The “first door which must be opened on the difficult path to patentability” is the utility requirement. The utility requirement in U.S. patent law traces its origins to the Article 1, Section 8 of the U.S. Constitution, which states: “To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries” (emphasis added). The utility requirement has been legislatively codified in 35 USC §101:Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title (emphasis added).

There are two basic components to the utility requirement as included in §101. The first concerns itself with statutory subject matter, meaning the types of inventions or discoveries that are patentable, which are limited to a “process, machine, manufactureor composition of matter.” The second component is the requirement that the invention falling within the defined statutory subject matter categories be “useful,” where the definition of useful relates to both the quantitative level of usefulness as well as the credibility of the proof of that usefulness.

Statutory subject matter that qualifies for a patent has to be a “new and useful process, machine, manufacture, or composition of matter or any new and useful improvement thereof.” The courts have generally found that the types of discoveries that are not patentable subject material are abstract ideas, laws of nature, and naturalphenomena; in effect, the invention or discovery must be reducible to a tangible form.

However, one might still be able to patent practical applications of any of these three categories. For example, even though Newton discovered gravity, he would not have been entitled to a patent on gravity itself, since gravity is a law of nature. However, a hydroelectric dam that generates electricity from gravity action on water might have been patentable. Likewise, one cannot patent a product of nature (mineral, natural organic product, protein) but one might be able to patent a manipulation of that product of nature such as patenting an isolated form, a method of using the product, etc.Understanding the point where a discovery crosses over from being the simple recognition of a scientific law to the practical application of that law is not always easy. For example, imagine a researcher were to “discover” that the level of folate and cobalamin (two vitamins) in a person was inversely related to that same person’shomocysteine levels such that a high homocysteine level would indicate a folate and cobalamin deficiency. As you can readily discern, such a discovery is not a process,machine, manufacture, or composition of matter but rather a natural relationship,akin to a natural law, and a claim to the relationship itself would not be patentable subject matter. However, think of how this discovery might be rewritten in a way that it could broadly protect the discovery without actually requiring any additional inventive input. In particular, imagine that the following claim was included in a patent application:

  1. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of homocysteine in said body fluid with a deficiency of cobalaminor folate.

Assume that monitoring homocysteine levels was not new at the time of the filing but that the combination of assaying the homocysteine level and correlating that level with a folate or cobalamin deficiency is new. As you can see, this claim now describes a process since it no longer stakes its claim in the natural law itself. By converting the natural law to a process that merely uses the principle of the natural law, the patentees gave their discovery the broadest possible scope without claiming the law itself. With this claim, anybody who assays an individual’s body fluid and correlates that result with a cobalamin or folate deficiency will infringe this claim. Notice that the claim does not require anything more. Do you think that a federal court with patent jurisdiction would find such a claim to be patentable subject matter since it is literally a process, or do you believe that the court would find that the patent applicants have simply rephrased a law of nature in such a way that it merely resembles a process and is actually aimed at capturing the full scope and value of the natural law? As it turns out, we may never know for sure!

As you might appreciate from the forgoing, the dividing line between a claim to a natural law or relationship and a process using that relationship can at times be very thin, gray and sometimes wavering.6 For those practitioners of the chemical arts that rely on the more theoretical aspects of the chemical arts (e.g., computer/molecular modelers), the statutory subject guidelines of the utility requirement need to be considered carefully so that the claimed “invention” represents more than an algorithm or the recognition of a relationship. For the majority of us more applied practitioners of the chemical arts, the discovery and patenting of basic scientific principles is not likely to be a common occurrence and thus will not likely affect our day-to-day working the industry.

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