To clarify our understanding of prior art, let’s consider a couple of hypothetical examples.The first hypothetical tells us the story of a chemist working for the Acme Major Chemical Corporation who conceived of a compound on May 6, 2005. In addition to the conception of the compound, he drew up a synthetic scheme that was likely to be useful for producing that compound; he recorded his conception and proposed synthesis in his lab notebook and had it witnessed and signed, all on May 6, 2005. He believed the compound would have good activity as a serotonin-reuptake inhibitor and therefore be useful as an antidepressant. He immediately ordered the starting materials, and when they arrived, began to prepare the compound. He completed the compound synthesis on June 3, 2005, and submitted it for internal testing to see if it was active. Fortunately, the compound demonstrated good activity in both binding and functional cell assays believed to be predictive of in vivo antidepressant activity;those tests were completed on June 17, 2005. Encouraged by these early results, an umber of in vivo studies were planned to take place over the coming year or so; the company had an orderly progression of in vivo assays, starting with certain rat models and proceeding to nonhuman primates. If the compounds were deemed desirable after all of the in vivo tests, a broad counter screen panel was employed, and if everything looked acceptable, a patent application was drafted and filed. In June 2006, all of the in vivo results were analyzed, and it was decided to advance the compound. On July15, 2006, the counter screen results were completed and, interestingly, the compound demonstrated surprisingly potent anti cholinesterase activity. When the chemist saw the results, he realized that the compound could be useful for cognition enhancement in the early stages of Alzheimer disease. He thought the serotonin-reuptake inhibition might be supportive of that indication as well since many Alzheimer patients suffer from depression. On September 29, 2006, his company filed a patent application in the U.S. Patent office containing the three claims shown in Figure below.
There are two questions we will explore for this scenario. First, on what date (ordates) 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?
FIGURE :Claims to compound A and methods of use thereof.
To determine on what date the reduction to practice took place, it first helps to understand that there are actually three inventions and not one. The first invention is the compound itself, the second is the method of using the compound for treating depression, and the third is a method of using the compound as a cognition enhancer.Let’s take them each in turn. We know that the compound was conceived on May6, 2005, and its synthesis was complete on June 3, 2005. Earlier we learned that an actual reduction to practice occurs when an invention is shown to work for its intended purpose. In general, the reduction to practice for a compound is complete when the compound is identified, a method of making it is available (or the compound is made)and a credible utility established. As we have learned, the utility of a pharmacological compound can be established through testing of the compound in in vitro assays that are at least reasonably predictive of in vivo activity. In the present case, the reduction to practice most likely took place upon the in vitro testing of the compound that established activity predictive of anti-depressant activity. At this point, the compound’s utility was established and recognized and so a reduction to practice for the compound took place on June 17, 2005. With respect to the method of treating depression, it should be fairly evident that the reduction to practice also took place on June 17, 2005. On that date, the method was credibly established.
The second method claim was evidenced by an actual reduction to practice when the testing to establish the anti cholinesterase utility took place: July 15, 2006.We now turn to the second question, What was the date of invention for each claim? The date of invention is the date of the reduction to practice, unless there was a prior conception followed by a period of uninterrupted due diligence from the period of conception to the time of the reduction to practice. If there was a prior conception but the due diligence linking the conception to the reduction to practice was not continuous, the invention date would be the period when the due diligence began that was continuous up to the time of the reduction to practice. In order for the conception to be complete, the entire claimed invention must be envisioned such that no additional inventive faculty needs to be invested. In this hypothetical, we are told that there were three claimed inventions: the compound, the method of using the compound for the treatment of depression, and the method of using the compound for the enhancement of cognition. It appears from the facts given that the compound was conceived on May 6, 2005, and that the conception was complete since the inventor knew the structure he wanted to make, the process for making it, and a practical use for the compound. Furthermore, he diligently pursued the synthesis since he immediately ordered the starting materials for the synthesis and when the starting materials arrived he started to work making the compound right away and actually completed the synthesis fairly quickly. Thus the date of invention of the compound can be traced back to the conception date, May 6, 2005. In the patent application more than just a compound was claimed, two methods of using the compound we reclaimed as well. Those two claims require both the specific compound and the use of that compound in the claimed method. The method of treating depression was part of the chemist’s original idea of how to use the compound, and the compound did show activity in assays that were believed to be predictive of the intended utility. To show diligence from the time of conception, the compound synthesis will have to been diligently pursued as well as its testing in assays to predict whether it will work for the intended method of treatment. Returning to the facts of the hypothetical, we see that the compound was submitted for testing right after the synthesis was completed,and the testing in the two in vitro assays believed to be predictive of the desired activity was completed in 2 weeks from the time the compound was submitted for testing, not an unreasonable period of time, so the invention date for the treatment of depression is also the conception date of May 6, 2005.
This leaves the method of using the compound for the enhancement of cognition in Alzheimer disease. As we discussed before, a conception date can be the date of invention where the conception is complete; all of the elements in the claim must be appreciated or recognized for the conception to be complete. In the earlier portion of this problem, we already learned that the compound was conceived on May 6, 2005.However, not all of the elements of claim3 were recognized or appreciated at that time because there was no expectation at the time that the compound was conceived that the compound would be useful in a method for enhancing cognition. The conception of claim 3 was not complete at the same time as it was for claims 1 and 2. Rather, it was when the compound was tested for antiholinesterase activity that the recognition of its special utility was appreciated and that occurred on July 15, 2006. Unlike the method of claim 2, the method to treat cognition was not appreciated or recognized until the compound actually demonstrated that unexpected activity. As a result, we cannot trace an earlier conception date to that method, but rather, the invention date was the date that the reduction to practice and recognition of the unexpected utility occurred, July 15, 2006.
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