Utility, credible

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

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-... 

If there is substantial physical evidence of contamination at a site, the threat will likely be deemed credible from a utility and a law enforcement perspective. In this case, law enforcement may take control of the site and limit the activities performed by other organizations at the site. 

It is also important for chemical facilities to develop partnerships with the communities and customers they serve. Partnerships help to build credibility within communities and establish public confidence in utility operations. People who live near chemical facility structures can be the eyes and ears of the facility, and can be encouraged to notice and report changes in operating procedures or other suspicious behaviors. 

The fire detection grading approach is a coarse hazard assessment, which documents the credible fire hazards and defines and establishes acceptable fire detection performance requirements. The fire detection performance requirements are defined by determining what size of fire presents a credible escalation hazard. The systematic application ofthe grading process then develops an engineered detection system whose performance can be verified. The general process utilized to develop the detection layout is as follows ... 

Equipment used during emergency response should have operating procedures that are utilized for training emergency responders. Equipment manufacturers and sales companies are often excellent sources for these procedures. However, the nature of a particular facility, the processes, or the range of potential credible emergency situations expected often requires additional procedures that address the proper and safe use of the equipment in site-specific situations. 

It must be emphasized that this is not a strict LCA method, rather it is the use of the methodology to address key issues in the industries that utilize solvents. Becanse of the large amount of data required by a full LCA, a lot of attention has been directed toward developing a streamlined LCA approach. The goal of streamlining LCA is to reduce the time and cost of doing an LCA withont sacrificing the credibility of the results. A streamlined approach would make LCA more applicable by more users, especially smaller companies that may be limited in resources and unable to condnct LCAs (Curran, 1996). 

All of these points being made, even computational chemistry is not without cost. In general, the more sophisticated the computational model, the more expensive in terms of computational resources. The talent of the well-trained computational chemist is knowing how to maximize the accuracy of a prediction while minimizing the investment of such resources. A primary goal of this text is to render more clear the relationship between accuracy and cost for various levels of theory so that even relatively inexperienced users can make informed assessments of the likely utility (before the fact) or credibility (after the fact) of a given calculation. 

Message s perceived utility, clarity, credibility, helpfulness, accuracy, and message... 

Much attention has been garnered by principles of communication that professionals are advised to follow. Well-known examples are seven principles articulated for the Environmental Protection Agency (EPA) accept and involve the public as a legitimate partner (see our Chapter 4) plan carefully and evaluate efforts (Chapter 4) listen to the public s specific concerns (Chapter 4) be honest, frank, and open coordinate and collaborate with other credible sources meet the needs of the media and speak clearly and with compassion (Covello and Allen 1988). Those and related principles have face validity and often practical utility despite their apparent obviousness and abstractness. For example, treating your constituents as though they are ignorant, hysterical, self-interested, or ideologically... 

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. 

Now, let s turn our attention to the second component of the utility requirement, which requires that the claimed subject matter must be useful. As one court opined a simple everyday word [such as useful] can be pregnant with ambiguity when applied to the facts of life. 7 The contours of the utility requirement can be defined by two principles. First, the claimed invention must have specific and substantial utility and must provide sufficient information to make its use readily apparent to those familiar with the technological field of the invention. 8 Second, the alleged utility must be credible. 

An intermediate product for use in making a final product, where the final product itself has no specific, substantial, and credible utility. 

A method for making a material where the material has no specific, substantial or credible utility. 

The second aspect of the useful portion of the utility requirement is that the utility asserted in the patent application must be credible. Normally, when we think of... 

As a practical matter, the ability to establish utility indirectly is an important aspect for credibly asserting utility, especially for chemical inventions that are designed ultimately for use in humans. As just mentioned, a company or organization probably will not have human data related to the use of their particular compound or composition before their filing of a patent application containing those compounds or... 

So let s briefly summarize what we know about utility. The utility of the invention must be statutory subject matter, meaning that it must describe a process, a composition of matter, a machine, or a manufacture. It must be tangible a purely mental process, scientific law, or mathematical relationship will not do. Further, the utility must be substantial and specific, meaning that the utility must be of immediate and real value and cannot be speculative. Finally, the utility asserted in the patent application must be credible. Fulfill these criteria, and you are on your way to a patent. But don t get too excited yet—as we have seen, the utility rejection hurdle is actually rather low. 

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. 

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... 

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 ... 

In retrospect, the early adsorption models identified most of the significant aspects of the adsorption problem. The relationship between adsorption energy and average chain configuration was explored extensively. The assumptions necessary for the calculations, however, limited the utility of these models in predicting the behavior of real systems and, hence, their credibility. Improved analyses of excluded volume and equilibrium required a more comprehensive mathematical framework. 

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