T 1019/22 - Obiter dicta and the right to be heard

Key points

• The OD decided that D1 was the closest prior art and that the claim was inventive over D1. By way of obiter, the OD gave reasons why the claim was also inventive over D11, wich was an inventive step attack presented late by the opponent.
• "During the oral proceedings in opposition, at the very end of the discussion of inventive step, after the relevant decision on inventive step starting from document D1/D15 had been announced, the appellant [opponent] brought up an objection of lack of inventive step starting from document D11 as an alternative closest prior art document against the subject-matter of claim 1."
• "The decision under appeal also contains an obiter dictum in point 9.10, [...] In this section the opposition division mentioned that document D11 was not the closest prior art, and thus it would not be necessary to decide on its basis. For the sake of completeness, however, and at the request of the opponent, an assessment of inventive step had also been provided on the basis of document D11. In that assessment, the opposition division found that the subject-matter of claim 1 was inventive over the disclosure of document D11."
• The Board: "An obiter dictum is any general statement, either implicit or explicit, in a decision which does not constitute a ratio decidendi of said decision."
• I'm not entirely sure why this definition is limited to general statements.
• Accordingly, in decisions of the boards of appeal it was stated that observations in an obiter dictum do not, by definition, form part of a decision [...]
• "Form a purely legal point of view obiter dicta have no significance for the decision of the specific case and have no binding force. They normally deal with issues that were not raised in the proceedings as a whole, or on which a decision does not actually have to be made. Accordingly, if a legal opinion expressed as an obiter dictum has no influence on the legal dispute, it cannot, by itself, constitute an infringement of one party's rights."
• "[The right to be heard] is not violated if a party did not have the opportunity to comment on observations in an obiter dictum "
• As a comment, the implication is that they form no part of the decision for the purposes of Article 12 RPBA either. In an appeal against a refusal, if the Board indicates it agrees with the obiter, this is a new objection of the Board.
• "A genuine obiter dictum does not make it necessary to file additional evidence [with the Statement of grounds]."
• In this case, the OD's decision that the claim was inventive, was inherently based on rejecting the inventive step attack over D11 and the use of an obiter was not appropriate.
• "After having decided that the subject-matter of claim 1 was inventive starting from document D1, the opposition division should have addressed further objections of lack of inventive step, if any were on file. Therefore, the opposition division should first have taken a decision on the admittance of the inventive step attack starting from document D11. Only if admitted, it should have then fully decided upon inventive step by also taking into account document D11 as the closest prior art after having heard both parties. Had the opposition division formally decided not to admit the attack based on document D11, there would have been no need for an obiter dictum."
• "the board also notes that in cases in which the skilled person has a choice of several workable routes, i.e. routes starting from different documents, which might lead to the invention, the rationale of the problem-solution approach requires that the invention be assessed relative to all these possible routes, before an inventive step could be acknowledged (see e.g. T 967/97, point 3.2 of the Reasons and T 21/08, point 1.2.3 of the Reasons)."
• Or the attacks be rejected as inadmissible, of course.

EPO 

The link to the decision and an extract of it can be found after the jump.

T 1425/21 - Would improved machine learning be technical?

