T 1075/06 – Bloody Monday

This decision deals with an appeal following the refusal of an application by the Examining Division, based on A 54 and A 52(4).

Claims 1, 24, 27, and 33 before the Board read :

1. A blood processing system (10) comprising

• a donor flow channel (266, 300) to convey fluid to and from a donor,
• a blood processing flow channel (18, 290, 312) including a blood separation chamber (18) to separate a blood component from donor blood,
• a blood component collection flow channel (292, 294, 306) including a blood component collection container (304, 308),
• a pump station (PP1, PP3) communicating with and adapted to receive fluid from the donor flow channel, the blood processing flow channel, and the blood component collection flow channel, and
• a controller (16) to operate the pump station (PP1, PP3) in multiple modes, including a processing mode, during which the pump station is operated to convey blood in the donor flow channel (266, 300) into the blood processing flow channel (18, 290, 312) for separation of the blood component in the blood separation chamber, and a collection mode, during which the pump station is operated to convey at least some of the blood component in the blood processing flow channel into the blood component collection flow channel (292, 294, 306) for collection in the blood component collection container (304, 308).

24. A blood processing method comprising the steps of:

• providing a blood processing circuit comprising a multi-function pump station (PP1, PP3), a donor flow channel (266, 300) for conveying fluid to and from a donor, a blood processing flow channel (18, 290, 312) including a blood separation chamber (18) to separate a blood component from donor blood, and a blood component collection flow channel (292, 294, 306) including a blood component collection container (304, 308), wherein the pump station is coupled to and adapted to receive fluid from the donor flow channel, the blood processing flow channel and the blood component collection flow channel, and
• operating the pump station in multiple modes, including a processing mode, during which the pump station is operated to convey blood in the donor flow channel into the blood processing flow channel for separation of the blood component in the blood separation chamber, and a collection mode, during which the pump station is operated to convey at least some of the blood component in the blood processing flow channel into the blood component collection flow channel for collection in the blood component collection container.

27. A method according to Claim 24 further including coupling the pump station to a utility flow channel including a processing fluid container, and operating the pump station during a blood component return mode to convey processing fluid in the utility flow channel into the donor flow channel for mixing with the blood component that is to be returned to the donor.

33. A method according to Claim 32 further including coupling the pump station to a utility flow channel including a processing fluid container, and operating the pump station during a blood component return mode to convey processing fluid in the utility flow channel into the donor flow channel for mixing with the red blood cells that are to be returned to the donor.

The Board also came to the conclusion that this subject-matter was excluded from patentability :

[2.1] The claimed method relates to an on-line blood fractionation technique […] wherein whole blood is drawn from a donor and separated into its liquid and cellular components, with certain components being collected and the remaining components being returned to the donor. The method is performed intermittently, with a predetermined sequence and repetition of various modes (in particular “collection mode”, “processing mode”, “processing fluid transfer mode”, “blood component return mode” as defined in the claims, each mode comprising various cycles and phases […]). It has to be decided whether the claimed blood processing method is a method for treatment of the human body by surgery or therapy falling under the exclusion clause of A 53(c). In particular with respect to the aspect of surgery, the criteria developed in decision G 1/07 of the Enlarged Board of Appeal (EBA) have to be taken into consideration. Before dealing with these in detail below and in response to the [applicant’s] assertion that exclusions from patentability should be construed narrowly, it is to be noted that the EBA found in G 1/07 [3.1] that a provision containing exclusions or exceptions from patentability is to be interpreted in the same manner as any other requirement for patentability, i.e. in such a manner that it takes its effect fully and achieves the purpose for which it was designed.

Surgery

[2.1.1] Independent method claim 24 comprises the step of “providing a blood processing circuit comprising a multi-function pump station (PP1, PP3), a donor flow channel (266, 300) for conveying fluid to and from a donor ...”.

From the description and drawings it becomes clear that the claimed blood processing method is performed on-line and that the donor forms part of the blood processing circuit […]. This is also reflected by the expression “for conveying fluid to and from a donor” comprised in method claim 24.

Access to the donor’s vasculature is achieved by means of venipuncture, i.e. performing an incision into the donor’s vein by means of a phlebotomy needle 268, 268’ […]. Consequently, the claimed method encompasses the implicit step of venipuncture […]. According to G 1/07 [headnote 1 and 4.1, last §] a claim which comprises a step encompassing an embodiment which is a “method for treatment of the human or animal body by surgery” within the meaning of A 53(c) cannot be left to encompass that embodiment. Moreover, the claimed method involves “conveying fluid to and from a donor”, wherein the “fluid” may include whole blood conveyed from a donor, or blood components or additives conveyed to a donor […]. It therefore has to be decided whether or not the steps of venipuncture and blood extraction are of a surgical nature according to the criteria developed in G 1/07. This has to be done on a case-by-case basis, with each category of cases being assessed on its own merits (G 1/07 [3.4.2.6]).

Venipuncture

[2.1.1.1] As ruled in G 1/07 [headnote 1; cf. 3.4.2.7, last §], a method which

“comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise, is excluded from patentability as a method for treatment of the human or animal body by surgery pursuant to A 53(c)” (emphasis added).

“Substantial physical intervention”

In this Board’s view, venipuncture represents a substantial physical intervention on the body. It is not comparable to treatments such as tattooing, piercing, hair removal by optical radiation, or micro abrasion of the skin, i.e. invasive techniques performed on uncritical parts of the body generally carried out in a non-medical, commercial environment which should not fall under the exclusion clause (G 1/07 [3.4.2.2]). Donor blood is commonly obtained from the median cubital vein, which can hardly be regarded as an “uncritical part of the body”, with a phlebotomy needle of a cannula diameter which is sufficiently large in order to collect and process the desired quantities of blood (for instance up to 1000 ml of red blood cells […]). The procedure generally takes place in a medical environment, usually a blood bank or a transfusion or apheresis centre with the required emergency equipment, under the supervision and presence of a physician.

“Professional medical expertise”

Venipuncture is usually carried out either by a physician or by a phlebotomist specifically trained in blood collection techniques, i.e. a medical practitioner having the necessary skills and knowledge of the respective anatomy, needle and catheter insertion techniques, associated health risks and precautions to be taken. Accordingly, performing a venipuncture belongs to the kind of interventions which represent “the core of the medical profession’s activities, i.e. the kind of interventions for which their members are specifically trained and for which they assume a particular responsibility” (G 1/07 [3.4.2.3]). There is no doubt that venipuncture requires professional medical expertise to be carried out. Even though by itself not decisive (“whether or not a method is excluded from patentability under A 53(c) cannot depend on the person carrying it out” G 1/07 [3.4.1] see also G 1/04 discussed therein), this criterion gives a further indication that the claimed method might fall under the exclusion clause.

“Substantial health risks”

Even when carried out with the required professional care and expertise, venipuncture entails certain health risks for the donor. In some countries, the responsible physician is legally required to inform the donor about all these risks, including their likelihood and severity, prior to the donation procedure (see for instance § 6 of the German “Transfusionsgesetz”). Known complications associated with venipuncture include infection, bleeding and hematoma, secondary vein perforation, phlebitis, tendon injury, and nerve irritation and injury. While some of these injuries are well treatable if necessary, others may lead to serious irreversible effects. In particular, traumatisation of nerves (for instance the medial antebracheal cutaneous nerve) may lead to chronic pain and even permanent paralysis of the surrounding tissue. Even though these risks may be rare, they are undoubtedly substantial.

If follows that venipuncture of blood donors represents a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise.

Shortly after the present case was decided at the oral proceedings, the Board became aware of the recent decision T 663/02 from another Board, dated 17 March 2011, which deals with the intravenous injection of a contrast agent (see point [3.2]). This is a procedure closely related to yet different from venipuncture for extracting large quantities of blood from a donor. As explained above, the assessment of the present case, following the criteria developed in G 1/07, is also different in a number of respects and would not have changed in the light of T 663/02.

Blood extraction

[2.1.1.2] The claimed method includes a “processing mode, during which the pump station is operated to convey blood in the donor flow channel into the blood processing flow channel ...”. Moreover, claim 24 states that “the pump station is coupled to and adapted to receive fluid from the donor flow channel”. Since the donor flow channel is in fluid communication with the vasculature of the donor (who remains connected to the blood processing circuit during the whole procedure until the final phase […]), this implies that large quantities of blood are being removed, via the donor flow channel, from the donor’s vasculature (if 1000 ml of red blood cells are to be collected as mentioned above, a considerably larger volume of whole blood has to be processed). Accordingly, the applicant’s argument that blood is merely conveyed from the donor flow channel of the blood processing circuit rather than from the donor himself is not accepted by the Board.

Moreover, in a medical sense, blood is a (flowing) organ of the human body, performing numerous functions which are essential to the health of the donor. Accordingly, the withdrawal of blood can be regarded to some extent as partial removal of an organ. As further specified in G 1/07 [3.4.2.5], manipulating a body part is traditionally considered surgical (even if the intervention were not invasive and did not require that tissues are penetrated, as is the case here).

