In Univ. of Strathclyde v. Clear-Vu Lighting LLC, the Federal Circuit grappled with the issue of whether claims directed to methods and systems for inactivating bacteria using blue light were obvious in view of a prior art combination that taught the claimed elements but lacked an indication of success. Ultimately, the Federal Circuit found that the patent’s success where the prior art failed – inactivation of the bacteria without a photosensitizer did not support a finding of obviousness.

The patent at issue, USP 9,839,706 (“the ‘706 patent”) owned by the University of Strathclyde (“Strathclyde”), relates to methods and systems for disinfection by inactivating Gram-positive bacteria such as Staphylococcus aureus (MRSA). Among other features, the patent recited inactivating the bacteria by exposing it to visible light in the range 400-420 nm without using a photosensitizer. Strathclyde’s exclusive licensee sued Clear-Vu Lighting (“Clear-Vu”), a manufacturer and distributor of disinfectant light fixtures and lighting solutions, for infringement of the ’706 patent.  In response, Clear-Vu filed an IPR petition, asserting that the claims of the ’706 patent were invalid as anticipated or obvious in view of several prior art references: Ashkenazi, Nitzan, and Jones.

The Ashkenazi reference disclosed a method for photoeradication of P. acnes bacteria using blue light, with some experiments utilizing the photosensitizer δ-aminolevulinic acid (ALA) when growing the bacteria while others did not. However, in all of Ashkenazi’s experiments, the media used to grow the bacteria contained riboflavin, a photosensitizer. Under these conditions, Ashkenazi reported a decrease in viability of the bacteria when irradiated with blue light at 407-420 nm.

The Nitzan reference continued the experiments from Ashkenazi, this time on MRSA. Like Ashkenazi, Nitzan prepared some cultures with ALA and some without. In these experiments, the bacteria was not exposed to any other photosensitizers. For the cultures prepared without ALA, Nitzan reported no decrease in viability of the bacteria after illumination. In other words, Nitzan failed to inactivate the bacteria without using a photosensitizer.

In the IPR proceedings, the PTAB agreed with Clear-Vu that Ashkenazi and Nitzan rendered claims 1 and 3 obvious, and that Ashkenazi, Nitzan, and Jones rendered claims 2 and 4 obvious. The PTAB concluded that one of ordinary skill in the art would have been motivated to combine the references and “would have had a reasonable expectation of successfully doing so.” The Board reasoned that, although neither Ashkenazi nor Nitzan achieved inactivation of bacteria without using a photosensitizer (as the ’706 claims require), a person of skill in the art relying on Ashkenazi’s teachings that increasing light doses, number of illuminations, and length of time the bacteria are cultured resulted in greater inactivation for both ALA and non-ALA cultures would have reasonably expected some inactivation for the non-ALA MRSA in Nitzan.

On appeal, the Federal Circuit reversed the PTAB’s obviousness findings. The court first took issue with the Board’s conclusion that one of ordinary skill would have been motivated to combine Ashkenazi with Nitzan. All of Ashkenazi’s experiments used a photosensitizer (either ALA and riboflavin, or just riboflavin) and Nitzan’s experiments without a photosensitizer did not inactivate any bacteria. Thus, the Federal Circuit rejected the Board’s finding that one of ordinary skill in the art would have been motivated to prepare an MRSA culture without a photosensitizer (as in Nitzan) and use increasing amounts of light energy, number of illuminations, and length of time (as in Ashkenazi) to arrive at the claimed invention.

The Federal Circuit also refuted the Board’s determination that one of ordinary skill in the art, when combining Ashkenazi and Nitzan, would have had a reasonable expectation of success in inactivating MRSA using blue light without also using a photosensitizer. The Federal Circuit pointed to the lack of evidence in the record showing bacterial inactivation without using a photosensitizer. Instead, the evidence of record showed that others had failed to achieve the desired results without photosensitizing despite trying different doses and wavelengths of blue light.

This decision affirms that while “absolute predictability of success is not required” to find a patent obvious, “failures to achieve that at which the inventors succeeded” weighs against such a finding.

Print:
EmailTweetLikeLinkedIn
Photo of Patrick Niedermeier Patrick Niedermeier

Patrick J. Niedermeier is Patent Counsel in the Litigation Department and Intellectual Property Group.

