|European Case Law Identifier:||ECLI:EP:BA:2012:T101308.20120710|
|Date of decision:||10 July 2012|
|Case number:||T 1013/08|
|IPC class:||A61K 31/232|
|Language of proceedings:||EN|
|Download and more information:||
|Title of application:||Use of lipoxin analogs to promote cell defense against gram-negative infections|
|Applicant name:||The Brigham and Women's Hospital|
|Relevant legal provisions:||
|Keywords:||Main request: novelty (no)
First auxiliary request: medical treatment (yes)
Second auxiliary request: clarity (no)
Summary of Facts and Submissions
I. European patent application No. 02 795 936.0, filed as international application PCT/US02/40620 and published as WO 03/051350, was refused by a decision of the examining division on the basis of Article 97(1) EPC 1973.
II. The relevant passages of claim 1 of the request before the examining division read as follows (note: starting from the formula, the claim is reproduced as facsimile including its numbering of the pages):
"Use of lipoxin or a lipoxin analog for the preparation of a pharmaceutical agent comprising the lipoxin or lipoxin analog in a therapeutically effective amount for causing a subject's tissue to express increased levels of bactericidal permeability increasing protein (BPI), thereby treating infection caused by gram-negative bacteria, wherein the lipoxin or lipoxin analog has the following formula:
III. The documents cited during the proceedings before the examining division and the board of appeal include the following:
IV. The examining division held the subject-matter of the request not to be new with respect to documents (1) and (2).
V. The appellant lodged an appeal against said decision of the examining division and filed grounds of appeal relating to the set of claims filed with letter of 28 April 2005 and on the basis of which the examining division had taken its decision. In addition, this submission of 10 March 2008 contained two further sets of claims as first and second auxiliary request.
The wording of claim 1 of the first auxiliary request is as follows:
"A method for lessening an inflammatory response resulting from a bacterial infection comprising:
administering to a subject a therapeutically effective amount of a purified lipoxin, such that the subject's tissues express increased levels of bactericidal permeability increasing protein (BPI); and
wherein the bacteria are sensitive to BPI and the infection is decreased."
Claim 1 of the second auxiliary request reads as follows:
"A method of investigating the ability of a lipoxin compound to treat an infection caused by gram-negative bacteria, which method comprises testing the effect of said lipoxin an the expression regulation of bactericidal permeability increasing protein (BPI)."
VI. Oral proceedings took place on 10 July 2012 in the presence of the representative of the appellant.
VII. The arguments of the appellant in both the written and oral proceedings may be summarised as follows:
With respect to Article 52(2) EPC and relating to claim 1 of the main request it was emphasised that documents (1) and (2) did not refer to the use of any lipoxin, as defined by the formulae, in a medicament for treating infection caused by gram-negative bacteria by way of causing a subject's tissue to express increased levels of bactericidal permeability increasing protein (BPI). This subject-matter was new in particular because of the disclosure of the mechanism for causing expression of increased levels of BPI.
In the applicant's opinion, the wording of claim 1 of the first auxiliary request involved no problem with respect to Article 53(c) EPC.
Claim 1 of the second auxiliary request was to be derived from the overall content of the application as filed, exhibited no problems with respect to Article 83 EPC because of the examples that were disclosed in the application and, finally, there were no problems with respect to Article 84 EPC, even with regard to the considerations set out by the examining division in the communications cited in its decision.
VIII. The appellant requested that the decision under appeal be set aside and that a patent be granted on the basis of the claims of the main request filed with the letter dated 28 April 2005 or, alternatively, on the basis of one of the two auxiliary requests filed with the letter dated 10 March 2008.
Reasons for the Decision
1. The appeal is admissible.
2. The amended claims filed by the appellant with letter of 10 March 2008 represent an attempt to overcome the objections raised by the examining division in its decision. Consequently, they are admitted into the proceedings.
3. Claim 1 of the main request; Article 52 EPC
3.1 The subject-matter of this claim relates to the use of lipoxin or a lipoxin analog selected from the pool defined by a generic formula for the preparation of a medicament for treating infection caused by gram-negative bacteria by causing a subject's tissue to express increased levels of bactericidal permeability increasing protein (BPI).
One example of a lipoxin or lipoxin analog comprised in the generic formula
is where R1 is the fourth member out of the list following the formula on page 94 of claim 1 and Ra is hydrogen (lines 6 and 7 on page 101 of the claim),
and where R2 is the sixth member out of the second list following the formula on page 95 of claim 1 and Rx is substituted phenoxy containing Zi, Zii, Ziii, Ziv and Zv as hydrogen according to lines 9 and 15 to 17 together with line 12 on page 101 of the claim,
which results in the following chemical formula:
3.2 Document (1) relates to the treatment of illnesses caused by gram-negative bacteria (see claim 12 together with page 2, lines 25 to 28) by use of lipoxin analogs (see claim 11 together with claim 10 and claim 2); the suggested lipoxin analogs comprise exactly the lipoxin analog of the application in suit as defined above (see document (1), figure 4 and page 30, lines 4 to 10).
Thus, one of the lipoxin analogs, disclosed as an individualised, particular substance administered in an experiment showing its usefulness for the treatment of illnesses caused by gram-negative bacteria according to document (1) matches the generic formula claimed in the application in suit.
3.3 Accordingly, the technical teaching set out in claim 1 of the main request in the form of a second medical use which refers to the substance to be used, to the medicament to be prepared and to the illness to be cured is the same in this claim 1 as in the technical teaching disclosed in document (1). The same substance must inevitably act in the same manner and follow the same mechanism or mechanisms in both cases.
Therefore, the subject-matter of claim 1 of the main request is not new with respect to the teaching of document (1).
4. Claim 1 of auxiliary request 1; Article 53(c) EPC
4.1 Article 53(c) EPC stipulates:
"European patents shall not be granted in respect of:
(c) methods for treatment of the human or animal body by surgery or therapy ...; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods."
4.2 Claim 1 of the first auxiliary request relates to
a method for lessening an inflammatory response resulting from a bacterial infection comprising:
administering to a subject .
with the definition of "subject" being "intended to include living organisms susceptible to conditions or diseases caused or contributed bacteria and pathogens as generally disclosed, but not limited to, throughout this specification. Examples of subjects include humans, dogs, cats, cows, goats, and mice. The term subject is further intended to include transgenic species." (see page 64 of the description as originally filed, lines 6 to 10).
4.3 "Lessening an inflammatory response resulting from a bacterial infection" is a therapeutical treatment. Consequently, the subject-matter of claim 1 of the first auxiliary request is a method for treatment of the human or animal body by therapy and therefore is not patentable.
5. Claim 1 of the second auxiliary request; Article 84 EPC
5.1 This claim relates to
a method of investigating the ability of a lipoxin compound .
The feature that "a lipoxin compound" is defined to be the subject of the investigation means that the pool of substances to be tested is intended to be limited in order not to comprise all organic compounds in their entirety.
Therefore, also this feature in claim 1 of the second auxiliary request - just like the other features contained in the claim - must comply with Article 84 EPC requiring the claims to define the matter for which protection is sought and to be clear and concise.
The term "a lipoxin compound" per se cannot provide a sufficient definition of the limited pool of related compounds, because it is not clear what kinds of compounds similar to lipoxines are being included by opening the term "lipoxin" to the broader term "lipoxin compounds".
5.2 Accordingly, the teaching of claim 1 of the second auxiliary request is in breach of Article 84 EPC.
For these reasons it is decided that:
The appeal is dismissed.