Reduction to practice

This is an issue that will only increase in seriousness as more information concerning genetic markers of drug response become an increasing part of routine medical practice. 

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The importance of an accurate and complete record of invention caimot be underestimated. The record of invention should serve as the basic document for estabUshing the date of conception and reduction to practice of the invention. The U.S. PTO issues patents to those who are first to invent. In a contest over inventorship, any available record of invention is submitted to the U.S. PTO to estabUsh proof of an inventor s rights. As of January 1, 1996, any inventor from a country belonging to the World Trade Organization may use such evidence before the U.S. PTO. Previously, this type of proof could be rehed upon only if the activity, documented in the notebook, record, etc, was undertaken in the United States. Similarly, activity undertaken after December 8, 1993 in Mexico or Canada may also be rehed upon to prove inventorship. 

Marteel, A.E., Davies, LA., Olson, W.W., Abraham, M.A. (2003) Green Chemistry and Engineering Drivers, Metrics, and Reduction to Practice. Annual Review of Environmental Resources, 28,401-428. 

After conceiving the invention, the inventor s next step is to reduce the invention to practice. A reduction to practice can be a constructive reduction to practice, which occurs when a patent application is filed. It can, however, also be an actual reduction to practice, which is the physical realization of the invention. For instance, in the case of a composition it includes the actual making thereof. With regard to aprocess, it includes the actual carrying out of the steps of the process. The determination that the invention will work for its intended purpose is usually also necessary. 

In both academia and industry, the laboratory notebook is a legal document that records the work done by an individual researcher. Even in the USPTO s own view, its Disclosure Document Program does not diminish the value of the conventional, witnessed, permanently bound, and page-numbered laboratory notebook or notarized records [6]. Without a doubt, any experimental work might be worthless unless it is properly recorded for later use. Evidence of the dates of conception and reduction to practice of an invention may be established by a well-maintained laboratory notebook. Therefore, researchers should become familiar with how to keep persuasive laboratory notebooks. Of course, no notebook is ever perfect. However, the closer one comes to this objective, the better it will be. 

Conception has been defined in various ways. A synthesis of many of these thoughts and perhaps a reasonable way to think of conception is that it is the complete idea of the invention such that the reduction to practice does not require additional inventive input or excessive effort. 

If a long time occurs between an actual reduction to practice (meaning the completion of the invention) and the filing of a patent application, then the concept of due diligence is not in play but rather the question becomes one of whether the inventor abandoned, suppressed, or concealed the invention. This possibility is covered separately by 102(c), which pertains to the abandonment of the invention and, more important, by 102(g) where, in a contest to prove who had invented the subject matter first (patent interference), a party found to have abandoned, suppressed, or concealed the invention can lose to a later-inventing party who did not commit one of those sins. More on these two sections later in this chapter. 

Let s review the law to see if the patent attorney should be so confident. In our discussion of section 102(a), we learned that prior invention could be proved by a reduction to practice before the reference date or a conception before a reference date followed by a period of due diligence until the actual or constructive reduction to practice. In the case of Chemist A, there was an actual reduction to practice that occurred when Chemist A synthesized the pigment and showed that it worked for its intended purpose, which occurred on September 26, 2007. The filing of the patent application is a constructive reduction to practice and would serve as a reduction to practice had an actual reduction to practice not occurred first. To use the conception date, however, Chemist A will need to show that he was diligent from the conception date to the date of the reduction to practice. If he is not able to show due diligence from the conception date to the reduction to practice, he will not be able to mark the conception date as the date of the invention. Instead, the date of the invention is... 

In reference to the second point, an item can be ready for patenting if it has already been actually reduced to practice. However, an actual reduction to practice is not necessary if the invention being sold is capable of being reduced to practice without extraordinary effort or skill—for example, if the inventor has prepared descriptions or drawings of such specificity to enable one of ordinary skill to practice the invention.36... 

There are two questions we will explore for this scenario. First, on what date (or dates) was the chemist s reduction to practice and were they actual or constructive reductions to practice Second, what date(s) of invention can the chemist establish for each of the claims ... 

The second method claim was evidenced by an actual reduction to practice when the testing to establish the anticholinesterase utility took place July 15, 2006. 

As we learned earlier, inventions can be broken down into two parts conception and reduction to practice. Conception has been defined as the complete performance of the mental part of the inventive act. 27 One might think of the conception portion of the invention as the idea to do the thing that eventually becomes the invention. Sometimes the bulb burns very brightly in an individual s head, and the conception for an invention comes about in a single, well-illuminated moment. Other times, the bulb glows only intermittently, perhaps borrowing its light from several individuals over a course of time. As a result, it is often the case that a claim to an 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. 

Although it takes both conception and reduction to practice to make an invention, the two parts are not treated equally in terms of determining inventorship. In fact, a person cannot be an inventor unless they contributed to the conception of the claimed invention because conception is the touchstone of invention. 29 However, the mere wish for the achievement of a particular result absent anything else is unlikely to qualify a person for inventorship. As was stated in a federal court decision where this issue was considered ... 

Likewise, merely providing technical assistance to facilitate the reduction to practice of an invention does not qualify one as an inventor unless the reduction to practice itself required inventive contribution that became part of the claimed invention. In a common scenario that often occurs in the chemical industry, one person may propose a compound or set of compounds or a particular composition that she wishes to see made and tested for a given property or activity. The actual production of the compound or set of compounds may ultimately be carried out by a different person. At first blush, one might guess that the person who proposed the compound(s) for the particular activities is the one who conceived the invention and the chemists synthesizing the desired compounds were technical support providing the actual reduction... 

Different organizations have different formats for the record of invention (i.e., invention disclosure) but some common threads include a brief description of the invention, key dates including conception and reduction to practice, references to key notebook pages, and a list of proposed inventors and their contact information. This document serves as an important record as well as a helpful aid to get the patent agent or attorney started on drafting the patent application. 

Evidence that others had tried to make the invention at issue and failed is also probative as secondary evidence of nonobviousness. The fact that others had failed where the patentee or applicant has succeeded can persuasively argue that the invention was not so obvious, and in particular, its enablement or reduction to practice required skill beyond what is ordinary in the art. It is interesting, in the present case, that Ortho presented evidence that the inventors themselves had failed in numerous attempts to produce the claimed invention. The Court rejected this evidence, pointing out that previous courts had generally focused on the failure of others and not the applicants or patentees themselves. As a result, the Court did not consider this evidence.86... 

In Chapter 2 we learned that the filing of a U.S. patent application serves as a constructive reduction to practice as of the date that the application is filed. However, we also learned that the patent application as filed needed to satisfy the requirements of 112 f 1. Similarly we learned that an applicant is awarded a priority date as of their date of filing the patent application, but this assumes that the filed patent application satisfies the requirements of 112 f 1 as well. This means that the value of the patent application to the patentee is largely premised on the ability of the patentee to fulfill the requirements of 112 f 1. 

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