T 1199/08 (Selected sperm/XY) 03-05-2012

Reasons for the decision

Procedural issues

Admissibility of late filed documents

1. In the course of the oral proceedings on 3 May 2012, the Board had to decide on the admissibility of late filed documents which the appellants wished to use in their pleadings in support of their views regarding the issue of inventive step.

2. A set of seven pages representing four different "documents" were submitted by appellant II. These "documents" are referred to hereinafter as documents A to D.

3. Document A consists of one page and shows the abstract, some lines of the text and parts of the references of a journal article dealing with an optical method of qualitative assessment of sperm mobility. Document B consists of one page and shows the title of a journal article dealing with a semen analysis system in combination with parts of the content of an unidentified page of this article. Document C consists of one page and gives some information derived from the internet referring to a journal article dealing with the motility of spermatozoa in combination with a kind of summary. Document D consists of 4 pages derived from a WHO laboratory manual dealing with human ejaculates.

4. The Board takes notice of the objection to the introduction of documents A to D raised by appellant I arguing that it was taken by surprise at such a late stage of the appeal proceedings and that it would be deprived of an opportunity to present appropriate comments, which is contrary to the requirements of Article 113(1) EPC.

5. Documents A, B and C represent patchworks of information picked from different parts of journal articles (A and B) or from different internet sites (C). They do not meet the usual standard requirements for a document to qualify as a reliable source of information before the Boards of Appeal. As regards document D, from which only a very limited number of pages has been submitted, and which deals with human ejaculates, the Board is not prima facie convinced that it is relevant for the assessment of any of the claim requests on file which all refer to bovine sperm.

6. In view of the above comments, the Board exercising its discretion according to Article 13(1) (RPBA), decides not to admit documents A to D.

7. Appellant I have relied on document D31, a document which was attached to third party observations filed on 3 April 2012.

8. Document D31 is a journal article concerned with investigations carried out on Friesian bull spermatozoa which led to conclusion that Tris- and milk-based diluents were equally efficacious in the cryopreservation of cattle sperm. The Board is not prima facie convinced that D31 qualifies as a more relevant document than those documents which were on file at the onset of the appeal proceedings of 3 May 2012.

9. In view of the above comments, the Board exercising its discretion according to Article 13(1) RPBA decides not to admit document D31.

Introduction of document D30 into the appeal proceedings

10. In its communication faxed on 21 November 2011, the Board informed the parties that, in the course of its final preparation for the first oral proceedings to be held on 24 November 2011, it had become aware of a scientific article published on behalf of appellant I and co-authored by the inventor of the patent. The document (D30) had been published on 1 January 1999, thus almost a year before the earliest priority date claimed for the patent and disclosed field trial 3 of example 8 of the patent. The Board indicated that it intended to hold oral proceedings as scheduled and to introduce the document into the proceedings.

11. The admissibility of document D30 was discussed at the onset of the oral proceedings of 24 November 2011. Appellant I neither contested that the content of document D30 corresponded to the description of field trial 3 of Example 8 as reported and commented in particular in paragraphs [0086] to [0092] and [0101] on pages 20, 21 and 23 of the patent specification nor objected to its introduction into the proceedings.

12. In the light of appellant I's reaction and being aware that document D30 is of high relevance for the issue of inventive step, the Board considers that it is exceptionally empowered by Article 114(1) EPC to introduce it into the proceedings.

Admissibility of the main request and the first auxiliary request

13. As both requests were filed at the oral proceedings held on 24 November 2011 as a reaction to the introduction on the same day of document D30, the Board admits them into the proceedings

Admissibility of auxiliary requests 1a, and 2 to 6 (all filed at the oral proceedings held on 3 May 2012)

14. Second oral proceedings were held on 3 May 2012, thus more than five months after the first oral proceedings, which had been adjourned to give the parties the possibility of making further submissions with regard to the issue of inventive step (Article 56 EPC) in the light of newly introduced document D30. The time limit to make such further observations was set at one month before said second oral proceedings. Document D30 has been published on behalf of appellant I and co-authored by the inventor of the present patent. It is not credible that its content was unknown to appellant I. The Board is therefore of the opinion that appellant I has been allowed sufficient time to consider its position in the light of this prior art document and, if necessary to file amended claims, at the latest within the time limit given at the end of the first oral proceedings. Therefore, the Board, exercising its discretion pursuant to Article 13(1) RPBA, does not admit auxiliary requests 1a, and 2 to 6 filed at the second oral proceedings.

