J 1/11 and J 18/10 – Second Thoughts (Again And Again)

These decisions deal with withdrawals from a withdrawal of an application.

J 1/11

In J 1/11, the application under consideration was filed as an international application and then entered the European phase. By letter dated 19 January 2009 received by fax on the same day, and confirmed by letter of January 28, 2009, the authorised European representative of the above application wrote the following:

“On behalf of the applicant I hereby formally withdraw the above application. Please refund the examination fee paid in relation to this application.”

On February 6, 2009, the withdrawal of the application was recorded in the European Patent Register (hereinafter “the Register”) after a confirmation of the withdrawal was sent to the representative one day earlier.

On February 26, 2009, that is, after the withdrawal was recorded in the Register, but before it was published in the European Patent Bulletin (hereinafter “the Bulletin”), a request for correction pursuant to R 139 was filed. The request stated that the withdrawal was made in error and a correction should be made to the effect that the application was not withdrawn.

The EPO did not allow this request and the applicant filed an appeal.

The appellant essentially argued in writing that a request for retraction of a withdrawal of the application should be allowable until such withdrawal has been officially notified in the Bulletin according to A 129 EPC rather than, as was held in the decision under appeal, the Register according to A 127 and R 143. The appellant pointed out an inconsistency between J 25/03 and J 14/04 on the one hand and J 10/87 and J 4/03 on the other hand. Should the Board not be minded to follow the reasoning of these latter two decisions, the appellant requested the Board to refer the following question to the Enlarged Board of Appeal (EBA):

“Is retraction by correction of a withdrawal of a patent application no longer possible if the withdrawal has already been recorded for inspection in the Register (per J 25/03 and J 14/04) or should publication of the withdrawal to the general public in the Bulletin (per J 10/87 and J 4/03) be decisive?”

As you might have guessed, the Board dismissed the appeal, for the following reasons:

[2] Explicitly withdrawing a pending patent application is a declaration of highest importance for the applicant, since all legal effects of the application such as establishing a preliminary right, are finally abandoned. In light of these consequences, utmost caution is therefore required when declaring the withdrawal of an application.

[3] A correction of errors in documents filed with the EPO under R 139 is only possible under strictly defined conditions. In the case at issue, the request for retraction of the withdrawal reached the EPO more than a month after the withdrawal was made and after it was recorded in the Register. Yet it is not primarily the EPO that is concerned with a withdrawal, but the public, for which a withdrawal is of potential interest. It is thus the public that can be regarded as the ultimate addressee of such a withdrawal. Therefore, a withdrawal cannot be retracted once the public has been officially informed thereof. In a broader sense, this is also reflected in the principle that a declaration of intent can only be retracted if the retraction reaches the addressee either before said declaration or at the same time, a rule that can be found in the civil law systems of many Contracting States of the EPC.

It is not disputed by the appellant that retraction of the withdrawal is no longer possible once the withdrawal has been published in the Bulletin. The question is thus whether a publication of the withdrawal in the Register should have the same legal consequences. In the present case, retraction of the withdrawal reached the EPO almost one month after the withdrawal was notified in the Register, while it had not yet been published in the Bulletin.

[4] Starting point for the Board’s analysis is decision J 10/87. The headnote of this decision (and also point [13] of the reasons) reads as follows:

“A request for retraction of a withdrawal of the designation of a Contracting State filed after publication of the patent application may be allowable under R 88 EPC [1973] in appropriate circumstances, in particular if

(a) the public has not been officially notified of the withdrawal by the EPO at the time the retraction of the withdrawal is applied for; ...”

In other words, retraction of a withdrawal, be it of a designation of a Contracting State, or, as in the current case, the application as a whole, is basically considered possible until the public has been officially notified of the withdrawal.

[5] In applying the criteria in decision J 10/87, the examining division had allowed a request for retraction of a withdrawal in considering that the withdrawal had not been officially notified to the public. While the withdrawal had already been entered into the Register, it had not yet been published in the Bulletin. The withdrawal could be noticed by the public via a public file inspection. The Board in that case took the view that the possibility of a public file inspection could not be equalled to an official publication, and paragraph 10 of the reasons reads as follows:

“[10] After due consideration, weighing the interests of the public against those of the applicant, the Board is of the opinion that a withdrawal which could only be noticed by inspection of the file can justifiably be treated differently from a withdrawal which was officially published. Legal certainty for third parties is of greater importance after official publication of a withdrawal by the EBO than after a withdrawal which can only be discovered by inspection of the file.”

[6] While the Board takes note of the distinction of public file inspection and publication in the Bulletin made in the decision J 10/87, it is of the opinion that internet technology as implemented by the EPO has made this distinction no longer relevant for determining the basic condition of the official notification of the withdrawal to the public. The Register nowadays allows for a file inspection online no different than the Bulletin allows for an online access of its contents. Since 1 January 2005, the Bulletin has been issued in electronic form only, and paper copies are no longer available. The previous distinction between “inspection” that required either a personal visit to the EPO or a specific oral or written request regarding a particular application, and a “publication” effected by sending out the Bulletin to the world at large seems no longer justified or justifiable. The progress of technology for the question of inspection of the Register and publication of the Bulletin was dealt with in detail in the decision J 25/03 that relates to facts very similar to the present case, and that goes into considerable detail as to the technical possibilities of access both for the Register and the Bulletin.

[7] In decision J 25/03, an application was unconditionally withdrawn, and such withdrawal was published in the Register before the applicant requested correction under R 88 EPC 1973 (now R 139) of its earlier withdrawal of the application. At that point in time, no publication of such withdrawal had taken place in the Bulletin. The question was thus whether mention in the Register according to A 127 and R 143 counted as an official information to the public. The Board in the above-mentioned case answered this question in the affirmative, and in its reasoning went into considerable detail. Paragraphs 8 to 10 of the decision in this respect read as follows:

“[8] Decision J 14/04 refers to the EPC, which in Chapter II of Part VII sets out the “Information to the public or official authorities”.

According to A 127 EPC [1973], the EPO shall keep a register, to be known as the Register, which shall contain those particulars the registration of which is provided for by this Convention.

R 92 EPC [1973] further lists the entries in the Register, which includes, in paragraph (n), the date on which the European patent application is refused, withdrawn or deemed to be withdrawn.

These references to the text of the European Patent Convention clearly support the official character of the entries in the Register, in particular the mention of the withdrawal of a patent application.

Moreover, A 129(a) EPC [1973] states that the Bulletin contains entries made in the Register.

This indicates clearly that the contents of the Bulletin relies on entries in the Register. It corroborates the official character of the entries in the Register and, to a certain extent, even its precedence over the Bulletin.

So, contrary to what is alleged by the appellant, legal effects are associated not only with the publication in the Bulletin, but also with entries in the Register. As an example, unless the conditions of R 20(3) EPC [1973] are met, it is the person registered as applicant, i.e. the person whose name is entered into the Register, who is the party to the proceedings and who is deemed to be entitled to exercise the right to the European patent, in accordance with A 60(3) EPC [1973] (J 26/95 [2]), irrespective of whether or not the right to a European patent belongs to him as a matter of substance (see A 60(1)).

[9] As to the public character of the content of the Register, A 127 EPC [1973] mentions that it is open to public inspection.

As regards the Bulletin, A 129(a) EPC [1973] explicitly refers to it as being a publication.

No conclusive difference can however be derived simply from this minor and strictly literal difference.

In a broader approach, the public dimensions of the Bulletin and of the Register have to be considered in the framework of how these official sources of information have actually been made available by the EPO to the public since the time the withdrawal of the patent application had been mentioned in the Register. Both the Bulletin and the Register are similarly offered freely to the public via EPOLINE®, on the internet. Not only is it possible for any person to access the Register on-line but also a service is offered which allows tracking changes in all files of published applications, using tailor-made lists of patent applications. Combined with an additional software tool, it renders it possible to compare data and identify changes immediately, or even automatically to receive an e-mail alert every time a change occurs in any of the cases previously selected in the Register (at that time through WebRegPro. See WebRegPro: monitoring patent applications using the epoline® online Register, EPIDOS News 4/2002, December 2002, also published on the EPO internet site, in the News, on 20 December 2002).

These factual elements surrounding the official character of the information available support the general availability to the public of the entries in the Register, from the day they appear therein.

Consequently, an entry in the Register also amounts to a notification to the public as well as a publication in the Bulletin.

