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.
Provisional patent applications can be a valuable tool for inventors. Such an application serves as a “place holder” for a later-filed nonprovisional (or utility) application. While inventors often debate the need to file a provisional application, filing a provisional application rather than going straight to a nonprovisional has several benefits.
1. Provisional applications establish a priority date. While it is not examined by the USPTO, a provisional application allows the researcher to establish a priority date for an invention that predates subsequent prior art from impeding patentability. One year after filing the provisional application, the researcher must file a nonprovisional application, which claims the benefit of the provisional filing, to maintain patent rights. If the one-year deadline is missed, patent rights that may have been afforded to inventions described in the provisional application as of the filing or priority date are lost and new prior art can be introduced.
To benefit from the filing date of a provisional, however, that provisional must adequately support and enable the subject matter claimed in the nonprovisional application. Simply put, the nonprovisional application can only claim the benefit of the provisional application’s filing date and disclosure if it supports the invention. This forms the basis of the 35 U.S.C. Section 112 written description requirement. How much support is required is a subject of constant debate but recent case law suggests that courts are becoming more strict on interpreting written description. Inventors are thus better off including more description in their provisional applications to maximize their chances of having their priority dates upheld. Failing to do so increases the risk that prior art disclosed after the priority date can impede patentability.
2. Provisional applications help buy you time. Provisional applications require only a minimal fee to be filed ($280 for large entity, $140 for small entity, and $70 for micro entity) and they provide a twelve-month window before the more costly utility and PCT applications need to be filed. During this window, inventors can find financing and generate more experiments to support the utility and PCT filings.
3. Provisional applications are not public. This means that a provisional patent application can be abandoned before the one-year mark and the information in that provisional will not become public. This is helpful, for instance, if an inventor has an idea but cannot generate enough data within that one year to support that idea. In those situations, the inventor could abandon the provisional and refile it when the necessary information is gathered.
4. Provisional applications can be updated with new information. From the time the first provisional application is filed to the one-year deadline of filing the nonprovisional application, the inventor can file multiple follow-on provisional applications to add data or information to that application. If the first provisional was filed only with hypothetical examples, follow-on applications can be filed with actual results of those examples. When filing follow-on applications, however, inventors should be mindful of having adequate support as discussed in the first point.
Provisional patent applications provide value benefits to inventors, such as establishing early priority dates and allowing the inventor time to either update the invention with follow-on applications or abandon it entirely without making it public. Careful attention, however, must be paid to making sure that the provisional application has sufficient disclosure in it so that a later-filed nonprovisional can benefit from its filing date.
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