Use the Wands factors to help prevent your biotech, chemical, AI, and other unpredictable arts patent application from being rejected for lack of enablement.
Patents are a contract between society and inventors – a limited monopoly for adequate disclosure for a new and useful invention. To enforce this, 35 USC 112(a) requires that the inventors describe their invention in:
“full, clear, concise, and exact terms as to enable any person skilled in the art to… make and use the same”
35 USC 112(a)
This is easier to do when the invention is in a well-understood technology area (e.g., engineering). It is more challenging when the invention is in the less predictable arts (e.g., biotechnology, chemistry, artificial intelligence) that often require some experimentation. It can also be difficult when the subject matter is highly complex or not completely understood.
Reasonable people can differ as to what is “enabling.” There have been many disagreements and court fights, and the law in this area has slowly developed over many different court decisions. In Biotech and AI, it is still evolving. MPEP 2164 valiantly attempts to summarize some of these many decisions. Here are a few high points regarding these 112 factors.
- In the 1916 Minerals Separation v Hyde case, SCOTUS determined a disclosure can be enabling even if it requires some experimentation. However, this must be “reasonable experimentation.” (I found this case easy to read, and it certainly improved my understanding of refining ore!)
112 factors: what is “unreasonable” experimentation?
But what is undue experimentation? In the more recent 1988 In re Wands case (biotechnology), which involved monoclonal antibody production and medical diagnostics, the Federal Circuit attempted to grapple with this complex subject. Their analysis considered eight 112 factors, now referred to as “Wands factors.” These are still in use today. These factors for 112 are:
(A) The breadth of the claims
In re Wands as summarized by MPEP 2164.01(a)
(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
(H) The quantity of experimentation needed
Accio patent! Using Wands 112 factors to help pass your 35 USC 112(a) review
Your invention is what it is, and you probably can’t control factors B-E. However, there are a few immediate take-home lessons when writing your patent. The trick is to use those Wands factors you can control to reduce the chance of 35 USC 112(a) “not enabled” rejections.
- Regarding Wands (A): Broader claims are more problematic – not only are you more vulnerable to any prior art, but you are also more vulnerable to a lack of enablement rejection. Consider having narrower claims as a backstop.
- Regarding Wands (F): The more direction you can give, the better
- Regarding Wands (G): Provide working examples when possible. More is better
- Regarding Wands (H): Consider providing tips to reduce the experimentation needed. (For example, for AI, teach how your AI system can be optimally trained.)
These take-home lessons become more important when you are in a less predictable technology area, such as biotechnology, chemistry, and AI. However, don’t take them for granted, even in “safer” areas such as mechanical engineering and conventional computer science.
Finally, draft a few narrow claims as backup because the courts are unpredictable. Indeed, SCOTUS is looking at this again.