What role does the state of the prior art play in determining enablement?

The state of the prior art is a crucial factor in determining enablement, as it provides context for assessing whether a person skilled in the art can make and use the invention without undue experimentation. The MPEP Section 2164.06(b) illustrates this through several cases:

In In re Wright, the court considered evidence that “in 1988, a vaccine for another retrovirus (i.e., HIV) remained an intractable problem.” This prior art evidence, combined with the complexity of RNA viruses, led to the conclusion that the invention was not enabled for all retroviruses or even all avian retroviruses.

Similarly, in In re Vaeck, the court took into account “the relatively incomplete understanding of the biology of cyanobacteria as of appellants’ filing date” when assessing enablement.

The state of the prior art influences enablement by:

  • Providing a baseline of knowledge in the field
  • Indicating the predictability or unpredictability of the technology
  • Helping to determine the amount of experimentation required
  • Contextualizing the inventor’s contribution

Inventors should consider the state of the prior art when drafting their specifications to ensure they provide sufficient guidance beyond what is already known in the field.

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Topics: MPEP 2100 - Patentability, MPEP 2164.06(B) - Examples Of Enablement Issues — Biological And Chemical Cases, Patent Law, Patent Procedure
Tags: biotechnology patents, Enablement, patent law