The Broadest Reasonable Interpretation and Applying Issue Preclusion to Administrative Patent Claim Construction

Inventions are tangible. Yet patents comprise words, and words are imprecise. Thus, disputes over patents involve a process known as “claim construction,” which formally clarifies the meaning of a patent claim’s words and, therefore, the scope of the underlying property right. Adversarial claim construction commonly occurs in various Article III and Article I settings, such as district courts or the Patent Trial and Appeal Board (PTAB). When these proceedings ignore each other’s claim constructions, a patent’s scope can become inconsistent and unpredictable. The doctrine of issue preclusion could help with this problem. The Supreme Court recently reemphasized in B & B Hardware v. Hargis Industries that administrative decisions can have issue preclusive effect. But district courts and the PTAB use formally different legal standards in claim construction, where the district court takes a narrower view of a patent’s scope. This Note contends that a claim construction determination made by the PTAB under the “broadest reasonable interpretation” standard should, indeed, be the broadest reasonable interpretation of a claim. To facilitate uniformity and public notice, issue preclusion should be applied such that the PTAB’s “broadest reasonable interpretation” is an outer interpretive bound of a patent’s scope in subsequent district court litigation

The Unified Patent Court and Patent Trolls in Europe

Healthy organisms inevitably produce cancer cells, and vibrant patent systems inevitably let bad patents slip through. These patents are harnessed by entities that leverage the uncertainty and expense of litigation to extract licenses from technological practitioners. Postissuance patent review (PIPR) has emerged as an invaluable errorcorrecting mechanism to prevent the socially harmful assertion of improperly issued patents. The United States, with the America Invents Act, established a new system for PIPR, expanding administrative routes to curtail bad patents. Europe is going a step further with the Unified Patent Court Agreement (UPCA). The UPCA enables a lowcost patent revocation action on a broad range of grounds and with a relaxed standing requirement. But this is an opt-in system with a loser-pays fee-shifting arrangement. Thus, although the structure of the Unified Patent Court (UPC) appears to be set up to facilitate efficient PIPR, the disincentives for opting in suggest that the UPC will be a less effective troll-fighting vehicle than expected. Indeed, patent trolls may simply opt for national patent systems

Hierarchy, Race & Gender in Legal Scholarly Networks

A potent myth of legal academic scholarship is that it is mostly meritocratic and mostly solitary. Reality is more complicated. In this Article, we plumb the networks of knowledge co-production in legal academia by analyzing the star footnotes that appear at the beginning of most law review articles. Acknowledgments paint a rich picture of both the currency of scholarly credit and the relationships among scholars. Building on others’ prior work characterizing the potent impact of hierarchy, race, and gender in legal academia more generally, we examine the patterns of scholarly networks and probe the effects of those factors. The landscape we illustrate is depressingly unsurprising in basic contours but awash in details. Hierarchy, race, and gender all have substantial effects on who gets acknowledged and how, what networks of knowledge co-production get formed, and who is helped on their path through the legal academic world

Genomics as a tool for natural product structure elucidation

Natural product discovery is in the midst of a transition from a largely serendipity-based effort to an informatics-driven one. For most of the 20th century, natural product discovery relied on genome-blind bioassay-guided isolation. This was initially exceptionally productive, yielding the golden age of antibiotics. The fact that a majority of all medicines—especially antibiotics—are in some way derived from or inspired by natural products is a testament to the importance of understanding and harnessing the chemical strategies for biological interaction that have evolved over millions of years. Unfortunately, the overwhelmingly frequent rediscovery rate of known compounds among screened natural extracts meant that what was initially a life-saving torrent of new drugs eventually dried up into a costly trickle. Unfortunately, this has coincided with the rise of drug-resistance superbugs as our initial stockpiles of antibiotics have become overdeployed. Fortunately, we are now poised to enact an antibiotic renaissance powered by the ease and affordability of large-scale genomic analysis. The ability to genome-gaze has not only revealed hundreds of thousands of yet-untapped secondary metabolites in sequenced organisms but also can facilitate strain prioritization, novelty determination (dereplication), structure elucidation, three principal bottlenecks in the discovery process, as reviewed in Chapter 1. We report here progress in the use of genomics to facilitate the discovery and contextualization of new chemical matter. In Chapter 2, we report the discovery, isolation, and structural elucidation of streptomonomicin (STM), an antibiotic lasso peptide from Streptomonospora alba, and report the genome for its producing organism. STM-resistant clones of Bacillus anthracis harbor mutations to walR, the gene encoding a response regulator for the only known widely-distributed and essential two-component signal transduction system in Firmicutes. Our results demonstrate that understudied microbes remain fruitful reservoirs for the rapid discovery of novel, bioactive natural product and also highlight the usefulness of genomics in combination with NMR and HR-MS/MS for determining the structure of ribosomal natural products. In Chapter 3, we use HR-MS/MS, reactivity-based screening, NMR, and bioinformatic analysis to identify Streptomyces varsoviensis as a novel producer of JBIR-100, a fumarate-containing hygrolide. Using a combination of NMR and bioinformatic analysis, we elucidated the stereochemistry of the natural product. We investigated the antimicrobial activity of JBIR-100, with preliminary insight into mode of action indicating that it perturbs the membrane of Bacillus subtilis. S. varsoviensis is known to produce compounds from multiple hygrolide sub-families, namely hygrobafilomycins (JBIR-100 and hygrobafilomycin) and bafilomycins (bafilomycin C1 and D). In light of this, we identified the biosynthetic gene cluster for JBIR-100, which, to our knowledge, represents the first reported for a hygrobafilomycin. Finally, we performed a bioinformatic analysis of the hygrolide family using our RODEO algorithm from Chapter 4, describing clusters from known and predicted producers. Our results indicate that potential remains for the Actinobacteria to yield novel hygrolide congeners and provides a survey of the hygrolide landscape. In Chapter 4, we report RODEO (Rapid ORF Description and Evaluation Online), an algorithm which combines hidden Markov model-based analysis, heuristic scoring, and machine learning to identify biosynthetic gene clusters and predict RiPP precursor peptides. We initially focused on lasso peptides, which display intriguing physiochemical properties and bioactivities, but their hypervariability renders them challenging prospects for automated mining. Our approach yielded the most comprehensive mapping of lasso peptide space, revealing >1,300 compounds. We characterized the structures and bioactivities of six lasso peptides, prioritized based on predicted structural novelty, including an unprecedented handcuff-like topology and another with a citrulline modification exceptionally rare among bacteria. These combined insights significantly expand the knowledge of lasso peptides, and more broadly, provide a framework for future high-throughput genome mining. In addition to lasso peptides, RODEO provides the ability to analyze local genomic regions using custom profile hidden Markov models (pHMMs) and is suitable for RiPP, polyketide (PKS), nonribosomal peptide (NRPS), and other natural product biosynthetic gene cluster types; as part of an effort to make it available as a community resource we have created a web portal with its code and tutorials

