Drafting a provisional application is often the first step in the road to obtaining a patent. However, due to time or budget constraints, provisional applications are often not afforded the attention that they deserve, resulting in applications that lack the necessary disclosure to support the later-filed non provisional or utility application. When this happens, potentially invalidating prior art that otherwise would have been precluded from the prosecution process by the provisional applications’s filing date could all of a sudden be used to impede patentability. This is becoming increasing true in today’s climate where courts and patent examiners are honing in on the Section 112 written description requirement against addition of new matter and demanding more support from patent applications.
While it is always best to draft thorough and complete provisional applications with all the necessary disclosure, sometimes that is not possible. When experiments are not fully completed, time is short, and budgets are tight, it is still possible to put together a provisional application that can be relied on. Below are several “must haves” when it comes to putting together a provisional application.
1. Start with the claims. While claims are not required for a provisional patent application, they nevertheless form the basis of the patent application and are ultimately what describe the invention. When drafting the claims, think about the various ideas that are part of the invention. If you have a composition, you may also have a method of making the composition or a method of using that composition, as well as kit claims, and even system claims. The claims do not have to be perfect, but they should at least cover the features of the invention. Drafting a set of claims will help put the invention into perspective and help focus the rest of the invention. There is no limit placed on the number of pages or the number of claims in a provisional application. Thus, if possible and if time permits, add more claims than may be necessary just to be sure each element and combination is captured somewhere.
2. Use the claims to outline the specification. Once the claims are drafted, use them as an outline to draft the specification. If they are complete, the claims should form a good basis for what needs to be included in the specification. Each different claim type can be the basis of a different section of the detailed description.
3. Whenever possible, include experimental data. Experiments provide support that shows that the invention does what it claims it does, i.e. that it is enabled. You cannot assert that a composition can be used to treat cancer without at least providing some experimental data to that effect. If no experiments have yet been conducted, hypothetical examples describing the future experiments could be included, but care must be taken to clearly reflect the fact these theoretical examples are prophetic and were not actually conducted.
4. Provide supporting figures, graphs, charts, data tables, schematics, and/or sequence listings whenever possible. Any supporting information should be included and described. This information should be easy to gather and provides further support for the invention. Even a power point slide presentation or figures from a recent draft of a scientific publication can form a good basis upon which to draft the remainder of the application and should be submitted with the application if no formal drawings are available.
5. To the extent that time and budget permits, fully describe the components of the claims. The purpose of a patent application is to fully describe every possible feature of an invention. Often times the patent application not only describes the features of the preferred embodiment but also numerous variations of each feature and potential work-arounds that competition could use to skirt around any issues patent. In a CAR T cell therapy application, for instance, not only is the preferred binder described, but other possible binders are described as well. This type of drafting protects not only the invention, but also modifications to it. If time is limited, however, focus should be given to adequately describing the preferred embodiments and essential or most critical features.
6. Provide proper definitions. A definition section should be included to define the various terms, especially those recited in the claims. The definition section should not be overlooked because it can provide important basis for claim interpretation and scope. Often times, certain terms, such as terms of art, in the definition section can be copied over from a similar application so including these should not be too time consuming.
7. Include a background section. The background section can be used to put the invention in perspective and in some cases even steer the application to a preferred art unit within the USPTO. It does not need to be long (it can be as short as two sentences), but it should describe the current state of the art and most importantly the problem that the invention intends to solve. By providing a background, the invention and its contribution can be better understood and appreciated.
8. Draft an abstract. Abstracts are limited to 150 words. Often times drafting an abstract before or after the claims can help crystallize the drafting process. If you can summarize the major gist or themes of the invention story into an abstract of 150 words or less, it shows you have a good grasp of the key parts of the invention upon which the claims should be based.
In today’s climate with courts and examiners requiring more and more proof of support of conception and reduction to practice, i.e. possession of the claimed invention, provisional applications need to include enough information to satisfy the Section 112 written description requirement and to avoid running afoul of new matter issues when using them as the basis of a non-provisional utility application. By focusing on the above seven points, inventors can improve the likelihood that their provisional applications will overcome the written description hurdle.
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