Patents best mode requirement

Worked examples are, where possible, included. If worked examples are not available it may be desirable to give prophetic or dummy examples which, although they have not been worked, describe how to carry out a particular aspect of the invention. The patent apphcation must give a sufficient disclosure of how to carry out the invention without undue burden (the sufficiency or enablemenf requirement). In the USA it is essential to describe the best way of carrying out the invention known to the inventors when the application is filed (the best mode requirement). For inventions using certain biological material (such as host cells, vectors, hybridomas, bacteria and the like) it may be necessary to make a special deposit of the material in order to fulfil the sufficiency requirement. 

Failure to meet the best mode requirement results in the invalidation for the one or more claims that the inventor s best mode was not adequately provided. The failure to provide the best mode can also result in the invalidation of the entire patent if the best mode was withheld with an intention to deceive (i.e. a finding of inequitable conduct renders the entire patent nonforceable). 

When extended beyond the scope of the claimed invention, the best mode requirement becomes as insidious and destructive as a hidden landmine. One of the cases emphasized by this opinion, Dana, 860 F.2d 415, illustrates those disturbing implications. In Dana, the inventor claimed a seal apparatus, not any method at all, let alone a method of treating elastomeric material to ensure its longevity. Having invented a unique seal apparatus, the inventor could not have guessed that the best mode would reach out to encompass a process to increase the useful life of one component of the invention—a process that was already well known in the prior art to boot. Dana, 860 F.2d at 419. Nonetheless, this court invalidated the patent because the undisclosed method affected the life of the elastomeric material and thus the satisfactory performance of the seal. 

When the best mode requirement is not violated by maintaining a trade secret, a trade secret can coexist with a patent in a single area of technology. In general, however, a trade secret is an alternative to patent protection. 

In some cases, deposit of biological materials may also be required to satisfy the best mode requirement. It is possible to include the best mode in the specification but to describe the best mode so poorly as to effectively conceal it. Because the potential penalty for failure to meet the best mode requirement is invalidation of the entire patent, considerable care should be taken to identify the best mode contemplated by the inventor and to describe it carefully and fully. 

In the absence of evidence of concealment (accidental or intentional) the patent examiner will assume that the best mode requirement has been satisfied, in re Sherwood, 204... 

An additional statutory requirement is that of disclosure. A patent must provide the pubHc with a disclosure which is enabling, definite, and shows the best mode for practicing the claimed invention. 

A patent application must disclose the claimed invention in sufficient detail to allow a person skilled in the art to carry out the invention. This requirement stems from the bargain that the patentee has with the state granting the patent in return for a limited monopoly, the patentee must disclose the invention to the public in his patent, so the pubhc can work the invention when the monopoly expires. In the USA the requirement is even more stringent than in Europe because the applicant must disclose in his patent application the best mode of carrying out the invention known to him as of when the application is filed. 

Basic Requirements of Patentability Written Description, Enablement, and Best Mode... 

In the section emphasis has been placed on the three key components of written description, enablement, and best mode. Each of these three requirements is separate and distinct, so that is how they will be treated in this chapter. Though it might seem obvious, each of the three sections of the written description requirement applies to the claimed invention only. It is surprisingly easy to get caught up with peripheral aspects of the invention that do not directly involve claimed elements and, as a result, overinterpret the ambit of 112 f 1. Likewise, it is easy to forget that written description is required for all of the elements in a claim and as a result, attempt to make claim amendments during patent prosecution that do not find adequate written description support in the patent specification. Making the claim elements the focus will help to keep one on track with respect to 112 f 1 issues. 

While we have properly focused on the inventor s perception of what the best mode is, the best mode does not have to be part of the applicant s invention per se but can be part of what is known in the art or even provided to the inventor by, for example, a particular commercial supplier. For example, if a claimed process requires a catalyst and the inventors have found that a particular commercial supplier s catalyst is best for practicing the claimed process, then that detail will need to be disclosed in the patent application. However, the potential inconvenience of this latter requirement is significantly tempered by the more fundamental requirement that the best mode applies to the claimed invention only. 

