Tuesday, 26 November 2013

T 677/11 – Filling In The Blanks

This is a revocation appeal in a case where there were no less than four opponents.

Claims 1 and 2 of auxiliary request 2 read:
1. Use of an enzyme resistant sugar polymer,
wherein the enzyme resistant sugar polymer is polydextrose,
for manufacturing an appetite suppressing medicine, which comprises a food intake suppressing amount of said enzyme resistant sugar polymer.

2. Non-therapeutic use of an enzyme resistant sugar polymer,
wherein the enzyme resistant sugar polymer is polydextrose,
for suppressing the appetite of a mammal. (my emphasis)
In what follows, the Board tries to understand what exactly “appetite suppression” is supposed to mean.

[3.1] The subject-matter of claims 1 and 2 of auxiliary requests 2 and 3 is directed to the appetite suppressing effect of an enzyme resistant sugar polymer, namely polydextrose (PDX). Since the claims do not explicitly require that the appetite suppressing effect be on satiation, on satiety or on both, it is necessary to define the meaning of the terms “appetite suppressing medicine” as used in claim 1 and “for suppressing the appetite” as used in claim 2. In the following these terms will be examined together by reference to the term “appetite suppression”. The interpretation of this term - be it narrow and concerning the combined effect on satiation and satiety, or be it broad and concerning each of them independently or in combination – has been at the core of the dispute between the [patent proprietor] and the [opponents].

Regarding the definition of the terms “satiation” and “satiety”, reference is made to E63-Exh1, the affidavit of Prof. Blundell, an eminent expert in the field of nutrition:
“9. Satiation develops during the course of eating and eventually brings the period of eating to a close. Accordingly, satiation can be defined by the measured size of the eating episode.” (emphasis added)

“10. Satiety is the state in which further eating is inhibited and follows the end of an eating episode. I am aware that a procedure used to assess the action of a food on satiety is the preload strategy, where precisely prepared foods are consumed in a “preload”. Effects on later food consumption are then measured over varying periods of time by visual analogue scales, and sometimes by additional eating tests, if appropriate.” (emphasis added)
These definitions confirm what the two terms were generally considered to mean in this field at the priority date of the patent in suit […].

Interpretation of the term in the light of the patent itself

[3.2.1] The [opponents] have pointed out that the patent specification does not contain any explicit narrow definition of the disputed term and the [patent proprietor] has not contested this fact during the oral proceedings. The board acknowledges that the patent uses interchangeably a number of terms related to appetite suppression without attaching particular meaning to any one of them and without any consistency or precision. Terms employed include: suppress appetite, reduce appetite, control appetite, control food intake, reduce food intake, suppress food intake, provide a feeling of fullness, control hunger, provide fullness sensation, suppress hunger, reduce hunger, induce fullness, appetite is depressed, curb the appetite, decrease the intake of food, provide feeling of satiation, give a significant calorie reduction, reduce caloric intake.

All these terms are neither necessarily correlated nor necessarily combined. Therefore there is no basis in the patent for a narrow construction of the term “appetite suppressing” requiring an obligatory cumulative effect on satiation and satiety as alleged by the [patent proprietor].

[3.2.2] In fact the contrary is true. The patent specification […] provides ample evidence that the term “appetite suppression” as used in the claims means a suppression of hunger (satiety induction) or induced fullness (induction of satiation).

Paragraph [0035]:
“By taking the satiety agent, before a meal or snack for a sufficient time for the satiety agent to be effective in suppressing hunger and/or inducing fullness, the animal, e.g. mammal, will be ingesting less food between meals and/or during meals” (lines 15-17);

“...as the satiety agent will act to curb the appetite” (lines 22-23);

“Typically, then the satiety agent, will be taken sometime in a period prior to a meal or at the time a usual meal is eaten, and this will serve to decrease the intake of food at a meal or may even eliminate the meal altogether, as the satiety agent, e.g. polydextrose, may provide a sufficient feeling of satiation to eliminate some normally eaten meals or snacks” (lines 23-27).
Paragraph [0052]:
it was possible to determine the satiating effect (i.e. suppression of hunger, or increase in fullness)”.
Paragraph [0070]:
“Furthermore, the sugar polymer, including the hydrogenated polymer, either alone or in combination, act with xylitol or other sugar alcohol in synergism to control the appetite of the animal and/or provide fullness”.
Thus the patent itself discloses that either an effect on satiation or an effect on satiety or both is to be considered as being an effect on appetite suppression.

Interpretation of the term in the light of the common general knowledge
of the person skilled in the art at the priority date of the patent in suit

[3.3.1] The [patent proprietor] did not dispute that the patent in suit allowed the term “appetite suppression” to be broadly interpreted. Rather, it argued that it was in the “mental furniture” of the average skilled person that when using the term “appetite suppression” he understood that both satiety and satiation must be affected. In other words, despite the broad meaning given to the term “appetite suppression” in the patent in suit, the skilled person would nevertheless give it a narrow interpretation.

Thus the interpretation of the term “appetite suppression” boils down to the question of what interpretation the average skilled person in the art would have given to this term at the priority date of the patent in suit, which is incontestably 9 April 2001. Regarding the average skilled person in the art, the board concurs with the [patent proprietor] that he should be the practitioner in the field of nutrition of mammals, in particular humans. Regarding the question as to whether Prof. Blundell should be considered as the average skilled person in the art, the board considers that Prof. Blundell is an eminent specialist with an extraordinary technical knowledge in this field and cannot represent the average skilled person. According to his curriculum vitae […] he has spent many years working in the field of nutrition and has extensively studied the effects of various foodstuffs on human appetite. Thus the statements in his affidavit (E63):
“19. It is my opinion that it is not satisfactory to assume that because a particular food has an effect on satiety it necessarily also has an effect on satiation. As a consequence and in the absence of an inevitable link between the two both must be independently affected in order to exert an effect on appetite control.”

