GRAHAM FACTORS ANALYSIS OF OBVIOUSNESS - Patent law

All of this preliminary material sets the stage for the crux of our present inquiry, What is obvious? This is a key inquiry for patent law and one of the most crucialyet challenging concepts to understand because its meaning goes to the core of the definition of inventiveness. We have seen and reviewed novelty and should well understand its predicates. Unlike novelty, however, obviousness is a much more open-ended inquiry. Where as novelty instructed us that we were limited to a single reference, obviousness can be based on information separately incorporated from numerous references. Obviousness does not require an element-for-element order match with the prior art and moreover, missing elements or limitations can sometimes be provided by the knowledge or typical practice of a PHOSITA(such as, for example,through the routine manipulation of experimental variables). In the remainder, we will review numerous examples, hypothetical and real, where the obviousness inquiry is carried out. Even though many apparent rules will be laid down, the ultimate satisfaction of an all-encompassing criterion of obviousness will remain forever elusive since obviousness at its very heart requires a value judgment.
It requires the fact finder to reach a conclusion that remains subjective in nature,no matter how much we might try to pretend otherwise. Undoubtedly, there will be arguments for and against the obviousness of an invention, and the ultimate decision will turn on how high the party performing the analysis decides to set the inventiveness bar. This in turn will be a function not only of the personal values of the one reaching the ultimate conclusion but the policy environment that person is operating in. Since patent policy is ultimately public policy, one might expect the inertia of case precedent to constantly adjust to the shifting tides of public policy.

After Congress passed the 1952 Patent Act creating 35 U.S.C. §103, it remained for the federal courts to interpret its meanings and color in the details through obviousness issues arising in patent cases. In 1966, two cases dealing with the interpretation and application of the statute reached the Supreme Court, in which they were consolidated and decided in Graham v. John Deere. While the subject of the two cases were the mechanical arts (in Graham v. John Deere, specifically, the issue was the shock absorber system for a plow shank16) and not directly applicable to the chemical arts, the Court’s broader holding has formed the touch stone interpretation of 35 U.S.C§103 and is applied to obviousness inquiries for all cases, including those in the chemical arts. Although an obviousness inquiry does not always end at Graham, it will always begin with it.

Graham Factors Patent

The Supreme Court in Graham set out a four-step inquiry that forms the beginning framework for any obviousness inquiry:

  1. Determine the scope and content of the prior art.

  2. Ascertain the differences between the claimed invention and the prior art.

  3. Assess the level of skill in the art.

  4. Evaluate evidence of secondary considerations.

We shall discuss each of these in turn (note that the sequence of examining these four factors may be different in various cases, but each factor will be considered).
The first requirement of determining the scope and content of the prior art makes logical sense since it is the prior art that will be a primary consideration in finding whether a claimed invention is obvious or not. As we have already discussed in our analysis of §103, the scope and content of the prior art is analogous to the priorart as laid out in §102, with the exception that the art must be analogous art. We also discussed that §103(c) provides an important exception to §102(e) art arising from the same entity or from a research collaboration. Furthermore, it is possible that an applicant’s own characterization of references as prior art can make those references prior art even where they might not have been considered so otherwise.
Ascertaining the scope and content of the prior art means evaluating all of the prior art and not just the prior art that supports a finding of obviousness. When an inventor makes his discovery, he may have been confronted with prior art that suggested to do what he ultimately did, but there may also have been conflicting art which pointed away from what he ultimately did. Art that suggests against doing what the patent applicant ultimately did is referred to as art that “teaches away,”and such contradictory prior art can be persuasive evidence of inventor ship. In a related way, the predictability of the art must be considered as well. The results of modifying highly unpredictable prior art are themselves highly unpredictable;an obvious variation from the prior art requires at least a reasonable expectation of success.
The second Graham step, ascertaining the differences between the claims to the invention of interest and the prior art, is central to the obviousness determination.This process requires interpreting the claimed invention as a whole as well as the prior art as a whole when making the comparison (recall our discussion of In reHirao, in which one obvious element in a claim did not render the entire claim obvious). The claims are not read in a vacuum but find their meaning in the context of how one of ordinary skill in the art would understand the claims in view of the broader teachings of the specification. Dictionaries and treatises can be consulted as secondary sources but are deemed to be inherently less reliable than the specification of the patent himself. Once the claims are properly constructed, it is the job of the patent examiner (or federal court judges) to compare the properly interpreted claimed invention as a whole to the prior art as a whole. An invention contained within a claim can not be reduced to an abridged version of the invention that a particular fact-finder thinks is the key component.

