What types of evidence can an applicant submit to support enablement?

Applicants can submit various types of evidence to support enablement claims. According to MPEP 2164.05:

• Factual affidavits under 37 CFR 1.132
• References showing what one skilled in the art knew at the time of filing
• Declarations or affidavits containing factual evidence
• In chemical and biotechnical applications, evidence submitted to the FDA for clinical trial approval (though not required)

The MPEP states, “The evidence provided by applicant need not be absolute but merely convincing to one skilled in the art, based on a preponderance of the evidence standard.” It’s important to note that “The weight to give a declaration or affidavit will depend upon the amount of factual evidence the declaration or affidavit contains to support the conclusion of enablement.”

To learn more:

• enablement evidence
• patent application
• affidavits
• declarations