How can indefiniteness rejections arise from biological deposit issues in patent applications?

Indefiniteness rejections related to biological deposit issues in patent applications can arise under 35 U.S.C. 112(b). According to MPEP 2411.01:

“A rejection for indefiniteness, as applied to a deposit issue, requires the examiner to provide reasons why the terms in the claims and/or scope of the invention are unclear because of an incomplete or inaccurate description or the absence of a reference to a biological material.”

In the context of biological deposits, indefiniteness rejections may occur when:

• The description of the biological material is incomplete or inaccurate
• There is an absence of a reference to a necessary biological material
• The terms used in the claims related to the biological material are unclear
• The scope of the invention is unclear due to issues with the biological material description or deposit

To avoid such rejections, applicants should ensure that biological materials are clearly and accurately described, properly referenced, and, when necessary, deposited in accordance with the regulations outlined in 37 CFR 1.802.

To learn more:

• Indefiniteness
• Biological Deposits
• 35 U.S.C. 112(b)
• Patent Rejections
• Biotechnology Patents