T 0951/19 - The OD changes opinion, opponent should request postponement

Key points

• The Board, in translation: "During the oral proceedings before the opposition division, the opponent requested that the filed auxiliary request 1 not be admitted due to late submissions, since the changes made were taken from the description and their subject-matter was surprising .
• However, the opposition division admitted auxiliary request 1, filed during the oral proceedings, into the opposition proceedings. The requirements of Rule 80 EPC and Article 123 EPC are met and the changes are [...] not surprising for the opponent [according to the OD]."
• Acccording to the opponent, the auxiliary request at issue involved significant differences compared to an earlier auxiliary request and was hence surprising.
• "In the present case, the opposition division took the preliminary view in its summons that granted claim 1 was new compared to E1 and changed this view at the oral proceedings after extensive discussion with the parties. The admissibility of auxiliary request 1, which was then filed, was discussed during the oral proceedings and both parties were heard, see points 41 to 48 of the minutes. The opponent also does not deny having been heard by the opposition division on the admissibility. She has not argued that the opposition division had not given her sufficient time, nor has she requested that the oral proceedings before the opposition division be interrupted or adjourned. To that extent the present case is different from T 789/83
• In T 789/83, the OD proposed amended claims of own motion (as they did in those days) and "[a]fter submitting the proposed amended Claim 1, the Opposition Division gave the parties ten minutes for studying the suggested version of Claim 1". This was a substantial procedural violation.
• I assume that the  Board refers to the opponent not requesting a break or adjournment of the oral proceedings after the OD decided to admit the auxiliary requests in the procedure. 
• "The board is therefore of the opinion that there has been no violation of the right to be heard and that the opposition division exercised its discretion correctly and also justified it in the decision under appeal,"
• 
  
• EPO 

The link to the decision is provided after the jump, as well as (an extract of) the decision text in machine translation.

T 1825/21 - Inventive crystalline form

Key points

•  The Board finds a crystalline form to be inventive.
• Claim 1 is directed to the compound ceritinib in free base form (i.e. not in the form of a salt).
• the subject-matter of claim 1 of the main request lacked inventive step starting from D1 as the closest prior art.
• the ceritinib HCl of example 7 of D1 is amorphous, and represents the disclosure in D1 which is structurally closest to the claimed crystalline ceritinib. This amorphous ceritinib HCl represents the starting point for the assessment of inventive step of the claimed crystalline ceritinib.

• the subject-matter of contested claim 1 is distinguished from this embodiment of D1 in that it concerns: - ceritinib in free base form, rather than as its HCl salt, - in crystalline, rather than in amorphous form.

•  the board acknowledges that the patent - or the application as filed, respectively - does not comprise any data comparing the claimed crystalline ceritinib with the amorphous ceritinib HCl of D1 [.] The board nevertheless concludes that the technical effects mentioned below may be accepted as being credible on the basis of the information in the patent and the common general knowledge of the skilled person.

• ", it is credible on the basis of this common general knowledge, which was known before the priority date of the claimed invention, that the effects of stability and ease of drying, demonstrated in the patent for crystalline ceritinib, represent improvements over the amorphous ceritinib HCl disclosed in D1. Therefore, an improvement over amorphous ceritinib HCl of D1 is acknowledged without taking the appellant's post-published evidence into account as proof of said improvement (supra). It follows also that case G 2/21 [still pending at the time of the decision], in which this issue is addressed, is not relevant to the present appeal case."

• The objective technical problem starting from the amorphous hydrochloride salt of D1 is hence the provision of a form of ceritinib having improved stability and ease of drying.

• "The appellant argued that the skilled person attempting to obtain a form of ceritinib with improved stability and ease of drying would have tried to prepare the ceritinib HCl known from example 7 of D1 in crystalline form. However, as set out in point 5 of D23, a declaration of a technical expert, any attempt to prepare ceritinib HCl only resulted in amorphous (i.e. non-crystalline) precipitates having chloride levels inconsistent with a stoichiometric salt.

  The board agrees. Having failed to solve the above problem in the most obvious way by providing a crystalline ceritinib HCl, there would have been no reason for the skilled person to turn to ceritinib free base in the expectation that it would provide a solution. "

• 
  

• EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 0215/20 - Dapagliflozin - plausibility requirement for prior art

Key points

• "claim 1 is directed to second medical uses of a crystalline solvate of [the compound] dapagliflozin with water and (S)-propylene glycol which comprises these three constituents in equimolar amounts (1:1:1 molar ratio) [;  for use in treating a disorder selected from diabetes, diabetic retinopathy, diabetic neuropathy, diabetic nephropathy, delayed wound healing, insulin resistance, hyperglycemia, hyperinsulinemia, elevated blood levels of fatty acids or glycerol, hyperlipidemia, dyslipidemia, obesity, hypertriglyceridemia, Syndrome X, diabetic complications, atherosclerosis or hypertension, or for use in increasing high density lipoprotein levels in a mammal] "
• "In accordance with claim 1, this crystalline solvate is referred to as form SC-3 below. "
• D1 is the CPA.
• "D1 describes the stepwise synthesis of dapagliflozin." 
• "The appellant put forward inventive-step objections starting from both forms of dapagliflozin disclosed in D1, i.e. amorphous dapagliflozin and the crystalline complex of dapagliflozin with L-phenylalanine."
• "It can be concluded that form SC-3 has a higher stability, i.e. a lower hygroscopicity, than amorphous dapagliflozin."
• " the objective technical problem can be considered that of providing a pharmaceutical composition comprising a crystalline form of dapagliflozin which is more stable, i.e. less hygroscopic."
• "As regards obviousness, the appellant pointed to D4."
  
• "D4 relates to PG solvates of APIs and states, quite generally, (on page 4, paragraph 4; page 3, paragraphs 2 and 3) that: (a) the formation of PG solvates makes it possible to obtain crystalline compounds from APIs [active pharmaceutical ingredient] which are difficult to crystallise (b) API PG solvates are more stable and less hygroscopic than the corresponding APIs"
• The Board: "the skilled person, in order to take the teaching of D4 into account, would also have had to have a reasonable expectation of success, i.e. a reasonable expectation that this teaching would solve the objective technical problem. However, this is not the case, as set out in the following."
• "On pages 45 to 296, D4 gives a very long list of APIs whose PG solvates are said to be covered by the invention in D4. Among these compounds is T-1095 (page 267, entry 4), i.e. a compound which is structurally similar to dapagliflozin. In view of points 12.1 (a) and (b) above, this list amounts to D4 pretending to have found an almost universal solution to the problem of providing a crystalline form of an API and in particular to the problem of providing a form of an API which is less hygroscopic. This alone would not have given the skilled person a reasonable expectation of success, i.e. a reasonable expectation of obtaining a crystalline form of the compound dapagliflozin which is less hygroscopic than amorphous dapagliflozin. The reason is that, as agreed by both parties at the oral proceedings, the formation of crystalline forms and their properties such as hygroscopicity is highly unpredictable. So while the board acknowledges that D4 demonstrates that four structurally very different and unrelated APIs can be transformed into crystalline PG solvates, D4 lacks experimental data showing that an API PG solvate is less hygroscopic than the API itself."
• "Furthermore, the examples in D4 cast legitimate doubt on whether the effect of a lower hygroscopicity is actually achieved as universally as suggested. "[follows an analysis of the examples]
• " the skilled person would have considered the effect suggested by D4, namely the universal decrease in hygroscopicity, to be a mere allegation. Given the generally recognised high unpredictability of properties of crystalline forms (see above), the skilled person would not have had a reasonable expectation of obtaining a less hygroscopic form of dapagliflozin."
• " In summary, the subject-matter of claim 1 involves an inventive step over amorphous dapagliflozin as disclosed in D1 in combination with D4 because the skilled person, considering the teaching of D4, would not have had a reasonable expectation of obtaining a form of dapagliflozin which is less hygroscopic than amorphous dapagliflozin."
• The patent is maintained in amended form. 
• I use the term 'plausibility' in the blog post title as a generic catchword. The Board does not use it. Possibly, still, the 'technical teaching' requirement of G 2/21, or the credible requirement for second medical use claims in the same decision, can also be operationalized along the lines of this decision: would the skilled person have a reasonable expectation of success on the basis of the application as filed and using common general knowledge at the relevant date?

