Posts Tagged: "patentability requirements"

CAFC Affirms District Court Finding that Naloxone Patents are Obvious; Newman Dissents

On February 10, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a decision by the U.S. District Court for the District of New Jersey, explaining that the district court did not err in finding several Adapt Pharma patents obvious. The asserted claims relate to U.S. Patent Nos. 9,468,747; 9,561,177; 9,629,965; and 9,775,838 (collectively, the “patents-in-suit”). The patents-in-suit claim methods of treating opioid overdose by intranasal administration of a naloxone formulation, as well as devices for intranasal administration. Naloxone is the active ingredient in Adapt’s NARCANâ Nasal Spray and is an opioid receptor antagonist, thus helping reverse the effects of opioid overdose. The opinion was authored by Judge Kara Stoll; Judge Pauline Newman dissented.

CAFC Corrects District Court’s On-Sale Bar Analysis

The U.S. Court of Appeals for the Federal Circuit (CAFC) today reversed the U.S. District Court for the District of Pennsylvania’s summary judgment that a medical device design patent was not invalid under the on-sale bar. Junker v. Medical Components, Inc. The district court found the patent was infringed and awarded damages in the amount of $1,247,910. But the CAFC held that a letter sent by the inventor’s business partner to Boston Scientific Corporation in 1999 represented a commercial offer for sale of the claimed design.

CAFC Upholds PTAB Ruling that Patents on Autonomous Driving Tech Are Not Obvious

On February 4, 2022, The U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed two decisions of the Patent Trial and Appeal Board (PTAB) on related inter partes reviews (IPRs) brought by Quanergy against Velodyne, explaining that the Board’s decision to uphold the validity of the disputed claims was correct considering the objective evidence provided by Velodyne. Quanergy challenged multiple claims of U.S. Patent No. 7,969,558, covering a lidar-based 3-D point cloud measuring system best known for helping autonomous cars sense their surroundings. In its decisions, the PTAB held that several claims of the ’558 patent are not unpatentable as obvious.

CAFC Orders New Trial on Damages, Clarifies IPR Estoppel Rule in Appeal of Caltech’s $1.1 Billion Win Against Apple and Broadcom

On February 4, in a mixed precedential decision, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed, vacated, and remanded in part a decision by the U.S. District Court for the Central District of California in a patent infringement suit filed by the California Institute of Technology (Caltech) against Broadcom Limited, Broadcom Corporation, and Avago Technologies (collectively “Broadcom) and Apple Inc. The suit was related to Caltech’s U.S. Patent 7,116,710 (‘710 patent), U.S. Patent 7,421,032 (‘032 patent), and U.S. Patent 7,916,781 (‘781 patent). The CAFC affirmed the district court’s denial of judgment as a matter of law (JMOL) on infringement because the jury’s verdict of infringement of the declared claims of the ‘710 and ‘032 patents was supported by substantial evidence and the district court’s construction of the claim limitation “repeat” was not erroneous.

O’Malley Dissents from ‘Concerning’ CAFC Ruling that Biogen’s MS Drug Patent is Invalid

The U.S. Court of Appeals for the Federal Circuit (CAFC) earlier today affirmed a district court ruling that Biogen International’s patent for a method of treating multiple sclerosis (MS) was invalid for lack of written description. Judge O’Malley dissented, arguing that the district court clearly erred in its finding that Biogen was judicially estopped from drawing a distinction between clinical and therapeutic effect, and that the entire analysis “might well change” if the case was remanded “for reconsideration of the record with the understanding that the patent is not about clinical efficacy” but therapeutic effect.

Hindsight Bias: An Ovine Survey

The arrival of a U.S. Patent and Trademark Office (USPTO) office action citing no less than six earlier patents directed to various sub-combinations in the features of the main independent claim in an application which I was handling prompted the present note. Readers may recall the decision of Judge Rich In re Winslow 365 F.2d 1017 (C.C.P.A. 1966): “We think the proper way to apply the 103-obviousness test to a case like this is to first picture the inventor as working in his shop with the prior art references — which he is presumed to know — hanging on the walls around him.” However, Boltzmann’s entropy formula S = k log W where S represents entropy, a concept associated with a state of disorder, randomness, or uncertainty, and W represents the number of possible states in the relevant system, leaves an unforgettable impression on those who have studied it. Even if the fields from which the earlier patents might be selected are restricted to relevant general classifications, the number of combinations of six references which might have been collected together from the body of prior art in the relevant technical field randomly and without knowledge of the invention is mind-boggling.

Alice-Insanity (Part One), or Why the Alice-Mayo Test Violates Due Process of Law

The Fifth Amendment of the U.S. Constitution guarantees, inter alia, that no person shall be deprived of property (including intellectual property), without due process of law. For instance, it is settled law that a federal statute may be so arbitrary and capricious as to violate due process. Similarly, it is settled that an administrative agency, e.g., the U.S. Patent and Trademark Office (USPTO), cannot escape the due process of law requirement when processing patent applications. In theory (less in reality), due process of the law extends to judicial as well as political branches of government, and judgments that violate constitutional limitations and guarantees are void or voidable.

CareDx v. Natera: The Latest in Patent Eligibility of Medical Diagnostics

The latest ruling involving patent eligibility of medical diagnostics comes from Chief Judge Connolly of the United States District Court for the District of Delaware in a consolidated case brought by CareDx, Inc. and the Board of Trustees of the Leland Stanford Junior University against Natera, Inc. (Civil Action No. 19-0567-CFC-CJB) and Eurofins Viracor, Inc. (Civil Action No. 19-1804-CFC-CJB). After initially denying the Defendants’ motions for summary judgment of invalidity of the asserted patents under 35 U.S.C. §101 in December 2020, the Court then later denied certification motions for interlocutory appeal and instead ruled sua sponte to reconsider its own denial of summary judgment. Following an evidentiary hearing during which expert testimony was heard, the Court reversed its previous ruling to find all claims of the asserted patents invalid as a matter of law under §101.