Key points

• This decision was published in April 2024, but I missed it then. Credits to Phyllis Luana Graf (linkedin) for flagging it on LinkedIn.
• The invention is about machine learning, applicant Google. The parent application was filed in 2015 and was granted.
• "The application relates to machine learning models such as deep neural networks. It proposes to approximate "cumbersome" machine learning models with "distilled" machine learning models which require less computation and/or memory when deployed. For instance the distilled model may be a neural network with fewer layers or fewer parameters. The cumbersome model may be an ensemble classifier, possibly combining full classifiers with specialist classifiers. The distilled model is trained on a "plurality of training inputs" and the associated outputs of the cumbersome model, so as to "generate outputs that are not significantly less accurate than outputs generated by the cumbersome machine learning model"
• "The Board notes that the features differentiating the invention from D1, or even the entire set of features defining the distilled model and its training, as a difference to a known cumbersome learning model, are mathematical methods which cannot, under the estab­lished case law of the boards of appeal (the "COMVIK" approach), be taken into account for inventive step unless they contribute in a causal manner to a tech­nical effect."
• "[The Board] accepts that the distilled model has reduced memory requirements when compared to the cumbersome model; after all this is expressly claimed. However, a reduction in storage or computational requirements of a machine learning model is insufficient, by itself, to establish a technical effect. One also has to consider the performance of the "reduced" learning model"
• The Board could have explained its reasoning in more detail. Is a technical effect the same as progress? Is it a generally accepted principle that a technical advantage constitutes no "technical effect" if there is also a technical disadvantage? E.g,. for a chemical reactor (my technical field), does a higher throughput constitute no technical effect if the reactor is more expensive? (or vice versa)? Or is this only a rule for software?
• "It is not credible in general that any model with fewer parameters can be as accurate as the more complex one it is meant to replace. For example, the complexity or architecture of the reduced model may be insufficient or inadequate for the given problem."
• "The Board also does not see that the temperature-based training process ensures that the smaller model has an equivalent accuracy. It is not clear how exactly the temperature must be first set (for both models), and then varied, and what accuracy may be expected. The application simply does not discuss this."
• "The soft outputs [of the distilled model] represent a class probability obtained according to a form of the softmax equation using a "temperature" parameter T, which is set higher during training than during subsequent use. [The softmax equation uses e^(x/T) instead of e^x.
• I can't evaluate the Board's technical assessment, of course. Apparently, there was not a lot of evidence on the file.
• " In principle, it appears possible to argue that the smaller model represents a "good" trade-off between resource requirements and accuracy, i.e that the smaller model may be less accurate but have (predic­tably) smaller resource requirements. However, the application lacks any information in that regard."
• Is the decision consistent with T 1952/21 ? 
• 
  

EPO 

The link to the decision and an extract of it can be found after the jump.

T 0104/23 - (The limits on) Witness prepping at the EPO

Key points

• As I understand it, preparing your witness is fine in USA civil litigation, while UK law has a "fundamental prohibition, that “you must not rehearse, practise with or coach a witness in respect of their evidence" (source). What about the EPO?
• The present decision gives some guidance. 
• " the proprietor submits that the opponent spoke with the witness just before the witness was heard"
• "Contact between the opponent and witness during an interruption of oral proceedings may potentially raise doubts about the witness's impartiality and therefore diminish the probative value of their testimony. However, these are merely factors to consider when assessing the witness's credibility, especially considering the - undisputed - link between the witness and the opponent.  "
• "It would also appear as manifestly unrealistic to expect from parties to wholly refrain from contacting witnesses before their hearing, in particular to refrain from consulting them before a hearing. It is in the overall interest of the procedure that the witness statement is directed at those facts that are relevant to the case, and it is only natural that the attorney will have to talk to a witness before offering him or her as witness in the proceedings. Otherwise it would be plainly impossible for the attorney to select the appropriate persons, possibly out of a larger circle of people, very often all the employees of the party. "
  
  
  
  
• "The opposition division held, based on the witness testimony E1 together with evidence D4, D6 and D26, that the sale and delivery of the "LINCO Killing Machine Model IID" on 27 May 2009 (indicated as public prior use LINCO Benelux, Linco Benelux B.V., Linco Benelux or LINCO) constitutes state of the art (section 8 of the appealed decision). The appellant patent proprietor, in their grounds of appeal, challenges this finding of the division."
• "The appellant proprietor reiterates the same objections to admissibility of El and to the witness credibility as in first instance, namely the arguments that the opponent spoke with the witness just before the witness hearing, also pointing at the contradictions, lack of recollection and the unsolicited answers in the testimony."
• However, note that the evidence is actually: "the appellant proprietor argues that the admission and reliance on the witness testimony of Mr. [K] from the grandparent application (El) "
• As a comment, it is not clear to me if the members of the OD had a live interrogation of the witness in this case, and I doubt that written documents can be treated as 'witness evidence' in the sense of Article 117 EPC. 
• The proprietor could have requested a hearing of the witness and that document E1 be excluded as evidence if no witness hearing of Mr K took place before the OD in the case at hand.  
• 
  
• Separately, under Rule 103(4)(c), a statement that the appellant will not attend the oral proceedings was treated as a withdrawal of the request for oral proceedings, giving rise to a 25% refund of the appeal fee. 
• "The Board is aware that the case law does not appear to be uniform on this issue."  