[10] For these reasons, the Board holds that the public has been officially notified of the withdrawal of the patent application by its mention in the Register on 11 January 2003, before the request for retraction of the withdrawal. Even after possible inspection of the complete file, there would not have been any reason for a third party to suspect at that time that the withdrawal could be erroneous and later retracted.

The Board considers that legal certainty and the balance to be made of the applicant’s and of third parties’ interests do not allow the application of R 88 EPC [1973] in the present circumstances to authorise the retraction of the withdrawal of the patent application.”

[8] In adopting the above considerations, the Board takes the view that decision J 10/87 was necessarily fact-specific in that in its analysis of what made the withdrawal officially notified to the public, it relied on certain, then existing technical features of the file inspection system that allowed for a distinction between inspection and publication. Subsequent development of technology no longer allows for such distinction, as had been set out in great detail in the decision J 25/03.

[9] Still, the Board acknowledges that the appellant advanced a second line of argument that has not been explicitly dealt with in previous decisions, namely, that despite the technical and functional approximation of Register and Bulletin, only the latter carries the presumption of an official publication. In other words, as much as the public may be able to obtain information from the Register technically and functionally equivalent, but earlier as from the Bulletin, the public is deemed to have been officially informed only by information that is contained in the Bulletin, and only information in the latter is “cast in stone” and can be relied upon by the public as legally certain.

[10] As a starting point, it should be said that both the Register according to A 127 and the Bulletin according to A 129(a) are official sources of information to the public. There is nothing that would allow a distinction as to which of the two is more official, reliable or decisive. Both are listed in the EPC under the same chapter II that is entitled “Information to the public or to official authorities”. The function of the Register as information to the public is confirmed by the heading of chapter IX of the EPC Rules “Information to the public” that in Rule 143 in particular deals with the Register.

[11] This is not to say that the Bulletin has no functions other than those of information. On the contrary. For example, only a publication in the Bulletin gives effect to the decision to grant a patent (A 97(3)), and only the publication of the mention of the grant of the European patent in the Bulletin triggers the nine-month period for a notice of opposition, A 99(1). Furthermore, only the Bulletin carries a specific publication date. It is, in fact, published on a weekly basis. Contrary to what the appellant alleges, entries into the Bulletin are no more “cast in stone” than those of the Register, and can be corrected either under R 140, or by way of a decision.

[12] Yet, as far as the function of information to the public is concerned, the Board is unable to deduce a fundamental difference between Register and Bulletin.

[13] For its request to refer the case to the EBA, the appellant relies on decisions J 10/87 and J 4/03 that allegedly conflict with decisions J 25/03 and J 14/04. As regards decision J 04/03, the Board is unable to see any conflict with decisions J 25/03 and J 14/04 already for the fact that in the specific circumstances of J 4/03, a request for correction of an allegedly erroneous withdrawal was made only after publication had been effected in the Bulletin. For that reason, the question as to whether an entry in the Register could qualify as a relevant notification to the public did not arise in that case. As regards decision J 10/87, it has been explained above why this case should be followed as to the condition of the absence of official notification of the withdrawal to the public, but distinguished from subsequent cases as to the actual application of that condition due to the limited technical possibilities of file inspection back in the 1980ies, as has already been decided in J 25/03 and J 14/04. Therefore, the Board in the present case sees no need to refer a question to the EBA under A 112(1) EPC.

[14] The Board thus takes the view, that, first, there is no reason to deviate from decisions J 25/03 and J 14/04, that, second, advanced technology has made the distinction of “inspection” and “notification” relied upon in case J 10/87 no longer applicable, that, third, there is no justification for distinguishing official information to the public by way of the Register or the Bulletin, and that, fourth, the decision J 4/03 does not address the case of a request for correction after entry of a withdrawal in the Patent Register, but before publication in the Bulletin.

[15] In conclusion of the above analysis, the appellant’s requests for retraction of the withdrawal of its application as a correction of an error under R 139 EPC must be refused. […]

The appeal is dismissed.

J 18/10

Decision J 18/10 deals with a similar case, but here the request for correction was made after the publication in the Register and in the Bulletin. Obviously, the appeal was dismissed, too.

What makes this decision interesting is that the appellant argued that a third party inspecting the complete file of the application at the time of the official notification of the withdrawal to the public would have had a strong suspicion that the withdrawal was made in error since the written opinion and the supplementary search report for the application were extremely favourable. A third party would have therefore expected that the application would proceed to examination with a probable grant of a patent. Further, the reference to the invitation from the EPO requesting it to confirm its intention to further proceed with its application, which the applicant made in the letter withdrawing the application would have surprised a person reading the file, in view of the very positive situation of the application and since there was no need for the applicant to express that it did not wish to continue with the examination of its application.

The Board will not have it:

[4] However, the appellant argued that a third party inspecting the file after the withdrawal would have suspected that the withdrawal was made in error, in view of the positive elements present in the file and the normal expectation that the examination would terminate with the grant of a patent.

The Board cannot follow that line of argument. Even in a case of the application being in a very favourable position in examination proceedings, it remains possible and consistent that, for other reasons, the applicant decides not to proceed further with its application. It is also possible that the applicant is interested in having its application withdrawn immediately instead of having it simply deemed to be withdrawn later.

[5] The appellant further argued that its reference to the invitation from the EPO requesting it to confirm its intention to further proceed with its application in the letter withdrawing the application would have surprised a person reading the file.

With regard to that argument, the Board notes that the withdrawal was explicit, unambiguous and unconditional. The Board sees no contradiction arising from the reference made to the invitation to confirm the intention to further proceed. It is not decisive whether a third party could possibly have been surprised by that reference, since it does not indicate an error.

To download the whole decision, just click here (J 1/11) and here (J 18/10).

The corresponding file wrappers can be found here and here, respectively.

T 2048/07 – Nothing Further

The applicant filed an appeal against the decision of the Examining Divison to refuse his application.

Claim 1 of the final request before the Board read:

A computer-implemented method (400) for dynamic data type enrichment comprising the steps:

• accessing (415), through an application programming interface, API, (190) by an application program (210), metadata (150), wherein the application program (210) uses at least one variable (201) being an ‘integer’, ‘character’, or ‘string’ and wherein the application program (210) calls through the application programming interface(190) at least one metadata service (191, 192, 193) that relates to the corresponding variable (201); and
• enriching the corresponding variable (201) with metadata (150) at runtime when the application program (210) is executed, wherein the metadata (150) is associated with a specific data type (120) defined in a metadata store (220) and the application program (210) provides a mapping (302) between the specific data type (120) and the corresponding variable (201), wherein to specify the specific data type (120), the corresponding metadata (150) includes data type details (151, 152, 153) including a text label, a range of allowed values, constraints or any other data that specifies the specific data type and wherein the data type details (151, 152, 153) are exposed to the application program (210) and its variable (201) through the API (190) in the form of the at least one metadata service (191, 192, 193).

The Board came to the conclusion that this claim lacked inventive step :

Further technical effect

[7.1] [… In] the statement of grounds of appeal […], the appellant identifies the effects achieved by the claimed invention thus:

“System failures due to an otherwise non-matching data type requirement in the underlying system [are] avoided and thereby robustness, reuse and consistency of (mobile) application programs is improved”.

However, the board is not convinced, at least insofar as this suggests that the claimed invention makes the computer system more reliable, in the sense of avoiding program or system crashes. A properly written program expecting a ten-digit customer number will not crash if presented with a twenty-digit one, it will simply reject the input. Indeed, if anything, the proposed invention introduces new dangers of system failure. The problems involved in at first accepting an assignment to a variable of a value consisting of twenty digits, and later changing the definition of that variable to specify that it can only have values of ten digits length, are evident.

The Board accepts that reading certain data usually embedded in program source code from a file would make at least that part of the source code more reusable and the program more flexible and portable […]. However, this is simply an advice on how to write a program, and belongs to the fundamentals of that art. To take an example, if one wanted to write a program to calculate the trajectory of a projectile, one option would be to embed the value of g (acceleration due to gravity, on the earth’s surface approximately 9.8 ms**(-2)) in the source, either as a number or as a defined constant. The program would, however, not work for trajectories on the moon; the system would “fail” if one tried to use it for such a calculation. To make the program cover all cases, the value of g could be made an input variable. It would simply be a programming option that would directly follow from the specification drawn up by a systems analyst: if the specification states that some data may change, the programmer will make it a variable.

