Patenting written description

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

Trade secrets are creative works (usually methods, processes, or designs) that are not covered by the strict definition of an invention required for a legal patent. Or they are actual inventions that a company or individual does not want to expose to public scrutiny through the patent process (since the published patent must contain a written description of the invention). 

As with any patent application, to obtain a patent on a gene, genetic component (e.g., EST or SNP), or diagnostic or therapeutic method, the applicant must demonstrate the utility, novelty, and nonobviousness of the discovery. The applicant must also supply a disclosure and written description of the subject of the proposed patent that is sufficient in detail to show that the inventor had possession of the claimed subject matter at the time of application and to enable one skilled in the field to make use of the claimed subject matter. Although the fundamental elements of patentability have been in place for decades for protection of such innovations as new mechani-... 

A thornier issue than written description for ESTs and SNPs, however, is that of utility. Section 101 of the patent statute requires that the subject of a patent must be a "useful invention." Under the Guidelines, an application satisfies the utility requirement if the invention has "specific, substantial, and credible" utility such that "a person of ordinary skill in the art" would recognize the claim as credible "in view of disclosure [contained in the patent application] and any other evidence of record. .. that is probative of the applicant s assertions"(Utility Examination Guidelines, 2001). The Guide-... 

Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, Paragraph 1, "Written Description" Requirement (Written Description Guidelines), U.S. Patent and Trademark Office, 66 Fed. Reg. 1099-1111 (2001). 

To be patentable, an invention must be new and useful, as well as non-obvious. The Patent Office detmnines novelty by searching prior patents and publications. The patent must also contain a written description to enable any person skilled in the art to which it pertains. .. to make and use the invention. Non-obviousness is determined in light of the prior art and involves asking whether a person skilled in the art would consider the invention to be obvious. ... 

Apart from the essentials of novelty, unobviousness, and utility discussed above, further challenges require special attention when seeking patent protection. The invention should be described in such a manner as to comply with both the written-description and the enablement requirement. These requirements are contained in 35 U.S.C. 112, which states that the specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same. .. . Similar regulations exist in other patent laws, as exemplified by Articles 83 and 84 EPC. 

Although the applicant is free to amend the claims in the patent application during the prosecution of the patent application, he cannot rewrite the claims in any way he pleases. Rather the claims must be fully supported by the text of the patent application as filed any attempt to add matter in the claims that is not supported by the patent application as filed will draw what is often referred to as a new matter rejection, meaning that the applicant has attempted to introduce new matter to the patent application that was not present as originally filed. An attempt to introduce new matter into the claims during the patent prosecution process violates the written description requirement and will be discussed in more detail in Chapter 9. 

The prohibition against placing new matter into an application after it s already been tiled is governed by the written description requirement as stated in 35 U.S.C. 132(a). The prohibition against introducing new matter into a patent application after tiling is discussed in detail in Chapter 9. 

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. 

Chapter 2, we know that patent applications can be considered like links in a chain. In the patent chain, filing date priority can be followed back through the chain until the earliest date that the particular subject matter was included in the patent application that provides the necessary written description support for the later set of claims, no matter how much later those claims occurred, provided that the support of the claimed subject matter was present in each one of the linking applications and the later-filed patent applications properly claimed priority to the earlier-filed cases.4... 

Although the written description requirement is most typically discussed in the context of when an applicant attempts to amend claims or the patent specification after the patent application has already been filed, there is a second, broader aspect to consider. This second aspect of the written description requirement relates not to the amendment process per se but rather to whether the claims, even where present in the original specification (such that there is no new matter issue), have written description support in the patent application. This written description requirement is separate from the new matter context discussed earlier, and is often discussed in the context... 

Pfizer alleged that the claimed invention was invalid for, among other things, failure to comply with the written description requirement. The District Court found for Pfizer, holding that Rochester s claimed invention was invalid for failure to comply with the written description because the Rochester patent neither disclosed a nonsteroidal compound that selectively inhibits the COX-2 enzyme nor provided any idea how such a compound could be made other than by trial and error research.23 Instead of a specific description of the invention all the public received was a method of identifying and using compounds without any description of the compounds themselves. As the District Court explained in its decision,... 

The District Court judge went on to explain that a patent for the philosopher s stone was actually issued during the reign of Edward III. Apparently, they were not as keen on the written description requirement back in those days. Neither were they very keen on the utility requirement—a credible utility must be alleged (though perhaps it was a credible utility at that time). However, there probably would be no rejections based on novelty for such a claim. 

Marijuana was first mentioned as a medicine in an American medical text in 1843 and in 1854 was listed in the U.S. Dispensatory. The latter year also marked the first written description by Bayard Taylor in The Atlantic Monthly of cannabis intoxication. In the 1850s, recommended medical uses for marijuana included the treatment of gout, rheumatism, tetanus, opiate and alcohol withdrawal, loss of appetite, dysmenorrhea, convulsions, depression, insanity, and asthma. Although its suggested uses were widespread, marijuana never actually achieved popular use in the medical community. The reasons for this include variations in potency of commercial preparations, variability in patients responses, slow onset of oral action, and lack of solubility preventing administration by injection. However, the drug was included in many patent medicine preparations and was officially recognized as a medicine in the U.S. Pharmacopoeia until 1937. In 1937 there were 28 pharmaceuticals that contained cannabis. 

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