EPO 

The link to the decision and an extract of it can be found after the jump.

T 2011/21 - Incorrect video inspection of a device

Key points

• "the opposition division found that [auxiliary request 1] met the requirements of Article 83, 84 and 123(2) EPC and that the subject-matter of independent claim 1 was novel and involved an inventive step in view, among others, of the public prior use represented by the child safety seat commercialized with the name "Sirona" (bundle of evidence M11). During the oral proceedings which was held by videoconference the "Sirona" child safety seat was inspected remotely by the opposition division. The inspection was transmitted by videoconference to all parties with every party having been given the chance to direct the camera used for inspection to specific details of interest. Screenshots showing several relevant views and constructional details of the child safety seat "Sirona" were taken and attached to the protocol of inspection."
  
  
• "The public availability of the prior use of the "Sirona" child safety seat is not contested by the respondent (patent proprietor). Based on the taking of evidence, the opposition division concluded that the subject-matter of claim 1 according to the auxiliary request 1 underlying the decision under appeal was novel over this public prior use. The opposition division held that the inspected "Sirona" child safety seat did not comprise the feature introduced in claim 1 of the auxiliary request 1 that:

  "the outer shell (2) comprises a side wing (13) and the housing component (7) is embedded into the side wing (13)".  ... The conclusion of the opposition division regarding the alleged distinguishing feature above was based on an interpretation of the term "side wing" [...] which was considered too narrow by the appellant (opponent)." The Board agrees with the opponent.

• "In view of all the above and contrary to the findings of the opposition division, the subject-matter of claim 1 of the patent as maintained lacks novelty over the public prior use "Sirona". An assessment of the further novelty attacks raised by the appellant (opponent) is thus not required."

• Auxiliary request 3 is considered to be novel and inventive.

• In connectio with the opponent's request for reimbursement of the appeal fee: "the appellant (opponent) contested the correctness of the decision of the opposition division to hold oral proceedings and to carry out the inspection of the child safety seat "Sirona" per videoconference hence in the physical absence of the opposition division and of the parties although it had been requested to hold them in person. The appellant (opponent) essentially pointed out that in view of the complexity of the structure and design of the outer shell, in particular of the rear part of the "Sirona" child safety seat, it was not possible by a mere video-inspection to correctly identify the effective location/extension of the portions of the seat functionally corresponding to the "side wings" recited in claim 1.  

• "The Board considers that the opposition division erred in not granting the opponent's request to take evidence by inspection be made in-presence. The opponent's request was namely substantiated and in the Board's view well-founded, in particular because the object to be inspected was a complex three-dimensional item, and it could not a priori be ruled out that the images on the screen would allow the participants to appreciate the full extent of the disclosure."

• However, the Board considers the procedural error to be harmless because in the end the OD only found the claim to  be novel based on an issue claim interpretation. Hence the opponent was not adversely affected by the procedural decision of the OD.

EPO 

The link to the decision and an extract of it can be found after the jump.