Patrick represents clients from large corporations to start-up entities before the U.S. Patent and Trademark Office. He is experienced in all phases of patent prosecution, including accelerated examination, provisional…

Patrick J. Niedermeier is Patent Counsel in the Litigation Department and Intellectual Property Group.

Patrick represents clients from large corporations to start-up entities before the U.S. Patent and Trademark Office. He is experienced in all phases of patent prosecution, including accelerated examination, provisional filings, continuation practice, appeal briefing, design patents and foreign patent strategy. He also has prosecuted several trademark filings to registration.

In addition, Patrick assists clients in obtaining and enforcing intellectual property rights both in the U.S. and abroad. He represents corporate clients throughout the complex patent litigation process, including pre-suit investigations and client counseling; negotiating discovery disputes; drafting claim construction, summary judgment, expert, and pre- and post-trial briefs; assisting with trial preparation; and participating at trial. He also has assisted with preparing appellate briefs for submission to the Federal Circuit.

Patrick’s work spans a broad range of technology sectors that include network security, wireless communications, telecommunications and telephony devices, video conferencing, mobile computing, weather and greenhouse gas instruments, optical discs, video compression and on-demand streaming, 3D image processing, machine vision, RFID/NFC technology and financial services software, as well as life insurance annuity products.

In addition to litigation and prosecution matters, Patrick is highly experienced in leading intellectual property due diligence review for large-scale corporate transactions. He regularly advises clients on intellectual property portfolio management and development including legal opinion work, and performs patent landscape and freedom- to-operate analyses.

Patrick also has written several articles for Proskauer’s New England IP Blog on various patent litigation and prosecution topics.

While at Boston College Law School, Patrick served as a legal intern to the Honorable Robert B. Collings, Magistrate Judge of the U.S. District Court for the District of Massachusetts. Prior to that, he was an IT Specialist at IBM Global Services and a software engineer and enterprise database administrator at New England Confectionery Co.

Photo of Baldassare Vinti Baldassare Vinti

Baldassare (“Baldo”) Vinti co-heads Proskauer’s Intellectual Property Litigation Group.

Baldo’s practice focuses on litigating patent, false advertising, trade secret, life sciences, trademark and contractual matters in federal and state courts and before the International Trade Commission. He is a seasoned trial attorney responsible…

Baldassare (“Baldo”) Vinti co-heads Proskauer’s Intellectual Property Litigation Group.

Baldo’s practice focuses on litigating patent, false advertising, trade secret, life sciences, trademark and contractual matters in federal and state courts and before the International Trade Commission. He is a seasoned trial attorney responsible for all aspects of litigation, including Markman hearings, appeals before the Federal Circuit, case preparation and strategy, depositions, motion practice, and settlement negotiations. He has represented clients in high-stakes matters involving a broad range of technologies, including medical devices, diagnostics, immunoassays, prosthetics, pharmaceuticals, dental implants, electronic medical records systems, encryption technology, wound dressings, digital video compression, electronic book delivery and security systems, mobile media technologies, navigation and location-based services, bandwidth management, bar code scanning, lasers , and other technologies. Baldo has represented numerous major corporations, including Arkema S.A., British Telecommunications PLC, Church & Dwight Co., Inc., Henry Schein, Inc., Maidenform Brands Inc., Mitsubishi Electric Corp., Ossur North America Inc., Panasonic Corp., Sony Corp., Welch Foods, Inc., and Zenith Electronics LLC.

In addition, Baldo regularly handles transactional work, including intellectual property due diligence, licensing, intellectual property structural transactions, patentability studies, infringement/non-infringement opinions, and client counseling in intellectual property matters.

Baldo is an author and frequent commentator on patent issues pertaining to medical devices and a host of other intellectual property topics, and has been quoted in the National Law Journal, Bloomberg BNA, Law360, Westlaw Journal and Inside Counsel magazine. He is also a regular contributor of articles published in Medical Product Outsourcing magazine that deal with the medical device industry.

Baldo served as a judicial intern for Hon. John E. Sprizzo of the United States District Court for the Southern District of New York and for Hon. Charles A. LaTorella of the New York Supreme Court.