[7.2] The program, therefore, contains only features that are necessary to ensure its proper functioning, independent of any technical context in which it should be used. As a consequence, the program lacks a “further technical effect”, i.e. an effect that goes beyond the normal technical effects that would be caused by any program within the computer system on which it runs (T 1173/97 [6]).

[7.3] During the oral proceedings, the representative reformulated the “reliability” argument as an increased availability of the system on which the program is running, since a change of the metadata could be effected without stopping the program. It was argued that this was the required “further technical effect”. However, the board considers that this again is simply a matter of how a program is specified. A correct program is precisely as flexible as it is designed to be. The way in which a formal specification is implemented in a computer program is part of the art of computer programming, which by virtue of A 52(2)(c) and (3) cannot of itself be adduced as an indication of “technical” activity (see G 3/08 [13.5]).

[7.4] In the course of discussion, the representative was asked if, taking the example trajectory program, he would consider there to be the same “further technical effect” in a program which read in the value of “g” rather than having it embedded in the source code. He said that there would indeed be a technical difference between the programs. The board agrees that if the “increased availability” argument were accepted, this would be the consequence. But the implication of this would be that any program which read in any data at all would show a “further technical effect”. The board can not accept this: reading in data is part of the fundamental definition of computing - input, process, output. Thus the board considers that reading in data does not go beyond the normal technical effects that would be caused by any program within the computer system on which it runs, i.e. that reading data is not a further technical effect in itself. Thus the “increased availability” argument, at least in the context of this particular claimed invention, equally fails.

[7.5] The board notes that the claims concern themselves with “metadata”, i.e. a particular subset of data in general. However, the arguments given above are not affected by what the nature of the data is, nor does “metadata” have any inherently technical nature, as might be argued in the case of data relating to some technical process.

Inventive step, A 52(1) and A 56 EPC 1973

[8] Since the program causes no further technical effect, it also solves no technical problem with respect to the prior art of computers in general. As a result, claims 1, 6, 7 and 11 lack an inventive step, according to the established case law of the Boards of Appeal (see e.g. G 3/08 [10.13]). […]

The appeal is dismissed.

Should you wish to download the whole decision, click here.

The file wrapper can be found here.

T 1525/10 – They Never Come Back

Interested in how the Boards apply Article 12(4) RPBA? If so, this decision is for you.

In this case the Opposition Division (OD) decided in its interlocutory decision of March 27, 2007, to maintain the patent under consideration in amended form. The opponent filed an appeal against this decision. Opponent 1 filed an appeal against this decision.

There were interventions pursuant to A 105 on January 17, 2008, and January 23, 2009.

On February 3, 2009, the Board set aside the decision and remitted the case to the OD because the interventions had created a fresh case (decision T 1469/07).

There was still another intervention on February 27, 2009.

In its decision taken on March 17, 2010, the OD revoked the patent. According to the OD, none of the requests met the requirements of A 84, because the feature “wherein the sustained release formulation releases the active ingredient over more than 3 hours” was not clear. Firstly, it was not clear whether the release rate referred to in vitro or to in vivo release. Secondly, the description did not provide any standard test for measuring it and finally, the release data provided in the patent specification were not sufficient for characterising the sustained release.

The patent proprietors filed an appeal against this decision. They filed a main request and auxiliary requests I to V together with the statement of the grounds of appeal.

Claim 1 of the main request read:

1. A sustained release pharmaceutical composition comprising a water soluble salt of fluvastatin as active ingredient and being selected from the group consisting of matrix formulations, diffusion-controlled membrane coated formulations and combinations thereof, wherein the sustained release formulation releases the active ingredient over more than 3 hours. (my emphasis)

Claim 1 of auxiliary request II did not contain this 3-hours feature any more:

1. A sustained release pharmaceutical composition comprising a water soluble salt of fluvastatin as active ingredient and being selected from the group consisting of matrix formulations, diffusion-controlled membrane coated formulations and combinations thereof.

The respondents pointed out that auxiliary request II was not admissible in the light of decisions T 1067/08 and T 23/10, which fully applied to the present case because requests omitting the the 3-hour feature had been withdrawn during the opposition proceedings. Therefore, the patent proprietors should be precluded to reintroduce such claims under Article 12(4) RPBA. The appellants should not have withdrawn the requests and thereby prevented a discussion on the merits if they had intended to pursue them. Moreover, the appellants’ submission was argued not to be allowable in view of reformatio in peius.

In what follows the Board dealt with this admissibility objection:

[2.1] Pursuant to Article 12(4) RPBA an appeal board can hold inadmissible facts, evidence or requests that could have been presented in the opposition proceedings. The boards of appeal thus retain discretion, as a review instance, to refuse new material including requests (claim sets) not submitted during opposition proceedings (T 240/04 [16.2], T 1705/07 [8.4]). The request at issue is one which was before the OD, but which was withdrawn so that no decision was taken thereon. In the board’s view, Article 12(4) RPBA equally confers discretionary powers to hold inadmissible requests that were filed and subsequently withdrawn in the first instance proceedings, since such a course of events shows that these requests could have been presented in the first instance proceedings. The discretionary power under Article 12(4) RPBA has to be exercised appropriately, which requires the appeal board to consider and weigh up the relevant factors having regard to the particular circumstances of each case.

[2.2] It is clear from the minutes of the oral proceedings (OPs) before the OD of 17 March 2010 that the appellants, following the discussion on the main request, withdrew auxiliary requests I to III filed on 25 November 2009, in which the wording “wherein the sustained release formulation releases the active ingredient over more than 3 hours” was omitted. The OD had beforehand informed the parties that it considered the main request to meet the requirements of R 80 […] and A 123 […], whereas the words “wherein the sustained release formulation releases the active ingredient over more than 3 hours” did not satisfy the requirement of A 84 […].

In view of this finding, the withdrawal of those claim requests, in which the objected wording was omitted, appears – as the respondents argue – to be made with the intention of preventing a decision on novelty and inventive step. However, the appellants adverted to the OD’s decision of 20 August 2007 which was later set aside by decision T 1469/07. According to this decision, the release time was critical for establishing novelty vis-à-vis document D13 […]. Bearing in mind the OD’s opinion on novelty, the [patent proprietor’s] regarded it pointless to discuss auxiliary requests I to III filed on 25 November 2009, since it was predictable that the OD would refuse these requests for lack of novelty. For procedural economy, the appellants did not maintain their request that would set back the discussions to the state of the proceedings before the OD’s decision of 20 August 2007.

[2.3] While the auxiliary requests I to III filed on 25 November 2009 may not have been withdrawn with the intention of delaying the opposition and appeal proceedings by seeking remittal upon introduction of these requests into appeal proceedings, the inevitable result of the withdrawal of the requests was that a decision thereon was avoided. As soon as those requests had been withdrawn, they were no longer the subject of a reasoned decision. However, the purpose of appeal proceedings is to review what has been decided at first instance and not to review what has not been decided (T 390/07 [2], also considering circumstances under which a request withdrawn at first instance may be admitted on appeal).

As has been repeatedly stated in the case law, it is neither the purpose of an appeal proceedings to give the patent proprietor the opportunity to recast its claims as it sees fit and to have all its requests admitted into the appeal proceedings.

Thus, if the appellants had wanted to preserve their right to have any of auxiliary requests I to III filed on 25 November 2009 considered by a board of appeal, they should have maintained them, all the more so in the light of the OD’s opinion on the main request. Procedural economy, which in the present circumstances consists in the time it would have taken at OPs to consider auxiliary requests I to III and to reach a decision thereon, and in the time for the OD to provide written reasons, is not a sufficient justification for the appellants’ way to proceed.

Moreover, it is incumbent on both the EPO and users of the European patent system who are parties to proceedings before it to act in good faith (G 2/97 [4.2]). A proprietor who files auxiliary requests by which it delimits the framework of the opposition proceedings and then deliberately withdraws them in order to avoid any adverse decision being reached infringes this general principle by seeking to introduce these requests into appeal proceedings.

In conclusion, the board, having regard to the facts and arguments presented to it, decided to make use of its discretionary powers according to Article 12(4) RPBA not to admit auxiliary request II, in which the words “wherein the sustained release formulation releases the active ingredient over more than 3 hours” had been omitted, into the appeal proceedings.

