Oral proceedings before the European Patent Office (“EPO”) provide insight on patent application drafting for global prosecution.

There are several parts to a patent application: Title, Field of Invention, Background, Objects and/or Summary of Invention, Brief Description of Drawings, Detailed Description, Examples, Claims and Abstract. The Background sets up a problem previously existing in the art and provides a “sales pitch” for why the invention is patentable. The Objects and/or Summary of Invention should parallel the claims.

Ideally, the invention is presented as an advance and/or a solution, but it should not be stated that the invention must achieve a specific object (but rather that it is only advantageous to achieve the object). During a litigation, everything written in a patent application will be scrutinized and subject to interpretation.

A patent application can be compared to a funnel. The broadest part of the funnel is the broadest area of disclosure and includes the Background. Just as liquid flows down a funnel from the broadest part to an area slightly narrower, in a patent application, where prior art leaves off is the point at which claims may be granted. The tip of the funnel includes the actual experimentation and Examples. The goal is to have claims as filed and granted to have a scope that extends from the broad part of the funnel, i.e., just outside the prior art, to the narrow part, i.e., the Examples.

In the United States, a detailed description is a written description that enables the skilled artisan to make and use the claimed invention, and it sets forth the best mode known to inventors at the time of the invention.¹ It is advantageous to avoid statements that imply or state that something is a necessity in every instance of practicing the invention; this may then need to be recited in the claims to meet the written-description requirement.² For example, instead of reciting “the chemical formulation requires a heterocyclic amine,” it is better to recite “the chemical formulation may include a heterocyclic amine.”

The Examples describe how an invention was worked or can be worked. Any actual work that was done is written in past tense, and hypothetical work is written in present tense. A patent application does not need to have examples.³ Enough examples should be included to comply with utility, written-description and enablement requirements, especially in an unpredictable art. If the art is “unpredictable” (for example, the treatment of cancer), then more examples endeavor to demonstrate in specification that both description and exemplification remove “unpredictability” as to the subject matter claimed.

In the United States, the Examples may be generalized from support claims; however, in Europe, the Examples may not be generalized from claim language. However, drawings and a Brief Description of Drawings may be relied upon as a basis for claims. The recommended approach is to include any pertinent data from the examples in the Detailed Description, and to generalize in the Detailed Description from the Examples. For instance, if a specific vector is claimed, broader examples of vectors (such as plasmid or viral) may be disclosed in the Detailed Description and, then narrowed to more specific vectors (such as bacterial, yeast or adenoviral vectors), before being further narrowed to a specific vector in the Examples.

Sometimes a detailed disclosure may become repetitive; however, for countries with strict disclosure requirements (including many countries in Europe), various iterations of preferred embodiments may be helpful. For example, for an invention directed to diagnosing a disease via a qualitative and quantitative method, it may be advantageous to present both methods separately and repeat similarities to avoid any confusion.

For patent prosecution in China, Korea and Japan, data is required at the time of filing. A practitioner should consider such data prior to pursuing applications in these countries.

The Claims set forth the invention. Claims should be commensurate in scope with the disclosure. For each claim, there must be a description in the application that enables the skilled artisan to make and use the invention. The claims should be clear and concise, and consistent with the disclosure; they should also be consistent with that which the inventor believes to be his or her invention. Any claimed use (such as a method of treatment) should have evidence to support such use in the application.

When the patent application is sent to the client and inventors, the application should be marked as confidential and attorney-client and work product privileged. It may also be a good idea to remind the client and inventors that the application is provided only for purposes of discussion and that it is not for distribution or intended as a publication or offer for sale. This will prevent the triggering of any publication or on-sale bars.

Practice Tips:

1. Present the invention as a solution to a problem, but avoid admitting that anything in the invention is absolutely required.

2. Draft the application with a funnel in mind—broadly and narrowly—and claim from what is believed to be outside the prior art to the Examples.

3. Include examples with data in an unpredictable art or if prosecution is planned in countries in which data is required.

4. Include recitations from examples in the Detailed Disclosure in countries in which examples are not relied upon to generalize.

5. Remind the client and inventors that the patent application is confidential and privileged until filing.

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¹ 35 U.S.C. § 112, first paragraph.

² Tronzo v. Biomet, 156 F.3d 1158 (Fed. Cir. 1998).

³ In Re Meir Strahilevitz, 668 F.2d 1229 (Fed. Cir. 1982).