Nearly seven years after the landmark Supreme Court decision in Alice Corp. v. CLS Bank Int’l, subject matter eligibility for patent claims under 35 U.S.C § 101 remains a moving target. In Alice, the Court found claims for a computerized escrow arrangement ineligible for patenting because they were directed to the abstract idea of “intermediated settlement” and did not recite an inventive concept that could impart eligibility under Section 101. While the Alice case focused on a software invention, a few recent lower court decisions suggest that, in certain circumstances, medical device patents may not be immune from similar patent eligibility challenges.

Late last year, in a case captioned DUSA Pharmaceuticals, Inc. v. Biofrontera Inc., a federal court in Massachusetts faced the question of whether patent claims directed to an improved light source for photodynamic therapy were ineligible for patenting. The representative claims at issue recited:

  • “An illuminator for diagnosing or treating a patient” including “a plurality of light sources…configured and controlled to provide a uniform output of light to the patient…such that uniform output of light is provided when measured at distances of 2 [inches] and 4 [inches];” and
  • “A method of photodynamically diagnosing or treating a patient” by “illuminating the patient with an illuminator whose measured output over an active emitting area is at least 60% of the measured maximum over all operation distances.”

Defendant Biofrontera argued the claims lack an inventive concept and therefore not eligible under Section 101 because they (i) are directed to light itself which is an unpatentable natural phenomenon and (ii) contain only generic components to produce the claimed uniform output of light.

The district court disagreed. In finding the claims patent eligible, the court stated that “[a]lthough the claims relate to light, they are not directed to light as a natural phenomenon … [t]he uniformity of light output is a requirement of and inseparable from the claimed illuminator.” Further, Biofrontera failed to provide evidence that the light produced by the illuminator—specifically, light whose measured irradiance over the active emitting area is at least 60% of the measured maximum from 2 inches to 4 inches—occurred in nature or could be produced by conventional illuminators.

While the DUSA Pharmaceuticals decision may give holders of medical device patents some comfort with respect to patent eligibility, a recent decision from the Federal Circuit raises fresh questions about the patent eligibility of device claims. In Yu vs. Apple, Inc., the court addressed claims directed to an improved digital camera that includes a plurality of image sensors and corresponding lenses. Each image sensor produces a separate digital image with a different intensity value, which the camera then merges to produce an enhanced digital image.

Defendants Apple and Samsung filed a Rule 12(b)(6) motion to dismiss, arguing that the patent claims were ineligible as being directed to the abstract idea of “taking two pictures and using those pictures to enhance each other in some way.” The lower court granted the motion, concluding that photographers have been using this technique for over a century, and the patentee had not shown any of the claimed elements were not well-known and conventional.

In a 2-1 decision, the Federal Circuit affirmed the lower court’s ruling. Despite the explanation of specific camera configurations and embodiments set forth in the patent specification, the majority found that the claims lacked elements that sufficiently covered this detail. As a result, because the image processing technique encompassed in the claims had been performed for over a century and the claims recited only conventional camera components (e.g., image sensors, lenses, memory, A-D converter, image processor) to carry out the image processing, the majority reasoned that the claims were ineligible for patenting as directed to an abstract idea.

Takeaways

These two decisions highlight the continued unpredictability of Section 101 jurisprudence and re-emphasize the importance of having both a detailed specification that fully describes the technical improvements realized by the invention, and claims of reasonable breadth that clearly incorporate the aforementioned improvements. With its Yu decision, the Federal Circuit has issued a caution to those seeking patents on medical device technology that inclusion of device structure and components in a claim set does not automatically exempt the patent from scrutiny under Alice. Instead, claims should be carefully drafted to account for the specific advancement over the prior art and contain limitations that go beyond generic, well-known process steps and hardware.

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 Vinti is a partner in the Patent Law and Intellectual Property Groups.

Baldo’s practice focuses on litigating patent, false advertising, trade secret, trademark and contractual matters in federal and state courts and before the International Trade Commission. He is a skilled intellectual…

Baldassare Vinti is a partner in the Patent Law and Intellectual Property Groups.

Baldo’s practice focuses on litigating patent, false advertising, trade secret, trademark and contractual matters in federal and state courts and before the International Trade Commission. He is a skilled intellectual property litigator with extensive experience in all aspects of litigation, including trials (jury and bench), Markman hearings, appeals before the Federal Circuit, case preparation and strategy, depositions, motion practice, and settlement negotiations. In the area of patent litigation, he has worked on cases involving a broad range of technologies, including medical devices, diagnostics, immunoassays, orthotics and prosthetics, proton pump inhibitor pharmaceuticals, dental implants, electronic medical records systems, wound dressings, pharmaceutical capsules, digital video compression, electronic book delivery and security systems, mobile phones and mobile media technologies, ATSC digital television standard, navigation, location-based services, bandwidth management, bar code scanning, irrigation equipment, waste management systems, laser inscription devices, and other related technologies. Baldo has represented numerous major corporations in patent litigations, including British Telecommunications PLC, Church & Dwight Co., Inc., Henry Schein, Inc., Maidenform Brands Inc., Mitsubishi Electric Corp., Ossur North America Inc., Panasonic Corp., Sony Corp., U.S. Philips Corp. and Zenith Electronics LLC.

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