What You Need to Know
- Key takeaway #1 The Guidelines maintain the status quo and instruct USPTO personnel to continue to apply the Wands factors.
- Key takeaway #2 The Guidelines state that the Amgen decision applies across technology fields.
- Key takeaway #3 The Guidelines highlight post-Amgen cases, but none demonstrate a case where the claims were found to be enabled.
On
In the Guidelines,
To assess the "reasonableness of experimentation," the Guidelines highlight a handful of post-Amgen cases that have applied the Wands factors in assessing enablement, such as
Notably, none of the cases highlighted in the Guidelines demonstrate a case where the claims were enabled—instead, every case ultimately concludes that the claims were not enabled. Even more, the cases highlighted in the Guidelines don't appear to be close-calls as far as enablement is concerned. In the Amgen and Baxalta cases, for example, the claims encompassed millions of antibodies, where only 26 or 11 exemplary antibodies, respectively, were disclosed, and the identification of new antibodies was to occur through an iterative, trial-and-error process, where each new antibody had to be screened for the appropriate activity. In the Medytox case, the claims encompassed a method of using a botulinum toxin composition that exhibits a responder rate of 100%, but the specification did not enable one to achieve anything higher than 62%. In the Starrett case, the claims potentially covered over 140 trillion embodiments, and the specification "fail[ed] to describe how the claim elements function."
The Guidelines do clarify that the Amgen decision, despite relating to biotechnology and antibodies, applies across technology fields, as it relied on precedent from cases covering a wide range of sectors.
While the Guidelines instruct USPTO employees, applicants, and patentees alike to continue adhering to the Wands factors when assessing whether one must engage in more than a reasonable amount of experimentation, they do not provide examples or feedback on cases that are a closer call. Practitioners are continuing to see guideposts of what is not enough, but questions still remain on what is "enough" disclosure for enablement under Amgen. The application of Amgen outside of functional claims also remains murky.
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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