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Methods of medical treatment

Surgery

8.46 Surgery refers to the treatment or manipulation of the body using manual, instrumental and/or robotic surgical techniques.

8.47 A broader interpretation of the definition of “methods of surgery” was considered in T 35/99 GEORGETOWN UNIVERSITY/Pericardial access OJEPO 2000, 447 where it was held that any surgical activity, irrespective of whether it is carried out alone or in combination with other medical or non-medical procedures should be excluded:

“In contrast to procedures whose end result is the death of the living being ‘under treatment’, either deliberately or incidentally (eg the slaughter of animals or methods for measuring biological functions of an animal which comprise the sacrificing of said animal, cf. T 182/90 SEE-SHELL/Blood flow OJEPO 1994 – not excluded), those physical interventions on the human or animal body which, whatever their specific purpose, give priority to maintaining the life or health of the body on which they are performed, are ‘in their nature’ methods for treatment by surgery within the meaning of Article 52(4) EPC.” (emphasis added in bold terms)

8.48 However, in G 01/07 MEDI-PHYSICS/Treatment by surgery OJEPO 2011, 134, the Enlarged Board of Appeal held that given the continuous advances in medical procedures, a more narrow interpretation of what is encompassed by “method of surgery” should be given, in which the purpose of the method should be irrelevant and a surgical method is defined by the nature of the method, namely the level of surgical skill required and health risks involved. Specifically, in G 01/07 paragraph 3.4.2.3 it is stated that:

“… thus any definition of the term ‘treatment by surgery’ must cover 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.”

8.49 For example, if a claim is directed to a method of introducing an agent (e.g. a pharmaceutical or contrast agent) it is the health risk of the invasive procedure that should be assessed. Even if the procedure is not physically performed by a medical professional, if it is risky enough to be the responsibility of a medical professional, it may be sufficient to be considered a method of surgery. On the other hand, if the procedure is a minor intervention which did not imply substantial health risks when carried out by said qualified paramedical professional with due care and skill, then it may not be considered to be a surgical method (T 663/02 PRINCE).

8.50 In a subsequent decision, T 1695/07 TRANSONIC SYSTEMS, it was considered that the term “medical profession” should not be limited to medical doctors and physicians and it should cover all health care providers. In this case, it was deemed that the claimed process comprised steps that qualified as a surgical method due to the substantial health risk associated with them, even if performed by paramedical support staff. Consequently, the level of medical skill needed to perform a method and the health risks involved in the procedure should be used by the Examiner as a guide to determine if that method constitutes a “method of surgery”.

8.51 If a method does not require medical skills or knowledge, such as, for example, a method for cosmetic ear-piercing, or a method of tattooing the body, then it would not be considered a method of surgery. Another example is that while the setting of bones is carried out by medical practitioners and thus considered to be surgical in nature, the making and applying a plaster cast is usually performed by a technician and so would not be regarded as surgery. In any case, as aforementioned, the Examiner should always take into consideration that even if the procedure is performed by a technician, if it is of such a risky nature that it falls under the responsibility of a medical doctor, it would still be a method of treatment by surgery.

8.52 In addition, a method claim can fall under the exclusion even if it comprises just one feature defining a physical activity or action that constitutes a method of surgery (G 01/07 paragraph 4.3.2). In T 2187/10 Z-KAT independent method claim 1 was confirmed to be not allowable on the grounds of it being a method of treatment of the human or animal body by surgery due to the step of “… performing the surgical procedure …”. In this regard, even if a disclaimer is used to omit the surgical step, the claims still need to adequately define the invention. As such, if the omitted surgical step is an essential feature of the invention then disclaiming or omitting this from the claim should be objected to as lacking support.

8.53 Some examples of “surgical methods” include:

(i) Catheterization, endoscopy, incision, excision or centesis (T 182/90 SEESHELL/Blood flow OJEPO 1994, 641);
(ii) “Closed surgery” (see T 182/90), such as setting of broken bones or relocating dislocated joints;
(iii) Implantation of an embryo which requires the intervention of a surgeon or a veterinary surgeon (Occidental Petroleum’s Application BL O/35/84);
(iv) Dental surgery (T 429/12 DENTAL VISION);
(v) Any implantation or insertion of devices by surgical means (Allen’s Application BL O/59/92);
(vi) Insertion of devices into respiratory cavities (with and without incision) (T 05/04 CAMTECH); and
(vii) Puncture/injections such as lumbar punctures to deliver epidural injections, venipunctures (T 1075/06 FENWAL).

8.54 On the other hand, a method that is not itself surgical but is useful during surgery by providing, for example, real-time feedback and enable a surgeon to decide on the course of action to be taken during a surgical intervention, should not be considered a method of surgery (see G 01/07). Additionally, claims to methods involving the internal operation of implanted devices, or the interaction between the implanted device and an external user or system, should not be considered a surgical method insofar as the method only concerns the operation of the device, if:

(a) there is no functional link to the effects produced by the device on the body (see T 245/87); or
(b) they are not related to the actual implantation of the device (T 09/04 KONONKLIJKE PHILIPS ELECTRONICS and T 1102/02 MAQUET CRITICAL CARE).

8.55 Additionally, claims directed to a technical method for improving the performance of a pacemaker without a surgical implantation step, would normally not be considered a method of surgery. Some examples of procedures generally not considered as “surgical methods” under Section 16(2):

(i) Simple injection methods, either for taking blood samples or introducing compositions (see T 663/02);
(ii) Cosmetic ear-piercing, or methods of tattooing the body, which does not represent the core of the medical profession’s activities and does not pose substantial health risks (see G1/07 para 3.4.2.3);
(iii) Methods to measure, make and apply a plaster cast or attaching exoprostheses to the skin using an adhesive (T 635/08 DOW CORNING FRANCE);
(iv) Methods of making artificial limbs; and
(v) Methods carried out on a dead body or interventions that result in the death of the subject (e.g. sacrifice of laboratory animals) (see T 35/99).

8.56 It is important to keep in mind that, while a method might not be considered as “surgery”, the said method could be a procedure that falls under the definition of “therapy” or “diagnosis”. In such cases, the method would still not be considered to be capable of industrial application under Section 16(2).

8.57 In general, any operation on the body which requires the skills or knowledge of a surgeon or other medical practitioner is regarded as surgery, whether or not it is therapeutic. In Unilever (Davis’s) Application, Falconer J. stated, as follows:

“[S]urgery can be curative of the disease or diseased conditions, or prophylactic, that is, preventive of diseased conditions, as for example, where an appendix or tonsils may be removed before any diseased condition starts up, and surgery may even be cosmetic without being curative or preventive. So that the subsection it seems to me is saying that any method of surgical treatment whether it is curative, prophylactic or cosmetic, is not patentable.” (obiter)

8.58 As stated in G 01/07 “… the meaning of the term ‘treatment by surgery’ is not to be interpreted as being confined to surgical methods pursuing a therapeutic purpose”. The Technical Board of Appeal has followed G 01/07 in the recent T 1213/10 SONY where a method of measuring in vivo enzymatic activity which included a surgical step of using a “penetration device” (e.g. an endoscope) to introduce a substrate to an organ in the body was excluded for being a method of surgery despite the Applicant’s argument that the method was carried out for analytical rather than therapeutic purpose.

8.59 Therefore, any methods of surgery, even for non-therapeutic purposes would be considered to be not capable of industrial application under Section 16(2).