Posts Tagged: "patent eligible"

U.S. Patent and Trademark Office (USPTO) Director, Andrei Iancu, joined day one of Virtual CON2020 today to chat with IPWatchdog CEO and Founder Gene Quinn about topics including counterfeiting, Chinese IP theft, and the continued confusion in the courts and at the Patent Trial and Appeal Board (PTAB) around patent eligibility. On the topic of Section 101 and patent eligibility, Quinn lamented the recent American Axle decision, wondering if the holding that an invention involving a drive shaft could be considered directed to a law of nature represents a broader and growing disrespect for intellectual property. Iancu could not comment on the case itself, but said that with respect to the basic principle, “you’re absolutely right.

The United States Patent and Trademark Office (USPTO) recently announced the COVID-19 Prioritized Examination Pilot Program, under which the USPTO will advance certain patent applications related to COVID-19 “out of turn,” resulting in prioritized examination for qualifying applications. Under this program, the USPTO reportedly aims to provide final disposition of qualifying applications within one year of the filing date, meaning that a final office action or notice of allowance will be mailed (or a notice of appeal will be filed) during this shortened one year timeframe. For comparison, it typically takes the USPTO roughly 16 months from the filing of an application to mail a first office action.

As detailed in Part I of this article, the recent opinion in AAM, Inc. v. Neapco Holdings, LLC, No. 18-1763 (Fed. Cir. July 31, 2020) misreads and misinterprets Supreme Court precedent as having long imposed the enablement-like requirements set forth in the AAM ruling. Similarly, the Federal Circuit cases cited by AAM do not reflect some longstanding Section 101 eligibility rule that the claim alone must show, with “specificity,” the “way” or “how to” “achieve” such an invention, beyond a mere “result.”

With its recent opinion in AAM, Inc. v. Neapco Holdings, LLC, No. 18-1763 (Fed. Cir. July 31, 2020), and a 6-6 stalemate by the court’s active judges on whether to take the case en banc, the Federal Circuit has now adopted—under the rubric of 35 U.S.C. §101—a formalized set of enablement-like requirements for patent claims. For a simple “threshold” eligibility test, section 101 has grown remarkably complex. Indeed, since the Supreme Court’s 2012 Mayo and 2014 Alice decisions re-cast patent eligibility into a “two-step framework,” the Section 101 test adjudges not just subject-matter eligibility and the three “limited” exceptions thereto, but also patentability or “inventive-concept” challenges predicated on comparisons to the prior art, see 35 U.S.C. §§ 102-103. And now the enablement-type requirements imposed by AAM v. Neapco.

On August 7, Techtronic Industries filed a brief in opposition to The Chamberlain Group’s petition to the U.S. Supreme Court asking for review of “whether the Federal Circuit improperly expanded § 101’s narrow implicit exceptions by failing to properly assess Chamberlain’s claims ‘as a whole.’” Techtronic’s brief asks the Court to deny the petition, and presents the following two questions in the case it is granted: “1) Whether the Federal Circuit, on the particular facts of this case, erred in analyzing the claims as a whole and 2) Whether Chamberlain forfeited and is estopped from making its current arguments about the scope and preemptive effect of its claims in view of its inconsistent arguments below.”

The 2012 Supreme Court decision in Mayo Collaborative Servs. v. Prometheus Labs changed the landscape for patenting diagnostic inventions in the United States. Patent eligibility/ineligibility in the United States stems from two sources: (1) 35 U.S.C. § 101, and (2) judicially-created exclusions, including laws of nature, natural phenomena, abstract ideas, and mental processes. In Mayo, the Supreme Court struck down method of treatment claims for being directed to a law of nature. While Mayo did not create this exclusion, it significantly expanded its applicability to diagnostic-based inventions. This paper explores Federal Circuit case law on patent eligibility of diagnostic-based inventions since the Mayo decision, as well as provides practical guidance on drafting diagnostic patent claims in light of these decisions.

In an August 3, 2020 modified opinion, the U.S. Court of Appeals for the Federal Circuit held certain claims directed to a method of preparation to be patent-eligible at Alice Step 1. The case is Illumina Inc. v. Ariosa Diagnostics Inc., 2019-1419 (Fed. Cir. 2020), and IP Watchdog has already published a more-detailed write-up on the modified opinion that can be found here. I write separately to highlight an interesting quote from the modified opinion that may have currency, not just in biotechnology, but also in computer technology and other arts.

