Working examples are an important part of a biotech patent application, especially because this is considered an unpredictable art in U.S. patent law. Thus, although not mandatory, working examples, which are often set out in a separate Examples section, usually help assure that claimed subject matter is enabled, described, and definite (i.e., meets the requirements of 35 USC 112 (a) and (b)). Furthermore, working examples can provide important data to help differentiate the claimed inventions over prior art (See our previous Surprising Results post highlighting the importance of surprising results). Finally, well-written working examples that are aligned with the claims provide excellent support for claims covering the sweet spot(s) of the patent application (i.e., embodiments that are supported by data).
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In many cases, since the first person to draft the working examples for a patent application is a scientist (e.g., an inventor), or an in-house patent liaison, in our experience, there can often be disconnects between the working example(s), and the rest of the specification, most importantly the claims , which are usually mostly drafted by a registered patent attorney or patent agent. One of the primary issues is that different terms can be used to describe the same term in the working examples versus the rest of the specification (e.g., claims). Additionally, patent profanity (e.g., “must”, “always”, “critical”) can often be present in working examples, as an inventor or patent liaison may not be trained in patent profanity. Finally, often claimed ranges are not centered around, and sometimes are not consistent with data that is provided in the working examples (i.e., the sweet spot of the patent application).
In order to avoid the above issues with your working Examples, we provide a list below, of key considerations for drafting working examples for biotech patent applications (Table 1).
Table 1: Key Considerations
During the drafting of a biotech patent specification, inventors and/or patent liaisons often work along with the drafting patent agent and/or attorney to ensure a high-quality work product. Therefore, efficient coordination between patent liaisons, and the drafting patent professional is essential to prepare a high-quality work product. Accordingly, Table 2 provides further suggestions to help assure that the patent team drafts claims of appropriate scope, supported by consistent and high quality working examples.
Table 2: More detailed suggestions for drafting working examples and claims
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Posted: 2/7/25 by VV, EV.
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