I 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].
On 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.
In ex parte Ho, the subject of my last post, the PTAB reversed the Examiner’s rejection of claims to a population of bone marrow cells obtained by two-stage culturing that expressed or failed to express certain markers. The PTAB wrote that, for the purposes of the appeal, it would be assumed that the cells were a natural product, but went on to find that they were markedly different from any naturally occurring counterpart cells. The problem with this abbreviated analysis is the PTAB’s assumption that the claimed cell population is a natural product, and effectively forcing the appellant to traverse Step 2 of the Mayo/Alice test. In ex parte Ho, the appellant was able to present evidence to this effect, including an expert’s declaration. But should they have had to?
Ex parte Parenteau, Appeal No. 2017-002191 (PTAB, August 22, 2018), is a slightly earlier decision in which the Board reversed both a s. 103 rejection and a s. 101 “natural product” rejection of claims directed to cultured tumor cells containing a population of 51-100% rapidly dividing C-RC cells that consists of 80-100% actively expanding and dividing VSEC, SDEC and SCEC cells and abnormal transit amplifying cells. The cultivating step is carried out in a serum-free, defined cell culture medium containing agents selected from the group consisting of 9 classes of agents, including TNF-alpha.