T 0314/20 - Interpreting G 2/21

Key points

• This decision was issued in writing on 20.12.2024.  The decision was taken on 16.11.2023 (!). 
• No communication under Art. 15(9) RPB is visible in the public online file. We must trust the President of the Boards was informed of the delay as prescribed.
• The catchword is "On the interpretation of decision G 2/21 ",  so I can see why the Board needed some time.
• Claimed is the combination of empagliflozin with linagliptin. 
• "In support of the alleged  [technical effect of] "increase in GLP-1", the respondent [proprietor] referred to post-published documents D55 and D56."
• "As explained below, the technical effect relied on by the respondent for inventive step (see point 6.9 above) and possibly shown by document D56 cannot be taken into account for formulating the objective technical problem in light of decision G 2/21 "
• "he current Board identifies three challenges in interpreting point 2 of the order of decision G 2/21."
• "First, the requirements "encompassed by the technical teaching" and "embodied by the same originally disclosed invention" were not used in the plausibility case law underlying questions 2 or 3 of the referral. Therefore, their relation to this case law remains to be defined, particularly in terms of whether, and to what extent, they replace, align with, or modify it."
• "Second, the Enlarged Board did not expressly define these requirements. It could be argued that the dependent clause "because such an effect does not change the nature of the claimed invention" in point 93 of decision G 2/21 (see point 6.12.2 above) serves as their definition. However, if this were the case, it would be unclear why the Enlarged Board did not simply state that a patent applicant or proprietor can only rely on a technical effect if such an effect does not change the nature of the claimed invention, instead of introducing two distinct requirements. "
• "Finally, the Enlarged Board did not expressly state the purpose of these requirements."
  
  
• " In decision T 116/18 [of July 2023, after the remittal], the competent [Technical] Board reached a number of conclusions on the relationship, the purpose and the content of the two requirements outlined in point 2 of the order of decision G 2/21."
• See my blog post on that decision.
• " This Board faces two issues with the interpretation of decision G 2/21 given in the passages quoted from decision T 116/18 in point 6.13.4 above. [...]
• "the [TBA in T116/18 of July 2023] effectively adopted what it defined in the referral T 116/18 as the "ab initio implausibility" standard."
• "some of the inferences drawn in the passages quoted above from decision T 116/18 are not supported by the text of decision G 2/21. "
  
  
• "In the present case, the current Board does not need to give a definitive answer as to whether it can endorse all the conclusions of decision T 116/18 regarding the two requirements set out in point 2 of the order of decision G 2/21. The Board considers that the purpose of these requirements is to prevent patents from being granted for inventions that are not complete at the filing date. Such speculative applications arise where either the existence of the claimed technical effect or its generalisation is speculative. This may occur because relevant data have not yet been generated or, if available to the patent applicant, have not been disclosed in the patent application.
• " If the Board's understanding of the purpose of the two requirements - which aligns with the view in T 116/18 - is correct, the respondent cannot rely on the technical effect in this case. This is because a skilled person would not expect the technical effect in question - an increase in active GLP-1 levels from the combination of empagliflozin and linagliptin compared to increases in active GLP-1 levels achieved with combinations of emplagliflozin with sitagliptin and vildagliptin, respectively - on the basis of the original disclosure of the application itself. This effect is not only unsupported and not made credible by the application as originally filed; it even contradicts its technical teaching. Therefore, whatever the meaning of the two requirements in G 2/21, they cannot be met in the present case if patenting for inventions not made at the filing date is to be excluded."
  
  
• "as observed by the appellants [opponents] at the oral proceedings, the application as originally filed presents combinations of empagliflozin with linagliptin, sitagliptin, vildagliptin, saxagliptin or alogliptin at an equal level of preference. This is apparent from the paragraph directly below Table 1 (see page 33, lines 2 to 5). This paragraph explains that among the 176 combinations exemplified in Table 1, the combinations numbered "97", "165", "166", "167" and "168" are most preferred. Combination 97 pertains to the currently claimed combinations, i.e. combinations of empagliflozin and linagliptin or a pharmaceutically acceptable salt of it []. Combinations 165 to 168 relate to combinations of empagliflozin with sitagliptin, vildagliptin, saxagliptin and alogliptin, respectively []"
• "the purported technical effect relied upon by the respondent [proprietor] for inventive step is an increase in plasma levels of active GLP-1 which is stronger and more prolonged in time than the one achieved by combinations 165 and 166, i.e. combinations of empagliflozin with sitagliptin and vildagliptin, respectively (see point 6.9 above)."
• The Board states it like this. It is not entirely clear to me what D2, the closest prior art, discloses. 
• "The Board concludes that the technical teaching of the claimed invention that the skilled person, with the common general knowledge in mind, understands at the filing date from the application as originally filed, encompasses the following.

