Director Iancu’s IPO Address and Judge Rich

Although Director Iancu’s address primarily aims at the difficulty of determining when a claim is directed to an abstract idea, his precursor guiding light is clearly the late Judge Giles Rich. Notably, Iancu quotes from Judge Rich. These quotes are all taken from Judge Rich’s lengthy opinion In re Bergy, 596 F.2d 952 (CCPA 1979):

“[Judge Rich] said at the time that problems [with s. 101 jurisprudence] can arise due to the unfortunate… though clear commingling of distinct statutory provisions which are conceptually unrelated, namely those pertaining to categories of invention in s. 101 which may be patentable, and to the conditions of patentability [ss. 102, 103, 112].”

“The genius of the 1952 Patent Act, of which Judge Rich is widely viewed as a principal author, was that it characterized the bases for patentability. Our recent s. 101 case law mushes them all up again. As Judge Rich said, this ‘may lead to distorted legal conclusions,’ And it has. And it must end.”

“Section 101 itself lists four categories [of invention]: process, machine, manufacture, and composition of matter. The judicial exceptions should likewise be clearly categorized. As Judge Rich explained, when we deal with s. 101, “the sole question… is whether the invention falls into a named category, not whether it is patentable.’’

“Judge Rich was again perceptive, which he noted 40 years ago that ‘To provide the option of making such a rejection under either 101 or [a condition for patentability] is confused and therefore bad law.’” Continue reading

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Remarks by Director Iancu at IPO’s Annual Meeting

USPTO director, Andrei Iancu, delivered remarks at the Intellectual Property Owners Association’s 46th Annual Meeting.  Dir. Iancu indicated that a major initiative is underway at the USPTO to reduce the arbitrary and capricious application of 101 patent ineligibility to patent applications.  To read the remarks as delivered, click here.

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“Big Data” Claims Meet Mayo/Alice Rule

Big DataI am going to try to discuss two recent decisions by the PTAB, Ex parte Fiesner, Appeal 2018-00530 (9-10-18) and Ex parte Lehrer, Appeal 2016-007941 (8-29-2018). Both have claims that employ computers to process large amounts of input data to, hopefully, yield lots of useful output. Lehrer claims a method to identify at least one therapeutic target in a cancer patient by assaying multiple characteristics in the genome or phenotype of a biopsy to identify “at least one dysregulated pathway” that deregulates a gene product in the cancer as compared to normal tissue and identifying at least one target that would overcome the dysregulation.

Friesner claims a method of scoring binding affinity of proposed ligand molecules for a protein using a computer to assign a penalty to the binding affinity score depending on the solvation of the receptor. This allows identification of one or more active ligand-receptor complexes that are used for competitive screening of proposed ligands against the complexes. The inactive complexes are screened out.

These are grossly simplified outlines of the two claims under consideration but, in each case, the printed claims are nearly as long as the remainder of the opinions. Examiner Borin handled both applications and concluded that “[a}s such, the claims are drawn to processing information, converting one form of numerical representation into another [by organizing information through mathematical concepts and applying rules and categorizing information.] Thus, the claims are directed to an abstract idea which is a judicial exception.” [Lehrer omits the bracketed phrase].

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BIO IP & Diagnostics Conference – Is the Titanic Turning Around?

TitanicOn September 28th, I will be moderating a panel on patenting diagnostic tests – and related subject matter – such as methods of medical treatment, at BIO’s annual IP & Diagnostics Symposium in Alexandria, VA. At the beginning of 2018, the outlook was bleak in this area. Following the Fed. Cir.’s Ariosa (natural product), Cleveland Clinic (law of nature, cert. petition filed) and Genetic Tech. v. Merial (law of nature), the challenge of getting a claim that would survive a s. 101 challenge seeming nearly insurmountable. The Mayo/Alice test was wielded like an anti-patent sword by district court judges, the PTAB and the Fed. Cir. to invalidate patents under 12(b)(6), e.g. at the pleadings stage of litigation, often before claim construction had been carried out.

In preparing my presentation, I reviewed all of the case law and related PTO materials that I had posted at Patents4Life. I had reviewed a pack of patents or applications confronted with s. 101 questions, and was surprised to see that, except for Cleveland Clinic – I had posted on their petition for cert. – Ex parte Patterson and Ex parte Nagy, a July decision on a method to diagnose Alzheimer’s Disease, all of the decisions listed below that addressed claims having diagnostic elements did not invalidate the patents or applications, as failing to pass s. 101 muster.

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