A Diagnostic Patent Is Found Patent Eligible At the Federal Circuit

Attorney: Richard D. Kelly
August 4, 2020

In March the Federal Circuit reversed a lower court decision finding Illumina’s patents (U.S.Ps. 9,580,751 and 9,738,931) for diagnosing Down’s Syndrome to be patent ineligible, 952 F.3d 1367 (Fed. Cir. 2020). On August 3, the Federal Circuit denied a petition for rehearing and rehearing enbanc but did issue a new decision adding the term “human-engineered” in several portions of the opinion discussing the separation of fetal DNA from maternal DNA which the inventors had discovered were of different sizes, fetal cell DNA is shorter than the maternal DNA. The inventors recognized that the DNA to be analyzed for genetic aberrations was that of the fetus. The problem was to isolate the small amount of fetal DNA from the maternal DNA so the fetal DNA could be analyzed for genetic aberrations. Prior to the invention there was no known way to distinguish and separate maternal DNA from the tiny fraction of fetal DNA present. The inventors found that by selectively removing DNA having more than 500 or 300 base pairs they could produce a sample where the fetal DNA content in the sample would be enriched and analyzed. The following claim is exemplary:<... Read more

"A Method of Preparation" and Patent Eligibility Under Section 101

Attorney: Marina I. Miller, Ph.D.
March 30, 2020

Before LOURIE, MOORE, and REYNA, Circuit Judges. Illumina, Inc. and Sequenom, Inc. ("Illumina") filed suit against Ariosa Diagnostics, Inc., Roche Sequencing Solutions, Inc., and Roche Molecular Systems, Inc. ("Roche") alleging infringement of U.S. Patents 9,580,751 and 9,738,931. Roche moved for summary judgment that the asserted claims were invalid under 35 U.S.C. § 101. The district court granted Roche's motion holding that the claims of the '751 and '931 patents were directed to ineligible subject matter. Illumina appealed. The Federal Circuit ("the Court") reversed the district court's grant of summary judgment and remanded for further proceedings.... Read more

Solicitor General on Patent Eligibility

Attorney: Richard D. Kelly
December 16, 2019

The Solicitor General (SG) was invited by the Supreme Court to provide comments on the certiorari petitions filed by Berkheimer and Hikma to review the Federal Circuit's 101 decisions adverse to them. The two briefs have numerous similarities including identifying the Court's decision in Bilski[1]as starting the patent eligibility confusion by not grounding its decision on interpreting the meaning of the 35 U..S.C. 101 terms "process, machine, manufacture, [and] composition of matter." The SG asserts that in Bilski the Court did not ground its decision on the stature terms but instead found three exceptions to be not required by the statutory text: laws of nature, physical phenomenon, and abstract ideas. While these concepts are found earlier Supreme Court decisions, Bilski represented the first time they were used independent of the statutory language or constitutional concept of the "useful arts." The SG then described Mayo[2] as continuing the Court's Bilski practice of not tying patent eligibility to any of the statutory or Constitutional language. Alice[3] characterized the Mayo decisional approach as a two step process.... Read more

Patent Eligibility Under 35 U.S.C. 101 of Articles of Manufacture

Attorney: Marina I. Miller, Ph.D.
November 6, 2019

FYF-JB, LLC sued Pet Factory, Inc. for infringing its U.S. Patent 9,681,643 ("the ‘643 patent") covering a tug toy for animals that emits a sound when it is pulled on both sides. Pet Factory moved to dismiss FYF-JB's complaint, arguing that the asserted claims were directed to patent ineligible subject matter under 35 U.S.C. § 101. The United States District Court for the Northern District of Illinois ("the Court") denied Pet Factory's motion to dismiss.... Read more

Prior Art Introduced During Prosecution Has Important Implications for 101 Challenges

Attorney: Richard D. Kelly
September 19, 2019

Five years after Alice Corp. Pty. v. CLS Bank Int'l, 573 U.S. 208 (2014) and the institution of the Alice test, district courts are still wading through precedent set by the Federal Circuit while it attempts to apply the test. Recently, one New Mexico District Court turned to prior art introduced during the prosecution process that was aimed at the questions of novelty and non-obviousness to determine whether there was an "inventive concept" for the Alice/Mayo test.... Read more

Method-of-Treatment Claims, Comprising Excluding Certain Patients from Treatment, Found to Be Patent-Ineligible Under 35 U.S.C. § 101

September 13, 2019

On August 27, 2019, in INO Therapeutics LLC v. Praxair Distribution Inc., in a 2-1 decision, the Federal Circuit upheld a district court decision that method-of-treatment claims, comprising excluding certain patients from treatment, were invalid under 35 U.S.C. § 101.... Read more

ATHENA DIAGNOSTICS - THE FEDERAL CIRCUIT AGAIN ABDICATES ITS RESPONSIBILITY

Attorney: Richard D. Kelly
July 15, 2019

In denying the petition for rehearing en banc the majority of the Federal Circuit abdicated its responsibility to define the limits of the Supreme Court's Mayo decision. Judge Dyk on the 25th birthday of the Federal Circuit noted that: Frequently, the Supreme Court in patent cases articulates a general principle and leaves it to our court to both administer the rule and apply it to the individual case.... Read more

The Proper Application of the Supreme Court's Alice Standard is an Evolving and Sometimes Hazy Area of Law

Attorney: Daniel J. Pereira, Ph.D.
April 29, 2019

Marijuana, for medical purposes and recreational purposes, is an area of great political, social and legal interest. By some accounts (https://www.forbes.com/sites/thomaspellechia/2018/03/01/double-digit-billions-puts-north-america-in-the-worldwide-cannabis-market-lead/#6d925dd76510), the industry is rapidly growing leaps and bounds. Not surprisingly, patents and disputes centered on patents for this industry are increasing in numbers.... Read more

Cleveland Clinic - Another Black Eye for the Federal Circuit and Dissing the USPTO

Attorney: Richard D. Kelly
April 3, 2019

In the April 1 Cleveland Clinic Foundation v. True Health Diagnostics LLC decision, the Federal Circuit has once again given itself a black eye in finding a new diagnostic procedure to be patent ineligible and with the same punch dissed the USPTO.... Read more

Natural Alternatives - Claim Construction Defeats A 101 Challenge On The Pleadings

Attorney: Richard D. Kelly
March 26, 2019

The Federal Circuit on March 19 in Natural Alternatives Intl. v Creative Compounds LLC. reversed a district court's opinion finding Natural's patent claims to be patent ineligible. The district court's decision arose out of a motion for judgment on the pleadings filed by Creative.... Read more


Category: Federal Circuit