Posts Tagged: "patentability requirements"

The U.S. Patent and Trademark Office (USPTO) published guidelines for examiners today on the topic of enablement in light of the Supreme Court’s May 2023 decision in Amgen v. Sanofi. The Office’s view seems to largely mesh with what our guest authors concluded earlier today—Amgen isn’t getting rid of In re Wands and—at the USPTO at least—the decision has seemingly maintained the status quo.

Last term, the U.S. Supreme Court did something strange: the Court unanimously affirmed a circuit decision, which had unanimously affirmed a trial court decision. Little about the law seemed ripe for dispute or change, nevertheless, in Amgen v. Sanofi the Supreme Court spoke. Seven months later, innovators and patent practitioners are still scratching their heads. What impact, if any, does Amgen have? Is there a sign lower courts are interpreting Amgen as signaling a change in American patent law or did it merely ratify what already existed?

Recent debates about AI patentability have focused on whether the outputs of an AI system, such as a neural network, can be patented. Such debates have been spurred not only by recent general advances in the power of AI but also by Dr. Stephen Thaler’s “Artificial Inventor” project’s attempts to obtain patents on devices generated using his neural network-based DABUS software. If you thought that whether an AI-generated output can be patented is a cutting-edge question, then consider whether an input to an AI system, such as a prompt to a large language model (LLM), can be patented.

On December 28, agricultural tech developer Inari filed an amicus brief  with the U.S. Court of Appeals for the Federal Circuit (CAFC) urging the appellate court to deny a petition for rehearing en banc of the court’s August ruling in In re Cellect. Inari’s brief highlights that the Federal Circuit’s application of the obviousness-type double patenting (ODP) doctrine to legislatively-prescribed patent term adjustments (PTA) is critical to the success of companies like Inari who build upon technologies once patent protections expire.

The U.S. Supreme Court’s Alice decision alleges that “…merely requiring generic computer implementation fails to transform that abstract idea into a patent-eligible invention.” And the Patent Eligibility Restoration Act (PERA) of 2023 alleges that “adding a non-essential reference to a computer by merely stating, ‘do it on a computer’ shall not establish such eligibility.” Clearly, it is assumed that “merely” doing something on a computer or “merely” saying “do it on a computer” is not a desirable thing in the eyes of some; a computer supposedly invalidates the inventive effort and “merely” doing something on a computer is undeserving of even consideration of a patent.

On Monday, the United States Supreme Court denied inventor Jeffrey Killian’s petition for a rehearing in his case asking the Court to provide clear guidance on – or else throw out – the Alice/Mayo test for patent eligibility. The Supreme Court denied Killian’s original petition in early October, but Killian filed a request for rehearing several weeks later. Killian first filed a petition for writ of certiorari to the Supreme Court in April, after the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed the Patent Trial and Appeal Board’s (PTAB)’s ruling rejecting claims of his U.S. Patent Application No. 14/450,042 under Section 101.

The United States Patent and Trademark Office (USPTO) issued its one millionth design patent on September 26, 2023. U.S. Patent No. D1,000,000 claims the ornamental design for a dispensing comb. This milestone comes during a particularly prolific period for design patents. In 2022 alone, the USPTO received more than 50,000 design patent applications. The Office has seen a 20% growth in design patent applications over the last five years. It is not hard to understand why inventors are seeking design patent protection at previously unseen levels. In an age of complicated technologies, design patents can protect marketable appearances of products in the same manner generally as trademarks identify source. Understanding design patent benefits underlying the recent growth in application numbers is a good lesson for businesses seeking to distinguish a brand—but keep an eye out for further developments and be prepared to adjust business and IP strategies.

The President’s recent Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence instructs the U.S. Patent and Trademark Office (USPTO) Director and Copyright Registrar to collaboratively issue recommendations to the President on further actions for advancing AI innovation through intellectual property, particularly with respect to AI inventorship and AI authorship. But the two offices currently regard AI differently in terms of assessing the creative and conceiving capabilities of machines, which poses a potential contradiction in how intellectual property law treats AI.

