Archive for the ‘Patentable Subject Matter’ Category

Obama Launches Cancer Moonshot Task Force – But Where’s The Patent Power?

Monday, February 8th, 2016

iStock_000035457638_SmallOn January 28, 2016, the White House issued a Memorandum establishing the Moonshot Task Force “to double the rate of progress in the fight against cancer – and put ourselves on a path to achieve in just 5 years research and treatment gains that otherwise might take a decade or more.” (A copy can be found at the end of this post.) The Task force, chaired by the VP, is to focus on “making the most of Federal Investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement initiatives, and other mechanisms to support cancer research and enable progress in treatment and care.” No mention of the importance of patent protection so far.

The membership will consist of the heads of 13 executive branch departments, agencies, and offices, including NIH, DOE, FDA, and NSF, among other. The head of the Department of Commerce is included, but the USPTO is not mentioned once.  However, I have been informed by the PTO Press Secretary that the USPTO, including Director Lee and Chief of Staff Aiyer attended the February 4th Task Force Meeting. The Task Force is to provide a report before the end of the year that includes seven recommendations, including to “identify and address any unnecessary regulatory barriers and consider ways to expedite administrative reforms.”


Ariosa v. Sequenom – Cert. Denied

Thursday, December 3rd, 2015

iStock_000016880645_SmallNot surprisingly, the Fed. Cir., on December 2nd, denied Sequenom’s petition for rehearing en banc of the invalidation of certain of the claims of U.S. Pat. No. 6,258,540 which were directed to methods of detecting and using cffDNA. (Appeal no. 2014-1139, 2014-1144). (A copy of the decision can be found at the end of this post.) Judge Newman was the lone dissenter. Judge Lourie, joined by Judge Moore, and Judge Dyk wrote separate concurrences that read like dissents (“Mayo made us do it!”). The concurrences are not lengthy, but they bring into focus – finally – the basics of the s. 101 debate. A summary of their opinions might go like this: Disembodied abstract ideas and natural phenomena like mathematical formulae and drug metabolites in the blood –or cffDNA per se– are not patent-eligible. However, real-world applications of the phenomena, such as a new method of performing a specific prenatal diagnosis using amplified cffDNA, as recited in claim 21 of the ‘540 patent, should be found to meet the Mayo two-part test for patent-eligibility.


Prometheus v. Roxane – A Glimpse of Christmas Future?

Monday, November 16th, 2015

iStock_000049739658_SmallA Fed. Cir. panel of Judges Dyk, Taranto and Hughes affirmed the district court’s invalidation of a Prometheus “add-on” patent (U.S. Pat. No. 6,284,770) to a method to treat a form of irritable bowel syndrome, IBS-D, with alosetron, as obvious in view of prior art related to the symptoms of the condition. The primary alosetron patent (the ‘880 patent) had expired. Although the claim did not recite optimizing the dosage of the drug, it still reminded me of the infamous claim in Mayo v. Prometheus, in that both claims were “regimen” type claims which claimed an improved method of treating a subset of patients. In Mayo, the subset was identified by determining which patients were receiving too much drug (= side effects) and which patients were receiving too little ( = not helped) – the subset was the group of patients who were (or could be) treated with the optimal amount of the drug, which was recited in the claim.


Janice Mueller’s New Article: Patent -Ineligible Methods of Treatment

Monday, October 12th, 2015

Patent-Ineligible Methods of Treatment

Janice M. Mueller 

booksChisum Patent Academy
October 3, 2015
Janice M. Mueller, Patent-Ineligible Methods of Treatment, in MUELLER ON PATENT LAW, VOL. I (PATENTABILITY AND VALIDITY) (Wolters Kluwer Law & Business 2012), last revised October 2015


The Supreme Court’s sweeping 2012 decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc. was soon to impact the medical diagnostics research community beyond the parties to Mayo. In the view of this author, the Mayo framework created the potential for (presumably) unintended negative consequences that may chill future medical diagnostic research (an issue raised by Prometheus and various amici in Mayo). The Federal Circuit’s June 2015 decision in in Ariosa Diagnostics, Inc. v. Sequenom, Inc., aptly illustrates the concern. Compelled by the Supreme Court’s broad language defining the second step of the Mayo framework, the Federal Circuit in Ariosa affirmed the invalidation under §101 of a groundbreaking patent on prenatal testing.

Mueller Patent Ineligible Methods of Treatment