Tuesday, 26 January 2016

T 1990/10 - Combining ranges

Can you puzzle the claimed range from multiple disclosed ranges?

The claims in this Opposition appeal contained ranges that were taken by combining ranges in the description. 

Claims 1 and 4 of the main request contained the ranges 'below 35°'C and 'about 26°C to 32°C'. Although these ranges are not explicitly disclosed, numerous other ranges are disclosed which might be combined to obtain the claimed ranges.  

For example, can you get 'below 35°'C from the disclosed ranges "below 37°C"  and "30°C to 35°C"? The board thinks not. In part because the qualifiers 'below' and 'about' are not disclosed correctly for the combined ranges.

The proprietor appellant (Appellant I) did not attend oral proceedings or respond in substance to the preliminary opinion. In response, the board canceled the oral proceedings.

Reasons for the Decision

Cancellation of the scheduled oral proceedings

1. In reply to the board's communication pursuant to Article 15(1) RPBA, appellants II and III filed further substantive arguments. Appellant I did not respond in substance, but, with a letter dated 30 September 2015, only informed the board in two lines that it will not attend the scheduled oral proceedings (cf. points VI-VII supra).

2. By its decision not to attend the scheduled oral proceedings and not to file substantive arguments in reply to the board's communication, appellant I has chosen not to make use of the opportunity to comment on the board's opinion, either in written form or orally at oral proceedings. This was done although the board's preliminary opinion was clearly in appellant I's disfavour, i.e. "the board is of the preliminary, non-binding opinion that the decision under appeal is to be set aside and the patent to be revoked" (cf. page 14, point 26 of the board's communication).

3. In the light thereof, the board decided to cancel the oral proceedings scheduled for 1 December 2015.

Main Request (claims as granted)

Article 100(c) EPC (Article 123(2) EPC)

4. It has to be decided whether the application as filed provides a basis for the temperature ranges "below 35°C" in claim 1 and "about 26 to 32°C" in claim 4.

The disclosure of the application as filed

5. The application as filed concerns a method for preparing pox-viruses, in particular Chordopoxviruses, characterized by cultivation of (infected, virus producing) host cells at specific temperatures (cf. inter alia, page 1, lines 3-5, page 6, lines 3-11, page 9, lines 19-26, page 14, lines 4-8 and claim 1). Various temperatures are disclosed, both specific temperature values, such as the most preferred temperature "30°C" (cf. inter alia, page 9, lines 6 and 10, page 11, lines 16 and 21), as well as temperature ranges, such as the broadest temperature range "below 37°C" (cf. inter alia, page 1, line 5, page 6, line 11, page 11, line 14, page 14, line 8 and claim 1).

6. The disclosed temperature ranges differ in nature and character. Some of them are open-ended, some are closed ranges with defined upper and lower-end values, and some are nested ranges. There are rather broad ranges, such as "30°C to 36.5°C" (cf. page 9, line 8 and page 11, line 20), and rather narrow ones, such as "30°C to 32°C" (cf. page 9, line 10 and page 11, line 20). The narrower temperature ranges are defined as sub-ranges comprised within broader ranges and are defined by the terms "preferably", "more preferably" and "most preferably".

7. A further layer of variation is introduced by using the term "about" which is defined as referring "preferably to the specifically mentioned temperatures and to temperatures being up to 0.5°C higher or lower than the specifically mentioned temperatures" (emphasis added by the board) (cf. page 9, lines 11 to 17). Thus, temperature values specifically mentioned in the application as filed are to be taken at their face value and temperature values accompanied by the term "about" are to be taken as the center of a small temperature range, encompassing temperatures "being up to 0.5°C higher or lower". In the application as filed, the term "about" is used to characterize both, specific temperature values, such as "about 30°C" (cf. inter alia, page 14, line 20 and claim 4), as well as temperature ranges. In the second case, the upper-end and lower-end values of nested and closed ranges, independent of their breadth, are preceded by the term "about", see for instance "between about 26°C and about 36°C", "about 26°C to about 36°C" and "about 30°C to about 33°C" (cf. page 9, line 4, page 14, lines 11 and 17).

