On November 14th, the PTO hosted a roundtable discussion in Alexandria on s. 101 issues in which both industry reps and practitioners were invited to dissect the current Office guidelines. The structure was unique as there were 33 invited speakers [I was one of them] compressed into 3.75 hours. We each had about 6 minutes to address three PTO representatives, including Robert W. Bahr, Deputy Director for Examination Policy, who has been signing off on the recent memorandums on examination policy. There was a representative from the solicitor’s office and another gentleman whose name was not audible from where I was sitting [seats were assigned based on the order of the presentations, and I was in the bleachers.] The speakers addressed all areas of technology affected by the rise of section 101.
Archive for the ‘Patentable Subject Matter’ Category
I first posted on this case in September 2014, and urge you to find the post and the district court’s opinion in the Archives. It provides a good – well, adequate– description of the patented technology, which is a method to automatically animate lip synchronization and facial expression of 3D animated characters. This art area has as much jargon as biotech, and I am not going to try to explain what a morph target, a phoneme or a visme is. The claimed method, which used pre-set “rules” to get animated characters to speak with the appropriate facial expressions, was certainly a great advance over using artists to adjust these activities by hand across a wide range of facial expressions and voices.
In a great leap backwards for patenting life sciences, Magistrate Judge Cabell invalidated claims in a number of patents licensed to Oxford Immunotec that are directed to e.g., “A kit for diagnosing infection in a human host by, or exposure of a human host to, a mycobacterium that expresses [protein/antigen] ESAT-6 comprising a panel of eight [ESAT-6 peptide fragments] represented by SEQ ID NOS 1 to 8.” (U.S. Pat. No. 7,632,646).
The Report was issued on August 31, 2016, in Action No. 15-cv-13124-NMG in Oxford Immunotec, Ltd. v. Qiagen, Inc. et al.
The FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated. (A copy of the first draft and second draft can be found at the end of this post.) The strategies involve the generation of reliable diagnostic conclusions for patients based on one or, oftentimes, many many mutations that are compared to those of other patients and to reference databases. Under “Scope,” the FDA has stated:
“[T]his paper discusses factors and principles to identify genetic databases that are of sufficient quality to support a regulatory submission…..[T]his paper discusses data quality and database operations as applied to the clinical interpretation of human genetic variants, i.e., for establishing the link between variants and the risk or diagnosis of disease or other states of health.”