Patent decision
- BL number
- O/604/19
- Concerning rights in
- GB1609984.8
- Hearing Officer
- Dr L Cullen
- Decision date
- 8 October 2019
- Person(s) or Company(s) involved
- The Scripps Research Institute
- Provisions discussed
- Section 14(3), 14(5)(c)
- Keywords
- Sufficiency, Support
- Related Decisions
- None
Summary
This application relates to the detection of subclinical acute rejection (subAR) in kidney transplant patients. It relies upon an analysis of gene expression profiles in samples taken from transplant patients and the identification of probe sets that can distinguish between subAR, well-functioning normal transplant (TX) and acute rejection (AR) in such patients, in contrast to current methods which only detect kidney graft rejection after initial injury has started.
The hearing officer (HO), taking note of the principles set down in Eli Lilly v Human Genome Sciences [2008] RPC 29, considered whether the application was insufficient by excessive claim breath. He identified the skilled team as a molecular biologist familiar with the identification of genes differentially expressed in normal and diseased patients, who is aware of the different methods used to detect such differences in expression, including microarray analysis and next generation sequencing (NGS); and a clinician who has knowledge of kidney damage arising from transplant rejection and would be aware of the current methods for detecting kidney damage, as well as their limitations. The HO found that the invention does not lie in the general principle of distinguishing between subAR, AR and TX in transplant patients with a normal level of creatinine by gene expression analysis, as this is already known from the cited prior art, but that it lies instead, in the identification of a specific set of genes that enables one to detect subAR in a transplant patient with a degree of accuracy greater than 75%, referred to as the Net Predictive Value (NPV). As a result, the HO considered that some disclosure in the specification is required to support a claim that all of the 818 genes listed in Table 14 could be used in a combination of 4 or more to distinguish subAR, AR and TX with the necessary degree of accuracy. The HO concluded that, in the absence of such disclosure, the application does not describe the invention in a manner which is clear enough and complete enough to enable it to be performed by a person skilled in the art and so failed to satisfy Article 14(3) of the Act. The HO also found that the claims were not fully supported by the description, and so contravened Section 14(5)(c) of the Act. The application was refused under Section 18(3) of the Act.
Full decision O/604/19 
302Kb
