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Last December, the US Patent and Trademark Office issued the “2014 Interim Guidance on Patent Subject Matter Eligibility” as further guidance to its examining corps for assessing patent eligible subject matter of claims reciting or involving laws of nature, natural phenomena, and natural products under 35 USC §101. The guidelines were issued in light of the high-profile Supreme Court decisions in Alice Corp., Myriad, and Mayo. Dr. Anthony Sabatelli, partner and chair of Dilworth IP’s pharmaceutical and biotech patent practice group provided his comments in person at the USPTO in January of this year.

Microbiome-related therapies typically involve compositions containing bacteria — often called probiotics — that treat disease or promote health. Some therapies change the composition of the gut microbiome by providing desirable bacterial species, nutrients that promote the growth of desirable microbiome members, or bacterial species that displace bacterial pathogens. Other therapies comprise bacteria or bacterial components that interact with the patient’s own organs, tissues, and systems. Many of these therapies stimulate the immune system, and therapies are being developed to treat various metabolic, inflammatory, and infectious diseases.

Research into the microbiome seeks to characterize the microorganisms that live in and on different environments. Although these environments can be broadly terrestrial, extraterrestrial aquatic, and biological, we often use the term specifically to describe the bacteria living in and on different sites of the human body. The word “microbiome” refers either to the organisms themselves (also called “microbiota”) or their collective genomes. Within the human gut, the most bacteria-rich organ, these genes outnumber those in the human genome 100: 1, providing attractive candidates for pharmaceutical intervention. Inflammatory bowel disease (IBD), childhood-onset asthma, diabetes, obesity, cardiovascular disease, colorectal cancer, and antibiotic-associated diarrhea are some of the diseases that involve changes in the composition or loss of the function of the microbiome.

On June 22, 2015 in Kimble v. Marvel Entertainment, 576 U.S. ___ (2015), the U.S. Supreme Court upheld a rule it established in 1964 in Brulotte v. Thys Co., 379 U.S. 29, which said that a patent holder cannot charge royalties for the use of a patented invention after the patent has expired. As a result of this ruling, Marvel does not owe royalties to Stephen Kimble based on sales of Spider Man “Web Blaster” accessory toys that fell under Kimble’s expired patent. (The Web Blaster lets would-be spidermen shoot foam web strands from their wrists, just like Peter Parker. Shazam!)

Jessica Miles, Technology Specialist at Dilworth IP and PhD candidate at Yale University, is presenting at the Boston Bacterial Meeting this Thursday, June 18 and Friday, June 19, 2015 at the Harvard University Science Center. The title of her poster is “Using Insertion Sequencing (INSeq) to identify genetic determinants of gut colonization.”

Dilworth IP’s Biotech and Pharmaceutical Practice Group has been joined by Jessica Miles, a Technology Specialist from Yale University’s Office of Cooperative Research (OCR). Ms. Miles is currently a Ph.D. candidate in Microbiology at Yale where her research has focused on identifying genetic mediators of interactions between the microbiome and infectious bacteria. She is also well-versed in biochemistry, molecular biology, and cell biology, having had over 10 years of research experience in five different academic laboratories. Jessica’s work at OCR involved a variety of technology areas including miRNA therapy, regenerative medicine, and immunotherapy. There, she evaluated early stage research and reviewed prior art to advance intellectual property with commercial potential. She also identified biotechnology and pharmaceutical companies for licensing opportunities and composed marketing material to promote technology licensing and research sponsorship.

Michael Dilworth and Dr. Anthony Sabatelli of Dilworth IP will be attending the 2015 BIO National Convention in Philadelphia (BIO 2015) June 15th-19th. They will be joined by several other organizations and businesses from Connecticut’s life science community showcasing the state’s leadership in the biosciences. The Firm is one of several sponsors of the Connecticut Booth along with Yale University, the University of Connecticut, The Jackson Laboratory, the Town of Branford, CT, and CURE (CT United for Research Excellence).

Cambria Alpha-Cobb, Ph.D., Technology Specialist at Dilworth IP, is presenting at a Career Development Workshop series at UConn Health this Thursday May 28, 2015, at 1:30 pm. The title of the presentation is How to stay close to science when you get pulled away from the bench: An introduction to a career in IP law.

The workshop series is designed to expose graduate students and postdoctoral scholars to various career opportunities in the life sciences. Dr. Alpha-Cobb will present on her career path in IP law, emphasizing the skill sets required at various stages of her career, including past, current and future positions!

A few weeks ago, the Federal Circuit Court of Appeals released its decision in Biosig v. Nautilus, (Fed. Cir. 2015) on remand from the U.S. Supreme Court, Nautilus v. Biosig, 134 S. Ct. 2120 (2014) which instructed the Federal Ciruit to reconsider whether the claims of the patent in suit were sufficiently clear to meet the requirements of 35 USC 112. The Federal Circuit had already reviewed those claims and found them to valid under that court’s prevailing formulation for clarity: the claims in question were neither “insolubly ambiguous” nor “not amenable to construction.” Biosig Instruments, Inc. v. Nautilus, Inc., 715 F. 3d 891 (Fed. Cir. 2013), but was required to review the claims once again under the new “reasonable certainty” standard.

As of June 2014, the American brewing industry hit a big milestone with more than 3,000 operating US breweries. This recent expansion not only signifies an increase in locally brewed delicacies, but it also means that brewers will find it increasingly difficult to differentiate their brew from that of their fellow brewmasters. In order to stand out in this sea of bottles, brewers often use clever names for their brews. However, be it a “hopcentric” pun or a “barley-legal” nickname, it is increasingly difficult to find a clever name for a new brew while avoiding a legal trademark battle.

Hartford’s own City Steam Brewery recently settled a trademark battle over the branding on its bottled beer. Anchor Brewing Co., based in California, filed suit against City Steam, in a case that ultimately led to a seemingly minute settlement agreement. City Steam will now market its beer under the one-word “CitySteam” name instead of the original “City Steam.” Another local, New England Brewing Company recently received a petition from an attorney in India over their highly popular brew, “Gandhi Bot”, claiming that this vegetarian, aromatic India Pale Ale, is “nothing but an insult to the Indian constitution!”