  (a) Combination 97 (i.e. the currently claimed combinations) gives rise, inter alia, to an increase in plasma levels of active GLP-1 in patients with metabolic disorders and related diseases.  (b) Combinations 165 to 168 (i.e. combinations of empagliflozin with sitagliptin, vildagliptin, alogliptin and saxagliptin, respectively), having the same level of preference, achieve the same increase in plasma levels of active GLP-1 in patients with metabolic disorders and related diseases as combination 97."

• "It follows from the analysis made in points 6.20 to 6.24 above that the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would not derive the increase in plasma levels of active GLP-1 relied on by the respondent (see point 6.25 above) as being encompassed by the technical teaching of the claimed invention and embodied by the same originally disclosed invention."

• "From the above it follows that the objective technical problem is to provide a specific combination of a glucopyranosyl-substituted benzene derivative of formula I as shown in document D2 with a DPP IV inhibitor in the context of diabetic diseases."

• "In the board's judgement, the proposed solution would have been obvious having regard to the state of the art. The reasons are as follows."

• "In such cases of arbitrary selections, the prior art does not need to contain a pointer towards the compounds claimed, i.e. empagliflozin and linagliptin.  Instead, all possible solutions have to be regarded as being equally suitable and obvious candidates for solving the objective technical problem as defined above "

• The request for a referral to the Enlarged Board is refused. "in the case at hand, the Board also believes that any tenable interpretation of the requirements introduced in decision G 2/21 would lead to the conclusion that the respondent cannot rely on the alleged "increase in GLP-1" of the claimed combination"

• To cite a few more paragraphs: 

• "Irrespective of how the term "technical effect" in point 2 of the order of decision G 2/21 is to be interpreted, it remains that the technical effect relied upon by the respondent for acknowledgement of inventive step rests on experimental data (i.e. document D56, Figures 1 to 3 and Table 1) which does not confirm the technical teaching conveyed by the application as originally filed (i.e. the same increase in active plasma levels of active GLP-1 for combinations 97, 165 and 166). Rather, these experimental data teach against it. "

•  As regards the respondent's argument that the technical effect relied on did not change the nature of the claimed invention since the claimed combination was disclosed in the application as originally filed and no additions or changes to this combination were required to arrive at this effect, the Board notes that this is not sufficient for the requirements stated in point 2 of the order of G 2/21 to be met. More precisely, it is not enough that the claimed invention is disclosed in the application as originally filed in terms of its technical features and that these same features (possibly) achieve this effect without requiring any modification. Rather, it is the purported technical effect relied on for inventive step that must be derivable by the skilled person, having the common general knowledge in mind, and based on the application as originally filed, as being encompassed by the technical teaching and embodied by the same originally disclosed invention. These requirements are not met in the case at issue. "" 

• "For the reasons set out above, the technical effect "increase in GLP-1" associated specifically with the combination claimed would be unexpected to the skilled person in view of the application as originally filed. As a consequence, the alleged "increase in GLP-1" relied upon by the respondent for acknowledgement of inventive step cannot be taken into account for the formulation of the objective technical problem."

