T 1075/06 17-05-2011

1. The appeal is admissible.

2. Method for treatment of the human body by surgery or therapy - Article 53(c) EPC

Pursuant to the transitional provisions having regard to the Act revising the EPC of 29 November 2000 decided by the Administrative Council on 28 June 2001, Article 53 shall apply to European patent applications pending at the time of its entry into force, and thus to the application under dispute in the present case.

2.1 Main request

The claimed method relates to an on-line blood fractionation technique (page 2, lines 16 to 28; page 3, lines 1 to 17) 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, see section "IV. The Blood Processing Procedures" on pages 37 to 79). 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 Article 53(c) EPC. In particular with respect to the aspect of surgery, the criteria developed in decision G 1/07 of the Enlarged Board of Appeal (EBA, see OJ EPO 2011, 134) have to be taken into consideration. Before dealing with these in detail below and in response to the appellant's assertion that exclusions from patentability should be construed narrowly, it is to be noted that the EBA found in G 1/07 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 (see point 3.1 of the Reasons).

2.1.1 Surgery

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 (see, for instance, page 2, lines 16 to 21; page 12, line 34 to page 14, line 3; Figures 37 to 39). 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' (see, for instance, the right-most columns of the tables on pages 42, 43, 53-57, 67, 68, 76, 77). Consequently, the claimed method encompasses the implicit step of venipuncture (see, for instance, page 4, lines 2 to 4, and page 41, lines 7 to 9). According to G 1/07 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 Article 53(c) EPC cannot be left to encompass that embodiment (see Headnote 2a and last paragraph of point 4.1 of the Reasons). 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 (page 13, lines 14 to 34). 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, point 3.4.2.6 of the Reasons).

2.1.1.1 Venipuncture

As ruled in G 1/07, 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 Article 53(c) EPC" (see Headnote 1 (emphasis added), see also last paragraph of point 3.4.2.7 of the Reasons).

"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 point 3.4.2.2 of the Reasons). 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, see page 38, lines 3 to 5). 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, point 3.4.2.3 of the Reasons). 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 Article 53(c) EPC cannot depend on the person carrying it out" G 1/07, point 3.4.1 of the Reasons, see also G 1/04 (OJ EPO 2006, 334) 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 of the Reasons). 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.

2.1.1.2 Blood extraction

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: see, for instance, page 50, lines 17 to 19 and page 64, lines 3 to 6), 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 (point 3.4.2.5 of the Reasons), 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 under point 2.1.1.1, 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.

2.1.2 Therapy

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 (see also page 3, lines 22 to 26). 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 (see, for instance, reference numerals 276 and 276' in Figures 10 and 34, respectively, page 19, lines 7 to 13, and page 57, lines 16 to 19). As mentioned at page 128, lines 30 to 33, and page 129, line 7, the 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 Article 53(c) EPC 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.

2.1.3 Method for operating a device

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 Article 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, OJ EPO 1989, 171, point 3.2.3 of the Reasons), has been endorsed by the EBA for treatments by therapy as well as surgery (G 1/07, point 4.3.2 of the Reasons). 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 (OJ EPO 1998, 241), referred to by the appellant, 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 Article 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 appellant'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 Article 53(c) EPC.

2.2 First auxiliary request

Claim 24 comprises the step of "coupling a multi-function pump station (PP1) to a donor flow channel (266, 270, 300) for conveying fluid to and from a donor ...", which also encompasses the implicit step of venipuncture of the donor. The "processing mode" is identical to that defined in claim 24 of the main request. Claims 27 and 33 of the first auxiliary request correspond to those of the main request. Consequently, the reasoning presented above under point 2.1 with respect to the main request applies mutatis mutandis to this request as well, and claims 24 to 37 are also directed to a method for treatment of the human body by surgery and therapy which is excluded from patentability under Article 53(c) EPC.

2.3 Second to eighth auxiliary requests

The independent method claims of all these requests comprise either 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 ..." (second auxiliary request) or that of "coupling a multi-function [fluid pressure actuated] pump station (PP1) to a donor flow channel (266, 270, 300) for conveying fluid to and from a donor ..." (third to eighth auxiliary requests). A "processing mode" as defined in claim 24 of the main request is comprised in the independent method claims of all these requests. A "blood component return mode" is either comprised in the dependent method claims (second, third, fifth, seventh and eighth auxiliary requests) or in the independent method claim (fourth and sixth auxiliary requests) of these requests. Accordingly, the method claims of all these requests are also directed to a method for treatment of the human body by surgery and therapy which is excluded from patentability under Article 53(c) EPC.

3. Ninth auxiliary request - novelty

Although filed at a very late stage of the proceedings, the ninth auxiliary request was admitted by the Board since the claims directed to the system had not been modified. This request, submitted during the oral proceedings, comprises only claims directed to the blood processing system, after deletion of the method claims of the main request.

Document D1 deals with a blood fractionation system. It discloses a blood processing system as defined in claim 1, comprising:

a donor flow channel 27 to convey fluid to and from a donor,

a blood processing flow channel 30, 31, 33 including a blood separation chamber 33 to separate a blood component from donor blood,

a blood component collection flow channel 41, 42, 43, 44 including a blood component collection container 42, 44,

a pump station 32, 46 communicating with and adapted to receive fluid (Figure 2) from the donor flow channel 27, the blood processing flow channel 30, 31, 33, and the blood component collection flow channel 41 42, 43, 44, and

a controller 81, 107 to operate the pump station in multiple modes (column 11, lines 22 et seq.), including a processing mode (see Figure 8a), during which the pump station 32, 46 is operated to convey blood in the donor flow channel 27 into the blood processing flow channel 30, 31, 33 for separation of the blood component in the blood separation chamber, and a collection mode (see Figure 8b), during which the pump station 32, 46 is operated to convey at least some of the blood component in the blood processing flow channel 30, 31, 33 into the blood component collection flow channel 41, 42, 43, 44 for collection in the blood component collection container 42, 44.

A "pump station (PP1, PP3)" as defined in claim 1 at issue may well comprise several pumps, as disclosed in D1. According to claim 23 of the present request, the pump station even explicitly comprises several "fluid pressure actuated pump stations (PP1, PP3)". Accordingly, it suffices that the ensemble of pumps 32 and 46 forming the pump station of D1, i.e. either one or both of pumps 32 and 46, is "communicating with and adapted to receive fluid" from the various flow channels, which is clearly disclosed in D1 as indicated above. The Board is not able to share the appellant's argument that D1 only discloses a "superstructure" including a number of individual pump stations, rather than a single pump or pump station as claimed.

Furthermore, the broad wording of the claim does not require the pump station to be communicating with and adapted to receive fluid directly from the various flow channels. Accordingly, other components such as the filter 33 of D1 may be located between the pump station and the collection flow channel. Moreover, according to the feature analysis presented above, the filter 33 already forms part of the "blood processing flow channel".

The claimed definition of the "processing mode" does not exclude some of the blood components being conveyed simultaneously to the blood component collection flow channel, and that of the "collection mode" does not exclude blood being conveyed simultaneously to the blood processing flow channel.

The fact that the pumps 32 and 46 forming the pump station of D1 operate at different rates is of no relevance, since claim 1 is entirely silent with respect to pumping rates.

It follows that the subject-matter of claim 1 is anticipated by D1 and therefore not novel (Article 54 (1) and (2) EPC).