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 0749/19 - Appeal fee reimbursement

Key points

• Rule 103 EPC is a gift that keeps giving (for text book authors).
• This time: the opponent gets a 25% refund of the appeal fee without withdrawing its request for oral proceedings and without withdrawing its appeal.
•  "The proprietor's indication that it would take no active part in the appeal proceedings, implies that the proprietor withdrew its request for oral proceedings "
• "in view of the conclusion that the patent must be revoked, the condition for the opponent's auxiliary request for oral proceedings does not arise."
• "Consequently, this decision is being issued on the basis of the parties' written submissions."
• "Both conditions of Rule 103(4)(c) EPC, that "any request for oral proceedings is withdrawn ..." and "no oral proceedings take place", are met"
• "It makes not difference that the withdrawing party and the appealing party are not the same (T488/18, reason 8)."
• The Board here seems to interpret "any request for oral proceedings"  as "at least one party withdraws its request for oral proceedings".
• The Board does not comment on T777/15 and T795/19, which came to the opposite conclusion, i.e. that the appellant must timely withdraw its own request for oral proceedings to obtain the partial reimbursement.
• " It also makes no difference that the withdrawal of the proprietor's request for oral proceedings was made prior to a "notification of the communication issued by the Board in preparation for the oral proceedings", or even of a summons. The Board shares the opinion expressed in T2361/18 at points 3.2 and 3.3, that the "within one month" of Rule 103(4)(c) EPC, rather than defining a time period starting with the notification of the communication, defines an "end point" for the withdrawal of the request for oral proceedings, if partial reimbursement of the appeal fee is to be obtained."
• "Consequently, the opponent's appeal fee is to be reimbursed at 25%."
• 
  

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 0435/20 - Admissibility rules for OD

Key points

• This decision contains a number of important points regarding the admissibility rules for procedures before the OD.
•  "The board considers that the opposition division decided according to the wrong principles and disregarded the principles of procedural fairness and of equal treatment of the parties in not admitting documents D59 to D62 and D81 to D90. The reasons are as follows."
• The OD had also held evidence inadmissible submitted by the opponents on a point where the preliminary opinion of the OD was in their favour. The Board:   "the mere fact that the opposition division's preliminary opinion was positive for one party cannot in itself justify not admitting any further documents by this party which are filed by the final date set by the opposition division for making written submission under Rule 116(1) EPC. " (emphasis added)
• "the fact that the opposition division's preliminary opinion was negative for the appellant but positive for the respondents cannot justify a different treatment of the parties, since a preliminary opinion is neither binding nor definitive."
• The opponents filed a declaration D81 to support an earlier argument. The held the declartion, with annexes, inadmissible on the grounds iner alia that "the arguments of the declaration ... (D81) ... are reflected in the representative's arguments in the [accompanying] letter" 
• The Board: "arguments submitted by a party's professional representative do not qualify as means of giving evidence under Article 117(1) EPC and may therefore have a different weight depending on whether or not they are supported by evidence in the form of a declaration by a technical expert accompanied by evidentiary documents supporting the content of the declaration. Accordingly, the opposition division was mistaken in holding that the declaration D81 with supporting documents on the one hand, and the representative's arguments on the other were equivalent and that this could justify non-admittance of [declaration D81].
• The opponents had filed post-published evidence under sufficiency, which was held inadmissible on that ground by the OD. The Board: " consideration of a document submitted in substantiation of an allegation of fact does not depend on whether or not the document forms part of the state of the art (see CLBA, section III.G.4.1). The board therefore does not agree with the opposition division that, as a matter of principle, post-published evidence is prima facie unsuitable for the substantiation of allegations of verifiable facts in the context of sufficiency of disclosure."
• I note that the OD reasoned that: "documents D82 to D90 "were published years after the priority date of the present application and are prima facie not suitable to establish the general knowledge and the skills of the skilled person required at the date of filing which is discussed in this declaration". 
• The OD also violated the "principles of procedural fairness and of equal treatment of parties": "as noted above, documents D81 to D90 had been filed as direct and immediate response to new evidence, submitted by the appellant on the last day for making written submissions under Rule 116 EPC. In admitting the late filed documents D80 and its supporting documents D64 to D79 into the proceedings but not admitting documents D81 to D90 filed by the respondents in direct response, the opposition division did not respect the principles of procedural fairness and of equal treatment of parties."
• "Furthermore, prima facie relevance is to be assessed with taking into account the outcome of the proceedings (see CLBA, IV.C.4.5.3) and the opposition division gave no reasons why this criterion was not fulfilled for documents D59 to D62 [filed by the opponents]. Accordingly, the board cannot assess whether the opposition division has exercised its discretion in this respect correctly."
• The OD decided to revoke the patent, so this remark is not clear to me.
• 
  

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 0116/20 - Inventive printed matter

Key points

•  Claim 1 is directed to a "venous access port assembly" with a radiopaque markings that comprises the letters "CT", in claim 10 these markings are printed on the surface.
• " the access port includes radiopaque markings (60) applied to a surface of the housing base (28), which include indicia (70) that comprise the letters "CT"."
• "Being radiopaque, these markings can be discerned on an X-ray and thereby provide information about the nature or characteristics of the access port assembly once it has been implanted in the patient."
• " D1 does not directly and unambiguously disclose at least radiopaque indicia that comprise the letters "CT"."
• I understand that D1 discloses radiopaque indicia.
• As to inventive step:  "the letters "CT" have no mirror symmetry. As explained in paragraph [0004] of the contested patent, these letters could, for example, be applied in a mirror-image orientation to the outwardly facing bottom surface of the port housing. In this case, they would appear right-side up on an X-ray when the port is viewed from above, and, conversely, mirror-inverted when the port is viewed from below. Due to the lack of mirror symmetry, the way the letters "CT" appear on an X-ray is uniquely correlated with the orientation of the port."
• " the objective technical problem starting from D1 [is] to enable a practitioner X-raying an implanted port to unambiguously determine the orientation of the port, including whether the port is being viewed from above or below."
• " D1 does not address the technical problem of determining the port orientation. It only discloses the alphanumeric message as having the purpose of identifying the port type []. Thus, in the absence of any teaching or suggestion in D1 that the message could be used to provide information about the port orientation, the person skilled in the art starting from D1 would have no motivation, even using their common general knowledge, to specifically select the alphanumeric message so that it has no mirror symmetry, let alone so that it specifically comprises the letters "CT"."
• As a comment, this decision illustrates that features defining presentations of information can contribute to inventive step namely if they have a technical effect.

EPO 

The link to the decision is provided after the jump.

T 1589/21 - Mentioned but not disclosed

Key points

•  This case reminds me of T 2842/18 where a verbatim statement was no valid basis for a claim amendment under Art. 123(2) EPC in a case about a second medical use claim.
• "One of the issues with respect to the amendments [under Article 123(2) EPC] was whether or not the application and the earlier application disclosed the purpose recited in the claim, i.e. protection against Lawsonia intracellularis, Mhyo and Porcine circo virus (PCV), in combination with the claimed vaccine and the administration route and scheme recited in the claim (intramuscular administration of the vaccine only once)."
• "Example 3 is the only passage in the application that discloses the administration of a composition of the three non-live antigens of the pathogens Lawsonia intracellularis, Mhyo and PCV as defined in the claim to subjects (pigs) intramuscularly and only once. However, as also disclosed in Example 3, after a single intramuscular injection, no Mhyo antibodies could be detected "
• "The information conveyed to the skilled person by Example 3 of the application is that the claimed vaccine does not confer protection against Mhyo when administered intramuscularly only once, yet the contrary is claimed, i.e. that it does confer such protection (see section I.). The claimed subject-matter hence relates to new technical information which is not directly and unambiguously derivable from the application."
  
• "The opposition division held that achieving the purpose recited in the claim was only a matter of sufficiency of disclosure, not of added subject-matter. In line with decision T 2593/11 (Reasons 3.4), it was sufficient that the inventors had "thought of" protection against Lawsonia intracellularis, Mhyo and PCV by intramuscular administration of the claimed vaccine only once. This was evident from the purpose of Example 3 described in lines 2 to 4 of page 14 of the application and from the vaccination experiment carried out for Group 2 of Example 3 "
• "the purpose of Example 3 was "to test" a combination vaccine comprising killed whole cells of Lawsonia intracellularis and antigens of Mhyo and PCV. However, a mere statement that a vaccine test experiment was conducted, without disclosing any results, does not amount to a disclosure of the tested vaccine for a specific therapeutic purpose"
• 
  
•  "The board considers that this conclusion is in line with the established case law on novelty of second medical use claims. By way of example, mere statements that a particular therapy is being explored do not amount to a novelty-destroying disclosure of a second medical use claim which includes the achievement of this therapy as a technical feature (T 1859/08, Reasons 13), and a document that describes the administration of a compound to diseased subjects but neither explicitly nor implicitly discloses an effective treatment of the disease by this compound does not directly and unambiguously disclose this treatment (T 239/16, Reasons 5.2 and 5.3). Although this case law is on novelty and not on added subject-matter, the concept of disclosure must be the same for the purposes of Articles 54 and 123 EPC (G 2/10, OJ EPO 2012, 376, Reasons 4.6, citing G 1/03, OJ EPO 2004, 413, Reasons 2.2.2)."
• "In line with this case law, the disclosure in the application that pigs were vaccinated with a combination vaccine comprising antigens of the three pathogens by intramuscular administration of the vaccine only once does not per se amount to a disclosure of protection against these three pathogens by this vaccine via this administration route and scheme. Moreover, as set out above (see point 9.), Example 3 in fact discloses that no protection against Mhyo could be obtained by an intramuscular administration of the combination vaccine only once. Therefore, Example 3 of the application does not directly and unambiguously disclose a vaccine comprising in combination non-live antigens of Lawsonia intracellularis, Mhyo and PCV for use in protection against Lawsonia intracellularis, Mhyo and PCV by intramuscular administration of the vaccine only once."
  