Substantial issues

Main request

15. At the oral proceedings held on 24 November 2011, the main request was found to meet the requirements of Articles 123(2), 123(3), 83, 84, 53(b) and 54 EPC. Furthermore, the objections raised under Article 52(4) EPC 1973 (now Article 53(c) EPC) and Article 53(a) EPC have not been pursued in view of the amendments made to the case. At the oral proceedings held on 3 May 2012, the main request was found not to meet the requirements of Article 56 EPC. Although, the Board in the present decision could restrict itself with regard to the main request to the issue of inventive step, it will also provide below a full reasoning regarding the sensitive issue of exceptions to patentability (Article 53(b) EPC).

Article 53(b) EPC

16. Article 53(b) EPC provides that:

"European patents shall not be granted in respect of:

(a) [...]

(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof."(emphasis added by the Board).

17. Appellant II considers that claim 1 contravenes this provision, insofar as the prohibition applies to essentially biological processes for the production of animals and argues that this objection extends to the other claims, including the product claims 14 to 15 and the use claims 16 to 17. In support of her objection, appellant II has referred to decisions G 2/06 (OJ EPO 2009, 306) and G 1/08 (OJ EPO 2012, 206), the proceedings of which were consolidated with those of decision G 2/07 (OJ EPO 2012, 130), as well as the Oliver Brüstle v. Greenpeace decision of 18 October 2011 of the Court of Justice of the European Union (CJEU decision C-34-10). As only an abridged version of decision G 1/08 was published, reference will be made hereinafter to decision G 2/07 which was published in its entirety.

18. Appellant II argues that, in accordance with the "whole content approach" developed by the Enlarged Board of Appeal in decision G 2/06 (see point 22 of the Reasons), not the explicit wording of claim 1 but the technical teaching of the patent as a whole should be taken into consideration for a correct assessment of whether claim 1 falls under the prohibition of Article 53(b) EPC. Appellant II contends that, following this approach which is reflected by the CJEU decision C-34-10, it becomes obvious that the only purpose of the claimed method is the production of an animal.

19. Appellant II considers further that, in the method of claim 1, the step of sex-selecting sperm by flow cytometry is a selection step which, together with the other technical steps, serves the only purpose of assisting in the crossing step and leads subsequently and inevitably to the breeding of an animal. Consequently, drawing a parallel with the reasoning made in decision G 1/08 regarding a process for the production of plants, the claimed method should be regarded as an essentially biological process for the production of animals.

20. In decision G 2/06, the Enlarged Board of Appeal has answered inter alia the question of whether Rule 28(c) EPC forbids the patenting of claims directed to products (in the referring decision: human embryonic stem cell cultures) which - as described in the application - at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products were derived, if the said method is not part of the claims. Regarding Rule 28(c) EPC which provides that, under Article 53(a) EPC, European patents should not be granted in respect of biotechnological inventions which, in particular, concern uses of embryos for industrial or commercial purposes, the Enlarged Board has noted that said rule does not mention claims, but refers to "invention" in the context of its exploitation and has indicated that "[W]hat needs to be looked at is not just the explicit wording of the claims but the technical teaching of the application as a whole as to how the invention is to be performed" (emphasis added by the Board). This defines the "whole content approach" as referred to by appellant II. The Enlarged Board of Appeal has noted further that "[T]o restrict the application of Rule 28(c) (formerly 23d(c)) EPC to what an applicant chooses explicitly to put in his claim would have the undesirable consequence of making avoidance of the patenting prohibition merely a matter of clever and skilful drafting of such claims" (see point 22 of the Reasons).

21. The present Board does not see any reason to apply this approach of decision G 2/06 to the situation underlying present claim 1. Said approach has been developed in the context of a particular exception to patentability governed by Article 53(a) EPC in view of Rule 28(c) EPC which focuses on the patentability of inventions related specifically to the ethical concerns associated with the destruction of a human embryo, whereas for present claim 1 the context to be considered is the one of another exception to patentability which is governed by Article 53(b) EPC. Present claim 1 is indeed directed to a method for the preparation of sex-selected bovine sperm resulting in a product with properties allowing its long term storage.

22. In the case underlying the CJEU decision C-34-10, the invention was concerned with neural precursor cells obtainable from human embryonic stem cells. The Court had to answer inter alia the question of whether technical teaching is to be considered unpatentable pursuant to Article 6(2)(c) of the Directive 98/44/EC (Rule 28(c) EPC) even if the use of human embryos does not form part of the technical teaching claimed by the patent, but is a necessary precondition for the application of that teaching. In paragraph 50 of the Decision, the Court noted that "Not to include in the scope of the exclusion from patentability set out in Article 6(2)(c) of the Directive technical teaching claimed, on the ground that if does not refer to the use, implying their prior destruction, of human embryos would make the provision concerned redundant by allowing a patent applicant to avoid its application by skilful drafting of the claim" (emphasis added by the Board). Thus, for the very same reason given at point 21 supra, the Board sees no reason to apply the approach of CJEU decision C-34-10 to the situation underlying present claim 1.

