CAS recently organized a symposium titled "Emerging Therapeutics at the Intersection of Biology and Chemistry." Held during ACS Fall 2023 at San Francisco's Moscone Center under the ACS Technical Division of Multidisciplinary Program (MPPG), the event provided a valuable platform for knowledge exchange and insightful discussions.

Dr. Gilles Georges, CAS Chief Scientific Officer, opened the symposium by outlining the CAS mission and showcasing its data analytics and exceptional talents. He highlighted broad scientific content coverage, connections, and unique technology that establishes it as a hub for knowledge sharing. He introduced the process by which our expert scientists extract insights through novel connections across disparate datasets.

Exploring the evolving landscape of immuno-oncology: A data-driven analysis of emerging concepts and therapeutic targets

Dr. Sabina Scott, a CAS information scientist, shared the trend analysis of immuno-oncology publications based on the CAS Content Collection™. Recently, research interest and publications in immuno-therapy have grown, but how can someone identify the right signals from the noise? To detect emerging concepts, a combination of natural language processing (NLP) technology and human intelligence is used to evaluate each document and verify similar content within a broader set of retrieved answers. Many of these emerging concepts are in the areas of immune-oncology biomarkers, types of target proteins, types of therapeutics, and biological mechanisms.

Immune responses and memory to SARS-CoV-2 and COVID-19 vaccination: Lessons for future vaccines

From La Jolla Institute for Immunology, Dr. Shane Crotty's presentation took center stage, offering a profound exploration of the latest discoveries in COVID-19 immunity and vaccine development. He shared their research discoveries of how acute and memory T cells, antibodies, and memory B cells respond to SARS-CoV-2 infections and vaccines. He then discussed their results by analyzing multiple compartments of circulating immune memory to SARS-CoV-2 from several hundreds of COVID-19 cases over 8 months, including memory B cells, antibodies, CD4+ T cells, and CD8+ T cells. Their findings from assessing humoral and cellular immune memory to four COVID-19 vaccines were another valuable gain. His session provided a timely perspective on the global challenge, introducing the concept of germinal centers, and underscoring their pivotal role in generating immunity upon vaccine introduction. This perspective illuminated the intricate mechanisms of immune response, resonating strongly with the audience given the worldwide concern surrounding the pandemic.

Antibody-drug conjugates: The rising drug class for targeted therapy 

Dr. Yacid Rodriguez, representing CAS, delved into the potential of merging biology and chemistry through antibody-drug conjugates (ADCs). Antibody-drug conjugates (ADC) are a quickly rising class of biopharmaceuticals for highly targeted disease treatment. They consist of a monoclonal antibody connected to a small molecule drug with a stable linker. ADCs are primarily used for cancer treatment and target specific antigens to kill cancer cells without healthy tissue damage.

The research team used data from the CAS Content Collection to provide a landscape view and outline trends and challenges in the research advancement regarding ADCs. Scientific publications were identified and analyzed with respect to factors such as time, geography, linker technologies, along with payload selection and loading methods. ADC development pipelines, along with their clinical applications in disease therapeutics, are also examined. Understanding the current knowledge of the field will help guide further refinement and development for successful future ADC technologies.

Exosomes: Nature's lipid nanoparticles, a rising star in drug delivery and diagnostics

Dr. Andy Chen, a CAS information scientist, offered insights into the impactful realm of exosomes in therapeutic and diagnostic applications. Exosomes are a subgroup of nanosized extracellular vesicles enclosed by a lipid bilayer membrane and secreted by most eukaryotic cells. Their distinctive properties: innate stability, low immunogenicity, biocompatibility, and good biomembrane penetration capacity, allow them to function as superior natural nanocarriers for efficient drug delivery.

