Monday, 27 August 2012

T 2068/10 – Lack of support

This is an appeal against the refusal of the application under consideration by the Examining Division (ED).

The ED raised objections under A 84 and A 123. In particular, the ED objected to the term “fixed-dried cells”, which in its opinion included also “rehydrated fixed-dried cells”. Additionally, it considered the term “active agent” to be very broad not allowing the claimed subject-matter to be distinguished from the subject-matter of the prior art. The ED also held that in the absence of experimental support as to the viability of the active agent after internalisation the claimed subject-matter lacked technical support.

Claim 1 of the sole request before the Board read:
Fixed-dried blood cells carrying an active agent, wherein said fixed-dried blood cells are fixed-dried platelets and wherein the active agent has been coupled to or introduced into the cells.
There were three more independent claims, one directed at a pharmaceutical composition, the second at a method of making fixed-dried blood cells carrying an active agent and the third at a method of making a pharmaceutically acceptable composition comprising rehydrated fixed-dried blood cells carrying an active agent.

Having found the request to comply with the requirements of A 123(2), the Board dealt with the objections regarding clarity and support (A 84):

[3.1] In the decision under appeal the ED objected to the term “fixed-dried cells” in claim 1. Contrary to the Applicant’s, now Appellant’s, opinion it considered that this term also included “rehydrated fixed dried cells”, because in its opinion further treatment of the cells after having been fixed was not excluded. In support of its interpretation the ED pointed to the prior art, without in this context specifying any particular document, wherein the term “fixed-dried” and “rehydrated lyophilised” (“RL”) were allegedly used interchangeably and to the application as filed “which states on page 6 that fixed-dried blood cells are cells which have been fixed (which of course is also true for cells which have been rehydrated in a subsequent phase)”.

[3.2] The Board does not agree with the ED’s findings. Claim 1 of the present main request, as was claim 1 of the main request before the ED, is directed to a product, namely fixed-dried platelets. When reading claim 1, the term “fixed-dried” suggests to a skilled person a product in a dry or water-free state. The meaning of this term therefore is clear per se. Furthermore, this meaning is confirmed in the description of the application. [… F]ixed-dried blood cells are described as blood cells “which have been fixed, and additionally have had water removed therefrom ....”. In contrast, fixed-dried blood cells which have been contacted with water so that the water is taken up into the intracellular cells, are defined as “rehydrated fixed-dried blood cells” […]. The prior art as cited in the supplementary ESR and the ISR makes the same distinction between dried or lyophilised cells and rehydrated dried or lyophilised cells. An interchangeable use of the term “fixed-dried” and “rehydrated-lyophilised” as argued by the ED is not apparent to the Board. In this context, the Board also notes that the term “fixed-dried” refers to dried cells which were treated with a fixation agent, while “rehydrated-lyophilised” merely refers to a freeze-dried product, which was rehydrated, but was not necessarily fixed […]. Thus, the terms cannot be considered equivalent or interchangeable.

The Board acknowledges that ultimately the fixed-dried cells will have to be rehydrated before being administered to a patient and that rehydration is therefore also described in the application. However, this does not justify the conclusion that rehydrated platelets form part of claim 1 contrary to its wording.

[3.3] An additional objection of the ED under A 84 was directed to the breadth of the claims. However, according to the jurisprudence of the Boards of Appeal, the clarity of a claim is not necessarily diminished by the mere breadth of a term. In the present case the ED has understood the term “active agent” as encompassing any compound with any kind of activity or function. The Board agrees with this admittedly very broad definition, which is also in line with the definition in the description of the application […]. The specific activity or function is not essential for the invention. According to the application […], active agents may encompass a wide variety of different compounds, for example RNA, DNA, proteins or peptides such as enzymes or antibodies, viruses, bacteria, small organic compounds, polymers, nanoparticles, having a wide variety of activity like antimicrobial, antibacterial or antiviral, blood coagulation or anti-coagulation activity, reporter or detectable activity, like radiolabels or fluorescent probes. Compounds with a different activity, for example stabilisers (trehalose, albumin) are, however, also included.

Whether or not this broad definition allows the claimed subject-matter to be distinguished from the prior art, is a matter that should be dealt with by the ED in the examination of novelty, taking into account the fact that claim 1 is not directed to a rehydrated product.

[3.4] The Board also does not agree with the ED’s finding of “lack of technical support” in the sense of A 84”. With lack of technical support, the ED refers to the absence of experimental results for example 5 directed to the internalisation of Ribavirin into platelets.

[3.4.1] Concerning the question of support under A 84, the Board observes that according to the jurisprudence of the Boards of Appeal the expression “support by the description” means that the technical features stated in the description as being essential for the invention must be the same as those used to define the invention in the claims (see decision T 939/92 [2.2.2], T 821/96 [3.2.1]). The ED did not argue that features which are mentioned as essential in the description are missing in claim 1. Nor can the Board find any such features. Instead the ED referred to the existence of an alleged prejudice in the prior art, namely that the active agent may not be viable when platelets were subjected to fixation and that in the absence of experimental results showing that ribavirin, the active agent of example 5, is still viable this prejudice was not considered to be overcome. In other words, concerning the embodiment of internalisation, the EDs doubted that the technical problem of delivering the active agent as stated on page 2 of the application was solved.

[3.4.2] However, the question whether or not this problem is indeed solved by the claimed subject-matter may be dealt with when assessing inventive step or examining sufficiency of disclosure. Moreover, the Board notes that the ED considered that support existed for embodiments where the active agent is carried on the surface of the platelets. According to the invention the internalisation of the active agent into the platelets is an alternative embodiment of the invention. There is no reason apparent to the Board why there should be any doubt as to the viability of the active agent, if it is internalised, where it is even less exposed to any fixing or cross-linking agent, instead of being carried on the surface of the platelet, and the decision under appeal fails to give any explanation in this respect. In this context, the Board also notes that according to the prior art cross-linking in platelets occurs on the surface of the platelets, i.e. cross-linking of surface proteins and lipids […]. Moreover, fixation in platelets is carried out under particularly mild conditions (room temperature, low concentration of formaldehyde, short reaction time) in order not to loose viability of the platelets […]. There is no plausible reason apparent to the Board why the skilled person would have concerns that under these conditions the viability of the active agent will be in jeopardy, while the viability of the platelets remains largely intact, i.e. many of the surface membrane functions despite a certain degree of cross-linking of surface proteins and lipids are retained. Thus, an objection of lack of support by the description cannot, in the Board’s judgement, be validly raised in the present case.

The Board finally remitted the case to the ED for further prosecution.

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