The crux of this so-called adequate description requirement — which arises under 35 U.S.C. 112 — is that once the first four patentability requirements are satisfied the applicant still must describe the invention with enough particularity such that those skilled in the art will be able to make, use and understand the metes and bounds of the invention disclosed. For the most part, this requirement can be explained as consisting of two major parts: (1) the enablement requirement; and (2) the written description requirement. Today we will address the enablement requirement.
In order for an application to be complete the invention must be enabled. What this means is that the disclosure must explain enough about the invention so that someone skilled in the art can both make and use the invention. The purpose of the enablement requirement is to require applicants to truly put the invention into the public domain and through that disclosure thereby advance the technical arts. Invitrogen Corp. v. Clontech Laboratories, 429 F.3d 1052, 1070-71 (Fed. Cir. 2005).
After a patent expires anyone can make, use, sell or import the invention covered by the patent claims, as well as any obvious variations thereof. Therefore, the enablement requirement is specifically aimed at ensuring the claimed invention is described with sufficient detail so the relevant person of skill in the art or technology area will understand both how to make and use what has been actually claimed in the patent. CFMT Inc. v. Yieldup International Corporation, 349 F.3d 1333 (2003).
Therefore, in order to ensure that the public can derive benefit from inventions after the term of exclusivity has expired the patent applicant must enable the invention, and this requirement must be satisfied at the time of filing in order to prevent against the inadmissible introduction of new matter during the prosecution of the patent application. See MPEP 2164.05(a).
Unfortunately, disclosures sometimes fail to be as complete as they can be or should be. Frequently, the failure of the disclosure is not an all or nothing proposition. As the Federal Circuit has explained, it is possible for a disclosure to sufficiently enable one or more claims while being found to be insufficient with respect to other claims. See In re Borkowski, 422 F.2d 904, 909 n. 4 (CCPA 1970). Nevertheless, a disclosure in a patent application can certainly be completely defective, thereby leading to an all or nothing proposition if the lack of explanation and clarity is so wanting.
In order to satisfy this enablement requirement the drafter should specifically and objectively define and describe how to make and use the invention.
The quickest way to explain the concept of enablement is by way of example. The popular children’s song “Skeleton Bones” explains how all the bones in the body are connected. The leg bone is connected to the knee bone, which is connected to the thigh bone, which is in turn connected to the back bone, which is connected to the neck and so on. Notice that this is a very general overview of how the bones in the body are connected. This is a good first step, but there is a lot more that can and should be written.
The backbone is really made up of many smaller bones. For example, there are seven cervical vertebrae in the necks of all mammals, and these bones together make up a portion of the backbone. Therefore, a more complete description of the backbone would point out that the neck is a part of the backbone. An even more complete description might include saying cervical vertebrae 1 (i.e., C1, which is a part of the neck) is connected to cervical vertebrae 2 (i.e., C2) and so on. The point is that the more description you provide the better, but you absolutely must have at least the big picture overview of how everything fits together, and how to make and use the invention. Therefore, be sure that you have disclosed with as much detail as possible how all the pieces of your invention connect, work together, function and interrelate.
Having said all of this, however, it is important to understand that the enablement requirement does not require an inventor to define the invention so that it must be a success in the commercial marketplace. The law does not require that a patent disclosure enable one of ordinary skill in the art to make and use a perfected, commercially viable embodiment of the invention. See CFMT Inc. at 1338. Likewise, “[p]atents are not production documents, and nothing in the patent law requires that a patentee must disclose data on how to mass-produce the invented product…” Christianson v. Colt Indus. Operating Corp., 822 F.2d 1544, 1562 (Fed. Cir. 1987). The law requires patent applications to disclose inventions, not the operation of factories that will output inventions in a commercially feasible, market sensible manner.
About Undue Experimentation
A patent needs to explain to those skilled in the art how to make and use the invention, as already discussed. But that begs the critical question about how much explanation is actually required. It is important to discuss and explain as much as possible about an invention, but that does not mean the inventor is required to provide blueprints or blueprint level detail.
The requirement that an invention be described so that it can be made and used comes with an important caveat. The law requires that an invention must be described so that it can be made and used without “undue experimentation.” Obviously, by the terminology selected to describe this important legal caveat there must be a certain level of experimentation is tolerable, and that is exactly correct.
While there is no particularly concrete and useful definition for what specifically constitutes undue experimentation, the requirement generally mandates that the description explain the invention so that it could be made and used without individuals having to go through a trial and error process in order to figure it out for themselves. In other words, the invention must actually teach so the invention can be achieved. The boundary between what is a sufficient teaching and what is undue experimentation will vary with the complexity of the field of the invention. Storer v. Clark, 860 F.3d 1340, 1350 (Fed. Cir. 2017). “The specification need not recite textbook science, but it must be more than an invitation for further research.” Id.
“Whether undue experimentation is required is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” Streck, Inc. v. Research & Diagnostic Systems, 665 F.3d 1269 (Fed. Cir. 2012). As summarized in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), relevant factors may “include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
“[I]t is not necessary that a court review all the Wands factors to find a disclosure enabling. They are illustrative, not mandatory.” Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991).
While not perfectly accurate, cases where there is not undue experimentation are generally marked by situations where the disclosure was sufficient to allow one of skill in the art to achieve the invention. Those cases where a great amount of time and energy was devoted to the attempt and the invention was never realized would lead to a finding of undue experimentation. In between is where the cases are interesting, difficult to predict and that means expensive to find an answer. As a party you don’t want to be in that uncomfortable in between, which is why absent very well thought out and thoroughly vetted strategic considerations more disclosure (and detailed disclosure) is generally the best policy when filing a patent application.
For more tutorial information please see Invention to Patent 101: Everything You Need to Know. For more information specifically on patent application drafting please see:
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