Dr. Chen shared the insights developed based on data from the CAS Content Collection and provided a landscape view of the current state and trends in research advancement on exosome applications in therapeutics and diagnostics across time, geography, composition, cargo loading, and development pipelines. He hopes that their work will be useful for understanding the current knowledge in the field of exosome medical applications to further solve the remaining challenges in fulfilling their potential. To learn more about the emerging landscape of exosomes, explore the CAS Insights Report which reveals the opportunities and challenges ahead.

Antibody oligonucleotide conjugates: Development of AOC 1001 for the treatment of myotonic dystrophy

Dr. Son Lam, the Director of Chemistry from Avidity Biosciences, shared an innovative drug candidate - an antibody oligonucleotide conjugate (AOC 1001) targeting Myotonic Dystrophy Type 1 (DM1), offering a glimpse into the future of medical intervention. Dr. Lam elaborated on how they used antibodies for targeted delivery of the oligonucleotide drug, ensuring specificity and stability.

There are more than 40,000 DM1 patients in the U.S., but none approved the drug for this type of disease. The AOC 1001 is designed to target underlying toxic Myotonin-protein kinase (DMPK) mRNA with a siRNA molecule. Preclinical studies showed this drug encompasses good safety and tolerability, targeted delivery to muscle, remarkable reduction of DMPK mRNA, and impact on disease mechanisms. Currently, AOC 1001 is Phase ½ development. Dr. Lam also introduced other two antibody oligonucleotide conjugates drugs, AOC 1044 and AOC 1020, targeting Duchenne Muscular Dystrophy (DMD) and Facioscapulohumeral muscular dystrophy (FSHD), respectively.

PEGylated lipid nanoparticle formulations: Immunological safety and efficiency perspective

Dr. Qiongqiong Angela Zhou's discussion on PEGylated lipid nanoparticles revealed their advantages in drug delivery while highlighting an area that warrants further attention. She stressed the importance of understanding how polyethylene glycol (PEG) triggers immune responses and its potential implications for future drug development. Angela presented an overview based on the analysis of data from the CAS Content Collection regarding the PEGylated LNP immunogenicity and overall safety concerns. Based on the literature review, she also summarized how various structural parameters of the PEG-lipids affect the immune responses and activities of the LNPs with regard to their efficiency in drug delivery. Dr. Zhou’s presentation serves as a message to the scientific community, calling for more research efforts in understanding PEG immunity. To learn more about PEGylated lipid nanoparticles and their immunogenicity concerns, explore our brief CAS Executive Summary and the more detailed peer-reviewed journal article in Bioconjugate Chemistry.

Looking forward

The symposium fostered meaningful discussions, enabling attendees to interact with experts and grasp cutting-edge advancements. It underscored the crucial role of uniting biology and chemistry to create innovative solutions for evolving medical challenges.

The level of investment into research and development has grown tremendously, with global spending expected to reach $2.476 trillion in 2022 alone. A robust intellectual property strategy is critical to protecting return on investment for new innovations. Understanding relevant patenting activity and conducting a prior art analysis before investing in an area is essential. Suppose disclosures have been made before your innovation’s patent filing date. In that case, the patent application will be rejected, so it is critical to identify relevant prior art early in the R&D process to determine future patentability.

Doing so can allow organizations to develop strategies to differentiate the innovation during the development and patent drafting stages and avoid wasted R&D spending.

Incomplete searches can lead to costly mistakes in IP strategy, given the significant amount of money invested in pre-market research and development of new inventions. Consequences of incomplete prior art analysis include rejection of patent applications, patent infringement, or invalidation of existing patents. For these reasons, understanding how to conduct an effective and thorough prior art analysis is crucial.

Where are prior art references found?

The most common place to begin a prior art search is with existing patents and patent applications. Rejected, pending, and abandoned patent applications can also be considered prior art if they disclose your innovation — wholly or in part. In addition to patent documentation, you can find prior art in non-patent literature, such as peer-reviewed publications, dissertations, conference presentations, and other similar disclosures.

