MPEP Q & A 79: Factors When Determining Sufficient Evidence Concerning Enablement Requirement

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Question:

List two factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is ‘undue’.

Answer:

The factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is ‘undue’ include, but are not limited to:

  • The breadth of the claims;
  • The nature of the invention;
  • The state of the prior art;
  • The level of one of ordinary skill;
  • The level of predictability in the art;
  • The amount of direction provided by the inventor;
  • The existence of working examples; and
  • The quantity of experimentation needed to make or use the invention based on the content of the disclosure.

Chapter Details:

The answer to this question can be found in chapter 2100 of the MPEP. This chapter covers patentability.

The answer is from the 9th Edition, Revision 07.2015. Depending on future changes to the MPEP, the question and answer may be applicable in later Editions or revisions.

Section Summary:

This question and answer comes from section 2164.01(a) of the MPEP.  The following is a brief summary of section 2164.01(a).

2164.01(a) Undue Experimentation Factors

There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” The specific factors are covered here.

In addition, a conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.

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