[2.4] Although the following considerations are not relevant for the board’s decision not to admit auxiliary request II into the proceedings, the board wishes to take a stance with regard to additional arguments submitted in this context.

[Opponent 1] argued that the admission of auxiliary request II would be contrary to the interdiction of reformatio in peius, i.e. the prohibition of a possible worse outcome of appeal proceedings for the (sole) appellant as compared to the decision under appeal. The legal situation in this regard has been elucidated in the decisions of the Enlarged Board (EBA) G 9/92 and G 4/93. The implications are limited to cases in which an interlocutory decision on the maintenance of a patent in amended form is appealed only by one of the parties. Since the present appeal lies from the OD’s decision to revoke the patent, the interdiction of reformatio in peius cannot have a bearing on the appeal and all the more on the question of admission of auxiliary request II.

[Opponents 2 to 4] relied on the decisions T 1067/08 and T 23/10 refusing late filed claim requests pursuant to Article 12(4) RPBA. The appellants contested the pertinence of these decisions in view of the different factual circumstances. The board notes in this respect that the exercise of the discretionary power under Article 12(4) RPBA requires the appeal board to have regard to the particular circumstances of each case. The facts of the individual case will thus clearly affect any decision on the admission of late filed requests. Therefore, the decision invoked by the respondents cannot foreclose the weighing of the relevant factors having regard to the particular circumstances of each case.

Nevertheless, as the EBA pointed out in its decision R 11/08 [11], the usefulness of case-law is not confined to similar or identical facts; rather it lies in the legal principles or guidance which, whether the facts are similar or not, can be extracted from earlier cases.

In this respect the present decision conforms with the legal principle stated in the cited decisions that there is no right of the patent proprietor, be it pursuant to A 133(1) or A 113(2), to have claim requests admitted at any stage of opposition and opposition appeal proceedings.

Thus, the admission of new claim requests remains a matter of discretion which may or may not be exercised in a party’s favour on the basis of the facts of the individual case. This legal principle has also been confirmed by the EBA (R 10/09 [2.2]; R 11/11 [9-10]).

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T 1744/09 – Retroactive Identification

The opponent filed an appeal after his opposition had been rejected by the Opposition Division (OD)

The notice of opposition contained in the letterhead the data identifying the patent and the proprietor. The letterhead further contained the following identifications:

Opponent: EADS Space Transportation GmbH (with address)

Address for correspondence: EADS Deutschland GmbH (with adress)

Immediately following the letterhead, the notice of opposition started with the following sentence (in English translation):

“In the name of EADS SPACE Transportation GmbH, a company affiliated (konzernverbunden) to EADS Deutschland GmbH, we hereby file an opposition …”

Following the detailed reasons of the opposition, the notice of opposition on the last page was signed as follows:

The patent proprietor argued during the opposition proceedings that the opposition was inadmissible, because the representative of the opponent appeared to be the EADS Deutschland GmbH, a legal entity not being entitled to represent the opponent.

The OD held that the opposition was admissible, and that the grounds invoked by the opponent did not prejudice the maintenance of the patent as granted.

The decision was reasoned both on the admissibility issue and on the substantive grounds of the opposition. In the minutes of the oral proceedings (OPs) the following order is recorded:

By contrast, the order of the written decision reads:

A notice of appeal was filed in the name of EADS Space Transportation GmbH, again signed by Mr H. (but not containing EADS Deutschland GmbH in the signature). The statement of grounds of appeal contained a letterhead and a signature similar to that of the notice of opposition, with the difference that a further general authorisation number (“AV-Nr. 48428”) was also indicated under the handwritten signature.

Here is the verdict of the Board:

Admissibility of the opposition and the appeal

[1.1] During the OPs the [patent proprietor] expressly acknowledged that the person of the (original) opponent has been clear from the very beginning and all through the procedure. The main objection against the admissibility of the opposition and the appeal is the missing signature, more precisely an “invalid” signature. The signatures in question as they stand must be considered to be the signature of EADS Deutschland GmbH. The invalidity is caused by the lack of power of EADS Deutschland GmbH, as a legal person, to represent EADS Space Transportation GmbH as a party before the EPO. According to the [patent proprietor], the undisputed fact that Mr H. was in fact a professional representative according to Article 134(1) EPC does not help the opponent. The [patent proprietor] contends that as the documents on file did not indicate that Mr H. is acting in his capacity as a professional representative, this has the effect that his actions (here the signing of the grounds of appeal) are without legal effect, in the sense that these are not to be recognised as actions taken by a professional representative.

[1.2] The board does not follow this line of argument for lack of any legal basis, as explained below.

[1.3] As an initial remark, the board notes that an “invalid” signature can hardly have more serious consequences than a missing one. A missing signature only leads to loss of rights if the deficiency is not remedied within a time limit after an invitation from the Office (R 50(3), last sentence). Even if the board were to find that the signature were missing or “invalid”, it could not order the legal effect (inadmissibility) desired by the [patent proprietor], but would have to invite the appellant to remedy the deficiency (R 50(3), second sentence).

However, as will be further explained below, the board finds that the opponent was properly represented and all the documents, in particular the opposition and the grounds of appeal, were properly signed.

[1.4] A 134(1) establishes that representation in proceedings before the EPO is mostly the privilege of the professional representatives registered as such with the EPO, with some exceptions which are not relevant here. Representation means the ability to make legal statements on behalf of the authorising party, with the legal effect that the relevant rights and obligations directly affect the authorising party, without any further confirming act of the latter. This is why a representative needs to be fully aware of the legal consequences of his actions, i.e. must have personally acquired the necessary professional competences to act for his client.

[1.5] The above explains why representation is mostly restricted to professional representatives. Otherwise, the EPO does normally not enquire for the specific conditions of employment between a party and the professional representative acting for the party, as long as the EPO is satisfied that the representative is indeed authorised by the affected party to act as such. This will normally have been expressed by the issuance of a formal power of attorney (authorisation) to the representative, but such power need not even be put in writing. The entitlement to represent is based on the factual existence of such a power, whether verbal or written, and the corresponding provisions of the Convention, A 133, which specifically permit parties to act in the proceedings through a representative.

[1.6] A 134, which is dedicated specifically to professional representatives, concerns only the personal conditions for acting as such. Some further formal conditions for exercising the power to represent are regulated by R 152 (A 134 EPC 1973 and R 101 EPC 1973 is applicable for the notice of opposition, but the differences are not relevant here). The single formality this rule foresees is the filing of an authorisation. R 152(1) and (5) further delegates power to the President of the EPO to determine eventual further formal conditions which need to be fulfilled so that the professional representatives (and also others) may make effective use of their powers to represent. However, it is to be noted that R 152(1) restricts the powers of the President to determine “the cases in which a signed authorisation shall be filed by representatives acting before the EPO”. This rule includes all types of representatives, and it is a further indication that the legislator foresaw the possibility for representatives to act before the Office without any special formalities. Similarly, R 152(5) restricts the powers of the President to determine “the form and content” of authorisations.

[1.7] The President made use of his delegated powers to regulate the question of authorisations in the “Decision of the President of the EPO dated 12 July 2007 on the filing of authorisations” (Special Edition No. 3, OJ EPO 2007, 128, hereafter “Decision”). However, neither R 152 nor the Decision contains any formal requirement that the documents signed by professional representatives must indicate their basis of entitlement in order to be recognised as valid. It is true that Article 1(1), first sentence of the Decision states that a professional representative who identifies himself as such shall generally not be required to file an authorisation (emphasis by the board). Obviously, such an indication is useful and to be recommended, but it has no immediate legal effect per se if it is missing. R 152(2) and the President’s Decision merely instruct the Office how to proceed in this case: The apparent representative is invited to furnish an authorisation (Article 1(3), 2 and 3 of the Decision). Obviously, such an invitation also permits the Office to enquire about the legal position of the apparent representative if this should not be clear from the submissions. Only when “a required authorisation is not filed in due time”, i.e. following an invitation from the Office, will a legal consequence follow pursuant to R 152(6), namely that the applicable procedural step shall be deemed not to have been taken (emphasis by the Board). Still, even in this case the legal consequence is not caused by the initially missing indication (declaration) of the legal position of the apparent representative (i.e. the missing indication whether he is a professional representative, a legal practitioner or an employee), but rather by the failure to prove that he has the powers and the entitlement to represent.

[1.8] For sake of completeness, the same holds for the previous Decision of the President (Decision of 19.07.1991, OJ EPO 1991, 421) and R 101(4) EPC 1973 applicable at the time of filing the notice of opposition.

