Skill in the art

Has the invention been described in enough detail to enable someone with skill in the art to make it ... 

Up to now, those skilled in the art never appreciated the advantage of the invention, although it is inherent. 

Furfuryl dimethyl amine is first produced. This may conveniently be accomplished by employing the Leuckart synthesis known to those skilled in the art, which involves the use of an aldehyde or a ketone, and formate of ammonia or an amine, or corresponding formamide derived by dehydration of formate of ammonia or an amine. 

The strychnine molecule presented an unparalleled challenge to anyone interested and skilled in the art of constructing complex molecules in the 1950s. The establishment of strychnine s exceed-... 

Chief requirement is that (1) it be an unob-vious to a person having ordinary skill in the art to which the claim pertains and (2) knowing everything that has gone wrong before is not applicable. 

Evidence was further presented that "eventual success [in separating the enantiomers] came only after several failures using known strategies for enantiomer separation" and that it "could be. .. difficult to separate the enantiomers of PC 4099. .. because it would be understood by chemists that the methyl ester substituent in PCR 4099 could make it more susceptible to re-racemizations, and thus resistant to successfully obtaining a separated product [22]." Accordingly, "neither the chemists at Sanofi nor a person of ordinary skill in the art could have reasonably expected that the separate enantiomers of PCR 4099 could be obtained. .. and if obtained, by what method and configuration [22]." Thus, Apotex s contention that separating the enantiomers was obvious was also refuted. 

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-... 

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. ... 

PYROTECHNIST A pcTson skilled in the art of making or using hreworks. 

Non-obviousness (inventiveness) means that the invention/innovation process must not be something that would be immediately obvious to somebody skilled in the art. Non-obviousness, although it sounds straightforward, is often a difficult concept to apply in practice. Obviousness could be described as a simple and logical progression of prior art, thus non-obviousness requires an additional ingredient of inspiration or often chanced good luck. 

The patent application document may be considered under a number of headings (Table 2.2). After the title comes the abstract, which identifies the innovation and the innovation area. Relevant prior art is then overviewed in detail in the background section. This is drawn mainly from published research articles and pre-existing patents. An adequate preparation of this section relies on prior completion of a comprehensive literature and patent search. Next, a short paragraph that details the problem the innovation will solve is presented. This should emphasize why the innovation should be considered novel and non-obvious. This in turn is followed by a detailed technical description of the innovation, such that an ordinary person skilled in the art could reproduce it. If, for example, microbial cultures or animal cells form part of the innovation, these must be deposited in an approved depository (e.g. the American Type Culture... 

The invention must not be regarded by a person of average skill in the art as a trivial or routine variant of, or follow plainly and logically from, something which has been disclosed publicly. 

For a prior disclosure to be novelty-destroying for a process, each and every step of the process will have to have been disclosed. In cases where the prior disclosure does not explicitly disclose a process step but it is impUcit that the step has been carried out in the prior disclosure, the step is considered to be disclosed. For example, if a prior disclosure of fermentation process for the production of a recombinant protein in yeast omits to mention that the fermentation is carried out at between 25°C and 30°C, but the person skilled in the art (see below) would immediately know this from the context of the disclosure of the fermentation process, this feature is deemed to be disclosed. 

The product or process invention claimed in a patent must have an inventive step that is to say the invention must not be obvious to a person skilled in the art . The rationale for this is to prevent novel, but trivial or obvious, variants of a known product or process from being given a monopoly. Inventive step is a separate requirement from novelty the question Is there an inventive step is only relevant once the novelty ol a claimed invention has been established. At least at the EPO, lor the purposes of inventive step, and for the purposes of sufficiency of disclosure (see below) the fictional person skilled in the art is deemed to have the same degree of knowledge, and for bicatalysis inventions is likely to be a team of suitably qualified people e g. one Ph.D. researcher assisted by two laboratory technicians fully acquainted with the known techniques relevant to the technolog> in question. 

In general, the EPO consider inventive step on a so-called problem-and solution basis if the solution to a known problem is not obvious to the person skilled in the art then there is an inventive step. The single closest prior disclosttre is iderrtified and the obviousness or non-obviousness of the solution is assessed in relation to that disclosttre. The US courts have generally considered whether the prior disclostttes wottld have suggested to those of skill in the art that they should make the claimed compositiorr, or carry out the claimed process and whether the prior disclosure would have revealed that in making the claimed invention or carrying out the claimed process, those of skill in the art would have a reasonable expectation of success. 

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. 

A modem monograph is devoted to a drug substance and starts with a concise description of the product. This is followed by instructions for packaging and storage, relevant USP reference standards, identification, and procedures for the assay of the drag or the product components. There is sufficient information for those skilled in the arts to be able to analyze the drug and its components, making the compendium... 

Skill in the art of the question can help make us surprisingly effective in our dealings with people. In our increasingly electronic, anonymous society, the art of conversation and one-on-one communication is being lost. It can be regained if we only take time to ask. 

Final recommendations should be sought from companies skilled in the art. Ultimate selection can then be based on field tests with a specific water. 

An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art... 

A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. 

The references cited by an examining authority have to be assessed in view of the so-called person skilled in the art . The skilled person is a fiction and represents a person who knows all references that have ever been published in whatever language, who however does not have too much creativity in posing and solving objects or problems on the respective technical field. This means that the person skilled in the art does not have the capacity of a Nobel Laureate, but does know more about the respective technical field than a technically interested layman. Of course, the knowledge of the person skilled in the art is stretchable and a matter of the respective case. Occasionally, a team of persons can be addressed as person skilled in the art , in particular in border-line technical fields. 

The issue of inventiveness is more complicated and ambiguous than the issue of novelty. It depends for example on the state of the art, the skill of the person skilled in the art, whether the invention uses well-known techniques, whether the invention solves the problem in the prior art only in a further way employing techniques that are known as such, and other issues. 

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. 

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. 

The party claiming conception of an invention must show that it was complete and operative and such as would enable a person skilled in the art to reduce the conception to practice without any further research or exercise of the inventive skill. It is not sufficient, therefore, to show that a party claiming an invention has conceived a result to be obtained the patentable thing is the means provided and disclosed by him to accomplish that result.30... 

Let s talk first about Charles. While Charles is a very sympathetic and hardworking guy (and I know we are all pulling for him), it appears that his contributions would not quality him as a co-inventor of the work being contemplated for a patent application. His work, albeit skilled and important, did not contribute to the conception of any of the claimed subject matter (the process or the compounds). He appears to have made the compounds he was asked to according to a route that was provided. Although he had to vary certain parameters to optimize certain reactions or separations, those types of changes would appear to be within the normal technical purview of one of ordinary skill in the art. 

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