Key points
- The Board, under inventive step: "The problem to be solved proved to be a contentious issue.".
- "The [opponent] appellant argued that the technical problem was to provide an infant formula suitable for newborn infants. For the [patentee] respondent, however, the correct technical problem was the one identified in the decision under appeal [probably: "resided in recognising that bioavailability of lutein from infant formula was low"]. In its view, the patent involved one of the rare cases of a "problem invention". It had not been recognised in the art that bioavailability of lutein from formula milk was lower than that achieved by human milk. Once this was known, the solution would have been obvious."
- The Board: "As the respondent [patentee] acknowledged, "problem inventions" are rare. One reason for this may be that they are somewhat at odds with the problem-solution approach. It is generally accepted that the formulation of the technical problem should not contain pointers to the solution or partially anticipate the solution. In contrast to this, "problem inventions" tend to do both."
- I'm not entirely certain of what the Board means with the last sentence.
- The Board reviews the foundational decision T 2/83. "T 2/83 concedes that the discovery of an unrecognised problem may in certain circumstances give rise to patentable subject-matter. This may be so even though once the formulation of the problem is accepted, the question of whether the solution was obvious becomes irrelevant. A situation may arise in which, if a subject-matter claimed is assessed as a "problem invention", an attack based on lack of inventive step can be successfully directed only against the recognition of the problem, not against the claimed solution. At the same time, T 2/83 makes it clear that in the context of a clearly desired improvement, side effects which may be interpreted as a solution of a yet unknown problem shall not be decisive for patentability."
- The Board then turns to the facts of the case at hand. I refer the interested reader to the text below the fold. I would be glad to learn from comments to what extent the Board applies a coherent framework.
- "Considering all this, it is not justified to accept the formulation of a "problem invention", as suggested by the respondent. Instead, the technical problem has to be regarded as that of providing a nutritional formula (with lutein) suitable for infants, including newborns."
- The patent is revoked.
2.3 Closest prior art D16
2.3.1 The parties agreed to use D16 as the closest prior art.
2.3.2 D16 discloses infant formulas containing lutein and zeaxanthin. Paragraph [0016] reports a study in which the total lutein and zeaxanthin content of human milk samples from 450 women in nine countries was analysed. The individual concentration of the two carotenoids was between 6 myg/liter and 230 myg/liter. Dependent claim 2 is directed to an infant formula composition comprising these concentrations of lutein and zeaxanthin.
2.3.3 Example 1 of D16 discloses a nutritional infant formula having a concentration of lutein and zeaxanthin of 25 myg/liter. The concentration of docosahexaenoic acid is calculated to be 75.6 mg/liter.
2.3.4 The parties agree that example 1 of D16 does not disclose the lutein concentration set out in claim 1 (i.e. 75 myg/liter).
2.3.5 As correctly pointed out by the respondent, a direct consequence of the low concentration of lutein in example 1 is that the weight ratio of lutein (myg) to docosahexaenoic acid (mg) of claim 1 is also not disclosed in D16.
2.4 The problem to be solved proved to be a contentious issue.
2.4.1 The appellant argued that the technical problem was to provide an infant formula suitable for newborn infants.
2.4.2 For the respondent, however, the correct technical problem was the one identified in the decision under appeal. In its view, the patent involved one of the rare cases of a "problem invention". It had not been recognised in the art that bioavailability of lutein from formula milk was lower than that achieved by human milk. Once this was known, the solution would have been obvious.
2.4.3 As the respondent acknowledged, "problem inventions" are rare. One reason for this may be that they are somewhat at odds with the problem-solution approach. It is generally accepted that the formulation of the technical problem should not contain pointers to the solution or partially anticipate the solution. In contrast to this, "problem inventions" tend to do both.
2.4.4 A relevant decision dealing with "problem inventions" is T 2/83. In point 6 of the Reasons, the following is stated.
"The discovery of a yet unrecognised problem may, in certain circumstances, give rise to patentable subject- matter in spite of the fact that the claimed solution is retrospectively trivial and in itself obvious ('problem inventions') ... It appears however, that whenever the modification of a known device involves no real choice in the direction of a clearly desired improvement, i.e the skilled man is in an inevitable 'one-way-street' situation, the additional provision of a yet unsuspected 'bonus' or side effect, which may be interpreted as a solution of a yet unknown problem, should not necessarily be decisive for patentability."
