What happens if a negative limitation lacks support in the original disclosure?

If a negative limitation lacks support in the original disclosure, it can lead to rejection of the claim. According to MPEP 2173.05(i):

“Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement.”

However, the MPEP also notes that the mere absence of a positive recitation is not always sufficient to establish a prima facie case for lack of descriptive support. The Novartis Pharms. Corp. v. Accord Healthcare, Inc. case clarified that while silence generally won’t suffice to support a negative limitation, there may be circumstances where a skilled artisan would understand a negative limitation to necessarily be present in a disclosure.

For a more detailed discussion on this topic, refer to MPEP § 2163 – § 2163.07(b), which covers the written description requirement of 35 U.S.C. 112(a).

To learn more:

Topics: MPEP 2100 - Patentability, MPEP 2173.05(I) - Negative Limitations, Patent Law, Patent Procedure
Tags: 35 u.s.c. 112(a), MPEP, Negative Limitations, Original Disclosure, patent claims, Written Description Requirement