Where We Are on AI Inventorship and Where We Should be Heading

The past few years saw a meteoric rise of artificial intelligence (AI) products, services, and applications. AI has evolved from merely a buzzword or a cool new idea to a substantively used tool in a variety of applications, including autonomous driving, natural language processing, drug development, finance and cybersecurity among others. Companies, universities, and inventors world-wide noted the importance of AI and began seeking to patent various aspects of AI technology. Until 2018, these patent applications identified a human inventor who invented a particular aspect of the AI technology. Then, Dr. Stephen Thaler filed a patent application for a food container and a light emitting device that identified an AI, known as DABUS, as an inventor.

CAFC Reverses PTAB Win for St. Jude, Finding Snyders’ Heart Valve Claims Not Unpatentable

On October 5, the U.S. Court of Appeals for the Federal Circuit (CAFC) reversed a decision by the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) that Snyders Heart Valve LLC’s (Snyders) patent claims for an artificial heart valve were unpatentable. The court said the PTAB relied on an erroneous claim construction. The CAFC previously vacated and remanded the appeal after only reaching Snyders’ argument under the Appointments Clause following its decision in Arthrex, Inc. v. Smith & Nephew, Inc. The U.S. government sought certiorari to challenge the remand, and after its decision in United States v. Arthrex Inc. (U.S. Supreme Court, 2021), the Supreme Court vacated the decision of the CAFC and remanded the matter back. Snyders waived the Appointments Clause challenge and asked the CAFC to consider the merits of the case on remand.

Reyna Concurs in CAFC Reversal of Ineligibility Holding, But Blasts Majority’s Approach to Alice

The U.S. Court of Appeals for the Federal Circuit (CAFC) today reversed a district court decision that patent claims directed to an “authentication method” were ineligible as abstract under Section 101. The CAFC said that the claims at issue satisfied Alice step two because they “recite a specific improvement to a particular computer-implemented authentication technique” and were thus eligible for patenting. The opinion was authored by Judge Stoll and a concurring opinion was filed by Judge Reyna.

A Kinder, Gentler ‘Death Squad’: Ten Years in, Despite Some Reforms, the USPTO is Still Killing U.S. Patents

Now that the 10th anniversary of the America Invents Act (AIA) has passed, we can look back not only at the past decade, but also the reactions of various interested parties and how they responded to that anniversary. There were two revolutionary amendments to U.S. patent laws enacted on September 16, 2011; one relating to the U.S. changing from first-to-invent to first-to-file, the other relating to the creation of the Patent Trial and Appeal Board (PTAB) and three new procedural mechanisms to invalidate issued patents. While from a philosophical and practical point of view, the change from first-to-invent to first-to-file had the largest impact on patent practice, it has essentially become a footnote in patent history. Yes, the United States had a bizarre system that allowed the second filer in some instances (i.e., the first to invent) to obtain a patent over the first-to-file, but that almost never happened. And now, the United States has a strange, hybrid first-to-file system that still theoretically allows the first-to-invent to prevail in even rarer circumstances, but that change became easily baked into the system, because overwhelmingly, the first-to-invent did file first. The real story of the change to first-to-file is that much more is now prior art, including foreign filed applications as of their foreign filing date, typically, which continues the theme of the last 15+ years of making it harder to obtain and keep patent rights in the United States.

Tillis and Leahy Urge USPTO to Address Inconsistent Prior Art Statements by Patent Applicants at the FDA

On Thursday, September 9, Senators Thom Tillis (R-NC) and Patrick Leahy (D-VT) sent a letter addressed to Drew Hirshfeld, performing the functions and duties of the Director of the U.S. Patent and Trademark Office (USPTO), discussing the issue of inconsistent statements made by patent applicants pursuant to their disclosure requirements at the USPTO and other federal agencies, especially the U.S. Food and Drug Administration (FDA). The Senators are asking the USPTO to take swift action to ensure that applicants are disclosing all known prior art at both the USPTO and the FDA.

It’s All in the Hardware: Overcoming 101 Rejections in Computer Networking Technology Classes

Technologies such as computer networking, which, unlike software inventions, typically incorporate at least some hardware elements, may be less vulnerable to rejection under the U.S. Supreme Court’s decision in Alice v. CLS Bank. However, responding to these rejections when they are issued still requires some finesse. In these cases, rejections usually revolve around whether the hardware included in the claims serves as an improvement over existing hardware or is merely used as a tool for a mental process or other abstract idea. If the examiner concludes that the networking hardware merely serves as a tool, the claims usually fail the Alice/Mayo test. However, if you can show that the networking hardware either presents novel features or is improved by the invention to become a more effective tool, you may overcome the rejection.

Building High-Quality Patent Portfolios in the United States and Europe: Part I – Intervening Prior Art

One ingredient that distinguishes a good patent portfolio from a great patent portfolio can be the synergistic strength of its U.S. and European patent family members. To develop this strength, it is not enough to have a U.S. attorney and a European attorney simply coordinate the procedural strategy for filing an application; rather, the drafter and manager of the application should analyze important issues upfront and prepare a patent application that accounts for the substantive differences between U.S. examination, U.S. courts, European examination, and national courts in Europe.