EPO 

R 0012/20 - Length of procedure

Key points

• The petition for review was filed by the opponent on 21.08.2020. The Enlarged Board, in a three-member panel, decided on the petition during oral proceedings of 19.07.2024. The decision was issued in writing on 07.10.2024.
• The OD had revoked the patent for insufficient disclosure. The TBA  reversed and remitted the case. The OD took a new decision in September 2022, i.e. two years  (!) after the petition for review was filed.  The OD rejected the opposition. The opponent did not appeal. 
• The EBA panel concludes that the petition is now moot, in translation: "No appeal was filed against this decision within the appeal period, so the parties were notified by communication dated 3 January 2023 that the patent was maintained in unchanged form and that the opposition proceedings had been concluded. The decision of the Opposition Division of 12 September 2022 thus has final effect."
• "The Enlarged Board of Appeal therefore concludes that the applicant can no longer rely on a continuing interest in bringing proceedings and that the admissibility requirements of the originally filed application for review are therefore no longer met."
• As a comment, perhaps there was no ground for appealing given that the TBA's findings in the first decision were still res iudicata. 
• According to the EBA, the opponent/petitioner is to blame ("has contributed on its own responsibility ", original "eigenverantwortlich dazu beigetragen, dass"): "By refraining from filing an appeal against the decision of the opposition division of 12 September 2022, at least as a precautionary measure, the applicant has contributed procedurally on its own responsibility not only to ensuring that this decision becomes final, but also to ensuring that the patent in dispute becomes final."
  
  
• I do not readily see how the finality of the decision / the patent in this case can be "larger" than in the case the Board had not remitted, i.e., reversed and simultaneously rejected the opposition in the appeal decision. I understand that in such a scenario, a petition for review does provide a remedy in case of one of the specified procedural defects. 
• 
  
• The panel of the EBA does not comment on the length of the procedure before it in the three-member panel composition. Should the EBA panel have managed to decide on the case in two years, there would have been no problem. 
• The first action of the EBA appears to be a communication of 13.12.2023, suggesting that the EBA did not process the petition for review  for a period of more than three years.
•  
• To cite the Explanatory Remarks to the EPC 2000, Article 112a EPC, from OJ 2007 Special Edition 4 (link): 
• 12. "The possibility of filing a petition for review must not cause long-lasting legal uncertainty for third parties. "
• 18. "In the interest of a quick and effective screening of petitions for review which are clearly inadmissible or not allowable, special procedural provisions apply to the three-member panel of the Enlarged Board established under Article 22(2), second sentence, and Rule 109(2) EPC 2000 (see explanatory remark n° 4 to Article 22 EPC). "
• "The proceedings before this panel shall be as simple and short as possible."
• "Therefore, this body shall decide in written summary proceedings without the involvement of other parties and on the basis of the petition (see Rule 109(3) EPC 2000). A quick screening procedure at the outset of review proceedings to sort out petitions which clearly cannot be successful is essential in order to avoid an inappropriate prolongation of legal uncertainty for third parties. It is also of great importance to counteract effectively intentional prolongation of proceedings by filing a petition for review."
• It seems the legislator did not even consider a scenario wherein the procedure before the three-member panel of the EBA would take so long as to become moot. 
• The EBA panel adds observations stating that the petition is clearly not allowable anyway. I understand these observations to be obiter and will not comment on them here: they should not distract from the procedural approach taken by the EBA panel. 
• To be clear: I'm not convinced that a petition for review can become moot because of the EBA's inaction in the way proposed by the EBA panel in this decision. Should the holding of the EBA panel in this case become established case law, it seems to me that it then will be even more important for the EBA panels that hear petition of review cases to avoid undue delay of the proceedings than it is now. 

EPO 

The link to the decision and an extract of it can be found after the jump.

