some limitations. Testing of reproductive and behavioral development is routine in rodents but for non-rodents can present some problems. Toxicokinetics are typically incorporated in these studies and metabolic assessments, such as enzyme induction, can also be added to provide information on hepatobiliary development. It is concluded that, whilst the development of various organ systems can be evaluated, care in the use of these evaluations in juvenile toxicology testing programs is needed to ensure appropriate studies.