The digitization of materials such as books, illustrations, objects, analog recordings, and photos has increased the volume of searchable materials to find prior art. At the same time, the volume of scientific publications is growing exponentially, leading to an increase in the amount of information required to review for a thorough prior art analysis. Moreover, modern-day scientific innovation often happens at the intersection of many disciplines. For these reasons, comprehensive prior art analysis is time-consuming and complex to navigate.

CAS STNext^® enables comprehensive prior art analysis by providing searchers with integrated access to the most current and complete collection of globally disclosed patent and non-patent, scientific, and technical content.

CAS combines over 100 diverse data collections, including leading chemistry content from the CAS Content Collection^TM — a comprehensive collection of databases and curated sources containing patent and non-patent literature. It is one of the few sources for searchable global patent Markush disclosures, containing over 1.2 million searchable Markush structures covered in patents from 1988 to the present, and is updated daily.

IP professionals can access these rich and authoritative datasets through CAS STNext, which offers an advanced interface and powerful precision search capabilities. By adding CAS STNext to your toolkit, you can thoroughly assess risks and commonalities with the prior art and guide smarter, data-driven decisions.

Explore the capabilities of CAS STNext.

How to identify appropriate search sources for prior art analysis

IP searchers have various options for sources when planning a prior art search strategy, and choosing the right resources is critical. If you're looking for a broad overview of the patent landscape, search engines and patent office interfaces are helpful places to start. However, these sources could be more extensive in their functionality and coverage. Many open-source search tools need more customized algorithms to navigate complex scientific information, such as chemical formulas and biological processes. Another major hurdle of open-source search engines is that, in many cases, they cannot pull information from documents such as image-based PDFs. Additionally, many open-source search engines don’t include the breadth of information needed to capture relevant documents. This causes gaps in prior art searches.

To close these gaps, IP analysts rely on multiple sources. Those innovating in scientific industries turn to trusted search platforms like CAS STNext to support an efficient and comprehensive review of existing literature and scientific information. In addition to enabling search across multiple sources, CAS STNext leverages cutting-edge technology and expert human curation to support precision searching and identify documents that are generally difficult to find—even for experienced IP researchers. CAS STNext also offers an “index look up” feature and artificial intelligence to enable searchers to identify the relevant information for their technology of interest quickly.

Check out this webinar to learn how CAS STNext uses artificial intelligence to boost your prior art analysis.

Defining the scope of a prior art search

When formulating a prior art search, it is critical to consider the currency and coverage of your sources. Searchers must consider the legal requirements of the search and understand the details of what information is covered (or not covered) within individual sources.

It is crucial to understand the details of the publication dates, content update schedule, country coverage, etc., of your sources to ensure your search meets the legal requirements of the requesting stakeholder.

Review the search scope periodically to ensure that it remains relevant and up-to-date. If the product strategy changes (for example, to expand into new global markets), it is vital to understand the scope of the original search to determine if the conclusions hold for the new requirements. This can help identify any potential gaps in the search and ensure that the conclusions drawn are reliable. 

Check out this article, which explains the importance of casting a wider net in a prior art search.

How to formulate an appropriate prior art query

When it comes to formulating the best prior art query, clearly defining the technical features of the invention is essential. A clear understanding of the technical features allows you to determine the relevant search terms (including synonyms) and sources for the search, reducing the chances of missing any relevant prior art.

Some considerations when identifying appropriate keywords include spelling variations, keywords in foreign languages, and historical terms for different patent classifications.

The field of innovation shapes the query. For example, querying a chemical structure for chemistry-based inventions can be an effective strategy for conducting an effective prior art analysis. In contrast, a query for numerical information such as pH ranges or temperature is an effective method in engineering. A precise query will save time during the post-search review and help identify prior art that less sophisticated methods may miss.

How do you know when you have completed a thorough prior art analysis?