  
• As a comment, this approach appears to merge, in a way, the requirements of sufficiency of disclosure and basis under Art. 123(2) (as is, incidentally, the case with the USA written description/enablement/possession case law).

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 0703/18 - Problem inventions are rare and somewhat at odds with the PSA

Key points

• The Board, under inventive step:  "The problem to be solved proved to be a contentious issue.". 
• "The [opponent] appellant argued that the technical problem was to provide an infant formula suitable for newborn infants. For the [patentee] respondent, however, the correct technical problem was the one identified in the decision under appeal [probably: "resided in recognising that bioavailability of lutein from infant formula was low"]. In its view, the patent involved one of the rare cases of a "problem invention". It had not been recognised in the art that bioavailability of lutein from formula milk was lower than that achieved by human milk. Once this was known, the solution would have been obvious."
• The Board: "As the respondent [patentee] acknowledged, "problem inventions" are rare. One reason for this may be that they are somewhat at odds with the problem-solution approach. It is generally accepted that the formulation of the technical problem should not contain pointers to the solution or partially anticipate the solution. In contrast to this, "problem inventions" tend to do both."
• I'm not entirely certain of what the Board means with the last sentence.
• The Board reviews the foundational decision T 2/83. "T 2/83 concedes that the discovery of an unrecognised problem may in certain circumstances give rise to patentable subject-matter. This may be so even though once the formulation of the problem is accepted, the question of whether the solution was obvious becomes irrelevant. A situation may arise in which, if a subject-matter claimed is assessed as a "problem invention", an attack based on lack of inventive step can be successfully directed only against the recognition of the problem, not against the claimed solution. At the same time, T 2/83 makes it clear that in the context of a clearly desired improvement, side effects which may be interpreted as a solution of a yet unknown problem shall not be decisive for patentability."
• The Board then turns to the facts of the case at hand. I refer the interested reader to the text below the fold. I would be glad to learn from comments to what extent the Board applies a coherent framework.
• "Considering all this, it is not justified to accept the formulation of a "problem invention", as suggested by the respondent. Instead, the technical problem has to be regarded as that of providing a nutritional formula (with lutein) suitable for infants, including newborns."
• The patent is revoked.

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 0130/19 - Correction of error appeal fee debit order

Key points

• The proprietor files an appeal using Form 1038E, specifying the appeal fee in the correct amount, but leaving the payment method as "Not specified". (The EPO Online Filing Software allowed for this).
• "due to the erroneous indication "not specified" in the "Method of payment" box on Form 1038E, the debit order for the payment of the appeal fee was not carried out before expiry of that time limit."
• " With letter of 7 February 2019 the appellant requested a correction under Rule 139, first sentence, EPC of Form 1038E submitted with the notice of appeal in the manner specified in above point VI."
• "It is undisputed that the requested correction fulfills the conditions set out in point 37 of the Reasons for decision G 1/12 (OJ EPO 2014, A114). The Board refers to decision T 0317/19 of 22 October 2019 which relies upon decision G 1/12 in which a correction under Rule 139, first sentence, EPC in a similar factual situation concerning an appeal in an ex parte case was allowed. It is in particular referred to the reasoning provided in points 1 to 3 of said decision in which the relevant legal provisions and case law are discussed. The Board fails to discern why the reasoning provided in T 0317/19 regarding the applicability of Rule 139 EPC to a correction of an erroneously filled out payment form in an ex parte case should not apply for an appeal in an inter partes case, since the ruling of G 1/12 upon which it is relied in T 0317/19 clearly applies to both ex parte and inter partes cases. "
• "In the present case, the indication "011 Appeal fee for an appeal filed by an entity other than those referred to in Rule 6(4) and (5) EPC" in original Form 1038E shows that the intention of the patent proprietor was to pay the appeal fee at the same time as filing the notice of appeal. The request for correction was filed on the day that the appellant was informed by a telephone call from the registrar that the payment method had not been specified, i.e. without delay."
• "The Board concludes therefore that the request for correction of Form 1038E is to be allowed and that the appeal is therefore deemed to have been timely filed."

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 1589/21 - (I) Evidence of c.g.k. is late-filed

Key points

•  " the appellant submitted that a party must be able to rely, at any stage of the proceedings, on common general knowledge and provide proof for that. This argument implies that a board does not have discretion to disregard documents (allegedly) supporting common general knowledge. However, the board cannot derive any such limitation from the EPC or the RPBA. The documents are evidence supporting allegations of fact which, under Article 114(2) EPC, may be disregarded if not submitted in due time by the party concerned. Article 12(3) and (5) RPBA confirms the board's discretionary power in this respect. The board therefore sees no reason for any preferential treatment of evidence for alleged common general knowledge. This is also in line with e.g. decision T 85/93, OJ EPO 1998, 183 (see also Case Law of the Boards of Appeal of the European Patent Office, 10th edition 2022, V.A.5.13.1(c))."
• 
  

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 2916/19 - Scientific paper is invalid prior art

Key points

• D1 is "Uehara et al., Structural characterization of ultrahigh-molecular-weight polyethylene reactor powders based on fuming nitric acid etching, Polymer, 1998, vol. 39, number 24, pages 6127- 6135;"
• "the respondent [patentee] was of the opinion that samples 1, 3 and 5 of E1 did not belong to the state of the art because E1 did not constitute an enabling disclosure as to how to (re)produce [the polymer] samples without undue burden"
• " it is however unclear to the Board why and on which basis the opposition division held that "the lack of enablement of a prior art document should not be contested/discussed in opposition proceedings"
• "it is established case law that a disclosure can only be regarded as having been made available to the public, and therefore as comprised in the state of the art pursuant to Article 54(2) EPC, if the information given therein to the skilled person is sufficient to enable them, at the relevant date of the document, to practise the technical teaching which is the subject of the document, taking into account also the general knowledge at that time in the field to be expected of him"
• "the question arose whether or not the skilled person would be able to prepare without undue burden any of samples 1, 3 and 5 of E1 in view of the very limited information provided in E1 regarding their preparation process, in particular regarding the catalyst system used,"
• " the [opponent] argued that E1 was a scientific publication which had been subjected to peer review and that D16 showed that E1 had been cited in numerous other publications articles"
•  "However, the fact that E1 was cited several times in subsequent scientific articles constitutes no evidence that the skilled person was in the position, at the priority/filing date of the patent in suit, to prepare samples 1, 3 and/or 5 in a reliable manner on the basis of the teaching of E1, if needed complemented by common general knowledge. In particular, it was not shown that said samples 1, 3 and 5 were effectively prepared in any of the publications citing E1. To the contrary, the respondent showed with D17 that the reference to E1 in at least one of these publications was not even related to the preparation of said samples"
• "according to established case law, each party bears the burden of proof for the facts it alleges (Case Law, supra, III.G.5.1.1). In the present case, the Board considers that since the appellant/opponent raised objections based on the disclosure of samples 1, 3 and 5 of E1, the burden of proof primarily resides on them to show that said samples of E1 effectively belong to the state of the art for the patent in suit. 
• 
  
• After further analysis, the Board concludes that "In view of the above, the disclosure of E1 is not sufficient for the skilled person to be able to prepare reliably any of samples 1, 3 and 5 as disclosed therein."
   

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 1045/19 - No apportionment of costs

Key points

• In this case, the appellant/patentee appealed the revocation of the patent and, shortly before the hearing, disapproved of the text of the patent.
• [The opponent's] request for a different apportionment of costs relates to costs arising due to having to respond to the [patentee's/  appellant's]  late change of case, being the withdrawal of the previously pending claim requests and the filing of replacement claim requests shortly before the scheduled oral proceedings.
• "the question of whether a different apportionment of costs is warranted is governed by Article 104(1) EPC which requires that, in order to find an exception to the rule that each party bears the costs it has incurred, "reasons of equity" must exist. It follows that the mere fact that an amendment of a party's appeal case is present does not mean that a different apportionment of costs must be ordered. It remains at the discretion of the board (see Article 16(1), second sentence, RPBA 2020) to order a different apportionment of costs taking into account the criterion of equity stipulated in Article 104(1) EPC."

