Think your invention is sufficiently enabled? If it’s a biological, chemical, or emerging technology invention then you might want to think again.
Einstein famously predicted that gravity travels in a wave in his general theory of relativity, and 100 years later, the first gravitational waves were experimentally observed. Some technologies, like those rooted in physics and mechanics, are considered “predictable” by the U.S. Patent and Trademark Office (USPTO), while others, like biological and chemical technologies, are generally considered “unpredictable.” It follows that the amount of disclosure required to enable an invention is related to the predictability of the technology, and so-called unpredictable arts require more description to teach a reader how to “make and use” the technology. Similarly, emerging technologies, being less well known, also require more disclosure to be fully enabled.
Physical and mechanical inventions in mature technology areas can be more easily understood, and therefore a simple disclosure can be sufficient to enable such predictable inventions. On the other hand, it can be difficult for a skilled person to predict which function or activity a chemical or biological substance may possess, or how all aspects of an emerging technology would work. For example, in biotechnology patents, additional examples and evidence of not only synthetic routes, but also biological activity, may be needed to support claims.
There is a silver lining – the unpredictability of biological and chemical technologies can also be advantageous. Being unpredictable, a newly found biological or chemical substance (and its use) is more likely to be considered “not obvious” to the skilled person.
In this month’s episode, of Patently Strategic, Dr. David Jackrel, President of Jackrel Consulting, along with our all-star patent panel, discusses some peculiarities of patenting unpredictable art and emerging technologies. The focus is on case law and statutes to arrive at a set of best practices for getting more predictable results when patenting these technologies.
Enablement for Unpredictable Art
When patents are examined, or later litigated in a courtroom, one of the requirements for a claim to be valid is that the claimed invention be fully enabled, including describing “how to make and use the invention.” Enablement (like obviousness) is considered from the point of view of a person of ordinary skill in the art (POSITA), and they should be able to make or use the invention from the disclosures in the patent “without undue experimentation.”
A landmark case from 1970, states that “[i]n cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” Obviously! But how open ended is this variable scope? The MPEP fortunately provides some constraint, stating that “even in unpredictable arts, a disclosure of every operable species is not required.” Similar rules also exist in patent systems outside of the US, such as in Europe.
One of the most effective ways to hedge against enablement issues is by drafting patent specifications in unpredictable arts with as many examples as possible. Examples of the synthesis and the activity of compounds can also be required to adequately teach one skilled in the art how to make and use the invention. And, since every species generally cannot be shown in an example, the next best thing is to provide guidance for how to extrapolate and interpolate the examples to the other claimed species. In this respect, as much as possible, it can be helpful to describe mechanisms by which the activity is gained.
Chemical and Biological Patent Peculiarities
There is a general rule in the US and many foreign patent systems that a general structural formula does not necessarily disclose the specific compounds falling under the formula. When you stop and think about it, that makes a lot of sense, since all conceivable new compounds fall under one known generic formula or another. It is, however, a bit different from the genus/species relationship in other claimed technology areas.
This has large implications. It means that if a new compound is claimed, then generic formulas that cover that compound cannot be used as prior art, as long as – and this is important – a person of ordinary skill in the art wouldn’t see that new compound as obvious. For example, if a side group of a known class of molecules is modified in a non-obvious way, then it would be patentable. But, if the modification is obvious, then it would not be patentable.
In this episode, we take a deep dive into three court cases (AbbVie v. Janssen Biotech, Wyeth v. Abbott Laboratories, and a German Federal Supreme Court case – Olanzapin, X ZR 89/07) that help to more specifically illustrate what has historically been considered obvious and enabling in biological and chemical patents.
Chemical and Biological Patents: Motivation Required?
Those of you following these enablement issues more closely may be asking yourselves how this works in light of KSR, the landmark US Supreme Court case from 2007, which said that there needs to be no explicit motivation in the prior art to modify a given teaching to arrive at the claimed invention. That is very true. However, the technology underlying the KSR decision involves a mechanism for combining an electronic sensor with an adjustable automobile pedal, a decidedly predictable art.
The US Court of Appeal for the Federal Circuit (CAFC) clarified that a different yardstick applies to unpredictable arts in a case about the differences between the known compound Lansoprazole and the claimed compound Raberprazole, which are the same molecules other than the substitution of an active group. This case established that there does need to be some reason (motivation) to modify a starting compound in order to arrive at the claimed compound. According to the court in this case, “[t]he record shows no discernible reason for a skilled artisan to begin with Lansoprazole only to drop the very feature, the fluorinated substituent, that gave this advantageous property [lipophilicity].”
Emerging Technologies Patents
Patents directed to emerging technologies are similar to biological and chemical patents because they also require more disclosure to be fully enabled. One way to think about this is that one of ordinary skill in the art of an emerging technology might not yet be very knowledgeable about a nascent field and may therefore require more details. As a result, many of the same principles described above apply to emerging technology patents as well. For instance, a patent drafter should ask themselves – can a person of ordinary skill in the art make and use the entire claimed invention without undue experimentation?
Due to these similarities, the same solution presents itself for patenting emerging technologies – include as many examples as possible. Somewhat counterintuitively, even aspects of the emerging technology that are well known may need to be described in detail, since the person of ordinary skill in the art in the emerging technology may not know sufficient details.
The case law here again is very illustrative in helping to understand how the courts have viewed obviousness and enablement for emerging technologies. In this episode, we discuss an innovator graveyard’s worth of invalidated claims found in Automotive Technologies International v. BMW of North America, Sitrick vs Dreamworks, and Trustees of Boston University v. Everlight Electronics Co., Ltd.
The main takeaway is that claiming inventions in unpredictable art and emerging fields require more disclosure, explanation, examples and teaching than those in predictable arts do. Failure to do so can result in rejection or potential later invalidation on the grounds of enablement. In such areas, it is important to cover as much breadth as possible with examples. There are always constraints, though – lack of experiments, desire to keep trade secrets, budgets, etc. – so the second-best thing to do is to provide rationale for extrapolating and/or interpolating from the examples that you can include to all of the claimed species.
In some situations, however, it might even make sense to keep an unpredictable art or emerging technology invention a trade secret rather than file a patent, if there is an unwillingness to disclose enough to sufficiently enable it. After all, as the court stated in Sitrick v. Dreamworks “[e]nabling the full scope of each claim is ‘part of the quid pro quo of the patent bargain.’”
David is joined by our always exceptional group of IP experts, including: