Can applicants present evidence to show no reasonable expectation of success?
Yes, applicants can present evidence to show that there was no reasonable expectation of success, which may support a conclusion of nonobviousness. The MPEP 2143.02 states:
“Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness.”
Applicants can provide various types of evidence, such as:
- Experimental data showing unexpected failures or difficulties
- Expert testimony indicating the unpredictability in the field
- Prior art teachings that suggest the combination would not work
- Evidence of others’ failed attempts at similar combinations
For example, in OSI Pharm., LLC v. Apotex Inc., the Federal Circuit found that given a 99.5% failure rate and no efficacy data or other reliable indicators of success, the only reasonable expectation at the time of the invention was failure, not success.
It’s important to note that the evidence should be commensurate with the scope of the claims and relevant to the state of the art at the time of the invention (for pre-AIA) or before the effective filing date (for AIA).
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