2.4.5 Although this passage of T 2/83 refers to a device, it is not apparent why the reasoning in it would not apply also to claims directed to compositions.
2.4.6 The decision T 2/83 concedes that the discovery of an unrecognised problem may in certain circumstances give rise to patentable subject-matter. This may be so even though once the formulation of the problem is accepted, the question of whether the solution was obvious becomes irrelevant. A situation may arise in which, if a subject-matter claimed is assessed as a "problem invention", an attack based on lack of inventive step can be successfully directed only against the recognition of the problem, not against the claimed solution. At the same time, T 2/83 makes it clear that in the context of a clearly desired improvement, side effects which may be interpreted as a solution of a yet unknown problem shall not be decisive for patentability.
2.4.7 In the case in hand, the following has to be taken into account when formulating the technical problem.
2.4.8 First, while the issue with bioavailability of lutein is new information, bioavailability of trace elements and lipids from infant milk has been well investigated. This was thoroughly discussed in the oral proceedings before the opposition division (minutes, points 7.1 and 7.2) and in the decision under appeal (e.g. pages 5 and 6).
2.4.9 Second, the "gold standard" for preparing an infant formula is and remains human milk. Therefore, when formulating the problem to be solved, one must draw closely on the teaching available in the art on human milk. D16 itself discloses that the individual concentration of lutein and zeaxanthin in human milk is distributed over a wide range (6 myg/liter to 230 myg/liter) and teaches the use of these concentrations in an infant formula (claim 2).
2.4.10 Third, the patent in suit relates to preparing an infant formula. The target group for the formula is not restricted in claim 1, but preterm infants are explicitly mentioned throughout the patent. Moreover, the patent also makes reference to newborns, i.e. infants of 0 months of age (paragraph [0013]). In other words, the formula of the patent in suit has to be suitable for newborns and infants born prematurely.
2.4.11 Considering all this, it is not justified to accept the formulation of a "problem invention", as suggested by the respondent. Instead, the technical problem has to be regarded as that of providing a nutritional formula (with lutein) suitable for infants, including newborns.
The Board’s statement that the PSA must be considered a rule and exceptions to its application should be as minimal as possible mischaracterises the PSA.
ReplyDeleteThe PSA is a welcome tool as it is based on the EPO’s concern to avoid hindsight bias in the assessment of inventive step – keeping in mind that hindsight is unavoidable anyway in the search of prior art, which can only rely on the knowledge of the claimed invention. But as any tool, there are limits to its relevance.
The cases of « problem inventions » are clearly cases in which the PSA is irrelevant, and it is surprising that the Board finds it necessary to lay out a reasoning justifying the application of the PSA to problem inventions. The Board’s position makes the PSA look like a Procrustean bed.
The PSA is well suited for improvement inventions but there are actually numerous cases in which the PSA is not so convenient. It entails in particular difficulties for the selection of the closest prior art when an invention is based on a new use of a known technique in a field different from that of the known technique. Another issue emerges when the « objective problem » has to be defined in very vague or artificial terms, which signal that the PSA is inadequate.
The term « problem » in itself is ambiguous, its use in the singular tends to disregard the fact that the « problem « for a skilled person typically encompasses a host of constraints relevant to the field of use which must be met in addition to solving a specific problem.
The PSA is generally presented as a three-step reasoning process beginning with the selection of a closest prior art. But this presentation misses a critical preliminary step i.e. the definition of the « art » of the skilled person mentioned in Article 56. This is critical because the « art » of the skilled person is the field of the claimed invention in which the « problem » to be solved arises. In the case of a new use, the field of that new use should be the « art « of the skilled person and the closest prior art should belong to the field of use.
It must also be kept in mind that the PSA is not the rule in major juridictions (UK, Germany) and French courts insist that they are bound to apply the PSA.
Typo to be correctement : French courts insist that they are not bound to apply the PSA
DeleteThanks for the comment. However, I can't find a statement in the decision stating (verbatim) that "statement that the PSA must be considered a rule and exceptions to its application should be as minimal as possible"
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