The University of Washington announced that a team of researchers has developed a prothrombin time/international normalized ratio (PT/INR) blood clotting test that requires only a single drop of blood and a smartphone. According to the team’s February 11, 2022 paper published in Nature Communications, the test uses a tiny cup containing copper, and a blood clotting agent that is attached to the smartphone below the camera, as shown in the figure below from the paper.
ALARM.COM INC. v. HIRSHFELD
Before Taranto, Chen, and Cunningham. Appeal from the United States District Court for the Eastern District of Virginia.
Summary: The Administrative Procedure Act (APA) permits judicial review of a Patent Office decision vacating an ex parte reexamination based on estoppel.
IN RE STEVE ELSTER
Before Dyk, Taranto, and Chen. Appeal from the Trademark Trial and Appeal Board.
Summary: The Patent and Trademark Office violated the First Amendment by refusing to register the trademark TRUMP TOO SMALL absent consent from former president Donald Trump.
The U.S. Food and Drug Administration (FDA) published on February 23rd, 2022, a rule proposal to overhaul medical device quality control regulation. According to the FDA, the proposed rule change would “amend the device current good manufacturing practice requirements of the Quality System Regulation to align more closely with the international consensus standard for devices by converging with the quality management system requirements used by other jurisdictions.”
ADAPT PHARMA OPERATIONS LTD. V. TEVA PHARMS. USA, INC.
Before Newman, Prost, and Stoll. Appeal from the United States District Court for the District of New Jersey.
Summary: Recent attempts by competitors to achieve patented technology, both before and after patent’s publication, not strong enough objective indicia of nonobviousness.
LARRY G. JUNKER V. MEDICAL COMPONENTS, INC.
Before Dyk, Reyna, and Stoll. Appeal from United States District Court for the Eastern District of Pennsylvania.
Summary: A letter containing specific delivery conditions, risk allocations, and payment terms may constitute a commercial offer for sale despite being sent in response to a “request for quotation.”
In addition to its significant efforts to fast track the approval of COVID-19 related devices, the FDA’s Center for Devices and Radiological Health (CDRH) has also maintained its high priority focus on supporting innovation of new medical devices in the United States.
IPR estoppel in district court proceedings applies to all claims and grounds which reasonably could have been included in the petition; a two-tier damage award providing a higher royalty for the same device at a different points in the supply chain was not permitted in the absence of compelling evidence.
Despite applying the standard of broadest reasonable construction, a claim term’s narrowed construction to refer to a specific detection method was proper in view of its exclusive use in the written description as referring to the specific method as well as its foundational relationship to the claims.
Construing a broad claim term to be re-defined as a disclosed species on a theory that the terms are interchangeable requires that the intrinsic record clearly manifest a departure from the term’s plain and ordinary meaning.