[1.9] Moreover, neither any article or rule of the Convention, nor the Decision does preclude that the professional representative identifies himself retroactively. Such a retroactive identification may also obviate the need for a formal authorisation (see also T 850/96 [3.3]). This is also superfluous in most cases, given that the Office maintains a continuously updated register of the professional representatives entitled to act before the Office, and this register is easily accessible for all the involved parties.

[1.10] Given the above, it is immaterial that Mr H. was probably an employee of a third party, and was using the address of his employer as the address of correspondence. It is equally irrelevant that probably out of habit, he also indicated his employer in his signature, thereby possibly implying that the signature is made on behalf of his employer, adding some confusion to the matter. But even this confusion does not detract from the fact that at the time of signing he was personally a professional representative registered with the EPO (A 134(1)) and as such entitled to represent the opponent and to sign on its behalf as well. For this signature, his own name and the indication that he is signing on behalf of the opponent was sufficient.

Moreover, his entitlement to represent did not stem only from his personal qualification as a professional representative and some unidentified agreement between him and the opponent, but this was further evidenced by a general authorisation issued by the opponent and deposited with the Office. The registration number of the general authorisation (AV-Nr. 48310) was explicitly referred to under his signature. On the other hand, on the basis of the totality of the facts, the indication of EADS Deutschland GmbH in the signature objectively did not serve any identifiable purpose for the opposition procedure before the EPO and therefore may be ignored. Whether it might serve some other purpose outside of this procedure need not be examined here.

[1.11] Therefore, the board finds that the representative of the opponent, now appellant, did validly sign both the opposition and the notice of appeal in his capacity as professional representative.

[1.12] The other argument advanced against the admissibility of the appeal is based on the fact that the original opponent, EADS Space Transportation GmbH did no longer exist by the time the notice of appeal was filed, and therefore no admissible appeal could have been filed in its name.

[1.13] However, it is undisputed that EADS Space Transportation does presently have a universal legal successor, and in fact did have one at all times during the proceedings.

[1.14] It is true that a person, whether natural or legal, which has ceased to exist, cannot perform legal acts, or put differently, cannot acquire rights or obligations. Nevertheless, what matters in the present case is the fact that the rights and obligations of the ceased person – here EADS Space Transportation GmbH – have been transferred to its universal legal successor as a matter of national law, without any interruption in the existence of the rights and obligations (see also T 425/05 [1.2]). These rights and obligations include all substantive and procedural rights before the EPO, no matter under what name they were established. The basis of the acquisition and the continued existence of these rights is the continuous factual existence of a person having legal capacity (“Rechtsfähigkeit”, “capacité juridique”) under the relevant national law, including the ability to legally succeed its legal predecessor. But the continuous existence and use of its original name is not required for maintaining the rights and serving the obligations, because the name is merely an identifier, an attribute of the person, but not a holder of rights. For the same reason, it is immaterial that the universal legal successor continued to use the original name in the proceedings before the EPO. The fact that the legal succession has not been recorded with the Office does not preclude the continued actions of the legal successor under the previous name, as long as a legal successor exists and remains identifiable. This means that in the present case, from a legal point of view the appeal has been filed on behalf of the universal legal successor of the original opponent existing at the relevant time, namely Astrium GmbH, even though the notice of appeal and the grounds of appeal were formally filed in the name of the original opponent EADS Space Transportation GmbH. This is why Astrium GmbH could later be recorded as the opponent and appellant, simply confirming towards the proprietor and third parties that it had been the original appellant all through the appeal proceedings. As such, it is not the same as a transfer of the opposition, which requires notification of and consent by the EPO.

[1.15] The legal conclusion argued by the respondent, namely that no legally valid actions can be taken in the name of the ceased person, would lead to untenable results. For example, the Office would not be able to take any action in the proceedings, because it would not be possible to notify communications or decisions, hence they would not be legally effective (see also T 425/05 [1.3]). Further, instead of relying on the subsequent filing of extracts from company registers in order to prove the changes in person, parties would need to declare immediately any changes in their person, in order to prevent any loss of rights. It would be most unrealistic to expect that any legal succession between natural or legal persons should be timed depending on actions which are to be expected from or need to be performed before the EPO. Now given the fact that the legal successor of a party may not even be immediately known – a situation not uncommon in case of inheritance between natural persons -, such an immediate declaration towards the office may simply prove to be impossible. It is also conceivable that a representative making legal statements to the Office on the basis of previous instructions from a party may not even be aware of a possible death or other form of cessation of his client, thus not even knowing that his actions are potentially invalid. This illustrates well why the arguments of the respondent cannot be followed.

[1.16] Otherwise, the notice of the appeal and the grounds of appeal were timely filed and the appeal fees were paid. The grounds of appeal were sufficiently reasoned.

[1.17] In conclusion, the board holds that the opposition and the appeal is admissible.

The Board then went on to assess inventive step and concluded that the subject-matter of claim 1 lacked inventive step. It then considered the opponent’s request for reimbursement of the appeal fee:

[3.1] Besides stating that the OD has decided to reject the opposition, the cover sheet of the notification of the written decision, form 2330, includes an “additional decision” that “the opposition is ... rejected as inadmissible”. This additional decision is not included in the decision duly announced at the OPs as indicated on form 2309.2 of the minutes. Moreover, it conflicts directly with the OD’s finding recorded at point 9 of the minutes, and the reasons given under the corresponding heading on pages 2 and 3 of the grounds of the decision. These record that admissibility was considered, but that the division found in favour of admissibility of the opposition.

[3.2] The Board concludes on the face of these facts that the “additional decision” indicated on form 2330 is an obvious mistake, as it clearly does not reflect the OD’s intention as evident from the reasons and the minutes and the decision’s announcement at the OPs. The Board holds that such an obvious mistake does not constitute a substantial procedural violation which might have justified a reimbursement of the appeal fee under R 103(1)(a). The mistake may have caused initial surprise to the [opponent]. However, the Board is unable to see how, once it became clear to the [opponent] that it was a mistake and what the division’s true intent had been, this might have deprived the [opponent] of his rights or affected due process. As the Board finds no substantial procedural violation it concludes that a reimbursement of the appeal fee is not justified.

[3.3] The proper remedy for obvious mistakes in decisions is provided by R 140. However, as the decision under appeal is to be put aside, the question whether or not to correct the decision is moot.

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T 1695/07 – More Bloody Stuff

Both the patent proprietor and the opponent filed an appeal against the decision of the Opposition Division (OD) to maintain the patent under consideration in amended form.

Claim 1 of the main request before the Board read:

1. A process for measuring the rate of blood flow in a shunt (12) in which blood is flowing, comprising:

continuously removing blood from a downstream

location in the shunt (12) by way of an inlet (28)

to an inlet side (26) of a circulating line;

delivering the removed blood flowing in said

circulating line by way of an outlet (34) connected to an outlet side (32) of said circulating line to an upstream location of said shunt (12), so as to cause it to travel downstream in the shunt (12) towards the inlet (28) as an admixture with the blood flow;

changing a selected physical property of the blood in said circulating line to produce a distinguishable blood characteristic at the outlet side (32) of said circulating line;

measuring the amount of change of said

distinguishable blood characteristic; and

determining the rate of blood flow in said shunt (12) from the amount of change of said distinguishable blood characteristic by reference to a dilution curve of said amount of change.

Obviously, the question arose whether this was a surgical method and, as such, excluded from patentability:

[5] Claim 1 is directed to a process for measuring the rate of blood flow in a shunt in which blood is flowing. It comprises the steps of “continuously removing blood from a downstream location in the shunt (12) ...” and “delivering the removed blood flowing in said circulating line by way of an outlet (34) connected to an outlet side (32) of said circulating line to an upstream location of said shunt (12), ...”.

[5.1] According to the very first paragraph of the patent in suit, the process of Claim 1 is for measuring arterio-venous shunt blood flow during haemodialysis. Still according to the patent in suit (Paragraph [0002]), haemodialysis is a process by which an artificial kidney replaces the function of a patient’s kidney. The majority of patients have an arterio-venous shunt implanted in a location having a high blood flow, to simplify the withdrawal of blood from a location close to the arterial side of the shunt and the return of the purified blood downstream of the withdrawal site, i.e. closer to the venous side of the shunt. The implanted shunt can be a native or artificial vessel that has been established surgically between a patient’s artery and vein.

