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Cancer immunotherapy or immuno-oncology (I-O) has gone mainstream. You may have heard about these topics in the media. Along with having surgery and radiation therapy, Former President Jimmy Carter was treated with the monoclonal antibody pembrolizumab (Keytruda®) that stimulated his immune system to fend or fight off melanoma that had metastasized to his brain. His remarkable response has highlighted the power of immunotherapy. After his son Beau succumbed to brain cancer, Vice President Joe Biden helped spearhead the Cancer Moonshot, a national initiative to cure cancer, one of the main goals of which is furthering immunotherapy research. The White House has dedicated $1 Billion to this initiative. This article will introduce you to immunotherapy and how it is now beginning to intersect with the microbiome. Recent patent filings suggest that intellectual property protection will be an important part of the research efforts in this field. Bolded patent documents are further summarized in the table at the end of this installment.

Dr. Anthony Sabatelli of Dilworth IP will be co-chairing the STEM Careers: Formulae and Solutions for Success event hosted by the Association of Yale Alumni (AYA) this Saturday, October 15th, from 9:00 AM to 6:00 PM at the Loria Center in New Haven, CT. This event seeks to help Yale students with developing career paths by connecting them with a network of Yale alumni who have had success in the work force. The day will include sessions on interviews, networking, public speaking and time management, as well as more specialized sessions on Computer Science, Biotech, Engineering and Physical Science.

On September 13, the Federal Circuit held that a series of ordered combination of steps related to lip-synch software did not constitute an abstract idea, and was subsequently patent eligible under §101 (McRO, Inc. v. Bandai Namco Games America). This decision reversed and remanded an earlier decision issued by the United States District Court for the Central District of California in McRO, Inc. v. Sony Computer Entertainment America, LLC. This case, which was followed closely by the IT community, also has important, positive implications for the patent eligibility of biotech inventions.

Dr. Anthony Sabatelli, Partner at Dilworth IP, will be presenting a talk entitled “Patent Overview for the Life Sciences” at the SAPA-CT 3rd Annual Conference on Saturday, October 8th. The Sino-American Pharmaceutical Professionals Association (SAPA) was founded in 1993 as an independent and nonprofit organization seeking to bridge the U.S. and Chinese pharmaceutical worlds by providing training in drug research and development, creating a broad network, and hosting delegations from China. This year’s conference will be held at the Omni New Haven Hotel at Yale from 8:00 am to 6:30 PM.

Many research efforts into the microbiome have focused primarily on the human microbiome, i.e. microorganisms within and on the body, and how changes in these microbial communities correlate with changes in health and disease. Less attention, however, has been paid to the microbial communities external to humans and how changes in these communities can affect health. These communities have a broad range, from the microbiome of indoor spaces, also called the microbiology of the built environment (MoBE), to microbial communities found outdoors. Microbial communities that give certain foods, such as San Francisco sour dough bread, various wines, beers, and even cheeses, characteristic qualities like taste and texture are also examples of external microbiomes. As with the human microbiome, scientists do not yet fully understand how changes in external or indoor microbiomes could alter human health, but we see plentiful possibilities for further research and intellectual property protection of subsequent innovation, especially with regards to the MoBE. This article concludes with a sampling of some of the patenting activity in this area.

A critical step to effectively fighting cancer is detecting it at a very early stage. Currently the clinical diagnosis of cancer mainly relies on imaging techniques such as X-ray, mammography, ultrasound, endoscopy, computed tomography (CT), magnetic resonance imaging (MRI) and histopathology [e.g., examination of a tissue biopsy under a microscope]). However, these techniques often cannot distinguish differences between healthy and diseased cells/tissues at the early stage of cancer, when the malignancy of tissues are not sufficiently visible, but the alternation of far more subtle protein and molecular markers due to the cancer have already presented. Although notable successful techniques have been developed in the molecular analysis such as enzyme-linked immunosorbent assay (ELISA), polymerase chain reaction (PCR), and fluorescence in situ hybridization (FISH), these techniques are labor intensive, involving complex operational procedures, and requiring high stability of reagents. Therefore, the market is calling to develop new techniques and tools to enhance the biomarker detection at the very early stages of cancer.

Dilworth IP has now added a Resources page to our website which will offer electronic versions of the Firm’s publications for download. Our intention is to provide you with relevant information on cutting-edge technologies, evolving patent trends and the best strategies for protecting your IP. Please CLICK HERE to visit our resources page, and be sure to check back for future publications.

Frederick A. Spaeth, Partner at Dilworth IP, will be hosting a FREE webinar on Wednesday, October 19th at 1:00 PM (EDT). This installment in the Dilworth IP Webinar Series is entitled Advanced Strategies for Drafting CDAs – Beyond the Boilerplate, and will focus on properly structuring Confidentiality Agreements (CDAs), or Nondisclosure Agreements (NDAs). NDAs seem to be used by everyone: businesses, politicians, religious organizations, celebrities, governmental bodies, etc., the single common denominator being an obligation not to share certain information with others. Beyond that…

A split of opinions on the scope of authorization for accessing a computer that is needed to avoid violation of the Computer Fraud and Abuse Act (“CFAA” or “Act”), 18 U.S.C. § 1030 was examined in Phillips Medical v. GIS (U.S. Dist. Of Puerto Rico) Aug. 2016, in which Magistrate Judge Bruce McGiverin adopted an inclusive view of the entities whose authorization is needed under 18 U.S.C. § 1030(a)(2).

Dilworth IP welcomes Nicholas Vincent, a Technology Specialist who will be joining the Firm’s growing Biotech and Pharmaceutical Practice. Nick is currently working toward his doctorate in Microbiology at Yale University where he received the Gruber Science Fellowship, awarded to the highest ranked PhD candidate in his/her field. He also currently serves as the Chairman of the Yale Graduate Student Assembly, and has previously served as the co-Editor-in-Chief of the Yale Journal of Biology and Medicine. Nick has a specialized background in microbiology, molecular and cellular biology, biochemistry, protein biology, RNA biology, microbial pathogenesis, and immunology. His expertise in these cutting-edge technologies further strengthens the Firm’s Biotech and Pharmaceutical Practice area and strengthens Dilworth IP’s commitment to providing our clients with the highest level of technical proficiency. We are excited to welcome Nick to our team.