What is the “burden-shifting” approach in examining product-by-process claims?
This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.
The “burden-shifting” approach in examining product-by-process claims involves two key steps:
- The examiner initially focuses on the product itself, regardless of how it was made.
- If the examiner finds a prior art product that appears to be identical or substantially identical, the burden shifts to the applicant.
As stated in MPEP 2113:
“Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product.”
This approach ensures that the examination focuses on the product’s patentability while allowing applicants to demonstrate any unique characteristics resulting from their specific process.