[5.2] Since Claim 1 as granted is thus directed to a process that is carried out in vivo on a human or animal body, from which blood is removed and reintroduced, it has to be decided whether the claimed process is a method for treatment of the human or animal body by surgery falling under the exception clause of A 53(c).

[5.3] In this regard, the criteria developed in decision G 1/07 of the Enlarged Board of Appeal (EBA) have to be taken into consideration.

The criteria developed in G 1/07

[6] Before dealing with the criteria of G 1/07 in detail, it is necessary to deal with the proprietor appellants’ assertion that exclusions from patentability should be construed narrowly.

[6.1] According to G 1/07 [3.1], a provision containing exclusions or exceptions from patentability is to be interpreted in such a manner that it takes its effect fully and achieves the purpose for which it was designed.

[6.2] As further explained in G 1/07 [3.4.2.1-3], the broad construction of the term “treatment by surgery” as previously developed in T 182/90 and T 35/99 was no longer justified. Also, the definition given in opinion G 1/04 [6.2.1] that “any physical intervention on the human or animal body ...” is a method of surgery within the meaning of A 52(4) EPC 1973 appeared too broad.

[6.3] A “narrower understanding” of what constitutes by its nature a “treatment by surgery” within the meaning of A 53(c) was hence required. It was generally stated (Reasons [3.4.2.2]) that “such a narrower understanding rules out from the scope of the application of the exclusion clause uncritical methods involving only a minor intervention and no substantial health risks, when carried out with the required care and skill, while still adequately protecting the medical profession” [emphasis added]. In particular it was found that it “appeared hardly still justified to exclude from patentability certain, albeit invasive techniques, at least when performed on uncritical parts of the body”, which were carried out in a non-medical, commercial environment like in cosmetic salons and in beauty parlours” [emphasis added]. This was said to apply “as a rule to treatments such as tattooing, piercing, hair removal by optical radiation, micro abrasion of the skin”. On the other hand, it was required that the “definition of the term “treatment by surgery” must cover the kind of interventions which represent the core of the medical profession’s activities, i.e. the kind of interventions for which their members are specifically trained and for which they assume a particular responsibility”. These physical interventions on the body were defined as those which “require professional medical skills to be carried out and which involve health risks even when carried out with the required medical professional care and expertise” [emphasis added].

[6.4] Therefore, G 1/07 [3.4.2.4] indicates a new direction in which further practice and jurisprudence should develop, namely that the exclusion from patentability should apply only to methods in respect of which it is justified on grounds of public health, the protection of patients and the freedom of the medical profession to apply the treatment of choice to its patients.

[6.5] In the present case it now has to be decided whether the process of Claim 1 as granted belongs to the kind of methods which should not be covered by the exception clause according to this “narrower understanding” of the EBA and according to the criteria developed in G 1/07. According to G 1/07 [3.4.2.6], this assessment has to be done on a case-by-case basis, with each category of cases being assessed on its own merits.

[7] The main criteria developed in G 1/07 concern the criticality of the parts of the body affected by the method, the degree of intervention, the environment in which the method is carried out, the required medical expertise, if any, and the health risks incurred (as highlighted in Point [6.3], supra). These points will be considered in the following sections.

Criticality of the parts of the body affected by the method

[8] The claimed process involves the continuous removal of blood from a shunt, its subsequent flowing through a circulating line of an extracorporeal circuit and the re-delivery of the blood to the shunt, where it forms an admixture with the blood flowing in the shunt.

[8.1] In a medical sense, blood is a (flowing) organ of the human body, performing numerous functions which are essential to the health of the patient (T 1075/06 [2.1.1.2]). Accordingly, it can hardly be regarded as an “uncritical part of the body”.

[8.2] As regards the arterio-venous shunt, it can be created by joining an artery and a vein together through anastomosis, to bypass the capillaries, whereby a high blood flow is created in the shunt. Alternatively, an artificial vessel can be used to join artery and vein. The shunt is usually created in the lower arm but may also be situated on the hand. In any case, at least when the shunt is created by anastomosis to ensure the required access to the blood, in order to carry out haemodialysis, the shunt too cannot be regarded as an “uncritical part of the body”.

[8.3] Therefore, the claimed process is practised on body parts (blood and shunt) that are not uncritical for the health of the patient, whereby at least one of them (blood) is manipulated during the process. As mentioned in G 1/07 [3.4.2.5], “manipulating a body part is traditionally considered surgical”. The Board considers that this traditional approach still applies to “in vivo” blood manipulation, blood not being an uncritical organ of the body.

[8.4] Hence, the claimed method surgically affects a not uncritical part of the body.

Degree of intervention on the human or animal body

[9] The specification of the patent in suit neither discloses a specific amount of the blood flow rate in the circulation line, nor the duration of the process. According to D19 […], a typical flow value is 300 ml/min. Taking into account a duration of about 10 min, acknowledged as typical by the proprietor appellants […], the total quantity of blood flowing through the circulation line of the extracorporeal circuit during the measurement would be about 3 litres, i.e. more than one half of the average total blood volume of an adult patient. Even if the duration of the measurement were to be shorter, a substantial volume of blood is nevertheless being circulated during the measurement.

[9.1] Since the process of Claim 1 as granted involves a continuous manipulation of a large part of the flowing organ blood in an extracorporeal circuit connected to the patient, it is far from being a “minor intervention”. The claimed process therefore involves a significant degree of intervention on the body.

The environment (medical, non-medical, commercial)
in which the method is carried out

[10] That the process of Claim 1 as granted is performed “during haemodialysis” is not only disclosed in […] the patent in suit but also indicated in D19 […]. As a rule, haemodialysis is carried out in a medical environment, i.e. hospital, clinic or dialysis centre. The fact that, in some countries, nowadays, haemodialysis may also be carried out at home represents the exception rather than the rule, an exception which is only available under very specific conditions for certain kinds of patients, who nevertheless require detailed instructions and temporary assistance of medically trained personnel.

[10.1] Although, as ruled in opinion G 1/04 [6.3], the fact that the method steps can also be practised by the patient himself or herself is not a decisive criterion with respect to the applicability of the exception clause, the conditions under which the claimed method is carried out are nevertheless not comparable to a “commercial environment like cosmetic salons and in beauty parlours”, where certain kinds of treatment may not be excepted from patentability.

[10.2] In the Board’s view, the process of Claim 1 as granted is performed in an essentially clinical environment, i.e. in a medical environment.

Required professional medical expertise

[11] Claim 1 itself does not address haemodialysis, but as indicated above its process is carried out during haemodialysis.

[11.1] Haemodialysis is usually prescribed and supervised by nephrologists, as a consequence of a serious kidney dysfunction, i.e. of the inability of the kidneys to ensure the cleaning of the blood and the water balance in the body, resulting in accumulation of water and dangerous substances in the body, eventually leading to dysfunctions in almost all of the organs of the body. The treatment is initiated and managed by specialised medical staff specifically trained in extracorporeal blood treatment techniques, according to the detailed instructions of the physician and under his or her control and responsibility.

[11.2] In order to perform the claimed measurement process, the dialysis treatment has to be interrupted, the direction of flow in the shunt is to be reversed and the rate should be set at a specific value (e.g. 250 to 300 ml/min, see D19 […]). In the Board’s view, these steps in particular require a dedicated decision of the responsible physician. This becomes also evident from the fact that D19 […] restricts the use of the claimed measurement process to “patients under stable cardiovascular condition” and specifically excludes “unattended monitoring of conditions which could result in imminent danger to the patient”.

[11.3] Therefore, the claimed in vivo process requires “professional medical expertise”.

[11.4] Referring to G 1/07 and T 663/02, the patent proprietor appellants argued that “professional medical expertise can only be considered to be the expertise of a doctor or ‘physician’”, which was to be distinguished from the care and skill of a “duly trained and qualified nurse or paramedical professional” to whom a physician may delegate minor routine interventions not implying a substantial health risk for the patient. Since the claimed method was routinely carried out by a nurse or dialysis technician, i.e. paramedical personnel, it represented a delegated act which could not be considered as belonging to the “core of medical activities” and should thus not fall under the exception clause.

[11.5] The Board cannot follow this approach for the following reasons. It is true that G 1/07 [3.4.2.3] states that “any definition of the term treatment by surgery must cover the kind of interventions which represent the core of the medical profession’s activities”. This positively formulated requirement, however, does not imply that interventions which do not represent the core of the medical profession’s activities do not generally fall under the exception.