T 1553/22 - Human-pig chimeras

Key points

• "Claims 3 [] of auxiliary request 2 read as follows: "3. A chimeric non-human blastocyst expressing human ETV2 and lacking expression of said non-human animal ETV2, wherein the blastocyst is porcine."
• "The application concerns the generation of pig-human chimeric animals with the aim of using them as a source of human vasculature and blood. The chimeric pigs are obtained by methods involving "blastocyst complementation". This involves creating a non-human (host) blastocyst lacking one or more genes involved in the development of the cells of interest. This creates a so-called "niche" which is complemented by introducing into the blastocyst human pluripotent (donor) cells having those lacking genes. Specifically, in the application, the host blastocyst lacks the Etv2 gene, whose function is to promote hematoendothelial development"
• " claims 3 and 4 do not include language that would exclude chimeras having human cell participation in the brain or germ cells."
• The applicant is a university.
• "In the appealed decision, the examining division refused the application for ethical reasons pursuant to Article 53(a) in conjunction with Rule 26(1) EPC and Recital 38 of the Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (point 4.16 of the Reasons). "
• The Board: " The ethical dimension of patent law has found its expression in Article 53(a) EPC, together with the implementing regulations in Rules 26 to 29 EPC. These Rules were introduced in the EPC to align the EPC with the Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (the "EU Biotech Directive"). In order to achieve harmonised protection in the field of biotechnological inventions in Europe, the EU Biotech Directive provides a supplementary means of interpretation for the EPC (Rule 26(1) EPC). Thus, when the compliance of a biotechnological invention with ethical principles has to be assessed, the legal framework is a composite one, in the sense that the EPC provisions should be understood in the light of the EU Biotech Directive, also including considerations which are outside the strict patentability requirements."
• "Human-animal chimeras are not mentioned in Rule 28(1)(a) to (d) EPC, nor in the provision from which this Rule is derived, namely Article 6(2) of the EU Biotech Directive. However, specific forms of human-animal chimeras are mentioned in Recital 38, which relates to the illustrative list of exclusions for reasons of ordre public and morality provided in Article 6(2) of the EU Biotech Directive. Recital 38 includes the following wording:

"...whereas processes, the use of which offend against human dignity, such as processes to produce chimeras from germ cells or totipotent cells of humans and animals, are obviously also excluded from patentability;".