Hierarchy, Race & Gender in Legal Scholarly Networks

A potent myth of legal academic scholarship is that it is mostly meritocratic and that it is mostly solitary. Reality is more complicated. In this Article, we plumb the networks of knowledge co-production in legal academia by analyzing the star footnotes that appear at the beginning of most law review articles. Acknowledgements paint a rich picture of both the currency of scholarly credit and the relationships among scholars. Building on others’ prior work characterizing the potent impact of hierarchy, race, and gender in legal academia more generally, we examine the patterns of scholarly networks and probe the effects of those factors. The landscape we illustrate is depressingly unsurprising in basic contours but awash in details. Hierarchy, race, and gender all have substantial impacts on who gets acknowledged and how, what networks of knowledge co-production get formed, and who is helped on their path through the legal academic world

From Petri Dish to Main Dish: The Legal Pathway for Cell-Based Meat

Meat grown outside an animal is no longer simply science fiction, and the market is poised for introduction of a variety of so-called cell-based meat products. Commercializing these products will require a clear regulatory path forward. In this Article, we explore that legal pathway. We introduce the concepts of cellular agriculture and cell-based meat, including the science, the state and history of the industry, and the general regulatory background, in which the USDA and FDA are the major players. Further, we explore in particular regulatory aspects of food safety and labeling in the context of cell-based meat. Overall, we contend that there is a viable pathway forward for cultivated meat companies under the current regulatory scheme. But a nontrivial degree of uncertainty remains, and regulators would do well to be proactive in issuing guidance in this space. Moreover, cell-based meat remains vulnerable to legal challenges

Acknowledgments as a Window into Legal Academia

Legal scholarship in the United States is an oddity—an institution built on student editorship, a lack of peer review, and a dramatically high proportion of solo authorship. It is often argued that this makes legal scholarship fundamentally different from scholarship in other fields, which is largely peer-reviewed by academics. We use acknowledgments in biographical footnotes from law-review articles to probe the nature of legal knowledge co-production and de facto peer review in legal literature. Using a survey of authors and editors and a textual analysis of approximately thirty thousand law-review articles from 2008 to 2017, we examined the nature of knowledge co-production and peer review in U.S. legal academia. Our results are consistent with the idea that substantial peer-review-like vetting occurs in the field. We also found evidence that both authors and editors use the information in acknowledgment footnotes as a factor in article submission and selection. Further, the characteristics of acknowledgment footnotes in articles in high-ranking law reviews differ dramatically from those in low-ranking law reviews in ways that are not simply due to differences in article quality. Finally, there are problematic gender differences in who is being acknowledged. We propose some modest changes to current practices that would help maximize transparency and minimize bias in legal scholarly networks and law-review article selection

On Lawyers and Copy Editors

Review of Benjamin Dreyer\u27s Dreyer\u27s English: An Utterly Correct Guide to Clarity and Style

The Broadest Reasonable Interpretation and Applying Issue Preclusion to Administrative Patent Claim Construction

Inventions are tangible. Yet patents comprise words, and words are imprecise. Thus, disputes over patents involve a process known as “claim construction,” which formally clarifies the meaning of a patent claim’s words and, therefore, the scope of the underlying property right. Adversarial claim construction commonly occurs in various Article III and Article I settings, such as district courts or the Patent Trial and Appeal Board (PTAB). When these proceedings ignore each other’s claim constructions, a patent’s scope can become inconsistent and unpredictable. The doctrine of issue preclusion could help with this problem. The Supreme Court recently reemphasized in B & B Hardware v. Hargis Industries that administrative decisions can have issue preclusive effect. But district courts and the PTAB use formally different legal standards in claim construction, where the district court takes a narrower view of a patent’s scope. This Note contends that a claim construction determination made by the PTAB under the “broadest reasonable interpretation” standard should, indeed, be the broadest reasonable interpretation of a claim. To facilitate uniformity and public notice, issue preclusion should be applied such that the PTAB’s “broadest reasonable interpretation” is an outer interpretive bound of a patent’s scope in subsequent district court litigation