T 191/08 – Don’t Trust Titles

The patent proprietor filed an appeal against the decision of the Opposition Division (OD) to maintain the patent in amended form.

Claim 1 of the main request before the Board (identical to claim 1 as granted) read:

Method for the immunochemical quantification of inactivated immunoreactive haemagglutinin molecule complexes of influenza viruses, which method comprises the following steps:

a) a sample which contains one or more haemagglutinin molecule complexes to be determined, which complexes have been formed by inactivation with formaldehyde, is incubated with a protein-binding solid phase, with haemagglutinin molecule complex being absorbed physically to this solid phase and not being bound by immunochemical reaction,

b) the liquid and the solid phases are separated,

c) the adsorbed haemagglutinin molecule complex is incubated with one or more specific antibodies which, directly or indirectly, carry a label.

d) the quantity of the label bound to the haemagglutinin molecule complex is determined, and

e) the quantity of the immunoreactive haemagglutinin molecule complex is determined from the quantity of the bound label by comparison with one or more standard values.

Claim 1 of the auxiliary request read (in English translation ; amendments with respect to the main request are underlined):

Method for the immunochemical quantification of inactivated immunoreactive haemagglutinin molecule complexes of influenza viruses, which method comprises the following steps:

a) a sample which contains one or more haemagglutinin molecule complexes to be determined, which complexes have been formed during the cleavage of the viruses by lipid-solubilizing agents and inactivation with formaldehyde, is incubated with a protein-binding solid phase, with haemagglutinin molecule complex being absorbed physically to this solid phase and not being bound by immunochemical reaction,

b) the liquid and the solid phases are separated,

c) the adsorbed haemagglutinin molecule complex is incubated with one or more specific antibodies which, directly or indirectly, carry a label.

d) the quantity of the label bound to the haemagglutinin molecule complex is determined, and

e) the quantity of the immunoreactive haemagglutinin molecule complex is determined from the quantity of the bound label by comparison with one or more standard values.

*** Translation of the German original ***

Main request – A 100(c)

[1] Claim 1 of the patent as granted is derived from claim 1 of the application as filed, which was amended as follows during the examining proceedings:

• Claim 1 of the patent application concerns a method for the immunochemical quantification of “inactivated immunoreactive antigens”, whereas the method according to claim 1 of the patent as granted is directed at the quantification of “inactivated immunoreactive haemagglutinin molecule complexes of influenza viruses”.

• In method step (a) three additional features characterising the haemagglutinin molecule complexes have been added, i.e. that the complexes (i) have been formed by inactivation with formaldehyde, (ii) physically adsorb to the solid phase and (iii) are not bound by immunochemical reaction.

[2] During the examining proceedings the applicant cited the passage extending from page 2, line 4, to page 3, line 4, of the application as filed as support for the first amendment […]. The “formaldehyde” feature and the feature related to “physical and not immunochemical adsorption” were said to be based on the second paragraph of page 2 and the third paragraph of page 5 of the application, respectively […].

[3] During the opposition proceedings, the opponent has invoked the ground of opposition pursuant to A 100(c) EPC 1973 […] against the feature “haemagglutinin molecule complexes […], which […] have been formed by inactivation with formaldehyde”.

[4] In its impugned interlocutory decision the OD has established that the first sentence of pargraph 3 of page 2 of the application was the only place in the application as filed where an inactivation of haemagglutinin molecule complexes of influenza viruses with formaldehyde is mentioned. The [patent proprietor] has not contested this [finding]. The passage to which the OD referred reads:

The corresponding passage taken from the Canadian counterpart to the EP application.

[5] The OD was of the opinion that this passage did not unambiguously disclose a method for the immunochemical quantification immunoreactive haemagglutinin molecule complexes of influenza viruses that have been inactivated with formaldehyde – without preceding lipid solubilisation.

[6] The Board of appeal shares this opinion. According to the Board, the feature “inactivation with formaldehyde” is not isolated in the cited passage of the application […] but is clearly put in the context of “cleavage of the viruses by lipid-solubilizing agents”. In contrast, the subsequent indications contained in the passage, which refer to document D8, belong to the exposition of the prior art; the skilled person reading the application would understand them within this context.

[7] The Board is not persuaded by the argument of the [patent proprietor] according to which the skilled person would realize that the cleavage of viruses by lipid-solubilizing agents was not essential for the invention. The skilled person would not interpret the omission of this step in the title of document D8, which obviously is an abridged statement of the contents of this document, that this feature characterising the haemagglutinin molecule complexes was not essential. The technical considerations invoked by the [patent proprietor] do not support its argument either. It is not relevant in the present case whether there are influenza vaccines where the viruses are not cleaved with lipid-solubilizing agents because the disclosure of page 2 of the application clearly refers to influenza vaccines where the viruses are treated with lipid-solubilizing agents before they are inactivated with formaldehyde.

[8] For these reasons, the Board of appeal cannot discern any clear, direct and unambiguous disclosure in the application as filed which could serve as a basis for claim 1 as granted. Therefore, the ground of opposition pursuant to A 100(c) makes it impossible to maintain the patent as granted.

Auxiliary request – A 123(2)

[9] Claim 1 of auxiliary request 1 differs from claim 1 of the main request in that the haemagglutinin molecule complexes have been formed by cleavage of the viruses by lipid-solubilizing agents and inactivation with formaldehyde.

[10] The Board, very much like the OD, cannot see any basis in the application as filed for an arbitrary sequence (beliebige Reihenfolge) of the steps “lipid solubilisation” and “formaldehyde treatment”. In the application as filed, these two steps are carried out in a given order, i.e. first the cleavage of the viruses by lipid-solubilizing agents and subsequently the inactivation with formaldehyde.

[11] Therefore, the Board is of the opinion that the amendment in claim 1 of auxiliary request 1 is in conflict with A 123(2). […]

The appeal is dismissed.

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