Deciding when it’s a good idea to stop searching is an important and challenging decision. One of the best ways to determine when to stop is by the principle of convergence. This can be accomplished by searching in different ways, such as using many keywords, citations, competitor reviews, or chemical information, and checking if the query returns the same results. Once the results converge, it’s safe to say that the search is thorough.

Applying this principle is essential for maximizing the value of your search strategy. Searching without convergence could mean missing important keywords or search terms, leading to a prior art analysis that misses crucial pieces of the prior art. At the same time, searching too deeply can be time-consuming and expensive without generating additional meaningful results.

Look at this article, which explains key points to consider when conducting a prior art search.

Consulting professionals with expertise in your industry and in prior art analysis will save you time and money

Comprehensive prior art searches are often conducted late and are incomplete, leaving the organization and its R&D pipeline at risk. The cost of missing relevant prior art is high; in 2020, the United States courts awarded $4.67 billion in damages for patent infringement. It is imperative to identify prior art before investing in R&D and to continue identifying new prior art after the innovation is successfully developed.

Even with top-tier IP search tools, ensuring your prior art analysis is airtight is challenging. Working with technology and IP search experts to assist in conducting comprehensive prior art searches can save time while ensuring that no piece of prior art is missed.

Consider CAS 
The CAS team comprises knowledgeable experts in chemistry and the life sciences, as well as in prior art analysis. Hundreds of scientists work daily to build the CAS Content Collection, ensuring that complex aspects of patent documents, including chemical substances, sequences, and Markush structures, are searchable and easily accessible.

This unique wealth of knowledge underpins CAS’s abilities, enabling them to curate comprehensive databases, offer reliable IP tools such as CAS STNext for self-service searches, and provide trusted search support when needed.

Get in touch to learn more about CAS STNext or to organize a demonstration of CAS IP solutions in action.

Patents are one of the most important forms of protection for innovations. If you are pursuing or considering a patent, there are several things to keep in mind.

The patentability of scientific innovations has unique challenges due to the complexities of the technology, the barriers to a thorough prior art search, and the ever-changing nature of these industries. This article explores the unique challenges of patentability assessments within scientific industries, offers best practices to help address those challenges, and highlights how CAS can help.

Scientific innovations are complex and multilayered, magnifying the patent search challenge

The more complex a technology is, the more there is to consider and query when performing a patentability assessment. Critical information could be hiding in various sources that go beyond patents and the typical non-patent literature that must be mined to get a comprehensive picture of prior art.

Let’s take a look at RNA innovations.

Nanoparticle delivery, ligands, conjugates, and types of chemical modifications must be considered when performing a patentability assessment. It's not a simple BLAST or motif search to find a related sequence. It's identifying the technology that has evolved over time and understanding who has a stake in it.

Companies turn to CAS Solutions to assist them in identifying the technology that's been disclosed publicly, minimize their risk, innovate earlier, and avoid the risk that comes with not doing due diligence early and thoroughly.

Keep an eye out for possible IP entanglements 

Intellectual property (IP) entanglements refer to situations where a company’s IP rights or freedom to operate are restricted by existing IP owned by another party. Such entanglements can arise due to several reasons including technology convergence, cross-licensing agreements, research collaborations, and mergers and acquisitions. IP entanglements can have a significant impact on the patentability of an invention, particularly in highly regulated industries such as pharmaceuticals and functional materials. Identifying and managing IP entanglements is important as it can impact a company’s ability to innovate, commercialize, and generate revenue.

Take a look at Enbrel, a blockbuster drug for treating rheumatoid arthritis. The drug was initially developed by Immunex Corporation, which was later acquired by Amgen. However, the original patent on Enbrel was co-owned by Immunex and Wyeth Pharmaceuticals, which was later acquired by Pfizer. This led to a complex legal battle over the patent rights of Enbrel, with both Amgen and Pfizer claiming ownership of the patent. The case was finally settled in 2017, with Amgen gaining full ownership of the Enbrel patent.