Startups often face many competing pressures. Two such pressures that are frequently at odds with each other are the need to adequately protect the intellectual property that will be the basis for future revenue and investment, and the need to bring such revenue and investment into the business to allow for continued technology development and commercialization. Many startups are aware of how the on-sale bar interacts with these pressures and the associated need to file patent applications on any technology prior to offering or placing it on sale. However, fewer startups are aware of the public-use bar and how activities pursued with the goal of growing their businesses may unwittingly invoke it.

Yesterday, Google waived its right to respond to a petition for writ of certiorari to the U.S. Supreme Court filed by the inventors of a method for protecting computers from malware. The inventors, Alfonso Cioffi and Allen Rozman (the patent is now assigned to Melanie, Megan and Morgan Rozman), are appealing a U.S. Court of Appeals for the Federal Circuit (CAFC) decision that reversed a district court ruling and $20 million verdict for the inventors. The CAFC held that the Texas district court erred in ruling that four claims across the three patents were not invalid and agreed with Google’s argument that the claims were invalid under the “original patent requirement” because they contained reissue claims not disclosed in the original patent.

Innovation has been the driving force behind our country since its inception. So much of our nation’s success has flowed from U.S. ingenuity and innovation. Yet much remains to be done on this front. Indeed, in a few short years, we will be celebrating the Semiquincentennial (also called the Sestercentennial)—250 years since the signing of the Declaration of Independence. We need the same approach moving forward, and we have the opportunity to do so with pending legislation, which brings me to a chance to reflect on some important questions of intellectual property and innovation policy.

Recent cases in the European Patent Office (EPO), the UK, and United States illustrate substantive differences between these jurisdictions as they continue to develop their inventive step/nonobviousness frameworks. In particular, the EPO and UK have recently provided guidance on a concept known as “plausibility,” i.e., whether the scope of the patent must be justified by the patentee’s technical contribution to the art in solving an identified problem. “If it is not plausible that the invention solves any technical problem then the patentee has made no technical contribution and the invention does not involve an inventive step.” Sandoz Limited v. Bristol-Meyers Squibb Holdings [2023] EWCA Civ 472. That standard, however, is quite dissimilar from the United States’ statutory standard of whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious…”

The Supreme Court decided Amgen Inc. v. Sanofi on May 18, 2023, nearly nine years after its decision in Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014). Amgen was concerned with the enablement statute of the patent law, 35 U.S.C. § 112. In comparison, Alice was concerned with the eligibility statute of the patent law, 35 U.S.C. § 101, and has been highly criticized for creating a mess of patent eligibility. At first glance, these cases are distinguishable from one another, since they deal with different aspects of the patent laws. However, statutory interpretation and analysis should be the same in both instances.

PERA is no doubt an ambitious bill. In terms of its design, the proposed legislation attempts to deal with each of the Supreme Court’s decisions in Alice, Mayo and Myriad, plus all of their progeny applications thereafter engendered by the Federal Circuit, the Patent Trial and Appeal Board (PTAB), all the way down to the U.S. Patent and Trademark Office (USPTO) examining corp. In a nutshell, the bill, if passed, would return us to a time when Bilski was the law of the land, which will no doubt be welcomed by many innovators.

The U.S. Court of Appeals for the Federal Circuit (CAFC) today affirmed a district court’s grant of summary judgment that Baxalta, Inc. and Baxalta GmbH’s Hemophilia patent claims are invalid for a lack of enablement. The court said the facts of the case are “materially indistinguishable from those in Amgen.”… While Baxalta tried to argue its screening process does not require the type of trial and error described in Amgen and instead “predictably and reliably generates new claimed antibodies every time it is performed,” the court said “this does not take the process out of the realm of the trial-and-error approaches rejected in Amgen.”