[11.6] Moreover, G 1/07 uses the definition of “the core of the medical profession’s activities, i.e. the kind of interventions for which its members are specifically trained and for which they assume a particular responsibility”. The term “medical profession” cannot be regarded as being restricted to medical doctors and physicians, i.e. academically trained personnel. It appears that the broad term “medical profession” was chosen to cover all health care providers who professionally practise medical acts, thus also physicians under training, nurses and other paramedical professionals, who are undoubtedly “specifically trained” and assume “a particular responsibility” for the interventions they perform. Any other interpretation would run against the purpose of the exception provision which is, as set out by the EBA, to free the medical profession from constraints which would be imposed on them by patents granted on methods for surgical treatments, because also paramedical staff act in the interest of public health and patients.

[11.7] This understanding is consistent with the choice of the similarly broad term “medical or veterinary practitioner” used in Opinion G 1/04 with respect to diagnostic methods, which was explicitly distinguished from the more specific term “physician” (Reasons, point [2]). In point [6.3] of the Reasons of this Opinion, it is clearly stated that

“whether or not a method is a diagnostic method within the meaning of Article 52(4) EPC [1973] should neither depend on the participation of a medical or veterinary practitioner, by being present or by bearing the responsibility, nor on the fact that all method steps can also, or only, be practised by medicinal or non-medicinal support staff, the patient himself or herself or an automated system”.

[11.8] Accordingly, no distinction is to be made between a delegating physician and paramedical (or even non-medical) support staff with respect to the performance of diagnostic methods, and it cannot be derived from G 1/07 that such a distinction should apply for surgical methods. On the contrary, the approach taken in G 1/04 is explicitly confirmed by G 1/07 [3.4.1] as follows:

“Whether or not a method is excluded from patentability under A 53(c) cannot depend on the person carrying it out. The findings of the EBA in point [6.3] of the Reasons of G 1/04 relate to diagnostic methods, but they quite generally deal with the exclusion from patentability under A 52(4) EPC 1973 and are thus equally valid with respect to the other exception conditions contained in A 53(c)”.

[11.9] Therefore, the present Board does not follow the approach (“paramedical profession”) suggested in T 663/02 [3.2.4].

Health risks

[12] In the extracorporeal circuit, the blood is subjected to conditions of a non-natural environment quite different from the vasculature within the patient’s body. In order to avoid deleterious effects on the blood in the extracorporeal circuit and resulting negative side effects on the patient upon its re-delivery, a number of measures and precautions must be taken. In particular, sterility must be maintained in order to avoid infections, and the temperature and the blood flow rate be properly controlled. Bubble traps are usually installed within the circuit in order to exclude the presence of air in the re-delivered blood which could lead to embolisms. Moreover, leakages resulting in blood losses have to be avoided. Blood clotting due to shear stresses and contact with artificial surfaces represents a serious risk since it may lead to thrombosis. This usually requires the addition of an anticoagulant, i.e. a medicament. Further problems and health risks might arise from the fact that the shunt, where flow is to be measured, can already be partially stenosed and that the inverted flow of blood therein causes blood clots to be dislodged into the patient’s circulatory system. All these conditions must be continuously monitored and carefully controlled, and in cases of deviations and problems, immediate action must be taken to prevent danger for the patient (who is normally already in an impaired health state due to chronic renal failure, thus particularly sensitive to treatment). This requires the attendance of specially qualified and medically trained personnel, and, as a rule, the presence of a physician who at least supervises the procedure. Moreover, the necessary emergency equipment and personnel must be available. Most of the above-mentioned aspects also become directly evident from page 3 of D19. It is therefore clear that the patient is subjected to a number of health risks, even when the process is carried out with the required medical professional care and expertise. Some of these risks are certainly “substantial”, even though the likelihood of their occurrence may be rare.

[12.1] The proprietor’s argument that they were not aware of any complications or health risks, these only being hypothetical and not based on any evidence or reports, is not convincing.

[12.2] In the Board’s view, the wording “entails” or “involves a substantial health risk” used in G 1/07 cannot be understood as requiring a factual risk analysis based on objective evidence for the following reasons.

[12.2.1] Firstly, any risk is “hypothetical” by its very nature. In principle, it may be possible to quantify the likelihood of occurrence of a certain risk in absolute terms, taking into account statistical data. However, in many situations, significant and reliable data are not available. This applies in particular to the evaluation of health risks for patients undergoing a medical treatment. Since the treatment is generally adapted to the individual patient, comparable and thus reliable data are difficult to obtain. For new kinds of treatment, such as are frequently the subject of patent applications, e.g. the reversal of blood flow in a shunt in the present case, such data as a rule do not yet exist at all.

[12.2.2] Moreover, what would seem relevant is not a risk analysis on an absolute scale, but a relative evaluation of the health risks for the patient. This implies a consideration of the physical state of the individual patient and a judgement of the health risks in relation to the potential benefit to be achieved by the intervention. This judgement or balance itself would require “professional medical expertise” and belongs to the “core of the medical profession’s activities”.

[12.2.3] For the above reasons, the Board is of the opinion that an objective and concrete analysis of the absolute or relative risks, which is hardly feasible, cannot have been intended by the EBA and should therefore not be required. Accordingly, the present Board has not followed the approach (“risk matrix”) suggested in T 663/02 [3.2.5].

[12.2.4] The assessment of the “risk-criterion” is therefore limited to a more abstract basis, i.e. to the questions “Is a certain health risk present?” and “Is it substantial?”. A health risk is considered to qualify as “substantial” whenever it goes beyond the side effects associated with the treatments mentioned in G 1/07 (piercing, tattooing, etc.) which are generally limited to harmless infections of superficial tissues due to non-sterile working conditions.

[12.2.5] In contrast thereto, the above-mentioned health risks of the claimed method, which are objectively present, are undoubtedly “substantial”.

Conclusion

[13] It follows from the above that the claimed process does not fall under the “narrower understanding”, i.e. does not belong to the kind of methods which should not be covered by the exception clause according to the criteria developed in G 1/07.

[13.1] Claim 1 comprises the steps of “continuously removing blood from a downstream location in the shunt (12) ...” and “delivering the removed blood flowing in said circulating line by way of an outlet (34) connected to an outlet side (32) of said circulating line to an upstream location of said shunt (12), ...”.

[13.2] It has been established that these steps are invasive and represent a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise (G 1/07 [headnote 1, 3.4.2.7, last §]).

[13.3] According to the established jurisprudence of the Boards of Appeal, a multi-step method falls under the exception clause of A 53(c), if it includes at least one feature that constitutes a method step for the treatment of the human body by surgery (G 1/04 [6.2.1]; G 1/07 [3.2.5]).

[13.4] The possible technical contribution of the invention as mentioned by the proprietor appellants is not a criterion to be taken into consideration in this context.

[13.5] The present case is quite different from that underlying T 329/94, referred to by the proprietor appellants, which related to a blood extraction assistance method for facilitating sustained venous blood flow through a human limb towards a venous blood extraction point. In that case the blood extraction itself did not form part of the claimed subject-matter. If that had been the case, it was stated that withdrawal of blood would have fallen under the exclusion clause of A 52(4) EPC 1973 three times, namely as treatment by therapy and surgery and as a diagnostic method (point [4] of the Reasons). With respect to the last two aspects it must be noted, however, that decision G 1/07 and opinion G 1/04 have subsequently been issued by the EBA and the criteria developed therein must now be taken into consideration.

[13.6] Therefore, Claims 1 to 8 of the Main Request are directed to a method for treatment of the human body by surgery which is excepted from patentability under A 53(c).

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More post-G 1/07 decisions can be found here, here and here.

T 2020/07 – Cutting Out Trade Marks

Let us come back to this decision which I presented in a previous post. 

Having found the main request as well as the first and second auxiliary request to lack novelty, the Board examined the third auxiliary request in which the patent proprietor tried to overcome the novelty objection by means of a noteworthy disclaimer.