• "The board considers that the late filing of claim requests alone (and the filing of a new document) does not, as such, justify such apportionment for reasons of equity. Instead, additional circumstances are needed for equity to dictate ordering a party to pay the other's costs because it had amended its case at a late stage (see T 1781/13, Reasons 14.2.1; T 467/15, Reasons 5.3)."

• "In the circumstances of the present case, the board does not consider a different apportionment of costs for reasons of equity to be warranted.  It is for the party requesting a different apportionment to put forward such additional circumstances and to demonstrate that they warrant an exception to the other above-mentioned rule that each party must bear its own costs. The party must show, for example, that the other party has neglected the level of care towards the requesting party that can be reasonably expected of it (see T 40/17, Reasons 5). The reasons put forward by respondent I are not sufficient in this respect."

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 1761/19 - Don't forget the rejoinder

Key points

• The opponent appealed. The patentee/respondent files Auxiliary Requests 1-13 with its reply.
• The Board finds the main request to be not inventive and turns to AR-1.
• Claim 1 of auxiliary request 1 differs from claim 1 of the main request by adding the feature of dependent claim 3 as granted.
• The Board, in machine translation: "The appellant raised objections to auxiliary request 1 for the first time during the oral proceedings before the board."
• "She argued that she had already objected to dependent claim 3 in her notice of opposition."
• "Although in the statement setting out the grounds of appeal the appellant made a general reference to the notice of opposition concerning the dependent claims, it must be noted that there it confined itself to asserting that the characteristic of dependent claim 3 as granted was known from documents D4 and D5a.

  Document D4 was not cited by the applicant during the novelty appeal proceedings or as a starting point for the examination of inventive step. The assertion that document D4 discloses the additional feature introduced in claim 1 of auxiliary request 1 does not constitute a reasoned objection with regard to novelty or inventive step."

• "Furthermore, the board found that the subject-matter of claim 1 of the main request was new in view of document D5a (see point 1.2 above). The assertion that the additional feature introduced in claim 1 of auxiliary request 1 is known from document D5a is not such as to call this finding into question. As regards a possible objection of lack of inventive step based on this assertion, what has just been said for document D4 also applies."

• "The inventive step of the subject-matter of claim 1 of auxiliary request 1 would therefore have been substantiated for the first time in the appeal proceedings during the oral proceedings. As the applicant did not invoke exceptional circumstances within the meaning of Article 13(2) RPBA 2020 to justify this modification of its pleas, the board decided, in the exercise of its discretion, not to admit this objection in the appeal procedure."
  
  

• The decision also deals with the point that product features in process claims are limiting. In particular, a method for coating a stack of articles was novel because the articles used as a substrate were not the same as the substrates in the prior art method. 

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 1426/21 - Inconsistencies between the claims and the description

Key points

•  An applicant wishes to have claim-like clauses in the description that are inconsistent with the allowable claims. The applicant let the application be refused and appeals.
• "In their communication pursuant Article 15(1) RPBA, the Board indicated that the claim-like clauses in the description of the main request, the first, second and third auxiliary requests were not consistent with the claims which led to the claims being unclear pursuant to Article 84 EPC (i.e. not supported by the description). However the Board indicated that the amendments made to the description of the fourth auxiliary request met the requirements of Article 123(2) EPC and overcame the inconsistencies between the the description and claims and met the requirements of Article 84 EPC."
• "With letter of 13 March 2023, the appellant made their fourth auxiliary request their main request"
• The Board: "According to Article 84 EPC, the claims define the matter for which protection is sought. They shall be clear and concise and be supported by the description. This means that any inconsistencies between the claims and those parts of the description disclosing ways to carry out the invention need to be removed. This understanding of Article 84 EPC is in line with the standard of claim interpretation for national proceedings enshrined in Article 69(1) EPC, which requires that the description also be taken into account when interpreting the claims."
• "In the present case the "claim-like clauses" do not render the subject-matter for which protection is sought unclear because the text in the description is consistent, and not in contradiction, with the set of claims. Moreover, the Board notes that the "aspects" on pages 11 and 12 [ situated in the middle of the description (at the end of the "summary" of the invention) ] cannot be mistaken for claims. It is obvious that they are part of the description and are not part of the claims defining the protection to be sought."
• Rule 42 EPC does not rule out claim-like clauses in the description. In the present case, the claim-like clauses disclosed as "aspects" on pages 11 and 12 can be considered as embodiments of the invention defined in terms of technical features. These claim-like clauses do not change or impair the understanding of the technical problem and the solution defined in the description. Therefore there is no reason to require their deletion.
• To conclude, the amendments to the description according to the main request remove the inconsistencies between the claim-clause like embodiments and the claims. The claims are thereby supported by the description pursuant to Article 84 EPC.
• The case is remitted with an order to grant a patent with the text as specified.

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

G 2/21 - The Enlarged Board on the basics of inventive step

Key points

• "In accordance with Article 52(1) EPC, patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application." (r.22)
• This is immediately followed by: "According to the established jurisprudence of the boards of appeal, the assessment of inventive step is to be made at the effective date of the patent on the basis of the information in the patent together with the common general knowledge then available to the skilled person (see T 609/02, T 1329/04, T 1545/08; ...)"
• As a comment, the assessment of inventive step is normally made on the basis of the prior art, I would say.
• This raises the question of what the Enlarged Board precisely means with the above sentence.
• The Board cites T 609/02 first. The headnote of this decision is as follows: "If the description of a patent specification provides no more than a vague indication of a possible medical use for a chemical compound yet to be identified, later more detailed evidence cannot be used to remedy the fundamental insufficiency of disclosure of such subject-matter." Hence, this decision is about Art. 83. 
• The Board also cites T 1329/04. The headnote of this decision states:  "The definition of an invention as being a contribution to the art, i.e. as solving a technical problem and not merely putting forward one, requires that it is at least made plausible by the disclosure in the application that its teaching solves indeed the problem it purports to solve. Therefore, even if supplementary post-published evidence may in the proper circumstances also be taken into consideration, it may not serve as the sole basis to establish that the application solves indeed the problem it purports to solve."
•  T 1545/08 states in r.67: "According to established case law (Case Law of the Boards of Appeal of the European Patent Office, 6th edition 2010, I.D.4.6) post-published documents can be taken into consideration to confirm (or not) whether what appears to be a plausible solution at the relevant date is indeed a solution and hence whether the claimed subject-matter indeed solves the problem it purports to solve."
• It appears that the Enlarged Board here puts the answers to the questions first.
• "The boards of appeal and the administrative departments of the EPO regularly apply the "problem and solution approach" in the course of deciding whether or not a claimed subject-matter involves an inventive step and fulfils the requirements of Article 56 EPC." (r.25)
•  The Enlarged Board here does not indicate that using the PSA is mandatory.
• "This approach consists essentially of the following methodologic steps:  
"(a) identifying the "closest prior art";
(b) comparing the subject-matter of the claim at issue with the disclosure of the closest prior art and identifying the difference(s) between both;
(c) determining the technical effect(s) or result(s) achieved by and linked to these difference(s);
(d) defining the technical problem to be solved as the object of the invention to achieve these effect(s) or result(s); and
(e) examining whether or not a skilled person, having regard to the state of the art within the meaning of Article 54(2) EPC, would have suggested the claimed technical features in order to obtain the results achieved by the claimed invention."
• The Enlarged Board refers to CLBA I.D.2.  Curiously, the PSA is stated with four steps in that document. The EBA adds step B, comparing the subject-matter of the claim at issue with the disclosure of the closest prior art and identifying the difference(s) between both.
•  As to step E, I think a more conventional statement is: examining whether or not a skilled person,  would have applied the claimed distinguishing technical features in order to solve the objective technical problem as defined under D.
• The above summary of the PSA is clearly not intended to be binding.
• "The technical problem must be derived from effects directly and causally related to the technical features of the claimed invention."
• More particularly, from the differences as defined under B.
•  "An effect could not be validly used in the formulation of the technical problem if the effect required additional information not at the disposal of the skilled person even after taking into account the content of the application in question"
• At first sight, this seems a consideration of sufficiency. The sentence comes from the headnote of T 1639/07.  To quote the relevant paragraph: "The appellant [applicant] put forward the argument that the user could make an "educated" guess of the print limit. The assumption that this would guarantee the success of the invention is speculative. The objective technical problem must be derived from physical, chemical etc effects directly and causally related to the technical features of the claimed invention. An effect cannot be validly used in the formulation of the technical problem if the effect requires additional information not at the disposal of the skilled person even after taking into account the content of the application in question. There is certainly not enough information in the present application for determining an appropriate print limit in any reliable and reproducible manner."
•  "Step (c), which is the most relevant in the context of the present referral, requires that, in order to determine the objective technical problem, the technical results and effects achieved by the claimed invention as compared with the closest prior art must be assessed. [It] rests with the patent applicant or proprietor to properly demonstrate that the purported advantages of the claimed invention have successfully been achieved."
• So the burden of proof of the technical effect being actually achieved rests with the proprietor, not the opponent, in opposition proceedings. 
• The EBA states that this is "[a]ccording to the established case law of the boards of appeal (see CLB, 10th edition, I.D.4.2, and the decisions therein [)]", but I don't see the burden of proof discussed there. It is in para I.D.4.2 of the 9th edition.
• It is discussed further in I.D.4.3.1 in the 10th edition: "If the patent proprietor/applicant alleges the fact that the claimed invention improves a technical effect, then the burden of proof for that fact rests upon him"
• Finally, the Enlarged Board does not really explain why we care about the formulation of the OTP at all. As explained in T 939/92 r.2.5.3: "the answer to the question as to what a person skilled in the art would have done depends on the result he wished to obtain", i.e. on the formulation of the objective technical problem. Under the PSA, "This means asking not whether the skilled person could have carried out the invention, but whether he would have done so in the expectation of solving the underlying technical problem" (CLBA I.D.5). The CLBA adds "or in the expectation of some improvement or advantage" but then step E is completely disconnected from the objective technical problem formulated under D so that can not be correct.
• T 939/92, r. 2.4.3: "The next step is then to decide whether the state of the art suggested the claimed solution of this technical problem [i.e. the objective technical problem] in the way proposed by the patent in suit"
• To anticipate the Enlarged Board's analysis of plausibility, I wish to recall that CLBA, I.D.4.4.2 also states that: "As a matter of principle, any effect provided by the invention may be used as a basis for reformulating the technical problem, as long as that effect is derivable from the application as filed (T 452/05, T 698/08, T 188/09, T 2483/11, T 605/14, T 1196/12, T 1406/15). A reformulation of the problem also may be appropriate if an alleged effect of a described feature could be deduced by the skilled person from the application in the light of the prior art or if new effects submitted subsequently during the proceedings were implied by or related to the technical problem initially suggested. In relation to new effects, it was not permissible to change the nature of the invention". This is further discussed extensively in CLBA I.D.4.4.3
• The requirement that the technical effect has to be derivable from the application as filed is in contrast with (or at least in tension with) the principle that "the technical problem can be reformulated, and in certain circumstances actually has to be reformulated, since the only factor of importance in determining the problem objectively is the result actually achieved in relation to the closest state of the art" (I.D.4.4.) 
• This case law (I.D.4.4) originates from the concept of reformulating the technical problem as set out in the patent (or application), typically in less ambitious terms, in order to correspond to a technical effect actually achieved by the differences between the claimed subject-matter and the closest prior art.