Therefore, in the Board’s view, the removal of large quantities of blood from the donor’s body also qualifies as a “substantial physical intervention on the body which requires professional medical expertise to be carried out”. It may result in hypovolemic reactions of the circulatory system (e.g. dizziness, nausea, fainting, collapse), i.e. “substantial health risks even when carried out with the required professional care and expertise”. As mentioned above […], the responsible physician may even be legally required to inform the donor about these risks, at least in some countries, and the transfusion centre or blood bank is required to hold available the necessary emergency equipment and personnel. Furthermore, during the blood extraction process, the donor has to be kept under continuous medical surveillance by a physician, who must be able to interrupt the procedure in case of health problems and complications.

Therapy

[2.1.2] The claimed method (see dependent claim 27) furthermore comprises the step of “operating the pump station during a blood component return mode to convey processing fluid in the utility flow channel into the donor flow channel for mixing with the blood component that is to be returned to the donor”. A similar wording is used in claim 33. Since the donor flow channel is in fluid communication with the donor’s vasculature as mentioned above, this implies that processed blood components are being returned to the donor […]. Accordingly, the applicant’s argument that blood is merely conveyed to the donor flow channel of the blood processing circuit rather than to the donor himself is not accepted by the Board.

The processing includes the removal of certain blood components such as red blood cells, platelets or plasma (which are to be collected) and the addition of an anticoagulant […]. [T]he purpose of the procedure may not only be storage, but also therapeutic (“blood component therapy”, “therapeutic plasma exchange”). In patients with pathologically elevated quantities or malignant properties of certain blood components, their removal by the claimed blood processing method and the return of the remaining components does indeed have a therapeutic effect.

Moreover, anticoagulants are medicaments and their administration to the donor via the return mode also results in a therapeutic effect on the donor’s body, namely the reduction of blood clotting, thus preventing, for instance, deep vein thrombosis, pulmonary embolism, myocardial infarction and stroke. According to the established jurisprudence of the boards of appeal, the term “therapy” also covers prophylactic methods for treatment (see “Case Law of the Boards of Appeal of the EPO”, 6th ed. 2010, I.B.4.4.1).

Consequently, the blood component return mode according to dependent claims 27 and 33 results in the re-administration of processed blood components which may generate various therapeutic effects on the human body. Methods with both therapeutic and non-therapeutic indications fall under the exclusion clause of A 53(c) as long as they are not limited to non-therapeutic applications (see “Case Law of the Boards of Appeal of the EPO”, 6th ed. 2010, I.B.4.4.2). Independent claim 24, on which claims 27 and 33 depend, also covers the return mode (“conveying fluid to and from the donor”) and thereby relates to a method for treatment of the human body by therapy.

Method for operating a device

[2.1.3] A method which is only concerned with the operating of a device without any functional link between the claimed method and the effects produced by the device on the body does not qualify as a method for treatment within the meaning of A 53(c) EPC 1973. If, on the contrary, there is such a functional link, the method is excluded from patentability. This principle, initially developed for devices for use in a therapeutic treatment (see, for instance, T 245/87 [3.2.3]), has been endorsed by the EBA for treatments by therapy as well as surgery (G 1/07 [4.3.2])). Whether or not a claimed method only concerns the operation of a device without any functional link to the effects of the device on the body “requires an evaluation of the overall technical circumstances of the case and is therefore a matter to be determined ... in the individual cases under consideration”.

As explained above under points [2.1.1.2] and [2.1.2], the claimed steps of operating the pump station in a processing mode and in a blood component return mode do have direct surgical and therapeutic effects on the donor’s body. Consequently, there is a direct functional interaction between the claimed method and the effects produced by the pump station on the body. Since the functional link is necessarily present in the case under consideration here, the method is excluded from patentability.

The present case is quite different from that underlying T 329/94, referred to by the [applicant], which related to a blood extraction assistance method for facilitating sustained venous blood flow though a human limb towards a venous blood extraction point. In that case it was found that none of the method steps claimed had a therapeutic effect in themselves, and consequently there was no functional link or physical causality between the measure implemented and any therapeutic effect produced on the body to which the measure was applied. Furthermore, it was found that the blood extraction itself did not form part of the claimed subject-matter. If that would have been the case, it was stated that withdrawal of blood would fall under the exclusion clause of A 52(4) EPC 1973 three times, namely as treatment by therapy and surgery and as a diagnostic method (point [4] of the Reasons). With respect to the last two aspects it has to be noted, however, that decision G 1/07 and opinion G 1/04 have been subsequently issued by the EBA and the criteria developed therein have now to be taken into consideration.

Finally, the [applicant’s] argument that the claimed method could also be carried out with stored blood is not convincing since the claimed method clearly refers to the donor (“conveying fluid to and from a donor”).

[2.1.4] From the above it follows that claims 24 to 37 are directed to a method for treatment of the human body by surgery and therapy which is excluded from patentability under A 53(c).

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