8. All indications of temperature, such as ranges, sub-ranges and specific values, are disclosed in the application as filed in a particular context. In the broadest context, there is no limitation to the type of poxvirus and of the infected host cell used for propagating the virus. In the narrowest context, the poxvirus is a specific chordopoxvirus, namely a "modified vaccinia virus Ankara (MVA), preferably MVA-BN as deposited at ECACC under No. V00083008" (cf. page 7, lines 20-22, page 8, lines 11-14 and claim 10), and the infected host cells are chicken embryo fibroblast cells suitable for propagating the vaccinia viruses (cf. page 11, lines 7-10, claim 14).

The open-ended temperature range "below 35°C" in claim 1

9. Appellant I does not contest that the temperature range "below 35°C" is not explicitly disclosed in the application as filed, however, it argues that this open-ended range is implicitly derivable from the application as filed.

10. The term "below" is explicitly disclosed in the application as filed, only for defining the broadest mentioned temperature range, namely "below 37°C".

11. Appellant I argues that, in line with the criteria set out in the decision T 2/81 (supra), the range "below 35°C" is implicitly derivable from the broadest open-ended range "below 37°C" in combination with the upper-end value of the closed range "30°C to 35°C" (cf. point XIII supra).

However, applying the criteria set out in the decision T 2/81 (supra), the combination of the lower-end and the upper-end values of the closed range with the broadest temperature range results in the temperature ranges "30°C to below 37°C" and "35°C to below 37°C". Both mixed ranges are different from the open-ended temperature range "below 35°C" present in claim 1 of the Main Request.

In agreement with appellants II and III, the board takes also the view that the closed temperature range "30°C to 35°C" includes the specific temperature "35°C" whereas the open-ended range "below 35°C" in claim 1 explicitly excludes this value (cf. point XIV supra).

12. Appellant I seems to argue that the closed range "30°C to 35°C" encompasses values which are "below 35°C", which, allegedly, can be described by using the terminology used in the context of the broader open-ended range "below 37°C". The board disagrees as this is not a combination of ranges and sub-ranges as defined in decision T 2/81 (supra). It merely amounts to the direct transfer of the term "below", which defines the openness of a disclosed broad range ("below 37°C"), to the upper end value of another temperature range disclosed in the application as filed ("30°C to 35°C"). In the absence of any indication in the application as filed to do so, this transfer of the term "below" to another temperature value or temperature range has no basis in the application as filed.

13. Thus, claim 1 does not fulfil the requirements of Article 123(2) EPC.

The temperature range "about 26°C to 32°C" in claim 4

14. The temperature range "about 26°C to 32°C" in claim 4 defines the cultivation temperature for propagating a Chordopoxvirus in specific infected host cells, i.e. chicken embryo fibroblasts (cf. point IX supra).

15. The application as filed refers, according to its broadest disclosure, to the propagation of pox-virus in general and Chordopoxviruses in particular without defining the infected host cells (cf. page 8, line 25 to page 9, line 17).

In this context, numerous temperature values and ranges are disclosed on page 9, lines 3 to 10: "... at a temperature below 37°C, preferably between 36.5°C and 26°C or between about 26°C and about 36°C, more preferably between 28°C and 33°C, even more preferably between 28°C and 32°C, most preferably at 30°C. Another preferred temperature range is 30°C to 36.5°C. Particularly good results have been obtained in the subranges 30°C to 35°C, 30°C to 33°C and 30°C to 32°C. The most preferred temperature is 30°C". It is also in this context that the term "about" is defined (cf. page 9, lines 12-17). On page 14, lines 4 to 20, under the heading "Summary of the Invention", the following temperature values and ranges are given: "below 37°C", "about 26°C to about 36°C", "about 28°C to about 33°C", "about 30°C to about 33°C" and "about 30°C".

In the application as filed, the term "about" is found only in this general context and, when present in a temperature range, the term is present in both upper-end and lower-end values of the range.

16. Claims 1 to 4 as originally filed refer to temperature ranges similar to those cited under the heading "Summary of the Invention", namely "below 37°C", "about 26°C to about 36°C", "about 30°C to about 35°C" and "about 30°C", respectively.