EPO 

The link to the decision is provided after the jump.

T 1128/19 - Double patenting

Key points

• "In the decision under appeal, the examining division held that the main request and auxiliary requests 1 to 3 were not allowable under Article 97(2) EPC together with Article 125 EPC, since they were in contravention of the principle of prohibition of double patenting with respect to the patent [...] granted on the parent application []"
• "Amgen Research (Munich) GmbH is the proprietor of both the granted parent and of the (divisional) application under appeal. Thus, the parent patent was granted to the same applicant as the applicant of the application under appeal."
• Under G 4/19 " it must further be determined whether "it claims the same subject-matter as a European patent which has been granted to the same applicant"."
• "claim 1 of the main request is a combination of claims 1 and 4 and a single embodiment (aa) from claim 5 of the granted patent."
• "The wording of claim 1 of the application under appeal [also] differs from that of the above mentioned claims of the patent in that it specifies that the first binding domain "is an antigen-interaction site"; but this difference in wording is no further discussed in the decision.
• "the subject-matter of claim 1 of the main request is an explicit alternative defined in the claims of the parent patent, being a combination the claim 1 and 4 and embodiment (aa) of claim 5 as granted."
• "The main request and auxiliary requests 1 are not allowable in view of the prohibition of double patenting because they claim the same subject-matter as claimed in the parent patent."
• As a comment, see the different analysis in T 2907/19, which allowed the patent to be granted with a claim 1 that "corresponds to dependent claim 2 of the granted parent application"
• 
  

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 2907/19 - Double patenting and dependent claims

Key points

•  The Board allows an appeal against a refusal decision.
• The Board assess whether there is impermissible double patenting: "According to the headnotes of G 4/19, a European patent application can be refused under Articles 97(2) and 125 EPC if it claims the same subject-matter as a European patent which has been granted to the same applicant and does not form part of the state of the art pursuant to Article 54(2) and (3) EPC. " 
• "The definition of "the same subject-matter was not subject of the referral and of decision G 4/19"
• "the present application is a divisional application of parent European application No. 06 803 439. European patent EP 1 935 007 B1 was granted for the parent application."
• "Claim 1 of according to the [operative] fifth auxiliary request differs from claim 1 of patent EP 1 935 007 by the step of separating the epitaxial layer from the carrier substrate."
• "Hence, independent claim 1 of the fifth auxiliary request is different from independent claim 1 of the granted parent application and thus does not define the same subject-matter. Hence, the prohibition of double patenting is not pertinent to the claims of the fifth auxiliary request. This is not precluded by the fact that claim 1 of the fifth auxiliary request corresponds to dependent claim 2 of the granted parent application."
• Hence, current claim 1 is narrower than already granted claim 1 and "corresponds to dependent claim 2 of the granted parent application" but that is no problem.
• As a comment, it appears that only the independent claims are relevant for G 4/19.
• As a further comment, this decision is of great practical value for the case that "The applicant may, for example, be interested in obtaining a first quicker protection for a preferred embodiment and pursue the general teaching in a divisional application. ... It is sufficient to say that such procedural behaviour is not abusive and even legitimate. "  G 2/10, r. 4.5.5.  The patentee can now let the patent lapse that was granted on the parent with narrow (but strong) claims lapse after the grant of the patent on the divisional with both the broad claims and, as dependent claims and fallback position (G 3/14), the same narrower claims.

• 
  
• EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 1889/19 - Intervention by related company

Key points

• A notice of opposition was filed by "XSYS Germany GmbH". A notice of intervention was filed by "XSYS Prepress NV". This is no issue and is not discussed in the present decision.
• As a comment, some USA patent attorneys may find this formalistic approach strange. 
• 
  
• The Board concludes that claim 1 as granted is not new over document E3 and not new over E4
• A new request AR-2 is admitted: "the board accepts that the second auxiliary request was filed (as former eleventh auxiliary request) as a direct response to the notice of intervention and as a reaction to the issues discussed therein."
• The Board remits the case.
• "According to the headnote of G 1/94, intervention of the assumed infringer under Article 105 EPC may be based on any ground for opposition under Article 100 EPC. Point 13 of the reasons further states: "[...] the purpose of intervention is to allow the assumed infringer to defend himself against the Patentee's action. Therefore, to prevent him from making use of all available means of attacking the patent, which he is accused of infringing, including the raising of new grounds for opposition under Article 100 EPC not relied upon by the proper Opponent, would run contrary to this purpose of intervention. [...] if a fresh ground for opposition is raised by the intervener, the case should be remitted to the first instance for further prosecution, unless special reasons present themselves for doing otherwise, for example when the Patentee himself does not wish the case to be remitted".
• "In the present case, the notice of intervention included the fresh grounds for opposition under Article 100(b) and (c) EPC and new lines of attack under the ground for opposition under Article 100(a) EPC in conjunction with Articles 52(1), 54(1), (2) and (3), 56 EPC in view of newly filed documents E14 to E22f, see section IV. above. None of these issues had been subject of the first instance proceedings, let alone the impugned decision.'

• "The opponent and the intervener requested that the second auxiliary request be examined regarding novelty and/or inventive step over document E3 before the case was remitted to the opposition division.

  The board takes the view that it would not be appropriate for the board to limit its examination of the second auxiliary request to the assessment of novelty and/or inventive step only with respect to the document E3 and leaving aside the other novelty and/or inventive step objections based on other documents."

Following G 1/94, the case is therefore to be remitted to the first instance for further prosecution.

The link to the decision is provided after the jump.