Understanding the invention as a whole also means placing the invention into the broader context of what the invention accomplishes in relation to what the art as a whole teaches. For example, consideration of whether the invention discovers the source or cause of a particular problem and whether the problem itself was known in the prior art are part of understanding the invention as a whole. Thus an obvious solution to a non obvious source of a problem can lead to a patentable invention provided that the solution to the problem was not the same solution used for asimilar problem known in the art. To better understand this principle, let’s look at a hypothetical problem.
Imagine that a particular commercial chemical process used to make an important intermediate in the fragrance business is subject to irreproducible yields, resulting in occasional significant loss of materials as well as increased effort and expense in isolating the product. After considerable effort, including modifying the catalyst,varying solvents, reaction times, and temperatures, the chemist realizes that the problem may not be in the catalyst but rather the starting material itself. Recognizing that the process to make the starting material includes an alkanethiol reactant, he wonders whether trace amounts of the alkanethiol are being carried over and poisoning the catalyst in the process. To investigate this possibility, the chemist washes a solution of the starting material with an aqueous sodium bicarbonate solution containingdilute hydrogen peroxide, and it is found that the alkanethiols can be removed without degrading the starting material and that the process of using the pre washed starting material results in a significantly more robust reaction and a higher-qualityproduct. Since the previous process used to prepare the fragrance intermediate is already known in the literature, the chemist’s organization files a patent application claiming the process including the oxidative wash step to remove the alkanethiolimpurities.
It is well known in the literature of analogous arts that washing materials containing alkanethiols with basic aqueous peroxide solutions oxidizes organic thiols to sulfonicacids, which are subsequently extracted into the aqueous solution as their conjugate base. As was mentioned previously, the process absent the washing step was already known as well. Given the prior art familiarity with both of these processes, an overzealous patent examiner might argue that a new process combining these two prior art processes together therefore is also obvious. However, this would be mistake because the patent examiner needs to keep in mind that which we just learned: It is the claimed invention as a whole that needs to be examined, including the problem that is solved by the claimed invention. The inventor was confronted with an irreproducible reaction and identified the problem as trace amounts of alkanethiolsin the starting material. The primary locus of inventive activity was the discovery of the problem. Once he discovered the source of the problem, the solution may have been obvious, but that misses the point. The claimed invention as a whole would not have been obvious because it would not have been obvious to wash the prior art starting material with sodium bicarbonate and hydrogen peroxide because the priorart did not recognize alkanethiol as an impurity that needed to be removed. Whereas the solution might seem obvious, the problem was identified from what was likely avery large number of candidates. The reality is that in many cases, problematic steps in chemical processes are never brought to such a clean and successful conclusion(paper chemistry is always easier than the real thing).
The third step of the Graham inquiry requires determining the level of skill that one of ordinary skill in the art would possess. As we learned earlier in this later,one of ordinary skill in the art is charged with the knowledge of the prior art that relates to the field of the invention, but the level of skill in the art relates more directly to the ability of one of ordinary skill in the art to apply that knowledge to solve problems. The higher the level of skill in the art, the greater the insight an ordinary practitioner is going to be assumed to have. Things obvious to one who understands chemical structure–activity relations through the eyes of an experienced chemist would not be obvious to one with no more than a high school level of chemistry knowledge. The baseline determination for the level of ordinary skill in the art would be an important exercise, except that one can expect a relatively universal standard of a high level of ordinary skill in the art across the chemical disciplines.As a practical matter, the average chemist is college-educated and possesses several years of practical experience.

The fourth step of the Graham inquiry requires that any obviousness determination must also consider secondary evidence of non obviousness. This is a very important consideration where chemical inventions are concerned, and we will see its practical application in due course, but for now let’s consider the overarching import of what the fourth step of Graham entails. By referring to “secondary” evidence of non obviousness, the Graham Court did not mean that such evidence is of secondary importance but rather that such evidence is not necessarily evident from the patent application itself or the prior art. These secondary considerations of non obviousness relate to the invention itself and include such items as unexpected results, commercial success, long-felt need, copying by others, licensing, skepticism of experts,and independent development; they will be explored further later.


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