23. In the case underlying decision G 2/07, the referring Board had to decide on the patentability of a process for the production of Brassica oleracea, which as claimed comprised in succession steps of a) crossing wild Brassica oleracea species with broccoli double haploid breeding lines, b) selecting hybrids, c) backcrossing and selecting plants with a the genetic combination encoding the expression of elevated levels of given compounds and d) selecting a broccoli line with elevated levels of said compounds. This was a non-microbiological process for the production of plants which contained a step of sexually crossing the whole genome of plants and of subsequently selecting plants, i.e. a traditional method of breeding new plant varieties

24. The Enlarged Board of Appeal came to the conclusion that "[S]uch a process does not escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes or plants or of subsequently selecting plants" (see decision G 2/07, point 2 of the Order).

25. Regarding additional technical steps performed either before or after the process of crossing and selection per se decision G 2/07 indicates: "For the previous or subsequent steps per se patent protection is available" (G 2/07, page 70, lines 4 to 5) and "[H]owever, in such case the claims should not, explicitly or implicitly, include the sexual crossing and selection process." (G 2/07, page 70, lines 10 to 12).

26. The process of claim 1 does not comprise a step of breeding an animal and none of its steps involves any crossing. Furthermore, it is an obvious fact, in an attempt to draw a parallel between a method for the production of plants and a method for the production of animals, that a selection step equivalent to a selection step in a traditional method of breeding new plant varieties which takes place after a crossing step between pre-existing varieties is not present in claim 1.

27. Therefore, appellant II's argument that it was only skilful claim drafting that avoided in the present case the application of the prohibition of Article 53(b) EPC, regarding processes for the production of animals, is not convincing.

28. From the analysis made at points 20 to 27 supra, the Board concludes that claim 1 is directed to a method which allows for the long term preservation of sex-selected sperm. This method does not qualify as an essentially biological process for the production of animals, and, therefore, in line with the parallel reasoning developed in decision G 2/07 regarding processes for the production of plants, it does not fall under the prohibition of Article 53(b) EPC. Thus, claim 1 meets the requirements of Article 53(b) EPC. The same conclusion applies to dependent claims 2 to 13.

29. Claim 14 and dependent claim 15 are directed to a frozen sex-selected bovine sperm sample, a product which is not mentioned in Article 53(b) EPC. In view of the fact that, according to established case law, any exception to patentability must be construed narrowly, Article 53(b) EPC provides an exhaustive list of possible exclusions from patentability. Therefore, the frozen sex-selected bovine sperm sample according to claim 14 or claim 15 does not fall under the prohibition of Article 53(b) EPC.

30. Claim 16 and dependent claim 17 are directed to the use of a sperm sample according to claim 14 or claim 15 for the manufacture of a formulation for artificial insemination. Such a use is also not mentioned in Article 53(b) EPC. Therefore, the use of frozen sex-selected bovine sperm sample according to claim 16 or claim 17 does not fall under the prohibition of Article 53(b) EPC.

31. In view of these remarks, the Board concludes that the main request as a whole complies with the requirements of Article 53(b) EPC. The Board regards it as relevant to note that, in the course of the oral proceedings of 24 November 2011, as clearly reflected in the minutes thereof which were not contested by the parties, appellant II withdrew her request to refer questions of law with respect to this issue. Therefore, the attempt made by appellant II in her letter of 31 March 2012 to re-open the debates in this respect was unsuccessful. When formulating her final requests, appellant II did not include such a request.

Article 56 EPC

32. Claim 14 is directed to a frozen sex-selected bovine sperm sample comprising a portion of the sperm present in a source sample and an extender (see Section XVII supra). The sperm sample is stained with a fluorescent dye and sex-selected by flow cytometry. The extender comprises a cryoprotectant and Tris[hydroxymethyl]aminomethane. Thawing yields sperm that can be used in artificial insemination and achieves pregnancy.

33. In order to assess inventive step in an objective and predictable manner, the so-called "problem-and-solution approach" has to be applied, which in its first step requires the determination of the document representing the closest prior art.

34. The Board considers document D30, which is concerned with the evaluation of the fertility of frozen bovine sperm that has been sex-selected by flow cytometry, to represent the closest state of the art. It contains the data of field trial 3 disclosed in example 8 of the patent in suit (see point 11 supra).

35. In view of appellant I's declaration made at the second oral proceedings, saying that the invention does not provide any improvement over the prior art, the technical problem underlying the invention is defined as the provision of an alternative frozen sex-selected bovine sperm sample.