T 1617/20 - Fairness trumps prima facie allowability

Key points

• "The respondent [opponent] argued that the opposition division correctly exercised its discretion in not admitting auxiliary request 2 (i.e. the current main request). The respondent submitted that the appellant had already filed 12 auxiliary requests prior to the oral proceedings before the opposition division. At the oral proceedings, two further auxiliary requests were filed, including auxiliary request 2, which corresponds to the present main request. No reasons were apparent as to why this auxiliary request could not have been filed earlier, especially since an objection made under Article 123(2) EPC to the term "stereochemical" in claim 1 as granted had already been raised in the notice of opposition. The appellant could and should have reacted to this objection by filing the current main request in a timely manner. When filing a request late, especially at the oral proceedings, only the prima facie allowability of the claims should be examined. The opposition division acted correctly in this regard, when it found that claim 1 did not comply with Article 123(2) EPC."
• "The board disagrees."
• "In order to decide whether the opposition division's discretionary decision not to admit into the proceedings what was then auxiliary request 2 (i.e. the current main request) suffered from an error, i.e. was based on a wrong principle, or was taken by applying the right principle in an unreasonable way, the file history of the present case needs to be considered. "
• "In applying this different criterion of prima facie allowability under Article 123(2) EPC, the opposition division reasoned that the feature of claim 1 expressing the ratio [aliphatic to aromatic compounds] was not prima facie allowable under Article 123(2) EPC."
• " However, this feature was already present in claim 1 as granted [] and in claim 1 of auxiliary request 1 as filed during the oral proceedings and admitted by the opposition division. More importantly, this feature had never been objected to before under Article 123(2) EPC, either by the respondent or by the opposition division. The respondent confirmed at the oral proceedings before the board that it had not objected to this feature prior to the oral proceedings before the opposition division, and then only when auxiliary request 2 (the current main request) was being considered"
• "the board acknowledges that prima facie allowability under Article 123(2) EPC of a late-filed amended claim request may be a valid criterion to be used by the opposition division when deciding on the admittance of this claim request []. However, using this criterion, to object for the first time at oral proceedings to a feature of the late-filed claim request that was already present in higher-ranking claim requests and had never been objected to before, not even when deciding on the allowability or admittance of those higher-ranking claim requests, goes against the principles of fairness and good faith."
• "the board has concluded that the opposition division, when deciding not to admit the current main request, used the available criteria in an unreasonable way. The opposition division's decision thus suffered from an error in the use of its discretion."
• It is not clear to me if the OD should have held the new attack inadmissible, according to the Board.
• " For these reasons, the board has decided to overturn the opposition division's decision on the non-admittance of what was then auxiliary request 2, and to admit the present main request into the appeal proceedings pursuant to Article 12(6) RPBA 2020."
• " the board has concluded that the respondent's sole objection under Article 123(2) EPC is not convincing. Therefore, the main request fulfils the requirements of Article 123(2) EPC. "
• "essential questions concerning the patentability of the claimed subject-matter have not yet been examined or decided upon by the opposition division. Hence, the board finds it appropriate to make use of its discretion under Article 111(1) EPC and to remit the case to the opposition division for further prosecution,"

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 0435/20 - Anti-IL-23 antibodies binding at conformational epitope

Key points

•  Claim 1 as granted: "1. An antibody ... that binds to  human IL-23p19 [i.e. subunit p19 of human interleukin-23] at an epitope comprising residues 82-95 and residues 133-140 of SEQ ID NO: 29."
• Hence, no sequence or structure of the antibody is specified, only of the epitope, i.e. the substrate.
• The patent is roveked for insufficiency of the Amgen/Sanofi type (https://patentlyo.com/patent/2022/11/rethinking-enablement-grants.html) 
• The Board: "The claim is not for a single antibody but for a pool of antibodies each of which binds human interleukin-23 at an epitope as defined in the claim."
• "While the epitope bound by the claimed antibodies must include both stretches of amino acids, the claim does not unambiguously delimit the spatial extent of the epitope. Interpretation is therefore required to determine its extent. The board does this according to the normal rules of claim construction, in which the terms used in the claim are given their broadest technically sensible meaning in the context in which they appear and having regard to the common general knowledge and the teaching in the patent"
• "in an embodiment, although the claim is not limited to this embodiment, the claim encompasses antibodies that are functionally defined by their ability to bind to human IL-23p19 and contact several of the amino acid residues within both amino acid stretches recited in the claim, i.e. antibodies with the same specificity as the exemplified antibody 7G10 [i.e. the antibody shown in the examples of the patent, probably with the sequence specified in the sequence listing /description], but which are not structurally related to it."
• "Antibody 7G10 is therefore one way of performing the claimed invention. However, claim 1 is not limited to antibody 7G10 and structural related variants but encompasses antibodies which are solely defined by the functional feature that they have the same specificity as the exemplified antibody 7G10"
• That the skilled person can manufacture 7G10 based on the patent is not disputed.
• Turning to sufficiency, "In a first line of argument the appellant [patentee] submitted that, at the priority date of the patent, the generation and screening of antibodies that bind to the p19 subunit of hIL-23 did not amount to an undue burden of experimentation for a skilled person and that according to the case law of the Boards of Appeal, it was a matter of routine to raise and screen antibodies to a known antigen "
• "The board acknowledges that raising and screening antibodies involves only routine experimentation. However, this is the case only if the skilled person knows from the disclosure in the patent or from common general knowledge (i) which antigens are suitable for raising antibodies having the desired properties and (ii) which screening process should be used to select these antibodies without undue burden"
• " the generation and screening of antibodies that bind (anywhere) to the p19 subunit of hIL-23 would not involve an undue burden for the skilled person.  However, the patent in suit discloses neither a suitable antigen nor a screening process that would ensure the reliable generation and selection of antibodies having the required properties by applying routine methodology and a reasonable amount of experimentation. It is common ground that peptides consisting of the primary sequence of the claimed conformational epitope are unsuitable for raising the claimed antibodies or screening for them."
• "It is moreover undisputed that the patent does not disclose how antibody 7G10 was prepared, i.e. which antigen/immunogen was used for its generation or the screening process that was used to select for it. The board must therefore conclude that the patent contains no guidance regarding a suitable antigen or screening process for the generation and selection of antibodies that are structurally unrelated to antibody 7G10. "
• The Board then discusses the issue of sufficiency in more detail, discussing screening with ELISA, and the choice of the immunogen.
• "that the evidence on file does not support the appellant's assertion that suitable methods for screening a pool of anti-hIL-23 antibodies for p19-specificity were part of the skilled person's common general knowledge at the priority date. Since the patent provides no guidance in this respect either, the skilled person wanting to perform the claimed invention would have to develop a screening process for identifying antibodies that bind an epitope on the p19 subunit of hIL-23 and without risking to miss antibodies that bind the claimed conformational epitope, an undertaking that cannot be regarded as routine."
• "the functional definition of the claimed antibody amounts to an invitation to perform a research program without any guarantee of success. Such a situation is considered to amount to an undue burden for the skilled person "

• 
  

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

https://www.epo.org/law-practice/case-law-appeals/recent/t200435eu1.html

Main request (patent as granted) - claim 1

The claimed invention - claim construction

16. Claim 1 is directed to antibodies (or antigen binding fragment thereof) that bind to subunit p19 of human interleukin-23 (hIL-23p19) at an epitope comprising amino acid residues 82 to 95 and amino acid residues 133 to 140 of the amino acid sequence of mature hIL-23p19 (SEQ ID NO: 29). The claim is not for a single antibody but for a pool of antibodies each of which binds human interleukin-23 at an epitope as defined in the claim.

17. The two amino acid stretches recited in the claim are not contiguous along the primary sequence of the hIL-23p19 protein chain, thus the epitope defined in the claim is a so-called discontinuous or conformational epitope.

18. While the epitope bound by the claimed antibodies must include both stretches of amino acids, the claim does not unambiguously delimit the spatial extent of the epitope. Interpretation is therefore required to determine its extent. The board does this according to the normal rules of claim construction, in which the terms used in the claim are given their broadest technically sensible meaning in the context in which they appear and having regard to the common general knowledge and the teaching in the patent (see also CLBA, II.A.6.1).

19. The broadest technically sensible construction of the epitope defined in the claim is one where the epitope includes amino acid residues outside the two recited stretches of amino acids, recited in claim 1. Firstly, this is in keeping with the claim wording "comprising". Secondly, it is supported by dependent claim 2, according to which the bound epitope comprises 16 residues located within the recited stretches and 1 additional residue, H106, that is located outside these stretches. Indeed, the claimed antibodies need not bind exactly the amino acid residues recited in the claim as long as their epitope comprises these amino acid residues.

20. The appellant's submission that binding at least one amino acid residue in each stretch would be the broadest technically sensible interpretation is not found persuasive for the following reasons. First, the appellant's interpretation is not supported by the teaching of the patent in the general part of the description (see paragraph [0019] of the patent) and second, it is also no supported by antibody 7G10, relied on in this context by the appellant. Indeed, antibody 7G10 was determined by X-ray crystallography (X-RC) to be within 4.0 Å of the antibody (i.e. to "bind") at 9 of the 14 amino acid residues in stretch 82 to 95 of SEQ ID NO: 29 and 7 of the 8 amino acid residues in stretch 133 to 140 of SEQ ID NO: 29 (see paragraph [0180] of the patent).

