T 2132/16 - No need for UK experts

Key points

• This is an opposition appeal about an actually rather interesting invention, about a prenatal test using circulating DNA (using a blood sample from the pregnant mother). The opposition appeal seems to have been a hard fight. Litigation is running in parallel in the UK. That brings me to the two paragraphs of the Board's decision I am going to quote: don't use UK experts testimony about inventive step as the patentee did in this case. The Boards consider themselves entirely competent to assess the technology at issue. 
• " [D70 and D8] are extracts from a transcript of the cross-examination of two technical experts called by the claimants in the UK litigation, among which was the present appellant I [patentee]. [D74 and D79 are written reports by two technical experts called by the present appellant III [opponent] in the UK litigation. These four documents contain the opinion of different technical experts on various issues relating to inventive step, in particular the interpretation of the content of [D6], and the knowledge and ideas of a skilled team in the relevant technical fields[]."  
• " It should be noted that, while in the UK litigation procedure technical experts are regularly called by the parties to provide technical assistance to the judge, the composition of the Technical Boards of Appeal includes at least two technically qualified members who are themselves able to assess technical facts. In the present case, the board considers itself in the position to decide upon the matter without the further technical assistance provided by the experts who gave evidence in UK litigation." 

EPO T 2132/16 - link

IV. Claim 1 according to auxiliary request 1 reads as follows:
"1. A method for performing prenatal diagnosis of a fetal chromosomal aneuploidy in a biological sample obtained from a female subject pregnant with a fetus, wherein the biological sample is maternal plasma or serum and wherein the sample includes cell-free nucleic acid molecules from the female subject and the fetus, the method comprising:
performing a random sequencing on at least a portion of a plurality of the nucleic acid molecules contained in the biological sample to obtain a pre-determined number of sequences, wherein the sequences represent a fraction of the human genome;
aligning, with a computer system, each sequence to a human genome;
determining a first amount of sequences identified as being aligned to a first chromosome;
determining a second amount of sequences identified as being aligned to one or more second chromosomes;
determining a parameter from the first amount and the second amount; wherein the parameter represents a relative amount between the first and second amounts; and
comparing the parameter to one or more cutoff values, to determine a classification of whether a fetal chromosomal aneuploidy exists for the first chromosome."

XII. Oral proceedings were held on 12 September 2017. During the oral proceedings, appellant I [patentee] withdrew its request to set aside the decision under appeal and maintain the patent as granted, and requested dismissal of the appeals of appellants II and III [opponent].

Reasons for the Decision

Admission of documents (69), (70), (74), (78) and (79) into the proceedings

5. Documents (70) and (78) are extracts from a transcript of the cross-examination of two technical experts called by the claimants in the UK litigation, among which was the present appellant I [patentee]. Documents (74) and (79) are written reports by two technical experts called by the present appellant III in the UK litigation. These four documents contain the opinion of different technical experts on various issues relating to inventive step, in particular the interpretation of the content of document (6), and the knowledge and ideas of a skilled team in the relevant technical fields, which in the UK litigation was considered to comprise a clinician, a molecular biologist and a biostatistician.

6. It should be noted that, while in the UK litigation procedure technical experts are regularly called by the parties to provide technical assistance to the judge, the composition of the Technical Boards of Appeal includes at least two technically qualified members who are themselves able to assess technical facts. In the present case, the board considers itself in the position to decide upon the matter without the further technical assistance provided by the experts who gave evidence in UK litigation.

7. Appellant I opposed the admission of documents (70), (74), (78) and (79) into the proceedings, and requested that, if these documents were admitted, additional evidence from the UK litigation, which was submitted with its reply, be admitted as well. The board, when exercising the discretion conferred by Article 13(1) RPBA, has to take into account the degree of procedural complication that the admission of documents (70), (74), (78) and (79) at the very late stage of the appeal proceedings is likely to cause. Also in view of the fact that, as stated above, these documents do not include any new technical facts, but rather mere opinions on technical and legal issues which the members of the board are able to understand and decide upon without the assistance of technical experts, the board decides not to admit these documents into the proceedings.

43. While appellant III did not contest the formulation of the problem in the decision under appeal, it contended that claim 1 failed to specify features essential for solving the technical problem. In its view, in the absence of a specific enrichment step for the fetal nucleic acid, neither random sequencing nor the steps for obtaining the parameter solved the problem of high maternal nucleic acid background.

44. For the following reasons, the board cannot accept this objection. First, rather than raising an issue of inventive step appellant III seems to question whether claim 1 in fact defines the matter for which protection is sought (Article 84 EPC). Compliance with Article 84 EPC is, however, not a ground for opposition, and an objection in this respect can only be considered by the board if the deficiency arises from an amendment introduced into the claims in opposition or appeal proceedings (see decision of the Enlarged Board of Appeal G 3/14, supra). This is not the case in the present appeal.

47. Appellant III put much emphasis on the definition of the person skilled in the art, which in its view is a skilled team comprising a clinician, a molecular biologist and a biostatistician. This has not been contested by appellant I.

48. The issue that remains to be decided is whether this skilled team, starting from document (6), would arrive at the claimed invention in an obvious manner. Appellant III pointed to various passages of document (6) (inter alia paragraphs [0090], [0259] and [0253]) allegedly providing an incentive to increase the amount of sequencing and/or to use cell-free fetal DNA instead of DNA extracted from a cell. This line of argument is unconvincing because, even if it were accepted that the fact that maternal plasma contains fetal DNA was part of the common general knowledge at the filing date, it does not explain how the skilled team would deal with the problem of the maternal nucleic acid background.

49. Alternatively, appellant III relied on document (2), in particular the statements on page 13121, right-hand column, first full paragraph. Like the opposition division in the decision under appeal, the board is not persuaded that document (2) provides an incentive to use random massively parallel genomic sequencing for the purpose of prenatal diagnosis. While it is true that the passage indicated by appellant III mentions massively parallel genomic sequencing among various promising approaches for conducting digital PCR, there is no clear suggestion of random sequencing. As appellant III asserted in the context of the discussion as to whether the claimed priority is valid, "massively parallel genomic sequencing" (MPS) is not the same as random sequencing. MPS can be conducted in either a random or a targeted manner. While the first does not require that the genomic origin of the nucleic acid molecules be known a priori, in the second - which is in fact the method described in document (2) - primers are designed to target specific desired genomic locations which must be known a priori.

50. For these reasons, the board concludes that, starting from document (6) and in view of either the common general knowledge or document (2), it was not obvious to a skilled team to arrive at the claimed method.