36. As solution to this technical problem the patent proposes the bovine sperm sample of claim 14 which contains an extender comprising a cryoprotectant and Tris[hydroxymethly]aminomethane (hereinafter also referred to as Tris). The experimental results reported in Example 8 regarding field trials 4 to 11 in which sex-sorted, frozen bovine sperm comprising a Tris-based extender and glycerol (see paragraphs [0086] to [0092]) were used for artificial insemination, show that the problem has been actually solved.

37. The question to be answered is whether it would have been obvious for a skilled person trying to solve the problem to amend the teaching of document D30 in such a way as to arrive at the subject-matter of claim 14.

38. The only difference between the sperm sample of claim 14 and the one of document D30 lies in the use of an extender comprising Tris, whereas in document D30 the extender consists of a combination of egg yolk and citrate sodium.

39. Document D5 is a basic textbook published in 1978 dealing with artificial insemination of cattle. In section 17-3.1 on page 498, it refers to extenders for freezing bovine sperm and lists the basic components of such extenders. The listed components include "dissolved ionic and nonionic substances to maintain osmolality and to buffer the pH of the medium". In the next paragraph on page 499, document D5 gives a short list (eight substances or groups of substances) of buffers and nonionic substances that have been used in extenders for freezing bovine sperm. Tris[hydroxymethyl]amino methane is mentioned on position two of this short list.

40. Appellant I argued that a skilled would have been discouraged to replace the egg yolk / citrate sodium extender of document D30 by a Tris-based extender and it referred in this context to document D22, which reports on a comparison of two bull semen processing systems based on either a skim milk-yolk extender or the Biladyl® Tris-based extender. The Tris-based extender is found to be inferior with regard to post-thaw mobility and nonreturn rates. However, a closer look to the data of document D22 shows that the two extenders compared differed in several aspects, including their antibiotic components, that they were diluted at different temperatures (the milk-yolk extender at 5**(o)C, the Biladyl® extender at room temperature) and that most of the differences found between the extenders were not significant (page 1520, first paragraph).

41. Thus, the skilled person looking for an alternative for the egg yolk / citrate sodium extender used in document D30, which is also mentioned in the short list on page 499 of document D5, would have had no reason to ignore the teaching in document D5. By exchanging the extender disclosed in the closest prior art by one of the extenders disclosed in document D5 as being known to be useful for freezing of bovine sperm he/she would have arrived at the subject-matter of claim 14 in an obvious manner.

42. Thus, the Board decides that the subject-matter of claim 14 does not involve an inventive step and that the main request does not comply with the requirements of Article 56 EPC.

Auxiliary request 1

Articles 123(2) and 84 EPC

43. Claim 14 of auxiliary request 1 differs from claim 1 of the main request in that it contains the additional technical feature that "thawing yields sex-selected sperm that achieves a pregnancy rate that is 90% or more of the rate of unsexed control sperm having 7 to 20 times more sperm than said sex-selected sperm".

44. The added technical feature has no support within the meaning of Article 123(2) EPC in the description as filed. The sentence on page 49, lines 29 to 30, which reads "Pregnancy rates with sexed sperm were generally 70-90 % of unsexed controls within experiments with 7 to 20 times more sperm", cannot be a basis for a pregnancy rate above 90%. The pregnancy rates achieved in the field trials of example 8 with sex-selected sperm according to the invention in comparison to pregnancy rates achieved with unsexed control sperm are shown in tables 13 to 16 and 18 to 20 on pages 45 to 49. Pregnancy rates that are 90% or more of the rate of unsexed control sperm samples are reported with regard to control sperm samples having (i) 6,6 times (20/3) more sperm (see Table 14, fourth line; Table 18, second and fourth lines; Table 19, second line; Table 20, second and fourth lines), (ii) 13 times (20/1,5) more sperm (see Table 16, second line), and 20 times (20/1) more sperm (see Table 19, first line; Table 20, first and third lines). This cannot serve as basis for the broad range of "7 to 20 times more sperm" as contained in claim 14.

45. Therefore, claim 14 does not comply with the requirements of Article 123(2) EPC.

46. The added technical feature is defined in terms of a result to be achieved by a complex process involving biological material, i.e. artificial insemination of cattle, which result depends on a plethora of conditions and parameters. These conditions and parameters include, amongst others, the thawing of the frozen sperm samples, the heifer management and the various parameters that have to be considered at the actual insemination process itself. Several of these parameters are discussed in the patent (see paragraphs [0093] to [0098] of the patent specification) and their influence on the outcome of the fertility tests is acknowledged, however none of them is referred to in claim 14. Therefore, claim 14 does not define clearly the matter for which protection is sought.

47. This leads to the conclusion that auxiliary request 1 does not comply with the requirements of both Articles 123(2) and 84 EPC.

Conclusion

48. As neither the main request nor auxiliary request 1 may serve as a basis to maintain the patent, in the absence of any further claim request on file, the patent must be revoked.