21. Contrary to the decision under appeal, a technically meaningful interpretation of claim 1 does not require that it be implied that X-RC must be used to determine binding of the antibody at the target epitope. First, the use of X-RC is not a necessary consequence of the express language of the claim and thus not an implicit feature. Second, construction of the claim in light of the teaching of the patent does not imply the use of X-RC either. While the patent discloses that binding may be determined by X-RC (see paragraph [0019] of the patent), it discloses further methods for determining binding of the antibody at the epitope, (see e.g. paragraphs [0110], [0111] and [0113]).

22. Accordingly, in an embodiment, although the claim is not limited to this embodiment, the claim encompasses antibodies that are functionally defined by their ability to bind to human IL-23p19 and contact several of the amino acid residues within both amino acid stretches recited in the claim, i.e. antibodies with the same specificity as the exemplified antibody 7G10, but which are not structurally related to it. Binding to the conformational epitope may be determined by X-RC, but this is not mandatory.

Disclosure of the invention (Article 100(b) EPC)

23. According to the established case law of the Boards of Appeal, a patent complies with the requirement of sufficiency of disclosure if the skilled person, on the basis of the information provided in the patent and taking into account the common general knowledge, is able to perform the invention as claimed in the whole range claimed without undue burden, i.e. with reasonable effort (see CLBA, II.C.1).

24. The patent discloses, inter alia, a mouse anti-human IL-23p19 antibody termed 7G10 (see Tables 2 and 3), and a humanised version of this antibody, hum7G10 (see Example 2 and Tables 2 and 3). As mentioned in

point 20. above, antibody 7G10 was determined by X-RC to bind 9 of the 14 amino acid residues in stretch 82 to 95 of SEQ ID NO: 29 and 7 of the 8 amino acid residues in stretch 133 to 140 of SEQ ID NO: 29 (see Example 6).

25. Antibody 7G10 is therefore one way of performing the claimed invention. However, claim 1 is not limited to antibody 7G10 and structural related variants but encompasses antibodies which are solely defined by the functional feature that they have the same specificity as the exemplified antibody 7G10 (see also point 22. above).

26. For meeting the requirement of sufficiency of disclosure it is required that the patent, when considered in combination with the common general knowledge at the priority date, provides technical guidance which is sufficiently clear and complete to allow the skilled person to reliably obtain the above mentioned, functionally defined antibodies without an undue burden.

27. In a first line of argument the appellant submitted that, at the priority date of the patent, the generation and screening of antibodies that bind to the p19 subunit of hIL-23 did not amount to an undue burden of experimentation for a skilled person and that according to the case law of the Boards of Appeal, it was a matter of routine to raise and screen antibodies to a known antigen (see decision T 431/96).

28. The board acknowledges that raising and screening antibodies involves only routine experimentation. However, this is the case only if the skilled person knows from the disclosure in the patent or from common general knowledge (i) which antigens are suitable for raising antibodies having the desired properties and (ii) which screening process should be used to select these antibodies without undue burden (see also decision T 431/96, Reasons, points 6, 7, 10, 11, 12).

29. Indeed, the generation and screening of antibodies that bind (anywhere) to the p19 subunit of hIL-23 would not involve an undue burden for the skilled person.

30. However, the patent in suit discloses neither a suitable antigen nor a screening process that would ensure the reliable generation and selection of antibodies having the required properties (see

point 22. above) by applying routine methodology and a reasonable amount of experimentation. It is common ground that peptides consisting of the primary sequence of the claimed conformational epitope are unsuitable for raising the claimed antibodies or screening for them.

31. It is moreover undisputed that the patent does not disclose how antibody 7G10 was prepared, i.e. which antigen/immunogen was used for its generation or the screening process that was used to select for it. The board must therefore conclude that the patent contains no guidance regarding a suitable antigen or screening process for the generation and selection of antibodies that are structurally unrelated to antibody 7G10. For these reasons, the conclusion reached in decision T 431/96 that generation of antibodies to known antigens is routine, does not apply.

32. In a further line of argument the appellant maintained that the process of generating antibodies to hIL-23p19 involved immunisation with hIL-23 heterodimer to raise a pool of antibodies, and then identifying those antibodies that bind specifically to the p19 subunit. Selected anti-hIL-23p19 antibodies could then be analysed by X-RC to determine their epitopes. Since suitable methods for raising and screening antibodies were part of the skilled person's common general knowledge at the priority date, the requirement of sufficiency of disclosure was met.

33. The board is not persuaded by this this line of argument for the following reasons.

Choice of immunogen

34. The patent does not teach that the complete hIL-23 heterodimer should be used for the generation of antibodies that bind to hIL-23p19 at the claimed conformational epitope (see paragraphs [0079] and [0080] of the patent).

35. The appellant asserted that the common general knowledge would have led the skilled person to understand that not any fragment or the p19 monomer but the complete hIL-23 heterodimer (composed of a p19 and a p40 subunit) was the most suitable immunogen to raise antibodies that bind to hIL-23p19 at the claimed conformational epitope. No evidence supporting the pertinent common general knowledge was provided by the appellant.

36. Since p19 is one of the two subunits of hIL-23, the board accepts, for the sake of argument, that the skilled person might consider that the complete hIL-23 heterodimer was a suitable immunogen to raise the claimed antibodies.

37. It is common ground that in using the hIL-23 heterodimer for immunisation, the skilled person would obtain a pool of antibodies recognising (linear and conformational) epitopes anywhere on the surface of the hIL-23 heterodimer and its subunits, p19 and p40.

38. Moreover, since the generation of antibodies to the claimed epitope on p19 cannot be controlled by using the hIL-23 heterodimer, it is a matter of chance whether the antibody pool comprises an antibody that has the same specificity as the exemplified antibody 7G10 (see point 22. above).

39. Therefore, if the skilled person were to choose the hIL-23 heterodimer for raising antibodies, they would obtain a pool of antibodies, which may or may not comprise antibodies having the required properties.

40. However, the board holds that starting from the above mentioned pool of antibodies, the skilled person would not be able to arrive at the claimed antibodies without an undue burden of experimentation for the following reasons.

Screening antibodies for p19 specificity

41. The appellant submitted that, having raised a pool of antibodies against the hIL-23 heterodimer, the skilled person, seeking to put the claimed invention into practice, would have screened the pool to identify those antibodies that bind an epitope on the p19 subunit using any conventional assay available in the art, e.g. an enzyme-linked immunosorbent assay (ELISA).

42. The board acknowledges that at the priority date of the patent, the skilled person was familiar with ELISAs, e.g., for screening hybridoma supernatants for antibodies that bind to a given antigen. For this, the antigen is offered in an ELISA as a binding partner allowing the selection from a pool of antibodies those candidates that bind the antigen.

43. The patent does not disclose which antigen should be used in an ELISA to screen the pool of antibodies raised by immunisation with the hIL-23 heterodimer to obtain those antibodies that bind a conformational epitope on the p19 subunit of hIL-23 (see paragraphs [0082] and [0084]). The only ELISA mentioned in the patent refers to testing of antibodies "for specificity of binding by comparing binding to IL-23 to binding to irrelevant antigen or antigen mixture under a given set of conditions" (see paragraph [0118]).

44. Document D32, relied on by the appellant as evidence that ELISAs were well known in the state of the art, merely confirms that an ELISA can be set up, provided an antigen suitable to screen for the desired property is available (see page 168, second and third paragraph). However, document D32 provides no information as regards antigens or screening steps, e.g. positive and/or negative, which would be suitable to select antibodies that bind an epitope on the p19 subunit, nor does it address the difficulties in selecting an antibody as claimed from a pool of antibodies raised against hIL-23 and without missing antibodies that bind at p19 in the conformation that this subunit adopts in the presence of p40.

45. Documents D13 and D43, relied on by the appellant to confirm that ELISA tests were commonly used in the field at the priority date, and in the "specific context of determining p19-specificity" are production information sheets for commercially available anti-IL-23p19 antibodies. These documents do not constitute what is commonly understood to represent the common general knowledge of the person skilled in the art (see CLBA I.C.2.8.1).

