T 1930/14 - Purpose in method claim

Key points

Claim 1 is directed to a method of producing an antibody. The claim recites active method steps, as well as the effect that “wherein said IgG2 antibody [...] elutes as several separate forms on RP-HPLC and said method [...] alters the relative distribution of said several separate forms on said RP-HPLC”.

The Board concludes that this feature does not provide for novelty.

“The second non-medical use claims considered in decisions G 2/88 and G 6/88 of the Enlarged Board of Appeal were directed to the use of a substance for achieving an effect but not to methods/processes/uses for the production of a product. For the former type of claim [use of a substance], attaining of a "newly discovered technical effect" should be considered as a functional technical feature of the claim, whereas for the latter type of claim [methods/processes/uses for the production of a product] it should not”.

“a disclosure in the state of the art of a method for producing a product having the same process steps as the claimed process would anticipate the claimed subject-matter even if that disclosure did not explicitly mention the effect of carrying out said process steps, since the effect would necessarily
be achieved by following the steps of the method.”.

“it is not relevant in the assessment of novelty whether the authors of document D1 recognised that this effect was taking place in the method that they disclosed.”

“Thus, document D1 discloses a method of producing an IgG2 antibody falling within the ambit of claim 1, the subject-matter of which therefore lacks novelty.”

T 1930/14 - link
See also T 0308/17 about a related patent.




IX. Claims 1, 6, 7, 12 and 13 of the main request read:

"1. A method of producing an IgG2 antibody or an IgG2 antibody fragment preparation enriched for one of several separate IgG2 forms comprising:
contacting an IgG2 antibody or an IgG2 antibody fragment that has been recombinantly produced by mammalian cells with a reduction/oxidation coupling reagent at a pH of 5 to 11; wherein said IgG2 antibody or IgG2 antibody fragment elutes as several separate forms on RP-HPLC and said method decreases the number of forms eluting on RP-HPLC, or alters the relative distribution of said several separate forms on said RP-HPLC;

further comprising contacting said IgG2 antibody with a chaotropic agent before, after or concurrently with said contacting with said reduction/oxidation coupling reagent.

Reasons for the Decision

 [...]

4. The claim further specifies that the starting IgG2 antibody elutes as several separate forms on RP-HPLC and carrying out the steps of the method leads to a decrease of the number of forms eluting on RP-HPLC, or an alteration in the relative distribution of said forms on said RP-HPLC.

5. In the decision under appeal, the opposition division held that these features (see preceding point) constituted a technical effect of the claimed method and that document D1 did not disclose them ("Thus, OD finds no reason why the principles of G2/88 should not be taken into account. In summary, the method of claim 1 defines an enrichment purpose based on a new technical effect obtained by process steps which have not been disclosed in the following prior art" - see page 7 of the decision under appeal).

6. The Enlarged Board set out in decision G 2/88 (OJ EPO 1990, 93, Reasons, point 2.2) that there are basically two different types of claim, namely those to a physical entity (e.g. product, apparatus) and those to a physical activity (e.g. method, process, use) - see also Case Law of the Boards of Appeal of the European Patent Office, 9th edition, 2019, II.A.1.2.

7. The case law of the Boards of Appeal has consistently differentiated between methods or processes for producing a product characterised by process steps wherein the purpose of carrying out said process steps is indicated in the claims and those for the use of a substance for achieving an effect.
The second non-medical use claims considered in decisions G 2/88 and G 6/88 of the Enlarged Board of Appeal were directed to the use of a substance for achieving an effect but not to methods/processes/uses for the production of a product. For the former type of claim, attaining of a "newly discovered technical effect" should be considered as a functional technical feature of the claim, whereas for the latter type of claim it should not (see Case Law of the Boards of Appeal of the European Patent Office, 9th edition 2019, I.C.8.1.1 and 8.1.3).

8. According to the case law mentioned above, a disclosure in the state of the art of a method for producing a product having the same process steps as the claimed process would anticipate the claimed subject-matter even if that disclosure did not explicitly mention the effect of carrying out said process steps, since the effect would necessarily be achieved by following the steps of the method.

[...]

12. With respect to the decrease of the number of forms/ the alteration of the relative distribution of several separate forms of the IgG2 antibody on RP-HPLC (see point 4.), the board must conclude that this is an inherent effect, achieved when performing the steps of the (claimed) method. The concentration of the redox reagent used in document D1 falls within the range specified in dependent claim 7 of the main request and thus also within the ambit of claim 1 of the main request (which does not specify a concentration of the redox reagent). The fact that in the method set out in Example 4 of the patent, the concentration of the redox reagent is significantly higher than that used in document D1 does not alter this conclusion.

13. As already noted above (point 8.), it is not relevant in the assessment of novelty whether the authors of document D1 recognised that this effect was taking place in the method that they disclosed.

14. Thus, document D1 discloses a method of producing an IgG2 antibody falling within the ambit of claim 1, the subject-matter of which therefore lacks novelty.