Claim 14, directed to a "process according to anyone of claims 1 to 13, wherein the poxvirus is propagated in chicken embryo fibroblast cells", by virtue of its dependency refers to all temperature ranges defined in claims 1 to 4, including the range "about 26°C to about 36°C" of claim 2.

The temperature range "about 26°C to 32°C" in claim 4 of the Main Request is neither disclosed in claims 1 to 4 as originally filed nor in the "Summary of the Invention".

17. Basis for the propagation in Chicken Embryo Fibroblasts (CEF) can be found on page 11, lines 7 to 21 of the application as filed, where it is stated that "(i)t was particularly unexpected that the process according to the present invention can be used for CEF cells since chicken have a normal average body temperature of 41°C".

Immediately after this passage, the preferred temperature values and ranges for this embodiment of the invention are disclosed. These are "below 37°C" and three nested (sub)ranges ("between 36.5°C and 26°C", "between 28°C and 33°C" and "between 28°C and 32°C") and the "most preferably [temperature] of 30°C" (cf. page 11, lines 13-19). In this context, it is again emphasized that these temperatures "are so different from the normal body temperature of the chicken that one would have assumed that these cells can not be used for the propagation of vaccinia viruses" (cf. page 11, lines 16-19).

In the sentence following immediately thereafter, three further temperature ranges are disclosed, namely "30°C to 36.5°C", "30°C to 33°C" and "30°C to 32°C" (cf. page 11, lines 19-21), which result from the straightforward combination of the most preferred temperature "30°C" with all upper-end values of the above mentioned nested ranges.

Significantly, there is no explicit disclosure of a range resulting from the combination of the most preferred temperature "30°C" with the lower-endpoints of the disclosed nested ranges. More significantly, none of the disclosed temperature ranges makes use of the term "about" and, therefore, there is no possible combination resulting in the temperature range "about 26°C to 32°C" of claim 4 of the Main Request.

18. In order to arrive at the temperature range "about 26°C to 32°C", it is necessary to combine the lower-end value of the range "about 26°C to about 36°C" in original claim 2 with the upper-end of either "between 28°C and 32°C" or "30°C to 32°C" described on page 11 of the application as filed. While these last two ranges are found in the specific context of CEF cells as host cells, the former range is found in the context of the broadest disclosure of the application as filed which does not refer to specific host cells.

19. Moreover, the combination referred to above results in a mixed temperature range "about 26°C to 32°C" which has a specific "closed" upper-end value ("32°C") and an "open" lower-endpoint ("about 26°C"). As discussed in point 7 above, the term "about" is defined in the application as filed as only "preferably" limiting the specific temperature indicated to "0.5°C higher or lower". This mixed range, with the term "about" defining only one end value of a temperature range, cannot be derived from the application as filed. Such mixed range could only be obtained if the term "about", and thereby its definition (preferably ±0.5°C), was transferred to all temperatures and temperature ranges disclosed in the application as filed. In the absence of any indication thereto in the application as filed, this transfer is not directly and unambiguously derivable therefrom (cf. point 12 supra).

20. Thus, claim 4 contains subject-matter which extends beyond the content of the application as filed, contrary to the requirements of Article 123(2) EPC.

Auxiliary Requests 1-5 and the request upheld by the opposition division
Article 100(c) EPC (Article 123(2) EPC)

21. Since all these requests either in claim 4 (Auxiliary Requests 1 and 2) or claim 3 (Auxiliary Requests 3 to 5 and the request upheld by the opposition division) refer to the temperature range "about 26°C to 32°C" (cf. points X, XI and XII supra), none of them fulfils the requirements of Article 123(2) EPC.

Order
For these reasons it is decided that:
The decision under appeal is set aside and the patent is revoked.

This decision  T 1990/10 (pdf) has European Case Law Identifier: ECLI:EP:BA:2015:T199010.20151210. The file wrapper can be found here. Photo "The word no made from jigsaw puzzle pieces“ by Horia Varlan obtained via Flickr.  Licenced under CC BY 2.0 (no changes made).

No comments :

Post a Comment

Statcounter