Today’s lesson on how not to draft patent applications deals with sufficiency of disclosure.
The Examining Division (ED) had found the subject-matter to be insufficiently disclosed.
Claim 1 on file before the ED and the Board read:
1. Use of an enhancer which preferentially enhances the enzymatic reactions between LIPG polypeptide and LDL cholesterol relative to the enzymatic reactions between LIPG polypeptide and HDL cholesterol and apolipoprotein AI in the manufacture of a composition for lowering the level of LDL cholesterol in a patient.
The decision in first instance
[5] In its decision the ED held that the application did not define any “enhancers” as recited in claim 1. The subject-matter of claim 1 was therefore purely speculative and defined as a mere statement of the result to be achieved. Although large compound libraries could be screened for the desired enhancer activity this did not provide the skilled person with immediate or testable knowledge of the compound or compound family which could fall within the ambit of the claim. In particular, enhancers of LIPG enzymatic activity could act at any of the numerous undefined levels of the extremely complex signalling pathways controlling the LIPG activity and have no structural or direct functional properties in common. Accordingly, undue experimentation was required to screen large compound libraries randomly, contrary to the requirements of disclosure (A 83).
Claim construction
[6] Claim 1 is directed to the use of an “enhancer” in the manufacture of a composition for lowering the level of LDL cholesterol in a patient. It is stated further that the enhancer “preferentially enhances the enzymatic reactions between LIPG polypeptide and LDL cholesterol relative to the enzymatic reactions between LIPG polypeptide and HDL cholesterol and apolipoprotein AI” (emphasis added by the board). For the purpose of claim construction, the latter feature therefore constitutes merely an optional feature and has no bearing on the definition of the subject-matter and scope.
[7] The application as originally filed defines an “enhancer” as “a molecule which increases the expression of the LIPG polypeptide or which increases the enzymatic activity of the LIPG polypeptide” […]. In line with established case law of the boards of appeal, a patent application, being a legal document, may be its own dictionary and may define technical terms and determine how a skilled person has to interpret a specific term when used in the description or claims (see e.g. decisions T 500/01 [6] and T 61/03 [4.2]). The board therefore construes the meaning of the term “enhancer” of claim 1 to comply with the functional aspect of the definition contained in the description.
[8] The board notes however, that the enhancer of claim 1 is not defined by any specific structural features, but merely by this functional feature and the capability to lower the level of LDL cholesterol in a patient. Consequently, claim 1 concerns all chemical compounds which increase the expression of the LIPG polypeptide or which increases the enzymatic activity of the LIPG polypeptide and can lower the level of LDL cholesterol in a patient without any restrictions to compound classes or chemical structure.
[9] The board can concur with the appellants that the application describes a number of assay methods which can be used to identify enhancers and inhibitors (modulators) of LIPG activity as recited in the claimed composition. The appellants argued accordingly that the skilled person was able to employ these methods to identify inhibitors and/or enhancers of LIPG activity as claimed.
[10] The board notes however, that the appellants have not denied the fact noted by the ED that the application as originally filed does not concretely identify any enhancer having the functionality as required by the claim. Furthermore, although the application does contain theoretical examples how enhancers which increase the expression of the LIPG polypeptide or which increase the enzymatic activity of the LIPG polypeptide could be identified, the application as filed does not contain any guidance for the skilled person which would allow her/him an educated guess as to for example a particular chemical structural class to which the enhancers recited in claim 1 belong. In addition, the application does not teach any guidance how to effectively select such compounds which also comply with the functional feature of lowering the level of LDL cholesterol in a patient.
[11] Accordingly, in a search for enhancers recited in claim 1, the skilled person would have to test a virtually unlimited amount of chemical compounds of various chemical structures. The board judges therefore that the application as filed does not provide the skilled person at the relevant date of the application with any guidance enabling her/him, without undue experimentation, to identify the enhancers as defined in claim 1.
[12] Therefore, similar to the findings and observations of the there competent board in decision T 1063/06 [5-6] the board in the present case judges that since the enhancers to be used are characterised in functional terms only and claim 1 merely represents for the skilled person an invitation to perform a research programme, it cannot carry out the invention within the entire scope claimed without undue burden (see also T 155/08 [6]).
[13] In view of the above considerations, the board comes to the same conclusion as the ED, that the requirements of A 83 are not met with respect to claim 1.
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1 comments:
I have some sympathy for the applicant. Where many different compounds can be used in the invention, a functional definition needs to be used in the claims, and European practice is strict on defining compounds functionally.
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