46. Furthermore, document D13 discloses an anti-p19 antibody that was selected for its ability to neutralise the bioactivity of human IL-23. As regards ELISA tests, document D13 discloses that the selected antibody detects the human IL-23 heterodimer and does not cross-react with rhIL-12 p35, rhIL-12 heterodimer, rmIL-23 p40, or rmIL-23 heterodimer. Document D13 does not disclose that any of these ELISA tests was used for isolating the antibody. As for document D43, it discloses another anti-p19 antibody, which was selected by passing sera from immunised goats over a human IL-23 affinity column and then passing the bound fraction over a human IL-12/23 p40 column to remove p40 specific IgG. However, neither document D13 nor document D43 discloses an ELISA that can be used to screen a pool of anti-hIL-23 antibodies to identify antibodies that bind to p19. A fortiori, these documents are unsuitable to provide evidence that the skilled person could have used a routine ELISA to identify and isolate antibodies that bind a conformational epitope on the p19 subunit of hIL-23.

47. The appellant's further argument that alternatively, or in addition, a routine ELISA could have been used to screen for antibodies that bind to the hIL-23 heterodimer but do not bind to the related hIL-12 heterodimer (which lacks the p19 subunit) or to p40 alone and a conventional bioassay to screen the antibodies for inhibition of IL-23 activity but not IL-12 activity is not found persuasive either.

48. There is no teaching or guidance in the patent that would suggest the use of any of these ELISA assays, nor has the appellant referred to any evidence that they were common general knowledge at the priority date. A fortiori, there is no guidance or information with respect to how these assays would need to be performed and whether they would at all be suitable to reliably identify antibodies that bind a conformational epitope on the p19 subunit of hIL-23.

49. Screening for antibodies inhibiting the biological activity of hIL-23, as also suggested by the appellant, cannot differentiate between antibodies binding to the p19 and the p40 subunit of hIL-23. Therefore, this method is not suitable to specifically select antibodies that bind a conformational epitope on the p19 subunit of hIL-23.

Optional additional pre-screening to narrow down the pool of anti-hIL-23p19 antibodies

50. The appellant's argument that the skilled person could narrow down an initial pool of anti-hIL-23p19 antibodies to a smaller group of candidates by a conventional cross-blocking assay to eliminate antibodies that are unlikely to bind at the claimed conformational epitope is not found persuasive either. In fact, the patent proposes to use such an assay for exactly the opposite purpose, namely "to screen for antibodies that bind to the epitope on human IL-23 (i.e. the p19 subunit) bound by an antibody of interest" (see paragraph [0110]), not to eliminate antibodies that are unlikely to bind.

51. Moreover, the appellant's reasoning for using a cross-blocking assay to eliminate antibodies that are unlikely to bind at the claimed conformational epitope is based on its knowledge of antibody 7G10's footprint on hIL-23. However, this footprint is only disclosed in post-published document D18 (see page 948). Based on the teaching in the patent, the skilled person had no reason to expect that a cross-blocking assay would significantly reduce the number of candidate antibodies in a preselected pool of anti-p19 antibodies.

52. Finally, even if the skilled person were to use a cross-blocking assay to eliminate antibodies unlikely to bind at the claimed conformational epitope, they would be aware that the remaining antibodies will not necessarily bind at the claimed epitope. Indeed the patent confirms that not all cross-blocking antibodies necessarily bind at precisely the same epitope, since cross-blocking may result from steric hindrance (see paragraphs [0110] of the patent).

53. As regards the further strategy proposed by the appellant to reduce a pool of anti-p19 antibodies, the board notes that the patent does not teach that grouping of antibodies based on CDR sequences should be included in the process for identifying antibodies that bind at the epitope defined in the claim. No evidence was presented by the appellant that such an assay represented common general knowledge or was routine for the skilled person. Furthermore, the board has seen no evidence to support the thesis that the probability of finding an antibody with the desired binding properties increases by grouping the candidate antibodies into such sub-classes (see also documents D80, points 20 and 21 and document D81, point 58).

Undue burden

54. It is apparent from the above considerations (see points 41. to 49.) that the evidence on file does not support the appellant's assertion that suitable methods for screening a pool of anti-hIL-23 antibodies for p19-specificity were part of the skilled person's common general knowledge at the priority date. Since the patent provides no guidance in this respect either, the skilled person wanting to perform the claimed invention would have to develop a screening process for identifying antibodies that bind an epitope on the p19 subunit of hIL-23 and without risking to miss antibodies that bind the claimed conformational epitope, an undertaking that cannot be regarded as routine.

55. The appellant's argument that it was a matter of routine for the skilled person to perform further screening and narrow down a pool of p19-specific antibodies to arrive at a subset of antibodies that is "most likely to bind the claimed epitope", is not supported by the evidence on file either. Indeed, none of the screening assays proposed by the appellant selects specifically for antibodies that have the same specificity as the exemplified antibody 7G10 (see points 50. to 53. above).

56. Moreover, as set out above (see points 38. and 39.), there is no guarantee that even a single antibody having the same specificity as the exemplified antibody 7G10 is generated when using hIL-23 heterodimer for immunisation. Therefore, removing antibodies that are unlikely to bind at the claimed epitope, does not guarantee that any of the remaining antibodies is more likely to have the required specificity. Indeed, there is no guarantee that even a single antibody that is taken forward to determine its epitope, by X-RC or otherwise, has the same specificity as the exemplified antibody 7G10.

57. The patent does not provide any information regarding the epitopes recognised by the antibodies raised against hIL-23 heterodimer. In particular, the patent provides no evidence that antibodies having the required properties would be generated frequently enough to be identified reliably. Whilst the appellant submitted that the pool of antibodies raised against hIL-23 heterodimer would be expected to include many p19-specific antibodies that are highly unlikely to bind to hIL-23p19 at either of the epitope regions recited in claim 1, it provided no argument let alone evidence on how likely it was that such a pool of antibodies would include ones that do have the required specificity.

58. In summary, given the lack of relevant guidance in the patent or in the common general knowledge, the skilled person attempting to carry out the claimed invention is confronted with having to develop an elaborate screening strategy, without a reasonable expectation of success. Indeed such a screening strategy relies on chance, without the skilled person having any knowledge of the likelihood of success.

59. Finally, if after such a screening process, the antibody taken forward for epitope determination does not have the required specificity, i.e. in case of failure, neither the patent nor the common general knowledge provides adequate information regarding what should be changed or how to guarantee success.

Conclusion on disclosure of the invention (Article 100(b) EPC)

60. An invention may be regarded as sufficiently disclosed even if it requires a certain amount of experimentation by the skilled person to carry it out, as long as this experimentation is not an undue burden on the skilled person. Such a situation may exist where the skilled person has sufficient information to lead them directly towards success through the evaluation of initial failures. Based on the evidence on file, the board considers that in the present case, critical information on the antigen suitable for raising antibodies with the desired properties and screening assays for reliably identifying them is lacking. Moreover, the board has seen no evidence that antibodies binding at the claimed epitope can be generated frequently enough and can be identified reliably enough to guarantee success (see points 34.

to 59. above). Therefore, the functional definition of the claimed antibody amounts to an invitation to perform a research program without any guarantee of success. Such a situation is considered to amount to an undue burden for the skilled person (see also CLBA, section II.C.6.7 and II.C.7.4).

61. Contrary to the appellant's submissions, the fact pattern of the case under consideration (see points 34. to 53. above) is comparable to the facts underlying the case considered in decision T 1466/05. Thus, also in decision T 1466/05, the claimed antibodies were defined functionally (by their binding activity) and while the application provided one exemplary antibody having this function, it failed to provide (i) the antigen required to raise further antibodies as claimed and (ii) a screening process for the specific selection of the same (see Reasons, points 9 and 25).

62. Disclosure of the specific regions within the p19 subunit of hIL-23 that are comprised in the epitope of the claimed antibodies does not distinguish the case at hand from the case underlying T 1466/05 because it does not equate with disclosure of a suitable antigen that can be used for raising and screening antibodies binding at the claimed epitope by applying routine methodology (see also point 30. above).

63. In the circumstances of the case at hand, serious doubts arise from the verifiable fact that there is no relevant guidance in the patent and in the common general knowledge with respect to (i) an antigen suitable for raising antibodies with the desired properties and (ii) screening assays for reliably identifying them. Contrary to the appellant's assertion, the respondents were therefore under no obligation to provide experimental evidence to support the insufficiency objection.

64. The claimed invention is not sufficiently disclosed in the patent and therefore the ground for opposition under Article 100(b) EPC prejudices the maintenance of the patent as granted.

Auxiliary requests 1 to 49

Disclosure of the invention (Article 83 EPC)

65. Claim 1 of these claim requests is directed to antibodies defined solely by the functional feature of binding the conformational epitope defined therein (see section VI. above). The provision of these antibodies involves an undue burden for the reasons set out in points 23. to 64. above. The invention defined in auxiliary requests 1 to 49 is thus not sufficiently disclosed within the meaning of Article 83 EPC.

Order

For these reasons it is decided that:

The appeal is dismissed.