Undue Experimentation Rejection Reversed in Biotech Patent Appeal

MARK TERRY, ESQ.

The Board of Patent Appeals and Interferences reversed a patent examiner’s 35 U.S.C. §112 rejection of a biotechnology invention describing a method for killing malignant melanoma cancer cells in Ex parte Chada.

The application described activating the MDA-7 gene in melanoma cells so the cells would produce proteins associated with suppressing and preventing the spread of metastatic cancer. The examiner argued that practicing the claimed method would require undue experimentation.

The examiner relied in part on a prior patent involving protection of healthy human cells from HIV. The Board found that reliance misplaced because the cited work sought to prevent destruction of healthy cells, while the claimed invention intentionally promoted destruction of cancerous cells. The two methods pursued fundamentally different therapeutic goals.

The Board concluded that the examiner had not supplied sufficient evidence, scientific reasoning, or logical analysis to establish that practicing the claimed method would require undue experimentation. The decision illustrates that an enablement rejection must be supported by more than a generalized concern about technical complexity.