Tag Archives: Subject Matter Eligibility

USPTO Finds SureGene Personalized Medicine Treatment Unpatentable Under Mayo

In Ex Parte Timothy, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s rejection of personalized medicine treatment claims. This decision highlights the PTAB’s willingness to invalidate claims that it finds similar to the claims at issue in Mayo. It also underscores the need for Congressional action to incentivize and protect investments in this … Continue reading this entry

A Look At The USPTO Patent Eligible Subject Matter Report

On July 24, 2017, the USPTO issued a 48-page report on Patent Eligible Subject Matter. The report summarizes key court decisions interpreting and applying 35 USC § 101, international views on eligible subject matter, and public comments and recommendations for addressing recent changes in this foundational issue of U.S. patent jurisprudence. While some have criticized the USPTO … Continue reading this entry

Magistrate Judge Nixes TB Test Kit Claims

In a “Report and Recommendation on Defendants’ Joint Motion To Dismiss,” U.S. Magistrate Judge Cabell of the U.S. District Court for the District of Massachusetts determined that TB test kit claims do not satisfy the patent eligibility requirement of 35 USC § 101, but declined to reach the same conclusion with regard to related method claims. The decision … Continue reading this entry

District Court Upholds Eligibility Of Personalized Medicine Method Claims For FANAPT

In Vanda Pharmaceuticals Inc. v. Roxane Labs., Inc., Judge Sleet of the U.S. District Court for the District of Delaware upheld the patent eligibility of personalized medicine method claims related to Vanda’s FANAPT® (iloperidone) product for treating schizophrenia. The claims recite a diagnostic step as well as a treatment step, and were found to recite “significantly … Continue reading this entry

USPTO Patent Eligibility Guidance In View Of CellzDirect And Sequenom

On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the Federal Circuit decision in CellzDirect, and notes that the Supreme decision denying certiorari in Sequenom “does not elevate” the significance of the panel decision … Continue reading this entry

CAFC Finds Cryopreservation Method Patent Eligible

The Federal Circuit ruled that the cryopreservation methods at issue in Rapid Litigation Mgmt. Ltd. v. CellzDirect Inc., are patent eligible under 35 USC § 101. It therefore vacated and remanded the decision of the U.S. District Court for the Northern District of Illinois that held the claims invalid on summary judgment. The Federal Circuit distinguished … Continue reading this entry

USPTO 101 Guidance: Microneedles Versus Prosthetic Devices

When I first wrote about the new natural products Subject Matter Eligibility Examples issued by the USPTO on May 4, 2016, I noted a puzzling difference between the treatment of a claim reciting a vaccine coated on a microneedle device versus a claim reciting a vaccine formulated in a cream carrier. Suzannah Sundby at Canady … Continue reading this entry

New USPTO Guidance On Patent Eligibility Of Natural Products

The new USPTO patent eligibility examples include two examples for “natural products” based inventions which appear to be consistent with the examples provided in the December 2014 set of patent eligibility examples. Although the new examples include additional discussion and guidance that could be helpful in some cases, they largely remain perplexing. Unfortunately, although the new diagnostic methods … Continue reading this entry

District Court Applies Mayo To Treatment Claims But Denies Motion To Dismiss BMS Keytruda Litigation

The U.S. District Court for the District of Delaware accepted Merck’s arguments that method of treatment patents asserted by BMS against its Keytruda product “touch[] upon a natural phenomenon” such that they should be analyzed under the Mayo/Alice patent eligibility framework. However, in view of disputed issues of fact, the presumption of validity, and other presumptions arising from … Continue reading this entry

Having A Bad Hair Day? The Federal Circuit Agrees That Method Of Cutting Hair Is Invalid Under 101

While I do not usually write about non-precedential decisions, In re: Brown caught my eye as an interesting patent eligibility case. It does not relate to diagnostics or computer programs, but rather to the art of cutting hair.… Continue reading this entry

Methods Exploiting Junk DNA May Be Useful But Lack Patent Eligibility

Striking another blow against patent eligibility in the field of biotechnology, the Federal Circuit agreed with the district court that methods that use “junk DNA” to detect genetic variations lack patent eligibility under 35 USC § 101. Although Judge Dyk found the claims at issue to be similar to claims held invalid in other Federal Circuit … Continue reading this entry

Australian Patent Office Provides Patent Eligibility Guidance

The Australian Patent Office (IP Australia) has issued final patent eligibility guidance under the Australian High Court’s decision in D’Arcy v. Myriad Genetics, Inc. Where the USPTO extrapolated from the U.S. Supreme Court decision when it promulgated its patent eligibility guidance, IP Australia seems to have taken a more conservative approach. This means that despite similar rulings against … Continue reading this entry

Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

The Federal Circuit has issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court’s finding that Sequenom’s claims are invalid under 35 USC § 101. The court’s decision shows the sweeping impact of the Supreme Court’s decision in Mayo v. Prometheus on the patent eligibility of diagnostic methods, and could have a ripple effect … Continue reading this entry

Waiting On Sequenom

As I write this there’s a voice in my head saying, “Be careful what you wish for!” but it has been five months since Sequenom was argued at the Federal Circuit, and the court has yet to issue its decision. (You can read my summary of the oral arguments here.) In the meantime, neither the … Continue reading this entry

Federal Circuit Invalidates Myriad Primer And Method Claims As Lacking Subject Matter Eligibility

In a case styled as In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (also known as Myriad v. Ambry), the Federal Circuit held four of Myriad’s “primer” claims and two of Myriad’s detection method claims invalid for lack of subject matter eligibility under 35 USC § 101. The timing of this decision–coming two days after … Continue reading this entry

Sequenom Deal May Avoid Federal Circuit Decision

Less than a month after their case was argued at the Federal Circuit, Illumina Inc. and Sequenom Inc. have announced a deal to settle their patent infringement litigation. While I haven’t seen an order dismissing the case, that is a likely next step. … Continue reading this entry

Third Time Is The Charm For WildTangent Challenge Of Patent Eligibility Of Ultramercial Patent

In its third opinion reviewing the same district court decision, the Federal Circuit this time affirmed the district court’s grant of WildTangent’s motion to dismiss Ultramercial’s patent infringement complaint because the claims at issue fail to satisfy 35 USC § 101. The Federal Circuit applied the analytical framework set forth in the Supreme Court decision in Alice … Continue reading this entry

Federal Circuit Looks For Inventive Concept In Sequenom Patent

On November 7, 2014, the Federal Circuit heard oral arguments in Aria Diagnostics, Inc. v. Sequenom, Inc., where Sequenom is appealing the district court’s summary judgment of invalidity under 35 USC § 101. The active questioning by the judges suggests that they are wrestling with how to apply the Supreme Court’s decision in Mayo to different … Continue reading this entry

District Court Finds Genetic Technologies Patent Invalid Under 101 On Motion To Dismiss

Judge Stark of the U.S. District Court for the District of Delaware granted defendants’ motion to dismiss Genetic Technologies, Ltd.’s patent infringement suit with regard to claim 1 of U.S. Patent 5,612,179 on the basis that the claimed sequence analysis method is invalid under 35 USC § 101 because it merely applies conventional methods to … Continue reading this entry

A Peek At The 60 Minutes GenePeeks Patents

Thanks to Kyle Canavera, an associate in the Electronics practice of Foley & Lardner LLP, for providing insight for this article. On October 26, 2014, 60 Minutes aired a story called “Breeding Out Disease” that included a segment about GenePeeks, a company that uses genetic information from prospective parents to make thousands of “digital babies” and “calculate … Continue reading this entry

Federal Circuit Hears Arguments In Other Myriad Gene Patents Case

On October 6, 2014, the Federal Circuit heard oral arguments in a case involving the claims of the Myriad gene patents that were not invalidated by the Supreme Court’s 2013 decision. The Federal Circuit is reviewing the district court’s denial of Myriad’s motion for a preliminary injunction against Ambry Genetics Corp., based on the finding that Ambry … Continue reading this entry

Airing The USPTO’s Naturally Occurring Dirty Laundry — The Subject Matter Eligibility Stain

It has been five months since the USPTO issued its Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products to aid examiners in applying the principles of Myriad and Prometheus to any claim “reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products.” While many of the rejections based on … Continue reading this entry

The USPTO Patent Subject Matter Eligibility Guidance TRIPS Over Treaty Requirements

With thanks to my colleague Dr. Christopher Swift for his expert advice on the intersections of US and international law. The “Myriad-Mayo” patent subject matter eligibility guidance issued March 4, 2014 reflects the USPTO’s interpretation of Supreme Court cases interpreting and applying 35 USC § 101 to claims involving laws of nature, natural phenomena, and natural products, but the … Continue reading this entry

Comments On Patent Subject Matter Eligibility Guidance Due By July 31

This week brings the July 31, 2014 deadline for submitting written comments on two USPTO patent subject matter eligibility guidance documents: The “Myriad-Mayo” Guidance issued March 4, 2014 (for claims involving laws of nature, natural phenomena, and natural products) and the “Alice Corp. v. CLS Bank” Guidance issued June 24, 2014 (for claims involving abstract … Continue reading this entry