In Chapter 2 we briefly discussed the possibility of claiming a priority date from an earlier filed patent application provided, among other things, that the earlier filed patent application met the requirements of 112, including providing the best mode of practicing the claimed invention. 

In addition to the above three requirements, inventors must also clearly and completely describe the invention. This is called sufficiency of disclosure. The specification of a patent application must clearly and sufficiently describe the subject matter, so that it can be carried out by a skilled person in the subject. Some countries (such as Brazil and the United States) also require an indication, when applicable, of the best way of executing the invention, called the best mode of the invention. 

Does the disclosure in the patent meet the legal requirements of patent allowance In the United States, the patentee must disclose a best mode, the best formula, and the best approach to use the research outcome. There is no need to disclose an industrial model but there should be a workable model. Keeping the information out of a patent can be a double-edge sword. 

Patentability can also be jeopardized during the application process by failure to disclose critical items in connection with the invention. One is the best mode of the invention, which is the favored embodiment or means of implementing the invention, particularly the one example that functions the best or enables the invention to perform to its utmost advantage, as known to the inventor at the date of applying for the patent. The best mode must be included in the text of the patent application, and cannot be reserved as a trade secret. A second disclosure requirement is the disclosure of relevant prior art that the inventor is or becomes aware of. This is a continuing requirement that lasts until the issuance of the patent, and encompasses any publications, disclosures, uses, sales or offers, and other acts or documents that qualify as prior art. 

Generally, it is not necessary to disclose trade secrets that are related to the invention but are not required for its operation and are not related to the best mode of operation known to the applicant as of the filing date of the patent application. Of course, by not disclosing related trade secrets in a patent application, one runs the significant risk that a court may later hold the patent invalid or unenforceable for failure to provide an enabling specification or to disclose the best mode. In a close case, it may be preferable to err on the side of disclosing more than the required minimum. After all, trade secrets, for the most part, have only a limited lifetime, especially if disclosed in submissions to the FDA or other federal agencies. 

Acceptable applications and valid patents must present inventions that are novel, unobvious, and useful. They show unity of invention, teach physical means to realize the inventions and, in several respects, disclose what attorneys call the best mode of practicing them. In a typical pharmaceutical patent, the best mode may refer to the compoimd most suitable as a drug, to the best way of making it, and to the disease it treats most effectively. Patent law requires inventors to reveal the best modes without, however, necessarily emphasizing or even identifying them. Although a patent relates... 

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 best mode provision of Section 112 may require the patentee to reveal information which it otherwise would hold as a trade secret. Patent protection only extends to the invention set forth in the patent claims. 35 U.S.C. 112, 154. The best mode of using the invention may itself not be patentable, but may be useful commercial information which would be protectable under state trade secret law if kept secret. However, courts often hold patents invalid for failure to disclose the best mode that was being considered for use whether or not the mode had been finally developed at the time the patent application was filed. Patentees may keep secret new modes of use for the invention that they first contemplate after the patent application is filed, even though those new modes may be superior to the best mode contemplated at the time of filing. 

An examiner reviews filed patent applications to determine whether they meet the statutory requirements for patentability, that is, that the invention is novel and not obvious over the prior art, and the description of the invention in the patent application provides an enabling disclosure, a written description of the invention, and the best mode of carrying out the invention as of the date the application is filed. As part of the examination, the examiner conducts a prior art search, and may rely on identified prior art to support a ground of rejection of the patent application. Through the process of issuing examination reports, Office Actions, and the applicant s responses to them, an official record is created of the... 

The patentability of combinatorial libraries is examined, requirement by requirement. In general, combinatorial libraries can be patented, as long as the library meets the statutory criteria of utility, novelty, and non-obviousness, and the application meets the standards of enablement, best mode, and written description. Licensing and alternatives to patenting are also considered, along with potential problems unique to combinatorial chemistry agreements. 

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