In view of the recent
The guidelines are not intended to announce any major change to accessing the enablement requirement, and state that USPTO personnel will continue to use the Wands factors from In re Wands 858 F.2d 731, 737 (Fec. Cir. 1988) to ascertain whether the experimentation required to enable the full scope of the claimed invention is reasonable.
In deciding Amgen, the
USPTO employees will continue to use the Wands factors, which were used by the USPTO prior to Amgen, to reasonably determine if the amount of experimentation required is enough to enable the claims. The Wands factors include: (A) the breadth of the claims, (B) the nature of the invention, (C) the state of the prior art, (D) the level of one of ordinary skill, (E) the level of predictability in the art, (F) the amount of direction provided by the inventor, (G) the existence of working examples, and (H) the quantity of experimentation needed to make and use the invention based on the content of the disclosure. See MPEP 2164.01(a).
Recent guidance on reasonable experimentation can be found in post-Amgen enablement decisions such as Baxalta, where the Federal Circuit stated "[w]e do not interpret Amgen to have disturbed our prior enablement case law, including Wands and its factors". See
To maintain consistency between examination and post-grant proceedings, the USPTO and the PTAB will both use the Wands factors to assess the enablement requirement in all utility applications and patents, regardless of the technology, and analysis using Wands factors should include an adequate explanation and reasoning for a lack of enablement finding.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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