“21. In summary, it is my opinion that the understanding of a claim about appetite suppression requires an affect on both the satiety and satiation of a subject.”
cannot be considered to represent the general technical knowledge of the average practitioner at the priority date of the patent in suit. Furthermore, E63 expresses a personal opinion on the date of 19 May 2011, i.e. ten years after the priority date of the patent in suit.

[3.3.2] Thus the board agrees with the [opponents] that the skilled person trying to assign a meaning to the term “appetite suppression” would start from the natural meaning to the term “appetite”, which is to be found in E61 (a dictionary). According to E61 the term “appetite” as used in everyday language expresses “the desire or wish for food”. Naturally “appetite suppression” can only mean suppression of this desire, whatever the mechanism involved is, irrespective of the extent and duration of appetite suppression. This is the literal and clear meaning of the claims for the skilled person and there is no reason to deviate from this definition, in particular as the patent specification does not attribute a different meaning to the term “appetite”.

On this basis the term “appetite suppression” would be understood by the skilled person as “the suppression of the desire or wish for food”, regardless how this effect is achieved, be it by acting on satiation or satiety or even on both.

It has not been disputed that two different mechanisms were known at the priority date of the patent which influence the appetite of a subject, namely satiation and satiety which, whilst closely related, can operate independently of each other […].

Nevertheless, an appetite suppressing effect of a compound could be evaluated by measuring of either its satiation effect or its satiety effect, with the combination of both satiation and satiety being the most effective alternative. Indeed the prior art uses interchangeably a plethora of different terms to designate the same concept: reduction of satiation, satiety, food intake suppression, satiating effect, satiation, energy intake suppression, and appetite suppression. The interchangeable use of “satiety” and “satiation” indicates that the interpretation of the term “appetite suppression” as only a combination of both satiation and satiety, as alleged by the [patent proprietor], was not well established in the state of the art at the priority date of the patent in suit. For illustration, reference is made to the following documents:
  • E1 […] discloses the use of carbohydrates for suppressing appetite, whereas only the low decrease of the insulin peak was monitored, thus revealing an effect on satiety (i.e. less hunger between meals and less snacking);
  • E2 discloses a method to retard the food’s digestion resulting in glucose being released into the bloodstream at a slower rate over a long period of time […] providing a feeling of prolonged satiety and helping to prevent snacking between meals […] and finally leading to the suppression of appetite […].
  • E32 […] discloses real appetite-suppressant compositions and recites under the title “Satiety” that “Perception of satiety (hunger, satiety, fullness, desire to eat, appetite estimation of how much one could eat, and thirst) was scored on anchored 100 mm visual analogue scales at day 4 during baseline and day 11 during each intervention period. … To characterize the development of satiation during a meal, questions on hunger, satiety and pleasantness of taste were answered on 100 mm visual analogue scales every 2 min during dinner consumed on the same day.” (emphasis added);
  • E35 (column 1, lines 58-62) mentions that “ the [xanthan] gum per se taken well before meals and without food will act to suppress the appetite, perhaps through a bulking phenomenon which possibly causes a signal of satiety, diminishing the desire for further food intake.” (emphasis added);
  • E64 discloses that Quorn® (a high protein, dietary fibre combination) has an appetite suppressing effect by having a strong impact on late satiety […].
  • E65 […] discloses that the modulation of appetite involves quite a variety of alternative possibilities (enhancing satiety and or inhibiting hunger or altering food selection) which do not have to be present in a cumulative way.
[3.3.3] Certainly, the state of the art at the priority date of the patent in suit discloses also the cumulative effect of satiation and satiety for the control of appetite. Reference is made to E63-Exh5 […], and the affidavit of Prof. Blundell […] confirms this fact. Nevertheless, the cumulative effect concerns the “optimum situation” for the suppression of appetite. The patent in suit […] incidentally defines the “effective” appetite suppression as a 20 to 30% reduction of food intake, although the highest exemplified reduction in food intake is only 16.8% […]. The fact that there is an optimum situation does not cast doubt on the fact that the state of the art cited above discloses also a less ideal suppression of appetite by affecting either satiation or satiety. The technical evidence of the patent in suit discloses […] values for food intake reduction such as 7.2%, 9.9%, 16.8% and 10.9%, which are much lower than the effectively reduced appetite suppression of 20-30% […].

[3.4] The board thus concurs with the [opponents] that the [patent proprietor’s] narrow interpretation of the term “appetite suppression” to require both satiety and satiation is an assertion made “a posteriori”, that is, in view of the [opponents’] various objections during the opposition and appeal proceedings before the EPO. The [patent proprietor] cannot be permitted to fill in the blanks after the priority date and provide now, when the granted patent is challenged, a new and completely unsupported interpretation of the patent language and maintain that this narrow interpretation is the only interpretation that the person skilled in the art would contemplate upon reading the patent.

[3.5] In summary, the contested term has to be interpreted as deriving from the control of satiation or satiety or both.

Should you wish to download the whole decision, just click here.

The file wrapper can be found here.