Person skilled in the art

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. ... 

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... 

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. 

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... 

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 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... 

While we have focused extensively on unexpected results as one of the secondary considerations of nonobviousness, there are several additional considerations that can be argued. In this opinion, the Court addressed these several additional secondary considerations of nonobviousness as well. These additional important factors include commercial success, simultaneous invention, fulfillment of long-felt need, prior failure, others copying of the invention, third-party praise and recognition, and skepticism of persons skilled in the art. 

The optically pure albuterol may be prepared by resolving a mixture of enantiomers methyl benzoate albuterol precursors which prepared by procedures well known to persons skilled in the art. The starting material 4-benzyl albuterol is commercially available from Cipla (Bombay, India). 

The following description is provided to enable any person skilled in the art to make and use the invention and sets forth the best modes contemplated by the inventor of carrying out his invention. Various modifications, however, will remain readily apparent to those skilled in the art, since the general principles of the present invention have been defined herein specifically to provide an improved colloidal silver product with significant abilities to kill human pathogens both in vivo and in vitro. 

The stance of the European Patent Office in general is to consider as indicative of the presence of the inventive step the existence of surprising or superior properties, which could not be anticipated by persons skilled in the art. In the case of a new protein, for instance, this might be fewer or less severe side effects, better absorption, or greater stability. 

Article 24. The description shall clearly and sufficiently describe the subject matter, thus enabling it to be carried out by a person skilled in the art, and shall where appropriate indicate the best manner of execution. 

Suggested Analytical Method Use this section to present a complete description of the analytical method sufficiently detailed to enable persons skilled in the art to replicate it. Include all important operational parameters and specific instructions such as reagent preparation, systems suitability tests performance, description of blanks used, precautions, and explicit formulas for calculating test results. 

The standard of 35 U.S.C. 112— how to use —is a factual standard, but the standard changes with time (38,48). A specification (46) which teaches those skilled in the art to use the process, i.e., by disclosing the manipulative steps of the process, the required operating conditions, and the starting materials so that the process may be used by a person skilled in the art, meets the requirements of 35 U.S.C. 112. It has been held not necessary to specify the intended use for the product produced... 

It is not necessary for a patentable invention to be the result of an ingenious idea. Article 56 EPC requires an "inventive step" which is "not obvious to a person skilled in the art", regarding the state of the art at the time the application was filed. Similarly in the USA "... a patent may not be obtained. .. 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" (35 USC, 103). 

Despite the conformity of both definitions (not obvious regarding the prior art to a person skilled in the art), there is considerable room to speculate how these terms are defined in each individual case. Almost inevitably these terms are interpreted differently by the applicant and the patent examiner during the prosecution of a patent application. In the absence of official general explanations for "non-obviousness to a person skilled in the art" the following attributes may help to decide whether an alleged invention meets this requirement (see also Vossius, 1982). 

A short paragraph usually outlines the unsolved problem, which the invention addresses, and emphasizes the inventive, non-obvious element of the invention. This is followed by a detailed description of the invention. It is a statutory requirement that the invention must be disclosed completely so "as to enable any person skilled in the art. .. to make and to use the same,. ..and shall set forth the best mode contemplated by the inventor of carrying out his invention" (35 USC, 112 similar wording in EPC, Article 83). 

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). 

Oppositions on the grounds of obviousness also depend on earlier publications, patents, and other evidence which demonstrates that the invention could have been deduced by a person skilled in the art without an inventive step. Objections against the utility of a patent are rare, because in most cases it will be very difficult to call into question that the subject of the invention will (also in future) be of no use. 

The explicit methodology of systematic reviews suggests that persons skilled in the art of systematic reviewing should be able to reproduce the data of a systematic review, just as researchers in chemistry or biochemistry expect to be able to reproduce published primary studies in their fields. This concept strengthens the credibility of systematic reviews, and workers in the field of EBM generally consider well-conducted systematic reviews of high-quality primary studies to constitute the highest level of evidence on a medical question. 

A patentable invention requires the exercise of the inventive faculty or the exercise of more than the expected skill of the art. In other words, the invention must have been non-obvious to a person skilled in the art when it was made. 

When considering whether there is inventive step, the question must always be asked Who is the person skilled in the art Who is presumed to know all the relevant prior art A person skilled in the art is presumed to have access to the entire state of the art and, in particular, it is presumed to possess common general knowledge applicable to his field of interest. Furthermore, it is part of the normal activities of the skilled person to select from the material known to him the most appropriate item. The skilled person is not regarded as having any inventive ingenuity. So, the teaching of a document may have narrower implications for a skilled person and broader implications for a potential inventor who first perceives the problem which the future invention is intended to solve. 

In fact, the patent application must explain the invention in a sufficiently clear and complete way for a person skilled in the art to be able to reproduce the invention without having to carry out research or lengthy and delicate operations. 

Patent literature is a useful source of technical, legal, and commercial information. It is extremely rich in technical information. In a patent application, applicants must disclose the invention in a sufficiently clear and complete way for a person skilled in the art to be able to reproduce the invention. New and inventive concepts give rise to a considerable number of refinements, improvements and modifications. Often, the importance of an invention is related to the number of patents and patent applications which protects it. 

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