Patent Drafting: Understanding the Enablement Requirement

By Gene Quinn
October 28, 2017

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.

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:

The Author

Gene Quinn

Gene Quinn is a Patent Attorney and Editor and founder of IPWatchdog.com. Gene is also a principal lecturer in the PLI Patent Bar Review Course and an attorney with Widerman Malek. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 13 Comments comments. Join the discussion.

  1. CP in DC October 28, 2017 2:44 pm

    Gene

    Another excellent article on the importance of proper drafting. One of many you have written on patent prosecution and so often is rarely discussed.

    I would like to contribute the recent case from the Federal Circuit: Amgen v Sanofi decided on October 5. It may be an advanced case, but necessary reading for those in biotech and pharma. It addresses the Enzo, Noelle, and Centocor line of cases.

    The case addresses description and enablement as it relates to genus-species, often a problem in pharma and biotech. In particular, it addresses the antibody exception and “newly characterized antigen” test.

    The case brings to light a common problem that seldom is addressed.

  2. Night Writer October 28, 2017 6:04 pm

    I have to deal with Alice at the PTO. Alice is treason. Alice completely undermines the 1952 Patent Act. The rejections are total garbage. The opinions from the CAFC are total garbage. The opinions from the PTAB are total garbage.

    Alice is not law. Alice is like going before a sovereign and begging for your life. The sovereign has almost complete discretion to come up with whatever they want.

    Each of the justices that put their name to Alice should be tried for treason and suffer the punishment for treason.

  3. Night Writer October 28, 2017 6:08 pm

    There is absolutely no law or structure to Alice. It gives the fact finder complete and total control over your destiny. Just outrageous.

    The justices are a joke. They knew exactly what they were doing with their Alice opinion in giving the judge the ability to invalidate any claim on SJ. Completely circumvents the 1952 Patent Act and is probably the biggest takings the US has ever done to its citizens.

    And, yes it is treason. Imagine if the justices just decided to hold that a judge could take your house on SJ. I don’t know how. They could make some crxp up like they did for Alice. And, then make it so that anyone can sue to take your house and return it to the government.

    Treason is really what Alice is. It undermines the rule of law and the Constitution.

  4. Night Writer October 29, 2017 9:39 am

    I challenge you to really think about this. Alice means that the 1952 Patent Act is void for all intents and purposes. Alice means that judges can decide cases using SJ with only intrinsic evidence.

    Really think about. Not only that but Alice itself is unconstitutional. I’ve gone through why it is before. So, what you have is a case that subverts an Act of Congress and is unconstitutional. Treason.

    I know you guys think I am out there, but if you spent some time thinking about what Alice actually does and look at the basis of Alice you might at least think that my position is reasonable.

  5. Night Writer October 29, 2017 9:40 am

    One other note: I think these kinds of opinions from the SCOTUS make it possible that a next president that is even madder than Trump could use a case like Alice to purge the SCOTUS.

    Cases like Alice destabilize our democracy.

  6. Anon October 29, 2017 12:20 pm

    Purging SCOTUS?

    Goodness know that I am no fan of judicial over reach, but how does this “purge” factor in?

    Is it like Roosevelt’s bench-packing plan?

  7. Night Writer October 29, 2017 1:49 pm

    @6 mass impeachment is one way.

    I know I sound a bit out there. But, if you agree that Alice is unconstitutional and that Alice circumvents the 1952 Patent Act is probably the biggest taking in the history of the US, then talk of impeachment is really not out there.

  8. Anon October 29, 2017 2:37 pm

    http://www.history.com/news/ask-history/has-a-u-s-supreme-court-justice-ever-been-impeached

    Does not appear to be an Executive power….

    With the tentacles of Citizens United in place, good luck with moving the legislative branch to such an action.

  9. Night Writer October 29, 2017 3:16 pm

    I don’t think it is very likely to happen right now. But, I do think that at some point in the near future it could particularly if we continue to see decisions like Alice.

    Plus, I think it is important for scholars to be intellectually honest about what Alice is.

  10. Anon October 29, 2017 4:17 pm

    I think that you will sooner see my (desired) congressional action of jurisdiction stripping prior to any impeachments.

    I think the action of jurisdiction stripping would be more beneficial for patent law (and this country) in the long run as well.

  11. Night Writer October 29, 2017 4:36 pm

    @10: Anon: maybe.

    But reform of 101 needs intellectual honesty and real analysis. The fact is that Alice is unconstitutional. The fact is that Alice circumvents the 1952 Patent Act (and the AIA). The fact is that Alice is probably the largest takings in US history by a SCOTUS case.

    Getting academics and the professional organizations to discuss these issues would go a long way to finding a solution.

  12. Night Writer October 29, 2017 4:51 pm

    And also understanding that Alice would be a basis for impeachment (reasonably).

  13. Joachim Martillo October 30, 2017 3:01 pm

    Shouldn’t we think of 112 (a) as three requirements:
    enablement for person skilled in the argument,
    clear disclosure of the the invention to the public, and
    proof of the possession of the invention by the inventor(s).

    http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/08-1248.pdf

    Proof of possession of the claimed invention is more important in the unpredictable arts like pharmacology than in predictable arts like electronic or mechanical engineering.

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