• "Recital 38 does not exclude chimeras as such, but specifically identifies processes to produce chimeras from germ cells or totipotent cells of humans. Since the present invention involves the use of pluripotent cells, which are distinct from totipotent cells and germ cells, it can be said that Recital 38 does not apply directly.
• This sets up the legal puzzle: if the EU legislator intentionally did not wish to exlcude human-animal chimeras in general (and, at the time of drafting, did not think of pluripotent cells, perhaps), what is excluded? Only the recited type of chemiras? Or some intermediate class?
• "The board takes the view that the exclusion of Article 53(a) in conjunction with Rule 28(1) EPC may extend to other chimeras, where the rationale underlying the examples identified in Recital 38 is also applicable to the chimeras concerned. Thus, by means of Rule 26(1) EPC a further special case is added to the non-exhaustive list of Rule 28(1) EPC."
• Rule 26(1): "For European patent applications and patents concerning biotechnological inventions, the relevant provisions of the Convention shall be applied and interpreted in accordance with the provisions of this Chapter. Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions shall be used as a supplementary means of interpretation."
• "the board finds that the reason why the chimeras identified in Recital 38 are regarded as offensive against human dignity is due to concerns that, in chimeras including human germ cells or totipotent cells, these human cells may integrate into the brain and/or develop into germ cells and result in a chimera with human or human-like capabilities. 
•  This reason is straightforward for chimeras including totipotent cells, which in view of their developmental capability to form an entire organism may form a brain with human-like cognitive abilities or human germ cells. 
• The Board finds it 'straightforward', but that may be a case of hindsight in solving a legal problem.
• "However the same reason applies to pluripotent cells, which despite lacking the ability to differentiate into totipotent cells or cells of the placenta, nevertheless have the ability to differentiate into neural cells or germ cells. Thus, if an invention relates to a situation where human cells might integrate into the chimera's brain, potentially giving the chimera human-like cognitive or behavioural capabilities, or into its germ line, potentially giving it the ability to pass on humanised traits, the board considers that the underlying rationale of Recital 38 of the Directive would be relevant and shall be taken into account in examining compliance with Article 53(a) in conjunction with Rule 28(1) EPC."
• "the board does not consider it necessary to refer to the preparatory work to the EU Biotech Directive. Whereas the recourse to the preparatory work is possible as supplementary means of interpretation under Article 32 Vienna Convention, the board finds that in the present circumstances there is no ambiguous or obscure meaning in the wording of the exclusions in Recital 38 which needs to be clarified, nor does the interpretation on account of its object and purpose lead to a result which is manifestly absurd or unreasonable."
• Article 32 Vienna Convention indeed limits the use of the preparatory documents to these two cases, though the EPC travaux are cited more freely by the Boards.
• "With regard to the present case it must therefore be established whether the invention defined in claims 3 to 5 includes embodiments that fall under the scope of Recital 38 [by analogy?], thus contravening the requirements of Article 53(a) EPC in conjunction with Rule 28(1) EPC. Specifically, it must be determined whether the claims define chimeras and methods of producing chimeras including embodiments where human cells participate in the brain or germ cells of the chimera."
• "Document D15 is a scientific article on research into ways of regulating the differentiation of the donor cells into the endodermal organs, in order to address concerns that human cells might be present in the germ line or participate in the brain of chimeras resulting from blastocyst complementation. These ethical concerns are set out prominently in the abstract of the document:"Blastocyst complementation, which exploits the capacity of PSCs to participate in forming chimeras, does not, however, exclude contribution of PSCs to the development of tissues - including neural cells or germ cells - other than those targeted ..."."
• "Even years after the date of filing of the application, these concerns remained undiminished, as evidenced by documents D9 and D10, which were made available to the public in 2019 and 2021 respectively."
• " On the basis of the documents on file and on the balance of probabilities, the board can only conclude that there is no technical reason to dismiss the ethical concerns, raised in the relevant literature, that human cells may be present in the brain or germ cells of a chimera according to the present invention. These concerns are relevant for chimeras resulting from the method defined in claim 5, as well as for the chimeras as defined in claims 3 and 4. This conclusion also takes into account that the method defined in claim 5 has no limitations as regards either the number of human cells injected in step (c) and that claims 3 and 4 do not include any limitations as to the number of human cells or exclude their presence in the brain or germ line."
• The relevant date is the filing date, I understand: "14. The assessment of objections under Article 53(a) EPC, as well as under Rule 28(1) EPC, should be based on the understanding in the technical field at the relevant date of the patent application, although evidence arising after that date may be taken into account, provided it reflects the state of the art at the effective date (see decision T 315/03, Reasons 8.2, 9.5, 9.7 and 10.9)."
• Cf. G 2/08: "Rule 28(c) EPC (formerly Rule 23d(c) EPC) forbids the patenting of claims directed to products 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 are derived, even if the said method is not part of the claims." (not cited in the present decision; and Article 83 EPC might be relevant here).
• "the appellant stressed also the dramatic importance of the present invention in the field of xenotransplantation, potentially the very first step to repair and replacement technology which was previously regarded as pure science fiction. This fact should be balanced against the unsupported ethical concerns raised by the examining division."
• "The board recognises the importance of the present invention. However, for the reasons stated above, balancing tests are irrelevant in the context of the categories of inventions which are excluded from patentability ipso facto. Considerations involving balancing the potential benefits of the invention for humanity/the medical benefit against prejudice to human dignity/animal suffering, are limited to the so-called "real" Article 53(a) EPC objections or to inventions related to the genetic modification of animals within the meaning of Rule 28(1)(d) EPC. Instead, where the legislator wanted to exclude inventions offending life and human dignity as such, there can be no room for manoeuvre (see also G 2/06, Reasons 31)."
  
  
• "since the claims were not drafted to exclude embodiments where human cells are present in the brain and/or germ cells of the chimera (for instance by the inclusion of features based on technologies capable of preventing the presence of human cells in the brain and/or germ cells of the chimera) the board did not have to decide on the patentability of such subject-matter."

• As a comment, if these "technologies capable of preventing the presence of human cells in the brain and/or germ cells of the chimera" are now available and common general knowledge, the Art. 53(a) EPC objection can be addressed with an undisclosed disclaimer (G2/03), most likely, and Article 83 EPC is complied with by the availability of these preventive technologies (and appropriate reference to them in the application as filed).
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• Suppose the preventive technologies also work for the chimeras from germ cells or totipotent cells of humans and animals" are these then patentable (under a dynamic interpretation, perhaps)?

EPO 

The link to the decision can be found after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t221553eu1