In the spring of 2018, a district court invalidated a patent claiming methods of manufacturing a pickup truck drive shaft for failure to recite patent-eligible subject matter. Industry stakeholders, scholars, and legal commenters were more than a little incredulous, since methods of manufacturing such tangible objects have long been patentable in the United States. In due course, the Federal Circuit (in a 2-1 decision) drew even more exasperation when it affirmed the district court’s holding. If the ensuing stream of bewildered blog posts, amicus briefs, and statements by public officials are anything to go by, many viewed the case as another high water mark in our uniquely American Section 101 jurisprudence…. Then, enter the July 31, 2020 re-written majority opinion in American Axle. Rather than allow the case to go to the full court for consideration, the majority decided to edit some of the troubling language from the original panel opinion.

Much has been written about the uncertainty in U.S. patent law concerning laws of nature, natural phenomena, and abstract ideas following the Supreme Court’s decisions in Mayo v. Prometheus and Alice Corp Pty Ltd v. CLS Bank Int’l. A recent decision from the Enlarged Board of Appeal at the European Patent Office (the Enlarged Board), however, demonstrates that the United States is not alone in grappling with issues surrounding patent eligibility. In the case of genetically modified plants and animals, questions arise on where to draw the line between human invention and biological processes. Earlier this year, the Enlarged Board reversed a 2015 decision that had held that product-by-process patents could be sought for genetically modified plants and animals despite a patent exclusion for “essentially biological processes.” 

On August 3, the United States Court of Appeals for the Federal Circuit (CAFC) denied a petition for rehearing en banc and issued a modified opinion, following a petition for rehearing filed by Ariosa in Illumina, Inc. v. Ariosa Diagnostics, Inc. Sticking closely to the reasoning of its March opinion, the CAFC reversed a decision by the United States District Court for the Northern District of California that claims of U.S. Patent Nos. 9,580,751 (the ’751 patent) and 9,738,931 (the ’931 patent) belonging to Sequenom and Illumina (Illumina) were invalid under 35 U.S.C. § 101 as being directed to an ineligible natural phenomenon.

On Friday, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued Orders granting a request for panel rehearing and denying a request for rehearing en banc in response to a joint petition filed by American Axle & Manufacturing (AAM). The CAFC also issued a precedential modified opinion of its October 3, 2019 opinion in American Axle & Manufacturing v. Neapco Holdings. In the Order Denying Rehearing En Banc, Judges Newman, Moore, O’Malley, Reyna, Lourie and Stoll dissented from the denial of rehearing en banc. Each of Dyk, Chen, Newman, Stoll and O’Malley wrote separately.

On July 22, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed a decision of the United States Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (the Board) in Uniloc 2017, LLC v. HULU, LLC. In particular, the CAFC found that the case was not moot despite a prior CAFC judgment of invalidity and that the Board did not err in rejecting Uniloc’s Request for Rehearing on the basis of Section 101 invalidity of the proposed substitute claims. Judge O’Malley issued a strong dissent, accusing the majority of “breath[ing] life into a dead patent and us[ing] the zombie it has created as a means to dramatically expand the scope of inter partes review (“IPR”) proceedings.”

It was a relatively light week in the district court compared with recent memory, with 56 new complaints filed; the Patent Trial and Appeal Board (PTAB) is holding steady with 27 filings (all inter partes reviews [IPRs] this week), a number nearly identical to the totals for the past few months. The District Court activity was driven by new complaints in existing campaigns, some new ANDA/aBLA litigations related to pharmaceutical generic entry, a smattering of company disputes, and a new campaign by Raymond Anthony Joao. At the Board, a trickle of petitions filed as part of ongoing licensing disputes between Dolby and Intertrust, some further challenges in the funded Neodron suits, some further filings by Verzion against Huawei, and a number of petitions in response to non-practicing entity (NPE) suits made up the balance.

On July 14, the United States Court of Appeals for the Federal Circuit, with Judge Lourie writing for the majority, affirmed-in-part and vacated-in-part a decision of the United States District Court for the Eastern District of Texas in Packet Intelligence, LLC v. NetScout Systems, Inc. The CAFC affirmed the district court’s judgments on the issues of infringement, invalidity, and willfulness, but reversed with respect to pre-suit damages. Judge Reyna wrote separately, dissenting on the issue of patent eligibility under Section 101.

A strategy for the COVID-19 pandemic is testing for antibodies to determine possible immunity. Such diagnostic tests may suffer from a high false positive rate. Improving accuracy is therefore desirable. However, the U.S. Patent and Trademark Office (USPTO) is generally not receptive to diagnostic claims that improve accuracy. The recent case of CardioNet v. Infobionic, makes patenting more accurate diagnostics easier. CardioNet considered whether a more accurate cardiac monitoring device was eligible. Claim 1 recites a device that detects abnormal heart rhythms (atrial fibrillation or atrial flutter) in a patient. The district court held that the claims were directed to an abstract idea of identifying atrial fibrillation or atrial flutter “by looking at the variability in time between heartbeats and taking into account ventricular beats.” The Federal Circuit reversed and held an improved cardiac monitoring device was not an abstract idea.