Undue experimentation

The term support in this context refers to die requirements of 35 U.S.C. 112, which requires adequate written description of die claimed invention, enablement, and best mode. Much more will be said about these requirements in Chapter 9, but for now it is necessary only to appreciate that die provisional application is good on die date it is filed to die extent that it provides enough detail so that a person of ordinary skill in the art can make and use die later-claimed invention without having to resort to undue experimentation and that a credible utility for die claimed invention is alleged. The best mode means that die application includes die inventor s best mode of practicing die claimed invention. 

As we already learned, reduction to practice can be actual or constructive. Actual reduction to practice refers to the production of the invention in a physical, tangible form that contains every element of the claim corresponding to that invention.28 Furthermore, an actual reduction to practice requires that the invention has been sufficiently tested to demonstrate that it will work for its intended purpose. In contrast, a constructive reduction to practice means that the invention is described in such a way that one of ordinary skill in the art can make and use the invention without undue experimentation, even though an actual working example has not been prepared— perhaps a well-detailed scheme or drawing is sufficient. In this case, one does not actually need to physically make the invention. A constructive reduction to practice normally occurs on the filing of a patent application since the patent application must, to be valid, provide sufficient instruction to allow one of ordinary skill ordinary skill in the art to make and use the invention without undue experimentation in the same way as a constructive reduction to practice requires. 

Finally, in order for the prior art reference to anticipate a later claimed invention, the prior art reference must be enabled. This requirement stipulates that one of ordinary skill in the art must be able to make and use the anticipating teachings in the prior art reference without resorting to undue experimentation. Something described in the prior art is not really described if one of ordinary skill cannot actually put the described thing together. The linchpin of the analysis turns on whether the allegedly... 

The second portion of the 112 f 1 is referred to as the enablement requirement and is typically considered to be made up of two separate requirements. The first part is the make and use part and requires that one provide in the specification enough instruction to teach one how to make and use the claimed invention without having to resort to undue experimentation. The second part of the enablement requirement requires that the use taught be credible this requirement is co-extensive with the utility requirement.27... 

The sixth Wands factor relates specifically to the direction actually provided by the inventor in the patent application. Where the inventor has provided a lot of direction on how to make and use the invention, it is less likely that undue experimentation will be required to practice the invention. 

The enablement requirement is difficult to understand and apply because it requires that we not only understand what the patent application actually teaches, but we also need to ascertain how that knowledge in combination with what is already known in the art would be applied by one of ordinary skill in the art to determine if the practice of the claimed invention requires undue experimentation. To further compound the challenge, there is very little enablement federal case law in the chemical and pharmaceutical arts to light our way. 

Before applying the Wand s factors to claim 1, we stipulate at the outset that the peptides of claim 1 can be made without undue experimentation. It is accepted that the state of the art with regard to peptide synthesis coupled with the applicants teaching are sufficient to satisfy this aspect of 35 U.S.C. 112 1. In contrast, however, a credible utility is not established throughout the claimed scope. The Wand s factors have been applied as follows ... 

Due to the diversity of microorganisms or cells it may be impossible for a person skilled in the art to repeat the invented solution without undue experimentation (a certain degree of experimentation to gain experience is acceptable) or without some inventiveness of his own. Therefore, it is mandatory in such cases to deposit a sample of the microorganisms or cells at an approved depository institution in order to provide the necessary enabling disclosure and to meet the requirements of a patent application (see below Deposition of Microorganisms). 

The enablement requirement does not mandate that each and every detail of the invention be included or that the specification be in the form of a detailed cookbook with every step specified to the last detail (74). Rather, the skilled artisan must be able to practice the invention without "undue experimentation." Generally, "a considerable amount of experimentation is permissible, if it is merely routine, or if the specification. .. provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed" (75). Although the acceptable amount of experimentation will vary from case to case, the factors normally considered by the PTO and the courts in determining the level of permissible experimentation include the following (1) quantity of experimentation required, (2)amount of direction or guidance provided by the specification, (3) presence or absence of working examples, (4) nature of the invention, (5) state of the prior art, (6 relative skill of workers in the art, (7) predictability or unpredictability of the art, and (8) breadth of the claims (76). The level of acceptable experimentation will vary as the state of the art advances and the level of skill in the art increases. 

Working examples are one factor in determining whether the specification is enabling. They are not required if the specification otherwise teaches one skilled in the art how to practice the invention without undue experimentation. However, in appropriate cases and if drafted with sufficient detail, such examples provide a relatively easy and straightforward way in which to make the specification enabling. So-called paper examples [i.e., examples describing work that has not actually been carried out (77)] can be used to satisfy the enablement requirement if the level of predictability for the art and invention is sufficiently high. 

Issuance of a patent obviates the legal necessity for keeping the information contained in the patent application secret. The Patent Act requires the patentee to make the knowledge behind the invention publicly available. Under 112 of the Act, a patent applicant must include in the patent application a written description of the patent that is clear, concise, full and exact enough to enable someone skilled in the most relevant art to make and use the invention without undue experimentation. The patent application must also set forth the best mode for carrying out the invention that the inventor contemplates at... 

The essence of the enablement requirement is whether the disclosure contains sufficient teaching regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention without undue experimentation. The critical question is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. In re Moore, 439 F2d 1232, 169 U.S.P.Q. 236 (CCPA 1971). 

Currently one of the most prevalent standards for measuring sufficient enablement to meet the requirements of the first paragraph of 35 U.S.C. 112 is that of undue experimentation. 

The test is whether there is sufficient working procedure for one skilled in the art to practice the claimed invention without undue experimentation. In re Stephens, 529 F2d 1343, 188... 

The basic issue in cases such as Jackson is undue experimentation. The PTO has the initial burden of giving reasons, supported by the record as a whole, why the specification disclosure is not considered enabling. Mere speculation will not suffice. Reasons and evidence sufficient to create a reasonable doubt as to the accuracy of a particular broad statement put forward as enabling support for a claim can take any of the following forms (1) statements on their face contrary to generally accepted scientific principles, (2) teachings in pertinent references, (3) unpredictability of... 

It must enable a person with knowledge in the field related to the invention to make or carry out the invention without undue experimentation (i.e., to make the claimed product or carry out the claimed process). 

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