The development of biosimilars adds another layer of complexity to IP entanglements. The production of biosimilars requires the use of cell lines and manufacturing processes, which may be protected by existing patents.

With the ever-changing patent landscape in the biotechnology industry, how do you keep up?

New patents are being filed every day, and the patent landscape is constantly shifting. For instance, our in-house experts estimated that over 10,000 patents have been issued in the last 10 years of the RNA innovation landscape. This creates challenges for innovators, as the complex documentation and literature to sort through become increasingly difficult to navigate. The question that arises for many in the industry, then, is “How do I keep up?”

The first step to a thorough and up-to-date patentability assessment is investing in a reliable IP search tool

The search tool you choose should be updated regularly with new patents and non-patent literature. There are many search tools on the market today, but not all of them offer the same features or quality of results. Some of the open-source options available lack customizable search algorithms—a must-have for the scientific industries—or do not provide the most relevant and new information.

CAS provides a range of solutions to help customers understand possible IP entanglements in various industries. For example, CAS' scientific and technical solutions, such as CAS SciFinderⁿ and CAS STNext^Ⓡ, provide access to a wealth of information on patents, scientific literature, and regulatory data, helping customers identify potential IP entanglements and navigate complex competitive environments.

CAS IP Services^SM provides customized solutions to help customers address specific IP challenges, such as freedom-to-operate assessments, patentability assessments, and patent portfolio analysis. These services leverage CAS' deep expertise in patent searching and analysis, as well as its extensive network of global patent experts.

Check out all that CAS STNext^® has to offer!

The effectiveness of your search strategy depends on the data sources

Inconsistent terminology and incomplete indexing are threats to reliable patent assessment for chemistry and biotech innovations. Chemical formulas, structures, biological sequences and modifications can go uncaptured, leading to gaps in your assessment. There is no single search strategy that can be used to efficiently and comprehensively retrieve this information from different data sources.

To identify all relevant prior art and conduct a thorough patentability assessment you need a strategy and effective tools built on comprehensive, well-structured databases.

The CAS Content Collection^TM is built with these challenges in mind, ensuring that complex aspects of patent documents and non-patent literature, including chemical substances, sequences, and Markush structures, are searchable and accessible.

CAS provides unique value with CAS STNext, a trusted solution that allows you to search more than 130 premium global databases in a single interface.

Go beyond the technology and consider geography

Conducting a search in the appropriate geographic scope is extremely important. If you search for literature in a too broad geographic area, you’ll end up with too many documents to sift through. However, if your search is too narrow, you may miss relevant documents and connections.

How do you decide the appropriate geographic scope of your search? Depending on the type of assessment you are considering, the appropriate geographic area may be different. For example:

• Patentability evaluation: The goal of a prior art search during a patentability evaluation is to find all relevant existing prior art that may impact the novelty of your innovation. If any such information is found, it can derail your R&D strategy. In the United States, any prior art worldwide is considered for patentability determinations.
• Freedom-to-operate search: When combing through the claims within in-force patents, your search strategy may differ depending on the location in which you plan to operate and sell your innovation. Our FTO search strategy will differ, depending on where you want to operate and sell your invention. Depending on your commercialization strategy, you may be able to narrow the scope of your search to limit to select major patent offices. For a global launch, you will need to be more expansive in your target search.

Summary

With evolving and quickly changing IP landscapes in scientific industries such as functional materials and pharma, having up-to-date and highly comprehensive tools to support IP search is essential.

The STN IP Protection Suite^TM contains the tools you need to protect your scientific IP and conduct thorough and comprehensive prior art and freedom to operate searches. You’ll have access to unparalleled content from patent and non-patent sources, aggregated, curated, and translated by scientists. Mitigate risk and protect your IP assets with monitoring tools, and specialized technology to stay ahead of competitors and protect your inventions. And if you need additional support, our IP experts are ready to help you and act as an extension of your IP team.