Claim 1 of this request read (in English translation) :

1. Process for the preparation of polyisobutenylphenol-containing Mannich adducts by

(a) alkylation of a phenol with polyisobutene having more than 70 mol% of vinylidene double bonds and a number average molecular weight of from 300 to 3000 at below about 50°C in the presence of an alkylation catalyst;

(b) reaction of the reaction product from a) with formaldehyde, an oligomer or a polymer of formaldehyde and at least one amine HNR4R5, wherein the radicals R4 and R5 are methyl, ethyl, n-propyl, isopropyl, n-butyl, isobutyl, sec-butyl, tert-butyl, n-pentyl or n-hexyl,

with the exception of a process wherein step (a) is carried out as follows:

Phenol (203.2 g, 2.16 mol) is melted at 40°C and added to boron trifluoride etherate (73.5 ml, 0.60 mol) in a 5 litre round bottomed flask. Ultravis 10 (1040 g, 1.09 mol), is dissolved in hexane (1863 ml) and the solution is added to the flask containing the phenol via a pressure equalizing dropping funnel, at a rate sufficient to maintain the temperature of the reaction mixture at 22-27°C over a period of three hours. The solution is stirred for an additional 16 hours at room temperature before ammonia (400 ml of 30% w/w aqueous, 2.88 mol) is added. Water (1000 ml) is added and the mixture is stirred. The solution is separated into an organic layer and an aqueous layer using a five litre separating funnel. The aqueous layer is extracted using hexane. Four extraction steps are used, with 500 ml of hexane being used in each extraction step. The organic layers from the four extraction steps are combined and dried over MgSO4 overnight, then filtered through a 12 mm Celite pad. The solvent is removed from the filtrate at 80°C/23"Hg on a rotary evaporator;

and the amine is dimethylamine, N-methyl-ethylamine, or dibutylamine. (Board’s emphasis)

*** Translation of the German original ***

[5] […] Claim 1 of the third auxiliary request also contains a disclaimer which is a complete translation of part A of the example of D1, with the exception of the last sentence (which is a statement on the para to ortho ratio of the PIB phenol mentioned there). According to the [patent proprietor] its only purpose is to exclude the novelty destroying disclosure of D1. […]

[5.1] As the third auxiliary request was filed only during the oral proceedings (OPs), [the Board] first has to examine whether it complies with the criteria for admissibility under the EPC (A 123(2)) and Articles 12 and 13 RPBA.

[5.1.1] According to the RPBA, the statement of grounds of appeal and the reply shall contain a party’s complete case, including all documents related to it. The appeal proceedings are based on these submissions of the parties (Articles 12(1)(2) RPBA). According to Article 13(1) RPBA the admission of any later submissions of the parties are considered at the Board’s discretion. The Board shall take into account the complexity of the new submission, the current state of the proceedings and the need for procedural economy.

[5.1.2] In the present proceedings, sets of claims containing a disclaimer with respect to D1 were first filed as auxiliary requests 6 to 11 on February 27, 2008, together with the statement of grounds of appeal.

[5.1.3] In the light of this fact, the third auxiliary request, which was filed during the OPs, cannot be considered to be an amendment of the submissions of the [patent proprietor] that would increase the complexity of the case or go against the due procedural economy within the meaning of Article 13(1) RPBA. Rather, when filing its statement of grounds of appeal, the [patent proprietor] had already tried to formulate a request allowing to avoid a negative assessment and, as a consequence, the loss of the opposed patent due to a lack of distinction over D1. In the subsequent appeal proceedings it had always maintained and, whenever and to the extent required, amended these auxiliary requests. Given this situation the Board has come to the decision to consider the third auxiliary request to be appropriate (sachdienlich) and to admit it into the proceedings.

[5.1.4] According to decisions G 1/03 and G 2/03 of the Enlarged Board of appeal (EBA), a disclaimer the content of which was not disclosed in the original documents of the application that led to the opposed patent may be allowable in order to restore novelty by delimiting a claim against state of the art under A 54(3) or against an accidental anticipation under A 54(2), or in order to disclaim subject-matter which, under A 52 to A 57, is excluded from patentability for non-technical reasons (see headnote 2.1). A disclaimer should not remove more than is necessary to reach that goal. Otherwise, the claim into which the disclaimer has been inserted violates A 123(2) (see headnotes 2.2 and 2.3). According to headnote 4, a claim containing a disclaimer must meet the requirements of clarity and conciseness of A 84.

[5.1.5] The definition of the process features in paragraphs (a) and (b) of claim 1 of the present third auxiliary request are identical with the definitions of features (a) and (b) in claim 1 of the second auxiliary request. As seen [above], process variant (b) [of claim 1] of the second auxiliary request does not comply with the requirement of novelty pursuant to A 54(1) and A 54(3) with respect to the prior but post-published document D1 […]. Therefore, in order to delimit the subject-matter of the third auxiliary request with respect to D1, a disclaimer was inserted into claim 1 of the second auxiliary request. Thus the disclaimer fulfils the first condition for admissibility of a disclaimer laid down in G 1/03 or G 2/03, respectively.

[5.2] Claim 1 of the third auxiliary request can be separated into two parts: on the one hand, there is the part defining the claimed invention, and on the other hand, the disclaimer excluding a certain subdomain of the domain defined by the first part, and which reads :

“, with the exception of a process wherein step (a) is carried out as follows: […] removed from the filtrate at 80°C/23"Hg on a rotary evaporator; and the amine is dimethylamine, N-methyl-ethylamine, or dibutylamine.”

This wording exactly reflects the structure of the wording describing the example of D1 and also excludes the secondary amines mentioned at the bottom of page 6, to the extent that they are encompassed by the first part of claim 1.

[5.2.1] Considering the arguments filed in written form or made orally, the Board understands that the [patent proprietor] also tried to comply with the further requirement formulated by the EBA, requiring the disclaimer not to exclude more than necessary to restore novelty over D1.

[5.2.2] The Board is of the opinion that any attempt to re-formulate the wording of part A of the example in D1 so that it formed one single sentence, or to even shorten it, would have destroyed the clear structure of the description of the trial in D1 and, therefore, would have led to a lack of clarity (A 84) or even to contradictions between the extent of the disclaimer and the disclosure of the example of D1, and, as a consequence, to a violation of A 123(2).

[5.2.3] It is precisely in view of the need to avoid any discrepancy and, therefore, any factual difference between the wording of the disclaimer and the definition of the part of the prior document to be excluded – and thus to comply with the headnote of decisions G 1/03 or G 2/03 – that the Board considers the use of a sequence of individual sentences according to the original text (Vorlage) in part A of the example of D1 to be justified.

[5.3] However, one essential starting material (the PIB) of the process of D1 to be excluded is only referred to by using its trade name “Ultravis” and a type designation “10”. Such a reference, however, has no clear technical meaning and it is doubtful whether and how a material referred to in this way can be unambiguously distinguished from another material (see T 480/98 [5.3]).

[5.3.1] Such a trade mark (Handelsmarke) is not suitable for unambiguously identifying a material, also because it can be modified at any time over the course of time. However, in the present case, such a modification of the meaning [of the reference] would shift the domain excluded by the disclaimer, i.e. it would also modify the scope of the claim.

[5.3.2] Decision T 762/90 [4.1.1] has expressed concerns against the definition of a material by a brand or trade mark (Warenzeichen) in the following way:

“… the Board has reservations against the use of such a designation in a claim because it is uncertain whether the meaning of this trade mark, even if known on the day of filing, will remain unchanged until the end of the life of the patent.”

[5.3.3] The differences in the definition of “Ultravis 10” in several documents referred to in these proceedings provide evidence that these doubts are justified. According to D1 (claiming a priority of June 22, 1999 […]) this PIB is a “a polyisobutene having a number average molecular weight of about 950 and a methylvinylidene content of about 82%”. According to […] D4 (filed on December 28, 1992) the MN value of “Ultravis 10” is within the same domain, but its methylvinylidene content is of “about 76%”. Example 1 of D8 (claiming a priority of September 5, 1996) refers to it as a “highly reactive' poly isobutene (PiB) (Mw = 1000)”.

[5.3.4] However, in the present case the disclaimer has to exclude the embodiment of the process disclosed in D1, the definition of which is only very general.

[5.3.5] As this cannot be done in an unambiguous way by using the trade name “Ultravis 10” in claim 1 of the third auxiliary request, as shown above, this auxiliary request has to be dismissed on the ground of lack of clarity pursuant to A 84.

This is the second time I see a lack of clarity imported from a prior art document via a disclaimer; another example of a disclaimer-transmitted disease can be found here.

Should you wish to download the whole decision (in German), just click here.

The file wrapper can be found here.